$Notes$	$Vaccine Manufacturer$	$Vaccine Manufacturer Code$	$Age$	$Age Code$	$Days In Hospital$	$Days In Hospital Code$	$Month Reported$	$Month Reported Code$	$VAERS ID$	$VAERS ID Code$	Adverse Event Description	Current Illness	History/Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$18-29 years$	$18-29$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0936805-1$	$0936805-1$	$Patient received the vaccine on 12/22/20 without complication. It was reported today that the patient was found unresponsive and subsequently expired at home on 1/11/21.$	$Whiplash injury to neck. Sprain of ligaments of cervical spine$	$Septal defect (heart)$ chronic sinusitis$Ceftriaxone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$18-29 years$	$18-29$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1034146-1$	$1034146-1$	$ARRIVED AT EVENT$ CONSENT FORM COMPLETED$ DID NOT REPORT HE HAD BEEN ILL$ DID NOT REPORT THAT HE TOOK ANY FEVER REDUCING MEDICATIONS$	$WAS NOT REPORTED AT TIME OF VACCINATION$	$$UNKNOWN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$30-39 years$	$30-39$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0939050-1$	$0939050-1$	$Patient vaccinated on 12/28.  Approximately one day later$ develops cough and on azithromycin x 1 week.  On 1/3$ patient develops left-sided weakness and aphasia.  Taken to the hospital$ tested COVID+$ required intubation -- acute hypoxic respiratory failure secondary to COVID - on H&P.  Patient died on 1/4/21 at 7:20am.$	$Unknown$	$Morbid obesity and hypothyroidism$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$30-39 years$	$30-39$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965256-1$	$0965256-1$	$Found deceased$ presumed while exercising$	$No current illness for this event.$	$Hypertension Hyperlipidemia Obstructive Sleep Apnea Obese Hearing loss Degenerative Disc Lumbar$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$30-39 years$	$30-39$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1040170-1$	$1040170-1$	$Received vaccine on 2/6/2021.  was a bit off all week per caregivers - low grade temp and reporting pain which they treated with Tylenol. She was pretty much herself on morning of 2/13/2021 - got up$ had shower.  caregivers noted her extremities were cool and face was red.  temp was 97.4.  She was placed in wheelchair with book in the living room.  caregivers noted she was not turning pages of the book as she usually would.  She was tracking$ so they don't think she had a seizure.  Caregiver moved her back to bed with blanket and noted that her lips were blue and at that point called 911.  She was found with agonal breathing$ CPR started$ intubated by EMS$  taken to the ER and diagnosed with cardiac arrest upon arrival.  CPR was continued until family could be reached and decision was made to stop resuscitation.$	$none.  she had been very stable on her medication regimen and in her living arrangement for years.  No issues whatsoever.  Caregivers had been caring for her for as long as 19 years.$	$cerebral palsy$ spastic quadriplegia$ dysphagia with g-tube in place$ developmental delay - minimally verbal$ tube feed dependency$ intrathecal baclofen pump$ osteoporosis$ white coat hypertension$ candidiasis of skin..$reclast -  caused fever in 2014$ leading to hospitalization$  seizure from the fever..   tegretol (no reaction noted)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$30-39 years$	$30-39$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1037207-1$	$1037207-1$	$She had pain in the injection site Tuesday night and then during Tuesday she got worse with nausea and some fever.  By Wednesday she was complaining that she could not pee even though she was drinking a lot of fluids.  She continued to complain it was the worst she ever felt and then at 0600 Thursday morning she woke us up and said she needed to go to the hospital.  We arrived at the hospital just before 0700 and she immediately threw up in the trash can.  We went into a treatment room and they took blood and started fluids as she became incoherent.  She said she had taken Tylenol so they started a drug to counter that but her liver function was all wrong and they started to look for a hospital that could transplant a liver.  She was air evade about 0930 to Medical center and just over 30 hours latter she was dead.  There is a pending autopsy.  She was a healthy 39 year old mother who got the shots because she worked as a surgical tech and she was the single mother of a 9 year old little girl.$	$none$$	$trigeminal neuralgia - has been in remission since she started doing botox$sulfa drugs$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$30-39 years$	$30-39$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1054160-1$	$1054160-1$	$2/12/2021 woke up with sore arm and back. 2/13/2021 woke up with headache around 1am. Headache and nausea all morning. Mid-late afternoon started having seizures. Admitted to Hospital 2/15/2021 expired. Reported per wife on 2/25/2021.$	$not applicable$	$Right VP shunt at birth.$Latex and Ceclor$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2020$	$2020/01$	$0929764-1$	$0929764-1$	$The patient was found deceased at home about 24 hours after immunization. Date of Death:: 12/29/2020; estimated time of death 6:00pm$	$No current illness for this event.$	$Hypertension$ sleep apnea$ obesity. based on medical record$no known allergies recorded in medical record$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0950057-1$	$0950057-1$	$Patient suffered a cardiac arrest and was unable to give details about her symptoms. Per husband$ patient did not complain of any symptoms after vaccine administration. She began seizing without warning which was complicated by cardiac arrest of uncertain etiology$	$No current illness for this event.$	$Hydrocephalus with ventricular shunting Prior history of leukemia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0961339-1$	$0961339-1$	$possibly got it at clinic$ possibly who administered shot. Pts. daughter said the pts boyfriend denied any symptoms the whole day but that in the middle of the night the pt passed away.$	$No current illness for this event.$	$COPD$ Sleep apnea$contrast die$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0977319-1$	$0977319-1$	$Notified by patient's sister on 1/26/2021 that patient died in his sleep on 1/25/2021. She did not know cause of death.$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0994913-1$	$0994913-1$	$patient passed away 2 days after vaccine. patient had temperature$ nausea$ and vomiting after vaccine.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020702-1$	$1020702-1$	$Passed away the morning of 2/9/21.$	$No current illness for this event.$	$calcaneal spur displacement of intervertebral disc without myelopathy female stress incontinence foot pain hand joint pain herpes simplex low back pain menorrhagia multiple sclerosis neck pain numbness of lower limb peripheral edema polyneuropathy$No known allergies.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1051803-1$	$1051803-1$	$unknown$ was informed by Health Director that person had passed away$	$unknown$	$unknown$unknown- not the facility that administered the vaccine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055070-1$	$1055070-1$	$Client died on 02/21/2021 and had received the second dose of the vaccine series on 02/19/2021.$	$Morbid obesity$ hypothyroidism$ Diabetes$ Iron deficiency anemia$  QT prolongation$ hyperlipidemia$ chronic hypoxia$ psychosis$ luteal phase dysphoria$ anxiety$ early onset schizophrenia$ moderate intellectual disability$ left ankle ORIF.$	$Same as item 11$ remove left ankle ORIF$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1061911-1$	$1061911-1$	$Died at home; Gasping for air/difficulty breathing; Soreness; A spontaneous report was received from a physician concerning a 45 years-old$ female patient who experienced soreness/MedDRA PT: pain$ gasping for air/difficulty breathing/MedDRA PT: dyspnoea and subsequently died/MedDRA PT: death.  The patient's medical history included blood pressure (disorder not specified)$ thyroid disorder$ depression and anxiety. Concomitant product use included blood pressure medication$ thyroid medication and possibly depression and anxiety medication.  On 28 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (Lot #007M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection.  On 28 Jan 2021$ following the vaccination$ the patient was fine but had experienced some soreness.  Per patient's coworker$ the patient did not take any medication as it made the patient sick. The physician was not aware of any complaints from the vaccine.  On 13 Feb 2021 at 3:31am$ the patient called 911. Per the 911 call$ the patient was gasping for air on the call and having difficulty breathing. The patient subsequently died on 13 Feb 2021 at home. The physician inquired whether Moderna gets involved with the autopsy and logistics of the death of patients and wanted to know the time frame for reporting a death of a patient who received the vaccine. The physician did not know who administered the patient's vaccine.  Action taken with mRNA-1273 in response to the events was not applicable as the patient deceased.  The event died was fatal. The outcome for the events soreness and gasping for air/difficulty breathing was unknown.  The patient died on 13 Feb 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of dyspnea and death has been provided at this time. Further information has been requested. Patient's medical history of blood pressure is considered a risk factor. Based on the current available information and temporal association between the use of the product and the onset of the pain$ a causal relationship cannot be excluded.; Reported Cause(s) of Death: Died at home$	$Anxiety depression; Blood pressure high; Thyroid disorder$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$40-49 years$	$40-49$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068993-1$	$1068993-1$	$Spontaneous intracerebral hemorrhage and death on 2/20/2021$	$Unknown$	$Hypertension$ morbid obesity$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0918518-1$	$0918518-1$	$syncopal episode - arrested - CPR - death$	$To be determined$	$To be determined$To be determined$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0920815-1$	$0920815-1$	$Found deceased in her home$ unknown cause$ 6 days after vaccine.$	$unknown$	$Per employee health records HTN$ DM$ Breast CA 2016 with radiation$ obesity$ gastric sleeve 10 years ago$ arthritis$ plantar fasciitis$ ankle tendonitis$ DeQuarvains$ carpal tunnel$ anxiety$Lisinpril$ Codeine$ Latex $ environmental (hay fever)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0928933-1$	$0928933-1$	$Patient had been diagnosed with COVID-19 on Dec. 11th$ 2020. Symptoms were thought to have started on 12/5/2020. Received Moderna vaccine on 12/23. Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0930910-1$	$0930910-1$	$Patient received COVID vaccination around 12:15pm. Patient was monitored for the appropriate amount of time by nursing staff. Patient passed away at 2:15pm.$	$None$	$Hemiplegia and hemiparesis following cerebral infarction affecting right dominant side$ major depressive disorder$ aphasia following cerebral infarction$ muscle weakness$ dysphagia$ hypothyrodism$ type 2 diabetes$ hyperlipidemia$ hypomagnesemia$ hypokalemia$ hypertension$ gastro esophageal reflux disease$ gastritis$ constipation$Metformin$ morphine$ statins$ latex$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0935511-1$	$0935511-1$	$Patient received the 1st dose of Moderna and was found deceased in her home the next day.$	$none known of$	$history of vaginal adenocarcinoma- removed with surgery in 2019$latex (skin reaction)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0959001-1$	$0959001-1$	$Patient woke apx 0200 complaining of nausea to group home staff.  Vitals were checked at that time and WNL.  Patient went back to bed.  When staff went to wake patient apx 0530$ he was unresponsive and had no pulse. Chest compressions were started and EMS called.$	$Unknown$	$Asthma    Developmental delay (Pediatric)    Eczema    HLD (hyperlipidemia)    HTN (hypertension)$Penicillin's$ Chocolate$ Lactase$ Fish$ Nuts$ Strawberry$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964401-1$	$0964401-1$	$Pt died 4 days after vaccine$ no known reaction to the vaccination$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965564-1$	$0965564-1$	$Cardiac arrest Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0966888-1$	$0966888-1$	$At 04:30 on 1/22/2021$ facility was notified of employee death at home.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974960-1$	$0974960-1$	$ON 1/14/2021 TYPICAL UTI SYMPTOMS FOR RESIDENT DEVELOPED INCLUDING FEVER AND RIGIDITY. RESIDENT IS NON-VERBAL. IV ANTIBIOTICS WERE STARTED. FREQUENT UTI'S ARE COMMON FOR THIS RESIDENT.$	$UTI$	$TRAUMATIC BRAIN INJURY$ VEGETATIVE STATE$ HYPERTENSION$ HEART FAILURE$ POST TRAUMATIC SEIZURES$ CHRONIC RESPIRATORY FAILURE$ FLACCID HEMIPLEGIA$ GASTROPARESIS$ APHASIA$AMOXIL$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975762-1$	$0975762-1$	$Pt deceased$	$N/A$	$- Hx of aortic dissection - Hx of mitral valve repair - Ascending aortic aneurysm (HCC) - Hearing loss of right year - Scoliosis of thoracolumbar spine - Fatigue - Overweight$- Fish containing products - Kale - PCN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982942-1$	$0982942-1$	$per recipient spouse - vaccine recipient became ill during the night of 1/21/21 or early morning of 1/22/21 and was deceased in the morning of 1/22/21.$	$unknown$	$unknown$peanuts$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0996156-1$	$0996156-1$	$$Client came to nursing station about 2pm to report she $$was not feeling well$$. Nurses took vital signs$ then referred her to the vaccination clinic that was onsite. She was observed by vaccination team for a period of time. She reported shoulder pain radiating into shoulder blade in arm vaccine was received. Vaccination team offered ice pack to her$ observed for a period of time$ and released back to work. About 10pm that evening$ she sent a text to another coworker that her pain was $$off the charts$$ and that she had pain covering her whole left side of her body.  She did not come to work in the morning and did not contact work. Well being check was performed at approximately 9am on 2/2/2021 and she was found dead in her home.  911 was immediately called and authorities took over the scene.$$	$Unknown$	$Hypertension$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006416-1$	$1006416-1$	$Patient died of a heart attack on 1/31/21$ 2.5 weeks after vaccination$	$No current illness for this event.$	$diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1010114-1$	$1010114-1$	$Patient passed away (Dead on Arrival on presentation to ER) on 02/03/2021$	$anemia$ NIDDM$ ESRD on Hemodialysis$ AFib$ CAD S/P CABG$ COPD $ HTN$ recently diagnosed with COVID in September$ 2020.$	$$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012047-1$	$1012047-1$	$Sudden death 2/7/21 @ 0309 Started acute encephalopathy & required intubation Soon after intubation went into cardiac arrest Likely severe acidosis.$	$DMII$	$Tobacco use$ Schizophrenia$ DMII$ Bipolar$ HTN$ COVID 19 hx$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1013145-1$	$1013145-1$	$Patient texted a friend on 2/7/2021 c/o arm pain and feeling tired. I don't know if he was taken to a hospital.  Autopsy today.$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026379-1$	$1026379-1$	$patient 6 hours post vaccination$	$HTN-Iron def-h/o PE-chronic renal failure$	$HTN-Iron def-h/o PE-chronic renal failure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032575-1$	$1032575-1$	$Two days later passed away; difficulty breathing$ shortness of breath; difficulty breathing$ gurgling; Not feeling well; Achiness; Severe fever; Chills; A spontaneous report was received from a physician concerning a 56-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever$ chills$ achiness$ shortness of breath$ gurgling and unresponsive.     The patient's medical history was not provided. Concomitant product use was not provided.  On 19 Jan 2021$ prior to the onset of the events$ the patient received their second of two planned doses of mRNA-1273 (Lot 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine on 19 Jan 2021$ the patient experienced fever$ chills$ shortness of breath$ gurgling and achiness. On 21 Jan 2021$ the patient was found unresponsive. Emergency medical services were called to perform life saving measures however$ they were unsuccessful. No further treatment information was provided.   The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was planned.; Reporter's Comments: This case concerns a 56-year-old$ female$ who experienced a serious event of death$ with many other events after receiving second dose of mRNA-1273 (Lot# 042L20A). Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1037124-1$	$1037124-1$	$Patient was at a gym watching his daughter. He slumped over unconscious. EMS was called. He was found to be in fine ventricular fibrillation and resuscitation efforts failed. He was brought to Hospital ED where he was pronounced dead. He had underlying cardiac disease but his family requested I report this event as possibly related to the recent COVID vaccination.$	$none$	$Coronary artery disease$ stent placed GERD$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1040633-1$	$1040633-1$	$Death due to hemorrhagic stroke.$	$No current illness for this event.$	$Hypothyroidism$ recent hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1040877-1$	$1040877-1$	$unknown if related to vaccine.  patient received 2nd vaccine at 0830$ observed 15 minutes$ discharged$ arrested at 0915 upon entering her home.  vaccine was administered by DOH at their community location.  patient was pronounced lifeless in the ED.$	$chest pain$ COPD$ Bipolar$ dyslipidemia$ stage 3 chronic kidney disease$	$as above$penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1043880-1$	$1043880-1$	$Pt received second Moderna COVID-19 vaccination administered in left arm at her assisted living facility by Pharmacist at 1153 on 2/19/2021. Pt was monitored for vaccine reaction with no known adverse reaction. Approximately  18 hours post-vaccine$ she was found deceased in her sleep at 0540 on 2/20/21. Per circumstances/pt history$ it is presumed that the patient aspirated while sleeping$ perhaps secondary to a seizure. Coroner was notified and declined as coroner's case. VAERS notification being made due to pt death within 24 hours of receiving a vaccine.$	$urinary tract infection$	$diabetes mellitus with polyneuropathy$ schizoaffective disorder$ chronic obstructive pulmonary disease$ essential hypertension$ bipolar disorder$ hypothyroidism$ history of cerebral infarction$ diabetic retinopathy$ overactive bladder$ Vitamin D deficiency$ encephalopathy$ chronic kidney disease$ seizures$iodine$ shellfish$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049963-1$	$1049963-1$	$Found lying face down without respiration or pulse$ believed to be within 5 minutes of event.  ACLS procedures unsuccessful.  Unable to get autopsy.  Believed to be heart attack secondary to COVID infection$ but unconfirmed.  Relative contribution of recent vaccination unknown.$	$No current illness for this event.$	$obese$ pre-diabetic$ hypertension$ atherosclerotic disease$ coronary artery blockage$ schizoaffective disorder Tested COVID-19 positive on 1/21/2021$ asymptomatic$ 1-1/2 weeks after first COVID-19 vaccination$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1051651-1$	$1051651-1$	$Abdominal pain$ nausea and vomiting$ shortness of breath$ acidosis$ hypoglycemia$ death.  Onset of abdominal pain was 30 minutes after administration of the vaccine followed by 20+ episodes of vomiting and dry heaving.$	$None$	$Colon Cancer Hypothyroidism Hyperlipidemia GERD Hypertension$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052106-1$	$1052106-1$	$While at counseling appointment on February 17  patient had witnessed sudden cardiac arrest and was not able to be resuscitated. She was pronounced dead at 12:09. At the time of death her glucose was about 500.$	$DM with proteinuria and foot complications hyperlipidemia$	$DM with proteinuria and foot complications Renal insufficiency hyperlipidemia alcohol abuse$Augmentin and NSAID$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052172-1$	$1052172-1$	$$Agency contacted 2/19 In evening by employer representative- client Died Suddenly after work$$$$	$unknown$	$unknown$statins- stated no allergic reaction but can't take$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058569-1$	$1058569-1$	$PATIENT DIED IN HIS SLEEP NIGHT AFTER ADMINISTRATION$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069316-1$	$1069316-1$	$death$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0950108-1$	$0950108-1$	$$$$Moderna COVID-19 Vaccine EUA$$ It has been reported to me that pt. had gone into hospital for a heart catheterization on 1/12/2021.  It was found during this procedure that pt. had suffered a MI.  She was release to home the following day and passed away at her residence on 1/15/2021.$$	$Pt. stated she was not ill at the time of vaccination.$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$0995977-1$	$0995977-1$	$Lethargy/altered level of consciousness lead to hospital admission.  Multiple interventions during hospitalization.  Final hospital diagnoses:  Acute respiratory failure with hypercapnia$ acute pansinusitis.$	$N/A$	$0        Profound intellectual disability (F73) secondary to Angelman's    Syndrome with microcephaly (Q38.2); Macroglossia (750.15)$    rumination (307.53) and aerophagia$ S|P aspiration pneumonia  9/98(507.0)$ history of coagulopathy (286.9); finger clubbing                                                               probably secondary to chronic pulmonary disorder; surgery 12/70 for                                        undescended testes; Nissen fundoplication w/pyloroplasty 5/2/88; H/o Acne Vulgaris (L70.0)  31 Inability to monitor own health care needs. Frequent urinary tract infections.      39 Gastroesophageal reflux (K21.9)      56 Megacolon and tendency to fecal impaction (K59.3$ K56.4)  57 Hand mouthing secondary to Angelman's syndrome      59 Chronic recurrent herpes simplex (B00.9)  60 Recurrent cyanosis (R23.0)$ secondary to mucus plugging  61 Maintain optimal nutritional status altered by severe dysphagia                                                  (R13.10)  62 Osteoporosis probably secondary to immobility (M81.0) 63 Needs to maintain optimal musculoskeletal status 64 Optic atrophy(H47.20)secondary to Angelman?s syndrome$ myopia(H52.10)       77 Prone to dehydration       83 Hiatal hernia (K44.9)       84 Peripheral vascular disease$ poor circulation of bilateral ankles and feet.       ?? Frequent UTIs.   Small bilateral renal stones.$Aspirin$ NSAIDs.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$6 days$	$6$	$Jan.$ 2021$	$2021/01$	$0946293-1$	$0946293-1$	$51 year old M with h/o O2 dependent COPD$ Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further$ and after discussing with family and palliative care$ He was changed to comfort care. He expired on 1/12/2021@2325 at medical center.$	$Pulmonary fibrosis on O2$	$COPD$Severe pulmonary fibrosis$HTN$GERD$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1003624-1$	$1003624-1$	$Patient awake at 0300. When going into the room to get him ready for dialysis he was cold to touch$ unresponsive other than to sound$ and nonverbal. O2 sat was 67 via finger probe. Oxygen immediately initiated and a venturi mask retrieved and initiated. When unable to arouse him via sternal rub this RN called 911.  Send to ED.  Febrile 39.2 and hypotensive 58/43.  Admitted.  unknown after that as patient expired in hospital.$	$PNA$	$MSSA$ DM$ ESRD/HD$ HTN$metaformin and sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$50-59 years$	$50-59$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1006168-1$	$1006168-1$	$The patient$  who was a pharmacist$ developed fatigue and shortness of breath hours after receiving vaccine.  Two days later$ on 01/28/2021$ the patient went to local urgent care for worsening shortness of breath and was referred to Hospital for worsening dyspnea and hypoxia.  The patient was admitted to the hospital   We was found to have bilateral pulmonary infiltrates and treated for pneumonia with Rocephin and azithromycin.  He was tested for COVID-19 multiple times$ but each of the results were negative.  Despite the negative results$ there was high clinical suspicion for COVID-19 and the patient was started on Remdesivir and Decadron.  The  patient's oxygen requirements continued to worsen and the patient was transferred to another facility for higher level of care.  There  his hypoxia worsened and he required mechanical ventilation.  Patient then developed hypotension and required vasopressors for blood pressure support.  Furthermore$ patient developed acute renal failure requiring hemodialysis.  Despite mechanical ventilation with FiO2 100%$ and for vasopressors$ patient clinically deteriorated and family decided to palliatively extubate on 02/05/2021.$	$No current illness for this event.$	$none$penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0918065-1$	$0918065-1$	$1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm$	$- covid-19$	$- SCHIZOPHRENIA$ UNSPECIFIED     - ANEMIA$ UNSPECIFIED  - OVERWEIGHT  - OVERACTIVE BLADDER  - ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS  - HYPOTHYROIDISM DUE TO MEDICAMENTS AND OTHER EXOGENOUS SUBSTANCES  - NICOTINE DEPENDENCE$ UNSPECIFIED$ UNCOMPLICATED  - CHRONIC VIRAL HEPATITIS C  - UNSPECIFIED AGE-RELATED CATARACT  - ESSENTIAL (PRIMARY) HYPERTENSION  - CHRONIC OBSTRUCTIVE PULMONARY DISEASE$ UNSPECIFIED  - UNSPECIFIED CONVULSIONS  - INHALANT ABUSE$ UNCOMPLICATED  - OTHER SEIZURES$- Clozaril  - Tegretol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0923993-1$	$0923993-1$	$Patient was vaccinated Dec 30$ 2020. Prime dose of Moderna vaccine. Observed for full 15 minutes post-injection. No complaints when asked during observation. Released.  Subsequently$ vaccine clinic staff learned from the patient's supervisor that on Jan 4$ 2021 that the patient had expired on Jan 2$ 2021. By report from the supervisor$ the patient was found dead at his home. The patient's primary care provider was unaware of his death when contacted by this reporter today (Jan 6$ 2021). Electronic Medical Record without any information since the vaccination.$	$No$	$History of stage II (T3N0) appendiceal carcinoma - s/p resection Dec 2014. CAD s/p stenting Diabetes Mellitus Hyperlipidemia Hypertension Glaucoma$Hay fever$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0930154-1$	$0930154-1$	$Notified today that he passed away. No other details known at this time.$	$unkown$	$unknown$Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0937569-1$	$0937569-1$	$patient reported expired 1/7/2021$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0941743-1$	$0941743-1$	$This person was found to be deceased on routine rounds during the night$ 3am. No symptoms of reaction noted post vaccine. No injection site reaction. No reports of any allergic reaction.$	$None$	$Benign polycythemia$ Type II DM$ Anxiety$ Epilepsy$ Blepharitis (bilateral)$ cataract (not specified)$ Allergic rhinitis$ constipation$ scoliosis$ osteoporosis$ dyspahgia$ urinary incontinence$ Dermatitis$ breast cancer (right breast lumpectomy)$ history of respiratory infection$  DNR AND MOLST were in place at time of death$No known drug or food allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0949523-1$	$0949523-1$	$Around 00:50am on 01/15/21$ C.N.A. reported that the resident looked different and not responding. Initiated Code Blue and started CPR. 911 arrived and pronounced resident dead at 1:01 am.$	$None$	$History of Stroke$ Diabetes Mellitus Type 2$ Dementia$ Dysphagia$ Depression$ Pressure Injuries Sacral and Left Heel$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0950073-1$	$0950073-1$	$$On 1/15/2021 at 1800$ resident noted to be lethargic and shaking$ stating $$I don't care.$$ repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 $ T 99.4$  Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21.$$	$Non-Hodgkin Lymphoma$ Rhabdomyolysis$ Anemia$ Acute Kidney Failure$  Chronic Embolism and Thrombosis of Lower Extremity$	$Epilepsy$ Hypertension$ Atrial Fibrillation$ Anxiety$Lisinopril$ Losartan$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0951688-1$	$0951688-1$	$Resident expired 1/17/21$	$11/25/20 Lower mid back abscess 11/4/20 toenail removal$	$CEREBRAL INFARCTION DUE TO UNSPECIFIED OCCLUSION OR STENOSIS OF LEFT MIDDLE CEREBRAL ARTERY$ PRESENCE OF AUTOMATIC (IMPLANTABLE) CARDIAC DEFIBRILLATOR$ UNSPECIFIED OSTEOARTHRITIS$ UNSPECIFIED SITE$ APHASIA$ DYSPHAGIA$ UNSPECIFIED$ WEAKNESS$ COVID-19$ OTHER REDUCED MOBILITY$ URINARY TRACT INFECTION$ SITE NOT SPECIFIED$ ABNORMAL WEIGHT LOSS$ TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS$ VITAMIN DEFICIENCY$ UNSPECIFIED$ VITAMIN D DEFICIENCY$ UNSPECIFIED$ ANEMIA$ UNSPECIFIED$ CHRONIC COMBINED SYSTOLIC (CONGESTIVE) AND DIASTOLIC (CONGESTIVE) HEART FAILURE$ CHRONIC KIDNEY DISEASE$ STAGE 2 (MILD)$ ESSENTIAL (PRIMARY) HYPERTENSION$ GOUT$ UNSPECIFIED$  INSOMNIA$ UNSPECIFIED$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0952713-1$	$0952713-1$	$Weakness$ Low O2$ death. Positive for COVID on 1/12/21$ dies on 1/16/21$	$No current illness for this event.$	$Diabetes$ Parkinson Disease$PCN$ Zithromax$ Flomax$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962995-1$	$0962995-1$	$No immediate reaction. Patient-reported deceased four days later on Jan. 19$ 2021. As of this date cause of death is unknown to our clinic.$	$Unknown$	$Unknown$No known allergies.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0963610-1$	$0963610-1$	$Patient deceased on 01/17/2021$	$TB DMII Hyperlipidemia GERD CKD Renal Failure$	$MII Hyperlipidemia GERD CKD Renal Failure$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0969219-1$	$0969219-1$	$patient received the Moderna Covid 19 vaccine on 1/23/2021 around 5:45pm  wife called management today and reported that he had collapsed and passed away today around noon$	$reported  on profile were hypertension$ pain$ gout$ bladder and urine flow issues$	$hypertensin  gout$no known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972370-1$	$0972370-1$	$patient received covid vaccine  and had a heart attack the next day and died$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975421-1$	$0975421-1$	$Resident was discovered deceased in his apartment on 1/23/2021. Family had$	$Patient had reported on 8/8/2019 having arthritis$ leg wounds$ COPD$ asthma$ incontinence of bladder. Resident may also have had blood clots in his legs$ per his sister.$	$Same as in Item 11.$none known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975918-1$	$0975918-1$	$death Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979990-1$	$0979990-1$	$sudden cardiac arrest$	$none$	$$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982218-1$	$0982218-1$	$resident was on hospice$ chronically ill w dementia$ COPD$ HTN$ failure to thrive$ passed away 1/13/21. Not certain injection related as he was declining already.$	$failure to thrive$ pressure ulcer$ pneumonitis d/t aspiration$ dementia$ COPD$ alzheimer's disease$$	$HTN$ see above$aspirin: severe unknown reaction$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0991677-1$	$0991677-1$	$got up in the night and stated that she couldn't breath$ ambulance was called$ pt expired in route to hospital.  *relayed to me by Facility staff RN.$	$diagnosed with Covid on 12/03/2020$	$hypertension$ hyperlipidemia$ diabetes$ GERD$Sulfa$ Flexeril$ trimethoprim$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992677-1$	$0992677-1$	$Low Grade Temp$ Persistent low back pain$ Projectile Vomiting.$	$No current illness for this event.$	$Huntington's Anxiety$ Depression$ Constipation.$Paroxetine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0997642-1$	$0997642-1$	$We were notified 02/02/2021 of patient's death. Unknown cause at this time.$	$possible blood clots$ not disclosed at time of vaccination$	$chronic back pain$vibramyacin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1004811-1$	$1004811-1$	$On 1/23/21 the patient had a single-car accident$ slid off icy road into snowbank. She was seen in our ER$ diagnosed w/ trauma and L4 compression fracture. She was transported to Hospital for further trauma workup. We believe she was treated and released. On 1/31/21 the patient had a headache but  did not seek medical attention. In the morning of 2/1 she became unresponsive and was pronounced dead on the scene when EMS arrived. Autopsy showed a left temporal subdural hematoma.$	$unknown$	$None$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011834-1$	$1011834-1$	$patient passed away within 60 days of receiving COVID vaccine series$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1015687-1$	$1015687-1$	$Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm.  Gradual development of SOB and cough. Temp of 101.4 at 10 pm.  pulse ox 92% at 10 pm.  Went to sleep$ woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler$ wife called emergency services at 0113.  EMS arrived around 0130 to patient's home. pulse ox 86%$ coughing$ sob$ hard time breathing. Walked to stretcher. Became unresponsive.  Found to have no pulse$ stopped breathing. CPR initiated at about 0140.  King airway placed in field$ I/O in left tibia. Patient from PEA to asystole$ to vfib$ to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.$	$none$	$a fib$ HTN$ CAD$ PTSD$ CHF$ anxiety$ gout$ reflux$ high cholesterol$ obese$ hypothyroidism.$nknda or food allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1023840-1$	$1023840-1$	$Pt was administered Moderna Covid-19 Vaccine on 2/4/2021.  Pt exhbited no symptoms of an adverse reaction of any sort.  Pt was ambulating alert and attentive.  Pt was observed for the alloted 15 mins by pharmacist and case worker who had escorted pt to vaccination clinic.  It was reported that Either on sunday 2/7/2021 or monday 2/8/2021 pt had passed away.  Circumstances revolving patient death is still unknown.$	$Hypertension$ Morbid Obesity$ DMII$ Neuropathy$ Cardiomyopathy$ Hyperurecemia$ Glaucoma$ Polyp$ Foliculitis$ Bi-Polar disorder.$	$Same as above.$NKDA$ NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1023948-1$	$1023948-1$	$$02/08/21--2 days after vaccine--Resident stated that she $$didn't feel good$$ (She is developmentally delayed and less able to communicate how she feels than those in the community) and stopped eating most foods; also had fatigue. Vitals$ coloring$ & behavior were normal. 02/09/21--Belly was firm and mildly distended (although she stated it didn't hurt); she coded this evening and CPR was performed before EMT could transport her to the hospital. 02/10/21--Resident passed.$$	$No$	$Intellectual Disability Disorder Behavior Disorder (OCD/IED) Hypertension Hyperlipidemia Hypothyroidism Constipation Osteopenia$Carbamazepine Loxapine Sulfa Antibiotics Tetracyclines Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1025081-1$	$1025081-1$	$No reported adverse reactions from 1st or 2nd vaccine doses Patient died on 2/6/2021 at Correctional facility- autopsy was performed at medical examiner's office. The COD was artherosclerotic cardiovascular disease$	$No current illness for this event.$	$ESRD on HD$ HCV cirrhosis$ refractory ascites$ CAD$ CHF (EF15%-20%)$ hyperparathyroidism$Bactrin$ NSAIDS$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033155-1$	$1033155-1$	$Vaccine given in clinic per protocol - patient monitored for 15 minutes$ no adverse reactions noted at the time. Patient stated he felt fine following 15 minute monitoring time. Patient left facility- it was later reported that pt had a fall at home. Upon review of pt's medical record - Pt's wife had to initiate CPR and call EMS for transportation and life saving measures enroute to the Emergency Room. Pt was intubated as pt was in asystole upon arrival to the ER$ ACLS was continued$ pt was noted to have a traumatic brain injury from his fall at home$ and pt was pronounced dead at 1620.$	$Generalized ischemic myocardial dysfunction$ lower leg edema with cellulitis$	$Ischemic Cardiomyopathy$ Diabetes$ Combined Systolic/Diastolic Heart Failure$ Edema$ Ventricular Tachycardia$ Pacemaker$ Stroke$ Myocardial Infarction$ Hyperlipidemia$ Hypertension$ Obesity$ Coronary arteriosclerosis$ Paroxysmal atrial fibrillation$ Left ventricular thrombus$ Cardiorenal Sydrome$ Bilateral lower leg cellulitis$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036585-1$	$1036585-1$	$$Patient called EMS approximately 1pm on 2/15 with complaints of generalized weakness. Upon arrival EMS found her to be diaphoretic and she had a witnessed syncopal episode with question of v-fib and seizures. She became unresponsive and had no pulse. CPR was begun and she was transported to ED. She remained asystole throughout. CPR was initially continued in the ED  for approximately 30 minutes and then stopped with Time of Death noted at 13:27. ED notes noted $$suspect given history that patient experienced massive MI$ PE or ruptured AAA$$.  Death certificate notes indicate $$signficant conditions contributing to death after cardiac arrest; ASCVD$$0$$	$Unknown at this time; nothing noted on vaccine screening form$	$Essential HTN$ Mixed hyperlipidemia$ Diabetes Type 2$ Osteoarthritis$ Heart Murmur$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038257-1$	$1038257-1$	$Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort$ feeling abnormal$ dyspnea$ fatigue$ swelling$ unresponsive to stimuli$ body temperature abnormal and the patient passed away .  Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate$ Renvela$ glipizide$ omeprazole$ aspirin$ vitamin D$ losartan$ furosemide$ rifampin$ and Sensipar.  On 14 Jan 2021$ the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection.  On 13 Jan2021$ the patient tested negative for COVID-19). On 16 Jan 2021$ the patient experienced a sore arm$ and feeling weird/funny. On 17Jan2021$ the patient experienced difficulty breathing and swelling. On 18 Jan 2021$ the patient declined dialysis$ was tired and wanted to lay down. At 8 am$ the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications.  Action taken with the mRNA-1273 was not applicable.  The outcome of the events of limb discomfort$ feeling abnormal$ dyspnea$ fatigue$ swelling$ unresponsive to stimuli$ body temperature abnormal$ was fatal.  On 18 Jan 2021$ the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea$ unresponsive to stimuli$ and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19$	$Dialysis; TB$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1044352-1$	$1044352-1$	$Stomach upset$ sudden heart failure$ death$	$None$	$Psoriatic Arthritis; Hypothyroidism$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046698-1$	$1046698-1$	$patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046795-1$	$1046795-1$	$Per ED note: Brought in ED by EMS at 1945 for acute shortness of breath and hypotension. Patient was placed on supplemental oxygen and covid test completed. Patient was placed on BiPAP to maintain oxygen greater than 90%. Found to be in metabolic acidosis. Patient became unresponsive and pulse could not be palpated. Chest compressions were initiated. ACLS medications given and pulses regained. Patient lost pulse 30 mins later and never regained pulse. Per ED noted; likely developed a PE. Passed away at 2127$	$Recurrent IVb uterine carcinosarcoma$ open ventral abdominal wall$	$uterine cancer$ PE$ CHF$Sulfa medications$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052226-1$	$1052226-1$	$Patient discovered unresponsive in cell$ blue coloration to skin$ vital signs$ undetectable.  CPR initiated$ Ambulance summoned.  Following EMS arrival with additional unsuccessful attempts to revive patient$ patient was determined to have expired.$	$No current illness for this event.$	$Arthritis$ Diabetes Mellitus$ Diabetic Neuropathy$ Venous Insufficiency in Lower Extremity$  Hypothyroidism$ Chronic Obstructive Pulmonary Disease$ Hypothyroidism$ Obesity$Bactrim$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1053694-1$	$1053694-1$	$Sudden Death on 2/17/2021$	$A-FIB$ DM2$$	$DM2$ A-FIB$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057853-1$	$1057853-1$	$on 2/218/2021 the patient was at home and developed chest pain. Patient was transported by family to urgent care then to the ED where the patient later died.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063758-1$	$1063758-1$	$$Patient died on 2/25/21 in the AM after receiving his COVID-19 Moderna vaccine #1 at approximately 2:30P on 2/24/21. I do not have a time of death. I contacted the County Medical Examiner's office who stated that they received his body after he was determined to be deceased at the shelter.  No autopsy was performed and his body was released to a funeral home on 2/26. The ME's office said that $$permit for burial/cremation is pending$$ and no other information on COD was available. Per staff$ he was also tested for COVID as part of shelter protocol on 2/24 and PCR was negative. He arrived to the shelter on 2/19/21.$$	$unknown$	$Fully treated for TB many years ago$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1067358-1$	$1067358-1$	$1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit$ cough is same and taking tessalon pearls  1-29-2021 Provider in office  visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2$ pulse ox 87%$ BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields$ more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER$	$Mild respiratory symptoms with cough$	$HIV  Obesity$Acetaminophen$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071903-1$	$1071903-1$	$No reported adverse effects after vaccine was administered. Someone reported to our clinic that patient was found dead at home on Sunday$	$unknown$	$unknown$reported none at time of vaccination$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$0993072-1$	$0993072-1$	$Pt. presented to the ER with abd pain and septic shock.   Pt. reported to feel ill shortly after receiving the vaccine.$	$None reported$	$Type 2 DM$ MGUS$ Cardiomyopathy with implanted Defib$ Chronic heart failure$Environmental and Magnesium succinate$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$60-64 years$	$60-64$	$6 days$	$6$	$Jan.$ 2021$	$2021/01$	$0979841-1$	$0979841-1$	$Pt likely presented to vaccine appt with asymptomatic/early infection of COVID-19$ as he presented 2 days post-vaccination and tested positive for COVID-19 on rapid and PCR test. He was hospitalized where he eventually died of complications from COVID-19 while in ICU. Date of death was 1/15/2021.$	$Evaluated for L flank pain in ED on 1/1/2021$ no acute findings on CT. Noted to be in mild CHF$ discharged home from local ED.$	$HTN$ CKD stage 5$ hemodialysis dependent$ DM type II$ hx renal transplant$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0909095-1$	$0909095-1$	$on 12/24/2020 the resident was sleepy and stayed in bed most of the shift.  He stated he was doing okay but requested pain medication for his legs at 250PM.  At 255AM on 12/25/2020 the resident was observed in bed lying still$ pale$ eyes half open and foam coming from mouth and unresponsive.  He was not breathing and with no pulse$	$End stage renal disease with dependence on renal dialysis$ COPD$ cirrhosis of the liver$ hypokalemia$ gout$ heart failure$ hyperlipidemia$ atrial fibrillation.$	$Refused dialysis frequently resulting in episodes of hypokalemia and hospitalization$ resident dependent on supplemental oxygen. The resident refused to go to dialysis on 12/23/2020 and said he was feeling fine.$alprazolam$ Lorazepam$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0910363-1$	$0910363-1$	$Patient had mild hypotension$ decreased oral intake$ somnolence starting 3 days after vaccination and death 5 days after administration. He did have advanced dementia and was hospice eligible based on history of aspiration pneumonia.$	$dementia declining oral intake$	$history of aspiration pneumonia BPH$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0913733-1$	$0913733-1$	$My grandmother died a few hours after receiving the moderna covid vaccine booster 1. While I don?t expect that the events are related$ the treating hospital did not acknowledge this and I wanted to be sure a report was made.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914621-1$	$0914621-1$	$Resident in our long term care facility who received first dose of Moderna COVID-19 Vaccine on 12/22/2020$ only documented side effect was mild fatigue after receiving. She passed away on 12/27/2020 of natural causes per report. Has previously been in & out of hospice care$ resided in nursing home for 9+ years$ elderly with dementia. Due to proximity of vaccination we felt we should report the death$ even though it is not believed to be related.$	$None$	$Resident in long term care facility for 9+ years Coronary Artery Disease Dementia Hypothyroidism Hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0915880-1$	$0915880-1$	$Patient died within 12 hours of receiving the vaccine.$	$Refused food for one week prior to death.$	$$No known allergies.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0922977-1$	$0922977-1$	$Fever$ RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0917117-1$	$0917117-1$	$After vaccination$ patient tested positive for COVID-19.  Patient was very ill and had numerous chronic health issues prior to vaccination.  Facility had a number of patients who had already tested positive for COVID-19.  Vaccination continued in an effort to prevent this patient from contracting the virus or to mitigate his risk.  This was unsuccessful and patient died.$	$Yes$	$Yes$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0917790-1$	$0917790-1$	$At the time of vaccination$ there was an outbreak of residents who had already tested positive for COVID 19 at the nursing home where patient was a resident.  About a week later$ patient tested positive for COVID 19.  She had a number of chronic$ underlying health conditions.  The vaccine did not have enough time to prevent COVID 19.  There is no evidence that the vaccination caused patient's death.  It simply didn't have time to save her life.$	$Patient was a resident of a long term care facility and had numerous chronic conditions prior to vaccination.$	$Thyroid disease$ chronic elderly conditions.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0917793-1$	$0917793-1$	$Prior to the administration of the COVID 19 vaccine$ the nursing home had an outbreak of COVID-19.  Patient was vaccinated and about a week later she tested positive for COVID-19.  She had underlying thyroid and diabetes disease.  She died as a result of COVID-19 and her underlying health conditions and not as a result of the vaccine.$	$Diabetes$ Thyroid disease$	$Diabetes$ Thyroid Disease$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0918487-1$	$0918487-1$	$Two days post vaccine patient went into cardiac arrest and passed away.$	$NSTEMI$  Dementia$ TIA$ COVID-19$ HTN$ CVA$ PVD$	$HTN$ PVD$ Dementia$Beta Adrenergic Blockers$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0919537-1$	$0919537-1$	$Resident exhibited no adverse events during 30 minute monitoring following vaccine administration. Resident found without pulse at 1900.$	$Resident had suspected vasovagal episode with drop in O2 saturation.$	$ACUTE ON CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE RHEUMATOID ARTHRITIS$ UNSPECIFIED ANEMIA$ UNSPECIFIED HYPOTHYROIDISM$ UNSPECIFIED CACHEXIA ESSENTIAL (PRIMARY) HYPERTENSION DEMENTIA IN OTHER DISEASES CLASSIFIED ELSEWHERE WITHOUT BEHAVIORAL DISTURBANCE AGE-RELATED PHYSICAL DEBILITY OTHER CHRONIC PAIN DILATED CARDIOMYOPATHY ERYTHEMATOUS CONDITION$ UNSPECIFIED UNSPECIFIED OSTEOARTHRITIS$ UNSPECIFIED SITE PRIMARY GENERALIZED (OSTEO)ARTHRITIS OTHER SPONDYLOSIS WITH RADICULOPATHY$ LUMBAR REGION HYPERKALEMIA OTHER INTERVERTEBRAL DISC DEGENERATION$ LUMBAR REGION AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE CERVICALGIA OTHER BIOMECHANICAL LESIONS OF LUMBAR REGION للل BILATERAL PRIMARY OSTEOARTHRITIS OF KNEE LOCALIZED EDEMA HYPO-OSMOLALITY AND HYPONATREMIA OTHER SPECIFIED DISORDERS OF BONE DENSITY AND STRUCTURE$ UNSPECIFIED SITE HISTORY OF FALLING WEAKNESS$Celebrex and Tramadol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0920326-1$	$0920326-1$	$Redness and warmth with edema to right side of  neck and under chin. Resident was on Hospice services  and expired on 1.1.21$	$G30.1 Alzheimer's disease with late onset (Primary) M19.90 Unspecified osteoarthritis$ unspecified site  J44.9 Chronic obstructive pulmonary disease$ unspecified  I95.1 Orthostatic hypotension  J45.909 Unspecified asthma$ uncomplicated  R13.12 Dysphagia$ oropharyngeal phase  M15.0 Primary generalized (osteo)arthritis  M85.80 Other specified disorders of bone density and structure$ unspecified site Note: Osteopenia  J30.9 Allergic rhinitis$ unspecified  F41.1 Generalized anxiety disorder  M24.511 Contracture$ right shoulder  M24.512 Contracture$ left shoulder  M24.521 Contracture$ right elbow  R29.3 Abnormal posture  M17.4 Other bilateral secondary osteoarthritis of knee  M25.561 Pain in right knee  R26.89 Other abnormalities of gait and mob$	$G30.1 Alzheimer's disease with late onset (Primary) M19.90 Unspecified osteoarthritis$ unspecified site  J44.9 Chronic obstructive pulmonary disease$ unspecified  I95.1 Orthostatic hypotension  J45.909 Unspecified asthma$ uncomplicated  R13.12 Dysphagia$ oropharyngeal phase  M15.0 Primary generalized (osteo)arthritis  M85.80 Other specified disorders of bone density and structure$ unspecified site Note: Osteopenia  J30.9 Allergic rhinitis$ unspecified  F41.1 Generalized anxiety disorder  M24.511 Contracture$ right shoulder  M24.512 Contracture$ left shoulder  M24.521 Contracture$ right elbow  R29.3 Abnormal posture  M17.4 Other bilateral secondary osteoarthritis of knee  M25.561 Pain in right knee  R26.89 Other abnormalities of gait and mobility  Z74.1 Need for assistance with personal care  Z91.81 History of falling  M62.81 Muscle weakness (generalized)  R29.6 Repeated falls  R27.8 Other lack of coordination  R63.3 Feeding difficulties  E73.8 Other lactose intolerance  R53.1 Weakness  I95.89 Other hypotension$Lactose$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0920368-1$	$0920368-1$	$12/30/2020 07:02 AM  Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days.  12/30/2020 07:32 AM  Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids$ medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any.  12/30/2020 08:41 AM  Received new orders to obtain Flu swab$ obtain CBC and BMP$ and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services$ but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline$ facility will accomandate resident family to be able to be at bedside when time comes to do so.  NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics$	$F03.90 Unspecified dementia without behavioral disturbance  E78.5 Hyperlipidemia$ unspecified  K21.9 Gastro-esophageal reflux disease without esophagitis  I10 Essential (primary) hypertension  Z74.09 Other reduced mobility  M62.81 Muscle weakness (generalized)  R13.12 Dysphagia$ oropharyngeal phase  R26.81 Unsteadiness on feet  R27.8 Other lack of coordination  R41.841 Cognitive communication deficit  R54 Age-related physical debility  D53.9 Nutritional anemia$ unspecified  R29.6 Repeated falls  M13.80 Other specified arthritis$ unspecified site  M25.512 Pain in left shoulder  M19.012 Primary osteoarthritis$ left shoulder  K59.09 Other constipation  R26.89 Other abnormalities of gait and mobility  R63.8 Other symptoms and signs concerning f$	$U07.1 2019-nCoV acute respiratory disease (Primary) F03.90 Unspecified dementia without behavioral disturbance  E78.5 Hyperlipidemia$ unspecified  K21.9 Gastro-esophageal reflux disease without esophagitis  I10 Essential (primary) hypertension  Z74.09 Other reduced mobility  M62.81 Muscle weakness (generalized)  R13.12 Dysphagia$ oropharyngeal phase  R26.81 Unsteadiness on feet  R27.8 Other lack of coordination  R41.841 Cognitive communication deficit  R54 Age-related physical debility  D53.9 Nutritional anemia$ unspecified  R29.6 Repeated falls  M13.80 Other specified arthritis$ unspecified site  M25.512 Pain in left shoulder  M19.012 Primary osteoarthritis$ left shoulder  K59.09 Other constipation  R26.89 Other abnormalities of gait and mobility  R63.8 Other symptoms and signs concerning food and fluid intake  M85.89 Other specified disorders of bone density and structure$ multiple sites Note: Osteopenia  M24.512 Contracture$ left shoulder  J43.9 Emphysema$ unspecified$quinine sulfate$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0921547-1$	$0921547-1$	$DEATH ON 1/4/2021$ RESIDENT RECIEVED VACCINE ON 1/2/20$	$CEREBRAL INFARCTION$ UNSPECIFIED(I63.9)$ LONG TERM (CURRENT) USE OF ASPIRIN(Z79.82)$ VITAMIN DEFICIENCY$ UNSPECIFIED(E56.9)$ ACUTE KIDNEY FAILURE$ UNSPECIFIED(N17.9)$ HYPERKALEMIA(E87.5)$ ACUTE RESPIRATORY FAILURE$ UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA(J96.00)$ PURE HYPERCHOLESTEROLEMIA$ UNSPECIFIED(E78.00)$ PAIN IN RIGHT FOOT(M79.671)$ ESSENTIAL (PRIMARY) HYPERTENSION(I10)$ ACIDOSIS(E87.2)$ ABNORMAL LEVELS OF OTHER SERUM ENZYMES(R74.8)$ HYPERLIPIDEMIA$ UNSPECIFIED(E78.5)$ DISORDER OF THYROID$ UNSPECIFIED(E07.9)$ GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS(K21.9)$ MUSCLE WASTING AND ATROPHY$ NOT ELSEWHERE CLASSIFIED$ UNSPECIFIED SITE(M62.50)$ MUSCLE WASTING AND ATROPHY$ NOT ELSEWHERE CLASSIFIED$ MULTIPLE SITES(M62.59)$ CO$	$UNCONTROLLED DIABETES MELLITUS ON INSULIN$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0921572-1$	$0921572-1$	$Resident had body aches$ a low O2 sat  and had chills starting on 12/30/20. He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again. He later went unresponsive and passed away.$	$Heart Failure$	$Chronic Kidney Disease$ Atherosclerotic Heart Disease$Lisinopril$ Losartan$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0924126-1$	$0924126-1$	$resident expired 1/1/2021$	$Low blood pressure requiring medication changes. Sent to ER on 1/1 with low b/p sent back same day$ heart failure. Family requests comfort measures only.$	$CHF$ Heart Failure$ hypertension$ Atrial-fibrillation$ Crohns disease.$Asa$ Cardizem$ delsyn$ doxycycline$ levaquin$ motrin$ prevacid$ vicodin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0924186-1$	$0924186-1$	$Resident expired 1/3/21$	$Covid  positive previous with no s/s poor appetite Chronic wound right leg$	$alzheimers dementia$ COPD $ DM- type 2$Codeine$ Penicillin$ Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0924664-1$	$0924664-1$	$At approximately$ 1855$ I was alerted by caregiver$ resident was not responding. Per caregiver$ she was doing her rounds and found resident in bed$ unresponsive$ mouth open$ observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately$ 1800 less than an hour prior to incident.  This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department.  At ER$ CT scan and X-ray was performed.  Per report from  ER RN$ CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN$ resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN$ resident recently received the first dose of COVID-19 vaccine on 1/2/21.  Primary caregiver received a call from Castle RN at 0700$ resident expired at 0615.$	$none$	$history of stroke$ hyperlipidemia$ dementia$ GERD$ and macular degeneration$Hydrochlorothiazide$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0925154-1$	$0925154-1$	$Deceased$	$NONE$	$COPD$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0926600-1$	$0926600-1$	$Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities  (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day.$	$Diabetes$ renal insufficiency$	$Diabetes$ renal insufficiency$Penicillin$ ibuprofen$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0926797-1$	$0926797-1$	$had a vaccination on 12/31/2020 late morning passed away early morning 01/01/2020.  This is a 93 year old with significant heart issues. EF of 20% among other comorbidities.  He died suddenly approximately 0430$ it is unlikely it was related to receiving the vaccine.$	$This is a 93 year old with significant heart issues?EF of 20% among other comorbidities.  He died suddenly approximately 0430$ it is unlikely it was related to receiving the vaccine$	$Heart disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0928513-1$	$0928513-1$	$Resident passed away in her sleep$	$Atrial fibrillation$ Anemia$ 1st degree AV block$ CDK stage 4$$	$CDK stage 4$ Atrial fibrillation$ 1st degree AV block$ Patient was under hospice care$Aldactone$ contrast dye$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0929997-1$	$0929997-1$	$Patient received vaccine on 1/4/2021.  He was in Hospice for CHF and renal failure$ but was able to get up in his wheelchair and eat and take medications and talk.  On 1/5/2021 am$ he was noted to be very lethargic an could only mumble$ could not swallow.  No localizing neurologic findings.  He was too lethargic to get up in chair.$	$none acute$	$He was on hospice for about the last 1 month for CHF (EF 20-25%) and renal failure (creat 3-4).  He was on hospice but was up and around and able to eat and take pills.  The day after he had his injection$ he was very lethargic and only mumbled.  Was not able to take meds or eat.  He was on hospice$ so did not want work-up or treatment.  He passed away on 1/7 am.   We don't know if it was a coincidence that he died or if the vaccine caused him to deteriorate more quickly.$Losartan$ lisinopril$  metoprolol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0930487-1$	$0930487-1$	$Medical docter state patient has a acute cardiac attack$	$na$	$bph$ apraxia$ $ dysphagia$ muscle weakness$ alzheimers disease$cephalexin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0930876-1$	$0930876-1$	$Death$	$No current illness for this event.$	$Prostate Cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0933846-1$	$0933846-1$	$$1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021  Complained Right arm hurt$ dizzy 1-4-2021  Felt better - did laundry$ daughter found her deceased at 3:30 pm.                        Dr. at hospital said it was $$cardiac event$$ according to death certificate.$$	$MACULAR DEGENERATION 10 YEARS OR MORE$	$NONE$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934050-1$	$0934050-1$	$Staff reported that patient was found Friday morning (Jan 8) sitting at a table with his head tilted forward and unresponsive to verbal or physical stimuli. Staff lowered patient to floor and started CPR. EMS was called and continued CPR at scene$ however they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of patient show that he had a fall about 1 hr. prior. It is unknown if this fall contributed to patient's death. An autopsy has been requested.$	$No Acute Illnesses$	$Diagnosis: - Impulse Control Disorder -  Epilepsy -  Tardive Dyskinesia -  Ulcerative Proctitis and Colitis -  Mental Retardation (mod) -  Hammer toes (bilat.) -  Dermatitis (scalp/torso) -  Seborrheic keratosis of left armpit -  Major Depression -  Infantile Meningitis -  History of Squamous Cell Carcinoma (L arm)$Allergies: NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934263-1$	$0934263-1$	$The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results$ although the reporter indicates his daughter reports his test was positive.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934539-1$	$0934539-1$	$Patient received COVID-19 (Moderna) vaccine from the Health Department on afternoon of January 8$ 2021 and went to sleep approximately 2300 that night. Was found unresponsive in bed the following morning and pronounced dead at 1336 on January 9$ 2021$	$Cellulitis of left lower limb (12/2020)$	$Hypertension$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0935222-1$	$0935222-1$	$Patient was reported to be deceased at home by law enforcement on 1/7/21$	$No acute illnesses$	$Diabetes$ CKD$ CHF$ HTN$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0936043-1$	$0936043-1$	$RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM$ RESIDENT FOUND UNRESPONSIVE ON 01/05/2021.$	$S82.001D Unspecified fracture of right patella$ subsequent encounter for closed fracture with routine healing(Primary$ Admission)$ M62.81 Muscle weakness (generalized)$ R29.3 Abnormal posture$ M19.90 Unspecified osteoarthritis$ unspecified site$ E11.9 Type 2 diabetes mellitus without complications$ Z86.73 Personal history of transient ischemic attack (TIA)$ and cerebral infarction without residual deficits$ E03.9 Hypothyroidism$ unspecified$ E78.5 Hyperlipidemia$ unspecified$ F03.90 Unspecified dementia$	$S82.001D Unspecified fracture of right patella$ subsequent encounter for closed fracture with routine healing(Primary$ Admission)$ M62.81 Muscle weakness (generalized)$ R29.3 Abnormal posture$ M19.90 Unspecified osteoarthritis$ unspecified site$ E11.9 Type 2 diabetes mellitus without complications$ Z86.73 Personal history of transient ischemic attack (TIA)$ and cerebral infarction without residual deficits$ E03.9 Hypothyroidism$ unspecified$ E78.5 Hyperlipidemia$ unspecified$ F03.90 Unspecified dementia$PENICILLINS$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0937127-1$	$0937127-1$	$The facility had positive cases of COVID when we were able to begin vaccinating residents.  Within about a week of vaccination$ patient was tested positive for COVID.  He was 91 years old and his immune system did not have the time to allow the vaccine to begin working before exposure.  His age was a major contributing factor to his death.$	$Chronic pain$	$Pain$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0937152-1$	$0937152-1$	$The facility had positive cases for COVID 19 when the vaccine was received and administered to patient.  With her advanced age and chronic conditions$ she did not have time to build immunity between the time of vaccination and her testing positive.$	$High blood pressure$ pain$ eye issues$	$Blood pressure$ pain$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0937186-1$	$0937186-1$	$The facility had a number of positive COVID 19 cases prior to patients vaccination.  Due to her advanced age$ chronic condition$ and exposure$ patient did not have the time to build immunity after exposure before becoming positive.$	$Chronic pain$	$Pain$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0937434-1$	$0937434-1$	$Pt expired due to possible cardiac arrest.  Unsure if this was vaccine related.$	$None known$	$only had 1 lung$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940855-1$	$0940855-1$	$Patient received her vaccination on 1/12/21 administered by pharmacy*+. She expired on 1/12/21 an approximately 7:30pm. Resident did not have any adverse reactions and was a hospice patient.$	$Resident was a hospice patient but POA requested that she get the vaccination. Resident was already near end of life and the vaccine may not have had anything to do with her death.$	$Resident on hospice care due to end of life.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940866-1$	$0940866-1$	$$Patient was found $$acting abnormal$$ on 1/9/2021 at 1215. VS HR 20-30's. EMS activated. EMS arrived and patient was found pulseless in PEA/ asystole$  CPR and ACLS initiated and then transported to the MC. Unsuccessful resuscitation  and expired on 1/09/2021 at 1348. Clinical impression Cardiopulmonary arrest.$$	$None$	$Hypothyroidism$ Bipolar$ Profound ID$ HTN$ Osteopenia$ dysphagia$ aphasia$ TBI as a young adult$Muscle spasm$ Hernia$Loxapine$ Thioridazine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0941561-1$	$0941561-1$	$Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician$ hospice$ and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on  1/11/2020.$	$Resident was on hospice for Alzheimer's disease.$	$Alzheimer's Disease$ Type II diabetes$ Major depression disorder$ Elevated B/P readings with Hypertension$ history of stroke (7/22/2019 - Acute Lacunar Stroke)$No known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0941607-1$	$0941607-1$	$The patient passed away today$ 1/13/2021.  She was a hospice patient.  She showed no adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement$ went limp and was non-responsive.  The patient passed away at 7:45 am.$	$N/A$	$End stage dementia$ cerebro vascular disease$ Hx left vertebral artery aneurysm$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0943362-1$	$0943362-1$	$Pt collapsed at home approx 5:30 pm and died$	$none known$	$none$none reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944641-1$	$0944641-1$	$Patient died on 1/21-2021$	$CAD$ angina$ coronary bypass in 1990's$  Cardiac Cath on 12/28/2020$	$CAD$Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944732-1$	$0944732-1$	$Resident found unresponsive and without pulse at 05:45am.$	$Covid-19 infection from 12/31-01/10/2021$	$CHF$ atrial fibrilation$ Dysphagia$ macular degeneration$ Vitamin D deficiency$ impaired fasting glucose$ benign prostatic hyperplasia$ osteoporosis$ retention of urine$ anemia$hydrocodone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947129-1$	$0947129-1$	$Resident received Moderna vaccine on 12/23/2020 around 5 pm.  At approximately 3:35 am on 12/25/2020$ resident had a CVA and died on 1/1/2021 at 3:00 am.$	$Anemia$ cardiac murmur$ atrial fibrillation$ osteoporosis$ dysphagia$ hyperlipidemia$ muscle weakness$ aortic valve stenosis$	$Anemia$ cardiac murmur$ atrial fibrillation$ osteoporosis$ dysphagia$ hyperlipidemia$ muscle weakness$ aortic valve stenosis$None known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947662-1$	$0947662-1$	$Accelerated decline in condition with decreased input$ decreased responsiveness$ somnolence$ and death$	$no acute illnesses$	$Alzheimers$ Dementia without behaviors$ Chronic Venous hypertension$ Aphasia$ Benign Prostatic Hypertrophy$ Aphasia$ Osteoarthritis$Lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947841-1$	$0947841-1$	$Patient had no immediate effects from the vaccine$ but died approximately 8 hours after receiving first dose of vaccine.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0949474-1$	$0949474-1$	$Resident had lunch on 01/14/21 and after lunch around 2:00pm$ he vomited and stopped breathing. We coded the resident and 911 paramedics came. They pronounced him dead at 2:18pm.$	$None but he has History of COVID-19 previously when initially admitted to the facility.$	$Parkinson's Disease$ Diabetes Mellitus Type 2$ Hyperlipidemia$ Dementia$ ASHD$ Psychosis$ Hypertension$ Dysphagia$ Acute Sinusitis$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0949630-1$	$0949630-1$	$This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm$ she was noted on vital sign checks (done every 4 hours for first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am$ pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted$ so she received liquid morphine 2.5 mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen$ became hypotensive$ and died peacefully on 1/8/2021 at 7:45 pm.$	$Redness to left foot about 1 week prior to vaccination that resolved a few days prior$	$Advanced Dementia$ Seizure disorder$ CAD$ prior stroke$ HTN$Simvastatin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0950979-1$	$0950979-1$	$Headache after dose was given at 10:00 a.m   Died at after 7:30 pm the same night the dose was given.$	$No current illness for this event.$	$IPF - Idoipathic Pulmonary Fibrosis Diabetic$Lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0951518-1$	$0951518-1$	$$Narrative: Patient with severe aphasia and only able to say $$hey$ hey$ hey$$ or $$uh huh$$ or shake his head no as a way to communicate. Patient previously able to ambulate with significant limp and hyperextension of right knee$ but mostly wheelchair bound over last several years as he had had a slow and steady decline in overall health and mobility. Patient developed aggressive behavior of shouting $$hey$$ and grabbing of groin in 2016. This was worked up with CT scans$ labs$ referral to urology$ neurology$ and referrals to psychiatry. The exact etiology of this action was never able to be affirmed$ but thought to be more psychiatrically related. It improved significantly with addition of antipsychotics$ worsened when antipsychotics were reduced$ and improved again with addition of injectable antipsychotic on 12-10-2020.Patient suffered from falls on occasion given his significantly impaired physical mobility. His last documented fall was 8-31-2019. Patient began utilizing wheelchair most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months$ patient would often refuse medications. He would sometimes indicate that they would cause dizziness$ and other times he would simply refuse. We attempted to hide medications in his food/fluid (with wife's blessing) and when he detected this he would occasionally refuse to eat. Patient previously on DOAC. After pharmacy review in 12/2020 it was recommended to discontinue this as no clear indication to continue use. He was high fall risk and would often refuse this medication as well since 10/2020. Noted to be in NSR on EKGs and decision made to discontinue the DOAC. Patient had no evidence of adverse effects noted after vaccination on December 28th. Patient seen by provider on the morning of his death (1/4/2021) with no noticeable significant change in health condition. Temperature 36.8Con January 4th at 19:45. During routine bedtime cares$ patient suddenly collapsed and death was pronounced January 4$ 2021 at 20:05. Autopsy was requested from next of kin and no autopsy was granted. Symptoms: & DEATH Treatment:$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0952881-1$	$0952881-1$	$Resident was seen by MD on 1/11/2021 due to increasing in edema and shortness of breath. Lasix 40 mg STAT given. New orders to get a STAT CBC$ CMP$ and BNP. Resident has been dependent on Oxygen since his diagnosis of COVID-19 on 11/23/2020. Labs were abnormal. Continued on the lasix 40 mgs. Resident remained short of breath with exertion and on oxygen. He was assisted to the toilet on 1/15/2021 in the morning where he subsequently passed away.$	$Edema$ Hypokalemia$ Hypertensive heart with heart failure$	$Parkinson's Disease; COPD; Heart failure unspecified; Old myocardial infarction$ Overactive bladder$ Hyperlipidemia$ Adult Failure to thrive$ Urinary retention$ Constipation unspecified$ Unspecified urinary incontinence$ Benign prostatic hyperplasia$ other seasonal allergies rhinitis$ unspecified glaucoma$ mild cognitive impairment$ Pressure ulcer of right heel$ history of falling$ dependence in wheelchair$ COVID-19 on 11/23/2020$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953129-1$	$0953129-1$	$Patient presented to our Emergency Department via EMS in full code status; asystole.  Patient expired. Per nursing$ husband stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went unresponsive and husband called EMS.$	$none known$	$hypertension; colon cancer (recovered); smoker$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953348-1$	$0953348-1$	$Patient was living in a nursing home with positive cases when administered.  His age and chronic condition was such that he did not have time after the vaccination to avoid exposure or develop immunity.$	$No current illness for this event.$	$Chronic pain$ high blood pressure$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953785-1$	$0953785-1$	$Death$	$None$	$None Known$Egg (anaphylaxis) Chicken$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953858-1$	$0953858-1$	$patient started to decline 1/10/2021$ patient seen at facility by medical professional - patient deceased 1/13/2021$	$COVID-19$ ARDS$ enterocolitis$ Sepsis$ UTI$ Acute renal failure$	$Chronic kidney disease$ dementia with lewy bodies$ COPD$ GERD$ anxiety$ anemia$ osteoarthritis$ unspecified heart failure$ paroxysmal atrial fibrillation$nka$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0954780-1$	$0954780-1$	$On 1/13/2021$  resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history.$	$None$	$Essential Hypertension Anxiety Disorder Unspecified Convulsions Pulmonary Candidiasis  Paroxysmal atrial fibrillation  Occlusion and stenosis of carotid arteries  Congestive Heart Failure  Left below the knee amputation  Peripheral Vascular Disease  Hypokalemia  Urinary Retention$Shellfish/Seafood$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0955425-1$	$0955425-1$	$resident had a pressure ulcer to RT hip$ was getting treatment on. Was scheduled to have wound debrided and wound vac applied on 1-19-2021. Appetite was poor$ not wanting to get out of bed$ and decline in alertness. Passed away on 1-16-2021$	$pressure ulcer$	$alxheimer's$ depression$ vitamin D deficience$ BPH$PCN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0955959-1$	$0955959-1$	$Patient died 1 week after vaccination.  According to family was having very rapid decline in status in recent weeks and they did not think related to vaccination.$	$recently diagnosed with progressive supranuclear palsy$	$BPH$ HTN$ gout$ GERD$ hyperlipidemia$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956903-1$	$0956903-1$	$mi Narrative: patient with asymptomatic covid 19$ covid positive 12/10/2020.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956966-1$	$0956966-1$	$hypoxia$ secretions$cough$ dyspnea Narrative: ALS patient on hospice with ongoing history of aspiration pna$ receiving tube feeds. Developed incr in secretions$ hypoxeia$ temp and with recently noted clogged feeding tube.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956994-1$	$0956994-1$	$The patient had severe shortness of breath resulting in cardiac arrest on the 5th day after the vaccine. Shortness of breath started 12 hours after injection. On the 5th day$ the patient was discovered to also have a rash throughout his body$ but it is unknown when this rash started.$	$No current illness for this event.$	$Hypertension$ Type II diabetes$ hyperlipidemia$ GERD$Aspirin$ penicillin$ vicodin$ acetaminophen$ niacin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0957116-1$	$0957116-1$	$Sudden death without warning symptoms 4 days after vaccine.  Many medical problems which most likely explain the outcome but spouse feels it is related and it is a new vaccine.  Monitor for pattern?$	$Diabetes$ Chronic renal failure on hemodialysis$ Atrial fibrillation$ Quadriplegia$ Thrombocytopenia$ Gastroparesis$ Vitamin D deficiency$ BPH$ Neurogenic bladder$ distant history of small intestine carcinoid tumor$ right cerebral artery aneurysm$ Barrett's esophagus$ MGUS$ Hypertension$ obstructive sleep apnea$ Pulmonary hypertension$ Junctional tachycardia.$	$see above.  Sudden death without warning likely due to medical problems above but spouse feels it was somehow related to the vaccine 4 days before and it is a new vaccine.$Cipro caused nausea$ Coreg caused bradycardia$ Hydrocodone$ calcium acetate$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958069-1$	$0958069-1$	$Started with cough$ mild shortness of breath and feeling terrible  in evening of 1/19.$	$None$	$Rheumatoid arthritis$ osteoarthritis$ lumbar spinal stenosis$ diabetes$ bradycardia with pacemaker$Codeine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958228-1$	$0958228-1$	$Patient has end stage renal disease and rapidly worsening dementia$ family could no longer care for him at home$ and he was admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse reactions. Patient started refusing oral intake on 1/16$ and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138 CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm.$	$none other than chronic conditions as listed under item 12.$	$acute on chronic kidney failure$ Alzheimer's dementia$ diabetes mellitus type II$  hypothyroidism$ bipolar disorder$ hypertension$ hyperlipidemia$Niacin - rash$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958565-1$	$0958565-1$	$Clients wife reported on 1/18/2021$ that her husband died unexpectedly the day after receiving the COVID 19 vaccine. I called and spoke with her. She stated that the client had started experienced some tightness in his chest the evening of 1/11/2021. She stated that it was normal for him to have the tightness in his chest if he got stressed. She stated that she found him on the garage floor on 1/12/2021 at 2120. He was taken by ambulance to the hospital. She stated that the hospital told her that his COPD had caused him to go into arrythmia.$	$lung infection treated with antibiotics a couple of weeks ago$	$Hypertension$ COPD$None Known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958745-1$	$0958745-1$	$Resident was noted to have increase weakness on 1/15/2021.  Resident was warm to touch with low grade fever of 99.3 F.  Resident was up propelling self in w/c on 1/16/2021 he was pleasant$ accepted medications and ate lunch.  He was found slumped over in his w/c not responding and vital signs absent.$	$Hx of TBI and schizophrenia with worsening behaviors over the past few months including refusing care including meals and medications and striking out with care.  Resident had a fall on 1/14/2021.  Resident received treatment for a UTI with Keflex for 7 days starting 12/6/2020.$	$Traumatic Brain Injury$ Shizophrenia$ hydrocephalus$ hemiplegia following cerebrovascular disease affecting right side$ aphasia$ reduced mobility with use of w/c$ repeated falls$ dysphagia$ major depression$ thrombocytopenia$ gluacoma$ epilepsy.$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958935-1$	$0958935-1$	$Sudden Death within 24 hours of vaccine$	$No current illness for this event.$	$Dementia$ HTN$ Hypothyroidism$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0959167-1$	$0959167-1$	$Patient received COVID 19 vaccine 01/14/2021. Patient died in his sleep 01/16/2021.$	$No current illness for this event.$	$Seizures were reported on vaccine form$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0959272-1$	$0959272-1$	$Patient died 4 days after immunization.  Probably unrelated to immunization$ as patient has been in poor health and was receiving hospice services.  I have no details related to his illness or symptoms.  Daughter is the HIPAA/emergency contact and will have all the information needed.$	$uncertain illness$ however$ patient was on Hospice.$	$uncertain illness$ however$ patient was on Hospice.  We are not his primary care providers$ just provided the vaccine.$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0959356-1$	$0959356-1$	$Pt passed away the day after the vaccine was given.$	$n/a$	$n/a$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0960752-1$	$0960752-1$	$Extreme Fatigue$	$No$	$Diabetic $ High Blood Pressure$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0961845-1$	$0961845-1$	$Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962318-1$	$0962318-1$	$$Called to schedule second vaccine and daughter reports that he died on01/19/2021 with $$COVID$$$$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962940-1$	$0962940-1$	$Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough$ denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127.$	$Unknown$	$Dementia$ Diabetes$ Chronic A Fib$ Dyslipidemia$ Depression$ Osteoarthritis$Galantamine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0963016-1$	$0963016-1$	$unknown.  Event occurred after leaving vaccination site$	$denied ill symtpoms at time of vaccination$	$denied$unknown.  Denied allergies on vaccine form$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0963163-1$	$0963163-1$	$Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0963167-1$	$0963167-1$	$Narrative: Symptoms:  & Cardiac Arrest; Death Treatment:  EPINEPHRINE$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0963269-1$	$0963269-1$	$Patient passed away on 01/18/2021$	$No current illness for this event.$	$Type 2 Diabetes$ HTN$ DJD$ Blindness bilateral$ Glaucoma$ Dyslipidemia$ Diverticulosis$ Osteoporosis$ Memory loss$ Chronic renal failure$ CAD$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0963388-1$	$0963388-1$	$Patient died unexpectedly 5 days after receiving vaccine (1/10/2021).$	$No known illnesses at time of vaccination.$	$COPD$ Aptyalism$ upper respiratory tract infection due to Influenza$ acute bronchitis$ Pnuemonia$ generalized anxiety disorder$ impaired intestinal carbohydrate absorption$ heart failure$ GERD without esophagitis$ long term current use of anticoagulant$ transplanted skin present$ history of UTISs$ constipation$ Periipheral vascular disease$ chronic pain$ history of amputation of lower limb above knee$ sick sinus syndrome$ candidiasis of skin$ dysuria$ Cerebrovasxular disease$ cellulitis of toe of right foot$ actinic keratosis$ psoriasis$ hyperlipidemia$ intertrigo$ dyspnea$ dysphagia$ and attention to gastrostomy$ history of impacted cerumen in ears.$Ceftriaxone sodium$ Augmentin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965571-1$	$0965571-1$	$1/13/21 pt came into clinic for vaccine.  Had difficulty remembering age.  Called me Mon. 1/18/21 stating she was sick.  When asked what her sx were$ she stated fatigue.  She was well the night of the shot$ Thur. and Fri. but became tired on Sat. and Sun.  I went through other sx with her such as h/a$ fever$ n/v$ muscle aches$ weakness and she said she experienced none of those.  I questioned her about eating and drinking and she said she ate and drank water.  She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911.  She agreed.  Two staff from clinic called her Mon. and Tues$ (1/18 and 1/19).  On Tues. she may have had sl slurred speech.  She was found deceased on$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965807-1$	$0965807-1$	$began itching within 24 hours$ within 5 days couldn't move on her own$ by 6th day was having respiratory issues$ by day 7 unresponsive$ by day 8 dead$	$nose bleeds$	$rheumatoid arthritis$ atrial fibrillation$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965831-1$	$0965831-1$	$Patient received her first dose of vaccine on Monday$ January 18th.  Two days later on Wednesday$ January 18th$ she retired to bed early.  Later that night when her husband went to bed$ he found her in the bed deceased.  No other details of the event are know.$	$Emergency Room Visit  1/7/2021 complaining of shortness of breath and swelling.  She and elevated D-dimer with no evidence of a Pulmonary Embolus.  Persantine Myoview showed small mild area of reversible ischemia to the inferolateral apical wall.  Mild symptoms of vague discomfort in her chest$ but nothing that has been reproducible with activity.  She is chronically short of breath with limited activities because of problems with her hip$	$Active Problems Abdominal distention (R14.0) Cellulitis (L03.90) Chronic hip pain (M25.559$G89.29) Chronic UTI (N39.0) Colon polyps (K63.5) Coronary artery disease involving native coronary artery of native heart with angina pectoris (I25.119) Edema$ leg (R60.0) GERD (gastroesophageal reflux disease) (K21.9) Gout (M10.9) Left kidney mass (N28.89) Lump of right breast (N63.10) Morbid obesity (E66.01) Neuropathy$ diabetic (E11.40) Pain with urination (R30.9) Protein in urine (R80.9) Respiratory crackles at right lung base (R09.89) Type 2 diabetes mellitus (E11.9) Venous (peripheral) insufficiency (I87.2)$Allergies: Brilinta$ ACE Inhibitors$ Bactrim$ Cipro$ Codeine Derivatives$ Penicillins$ Statins$ sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965860-1$	$0965860-1$	$Patient had increased SOB while at home.  EMS was called.  Patient coded in the squad$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965922-1$	$0965922-1$	$We were alerted that the patient died at home.$	$pt denied$	$pt denied$pt answered no$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0966359-1$	$0966359-1$	$Headache$ pain in the injection site$ threw up. A few hours later she died.$	$Diabetes$ hyper tension$	$Diabetes$Aleve$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0966844-1$	$0966844-1$	$$Patient is reported to have died at home$ the day after his COVID test.  Family member states that he did good the afternoon and evening after his COVID-19 injection$ but that he started not feeling good the next day.  The patient $$was having palpitations$$.  The family tried to convince him to go to the Emergency Room$ but he refused.  Patient died at home.$$	$DM II$	$DM II$KNA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967506-1$	$0967506-1$	$Died within 5 days of receiving vaccine.  Exact cause and day unknown.$	$No current illness for this event.$	$Congestive heart failure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967747-1$	$0967747-1$	$Pt passed away evening of 1/13 - unknown reason currently Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0968195-1$	$0968195-1$	$My dad got the Moderna Vaccine on Tuesday$ January 12$ 2021 in his left arm at the Mall injection site for the Health Department. He was told that the side effects could mean his arm hurting$ tiredness$ headache$ and even a low grade fever. Additionally$ the site informed us both (as I was with him to get the injection) that this was all normal and not to seek medical attention unless these symptoms last longer than 72 hours. That evening$ my dad was experiencing all of those symptoms$ and went to bed at 7pm. A little after 10am on Wednesday$ January 13$ 2021$ when he awoke$ my dad went to the bathroom vomiting. This was where he collapsed and went into cardiac arrest. Fire/Rescue was dispatched about 10:30am after my mom started CPR. County Fire Rescue EMTs and Paramedics continued CPR and other attempts at reviving him all the way to Hospital Emergency Department. He was pronounced dead at 12:14pm on Wednesday$ January 13$ 2021. We have no doubt my dad$ following the instructions of the injection facility$ thought he was just experiencing the side effects of the vaccine. He had no chance. Had this injection been done in the RIGHT arm$ perhaps he could have recognized the arm numbness being that of an impending heart attack. We really miss Dad. He served this country with distinction for over 50 years$ and we believe his country failed him.$	$None known$	$Type-2 Diabetes$ Hypertension.$None known.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0968707-1$	$0968707-1$	$My mother died 12 hours after the vaccine was administered$	$unknown$	$none$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0969363-1$	$0969363-1$	$Patient obtained initial dose of Moderna vaccine on Thurday$ Jan 14. No adverse effects reported during initial 15 minute post vaccine waiting period. Saturday morning (Jan 16)$ patient developed severe cough$ labored breathing$ and fever. Additionally patient mental status changed suddenly$ became non-communicative (unable to speak$ but would scream if she was touched). O2 status was irregular$ dropping to 78.  Sunday morning$ EMT and then hospice was hospice called. Monday morning$ after hospice emergency kit was initiated$ patient passed away.$	$No current illness for this event.$	$Hypothyroidism Hypertension Diabetes Hypercholesterolemia Chronic pain GERD$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0969636-1$	$0969636-1$	$Found dead at home slumped on the floor; Loss of appetite; Body aches; Feverish; A spontaneous report was received from a physician$ concerning a 65-years-old male patient$ who received Moderna's COVID-19 Vaccine and experienced feverish$ body aches$ loss of appetite$ and death.  The patient's medical history$ as provided by the reporter$ included diabetes$ hypertension$ Hashimoto's$ smoker$ cataracts$ atrioventricular block$ occasional premature ventricular contractions$ and hypertriglyceridemia. Concomitant medications reported included metformin$ glimepiride$ lisinopril$ atorvastatin$ aspirin$ methimazole$ propranolol$ and cilostazol.   On 05 Jan 2021$ prior to the onset of events$ the patient received the first of two planned doses of mRNA-1273 (lot number 037k20a) for COVID-19 infection prophylaxis.  On an unknown date in Jan 2021$ some time after receiving the vaccine$ the patient was feeling feverish with body aches and loss of appetite.  On 09 Jan 2021 at approximately 21:30$ the patient was found dead at home slumped on the floor. According to the paramedics$ the patient was dead longer than when his wife found him$ and no resuscitation was performed.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events$ feverish$ body aches$ loss of appetite$ was considered resolved. The patient died on 09 Jan 2021. The cause of death was not reported.  The reporter assessed the event$ death$ as not related to Moderna's COVID-19 Vaccine. The reporter did not provide assessment for the events$ feverish and body aches$ in relation to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 65 year old male patient with medical history of diabetes$ hypertension$ Hashimoto's$ smoker$ cataracts$ atrioventricular block$ occasional premature ventricular contractions$ and hypertriglyceridemia$ who experienced the serious unexpected event of death$ non-serious unexpected event of loss of appetite$ and non-serious expected events of fever and body pain.  The event of death occurred 5 days after the first dose of mRNA-1273. The events of fever$ body pain and loss of appetite occurred an unspecified period of time after the first dose of mRNA-1273.  Very limited information regarding these events has been provided at this time.  Based on temporal association between the use of the product and the start date of the events$ a causal relationship cannot be excluded.   Definitive causal association is confounded by age and medical history of diabetes$ hypertension$ Hashimoto's$ smoker$ cataracts$ atrioventricular block$ occasional premature ventricular contractions$ and hypertriglyceridemia.$	$No current illness for this event.$	$Medical History/Concurrent Conditions: AV block; Cataracts; Diabetes; Hashimoto's disease; Hypertension; Hypertriglyceridemia; Premature ventricular contractions (Occasional); Smoker$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0969699-1$	$0969699-1$	$Patient died.$	$Metastatic duodenal adenocarcinoma $ bladder cancer$ undergoing chemotherapy with success.  Dual chamber pacemaker$	$Coronary heart disease$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0970495-1$	$0970495-1$	$Patient expired three days after receiving first dose  of Moderna COVID-19 vaccine.  The death certificate states cause of death is sudden cardiac arrest.$	$No current illness for this event.$	$Hypertension$ Diabetes Type 2$  cardiac disease.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0971176-1$	$0971176-1$	$$Pt. woke up the next morning after vaccination and $$didn't feel well$$$ described by wife as fatigue$ no energy.  At approximately 2 PM$ he vomited.  His wife checked on him at 4:20 PM and he wasn't breathing sitting in his chair.   EMS squad was called but when they arrived he was asystole and mottling present.  Did not start CPR since he was already gone too long.  Pronounced by coroner on scene.$$	$last doctor visit on 10/27/2020 and no illness at that time$ routine follow up$	$BPH reflux (Gerd) Osteoarthritis high cholesterol$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0971813-1$	$0971813-1$	$patient received vaccine on 1/20/2121$ later that night husband found her slumped in chair$ called EMS and patient was taken to Hospital where she died on 1/21/2021$	$A fib$ type 2 diabetes$ HTN$ seizure disorder$  CHF$	$A fib$ type 2 diabetes$ HTN$ seizure disorder$  CHF$ Z alpha hydroxylase deficiency$Iodine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972113-1$	$0972113-1$	$Resident became lethargic and reports of blood coming from resident's nose and mouth on the morning of 1/13/21. Resident went out to ER for eval$ and came back to facility with dx of pneumonia and recommendations for resident to be placed on hospice. Resident deceased on 1/14/21. Unknown if vaccine related$ but with timeline of events I was advised to report this per medical director of facility$ as well as Pharmacy who administered the vaccine.$	$Resident was Dx with pneumonia the day after vaccine.$	$ENCEPHALOPATHY$ UNSPECIFIED$ ACUTE KIDNEY FAILURE$ UNSPECIFIED$UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE$ UNSTEADINESS ON FEET$ UNSPECIFIED HEARING LOSS$ UNSPECIFIED EAR$ DRY EYE SYNDROME OF BILATERAL LACRIMAL GLANDS$ CONSTIPATION$ UNSPECIFIED$ LONG TERM (CURRENT) USE OF ASPIRIN$MOOD DISORDER DUE TO KNOWN PHYSIOLOGICAL CONDITION WITH MIXED $ GENERALIZED ANXIETY DISORDER$ AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE$HYPERLIPIDEMIA$ UNSPECIFIED$ LOCALIZED EDEMA$ ESSENTIAL (PRIMARY) HYPERTENSIONGASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS$ UNSPECIFIED URINARY INCONTINENCE$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972148-1$	$0972148-1$	$VACCINATION WAS RECEVIED THE MORNING OF 1/5/2021- IN THE EVENING OF THAT DAY RESIDENT SUSTAINED A FALL AND WAS TRASNPORTED TO FACILITY FOR TREATMENT. IT IS NOT UNUSUAL THAT RESIDENT WAS SELF TRANSFERRING AND HAS A HISTORY OF FALLS.$	$RESIDENT SUSTAINED A FALL ON 1/5/2021.$	$HYPOTHYROIDISM HYPERTENSION GERD ANXIETY DEPRESSION OSTEOARTHRITIS  TRAUMATIC SUBDURAL HEMORRHAGE  DEMENTIA  HYPERLIPIDEMIA  ALZHEIMERS SPINAL STENOSIS  ATHEROSCLEROTIC HEART DISEASE PULMONARY FIBROSIS  ABDOMINAL HERNIA  BLADDER DISORDER$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972394-1$	$0972394-1$	$Died  about 24 hours later$	$Unknown$	$No chronic health conditions$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972610-1$	$0972610-1$	$$Patient was tested positive for Covid-19 on 12/9/20.  Patient received Covid Vaccine on 1/21/21. Patient was observing for 15 minutes in treatment room by Nursing staff. Patient denied any signs/symptoms adverse effect: headache$ dizziness & weakness$ difficulty breathing$  muscle pain$ chills$ nausea and vomiting$ and fever . Patient seated on treatment table appeared to be relaxed$ respiration even and unlabored. Health teaching provided. Patient educated to report any changes in condition to staff immediately. Patient verbalized understanding and able to verbalize signs and symptoms and adverse effects to be aware of related vaccine.  On 1/22/21:  patient was seen by medical provider for $$altered behavior$$. Per medical provider's documentation: $$Patient was fallen on 1/2/21 and was sent out to outside hospital on 1/4/21. CT head: no intracranial abnormality$ age-related changes. Patient had labs (B12$ RPR$ folate) were within normal limit$$. We did MMSE today: 22/30 score $$mild dementia$$  On 1/23/20:  $$Patient  was inside his cell. He was walking towards cell door to obtain his breakfast$ when custody witnessed him collapse and activated the alarm. Nursing staff arrived at cell front at 06:34 am and found the patient pulseless and unresponsive$ and CPR was immediately initiated. AED was attached at 06:35 am and no shock advised. AMR then arrived and patient did not have ROSC$ and was pronounced dead at 06:54 am.$$$$	$Fall on 1/2/2021$	$Allergic Rhinitis$ Back Pain$ BPH$ Cataract$ DM2$ Essential hypertension$ Hyperlipidemia$ Morbid Obesity$ Schizophrenia$No known allergy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972890-1$	$0972890-1$	$On the evening of 10JAN2021$ patient experienced a low grade fever$ decreased oxygen saturation of 38%$ heart rate of 124$ confusion.  Patient received oxygen via face mask$ morphine and ativan.  By 11JAN2021$ patient was no longer verbal$ able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021$ the patient passed away.$	$COVID-19 positive on  November 19$ 2020 and didn't test negative until December 26$ 2020$	$Macular Degeneration$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0973814-1$	$0973814-1$	$DEATH Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0973820-1$	$0973820-1$	$Narrative: Symptoms:  & DEATH DUE TO COVID 01/13/21 Treatment:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974033-1$	$0974033-1$	$Resident deceased on 1/26 at 445am. No signs ahead of time.$	$No current illness for this event.$	$coronary artery disease$ diabetes mellitus$ hypertension$ TIA$ asthma$ CVA stroke$ anemia$ peripheral neuropathy$ heart failure$ heart disease with congestion$Macrobid$ depacote$ sulfamethoxazole/trimethorpim$ lisinopril$ lyrica$ sumatriptan succinate$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974443-1$	$0974443-1$	$Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later$ patient began bleeding from his eyes$ nose$ and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine$ but needed to be reported nonetheless.$	$Unkown$	$Unknown$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974454-1$	$0974454-1$	$Patient passed away 23 days after receiving COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974573-1$	$0974573-1$	$ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS.  FOLLOWING THIS EPISODE BECAME UNRESPONSIVE$ PALE$ DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED.  RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.$	$URINARY TRACT INFECTION$	$HYPERTENSION DEMENTIA  INTERSTITAL PULMONARY DISEASE GERD HYPOTHYROIDISM  PAIN HYPERLIPIDEMIA  MALIGNANT NEOPLASM OF PROSTATE OSTEOARTHRITIS CONSTIPATION WEAKNESS UTI  PERIPHERAL VASCULAR DISEASE$STATINS$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975023-1$	$0975023-1$	$CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME$ BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01).$	$No current illness for this event.$	$PULMONARY FIBROSIS$ HYPERTENSION$ DIABETES MELLITUS$ COPD$ TOBACCO USE$ ALCOHOL INTAKE$ RESPIRATORY FAILURE$ PVD$ PROTEINURIA$ PERICARDITIS$ HYPERLIPIDEMIA$ OBESITY$ ILD$ HYPONATREMIA$ CKD STAGE 3$ BPH$ ANEMIA$ BILATERAL HEARING LOSS$ GERD$ HYPERSENSITIVITY PNEUMONITIS$ DIASTOLIC CONGESTIVE HEART FAILURE$ SOLITARY PULMONARY NODULE$SULFA$ IODINE-BASED CONTRAST MEDIA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0976112-1$	$0976112-1$	$Resident expired on january 21$ 2021$	$Resident started manifesting loss of appetite and body weakness on January 10$2021 a few days after vaccination. She expired in our facility 1/21/2021.$	$HEMIPLEGIA AND HEMIPARESIS FOLLOWING OTHER NONTRAUMATIC 10/28/2020 Principal Diagnosis  INTRACRANIAL HEMORRHAGE AFFECTING LEFT DOMINANT SIDE TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS  DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE UNSPECIFIED ATRIAL FIBRILLATION  ENTIAL (PRIMARY) HYPERTENSION 10/28/2020 Diagnosis 4 Admission HISTORY OF FALLING 10/28/2020 Diagnosis 5 Admission OTHER ABNORMALITIES OF GAIT AND MOBILITY 01/13/2021 Other Diagnosis During Stay COVID-19$ASPIRIN PENICILLIN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0976146-1$	$0976146-1$	$Resident is asymptomatic$	$No symptoms after COVID vaccinations$	$ENCOUNTER FOR SURGICAL AFTERCARE FOLLOWING SURGERY ON THE DIGESTIVE SYSTEM ENCOUNTER FOR ATTENTION TO GASTROSTOMY CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE DEGENERATIVE DISEASE OF NERVOUS SYSTEM$ UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS UNSPECIFIED SEQUELAE OF UNSPECIFIED CEREBROVASCULAR DISEASE PAROXYSMAL ATRIAL FIBRILLATION UNSPECIFIED CIRRHOSIS OF LIVER ESSENTIAL (PRIMARY) HYPERTENSION UNSPECIFIED VIRAL HEPATITIS B WITHOUT HEPATIC COMA HYPERLIPIDEMIA$ UNSPECIFIED GASTRITIS$ UNSPECIFIED$ WITHOUT BLEEDING UNSPECIFIED PROTEIN-CALORIE MALNUTRITION$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0976166-1$	$0976166-1$	$ASYMPTOMATIC$	$NONE$	$HEMIPLEGIA AND HEMIPARESIS FOLLOWING NONTRAUMATIC INTRACEREBRAL HEMORRHAGE AFFECTING RIGHT DOMINANT SIDE CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER VIRAL COMMUNICABLE DISEASES ACIDOSIS ANEMIA UNSPECIFIED SEVERE PROTEIN-CALORIE MALNUTRITION PERSONAL HISTORY OF OTHER MALIGNANT NEOPLASM OF LARGE INTESTINE ACUTE KIDNEY FAILURE$ UNSPECIFIED UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE NEURALGIA AND NEURITIS$ UNSPECIFIED ESSENTIAL (PRIMARY) HYPERTENSION$NONE$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0977426-1$	$0977426-1$	$Patient has a history of advanced melanoma with brain metastasis. He developed seizure disorder as well and had some mild seizures at home over the prior month. He received the vaccine at 4pm and was monitored in the office for 15 minutes. He then went home with his daughter whom he lives with. He ate dinner with her and read until 8pm when he went to his room. She found him in his room at 9pm unresponsive with seizures. Hospice was alerted and recommend oral valium. He continued to be unresponsive and expired the following day at 7:30 pm.$	$1. Melanoma with brain metastasis 2. Seizure disorder$	$1. Melanoma with brain metastasis 2. Seizure disorder$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0978567-1$	$0978567-1$	$Resident received the first dose of Moderna Vaccine on 01/12/2021 and Tested for COVID-19 on 01/12/2021. Resident tested positive on 01/13/2021.  Resident was transferred to acute hospital on 01/19/2021 due to desaturation.  Resident expired at Hospital on 01/24/2021.$	$None$	$DM2$ Seizure$ HTN$ Hyperlipidemia$ PVD$ History of CVA$ Contractures of both knees$  Dysphagia.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979081-1$	$0979081-1$	$Patient found dead in home the next morning.  May or may not be connected to vaccination.  Instructed to report it from our medical director and director of nursing.$	$None$	$Acute systolic congestive heart failure$ Atrial Fibrillation$ Coronary Artery Disease$ Left Ventricular Hypertrophy$ Arteriosclerotic Heart Disease$ Carotid Artery Stenosis$ Ischemic Cardiomyopathy$ Hypertension$ Osteoarthritis$ Myelodysplasia$ COPD$ Dyslipidemia$ Malignant Neoplasm of Colon$ Anemia$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979533-1$	$0979533-1$	$Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021.  She felt poorly and did not know her son's name which was not normal.  She went to ER on 1/24.  She was assessed as not having fractures.  She was going to be transferred to a skilled nursing facility.  She was not having respiratory complaints.  She was awaiting transfer when her O2 levels started dropping substantially.   She declined aggressive intervention and she died within a few hours.$	$chronic copd is stable condition; no illnesses at time of vaccination$	$copd hypertension$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979773-1$	$0979773-1$	$Not sure if it has to do with the COVID vaccine but her caregiver reported to me today (1/27/20201) that she passed away on 01/16/2021 from a pulmonary embolism  that was 18 days after vaccine$	$none per care giver$	$none that was reported$none reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979796-1$	$0979796-1$	$Patient went to hospital with COVID symptoms on  01/10/2021 and passed away on 01/22/2021$	$$not known.  I spoke with his wife when he was in the hospital a couple of days after the first dose of Moderna vaccine.  She mentioned that he felt ill a few days before and up to the vaccine date.   Despite feeling ill$ he checked off $$no$$ on the questionnaire section that asked if patients were feeling ill that day.$$	$Diabetes$ hyperlipidemia$ hypertension$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0981061-1$	$0981061-1$	$Patient died 3 days post Moderna vaccine.$	$None$	$Unsure$Unsure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0981849-1$	$0981849-1$	$died 01/16/2021$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0981912-1$	$0981912-1$	$Patient presented to the  Emergency Department complaining of chest pain$ pale$ cool diaphoretic$ and hypotensive. The patient was discovered to have a large saddle pulmonary embolism$ went into cardiac arrest and expired. Of note$ the patient received her second Moderna COVID vaccine on 1/23$ which would place her first one approximately 12/25 if she received them at the appropriate interval. This information is from the patient's daughter and the ED record$ the information is not available in CAIR. Per the daughter$ the patient started feeling ill on 1/21$ improved on 1/25$ and then acutely worsened on 1/27$ resulting in the ED visit.$	$No current illness for this event.$	$hypertension$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0981938-1$	$0981938-1$	$UNKNOWN/ASYTOLE Narrative:  Please refer to section 6. 68y/o male with h/o severe peripheral vascular disease with previous left AKA 2/3/20$ s/p bilateral bypasses in the past. Pt recently underwent right AKA on 1/12/21. Per Hospital remote data 1/10/21 pt c/o shortness of breath$ CXR demonstrated right lower lobe opacity & left basilar infiltrate. Pt s/p >10 days emperic IV abx. Moderna vaccine 0.5ml IM was administered via left deltoid on 1/22/21 around 16:21. On 1/23/21@05:14 code blue was called as pt found to be unresponsive$ breathless and pulseless$ facial cyanosis noted$ CPR started immediately.Pt found to be in asystole. ACLS guideline followed but no return of spontaneous circulation$ At 05:32 pt remained pulseless and breathless and was pronounced. Autopsy currently pending.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982354-1$	$0982354-1$	$patient received COVID vaccine on 12/29/2020 and passed away on 1/23/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982370-1$	$0982370-1$	$Patient died at hospital on j/16/2021 approximately 48 after receiving vaccination. Believe death related to fall at home prior to vaccination.$	$Patient fell at home night before vaccination.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982495-1$	$0982495-1$	$Client's sister called crying and said the family just found out yesterday that Client had died some time last week. The last time any family talked to him was on the 19th of January$ missed calls show on the phone on the 21st. His last internet search was sternum pain. . She will also call the Agency and report this. The vaccine isn't in Registery at this time$ do I don't know the lot number but she said he was due back in one month. She said he was very healthy and ran triathalons.$	$none$	$none$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982517-1$	$0982517-1$	$patient received COVID vaccine on 1/11/2021 and passed away on 1/25/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982541-1$	$0982541-1$	$36 hours after vaccination$ the patient had increased respiratory distress. He was placed on high flow nasal cannula oxygen with mild improvement. He then continued to be hypotensive requiring IV fluids and subsequently IV vasopressors. Patient's BP was stabilized with vasopresor$ however he continued to deteriorate clinically with altered mental status and lethargy$ concerned for bowel peroration based on physical exam by MD. He was then emergency intubated and placed on mechanical ventilation. He was then transferred to acute care hospital near by.$	$COVID pneumonia 12/2020$	$Coronary artery disease s/p PCI prxima and mid left circumflex in July 2011$ carotid stenosis$ peripheral vascular disease$ dyslipidemia$ hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982890-1$	$0982890-1$	$Pt presented to ER via EMS at 1556  3 days after receiving vaccine. pt was breathing approximately 50 times a minutes and o2 sats in the 70's upon arrival. NP decided to intubate$ Rocuronium and Versed given. Pt became bradycardic and 1 amp of Atropine was given without improvement. No pulse felt$ CPR started per ACLS protocol. 7 Epi's given. Time of death- 1632. After TOD pt was swabbed for COVID-19 and the results were positive.$	$GI Bleed and Anemia- DX: 1/31/2021$	$ASCVD$ HTN$ Blindness$ Diverticulous$No Known Drug Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983720-1$	$0983720-1$	$Death Narrative: Patient had Parkinson's and advanced Dementia. He was on a palliative care unit and a DNR.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983721-1$	$0983721-1$	$Death Narrative: Patient with Severe Dementia and on Hospice for end of life care.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0985205-1$	$0985205-1$	$Patient was feeling dizzy and under the weather after the vaccination. The following day he died in his sleep during a nap.$	$No$	$None$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0985715-1$	$0985715-1$	$Patient received the vaccine on 12/29/20 and presented at the ER at the Hospital on 12/30/20 stating that he wasn't feeling well.  It is stated that his health had declined over the past few weeks and currently on hospice.  Visit was unremarkable.  Patient stated that wanted to stop dialysis.  Patient passed away on 01/02/2021.$	$high blood pressure dialysis  GI bleed/ symptomatic anemia$	$$no known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0985814-1$	$0985814-1$	$started having generalized weakness on 1/21/21$ fatigued.$ nausea/vomiting.  went to doctor on 1/25/21 with complaint of sore throat$ cough$ and felt congested.  Went to ER on 1/25/21 with complaints of increased shortness of breath$ worsening nausea and vomiting.  started on oxygen for sats of 87%.  admitted on 1/25/21.  On 1/26/21 needed intubated$ CXR showed worsening consolidative change right lung at right hilar level. Echocardiogram showed ejection fraction 35-40%$ left atrium is moderately dilated.$	$started with a sore throat the day before vaccination$	$anemia$ BPH with obstruction$ cervical neuritis$ cervical spondylosis$ cervicalgia$ enlarged prostate$ HLD$ HTN$ left sciatic nerve pain$ low back pain$ lumbar spinal stenosis$ osteoarthritis$ pacemaker$ pancytopenia$morphine$ oxycodone$ hydrocodone$ hydromorphone$ coumadin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986857-1$	$0986857-1$	$Extreme bouts of  nausea first few days after vaccine.  Estimated that patient died at home within 3-4 days after receiving the vaccine.   Last phone call to daughter expressed extreme nausea and seemed to have altered mental status.  Found dead  by daughter on 01/04/2021.$	$Uncontrolled insulin levels (high glucose)$	$HIV COPD Diabetes Mellitus Type II Schizophrenia Psychosis Suprapubic catheter$Fish / seafood$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987029-1$	$0987029-1$	$Resident passed away at 8:15 am on 1/28/21-found to be without pulse/respirations/DNR order in place.$	$PRESSURE ULCER OF RIGHT HEEL$ STAGE 2 ATHEROSCLEROSIS OF NATIVE ARTERIES OF LEFT LEG WITH ULCERATION OF OTHER PART OF FOOT ATHEROSCLEROSIS OF NATIVE ARTERIES OF LEFT LEG WITH ULCERATION OF HEEL AND MIDFOOT$	$TRAUMATIC SUBDURAL HEMORRHAGE WITHOUT LOSS OF CONSCIOUSNESS$ SUBSEQUENT ENCOUNTER MUSCLE WEAKNESS (GENERALIZED) UNSPECIFIED LACK OF COORDINATION FEEDING DIFFICULTIES OTHER REDUCED MOBILITY NEED FOR ASSISTANCE WITH PERSONAL CARE DIFFICULTY IN WALKING$ NOT ELSEWHERE CLASSIFIED  DYSPHAGIA$ OROPHARYNGEAL PHASE OTHER SYMBOLIC DYSFUNCTIONS ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS  ORTHOSTATIC HYPOTENSION HYPERLIPIDEMIA$ UNSPECIFIED DEMENTIA WITH LEWY BODIES CHRONIC DIASTOLIC (CONGESTIVE) HEART FAILURE  HYPOKALEMIA PRESSURE ULCER OF LEFT HEEL$ UNSTAGEABLE CONSTIPATION$ UNSPECIFIED BENIGN PROSTATIC HYPERPLASIA WITH LOWER URINARY TRACT SYMPTOMS  ESSENTIAL (PRIMARY) HYPERTENSION REPEATED FALLS RETENTION OF URINE$ UNSPECIFIED PRESENCE OF AORTOCORONARY BYPASS GRAFT   PARKINSON'S DISEASE LOCALIZED SWELLING$ MASS AND LUMP$ RIGHT UPPER LIMB$Penicillins Green Food Dye Dust Mites Aricept Namenda$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987877-1$	$0987877-1$	$REC'D CALL FROM PT'S SON$ PT HAS BEEN ON HOSPICE CARE AND PASSED 1/26/21. DOES NOT BELIEVE THIS IS RELATED TO VACCINE ADMINISTRATION$ BUT WANTED TO REPORT TO US.$	$PT WAS ON HOSPICE CARE AT TIME OF VACCINATION$	$UNKNOWN$PCN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0988245-1$	$0988245-1$	$93 y/o with complex medical history (severe COPD on oxygen$ diastolic CHF$ CKD3$ myelofibrosis$ marginal zone lymphoma of spleen with recent progression and no active treatment$ chronic anemia$ afib$ CAD$ pulmonary artery hypertension$ h/o bladder cancer$ hypertension$ hypothyroidism$ h/o bilateral PE$ sick sinus syndrome s/p pacemaker$ h/o Hodgkin's disease). Has had multiple hospitalizations over the last 3 months for dyspnea$ most recently in 12/2020. Enrolled in palliative care. Has had multiple transfusions (most recently 01/13/21) for his chronic anemia due to myelofibrosis$ and recently started on darbepoetin. No documented history of anaphylaxis to medications or prior vaccinations. He received COVID19 vaccine (Moderna) on 01/16/21. He passed away suddenly at home on 01/17/21. Symptoms:  & cardiac arrest Treatment:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0988270-1$	$0988270-1$	$Narrative: Symptoms: & death Treatment:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0988369-1$	$0988369-1$	$aspiration pneumonia/death$	$No current illness for this event.$	$diabetes gastroparesis MitraClip$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0990034-1$	$0990034-1$	$I helped facilitate scheduling for his COVID vaccine and received notification from his wife that he passed away unexpectedly this morning. She reported he had  been experiencing a rheumatoid arthritis flare and was on steroids.  His diabetes was not well controlled as a result.   He did not have any reactions in the days immediately after the vaccine.$	$No current illness for this event.$	$Rheumatoid arthritis$ diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0995146-1$	$0995146-1$	$Narrative:  Patient experienced cardiac arrest with PEA and a witnessed collapse upon arrival to the emergency department on 1/24/21. Patient received his first dose of the COVID vaccine on 01/15/2021and felt poorly thereafter. He was describing shortness of breath to his wife and requiring 5L of O2 at home to maintain saturations in 80s$ while he usually was on 3L to maintain saturations in the mid 90s. He had been oriented but more fatigued than normal and described bilateral shoulder pain (which was not new for him) as well as indigestion. Took Tylenol with some relief. He had decreased PO intake and less appetite. The patient's wife encouraged him to come to the hospital daily for a week prior to admission$ but the patient did not want to because he felt his side effects were secondary to the vaccine. Symptoms:RespDepression$ Palpitations$ Syncope & cardiac arrest Treatment: EPINEPHRINE 1 MG ONCE 3 rounds given $CALCIUM CHLORIDE 1000 MG ONCE$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0990780-1$	$0990780-1$	$patient passed$	$Marko Cell Carcinoma Matasisized$	$was in hospice since 8/11/20 had cancer$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0991080-1$	$0991080-1$	$Patient sudden death reported by family.  No further details available at this time.$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0991216-1$	$0991216-1$	$Vaccine given on 01-25-2021. Wife reported on 01-29-2021 that patient had a ran a fever on 01-26-2021$ Was better on 01-27-2021. She found him dead when she came home work on the evening of 01-28-2021.$	$No current illness for this event.$	$History of Heart Condition$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0991849-1$	$0991849-1$	$Congestion$ Hypoxia$ SOB$ Tachycardia$ Weakness. Started on O2 @ 3L$ HOB elevated$ Tylenol supp$	$No current illness for this event.$	$Epilepsy$ HTN$ BPH$ ASHD$ GERD$ Alzheimer's Disease$ Depression$ OCD$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0991859-1$	$0991859-1$	$Per granddaughter's report$ pt became very weak within hours of receiving the first dose of the Moderna COVID-19 vaccine and could not get out of bed the next morning without assistance$ reported difficulty seeing$ and did not recognize some family members. By Sunday$ 1/31$ pt was unable to be awakened$ would not eat$ and had low urinary output. Granddaughter reports that the morning of 2/1 he was awake and ate a small amount and seemed to be improving although still weak and unable to get out of bed.  Granddaughter reported he died 2/1 around 10am in the morning.$	$No current illness for this event.$	$hospice patient for 1 year$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0991927-1$	$0991927-1$	$Patient was found deceased at  Nursing Home in his room 01/12/2021 at 5:25 AM.$	$No current illness for this event.$	$Constipation$ acute exacerbation of chronic congestive heart failure $ osteoarthritis$ mitral and aortic incompetence$ abnormal renal function$ hernia of abdominal cavity$ polyp of colon$ coronary arteriosclerosis$ atrial fibrillation$ aortic valve stenosis$ aortic valve disorder$ cerebrovascular disease$ long term current use of anticoagulant$ sick sinus syndrome$ edema$ gout$ angina co-occurrent and due to coronary arteripolyneuropathy$ essential hypertension$ mixed hyperlipidemia$ chronic kidney disease stage 3$ chronic systolic heart failure$ angina$ prosthetic cardiac paravalvular leak$ prosthetic heart valve in situ$ aortic stenosis-non-rheumatic$ macrocytic anemia$ diarrhea-occasionally$ heart disease$ cerebrovascular accident$ old MI$ Squamous cells carcinoma of skin of face$  long QT syndrome- 6/18/2020 PPM placed.$No known defined allergies.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992154-1$	$0992154-1$	$No adverse events reported post vaccine. 1 st dose on 1/11/21 by public health.  Death 1/31/21 Patient was on hospice for gradual decline.$	$None$	$Alzheimers Dementia late onset without behavioral disturbance$ Hypotension$ benign prostatic hyperplasia$ Left inguinal hernia found 2016$ Left shoulder lesions$ Hypothyroidism$ GERD (gastroesophageal reflux disease)$ Mixed hyperlipidemia$ Basal Cell Carcinoma$ Kyphosis$ Hx of shingles$ dysphagia$ Legally blind LEFT eye$ cataracts both eyes$ frality$ hard of hearing Hospice- general decline in the past year.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992347-1$	$0992347-1$	$Death$	$none known$	$degenerative disc disease$ chronic back pain$ hypothyroidism$ hypertension$ GERD$ COPD$ tobacco dependence$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992571-1$	$0992571-1$	$Patient's wife called the physician's office with increasing SOB.  MD advised that the patient go to the ED.  While dressing$ the patient became unresponsive$ 911 called.  Patient expired in ED.$	$He stated he was experiencing some shortness of breath with cold and walking up the steps.   The patient did report that they had some bloody stool early in the week but that had resolved.$	$PMH: DM$ HTN$ Obesity$ hyperlipidemia$ Chronic kidney Disease$ polyp?s removal. History of Angioedema secondary Ace Inhibitor$ACE inhibitor$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992846-1$	$0992846-1$	$Patient complained to wife of not feeling well in evening after the vaccination and expired at home during the night.$	$CRT-P upgrade on 1/7/2021 Pacemaker 0107 on 1/7/2021$	$Acute MI; arthritis; atrial fibrillation; bleeding; bronchitis; bypass; cholecystitis; chronic anemia; COPD; CKD; CAD; Heart block Hypercholesteremia; HTN; hypothyroidism; MI$CeleBREX-GI Bleed Morphine-urticaria$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992977-1$	$0992977-1$	$spoke with patient husband on Saturday 1/23 and he said that she had been in the hospital. that she had had a stroke$ the MD's at the hospital told him that it was not contributed to the vaccine and that they were unsure even if the stroke had occurred prior to the vaccine or after. spoke with him again on 1-29 and he stated that she had passed away on 1/25/21$	$unsure$	$unsure$cephalosporins$ sulfa$ penicillins$ opiods$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0994544-1$	$0994544-1$	$The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. She was eating breakfast after at home and complained to a neighbor that her teeth hurt and she was nauseated after eating. In the afternoon$ she felt dizzy and had diarrhea accompanied with blood. Close to 9 PM$ her son went to check on her. The patient was found on the floor--she was unresponsive and had purple lips. Her son called an ambulance and started chest compressions. The patient passed away at the hospital. The doctor has ordered an autopsy$ and the results are pending.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0994778-1$	$0994778-1$	$Resident received the vaccine on 1-22-21 and she was diagnosed with COVID-19 during routine testing on 1-28-21.  She didn't have any symptoms except feeling weak and she had a decrease in her appetite.  She already had a poor appetite prior.  She died on 2-2-21.$	$No current illness for this event.$	$OTHER INTERVERTEBRAL DISC DEGENERATION$ LUMBAR REGION$ Macular Degeneration$ Anorexia$ Peripheral Vascular Disease$ Cardiac Arrhythmia$$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0995147-1$	$0995147-1$	$Death Narrative: Patient received the first COVID-19 dose on 12/23. Afterwards$ patient complained of localized pain on L deltoid area where the vaccine was administered; his temperature was 98.1 F. On 12/26-27$ staff reported that patient appeared more fatigued than usual and was shivering on 12/27$ which seized after blanket was given. On 12/28$ patient presented with fever (Tmax 100.2 F) and acetaminophen was administered for alleviation of fever. ADR was reported for the fever on 12/29. Patient continued to decline and was placed back on hospice care on 12/29; on 12/30. the symptoms reported on nursing note include erythema and pain on whole L arm. Lidocaine was applied. Patient's family and provider mutually agreed not to administer the second dose of vaccine. He continued to decline and was started on end-of-life care around 1/4 and passed on 1/20 1417.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0995224-1$	$0995224-1$	$Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old$ female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm$ severe abdominal pain$ muscle aches and cardiac arrest.    The patient's medical history was not provided Concomitant product use was not provided by the reporter.  On 14 Jan 2021$ approximately five days prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 19 Jan 2021$ the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later$ the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol.   Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died.   The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest$ upper right chest pain and underneath the arm$ severe abdominal pain$ muscle aches.  The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown$ expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine$ in the absence of critical details such as the patient's medical history$ any diagnostic test or autopsy result$ adequate evaluation and assessment cannot be established. Main field defaults to وpossibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0995825-1$	$0995825-1$	$Client unexpectedly collapsed and passed away on 1/13/21 from suspected sudden cardiac death.  Prior to her death$ she was in skilled care for rehabilitation following hospitalization from 12/21-12/31/20 for an acute lower GI bleed.  Her hospitalization and skilled care stay were complicated by delirium and she was being treated for delirium with olanzapine (Zyprexa) at time of death.$	$Acute lower GI bleed (diverticular bleed) occurred in 12/21/2020 and hospitalization from 12/21-12/31/20 complicated by delirium$	$Type 2 DM HLD Macular degeneration Hearing loss HTN Hypothyroidism  Osteopenia$Statins$ ace inhibitors$ hydrocodone$ metformin$ codeine$ metoprolol XL$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0996259-1$	$0996259-1$	$Unknown. Was informed that the patient went to E/R on 1/25/21 (6 days after receiving vaccine. Died 1/29/21 ( 10 days after receiving vaccine).$	$COPD$ Chronic Hypoxemic respiratory failure$ Chronic bronchitis$ Atrial Fibrillation$ OSA on CPAP$	$COPD$ Chronic Hypoxemic respiratory failure$ Chronic bronchitis$ Atrial Fibrillation$$Wellbutrin$ Niaspan$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0996423-1$	$0996423-1$	$Patient had a CVA and passed away suddenly 1/10/21$	$No current illness for this event.$	$Wife reported patient had diabetes and high blood pressure.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0997297-1$	$0997297-1$	$Death on 1/17/21.  Death certificate reports:  Septic Shock$ UTI$ Pneumonia$ Chronic Renal Failure$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0997677-1$	$0997677-1$	$Rapid decline in health status$ Elevated BP&P$ posturing$ loss of consciousness$ Glasgow coma Scale 4  starting 2/1/2021$ Deceased 2/3/21$	$No current illness for this event.$	$PULMONARY FIBROSIS$ CHRONIC RESPIRATORY FAILURE WITH HYPOXIA$ CHRONIC OBSTRUCTIVE PULMONARY DISEASE$ HYPOTHYROIDISM$ HYPERTENSION$ IRON DEFICIENCY ANEMIAS$Amlodipine$ Ciprofloxacin$ Citalopram$ Codeine$ Penicillin$ traMADol$ Spiriva Respimat$ Sulfa Antibiotics$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0998228-1$	$0998228-1$	$Found unresponsive$	$COPD Gastro-espohageal reflux Osteoarthritis Essential Hypertension Dermatitis COVID-19$	$$NONE$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0998421-1$	$0998421-1$	$Resident passed away unexpectedly on 1/27/21 from presumed sudden cardiac death.$	$Basal cell carcinoma of right ear$	$Parkinson's  CAD Labile HTN Renal artery stenosis HLD Basal cell carcinoma Squamous cell carcinoma BPH Prostate CA Urge incontinence Mild cognitive impairment$Verapamil Amlodipine Morphine Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0998463-1$	$0998463-1$	$Resident passed away unexpectedly on 01/19/21 after developing acute hypoxic respiratory failure on morning of 01/19/21.  She was transferred to hospital via EMS  where she was intubated$ coded$ and ultimately expired with uncertain underlying cause$ potentially ACS.$	$pneumonia$ acute hypoxic respiratory failure$	$HTN HLD Osteoarthritis osteoporosis impaired mobility secondary to avascular necrosis or right humeral head$ and s/p ankle fusions$ bilateral knee replacements  Sciatica open angle glaucoma$horse chesnut seed extract$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0998544-1$	$0998544-1$	$Patient had heart attack.   Spoke with spouse on 2/3/2021 stated had multiple health issues including heart and lung issues.$	$diabetes$  heart trouble$  dementia$	$as above$Morphine  and iodine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0998770-1$	$0998770-1$	$Patient had no symptoms or adverse events until the next evening after shot (1/29/21) where daughter reported her having heart palpitations. Family told her to rest and did not seek medical attention. Saturday afternoon (1/30/2021)$ patient started experiencing labored breathing. Daughter called 911 and before the ambulance arrived$ the patient's breathing became more and more shallow. Patient was taken to the local hospital and passed away Saturday evening around 5:30 pm.$	$No current illness for this event.$	$High blood pressure High Cholesterol Diabetes Restless Legs syndrome depression/anxiety$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002187-1$	$1002187-1$	$PATIENT WAS IN CLINIC FOR 1ST CLINIC. WAS DISCHARGED BEFORE OUR 2ND CLINIC. HE CAME BACK TO OBTAIN HIS 2ND SHOT. WE WENT OUT TO THE CAR GAVE SHOT. THE NEXT DAY TO MY KNOWLEDGE$ HE STARTED CODING AT HOME. AMBULANCE WAS CALLED AND HE CONTINUED TO CODE. THE AMBULANCE CREW TRIED CPR FOR 30 MINS WITH NO LUCK. PATIENT PASSED 2-3-21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002229-1$	$1002229-1$	$spontaneous death$ found  unresponsive in cell after normal morning activities$	$none known$	$CAD with stent placement 2000$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002813-1$	$1002813-1$	$Patient was seen at 0710 he was sleeping but at normal cognitive behavior Patient was again assessed at 0720 where he was noted to be unresponsive$ BP 180/100s$ HR 230s$ he was a DNR therefore not CPR was administered. EMS arrived at facility patient was noted to be in full cardiac and respiratory arrest. Time of death 0735$	$None$	$medical diagnosis chronic conditions Epilepsy$ alzehimer's disease$ acute resp. failure$ non-st MI$encephalopathy$ ETOH use$ claucoma$ anxiety/depression$ HTN$ macular degeneration$ extropia$ presbyopia$ hearing loss$$no allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002840-1$	$1002840-1$	$Client lives alone and had dinner at his home with family members after the 4:40 appointment. Client stated that in general he did not feel well but did not give any specific symptom. Family states they asked the client to go to the ER and the client refused. Family states they helped the client to his chair in the living room and then left to go home. Family states that the client was found in his bedroom the next morning at 7:54 a.m. deceased.$	$none$	$DM II$ HTN$ Hyperlipidemia$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002931-1$	$1002931-1$	$CARDIAC ARREST$ DEATH Narrative: The patient presents to the emergency department in cardiopulmonary arrest. CPR was continued upon arrival. The Combi tube was removed and an endotracheal tube was placed without complications. ROSC was obtained multiple times but the patient continued to go into PEA. The patient was seen in the emergency department by both critical care and Cardiology. EKG shows ST elevations$ but the patient was unstable to go to catheterization. The patient had 1 episode of asystole. Despite best efforts and multiple attempts we were unable to resuscitate the patient. Time of death 1253 on 1/24/21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1003390-1$	$1003390-1$	$On 2/1/2021$ the patients daughter$ who claims is a nurse$ reported this incident to me.  She stated that the evening after the patient received the vaccine$ she felt some mild injection site pain.  The morning after$ the patient reported severe abdominal pain$ diarrhea and vomiting.  The patients daughter then called her physician to report these symptoms and attributed them as an adverse reaction to the vaccine at that time.  These symptoms were intermittent for one week and no other adverse reactions were noted.  In the early morning hours of 1/27/2021$ the patient was toileting and had expired while doing so.  An ambulance was called and cause of death was not found. An autopsy was not performed.$	$No current illness for this event.$	$$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1004206-1$	$1004206-1$	$$Death; A spontaneous report was received from a nurse concerning a 91-year-old$ female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died two days later.  The patient's medical history included dementia.  Concomitant medications reported included paracetamol.  On 21 Jan 2021$ approximately two days prior to her death$ the patient received the first of two planned doses of mRNA-1273$ intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021$ the patient died.  The nurse reporting the event stated that the patient's death was considered as due to $$natural causes$$ and that she was not aware of any new-onset symptoms of illness prior to the patient's death.  The patient was described as $$fragile$$ and was under hospice care at the time of her death.  An autopsy was not performed.  Action taken with the drug in response to the event is not applicable.  The patient died on 23 Jan 2021. The cause of death was natural cause of death related to dementia. Autopsy was not performed.; Reporter's Comments: This case concerns a 91-years-old female patient$ with medical history of dementia$ who experienced a serious unexpected event of death. This event occurred 2 days after first dose of mRNA-1273$ lot # unknown. At the time of death$ the subject was very fragile and was in hospice care. Concomitant medication included Tylenol. Treatment details were not provided. The doctor considered that the death was due to natural causes. However$ autopsy was not performed. Very limited information regarding this event has been provided at this time.  Based on the limited information available$ it is difficult to assess a cause and effect relationship. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Natural cause of death related to dementia$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No adverse event was reported.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1004956-1$	$1004956-1$	$Wife reported patient expired on 2/3/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005130-1$	$1005130-1$	$Report of patient expired on 2/3/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005217-1$	$1005217-1$	$Nursing home called 911 for decline in condition.  Patient transported to ER where she was admitted to inpatient care and expired 1/30 at 16:13$	$No current illness for this event.$	$asthma$ CHF$ Hypokalemia$ hypothyroidism$Morphine$ penicillin$ quinidine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005276-1$	$1005276-1$	$chills 1 day after vaccine administration; found dead by family 1/18/2021 Narrative:  Per patient family report$ patient said the next day after vaccination that he didn't feel well because of chills. Patient was found dead at home by his family on January 18th. He was a 74yo man with castrate resistant prostate cancer and liver and bone metastases with rising PSA$ status post intravenous chemotherapy 1/7/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005377-1$	$1005377-1$	$$Significant other reported  patient expired $$a week before 2nd vaccine was due$$0$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005455-1$	$1005455-1$	$We don't know what happened. 25 hours after the shot$ he started gagging and stopped breathing. He was pronounced at OSF at 8:07pm after we took him off life support.$	$Gallbladder not working$ one kidney functioning at 25%$	$Rheumatoid arthritis$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005568-1$	$1005568-1$	$Pt. deceased.$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006216-1$	$1006216-1$	$Notes of the checks/events with resident:  18:36 2/2/21  Resident had no complaint of pain$ swelling$ redness or warmth to vaccine site.  No signs and symptoms of fever$ chills$ tiredness or headache. T 97.2 02:50 2/3/2021  Resident received 2nd COVID vaccine.  No complaint of pain$ swelling$ redness or warmth to vaccine site.  No signs and symptoms of fever$ chills$ tiredness or headache. T 98.1 07:15 2/3/2021  Resident was observed not breathing.  911 was contacted along with the doctor.  Resident was confirmed having passed away.$	$None$	$ESSENTIAL (PRIMARY) HYPERTENSION ATRIOVENTRICULAR BLOCK$ COMPLETE NONRHEUMATIC AORTIC (VALVE) STENOSIS WITH INSUFFICIENCY PAROXYSMAL ATRIAL FIBRILLATION HYPOXEMIA BRADYCARDIA$ UNSPECIFIED PRESENCE OF UROGENITAL IMPLANTS$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006228-1$	$1006228-1$	$2/2/21-1000-patient presented to the local emergency room with complains of fever$ shortness of breath and decreased oxygen sats. temp 101.7$ pulse 102$ respirations 36$ BP 141/92$ oxygen 94%. Lung sounds crackles bilaterally with rhonchi on the left. patient worked up for sepsis$ CXR shows mild atelectasis. blood pressure dropped$ and continued to drop through treatment requiring levophed drop to be initiated. Patient POA determined that this would not be her sister's wishes and made the decision to make patient comfort care status.  2/3/21- patient lethargic throughout night. 0640-patient demise.$	$none known.$	$atrial fibrillation$ hypertension$ high cholesterol$ PUD$ kidney stones$ osteoarthritis$ osteoporosis$ seizure$ anxiety$ depression$ hypothyroidism$ melanoma$cephalosporins$ codine$ diazepam$ morphine$ penicillins$ phenobarbital$ sulfailamide$ clindamycin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006289-1$	$1006289-1$	$death- 2/1/2021$	$none$	$HTN: Renal failure with hemodialyis; hypercholesterolemia; reflux; behavioral disorders$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006303-1$	$1006303-1$	$death- 2/1/2021$	$none$	$CVA; HTN; vascular dementia; BPH; neurogenic bladder; COVID positive on 9/12/2020.$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006316-1$	$1006316-1$	$death- 2/2/2021$	$none$	$Trach; tube feeder; ileostomy; HTN; CAD; HLD; hypothyroidism; renal cell carcinoma; prostate cancer; Previously COVID positive but unkown date- it was before entering nursing home.$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006577-1$	$1006577-1$	$Patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006633-1$	$1006633-1$	$EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH  AND CHEST AND BACK PAIN.  SHE CODED WHEN SHE GOT IN THE ER AND LATER PASSED AWAY THE MONDAY.   DIAGNOSIS WAS PNEUMONIA AND HEART FAILURE PER STEP DAUGHTER.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1007033-1$	$1007033-1$	$Patient presented to emergency room on 2/1/2021 with a chief complaint of having a chronic headache  and fatigue following receipt of the Moderna vaccine 10 days prior.  Following examination by the physician$ the patient was diagnosed with an acute subdural hematoma. The patient subsequently underwent decompressive surgery$ however demonstrated worsening neurologic status over the next several days and ultimately expired on 2/4/2021.$	$History of headaches$	$Memory impairment$ headaches$ hypertension$ prostate cancer$ prior stroke$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1008041-1$	$1008041-1$	$itchy skin$ swelling$ disorientation that led to a fall$	$gout$	$congestive heart failure diagnosis$ alzheimers$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1009813-1$	$1009813-1$	$Patient became immobile on 1/25/21 (4 days after receiving Moderna COVID-19 vaccine). He died on 1/27/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1009866-1$	$1009866-1$	$pt was given vaccine on the afternoon of 01-29-2021. Pt was administered the moderna covid-19 shot into the deltoid muscle of this pt. Pt was observed and left pharmacy. on 2-6$ pts daughter calls pharmacy$ and says the night of 1-29$ after recieveing the vaccine$ her mother had a hemmorhagic stroke and passed away$	$unknown new pt$	$unknown$penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1010989-1$	$1010989-1$	$Brain aneurysm; Anaphylactic reaction; Collapsed; BP sky rocketed; Shortness of breath; A spontaneous report was received from a consumer concerning a 69-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blood pressure skyrocketed$ shortness of breath$ loss of consciousness$ massive anaphylactic reaction$ and brain aneurysm.    The patient's medical history$ as provided by the reporter$ included high blood pressure and arthritis. Products known to have been used by the patient$ within two weeks prior to the event$ included an antihypertensive.   On 04 Jan 2021$ prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  Twenty-two minutes later she had a massive anaphylactic reaction. She experienced shortness of breath$ blood pressure skyrocketed$ and loss of consciousness. She was taken to the emergency room. The patient had a brain aneurysm and never recovered. No treatment information was provided.   The patient died on 04 Jan 2021. The cause of death was reported as brain aneurysm. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 69-year-old$ female patient with a medical history of hypertension$ who experienced fatal$ serious$ unexpected events of Anaphylactic reaction$ hypertension$ dyspnea$ loss of consciousness and brain aneurysm. The events occurred 22 minutes after the first dose of mRNA-1273 was administered. No treatment information was provided. The patient never recovered and died. The cause of death was reported as brain aneurysm. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event$ a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Brain aneurysm$	$Arthritis; Hypertension$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011362-1$	$1011362-1$	$Patient's son came to the vaccine clinic today 2/8/2021$ stated that his father 2/24/1948 passed away the same day as the vaccine.$	$No current illness for this event.$	$COPD Diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011487-1$	$1011487-1$	$Received Covid vaccine in am.  Last seen by family at 17:30 pm and observed to be well. About an hour later he collapsed$ unresponsive.   A 911 call was initiated at 18:29.  Paramedics arrived to find the patient in cardiac arrest.  CPR/ACLS was initiated$ but resuscitation was unsuccessful.  Pt. was transported to MC where he was pronounced dead at 19:32.  There was no sing of an injection site reaction$ nor of allergic reaction..$	$No current illness for this event.$	$ESRD (dialysis fistula)$ peripheral vascular disease (R mid-foot amputation)$ cardiac disease (pace-maker)$ malnutrition (cachexic)$ possible liver disease (distended abdomen)$Protein Supplement$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011577-1$	$1011577-1$	$Resident expired on 2/5/21 at 03:35pm$ about 25 hours after second dose of vaccine. At breakfast$ resident was spitting a lot of secretions$ coughing up liquids from nose and phlegm$ facial swelling$ which were all symptoms that he was struggling with prior to both doses of COVID vaccine$ but had increased more than prior incidences on 2/5/21. Gurgling noted in upper airways$ hyscolamine given$ bath given to loosen secretions$ morphine given. Family notified and came into facility for compassionate care visit around 1300. 1400 HR was 3 and RR was 2$ but increased back to 60 and 12 within 20 minutes. Then resident expired at 1535.$	$Was started on hospice between first dose of vaccine (1/7/21) and second dose (2/4/21)$ primarily for inability to control fluid balance due to heart failure and kidney failure. Started to have increased edema and respiratory symptoms (nasal drainage$ raspy voice but denied sore throat) and tested negative for COVID twice starting 1/5/21 and 1/7/21 (day of first vaccine)$ and once again after the vaccine$ increased confusion at that time and continued between vaccination. Later the nasal drainage was attributed to fluid overload. UTI on 1/11/21. Hospice referral by MD on 1/15/21.$	$History of type 2 diabetes$ benign prostatic hyperplasia$ heart failure$ hypertension$ constipation$ vitamin D deficiency$ hypothyroidism$ chronic kidney disease stage 3$ insomnia$ tinea corporis$ macular degeneration$ polyosteoarthritis$ UTIs. Short term memory difficulties. Resided in LTCF for 3 years prior to death.$no known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011732-1$	$1011732-1$	$patient passed away with in 60 days of receiving COVID vaccine series$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011774-1$	$1011774-1$	$Cardiac arrest resulting in death on the third day post vaccine administration$ 0224. Reported syncopal event post toileting. Rescue measures attempted but not successful. Time of death 0358$ 02/06/2021.$	$CAROTID ARTERY STENOSIS CORONARY ARTERY DISEASE PACEMAKER CABG$ 4-VESSEL BPH$	$SAME AS ABOVE$NONE KNOWN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011894-1$	$1011894-1$	$patient passed away within 60 days of receiving COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011929-1$	$1011929-1$	$Within a few days$ my mother started reporting profound fatigue and shortness of breath while conducting routine household activities. She no longer had to energy for her daily exercise walks and became increasingly lethargic. She died in her sleep while taking an afternoon nap on Thursday$ February 4th. I am highly concerned this could be a vaccine related.$	$none$	$hypercholesterolemia$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011935-1$	$1011935-1$	$Patient received his second dose of Moderna COVID vaccine on 2/6 at 12:40PM. Patient was observed for 15 minutes post-vaccination with no adverse events. On the evening of 2/6 (time unknown) the patient began to develop dry cough and fatigue. He was checked by a physician at that time (who was a family member). Patient continued to feel unwell into Sunday. His lungs were clear when checked Sunday afternoon (time unknown). At approximately 5:30pm on 2/7 the patient began experiencing sudden onset shortness of breath. A pulse ox was conducted at that time and it was 92%$ and again shortly thereafter and it was 90% (as reported by family member). 9-1-1 was contacted at this time. CPR was initiated when he arrived at the emergency department$ pulse ox was 60%  (as reported by family member). The patient passed away shortly thereafter on 2/8/2021.$	$Unknown$	$Unknown$No known drug/food allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012604-1$	$1012604-1$	$Death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012894-1$	$1012894-1$	$1-2 days after vaccine$ pt developed weakness$ fatigue$ body aches$ nausea$ headache and poor appetite.  Pt was admitted to the hospital on 2/5/21 and death occured on 2/6/21$	$Anxiety A. Fib Cardiac Pacemaker Cerebral Infaction CHF Urinary Incontinence$	$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1013041-1$	$1013041-1$	$Vaccine was administered on 1/15/2021 and death occurred on 1/31/2021.$	$None$	$Heart failure$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1013087-1$	$1013087-1$	$Patient received vaccine on 1/23/2021 and death occurred on 1/30/2021.$	$None$	$Heart problems$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1014628-1$	$1014628-1$	$Death within 8 hours.$	$none$	$melanoma$ skin cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1014740-1$	$1014740-1$	$Patient found down at home with agonal respirations and per EMS asystole$ received 2 rounds of epi at her house with return of spontaneous pulses$ lost pulse again in route to ER and another round of epi was given$ CPR in progress when arrived at hospital.  Prior to this patient's husband states he heard her fall in the bathroom but did not immediately check on her as he states that this has happened before.  He checked on her 10 min later and that's when he found her unconscious.  Daughter called 911 and she began CPR.  No previous complaints of headache$ chest pain$ back pain$ fever or chills.  Husband states patient was drinking that evening which is not unusual for her.  Patient died at hospital.$	$no acute illnesses$	$HTN$ Cavernous hemangioma of liver$ RBBB$ hx of bilateral carotid bruits$ hx of squamous cell carcinoma of right hand$ arthralgia of both knees$ spondylolisthesis at L3-L4$ DDD thoracic$ ovarian cyst$ hx of pneumonia$ cholelithiasis w/o obstruction$ liver lesion$ depression$ hyperlipidemia$ hypercalcemia$ vitamin d deficiency$ osteoporosis$ former smoker$ depression$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1014774-1$	$1014774-1$	$We were informed the patient passed away 2 days after receiving the vaccine.  We do not have any details about what happened$ we were informed by one of his employees.   We have no knowledge that this had anything to do with the vaccination in any way.$	$Unknown$	$None Reported$None Reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1014865-1$	$1014865-1$	$He had not been feeling well after his second Covid vaccination (on 01/23/2021) and was found unresponsive in his room at the nursing home (late evening on 02/02/2021). He was taken to a hospital where they did tests and he had pneumonia and kidney failure$ but he was being transferred to a larger hospital when he arrested and died (02/03/2021)$	$Tested positive for Covid in November$	$Muscular dystrophy$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1015465-1$	$1015465-1$	$DISCOVERED UNRESPONSIVE WITHOUT PULSE$ RESPIRATIONS$ HEART BEAT ON 2/7/21 AT 0435 A.M. RESIDENT WAS DNR STATUS.$	$U07.1 2019-nCoV acute respiratory disease (Primary) N39.0 Urinary tract infection$ site not specified (Admission) K21.9 Gastro-esophageal reflux disease without esophagitis  G89.4 Chronic pain syndrome  E66.01 Morbid (severe) obesity due to excess calories  M54.2 Cervicalgia  F41.9 Anxiety disorder$ unspecified (History of) G47.00 Insomnia$ unspecified  E11.29 Type 2 diabetes mellitus with other diabetic kidney complication  E03.9 Hypothyroidism$ unspecified  F06.30 Mood disorder due to known physiological condition$ unspecified  I50.22 Chronic systolic (congestive) heart failure  I10 Essential (primary) hypertension  M81.0 Age-related osteoporosis without current pathological fracture  Z95.0 Presence of cardiac pacemaker  F39 Unspecified m$	$U07.1 2019-nCoV acute respiratory disease (Primary) N39.0 Urinary tract infection$ site not specified (Admission) K21.9 Gastro-esophageal reflux disease without esophagitis  G89.4 Chronic pain syndrome  E66.01 Morbid (severe) obesity due to excess calories  M54.2 Cervicalgia  F41.9 Anxiety disorder$ unspecified (History of) G47.00 Insomnia$ unspecified  E11.29 Type 2 diabetes mellitus with other diabetic kidney complication  E03.9 Hypothyroidism$ unspecified  F06.30 Mood disorder due to known physiological condition$ unspecified  I50.22 Chronic systolic (congestive) heart failure  I10 Essential (primary) hypertension  M81.0 Age-related osteoporosis without current pathological fracture  Z95.0 Presence of cardiac pacemaker  F39 Unspecified mood [affective] disorder  C85.84 Other specified types of non-Hodgkin lymphoma$ lymph nodes of axilla and upper limb  C82.94 Follicular lymphoma$ unspecified$ lymph nodes of axilla and upper limb  F31.62 Bipolar disorder$ current episode mixed$ moderate  K59.09 Other constipation  Z45.2 Encounter for adjustment and management of vascular access device  D64.9 Anemia$ unspecified  Z79.01 Long term (current) use of anticoagulants  Z51.81 Encounter for therapeutic drug level monitoring  M17.9 Osteoarthritis of knee$ unspecified  M15.0 Primary generalized (osteo)arthritis  I87.2 Venous insufficiency (chronic) (peripheral)  F31.9 Bipolar disorder$ unspecified  C85.89 Other specified types of non-Hodgkin lymphoma$ extranodal and solid organ sites  I73.9 Peripheral vascular disease$ unspecified  F32.9 Major depressive disorder$ single episode$ unspecified  I89.0 Lymphedema$ not elsewhere classified  Q24.5 Malformation of coronary vessels  I42.8 Other cardiomyopathies  E03.9 Hypothyroidism$ unspecified  J30.9 Allergic rhinitis$ unspecified  Z86.718 Personal history of other venous thrombosis and embolism  R33.9 Retention of urine$ unspecified  K42.9 Umbilical hernia without obstruction or gangrene  Z90.89 Acquired absence of other organs  R20.8 Other disturbances of skin sensation  L03.111 Cellulitis of right axilla  I87.2 Venous insufficiency (chronic) (peripheral)  Z87.81 Personal history of (healed) traumatic fracture  H04.121 Dry eye syndrome of right lacrimal gland  R42 Dizziness and giddiness  R53.81 Other malaise  F48.2 Pseudobulbar affect  R06.02 Shortness of breath  H26.9 Unspecified cataract  C85.80 Other specified types of non-Hodgkin lymphoma$ unspecified site  H53.2 Diplopia  E11.51 Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene  G89.4 Chronic pain syndrome  E78.5 Hyperlipidemia$ unspecified  G47.33 Obstructive sleep apnea (adult) (pediatric)  G60.8 Other hereditary and idiopathic neuropathies  K57.92 Diverticulitis of intestine$ part unspecified$ without perforation or abscess without bleeding  I48.91 Unspecified atrial fibrillation  J02.9 Acute pharyngitis$ unspecified (Preliminary) F31.63 Bipolar disorder$ current episode mixed$ severe$ without psychotic features  Z46.89 Encounter for fitting and adjustment of other specified devices  R09.81 Nasal congestion  Z46.89 Encounter for fitting and adjustment of other specified devices  M25.562 Pain in left knee  L53.9 Erythematous condition$ unspecified  R29.3 Abnormal posture  F31.30 Bipolar disorder$ current episode depressed$ mild or moderate severity$ unspecified  T81.30XA Disruption of wound$ unspecified$ initial encounter  R05 Cough (Preliminary) F31.64 Bipolar disorder$ current episode mixed$ severe$ with psychotic features  S28.222A Partial traumatic amputation of left breast$ initial encounter  Z48.3 Aftercare following surgery for neoplasm  F31.64 Bipolar disorder$ current episode mixed$ severe$ with psychotic features  R41.841 Cognitive communication deficit  N63.0 Unspecified lump in unspecified breast  H25.012 Cortical age-related cataract$ left eye (Preliminary) H25.011 Cortical age-related cataract$ right eye (History of) H25.091 Other age-related incipient cataract$ right eye  Z23 Encounter for immunization  Z74.1 Need for assistance with personal care  M62.81 Muscle weakness (generalized)  K59.00 Constipation$ unspecified  I49.9 Cardiac arrhythmia$ unspecified  E55.9 Vitamin D deficiency$ unspecified (History of) L23.9 Allergic contact dermatitis$ unspecified cause (History of) F33.8 Other recurrent depressive disorders (History of) Z11.1 Encounter for screening for respiratory tuberculosis  D51.9 Vitamin B12 deficiency anemia$ unspecified (History of) R13.11 Dysphagia$ oral phase  N18.31 Chronic kidney disease$ stage 3a  G44.021 Chronic cluster headache$ intractable (Preliminary) C50.912 Malignant neoplasm of unspecified site of left female breast$Iodinated Contrast- Oral and IV Dye$ Penicillins (PCN)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1015773-1$	$1015773-1$	$Resident passed away in her sleep. No s/s of adverse events leading up to the residents death. Resident was previously declining- MD stated the vaccine had nothing to do with the death.$	$skin rash$	$Demenita$ GERD$ Heart failure$ Kidney disease$ stage 3$$Lisinipril$ Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1015996-1$	$1015996-1$	$Family reported patient expired 1/31/2021.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1016097-1$	$1016097-1$	$Patient died 02/08/21$	$No current illness for this event.$	$CABG-2014$ CAD$ HTN$ hyperlipidemia$ systolic murmur$ type 2 diabetes$ diabetic neuropathy$ cervical dystonia$ benign essential tremor$ degenerative disc disease$ intermittent claudication$ PVD$ former smoker-greater than 30 pack year$ cervical spinal stenosis$ long-term use of anticoagulant$Hydrochlorothiazide$ ACE inhibitors$  Lisinopril$ Valsartan$ Angiotensin Receptor blockers$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1016155-1$	$1016155-1$	$2/7/2021 at 0630$ resident found in recliner without pulse or respirations. Resident had not been found to have any adverse reactions to the vaccine between the time of the vaccine on 2/4 until found deceased on 2/7.$	$Acute Exacerbation CHF Cellulitis of intergluteal fold due to decubitus ulcer$	$Unspecified Dementia without Behavioral Disturbance Edema Hypokalemia Chronic Bronchitis Heart Failure Vitamin D Deficiency Atherosclerotic Heart Disease of Native Coronary Artery Without Angina Pectoris History of Aortic Stenosis LBBB$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017960-1$	$1017960-1$	$Pt was deceased when we came for second dose. COD unknown to pharmacy.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017971-1$	$1017971-1$	$Pt was deceased when we came for second dose. COD unknown to pharmacy$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017974-1$	$1017974-1$	$Pt was deceased when we came for second dose. COD unknown to pharmacy$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017978-1$	$1017978-1$	$Pt was deceased when we came for second dose. COD unknown to pharmacy$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1018126-1$	$1018126-1$	$Patient received vaccination on 2/4. Patient's wife reported that he felt a slight soreness in his arm the day following the shot$ but had no other symptoms. On 2/8 he passed away. Wife reports that it was related to his heart and they never made it to a hospital. The wife also reported that the patient had been in poor health prior to the vaccination$	$chronic conditions listed below$	$per wife-diabetes$ hypertension$ hypercholesterolemia$ depression$ cvd$ previous stroke$na$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1018146-1$	$1018146-1$	$Four days later$ my father had a severe brain aneurysm.$	$None$	$Type 2 diabetes$ BPH$ gout$ high blood pressure$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1019669-1$	$1019669-1$	$the following morning the patient became unresponsive while taking a shower$ became asystolic and died despite about an hour of ACLS and 8 rounds of epi$	$No current illness for this event.$	$heart failure with EF of 20-30%$  coronary artery disease$ type two diabetes$ obstructive sleep apnea$ diabetic nephropathy$sulfonamides$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1019964-1$	$1019964-1$	$The resident received his COVID-19 Moderna vaccination on 2/6/2021 2:11 pm and expired on 2/7/2021 at 6:04 am.  There were no signs or symptoms of vaccination reaction leading up to death.$	$Peg tube placement  Malignant neoplasm of esophagus$	$Attention and concentration deficit$ Hyperlipidemia$ Acute embolism thrombosis of Deep veins or upper extremity$ cognitive communication deficit$ cerebral infarction$ Dysphagia$ Thrombocytopenia$ Obstructive and reflux uropathy$ Hypomagnesemia$ Allergic rhinitis$ GERD$ Hydronephrosis with renal and ureteral calculous obstruction$ Benign prostatic hyperplasia with lower urinary tract symptoms$ anemia$ ulcerative pancolitis$ cerebral cysts$ chronic obstructive pyelonephritis$ hypo-osmolality and hyponatremia$ HTN$ Vascular dementia with behavioral disturbances$ DM II$  Moderate protein-calorie malnutrition$ Vitamin D deficiency$ Folliculitis$ Hypokalemia$  Aphasia following cerebral infarction$ metabolic syndrome$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020002-1$	$1020002-1$	$Given First Moderna covid vacc 1/19/2021.  Doing well on multiple contacts from health care providers$ then 2/5/2021 was driving$ pulled over to the side of the road into a yard$ got out of the car and told an observer that he could not breathe$ collapsed face down in the snow$ EMS called$ unable to revive him.$	$CHF$	$CHF$ DM$ CAD$ CKD$ Sleep apnea$ COPD$cyclobenzaprine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020018-1$	$1020018-1$	$Patient reported to be unresponsive on the morning after receiving his second dose of Moderna COVID-19 vaccine.  Patient had expired during the night.$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020079-1$	$1020079-1$	$Received Moderna covid vaccination 1/14/2021. 1/16/2021 received report of cough and difficulty breathing.  Proceeded to hospital and was diagnosed Covid+ on testing. Continued to decline$  died 1/31/2021.$	$No current illness for this event.$	$Ischemic Cardiomyopathy$  Coronary Artery Disease (MI x2 1989 and 1995)$  VT (ablation 2009) with Boston Scientific ICD Sick Sinus Syndrome (PPM)$  Type 2 Diabetes$  Chronic Kidney Disease$  Hypertension$  Hyperlipidemia  Peripheral Vascular Disease$  Parkinson's Disease Antiphospholipid Antibody Syndrome  Heparin Induced Thrombocytopenia$Heparin Atorvastatin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020195-1$	$1020195-1$	$Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening shortness of breath. Went to hospital  and diagnosed with anemia$ 4 negative fecal tests$ neg EGD and colonoscopy.  Discharged and readmitted (circumstances unknown for this episode) then readmitted a third time 1/20/2021 for shortness of breath. Diagnosed covid + at third hospitalization and continued to get worse.  He died 1/23/2021.$	$None$	$HTN$ Osteoarthritis$ brain aneurysm$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020227-1$	$1020227-1$	$This is the patient who passed away 2d after his second COVID vaccine. Of note$ the 2/8 telephone note makes it sound like he was hospitalized at time of death - that is incorrect. His daugther  listed as EM contact works in the eye clinic here. He had mild illness$ completed 10d isolation but missed his scheduled booster dose on 2/2 due to isolation. He was called on 2/5 when there was a booster visit cancellation and received his booster dose on that day. His daugther reported that he was doing fine and looking well on 2/7 AM$ ate breakfast$ shortly after stood up and just collapsed.$	$Pt had COVID with symptom onset 1/27/21$ pos test 1/28/21 admitted to Hosptial and was treated w/ remdesivir at $ discharged 1/30 on Dexamethasone 6mg daily$ no need for O2 supplement. First moderna COVID vaccine was 1/5/21.$	$1)*AU SEVERE LOSS  2)Anemia -   3)Tubular adenoma of colon -   4)*SCLERAL PLAQUE EXCISION OS - STILL PO 2+ MONTH  5)Osteoarthritis - bilateral knees...worse in right knee    -QUALIFIERS:    Severity Moderate to severe  6)Chronic obstructive lung disease -   7)Onychomycosis - x10     -QUALIFIERS:    Severity Mild to moderate    Clinical course Chronic  8)Artificial lens present - OU  9)Hypermetropia - OD 10)Presbyopia - OU 11)Regular astigmatism - OD 12)Arcus of cornea - OU 13)Scarred macula - OS 14)Osteoporosis -  15)Osteoarthritis of knee -  16)Hypothyroidism -  17)Benign prostatic hyperplasia -  18)Hip pain$ Right - Had right hip fracture pinning and has post traumatic DJD 19)Chronic pain -  20)Dry eyes -  21)Sensorineural hearing loss$ Bilateral -  22)Nonexudative age-related macular degeneration$ Bilateral -$Allergies: CODEINE$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020684-1$	$1020684-1$	$Patient received vaccine at Public Health Clinic. Patient ended up having a seizure 3 days later and ended up in the hospital. Found to have right lobe pneumonia and low depakote level. Patient noted to have multiple seizures at hospital$ issues with stabilizing HR and BP$ and passed away on 1/20/21.$	$No current illness for this event.$	$history of seizure disorder$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020749-1$	$1020749-1$	$Patient had no reaction at the clinic.  Patient is a medical doctor whose partner called in this death.  States patient had no  complaint on 1/13 nor 1/14 while at work.  States patient died at home on 1/15 a.m.  Physician who stated she was called to the patient's home @ 0157 1/15/2021 and found cyanotic from head to toe.  State girlfriend found him sitting in the chair a few minutes before they called her.  The Coroner did not order autopsy.  Did not sent patient to the hospital.  Sent him directly Funeral Home.  Death Certificate Number 123-2021-002593 list cause of death as pending.  I spoke with the patient's primary doctor who gave me the history of HTN$ Diabetes$ & High Cholesterol.  States he had not seen this patient since April 2020.  They were also friends and he was not aware of any medical problems.   The Coroner state she thinks patient has a heart attack.   Neither the Coroner nor PMD think death was related to COVID Vaccine.    Informed both that MSDH would have to complete VAERS.  Both voiced understanding.$	$Unknown$	$HTN$ Diabetes$ High Cholesterol$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020830-1$	$1020830-1$	$This resident of the assisted living facility received his Covid-19 Moderna (1st) vaccination and he  has a leaking Aortic Aneurysm which resulted in hospitalization  and he entered into  Hospice care on 1.30.2021 and passed away on  1.30.2021.$	$Leaking Aortic Aneurysm -$	$Aortic Aneurysm$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021038-1$	$1021038-1$	$Patient had passed since the first dose was given.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021045-1$	$1021045-1$	$Patient had passed since the first dose was given.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021052-1$	$1021052-1$	$Patient had passed since the first dose was given.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021058-1$	$1021058-1$	$Patient had passed since the first dose was given.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021171-1$	$1021171-1$	$Patient received first dose of Moderna COVID-19 vaccine on 2/3/21.  Primary Care physician received call from coroner's office 2/8/21 asking for information contributing to cause of death.  Per Primary Care Physician notes$ wife states she and patient took turns shoveling snow on 2/4/21.  On one trip back into the house she found him unresponsive on the floor and called 911.  Paramedics were unable to revive patient and he passed away (2/4/21).$	$Hypertension$ chest pain x 1 month$ nausea (1/18/21 primary care visit); memory loss$ small left cerebellar infarct (neurology 2/1/21)$	$HTN$ CAD$ cerebellar dysfunction$ claudication$ old myocardial infarction$ COPD/dyspnea/sleep apnea$ hx thoracic aortic aneurysm$ CHF$ DM II (insulin dependent)$ CKD stage 3$ anemia$ irregular heartbeat$ PVC$  hx of smoking$ atelectasis$ BPH$ vascular dementia$ angina of effort$ GERD/abnormal barium swallow/DM gastroparesis$ dyslipidemia$ depression$Statin intolerance (muscle tightening)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021919-1$	$1021919-1$	$Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old$ female patient$ who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath$ kidney failure and death.     The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported.   On 06 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Jan 2021$ the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath.  Action taken with mRNA-1273 in response to the events was not applicable.  On 20 Jan 2021$ the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old$ female patient with the medical history of advanced kidney and heart disease$ who experienced fatal unexpected event of dyspnea$ renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown.  Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event$ a causal relationship cannot be excluded.  However$ the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death$	$Heart disease$ unspecified; Renal disease$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022440-1$	$1022440-1$	$$The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a $$severe reaction$$ to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours$ the symptoms were the most severe and he was going to seek medical attention$ but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21$ when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.$$	$None$	$HTN$ hyperlipidemia$ pericarditis (diagnosed in 2014)$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022552-1$	$1022552-1$	$Patient died of cardiac arrest on 01/21/2021$	$Nervous Coronary artery disease of native artery of native heart with stable angina pectoris (CMS/HCC) Acute chest pain Unstable angina (CMS/HCC) ل Circulatory VT (ventricular tachycardia) (CMS/HCC) Occlusion and stenosis of unspecified carotid artery PVD (peripheral vascular disease) (CMS/HCC) Non-rheumatic mitral regurgitation Hypertensive heart disease with chronic systolic congestive heart failure (CMS/HCC) Chronic systolic congestive heart failure (CMS/HCC) Idiopathic hypotension ل Endocrine/Metabolic Mixed hyperlipidemia Hyperkalemia ل Other ICD (implantable cardioverter-defibrillator) in place Increased BMI ل$	$Nervous Coronary artery disease of native artery of native heart with stable angina pectoris (CMS/HCC) Acute chest pain Unstable angina (CMS/HCC) ل Circulatory VT (ventricular tachycardia) (CMS/HCC) Occlusion and stenosis of unspecified carotid artery PVD (peripheral vascular disease) (CMS/HCC) Non-rheumatic mitral regurgitation Hypertensive heart disease with chronic systolic congestive heart failure (CMS/HCC) Chronic systolic congestive heart failure (CMS/HCC) Idiopathic hypotension ل Endocrine/Metabolic Mixed hyperlipidemia Hyperkalemia ل Other ICD (implantable cardioverter-defibrillator) in place Increased BMI ل$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022918-1$	$1022918-1$	$$Resident complained of feeling $$hot$$ at supper time.  Had emesis an hour or so later.  Became hypoxic and was transferred to the hospital emergency room.  Her evaluation in the ED revealed continued presence of UTI$ leukocytosis (19.8)$ and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics.  She expired 2/6/2021$$	$Urinary Tract Infection$	$Atrial fibrillation$ heart failure$ Gerd$ Dysphagia$ PVD$ dementia$ anxiety disorder$ osteoarthritis$Ciprofloxacin$ Shellfish$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1023061-1$	$1023061-1$	$Pt received the vaccine on 1/30/21  Pt reported symptoms of left armpit pain to wife on 2/7/21$ went to work 4 am 2/8/21 and found face down$ dead at work later that morning. Pt worked at a pet store$ per wife he did complete his tasks and generally comes home by 7:30 am. Wife called when pt did not come back home and he was found dead.$	$pt had teeth pulled for possible dental implants $ non ulcer dyspepsia$ treated for diverticulitis 1/6/21$	$COPD; hypothyroidism; cricopharyngeal achalasia post surgical treatment$ aortic atherosclerosis$ hx of perforated ulcer from aspirin use$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1023673-1$	$1023673-1$	$Patient was vaccinated on 1/14/2021.  On 1/22/2021$ patient tested positive for COVID-19 and admitted to the hospital for acute hypoxemic respiratory failure$ COVID-19 pneumonia$ and severe ARDS.  Patient was intubated on 1/23/2021 and later died on 2/10/2021 after being extubated and placed on comfort measures.$	$unknown$	$HTN$ HLD$ diabetes type II$ iron deficiency anemia$ GERD$ BPH$ COPD$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1023791-1$	$1023791-1$	$DIED WITHIN 5 DAYS OF RECEIEVING THE 2ND DOSE$ EXPERIENCED GENERALIZED WEAKNESS.$	$: G93.40 Encephalopathy$ unspecified(Primary$ Admission)$ R56.9 Unspecified convulsions$ S06.5X9D Traumatic subdural hemorrhage with loss of consciousness of unspecified duration$ subsequent encounter$ M62.81 Muscle weakness (generalized)$ R26.89 Other abnormalities of gait and mobility$ Z48.811 Encounter for surgical aftercare following surgery on the nervous system$ W19.XXXD Unspecified fall$ subsequent encounter$ R47.01 Aphasia$ N17.9 Acute kidney failure$ unspecified$ N18.30 Chronic kidney disease$ stage 3 unspecified$ D64.9 Anemia$ unspecified$ N28.1 Cyst of kidney$ acquired$ E11.9 Type 2 diabetes mellitus without complications$ E03.9 Hypothyroidism$ unspecified$ I25.10 Atherosclerotic heart disease of native coronary artery without an$	$: G93.40 Encephalopathy$ unspecified(Primary$ Admission)$ R56.9 Unspecified convulsions$ S06.5X9D Traumatic subdural hemorrhage with loss of consciousness of unspecified duration$ subsequent encounter$ M62.81 Muscle weakness (generalized)$ R26.89 Other abnormalities of gait and mobility$ Z48.811 Encounter for surgical aftercare following surgery on the nervous system$ W19.XXXD Unspecified fall$ subsequent encounter$ R47.01 Aphasia$ N17.9 Acute kidney failure$ unspecified$ N18.30 Chronic kidney disease$ stage 3 unspecified$ D64.9 Anemia$ unspecified$ N28.1 Cyst of kidney$ acquired$ E11.9 Type 2 diabetes mellitus without complications$ E03.9 Hypothyroidism$ unspecified$ I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris$ I50.22 Chronic systolic (congestive) heart failure$ I21.4 Non-ST elevation (NSTEMI) myocardial infarction$ N28.9 Disorder of kidney and ureter$ unspecified$ F33.9 Major depressive disorder$$methadone$ morphine$ nortriptyline$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1023979-1$	$1023979-1$	$Moderna administered 02/01/21.  Patient expired 02/10/2020 unexpectedly$	$Dehydration  Leukocytosis  Dysphagia UTI - Sepsis-resolved  Hypernatremia  Paroxysmal atrial fibrillation with sick sinus syndrome;  S/P pacemaker placement 12/29/20  Acute kidney injury secondary to hypovolemia  Macrocytic anemia$	$Active Problems Coloboma of iris Atrial fibrillation Mild to moderate hearing loss Dysphagia Peripheral vascular disease Dementia with behavioral disturbance Seborrhea Lagophthalmos Benign prostatic hyperplasia Chronic constipation Gastroesophageal reflux disease Osteopenia Epilepsy Profound ID (IQ <20) ASCVD risk Age-related nuclear cataract$ left eye Cardiomegaly Chronic Ileus and megacolon Chronic conjunctivitis Chronic diastolic (congestive) heart failure Chronic obstructive pulmonary disease$ unspecified Colostomy and ileostomy status Cyst of right kidney$ acquired Dementia with behavioral disturbance Dry eye syndrome of bilateral lacrimal glands Hypocalcemia Hypothyroidism Hypovitaminosis D Iron deficiency anemia Mild hearing loss Mood disorder Nonexudative age-related macular degeneration$ left eye$ intermediate dry stage Obstructive sleep apnea (adult) (pediatric) Ogilvie's syndrome Other seasonal allergic rhinitis Presence of cardiac pacemaker 12/29/2020 Primary open-angle glaucoma$ bilateral$ moderate stage Proteinuria Recent weight gain Recurrent UTI - urinary tract infection Recurrent hypernatremia and dehydration Sick sinus syndrome Sick sinus syndrome s/p pacemaker 12/29/20$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024325-1$	$1024325-1$	$Patient passed away on February 5$ 2021. There was no reaction after the shot was given$ the patient's son said the death was not related to the vaccine. The patient had a bad case of shingles about a month prior to receiving the vaccine which the son said had been hard on the patient$ the patient was also 90 years old.  Per the son$ the patient's doctor had wanted the patient to get the vaccine.  Due to the close proximity of the date the vaccine was given and the date Patient passed away we wanted to complete the VAERS form.$	$SHINGLES ABOUT A MONTH AGO$	$AFIB$ HIGH BLOOD PRESSURE$  HIGH CHOLESTEROL$LATEX$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024420-1$	$1024420-1$	$Patient had the first Moderna Covid vaccine on Thursday 1/21/2021.  She had a bit of sore arm on that day and the day after.  On Saturday 1/23/2021$ she had a fever of 100.5 F (11AM)$ nausea$ light headache and chills. The temperature went down after she took ibuprofen.  Patient's husband enrolled her to V-Safe to report all the adverse effects she experienced. On Sunday 1/24/2021$ her temperature was 98.3F. She still had nausea and no appetite.  She and her husband watched a football game in their bedroom upstairs.  Husband noticed that his wife was pacing around the room many times. At 7Pm$ Husband went downstairs for dinner but she refused to come down to eat. He went upstairs around 8pm$ TV was still on. He turned off TV and went down stairs again thinking his wife felt as sleep while watching TV. He went back upstairs for bed around 10:30 PM. Husband said his wife had a deviated septum so she would snore very loudly when asleep.  He didn?t hear her snoring so he went to check on her and found her not responsive.  Husband called emergency services. Paramedic came at 10:45 and said patient was passed. Husband sent many texts to V-safe after that to report the incident. No response was received from V-safe. Patient?s doctor told her husband that she died due to cardiac arrest.$	$No current illness for this event.$	$Heart Disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024626-1$	$1024626-1$	$DEATH ON 5TH DAY OF 2ND DOSE.$	$N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms(Primary$ Admission)$ Z48.816 Encounter for surgical aftercare following surgery on the genitourinary system$ M62.81 Muscle weakness (generalized)$ R26.2 Difficulty in walking$ not elsewhere classified$ R13.12 Dysphagia$ oropharyngeal phase$ R48.8 Other symbolic dysfunctions$ I66.3 Occlusion and stenosis of cerebellar arteries$ G95.20 Unspecified cord compression$ I69.359 Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side$ M47.12 Other spondylosis with myelopathy$ cervical region$ I10 Essential (primary) hypertension$ E78.5 Hyperlipidemia$ unspecified$ E55.9 Vitamin D deficiency$ unspecified$ E11.9 Type 2 diabetes mellitus without complicati$	$N40.1 Benign prostatic hyperplasia with lower urinary tract symptoms(Primary$ Admission)$ Z48.816 Encounter for surgical aftercare following surgery on the genitourinary system$ M62.81 Muscle weakness (generalized)$ R26.2 Difficulty in walking$ not elsewhere classified$ R13.12 Dysphagia$ oropharyngeal phase$ R48.8 Other symbolic dysfunctions$ I66.3 Occlusion and stenosis of cerebellar arteries$ G95.20 Unspecified cord compression$ I69.359 Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side$ M47.12 Other spondylosis with myelopathy$ cervical region$ I10 Essential (primary) hypertension$ E78.5 Hyperlipidemia$ unspecified$ E55.9 Vitamin D deficiency$ unspecified$ E11.9 Type 2 diabetes mellitus without complications$ I63.9 Cerebral infarction$ unspecified$ R33.9 Retention of urine$ unspecified$ D64.9 Anemia$ unspecified$ N18.9 Chronic kidney disease$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024788-1$	$1024788-1$	$Pt had passed away before second dose given.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024790-1$	$1024790-1$	$Pt had passed away before second dose given.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024795-1$	$1024795-1$	$Pt had passed away before second dose given.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024853-1$	$1024853-1$	$Feb 8 states she had a cold. Feb 9 added stomach ache and nausea.  Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine.  Told to go home and rest. Feb 10 at 9:00 am found dead on the floor  in pool of blood and aspirated. Excessive blood in toilet$ pooled on floor and hallway rug.$	$Essential Thrombocytopemia Alzheimer?s$	$Essential Thrombocytopemia Alzheimer?s$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1025079-1$	$1025079-1$	$Patient found by  family in his home  deceased  on the morning of 02/10/2021.$	$None known$	$Aortic Stenosis Coronary Artery Disease asthma Hypertension cardiac pacemaker COPD Chronic kidney disease diastolic heart failure hyperlipidemia thrombocytopenia$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1025398-1$	$1025398-1$	$Patient received vaccine on 2/5.  We were told on 2/9 that the patient visited another emergency department on 2/6 but no information was given as to what prompted that visit.  She was sent home.  Daughter found her on 2/6 or 2/ 7 unresponsive and she died.$	$No current illness for this event.$	$COPD$ type II diabetes$ HTN$Latex$ Abilify$ Gadolinium contrast media$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1025493-1$	$1025493-1$	$Patient expired on the morning of 2/11/2021.  No known adverse events prior to death.  Patient was observed for 20 to 25 minutes after administration of vaccine and reported experiencing no signs or symptoms of adverse events at that time.$	$Cancer$	$Cancer$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026396-1$	$1026396-1$	$Patient  experienced loss of taste and lack of appetite. Passed away on 1/23/21.$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026443-1$	$1026443-1$	$Received first 1/15/2021 with no adverse reaction.  Received 2nd dose 2/9 @ 0846 with no adverse reaction or report of feeling ill.  Traveled to store and arrived approx. 2 hours after receiving vaccine.  Daughter stated patient felt well and had to go to the restroom to have BM.  Collapsed in bathroom.  Transported by ambulance to Hospital @ 1439 in cardiac arrest.  Was in PEA and went in v fib back to PEA. Resuscitation efforts initiated and patient expired with time noted at hospital records at 15:11.$	$Unknown$	$High Blood Pressure$ Adult Onset Diabetes Mellitus$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026451-1$	$1026451-1$	$Resident expired 2/2/2021 one day after the vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026499-1$	$1026499-1$	$Resident reviewed for incident. Resident received the second dose of the Moderna Covid-19 vaccine lot# 016M20A Exp 5/2/2021 on 2/5/2021 from clinic through pharmacy.  Resident had her temp/O2 taken on AM shift and was 98.6/93%$ beginning PM shift 98.4/95%. A few hours later noted that resident to have chills and was shaking RN assessment completed and vitals taken resident noted to have temp of 102.2$ oxygen 95%$ pulse 110. Resident alert and oriented at that time and talking to staff. Reported findings to APNP with order to send to ER. 911 called$ residents brother updated. Upon EMT arrival RN went down to residents room with EMT and resident had an emesis as resident was getting cleaned up resident went unresponsive. Pulse noted to still be present at that time$ resident did briefly respond to sternal rub and then went unresponsive again. Resident full code and EMT transferred to gurney and said that if they lost a pulse in route that they would transfer to hospital B instead of hospital A being the closest facility. RN called brother and gave update. Facility notified from Hospital that resident had passed away.$	$Enterococcus UTI$ acute on chronic systolic and diastolic heart failure$	$$chronic kidney disease stage 3$ cirrhosis$ HTN$ hypomagnesemia$ hypothyroidism$ neurocognitive disorder$ hx of hepatic encephalopathy$Carvedilol$ Tizanidine$ Augmentin$ ACE inhibitors$ Bees$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026581-1$	$1026581-1$	$He had sudden death on Feb 4th. Unclear if this could be related to vaccination but since it was close in timing report has been filed.  No known immediate reaction to vaccination.$	$He had sudden death on Feb 4th. Unclear if this could be related to vaccination but since it was close in timing report has been filed.$	$Hyperparathyroidism s/p surgical correction in 2020$ MGUS$ Idiopathic peripheral neuropathy$ gout$ OSA$Erythromycin$ PCN$ Hmg-coa reductase inhibitors$ nifedipine$ tetanus toxoids$ tetracyclines$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026841-1$	$1026841-1$	$Resident passed away this morning.  No signs or symptoms prior to his death of an issue with the vaccine.  He was an end stage dementia resident at the nursing home.$	$No current illness for this event.$	$Dementia$ Hyperlipidemia$ Hypertension$ Osteoarthritis$ Cerebral Infarction$ COPD$Aloe$ Tetracycline$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027141-1$	$1027141-1$	$The patient reported feeling well.  I discussed with him the Covid-19 vaccine and he was able to state that he wanted it and to sign his consent form.  The facility reported they had discussed this with him and he had agreed prior to my visit.$	$None$ Last prior illness was November 2020 he had Cdiff and was at Hospital but per facility the patient was fully recovered from this.$	$Forgetfulness/Mild Dementia$ Diabetes$ Obese$ Urinary Flow Issues all per facility and MAR$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027158-1$	$1027158-1$	$$death. Per son pt was not  feeling well after the vaccination $$like her legs were weak.$$ Son found the mom in her bed 1am on 2/12/2021 unresponsive.$$	$CKD-4  Dementia  Incontinence of stool  Insomnia  Skin breakdown right gluteus$	$Chronic insomnia CKD Constipation Dementia Hepatitis B non-immune Onychomycosis Osteoporosis NOS Stool incontinence x2 ( 2 months and one week ago while out on stret) TIBC - Total iron binding capacity low Tinea pedis Vitamin B12 deficiency Vitamin D deficiency$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027502-1$	$1027502-1$	$My dad received his first COVID vaccine on January 14$ 2021.  On January 16$ 2021 he ate breakfast around 7:00 am and went back to his room.  When the staff checked on him around 8:00 am they found my dad unresponsive.  His blood pressure was over 220 and his pulse was 43.  They began manual CPR until the paramedics arrived$ but my dad died.$	$N/A$	$COPD$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027757-1$	$1027757-1$	$Death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027967-1$	$1027967-1$	$Patient received vaccination on 1/15/2021. Hemorrhagic Stroke on 1/20 $ then diagnosed with complicated idiopathic coagulopathy$	$none$	$PMH: Acquired Deformity of toe- Hallux Rigidus$ Actinic Keratosis$ Anemia Macrocytic$ Atherosclerosis$ Atopic Dermatitis$ Atrophy testis$ Bph Local W/urinary Obstruct with LUTS$ Cerumen Spondylosis$ Cervicalgia$ CKD stage 2$ Colonic Diverticulosis$ Dyspepsia$ Dysphagia$ Epitaxis$ Esophageal Reflux$ Hearing loss$ Hepatic Cyst$ Impaired fasting glucose$ Lumbar spondylosis$ Male Erectile  Disorder$ Microscopic Hematuria$ Migraine$$unconfirmed childhood allergy to penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1028596-1$	$1028596-1$	$*extreme* fatigue.  could not awaken for more than few seconds. When briefly awake she was coherent and not confused.   slept deeply from 4pm and could not wake to eat or drink.  No fever$ bp normal$ blood oxygen ok.  Blood sugar at 11pm was 230.  Gave her 15u lantus at 11pm (normally 25u).  Was sleeping at 2:30am but had died at next check at 3:30am.$	$No current illness for this event.$	$diabetes$ arthritis$ PVC's$ macular degeneration$ diseased colon$ thyroid partially removed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029003-1$	$1029003-1$	$I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was talking in complete sentences and responded appropriately. She was upright in bed and made eye contact. She smiled and denied pain. By Sunday$ she was extremely weak and unable to sip water with a straw. Her health had changed dramatically and rapidly. She moaned in pain and was very fatigued. Her condition continued to deteriorate over the week and she stopped talking and was constantly sleeping. They started antibiotics for the oozing cancer lesion and then morphine for pain and end of life care. She passed away on January 22nd which was 15 days post vaccination.$	$No current illness for this event.$	$advanced leukoaraiosis with moderate cerebral atrophy$ htn$ right breast carcinoma$ spinal stenosis$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029068-1$	$1029068-1$	$Patient was given vaccine the following day he died $$	$Mental health$ dementia$	$$No known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029335-1$	$1029335-1$	$Cardiopulmonary arrest$	$none$	$Coronary Artery disease with 2 stents Congestive Heart Failure Hyperaldosteronism History of Pulmonary embolus HTN Hyperlipidemia$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029412-1$	$1029412-1$	$Death$	$None$	$None$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029514-1$	$1029514-1$	$patient deceased$	$acid reflux$	$acid reflux$n\a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029554-1$	$1029554-1$	$Patient died suddenly on 2/1/21 from unknown causes according to his son.$	$Unknown$	$Unknown$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1030323-1$	$1030323-1$	$$Patient had COVID vaccination on 2/3 with no adverse s/s before leaving unit.  Upon coming to treatment Friday 2/5 he reported to the RN that he had fallen on thursday 2/4 due to $$getting up fast$$  did not hit head or hurt anything per RN discussion.  Began treatment without difficulty.  About 3/4 way through treatment was  talking with staff and became unresponsive - code was called and pt expired after 30 minute resuscitation efforts.$$	$Asymptomatic COVID Hospital for Polymosis January$	$ESRD Diabetes Type 2 Heart disease CHF CAD CABG$Niacin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1030586-1$	$1030586-1$	$This individual's employer informed our facility that he passed away at his home on 2/14/2021. Since he was not brought into our hospital$ we do not have information regarding other health conditions or active medications. Since this individual received his second covid vaccine three days prior$ this was reported to Moderna in addition to this VAERS report being completed. The coroner for County can be contacted.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1030712-1$	$1030712-1$	$2/10: Fever$ fatigue$ tylenol 2/11 @ 1300: pt made DNR$ hospice consulted 2/11 @ 1800 decreased LOC$ increased RR$ fever$ chills - 1/5L NS bolus IV$ rectal tylenol. Refusing to eat/drink$ PO morphine 2/12 @ 16:30$ deceased at facility **resident was not doing well prior to vaccination$	$In the hospital one week prior to vaccination for decreased LOC$ and lack of appetite$	$non-Hodgkin lymphoma$ epilepsy$ advanced dementia$ SDH$ depression$ COVID-19$ malnutrition$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031176-1$	$1031176-1$	$Death Narrative: Patient received Covid vaccine on 2/2/21$ person reports his legs were more rigid with some sweating the day of the vaccination with leg rigidity that was slowly improving. No other adverse effects reported for following 7 days. Person states he had vomiting episode earlier this week$ person states he had no other symptoms before or after the vomiting episodes. On morning of 2/12/21$ person reports patient got up ready for breakfast with no issues. She says he asked for chorizo and oatmeal but she laughed and said don't you mean chorizo and eggs. He said yes. They got him into W/C and he was rolling himself into dining room got stuck in hallway. She says he took several breaths then 3 very deep breaths and passed away. She called 911 they took his VS but he has passed. She told them to leave him along no resuscitation.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031544-1$	$1031544-1$	$Patient family had been noticing onset confusion for a few weeks prior to vaccine and event. Patient was taken to ED when found unconscious and died of a subdural hemorrhage a few days after vaccine clinic at retirement home.$	$Diagnosed with subdural hemorrhage at time of incident$	$Hyperlipideia Hx stroke Hypothyroidism Gastric ulcer HTN Stress incontinence Uterine cancer Late onset Alzheimer's Osteopenia Osteoarthritis Varicose veins in legs Venous insufficiency Adjustment disorder with anxiety$Ibandronic acid- nausea and vomiting Sulfa- nausea and vomiting Risedronate Environmental- pollen Nitrofurantoin macro Ezetimibe-Simvastatin Codeine- anxiety Erythromycin- nausea$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031593-1$	$1031593-1$	$On February 11$ 2021 around 10:15 am$ patient was given the Moderna brand COVID-19 vaccination. After his vaccination$ he was instructed to wait around for 15 minutes after the administration of the vaccine. During this time$ there were no reported issues with the patient. On February 15$ 2021 around 9:15am$ patient's wife called the pharmacy and spoke with the pharmacist informing her that patient had passed away in his sleep on Saturday evening. Patient's wife inquired about whether death may have been caused by an adverse reaction to the vaccine. During the call patient's wife mentioned that patient slept a lot the day of the vaccine and the day after. patient's wife mentioned that patient woke up Saturday to eat breakfast and lunch. She states that later that evening$ she found patient asleep and cold which she then realized that he'd passed away.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031629-1$	$1031629-1$	$Patient became nauseated about 10 minutes after vaccine administered$ this subsided but returned several hours after the vaccine was given. She continued with intractable nausea and vomiting for about 24 hours.  This patient was enrolled in hospice and she continued to decline and refused to eat or drink. She was taking Ibuprofen due to intractable back pain. Her emesis was coffee ground color. After this her condition continued to decline until her death$	$Compression fracture$	$Abdominal Aortic Aneurysm$ Constipation$ Malnutrition$ Peripheral Vascular Disease$GI upset from Fentanyl$ No other food or drug allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031993-1$	$1031993-1$	$Patient reported mild flu like symptoms from vaccination later that evening.  Next morning LTCF staff found pt deceased$	$No current illness for this event.$	$$KNDA or other allergies listed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032252-1$	$1032252-1$	$Resident tested COVID-19 confirmed positive a few days after covid vaccination.$	$Loss of appetite and generalized body weakness$	$DM Type 2$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032265-1$	$1032265-1$	$Resident tested NEGATIVE for COVID-19 last 1/25/2021. She was on monitoring for desaturation and low blood pressure on Jan. 27$2021$	$NONE$	$ANEMIA DEMENTIA HYPERLIPIDEMIA HYPERTENSION GERD$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032279-1$	$1032279-1$	$Resident tested NEGATIVE for COVID-19 on 1/25/2021. She was on monitoring for declining in condition on 1/29/2021.$	$NONE$	$ATHEROSCLEROTIC HEART DSE DEMENTIA HLD$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032303-1$	$1032303-1$	$On monitoring for declining in condition$ loss of appetite and generalized body weakness on2/1/2021. Was confirmed COVID-19 positive 4/23/2020.$	$On monitoring for declining in condition$ loss of appetite and generalized body weakness on2/1/2021$	$Hemiplegia & Hemiparesis on left non-dominant side Atherosclerotic heart Dse. Type 2 Diabetes Mellitus Cerebral Infarction PAF Thyroid Disorder Hypertension Cerebral edema GERD Occipital Neuralgia$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032321-1$	$1032321-1$	$Resident has shortness of breath on 1/19/2021 and was transferred to Hospital 1/20/2021$	$none$	$Wedge Compression Fracture of T-11-T12 Atrial Fibrillation BPH GERD$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032327-1$	$1032327-1$	$On monitoring for weight loss .$	$None$	$Heart Failure Chronic Kidney Dse. Dementia Atheroschlerotic Heart Dse. Anemia Hypothyroidism Major Depressive Disorder Nonrheumatic aortic valve stenosis Cardiomegaly Hypertension Dysphagia Osteoporosis$Fosamax$ Linzess$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032873-1$	$1032873-1$	$He had rigors starting 6 pm the day after the vaccination. He was treated with one 500 mg tylenol. He had increased wheezing but did not complain of SOB. At 0400 the next morning$ he died.$	$Had Covid 19 in Dec. 2020$ Tested negative at beginning of Feb. 2021. No other illness.$	$Type 2 diabetes. Controlled hypertension.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033263-1$	$1033263-1$	$patient passed away within 60 days of receiving COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033448-1$	$1033448-1$	$Fever by the next day$ difficulty breathing$ pneumonia$ and then DEATH within a few days. (Died 02/01/2021)$	$Had Covid-19 one month prior$	$Irregular Heart Asthma pneumonia prone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033607-1$	$1033607-1$	$Vomiting$ death.$	$Allergies$	$Diabetes$ circulation problems$ awaiting stent surgery on neck artery.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1034349-1$	$1034349-1$	$Patient awoke on 2/12/21 with altered mental status$ confusion$ respiratory distress$ was taken to hospital by ambulance. Per ED notes from ED attending Pt presented with hypotension and respiratory distress. DNR status$ patient given comfort measures and passed away in ED at 11:24 am on 2/12/21.$	$Unknown$	$Congestive heart failure Hypertension Type 2 Diabetes Chronic venous insufficiency Hypothyroidisn Coronary artery disease Dyslipidemia$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035845-1$	$1035845-1$	$We were informed by EMS that the patient was found deceased on 2/11/2021 at her home.  EMS states she was dead for some time$ no medical care given.$	$Not sick at time of vaccination$ unknown prior.$	$Unknown$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035866-1$	$1035866-1$	$Pt died on 2/15/21. On 2/13/21$ pt complained of muscle aches.$	$None$	$Chronic atrial fibrillation [Chronic atrial fibrillation$ unspecified] Hyperlipidemia [Hyperlipidemia$ unspecified] Benign essential hypertension [Essential (primary) hypertension] GERD - Gastro-esophageal reflux disease [Gastro-esophageal reflux disease without esophagitis] Carcinoma of colon [Carcinoma in situ of colon] Rosacea [ROSACEA]$Simvastatin Influenza$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035872-1$	$1035872-1$	$Patient was found unresponsive at 8 am on 2/12; patient was deceased$	$None$	$None$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035878-1$	$1035878-1$	$Daughter called to report that the patient died on 02/15/2021.  No report of symptoms from the vaccine on 02/13/2021$	$AIED; CHF; Type 2 DM; HTN; Chronic Renal Failure; Lung CA$	$See above$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036047-1$	$1036047-1$	$Short version The patient has long-standing health issues.  The patient received the first dose of Moderna COVID-19 vaccine on 1/16/2021 (unknown location). The patient suffered an event in his home on 1/24/2021.  CPR and treatment was begun and he was transported to the ED.  He was pronounced dead in the ED at 0846.  Long version 70-year-old male with past medical history of CAD with pacemaker$ A. fib$ COPD$ hypertension/hyperlipidemia presenting in cardiac arrest.   911 call at 0724. Per EMS$ patient was witnessed by family to have seizure-like activity and then collapsed and became unresponsive.  Patient was noted by family to be pulseless and CPR was started right away.  Patient received two doses of epi by police were on scene first (AED defibrillation x2)  and six doses of epi (plus 6 more AED shocks) by EMS when they arrived.  Patient had CPR performed for 45 minutes prior to arriving at the hospital.  On route$ patient had episodes of paced rhythm and V. fib.  Patient received one amp of bicarb and one amp of calcium en route.  Patient also received 300 mg of amiodarone en route.  Arrived in ED at 0810 Patient received ongoing compressions$ shocks and additional medications (epinephrine x6$ lidocaine IV$ sodium bicarbonate) until time of death called at 0846 in the ED.$	$Hospitalized 12/20 - 12/24/2020 Discharged to home with home care services Hospital Course 12/20 - 12/24/20: 74-year-old male with multiple medical problems presented to the ED with sudden shortness of breath and some palpitations.  He was seen in the emergency room after being transported to the ED on CPAP was found to be febrile to 101 tachycardic tachypneic put on BiPAP in ED.  EKG showed atrial flutter with left bundle branch block no ST segment elevations COVID-19 was negative RSV and flu was negative chest x-ray showed pneumonia in the right lower lobe.  Subsequent chest x-ray showed bilateral lower lobe airspace disease consistent with pneumonia Patient also had a CT abdomen in the ED showing left pleural effusion .  The CT report is$	$Anxiety ل  ? Atrial fibrillation ل ? CHF (congestive heart failure) ل ? COPD (chronic obstructive pulmonary disease) ل ? Coronary artery disease ل  ? Diabetes mellitus$ type II ل ? Gangrene of toe of left foot ل ل  ? GERD (gastroesophageal reflux disease) ل ? Hyperlipidemia ل ? Hypertension ل ? Insomnia ل ? Myocardial infarction Oct 2012 ? Osteoarthritis ل ? Peripheral vascular disease$penicillin diazepam$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036098-1$	$1036098-1$	$Patient received the vaccine on 1/31/2021. Patient complained of bleeding 2/7/2021.  Went to clinic where labs were conducted.  Patient had an INR of 12. Previous INR results were normal prior to vaccination.  Patient was also diagnosed with UTI and given antibiotics.  Patient was encouraged to go to ER. Patient died on 2/12/2021.$	$No current illness for this event.$	$Hypothyroidism;  History of coronary artery stent placement; Essential hypertension; Current use of long term anticoagulation$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036418-1$	$1036418-1$	$ER visit 1/25/21 patient walked into a prompt care and collapsed$ witnessed and pulseless CPR with ROSC after 6-7mins$ no shock no meds.  Awake and speaking upon arrival to ER.  2 plus pitting edema ble ER diagnosis Anasarca$ cardiac arrest$ hypotension$ elevated troponin I levels$ Acute kidney injury and syncope.  ER notes reveal a syncopal episode in the shower prior to collapse at prompt care.  Central line placed and plan to ship to another facility$ patient continued to decline despite dopamine and dobutamine expired in ER prior to transfer.$	$Outpatient hospital admit 12/20-12/21 with CHF exacerbation; BNP 2510$ platelet count 99; total bili 2.3; BUN 26$ Cr 1.42 and GFR 47. Repeat labs 12/31/20 BUN 28; Cr 1.52; GFR 44; 1/2/21 total bili 2.6; platelet count 89. PCP visit 1/7 noted pitting edema BLE and wife stated more confused lately diagnosis hypertension$ elevated bilirubin$ thrombocytopenia and shortness of breath$ CXR 1/7 cardiomegaly$ central vascular congestion$ tiny bilateral pleural effusions and mucous plugging. Cardiologist visit 1/20/2021 with med changes.$	$Anemia$ CABG$ apnea; CHF; dysrhythmia; pacemaker/defibrillator; cardiomegaly; heart disease; aortic valve replacement; former smoker; ischemic cardiomyopathy; perivalvular leak of prosthetic heart valve$No Known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036437-1$	$1036437-1$	$Patient is deceased. Family called the pharmacy on 2-17-21 to let us know he would not be coming for his second appointment. When the pharmacist tried to call the family back for more info$ the phone number on file doesn't work.$	$None reported$	$None reported$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036440-1$	$1036440-1$	$Patient died at home in hospice care from complications of stage 4 bladder cancer$	$Stage 4 bladder cancer$	$Stage 4 bladder cancer$ CHF$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036460-1$	$1036460-1$	$death 2-5-21$	$liver cancer$	$liver cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036770-1$	$1036770-1$	$Feb 10th died in her sleep. No apparent reason.$	$none$	$none$ very healthy$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036787-1$	$1036787-1$	$passed away 2 days after vaccine was given$	$No current illness for this event.$	$late stage dementia$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036881-1$	$1036881-1$	$Myocardial Infarction$	$No current illness for this event.$	$Chronic cardiac conditions$ chronic lung.   Chronic smoker$Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036993-1$	$1036993-1$	$Patient reported at review of questionnaire had headache that day. Temp was taken$ 97.8$ okay. proceeded. Conversing customer friend in store afterward. When timer went off$ said he was fine$ he and his wife left. Daughter called to store Wednesday morning$ said Pt had passed away Tuesday$ that it was unknown the cause$ and just wanted to let us know.  We did not take down her phone number and last name.  The patient was a long time customer.$	$No current illness for this event.$	$Hx of migraine headaches$noted on admin form: Ibuprofen$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038517-1$	$1038517-1$	$Pt. received vaccine on 2/3/2021. Coded at home on 2/17/2021.$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038527-1$	$1038527-1$	$Per EMS/Hospital report patient had difficulty breathing and cardiac arrest with prolonged CPR (greater than 45 mins in the ER) who was resuscitated.  Family subsequently arrived including son and daughter and all family members were in the ER room are in agreement that patient would not want further aggressive cares given her extremely poor prognosis in light of chronic debilitation with numerous medical issues and now a very long period of CPR.   Hospital Course After updating family they stated patient would not want further aggressive cares given her grim prognosis and chronic severe and debilitating medical issues.  She continued to have myoclonic jerking.  She was extubated to comfort cares in the ER and did not pass immediately therefore brought to a room.  She received comfort cares and passed away at 0450 with family present.$	$$Arthritis hands  Cardiovascular disease  dyslipidemia  Chronic bronchitis  COPD (chronic obstructive pulmonary disease)  Coronary artery disease  History of transfusion  Hypertension  Myocardial infarction  stent  Peripheral vascular disease  Psychiatric illness  $$feels depressed$$ on ocassion  Renal artery stenosis  TIA (transient ischemic attack)  $$short spurts$$ of tingling on face  Urge incontinence of urine$$	$$Arthritis hands  Cardiovascular disease  dyslipidemia  Chronic bronchitis  COPD (chronic obstructive pulmonary disease)  Coronary artery disease  History of transfusion  Hypertension  Myocardial infarction  stent  Peripheral vascular disease  Psychiatric illness  $$feels depressed$$ on ocassion  Renal artery stenosis  TIA (transient ischemic attack)  $$short spurts$$ of tingling on face  Urge incontinence of urine$$epinephrine$ penicillin$ procaine per EHR$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038633-1$	$1038633-1$	$Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21$ at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration$ team attempted to draw lab specimen with vein finder$ but patient was possibly Narrative:  Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21$ at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration$ team attempted to draw lab specimen with vein finder$ but patient was possibly dehydrated. CG/wife reported to APRN on 2/10/21$ patient was sleeping and snoring and then began to sleep more quietly. She checked on patient and found that he had no pulse and had passed away$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038635-1$	$1038635-1$	$The patient fell the day after receiving the Moderna COVID-19 vaccine. She broke her hip in this fall. During surgery to correct the broken hip$ she went in to sudden and unexpected cardiac arrest. The anesthetist did not notice any ST changes or A fib; dysrhythmia was very unexpected. The patient had a DNR. She died at 13:00 on 02/07/2021.   Causes of death are listed as 1. Cardiac Arrest 2. Recent hip fracture with hip placement 3. History of Breast Cancer 4. Hypothyroid and 5. Dementia$	$A fall occurred on the day after vaccination; she fractured her hip  in this fall. The  physician reports she went into sudden and unexpected cardiac arrest during surgery and died.   Patient had  COVID-19  approx  11/06/2020.   Possible urinary tract infection on admit for the fall$	$$History of breast cancer (bilateral; patient is post-bilateral masectomy) Hypothyroid  Dementia ($$always confused about time and place$$) Recurrent urinary tract infections  The patient was admitted August 2020 with suspected seizure but this was attributed to UTI and/or dementia) Hypertension Diffuse Arthritis Resident of assisted living facility$$Erythromycin     Codeine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038658-1$	$1038658-1$	$$86yo female alert$ stable with ankle abrasion eating 100% prior to vaccine in assisted living facility.   On 2/1/2021$ received Moderna vaccine.  Starting thereafter$ eating 50% on 2/2/21. Temperature was 98 tympanic.   On 2/3$ the leg abrasion started having moderate bleeding.  On 2/4$ the caregiver noted patient $$not looking good$ unable to talk$ arms moving aimlessly$ grasping$$.  BP 95/41$ temperature 98$  oxygen on room air 92-93%.  POA did not want hospital transfer.  2/5 Hospice started$ oxygen given$ morphine given.   2/5-2/8 comfort care given$ patient responsive to tactile stimuli$ resting$ not taking oral medications or food.  2/8/2021 patient expired.$$	$ankle/leg wound healing and being treated topically$	$history of TIA$ breast neoplasm$ dementia$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038719-1$	$1038719-1$	$death attributed to unknown cause$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1039090-1$	$1039090-1$	$$The patient came to the Emergency Room at approx 3:30 am on 02/03/2021 with pain in right arm (same arm the COVID vaccine had been administered in approx 12 hours earlier) and feeling generally unwell. Patient was concerned about possibility of gout flare or that something was wrong with her arm. Elevated blood pressure was noted; this was attributed to anxiety. She was evaluated$ given 500 mg Tylenol$ and discharged since the pain was decreasing and blood pressure was stabilized. Patient instructed to follow-up with physician.  The next day$  on 02/04/2021$ the patient arrived at the Emergency Room by ambulance; cardiac arrest was the chief complaint. The patient's daughter stated the patient had been $$feeling generally poor and then suddenly collapsed.$$ Daughter described $$gurgling respirations$$ and being unresponsive. 911 was called$ police arrived within 5 minutes and initiated CPR. Epinephrine$ atropine$ lidocaine and bicarb administered after arrival to Emergency Room.  Shockable rhythm never demonstrated. Patient never recovered spontaneous respiration or movement.   The death was called at 23:04. Coronary artery disease with cardiac arrest is the cause from the ER records; the coroner is putting COVID-19 vaccination in Part 1 of the death certificate.$$	$No current illness for this event.$	$GERD (Gastroesophageal Reflux Disease) Hypertension Previous Squamous Cell Skin Cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1040005-1$	$1040005-1$	$Patient was found unresponsive and had passed away.$	$Unknown$	$Unknown$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1040574-1$	$1040574-1$	$Patient collapsed and could not be revived. There was no prior warning. She was otherwise in good condition for her age. The death was listed as probable cardiac arrest but no autopsy was performed. Since it occurred so close to the vaccine shot I thought someone may want to know.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1040802-1$	$1040802-1$	$Toileting and had expired while doing so; Severe abdominal pain; Diarrhea; Vomiting; Mild injection site pain; A spontaneous report was received from a healthcare professional concerning an 88-year-old $ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events$ toileting and had expired while doing so (death)$ mild injection site pain$ severe abdominal pain$ diarrhea$ and vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021$ the patient felt mild pain at the injection site after receiving the vaccine.  On 21 Jan 2021$ the patient reported severe abdominal pain$ diarrhea and vomiting. These symptoms were intermittent for a week and no other adverse events were noted.  On 27 Jan 2021$ the patient passed away while toileting.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 27 Jan 2021. The cause of death was unknown. An autopsy was not performed.; Reporter's Comments: The gastrointestinal events were consistent with increased risk associate with elderly age of patient. The cause of death was unknown. Autopsy was not performed. Very limited information regarding the events is available at this time. Based on the current available information and temporal association between the use of the product and the start date of the events$ a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No medical history reported.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1040927-1$	$1040927-1$	$Patient previously had dizzy spills$ but about a week after receiving the vaccine her dizzy spills began to get worse. The whole prior she kept saying I am just not right. On the 2/7/21 she a COVID test done$ a nurse came to her house and preformed. On the morning of the 8th patient was on the phone with someone else and patient asked this person to call me and go check on her. Within 5 minutes I was over at her house$ and I found her on the floor$ she on her belly facedown. It looked like she was on the toilet$ and it looked like she fall getting her off$ she was still wet$ she still felt warm. I called the ambulance and immediately  began CPR. When EMS arrived they took over the CPR and transported her to the Hospital. The EMS was there for about 40 minutes and used an machine to preform the compressions. She was pronounced deceased at the hospital.  No autopsy was done.$	$No current illness for this event.$	$Hypertension$ Hypothyroidism$  early dementia$ Vertigo$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041064-1$	$1041064-1$	$CLIENT EXPIRED 1 WEEK FOLLOWING THE VACCINE.$	$No current illness for this event.$	$$NONE$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041333-1$	$1041333-1$	$He developed a fever on 1/8$ become unable to swallow and bedbound. He was already end of life and Hospice care at the time of the vaccine.$	$End stage Dementia$ End stage Parkinson's Disease$ on Hospice care. Dependent in all cares$ non-verbal.$	$End stage Dementia$ End stage Parkinson's Disease$ on Hospice care$Penicillin$ Vicodin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041832-1$	$1041832-1$	$Patient was found unconscious without a pulse. Patient remained in asystole without pulse or respirations despite CPR.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041839-1$	$1041839-1$	$Death- ~ 7 hours after vaccine$	$HTN HLD CAD Type 2 Dm GERD hypothyroidism$	$HTN HLD CAD Type 2 Dm GERD hypothyroidism$Sulfur$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1042351-1$	$1042351-1$	$death$	$mild liver disease$	$$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1043123-1$	$1043123-1$	$Death$	$Positive COVID-19 PCR collected postmortem$	$Hypertension$ COPD$ T2DM$ Obesity$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1045895-1$	$1045895-1$	$He was found deceased in his home by Sheriff and paramedics evening of  2/21/21.$	$None know$	$Heart arrhythmia$ enlarged prostate$ low blood pressure$ CAD$ asthma$ season allergies/hay fever$ spinal stenosis$ with neuropathy$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046230-1$	$1046230-1$	$Death.  My father-in-law was found unexpectedly deceased in his home Saturday morning.  He worked the previous day.$	$Diabetes$	$Diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046347-1$	$1046347-1$	$When family members came to receive the second dose of their COVID vaccine$ they informed us that the above patient had passed away.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046542-1$	$1046542-1$	$patient passed away with in 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046613-1$	$1046613-1$	$patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046845-1$	$1046845-1$	$Deceased 02/18/2021 with an unknown cause of death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046881-1$	$1046881-1$	$Code blue called at 11:00pm. Patient had code status of Do Not Resuscitate.$	$UTI$	$CHF$ CKD$ MI$ Encephalopathy$ Aortic stenosis$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1047183-1$	$1047183-1$	$Pt had expired before second dose was delivered.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1047197-1$	$1047197-1$	$death$	$Pt on hospice$	$$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1047282-1$	$1047282-1$	$Patient felt fine on Friday afternoon and evening after shot. Felt fine on Saturday until the afternoon when she started feeling fatigued and chilled. Decided to take a warm bath at about 6pm. Was found dead in bathtub at approximately 7pm with blisters on arms$ legs$ and face.$	$none$	$none$ other than back pain$Benadryl Diazepam Valium$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1047326-1$	$1047326-1$	$According  to patient's caregiver$ patient presented with symptoms of fever (101.6 F) and purple blotches all over the body within an hour. Since patient was in hospice $ caregiver called Hospice and a pharmacy and was told to give patient Benadryl and Tylenol. Patient was given both medications and the fever subsided in a few days but the purple blotches never went away. Patient passed away at the facility a week later.$	$Decubitis Ulcer$	$Diabetes Mellitus Type 2$ TIA (never diagnosed per Caregiver)$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1048786-1$	$1048786-1$	$$Was given vaccine around 1:30Pm on 2-11-2021. He and his wife waited in the building for 15 minutes and then left. he denied complaint. (He was waiting to have both Covid shots before he went to cardiologist Re: CAD.) He had an alarm going off in his house$ was going to basement to check it out. Police officer heard alarm$ came into house$ & heard a thud when Doc fell. He was in PEA (Pulseless Electrical Activity) when brought into ER. Given 5 $$rounds of Epinephrine with no response.$$	$? sepsis$ CAD$ HTN$ increased lipids$	$hypertension$ constipation$ hyperlipidemia$ CAD$ BPH$Orudis$ Statins (intolerance)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1048882-1$	$1048882-1$	$Vaccine was administered 2/1/2021 at approximately 9am.  Due to self reporting of allergic reaction (hives) to Augmentin$ patient was monitored on site for 30 minutes.  After the monitoring period$ she was cleared to go with no issues reported at the time.  We were later informed that the patient passed away from a pulmonary embolism on 2/12/2021.$	$No current illness for this event.$	$diabetes$Augmentin (hives)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1048947-1$	$1048947-1$	$Patient experienced an episode of emesis and loss of consciousness several hours after vaccine on 2/16/21.  He was taken by EMS to the hospital and was noted to be hypoxic and hypotensive.  He was admitted to the hospital and subsequently intubated.  He was also found to have a small bowel obstruction and a nasogastric tube was placed to decompress the bowel.  He required pressor support as well.  He expired on 2/17/21.$	$No current illness for this event.$	$End stage renal failure on dialysis Hospitalization on 2/5/21 for ESRD and initiation of hemodialysis Anemia of chronic disease Chronic atrial fibrillation on anticoagulation Congestive Heart failure Recurrent abdominal wall hernia$keppra decadron$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049012-1$	$1049012-1$	$Patient was given vaccine on friday$ one week later she passed away. The family called the pharmacy to inform us on Saturday$ Feb 20$ 2021. After the phone call was over$ we saw in her pharmacy profile that she had received the vaccine one week prior$	$No current illness for this event.$	$$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049389-1$	$1049389-1$	$Patient passed away Saturday at 14:04pm. Patient's wife reports his death was sudden$ he passed away sitting in his chair his heart just stopped she said. They tried to perform CPR$ 911 was called and paramedics arrived at the scene and he was given medication but never had any return of vital signs and so his death was called at the scene. Wife reports he was not ill$ did not have any symptoms prior to the event. They are not going to be doing a autopsy. She wanted us to know based on timing that there may be some possible correlation with his COVID19 vaccine. He obtained the vaccine on 02/09/2021 - wife reports he had no symptoms$ not even arm soreness after the vaccine. Had no fever$ shortness of breath. Did not complain of chest pain. We can update chart to reflect the patient is deceased and lets make a card for the family.$	$No$	$Type 2 DM$ HTN$ COPD$ Hyperlipidemia unspecified$ A-fib unspecified$ Chronic pain$ Morbid Obesity$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049406-1$	$1049406-1$	$Patient rcvd 1st covid 19 vaccine on 1/26/2021.  Patient had house guests on 1/30/21.  Those house guests tested positive for covid on 2/1/2021.  Patient started getting symptoms on 02/2/2021.  Patient tested postivie on 2/4/2021.  Patient was hospitalized 2/7/2021.  Patient passed away on 2/21/21.$	$unknown$	$unknown$none listed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049648-1$	$1049648-1$	$I was notified on 2/22/21 that this patient passed away over the weekend. I do not know the details$ nor can I confirm anything beyond what I was told. I believe the death occurred on 2/20/21 due to a massive stroke.$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049852-1$	$1049852-1$	$When calling to get billing information we were notified that patient had passed away. Patient's daughter said patient was having cvd a/s on 2.1.2021 got vaccine 2.2.2021 and passed away 2.5.2021. Cardiologist said not related$	$No current illness for this event.$	$cvd$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049997-1$	$1049997-1$	$Vaccine was administered at Nursing Facility.   Patient is an 89-year-old female with prior medical history of CVA with dysphagia$ history of possible dementia$ GERD$ hyperlipidemia$ and a pacemaker.  She is a resident from town.  She was sent for hypotension with a blood pressure of 90/52$ tachypnea respirations of 54$ possible aspiration pneumonia.   Status post Covid vaccine earlier today.  History is limited as patient is nonverbal on my exam.  Death within 24 hours of vaccination$	$none identified$	$Heart Rhythm Irregularity$ High Cholesterol$ Arthritis$ Hypertension$ CVA/TIA/Stroke$ GERD/Reflux$ Sleep Apnea$ Heart Disease$Ace inhibitors$ solifenacin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1050137-1$	$1050137-1$	$Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy.  Pt present on 2/22/21 to ER via ambulance at 1940.  Upon presentation C/C hypotension Post COVID vaccine.  Nurse notes states that Home Health nurse sent patient to ER secondary to hypotension and hyperglycemia.  Pt states back ached and was holding his head.  Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization).  Patient was treated with IVF bolus in addition to initiating Dopamine for hypotension$ patient became agonal and daughter at bedside presented Adv. Directive$ pt was DNR.  Pt pronounced time of death was 2110pm.  (Pt only reported a sore shoulder secondary to vaccine).$	$Fall on 2/15/21 pm resulting in skin tear requiring dressing. Pt Seen on 2/16 for skin tear repair secondary to fall the pm prior.  Vital signs WNL.  Pt returned on 2/20/21 for dressing change.  Vital signs WNL.  Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy.  Pt present on 2/22/21 to ER via ambulance at 1940.  Upon presentation C/C hypotension Post COVID vaccine.  Nurse notes Home Health nurse sent secondary to hypotension and hyperglycemia.  Pt states back ached and was holding his head.  Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization)$	$Hypertension$ MI$ CHF$ DM$ CRF$ Thyroid$ High Cholesterol$ Prostate$Shrimp$ Red Man Syndrome$ Cleocin$ Clindamycin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1050172-1$	$1050172-1$	$Individual developed severe body aches$  severe shoulder discomfort$ high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers$ and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting$ diarrhea and patient died on 2/9/2021.$	$Inpatient admission to Medical Center 12/26/2020 - 01/07/2021 for Congestive Heart Failure$	$Pulmonary Hypertension$ Congestive Heart Failure$ Insulin Dependent Diabetes$ Oxygen dependant$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1050201-1$	$1050201-1$	$Died 7 days after receiving 2nd dose of Moderna vaccine. Had underlying hx Lung CA w/mets.$	$Metastatic Lung Cancer$	$see above$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1050281-1$	$1050281-1$	$Per family$ patient has been feeling sick since he was vaccinated$ patient went to ER on 02/15/2021$ and after few hours at ER patient passed away.$	$No current illness for this event.$	$Z86.39 History of vitamin D deficiency Z99.89 Uses continuous positive airway pressure (CAPAP) ventilation at home E11.40 Type 2 diabetes mellitus with diabetic neuropathy$ without long-term current use of insulin I10 HTN (hypertension) N40.0 BPH (benign prostatic hyperplasia E11.29 Microalbuminuria due to type 2 diabetes mellitus Z87.09 Hx of emphysema G47.33 Severe obstructive sleep apnea G47.30 Sleep apnea H25.13 Age-related nuclear cataract$ bilateral Z68.36 BMI 36.0-36.9$ adult I83.813 Varicose veins of both lower extremities with pain E00.36 Type 2 diabetes mellitus with diabetic cataract$ without long-term current use of insulin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1050431-1$	$1050431-1$	$Since I was not with my husband I can only tell you what was told to me.  He walked out of the store toward our car.  Someone watched him$ concerned$ because he was walking very slowly (normally has a slow gait because of leg braces and toe amputations so I don't know if it was unusually slow).  The woman saw him fall and she ran to help-administered CPR immediately-and told me he died instantly. Medics tried to resuscitate and failed to bring a pulse.  (My husband left our home around 11:15 to drop a package off at store. The store is one mile from our home. At around 12:30 a deputy came to my door and when I saw him my knees buckled.  I knew something horrible happened.$	$None$	$Heart disease$ diabetes in the past but not for the past 4 years; had 3 toe amputations; poor circulation in his legs.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1051267-1$	$1051267-1$	$Passed away; Slight soreness in arm; A regulatory report was received from a pharmacist concerning a 72-year-old male patient who received Moderna covid-19 vaccine and death occurred 4 days after the vaccine and also experienced soreness in his arm after the vaccine administration.  The patient's medical history includes diabetes mellitus$ Hypertension$ Hypercholesterolemia$ CVD$ previous stroke and Depression. No relevant concomitant medications were reported. No information on allergies.   On 4-FEB-2021 at 10:43 am$ prior to the onset of events$ the patient received his first of two planned doses of covid-19 vaccine for the prophylaxis of covid-19 infection.   He had soreness in his arm the day following the shot$ but he had no other symptoms.   He passed away on 08-FEB-2021 at 10 am. As per his wife$ they never made it to the hospital$ and he had poor health prior to vaccination.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable.  The outcome of the event death is fatal.; Reporter's Comments: This is a 72 year old male with hx of diabetes mellitus$ hypertension$ hypercholesterolemia$ and CVD who died 4 days after the vaccine was administered. No autopsy report provided. No further information is expected in this regulatory report case.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cardiovascular disease$ unspecified; Depression; Diabetes mellitus; Hypercholesterolemia; Hypertension; Stroke (Previous stroke.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1051923-1$	$1051923-1$	$Patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1051975-1$	$1051975-1$	$Patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052045-1$	$1052045-1$	$Patient passed away with in 60 days of receiving the COVID vaccine series$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052108-1$	$1052108-1$	$Patient passed away within 60 days of receiving the COVID vaccine series$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052164-1$	$1052164-1$	$911 called to patients house for trouble breathing and abdominal pain. Patient coded$ wife presented DNR paperwork. Patient presented to Hospital DOA at 0958.$	$No current illness for this event.$	$Stage 4 Kidney Disease Hypertension Ischemic Bowel Hyperlipidemia GERD CAD$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052179-1$	$1052179-1$	$Patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052738-1$	$1052738-1$	$He vaccine on 2/5/2021 I went to see my husband the next day he was shaking and his mouth was open shaking$ and he had fever of 105$ they gave him Tylenol suppositories and he passed away 2 hours later.  They should not have given him should not have given him the vaccine that is on hospice$ it was not the right decision. I am worried about the elderly and those very sick.$	$no$	$CHF$no$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052809-1$	$1052809-1$	$Patient passed away$	$Pressure ulcers$	$BPF$ CAD$ Essential HTN$ Diverticulosis of colon$ Hyperlipidemia$ Osteoarthritis$ chronic respiratory failure$ DM2 with peripheral vascular disease$ peripheral edema$ GERD$  obstructive sleep apnea$  osteoarthritis of knees$$Lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1053191-1$	$1053191-1$	$Vaccine administered 02/08/2021 $ by Thursday 02/11/2021 patient almost nonverbal$ by Monday 02/15/2021 patient went to the hospital with bruising$ sores on her stomach and clots reported as thrombocytopenia$ deceased by Friday 02/19/2021.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1053322-1$	$1053322-1$	$Pt had passed away before second dose$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1053788-1$	$1053788-1$	$Received call that patient is now deceased$	$None reported$	$None reported$None reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1053978-1$	$1053978-1$	$pt woke up at 0400 with fever$ chills$ and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911$ pt was declared dead at the time of EMS arrival around 1200$	$none$	$CKD Stage 3$ COPD$ hyperlipidemia$ secondary hyperparathyroidism$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054080-1$	$1054080-1$	$cardiac arrest$ death:  2/21/21$	$none$	$hypertension$ COPD$ schizophrenia$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054192-1$	$1054192-1$	$Pt's wife reports death 2/23/2021$	$None listed$	$None listed$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054337-1$	$1054337-1$	$FOUND DEAD IN HIS OWN BED$	$NONE$	$HEART CONDITION$UNKNOWN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054435-1$	$1054435-1$	$Patient passed on 01/28/2021 per family member.$	$Patient has CLL$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054699-1$	$1054699-1$	$Patient was found at 6 AM on 01/21/2021 - he passed away during his sleep$	$No current illness for this event.$	$PRimaRy hypertension$ HypeRlipidemia$ BRadycaRdia$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054813-1$	$1054813-1$	$Chest clear - Hospitalized for a UTI$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054859-1$	$1054859-1$	$No details - patient died on 1/22/2021$	$No current illness for this event.$	$COPD$ chronic kidney disease$ heart disease$not reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055149-1$	$1055149-1$	$This is a hospice patient under the care of Hospice at an affiliated nursing home. Pt received the vaccination around noon on 2-16-21 by a representative from Pharmacy.  The following afternoon 2-17-21 at 14:45 the pt started to experience severe SOB resp rate 36$ audible wheezing and use of respiratory accessory muscles. BP180/80$ 113 pulse temp 98.  Pt was given morphine and ativan.  The respiratory distress was eased however pt never returned to baseline and died 2-22-21 around 4am.$	$MEDICAL HISTORY; CHF (EF=20%)$ CAD$ AAA (NO REPAIR) 5.3CM$ ANEMIA (HISTORY TRANSFUSIONS ARANESP/PROCRIT)$ CKD STAGE 5 (BUN=110/CREATININE=6.09)$ HTN$ ISCHEMIC CARDIOMYOPATHY$ GLAUCOMA$ HOH$ COVID-19 PNEUMONIA 11-27-2020 THROUGH 12-12-2020$ SEVERE NONRHEUMATIC MITRAL VALVE REGURGITATION$ NSTEMI 03-27-2019$ CAROTID ARTERY STENOSIS$ CABG 2009$ CARDIAC STENT PLACEMENT$ FORMER SMOKER.$	$see above$ace inhibitors$ codeine$ lysynopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055290-1$	$1055290-1$	$Death occurred 02/14/2021$	$unknown$	$elderly$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055418-1$	$1055418-1$	$Patient suffered a stroke and passed away$	$No current illness for this event.$	$$Codeine$ Morphine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055563-1$	$1055563-1$	$Pt tested positive for COVID-19 on 2/10/2021 and died from illness related to COVID-19 on hospice at home on 2/18/2021$ per care facility.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055588-1$	$1055588-1$	$Pt tested positive for COVID-19 on 2/10/2021 and was hospitalized on 2/15/2021 and deceased on 2/18/2021 at the hospital of admission$ per caregiver.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055613-1$	$1055613-1$	$Pt tested positive for COVID-19 on 2/10/2021 and was deceased on 2/16/2021 per the caregiver.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055618-1$	$1055618-1$	$Pt tested positive for COVID-19 on 2/10/2021$ and was deceased on 2/16/2021 at.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055629-1$	$1055629-1$	$Pt tested positive for COVID-19 on 2/10/2021$ and deceased on 2/12/2021$ per caregiver at.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055791-1$	$1055791-1$	$Was given without consent from POA patient got severely sick and never recovered later passed away only live 1 month POA did not allow second vaccine to be given just wanted to report this vaccine was given illegal without POA knowledge$	$Yes Dementia$	$Yes$Yes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1056011-1$	$1056011-1$	$$My grandpa had a stroke on the 15th of February. He claimed he had been feeling $$off$$ for a few days$ but didn't say anything. A blood clot had formed in his brain. He was doing better and about to go to rehab to strength his right side of his body. On the 22nd he took a turn for the worst. He was having trouble breathing and they sedated and partially paralyzed him to put a tube in his mouth. I believe another blood clot had formed and oxygen wasn't properly going through his body. They could not stabilize him$ and he passed away the same day.$$	$Kidney disease$	$Kidney disease$None.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1056518-1$	$1056518-1$	$The coroner said it was some type of heart attack; A spontaneous Report Received from a Health care professional concerning a 84 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a heart attack / myocardial infarction.  The patient's had undergone triple bypass surgery years ago. Concomitant medications were vitamins.  On 18-Jan-2021 prior to onset of events the patient received his first of first two planned doses of (mRNA-1273) COVID-19 vaccine of unknown batch no$ unknown route and unknown site of administration for prophylaxis of COVID-19 infection.  On 13-Feb-2021 the patient experienced death 27 days after the first dose of the vaccine. The coroner said it was some type of heart attack and think he expired sometime Saturday 13-Feb-2021.  On 16-Feb-2021 the patient was supposed to have his second dose of (mRNA-1273) COVID-19 vaccine.  The event$ heart attack$ was fatal.; Reporter's Comments: This is a case of death to heart attack in a 84-year-old female subject with a hx of triple bypass surgery$ who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No death certificate provided. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of Death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Bypass surgery$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1056842-1$	$1056842-1$	$The medical facility did not treat patient as her primary care$ but were informed that she passed away on 15 February 2021 of a stroke.  I do not have further information on the medical aspect of this as we were not her treating provider but did administer the vaccine on 12 February.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057281-1$	$1057281-1$	$patient's husband reported her death that happened after first COVID-19 vaccine$	$per husband$ stage 4 pancreatic cancer$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057363-1$	$1057363-1$	$Patient with severe dementia in Hospice Care$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057828-1$	$1057828-1$	$Patient unexpectedly died on 2/17 after 14 days of receiving first dose of COVID-19 vaccine. EMS presumed it could be from possible myocardial infarction.$	$No current illness for this event.$	$hypertension$ type 2 diabetes$ prostate cancer$ melanoma$ lumbar spondylosis$ renal stones$ GERD$empagliflozin 10mg caused dizziness$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057997-1$	$1057997-1$	$$$$Feeling Hot$$ without fever and nausea 10 hours post vaccine and resolved within 1 hour. Seizure$ Hypotension$ Unresponsive followed shortly by cardiac arrest and pulseless electrical activity 21 hours post vaccine. Pronounced dead 22 hours post vaccine$$	$None$	$Prostate Cancer and High Cholestrol$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058160-1$	$1058160-1$	$Resident expired on 2-25-21$	$None$	$Hypertension$ Hypothyroidism$  Hyperlipidemia$  seizures$  Dementia$ Edema Legs$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059048-1$	$1059048-1$	$Fever$ chills$ fatigue$ muscle aches$ nausea$ death 48 hours after injection$	$None$	$Long QT Syndrome  Atrial fibrillation$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059207-1$	$1059207-1$	$Unknown symptoms overnight. Appears patient passed away sometime after waking up next morning after receiving vaccine.$	$No current illness for this event.$	$Heart disease$ strokes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059360-1$	$1059360-1$	$Cardiac arrhythmia$ EMS on site within minutes$ outcome of death.$	$None$	$Coronary artery disease$ arrhythmia$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059825-1$	$1059825-1$	$30 hours after the first Covid vaccination$ the resident was lethargic$ non responsive with shortness of breathe.$	$none while at community- new move in.$	$Dementia HTN A-Fib Cancer$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060190-1$	$1060190-1$	$Patient received Covid Vaccine Moderna at 1145$ multiple syncopal episodes at pharmacy$ sent to ER. Outcome Death$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060525-1$	$1060525-1$	$death Narrative: This was reported to VAERS by another entity and records were requested.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060527-1$	$1060527-1$	$loss of consciousness;febrile Narrative: Patient received his 2nd vaccine at 10am 2/17. That evening he felt subjectively febrile and then suffered a ground level fall at 0400 on 2/18. He did not lose consciousness or injure his head. EMS was contacted and assisted him into bed. At 0600$ wife noted increased work of breathing$ which prompted another EMS call$ who found him hypoxic with fever of 106. He was transported to a community hospital$ where he was found to have temp 102.9 and blood pressure in 70s-80s systolic. He was transferred to hospital at 1300 on 2/18/21$ requiring norepinephrine for pressure support after fluid resuscitation. He c/o stiffness and soreness all over but presenting ROS was otherwise negative. Patient was treated with 4L IV fluids and vancomycin and piperacillin/tazobactam at the outside ER. Here at the hospital he was treated with vancomycin$ piperacillin/tazobactam and levofloxacin along with IV fluids and norepinephrine. Despite this he had several fevers with Tmax 103.5F the night of 2/18-2/19 and he required norepinephrine plus vasopressin overnight to maintain blood pressure. Piperacillin/Tazobactam was discontinued in favor of meropenem. His last fever was at 6am on 2/19. ID consult was obtained 2/19/21 and vancomycin and levofloxacin were weaned off. Ultimately his blood pressure improved and he was weaned off of all vasopressors the morning of 2/20. Notably$ he never developed severe hypoxemia at rest while in the ICU$ but did require BiPAP non-invasive ventilation at night instead of his usual CPAP to keep his oxygen levels > 90% while sleeping and additionally had desaturations into the low 80% range with exertion from which he was slow to recover. His oxygen saturation was >90% on 30-40% FiO2 via aerosol mask overnight and 3L (his current baseline) NC during the day. He was transferred out of the ICU on 2/21 based on hemodynamic improvement$ stable oxygenation$ and improved mentation and symptoms. Unfortunately$ on the morning of 2/22/21$ patient had an abrupt change in status and was found to be unresponsive with hypercarbic respiratory failure and hypotension. ABG during this event was 7.16/121/65. BiPAP was initiated as patient's code status was DNR/DNI. CXR with no significant change from 2/18/21. CT of head without contrast was negative for acute processes. Based on lack of rapid improvement$ the decision was made by wife to transition to comfort care. Patient died at 1446 on 2/22/21. **Of note: patient was admitted for 1 week for covid 19 pneumonia November 2020. During this hospitalization he was found to have chronic R sided PE$ no acute PE.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060529-1$	$1060529-1$	$Hypoxia$ Decreased responsiveness$  Narrative: 86yo male with PMHx HTN$ Afib not on AC after head trauma$ CVA$ and colon cancer who was brought to the ED by his family on 2/17. Per documentation the pt was in his usual state of health until 2/16. Received Moderna covid vaccine #2 on 2/16/21 at 0900$ and was monitored for 15 minutes following immunization no noted issues. Later that night$ had myalgias and took Tylenol. Per the family he slipped on the ice and fell on his butt. Overnight$ had several dark stools and vomitus. was brought to the ED by his family because he was being less responsive. Pt arrived to the emergency department in extremis. No pulse identified. CPR immediately initiated for several rounds lasting about 25-30 minutes. ROSC unable to be achieved. Patient expired on 2/17 at 1941. Of note$ per previous documentation had waxing and waning mental status at baseline. No symptoms noted with 1st dose of Moderna vaccine$ which was administered on 1/16/21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1061077-1$	$1061077-1$	$Day after second dose decedent had fever and tremors$ subsided on day three (less than 72 hours) after dose with exterem wekness followed by death less than 72 hours after second dose$	$None$	$pulmonary fibrosis$ coronary artery disease$ hypertension$ hyperlipidemia$ CKD$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1061184-1$	$1061184-1$	$$Possible heart attack on 2/5/21. Complaint: $$ On Feb 5th l believe l experienced a mild hear attack$$  (Comment: He said he felt $$clammy$ sweaty$ excruciating pain on my left side - including his left arm$ and left leg$ dizzy$ exhausted.$$ This happened after work$ and after taking a shower. He said that was the first time he's experienced it$ and that it has not happened since then. He said he has constant headaches$ $$It just went away yesterday.$$$$	$none$	$Hyperlipidimia Hypertension$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1061909-1$	$1061909-1$	$Massive stroke; A spontaneous report was received from a consumer (patient's daughter)$ concerning an 85-year-old female patient$ who received Moderna COVID-19 vaccine and death occurred in two days.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination.   On 29-JAN-2021$ prior to the onset of events$ the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day$ she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating$ and she was breathing at that time$ but did not have consciousness. According to her daughter$ the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am.  No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done.  Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable.  The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke$ a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1068357-1$	$1068357-1$	$No pulse and no heart beat; couldn't wake him up; passed away; A spontaneous report was received from a daughter concerning a 84-year old$ male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced no pulse or heartbeat$ couldn't wake him up and passed away.  The patient's medical history$ as provided by the reporter$ included high blood pressure and prostate cancer. No relevant concomitant medications were reported.   On 19 Jan 2021$ the patient had a blood pressure reading of 133/84 at a cardiology visit.   On 13 Feb 2021$ approximately 3 hours prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 (batch number 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021 at 3:30 pm$ the patient could not be woken up and was found with no pulse or heartbeat.   Action taken with the drug in response to the events was not applicable.  The outcome of the events$ no pulse or heartbeat and couldn't wake him up$ were not provided. The patient died on 13 Feb 2021. The cause of death was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.   The patient's medical history of high blood pressure and prostate cancer remains the risk factors. The cause of death was unknown. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death$	$Hypertension$	$Medical History/Concurrent Conditions: Prostate cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1071367-1$	$1071367-1$	$Blood pressure went down until he died; Couldn't hear his heartbeat; neck was sweating; He was cold; Couldn't get up; Death; Sick; immediately very tired; he was tired; Hands were shaking; Slept for too long; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 81-years-old$ male patient who received Moderna's COVID-19 vaccine and developed immediately very tired$ hands were shaking$ neck was sweating$ was cold$ sick$ couldn't get up$ couldn't hear his heartbeat and blood pressure went down until he died.  Patients' medical history$ as provided by patient's spouse$ was emergency room(ER) admission in November 2020 because he had a congested chest (he had fluid around his heart). At that time$ they gave him pills for kidney function. Other concomitant medication reported was Coumadin$ blood thinner. Two weeks before receiving the vaccine$ patient's EKG was normal.  On 11 Feb 2021$ in the morning$ patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 007M20A) probably in the right arm for the prophylaxis of COVID-19 infection.  On 11 Feb 2021$ approximately after 15 minutes of receiving vaccine$ they left and patient was immediately very tired$ his hands were shaking. So$ patient's spouse made them down sleep for too long. On Friday$ 12 Feb 2021 she tried to pick him up$ but he was tired$ exhausted$ and sick.   On Saturday$ 13 Feb 2021$ she brought him a coffee and he couldn't hold it because his hands were shaking$ so she gave him the coffee and then made him pee on the bed because he couldn't get up. At lunch time she made him eat something and he fell sleep again. His wife was hanging around him all day and around 7:30pm she realized that he was cold$ and his neck was sweating$ she couldn't hear his heartbeat. So$ she called emergency services and when they arrived$ her husband's blood pressure went down until he died. Treatment for the events were not provided.  Action taken with mRNA-1273 was not applicable.  Patient was pronounced dead on 13 Feb 2021 20:00. The cause of death was not provided. The plans for an autopsy were not provided.  The events of blood pressure went down until he died and couldn't hear his heartbeat were fatal. The outcome for the remaining events were unknown.; Reporter's Comments: This case concerns an 81 year old$ male patient$ who experienced a serious event of death among others$ 2 days after receiving mRNA- 1273 (Lot# 007M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Heart failure$ congestive$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1062666-1$	$1062666-1$	$2-24-21 patient with development of cough$ fatigue$ increasing on chronic disability worsening debility and falls.  scheduled for office visit 2-25.21 0900 call from spouse 0210 am patient was not breathing and lvad alarming low flow alarm on arrival of ems confirm asystolic  not breathing and dead$	$CONGESTIVE HEART FAILURE ON LEFT VENTRICULAR ASSIST DEVICE MALNUTRITION$ DEBILITY$	$EOSINOPHILIC MYOCARDITIS GI BLEED$NO KNOWN DRUG ALLERGIES$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1062895-1$	$1062895-1$	$patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063000-1$	$1063000-1$	$Patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063561-1$	$1063561-1$	$Patient was a Resident on our LTC wing.  Per the LTC Manager: Resident had hx of CVA with deficits in speech and extremities. Hx of decreased circulation to BLE's which resulted in wounds to bilateral feet on and off that needed treatment. Average meal consumption 25-50% of meals$ started refusing more often in December and January. Would consume small amounts 60-120mL of fluids here or there. Vaccinated on 1/7/21. Stopped eating 1/18/21. Attempted bolus NS fluid 1/25/21. Resident refused all treatment afterwards. Went hospice on 2/3/21 and passed away on 2/7/21.$	$Resident had hx of CVA with deficits in speech and extremities. Hx of decreased circulation to BLE's which resulted in wounds to bilateral feet on and off that needed treatment. Decreased oral Intake. Average meal consumption 25-50% of meals$ started refusing more often in December and January. Would consume small amounts 60-120mL of fluids here or there.$	$CVA$ Decreased circulation to BLE$ Decreased oral intake$Lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063681-1$	$1063681-1$	$Pt got his vaccine 1/27 and was found dead at his residence on 2/7/21.   I heard from our county health officer who talked to the coroner who said that they estimated that the patient had been deceased for 2-3 days prior to when they were found. No apparent cause of death was found.$	$none$	$Mild hypertension$ GERD$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063727-1$	$1063727-1$	$Called pt for Dose 2 appt. Pt had passed away.$	$dementia$	$dementia$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063812-1$	$1063812-1$	$Resident had severe CAD$ DM type 2$ and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. After last surgery$ resident did not have a good appetite$ more restless$ increased confusion with dementia. Significant other passed away on 12/30/20$ resident began refusing meals$ decreased eating. Vaccinated on 1/13/21. On 1/25/21 Resident labs showed kidney failure. Dr. spoke with family and transitioned to Comfort care$ on 2/5/21 went hospice.  Patient passed away on 2/13/2021.$	$severe CAD$ DM type 2$ and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. Decreased appetite$  more restless$ increased confusion with dementia$ On 1/25/21 Resident labs showed kidney failure$ on 2/5/21 went on comfort care$	$severe CAD$ DM type 2$ and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical.$Doxycycline$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063846-1$	$1063846-1$	$Hx dementia$ CVA$ CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may$ gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21.$	$Hx dementia$ CVA$ CAD. 2-3 year history of only consuming 25% of 1-2 meals daily$	$Hx dementia$ CVA$ CAD. 2-3 year history of only consuming 25% of 1-2 meals daily$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063863-1$	$1063863-1$	$Resident had Hx of DM T2$ Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average. Decreased energy to participate in activities and refused getting out of bed or meals.  Was vaccinated on 1/13/21. Hospice care started on 1/25/21. Resident passed away 2/23/21.$	$Hx of DM T2$ Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average. Decreased energy to participate in activities and refused getting out of bed or meals.$	$Hx of DM T2$ Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average.$Penicillins- Hives/ Urticaria$ Rash$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063903-1$	$1063903-1$	$NO SPECIFIC ADVERSE EVENT DUE TO THE VACCINE BUT THE PATIENT PASSED AWAY 02/10/2021 DUE TO COVID$	$No current illness for this event.$	$CONGESTIVE HEART FAILURE$ KIDNEY FAILURE$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1064265-1$	$1064265-1$	$Death$	$n/a$	$n/a$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1064294-1$	$1064294-1$	$Death on 2-28-21.  Not felt by this provider to be likely related to vaccination.$	$none$	$Hypertension$ Hyperlipidemia$ Diverticulosis$ Osteopenia$ Kyphosis$nkda$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1064433-1$	$1064433-1$	$Cardiac Arrest$	$No current illness for this event.$	$$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1065507-1$	$1065507-1$	$EXTREME PAIN$ STOPPED EATING/DRINKING -- STARTED MORPHINE$	$DEMENTIA$	$DEMENTIA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1065719-1$	$1065719-1$	$My grandpa got his second covid vaccine on Thursday. Saturday he complained of stiff neck. Sunday he had low grade fever$ nausea and vomiting$ chills$ and mild headache. He was feeling bad enough to call squad at 3 pm. The paramedics did evaluation and thought he was just experiencing normal side effects from vaccine and felt no need to transport to hospital so my grandpa decided to stay home and just rest. At 2 am that same night he went into cardiac arrest and was not able to be brought back$	$No current illness for this event.$	$chf copd dm$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066199-1$	$1066199-1$	$Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom.  Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course:   Examination.   Epinephrine 1 mg IO x4 CBC$ CMP$ cardiac panel MDM:   1447 patient arrival$ per EMS report patient had been sick and vomiting all morning.  Bradycardia noted at arrival with rates in the 30s$ CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device$ 1 mg epinephrine given IV push 1451 CPR pause rhythm check.  CPR resumes 1453 CPR paused for rhythm check.  No central pulses$ CPR resumed$ glucose of 99 per fingerstick 1454 King tube removed.  Oral airway placed respirations by BVM.  1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check.  No central pulses noted.  CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via Lucas.  1 mg epinephrine IV push 1459 warm blankets applied.  CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed 1501 CPR pause for pulse and rhythm check.  No central pulses.  CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check.  No central pulses noted.  CPR resumed via the Lucas device 1506 resuscitation is ceased at this time.  Time of death recorded at 1506$	$Per EMS report patient had been having diarrhea and vomiting for the last 3 to 4 days.$	$Hyperlipidemia (disorder) Generalized osteoarthritis (disorder) Hypothyroidism (disorder) Tinnitus (finding) Benign essential hypertension (disorder)$LIPITOR$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066484-1$	$1066484-1$	$Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition$ to wait on bus to take him home. At 18:00 his neighbor heard him fall$ could not get patient to answer phone$ found him unresponsive. Neighbor called 9-1-1$ ambulance personnel could not revive patient.  Coroner's office ruled his death as Natural Causes due to Hypertension$ Cardiac disease$ Diabetes$ ESRD.  There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.$	$Same as listed in # 12.$	$Hypertnesion$ Cardiovascular disease$ Diabetes Type 2$ End Stage Renal Disease$ Amputee$$Morphine  Xarelto$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066715-1$	$1066715-1$	$epistaxis.$	$copd$ prostate ca$	$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066770-1$	$1066770-1$	$died$	$No current illness for this event.$	$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066852-1$	$1066852-1$	$History of terminal cancer$ entered hospice care 1/2021$  expired 2/28/2021.  No reported adverse events from patient or family after receiving vaccine$	$None$	$Terminal cancer- Hospice care started 1/2021$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1067036-1$	$1067036-1$	$Patient received dose 1 of Moderna Vaccine on 1/14/21 administered by pharmacy. Patient was hospitalized on 1/31/21 due to shortness of breath and diminished O2 sats down to 88%. Patient was in atrial fibrillation. Patient discharged from hospital on 2/25/21 to home. Patient received dose 2 of Moderna Vaccine on 2/25/21 prior to discharge from hospital. Last hospital note stated that patient was pleasant and cooperative with good motivation. Patient passed away after discharge from the hospital on 2/26/21. Patient's son called the hospital to report his passing.$	$Patient was discharged from the hospital to a home on 2/25/21 after a complicated 25 day hospitalization.$	$history of hypertension$ diabetes mellitus$ history of chronic AFib$ on anticoagulation$ history of MI with a stent$ history of BPH$ history of dementia$ chronic kidney disease$ GERD and benign essential tremor$ who was at a nursing home$lisinopril$ metoprolol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1067125-1$	$1067125-1$	$was reported to staff at Health Department that client passed away hours after receiving Moderna vaccine$ also reported that client had multiple health conditions.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1067177-1$	$1067177-1$	$Patient had sudden death 1 week after 2nd COVID vaccine.  Had complained of dizziness throughout the week leading up to it.$	$No current illness for this event.$	$diabetes$ hypertension$ hypothyroidism$ osteoporosis$ chronic kidney disease$actonel$ aspirin$ bextra$ celebrex$ iodine$ novacaine$ penicillin$ sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068564-1$	$1068564-1$	$On 3/2/2021$ clinic was notified by patient's family that patient had deceased on 2/28/2021 from a heart attack. Unsure of any relation to the Moderna vaccine but reporting for due diligence.$	$unknown$	$chronic kidney disease stage 3; congestive heart failure; diabetes; hypertension; hyperlipidemia; morbid obesity; bilateral paresis of lower extremity; peripheral edema; sleep apnea; stented artery; history of malignant neoplasm of prostate$nkda$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068814-1$	$1068814-1$	$9 days after vaccination$ the patient was found deceased in his home$ sitting on his couch. Determined to be due to pulmonary embolism.$	$none$	$Gout$no$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068882-1$	$1068882-1$	$DEATH Narrative:  Son stated that patient was doing well$ still working and driving places. He stated that he called his son and stated that he wasn't feeling well and died shortly after that.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068887-1$	$1068887-1$	$DEATH Narrative:  UNSURE DETAILS OF EVENT$ NO DOCUMENTATION IN PROGRESS NOTES$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068888-1$	$1068888-1$	$DEATH$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068890-1$	$1068890-1$	$death Narrative: unclear of details$ s/p spine surgery on 2/2/21 and discharged on 2/6/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068901-1$	$1068901-1$	$ER admit for CP and Jaw pain$ exhaustion$ Aortic arteritis normal SED rate found on CT scan hospital admit IV medications required Solumedrol and Actemra questionable how much medications received d/t IV's not working. Released from care on 2/19 with prednisone . Symptoms still present off and on. 2/21 922pm CP Jaw Pain severe EMT's called EKG done reported no heart attack$ pain better$ EMTs left. 10/15 severe Pain collapsed with no pulse and no breathing$ EMTs returned unable to obtain a shock-able rhythm time of death pronounced. reason for death on certificate Aortitis - hospitalist thinks aortic dissection d/t severe inflammation$	$COVID prior to vaccination - still having symptoms SOB$ Tired$ foggy head -thinking$	$GCA Arthritis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068931-1$	$1068931-1$	$Case passed away on 2/28/21.  During post vaccination monitoring$ case did not have any adverse reactions. When writer spoke to him on 2/26/21 to schedule his second dose$ he sounded well.$	$$No other illnesses.  He spent six days at a nearby hospital last week. Came home Thursday$ February 25$ 2021$ as his blood work indicated that he had stopped bleeding and was stable. Per family$ $$he was in good spirits Friday and Saturday which started to change Sunday morning.$$  He passed way in his sleep sometime late Sunday night or very early Monday morning. I believe his date of death will be 3/1/2021.$$	$Diverticulitis Spinal Stenosis$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068963-1$	$1068963-1$	$approximately 24 hours post vaccine Patient developed a low grade fever of 99.5 and had increased fatigue. 48 hours later she had decreased neurological functioning. 02/23 she had difficulty swallowing. 02/23 She was admitted to hospice services. 02/26 she passed just before 10 am.$	$Adenocarcinoma of colon$ hypothyroidism$ Alzheimer's dementia with behaviors disturbance$ Anxiety$ A Fib$ GERD$ recurrent UTI$ Vitamin B 12 deficiency.$	$See Item 11$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069009-1$	$1069009-1$	$Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.$	$Swollen hands$	$None$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069026-1$	$1069026-1$	$Death Narrative: Family was able to be present at bedside shortly after patient was extubated. Fentanyl bolus given 10-15 minutes prior. Patient passed away soon after endotracheal tube removed. Time of death 10:14am.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069118-1$	$1069118-1$	$Within 10 minutes following the second vaccination$ patient reported dizziness and nausea$ had an episode of vomiting but recovered within 30 minutes.  It was reported to our clinic that the patient was found deceased on March 1$ 2021 at approximately 10 pm.  Cause of death is not determined at this time.$	$First covid vaccine received 1/28/2021 without incident.  Had been hospitalized prior to vaccination for intractable vomiting.$	$history of acute respiratory failure$ carotid artery stenosis$ chronic back pain$ chronic esophagitis$ chronic hyperglycemia$ chronic obstructive lung disease$ chronic sinusitis$ coronary arteriosclerosis$ depressive disorder$ exposure to SARS-CoV-2$ history of polyp of colon$ hyperlipidemia$ hypertensive disorder$ hypoxia$ nicotine dependence$ non-small cell lung cancer$ osteoarthritis$ peripheral nerve disease$ peripheral vascular disease$ tremor$codeine$ Zithromax$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069140-1$	$1069140-1$	$The day after the administration of the vaccine$ the fever began$ the patient claim that he had no blood pressure problems. He was given acetaminophen every 4 hrs. and vitamin C and D. On February 11$ he was stabilized$ he had his regular meals without any problem but in the afternoon his temperature rose again and they put him to bed. The patient died that same afternoon around 4:00 pm$	$None reported$	$Hypertension$ stroke$ pacemaker$None reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069570-1$	$1069570-1$	$2nd dose of Moderna at 9:00am. No side effect (except pinch at injection site) throughout the day and evening. At ~9:45pm$ my wife suddenly fell unconscious. Immediate CPR & with Paramedic were not able to revive her. SHE PASSED AWAY at home. We believe it may be triggered by the vaccine.  Did not have a chance to go to hospital or emergency room - it was too sudden. A sad day for us.$	$None$	$High Cholesterol level.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069647-1$	$1069647-1$	$Beginning in the evening 2/19/21$ fever/chills/fatigue; worsening of symptoms 2/20/21 with lethargy/lack of appetite/weakness; unable to arouse on 2/21/21 then breathing stopped$ patient's spouse called 911 performed CPR$ EMS continued for 15 min then while in ambulance to hospital  where he was pronounced dead.  Official time of death 2:20pm$	$s/p CABG with valve replacement (1/28/21) with slow recovery (in ICU 2 weeks)$	$COPD$ prostatitis$ Celiac disease$ arthritis$ LBP$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069938-1$	$1069938-1$	$expired at Hospital$	$unknown$ none listed on pre checklist$	$unknown$ takes blood thinner$nkma$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1070038-1$	$1070038-1$	$Client passed away 8 days after being vaccinated.  It is unknown if it occurred from the vaccine or other comorbidities.$	$COPD$	$COPD Vascular Disease Chronic Pain Opioid Dependence HTN$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1070562-1$	$1070562-1$	$The coroner called Dr. on 3.2.2021 to advise that he had a witnessed collapse and Mr. was taken to the ED where he was pronounced.$	$No current illness for this event.$	$Relatively severe aortic valve stenosis$ bradycardia$ orthostatic hypotension and Parkinson's disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1070937-1$	$1070937-1$	$Unwitnessed Cardiac arrest. ACLS protocols were performed.  Cessation of resuscitation was called in the field by Dr.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071618-1$	$1071618-1$	$Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later$	$none$	$irregular heart beat$biaxin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1072156-1$	$1072156-1$	$Vaccine manufacturer and lot number unknown$ vaccine given at alternate location.  2/23/21  8:27 PM: The patient is a 68-year-old male   comes to the emergency department by paramedic ambulance for altered mental status that$ began at around noon in association fever temp 102.9.  PMH of myelofibrosis (on Jakafi and hydroxychloroquine)$ depression$ anxiety$ OSA$ and history of AVR.  Given history of myelodysplasia and Jak inhibitor predisposing to some opportunistic infections most notably viral reactivation with history of HSV and possible bacterial endocarditis he was admitted to the ICU for further monitoring and pressors.    Patient has a MOS procedure 14 days prior   - Status post MOSs procedure with large wound deficit on forehead -- Does not appear to be overtly infected at the time of admission.   ED physician indicated mild facial cellulitis.  2/23/21- WBC 16.1 on admission.     ECHO 2/26 indicated - no vegetation visualized. Of note second COVID vaccine 2 days prior to admission. Dr. felt incident was possible cardiogenic shock secondary to COVID vaccine.  He did not feel the patient has a source of infection upon admission.  Questionable given wounds on forehead Dr. (CMO) review of case- his impression was  septic shock with and underlying case of chronic cardiac compromise making the hemodynamics worse$	$erythema of face consistent with mild cellulitis recent MOS procedure for skin cancer$	$myelofibrosis History of aortic valve replacement in 2014 hx of depression$ anxiety$amiodarone$ doxycycline$ penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073225-1$	$1073225-1$	$Death within 30 days: Admit 2/8/21-2/13/21 s/p fall with left hip fracture (repaired)$ severe debility with recurrent falls discharged to SNF. Not doing well postop at the SNF$ brought to ED due to failed foley insertion with bright red blood upon arrival to ER febrile$ hypotensive$ tachycardic$ severe sepsis. Gran negative bacteremia likely from chronic ascites$ family decided on comfort care and he expired within hours of admission.$	$Chronic Illness with debilitation$	$chronic hyponatremia$ chronic low back pain$ ascites$ cirrhosis of liver$ non-alcoholic fatty liver$ dyslipidemia$ diabetes$ esophageal varisces. obstructive sleep apnea$NSAIDS$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073344-1$	$1073344-1$	$patient died.$	$No current illness for this event.$	$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073361-1$	$1073361-1$	$passed away$	$No current illness for this event.$	$$PCN$ ASA$ Amantadine$ IVP dye$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073773-1$	$1073773-1$	$Patient was found deceased later in the afternoon.$	$No current illness for this event.$	$Alzheimer's/Dementia$ BPH$ HLD$ HTN$ Aortic stenosis$ Osteopenia$ allergic rhinitis$penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073808-1$	$1073808-1$	$Prt was found deceased$	$PTSD$ H/O AAA$ HTN$ Afib$ hemiplegia secondary to CVA$ depression$	$PTSD$ H/O AAA$ HTN$ Afib$ hemiplegia secondary to CVA$ depression$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073813-1$	$1073813-1$	$DEATH Narrative: UNCLEAR WHY PATIENT WAS HOSPITALIZED AS LIMITED INFORMATION IN RECORD$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073895-1$	$1073895-1$	$Patient passed away after getting the 1st dose of COVID vaccine. He seemed otherwise very healthy.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1074067-1$	$1074067-1$	$Patient received Moderna COVID-19 vaccine on 2/25/2021.  Patient found dead by family the morning of 2/26/2021.   Family requested an autopsy.$	$kidney / bladder cancer with extension into soft tissue inferior vena cava clot extending to liver$	$atherosclerosis$ history of CVA$ history of stage 1 squamous cancer of LUL$ LU lobectomy$ sleep apnea$ emphasema$ tardive dyskenesia$ squamous cell cancer skin$ constipation$ schizoaffective disorder$ hyperlipidemia$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0927260-1$	$0927260-1$	$No adverse effects noted after vaccination.  Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns$ eyes partially closed  SPO2 was 41%$ pulseless with no cardiac sounds upon auscultation.  CPR and pulse was regained and patient was breathing.  Patient sent to Hospital ER  were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.$	$Digestive Surgery for bowel obstruction$	$HTN$  AAA$ Chronic Diastolic Heart Failure$ Diabetes Type 2$   Paroxysmal atrial fibrillation$  bradycardia$  Hx of STEMI$ Hx of CVA$ HX of uterine cancer$$Codeine$ Meperidine$ Morphine$ Estrogens$ Penicillins$ Tetanus Toxoids$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0974833-1$	$0974833-1$	$1/24/21 0445- patient presents to the ED with complaints of  neck pain$ chest pain$ and back pain for about a week. States also feels SOB$ intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms$ found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE.  Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen.  1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large  brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci  in clusters growing after 9 hours.$	$unknown$	$CHF$ heart murmur$ hyperlipidemia$ hypertension$ aortic valve leak$ acute renal failure$ history of CABG$ AICD and heart stent placement$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0975002-1$	$0975002-1$	$on 1/13/2021 at 3:40am Cliff called for assistance. He lost his balance and had fallen. Cliff refused vitals$ refused emergency department$ denied hitting his head.  As the day progressed patient developed a headache$ diarrhea$ and vomiting. He again declined the offer for the emergency room. At supper time wife and staff found Cliff unresponsive$ 911 was called and he was taken to the emergency department. The ER did a CT scan and found an acute subdural hematoma. Patient was placed on comfort cares and expired at 3pm on 01/14/2021.  Cliff did not have a history of falls.$	$Stable$	$Chronic atrial fibrillation (on warfarin)$ coronary artery disease$ chronic heart failure with preserved ejection$Bee venum$ shellfish$ adhesive tape$ cardizem$ primidone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0977320-1$	$0977320-1$	$about 20+ hours after vaccination resident was having hard time breathing$ 911 was called.  Resident coded multiple times at the  facility after CPR she was taken to ICU.  She coded again and was placed on life support.  Due to her choice to not be on life support she passed on 11/26/2021.$	$acute pancreatitis$ gerd$ ibs$ OA$ rheumatoid arthritis$ HTN$ H/o falls$ osteoporosis$ pre-diabetes$ hyperlipidemia$ diverticulosis$ interstitial lung disease$ permatomyoitis$	$acute pancreatitis$ gerd$ ibs$ OA$ rheumatoid arthritis$ HTN$ H/o falls$ osteoporosis$ pre-diabetes$ hyperlipidemia$ diverticulosis$ interstitial lung disease$ permatomyoitis$azathioprine (Imuran)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0977358-1$	$0977358-1$	$cough congestive heart failure death$	$No current illness for this event.$	$anemia$ mild renal insufficiency$ hypertension$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$0991997-1$	$0991997-1$	$Resident c/o nausea evening of 1/29 (nausea common for her post dialysis)$ had a large emesis at approx 2220$ 0030 (unusual for resident to vomit)- received Zofran per order.   Skin cool and damp$ Blood sugar 147 (checked due to h/o diabetes and poor intake).  At approx 230am Blood pressured checked and noted to be 52/29.   Resident transferred to ER$ intubated and transferred to higher level of care where she passed away on 1/30 at 736pm.     Resident's medical notes indicated likely shock$ cardiogenic in nature$ sepsis (source unknown) along with a multitude of other co-morbidities that resident has.$	$COVID + diagnosis (12/17/2020) ASYMPTOMATIC Multiple oral extractions completed by dentist on 1/26/2020 ESRD (on 3x week dialysis-last date of dialysis 1/29/2020)$	$ESRD$ Diabetic$ Heart Disease$ Vascular Disease$ HTN$$Bactrim/Sulfa$ Cyclobenzaprine$ Fentanyl$ Gabapentin$ Lisinopril$ Metoprolol$ Primidone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$0992342-1$	$0992342-1$	$Shortness of Breath$ decreased oxygen saturation$ irregular heart rhythm$ hypertension$ Positive for COVID$ bilateral pneumonia$	$none$	$Diabetes Type 2$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$1042967-1$	$1042967-1$	$Patient called son around 6:30am on 2/18/21. When son tried to contact patient around 8:30am$ he was not able to get a hold of patient. Son sent someone over to check on patient. They found patient on the floor. He was coherent at first but then lost consciousness. It believed he experienced a stroke sometime around 8:30-9:00am of 2/18/21. Patient was taken to hospital and then transferred to another hospital. He was put in a medically induced coma. He passed between 4:00 and 4:30 pm on 02/19/21.$	$Sinus infection$	$Hypertension$ Diabetes$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Mar.$ 2021$	$2021/03$	$1062830-1$	$1062830-1$	$92 yo female who received her first dose of Moderna vaccine on 1/11/2021 with no known adverse effects.  Admitted to the hospital on 1/17/21 with a spine compression fracture. Discharged and readmitted on 1/19 /21 with nausea and vomiting. Found to have new atrial flutter and elevated troponin attributed to NSTEMI.  Discharge on Aspirin and Plavix.  No cath.  Second dose of Moderna vaccine 2/25/21.  No immediate reaction.  One hour later began to feel progressively weak.  EMS called shortly after getting home.  Intubated in the field.  Died at 0658 on 2/26/21 s/p PEA arrest without ROSC.$	$1/17/21 Spine compression fracture 1/19/21 New diagnosis of atrial flutter and NSTEMI$	$HTN Chronic back pain  Osteoarthritis$Trazodone - tachycardia and numbness of extremities (hands/feet)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$1 day$	$1$	$Mar.$ 2021$	$2021/03$	$1069830-1$	$1069830-1$	$From CT Scan in ED at 7:40 pm on 1/25/2021 -- There is a large intraparenchymal hemorrhage with Surrounding vasogenic edema within the left occipital lobe. There is additional subdural hemorrhage layering along the left frontal$ temporal and parietal convexity which may be decompressing from the area of intraparenchymal hematoma. No visualized intraventricular hemorrhage.There is some trace hemorrhage layering along the left tentorium cerebelli. Severe associated mass effect with left-to-right midline shift of 2.1 cm. There is subfalcine and downward transtentorial herniation with complete effacement of the basilar cisterns. Evaluation of the craniocervical junction is limited due to beam hardening artifact. Near-complete effacement of the left lateral ventricle.  No head trauma or fall.  Deceased 1/26/2021$	$No current illness for this event.$	$arthritis$ osteoporosis$ prior heart stent$NSAIDS$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$2 days$	$2$	$Jan.$ 2021$	$2021/01$	$0959568-1$	$0959568-1$	$Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well$ and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday$ January 19th$ 2021$ the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours$ at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th$ and she passed away shortly thereafter.$	$None disclosed$	$None disclosed$None disclosed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$0991060-1$	$0991060-1$	$Fever 101.1$ unresponsive episode.  Transferred to Hospital on 1/28. Diagnosis there was anemia and CHF$ aware that he had vaccine day prior. Transfused with 2 units pRBC's. Transferred back to Nursing Home on 1/30 and passed away 0140 1/31/2021$	$Dementia$ heart failure$ paroxysmal atrial fib.. BHP$ HTN$ thorasic aortic aneurysm$ polyosteoarthritis$  history of falls$ anemia$	$as above Resident was transferred to hospital on 1/28/21.  Returned to nursing facility on 1/30 and passed away on 1/31/21.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1018448-1$	$1018448-1$	$2/6/2021 stroke. 2/8/2021 he died$	$none$	$dementia. hx stroke. carotid disease. emphysema. hyperlipidemia. BPH$oxycodone. penicillin. simvastatin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1027300-1$	$1027300-1$	$Nausea$ vomiting and generalized weakness.$	$None known$	$Aortic aneurysm$ aortic stenosis$ CAD$ HTN$ CHF$  A-Fib$ HLD$ Ischemic heart failure$ pacemaker$ V-Fib$ PVD$ palpitations$ hypotension$ and small bowel obstruction.$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1029511-1$	$1029511-1$	$Developed severe shortness of breath.$	$None$	$None$ never sick$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1061059-1$	$1061059-1$	$Do not know if patient informed her physician that she received vaccine on 1/29/2021. She had appt at 3:15 pm on 1/29 and afterwards stated she received the Moderna vaccine. Reporter is uncertain if this was at a health office or clinic. She drove herself to the ER at about 3am on 1/30/2021 with increased cramping and pain.$	$Was undergoing diagnostic testing for gastrointestinal complaints of several weeks duration. Had CT morning of 1/29/2021.$	$History of type 2 diabetes Hip replacement had been postponed due to pandemic$not known to reporter$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$2 days$	$2$	$Mar.$ 2021$	$2021/03$	$1070040-1$	$1070040-1$	$Admitted to hospital 2/22/21$	$Thyroid nodule$	$Diabetes$ HTN$ Depression$ chronic pain$Morphine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$3 days$	$3$	$Jan.$ 2021$	$2021/01$	$0983766-1$	$0983766-1$	$Pt started complaining of chest heaviness and shortness of breath on the afternoon of 1/21/21. EMS was called to the patients home and she was found to have an O2 sat in the 70's. She was admitted to hospital and found to have a proBNP of 5000.  She tested negative for Covid-19. She was determined to be in acute-on-chronic heart failure and was referred for hospice care. She passed away on the evening of 1/24/21.$	$Heart failure with reduced EF$ history of moderate pulmonary hypertension$ history of moderate mitral valve regurgitation and moderate pulmonary valve regurgitation. History of A. fib.$	$Heart failure with reduced EF$ history of moderate pulmonary hypertension$ history of moderate mitral valve regurgitation and moderate pulmonary valve regurgitation. History of A.fib.$No known allergies to drugs or food$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1002636-1$	$1002636-1$	$On 1/17/2021 patient woke and began her day as usual$ was found down by family member 1 hour later conscious but unable to speak and unable to move her R side.  She was admitted to the hospital - Initial NIHSS was 26 and CT imaging showed no acute hemorrhage but mild hypodensity of greater than 1/3 of the MCA territory (TPA not recommended).  CTA did show distal L M1/M2 occulsion and she was transferred to larger facility for thrombectomy.  Unfortunately the patient had persistent severe neurological deficits after thrombectomy.  Was discharged home on hospice care and expired on 1/23/21.$	$None - had exposure to COVID19 + case on 12/18/2020 but tested negative.$	$CHF$ HTN$ hyperlipidemia$ atrial fibrillation$ COPD (O2 dependent) $ CKD Stage 4$ type 2 diabetes (diet controlled).$Oxycodone$ Percodan$ atenolol$ PCN VK$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1005499-1$	$1005499-1$	$Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes patient had a near syncopal episode. She felt lightheaded and shortly after had episode of nonbloody vomiting. Hypotensive 81/69 and started on levophed. Alert and orientated. Lungs clear$ abdomen benign on admission. Patient had no reaction when received first dose of the vaccine.  Patient developed worsening shortness of breath$ tachypnea$ Afib with RVR$ hypotension and required intubation and multiple pressors.$	$No current illness for this event.$	$depression$ hearing difficulties$ osteoporosis$ hyperlipidemia$ PVD$ breast cancer in situ$ hypertension$ aortic aneurysm$Adhesive tape-silicone celecoxib hydrocodone-acetaminophen pravastatin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1012612-1$	$1012612-1$	$Patient was hospitalized on 31 Jan for COVID pneumonia after 3 days of increasing baseline supplemental O2 requirements and dyspnea and ultimately died on comfort care on 3 Feb 2021.$	$COPD exacerbation 2 weeks prior$	$Atrial fibrillation on anticoagulation benign prostatic hyperplasia CKD stage 3 Chronic obstructive pulmonary disease - on baseline 2L NC supplemental O2 Gastro-esophageal reflux disease Hyperlipidemia Hypertension Hypothyroidism Obstructive sleep apnea Type 2 diabetes mellitus asbestosis$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1042145-1$	$1042145-1$	$Patient reported feeling weak$ fatigue$ fever (102)$ and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date).   See following discharge summary from ED:  82 y.o. female who initially presented to the ED with complaint of generalized weakness$ fatigue$ fever$ and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47$ Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt.   During her stay in the hospital$ pt did test positive for Covid 19. She developed rapidly progressive respiratory failure$ felt to be secondary to ARDS. There was also question of contributing pulmonary edema$ however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status$ thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately$ she continued to suffer greatly with the BiPAP in place$ and therefore made the decision to transition herself to comfort measures only after visitation from her family.   Her other medical issues were supported as appropriate during her stay$ with dextrose infusion for hypoglycemia and AKI$ also hyponatremia felt to be due to IVVF.   Unfortunately$ am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine، enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless$ she developed ARDS as result of her Covid 19 illness.    Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia.$	$None reported$	$PE$ Asthma$ Obesity$ Diabetes$ COPD$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1047634-1$	$1047634-1$	$Patient was admitted to hospital on 2-9-21 for urinary tract infection and tested positive for Covid. Developed pneumonia and expired on 2-12-21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1051942-1$	$1051942-1$	$Hepatorenal syndrome- Death$	$Acute Hepatitis$$	$CAD$ MI$ RLS$ Peripheral Neuropathy$ PD$ hyperlipidemia$ orthostatic hypotension$ Shy-Drager$Intolerance to Morphine$ Propoxyphene$ Statins$ Bisphosphonates$ Tramadol$ Methadone$ and Meperidine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Jan.$ 2021$	$2021/01$	$0935350-1$	$0935350-1$	$Patient was found unresponsive at home with SpO2 20% 1/2/2021$	$Dyspnea$ Shortness of breath$	$Paroxysmal atrial fibrillation Hypertension Chronic iron deficiency anemia Congestive heart failure with chronic diastolic$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Jan.$ 2021$	$2021/01$	$0970412-1$	$0970412-1$	$Fever  Feeling tired  short of breath all night and morning after the vaccine  My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed.$	$High blood pressure. Dialysis$	$kidney failure$ Dialysis patient$no$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$0992372-1$	$0992372-1$	$$This is a 73 year old female that received her 1st dose with Moderna vaccine on 1/8/21 at approximately 1600.  Within one hour$ the patient developed altered mental status and increasing weakness.  She was transported to the hospital by the staff at her Assisted Living Facility for concern of a vaccine reaction. On admission$ oxygen saturation was found to be 89% on room air$ BP=137/86$ HR=94.  Labs were normal$ with the exception of WBC=15 (leukocytes normal$ chest xray clear$ COVID test negative)$ and a detectable troponin=63.  Head CT negative.  Physical exam was only notable for 'slight superficial erythema over distal right forearm and dorsal hand. No significant edema.' The patient was treated for a possible allergic reaction to vaccine with NS bolus$ methylprednisolone 125mg$ famotidine 20mg$ and aspirin 300mg PR.  She was admitted for monitoring given continued altered mental status/weakness.  The next day$ she continued to show no improvement$ so a head MRI was ordered.  MRI showed $$ 1. Numerous acute cerebral and cerebellar infarcts involving both anterior and posterior circulations consistent with a central embolic source. 2.  Minimal right parietal petechial hemorrhage. 3.  Moderate atrophy and moderate nonspecific white matter signal abnormalities compatible with chronic microvascular ischemia  $$  Neurology was consulted$ who approved the start of aspirin and to continue DVT prophylaxis.  The patient's advanced dementia and timeline preclude other intervention.  The patient's status was DNR/DNI. The patient was discharged on hospice to her assisted living facility on 1/11/21 (with reports of continued somnolence).  It was reported that date of death was 1/24/21.$$	$No current illness for this event.$	$(1) Advanced dementia (2) Hypothyroidism (3) Anxiety (4) Hx falls$(1) Etodolac (rxn = n/v$ diarrhea$ SOB) (2) Bee Pollen (3) Escitalopram (rxn = 'intolerance') (4) Paroxetine (rxn = 'ineffective') (5) Venlafaxine (rxn = 'ineffective')$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1017339-1$	$1017339-1$	$Admitted to hospital with sob upon exertion that started prior to vaccine. Hx COPD$ HTN$ CKD$ hyperlipidemia$ bladder cancer in remission.  Stated he has been taking Eliquis and Xarelto between renal doctor and cardiologist Dr.  Anticipating going home 2/5/21 but then turned blue and stopped breathing under a DNR. COVID test negative.  Labs show acute on chronic renal failure with an elevated troponin likely from demand ischemia.$	$sob with exertion$ started just prior to vaccine$	$A-fib Bladder cancer history CKD COPD HTN$Penicillin hives Sulfonamide Antibiotics hives$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1020724-1$	$1020724-1$	$$Patient sent to the ED or sudden onset of shortness of breath on 02/02/2021. Per documentation by the MD$ the patient had COVID19 $$several weeks ago$$ and the nursing facility felt like he had recovered. A rapid test done in the ED was negative. When the patient worsened and seemed to be following the same path as other COVID patients$ a send out PCR test was done$ which was positive. The patient worsened and passed away that same day (02/05/2021) I was not made aware that the patient had the vaccine on 01/21/2021 until Monday 02/08/2021.$$	$COVID19$$	$hypertension and Coronary Artery Disease$codeine$ penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1026534-1$	$1026534-1$	$resident had a stroke$ sent to the hospital and died 4 days later$	$No current illness for this event.$	$$ HTN$ CKD$ Alzheimer's$ciprodex$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1030701-1$	$1030701-1$	$unknown$ husband reported hospitalization 02/12 and deceased  02/15$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1047169-1$	$1047169-1$	$jaundice->hemolytic anemia-> hemorrhagic shock->multi organ failure->death pt admitted to ICU 2/16 with Hgb=3.4$ treated with steroids$ supportive care $ pressors$  pt died 2/20/21$	$none$	$$mild anemia hypothyroid $$prediabetic$$ dyslipidemia macular degeneration$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1048917-1$	$1048917-1$	$Resident yelling for assistance in apartment. Nursing personnel found resident on floor at 6:10 AM on 2/18/2021.  Resident was transported to Hospital on 2/18/2021. Status update on 2/18/2021 from son$ resident CT & X-rays were done all normal. Labs done and WBC count was elevated and awaiting results. Resident stable and admitted to hospital for observation. Resident passed away on 2.21.2021.$	$No acute illness$	$Diagnosis Codes obtained upon admission in 11.17.2015 I45.10$ J30.9$ J44.9$ E78.0$ i10$ K21.9$ H40.9$ D69.6$ G93.40$ K59.0$ Z96.641$ sm869$ sm859$Morphine$ Shellfish$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1055691-1$	$1055691-1$	$Massive ischemic stroke with aspiration$ unable to arouse on the morning of 1/21/2021 and placed on Hospice with death 1/24/2021$	$dyslipidemia$ mild dementia$ lumbar stenosis with indwelling suprapubic catheter - no known infection/symptoms of infection$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$5 days$	$5$	$Jan.$ 2021$	$2021/01$	$0963235-1$	$0963235-1$	$Patient diagnosed with COVID on January 9$ 2021 after being exposed to family member that was under quarantine in the same household.  Admitted to the hospital and was discharged on January 14$ 2021 with home hospice.  Patient passed away on January 18$ 2021$	$No current illness for this event.$	$HTN$ Depression$ Atherosclerotic heart disease$ GERD$ Hypothyroidism$ Chronic renal failure stage 3$ CHF$Lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$5 days$	$5$	$Jan.$ 2021$	$2021/01$	$0970930-1$	$0970930-1$	$Pt developed COVID-19 infection$ symptoms starting 7 days after first dose was given.  Patient was admitted to hospital on 1/21 after falling (secondary to weakness) and striking head on toilet. Patient expired due to respiratory complications of COVID on 1/25.$	$0$	$AAA$Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$5 days$	$5$	$Jan.$ 2021$	$2021/01$	$0975689-1$	$0975689-1$	$Resident vaccinated on 01/06/21  she acquired COVID 19 on 01/10/2021. Resident had multiple co morbidities and was declining prior to the vaccine. Resident expired on 01/20/2021$	$COVID 19 01/10/2021 HYPEROSMOLOTY AND HYPERNATREMIA HERNIA HYPERGLYCEMIA LOW BACK PAIN ANEMIA OSTEOPOROSIS DEMENTIA WITH BEHAVIORS CONSTIPATION CARDIAC MURMUR/HEART DISEASE POLYNEUROPATHY HX OF BREAST CANCER HTN DEPRESSION$	$$PCN  and NKFA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$0992137-1$	$0992137-1$	$6 days after vaccine developed bloody diarrhea. Thought to have ischemic colitis but negative evaluation. became hypotensive bradycardic   placed on ventilator. Subsequently was poorly responsive and eventually coded once more and succumbed$	$No current illness for this event.$	$pan-hypo pituitarism$ hypertension$ hyperlipidemia chronic pain sleep apnea$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$1031767-1$	$1031767-1$	$1/31/2021 12:50 Nursing Note Note Text: Res had low BP$ low O2 sats$ 30 breaths per minute$ eyes open wide$ making confused utterances. Started supplemental oxygen via NC$ 2L$ then 3L. Sats went up to 93% for a while$ Sprvsr called. Unable to auscultate Left lung sounds. Called to update Res daughter. Called to page NP$ writer went back to assess Res and O2 sats were 88%$ turned O2 to 4LPM$ called 911 for transport to Hospital ED. Left around 1030. NP called back afterwards$ was updated. Family updated that Res was sent to Hospital ED.  Note Text: Received phone call from daughter as well as information from hospital. Resident has pneumonia with septic shock. She is on abx and had thoracentesis performed for large pleural effusion. [linked]$	$ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS ESSENTIAL (PRIMARY) HYPERTENSION POLYNEUROPATHY$ UNSPECIFIED GENERALIZED ANXIETY DISORDER LOCALIZED EDEMA GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS INSOMNIA$ UNSPECIFIED UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE DYSPHAGIA$ UNSPECIFIED DIFFICULTY IN WALKING$ NOT ELSEWHERE CLASSIFIED WEAKNESS MAJOR DEPRESSIVE DISORDER$ SINGLE EPISODE$ UNSPECIFIED ACUTE POSTHEMORRHAGIC ANEMIA DISPLACED INTERTROCHANTERIC FRACTURE OF LEFT FEMUR$ SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING HYPERLIPIDEMIA$ UNSPECIFIED AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE OLD MYOCARDIAL INFARCTION HISTORY OF FALLING PERSONAL HISTORY OF PEP$	$ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS ESSENTIAL (PRIMARY) HYPERTENSION POLYNEUROPATHY$ UNSPECIFIED GENERALIZED ANXIETY DISORDER LOCALIZED EDEMA GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS INSOMNIA$ UNSPECIFIED UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE DYSPHAGIA$ UNSPECIFIED DIFFICULTY IN WALKING$ NOT ELSEWHERE CLASSIFIED WEAKNESS MAJOR DEPRESSIVE DISORDER$ SINGLE EPISODE$ UNSPECIFIED ACUTE POSTHEMORRHAGIC ANEMIA DISPLACED INTERTROCHANTERIC FRACTURE OF LEFT FEMUR$ SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING HYPERLIPIDEMIA$ UNSPECIFIED AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE OLD MYOCARDIAL INFARCTION HISTORY OF FALLING PERSONAL HISTORY OF PEPTIC ULCER DISEASE BARIATRIC SURGERY STATUS PRESENCE OF LEFT ARTIFICIAL KNEE JOINT PRESENCE OF RIGHT ARTIFICIAL SHOULDER JOINT PRESENCE OF LEFT ARTIFICIAL SHOULDER JOINT$Dilaudid$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$1052273-1$	$1052273-1$	$Patient admitted to the hospital the day after receiving a COVID vaccine x 5 days. Patient passed away on 2/23/2021.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$1054966-1$	$1054966-1$	$Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes.  Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration$	$None. Recently in hospital for a fall.$	$Dementia$ atrial fibrillation$ type 2 diabetes$ heart failure with reduced ejection fraction$ gout$ hyperlipidemia$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$6 days$	$6$	$Jan.$ 2021$	$2021/01$	$0982472-1$	$0982472-1$	$Worsening respiratory failure 1/20/2021 death 1/27/2021$	$Chf$ CKD$	$CHF$ CKD$ DM$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$6 days$	$6$	$Jan.$ 2021$	$2021/01$	$0987301-1$	$0987301-1$	$My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call from the nursing facility that my Mother was having uncontrollable seizures and had to be transported to the nearby hospital. The ER doctor confirmed that my Mother had tested positive to Covid. She was treated for Covid and was on life support. A few days later we received a call that my Mother had a  major stroke. She passed away on January 4$ 2021$	$Previous Stroke$	$Not Sure$Not aware$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1057802-1$	$1057802-1$	$Patient was transferred from hospital for further evaluation and care by pulmonologist. He started having symptoms a week before with fatigue$ emesis$ decreased p.o. intake$ shortness of breath$ vomiting and diarrhea. The two previous takes before death required increasing oxygen and family wanted everything done including intubation. He was transferred to ICU.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1061434-1$	$1061434-1$	$I am the patient's daughter as well as an RN-BSN. My mother was given the Moderna vaccine on Feb 11$ 2021 and on Feb 15$ 2021 she had a CVA and MI. She was found on her apt. floor unconscious. She was transferred to the Hospital by ambulance where a CT scan and other tests were done. It was determined she had a stroke and heart attack. My mother was in great health$ took no medications$ and lived alone in her apt. before this incident. The medical professionals determined she would not recover so she was admitted to hospice and died on Feb. 21$ 2021. I believe there is a relationship between the vaccine and the CVA and MI.$	$None$	$None$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$7 days$	$7$	$Feb.$ 2021$	$2021/02$	$0997145-1$	$0997145-1$	$$85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine$ hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not.   $$...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)$$$$	$No current illness for this event.$	$diabetes$ cancer$ COPD$ hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$8 days$	$8$	$Jan.$ 2021$	$2021/01$	$0974794-1$	$0974794-1$	$Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination.  Patient denied any ill feeling$ no fever$ cleared for vaccination. Is chronically SOB due to COPD$ but patient reported no different than usual.   Presented to the ED the next day c/o SOB and weakness for the last week.  Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID).  Patient did admit she lied about her symptoms on the day of vaccination to get the shot.$	$Pneumonia$ pleural effusion$  COPD$$	$macular degeneration$ hyponatremia$ osteoporosis$ anemia$ hx of breast cancer$ GERD$ hyperlipidemia$ OSA$ ex-smoker$Sulfa$ duloxetine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$8 days$	$8$	$Feb.$ 2021$	$2021/02$	$1019979-1$	$1019979-1$	$Patient received the Moderna COVID vaccine 1/28/21.  He was tested for COVID 19 on 1/29/31.  Results were received 1/30/21$ at which time he was evaluated and found to be hypoxic with tachycardia.  He was sent to the local ER and returned this same day.   On 2/2/21$ he was evaluated by the provider$ who sent him to the emergency room with acute respiratory distress and poor O2 sats$	$Vitamin Deficiency$	$GERD$ COPD$ HTN$ Hyperlipidemia$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$8 days$	$8$	$Feb.$ 2021$	$2021/02$	$1024539-1$	$1024539-1$	$patient tested positive for covid on 1/29/21. was hospitalized on 2/8/21  for shortness of breath$ generalized weakness$ nausea.$	$shoulder pain$ dermatitis$ chronic kidney disease$ edema$  gerd$ venous insufficiency$ hypertension$ RA$ hypothyroidism$ osteoporosis$ depression$ radiculopathy$ rosacea.$	$$alupent$ coumadin$ cephalexin$ saccharin$ gabapentin$ codeine sulfate$ sulpher$ onion$ perfumes and fragrances$ adhesive.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$9 days$	$9$	$Feb.$ 2021$	$2021/02$	$1017176-1$	$1017176-1$	$Patient had Covid-19 in October of 2020. He recovered. He received the vaccination on 12/30/2020 with no complaints. On 01-05-2021 it was noted to he was incontinent of urine and bilateral lower extremity edema. Lab work was completed showed acute kidney injury. He had decreased blood pressure and oxygen saturations on 01-06-2021 He was admitted to the hospital with rapid progression of symptoms and suggested multi-system failure. He had a long cardiac history. On 01-14-2021 he passed away with a diagnosis of Cardiomyopathic CHF$ A.Fib contributory.$	$Hypertension$ Chronic ischemic heart disease$ COPD$ Atrial Fibrillation$ Cardiomyopathy$ Edema$ Dementia$ Anemia$ Hyperlipidemia$	$COPD$ Chronic ischemic heart disease$ A fib$ Hypertension$NKA$ NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$9 days$	$9$	$Feb.$ 2021$	$2021/02$	$1026233-1$	$1026233-1$	$patient developed autoimmune thrombocytopenia$	$none$	$hypothyroidism$/ acute on chronic diastolic heart failure / polymyalgia rheumatica / hx of cva / hx of CABG/ gerd / bph/ polyarthritis$hayfever / Darvocet / norco$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$9 days$	$9$	$Feb.$ 2021$	$2021/02$	$1041200-1$	$1041200-1$	$Patient described feeling nervous$ anxious the next morning (Wednesday) after the vaccine. He later fell in the bathroom after using the restroom$ his legs gave out (his words) and consequently was on the ground for 23 hours before being transported to the hospital. That was Thursday afternoon. He was diagnosed with COVID-19 on Saturday night and died the following Friday morning.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Jan.$ 2021$	$2021/01$	$0959591-1$	$0959591-1$	$Resident has increase weakness and lethargy with abnormal labs.  He was transferred to the ER.  He was admitted to the hospital and treated for worsening AKI and hypotension.$	$He was treated for pneumonia and C-Diff at the beginning of December.  He had abnormal blood work with elevated BUN and WBC  on 12/31 and 1/3/21.  Appetite was fluctuating and recently began increase medication for depression.  Decrease responsiveness sent to ER on 1/4/2021.$	$oxygen dependent$ metabolic encephalopathy$ atrial fibrillation$ hypertension$ diabetes$ cardiac pacemaker$ depression$ congestive heart failure$ obesity$ hypothyroidism$ sleep apnea$ hyperlipidemia$ cushing's disease.$Amoxicillin$ Ceftriaxone$ Lisinopril$ Niacin$ Pilglitazone$ Rosiglitazone$ Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Jan.$ 2021$	$2021/01$	$0975735-1$	$0975735-1$	$VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21 RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT EXPIRED ON 01/25/2021$	$COVID 19 01-10-2021 GERD DELUSIONS VASCULAR DEMENTIA WITH BEHAVIORS INSOMNIA CHRONIC DVT LEFT LOWER EXTREMITY  HEMOCHROMATOSIS PSYCHOSIS MAJOR DEPRESSIVE DISORDER WITH ANXITY IMPULSE DISORDER VITAMIN DEFICIENCY EDEMA CONSTIPATION HALLUCINATIONS HYPOTHYROIDISM HX OF SKIN CANCER CARPAL TUNNEL LT HAND DYSTHYMIC HTN$	$ALZHEIMERS CONTRACTURE OF LEFT HAND$Aricept$ codeine$ hydrocodone$ sulfa abx$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Jan.$ 2021$	$2021/01$	$0983428-1$	$0983428-1$	$Pt. was admitted to hospital on 1/6/21 with fatigue$ weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2$ HBG 10.5$ NA-131$ K+ - 3.1$ Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis$ bacteremia$ ARF$ Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis$ complete heart block$ staphylococcus epidermidis bacteremia.$	$Denied any illness at time of the vaccination. November 2020 was diagnosed with Covid-19. Admitted to Hospital on 01/6/2021 with c/o weakness. Reported that her weakness was over her entire body. Reports having episodes of vomiting once or twice a week.$	$Erysipelas$ Aphthous pharyngitis$ Sixth nerve palsy$ Heart mumur$ Acute renal insufficiency$ Hypertension$ Diabetes Mellitus$NKA to medications$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$0994309-1$	$0994309-1$	$Got vaccine on 1/15/21. He was tired right away$ bedridden the next 3 days. He couldn't breathe so he was taken by ambulance on 1/18/21. He was in hospital for several days. put on remdesivir cocktail for 10 days. Slowly getting worse and died in hospital on 1/30/21.$	$No current illness for this event.$	$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1034192-1$	$1034192-1$	$Patient presented with spontaneous IVH of small vessel origin with essentially no past medical history. She then acutely developed mesenteric ischemia. Died due to all dead small bowel which also appeared to be small vessel disease and not embolic/thrombotic. This process started one week after$	$Glaucoma$ HLD$	$Glaucoma$ HLD$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1038147-1$	$1038147-1$	$Patient went into new-onset atrial fibrillation$ resulting in a catastrophic stroke. Patient passed away on 2/11 as a result of the stroke.$	$None$	$Hypertension$ hypothyroidism$Sulfa drugs$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1039304-1$	$1039304-1$	$Resident getting rehab therapy in the facility and has a long history of Parkinson's Disease. On 01/29/21$ he received the COVID vaccine on left deltoid$ resident was recently hospitalized due to Pneumonia and was on antibiotic IV and was recently placed on GT feeding due to severe dysphagia from his Parkinson's disease. On 01/31/21$ started having increased congestion. On 02/02/21$ started having increased temperature and WBC went up >20$000 on 02/03/21$ started on Vancomycin IV on 02/04/21 but was transferred to the hospital. Facility was notified today (02/18/21) that resident expired in the hospital.$	$Parkinson's disease$ S/P GT Placement$ HTN$ Allergic Rhinitis$ Protein Calorie Malnutrition$ Herpes Viral Infection$ Dysphagia$ S/P Pacemaker Insertion$	$End Stage Parkinson's Disease$Flomax$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1045894-1$	$1045894-1$	$COVID infection$ death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$15-30 days$	$15-30$	$Feb.$ 2021$	$2021/02$	$1025330-1$	$1025330-1$	$On 1/26 at breakfast table began vomiting.  Continued thru am when at noon a caregiver did his O2 saturation and found it was 75%.  This was confirmed$ and resent sent to ER .$	$None$	$Dementia$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$15-30 days$	$15-30$	$Feb.$ 2021$	$2021/02$	$1046752-1$	$1046752-1$	$Pt was hospitalized Jan 18$ 2021 after he had fallen outside overnight and lay there approximately 12 hours until he was found. Hypothermic & rhabdomyolis diagnosis. Gradually improved w/ strength & mental status - was in swing bed @ hospital. He got his first Covid 19 shot on 2-8-21. Was fine @ 0300 on 2-9-21 and @ 0430 he was found unresponsive. Dx: probable arrythmia & pronounced dead @ 0454. Noted on pain scale @ 2/8/21 @ 21:11$ clients pain was a 7/10 They offered pain med & he refused They repositioned & distracted him @ 2047 on 2/8/21 Pain had decreased to 3/10 and nothing given. Then @ 0300 check he was sleeping and @ 0430 unresponsive.$	$Rhabdomyolysis$ dementia d/t Parkinsons disease w/ behavioral disorder$	$Atypical Parkinsonism$ HTN$ diplopia$ Neurological gait disorder$ osteoarthritis$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$15-30 days$	$15-30$	$Feb.$ 2021$	$2021/02$	$1052820-1$	$1052820-1$	$Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine$ they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia.   The doctors said it was unrelated$ but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria$ I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize$ the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons$ however she died within a week or so of the surgeries.  She had other comorbidities as well which I'm sure predisposed her such as diabetes$ hypertension and cancer for many years.$	$Diabetes$ hypertension$ cancer (lung)$	$cancer for many years.$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$31-60 days$	$31-60$	$Feb.$ 2021$	$2021/02$	$1055819-1$	$1055819-1$	$On January 1$ 2021$  patient was admitted to Medical Center with COVID. Tested positive on January 2$ 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone$ on January 10$ 2021$  she was transferred to Rehabilitation Center for continued treatment.  She spent 16 days there.  She developed UTI and CDIF infections and was on/off oxygen.  She started physical therapy.  She was scheduled to  be released to go home on January 27$ 2021.  On January 26$ 2021$ the day before going home$ Rehabilitation Center gave her the Moderna vaccine.  On January 27$ the day she went home$ she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center$ with high fever and possible stroke symptoms (which later was negative).  Two days later$  she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung$ heart$ etc.) and all was negative.  The only thing they could trace it to was an adverse reaction to the vaccine. After spending  11 days at hospital and treating her for various infections$ her heart stopped and she passed away suddenly.$	$Treated for COVID pneumonia. Tested positive on Jan 2$ 2021.  This caused other infections  (UTI$ CDIF)$ required oxygen.$	$Treated underlying conditions for diabetes$ high sodium$  high blood pressure$ kidney disease.$NA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0948164-1$	$0948164-1$	$Abdominal pain$ Headaches$ chest pain$ loss of appetite$ confusion$ elevated liver enzymes 1/8-1/15/21$	$UTI and Sinus infection$	$Encephalopathy$ Type 2 diabetes$ Morbid obesity$ hypothyroidism$ CKD$ HTN$ iron deficiency anemia$ Atrial fibrillation$ IBS$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0957799-1$	$0957799-1$	$Presented to Urgent Care for weakness and confusion$ transferred to ED$ patient had a cardiac arrest and was unable to be resuscitated$	$No current illness for this event.$	$HTN AAA with endovascular stent  ESRD COPD$Lipitor$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0958971-1$	$0958971-1$	$Hemorrhagic Stroke$  Right Basal Ganglion$	$No current illness for this event.$	$Aortic Insuf Dyslipidemia  h/o prostate CA$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0978529-1$	$0978529-1$	$Patient developed Covid pneumonia dx 1/15/21$ patient expired$	$None$	$Diabetes$Bee Stings$ Statins$ Flecinide$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0979223-1$	$0979223-1$	$Patient developed SOB but reported good O2Sats. Instructed on going to ER if worsening symptoms. Patient eventually expired on 1/22/21$	$CHF$ hypertension$ type 2 DM$	$same as 11$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0981406-1$	$0981406-1$	$Stroke$ death$	$No current illness for this event.$	$COPD$ smoker$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0981945-1$	$0981945-1$	$weakness and fallsNarrative:  95 yo male w/ a PMH significant for Afib$ legal blindness$ Hx of CVA$ cognitive impairment$ GERD$ HTN$ pseudogout$ BPH$ chronic knee infection$ and DJD who received his first dose of the Moderna COVID-19 vaccine on 01/08/21. The pt's COVID-19  screening questionnaire prior to receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for weakness and m  PCR test on ultiple recent falls (since receiving his first dose of the COVID-19 vaccine). The pt's COVID-19 01/13/20  was positive and he was admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The pt initially required supplemental oxygen via low-flow NC$ however his oxygen requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care.  The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the patient's hospitalization and eventual death$ or whether these events occurred from COVID-19 itself$ however this case is being reported the FDA since this vaccine is under an emergency use authorization (EUA).$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0998576-1$	$0998576-1$	$Had acute respiratory failure$ dysuria NSTEMI after Dose #1 Lot # 025L20A (Moderna) hospitalized same day 12/31/20 administered @ 1040 back to baseline. 2nd Dose on 1/27/21 0950 Lot as above. Unknown exact onset same day$ ED by EMS @ 1745$ respiratory distress$ febrile 39.4 degrees C BP 150/105 RR 29$	$NSTEMI after COVID vaccine #1$	$CAD$ CKD4$ Hypertension$ Anemia$ dementia$DIPYRIDAMOLE$ ERYTHROMYCIN$ TERAZOSIN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1005164-1$	$1005164-1$	$unresponsive Narrative:  74yo patient with pacemaker$ type 2 DM$ parkinson's and history of syncopal epsisodes presented to emergency dept on Jan 24th. He was observed and discharged on Jan 26th back to the home where he continued to have cognitive decline and later passed away on 2/2/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1005533-1$	$1005533-1$	$Narrative:  89yo with type 2 DM$ HT$ pacemaker and prior COVID+ in Nov 2020. Shortly after administration of 2nd Covid vaccine$ patient began to have increased cognitive decline and 2 days after he expired at the facility$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1016709-1$	$1016709-1$	$ON 02/08/2021 AROUND 0600 RESIDENTCOMPLAINED OF MOUTH PAIN AND RECEIVED OXYCODONE. DURING THE COURSE OF THE MORNING$ RESIDENT EXHIBITED A FEW EPISODES OF LABORED/SHALLOW BREATHING AND SOB AT RESTING. 0XYGEN SATURATION RATE WAS 93-98% ON ROOM AIR$ LUNG SOUNDS CLEAR IN ALL LOBES AND PULSE AND TEMPERATURE WITHIN NORMAL RANGE. AS THE DAY PROGRESSED$ VITAL SIGNS REMAINED STABLE BUT RESIDENT CONTINUED TO HAVE PERIODS OF SOB/LABORED BREATHING.FAMILY AND NURSE PRACTIONER UPDATED AND THE ORDER WAS RECEIVED TO SEND PATIENT TO MEDICAL CENTER ER FOR EVALUATION PER AMBULANCE. RESIDENT TRANSPORTED AT 1425. RESIDENT RETURNED FROM THE ER AT 1830 ON HOSPICE CARE WITH THE DIAGNOSIS OF: ACURE RESPIRATORY FAILURE  WITH HYPOXIA AND END OF LIFE DECISION MAKING. RESIDENT WAS MADE COMFORTABLE AND MONITORED DURING THE NIGHT AND EXPIRED AT 0630 ON 02/09/2021.$	$ACUTE RESPIRATORY FAILURE$ PALLATIVE CARE$	$ATRIAL FIBRILLATION$ ALZHEIMERS$ CHARLES BONNET SYNDROME$ NON RHEUMATIC MITRAL VALVE DISORDER$PENICILLIN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1017051-1$	$1017051-1$	$pt received vaccine on 2/3.  early on 2/4 developed chest pain$ dyspnea$ and was seen in ED and diagnosed with acute exacerbation of CHF and NSTEMI type 2$ and anemia.  on 2/5 transfusion was started and pt developed worsening dyspnea and then PEA arrest.  Pt achieved ROSC and was transferred to the cardiac intensive care unit where he required vasopressor support.  he subsequently declined and died on 2/7$	$No current illness for this event.$	$coronary artery disease with prior two-vessel CABG in 2006$ Ischemic cardiomyopathy$ hypertension$ hyperlipidemia$ bilateral carotid artery disease$ paroxysmal atrial fibrillation$ systolic heart failure$ pulmonary hypertension$ and  moderate -severe aortic stenosis$ ulcerative$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1024627-1$	$1024627-1$	$covid shot 2/2; feel bad 2/5; covid positive diagnosis  - 2/8 s/s cough$ fever$ shortness of breath $ hypertension$ afib (in er) - admitted  went into DIC per intensivist 2/11 patient died$	$none$	$DVT - popliteal in 1995 hypertension hyperlipidemia$nkda$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1025472-1$	$1025472-1$	$Patient received COVID19 vaccine at clinic at 11:52 am$  discharge post treatment stable.  Got home around 2:30 pm went to bed.  He usually got tired post dialysis. He did not wake up at 6 pm.  His wife went check on him. found patient cold and unresponsive.  911 pulseless PEA. ER Medical hospital. Pronounced death at 7:40 pm$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1026752-1$	$1026752-1$	$Developed vomiting$ seizure and cardiac arrest$ V Fib$	$No current illness for this event.$	$Heart Disease Hx of Triple Bypass surgery Atrial Fib CAD Diabetes GERD Hyperlipidemia HTN Hypothyroid Idiopathic Small Intestine Ulcers PAD Polycythemia$Ace Inhibitor Allergy Morphine- Adverse Rxn$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1030468-1$	$1030468-1$	$Pt presents to ER with increased weakness$ hypoxia$  history of COPD$ but not oxygen dependent.$ hypotension.  Acute Kidney failure  noted in labs$  not previously  diagnosed $ new hyperkalemia.  BP 73/39$ HR 67. dopamine  initiated$ and switched to Levophed.  Oxygen Sat  86%$ requiring 10 L  O2.  Transferred from this critical access hospital to another Hospital.  Expires later 2-13-2021$	$ACUTE KIDNEY FAILURE$  QUESTION SEPSIS$ CHF$ ATRIAL FIBRILLATION$ COPD$ GERD$ RESTLESS LEG SYNDROME$ HISTORY OF PROSTATE CANCER$ HYPERTENSION$ CURENT TOBACCO USAGE$	$COPD$ CHF$ ATRIAL FIBRILLATION$ GERD$ RESTLESS LEG$ HISTORY OF PROSTATE CANCER$ HYPERTENSION$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1044247-1$	$1044247-1$	$Moderna COVID 19 Vaccine: Patient started with symptoms of covid 5 days after first vaccine.  She was hospitalized and passed due to COVID 19 on 2/6/21.  Patients family informed us when she was due for the second dose.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1051263-1$	$1051263-1$	$Passed away; Found unconscious; Coma; Lack of oxygen to the brain; A spontaneous report was received from a consumer$ concerning his mother$ a 71-year-old female patient$ who received Moderna's COVID-19 vaccine (mRNA-1273) and passed away$ prior to death$ patient experienced lack of oxygen to the brain and was found unconscious and went to coma.  The patient's medical history reported included seizures. Concomitant medications included phenobarbital$ lamotrigine and levetiracetam.   On 27 Jan 2021$ approximately six days prior to the onset of events$ the patient received their first of two planned doses of mRNA-1273 (lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Feb 2021 at 4 am$ the patient was found to be unconscious on the couch$ hence she was rushed to the hospital with lack of oxygen to the brain. Later$ she went into a coma$ hence she was in hospital for 30 hours and then was transferred to a different hospital for a second opinion on 06-Feb-2021$ where she was passed away at 02:20 PM. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of events$ lack of oxygen to the brain$ found unconscious and coma were considered unknown.  The outcome of event passed away was fatal as she died on 06 Feb 2021 at 2:20 pm.  The cause of death was not provided.  Plans for an autopsy were unknown.; Reporter's Comments: This is a case of 71-year-old female subject with a history of seizures who died 6 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Passed away$	$Seizures$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1057750-1$	$1057750-1$	$Started feeling unwell; Headaches; Body aches; Chest pain; Didn't had wishes to eat; Diarrhea; COVID-19 pneumonia; A spontaneous report was received from a consumer concerning a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19 pneumonia$ feeling unwell$ headaches$ body aches$ chest pain$ decreased appetite and diarrhea  The patient's medical history high blood pressure which was controlled with medication. Concomitant product use included nifedipine and fenofibrate.  On 20-JAN-2021$ approximately a week and a half or two prior to the onset of the symptoms$ the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  A week and a half or two later the patient stated feeling unwell$ headaches$ body aches$ chest pain$ decreased appetite and diarrhea for which patient was hospitalized on 06-FEB-2021. Since everything seemed to be fine the patient was discharged on an unknown date in FEB-2021 however$ patient's family was not notified that it was a late reaction to the vaccine's first dose. Later$ due to shortness of breath he was hospitalized again on 08-FEB-2021 and was diagnosed for pneumonia and was intubated on the same day. Due to COVID-19 situation patient's family could not be in the facilities and that there wasn't any follow up of the patient given to the family$ so family did not have much information.  During the first hospitalization(06-FEB-2021) the patient had a blood test which showed a normal result and was tested for COVID-19 and Influenza$ both were negative. During second hospitalization (08-FEB-2021) the hospital said that the patient was stable. The patient's family did not know the results of the tests conducted at the time.   The action taken with the vaccine in response to the events is not applicable.  The outcome of COVID-19 pneumonia was fatal. The patient died on 14 Feb 2021  The cause of death was reported as COVID-19 related pneumonia. The autopsy was not done.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The cause of death was reported as COVID-19 related pneumonia. Based on the current available information and the mechanism of action of mRNA-1237 vaccine$ the events are assessed as unlikely related. Further information has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia$	$Blood pressure high$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Mar.$ 2021$	$2021/03$	$1065543-1$	$1065543-1$	$It was reported to staff that this gentleman suffered thrombocytopenia following his vaccine$ a platelet infusion was done and he expired on 2-14-21$	$unknown$	$unknown$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$65+ years$	$65+$	$Unknown$	$U$	$Mar.$ 2021$	$2021/03$	$1073902-1$	$1073902-1$	$Patient seemed otherwise healthy before the vaccination. Patient was hospitalized then shortly passed after getting the 1st dose.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0969648-1$	$0969648-1$	$death of unknown cause; Swelling on Right side of the neck and under chin; Warmth on right side of neck and under chin; Redness on right side of neck and under chin; A spontaneous report was received from a healthcare professional concerning an 89-year-old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of redness$ warmth and swelling on right side of neck and under chin$ and death of unknown cause.  The patient's medical history included Alzheimer's and chronic obstructive pulmonary disease (COPD). No concomitant medications were reported.  On 29 Dec 2020$ prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020$ the patient experienced the events of redness$ warmth and swelling on right side of neck and under chin. There was no indication that the patient was transferred out to hospital$ which was unlikely because she was under hospice care.  On 01 Jan 2021$ the patient died due to an unknown cause of death.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 01 Jan 2020. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a 89-year-old$ female subject with a medical history of Alzheimer's and chronic obstructive pulmonary disease (COPD) who experienced redness$ warmth and swelling on R side of neck and under chin and expired from an unknown cause. The events of redness$ warmth and swelling on R side of neck and under chin occurred 2 days after administration of the first and only dose of the mRNA-1273 vaccine and patient expired 4 days after mRNA-1273 vaccine administration.  Lot # of the vaccine was not provided.  De-challenge and re-challenge are not applicable.  The events of redness$ warmth and swelling on R side of neck and under chin are temporarily associated with the administration of the mRNA-1273 and thus$ a causal relationship cannot be excluded. Due to limited information$ the fatal outcome was considered unrelated to mRNA-1273 administration pending additional information.  Fatal outcome is confounded by the patient's underlying condition and advanced age.; Reported Cause(s) of Death: Unknown cause of death$	$Alzheimer's disease; COPD$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0985933-1$	$0985933-1$	$Died; Increased respirations (22 and labored at times); Pulse 105; 94% O2 on RA; Labored breathing at times; leukocytosis; elevated BUN; left lower lung congestion; elevated creatinine; Temperature of 102.0F; Redness on face; A spontaneous report was received from a nurse concerning a 92-year-old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on face$ increased respirations$ labored breathing at times$ temperature of 102F$ pulse of 105$ 94 percent O2$ leukocytosis$ elevated BUN$ left lower lung congestion$ elevated creatinine$ and death.   The patient's medical history$ as provided by the reporter$ included dementia and reduced mobility.  No relevant concomitant medications were reported.   On 29 Dec 2020$ the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020$ the patient began to experience redness on her face$ increased respirations (reported as 22 and labored at times)$ pulse of 105$ and 94 percent oxygen saturation on room air. The patient had a fever of 102 degrees Fahrenheit. Laboratory tests revealed a negative influenza swab$ elevated white blood cell count of 14.1$ elevated BUN at 113$ and creatinine 2.7. Chest x-ray showed mild$ left lower lung infiltrate.   On 31 Dec 2020$ the patient went under hospice care per her family request..    Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 01 Jan 2021$ the cause of death was unknown.; Reporter's Comments: This case concerns a 92-year-old$ female subject with medical history of dementia and reduced mobility$ who experienced the serious unexpected events of death$ respiratory rate increased$ heart rate increased$ oxygen saturation decreased$ elevated BUN$ elevated creatinine$ left lung congestion and dyspnoea and the non-serious events of erythema and pyrexia. The events of respiratory rate increased$ heart rate increased$ oxygen saturation decreased$ dyspnoea$ erythema and pyrexia occurred 2 days after the first dose of the study medication administration$ and the event of death occurred 4 days after the first dose of the study medication administration. Very limited information regarding the events is available at this time and no definite diagnosis or autopsy report have been provided.  Additional information has been requested.; Reported Cause(s) of Death: Died$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Dementia; Walking disability$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002052-1$	$1002052-1$	$Passed away yesterday$ found deceased in her apartment; This spontaneous report was received from a consumer which refers to a 91-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and next day the patient passed away.   The patient's medical history was not provided. Concomitant medications were not reported.   On 19 Jan 2021$ the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided) for prophylaxis of COVID-19 infection.  On 20 Jan 2021$ the patient passed away and she was found deceased in her apartment. No treatment medication was provided.  Action taken with mRNA-1273 in response to the events was not applicable as the patient passed away.   On 20 Jan 2021$ the patient died$ cause of death was unknown. Autopsy result was unknown.  The reporter assessed the causality as related between the event and Moderna COVID-19 vaccine.; Reporter's Comments: This case concerns a 91-year old female patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event$ a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.; Reported Cause(s) of Death: Unknown Cause of Death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021926-1$	$1021926-1$	$Passed away; Positive result; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and passed away.    The patient's medical history was not provided. Concomitant product use was not reported.  On 05 Jan 2021$ prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021$ the patient had a positive COVID-19 test.  On 18 Jan 2021$ the patient passed away. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 18 Jan 2021. The cause of death was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced COVID-19 and passed away. The event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273 vaccine administered and death occurred 14 days after administration of the mRNA-1273 vaccine.  Based on the information provided and the known etiology of  COVID-19$ it is unlikely to be associated with mRNA-1273 vaccine administration. With no definite information on the clinical details of the death$ it is difficult to adequately assess a causal association with mRNA vaccine.  Main field defaults to وpossibly related'; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1030273-1$	$1030273-1$	$Death; A spontaneous report was received from a reporter concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 28 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020$ 2am the patient passed away. Administrator marked as natural causes. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was fatal. The patient died on 30 Dec 2020. The cause of death was reported as unknown.  The reporter did not provide an assessment for the event$ passed away.; Reporter's Comments: This case concerns a patient of unknown age and gender. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event$ a causal relationship cannot be excluded. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036480-1$	$1036480-1$	$Patient passed away on 2/2/21 after being admitted on 1/31/21 after receiving COVID19 Moderna Vaccine on 1/26/21. On initial report to the hospital patient reported having a cough for over 2 weeks (starting approx. 1/17/21). He had a postive COVID19 PCR on 1/31/21. Intubated on 1/31/21 and passed away on 2/2/21$	$had a cough since 2/17/21$	$diabetes type 2$ hypertension$ hypothyroid$ hyperlipidemia$ MRSA$$Sulfa causes a rash$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038253-1$	$1038253-1$	$Died the next day; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died the next day.     The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 12 Jan 2021$ approximately one day prior to the event$ the patient received one of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021 the patient died. No additional information was provided in regards to the event.   Action taken with mRNA-1273 in response to the event was not applicable.   The patient died on 13 Jan 2021. The cause of death was unknown.; Reporter's Comments: This case concerns a male patient of unknown age. The medical history and concomitant medication were not provided. The patient died approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No medical history reported.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1045540-1$	$1045540-1$	$death; hemiparesis; respiratory failure; Aphasia; SARS-COV-2 test positive; cough; A spontaneous report was received from other health care professional concerning a 32- year -female patient who received Modena's COVID-19 vaccine (mRNA-1273) and experienced aphasia$ cough$ death$ endotracheal intubation$ hemiparesis$ respiratory failure and SARS-COV-2 tested positive.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 28-Dec-2020$ the patient received their first of two planned doses of mRNA-1273 (lot/batch 039k20A) intramuscularly on left arm for prophylaxis of COVID-19 infection.  Approximately$ one day later$ patient  developed cough and on treatment with azithromycin for one week. On 03-jan-2021$  she experienced left sided weakness and aphasia and was shifted to hospital. Patient was confirmed COVID-19 positive which required intubation for acute hypoxic respiratory failure secondary to COVID-19.   No laboratory data was provided.  Action taken with mRNA-1273 in response to the events aphasia$ cough$ death$ endotracheal intubation$ hemiparesis$ respiratory failure and SARS-COV-2 tested positive not applicable.   On an unknown date$ the outcome of the events aphasia$ cough$ death$ endotracheal intubation$ hemiparesis$ respiratory failure and SARS-COV-2 tested positive was fatal.  On 04 Jan 2021$ the patient passed away due to the unknown cause. Autopsy results were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and the mechanism of action of mRNA-1237 vaccine$ the event of COVID-19 is assessed as unlikely related. The cause of death was not reported. Autopsy results were unknown.; Reported Cause(s) of Death: Unknown cause of death$	$Endotracheal intubation$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057704-1$	$1057704-1$	$High grade MDS; Multiorgan failure; Pancytopenia; shortness of breath; Inflammatory marker increased; Chills; Fever; Fatigue; A spontaneous report was received from a healthcare provider concerning a 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills$ fever$ fatigue$ pancytopenia$ shortness of breath (dyspnoea)$  multi organ failure$ and myelodysplastic syndrome (MDS).  The patient's medical history was reported to include Breast Cancer and mastectomy. No relevant concomitant medications were reported.  On 16 Jan 2021$ prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021$ The patient experienced events like chills$ fever$ and fatigue.  On an undisclosed date$ the patient was admitted to the hospital for shortness of breath. Laboratory details include Bone Marrow biopsy with abnormal results such as showed high grade MDS with 19% blasts. Blood work done with normal results. Body temperature results came out 103 degrees Fahrenheit.  On 30 Jan 2021 the patient experienced worsening shortness of breath and was intubated.  Her IL-6 was very high$ and she had profound liver failure. She ended up needing pressors and requiring continuous renal replacement therapy.  Treatment included steroids.  Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Feb 2021. The cause of death was reported as high grade MDS. An autopsy was planned.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Breast cancer (in the 1990s); Mastectomy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1062350-1$	$1062350-1$	$Death; A spontaneous was received from a consumer concerning a male patient$ who received Moderna's COVID-19 vaccine and who died.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23-Jan-2021$ prior to the onset of the event$ patient received their first of two planned doses of mRNA-1273 (Lot number:013620A) intramuscularly for prophylaxis of COVID-19 infection.   On 25-Jan-2021$ approximately 2 days after injection$ patient Died. On 26-Jan-2021$ neighbor Reporter called in to report a potential AE death. She shared that she lives in a condo building with other elderly. She shared that she and 2 other neighbors went to a vaccination site in Miami at a fire department. She shared that she is fine but that her neighbor died two days after shot. She shared that she didn't know if he had symptoms and that she knows that he had a lot of medical issues and was on about 15 medicines. She shared that she didn't know his age but guessed 70. She said we can contact his wife$ but it must be a Spanish speaking agent because she speaks little English. She is concerned because they all received the vaccine at the same time. She wanted to reiterate that she was fine but believed we should know about the neighbor's death. No treatment information was provided.    Action taken with the second dose of mRNA-1273 in response to the event death is not applicable.   The patient died on 26-Jan-2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. The cause of death was not provided.; Reported Cause(s) of Death: Unknown$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071117-1$	$1071117-1$	$Passed away; UTI; Abnormal bleeding; A spontaneous report was received  from a healthcare professional concerning a patient who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced abnormal bleeding$ UTI$ and passed away.   The patient's medical history included a long term history of anticoagulation therapy. Concomitant product use included anticoagulation therapy.  On 31Jan2021 prior to the onset of the events the patient recieved their first dose of mRNA-1273 (Lot number:not reported) intramuscularly for prophylaxis of COVID-19 infection.  On 07Feb2021$ the patient complained of abnormal bleeding. Patient was seen at clinic on 10Feb2021 and was diagnosed with a UTI and given antibiotics. An INR was also completed that day due to patient having a long term history of anticoagulation therapy. Results of that showed the INR to be 12. Prior to vaccination$ patient's INR was normal and no changes to medications and diet were made after vaccination and prior to complaint starting.   On 12Feb2021 the patient passed away.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 12Feb2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns an 82 year old male patient$ with history of long term anticoagulation therapy (unknown indication)$ who experienced a fatal event of death and abnormal hemorrhage$ 13 days after receiving second dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$Anticoagulant therapy (Long term history of anticoagulation therapy.)$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071128-1$	$1071128-1$	$Unresponsive; A spontaneous report was received from Pfizer concerning a 32-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 DEC 2020$ prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 04 JAN 2021$ at 7:20 am$ the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 04 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 32-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death. The cause of death was unknown. Plans for an autopsy were not provided. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071129-1$	$1071129-1$	$Unresponsive; A spontaneous report was received from Pfizer concerning a 43-year old$ male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021$ prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 09 JAN 2021$ the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 08 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (no reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071130-1$	$1071130-1$	$Unresponsive; A spontaneous report was received from Pfizer concerning a 45-year old$ male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 Dec 2020$ approximately 24 hours prior to the onset of the events$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 29 Dec 2020$ the patient was found deceased at home. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 29 Dec 2020. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071131-1$	$1071131-1$	$Unresponsive; A spontaneous report was received from Pfizer concerning a 50-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 31 Dec 2020$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  intramuscular for prophylaxis of COVID-19 infection.  On 31 Dec 2020$ the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 31 Dec 2020. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 51 year old$ female patient$ who experienced an unexpected event of Death$ after receiving 1st dose of mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time. There is no contact information and no further follow up information is expected.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071133-1$	$1071133-1$	$Unresponsive; A spontaneous report was received from Pfizer concerning a 52-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021$ approximately 2 hours prior to the onset of event$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 08 Jan 2021$ the patient was monitored for the appropriate amount of time by nursing staff$ following vaccination. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 08 Jan 2021 at 2:15pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This case concerns a 52-year old$ female patient$ who experienced a sudden death 1 day after administration of first dose of mRNA-1273. The cause of death was not provided. Plans for an autopsy were unknown. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (no reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071134-1$	$1071134-1$	$Death; A spontaneous report was received from a reporter concerning a 56-year old female patient$ who received Moderna's COVID-19 vaccine (mRNA-1273) and had experienced death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2021$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 08 Jan 2021$ the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 08 Jan 2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (no reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071135-1$	$1071135-1$	$Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 08 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 09 Jan 2021$ the patient was found deceased in her home. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 09 Jan 2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071137-1$	$1071137-1$	$Unresponsive; A spontaneous report was received from Pfizer concerning a 58-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 30 Dec 2020$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 04 Jan 2021$ the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 04 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No Reported Medical History)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071138-1$	$1071138-1$	$Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old$ male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 08 Jan 2021$ the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 08 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071139-1$	$1071139-1$	$Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 13 Jan 2021$ the patient was found to be deceased at 3:00 am. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 13 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided. .; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (no reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1074599-1$	$1074599-1$	$Death; A spontaneous report was received from a other health care professional concerning a 57-year-old$ male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died.  The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided.  On 02 Feb 2021$ prior to onset of the events$ the patient received his first of two planned doses of mRNA-1273 (Lot number: 043L20A) in the left arm for prophylaxis of Covid-19 infection.  03 Feb 2021$ it was reported that the patient died. The patient was not experiencing any symptoms prior to death. He was on hospice care$ not hospitalized. No further information was provided. Treatment information was unknown. The cause of death was not reported. Plans for an autopsy were unknown.  Action taken with the mRNA-1273 in response to the event was not applicable.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown$	$COPD$	$Medical History/Concurrent Conditions: Hospice care$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$Unknown$	$U$	$Mar.$ 2021$	$2021/03$	$1071132-1$	$1071132-1$	$chronic hypoxia respiratory failure; Unresponsive; A spontaneous report was received from Pfizer concerning a 51-year old$ male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had developed hypoxia a sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown)  for prophylaxis of COVID-19 infection.  On 07 Jan 2021$ around 6:00 pm$ the patient became increasingly hypoxic. He was transported to the hospital for acute on chronic hypoxia respiratory failure. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Jan 2021 at 11:25pm. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No Reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$MODERNA$	$591$	$Unknown$	$U$	$Unknown$	$U$	$Mar.$ 2021$	$2021/03$	$1071136-1$	$1071136-1$	$sepsis; respiratory failure; Fever; Unresponsive; A spontaneous report was received from Pfizer concerning a 56-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure$ sepsis$ fever and sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021$ the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 11 Jan 2021$ the patient began to have a fever. She was sent to the emergency room for evaluation. That evening$ she died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 11 Jan 2021. The cause of death was reported as respiratory failure and sepsis. Plans for an autopsy were unknown/not provided.; Reporter's Comments: This is a case of 56-year old$ female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis$ fever$ respiratory failure and sudden death. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Respirtory Failure; Sepsis$	$No current illness for this event.$	$Medical History/Concurrent Conditions: No adverse event (No reported medical history)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$1-2 years$	$1-2$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958443-1$	$0958443-1$	$death by suicide Narrative:  death by suicide; 12/26/20$ self inflicted gun shot wound; found deceased by family member$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$18-29 years$	$18-29$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0943397-1$	$0943397-1$	$On day due for 2nd dose$ Patient was found unresponsive at work in the hospital.  Patient pupils were fixed and dilated.  Full ACLS was initiated for 55 minutes with multiple rounds of bicarb$ calcium chloride$ magnesium$ and epinephrine. Patient was intubated.  Patient continued into V. Fib arrest and was shocked multiple times.$	$None$	$None$Ceclor$ Penicillin$ Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$18-29 years$	$18-29$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0960841-1$	$0960841-1$	$Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics$ IV fluids$ cooling methods. CXR does show a new right perihilar infiltrate. However$ his fever came down within the next 24-48 hours. Unfortunately$ he suffered a cardiac arrest on 1/21/21 in the early morning and expired.$	$none$	$ventilator dependent$ anoxic encephalopathy$ seizure disorder$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$18-29 years$	$18-29$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033873-1$	$1033873-1$	$PATIENT PASSED AWAY ON 2-1-2021$	$No current illness for this event.$	$CHRONIC KIDNEY DISEASE$UNKNOWN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$18-29 years$	$18-29$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071935-1$	$1071935-1$	$Patient received the vaccine around 11 am.  He hadn't been feeling well (headache$ dizziness) per report and initially called in to work.  He then decided to come to work and was found down in a patient bathroom during his shift on our Facility while taking care of a patient (he was a nurse aid).  Patient was coded and the team and was transferred to our Facility ED.   He expired 3/3 2112$	$HTN$ sleep apnea$	$HTN$ sleep apnea$ hx of MRSA wound infection in groin$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$30-39 years$	$30-39$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0921667-1$	$0921667-1$	$LTCF Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call indicating that a staff member deceased somewhere between 1/3/2021 and 1/4/2021.   Cause of death is unknown$ and an autopsy is being performed.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$30-39 years$	$30-39$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0948418-1$	$0948418-1$	$Expired on 1/12/2021; unknown cause of death$	$Received 1st Covid vaccine 12/18/2020; 2nd 1/7/2021.  This patient is now deceased 1/12/2021.$	$Per patient health history: hearing loss$ asthma$ bronchiolitis$ chronic cough$ anemia$ depression$No known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$30-39 years$	$30-39$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986901-1$	$0986901-1$	$Patient received vaccine uneventfully with no acute concerns. Left clinic and by report went out with friends. Spoke to father on phone at or around 9:00 pm. Failed to show up to work and was found dead at home. Other details pending$	$No current illness for this event.$	$Optic neuritis; asthma$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$30-39 years$	$30-39$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026362-1$	$1026362-1$	$Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th.$	$No current illness for this event.$	$Duchenne muscular dystrophy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$30-39 years$	$30-39$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$1046447-1$	$1046447-1$	$2/12/2021 Vaccine 2/13/2021 Weakness$ oral ulcers 2/17/2021 Brought to ER for loss of consciousness$ altered mental status$ rectal bleeding; work up showed sepsis$ UTI$ anemia$ pneumonia$ pleural effusion$ pancytopenia$ hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM$	$1/17/2021 Fell while drunk$ right distal humerus fracture$ right facial bruising$	$Metabolic disorder$ anemia$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0937527-1$	$0937527-1$	$unsure if related to vaccine$ but was notified by her next of kin that she died on 1/4/2021.  No reports of side effects or hospitalization were reported to the facility prior to the notification of death.$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0939270-1$	$0939270-1$	$Sudden cardiac death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965441-1$	$0965441-1$	$Death unexplained; This is a spontaneous report received from a contactable pharmacist via regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202101140831416270. Sender's (Case) Safety Report Unique Identifier: GB-MHRA-ADR 24595177.   A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0739$ expiry date not reported) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 vaccination. The patient had not had symptoms associated with COVID-19$ not had a COVID-19 test. She was not enrolled in clinical trial. She was not pregnant. She had no pre-existing medical conditions$ no allergies$ no history of anaphylaxis$ no bleeding disorders / blood thinning medication. The concomitant medications$ if any$ were not reported. The patient was not registered at the practice. The patient did not experience direct or immediate reaction at the time of the vaccine. The practice was informed that approximately 6 hours post vaccine the patient had passed away. The patient died on 13Jan2021. An autopsy was not performed. The cause of death was unknown$ death unexplained.   No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained$	$No current illness for this event.$	$Comments: Not registered at this practice$  During vaccination screening Pt was asked to confirm;  Pregnancy - Not Pregnant Pre existing medical conditions - None Any Allergies - None History of anaphylaxis  - None Bleeding disorders / blood thinning medication - None   Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967240-1$	$0967240-1$	$Patient unexpectedly died on o1/6/2020.  No known signs or symptoms.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0981407-1$	$0981407-1$	$Expired in sleep on 1/24/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982826-1$	$0982826-1$	$Was at work on 1/26/21 and collapsed$ no known complaints a the time.   CRP was initiated immediately$ transported to ER and  pronounced dead$	$immunocompromised with reportable conditions$	$immunocompromised with reportable conditions$ positive for COVID-19 September 2020$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992237-1$	$0992237-1$	$1/28/2021- Seen by FNP for indigestion$ chest pressure and palpitations.  EKG reviewed and referral made to Cardiology. 1/29/2021-1800 Presented to ED in cardiac arrest-onset PTA.  Patient was found unresponsive by his wife at their home.  The last known well was at 1530 when she called him on the phone.  The patient was pronounced at ~1850.$	$No current illness for this event.$	$Hypertension; Hyperlipidemia; decreased GFR.  Family history of CAD$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000228-1$	$1000228-1$	$dead; Collapsed; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; bnt162b2 was given to patient with immunocompromised w/ reportable conditions; This is a spontaneous report from a contactable nurse. A 40-year-old male patient receive first dose of bnt162b2 (Lot number: EK9231$ Brand: Pfizer)$ intramuscular in left arm on 21Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included immunocompromised w/ reportable conditions from an unknown date and unknown if ongoing$ positive for Covid in September from Sep2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced dead$ collapsed on 26Jan2021. Therapeutic measures were taken as a result of collapsed. The outcome of collapsed was unknown. The patient died on 26Jan2021. It was not reported if an autopsy was performed. Received Covid vaccine here on 21Jan2021$ was at work on 26Jan2021 and collapsed$ no known complaints at the time$ CPR (cardiopulmonary resuscitation) was initiated immediately$ transported to ER (Emergency room) and pronounced dead. Unknown if other vaccine in four weeks. The patient had COVID prior vaccination. Unknown If COVID tested post vaccination.; Sender's Comments: Based on the information currently provided$ the patient was immunocompromised and had prior COVID infection.  The death and syncope more likely are associated with the patient underlying medical conditions.  More information such medical history$ concomitant medications$ treatment indication and event term details especially death cause and autopsy results are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: Dead$	$No current illness for this event.$	$Medical History/Concurrent Conditions: COVID-19; Immunocompromised$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000261-1$	$1000261-1$	$Unclear death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB DE-PEI-PEI2021001514.  A 46-year-old female patient received bnt162b2 (COMIRNATY) (batch no.: EM0477) on 20Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. 12 hours after vaccination the patient developed unclear death (unknown cause of death) (Jan2021)$ lasting for unknown. The patient is dead. It was not reported if an autopsy was performed.  Reporter's comments: Connection unlikely.  No follow-up attempts possible. No further information expected.; Reporter's Comments: Connection unlikely; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006640-1$	$1006640-1$	$$In discussion with Dr.$ medical director at Detox$ she  arrived night of 2/3/21 was quite intoxicated so was not going through any  withdrawal.  She was getting vitals and CIW  checked regularly.  First dose of  chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9.  She had repeat vitals at  5:50pm$ CIWA 1$ vitals: P 67$ 118/79$ 94% on RA$ T 98.3.  she had complained of  some $$pressure in her head$$ and feeling anxious$ but otherwise denied other  complaints.  she was talking with others in the group$ then other patients report  she suddenly started having seizure like activity around 6:45pm$ med techs came  to help and found her stiff$ gurgling.  they tried to get vitals on her$ called  911$ noticed that at 6:54pm she had lost a pulse and they started CPR.  paramedics arrived at 7:08pm and she was brought to ED.   Pt BIBA in cardiac arrest. Pt was at Detox Center when she  was reported to have seizure-like activity followed by collapse. She  was found to be pulseless and CPR initiated by staff members. EMS  arrived and performed approx 15 min of CPR and gave pt epi x 3 and  bicarb. No shocks administered but they did not report a rhythm.   In the emergency room the patient arrived and was found to be pulseless with PEA arrest$ CPR was initiated$ patient was intubated. ROSC ultimately achieved$ patient remained very acidotic despite ventilator adjustment$ head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37$ she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia$ consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5$ pronounced dead at 2:48AM.$$	$Alcohol use disorder$ facial laceration$ alcohol intoxication$ secondary syphillis$	$Alcohol use disorder$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1021040-1$	$1021040-1$	$Pfizer-BioNTech COVID-19 Vaccine  Hospital Emergency Room Provider reported cause of death as COVID vaccine administered 11 days prior to death.  Additional information being reported from LTCF.$	$Unknown - LTCF will also be reporting$	$Obesity$ others unknown$Unknown - LTCF will also be reporting$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027619-1$	$1027619-1$	$Swollen leg/pain- taken to urgent care- became unresponsive - CPR initiated- expired$	$no acute$	$Anemia$ unspecified  Congenital malformation syndromes predominantly associated with short stature Constipation$ unspecified Dysphagia$ unspecified Gastro-esophageal reflux disease without esophagitis Illness$ unspecified Intermittent explosive disorder Moderate intellectual disabilities Neuromuscular dysfunction of bladder$ unspecified Other iron deficiency anemias Other specified eating disorder Pica of infancy and childhood Thrombocytopenia$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1028778-1$	$1028778-1$	$On December 17$ 2020$ my husband$ received his first BioNTech BNT162b2 COVID-19 vaccination. On Thursday January 7$ 2021$ he received this second COVID-19 vaccination. The following three days after his second vaccination$ he felt fine. The fourth day$ on Sunday January 10$ my husband felt extremely fatigued. On Monday the 11th and Tuesday the 12th$ he worked a full shift but complained of extreme fatigue and extreme chills to the point that his teeth were chattering while on the phone with me. He decided to work through it. When he got home on Monday night$ he started vomiting. On Wednesday January 13$ he woke up and had swollen eyes. Once again$ he felt extremely fatigued$ even after a full nights rest. He had the day off but had an early meeting. After his meeting$ he was still tired so he went back to sleep. I left to get lunch$ and drop off our kids$ and upon my return$ I found him on the walk in closet floor$ face up$ having passed away. He felt as cold as ice. The rapid test done after they called the paramedics resulted in a negative COVID-19 test for him.$	$No current illness for this event.$	$Arrhythmia 20 years ago$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035597-1$	$1035597-1$	$Death on 1/17/2021. Found at home deceased.$	$unknown$	$Unknown.  Patient died on 01/17/2021. Related to vaccine?  I do not know but am reporting because I sent an email to VAERS and never received an answer whether it should be reported or not. So$ erring on the side of caution$ I am reporting.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035641-1$	$1035641-1$	$Healthcare was advised that this patient expired approximately two weeks after receiving her initial COVID vaccination$	$Tobacco Use - 0.5 pack per day cigarette use Autoimmune Hepatitis - flare in 2020$ improved with increased immunosuppressants per GI note 12/15/20 Bilateral  leg swelling 1/21/21 - Primary care office visit$	$Tobacco Use - 0.5 pack per day cigarette use Autoimmune hepatitis Essential Hypertension Migraine Mood disorder Allergic Rhinitis$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046179-1$	$1046179-1$	$patient was not vaccinated at hospital.  Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21.  Tuesday patient experienced n/v/d.  Went to an ED on Wednesday and was cleared and sent home.  Thursday reported shortness of breath to her caregiver and then collapsed.  Patient was brought to as PEA arrest and ultimately died.$	$unknown$	$MRDD$NKMA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1065434-1$	$1065434-1$	$Patient died; This is a spontaneous report from a contactable consumer (parent's patient).  A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ solution for injection)$ via unknown route on 13Feb2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Feb2021 the patient died. The cause of death was unknown. An autopsy was not performed. No COVID prior vaccination. The patient had not been tested for COVID post vaccination.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: Patient died$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066118-1$	$1066118-1$	$Patient had an unwitnessed cardiac arrest while outside walking his dog.  AED in the field initially advised shock and was shocked 3 times without effect. At the time EMS ALS arrived$ patient was in PEA arrest. He was transferred to Hospital with CPR in progress. Time of death called at 1857.$	$None$	$Type 2 Diabetes  Hypertriglyceridemia Hypertension Recurrent pancreatitis  Obesity  Nicotine dependence$Apple$ cherry$ pear$ pollen - throat swelling and itching$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066274-1$	$1066274-1$	$death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$40-49 years$	$40-49$	$Unknown$	$U$	$Mar.$ 2021$	$2021/03$	$1072113-1$	$1072113-1$	$Death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0921768-1$	$0921768-1$	$Vaccine received at about 0900 on 01/04/2021 at her place of work$ Medical Center$ where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash$ nausea$ and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic$ then a short time later$ at about 1600 hours$ upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed$ then when medics arrived$ she was still breathing slowly then went into cardiac arrest and was unable to be revived.$	$No current illness for this event.$	$$None Known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934968-1$	$0934968-1$	$he passed away; not responsive; mind just seemed like it was racing; body was hyper dried; Restless; not feeling well; ate a bit but not much; kind of pale; Agitated; Vomiting; trouble in breathing; This is a spontaneous report from a contactable consumer (brother of the patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration$ on 04Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure. Concomitant medications included metformin (MANUFACTURER UNKNOWN) taken for diabetes$ glimepiride (MANUFACTURER UNKNOWN) taken for diabetes$ lisinopril (MANUFACTURER UNKNOWN)$ and amlodipine (MANUFACTURER UNKNOWN). The patient experienced not feeling well$ ate a bit but not much$ kind of pale$ vomiting$ trouble in breathing$ and agitated on 04Jan2021; body was hyper dried and restless on 05Jan2021; mind just seemed like it was racing on 06Jan2021; and not responsive and he passed away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical course was reported as follows: The patient received the vaccine on 04Jan2021$ after which he started not feeling well. He went right home and went to bed. He woke up and ate a bit but not much and then was kind of pale. The patient then started to vomit$ which continued throughout the night. He was having trouble in breathing. Emergency services were called$ and they took his vitals and said that everything was okay$ but he was very agitated; reported as not like this prior to the vaccine. The patient was taken to urgent care where they gave him an unspecified steroid shot and unspecified medication for vomiting. The patient was told he was probably having a reaction to the vaccine$ but he was just dried up. The patient continued to vomit throughout the day and then he was very agitated again and would fall asleep for may be 15-20 minutes. When the patient woke up$ he was very restless (reported as: his body was just amped up and could not calm down). The patient calmed down just a little bit in the evening. When the patient was awoken at 6:00 AM in the morning$ he was still agitated. The patient stated that he couldn't breathe$ and his mind was racing. The patient's other brother went to him and he was not responsive$ and he passed away on 06Jan2021 around 10:15 AM. It was reported that none of the symptoms occurred until the patient received the vaccine. Therapeutic measures were taken as a result of vomiting as aforementioned. The clinical outcome of all of the events was unknown; not responsive was not recovered$ the patient died on 06Jan2021. The cause of death was unknown (reported as: not known by reporter). An autopsy was not performed.  The batch/lot number for the vaccine$ BNT162B2$ was not provided and has been requested during follow up.; Reported Cause(s) of Death: not responsive and he passed away$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Blood pressure high; Diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0942106-1$	$0942106-1$	$54 y/o M with PMH of HTN$ HLD$ Alcoholic Cirrhosis$ Aortic Valve Stenosis$ and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per EMS$ the patient called because he was having constant$ diffuse abdominal pain x 1 day that radiated to his chest. On scene$ the patient had a witnessed arrest with EMS starting CPR. He was given 3 rounds of epi without ROSC. Pt had no associated shockable rhythm. Of note$ pt's wife$ had noted pt had received covid vaccine the prior day.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0955597-1$	$0955597-1$	$Death$	$No current illness for this event.$	$Major Depressive Disorder Hepatitis C Essential Hypertension Diabetes Type 2 Alcoholic Cirrhosis Hypothyroidism Chronic Kidney Disease Stage 5 Asthma$Contrast media$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965910-1$	$0965910-1$	$The employee found dead at her home on 1/21/2021.$	$not known$	$not known$not known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967399-1$	$0967399-1$	$Sudden death$	$No$	$diabetes$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0981225-1$	$0981225-1$	$Patient with inoperable pancreatic cancer received second Pfizer vaccine approximately 12:30 pm on 1/27/21. At approximataely 16:30$ patient complained of abdominal pain and was given Levsin 0.125mg and morphine 5mg orally.  At approximately 19:30 patient was found on the floor covered in a large amount of emesis$ unresponsive  without a pulse.$	$No current illness for this event.$	$C25.9 MALIGNANT NEOPLASM OF PANCREAS$ UNSPECIFIED B19.20 UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA S82.002D UNSPECIFIED FRACTURE OF LEFT PATELLA$ SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING J44.9 CHRONIC OBSTRUCTIVE PULMONARY DISEASE$ UNSPECIFIED F03.90 UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE D64.9 ANEMIA$ UNSPECIFIED Z91.81 HISTORY OF FALLING E46 UNSPECIFIED PROTEIN-CALORIE MALNUTRITION G31.84 MILD COGNITIVE IMPAIRMENT$ SO STATED I10 ESSENTIAL (PRIMARY) HYPERTENSION G40.89 OTHER SEIZURES F32.9 MAJOR DEPRESSIVE DISORDER$ SINGLE EPISODE$ UNSPECIFIED F41.9 ANXIETY DISORDER$ UNSPECIFIED M62.81 MUSCLE WEAKNESS (GENERALIZED) R26.89 OTHER ABNORMALITIES OF GAIT AND MOBILITY R41.841 COGNITIVE COMMUNICATION DEFICIT Z11$Imipenem$ Penicillins$ Peanut$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0989006-1$	$0989006-1$	$After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing.  EMS was called as I made my way outside.  Upon my arrival patient was leaning out of the car and stating that she could not breath.  She was able to tell me that she was allergic to penicillin.  Oxygen was immediately placed on the patient with minimal relief.  Lung sounds were coarse throughout.  She then  began to vomit about every 20-30 seconds.  Epipen was administered in the right leg with no relief.  Patient continued to complain of troubles breathing and vomiting.  A second epipen was administered in the patients right arm again with no relief.  A few minutes later patient was given racemic epinephrine through the oxygen mask.  There appeared to be mild improvement in her breathing as she appeared more comfortable$ but still complaining of shortness of breath and vomiting.  When EMS arrived patient was unable to transport herself to the stretcher.  When EMS and clinical staff transferred patient to the stretcher she became unresponsive.  She appeared to still be breathing.  She did not respond to verbal stimuli.  Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance.  When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned.  At that time patient was found to be in PEA$ shock was delivered.  Shortly thereafter no cardiac activity was found and patient pronounced dead.$	$unknown$	$diabetes obesity hypoventilation syndrome$penicillin latex$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992884-1$	$0992884-1$	$The next morning after vaccine$ patient ran a fever$ vomited$ and was very tired.  Mom laid her down to sleep and when she checked later$ patient had passed away.$	$Unknown$	$Unknown$Sulfa Allergy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0994790-1$	$0994790-1$	$Resident found unresponsive in room this am at approx. 9:30 am. Resident was observed eating breakfast around 8:45 am. Housekeeper reported seeing resident between breakfast and time found unresponsive. Resident had voiced no complaints. Code was initiated until EMS arrived and transported resident to hospital. Resident expired.$	$none$	$COPD$ cad$ morbid obesity$ depression$ bipolar$ hypothyroidism$ hypertension and gerd.$Ibuprofen$ ketorolac$ morphine$tramadol.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0994989-1$	$0994989-1$	$Employee was found unresponsive in floor at her home. EMS arrived and person had expired.$	$unsure$	$unsure$unsure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002418-1$	$1002418-1$	$Patient death$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1019670-1$	$1019670-1$	$2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose.  Redness to bilateral upper extremities$ c/o some pain with urination$ weak.  V/S stable$ afebrile in ED.  Assess for infection.   No significant abnormal labs (see below)$ hydrated and discharged.   2/4/2021-  arrived in ED with c/o vomiting$ seen earlier by PCP that day labs drawn.  Shortly after arriving in the ED copious amouts of emesis noted$ the patient went into full cardiac arrest and CPR was started.   -Please see HPI above$ in addition after intubation the patient coded again.  More epinephrine and lidocaine were given.  CPR was resumed.  We did obtain ROSC and targeted temperature management was pursued.  He is placed on a lidocaine drip and a right femoral central line was placed by myself.  At this time$ norepinephrine drip was initiated given his continued hypotension.  Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further$ he was sent to the CT scanner where CT head without IV contrast and CT chest$ abdomen and pelvis with IV contrast was obtained.  He did lose pulses once in the radiology suite.  This was brief.  IV fluids were initiated and he received over 2 L of crystalloid therapy.  He continued to be hypotensive in the emergency department and vasopressin was added.  He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up.  CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant.  I did try to initiate consult with critical care and possible transfer$ however he continued to be unstable and coded requiring CPR multiple times.  He was given IV bicarbonate given his prolonged CPR state and pH.  Ultimately$ the family decided to make the patient comfort measures only given his critical illness.  Shortly after making this decision he did pass away in the emergency department.  RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED  Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia.  Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities.   Final Report Signed by: M.D.$  Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED  Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process.  No evidence of mass effect$ acute hemorrhage or definite acute cortical infarct.   Final Report Signed by: M.D.$ Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED  Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes$ right middle lobe$ in consolidative opacities within bilateral lower lobes which could represent aspiration$ and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through$	$No current illness for this event.$	$Cerebral Palsy$ Anxiety$ Crohns$ Bipolar$ GERD$ Nutrition deficiency$ Iron deficiency$lactose$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024067-1$	$1024067-1$	$1/15: Pfizer vaccine dose 1 administered 1/16: Fever$ chills 1/22: Sore throat$ coughing w/white phlegm$ taking Tylenol and Mucinex.  Fever and chills from 1/16 subsided. Had telehealth consultation with PA. Per her notes$ patient said he gets these symptoms annually$ requested for an antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms do not subside.  1/23: COVID test administered 1/25: Reported positive for COVID 1/26: Telehealth session w/PA: she informed patient of his positive test$ advised to quarantine and seek medical help at hospital if symptoms worsen. Patient reported that his sore throat mostly subsided but is still coughing at night. Said that the pharmacy didn't receive the prescription order for the antibiotic$ so this was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed.  Death certificate issued by state says cause of death: COVID. Autopsy was not performed. Buried on 2/9/21.$	$N/A$	$None$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031189-1$	$1031189-1$	$COVID 19 symptoms and a positive test was confirmed on 1/6$ employee noted previous exposure to positive family members Narrative: Employee noted exposure to COVID prior to presenting for 1st dose of vaccine on 1/5/21. On 1/6/21 employee reported the onset of symptoms and was tested and was confirmed COVID positive that day. Positive result was reported to employee health on 1/8/21. Employee Health continued to track employees progress and was informed of the need for hospitalization on 1/14/21. Course of hospitalization noted the need for intubation and significant issue with comorbid condition (rheumatoid arthritis). Employee died on 2/9/2021. Unable to confirm a direct connection to Vaccine vs. COVID infection$ but felt it should be reported.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1034116-1$	$1034116-1$	$Presented from clinic with 3-4 days of extensive rash.  There were multiple areas of skin sloughing on bilateral upper extremities and abdominal wall.$	$Diabetes - Type 2 Dementia CVA s/p L-sided weakness Psychiatric disorder$	$$Buspirone Morphine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038442-1$	$1038442-1$	$Death within thirty days of vaccine.  Multiple co-morbidities and placed on hospice 12/28/20.$	$Inpatient 12/21/20 with COVID (+ test 12/17/20) and cellulitis of leg treated with antibiotics. Readmitted 12/25-12/28 with seizures and acute kidney injury discharged to SNF on hospice care.$	$Obesity$ TBI$ quadriplegia secondary to GSW; COPD; seizures; gout; neurogenic bowel and bladder; major depressive disorder; dextroscollosis; DM$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1042012-1$	$1042012-1$	$Patient died suddenly 2/14/2021$	$None known$	$Prolactinoma/Pituitary adenoma (2018)$ HTN$ Meniscal tear (knee)$ h/o myomectomy$ h/o C-section$None known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1045150-1$	$1045150-1$	$Patient found in home deceased.$	$Unknown$	$Dyslipidemia Hypertension Seizure Disorder$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073167-1$	$1073167-1$	$She passed away 2/24/2021$	$No$	$Hypertrophic obstructive Cardio myopathy Endocarditis$No/Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0933739-1$	$0933739-1$	$$Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe.  911 was called and taken to the hospital.  While in the ambulance$ patient coded.  Patient was given CPR and $$brought back$$.  Once at the hospital$ patient was placed on a ventilator and efforts were made to contact the guardian for end of life decisions.  Two EEGs were given to determine that patient had no brain activity.  Guardian$ made the decision to end all life saving measures.  Patient was taken off the ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021.  The initial indication from the ICU doctor was the patient had a mucus plug that she couldn't clear.$$	$Recent g-tube placement$ Several hospitalizations over the pas few months due to low Oxygen Levels.$	$Major depression$ borderline personality disorder$ Cerebral Palsy$ History of dissected left carotid artery$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$2 days$	$2$	$Jan.$ 2021$	$2021/01$	$0938118-1$	$0938118-1$	$on 1/8/2021 17:30 patient taken to ER$ cerebellar hemorrhage$ stroke$  aneurysm$	$none mentioned$	$no significant past medical history$latex$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$2 days$	$2$	$Jan.$ 2021$	$2021/01$	$0944595-1$	$0944595-1$	$Cardiac arrest within 1 hour  Patient had the second vaccine approximately 2 pm on   Tuesday Jan 12th  He works at the extended care community and was in  good health that morning with  no  complaints.  He  waited  10-15 minutes at the  vaccine  admin site  and then   told them  he  felt  fine and was  ready to get back to work.  He  then was  found unresponsive at 3 pm within an hour of the 2nd vaccine.   EMS called immediately  worked on him 30 minutes in field then 30 minutes at ER  was able to put him on  life support  yet deemed Brain  dead  1-14-21 and pronounced dead an hour or  so later$	$No known new illnesses$$	$Cardiomyopathy$nkda$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1034055-1$	$1034055-1$	$Associate developed SOB on 2/12/21.  Taken to Hospital on 2/13/21.  Reported deceased 2/14/21.$	$Kidney Failure- on dialysis$	$Kidney Failure- on dialysis$UNKNOWN- none reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1047351-1$	$1047351-1$	$Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis$ prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness$ diarrhea$ foot ulcer$ and loss of appetite.  Diagnosed:   1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs$ ferritin$ d-dimer$ troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.$	$Covid-19 positive on 2/2/2021$	$Diabetes type 2$ Hypertension$Morphine$ Zosyn$ Piperacillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$1032163-1$	$1032163-1$	$Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days$ she developed petechiae up to ankles$ later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP$ 4 units PRBC$ 1 unit cryoprecipitate$ and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura  with pain and weakness. Palliative care consulted. Patient passed away on 2/11.$	$Progressive liver metastases seen on CT 1/26/21 in the setting of metastatic non-small cell lung cancer (diagnosed 9/2020)$	$HPV$ iron deficiency anemia$ abnormal uterine bleeding$ history of COVID-19 hospitalization ( 8/2020)$ migraines$ nonalcoholic fatty liver disease$ GERD$ pre-diabetes$iodinated contrast (rash$ itching)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1031909-1$	$1031909-1$	$Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech) on 1/8/21. On 1/30$ patient was evaluated at urgent care due to back pain. No bloodwork done; metronidazole prescribed for 7 days. On 2/8$ patient was admitted to outside hospital due to ongoing symptom progression. At time of admission$ hgb 5 g/dL and plt 9k. Per Dr. (hematology/oncology)$ pt with schistocytes$ LDH 1500$ and elevated reticulocyte count consistent with thrombotic thrombocytopenic purpura (TTP). SCr >2 mg/dL. Patient immediately treated with plasma exchange and steroids$ however continued to decline. Patient expired on 2/14/21.$	$None known$	$Allergic rhinitis$ insomnia$ anxiety state$ Sjogren's disease$ joint pain$ GERD without esophagitis$ hypertension$ vulvar cysts$ recurrent maxillary sinusitis$ herpres$amoxicillin (swelling)$ sulfur (swelling)$ loratadine (rash)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$0996086-1$	$0996086-1$	$Pt received vaccine on 7 jan. 2021   Twelve days later$ on 19 January 2021$ Pt developed symptoms of COVID (cough$ sore throat$ fever$ myalgias)$ on 20 Jan$ pt admitted to hospital for worsening symptoms. Pt tested positive for COVID 19.  Pt admitted to ICU where pt had complicated hospital course to include ARDS secondary to COVID pneumonia$ nonSTEMI$ with biventricular heart failure$ on  multiple pressor$  rhabdomyolysis with acute kidney injury$ requiring CRRT.   Pt was in hospital for 10 days; he passed away on 31 Jan 2021.$	$No current illness for this event.$	$h.o HTN$ elevated BMI$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0958072-1$	$0958072-1$	$Death 3 days after receiving 2nd dose of COVID vaccine$ unknown if related to vaccine administration.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$50-59 years$	$50-59$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1006662-1$	$1006662-1$	$$Pt had 2nd vaccine$ went home and started having $$cramping$$ in all of her muscles.  It became bad enough that she was taken to local ED where she then started coughing up blood$ required intubation and about 6 hrs later$ died.$$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914805-1$	$0914805-1$	$RESIDENT CODED AND EXPIRED$	$none$	$dysphagia$ violent behaviors$ depressive disorder$ schizophrenia$ aspiration$ gerd$ hyperlipidemia$ dipolar$ rectal bleeding$ HTN$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914917-1$	$0914917-1$	$Death by massive heart attack.  Pfizer-BioNTech COVID-19 Vaccine EUA$	$None$	$hypertension$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0924464-1$	$0924464-1$	$coughing up blood$ significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer$	$COPD$ lung cancer$	$COPD$ lung cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0932898-1$	$0932898-1$	$The patient had an apparent cardiac arrest on 12/23/20 and was admitted to the ICU. He was taken off of life support on 12/30/20.  He had known cardiac disease.$	$No current illness for this event.$	$High blood pressure. Congenital unicuspid aortic valve s/p aortic valve replacement 2001 & 2011.  Pacemaker placement 2011.  Melanoma$None known.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0933090-1$	$0933090-1$	$Patient died$ I have a copy of his vaccination card$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0935815-1$	$0935815-1$	$Difficulty breathing$ death.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0942085-1$	$0942085-1$	$No adverse effects from vaccination seen on 1/2/21.   On 1/6/21 resident was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen 4$000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous rate over 3 days.   On 1/8/21 at 0615 resident was shaking$ lower extremities mottled$ Sa02 70%$ pulse 45. Oxygen started at 2 L/m per NC. At 0715  her primary physician was notified as well as her daughter. Oxygen increased to 4 L/min$ sats at 83%. SOA noted$ reported all over pain. At 0850 when they attempted to reposition the resident$ she was not responsive. Licensed nurse assessed her and no heartbeat heard or pulse found.$	$Medical diagnosis: quadriplegia$ Atherosclerotic heart disease$	$see #11.$Amoxicillin$ Clavulanic Acid$ Codeine$ Morphine$ Pencillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944439-1$	$0944439-1$	$Resident expired on 1/2/21.$	$Receiving hospice services$	$Stage 4 kidney function$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956458-1$	$0956458-1$	$Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment$ a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough.  Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage.  His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64.  He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin$ an Albuterol inhaler$ guaifenessin with codeine cough syrup$ and Zofran. Labs were drawn and he was discharged.  His lab results were reported after his departure and were significant for a white blood cell count of 1.33$ platelet count of 73$ 2% myelocytes$ 1% metamyelocytes$ an absolute neutrophil count of 0.75 K/ul$ a creatinine of 1.83$ total bilirubin of 1.3$ with direct bilirubin of 0.8$ alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative.  Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21$ Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene$ the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home.  On 19-Jan-21$ I contacted the State Medical Examiner's Office.  They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.$	$None$	$Hypertension$ hyperlidemia$ gout$ pre-diabetes$Nnone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958322-1$	$0958322-1$	$Shaking and then became unresponsive$	$Hyperlipidemia$ Head Trauma$ Hx of Seizures$ Unspecified Psychosis$ Depression$ Mood Disorder$ Substance Abuse$	$Hyperlipidemia$ Psychosis$ Depression$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0961705-1$	$0961705-1$	$approximately 3 hours prior to expiring the patient was experiencing forceful emesis.  later was found to have expired$ patient was comfort care only.$	$none$	$Frontotemporal dementia$ copd$ type 2 diabetes with kidney disease$ Anxiety$ Atherosclerotic heart disease$ covid 19 on 10/15/2020$no known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962716-1$	$0962716-1$	$Patient deceased$	$No current illness for this event.$	$$CEPHALEXIN$ CODEINE$ PENICILLIN$ TETRACYCLINE$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964629-1$	$0964629-1$	$Death - Hospice patient with metastatic CA admitted to facility and received vaccine during stay. No adverse sequelae noted from vaccine administration$ but reporting as required because pt died 7 days later. Narrative: Reporting this event because patient died 7 days after receiving vaccine in the facility where he was in hospice care for metastatic cancer. Vaccine was administered by protocol without complications. The patient had been asked and denied any prior severe reaction to this vaccine or its components and gave permission to receive it. No vaccine adverse sequelae were documented after the immunization as monitored for 15 minutes nor in facility notes for 7 days after the immunization. The patient's death was felt to be due to underlying terminal illness.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965561-1$	$0965561-1$	$respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program  from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot and expiry not reported)$ via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad)$ neuroleptic malignant syndrome (broad)$ anticholinergic syndrome (broad)$ acute central respiratory depression (broad)$ hypersensitivity (broad)$ respiratory failure (narrow)$ drug reaction with eosinophilia and systemic symptoms (broad)$ hypoglycaemia (broad)$ COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine$ the patient experienced fever$ respiratory distress$ and anxiety developed requiring oxygen$ morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal$ while of the other events was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Anaphylactic reaction; Anticholinergic syndrome; Central respiratory depression; COPD; COVID-19; Drug reaction with eosinophilia and systemic symptoms; Hypersensitivity; Hypoglycaemia; Neuroleptic malignant syndrome; Respiratory failure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967830-1$	$0967830-1$	$Patient was was brought to the ED from facility which  he received the vaccine via ambulance with BiPAP$ hypoxia$ and one dose of Epi of 0.3 mg. He then required intubation$ and had struggled with hypoxia$ even on increasing PEEP. CODE BLUE called in the ED for PEA. He was medicated for such (please see the code run sheet for details)$ and he came in and out of the code 5 times. After 95 minutes$ with the wife at the bedside$ and family conference by phone$ the code was called$ and he was pronounced at 18:20. He received in total 8 me of Epi$ 3 shots of Atropine$ 3 amps bicarb. He got lasix 40 mg$ lovenox 60 mg subcutaneous once. He had a CVC into the right internal jugular$ and levophed was started$ then Epinephrine drip was started.  Prior to the code he got steroids (solumedrol 125 mg$ then later decadron 6 mg iv)$ benadryl iv$ antibiotics (ceftraixone / zithromax)$ and lasix 40 mg. All this time while in the ED$ the Rt was at the bedside$ and lots of secretions from the lungs were aspirated$ bloody color. ل Code was the result of PEA secondary to hypoxia (</= 85%)$ despite being on the vent$ with PEEP 12$ FiO2 of 100%$ with acidosis. ل After 95 minutes of active resuscitation$ the patient was found not responsive to painful stimuli. There was no palpable pulse. No spontaneous respirations. No heart or breath sounds by auscultation. Absence of pupillary light reflex.$	$HTN$ DM2. COVID-19 infection$ 12/24/20.$	$HTN$ DM2.$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979101-1$	$0979101-1$	$cardiac arrest - no warning signs$	$none$	$Ventilator dependant r/t acute respiratory failure with hypoxia$ chronic diastolic heart failure$ diabetes$ cerebral infarct with hemiplegia$Penicillin$ Chocolate$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982891-1$	$0982891-1$	$All residents had been in isolation due to multiple cases of COVID in the facility. Resident voiced no health related complaints. He continued to visit with staff and required moderate assist with toileting.  Resident had fall 0130 on 1-15-2021$ which resulted in laceration with surgical repair.  Resident was noted to change in mental status and respirations on morning of 1-16-2021 during morning blood sugar check. Resident had O2 @1.5l/m via n/c and respirations of 10 with periods of apnea and unresponsive to verbal stimuli. Blood sugar was 583.  Resident deceased upon re-check after calling PCP to report status change.$	$No current illness for this event.$	$Heart Failure$ unspecified$ Acute and Chronic Respiratory Failure with Hypercapnia$ Chronic Obstructive Pulmonary Disease$ Morbid (Severe) Obesity with Aveolar Hypoventilation$ Essential Hypertension$ Type 2 Diabetes Mellitus with Diabetic Neuropathy$ Hypothyroidism$ Obstructive Sleep Apnea$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982929-1$	$0982929-1$	$Client was being treated with antibiotics by her PCP for diverticulitis flare up.  It had not been resolved on the date of her death which occurred 01/27/21$ She was found unresponsive by staff$ 911 contacted$ and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.$	$Ongoing Sinus and ear infections being treated by PCP$	$COPD$ Hypothyrodism$ non-alcoholic fatty liver$ diabetes type 2$ hypertension$  diverticulitis$Quetiapine$ Zyprexa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987513-1$	$0987513-1$	$Note Text: Resident oxygen was going down to 74% during change of shift 3-11$ oxygen initiated 3liters via nasal canula per standing order want up to 84-86% NP notified$ ordered Prednisone 20mg stat$ Rocephin 1gram IM stat administered$ Per NP statement if pt's condition worsening sent him to ER$ continue monitoring pt and his oxygen going to 82% increasing distress. Notified Nurses supervisor$ 911 was called pt left building at 1819 to Hospital alert oriented. Vs bp. 165/60$ temp. 98.3$m pulse 109$ res 22$ 02. 82%. Resident father notified.$	$UTI And PNA$	$COPD $ anxiety history of ETOH abuse $thrombocytopenia$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1007371-1$	$1007371-1$	$Called PCP$ from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21$	$None known$	$Transplant patient.$Not on File$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020134-1$	$1020134-1$	$$anxious$ restless$ weak$ dizzy$ felt $$horrible$$. Continued to C/O symptoms$. At 01:15$ patient lost consciousness $ then stopped breathing and lost pulse. Narrative:  Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob$ with multiple medical conditions including hypertension$ atrial fibrillation on apixaban$ cardiomyopathy with poor EF$ dyslipidemia$ COPD$ CVA$ lung CA s/p radiotherapy$ PTSD$ depression$ Churg Strauss Syndrome$ Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days$ also complains of cough productive of yellowish sputum$ no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis$ palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently$ thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27$ Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop$ transferred. 1/28$ struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00$ relieved with NTG. HR = AF$ with RVR 145. At about 08:00$ Cardiology sees patient and signs off$ $$shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease.$$ No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic$ stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got $$that shot$$ he hasn't felt well. When asked what shot pt replied $$COVID shot.$$ Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt$ asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure$ body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi$ 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA$ Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40$ survived$ but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside$ Mother asks for code to be stopped.$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024226-1$	$1024226-1$	$New onset dizziness with hypotension$ tachycardia$ and vomiting blood. Sent to ER - told he went into cardiac arrest and died.$	$No current illness for this event.$	$CAD$ Atrial Fibrillation$ dementia$ stroke$ htn$ ckd$ AAA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033323-1$	$1033323-1$	$patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1039597-1$	$1039597-1$	$$Death Narrative:  Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: $$due to sepsis (related to bed sores) and aspiration pneumonia$$$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1062550-1$	$1062550-1$	$Patient's daughter called to report that about 30 hours after receiving the vaccine he passed away at home. She said she didn't know the cause of death but she felt like she should let us know about it.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063201-1$	$1063201-1$	$The recipient was feeling well immediately after the vaccination$  all day on 2.8 and in the morning of 2.9.  His daughter in law text him at 0930 and he did not respond to the text (atypical) and then he missed a morning meeting.  His wife was downstairs in a meeting herself and after the meeting was over she called to him and he did not respond.  She found him with no pulse and was not breathing.  She called 911 and attempted CPR.  They did not complete an autopsy$ they stated that they believe the cause of death was either an embolism$ Heart attack or aneurism.   The wife stated that she does not believe the death was due to the vaccination; however$ there were no tests completed to prove or disprove.$	$no other illnesses$	$High Blood pressure enlarged prostate$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063457-1$	$1063457-1$	$On date on second dose$ 2/27/2021$  the pt began have fatigue and diarrhea at around 10:30 am.  This continued to the following day.  On 2/28/2021$ the patient was last seen around 4:20 pm by his wife in their residence.  She found him unresponsive at 5:30 pm in their bedroom.  EMS was called and the decedent was declared deceased.    The pt had his first dose on 2/9/2021.  Both doses were given at the hospital. Per family$ the pt had no adverse affects following the first dose.$	$PTSD$	$PTSD$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066093-1$	$1066093-1$	$No known side effects; however$ on 1/20 the decedent suffered lethargy.  On 2/12/2021$ the decedent had a possible seizure and was transported to emergency department where shortly after arrival$ he was pronounced dead.$	$Hypertension$ diabetes mellitus$ hyperlipidemia$ chronic systolic heart failure$ paroxysmal atrial fibrillation$ low back pain with intermittent radiculopathic symptoms$ history of ruptured gastrointestinal ulcer in 2018 with resultant internal bleeding and cerebrovascular disease with right-sided neurologic deficit$ neurogenic bladder with indwelling catheter$ Covid-19 positive (7/2020) with subsequent negative tests 12/2020$ 01/2021$ and 2/2021$	$same as other illnesses$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069560-1$	$1069560-1$	$Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at home when children noticed his lips were blue$ ems arrived and found him to be 50% on RA$ on Non-rebreather pt got to 78%$ covid on 01/26   Shortness of Breath   61-year-old male presents with EMS for evaluation of shortness of breath hypoxia.  History is limited due to the patient's current clinical condition and so is primarily obtained from EMS.  EMS reports that he tested positive for COVID-19 5 days ago.  He began developing shortness of breath yesterday and his family called because his lips and fingers were blue today and he appeared short of breath.  On EMS arrival he had a room air saturation of less than 50% so he was placed on nonrebreather with improvement in his saturation to 70% and he was transported to the emergency department.  Patient does admit to shortness of breath.  He denies any chest pain.  He is noted to have a cast on his left ankle and said that he broke his left ankle on 23 December but has not had surgery.  He denies any new pain or swelling of the leg.  In the ED he was placed on 15L nasal cannula and NRB mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of 1.35$ lactic acid 5.8$ and d-dimer 14.4.  He received dexamethasone and was placed on heparin gtt.   1/31 admitted to ICU Acute hypoxic respiratory failure due to COVID-19 vs heart failure vs PE.  CXR with bilateral hazy infiltrates more pronounced in the bases and left periphery and suspected multifocal pneumonia.   At risk for PE given LLE immobility in the setting of COVID-19 with significantly elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy. Continue with empiric treatment with heparin gtt.   Admitted to ICU with SO2 in 60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s and PO2 42 so the decision was made to intubate.  Oxygenation improved following intubation$ with further improvement following recruitment maneuver and increase in PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2 as able.  ARDS net protocol as much as possible. Consider prone ventilation and/or epoprostenol if unable to improve .  VAP Bundle: HOB >30 degrees; Oral care per nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG levels.    COVID - 19: Convalescent plasma: Not indicated  Steroids: Dexamethasone 6 mg / day for 10 days Remdesivir: Not indicated d/t AKI   IL-6 inhibitor: Meets criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets and Hb stable).  Antibiotics: Start 3 and 7 day course of azithromycin and ceftriaxone$ respectively.  Elevated troponin  Suspect demand ischemia d/t hypoxia; EKG does not show any ischemic changes    AKI: Suspect d/t hypoxia in the setting of COVID infection. Urine output and electrolytes acceptable.  Closed fracture of left ankle Suffered fracture following a fall on ice in December. Cast was placed on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal.    Inhaled epoprostenol started  Considered for ECMO but not initiated due to not a candidate  Vasopressors required at times  Antihypertensive infusion required at times  severe hypoxia with position changes  switched from heparin drip to enoxaparin prophylaxis  2/20 discharge summary 61 y/o male admitted to Hospital on 1/31 with hypoxia.  He was diagnosed with COVID 19 5 days prior to admission$ and had worsening respiratory status.  He was intubated after arrival$ and was on ventilator for the entire intervening time$ until he was extubated on 2/20 at the time of transition to Comfort measures only.    Prior to developing COVID 19$ he had received his first dose of the Pfizer vaccine$ as a member of the school system.  He had a fractured L ankle after a fall on 12/31/20$ and had a cast in place at the time of admission.  He received Tocilizumab on 1/31$ and underwent several cycles of prone positioning$ beginning on 2/2.  He completed a course of Decadron$ he received  Ceftriaxone and azithromycin beginning on admission$ and completed a course of these.  Anticoagulation with enoxaparin was utilized due to coagulopathy associated with COVID 19.  Vasopressor support was required at times$ as well as diuresis for fluid management.    He required high levels of sedation to maintain ventilator synchrony$ and high levels of ventilator support with high oxygen levels throughout his stay.  Tracheostomy was being considered$ but family decided that since he was not going to have good recovery$ withdrawal of support$ and allowing death was the appropriate choice for the patient and for them.   He was extubated at 2100 on 2/20/2021.   Death was pronounced at 2123 on 2/20/2021.  Children were at bedside.$	$Ankle fracture$	$Past medical history Ankle fracture$ left 12/30/2020  Asthma   Diabetes mellitus   Hypertension Obesity 104.3kg; Height 5?6?$Iodine ? hives Shellfish - hives$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$1047072-1$	$1047072-1$	$Patient had sore arm on the day of vaccination. Per patient's nephew $ the next morning patient experienced body pains$ aches$ headache . Onn Tuesday patient had fever.  Patient's condition  progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am$	$COPD$ seizures( patient  on medications and controlled)$ Hernia operation 2 years ago$	$COPD and seizures$ asthma$no allergies to medications$ or food but allergic to cats$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1036874-1$	$1036874-1$	$Patient developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia and passed away on 12/27.$	$No current illness for this event.$	$COPD$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$9 days$	$9$	$Feb.$ 2021$	$2021/02$	$0993112-1$	$0993112-1$	$she was injected$ sh stopped eating and talking$ the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital  she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later$ was on a ventilator 4 days after that   then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.$	$Broken ankle$	$Mid intellectual Disabilities$ Schizoaffective Disorders$ Obesity$ Unspecified Heart Disease$ Unspecified Hypothyroidism$ unspecified Allergic rhinitis$PCN$Lactose Intol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1036675-1$	$1036675-1$	$61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath$ nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%$ improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone$ plasmapheresis$ IVIG$ Thymoglobulin. She continued to decline and ultimately required intubation$ proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside$ brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.$	$ل$	$Bilateral Lung لTransplant due to Advanced Lymphoangioleiomymatosis Immunosuppressed status (HCC) Antibody mediated rejection of lung transplant (HCC) Bronchiolitis obliterans syndrome$ grade 0P (HCC) Major depressive disorder with single episode$ in full remission (HCC) RLS (restless legs syndrome) Chronic insomnia Long term current use of systemic steroids OSA (obstructive sleep apnea) Iron deficiency anemia Bilateral sciatica Pure hypercholesterolemia Hoarseness of voice Memory change Laryngeal stridor Senile nuclear cataract$ bilateral Myopia of both eyes Osteoporosis without current pathological fracture$ unspecified osteoporosis type Dry eyes$ bilateral$Voriconazole$ NSAIDs$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1051445-1$	$1051445-1$	$chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional.  A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EL9261)$ intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization.  The patient medical history included bilateral lung transplant on 23Jun2017$ lymphangioleiomyomatosis$ hepatocellular carcinoma$ antibody mediated rejection of lung transplant $ bronchiolitis obliterans syndrome$ grade 0P$ major depressive disorder$ RLS (restless legs syndrome)$ chronic insomnia$ long term current use of systemic steroids OSA (obstructive sleep apnea)$ iron deficiency anemia$ bilateral sciatica$ hoarseness of voice$ memory change$ laryngeal stridor$ pure hypercholesterolemia senile nuclear cataract$ bilateral myopia of both eyes$ osteoporosis without current pathological fracture$ alopecia$ immunosuppressed status$ all from an unknown date and unknown if ongoing.  Concomitant medication included acyclovir (formulation: capsule$ strength: 200 mg) oral at 200 mg twice daily$ salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath)$ atorvastatin (LIPITOR$ formulation: tablet) oral at 80 mg once a day$ azithromycin (ZITHROMAX$ formulation: tablet)oral at 250 mg (every Monday$ Wednesday$ Friday)$ bupropion hydrochloride (WELLBUTRIN XL$ formulation: tablet$ strength: 150 mg) oral at 150 mg once a day$ calcium citrate/cholecalciferol (CALCIUM + VITAMIN D$ formulation: tablet) oral at 2 dose form once a day (every morning)$ everolimus (ZORTRESS$ formulation: tablet$ strength: 1 mg) oral at 2 mg twice a day$ fluticasone propionate/salmeterol xinafoate (ADVAIR$ strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation)$ gabapentin (NEURONTIN$ formulation: capsule$ strength:100 mg) oral at 300 mg daily (by mouth nightly)$ loratadine (CLARITIN$ formulation: tablet$ strength: 10 mg) oral at 10 mg as needed$ metoprolol tartrate (LOPRESSOR$ formulation: tablet$ strength: 25 mg)oral at 50 mg twice daily$ minoxidil (ROGAN$ strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia$ ondansetron (ZOFRAN$ formulation: tablet$ strength: 4 mg) oral at 4 mg as needed for nausea$ pantoprazole sodium sesquihydrate (PROTONIX$ formulation: tablet$ strength: 40 mg) oral at 40 mg once a day$ prednisone (DELTASONE$ formulation: tablet$ strength: 5 mg) oral at 5 mg daily (every morning)$ sertraline hydrochloride (ZOLOFT$ formulation: tablet$ strength: 100 mg) oral at 100 mg twice a day (every morning)$ sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday$ Wednesday$ Friday)$ tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night)$ salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath)$ salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) $ salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath)$ ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL$ formulation: tablet) oral daily.  The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath$ nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone$ plasmapheresis$ IVIG$ thymoglobulin. She continued to decline and ultimately required intubation$ proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside$ brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021.  It was not reported if an autopsy was performed.; Sender's Comments: Based on available information$ a possible contributory role of the subject product$ BNT162B2 vaccine$ cannot be excluded for the reported events due to temporal relationship. However$ the reported event may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case$ including complete medical history$ diagnostics$ counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Alopecia; Antibody-mediated rejection; Bronchiolitis obliterans syndrome (grade 0P); Chronic insomnia; Hepatocellular carcinoma; Hoarseness of voice; Immunosuppression; Iron deficiency anemia; Laryngomalacia; Lung transplant; Lymphangioleiomyomatosis; Major depressive disorder; Memory impairment; Myopia; Nuclear cataract; Obstructive sleep apnea syndrome; Osteoporosis; Pure hypercholesterolemia; Restless legs syndrome; Sciatica$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$60-64 years$	$60-64$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1062962-1$	$1062962-1$	$[COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)$	$No current illness for this event.$	$61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath$ nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%$ improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11/07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone$ plasmapheresis$ IVIG$ Thymoglobulin. She continued to decline and ultimately required intubation$ proning and paralyzing on 2/8/2021 and the VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside$ brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0913143-1$	$0913143-1$	$Vaccine administered with no immediate adverse reaction at 11:29am. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 1:30pm the resident passed away.$	$No current illness for this event.$	$dementia$ aphasia$ type 2 DM$ iron deficiency$ asthenia$ osteoporosis$ polyneuropathy$ anxiety$  MDD$codeine$ phenobarbital$ penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0913881-1$	$0913881-1$	$the patient died; This is a spontaneous report from a contactable consumer through a Pfizer employee. A 98-99 years old patient of an unspecified gender received bnt162b2 (COMIRNATY)$ via an unspecified route of administration possibly on 27Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died on 29Dec2020. Event details: The Pfizer employee was informed$ by a member of the Covid vaccine team at the ministry of health$ that an elderly person 98-99 years old$ who used to stay in an elderly home$ who also had other serious diseases and received the vaccine possibly on 27Dec2020$ had died this morning (29Dec2020). As it was mentioned to the Pfizer employee$ they were 'sure' that the cause of death did not related to the vaccine. It was not reported if an autopsy was performed.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: unknown cause of death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914604-1$	$0914604-1$	$Spouse awoke 12/20 and found spouse dead. Client was not transferred to hospital.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914690-1$	$0914690-1$	$Within 24 hours of receiving the vaccine$ fever and respiratory distress$ and anxiety developed requiring oxygen$ morphine and ativan. My Mom passed away on the evening of 12/26/2020.$	$none known$	$COPD$none known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914895-1$	$0914895-1$	$Injection given on 12/28/20 - no adverse events and no issues yesterday; Death today$ 12/30/20$ approx.. 2am today  (unknown if related - Administrator marked as natural causes)$	$Alzheimer's Disease$ Encephalopathy$ Hypertension$Acute Kidney failure$ Urine Retention$ Recent UTI$	$Alzheimer's Disease$ Encephalopathy$ Hypertension$No known drug allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914961-1$	$0914961-1$	$pt passed away with an hour to hour and 1/2 of receiving vaccine.  per nursing home staff they did not expect pt to make it many more days.  pt was unresponsive in room when shot was given.  per nursing home staff pt was 14 + days post covid$	$per nursing home staff over 14 days post covid$	$$none listed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0914994-1$	$0914994-1$	$pt was a nursing home pt.  pt received first dose of covid vaccine.  pt was monitored for 15 minutes after getting shot. staff reported that pt was 15 days post covid.  Pt passed away with in 90 minutes of getting vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0915562-1$	$0915562-1$	$pt received vaccine at covid clinic on 12/30 at approximately 3:30$ pt vomited 4 minutes after receiving shot--dark brown vomit$ staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night.  Pt had DNR on file.  pt passed away at approximately  10pm.  Staff reported pt was 14 + days post covid$	$No current illness for this event.$	$$none listed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0915682-1$	$0915682-1$	$Resident received vaccine per pharmacy at the facility at 5 pm.  Approximately 6:45 resident found unresponsive and EMS contacted.  Upon EMS arrival at facility$ resident went into cardiac arrest$ code initiated by EMS and transported to hospital.  Resident expired at hospital at approximately 8 pm$	$No current illness for this event.$	$Respiratory Disease$ Essential Hypertension$ Coronary Artery Disease$ History of positive COVID 11/17/20$No Known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0915920-1$	$0915920-1$	$Resident received vaccine in am and expired that afternoon.$	$Resident was living in an assisted living facility.  She fell on 11/24/2020 and was seen in the ER. There$ she tested positive for COVID 19. She was admitted to this facility for rehab. She showed a decline after admission and was referred to hospice.$	$Vitamin deficiency$ hyperlipidemia$ hypertension$ anemia$ dementia$ chronic kidney disease III$ osteoporosis$ history of breast cancer/MI/pulmonary embolism$ depression.$Tetanus toxoid$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0918388-1$	$0918388-1$	$Resident found unresponsive without pulse$ respirations at 04:30 CPR performed$ expired at 04:52 by Rescue$	$No acute illness at time of vaccination.  History of: CVA SCPT Dementia Seizure Disorder HTN COPD$	$As noted above$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0918418-1$	$0918418-1$	$Resident became SOB$ congested and hypoxic requiring oxygen$ respiratory treatments and suctioning.  Stabilized after treatment and for the next 72 hours with oxygen saturations in the 90s.  On 1/3/2021 was found without pulse and respirations.  Resident was a DNR on Hospice.$	$Hypoxia started on 1/1/2021.  History of: Osteomyelitis CVA Pain Pressure Ulcers PVD Hepatitis C COPD HTN HLD Constipation SCPT Anemia Seizure disorder Depression AKA$	$As noted above$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0919108-1$	$0919108-1$	$Fever$ Malaise$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0920545-1$	$0920545-1$	$$The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was $$abnormal$$ how he was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was found without a pulse$ respirations$ or blood pressure at 1:54 pm. He was a DNR.$$	$No current illness for this event.$	$ACUTE POSTHEMORRHAGIC ANEMIA$ ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITH OTHER FORMS OF ANGINA PECTORIS$ CARDIAC MURMUR$ UNSPECIFIED$ CHRONIC KIDNEY DISEASE$ STAGE 2$ CHRONIC OBSTRUCTIVE PULMONARY DISEASE$ EMPHYSEMA$ ESSENTIAL (PRIMARY) HYPERTENSION$ FRACTURE OF NASAL BONES$ INITIAL ENCOUNTER FOR CLOSED FRACTURE$ HYPOXEMIA$ PAROXYSMAL ATRIAL FIBRILLATION$ PRESENCE OF CARDIAC PACEMAKER$ THROMBOCYTOPENIA$ UNSPECIFIED CIRRHOSIS OF LIVER$ and UNSPECIFIED DIASTOLIC (CONGESTIVE) HEART FAILURE.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0920832-1$	$0920832-1$	$Vaccine 12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test result came back positive 1/2/2021 Deceased 1/4/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0920891-1$	$0920891-1$	$$deceased on 31Dec2020 with no previous side effect; This is a spontaneous report from a contactable physician via $$Pfizer$$. An 87-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: $$not known because vaccination team vaccinated at care home$$)$ via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included upper respiratory tract infection$ changing patient weakness; both from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient experienced: deceased on 31Dec2020 with no previous side effect; which resulted in death on 31Dec2020.  The clinical course was reported as follows: the patient received the first dose of the PFIZER-BIONTECH COVID-19 MRNA VACCINE on 29Dec2020; and the patient was deceased on 31Dec2020 with no previous side effect. The patient received the vaccination with a negative COVID-test on 25Dec2020; $$in case of upper respiratory tract infection and changing patient weakness$$. The physician reported that $$after good breakfast at 09:13 found without vital signs during routine control.$$ The clinical outcome of the event was fatal. The patient died on 31Dec2020 due to unknown cause of death. It was unknown if an autopsy was performed.   The batch/lot numbers for the vaccine$ PFIZER-BIONTECH COVID-19 MRNA VACCINE$ were not provided and will be requested during follow up.; Sender's Comments: The limited information available does not allow a meaningful assessment by the company. The advance old patient had upper respiratory tract infection$ changing patient weakness; further information such as complete medical history$ concomitant treatments$ particularly death cause and autopsy results are needed for fully medical  assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to regulatory authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: deceased on 31Dec2020 with no previous side effect$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Upper respiratory tract infection; Weakness$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0921481-1$	$0921481-1$	$Vaccine given on 12/29/20 by Pharmacy. On 1/1/21$ resident became lethargic and sluggish and developed a rash on forearms. He was a Hospice recipient and doctor and Hospice ordered no treatment$ just to continue to monitor. When no improvement of codition reported$ doctor and Hospice ordered comfort meds (Morphine$ Ativan$ Levsin). Resident expired on 1/4/2021$	$Dementia Chronic PVD$	$Dementia PVD$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0921880-1$	$0921880-1$	$The resident was found deceased a little less than 12 hours following COVID vaccination$ and he had had some changes over the last 2 days.  He was 96 and had been on hospice care for a little while. Noone noticed any side effects from vaccine after it was given$	$was under hospice care$	$alzheimers disease$ ataxia$ HTN$ Kidney malignancy history$ Prostate cancer history$ GERD$ sleep apnea$ history falls$oxycodone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0924456-1$	$0924456-1$	$Patient did not display any obvious signs or symptoms; the vaccination was administered at approximately 10:00 AM and the patient continued throughout her day without any complaints or signs of adverse reaction. Patient was helped to bed by the nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's COVID-19 specimen collection from Sunday$ 1/3/21$ detected COVID-19. When the nursing staff went to the room to check on the resident and prepare her to move to a COVID-19 care area the patient was found unresponsive$  no movement$ no chest rises$ noted regurgitated small amount of food to mouth left side$ lying on left side. Pupils non reactive.$	$COVID-19 detected after vaccination; asymptomatic$	$Hyperlipidemia; Alzheimer's disease; Atherosclerotic heart disease of native coronary artery w/o angina pectoris; Osteoarthritis; Major depressive disorder$ single episode$ unspecified; unspecified severe protein-calorie malnutrition$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0925556-1$	$0925556-1$	$Expired 1/05/2021$	$Acute on chronic heart failure$ sepsis$	$CAD$ CKD$ DM type 2$ CHF$ Hx TIA$ Atrial fibrillation$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0926269-1$	$0926269-1$	$$Pt last seen at 1200 by nurse for ID band check. No visible signs of distress noted. Pt states $$I just want to be left alone$$. 1230 nurse was called to pt room. Pt was noted unresponsive$ no pulse and respiration noted. CPR started immediately$ at 1239 first shock given. 1245 EMT took over$ at 1319 EMT called time of death$$	$Fracture of right superior and inferior pubic rami$ fracture of the right sacral alla$ and fracture of the L3 vertebral body.  UNSPECIFIED PROTEIN-CALORIE MALNUTRITION$	$Abdominal aortic aneurysm CHRONIC OBSTRUCTIVE PULMONARY DISEASE tobacco abuse$ EtOH abuse Ambulatory dysfunction$ debility$ high risk for falls$ deconditioning$ ambulatory dysfunction/debility/deconditioning/high fall risk/generalized weakness  MAJOR DEPRESSIVE DISORDER$ RECURRENT$ UNSPECIFIED PERSONAL HISTORY OF MALARIA$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0927189-1$	$0927189-1$	$Patient was vaccinated at 11am and was found at the facility in his room deceased at approximately 3:00pm. Nurse did not have cause of death$	$stroke$	$hypertension$ atrial fibrillation$ atherosclerosis$$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0929023-1$	$0929023-1$	$possible myocardial infarction; Dyspnoea; unwell; Cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency. Regulatory authority GB-MHRA-WEBCOVID-20210105105739$ other manufacturer number is GB-MHRA-ADR 24556743.  A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ Lot number: EJ0553-v0003)$ via unspecified route of administration on 19Dec2020 at single dose for COVID-19 vaccination. Medical history included diabetes mellitus$ angiocardiogram$ cardiac failure$ hypertension$ all from unspecified date and unknown if ongoing and cerebrovascular accident from 2001 and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Unsure if patient is enrolled in clinical trial. Concomitant medication included amlodipine$ acetylsalicylic acid (ASPIRIN (E.C.))$ atorvastatin$ bisoprolol$ fluticasone propionate (FLIXONASE)$ folic acid$ colecalciferol (FULTIUM-D3)$ furosemide$ latanoprost$ levothyroxine$ insulin aspart (NOVORAPID)$ ramipril and insulin detemir (LEVEMIR). On 24Dec2020$ the patient experienced a cough. It was noted that the patient's son and wife had already been coughing but no coronavirus tests had been done at the time of this event. On an unknown date$ the patient experienced dyspnoea. It was noted that the he had become increasingly short of breath and unwell. On 28Dec2020$ the patient died. It was noted to be a possible myocardial infarction. The patients COVID test score was unknown. The autopsy was awaited at the time of this report. The outcome of the event possible myocardial infarction was fatal$ while other events were unknown.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: possible myocardial infarction$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cerebrovascular accident; Coronary angiogram (nov); Diabetes; Heart failure; Hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0929359-1$	$0929359-1$	$3:07 pm lung sounds diminished oxygen sats 68%$ oxygen applied Oxygen sats remained low for next 36 hours ( patient on Hospice care ) expired 6:22 am 1-8-21$	$Cerebral Atherosclerosis$ malnutrition$ thrombocytopenia$ cva$ hypothyroidism$	$Cerebral Atherosclerosis$ malnutrition$ thrombocytopenia$ cva$ hypothyroidism$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0930466-1$	$0930466-1$	$Fever$ shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination$	$No current illness for this event.$	$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0932346-1$	$0932346-1$	$1/7-21 - Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever$ dizziness$ headache 1/10/21 0250 was found not breathing.  EMS performed CPR and patient deceased$	$none known$	$hypertension$ hyperlipidemia.$Statin - muscle aches$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0932787-1$	$0932787-1$	$RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21$ NO ADVERSE REACTIONS NOTED$	$PNEUMONIA$	$DEPRESSION   CHRONIC LUNG ANEMIA$TRAMADOL$ methocarbamol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934059-1$	$0934059-1$	$Acute anterior MI with death$	$Had Covid 19 infection in November recovered$ had spinal stenosis with leg weakness chronic$	$$anastrozole$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934373-1$	$0934373-1$	$Patient went to bed around 11pm on Saturday PM and sometime between then and 1:30am on Sunday morning got up and went into the living room without waking up her husband (which is normal).  At 1:30am$ the husband got up to use the restroom and she was out of bed then$ but the husband did not know if she was having any problems at this time.  When he got up at 7:45am$ she was in the recliner and did not move or anything$ which is normal for her.  At 8:45am$ the husband went back into the living room and tried to wake his wife and that is when he noticed there was no pulse and he called 9-1-1 at this time.  EMS got on scene and did CPR for 30 mins and she was pronounced dead at 9:21am.$	$Newly diagnosed heart murmur the week prior by PCP.  Was referred to her cardiologist.$	$She did have open heart surgery in 2013.  She last saw her cardiologist 4 months ago$ and she did a phone consult with him a week or so ago.$PCN & Sulfa drugs$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934507-1$	$0934507-1$	$Resident died suddenly and expectantly on 01/05/2021$	$No other illness prior to vaccination or within the month prior$	$Covid 19 Recovered spring 2020 Chronic stage 5 kidney disease with dialysis 3 times weekly Chronic diastolic congestive heart failure Chronic A-fib Diabetes Mellitus with other circulatory complications  Hypertension  Right and Left Below the knee amputations$KNDA KNFA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0935343-1$	$0935343-1$	$There were no adverse reactions. Resident Died$ she had a history of issues with her health prior to the vaccine.$	$No current illness for this event.$	$This resident had covid a couple months ago. she had a bad heart and also dementia. I do not believe it was the vaccine that killed her. I was instructed by EMS to report because the date of vaccination was three days ago.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0935767-1$	$0935767-1$	$My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!!$	$Pneumomia$	$Dementia$IDK$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0936738-1$	$0936738-1$	$loss of consciousness Narrative:  Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes$ patient did not experience any injection site reactions$ denied pain or tenderness at injection site$ no dizziness$ no n/v$ remained afebrile. Around 1/9/21 @1810$ patient became acutely nonresponsive after being helped to the edge of bed. Per nurses$ he was previously awake/alert$ talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note$ patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%$ HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0937444-1$	$0937444-1$	$Resident was found deceased at approximately 6pm in her apartment$	$Brain bleed$ sleep apnea$ htn$	$Brain bleed$ sleep apnea$ htn$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0938974-1$	$0938974-1$	$Hospice Resident received first Covid 19 vaccine dose on 1/6/21.  1/7/21 resident had decreased appetite noted in am but ate 100% of meal at dinner.  1/9/21 resident had decreased appetite with emesis x 2$ loose BM x 2.  Call placed to hospice.  1/10/21 5:44 am resident able to take HS meds$ ingest 2 cups of shake.  No emesis or loose stool noted.  12PM nurse noted resident not eating meals but ingesting milkshake and medications without any problems.  Hospice contacted for change in condition.  1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN.  Labs to be drawn 1/11/21. Hospice notified POA.  1/11/21 12:24am Resident had blood in stool. Resident denies any pain$ on 2L of O2 for comfort.$	$Hospice$	$$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0939845-1$	$0939845-1$	$Three hours after receiving COVID 19 vaccination$ Patient oxygen level decreased to a  critical level and went into cardiac arrest. Staff performed full code but was unable to bring back patient from  cardiac arrest.$	$No current illness for this event.$	$CHF$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940822-1$	$0940822-1$	$patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse.  An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)$ intramuscular  into the right arm on 07Jan2021 at 0.3 mL$ single for covid-19 immunization.  There was no medical history and no concomitant medications.  On 08Jan2021$ the patient passed away after receiving the COVID vaccine.  The patient died on 08Jan2021.  An autopsy was not performed. Investigations indicate that unspecified labs were done$ but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director$ and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency.  The batch/lot number for the vaccine$ BNT162B2$ was not provided and will be requested during follow-up .; Sender's Comments: Based on the limited information available$ it is medically not possible to make meaningful causality assessment$ it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine$	$No current illness for this event.$	$Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940955-1$	$0940955-1$	$$Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF$ spinal stenosis$ morbid obesity$ epilepsy$ pulmonary hypertension and COVID-19 (Prior to vaccination$ the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone$ melatonin$ venlafaxine hydrochloride (EFFEXOR)$ ibuprofen$ aripiprazole (ABILIFY)$ lisinopril$ cranberry capsules$ diltiazem$ paracetamol (TYLENOL)$ famotidine$ furosemide (LASIX [FUROSEMIDE])$ ipratropium bromide$ salbutamol sulfate (IPRATROPIUM/ALBUTEROL)$ buspirone$ senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF])$ polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin$ propranolol$ quetiapine$ topiramate$ Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination$ the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021$ covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed$ and autopsy remarks was unknown. Autopsy-determined cause of death was unknown.  It was reported as non-serious$ not results in death$ Life threatening$ caused/prolonged hospitalization$ disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity$ diastolic CHF$ epilepsy$ pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However$ based on a close temporal association ($$Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration$ contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination$ the patient was diagnosed with COVID-19); Diastolic heart failure; Epilepsy; Morbid obesity; Pulmonary hypertension; Spinal stenosis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0941215-1$	$0941215-1$	$Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the reporting responsibilities to report that a friend of hers$ informed that the patient passed away on Friday$ and had received the COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time$ if the friend had called to complete a report herself$ regarding the incident. Their conversation was very brief. The patient was 90 years old$ and it was her friend's mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday 06Jan2021$ and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Aortic valve replacement (Verbatim: Aortic valve replacement)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0942040-1$	$0942040-1$	$little bit of a reaction light headed after 5 minutes.   vitals were low$ so observed for 30 minutes after being light headed.  Patient was found unresponsive and pronounced dead later that day.$	$none$	$yes$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0942072-1$	$0942072-1$	$Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age 87. No evidence of acute vaccine reaction.$	$aspiration pneumonia-  completed treatment prior to vaccination.$	$Advanced dementia with severe violent behavioral symptoms. Progressive decline and frailty due to late stage dementia with likely terminal aspiration after completion of treatment for previous aspiration pneumonia. Death attributed to complications of her advanced dementia. No evidence of acute reaction to vaccine (rash$ dyspnea$ swelling$ redness). Chronic kidney disease$ hypothyroidism$ type 2 diabetes$ gout$ B12 deficiency$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0942290-1$	$0942290-1$	$Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB$ increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall$ O2 sats 88-92$ dizzy$ weakness.  Rapid COVID test performed with negative results.  Evening of 8th resident was lethargic and diaphoretic with fever of 99.9.  Resident transferred to ER$ on 5lt of oxygen.  Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice.  Continued with fever$ crackles and N/V and loss of appetite from the 9th and 10th of January.  Resident expired at 820am on 1/11/2021.$	$No current illness for this event.$	$Glaucoma$ Low back pain$ restless leg syndrome$ Osteoporosis$ Compression Fx-Lumbar$Dilaudid; Morphine Sulfate; Sulfonamides; Influenza Virus Vaccines$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944282-1$	$0944282-1$	$resident coded on 09Jan at 8am and expired; This is a spontaneous report from a contactable Other Health Professional. A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ Batch/lot number: EL0140)$ intramuscularly in left arm on 05Jan2021 15:15 at single dose for COVID-19 immunization. Medical history included DM2(Type two diabetes mellitus)$ CHF(congestive heart failure)$ open wound$ wound infection$ heart failure. Allergies to medications$ food$ or other products: none. Concomitant medications included unspecified products (List of any other medications the patient received within 2 weeks of vaccination: yes). If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The resident coded on 09Jan2021 at 8 AM and expired. The patient died on 09Jan2021. An autopsy was not performed. AE resulted in: patient died. Death cause: unknown at this time. Was treatment received for the adverse event: Unknown. Prior to vaccination$ was the patient diagnosed with COVID-19: No. Since the vaccination$ has the patient been tested for COVID-19: No. Serious: Yes. Seriousness criteria-Results in death: Yes. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The old patient had diabetes mellitus$ congestive heart failure$ open wound complicated by infection$ all these pre-existing medical conditions contribute to the patient death.  More information including complete medical history$ concomitant medications and event term details especially death cause and autopsy results are needed for a full assessment of the case.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at 8am and expired$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Congestive heart failure; Heart failure; Open wound; Type 2 diabetes mellitus; Wound infection$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944365-1$	$0944365-1$	$Resident expired on 12/30/20$ dx cardiac arrest.$	$None$	$Schziophrenia$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944998-1$	$0944998-1$	$On 1/11/21  noted with headache$ nausea/vomiting$ severe melaise.  On 1/12/21 resident expired.$	$No current illness for this event.$	$Asthma$ hypothyroidism$ essential hypertension$ atherosclerotic heart disease of native coronary artery$ spinal stenosis$ fibromyalgia$  dementia. Please contact nursing facility for further needed information.$Phenazopyridine$ Demerol$  Pyridium$ Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0945241-1$	$0945241-1$	$71yo female resident who died after receiving Pfizer BioNTech vaccine.  On 1/14/2021$ VS taken at 10am$ B/P 99/60$ O2 sats$ 95% (trach w/O2). At 11:30am$ Patient showed no s/sx of distress$ A&Ox3.  At 11:50am$ a nurse went to perform a COVID test and assessment (the facility is experiencing an outbreak)$ and found the patient unresponsive on the bathroom floor.  CPR was immediately started; no shock advised per AED; 12:15pm EMS arrived and took over.  At 12:38pm$ EMT called time of death.$	$UNK$	$UNK$UNK$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0945247-1$	$0945247-1$	$Has underlying dementia and often with difficulty eating.  1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing.  Comfort measures instituted.  Not sure if this is related to the vaccine$ but thought I should report$	$Nothing acute prior$	$dementia$ hypertension$ depression$ delusions$ anxiety$aricept$ namenda$ penicillin$ actonel$ erythromycin$ niacin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0945253-1$	$0945253-1$	$$83yo female resident who died after receiving Pfizer BioNTech vaccine.  On 1/14/2021$ the patient reportedly got up in the middle of the night with c/o feeling $$blah$$$ restlessness$ and nausea.  VS normal$ no other s/sx. At 4:15am$  the patient was asked to go back to bed$ assisted by a nurse and GNA.  At 6am$ GNA was going to do morning VS and found the patient unresponsive$ no pulse$ no respirations.  GNA notified the nurse. At 6:03am$ CPR started and EMS called.  At 6:15am$ EMS arrived and took over.  At or around 6:30am$ EMT called time of death$$	$UNK$	$UNK$UNK$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0945578-1$	$0945578-1$	$No reactions immediately after vaccine was given. Resident has dementia$ has had multiple hospitalizations related to a renal stone recently. Had a tooth that was bothering her$ went to see her dentist and it was extracted on 1/6/21. On 1/10 they noted feet and ankles are dark purple with white splotches appears to be mottling. Minimally responsive to voice and touch. Not eating. Compassionate visit with family. Family did not want hospice$ did not feel it was needed$ said$ what more could they do for her than you're already doing?  On 1/11 at 1950 was determined to be deceased.$	$Had a tooth extraction done on 1/6/21. Was on amoxicillin for 7 days and it caused diarrhea. Changed to Keflex.$	$Dementia$ COPD$ Type 2 DM$ Atherosclerotic Heart Disease$ Depression$ Hypertensive Heart disease without heart failure GI hemorrhage$ calculus of ureter$ systolic CHF$ Peripheral vascular disease$ GERD$ anxiety.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0945603-1$	$0945603-1$	$Had no immediate issues with the vaccine. He had returned from the hospital on 12/21 and had some concerns about his weight which were shared with his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for a pacemaker check. On 1/8/21 staff were called to his room$ he was on the floor$ bluish skin color. No vital signs found$ no heart rhythm heard at 2200.$	$Hospitalized for abnormal heart rhythm 12/18/20.$	$anemia$ hypothyroidism$ BPH$ paroxysmal atrial fib$ HTN$ atherosclerotic heart disease$ Chronic Kidney dz stage 3$ CHF$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0946959-1$	$0946959-1$	$Sudden death 18 hours post vaccine .$	$Post COVID-19 complications$ A-fib$ CHF$	$Diabetes$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947642-1$	$0947642-1$	$died two days after receiving the vaccine; Fever; This is a spontaneous report from a contactable consumer (patient's stepchild). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)$ via an unspecified route of administration$ on 07Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included an unspecified statin. The patient experienced fever on 08Jan2021. The patient died two days after receiving the vaccine on 09Jan2021$ which was reported as fatal. The clinical course was reported as follows: The patient had a fever the day after getting the vaccine and then he just died in the middle of night. It was reported that it was not clear what exactly happened$ but they are looking into this. The clinical outcome of fever was unknown and of died two days after receiving the vaccine was fatal. The patient died on 09Jan2021. The cause of death was not reported.  An autopsy was not performed (was reported to be taking place soon).  The batch/lot number for the vaccine$ BNT162B2$ was not provided and has been requested during follow up.; Reported Cause(s) of Death: died two days after receiving the vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0948228-1$	$0948228-1$	$Patient reportedly expired the day following receipt of the vaccine.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0949657-1$	$0949657-1$	$Veteran was found by family slumped over and unresponsive  at the breakfast table  on 1/13/21$  had expired$	$No current illness for this event.$	$Atrial fibrillation$ Congestive heart failure$ Anterior ischemic optic neuropathy of right eye$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0949965-1$	$0949965-1$	$Patient 101 years old$ nursing home resident$ received vaccine 1/11$ on 1/13 found on floor without obvious trauma$ unresponsive.  Brought to ED and was bradycardic$ hypotensive$ hypothermic and refractory to aggressive medical management.  No obvious cause of death found on exam or labs$ cxr.  Unknown if event could be related to vaccine or not.  Medical Examiner accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as soon as discovered.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0950441-1$	$0950441-1$	$Pt had witnessed arrest by wife. Pt wife started CPR and called EMS. CPR started at 15:12. Continued by EMS. Pt arrived to medical center asystole with CRP in progress and ventilated via igel device.  He was in refractory ventricular fibrillation and continued CPR for a total of 1 hour.  At that point$ we checked a bedside ultrasound which showed his heart at a standstill.  He was unresponsive to verbal and tactile stimulus and had fixed unreactive pupils.  He was pronounced at 16:13.$	$Chronic systolic heart failure Coronary artery disease involving native coronary artery of native heart without angina pectoris$	$Chronic systolic heart failure Coronary artery disease involving native coronary artery of native heart without angina pectoris lower extremity edema$Walnuts$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0950893-1$	$0950893-1$	$Death$	$Diabetes dementia$ cll$ trigeminal neuralgia$	$Diabetes dementia cll trigeminal neuralgia$Shellfish$ other$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0951519-1$	$0951519-1$	$Narrative: Symptoms: Palpitations & Syncope Treatment: EPINEPHRINE 1 MG ONCE $EPINEPHRINE 1 MG ONCE $SODIUM BICARBONATE 50 ML ONCE$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0952204-1$	$0952204-1$	$Patient became sick 3 hours after the vaccine and was found deceased 1 day after his vaccination. He passed away in his sleep.$	$None: Clean bill of health and a full cardiac exam was performed 2 months prior.$	$None.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0952704-1$	$0952704-1$	$Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021.  Patient sought care twice at  ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room.  1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot$ fever$ Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine$ acute anxiety. Reportable patient symptoms at$ 1st visit : fever$ shaking stomach cramps$ breathing issues.  Medical Center  -- No fever$ confusion and dementia type$ patient would not stay in patient bed; patient would get up and sit down again repeatedly$ agitated and anxious. Attempted to urinated hospital bed.  Patient committed suicide in home.$	$Pneumonia 12/20 not Covid19 related$	$COPD$  Curvature of Spine pressed against lung$  High blood pressure$ Diabetes$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0952799-1$	$0952799-1$	$On 1/17/2021 at 4:35 am resident found apneic and pulseless$ at 4:40am death confirmed$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953183-1$	$0953183-1$	$1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83  O2  to 10 liters.  Resident continued to decline until CTB on 1/14/2021 at 1325$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953452-1$	$0953452-1$	$Letal death; Asystolia; Pulmonary embolism; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB (DE-PEI-PEI2021000071).  An 82-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EJ6797)$ intramuscularly from 30Dec2020 at 0.3 mL$ single for COVID-19 immunization.  Medical history included diabetes and hypertension.  The patient's concomitant medications were not reported. At the time of vaccination there was no evidence of decompensation of the underlying disease. The patient experienced letal death$ asystolia and pulmonary embolism on 31Dec2020$ which were reported as life-threatening and fatal.  The outcome of letal death$ asystolia and pulmonary embolism was fatal.  The patient died on 31Dec2020.  An autopsy was not performed.  The causality assessment for the events$ death$ asystolia and pulmonary embolism to the suspect product was reported as inconsistent causal association.; Reported Cause(s) of Death: Asystolia; Pulmonary embolism; Letal death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Diabetes; Hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953590-1$	$0953590-1$	$resident expired; This is a spontaneous report from a contactable healthcare professional.  An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140)$ intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization.  Medical history included metabolic encephalopathy from$ failure to thrive (FTT)$ diabetes mellitus (DM) 2 $ chronic obstructive pulmonary disease (COPD)$ arthritis$ weakness$ hyperlipidemia$ chronic kidney disease (CKD)$ dementia.  Known allergies was none.  The patient took unspecified concomitant medication.  On 11Jan2021$ the resident expired.  The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021.  There was no treatment given for the event. The patient died on 11Jan2021.  An autopsy was not performed.; Sender's Comments: Lacking information on the cause of patient's demise$ the Company cannot completely exclude a causal relationship between COVID 19 vaccine$ BNT162B2$ and patient's death of unknown cause$ as a cautionary measure and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from$ failure to thrive (FTT)$ diabetes mellitus (DM) 2 $ chronic obstructive pulmonary disease (COPD)$ arthritis$ weakness$ hyperlipidemia$ chronic kidney disease (CKD)$ dementia may have provided the contribution to the event in this 82-year-old male patient.  The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: resident expired$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Arthritis; Chronic kidney disease; COPD; Dementia; Diabetes mellitus; Failure to thrive; Hyperlipidemia; Metabolic encephalopathy; Weakness$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953754-1$	$0953754-1$	$patient suddenly developed pneumonia 7 days after vaccination and died the evening of developing pneumonia$	$No current illness for this event.$	$COVID-19 4/24/2020$ hyperlipidemia$ type 2 diabetes$ generalized idiopathic epilepsy$ chronic gingivitis$ paranoid schizophrenia$ extrapyramidal movements (G25.9)$ BMI 29$ major depressive disorder$ hypertensive heart disease$ GERD$no known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953865-1$	$0953865-1$	$REPORTING ONLY AS RESIDENT EXPIRED ON 1/17/2021 3 DAYS AFTER. S/S HYPOXIA/CONGESTED LUNG SOUNDS$	$NONE$	$HYPOTHYROIDISM$  DEMENTIA$ SCHIZOPHRENIA$  HTN$ DYSPAGIA$ INTELLECTUAL DISABILITIES$ CKD MACULAR DEGENERATION$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0954812-1$	$0954812-1$	$She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine$ she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16$  she awakened and continued to feel at her recent baseline. However$ in the early afternoon$ she complained of  headache$ nausea/epigastric pain$ and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently.  Per her niece$ who has a home O2 sat device$ her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)$	$Unknown$	$non stentable distal occlusive disease$ coronary heart disease$ stroke$ heart failure$ diabetes mellitus$ (cont. p 2)$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0955261-1$	$0955261-1$	$Death$	$Hip fracture$$	$afib$ hyperlipidemia$darvocet$ toradol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0955436-1$	$0955436-1$	$patient received vaccine 12/29. Unexpected death 1/5.$	$CAD s/p CABG$ prior ischemic HFpEF (EF 45% > 50%)$ mild-mod  Mitral Stenosis$  bradycardia s/p PPM$  HTN$  HLD$  DMII (A1C 6.5)$  CKD (baseline Cr 2-2.5)$ GERD$  BPH$  seizure disorder (on keppra)$	$as above$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956365-1$	$0956365-1$	$12/28/2020: generalized weakness and fell twice at home$ cough$ nausea$1/04/2021: cough$ nausea$ fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia$ shortness of breath$ covid postive$ 1/09/2021: pt on bipap$ 1/15/2021: pt was intubated$ on TPN$ pt DNR$ 1/18/2021: was extubated and put on comfort measures and passed away$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956761-1$	$0956761-1$	$Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on 1/14)$ which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He did say that he felt tired$ but he often complained of feeling tired over time.$	$episode of congestive heart failure two months ago requiring hospitalization$	$hypertension$ atrial fibrillation$ congestive heart failure$ prior aortic valve replacement$ permanent pacemaker$ venous insufficiency$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956843-1$	$0956843-1$	$Resident was found deceased in his bed at 7:15 am.$	$No illnesses at time of vaccination or up to one month prior$	$Stage V Chronic Kidney Disease;  Depression; Hypertension; Hyperthyroidism; Anemia; A Fib; Hyperlipidemia; Aortic Aneurysm; Neuropathy; History of Alcohol Abuse; CAD;$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0958914-1$	$0958914-1$	$Death on 1/15/2020$	$No current illness for this event.$	$Alzheimer's$ disorganized schizophrenia$ HTN$ CKD stage 3$ Athritis$ legal blindness$ Dementia$ Major Depression Disorder$ Parkinson's$ GERD$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0959079-1$	$0959079-1$	$On 1/9/2021 observed  with elevated respirations of 38-42 per minute$ BP manually 72/50. pulse is jumping rapidly between 110-16 bpm. oxygen sat 76% RA$ resident refusing oxygen at first attempt$ allowed oxygen to be placed$ is now 84% on 4L. resident shaking head yes that he is hurting$ and yes that he would take medication for pain. Dr. notified$   branch block.  Received order for morphine 2mg per hr as needed for elevated respirations and pain. Dr. also gave orders to D/C Tamsulosin and finasteride.  Resident continue with decreased O2 sats and elevated respirations. Absence of vital signs on 1/10/21 at 826PM.$	$Residents condition was declining over the past several months and has been treated for depression and dementia.  Resident refusing care including meals$ medication and ADL care.$	$Atrial Fibrillation$ obstructive uropathy$ chronic kidney disease$ asthma$ bradycardia$ major depression$ dysphagia$ Parkinson's disease$ dependence on supplemental oxygen$ osteoporosis$ hyperlipidemia$$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0960052-1$	$0960052-1$	$Die 50 hours after vaccination; Especially kidney failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory authority report number DE-PEI-PEI2021000192.   A female patient of 88 years old received bnt162b2 (COMIRNATY$ batch/lot number EJ6797$ expiration date unknown) $ via an unspecified route of administration on 02Jan2021 at single dose for covid-19 immunisation.  Medical history included renal failure from Dec2018 to an unknown date $ Maxillary sinusitis from 2018 and unknown if ongoing $ ongoing reduced general condition $ leukoencephalopathy from 2018 and unknown if ongoing $ ongoing Weakness$ Exsiccosis from 2018 and ongoing $ ongoing Dyspnoea$ ongoing Chronic anaemia$ ongoing renal insufficiency(grade 4)$ ongoing arthrosis multiple$ Ongoing Cardiac disorder$ Carcinoma cervix from an unknown date and unknown if ongoing$ ongoing Chronic pain$ wheelchair dependent.  The patient's concomitant medications were not reported.  On 04Jan2021$ the patient developed die 50 hours after vaccination and especially kidney failure$ lasting for unknown. The patient was dead on 04Jan2021. Death cause was reported as die (unknown cause of death). Injection site showed no abnormalities. Patient had Renal insufficiency grade 4. No suspicion of vaccination complication due to disease course and clinical course. General condition deterioration already before vaccination since Christmas$ bedridden since 1st day before vaccination$ on the day of vaccination lungs were clear$ O2 saturation at 97%. Symptoms shortly before death: Dyspnea$ weakness$ injection site unremarkable. A rapid antigen test was done before vaccination (result: negative). There will be no autopsy$ the family decided against it. The patient died on 04Jan2021. Outcome of especially kidney failure was unknown. An autopsy was not performed. Event Assessment was unclassifiable.; Reported Cause(s) of Death: die 50 hours after vaccination.$	$Arthrosis multiple; Cardiac disorder; Chronic anaemia; Chronic pain; Dyspnoea; Exsiccosis; Reduced general condition; Renal insufficiency (grade 4); Weakness$	$Medical History/Concurrent Conditions: Carcinoma cervix; Leukoencephalopathy; Maxillary sinusitis; Renal failure; Wheelchair user$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0960460-1$	$0960460-1$	$$died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program$ Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)$ via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose for COVID-19 immunization; administered by the nursing home.  Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included: $$used a sav for skin tears$$$ and $$eye drops for glaucoma$$ from an unknown date to an unknown date. On 07Jan2021$ the patient experienced: tested positive for COVID (medically significant). The patient died (death$ medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated that in regard to the patient's height and weight: $$was probably getting down to about five foot eight. Shrinking.$$ The reporter stated that If she remembered correctly$ they were trying to maintain the patient's weight 135 to 136 pounds.    The reporter stated that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died on 17Jan2021. The reporter stated that she $$wanted Pfizer to know that the little old people in the nursing might not be strong enough for the vaccine.$$ The reporter stated that she was $$not calling to complaining.$$   The reporter stated that there was nothing wrong with her dad. He was elderly with no health issues.  $$He was literally on no medications. The only reason he was in the nursing home was because he was afraid to walk.$$ The reporter stated that she received a call about giving the patient the vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine$ the patient tested positive for COVID $$like all the other people$$ (no further details provided). The reporter stated that her dad had no symptoms of COVID. The director of nursing said the patient was doing so well. The patient ate his lunch$ he laid down for nap$ and at 14:30 he was gone. The patient $$went peacefully in his sleep.$$ The reporter then again stated that the patient literally had nothing wrong with him. $$They were shocked. They fed him and he took a nap. He was sleeping$ but it was eternally.$$ The reporter stated that$ $$it might not have been the Pfizer vaccine$ maybe his heart wore out.$$  In regard to an autopsy: the reporter stated that they would get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none.  It was unknown if there were additional vaccines administered on the same date of the Pfizer suspect$ but the reporter doubted it. There were no prior vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event$ died$ was fatal. The clinical outcome of the event$ tested positive for COVID$ was unknown. The patient died on 17Jan2021 due to an unknown cause of death.  An autopsy was not performed.  The batch/lot numbers for the vaccine$ PFIZER-BIONTECH COVID-19 MRNA VACCINE$ were not provided and will be requested during follow up.; Reported Cause(s) of Death: died$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Glaucoma$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0960552-1$	$0960552-1$	$At approximately 930am I arrived at Memory Care.  I met with the director of the facility and she directed me to where my team would be setting up.  My team consisted of (technician)$ (nurse) and I. As we were setting up$ the director asked how she can help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed$ and proceeded to designate her staff and the cafeteria area$ facing the vaccination station$the monitoring station.   Throughout the day$ nurse and I were both vaccinating$while the staff of the facility would monitor the vaccinated patients. I would also stop occasionally to mix the vaccine and check the temperature of the aero safe.   At approximately 12:50pm$ the director rushed in and stated that a patient is not responding$ and that she had been vaccinated. At that point$ I grabbed epipens and a thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we got to the room$ the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the patient has passed. At that point I asked the staff how long ago did the patient get the vaccine$ they stated about 30 minutes ago. They also stated that the patient was a hospice patient and that the patient had declined$ and was rapidly detiorating and had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I then left the room and grabbed the patients COVID Vaccine intake consent form.     I looked at the answered questionaire and all the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was monitoring her for 15 minutes$ the director stated they had staff monitoring her. She also stated the Hospice nurse has to announce her death$ so they waited for the Hospice Nurse to come.  I then called Corporate and explained the situation. After speaking to corporate$ I also asked nurse$ if she remembered the patient. She stated that she did and at the time of the vaccination the patient was not alert$ there were two staff members with the patient. She was non oriented and she kept closing her eyes. At that point$ Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to vaccinate her. Both Staff members stated that it its ok$this is how she is. The Nurse then proceeded to vaccinate.  At approximately 3:10pm$ as I was leaving I spoke to the director$ and one of her Staff members. Staff that the patient has actually not eaten/ or drank anything for the past several days$ including today(01/18/21). Staff also stated that on Friday$ Jan 15th$2021$ they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the clinic.$	$Patient was a hospice patient who was not doing well for several days per nurse. Patient had not eaten or consumed liquids in a few days.$	$Patient was a hospice patient.$No known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0961434-1$	$0961434-1$	$This is a 94-year-old male who is brought in by ambulance after being found on the floor with unknown downtime.  He was in asystole upon EMS arrival.  He remains in asystole.  No advanced airway is in place.  The patient is getting compressions from Lucas device upon arrival.  It was reported that he was last talked to by family at 2 PM.  The patient got his SARS-CoV-2 vaccination this morning.  The patient is evaluated emergently.  CPR was ongoing with 3 rounds of epinephrine given.  The patient remains in asystole.  He has rigor mortis.  The patient's pupils are fixed and dilated.  The patient has compressions paused and ultrasound is used to evaluate for cardiac activity.  None is detected.  The patient has no electrical activity on monitor.  The patient's time of death is 2113.$	$Chronic back pain$	$Cardiovascular  LBBB (left bundle branch block) HTN (hypertension) Pure hypercholesterolemia CAD (coronary artery disease) Acute systolic heart failure (HCC) Atrial fibrillation (HCC) ل Nephrology Stage 3 chronic kidney disease ل Endocrinology Controlled type 2 diabetes mellitus with microalbuminuria$ without long-term current use of insulin (HCC) Amiodarone-induced thyroiditis ل Other BPH (benign prostatic hyperplasia)$No know allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0961776-1$	$0961776-1$	$1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed$ began CPR$ and called 911. 1/14/2021 23:08: Pronounced deceased.$	$None$	$Hypertension$ Type 2 Diabetes$None Known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962307-1$	$0962307-1$	$tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient received vaccine around 11:00 a.m. About two hours later$ he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room$ where he said his legs felt heavy. Soon after$ he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962325-1$	$0962325-1$	$$Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830$ patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife$ patient's only complaint was pain at the injection site. At 1300$ wife states that patient complaint of dizziness which $$dissipated after a few minutes$$ followed by a headache which $$dissipated after a few minutes$$ as well. Then patient complained of nausea$ no vomiting and $$couldn't relax.$$ Per wife$ from around 1400/1500$ patient stayed on his recliner while still having a conversation with her--$$he didn't get up to eat.$$ Last conversation they had was around 2000/2100. Per wife$ at around 2100/2200$ patient was quiet and when she checked on him$ $$he wasn't responding anymore.$$ Wife then called 911$ $$but they couldn't revive him.$$$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962714-1$	$0962714-1$	$We do not believe that the patient's death was an adverse event from the vaccine.  Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction.  Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden.  We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination.$	$Aspiration pneumonia (dx on 12/16/2020)$	$Congestive heart failure$ chronic respiratory failure$ dementia$ chronic mylomonocytic leukemia$ chronic COPD$ coronary artery disease$ dysphagia.$lisinopril$ shellfish$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962764-1$	$0962764-1$	$Patient did not have any adverse reaction to the COVID vaccine$ but we were asked by our health dept to submit a VAERS report since the patient died between his first and second dose.  Received Pfizer Dose #1 12/17/2020. No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction.  Date of death 12/23/2020 from aspiration pneumonia complicated by end-stage heart failure and ischemic cardiomyopathy. Death was anticipated and not sudden.$	$Scrotal edema$ aspiration pneumonia$	$Ischemic cardiomyopathy$ congestive heart failure$ hypertensive heart disease$ type 2 diabetes with diabetic neuropathy$ spinal stenosis with neurogenic claudication$ chronic kidney disease$ atrial fibrillation$ COPD$ venous insufficiency.$lisinopril$ seroquel$ penicillins$ beer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962784-1$	$0962784-1$	$patient expired 1/15/2021; had been treated as outpatient for pneumonia$ likely COVID-19 but no positive test result in December 2020. PMH diabetes$	$PNEUMONIA$	$$LATEX$ NATURAL RUBBER$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0962966-1$	$0962966-1$	$On Saturday$ 1/16/2021$ Patient went to the grocery store.  Upon her return$ she indicated she was experiencing N/V and some throat swelling.  Patient subsequently collapsed and expired before she could be brought to an emergency room.  During  investigation by Coroners Office$ it has been reported that Patient may have gotten some takeout food while she was out.  Labs are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine.$	$No current illness for this event.$	$atrial fibrillation$ hypertension$ and hyperlipidemia$Codeine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964617-1$	$0964617-1$	$Death$ which I believe is unrelated to vaccination$	$Alzheimers$ Covid$ COPD$ Mood disorder$ convulsions$ HTN$ anxiety$ DM$ parkinson's$$	$Alzheimers$ Covid$ COPD$ Mood disorder$ convulsions$ HTN$ anxiety$ DM$ parkinson's$$Codeine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964636-1$	$0964636-1$	$Pt on hospice in facility for severe cardiomyopathy unable to perform interventions received vaccine without adverse sequelae died 5 days later. Reporting as required. Narrative:  Reporting as required patient death 5 days after immunization with Pfizer vaccine. However$ no adverse sequelae were noted to the vaccine in the 15minute observation period$ nor in the days following the immunization related to the vaccine. The patient denied any prior severe reaction to this vaccine or its components$ and the patient gave verbal consent to receive the vaccine. Patient had been in the facility on hospice since 11/18/20 for severe decompensated HF and newly diagnosed cardiomyopathy$ unable to perform interventions$ also LE ischemic wounds with very poor potential to heal due to advanced PVD.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964653-1$	$0964653-1$	$loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well$ on 12/16/2020$ and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination$ with a decreased appetite and some increased fatigue per nursing report$ but no significant changes. He experienced nausea on the evening of 1/6/21$ which was effectively managed$ but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically$ the presentation was most consistent with an aspiration pneumonia.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964671-1$	$0964671-1$	$Death on 1-5-21$	$DM$ HTN$ anemia$ gout$ BPH$ atrial fib$ heart failure$ CAD$ CKD$$	$DM$ HTN$ anemia$ gout$ BPH$ atrial fib$ heart failure$ CAD$ CKD$$NKDA$ NKFA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964724-1$	$0964724-1$	$Death 1-15-21$	$Dementia$ Bipolar$ COPD$ HTN$ Schizoaffective$	$Dementia$ Bipolar$ COPD$ HTN$ Schizoaffective$NKDA$ NKFA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0964795-1$	$0964795-1$	$Symptoms of fever (Tmax 102.9)$ diarrhea$ and altered mental status started ~ 24 hours after vaccination.  No evidence of septicemia with negative blood cultures Minimal improvement over 3 days$ transferred to tertiary care center for MRI brain after which LP was recommended. However family declined as intubation would have been required and was not consistent with patient's goals of care.$	$Metastatic Renal Cell Carcinoma Diagnosed with COVID-19  on 12/7/2020$ unknown severity of disease. Received first Pfizer SARS-COV-2 vaccine at the end of December$	$Insulin dependent Type 2 Diabetes$ CKD3$ atrial fibrillation$ sick sinus syndrome s/p pacemaker on warfarin$ hypertension$ diastolic heart failure$ gastric ulcers$ emphysema$Penicillin- Swelling of tongue and neck$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965548-1$	$0965548-1$	$passed away; This is a spontaneous report from non-contactable consumers received via a Pfizer-sponsored program An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot EL0142) via an unspecified route of administration on 30Dec2020 at a single dose (1 dose) in the left arm (LA) (administered by: senior living) as Covid vaccine. Medical history included patient was 14 plus days post COVID and unresponsive. The patient had no listed allergies. Concomitant medications were not reported. The patient passed away with an hour and half of receiving vaccine on 30Dec2020. Per nursing staff$ they did not expect the patient to make it many more days. She was unresponsive in the room when shot was given. It was unknown if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away$	$No current illness for this event.$	$Medical History/Concurrent Conditions: COVID-19 (patient was 14 plus days post COVID); Unresponsive to stimuli$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965565-1$	$0965565-1$	$Narrative:  Please note that patient is a hospice patient. Death occurred 10 days post vaccination. Providers do not believe that there was a correlation. Facility requires that we reports all death even if we suspect no correlation between death and vaccine.  Symptoms: & death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0966178-1$	$0966178-1$	$Pt called son to let him know he couldn't breath around 2 AM.  Pts son showed up at his house 10 minutes later and ambulance arrived with in 20 minutes at 2:15$	$skin ulcer of lower right leg due to old gun shot wound$	$alcoholism in remission$ aortic stenosis-mild$ arthritis$ blood loss anemia$ carpel tunnel syndrome bilateral$ cellulitis of right leg$ chronic insomnia$ COPD$ diverticulosis of sigmoid and descending colon$ eczema$ gun shot wound of leg$ heart murmur-right upper external border$ hemorrhoids$ history of blood transfusion$ history of falling$ lyme disease$ osteoarthritis of left knee$ pneumonia$ polyp of colon flat$ peripyloric ulcer$ peptic ulcer disease$ sleep apnea$ unspecified essential hypertension$ viral meningitis$aminoglycosides and sulfa meds$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967743-1$	$0967743-1$	$Possible seizer$ unknown at this time$ aprox 1hr and 20min after vac given. Passed away aprox 2hrs after vac.$	$n/A$	$Dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967749-1$	$0967749-1$	$Cardiac Arrest Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0967754-1$	$0967754-1$	$Death - unknown cause$ no reported side effects Narrative: Unknown cause of death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0969220-1$	$0969220-1$	$Patient expired one week after vaccine.  Cause of death unknown to me.$	$No current illness for this event.$	$$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0970976-1$	$0970976-1$	$At approximately 12:15 pm the resident had a brief unresponsive episode that resolved quickly. Her Vital signs were stable and her mentation was at baseline.  Later that evening approximately 10 pm she had labored respirations$ shortness of breath$ lethargy with bilateral crackles$  Oxygen desaturated to 76% on room air$ tachycardia and hypotension. She expired at 6:30 a.m. the following day.$	$Admitted from home to hospital on 1/5 for pancreatitis$ Chocystitis$ GI bleed. HAd a biliary stent placed. TEsted positive for Covid 19 on 1/7/21. Transferred from hospital to a covid recovery Short term facility and transferred to this facility on 1/18/21 for long term care. She was admitted on comfort measures due to prior decline$	$as above.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0971736-1$	$0971736-1$	$Vomit 30 minutes after administration.  approx. 9 hours later$ resident has Stroke-like symptoms.  He was previously on Hospice before admitting to our facility and planned to be readmitted to hospice upon discharge.$	$DISPLACED INTERTROCHANTERIC FRACTURE OF LEFT FEMUR$ SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING (S72.142D)$ MALIGNANT NEOPLASM OF PROSTATE(C61)$ UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE(F03.90)$ ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS(I25.10)$ DISPLACED FRACTURE OF BASE OF NECK OF RIGHT FEMUR$ SUBSEQUENT ENCOUNTER FOR CLOSED FRACTURE WITH ROUTINE HEALING(S72.041D)$ ESSENTIAL (PRIMARY) HYPERTENSION(I10)$ ANEMIA$ UNSPECIFIED(D64.9)$ HYPOKALEMIA(E87.6)$ ST ELEVATION (STEMI) MYOCARDIAL INFARCTION OF UNSPECIFIED SITE(I21.3)$ MAJOR DEPRESSIVE DISORDER$ RECURRENT$ UNSPECIFIED(F33.9)$ HYPERLIPIDEMIA$ UNSPECIFIED(E78.5)$ ALZHEIMER'S DISEASE WITH LATE ONSET(G30.1)$ OTHER ABNORMALITI$	$see #11$terbinafine$ ACE inhibitors$ tetanus toxoids$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0971969-1$	$0971969-1$	$brought by EMS to ED; seizures at home in bed; 6 Epi and 1 bicarb; no hx of seizure$	$No current illness for this event.$	$HTN$ BCC$ HLD$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972092-1$	$0972092-1$	$Reportedly$ this employee's mother died the night of the vaccine.  The details are not known at this time.$	$Diabetes Mellitus$	$Diabetes Mellitus$None reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972782-1$	$0972782-1$	$Resident expired on  1/23/21 . Resident receiving care under  hospice $diagnosis Acute Myeloid Leukemia.$	$Acute Myeloid Leukemia$	$Myelofibrosis Hypertension Generalized Weakness Ulcerative Colitis Lymphadenopathy Diabetes Mellitus Type 2 Mets to Bone$ Lymph node metases$ DVT$Compazine  Trazadone$ Augmentin Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0972836-1$	$0972836-1$	$sudden death$	$no$	$Alzheimer's disease$Levofloxacin$ ACE inhibitors$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0973808-1$	$0973808-1$	$$shortness of breath$ chest xray with pulmonary edema$ periorbital edema Narrative:  73 yo M w/ PMH HTN$ HLD$ EVAR (2013) for AAA c/b persistent type II endoleak s/p multilple repairs (2015 & 2017) c/b glue embolization down into the R CIA secured with additional stent placement with the R iliac limb$ s/p b/l Iliac artery aneurysm stent 08/31/20$ and PTSD. Former smoker$ quit 12+ yrs ago. 11/1/20-11/6/20: Hospitalized for acute on chronic back pain$ found to multiple hypermetabolic lesions in the axial skeleton. Diagnosed with epithelioid angiosarcoma. Patient discharged to facility. 12/17/20: Patient received his 1st COVID-19 vaccine w/o complications at facility. 12/21/20: Underwent cyberknife treatment. 12/31/20: Transferred from facility to ER for new O2 requirement$ SOB$ cough$ chest X ray / pulm edema$ tachycardic and new periorbital edema. 12/31/20: Admitted to ICU before transfer to acute care. 1/1/21: Pulmonary consult$ $$Labs are notable for progressive left shift with bandemia$ markedly elevated inflammatory markers (D-dimer$ ESR$ CRP$ ferritin$ LDH)$ mild elevation in procalcitonin$ mild elevation in lactate that has improved$ and negative viral panel including COVID-19 x2. CT chest is notable for b/l GGOs along with some interstitial infiltrates with an upper and particularly mid zone and perihilar predominance$ septal thickening and crazy paving$ and numerous cystic lesions or pneumatoceles. There is a lack of lobar consolidation and pulmonary nodules. Of note$ PET/CT about 2 months ago only demonstrated some mild to moderate emphysema mostly in the upper lobes. Therefore$ there has been a relatively dramatic change in a few months$ suggesting a more subacute process$ rather than an acute infectious process such as a viral pneumonia$ including COVID-19 infection$ in which the GGOs tend to be subpleural and peripheral. Overall$ our suspicion for COVID-19 is relatively low$ with negative testing x2 yesterday$ negative testing a few weeks ago$ and lack of sick contacts$ but it is possible. Therefore$ higher on the differential is a more subacute infection or chemotherapy-induced pneumonitis. Risk factors include malignancy$ chemotherapy$ and use of steroids (equivalence of about 27 mg of Prednisone in the form of Dexamethasone since 11/6/20 without PJP prophylaxis). These risk factors$ along with consistent imaging and elevated LDH$ make PJP quite likely. Fungal infection is less likely based on imaging. Chemotherapy-induced pneumonitis is a possibility$ especially given the more subacute picture based on imaging. Both Gemcitabine and Docetaxel can cause pneumonitis. However$ the patient has been on steroids$ which is used to treat drug-induced pneumonitis$ although this does not exclude it completely.$$ 1/2/21: Transferred to ICU for worsening hypoxemia as patient reached 40L/100% FIO2 and remained on COVID isolation/COVID patient under investigation per ID recommendation. 1/4/21: Isolation precautions discontinued due to lower suspicion for active COVID infection to explain current presentation 1/6/21: Went into atrial fibrillation w/o RVR overnight 1/6. Tolerating$ with MAPs in low 60s and HR in high 90s/low 100s. Suspect due to being-1L yesterday from diuresis$ lasix stopped. S/p amiodarone bolus + drip$ albumin 5% bolus 1/5/21: Macrocytic anemia NOS w/ slowly worsening H/H s/p PRBC x 1 unit 1/7/21: Per ICU Life-sustaining treatment note$ $$Following discussion w/ patient that his lung dx has been refractory to txt and hasn't improved despite maximal therapy$ patient agreed to transition to hospice after he settles affairs. $$ 1/7/21 Infectious Disease note: $$This is an immunocompromised host due to cancer on active chemotherapy (albeit ANC>4000 on admission) and notably had been on daily PO dexamethasone 1 mg TID (total daily dose 3 mg$ equivalent to 20 mg PO prednisone) since 11/6/20 without any PJP ppx. There was elevated c/f COVID-19 infection in setting of patient's presenting symptoms$ especially in conjunction with b/l GGOs on imaging. Has undergone multiple COVID test that have all resulted negative. Discussed radiographic findings with radiology colleagues$ and overall$ it is difficult to definitively narrow the differential with imaging alone$ but overall density of GGOs seem to appear less likely PJP and more in line with chemical pneumonitis vs COVID$ although less typical for viral pneumonia as well. Given false-negative COVID tests are not unheard of$ especially in the immunocompromised population$ patient was kept on isolation precautions as a PUI for abundance of caution. He is now off precautions. In setting of patient having been on prednisone for some time without PJP ppx$ he was also started on treatment dose TMP/SMX. Beta-d-glucan has returned positive$ and although not the ideal test for PJP$ this can certainly support a potential dx of PJP. Unfortunately$ DFA from sputum was not performed due to insufficient sample and currently the patient is unable to produce an additional sample for testing. He is tolerating the high-dose TMP/SMX; we adjusted the dose to three SS tablets TID based on his somewhat declining UOP. Other fungal etiologies are pending work-up as well. Lastly$ patient's chemotherapy is known to cause pneumonitis$ but per pulmonology team$ he receives prophylactic dexamethasone with his chemo cycles that should help to prevent drug-induced pneumonitis. Remains on the differential for now and this should also be concurrently treated with the steroids he is receiving.$$ 1/10/21: Comfort care initiated. All non-comfort measures were discontinued. Time of death: Jan 10$2021@14:56; immediate cause of death per death note is $$hypoxic respiratory failure$$$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974172-1$	$0974172-1$	$Resident passed away 1/25/2021 at 1048pm after the vaccine was given on 1/24/2021. Resident had been being monitored but death was not expected.$	$COVID-19 diagnosis 12/29/2020$  pneumonia$ CHF$ depression$  rheumatoid arthritis and anemia.$	$CHF$ acute on chronic anemia$ pulmonary hypertension$ chronic pain$ chronic kidney disease stage 3$$lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974422-1$	$0974422-1$	$Patient developed fever to 102 within 24 hours with decreased mentation.  Stopped eating/drinking despite aggressively treating fever.  Was DNR B status.  Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts.   Family wanted only comfort measures with no transfer to hospital.  Patient continued to have fevers to 102-103 range. Patient passed on 1/23 .  Patient did test positive for COVID in early September without significant illness.  She was in usual state of health prior to vaccination.$	$none$	$dementia with behaviors$ GERD.  H/o HTN  and diabetes in past$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974489-1$	$0974489-1$	$No immediate symptoms.  No symptoms ever reported.  Patient was found dead in her home on 1/25/2021 and last seen on 1/24/2021. Neighbor called for welfare check because they had not seen her and she had not checked mailbox. No evidence of foul play.$	$Asthma$ COPD exacerbation.$	$Essential hypertension$ dyslipidemia$ allergic rhinitis$ COPD$ brain aneurysm$ hiatal hernia$ tobacco abuse$ hyponatremia$ normochromic$ normocytic anemia$ hx of MI$ anxiety$ intractable pain.$Clarithromycin$ cefaclor$ ciprofloxacin$ codeine$ erythromycin$ penicillins$ tramadol$ naproxen.  All of these cause shortness of breath.  Generic lisinopril-HCTZ caused severe headache and nausea.  Statins cause joint pain and stiffness$ couldn't walk.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0974855-1$	$0974855-1$	$decedent had shortness of breath and hypoxia$ cardiac arrested in front of the EMS crew$ ACLS initiated$ arrived in the  Hospital ED asystole and pronounced dead$	$hypothyroid$ hypertension$	$same$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975206-1$	$0975206-1$	$1 fall after first dose on 1/8/2021 at 1930; no injuries; 4 falls after second dose on 1/14/21 at 1545$ 1/15/21 at 1700$ 1/21/21/at 1220 and 1/21/21 at 1330 all falls with no injuries. Started Ceftriaxone 1 GM IM daily for 5 dyas on 1/21/21 for UTI: E. Coli$	$11/30/2020 positive for Covid-19$	$Alzheimer's Dementio; Esential hypertension; major depressive disorder$ recurrent; osteoarthritis bilateral knees; Hyperlipidemia; specified diorders of thyroid; Vit D deficiency; Impulse control disorder; Unspecified dementia with behavioral disturbance; Hypertensive retinopathy; unspecified abnormalities of gait and mobility; feeding difficulties; other dysphagia.$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975382-1$	$0975382-1$	$01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises$ with some compliance$ continues ABT/pneumonia $ no s/s adverse  1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.$	$Anemia$ Dementia$ COPD$	$Anemia$ Dementia$ COPD$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975434-1$	$0975434-1$	$$vomiting x3 1/8/21 1/9/21 00:34 - called to resident room by CNAs$ staff stated resident was $$different$$. Vitals taken and 02 sat was low$ O2 in room and applied via NC @3L$ O2 sat returned to 98 and all other vitals WNL including BS. Resident asked how he felt$ stated he felt $$okay$$. Resident exhibiting some shakey movements and clearing throat$ states he does not have any phlegm or drainage or trouble swallowing. MD called and updated on situation$ voicemail left. 1/9/21 11am-  resident has been making a $$growling$$ noise this shift. resident also has tremors. resident alert and answers questions appropriately. when asked if resident wants to go to hospital$ resident firmly states $$no$$. vitals wnl. no emesis noted. will continue to monitor resident. 1/9/21 12p-  resident not answering questions appropriately. resident only answering yes or no. resident cannot tell me name$ or the year$ resident cannot state where he is currently or birthdate.$$	$OTHER INJURY OF UNSPECIFIED BODY REGION$ SUBSEQUENT ENCOUNTER $ LOCAL INFECTION OF THE SKIN AND SUBCUTANEOUS TISSUE$ UNSPECIFIED $ CELLULITIS OF LEFT LOWER LIMB$ CELLULITIS OF RIGHT LOWER LIMB $ END STAGE RENAL DISEASE  $ DEPENDENCE ON RENAL DIALYSIS  $  TYPE 2 DIABETES MELLITUS WITH DIABETIC CHRONIC KIDNEY DISEASE$UNSTEADINESS ON FEET  $ CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH (ACUTE) EXACERBATION$ DIFFICULTY IN WALKING$ NOT ELSEWHERE CLASSIFIED  $ MUSCLE WASTING AND ATROPHY$ NOT ELSEWHERE CLASSIFIED$ UNSPECIFIED SITE  $ COGNITIVE COMMUNICATION DEFICIT$ REPEATED FALLS$ OTHER LACK OF COORDINATION$ SPINAL STENOSIS$ LUMBAR REGION WITH NEUROGENIC CLAUDICATION$ ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS$ $	$listed in Item 11$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0975952-1$	$0975952-1$	$Narrative:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0976032-1$	$0976032-1$	$Patient stated he wasn't feeling well on January 25$ 2021$ wasn't eating and complained of abdominal pain.  Patient noted to have indigestion and was constipated.  Meds provided and labs ordered.  On morning of January 26$ 2021$ patient became weak$ lethargic and hypoxic and was sent to emergency department around 0700 hours on January 26$ 2021.  At approximately 1100 hours$ emergency physician notified this writer that patient was not going to overcome his illness and would be placed on comfort care.  At approximately 1130 hours$ this writer was notified that patient had passed away from multi-organ failure.$	$CHF exacerbation in November 2020$	$CHF$ CAD w/CABG$ Pacemaker$ CKD IV$ HTN$ Hyperlipidemia$ Hypothyroidism$ Osteoarthritis$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0976111-1$	$0976111-1$	$$CC:full arrest HPI:HPI and ROS limited due to patient's condition. History is via EMS$ medical record$ and son.  Per Son patient had Covid vaccine on Saturday morning. Slept all day Sunday. Woke up Sunday night a bit $$like coming out of a deep sleep per son$ around 10 pm. Shortly after that patient was having a hard time breathing. Emergency called. Arrested around the time EMS arrived. King airway$ I/O and CPR initiated. Patient has been in v fib. Was shocked multiple times$ given 4 rounds of epi$ bicarb and amiodarone. ACLS continued on arrival. Multiple rounds of epi$ and attempted defib. Patient given epi$ bicarb. Rhythms included fine v fib$ asystole$ and PEA.  Unrecoverable with no cardiac motion. Time of death 11:50 pm.$$	$Pt admitted with closed-loop bowel obstruction with subsequent surgery for ex-lap$ SBR ~160cm jejunem and ileum$ left with open abdomen with Abthera wound vac 12/22. Now s/p Exploratory laparotomy$ primary stapled small bowel anastomosis$ abdominal fascial and skin closure on 12/24.$	$Neurology Myalgia Secondary hypothyroidism ل Cardiovascular  Coronary atherosclerosis of native coronary artery Postsurgical aortocoronary bypass status Chronic atrial fibrillation (HCC) Aortic insufficiency RBBB Essential hypertension$ benign Pure hypercholesterolemia Bradycardia Typical atrial flutter (HCC) Severe aortic stenosis History of acute anterolateral myocardial infarction Thoracic aortic aneurysm without rupture (HCC) Ischemic cardiomyopathy Coronary artery disease involving autologous vein coronary bypass graft without angina pectoris Acute on chronic systolic heart failure (HCC) Acute on chronic systolic (congestive) heart failure (HCC) Chronic systolic congestive heart failure (HCC) ل Gastrointestinal Malnutrition of moderate degree (HCC) ل Nephrology BPH with obstruction/lower urinary tract symptoms Stage 3 chronic kidney disease (HCC) ل Endocrinology Acquired hypothyroidism ل Genetics/Metabolics Chronic gout of ankle ل Ophthalmology Nuclear sclerotic cataract of right eye Pseudophakia of left eye Exudative age-related macular degeneration of left eye with active choroidal neovascularization (HCC) Ocular trauma of right eye ل Rheumatology Primary localized osteoarthrosis$ pelvic region and thigh ل Musculoskeletal Left leg swelling ل Psychiatry Delirium ل Other Statin intolerance Transient global amnesia CVA$ لPossible lacunar infarct right cerebellar Long term current use of anticoagulant therapy$Statins (muscle weakness)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0977963-1$	$0977963-1$	$(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home.$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0978199-1$	$0978199-1$	$Arm hurting used his oxygen at time of bed appeared vomited.$	$Heart disease$	$Sleep apnea$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0978754-1$	$0978754-1$	$No symptoms appeared immediately after vaccination$ although patient passed away around 6:00 pm unexpectedly. Staff talked with her last time at 5:30 pm and then found her at 6:00 pm passed away.  Unknown at this time if death is directly related to receiving the vaccine.$	$Hospice client Some diarrhea with colostomy bag in place general decline$	$Hypertension$ Dyspnea$ Primary Pulmonary hypertension$ Muscle weakness$ pulmonary fibrosis$ intraductal carcinoma breast$ dizziness$Fosamax$ Codeine derivatives$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979155-1$	$0979155-1$	$Jan 3 vaccine administered$ jan 4 started headaches$ vomiting$ pain in the back of the neck$ Headaches$ chills$ loss of speech$$	$No current illness for this event.$	$Heart Disease$ Polyneuropathy$ Anemia and chronic Kidney disease$ Type 2 Diabetes$ hypotension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979255-1$	$0979255-1$	$Patient received COVID 19 vaccine the morning of 1/18/21 at Public Health COVID-19 vaccine clinic. I (person completing this report) work for PH. Later that night while in bed$ patient reported difficulty breathing to his wife$ then turned blue$ and became unresponsive. Family report pt was without any symptoms prior to event.  911 called; CPR started by family member 15 min. after pt became unresponsive. EMS performed resuscitation for about 30-40 minutes with multiple defibrillation for V-fib.  Between EMS and Medical Center ER$ pt had 9 rounds of epi$ CPR w/ LUCAS  machine$ given 2 doses of amiodarone (150 mg and 300 mg). Patient had 3 EKGs$ which did not show STEMI$ but did show nonspecific conduction delay and sinus arrest with junctional escape vs sinus bradycardia (HR 50's).  Pt had return of spontaneous circulation. Pt intubated$ and started on Levophed. Pt transferred to ICU$ and had central line placed.  Family decided to make patient DNR. Pt went into coarse VFib again$ and as per wishes of family$ code blue not called.  Patient expired at 01:53 on 1/19/21.$	$unknown; family report pt without symptoms prior to event$	$hx of gastric bypass; s/p CABG 3 years ago$ HTN$ HLD$ morbid obesity$none; + bee allergy listed in records$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979818-1$	$0979818-1$	$Patient arrived at ER with complaints of CPR in progress. Per EMS$ patient became short of breath while performing yard work on 1/26/2021. At arrival$ patient was in fine v fib with a total of 6 shocks delivered along with 300 mg amiodarone followed by 150 mg amiodarone$ 1 amp epinephrine and 2 epinephrine drips adminstered en route to ED.  CPR initiated at 1755 and EMS reports asystole at 1829.  TOD 1909 pronounced by ED DO Dx: Cardiac arrest$	$Malignant neoplasm of colon dx Stage IIB in 2018. Surgery in 2018 to remove mass  Inguinal hernia (rt)  CT follow up in 12/2020 r/t above found no evidence of metastatic disease in abdomen or pelvis$ inguinal hernia still present.  Distension in abdomen reported in 11/2020 through 12/2020 at office visit$	$Malignant neoplasm of colon dx Stage IIB in 2018. Surgery in 2018 to remove mass  Inguinal hernia (rt)  CT follow up in 12/2020 r/t above found no evidence of metastatic disease in abdomen or pelvis$ inguinal hernia still present.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979837-1$	$0979837-1$	$Per EMS$ the patient was last seen walking and talking to wife 10 minutes prior to EMS arrival. EMS reports via patients wife$ that patient was upstairs to change for his doctor appointment then patient's wife found him down. The patient received his COVID-19 vaccine on 1/25/21. EMS states they gave 5 rounds of EPI then patient moved into vfib then was shocked once but returned to asystole. In ED$ the patient initially in asystole CPR was started immediately. The patient was given 3 rounds EPI$ 1 round bicarb. The patient stayed in PEA throughout. Patient was given tPA. Patient continued to be in asystole and time of death was called at 11:35 am.$	$History of benign prostatic hyperplasia$ hypertension$ urinary tract infection$ cerebrovascular accident. 1/25/21 Brought to Hospital ED by EMS from Health District for near syncope and hypotension post Pfizer vaccine administration. 1/27/21 Brought to  Hospital ED by EMS from home after wife found.$	$History of benign prostatic hyperplasia$ hypertension$ cerebrovascular accident.$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0979926-1$	$0979926-1$	$Pt began experiencing shortness of breath 3 days after vaccine and expired later that day.$	$Pt was on hospice in LTCF at time of death$ but expired 3 days after receiving vaccine. She exhibited shortness of breath the morning of death.  12/7-12/17 covid positive but seemed to be recovering HTN Alzheimer?s$	$HTN Health Conditions$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0980107-1$	$0980107-1$	$Patient noted to have a change in status at 11:23PM that night. Her oxygen saturation had dropped from normal on room air to 82% and required oxygen. She was also noted to be lethargic with altered mental status and not responding verbally. She then began to mottle. Her oxygen saturation worsened to 51% on 4Liters of oxygen by the next day and she expired on 1/14/21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0982417-1$	$0982417-1$	$Resident tested positive for COVID on 1/7/2021.$	$This person had been on HOSPICE for Failure to Thrive since November 2019. She was treated for weight loss with nutritional supplements and served meals of her choice. She had noted increase in sleep in weeks prior to death$ but would have times she wanted out of bed for meals and to attend some activity.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983169-1$	$0983169-1$	$Client received the COVID-19 vaccine on 1/5/21 by the Vaccine clinic.  Plans were for Hospice services.  Client tested positive for COVID-19 by rapid testing on 1/8/21.  On 1/10/21 at 0900 Client was unresponsive and without vital signs.  Orders were for DNR$ and CPR was not initiated.$	$COVID-19$	$Alzheimer's Disease$ Dysphagia$ AAA$ PVD$ Neuropathy$ RLS$ Hypothyroidism HTN$ GERD$Olanzapine$ Risperidone$ Aggrenox$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983173-1$	$0983173-1$	$Client recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Client tested positive for COVID-19 by rapid testing on 1/21/21$ with c/o hurting all over and loose stools.  She became non-verbal on 1/23/21 with poor intake.   On 1/24/21 at 0537 Client was unresponsive and without vital signs.  Orders were for DNR$ and CPR was not initiated.$	$COVID-19$	$Alzheimer's Disease$ Anemia$ DM type 2$ Hyperlipidemia$ HTN$ GERD$Avandia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983184-1$	$0983184-1$	$Patient has been under Hospice services for almost a year.  She began to demonstrate a large amount of oral secretions on 1/10/21 at 2130.  She was suctioned and a Rapid COVID-19 test was performed$ which was negative.  The COVID-19 Rapid test was repeated on 1/11/21 and was positive.  Oxygen saturation was noted to be 78% on 1/12/21$ and oxygen was initiated at 1133 at 3L per nasal cannula.  Oxygen was increased to 4L at 1635 d/t shortness of breath.  On 1/15/21 @ 0645 patient was unresponsive and without vital signs.  Orders were for DNR and CPR was not initiated.$	$COVID-19$	$Alzheimer's Disease$ Dysphagia$ Anxiety$ Ischemic Heart Disease$ Hypertension$ Hypercholesterolemia$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983187-1$	$0983187-1$	$Client tested positive for COVID-19 by rapid test on 1/8/21.  On 1/9/21 at 1405 his oxygen saturation dropped to 86% and oxygen was initiated at 2L per nasal cannula.  A non-productive cough was noted on 1/10/21 and oxygen was increased to 3L.  On 1/12/21 Client became non-responsive with 30 second periods of apnea.  Dexamethasone was initiated on 1/13/21.  Lung sounds were noted with crackles on 1/15/21 at 1158 and at 2120 Client was unresponsive and without vital signs.  Orders were for DNR and CPR was not initiated.$	$COVID-19$	$Alzheimer's Disease$ Dysphagia$ Encephalopathy$ Syndrome of Inappropriate Secretion of Antidiuretic hormone$Risperidone$ Memantine$ Haldol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983189-1$	$0983189-1$	$Patient tested positive for COVID-19 by rapid test on 1/6/21.  She began to demonstrate a dry cough on 1/11/21.  On 1/12/21 at 1723 her oxygen saturation dropped to 79% and oxygen was applied at 4L per nasal cannula.  On 1/19/21 at 2130 Patient was unresponsive and without vital signs.  Orders were for DNR and CPR was not initiated.$	$COVID-19$	$ASHD$ Hyperlipidemia$ Hypertension$ Dementia$ Anxiety$ Dysphagia$Fosomax$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983192-1$	$0983192-1$	$Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21.  She demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was initiated on 1/7/21.  Oxygen saturation was initiated on 1/12/21 at 4L per nasal cannula.  for shortness of breath.  On 1/22/21 at 0310 Patient was unresponsive and without vital signs.  Orders were for DNR and CPR was not initiated.$	$COVID-19$	$Alzheimer's Disease$ Dysphagia$ Dementia$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0983193-1$	$0983193-1$	$Patient began to demonstrate a cough the evening of 1/5/2021$ after receiving the COVID-19 vaccine earlier in the afternoon. A rapid COVID-19 test was performed and was positive. She began to demonstrate shortness of breath with exertion on 1/7/21$ and lethargy on 1/12/21. Appetite and oral intake began to decline on 1/12/21$ and Oxygen saturation dropped on 1/16/21 to 82%$ and oxygen was initiated at 3L per nasal cannula. On 1/19/21 at 0414 patient was unresponsive and without vital signs. Orders were for DNR$ and CPR was not initiated.$	$COVID-19$	$Dementia$ Atrial Fibrillation$ Hypothyroidism$ Dysphagia$Atorvastatin$ Donepezil$ Corticosteroids$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0985449-1$	$0985449-1$	$Patient was an 87 y/o female admitted for septic shock. She was started on and eventually maxed on 3 pressors. CT abd showed colonic obstruction with dilatation of large and small bowel. Patient was made DNR in the ED. Palliative care consulted on case. Family opted for comfort care.  Patient was asystole on monitor. No spontaneous breath/cardiac sounds ausculted. Patient did not withdraw to pain. Pupils fixed and dilated. She was pronounced and 1230 on 1/28/21$	$colonic obstruction with dilatation of large and small bowel$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0985451-1$	$0985451-1$	$COVID-19 + 1/11/2021$ EXPIRED ON 1-24-2021$	$No current illness for this event.$	$VASCULAR DEMENTIA  HEART FAILURE BULLOUS PEMPHIGOID$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0985501-1$	$0985501-1$	$family states seemed short of breath since after the covid vaccine.  Staff said beginning on 1/22/21 the patient seemed sluggish$ more tired$ and nausea noted.  She stayed in her room more after the vaccine because worried about giving/getting COVID to others.  was talking on the phone at 11:30 PM on 1/26/21 to staff person about temperature of room.  at 12:15 AM on 1/27/21 staff noted not breathing$ started CPR and called EMS.  When EMS arrived they stopped the code because she was too long deceased.$	$none$	$hypertension$ hyperlipidemia$ hyperthyroidism$ thyroid nodules$ constipation$ osteopenia$ insomnia$ incontinence$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986063-1$	$0986063-1$	$Resident was vaccinated on 1/13/21.  Resident passed away on 1/16/21$	$COPD$ CHF$ Major Depressive Disorder$ Anxiety$ Respiratory Failure$ Insomnia$ OsteoArthritis$ Hypertension$ Irritable Bowel Syndrome$ Atrial Fibrillation$ COVID recovered$	$Resident was a Hospice Patient as of: 11/17/2020$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986200-1$	$0986200-1$	$Death$	$None.$	$Uncontrolled DMII and HTN.$NKA.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986773-1$	$0986773-1$	$Resident was vaccinated on 12/31/20. Then on 1/14/21 he tested positive for SARS-CoV-2 on routine surveillance PCR testing.  Another resident on the same hall was COVID positive on 1/11/21.  Results of the PCR test were obtained on 1/16/21.  He appeared asymptomatic at that time. Given his COVID positive status$ all aerosol generating procedures had to be stopped. Overnight on 1/16/21 into 1/17/21$ he had the onset of acute respiratory failure and was transported to the hospital. Per notes$ he was put on BiPAP for several hours$ but his CO2 level did not improve. Per prior advance directives completed with the resident and his two brothers$ he had DNR/DNI orders.  The hospital physician spoke with his brother and the decision was made to  move to comfort care. He was discharged to inpatient hospice and died around 4pm on 1/18/21. This outcome does not appear to be vaccine-related$ but death from COVID-19 infection is listed as a reportable event following COVID-19 vaccination.$	$Intermittent episodes of acute on chronic worsening of multi-factorial chronic respiratory failure with clear goals established through advance care planning. Overall$ was stable in the month prior to vaccination.$	$1. Status post TBI as a young child resulting in a cerebral palsy like syndrome w/ ID and spastic quadriparesis$ R>L 2. Seizure disorder 3. OBS/Psychiatric disorder with bipolar aspects and psychosis$ better on Lithium. Symptoms well-controlled on Paxil$ Risperdal and Lithium. 4. Asthmatic bronchitis w/ poor baseline respiratory function (chronic respiratory failure) and chronic cough$ stable on regimen of inhaled budesonide$ Duonebs and VEST therapy. 5. Complex Sleep apnea$ controlled with Bi-PAP 6. GERD$ stable on daily PPI. 7. Hypertension$ controlled with spironolactone and terazosin. 8. CHF?$ stable on spironolactone. Unable to get more records.  9. Hypothyroidism$ stable on levothyroxine.  10. Dysphagia with Recurrent Aspiration (Does not want a Peg tube). Stable on puree diet and thickend liquids.$Quinolones$ Latex$ Natural rubber$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986869-1$	$0986869-1$	$Patient noted with respiratory distress on 1/10/2021$ transferred to hospital via 911.$	$Pembro associated pneumonitis and nuronal inflammation$ Candida Esophagitis$	$HTN$ MVP/Mod MR$ Prior Renal Ca s/p R nephrectomy$ Active Lung Ca (Prior lobectomy/SRT on pembrolizumab)$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986948-1$	$0986948-1$	$Cardiac arrest on 1/24/21 in the early morning hours then passed away on 1/25/21 around 1:51am in the hospital$	$alcoholic cirrhosis$ thrombocytopenia$ anemia$ lymphedema$	$hypertension$ hypothyroid$ rheumatoid arthritis$ depression$ GERD$acetaminophen$ atorvastatin$ belsomra$ benadryl$ benzoin$ cefazolin$ cephalosporins$ codeine$ cymbalta$ darvocet$ dilaudid$ duragesic$ floxin$ guaifenesin$ hydrocodone$ indocin$ lovenox$ morphine$ nafcillin$ oxycodone$ paxil$ sudafed$ sulfa$ vancomycin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987126-1$	$0987126-1$	$Patient died. Patient had been declining in health rapidly prior to receiving the vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987469-1$	$0987469-1$	$emesis bright yellow in color$ liquid BM$ increased respirations$	$was being treated with antibiotic prednisone for hand swelling day prior$	$history of bowel obstructions and diverticulosis$ AFIB$ Dementia$  PANCYTOPENIA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987533-1$	$0987533-1$	$The patient was observed to be lethargic on 1/29/21 at 1515. BP-80/50$ P-75$ RR-27$ T-100.1. He was given a bolus of  NS 150 mlx2. and Rocephin 1 gram IM.$	$See item 12$	$COPD$  CHF$ DM$ Asthma$ HTN$ Dementia$ Depression$ GERD$ Parkinson$Dexamethasone$ Versed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987636-1$	$0987636-1$	$Legs started swelling and shortness of breath Thursday January 21 2021 Was rushed to hospital with kidney failure and fluid build up around lungs and entire body Blood pressure dropped and had multiple organ failure$	$Diabetes$	$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0987663-1$	$0987663-1$	$Died$	$None$	$For a year he had a catheter as part of treatment of a prostrate issue without surgery.$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0988246-1$	$0988246-1$	$$Narrative:  See $$Other Relevant History$$ in Section 6 above Symptoms:  ElevatedLiverEnzymes & death$ pneumonia$ afib Treatment:$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0989015-1$	$0989015-1$	$Myocardial Infarction$	$No current illness for this event.$	$End Stage Renal Disease$ NON ST Elevation (NSTEM) Myocardial Infarction$$ Type II Diabetes Mellitus$ Cardiac Arrest cause unspecified$ Paroxysmal atrial fibrillation$ acute embolism and thrombosis of unspecified deep veins of right lower extremity$ Alzheimer's disease$ Chronis systolic heart failure$$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0993828-1$	$0993828-1$	$$Heart stopped; Could not swallow; This is a spontaneous report from a contactable nurse (patient's wife). An 85-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)$ via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization.  Medical history included blood pressure abnormal (verbatim: blood pressure) from an unknown date and unknown if ongoing$ neuropathy from an unknown date and unknown if ongoing$ weight issue from an unknown date and unknown if ongoing$ diabetes from an unknown date and unknown if ongoing$ walker user from an unknown date and unknown if ongoing.  Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes from an unspecified date to an unspecified date; and he was taking a long acting one as well. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates ($$had flu shots before with no reactions and everything$ nothing before$$). On 24Jan2021$ the patient's heart stopped (death$ medically significant)$ and could not swallow (medically significant).  The clinical course was reported as follows: The patient's wife stated the patient was taking insulin aspart (NOVOLOG) and he was taking a long acting one as well. The reporter$ the patient's wife and a retired registered nurse (RN) stated$ her husband (patient) just died and she thought he died from the COVID vaccine (later clarified the reason of death was-heart stopped). The patient had the vaccine on 21Jan2021$ which was on a Thursday$ and he was fine. On the following Sunday around 1:30 (on 24Jan2021)$ the patient was feeling a little weak$ however$ the patient's wife thought maybe his blood sugar was low. The patient's wife checked$ and the patient's blood sugar was 91. The patient's wife went to get some yogurt to feed him in order to get his blood sugar up a little; $$which was a normal thing for him$ it was not that low for him.$$ Then$ suddenly$ the patient fell$ and the patient's wife could not get a pulse or anything. The patient's wife called an unspecified number and she started compressions; however$ he was dead. The patient's wife stated the patient just had his heart test$ a three hour long one$ and it was $$perfect three weeks ago.$$ The patient had just gone to the doctor the other day and his blood pressure was $$fine and everything.$$ The patient's wife stated that other than his diabetes$ $$which he had for (sentence incomplete).$$ Regarding lab tests$ the patient's wife stated$ $$No$ he had it before but not in the last two weeks. He was going for one because we just went to the doctor last week and he was going to call yesterday to make the appointment request to get his blood work done. Blood work has been good except his A1C was always high$ but other than that everything was good$$ (as reported). Regarding causality$ the patient's wife stated$ $$I do$ because he was fine until about half an hour before he died. He said to me$ I feel a little weak today and then I was talking to him that your upper body strength is really good and then I said$ we just have to work on your weight a little more because he did have neuropathy. And then$ I went out of the room and all of a sudden I just heard him fall and that is when I just went in to check his blood sugar and it was 91 and I got him yogurt and he started eating that and then that was it$ he started spitting it out and he said$ I could not swallow and that was it$ he just died.$$  The patient's wife further added$ $$I just wanted other people to know that things like this happen and I am sure it was from that because he was healthy as could be. He was walking with his walker$ the day before outside and he felt fine.$$ The clinical outcome of the event$ heart stopped$ was fatal. The clinical outcome of the event$ could not swallow$ was unknown. The patient died on 24Jan2021 due to $$heart stopped.$$  An autopsy was not performed.  The batch/lot numbers for the vaccine$ PFIZER-BIONTECH COVID-19 MRNA VACCINE$ were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart stopped$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Blood pressure abnormal (Verbatim: Blood pressure); Diabetes; Neuropathy; Walker user; Weight abnormal$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0993998-1$	$0993998-1$	$passed away; cough; This is a spontaneous report from a contactable consumer$ the patient's daughter.  A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)$ via an unspecified route of administration in the left arm on 13Jan2021 at 11:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization.   Ongoing medical history included nursing home resident$ admitted to hospice on 13Jan2021 (prior to vaccination)$ and oxygen supplementation (due to low oxygen levels) from a few days prior to the vaccine (Jan2021). Other relevant medical history included congestive heart failure from Dec2020 and sulfa allergy. Prior to the vaccination$ the patient was tested numerous times (as reported) for COVID-19 and was negative.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. A few days before the vaccination$ her oxygen level had gone down$ and she had been placed on oxygen. Prior to receiving the vaccine$ the patient was reported as being 'fine'. On 13Jan2021$ the patient received the vaccine at 11:00. The patient coughed maybe 5 or 6 times and then dropped her head. Resuscitation was not performed as patient had a do not resuscitate (DNR) order. The patient passed away on 13Jan2021 at 13:05. The cause of death was not reported. An autopsy was not performed. The clinical outcome of the cough was unknown at the time of death.     The lot number for the vaccine$ BNT162B2$ was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away$	$Hospice care (prior to vaccination); Living in nursing home; Oxygen supplementation (few days before vaccine was given oxygen level was low and started on oxygen)$	$Medical History/Concurrent Conditions: Congestive heart failure; Sulfonamide allergy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$1011983-1$	$1011983-1$	$$Narrative:  See $$Other Relevant History$$ in Section 6 above Other Relevant Hx:  76yo man with a history of for C5 tetraplegia 2/2 cervical stenosis leading to neurogenic bowel/bladder (chronic suprapubic catheter) and chronic respiratory failure with tracheostomy$ severe dysphagia s/p G tube placement and multiple aspiration pneumonias$ COPD GOLD III$ hx MRSA bacteremia (7/2018) and E coli bacteremia (12/2019). Patient transferred from Spinal Cord Injury until to ICU on 1/11/2021 due to worsneing dyspnea$ hypoxia (80s) and tachycardia and was found to have acute hypoxic respiratory failure likely 2/2 multifocal pneumonia. CXR findings of $$There is interval increase in patchy airspace infiltrates and consolidation in bilateral lungs concerning for pneumonia$$ Patient was started on vancomycin and pip/tazo on 1/11 and tracheal aspirate cultures were obtained for VAP diagnosis which ultimately grew Serratia liquifaciens and Proteus mirabilis. Infectious Diseases was consulted who recommended a switch to ertapenem therapy for a total 10 day course for VAP. UCx/BCx remained negative. On 1/20$ a therapeutic bronchoscopy was completed with cultures growing Stenotrophomonas maltophilia and pan-S Klebsiella pneumoniae. The following day a chest tube was inserted and the course of ertapenem completed but vancomycin was continued. By 1/22$ patient developed shock liver with ALT/AST 2135/1579 from normal range the day prior and SCr increased to 1.3 from baseline 0.7/cystatin C of 2.46 up from 1.15. Levofloxacin was added for Stenotrophomonas coverage. By 1/25$ patient's clinical status continued to decline and Cardiology was consulted for new onset Afib with RVR. Discussion was documented with patient's family who requested DNR. Patient passed away in the early AM on 1/26. Demise does not appear to be related to COVID-19 vaccination but occurred in recent timeframe.   Symptoms:  ElevatedLiverEnzymes & death$ pneumonia$ afib$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0991622-1$	$0991622-1$	$Death$	$Cerebral Infarction due to embolism Crohn's Disease Gastric Reflux Hyperlipidemia HTN SENILE DEGENERATION OF BRAIN$ NOT ELSEWHERE CLASSIFIED PRIMARY GENERALIZED (OSTEO)ARTHRITIS$	$See Item 11$Adhesive Tape (intolerance) Procaine (intolerance)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992209-1$	$0992209-1$	$Death$	$Hyperlipidemia$	$Hyperlipidemia$NKDA$ NKFA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0992599-1$	$0992599-1$	$right arm redness$	$COVID-19 POSITIVE 12/14/20$	$COPD$ DM TYPE 2$ CHF$ GERD$ HYPERTENSION$ HYPERLIPIDEMIA$Ciprofloxacin$ Codeine$ Bactrim$ Lactose Intolerant$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0994788-1$	$0994788-1$	$Patient death on 2/1/2021 at 4:55am at hospital.$	$Patient was a nursing home resident$ please contact the facility for further diagnosis.$	$Patient was a nursing home resident$ please contact the facility for further diagnosis.$Ativan$ Buspar$ Cymbalta$ Levaquin$ Lyrica$ Mirapex$ Pristiq$ Symbicort$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0995165-1$	$0995165-1$	$Died in sleep$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0995441-1$	$0995441-1$	$The vaccine was given on Monday.  Tuesday afternoon he developed weakness in both legs and could not stand up.  This was a new development;  he had neuropathy in one leg but he had been able to stand up and walk three hours before.  He was helped to the bathroom.  He said he felt better and might want to stand up again.  He was helped to bed.  He was found dead around 5:30 Wednesday morning.    He was 94 years old and had a lot of medical conditions.  No one has indicated his death had anything to do with the vaccine.  I'm sure it's just a coincidence that he died so soon after receiving the vaccine$	$None$	$Mild Cognitive Impairment$ Hypothyroidism$ Coronary Artery Disease$ Hyperlipidemia$ Hypertension$ Neuropathy$ Vertigo$ Vitamin B deficiency$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0995520-1$	$0995520-1$	$1-12-21 Resident is complaining of heart pain. Resident blood pressure is 228/105.  1-22-21 Dx UTI 1-13-21     His nurse called MD at approximately 0645$ reported to him that it was reported to this nurse that resident has not slept in 2 days and night$ has an increased blood pressure$ reports severe pain in lower back$ and appears to be uncomfortable Resident is able to verbalize his pain and where it is at$ but is unable to explain the quality of the pain or give a number on the 0/10 pain scale.$	$No illness at time of vaccination or one month prior.$	$Atherosclerotic heart disease$ Hypertension$ Borderline personality disorder$ Dysthymic$ Chronic ischemic heart$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0995649-1$	$0995649-1$	$Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021.  Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA.$	$none$	$Thyroid disorder$ HTN$ Peripheral neuropathy$ anxiety$Augmentin$ sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0996105-1$	$0996105-1$	$patient received vaccine on Jan 23$ 2021 passed away on Jan 24$ she was already on hospice$ so unclear if due to vaccine or other issues. Was at her baseline before and after vaccine per facility$ had b'fast and passed away at noon on Jan 24$	$Dementia$ hypothyroidism$ coronary artery disease$ patient was already on hospice$ so unclear if vaccine related . Pt was at her baseline until she passed away$	$Dementia$ hypothyroidism$ coronary artery disease$ HTN$ multiple other medical issues$Egg$ co-trimoxazole$ Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0996291-1$	$0996291-1$	$Death$	$HTN$ Cerebral Infarction$ Anxiety$ Hx breast neoplasm$	$HTN$ Cerebral Infarction$ Anxiety$ Hx breast neoplasm$Codeine$ Tramadol$ Valsartan$ Keflex$ Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0996591-1$	$0996591-1$	$patient received vaccine on Jan 23$ 2021. developed weakness on Jan 25$ 2021. Sent to ED on Jan 27$ 2021 with hypoxia requiring 6 L O2$ low Bp$ declining mental status. Per family request transitioned to hospice and passed away on Jan 30$ 2021$	$Dementia$ depression$ arthritis$ IBS$ atherosclerosis of aorta$ hyperlipidemia$ osteoporosis$	$Dementia$ depression$ arthritis$ IBS$ atherosclerosis of aorta$ hyperlipidemia$ osteoporosis$Codeine Penicillin simvastatin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0996959-1$	$0996959-1$	$Vaccine was administered Thursday and my father Died early Monday morning unexpectedly$	$CHF. COPD Chronic Pain$	$CHF$ COPD$ Polio as a child$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0997553-1$	$0997553-1$	$fatigue x 5 days$ including day of vaccination$ death the night of day 5/early morning of day 6$	$none$	$hypertension$ CAD$ CRF$ hyperlipidemia$isoniazid$ diltiazem$versed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0997783-1$	$0997783-1$	$patient passed away subsequent to receiving dose on 02/01. Staff does not have reason to believe vaccine was involved.$	$unknown$	$pt lived in long term care facility$ unknown health conditions$none known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0998138-1$	$0998138-1$	$Same day as vaccination given$ developed pain went from arm up to shoulder$ to back$ to neck to head - right side of body; chills/body aches$	$Was hospitalized in December for testing positive for COVID 12/18/2020 - hospitalized for 4 days then released back to nursing home facility.$	$Type 2 diabetes; high blood pressure$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999484-1$	$0999484-1$	$corona test was positive; corona test was positive; Weakness; Pain (morphine administration); Shortness of breath; Unresponsive; Deterioration in general condition; This is a spontaneous report from a non-contactable consumer downloaded from the database. The regulatory authority report number is  DE-PEI-CADRPEI-2021012826.    A 91-year-old female patient received BNT162B2 (COMIRNATY; Lot number unknown)$ via an unspecified route of administration on 30Dec2020 as single dose for covid-19 immunization.  Medical history included being almost blind and  mild dementia from an unknown date.  The patient's concomitant medications were not reported.  On an unspecified date$ corona test was positive. On 01Jan2021$ the patient experienced  fatal events weakness$ pain$ shortness of breath$ death after corona vaccination$ unresponsive and deterioration in general condition.  The patient underwent lab tests and procedures which included coronavirus test: positive an unspecified date. Detailed event description were as follows: Patient was vaccinated  on 30Dec2020. On 01Jan2021$ she became ill$ was weak and had shortness of breath$ was given oxygen$ was on a drip$ and was hardly responsive. The corona test was positive$ date unspecified . After a few days she felt a little better; patient was even able to speak on the phone. Her condition deteriorated rapidly$ she was now also in severe pain$ and the doctor administered morphine. The patient passed away on the morning of 17Jan2021. Therapeutic measures were taken as a result of weakness$ pain and shortness of breath as aforementioned. The patient died on 17Jan2021.  It was not reported if an autopsy was performed.  Senders comment: Almost blind$ mild dementia$ otherwise healthy and still mobile.  The batch/lot number for the vaccine$ BNT162B2$ was not provided and will be requested during follow-up.; Reported Cause(s) of Death: Sudden death$ cause unknown$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Blind (almost); Dementia (mild)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999488-1$	$0999488-1$	$Sudden death$ unknown cause; This is a spontaneous report from a non-contactable physician downloaded from the database. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-PEI2021001410.  An 82-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477)$ via an unspecified route of administration on 17Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 20Jan2021$ the patient experienced sudden death due to an unknown cause. It was not reported if an autopsy was performed. The regulatory authority assessed the causality between the sudden death and vaccine as unclassifiable.   No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden death$ cause unknown$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999489-1$	$0999489-1$	$Collapse on the edge of the bed before going to the toilet; This is a spontaneous report from a non-contactable physician downloaded from the database regulatory authority$ DE-PEI-PEI2021001427. A 94-year-old female patient received the second dose of bnt162b2 (COMIRNATY$ batch no. was not reported)$ via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included adipositas from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY$ batch no. was not reported) on 27Dec2020 for COVID-19 immunisation. The patient experienced collapse on the edge of the bed before going to the toilet in Jan2021. Death cause was reported as circulatory collapse. The patient died in Jan2021. It was not reported if an autopsy was performed.  Reporter's comments: Pulmonary embolism conceivable in obese patients. Event/ Unclassifiable.  No follow-up attempts are possible$ information on batch number cannot be obtained.; Reported Cause(s) of Death: Collapse on the edge of the bed before going to the toilet$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Adipositas$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999490-1$	$0999490-1$	$Asystolia; Collapse circulatory; This is a spontaneous report from a non-contactable physician downloaded from the database DE-PEI-PEI2021001474.  An 84-year-old female received bnt162b2 (COMIRNATY$ batch/lot number and expiration date not provided)$ via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation. Medical history included dementia and atrial fibrillation$ both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Jan2021 after vaccination the patient developed Death and Collapse circulatory and Asystolia$ lasting for unknown. The patient is dead. The outcome of the events was fatal. The patient died on 22Jan2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible$ information on batch number cannot be obtained.; Reported Cause(s) of Death: Collapse; Asystolia$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Atrial fibrillation; Dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999494-1$	$0999494-1$	$Death; Fever; Weakness; Dyspnoea; Hypotension; This is a spontaneous report from a non-contactable physician downloaded from the database [DE-PEI-PEI2021001479]. An 80-year-old female patient received BNT162B2 (COMIRNATY) at single dose on 29Dec2020 for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 21Jan2021$ 23 days after vaccination$ the patient developed fever$ weakness$ dyspnea$ hypotension and unknown cause of death (as reported)$ lasting for unknown. The patient was dead on 21Jan2021. Death cause was reported as unknown cause of death. It was unknown if an autopsy was performed or not. The outcome of events was fatal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Dyspnoea; Hypotension; Fever; Weakness; Unknown cause of death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999496-1$	$0999496-1$	$Death; SARS-CoV-2 test with positive result; SARS-CoV-2 test with positive result; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021001558 and received  via Regulatory Authority.  An 84-year(s)-old male patient was vaccinated with the first dose of BNT162B2 (COMIRNATY$ Lot number: not reported) at single dose for COVID-19 immunisation on 23Dec2020. Relevant history included Osteomyelitis$ Arteriosclerosis$ Myocardial infarction$ Depression$ Aggression$ Recurrent urinary tract infection$ Transient ischemic attack$ Atrial fibrillation$ Fall$ Stroke$ Disorientation. Relevant concomitant was not reported. The patient was dead on 20Jan2021$ 29 day(s) after the vaccination. The cause of death was unknown. It was unknown if the autopsy was performed or not. Relevant lab tests included SARS-CoV-2 test with negative result on unknown date; SARS-CoV-2 test with positive result on 20Jan2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Aggression; Arteriosclerosis; Atrial fibrillation; Depression; Disorientation (Gerontopsychological abnormalities); Fall; Myocardial infarction; Osteomyelitis; Recurrent urinary tract infection; Stroke; Transient ischemic attack$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999777-1$	$0999777-1$	$Died in sleep/passed away; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101251422035050$ Safety Report Unique Identifier GB-MHRA-ADR 24643393.  A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not known)$ via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Medical history included previous large haemorrhagic stroke in 2011. Subsequent vascular dementia. Recent transient ischaemic attack (TIA's). Poor functional ability. Using wheelchair and very limited verbal communication. Concomitant medication included alendronic acid$ fluoxetine$ macrogol 3350$ potassium chloride$ sodium bicarbonate$ sodium chloride (LAXIDO)$ zopiclone for poor quality sleep. The patient had the Pfizer vaccine on the morning of the 06Jan2021. She was well throughout the day with no immediate reactions and no side effects. She was in bed in the evening and was found to have passed away. The reporter thought this lady had another large stoke. This would fit with her previous history and frailty. The patient died on 06Jan2021. It was not reported if an autopsy was performed.  No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Died in sleep/passed away$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Communication disorder; Haemorrhagic stroke; Movement disorder (Using wheelchair); Transient ischaemic attack; Vascular dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000270-1$	$1000270-1$	$Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB. The regulatory authority report number is ES-AEMPS-728224.    An 89-year-old female patient received BNT162B2 (COMIRNATY; Lot number EM0477)$ via an unspecified route of administration on 05Jan2021 as single dose for covid-19 immunization.  Medical history included cancer (CA) breast with metastasis$ in palliative care (final situation)$ from an unspecified date. Concomitant medication included escitalopram (MANUFACTURER UNKNOWN)$ paracetamol (MANUFACTURER UNKNOWN)$ ferrous sulfate (TARDYFERON)$ diazepam (MANUFACTURER UNKNOWN).  The patient experienced sudden death on 05Jan2021. Details were as follows: patient with basic  pathology that justifies the death; CA breast in palliative care (final situation) was noted. But since  the death occurred at 30 minutes after the vaccine administration$ it was decided to declare it. The patient died on 05Jan2021.  It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Breast cancer metastatic (IN PALIATIVE CARE)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000277-1$	$1000277-1$	$Death unexplained; tired; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-LY20210170.  A 92-years-old female patient received her first dose bnt162b2 (COMIRNATY)$ lot number: EM0477$ intramuscular on 15Jan2021 at single dose for covid-19 immunisation.  Medical history included basedow's disease from an unknown date and unknown if ongoing. Usual treatment was L Throxine. The patient's concomitant medications were not reported.  On 15Jan2021$ the patient received a first dose of bnt162b2 vaccine$ her neighbors saw her in the evening and she reported being tired. On 17Jan2021 the neighbors heard a falling noise and found the deceased patient. The patient died unexplained on 17Jan2021. The outcome of event tired was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Basedow's disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000379-1$	$1000379-1$	$Chest infection; positive COVID-19 virus test/suspected COVID-19; positive COVID-19 virus test/suspected COVID-19; This is a spontaneous report received from a contactable other healthcare professional by Pfizer from the products Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202101280002382610$ Safety Report Unique Identifier GB-MHRA-ADR 24657514. A 100 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine$ Lot Number and Expiration Date unknown) via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient's medical history heart failure. Patient is not enrolled in clinical trial. The concomitant medications was not reported. Patient had suspected COVID-19 from 15Jan2021. Onset of chest infection on 15Jan2021$ revived the course of antibiotics. But the course not completed as became too poorly moved to the stage of end of life. Patient died on 27Jan2021. Lab test included positive COVID-19 virus test on 06Jan2021. The outcome of events was fatal. Unknown if autopsy was done.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: chest infection; positive COVID-19 virus test/suspected COVID-19; positive COVID-19 virus test/suspected COVID-19$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Heart failure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000473-1$	$1000473-1$	$DIARRHEA; VOMITING; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority with Regulatory authority report number NO-NOMAADVRE-FHI-2021-U4eqa$ Sender's (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014144.  An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY$ Solution for injection$ lot number: EJ6795)$ intramuscularly on 06Jan2021 09:00 at single dose in Left arm for Covid-19 vaccination. Medical history included diabetes mellitus$ angina pectoris$ decreased appetite (Reduced food intake two weeks before vaccination) cognitive impairment$ gastrointestinal spasm$ nausea$ hypertension$ unrest$ all from an unknown date and unknown if ongoing. The patient was Living in nursing home. Concomitant medication included hyoscine butylbromide (BUSCOPAN) from 12Jan2021 to 17Jan2021 for gastrointestinal spasm$ metoclopramide hydrochloride (AFIPRAN) from 12Jan2021 to 17Jan2021 for nausea$ paracetamol (PARACET) from an unknown date to 13Jan2021 for pain$ paracetamol (PINEX) from an unknown date to 11Jan2021 for pain$ metoprolol succinate (SELO-ZOK) from an unknown date to 12Jan2021 for hypertension$ fentanyl (FENTANYL SANDOZ) from 11Jan2021 to 17Jan2021 for pain$ insulin glargine (LANTUS) from an unknown date to 13Jan2021 for diabetes mellitus$ morphine hydrochloride (MORPHINE ORION) from 12Jan2021 to 17Jan2021  for pain$ oxazepam (SOBRIL) from an unknown date to 13Jan2021 for unrest$ losartan potassium (COZAAR) from an unknown date to 12Jan2021 for hypertension$ haloperidol (HALDOL) from 12Jan2021 to 17Jan2021  for unrest$ midazolam from 12Jan2021 to 17Jan2021  for unrest. The patient experienced vomiting on 06Jan2021 and diarrhea on 08Jan2021$ reported as serious with serious criteria death.  The patient experienced vomiting once on the same day as vaccination on 06Jan2021. Two days after vaccination on 08Jan2021$ he developed diarrhea$ gradually continuous running stools$ no food/fluid intake. Reporter states that it is not certain that the symptoms are due to a side effect of the vaccine as the man had reduced appetite a few weeks before vaccination$ as well as comorbidity. In the time before vaccination$ the man also did not want to take his medication$ including long-acting insulin. The patient died on an unspecified date in Jan2021.  It was not reported if an autopsy was performed. The outcome of events vomiting and diarrhea was fatal.  Sender Comment: Nausea is reported as a side effect of the vaccine Comirnaty$ while diarrhea is not listed as a known side effect. In some people$ reactions such as short-term / transient nausea and loose stomach can be linked to being vaccinated$ but then as a form of physiological stress response to the event / vaccination. In this case$ there is a relatively close temporal relationship between vomiting$ diarrhea and vaccination. It is stated that the patient had reduced food intake in the period before vaccination$ and it can therefore not be ruled out that vomiting and diarrhea may have been symptoms of an underlying condition that was present in before vaccination. On the basis of the information in the report and in accordance with criteria$ the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction$ including pathological laboratory tests$ which occurs in a temporal relationship to the use of a drug$ but which may also be due to an underlying disease$ other drugs or chemicals. Since the patient's death$ the message is classified as serious$ even though no causal link between the vaccine and the death has been established.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vomiting; diarrhea$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Angina pectoris; Cognitive impairment; Decreased appetite; Diabetes mellitus; Gastrointestinal spasm; Hypertension; Living in nursing home; Nausea; Unrest$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000474-1$	$1000474-1$	$$RESPIRATORY ARREST; REDUCED GENERAL CONDITION; DYSPNEA; health condition was already reduced (reduced general condition and possible dyspnea) from before$ and it got worse the same day as the vaccination; This is a spontaneous report from a contactable Other Health Professional downloaded from the Agency Agency-WEB NO-NOMAADVRE-FHI-2021-Uedw5$ Sender's (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014102. A 94-years-old male patient received his first dose bnt162b2 (COMIRNATY)$ lot number: EM0477$ intramuscular on left arm on 14Jan2021 12:25 at single dose for covid-19 immunisation. Medical history included wheelchair user$ respiratory arrest$ reduced general condition$ possible dyspnea$ generalised pain and started morfine (subcutanous) 01Jan2021 for generalised pain$ he was not completely clear and oriented afterwards and was more drowsy/confused; urinary tract infection (Per oral antibiotics 30Dec2020 to 06Jan2021 for possible urinary tract infection)$ all from an unknown date.  Concomitant medication included morfin [morphine] subcutaneous from 01Jan2021 for generalised aching. The patient experienced dyspnea and reduced general condition the same day as vaccination with covid-19 vaccine bnt162b2 on 14Jan2021$ and experienced respiratory arrest and death the day after on 15Jan2021. His health condition was already reduced (reduced general condition and possible dyspnea) from before$ and it got worse the same day as the vaccination on 14Jan2021. He could not either eat/drink or take his medicines and was bedridden to the day after the vaccination when he died (15Jan2021). It was reported $$Start-up with oxygen 0.5-1 L on spectacle catheters after clearly reduced breathing pattern.$$ He was independent in meal situations from an unspecified date. The patient underwent lab tests and procedures which included c-reactive protein: 20 on 07Jan2021$ c-reactive protein: 30 on 15Jan2021.  The patient died on 15Jan2021.  It was not reported if an autopsy was performed.  Sender Comment: A 94-year-old man with dyspnoea and reduced general condition same day as vaccination with covid-19 vaccine (Comirnaty). Respiratory arrest and death the next day. His health was already reduced from before the vaccination$ but the situation worsened after the vaccination. When vaccinating marginal patients who are ill with many underlying diseases$ some serious events$ including death$ may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient's underlying disease. In each case$ it is difficult to know whether the death is due to the vaccine$ the patient's underlying disease or some other random incident$ happening at the same time but that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria$ the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction$ including pathological laboratory tests$ which occurs in a temporal relationship to the use of a drug$ but which may also be due to an underlying disease$ other drugs or chemicals. Since the patient died$ the message is classified as serious$ even though no causal link between the vaccine and the death has been established.  Reporter's comment: 21Jan2021: Received additional information from reporter (phone call): date of death$ date of adverse events$ other details.  No follow-up attempts possible. No further information expected.; Reporter's Comments: 21Jan2021: Received additional information from reporter (phonecall): date of death$ date of adverse events$ other details; Reported Cause(s) of Death: reduced general condition; RESPIRATORY ARREST; His health condition was already reduced (reduced general condition and possible dyspnea) from before$ and it got worse the same day as the vaccination; dyspnea$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Confused; Disorientated; Drowsiness; Dyspnea; Pain (Started morfine (subcutanous) 01Jan2021 for generalised pain); Reduced general condition; Respiratory arrest; Urinary tract infection (Per oral antibiotics 30Dec2020 - 06Jan2021 for possible urinary tract infection); Wheelchair user$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000665-1$	$1000665-1$	$Death 2 days later; This is a spontaneous report from a contactable Other HCP. A 97-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EL0140) via intramuscular in the left arm on 18Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included prostate cancer$ macular degeneration$ type 2 diabetes$ atrial fibrillation. No known allergies. Concomitant medications included glipizide$ warfarin and metformin in two weeks. The patient had no other vaccine in four weeks. The patient experienced death on 20Jan2021 at 09:00 PM. Death cause was undetermined. No autopsy was performed. No treatment was received for AE. The patient had no covid prior vaccination$ no covid tested post vaccination. Outcome of the event was fatal.; Sender's Comments: Event unknown cause of death is assessed as Related until sufficient information is available to confirm an unrelated cause of death or if there is sufficient information to allow an unrelated causality assessment. Case will be reassessed when follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to regulatory authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: Death 2 days later$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Atrial fibrillation; Macular degeneration; Prostate cancer; Type 2 diabetes mellitus$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000709-1$	$1000709-1$	$Patient with past medical history of CAD$ CKD$ sCHF$ LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN$ complete heart block$ T2Diabetes$thyroid issues$ stroke$ papillary CA of thyroid$ dyslipidemia$ anemia$ hypercalcemia$ pulmonary nodule$ hypoparathyroidism$ pacemaker$ bilat carotid stenosis$ afib$ pleural effusion$ pancytopenia$ cardiomyopathy$ severe aortic stenosis$ sick sinus syndrome$ Dressler syndrome$ empyema$ ESRD$	$see below$	$see below$Heparin$ Amoxcillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000711-1$	$1000711-1$	$in addition to above$ pt had the  following diagnosis: portal HTN$ abnormal blood chem$ essential tremor$ depressive disorder$ abnormal glucose tolerance test$ hyperlipidemia$ hypothyroidism$ insomnia$ localized osteoarthrosis$ calculus of kidney$ pancytopenia$ odule on liver$ hepatocellular CA$ hyotension$ hypovolemia$ hepatorenal syndrome   additional meds: zoloft$ aldactone$ thiamine$demadex$ ultram$ kenalog$ vitamins$ bactroban ung$	$chronic liver disease$ hypoganadism$ alcoholic cirrhosis$ cont$	$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000739-1$	$1000739-1$	$Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity$ staring straight ahead and strong allover muscle jerking of both the up and lower extremities$ color became gray$ activity lasted approximately 3 minutes$ resident then became relaxed$ color returned to normal$ BP-140/80$ 97.8$ 60$ 16$ sleeping the remainder of the shift$. Resident continued to decline until resident CTB on 1/19/21$	$NKA$	$Frontotemporal Dementia$ Dysphagia$ Tinea Unguium$ Peripheral Vascular Diseases$ Difficulty Walking$ Primary Hypertension$ Hypercholesterolemia$ Hyperlipidemia$ Personality Change dur to known physiological condition$ History of other mental and Behavioral Disorders$ Constipation$ Atherosclerotic Heart Disease of Native Coronary Artery$ Nail Dystrophy$ Dermatitis$ Idiopathic Epilepsy and Epileptic Syndromes with Seizures of Localized Onset$ Protein Caloria Malnutrition$ Muscle Weakness$nka$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000752-1$	$1000752-1$	$$Pt son$ reports patient passed away on 2/1/21 in the early hours. Pt wife$ told Pt's son that patient started feeling $$bad$$ with common cold like symptoms on 1/31/21$ had a temp of 99.0. Pt's wife went to take a shower$ when she got out patient was unresponsive. She called EMS$ they pronounced patient deceased upon arrival.  ل Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.$$	$none that I'm aware of$	$aortic atherosclerosis$ essential hypertension$ depression$ type 2 diabetes with stage 4 chronic kidney disease$penicillin$ procain$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000856-1$	$1000856-1$	$$Myocardial infarction Narrative: PMH significant for aortic valve stenosis$ mitral valve stenosis$ CKD$ CHF$ DM$ HTN$ obesity$ hypothyroidism and dyslipidemia. Per report from primary care - the patients wife reports that the patient went on Saturday (1/30/21 - about 1050) morning to receive his COVID vaccine. He returned home and told her about the experience and denied any side effects. He then proceeded to sit in his easy chair for a while and around 1:30$ she asked him if he wanted any lunch. The patient's wife reports he $$grumbled$$ at her$ and then got up to go to the bathroom. She then heard a loud crash and found him lying on the floor of the bathroom$ with his head knocking hole in the wall as he fell. She could not detect a pulse. She called 911 and began compressions. First responders to the scene likewise tried to revive him but were not successful in her efforts. Per primary care documentation - Uncertain if related to Pfizer vaccine; vaccine administered on 1/30/21 and approximately 3 hours later suffered fatal MI at home.$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1001567-1$	$1001567-1$	$Death </= 24 hours post-vaccination$	$No current illness for this event.$	$Left anterior fascicular block$ hyperlipidemia$ hypertension$ allergic rhinitis$ dysphagia$ gastroesophageal reflux disease$ benign prostatic hyperplasia$ equinovarus deformity$ toe amputation$ stroke$ essential tremor$ parkinson's disease$ hemiplegia due to old stroke$ neuropathy$ spasticity.$Hay fever$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002057-1$	$1002057-1$	$Sudden death$	$1) Deconditioning 2) Osteoporosis with acute T4 compression fracture from coughing in 12/15/20 3) Chest wall pain 4) Anemia due to GI bleed 5) HTN 6) DM 2 7) HFrEF 8) Hyperlipidemia 9) Paroxysmal atrial fibrillation 10) PVD 11) CAD 12) Aortic stenosis 13) Hypothyroidism 14) Anxiety disorder$	$See above$Baclofen$ Sulfa antibiotic$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002535-1$	$1002535-1$	$On 1/29/21 patient began not feeling well and saw her provider.  The doctor gave her fluids and tramadol for pain.  They noticed increased confusion$ but thought that could have been due to the tramadol.  They also increased her gabapentin as she was experiencing nerve pain.  Patient also developed a rash and was diagnosed with shingles on 2/1/21.  Patient died on 2/3/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1002937-1$	$1002937-1$	$death Narrative:  Pt attended arthritis clinic appt 0900; labs shortly after; rec'd vaccine in clinic ~ 1113; seen on surveillance camera walking to parking garage ~ 1145; medical center rec'd call from wife ~ 1900 that pt never returned home; police found vehicle running in parking garage$ code called$ pt obviously deceased by that time 1930$ body sent to medical examiner for autopsy.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1003106-1$	$1003106-1$	$Resident received vaccination at 9:12 am$ she was monitored and checked at the 15 minute interval 9:27 am$ reassessed$ vitals were fine.    Within 20 (9:32 am) minutes of receiving the vaccine she was unresponsive$ pupils were fixed at 9:45 am$ no vital signs noted; hospice came out and reported her time of death 10:21 am.  This person was on hospice.$	$CARDIOMEGALY; LOW BACK PAIN;  MUSCLE WEAKNESS (GENERALIZED); NEED FOR ASSISTANCE WITH PERSONAL CARE;  - OTHER ABNORMALITIES OF GAIT AND MOBILITY;  LUMBAGO WITH SCIATICA$ UNSPECIFIED SIDE; R26.81 - UNSTEADINESS ON FEET;  REPEATED FALLS; CERVICAL SPONDYLOSIS;  Other Diagnoses PRESENCE OF CARDIAC PACEMAKER;  DYSPHAGIA$ OROPHARYNGEAL PHASE; HYPERLIPIDEMIA$ UNSPECIFIED;  CHRONIC ATRIAL FIBRILLATION$ UNSPECIFIED ;  ATHSCL HEART DISEASE OF NATIVE CORONARY ARTERY W/O ANG PCTRS; ESSENTIAL (PRIMARY) HYPERTENSION;  INSOMNIA$  UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE;$	$On hospice$Diltiazem$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1003329-1$	$1003329-1$	$Patient's primary care provider received a death certificate to be signed for this patient. He spoke with the patient's husband and son$ who reported that the patient had pain and swelling at the vaccine administration site after receiving the vaccine and was feeling unwell after receiving the vaccine. The patient's family reported that they found her unresponsive on 2/2/21 and called 9-1-1. The patient was pronounced dead upon arrival of emergency responders.$	$No known recent illnesses per medical record$	$Per medical record: type 2 diabetes$ hypercholesterolemia$ hypertension$ non-proliferative diabetic retinopathy$ borderline glaucoma$ osteoarthritis$ obesity$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1003382-1$	$1003382-1$	$Began with vomiting and diarrhea. C/O chest pain. Bradycardia. Hypotension.  2 seizures in 45 minutes after not having one in years.  We gave fluids. Gave Zofran. Comfort measures.  Pt passed at midnight. Was completely fine one day before. Had minimal issues with COVID though did have a pneumonia that was treated w ATB early on and resolved.$	$COVID dx on 1/4/2021$	$Dementia$ epilepsy$ HTN$ PVD$ osteoporosis$$PCN$ Sulfa ATB$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1003494-1$	$1003494-1$	$Possible transverse myelitis developing 2 days after vaccine injection. Death on day 9 after vaccination$	$Recent hemorrhagic stroke$	$Seizure disorder$ prior subdural bleed status post cranioplasty$ bipolar disorder$ hypertension$ hyperlipidemia$  and vasovagal syncope$Penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1003587-1$	$1003587-1$	$My father was in weak condition to begin with.  He didn't get out of bed for the next few days after receiving the vaccine.  The little amount that he ate was consumed in bed.  He began aspirating his food which lead to pneumonia.  He wasn't strong enough to fight off the pneumonia even with antibiotics.   He died on 1/23/21.   While he might have passed soon in any case$ I believe that the vaccine may possibly have increased his weakness/exhaustion thereby hastening his demise.$	$congestive heart failure$	$congestive heart failure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1003806-1$	$1003806-1$	$sudden death; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MP20210082.  A 87-years-old female patient received first dose of bnt162b2 (COMIRNATY$ Lot number: EM0477)$ via intramuscular on 20Jan2021 15:00 at single dose on the left arm for COVID-19 vaccination. Medical history included Alzheimer's disease$ bedridden$ dyslipidaemia and altered state for a few weeks in December$ needed to be transfused for anemia at 7.6g/l with no cause found. Concomitant medication included paracetamol$ mianserin$ alprazolam$ colecalciferol (ZYMAD)$ sotalol$ cyamemazine (TERCIAN)$ potassium chloride (DIFFU-K) and nacl. The patient experienced sudden death on 20Jan2021 23:00. Last assessment carried out on this patient 08Jan2021: Hemoglobin 9.2 g/dl$ potassium 4.52 mmol/l$ GFR 96 .9 ml/min. Regarding the follow-up after vaccination at the center: Evolution: refused the snack and at 7:00 p.m. took half a dessert. Patient found dead 8 hours after the vaccination on 20Jan2021 at 11 pm. It was unknown if an autopsy was performed.  No follow-up attempts are possible$ no information is expected.; Reported Cause(s) of Death: Sudden death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Alzheimer's disease; Anemia (need to be transfused for anemia at 7.6g/l with no cause found); Bedridden; Dyslipidaemia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1004864-1$	$1004864-1$	$$Patient expired. Per Emergency MD note: $$This is a 72-year-old male with what sounds like diabetes$ atrial fibrillation$ and hypertension who presents via EMS in cardiac arrest.  It sounds like he received his Covid vaccine last week.  Initially he had some mild effects from it.  However over the last day or so he has felt very unwell.  He apparently called his wife today and told her that he was not feeling well and so she returned home.  Shortly thereafter he attempted to get up from his chair.  He then collapsed and fell forward onto his face.  Sounds like his wife had some difficulty rolling him over to perform CPR.  When EMS arrived they found him in PEA.  He received a total of 5 rounds of epinephrine.  At some point they did have return of spontaneous circulation.  However just prior to arriving in the emergency department they lost pulses again.  The patient was intubated with an 8 oh endotracheal tube prior to arrival.$$$$	$n/a$	$Atrial fibrillation hypertension hyperlipidemia Type 2 diabetes Heavy drinker$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005301-1$	$1005301-1$	$Patient tested positive for COVID-19 on 1/8/21.  She demonstrated a decline in appetite and the ability to feed herself d/t this illness$ but no respiratory or other symptoms.  She received COVID-19 vaccine #2 on 1/26/21.  She demonstrated an SDTI wound to the Lt. heel on 1/27/21.  On 1/31/21 she was noted to have a significant weight loss.  She was admitted to services on 2/1/21 with comfort care orders.  On 2/2/21 she was observed to be without vital signs.  Orders were for DNR$ and CPR was not initiated in accordance with that order.  She was pronounced dead at 0112 on 2/1/21.$	$COVID-19$	$Dementia$ Dysphagia$ HTN$ Diabetes Mellitus Type 2$ Hypercholesterolemia$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1005686-1$	$1005686-1$	$death. No known symptoms or complaints. found unresponsive in bed. Released to funeral home as the Medical Examiner will not perform and autopsy. Dr. will sign the DC.$	$n/a$	$CHF$ HTN$ HLD$ pacemaker$ DM$ and severe osteoarthritis leading to chronic back pain and the use of a scooter for mobility.$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1006994-1$	$1006994-1$	$Patient had one occurrence of thrombotic thrombocytopenic purpura in 1996 for which she had plasma exchange therapy in 1996.   No other occurrence since 1996 until she received her first dose of the Pfizer covid vaccine.$	$No current illness for this event.$	$Diabetes  Hyperlipidemia$penicillin and sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1007310-1$	$1007310-1$	$view     2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning.  view     2/5/2021 08:39 Orders - Administration Note Note Text: Resident passed.  view     2/5/2021 08:33 Nurses Note Note Text: Body released to funeral home at this time. Personal effects sent with resident include: 1 pair of glasses$ 1 yellow wedding band$ 1silver spoon ring$ 1 ring with black and clear stones. Resident has own teeth  view     2/5/2021 08:32 Nurses Note Note Text: cause of death per CRNP failure to thrive.  view     2/5/2021 07:44 Orders - Administration Note Note Text: Take and document temp & PO2  every 4 hours for MONITORING  Resident passed.  view     2/5/2021 06:49 Nurses Note Note Text: Son returned call and was updated of resident's passing this am  view     2/5/2021 06:33 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger  PRN Administration was: Unknown  Resident expired @ 0604 [linked]  view     2/5/2021 06:06 Nurses Note Note Text: Res found without pulse or respirations. Pronounced at 0604. Updated. N/o's for RN to pronounce$ release body to funeral home$ dispose of medications per facility policy. Daughter updated. Funeral Home called to release body.  view     2/5/2021 05:26 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger  Pulse ox 60% on O2 @ 5L/min via mask. Resps 44 per minute.  view     2/5/2021 01:57 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger  PRN Administration was: Effective  Follow-up Pain Scale was: 2 [linked]  view     2/5/2021 00:52 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger  Residents resps are 40 per minute$ pulse ox 76% on O2 @ 5L/min via mask. Resps are labored$ shallow and rapid.  view     2/5/2021 00:48 Nurses Note Note Text: Nonresponsive to verbal and tactile stimulation. Appears comfortable.  view     2/4/2021 22:01 Nurses Note Note Text: Resident resting comfortably$ breathing becoming increasingly shallow$ wearing O2 via mask at 5L via mask$ no dyspnea noted$ feet are mottled$ oral and peri care provided Q2H. No s/s of pain or discomfort.  view     2/4/2021 21:40 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger  PRN Administration was: Effective [linked]  view     2/4/2021 19:32 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger  medicated for air hunger$ RR 28 to 32/ min  view     2/4/2021 19:22 Nurses Note Note Text: Daughter updated on N/O to increase Morphine Sulfate 20mg/mL 0.25mL to Q2H prn from Q6H prn.  view     2/4/2021 18:06 Nurses Note Note Text: POA Daughter and daughter aware of residents current condition.  view     2/4/2021 11:58 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 6 hours as needed for pain/SOB  PRN Administration was: Effective  Follow-up Pain Scale was: 2 [linked]  view     2/4/2021 11:13 Nurses Note Note Text: Pt. noted to be lethargic at this time. Does respond to verbal and tactile stimuli by opening her eyes but non verbal currently. Skin warm and dry. No mottling or apnea observed at this time. O2 sat 88% with O2 at 2 LPM via n/c. On increased to 3 LPM via mask as pt. noted to be mouth breathing. Respirations 28. F/U O2 sat 93%. HOB elevated. Pt. medicated with morphine by LPN. Daughter updated on pt.'s condition. Does not want pt. sent out to hospital and would like comfort measures to continue. Daughter also in agreement with delay in d/c d/t pt.'s condition.CRNP updated on pt.'s condition$ delay in d/c and daughter's wishes. No n/o's at this time.  view     2/4/2021 10:56 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 6 hours as needed for pain/SOB  Resident showing s/s of discomfort. SOB at this time and high respirations. Repositioned$ changed for incontinence care and mouth care provided.    view     2/4/2021 10:34  Progress Note Note Text: Spoke with RN regarding change in condition. Updated Sr Living regarding change. Recommendation to cancel d/c/transfer for today$ see how resident does through the weekend and re-evaluate on Monday. Daughter updated on cancellation of d/c today.  view     2/4/2021 10:04 Nurses Note Note Text: Daughter aware that resident's O2 sat was 88% on room air on 3-11 shift and that oxygen was applied via nasal cannula.  view     2/4/2021 10:03 Nurses Note Note Text: N/O: Discharge 2/4/21 with scripts to Sr. Living. Daughter aware.  view     2/4/2021 09:53 Nurses Note Note Text: Pt. to be d/c'd to another facility this am as per MD order. Pt. alert and responsive. Skin assessment done as per facility policy. No pressure areas noted at this time. No s/sx of pain or discomfort observed at this time. V.S. 97.0 67 20 O2 sat 95% with O2 at 2 LPM via n/c.  view     2/4/2021 07:45 Nurses Note Note Text: Resident seen by Dr. for discharge. Orders pending at this time.  view     2/4/2021 07:36 Nurses Note Note Text: CRNP and Dr. updated on O2 sat 88% on RA with f/u of 93% with O2 on at 2 LPM as well as rest of VS$ 3-11 shift 2/3/21. No n/o's at this time.  view     2/3/2021 21:17 Nurses Note Note Text: Resident Sp02 88% on RA. Pulse 124. Respirations 40. PRN morphine given and O2 applied via NC at 2L/min. After recheck pulse ox up to 93%$ pulse 100$ and respirations 22. Resident appears comfortable at this time.  view     2/3/2021 20:05 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 6 hours as needed for pain/SOB  PRN Administration was: Effective [linked]  view     2/3/2021 19:48 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML  Give 0.25 ml by mouth every 6 hours as needed for pain/SOB  PRN given for SOB after elevation of HOB not effective.  view     2/3/2021 11:51 Nurses Note Note Text: CRNP updated rapid COVID test done for d/c tomorrow was negative. No n/o's at this time.  view     2/3/2021 11:44 Nurses Note Note Text: Daughter notified of rapid covid swab being negative.  view     2/3/2021 09:50 Orders - Administration Note Note Text: Obtain Rapid Covid test on 2/3/2021 for discharge. Please give copy of results to Social Worker  every day shift for covid testing for 1 Day  Completed and negative.  view     2/3/2021 08:45 Skilled Nursing Note Reason for skilled service: Therapy  describe skilled service: Nursing$ therapy  assessment: V.S. 97.8 79 18 138/84  Orientation: Oriented to self only.  Oxygen: O2 sat 94% on RA  Edema: Trace edema noted BLE. Pedal pulses present.  Pain: Denies pain or discomfort at this time.  Nursing note: Pt. alert and responsive. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen soft. BS+ in all 4 quads. Continent/Incontinent of B&B. 1 assist with ambulation$ transfers. 1 assist with ADL's. Working with therapy on gait training$ therapeutic exercise$ therapeutic activities & neuromuscular reeducation.  view     2/2/2021 14:37 Progress Note Note Text: Per health professional at Sr Living$ prepared to accept patient to their Memory Care Unit 2/4. Transportation arranged for 11 AM per family request. Daughter (POA) updated on d/c time on 2/4/21. Facility requesting rapid COVID test completed prior to d/c and results sent to them. All other information sent for continuity of care.$	$ALTERED MENTAL STATUS$ UNSPECIFIED CARDIAC ARREST$ CAUSE UNSPECIFIED UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE ESSENTIAL (PRIMARY) HYPERTENSION HYPERLIPIDEMIA$ UNSPECIFIED ANEMIA$ UNSPECIFIED PERIPHERAL VASCULAR DISEASE$ UNSPECIFIED COVID-19 Resolved 1-1-21 AGE-RELATED COGNITIVE DECLINE CHRONIC ATRIAL FIBRILLATION$ UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY UTI$	$ALTERED MENTAL STATUS$ UNSPECIFIED CARDIAC ARREST$ CAUSE UNSPECIFIED UNSPECIFIED DEMENTIA WITH BEHAVIORAL DISTURBANCE ESSENTIAL (PRIMARY) HYPERTENSION HYPERLIPIDEMIA$ UNSPECIFIED ANEMIA$ UNSPECIFIED PERIPHERAL VASCULAR DISEASE$ UNSPECIFIED COVID-19 AGE-RELATED COGNITIVE DECLINE CHRONIC ATRIAL FIBRILLATION$ UNSPECIFIED ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY UTI$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1008758-1$	$1008758-1$	$Patient began feeling nauseated on 1/18/21  around 6pm$ and had uncontrolled diarrhea$ reported that she did not feel right.  Staff reported to this writer$ that her skin tone was gray in tone and she just didn't look good.  She was transferred to the HOSPITAL ER VIA AMBULANCE.$	$No current illness for this event.$	$Thrombocytopenia$ A-fib$ CHF$ Spinal stenosis$ Renal stent$Codine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1009266-1$	$1009266-1$	$Patient with failure to thrive symptoms prior to 2nd dose$ not eating$ not taking medications.$	$Kidney Stones$	$CVA$ AFib$ SSS$ Epilepsy$ Vascular Dementia$Garlic; IV contrast$ Iodine containing; mirabegron$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1009991-1$	$1009991-1$	$73-year-old man s/p first dose of Pfizer at 10:20 AM Ambulated comfortably to exit after 20 minutes in observation but 10:45 collapsed while exiting the building  10:47 CPR initiated 10:49 medical team/EMS  found no pulse$ agonal respirations$ ventricular fibrillation Paramedics and team performed ACLS; of note patient was intubated 7.5 ETT with bilateral breath sounds on ventilation; paramedic reported easy intubation with no apparent throat swelling;  11:02 transported to Emergency Department 11:30 Pronounced dead at Emergency Department$	$Unknown$	$Believed to have chronic atrial fibrillation$ believed not to be on anticoagulants$No severe allergies reported on questionaire$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1010025-1$	$1010025-1$	$Patient Expired$	$NIDDM$ CHF$ HTN$ HLD$	$NIDDM$ CHF$ HTN$ HLD$None known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011130-1$	$1011130-1$	$Temp of 100.1 and unproductive cough on 1/17; temp of 100.4 1/28;  O2 desaturation 88% on RA 1/28;  Diagnosed with Covid-19 on 1/18/2021 Patient passed away on 1/29/2021$	$NONE$	$Aricept                                      Acetaminophen Citalopram Diltiazem Lisinopril Synthroid Vitamin D 3$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011149-1$	$1011149-1$	$Developed heart arrhythmia and was unable to be revived.$	$paronychia of right index finger$	$Borderline Intellectual Functioning.*Paranoid Schizophrenia.*Depression.*Anxiety.*Diabetes Type II.*Esophageal Reflux.*Hiatal Hernia.*Diverticulosis.*CAD.*COPD.*NSTEMI.*Constipation.*BPH.*Urethral Stricture.*Hearing Deficit.*Sleep Apnea- uses C-PAP.*Hypercholesteremia.*HX Pancytopenia.*CHF.*Right Eye Floaters.*Hyponatremia.*Vit D Deficiency.*Dysphagia-moderate.*Hypertension.*$PCN$ ACE inhibitors$ erythromycin$ Tamsulosin$ ranexa$ sulfasalazine$ lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011222-1$	$1011222-1$	$My mom received the Covid 19 vaccine on Jan 5$ 2021 and became very about a week later. I was informed that she tested positive for Covid 19 on January 14th. One January 17th she became very tired and weak and would not eat. Hospice called me and told me that she was in a decline state. I saw her on January 25 and 26 and she was just sleeping and could not open her eyes. Her vitals were good and she seemed to understand when I talked to her - she would squeeze my hand and moan but she could not talk or open her eyes. My mom passed away on January 27$ 2021 just 22 days after receiving the Covid 19 vaccine. She was very think to begin with and being to weak and tired  to eat resulted in her losing even more weight. Some of the other residents were given fluids to help and they recovered. My mom was not given fluids. I believe there were 20 deaths in her care home for the month of January when they vaccinated. This was an alarming number of deaths for the home. The facility had very few Covid deaths in 2019 and 2020. I asked every week if they had any Covid and or Covid deaths and this amount was shocking to me and the workers there.$	$Dementia. Physical health was good. Hospice was thinking of releasing her because she was doing so well.$	$Dementia. I am told that 20 other residents passed in January after the vaccine was administered. A monthly death count very high for the care home.$Allergies to grass and environment and a touch of asthma$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011440-1$	$1011440-1$	$unanticipated death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011492-1$	$1011492-1$	$1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic$ unable to swallow. 1/24 Although 90% O2 sat on RA$ it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.$	$NONE$	$CAD$ Bradycardia$ HTN$ Hyperlipidemia$ Protein Calorie Malnutrition$ GERD$ STEMI$ Vitamin D deficiency$Macrobid$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011595-1$	$1011595-1$	$On 2/5/2021 resident noted to be azotemic. Creatinine up to 3.8 and BUN in 80's. He was started on NS hydration. On 2/7/2021 he was noted without VS$ per MD notes$ possible VF arrest$ renal failure; death unclear exact cause.$	$ACUTE RESPIRATORY FAILURE WITH HYPOXIA$ COPD$ CHF$ HTN$ ANEMIA IN CHRONIC KIDNEY DISEASE$ TYPE 2 DIABETES MELLITUS WITH DIABETIC NEPHROPATHY$ GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS$ HYPERLIPIDEMIA$ UNSPECIFIED$ DEMENTIA$ AFIB$ CKD STAGE 4$  BENIGN PROSTATIC HYPERPLASIA WITHOUT LOWER URINARY TRACT SYMPTOMS$ UNSPECIFIED ASTHMA$ UNCOMPLICATED$ HYPERPARATHYROIDISM$ UNSPECIFIED$	$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011677-1$	$1011677-1$	$Lethargic$ refusing medications and meals.  1/11/2021- Covid+$ poor appetite.$	$01/16/2021 Pt had bried unresponsive episode$	$Alzheimer's disease$ Hx of TIA$ Vitamin D deficiency$ HTN$ Syncope and collapse$ Hyperlipidemia.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011771-1$	$1011771-1$	$Narrative: Patient with history advanced vascular dementia$ hypertensive cerebrovascular disease and stroke$ T2DM. Received her second dose of Pfizer COVID-19 vaccine at approximately 14:00 and was reported to have expired at home at 20:55. Dr. (Medical Director) spoke with patient's son/caregiver 2/4/21. Son reports that patient was in her usual health yesterday morning$ deemed well enough by son to travel for vaccination. He reports she had no bothersome symptoms after either first or second vaccinations. Specifically denied rash$ wheeze$ and difficulty breathing. Son was with patient throughout the day. In the evening$ when preparing for bed$ he noted she became suddenly unresponsive in a similar fashion as she has done several times in past years. While in all previous such episodes she recovered within minutes$ last evening she did not regain consciousness$ experiences a brief period of labored breathing$ and died. Patient's son called 911 and the patient's body was brought to the medical examiners. The medical examiner declined to proceed with autopsy. Patient's son is not interested in autopsy. Patient's son reports confidence that his mother's underlying hypertensive/diabetic cardiovascular disease is the natural cause of her death. Other Relevant Hx:  Symptoms: & Death Treatment:$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1011905-1$	$1011905-1$	$Ongoing decline overall. Remained on Hospice with increased lethargy documented on 1/20/21 and progressively worsening thereafter.$	$Recent overall decline with generalized weakness$ refusal of meals and medications$ weight loss$ and frequent falls.  1/5 Overall decline reviewed with APRN and ADPOA updated.  1/6-CBC WNL$ BUN/Cr 55/1.93$ GFR 24. Admitted to Hospice Services on 1/6. Covid  Antigen Test negative on Jan 4th$ 5th$ 6th$ 7th$ 8th$ & 9th. Covid positive on 1/10.$	$Dementia $ Expressive aphasia$ right-sided neglect and right sided weakness$ high fall risk. S/P CEREBRAL INFARCTION DUE TO THROMBOSIS CORONARY ARTERY ANEURYSM ESSENTIAL (PRIMARY) HYPERTENSION PAROXYSMAL ATRIAL FIBRILLATION ABNORMAL RESULTS OF KIDNEY FUNCTION STUDIES CEREBRAL ANEURYSM$ NONRUPTURED$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012021-1$	$1012021-1$	$Resident on Hospice. 1/18 Hand Shaky.  1/19- Covid +19.  1/20 Desat 85% on RA$ provided 2L O2 supplement= 97% 1/20 congestive cough$ 1/28- RR-28;1/29- Hypoglycemia 1/30-NPO.  1/30-resident passed away.$	$None$	$CAD$ Anemia$ CKD Stage 3$ Type 2 DM$  HTN$ Hyperlipidemia$Codeine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012703-1$	$1012703-1$	$1/14/2021-0545$ blood noted left and right ear. 0715$ vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.$	$Intermittent delusional periods-followed by Generations Mental Health.1/6 Increased BLE edema$ BP trending up. Acute visit with APRN$ N.O. started Lasix & KCL. CBC and BMP ordered for 1/8 with elevation in BMP/Creatinine. Lasix and KCL placed on hold. On palliative services presently.$	$Alzheimer?s Disease/Depression; HTN; CAD$ CKD$ AAA w/o Rupture$ no surgical intervention per ADPOA$ Dyslipidemia$ GERD.$HEPARIN LATEX BLEACHED SHEETS$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012717-1$	$1012717-1$	$Patient that received his first dose of Pfizer vaccine on 2/1/2021  passed away on 2/2/2021.  No further information is available at this time.$	$unknown$	$unknown$No per screening form completed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012795-1$	$1012795-1$	$Patient was administered second dose of Pfizer vaccine in Nursing Home on 2/5/2021 around noon and was found unresponsive at 5:03AM the following day 2/6/2021. Patient arrived to Hospital in cardiopulmonary arrest and was pronounced dead.$	$Unknown$	$Hypertension$ Coronary Artery Disease$ Previous Myocardial Infarction$ Atrial Fibrillation$ Hyperlipidemia$ Arthritis$Adhesive Tape$ Niacin$ Banana$ Bandaids$ Benzodiazepines$ Calcium Channel Blockers$ Digoxin$ Hydralazine$ Levaquin$ Minoxidil$ Tomatoes$ Oranges$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1012926-1$	$1012926-1$	$Early in the shift on  January 31 resident was noticed to be more tired than usual and  was not eating well.  Lung sounds were crackly and resident was found to be hypotensive.  He was evaluated in emergency department.  He was diagnosed with pneumonia.  Received a loading dose of antibiotic and returned to facility.$	$No current illness for this event.$	$CHRONIC OBSTRUCTIVE PULMONARY DISEASE$ UNSPECIFIED ATRIAL FIBRILLATION$ ESSENTIAL (PRIMARY) HYPERTENSION ATRIOVENTRICULAR BLOCK$ COMPLETE$ NONINFECTIVE GASTROENTERITIS AND COLITIS$ UNSPECIFIED$ PERSONAL HISTORY OF PULMONARY EMBOLISM$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1013006-1$	$1013006-1$	$Patient complained of soreness in muscles morning after receiving the shot.  She went about her day had a smoothie$ spoke to people and also went for a walk came home and went into her jacuzzi tub and consequently passed away while in the tub. She was found by her husband at around 545pm$ time of death is unknown and cause of death is  currently pending.$	$no illness$	$High cholesterol$No allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1013297-1$	$1013297-1$	$Patient was vaccinated at 11:30am.  By 7pm he started presenting symptoms of fatigue$ chest pain.  Patient urinated and defecated in himself.  Was not feeling well.  Patient died at 10:30pm.$	$NONE$	$DIABETES TYPE 2 POLIMIALGYA HIGH BLOOD PRESSURE HIGH CHOLESTEROL STENT PACE-MAKER$NONE$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1014559-1$	$1014559-1$	$Unsure if related to vaccine$ but wanted to report event of death due to brain bleed on evening of administration of the vaccination.$	$No current illness for this event.$	$CAD Migraine Hyperlipidemia$Codeine Hydrocodone Hydroxyzine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1015670-1$	$1015670-1$	$Xrays showed covid Poss pockets all in her lungs on 15Jan; Xrays showed covid Poss pockets all in her lungs on 15Jan; This is a spontaneous report from a contactable consumer. An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia. Concomitant medications were not reported. Patient popped hot 02Jan2021 along with 4 others on the hall she lived. Within 9 days 50+ patients were positive. All had the vaccine the same day. Patient was test positive on 02Jan2021. She was on day 12 of her quarantine when she started to get worse. She was unresponsive by 16Jan2021 and passed 18Jan2021. We were with her from 14Jan2021 to 18Jan2021. But had not been allowed to visit with her since Mar2020. And what post treatment pairs well with it? Publicly we hear Remdesivir and Bamlanivimab but these patients only received a general antibiotic and some vitamins. Death cause was Xrays showed covid Poss pockets all in her lungs on 15Jan2021. No autopsy was performed.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available$ a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However$ based on the mechanism of action of the vaccine$ it is unlikely the patient would have fully developed immunity for the vaccine to be effective$ due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information; Reported Cause(s) of Death: Xrays showed covid Poss pockets all in her lungs on 15Jan$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1015671-1$	$1015671-1$	$bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer.   An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation$ administerd at nursing home/senior living facility  Medical history included dementia$ arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID$ diclofenac (manufacturer unknown) BID$ carbidopa$ levodopa (manufacturer unknown) 25-100 mg TID$ quetiapine (manufacturer unknown) 12.5 mg q HS$ escitalopram oxalate (LEXAPRO) 10 mg q HS$ paracetamol (TYLENOL) 650 mg BID$ glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks.  The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care$ Life threatening illness (immediate risk of death from the event)$ and death. On 18Jan2021 07:30 AM$ less than a week after the second shot$ she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation.  An autopsy was not performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Arthritis; Dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1016067-1$	$1016067-1$	$Resident was weak$ fatigued and had a fever of 101. F the following morning after receiving the 2nd dose of vaccine. Later in the day she was feeling better and vital signs were WNL. The next morning$ she was found unresponsive and pronounced dead by paramedics.$	$nasal congestion$	$diabetes$ heart failure$ Afib$ HTN$Procaine$ epinephrine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1016111-1$	$1016111-1$	$her arm was sore but no other adverse reactions until Saturday$ Feburary 6th 2021 she had stroke between 4 and 6pm.  She died within 6 to 7 hours later.$	$no$	$High Blood Pressure High Cholesterol A-Fib$Penicillin Amoxicillin Sulfa Drugs$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1016222-1$	$1016222-1$	$My mom only had site soreness after her covid vaccine on 1/21 which resolved within a couple days. However$ she died in the early morning hours of 1/25$ she was fine the day before$ no sign of injury.  We found her collapsed on the ground and although we tried cpr she was already dead.  She had gone to the hospital on 12/28 for shortness of breath$ angina and symptomatic anemia$ her ekg was unchanged and blood work normal except for anemia. The cardiologist did not think a cardiac cath was needed. Her shortness of breath improved with a blood transfusion and a dose of lasix (no heart failure).$	$3 weeks prior to immunzation hospitalized for one day due to symptomatic anemia and got a blood transfusion$	$Hypertension$ CAD s/p cabg 1996 s/p multiple stents last 2013$ history of stroke 1996$ high cholesterol$ diabetes type 2$ iron deficiency anemia$Contrast dye$ lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1016770-1$	$1016770-1$	$Patient received 2nd dose of Pfizer vaccine on 2/2/21 and on 2/6/21 he died in his sleep in the a.m. No other signs or symptoms were observed prior to death.$	$None$	$Fahr syndrome$ Dementia$ hypercholesteremia$ metabolic encephalopathy$ syncope$ hypothyroidism$ seizures$ Coronary Artery Disease$ iron deficiency anemia$ asthma$ ataxia.$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1016907-1$	$1016907-1$	$Resident coughing in dining room$ staff suctioned$ physician stated to transfer via 911 to hospital$ 6:33 PM. Hospital notified Nursing Home staff resident passed away at 8:25 PM.  No adverse reaction noted to the Covid vaccine 24 hours after each dose at Nursing Home.  There was no airway obstruction$ cardiorespiratory arrest$ death was natural at hospital.$	$No current illness for this event.$	$acute respiratory disease$ unspecified dementia$ weakness$ hx of falling$ ostearthritis$ hypothyroidism$ unsteady on feet$ cognitive communication deficit$ expressive long. disorder$ anxiety$ hypertension.$KNA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017011-1$	$1017011-1$	$Resident expired 01/26/21 at 5:25am.$	$Dialysis$	$Chronic Kidney Failure Respiratory Failure$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017129-1$	$1017129-1$	$Sudden cardiac death.  Autopsy report: right coronary artery thrombosis.$	$No current illness for this event.$	$Hypertension.  Diet & exercise-controlled diabetes.  History of DVT 4 yrs prior to event.  After completing a course of Xarelto has been on aspirin ever since.$None known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017367-1$	$1017367-1$	$Individual collapsed 9 days post-vaccination with no known reason.  Despite being healthy prior to vaccination$ individual's condition deteriorated rapidly.  Individual passed away on 1-17-2021.$	$Individual was healthy prior to vaccination.$	$Individual had Alzheimer's disease.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017381-1$	$1017381-1$	$Resident passed away 2 days after receiving the vaccine. oxygen level has decreased shortly 1 day after receiving the vaccine.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017393-1$	$1017393-1$	$Patient received the vaccine on 1/26/2021 and per employee at facility patient passed away on 2/01/2021.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017549-1$	$1017549-1$	$Dr. received an urgent request to call a local Justice of the peace regarding one of her patients who was found dead in her home today.   At this time no foul play is suspected.  Dr. said the patient was relatively healthy with no major issues other than some hypertension$	$No current illness for this event.$	$Problem List: abscess of sublingual space abscess of submandibular region chronic ethmoidal sinusitis chronic maxillary sinusitis disorder of salivary gland essential hypertension history of asthma hyperglycemia hyperlipidemia leukocytosis localized enlarged lymph nodes mass of hand seasonal allergic rhinitis$Penicillins$ Levofloxacin$ sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017675-1$	$1017675-1$	$This 96 year old resident was diagnosed with COVID on 10/28/2020. She has a significant$ complicated medical history and  did not return to her pre-infection level of health. She began declining in early  January and was made care and comfort measures only on 1/2/2021.  Most of her medications were d/c'd except for those that provided comfort.  No obvious reaction to the vaccine was seen and we do not suspect that her death was vaccine related$ however we were directed by Dept of Epidemiology to report her death as it was within one week of receiving the vaccine.$	$COPD$ Diabetes Mellitus type  2$	$Nalignant neoplasm of cecum$ COVID positive 10/2020$ cerebral infarction$athersclerotic heart disease$ heart failure$ AV block$sulfa antibiotics$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1017744-1$	$1017744-1$	$Unknown$	$Unknown$	$Unknown$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1018278-1$	$1018278-1$	$death- unexplained cause$	$No current illness for this event.$	$Hypertension$ breast cancer$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1019850-1$	$1019850-1$	$HPI Patient is a 77 y.o. male who presents with in full cardiac arrest.  Patient is resident of local nursing home.  According to nursing home staff$ a tech was in his room talking with him as patient was laying in bed.  Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive.  Patient had no spontaneous respirations or pulse$ subsequently CPR was started immediately.  911 was called.  This occurred around 5:30 a.m.. ل Upon EMS arrival on scene$ they found a male unresponsive with CPR being performed.  There was no spontaneous respirations or circulation.  Thus$ ET tube was placed and ACLS guidelines initiated.  Patient was found to be in PEA$ and according to EMS$ patient was given a total of 6$ 1 mg epinephrine IV push and 1$ 1 Amp sodium bicarb.  Patient was worked on at the scene for approximately 40 min before being transferred to ER. ل Upon arrival to ER trauma room 1 patient is still in full arrest.  ET tube in place with good ventilation.  Patient remains in PEA.  Chest compressions and ACLS guidelines initiated. ل In reviewing patient's chart and nursing home notes$ patient is a full code.  Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG.  Patient also has history of 3rd degree heart block and pacemaker placement.  Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.$	$No current illness for this event.$	$$sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020119-1$	$1020119-1$	$My mother died suddenly on February 3rd. She went into shock/cardiac arrest and appeared to have internal bleeding. No autopsy has been performed. Unsure if it was related to the COVID vaccine.$	$Unknown$	$Chronic lukemia$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020135-1$	$1020135-1$	$$death Narrative: 92 yo male seen in clinic on 12/30/2020 for transfusion$ hbg 6.9. PMH includes HLD$ CKD$ myelodysplastic syndrome$ DM$ prostate cancer$ HTN. Pt also received COVID19 Pfizer vaccine the same day. The patient denied any prior severereaction to this vaccine or its components. Post-transfusion$ patient had a mechanical fall (per patient he was seated and used the cane to help him stand. However the cane slipped on the floor causing the patient to fall$ patient hit his head and injured his right hip$ no loss of consciousness at the time). Rapid response team was called and patient was admitted to the ED. Pt was found to have subcapital right femoral neck fracture$ scalp contusion$ and TBI (per ED provider's note). Ortho evaluated and said patient wasn't a surgical candidate. During his hospitalization$ patient tested positive for COVID19 on 1/12/2021$ pt was asymptomatic at the time. On 1/13/2021$ pt exhibited mild URI symptoms$ no respiratory distress. He was started on cetirizine$ Montelukast$ albuterol$ and inhaled steroids to manage his symptoms. Dexamethasone was started on 1/14/2021. Chest Xray was ordered on 1/17/2021$ pt's respiratory was slowly getting worse$ resting O2 sats were in the high 80s and low 90s with IS. On 1/18/2021$ CXR shows patchy bilateral airspace opacities suspious for pneumonia of bacterial or viral etiology. Pt was started on remdesivir 01/18/2021 (5 doses$ from 1/18-1/22/2021). Pt required 5-6 LPM of oxygen at rest. Pt was then transferred to the ICU. His oxygen demand continued to increase and his condition worsened. On 2/14/2021$ pt started to desat into the 70s on max high flow. Patient/family agree to comfort care. Medical cause of death was listed as $$acute hypoxic respiratory failure due to COVID19.$$ Patient expired 1/24/2021.$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020183-1$	$1020183-1$	$Death.  I actually not sure which Covid Vaccine she took. I just know the date and time she took it at her local school where she worked. Died in her sleep after complaining of a headache. I talked to her around 5pm on sunday through a videochat and she seemed happy and well. But a local friend commented that she had complained of a headache late in the afternoon.$	$Unknown$	$Angina$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020443-1$	$1020443-1$	$For the  two days prior to presentation the patient had been complaining of chest pain$ his breathing seemed to be labored Monday.  He and the family thought the pain was due to shingles as he  carried this diagnosis from a month ago. Patient had also received the COVID vaccine 2 days prior to presentation and assumed he was feeling unwell due to the vaccine.  Family wanted to take him to the hospital yesterday and earlier today but he refused.  She left him in his home earlier this afternoon prior to  presentation and returned to check on him finding him unresponsive and apneic at which time EMS was activated.    #cardiac arrest -- suspect primary cardiac given collateral from family at home$ consider hypoxemia which was corrected with advanced airway and 100% FiO2$ patient clinically euvolemic and with soft brown stool in diaper not suggestive of GI hemorrhage$ attempt to address acidosis with CPR and bicarbonate$ not  hypoglycemia$ on bedside ultrasound FAST neg and no pericardial effusion suggestive of tamponade and +lung sliding bil not spontaneous pneumothorax  Assessment/Diagnosis:  -cardiac arrest$ cause unspecified$	$Unknown$ per patient's daughter patient had unevaluated chest pain for 2 days prior to presentation$	$Unknown$No known drug allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1020654-1$	$1020654-1$	$Patient found unresponsive in room with no pulse or respirations.  She was pronounced dead by paramedics at 06:25am on 2/5/2021.$	$Acute Onchronic Respiratory Failure$ Aspiration Pneumonia$ and NSTEMI$ Diarrhea$ Hypertrophic cardiomyopathy$ Gram positive bacteremia$ Acute kidney injury$ Afib$$	$COPD$ Non-small cell lung cancer$ CAD$ Rheumatoid Arthritis$ Chronic Normocytic Anemia$ GERD$ HTN$ Hypokalmia$ Aneurysm of the thoracic aorta$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022127-1$	$1022127-1$	$One week to the day after patient's first vaccine he died of a heart attack; This is a spontaneous report from a contactable consumer and from a contactable physician. A 71-year-old male patient (husband) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 12Jan2021 at single dose on the right arm for COVID-19 immunization. The patient medical history included past heart conditions. No known allergies. Patient took other medications in two weeks. Facility type vaccine was doctor's office/urgent care. No other vaccine received in four weeks. One week to the day after patient's first vaccine he died of a heart attack on 19Jan2021 18:30. Cause of death was heart attack. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if an autopsy was performed. The physician  reported that the patient arrived DOA. Physician signed the death certificate based on the patient's prior diagnosis. Physician would not provide additional cause of death medical background without consent. He was not aware of any adverse events experienced from the time of vaccination to the date of death.   Follow-up (05Feb2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to HCP telephonic follow up activity which the following: patient death and cause of death were confirmed.  Follow-up attempts are completed. No further information is expected. Information about Lot number is not available.; Sender's Comments: Based on the temporal relationship$ the association between the event fatal heart attack with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to regulatory authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: One week to the day after patient's first vaccine he died of a heart attack$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Heart disorder$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022160-1$	$1022160-1$	$24 hours after shot had high fever 101$ chills$ weakness$ became listless$ family called 911$  client became unresponsive and died  in the Emergency room.$	$Kidney failure required dialysis 5x weekly$	$Cardiac$ Diabetes$ Kidney failure    Kidney transplant with kidney failure$no$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022397-1$	$1022397-1$	$Death 2/9/21$	$Resident was end of life/comfort measures which started 7/2/2020.  diagnosed with covid 1/20/21. received first vaccination 1/16/21 and second dose 2/6/21.  expired 2/9/21.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022529-1$	$1022529-1$	$Pt suffered Cardiac Arrest and respiratory arrest on 2/9/21 and passed away at a local hospital. He had multiple health conditions likely contributing to this.  he arrested at home and CPR was attempted and unsuccessful. Pt received his Covid vaccine #1 on 1/27/21. No issues were noted after vaccine and was due for his 2nd dose next week. However$ we were notified he passed away on 2/9/21.  Very likely death not at all related to vaccine but wanted to document as patient was in the middle of the covid vaccine series.$	$pt was seen 1/8/21 for a Scatica flare Pt had a follow up colonscopy performed 1/21/21 where a couple polyps were found and diverticulosis$	$pt has COPD and used Oxygen at night$ Coronary atherosclerosis$ Diabetes Type 2$ hypertriglyceridemia$ OSA$ hyperlipidemia$ hypertension$ IBS$ pulmonary emphysema$ acute or chronic heart failure$  morbid obesity$ atrial fibrillation$ depression$ hypercholesteremia$ stage 3 kidney disease$Amoxicillin(rash)$ Lisinopril (cough)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022685-1$	$1022685-1$	$Received Pfizer Covid Vaccine in the AM on 2/9/21. Arrived to emergency department later the same day complaining of nausea$ weakness$ fatigue$ Vomiting$ Diarrhea. Post operative diagnosis$ Ischemic colon/toxic megacolon.$	$No current illness for this event.$	$Parkinson's disease$ Diabetes$ Leukemia$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1022902-1$	$1022902-1$	$$death Narrative:  71 yo male who passed away on 1/29/2021$ medical cause of death $$cholangiocarcinoma$ interval between onset and death 14 months. Since patient passed away within 42 days of the covid19 vaccine administration$ we are required to complete a report to VAERS. Vaccine (Pfizer) was administered without complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Synopsis- 1/23 71 yo male presented to ED with upper GI bleed. PMH: DM$ HTN$ cholangiocarcinoma of biliary tract requiring recurrent paracentesis$ COPD$ perigastric and lower esophageal varices (not on beta blockers due to bradycardia). Pt has had 2 episodes of coffee ground emesis. Lactic 2.6$ ammonia 52. Rec'd protonix$ octreotide$ and ceftriaxone in ED. Family has been previously encouraged to speak to palliative care but has never been willing to. GI consulted. 1/24 EGD completed. No signs of active bleed. MDs recommending hospice. CT + for small bowel ileus. 1/26 Requires placement of NG tube to suction. Palliative care consulted. 1/27 Paracentesis completed. 4100mls removed. 1/28 Pt changed to palliative status. 1/29 Pt passed away.$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1023803-1$	$1023803-1$	$Was contacted by the person's daughter on 2/5/21.  Patient started vomiting 2 days after vaccination.  She aspirated and passed away 1/16/21.  Patient had history of stroke and swallowing problems.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024157-1$	$1024157-1$	$7 days after receiving the vaccine$ patient suffered excessive diarrhea and slight coughing.  9 days after vaccine$ patient was tested for Covid 19$ and received positive results.   Patient was transported to hospital via ambulance but hospital returned her to the nursing home since chest was clear$ no respiratory issues$ and no fever.  10 days after receiving the vaccine$ patient was turned over to hospice care but still in the nursing home.  Hospice was called in to provide better physician advice and access 24/7.  14 days after receiving vaccine$ patient began experiencing excruciating body aches$ coughing$ low oxygen levels$ and no appetite.  18 days after vaccine$ patient died.$	$Alzheimer's$ Type II Diabetes$	$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024592-1$	$1024592-1$	$No adverse reactions noted. Resident is on hospice for end of life care for terminal diagnosis cerebral atherosclerosis. Experiencing respiratory distress 2/10/2021 r/t to hospice prognosis.$	$acute pyelonephritis$ acute respiratory failure$	$Metabolic Encephalopathy$ Sepsis$ anemia$ neuropathy$ chronic kidney disease$ aspergers syndrome$ hydronephrosis with  uretral calculous obstruction$ uterovaginal prolapse$ obstructive and reflux uropathy$ protein-calorie malnutrition$ anxiety$ major depressive disorder$ gastro-esophageal reflux disese$ diabetes mellitus 2.$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1024743-1$	$1024743-1$	$pt became lethargic$ stopped eating.  No fever;  no nausea$	$none$	$vascular dementia$ glaucoma$ osteoporosis$none known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1025579-1$	$1025579-1$	$Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she screamed out and fell out of her chair. EMS was called and patient was found to be in Vfib. ACLS was performed for approximately 42 minutes prior to arrival at ED. At that time the patient had been pulseless for 25 minutes. Patient received 450 mg of amiodarone$ epinephrine x7$ sodium bicarbonate x2$ and 7 AED shocks. In the ED 3 more doses of epinephrine were given$ one more dose of sodium bicarbonate$ and 5 additional shocks. ROSC was not achieved and time of death was called at 1416.$	$none reported$	$coronary artery disease$  history of CABG$ history of MI$ hypertension$  COPD$ polymyalgia rheymatica$ hypercholesterolemia$ hear failure$ carotid artery stenosis$ type 2 diabetes$ morbid obesity$ rheumatoid arthritis$  panlobar emphysema (on 3L home O2)$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1025641-1$	$1025641-1$	$Complained of dizziness on January 18$th seen by MD this date.  Passed away on 22nd.$	$No other vaccinations no other illnesses$	$diabetes$Aspirin$ Simvistatin$ Tamsulosin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026095-1$	$1026095-1$	$DEATH 2/12/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026141-1$	$1026141-1$	$death 2/12/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026270-1$	$1026270-1$	$At 10:33 am Patient pushed her pendant for staff$ staff arrived to her apartment and Patient was found unresponsive in her bathroom. Patient received her second COVID-19 Pfizer vaccine about 75 minuets prior to this$ she had no adverse reaction's within the first hour of receiving the second dose. CPR was started until paramedics arrived$ they took over and tried to resuscitate. Patient was pronounced dead at 11:33 am at scene.$	$No current illness for this event.$	$primary hypertension  Mitral Valve regurgitation  COPD  Osteoporosis  Kyphoscoliosis deformity of spine  Rheumatoid factor positive  GERD  history of cellulitis of leg  history of C-diff post ATB therapy   Monoclonal gammopathy   Iron deficiency anemia$ unspecified  Hypothyroidism$ unspecified  Hyperlipidemia$ unspecified Coronary atherosclerosis due to lipid rich plaque  Nonrheumatic tricuspid valve disorder$ unspecified Chronic atrial fibrillation Allergic rhinitis$ unspecified  Barrett's esophagus without dysplasia  Other specified urinary incontinence$Ceftin$ Cefuroxine$ Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1026699-1$	$1026699-1$	$Had a stroke 3 days after round one of Covid vaccine and subsequently died the next week due to complications of stroke. Upon admission to hospital$ was in afib.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027051-1$	$1027051-1$	$Few minutes post vaccination$ after moving to observation area via wheelchair$ the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1.  Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed$ V- Fib was rhythm$ Shock # 1 given$ CPR resumed. Shocked again.  Fire truck and additional EMT arrived on site and  took over care. Epinephrine was given 3 times via intra-osseous route$ Amiodarone given intra-osseous route.  Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag$ no airway obstruction or peri-oral edema noted.  Code called at 12:40 PM.$	$Patient not feeling well this morning prior to arrival$ complaints of shortness of breath$	$Diabetes Status Post MI x 4 Status Post left stent Status Post right stent Breast CA Status Post Bilateral Mastectomy$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027071-1$	$1027071-1$	$Adverse reaction to the vaccine started with variable weakness beginning 1/29/2021.  On 1/30/21 around 8:30pm$ he needed assistance in the bathroom related to weakness and had what was later identified as a stroke with left side weakness and slurred speech.  In accordance with his wishes$ he had care at home.  Due to his advanced age and frailty$ a CT scan was not pursued.  The 325 mg of aspirin that he was previously taking daily was discontinued.  After the stroke$ he needed total care. Hospice was established at home.  Nursing assistant care was delivered by daughter.  Death followed 9 days later (2/9/2021).$	$Very elderly$	$Previous heart bypass surgery (1995) and later two stents between 1995-2000$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1027503-1$	$1027503-1$	$Patient died on 02/08/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1028101-1$	$1028101-1$	$Pt develops left leg pain The day after vaccination in AM subsequently drove approximately 150 miles On his way back stopped at his brothers place for lunch. He then collapsed coning down the steps$ EMS started CPR. took him to ER  Resuscitated briefly  but went into CardioPulm Arrest again and PEA Resucitaion for aprox 1 hour but was unsuccessful. Noted to have Left leg more swollen than Right by 3 to 4 CM presumed to have died from massive Pulmonary embolism and inferior wall myocardial ischemia$	$Hyperuricemia Renal stone$	$Hyperuricemia Renal Stones$Shellfish$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1028217-1$	$1028217-1$	$DEATH$	$no$	$arthritis$ type 2 diabetes$ back issues$ blood pressure.$no$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1028885-1$	$1028885-1$	$Patient (now deceased) received 1st dose of Pfizer-BioNTech vaccine around December 21$ 2020 and was noticed to be scratching$ fatigued$ and unresponsive by a family member on December 24$ 2020. He received the second dose of the same vaccine around January 22$ 2021. Pockmarks and bleeding scratch marks were noted by a family member on the patient's face prior to this second dose. On January 28$ 2021 a family member was alerted that the patient was suffering from severe bullous pemphigoid- a skin condition that has never been experienced by the patient$ has been reported to be related to COVID-19 viral infection$ and to T-cell responses promoted by vaccines. A corticosteroid was given$ but did not work. Blisters developed to the point hands had to be dressed.$	$No.$	$None known.$None known.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1028921-1$	$1028921-1$	$Patient had no energy in the first 24 hours and then began a steady decline that started with vomiting after 48 hours$ then an inability to swallow and ultimately the patients death on 2/5/21.$	$Parkinsons$ Type 2 Diabetes$	$Parkinsons$ Type 2 Diabetes$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029374-1$	$1029374-1$	$On 2/4/21$ at around 3:00pm he began feeling very tired and he began burping in the evening.  The following morning$ he woke up early and was still burping and not feeling well.  At around 5:00am$ he collapsed.  My mother called 9-1-1 and began giving CPR.  The parademics arrived and tried to revive him$ and transported him to the hospital but at 6:11am$ he was pronounced dead of a heart attack.  He was healthy.$	$none$	$none$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029744-1$	$1029744-1$	$right arm swelling  immediately after injection. followed by bilateral lower leg edema$ chills and body aches that continued  daily at 2 weeks post immunization admin  2/4/21 treated with  dexamethasone 6mg PO x 7 days- this resolved his s/s   2/13/21 patient passed away at facility$	$none$	$hyperlipidemia$ hypertension$ digenerative disc disease$ BPH$ osteoporosis$  skin cancers- removed$ constipation$ allergic rhinitis$chlorpheniramine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1029790-1$	$1029790-1$	$Taken to Emergency about 8 hours later and died in ER$	$Dementia$	$Anemia$  Osteoporosis$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1030729-1$	$1030729-1$	$deceased$ 2/1/21$	$n/a$	$kidney$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1030893-1$	$1030893-1$	$Resident had slight/slow decline in health prior to vaccine but continued to be able to walk around with walker at community. The day of the vaccine she had a fever. 2 days after vaccine resident did not get out of bed all day and refused to eat. She had small amounts of orange juice as her blood sugar level was low due to not eating. Resident was diagnosed with a UTI and began an oral antibiotic. 3 days after and on day 5 after vaccine resident began feeling weak and had a fall on each day. The following day again resident spent the day in bed. The next day she was quite restless$ was on the edge of her bed attempting to self transfer often throughout the day. Resident continued to be restless on the 10th of Feb$ had further decline on the 11th of Feb. Resident passed away early the AM of Feb. 12th.$	$Resident had a low grade fever day of vaccine and was not feeling well. Pharmacy stated it would be ok to have vaccine and administered in resident's room.$	$Osteoporosis$ type 2 diabetes$ vitamin B deficiency$ anxiety$ achalasia of cardia$  GERD$ iron deficiency$ atrial fibrillation$ chronic kidney disease$Fluoxetine and Metformin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031595-1$	$1031595-1$	$Unresponsive$ Increase BP and H. Hospital Dx Renal Failure$	$Covid + 1/6/2021$	$CHF$ Heart Disease$ Dementia$ A Flutter HTN$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031780-1$	$1031780-1$	$Patient was not seen at our facilities prior to or after COVID-19 vaccination. Patient received first dose on 1/23/2021 and as reported by the family member$ patient expired on 2/5/21. Symptoms were reported to have stared on 2/1/2021$ 9 days after receiving the first dose with a drop in oxygen levels and fever.  He was reported to also have a history of chronic lung disease.  Patient's family member to be contacted if necessary.$	$Unknown$	$Reported chronic lung disease. Additional details are unknown.$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032161-1$	$1032161-1$	$$The day after the 2nd shot$ patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21.  Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3$$ and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit$ he had recovered from COVID$ but was very thin and weak. He could not bathroom alone and kept falling.  He didn't seem to have a bad reaction to the 1st COVID shot$ But he immediately reacted to the 2nd shot and passed away within 6 days.$$	$Dementia$ Arthritis$	$Dementia$ Arthritis$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032193-1$	$1032193-1$	$Patient received his first dose of Covid vaccine on Jan. 30$ 2021. On Jan 31$ 2021 at 6:08 AM$ patient noted unresponsive per facility. Code blue was called and 911 dispatched. He expired in the ER.$	$Unknown$	$Diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032662-1$	$1032662-1$	$Death$	$Absolutely  none. Unusually healthy for 86$	$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1032880-1$	$1032880-1$	$Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB$ cough$ confusion. COVID assoc. resp. failure$ stage 4 lung cancer$ COPD$ HTN$ former smoker. patient in hospice  and died 2/10/2021.$	$Hospice Chronic  COPD$	$Cancer chest pain  COPD  Cough $ HX of Radiation and Chemotherapy   Hypercholestemia $ HTN$ Seizure $ Shingles$ SOB$Phenergan$  Codeine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033444-1$	$1033444-1$	$symptoms of ongoing congestive heart disease just progressed$	$Addison's disease$ abdominal hernia$	$Congestive heart disease    Addison's disease$sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1033682-1$	$1033682-1$	$L hand edema$ hematoma which burst and caused bleeding sending pt to the ER for pressure dressing and 2 stitches.  L hand and arm progressively got more edematous and bruised looking (severely black/blue/purple) and the hand continued to bleed and swell on 2/6/21.  Severe arterial and venous issues and apparent blood clots.  On 2/7/21 there were also lumps noted on left inner thigh.  Pt. stopped eating or drinking on 2/8/21 and expired on 2/12/21.$	$polycythemia vera$ dementia$ type 2 diabetes mellitus$ HTN$	$Type II DM$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035542-1$	$1035542-1$	$passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE$ Batch/lot number: EN9581)$ via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016)$ on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that$ and by 16:30$ he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Heart valve replacement; Oxygen supplementation (On Oxygen at night)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035841-1$	$1035841-1$	$Death on 2/8/2021 unknown signs and symptoms at time of death; multiple co-morbidities$	$Diarrhea with Cdiff etiology$ seen in the Wound Center on 2/3/2021 for a pressure ulcer; Seen in ER on 1/14 with diarrhea$ fatigue$ cough and shortness of breath labs revealed BUN 20; Cr 1.68; GFR 29; Alk Phos 152.$	$AAA with stent; COPD; Dyslipidemia; Hypertension; Kidney Disease; Murmur; Osteoarthritis; Home oxygen use; Stroke; Parkinson's; Former Smoker; Lung Cancer.$Gluten; NSAIDS; Penicillin; Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035897-1$	$1035897-1$	$Patient received her vaccine on 2/2/2021 in the morning. She was observed for over 15 minutes and had no history of any anaphylactic reaction of any sort. She felt fine and went home. 2/15/2021 we were notified by her family that she had passed away on 2/7/2021 at home. The cause of death was stated as myocardial infarct secondary to coronary artery disease. We do not think it had to do with the vaccine administration. The patient had many comorbidities.$	$Acute chronic diastolic CHF exacerbation one month prior One oxygen for stage IV COPD$	$Diastolic CHF$ Stage 3 chronic kidney disease$ adrenal adenoma$ COPD stage IV$ Coronary artery disease with stents$ diabetes mellitus$ chronic atrial fibrillation$ chronic hypertension$ osteopenia.$Jardiance: Caused a yeast injection$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035943-1$	$1035943-1$	$Patient had no reaction at the time of vaccination. Waited the required 15 minutes and was allowed to go home.$	$No current illness for this event.$	$Incomplete Quadriplegic. Wheelchair bound after accident where he sustained brain damage after being knocked over by a wave and hitting his head on a sand swell.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035950-1$	$1035950-1$	$Patient found deceased at home on 2/15/2021. There was no known cause of death with no significant medical history.$	$none reported$	$non reported$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036532-1$	$1036532-1$	$Patient was found unresponsive the following day and then pronounced deceased$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036634-1$	$1036634-1$	$Patient had COVID in Sept.  Minimal symptoms.  Received 1st dose 1/18 without adverse reactions.  Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health.  On 2/14 @ 2 hours after having lunch$ patient was found unresponsive with Respirations 60$ pulse 130$ PO 84%$ blood pressure 105/68.  Patient with lots of white foam coming out of mouth.   Temperature to 101.3.  Patient DNR B and family deferred transfer$ wanted comfort measures only.  Nursing received order for MSIR.  Patient continued with temps in 99-100 range with tylenol suppositories.  Patient passed on 2/16.$	$none$	$HTN$ dementia$ Downs syndrome$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036655-1$	$1036655-1$	$Death on 1/31/2021 multiple comorbidities$	$Chronic Stage IV sacral decubitis ulcer infected with necrotic tissue. Inpatient admit 1/14-1/27 for infected decubitis ulcer$ osteomyelitis; bacteremia and possible cirrhosis and underwent multiple debridements while hospitalized.$	$ESRD on Dialysis; heart cath; anemia; bells palsy; CHF; Uterine Cancer s/p hysterectomy; CKD; DM; dyslipidemia; HTN; Obesity; AFib.$Captopril$ lisinopril and plavix$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036678-1$	$1036678-1$	$Resident did not exhibit any side effects from the vaccine.  Staff spoke with him in his room at approximately 7:20am and returned to his room  just a few minutes later and he was unresponsive.  When the RN got to the room he had CTB.  Physician  documented heart failure and end stage kidney disease on the death certificate.$	$pneumonia-recent infection$	$chronic kidney disease-stage 4$ schizophrenia$ heart disease$ COPD$ hypertensive heart disease with heart failure$  myalgia$ nonrheumatic aortic valve stenosis$hydantoins$ lipitor$ phenytoin$ statins-hmg-coa$ reductase inhibitors$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036697-1$	$1036697-1$	$Multiple co-morbidities history of COVID-19 6/8/2020 and 12/28/2020.  At time of vaccination fighting osteomyelitis.  1st dose 1/13/21$ 2nd dose 2/3/2021 expired 2/8/2021.$	$Stage 4 sacral pressure ulcer with osteomyelitis with indwelling urinary catheter and peripherally inserted central catheter.  IV Vancomycin$	$Neurogenic bladder$ traumatic brain injury; metabolic encephalopathy; aphasia; Tourette's; Hypertension; insomnia; apraxia; GERD; Pseudobulbar affect; chronic pain; anxiety; major depressive disorder$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036748-1$	$1036748-1$	$Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis.  Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice$ dialysis stopped resulting in death.$	$ER visit 1/7 due to fall$ CT negative  current Dialysis$ pneumonia$ hospice patient.$	$DVT$ dementia$ hep c$ hyperlipidemia; occlusion of internal carotid artery; paroxysmal Afib; traumatic brain injury$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1037878-1$	$1037878-1$	$Is patient deceased: Yes; Low pulse; This is a spontaneous report from two contactable nurses reporting for a patient. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0140 expiration date Mar2021) intramuscular on 22Dec2020 at 10:30 at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Nursing Home. Patient age at time of vaccination was 70 years. Patient's Medical History included ongoing Type 2 Diabetes Mellitus Without Complication onset date: admission 22Oct2020$ ongoing morbid obesity due to excess calories onset date: admission 22Oct2020$ cardiac disorder$ essential hypertension$ hypertension$ schizophrenia$ hyperlipidemia$ benign prostatic hyperplasia (BPH)$ Gastrooesophageal reflux disease (GERD)$ depression$ hypothyroid$ epilepsy$ pain$ dry eyes$ anxiety$ restlessness$ 17Jan2020 Slid out of chair to floor$ no injury$ on 27Jan2020$ 28Jan2020$ 29Jan2020 diarrhea noted. Concomitant medications included acetylsalicylic acid (ASPIRIN EC) for Cardiac Health$ atenolol (ATENOLOL) for Essential Hypertension$ atorvastatin calcium (ATORVASTATIN CALCIUM) for hyperlipidemia$ finasteride (FINASTERIDE) for benign prostatic hyperplasia$ tamsulosin hydrochloride (FLOMAX) benign prostatic hyperplasia$ insulin glargine (LANTUS) for diabetes mellitus$ lithium carbonate (LITHIUM CARBONATE) for Schizophrenia$ losartan potassium (LOSARTAN POTASSIUM) for hypertension$ lurasidone hydrochloride (LURASIDONE HYDROCHLORIDE) for Schizophrenia$ omeprazole (OMEPRAZOLE) for gastrooesophageal reflux disease$ sertraline hcl (SERTRALINE HCL) for depression$ levothyroxine sodium (SYNTHROID) for hypothyroid$ ergocalciferol (VIT D) for supplement$ haloperidol (HALOPERIDOL) for Schizophrenia$ levetiracetam (KEPPRA) for epilepsy$ paracetamol (TYLENOL EXTRA-STRENGTH) for pain$ propylene glycol (ARTIFICIAL TEARS) for dry eyes$ lorazepam (ATIVAN) for a anxiety or restlessness. As antipyretic use was reported Tylenol ES (500 mg) Tab$ 2 Tabs by Mouth Routine use three times a day given at time of vaccination and after. It was reported the patient was Covid+. He was tested on 21Dec2020 and was not admitted to hospital. Event Onset Date was reported as 24Dec2020 (clarification pending). On 30Dec2020 the patient was started on O2 at 2L for low pulse. O2 was increased over time to eventually O2 at 8L on 03Jan2021. Morphine Sulfate was started on 03Jan2021 at 5 mg sl/by mouth every 2 hours as needed for pain or airhunger. The patient deceased on 03Jan2021. The cause of death was unknown. It was not reported if an autopsy was performed. The AEs did not require a visit to Emergency Room or Physician Office. Outcome of Low pulse was unknown.; Sender's Comments: Based on the information available the events Death (unknown cause) and Heart rate decreased are attributed to patient's multiple underlying medical conditions including Type 2 Diabetes Mellitus$ morbid obesity$ cardiac disorder$ hypertension$ epilepsy etc. However$ based solely on a vaccine-event chronological association$ contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the above mentioned events cannot be completely excluded. The case will be reevaluated should additional information$ including the cause of death$ become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: Is patient deceased: Yes$	$Morbid obesity (Onset Date: Admission 22Oct2020); Type 2 diabetes mellitus (Onset Date: Admission 22Oct2020)$	$Medical History/Concurrent Conditions: Anxiety; BPH; Cardiac disorder; COVID-19 virus test positive; Depression; Diarrhea; Dry eyes; Epilepsy; Essential hypertension; Fall; GERD; Hyperlipidemia; Hypertension; Hypothyroidism; Pain; Restlessness; Schizophrenia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038225-1$	$1038225-1$	$Death$ 2-17-21 at 1802 hours$	$G60.9$ D72.1$$	$G60.9$ D72.1$$Tomato$ cheese$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038290-1$	$1038290-1$	$Death on same day as vaccination$	$Outpatient admission 1/25-1/27 with Hypertension urgency and inability to care for self at home$ discharged to Agency;  1/28/21 had a choking episode and continued to decline from there.  ER 1/31 and 2/1 for low grade fever and continued decline returned to SNF and wife placed patient on hospice.$	$Apnea; diabetes; dyslipidemia; ischemic stroke; prostate disorder; multiple CVAs with residual weakness$Sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038561-1$	$1038561-1$	$(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness$ increased congestion and mucous production.  (02/16-17/2021) : death possibly during the night$	$AAA$ GERD$HTN$ CAD$ CA$ arthritis$	$AAA$ GERD$ HTN$ CAD$ CA$ arthritis$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038579-1$	$1038579-1$	$Death$	$COPD HTN Lung Cancer$	$COPD HTN Lung Cancer Prostate Cancer$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1038720-1$	$1038720-1$	$Resident complained about back pain in the middle of the night and when they went to do a blood pressure examination$ she passed away at 2:40 am.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1039250-1$	$1039250-1$	$Daughter of decedent reported that he quickly declined within 2 weeks of receiving vaccine and developed shortness of breath. Decedent received vaccine 1/30/2021 and died 2/15/2021. Only received first dose of series.$	$No current illness for this event.$	$dementia$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1039922-1$	$1039922-1$	$$death was from natural causes; collapsed; This is a spontaneous report from a contactable consumer.  A 73-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)$ via an unspecified route of administration on 05Feb2021 at 73-years-old at a single dose for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (on oxygen as needed$ but not every day)$ oxygen therapy from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates (Gets flu shot every year around October). On 06Feb2021$ the patient collapsed (medically significant) and experienced death was from natural causes (death$ medically significant).  The clinical course was reported as follows: The reporter stated that his grandmother received the first dose of the Pfizer COVID-19 vaccine on 05Feb2021 and passed away on the morning of 06Feb2021.  The patient went to bed and woke up in the middle of the night around 03:00 to use the bathroom and collapsed and died within 10-15 minutes of collapsing. The patient was pronounced dead at the scene. The reporter asked: $$What do you know about the news in the media about reports of death in nursing home elderly patients?$$  The reporter wanted to know the ingredients of the Pfizer COVID-19 vaccine. The reporter wanted to know about the use of the Pfizer COVID-19 vaccine in patients with underlying conditions. The patient had COPD and was on oxygen as needed$ but not every day. The Medical examiner said the death was from natural causes and the family was not doing an autopsy.  The patient had been tested for COVID and was negative. The patient underwent lab tests and procedures which COVID test: negative on an unspecified date. The clinical outcome of the event$ death was from natural causes$ was fatal. The clinical outcome of the event$ collapsed$ was unknown. The patient died on 06Feb2021 due to death was from natural causes.  An autopsy was not performed.   The batch/lot numbers for the vaccine$ bnt162b2$ were not provided and will be requested during follow up.; Reported Cause(s) of Death: death was from natural causes$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: COPD (on oxygen as needed$ but not every day); Oxygen therapy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041185-1$	$1041185-1$	$Death within 30 days$	$COVID + 12/10/2020 recovered. Placed on Hospice care 10/2020$	$Dementia; HTN; Parkinson's; Bladder Cancer$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041230-1$	$1041230-1$	$Patient received first dose of covid vaccine on 1/22/2021.  Patient had no immediate reaction.  Patient presented  to the Emergency Department on 1/26/2021 c/o shortness of breath and chest pain. ECG showed a ST elevation myocardial infarction.  Patient was treated and transferred to a cath lab where he died.  Patient had significant coronary artery disease.$	$n/a$	$Hyperlipidemia$ GERD$ Monoclonal B-cell Lymphocytosis$ Asthma$ DJD of spine$ osteoarthritis$ hypertension$n/a$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041656-1$	$1041656-1$	$she died 2/12/2021 at close to 2pm$	$no$	$congestive heart failure$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041740-1$	$1041740-1$	$Patient died on 2-13-21$	$No current illness for this event.$	$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1041789-1$	$1041789-1$	$As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday$ than  she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD$ Lung Ca and ASHD.$	$no$	$Advanced COPD on Oxygen therapy$   Stage 1$ lung Ca$ Adenocarcinoma$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1043690-1$	$1043690-1$	$Ventricular fibrillation/sudden death$	$No current illness for this event.$	$HLD$ GERD$ OSA$ rosacea$ pulmonary HTN$ HTN$ CAD$ hx of prostate cancer$ sinus node dysfunction$ aortic stenosis$ diastolic dysfunction$ cardiac pacemaker$Amiodarone - pulmonary toxicity Lipitor - rash Penicillins - mild hives Adhesive tape/silicones - rash$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1044704-1$	$1044704-1$	$Light headedness$ fatigue$ nausea$	$None$	$High blood pressure$ COPD$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1045635-1$	$1045635-1$	$Death; Passed out; Stomach was bothering; Constipated; Difficulty breathing; Weakness/Event: Weakness was reported as worsened; a temperature of 99.4 degrees; Sweaty; Cold; Muscle ache; Body Aches; Diarrhea; Nausea; Vomiting; Fatigue/Tiredness; His raspy throat felt like he had mucus stuck in his throat; Cough; Raspy throat/worsened; This is a spontaneous report from a contactable consumer reporting her husband. A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ Batch/lot number: EM9810$ Expiry Date: Jun2021) at the age of 74- year-old via an unspecified route of administration on 04Feb2021 09:15 at single dose in Arm$ Right for COVID-19 immunisation. Medical history included type 2 diabetes mellitus for about 20-25 years$ ongoing kidney disease from 2005$ ongoing chronic kidney disease$ cardiac pacemaker insertion. The patient was diagnosed with kidney disease in 2005$ but it was about 1 to 1-1/2 years ago that his kidney disease progressed to Stage 4 Kidney Disease. She said the Veterans Administration diagnosed her husband with his kidney disease$ but her husband saw a private doctor$ as well as$ a VA doctor for his care. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot Number: EL3248; Expiration Date: Apr2021) at the age of 74- year-old Intramuscularly at approximately 08:45AM on 15Jan2021 in right arm for COVID-19 immunisation and had no reaction. There were no additional vaccines administered on same date of the Pfizer suspect. There were no Prior Vaccinations within 4 weeks. The patient had symptoms start earlier in the day of Tuesday$ 09Feb2021$ after his second COVID-19 Vaccine shot (04Feb2021). The reporter said she and her husband didn't think anything of his symptoms at first. The patient had a temperature of 99.4 degrees on 09Feb2021. She didn't check her husband's temperature again after that time because the nurse at her husband's doctor's office said her husband's temperature was not at an area of concern. The patient was sweaty$ off and on$ starting 09Feb2021. She clarified he would be sweaty and the cold$ but nothing extreme. The patient developed muscle aches$ body aches$ diarrhea$ nausea$ and vomiting on 09Feb2021. She clarified her husband had fatigue$ tiredness$ and had trouble with a raspy throat. His raspy throat started Tuesday evening (09Feb2021). His raspy throat felt like he had mucus stuck in his throat$ and he was unable to clear the mucus from his throat. The reporter called her husband's primary care doctor on the morning of 10Feb2021 because her husband was having trouble with a raspy throat$ and difficulty breathing. She said on Tuesday night (09Feb2021) her husband had to sleep sitting up because he couldn't lay down with his breathing.  He was able to eat breakfast (clarified as oatmeal and an orange)$ lunch (clarified as soup and a salad)$ and dinner (clarified as soup and half a sandwich. She said her husband ate all the meat and half of the bread on the sandwich) on 10Feb2021. Her husband's primary care doctor wasn't available to speak to on Wednesday morning (10Feb2021)$ but the doctor's nurse said it sounded like her husband was having a reaction to his second COVID-19 Vaccine shot. The reporter said her husband's doctor instructed her later in the day to take her husband to the Emergency Room or Urgent Care if he didn't feel any better. Her husband's throat raspiness got worse in the evening of 10Feb2021. His breathing also became worse after dinner in the evening of 10Feb2021. The patient leaned forward over a couple pillows while sitting on their couch as it was easier for him to breath by doing that. They decided at 11:00PM that her husband should go to the Emergency Room. She said her husband was getting very weak$ so she and her husband debated if she should call # for an ambulance$ or if she should drive him to the Emergency Room. She said her husband was able to dress himself$ but with some difficulty$ and she assisted walking him from their house to their car. She said she had turned to walk away from her husband while he was at the side of their car$ and then she heard her husband make a noise. He had appeared to have passed out. She clarified in the past$ her husband had passed out prior to his pacemaker. She said she dialed #$ and the # operator told her how to tell if her husband was still breathing. She said she couldn't tell if her husband was still breathing. She said when the ambulance arrived at her house$ the ambulance staff worked on her husband for a long time. The reporter thought her husband had died at the time he had collapsed at the side of their car. The patient took a sugar free cough syrup Tuesday night (09Feb2021)$ and then again a couple times on Wednesday (10Feb2021) as treatment. The patient had thrown up a couple times$ but found that the sugar free cough syrup soothed his cough the night before (09Feb2021). She said her husband had taken 2 TUMS early on Wednesday morning at approximately 2:00AM (10Feb2021). He had said his stomach was bothering him on 10Feb2021. He said he thought he may be constipated$ so he took 1 Senokot (Clarified as GeriCare Senna-Plus Natural Vegetable Laxative with Stool Softener) on 10Feb2021. She clarified her husband had diarrhea on 09Feb2021$ but felt on 10Feb2021 he may have been constipated. There were no adverse events required a visit to Emergency Room since Patient's wife stated she was getting her husband to their car$ so she could drive him to the Emergency Room$ when her husband collapsed and died or to Physician Office as they spoke with the nurse at her husband's primary care doctor's office. Weakness was reported as worsened. The outcome of events Sweaty$ Cold$ Muscle ache$ Body Aches$ Fatigue/Tiredness$ Raspy throat/worsened$ Difficulty breathing$ Weakness was not recovered; and of the remaining events was unknown. The patient died on 11Feb2021. The patient's official time of death was Thursday$ 11Feb2021$ at 12:08AM. Cause of death was unknown. An autopsy was not performed and it would take 3 weeks for a death certificate to be issued. The reporter stated she thought it was important to notify Pfizer of her husband's passing because his side effects fell within the expected time period after receiving his second COVID-19 Vaccine.; Reported Cause(s) of Death: Death$	$Chronic kidney disease stage 4; Kidney disorder$	$Medical History/Concurrent Conditions: Pacemaker insertion (cardiac); Type 2 diabetes mellitus$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1045803-1$	$1045803-1$	$Patient was found with no pulse no heart rate by a staff member around 11 pm.  Earlier that day seen by myself for fatigue$ sorethroat$ nausea.$	$symptoms of nausea and sorethroat 1 week prior to vaccine$	$Hypertension$ hyperlipidemia$ dementia$ lymphedema$ glaucoma$sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1045972-1$	$1045972-1$	$patient passed away within 60 days of receiving a COVID vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046265-1$	$1046265-1$	$Received 2nd dose of COVID19 Pfizer vaccine at 1103 am on 2/19/21$ was last seen at 1159$ found around 1615 by kitchen staff who were serving dinner.$	$No current illness for this event.$	$A-fib$ dementia$ BPH$ HTN$ CEREBROVASCULAR DISEASE and anemia.$No known allergies.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046317-1$	$1046317-1$	$Patient passed away from chronic respiratory failure with cardiogenic shock 24 hours from 2nd dose of vaccine. Patient with longstanding history of pulmonary HTN and heart failure with desire for comfort care only.  Entering into VAERS out of abundance of caution.$	$No current illness for this event.$	$chronic respiratory failure due to pulmonary hypertension$ hypothyroidism$ right heart failure$ chronic kidney disease stage IV$ IDDM$ BPH$ essential hypertension$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046397-1$	$1046397-1$	$Death$	$Dementia$ HTN$ Hypothyroid$ Intestinal malabsorption$ Hx neoplasm$ breast$$	$Dementia$ HTN$ Hypothyroid$ Intestinal malabsorption$ Hx neoplasm$ breast$$Lisinopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046666-1$	$1046666-1$	$Patient had no adverse events during the observation period after vaccine. He was conscious and having conversation with facility staff. He was observed for 15 minutes at least. When the facility staff returned later$ approximately 60 to 90 minutes$ patient had passed away.$	$None$	$Heart and artery diseases$KNDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046722-1$	$1046722-1$	$No symptoms or signs on the day 1st dose of vaccine was received (2/11/2021).  3 days later$  (2/14/2021) patient experienced chills for approximately 6 hours$ followed by severe (visible) chest spasms$ and then cardiac arrest.  911 was called upon witnessing chest spasms$ but cardiac arrest/death occurred before patient could be transported to the hospital.$	$UTI$	$Congestive Heart Failure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046763-1$	$1046763-1$	$1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of mental acuity compared to previous day.  1/24 - Continued loss of appetite. Near complete loss of ability to move. Continued decline of mental acuity. Very little speaking. 1/25 - Stopped speaking completely. Loss of bowel control in the evening and continued until death. Complete loss of appetite. 1/26 - Near complete loss of ability to swallow. Moved to hospice 4:00pm. 1/27 - Died 4:00am$	$bilateral pneumonia$	$lung cancer (metastatic non-small cell carcinoma)$ emphysema$ pulmonary hypertension$scallops$ contrast dye (ivpDye$ iodine containing)$ epinephrine$ reglan$ compazine$ adhesive tape$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1046915-1$	$1046915-1$	$Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches$ and chills$ Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2$ and vomiting. RN came to assess @ 1220 am She was noted to be vomiting$ diaphoretic$ pale and having trouble breathing. Temp was 97.3 after vomting$ Pulse 53$ Resp 20$ o2 sats were 40-45%$ unable to obtain Blood pressure$ Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.$	$No current illness for this event.$	$Above the knee amputation of left lower extremity$ Coronar Artery Disease$ Clotted Dialysis access$ Previous COVID-19 Virus Infection 11/2/20. Diabetes$ Dialysis patient$ End Stage Renal Disease$ Gastric Bypass status for obesity$ Hypertension$ Non healing wound of amputation stump$ Polyneuropathy$ Pneumonia secondary to COVID infection$ Atrial Fibrillation$ Hx of stroke$$Tramadol (vomiting$ nausea)$ Tape (Rash$ Itching)$ Bee stings (anaphylactic reaction)$ Betadine (rash$ Itching)$ Wasps (anaphylactic reaction)$ Clonidine( vomiting)$ Isosorbide (vomiting)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1047434-1$	$1047434-1$	$Patient died 3 days after receiving his first dose of the Covid vaccine. He saw his doctor 2 weeks prior to his death with absolutely no complaints$ very healthy. He had no prior heart conditions and was pronounced dead of a heart attack.$	$Completely healthy check-up 2 weeks prior to vaccination and death.$	$none$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1047455-1$	$1047455-1$	$Resident deceased$	$Multiple falls$ HTN$ TIA$ mild cognitive impairment$ Gait abnormality$ hearing loss$ major depressive disorder$ osteoporosis$ central pontine myelinolysis$	$HTN$ TIA$ mild cognitive impairment$ Gait abnormality$ hearing loss$ major depressive disorder$ osteoporosis$ central pontine myelinolysis$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1048690-1$	$1048690-1$	$presumed cardiac failure; This is a spontaneous report from a contactable nurse. An 89-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EL9261)$ intramuscular at arm left on 10Feb2021 (at the age of 89 years) at single dose for COVID-19 immunization. The patient medical history included congestive heart failure$ coronary artery disease$ hypertension$ hyperlipidemia$ osteoarthritis$ presence of prosthetic heart valve and allergies$ all from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine besilate/benazepril hydrochloride$ amlodipine$ acetylsalicylic acid (ASPIRIN E.C.)$ atorvastatin$ benazepril$ carvedilol$ ubidecarenone (COQ10)$ furosemide$ acetaminophen and potassium chloride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EL0142)$ intramuscular at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient experienced presumed cardiac failure on 12Feb2021 at 03:30 with fatal outcome. The patient died on 12Feb2021.  An autopsy was not performed.; Sender's Comments: Based on the current available information$ the event Cardiac failure is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The patient medical history of congestive heart failure$ coronary artery disease$ hypertension$ and hyperlipidemia provide plausible explanations for the event.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: presumed cardiac failure$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Allergy; Congestive heart failure; Coronary artery disease; Hyperlipidemia; Hypertension; Osteoarthritis; Prosthetic cardiac valve malfunction$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1048745-1$	$1048745-1$	$Death on February 12$ 2021 acute cardiac tamponade$	$No current illness for this event.$	$Allergic rhinitis benign essential hypertention Depression  Generalized Anxiety Hip Pain Total revision of left hip$Gabapentin- Pain in eye$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049428-1$	$1049428-1$	$2/7/21 Increased difficulty chewing$ swallowing$ evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss.  2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP$ Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24$ radial pulse 134$ O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition$ poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization$ no IV's$ no G-tubes$ no labs etc$ D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy$ elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml$ give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice$ Lethargic$ diaphoretic$ T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon$ 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.$	$1/6/2021-Resident noted with increased irritability and increased signs/symptoms of discomfort. Followed by Palliative APRN. Labs ordered and Tylenol increased for pain management.  1/7 labs BUN 28mg/dl/Creatinine 0.53mg/dl. CBC unremarkable.  1/7/2021-1st Pfizer Covid-19 Vaccine dose given.   1/15/2021 Palliative APRN came to visit reviewed labs Valproic Acid level WNL. Hepatic Panel with Albumin low at 2.6g/dl. Plan of care discussed with Guardian. N.O. DNR/DNH$ may have draws labs and treat with ABX if needed.  1/24/2021 Patient vomited large amount of undigested food. 1/28/2021 2nd Pfizer Covid-19 Vaccine dose given.$	$Hx Covid + June 4$ 2020; HYPERLIPIDEMIA$ UNSPECIFIED (E78.5); UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE; TYPE 2 DIABETES MELLITUS WITH HYPERGLYCEMIA (E11.65); ESSENTIAL (PRIMARY) HYPERTENSION (I10); glaucoma; UNSPECIFIED MOOD [AFFECTIVE] DISORDER (F39); HYPOKALEMIA (E87.6); GASTROESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS (K21.9); HYPERLIPIDEMIA$ UNSPECIFIED (E78.5);$Nylons$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049724-1$	$1049724-1$	$Emergency room 1/11/21   Patient is a 72 year old female who presents with decreased level of consciousness.  The patient is a nursing home patient and had an episode of choking yesterday that was treated with a Heimlich maneuver.  Nursing staff at the nursing home reports that she seems to be a bit less responsive today.  However$ the patient has been for the most part unresponsive for 3-4 months time following a COVID-19 infection.  Of note$ her oxygen saturation on room air is 72%.  The patient is also febrile to 100.8¦.  She was unable to provide any information and the aforementioned information is gathered from nursing home staff report.$	$No current illness for this event.$	$$Bandage adhesive Celebrex Latex Lincomycin Macrobid$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1049864-1$	$1049864-1$	$1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed$ his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived$ patient was back to 95% on 4 L. On arrival to the ER$ he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently$ he has no pain$ no shortness of breath$ no weakness$ no cyanosis. He is afebrile and sitting comfortably in bed.   2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest.  Patient is resident of local nursing home.  According to nursing home staff$ a tech was in his room talking with him as patient was laying in bed.  Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive.  Patient had no spontaneous respirations or pulse$ subsequently CPR was started immediately.  911 was called.  This occurred around 5:30 a.m.. ل Upon EMS arrival on scene$ they found a male unresponsive with CPR being performed.  There was no spontaneous respirations or circulation.  Thus$ ET tube was placed and life support guidelines initiated.  Patient was found to be in PEA$ and according to EMS$ patient was given a total of 6$ 1 mg epinephrine IV push and 1$ 1 Amp sodium bicarb.  Patient was worked on at the scene for approximately 40 min before being transferred to ER. ل Upon arrival to ER trauma room 1 patient is still in full arrest.  ET tube in place with good ventilation.  Patient remains in PEA.  Chest compressions and life support guidelines initiated. ل In reviewing patient's chart and nursing home notes$ patient is a full code.  Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG.  Patient also has history of 3rd degree heart block and pacemaker placement.  Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.$	$No current illness for this event.$	$$Sulfa Antibiotics$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1050158-1$	$1050158-1$	$Resident is a Hospice patient. On 1-23-2021 am shift  resident was observed by nursing have chest congestion and had a emesis times 1 with SOB$ Zofran 4 mg was given. HOB (02 sats 88%) was elevated resident on 02 via nasal canula with 02 sat now @ 90% . no respiratory distress noted. MD was called with response pending for orders. @ 1400 resident with no signs of life. vs 90%-24-97/71-97.6. Hospice on site and time of death 1436$	$Dementia$ History of CVA affecting left side$ history of COVID 19 in December 2020$  Aphasia.$	$Dementia$ History of CVA affecting left side$ history of COVID 19 in December 2020$  Aphasia.$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1051699-1$	$1051699-1$	$Death on 02.15.2021.$	$None$	$COPD$N/A$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1051993-1$	$1051993-1$	$Notified on 2/24/2021  that patient passed away on 2/14/2021.   Other cause of death  - non-covid -19 related$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052014-1$	$1052014-1$	$Extreme difficulty breathing upon exertion$ collapsed shortly after walking started$ loss of conciousness$  and death$	$COPD exascerbation'  UTI flare-up$	$Advanced severe COPD$  UTI$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052049-1$	$1052049-1$	$Patient was into the clinic on the afternoon of 2/23/21 for a COVID-19 vaccine.  He had a podiatry clinic visit after his vaccine same day.  It was reported by the patients family physician that patient stated he didn't feel well and suddenly collapsed at home at approximately 4:45 pm.  Emergency medical personnel were not able to revive him.   Patient died at approximately 4:45 pm on 2/23/21.$	$None known at the time of the vaccination.  However$ patient did have a podiatry visit after the vaccination for right foot pain and swelling$	$None$None known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052070-1$	$1052070-1$	$2/22/2021 10:09 pm resident reported 1 episode of being nauseous and having dry heaves$ no temperature$ MD notified and nurse was told to continue to monitor$ no new orders$ daughter made aware. Vital signs being done every 4 hours. 2/23/2021    3:04am resident complains of nausea$ scant BM amount x 2$ MD notified and no new orders$ continue to monitor and encourage fluids$ vital signs continue every 4 hours.$	$No$	$Acute Diastolic (Congestive) Heart Failure$ Bell's Palsy$ Essential Hypertension$ Unspecified Atrial Fibrillation$ Unspecified Macular Degeneration$ Atherosclerotic Heart Disease of Native Coronary Artery without Angina Pectoris$ Gastro-esophageal Reflux Disease without Esophagitis$ Dementia without Behavior Disturbances$ Muscle Weakness$ Overactive Bladder$ H/O Ottis Media$  Legal Blindness and Dysphagia$No known drug or food allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1052217-1$	$1052217-1$	$Elevated heart rate$ flushing of the face and ears$ vomiting$ trouble breathing$ pulmonary edema$	$none$	$diabetes$ arterial fibrillation$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1053393-1$	$1053393-1$	$$Patient felt achy$ tired starting the day after the vaccine.  Per his wife$ he was very tired  and $$losing stamina$$.  On 2/13/21$ he woke up feeling dizzy and weak.  His wife asked him if he wanted to go to the doctor and he declined.  He ate breakfast and went to rest in his easy chair.  He  passed away an hour later.$$	$No current illness for this event.$	$cardiovascular disease smoker$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1053879-1$	$1053879-1$	$Shortness of breath - related to chronic comorbidities$	$Esophageal Cancer with Radiation and Chemotherapy. Patient chose to stop treatment$	$Malignant neoplasm of the breast$ Esophageal cancer$ CAD$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054171-1$	$1054171-1$	$Resident found unresponsive in his room. CPR performed and patient expired.$	$ACUTE ON CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE$ HYPERTENSIVE CHRONIC KIDNEY DISEASE WITH STAGE 1 THROUGH STAGE 4 CHRONIC KIDNEY DISEASE$ OR UNSPECIFIED CHRONIC KIDNEY DISEASE$ PARKINSON'S DISEASE$ ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS$ CHRONIC KIDNEY DISEASE$ STAGE 3 UNSPECIFIED$	$ACUTE ON CHRONIC SYSTOLIC (CONGESTIVE) HEART FAILURE$ HYPERTENSIVE CHRONIC KIDNEY DISEASE WITH STAGE 1 THROUGH STAGE 4 CHRONIC KIDNEY DISEASE$ OR UNSPECIFIED CHRONIC KIDNEY DISEASE$ PARKINSON'S DISEASE$ ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS$ CHRONIC KIDNEY DISEASE$ STAGE 3 UNSPECIFIED$$Ropinirole$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054175-1$	$1054175-1$	$Resident found unresponsive$ CPR initiated and EMS called. EMS called time of death after arrival.$	$Acute Kidney Failure$	$Cognitive communication deficit$ dysphagia$ gout$ hyperlipidemia$ other abnormalities of gait and mobility$ personal history of TI and cerebral infarction without residual deficits$ unspecified osteoarthritis$ benign prostatic hyperplasia with lower urinary tract symptoms$ constipation$ essential hypertension$ history of falling$ obstructive and reflux uropathy$ overactive bladder$ unspecified dementia without behavioral disturbance.$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054551-1$	$1054551-1$	$Resident expired on 2/29/21.$	$N/A$ under hospice care for end of life$	$Major Neurocog Disability$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054592-1$	$1054592-1$	$Resident expired on 2/24/21$ under hospice care.$	$N/A$	$1.  Mood disorder with behavioral disturbance #2 psychotic disorder #3 atypical anxiety #4 dementia with behavioral disturbance #5 cognitive communication deficit #6 impulse control disorder #7 chronic constipation #8 generalized chronic pain #9 hypomagnesia anemia #10 seborrheic dermatitis #11 B12 deficiency #12 type 2 diabetes mellitus #13 hypertension #14 anemia #15 degenerative joint disease #16 seizure disorder #17 GERD #18 hyperlipidemia #19 history of peptic ulcer disease #20 diverticulosis of the colon #21 thrombocytopenia unspecified$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054694-1$	$1054694-1$	$$Pt received vaccine on 1/29/2021 and died on 2/13/2021.  Wife called agency and noted the pt received his 1st dose of vaccine and was having $$side effects and began declining$$.    It is unknown what side effects he was having.$$	$No current illness for this event.$	$HTN$ BPH$ OSA$ Obesity$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1054698-1$	$1054698-1$	$THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON 1/29/21 AND POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST$ BUT DEVELOPED SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21$	$No current illness for this event.$	$PVD$ A. FIB$ HYPERLIPIEMIA$ HYPOTHYROIDISM$ DEPRESSION$PENICILLIN$ PRADAXA$ REMERON$ VESICARE$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055009-1$	$1055009-1$	$Patient deceased 2/9/2021 when called for second dose vaccine appointment$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055027-1$	$1055027-1$	$patient deceased no show to 2nd appointment notified by family$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055107-1$	$1055107-1$	$No documented vaccine reaction  Hospitalized due to co-morbities$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055122-1$	$1055122-1$	$Pale$ Short of Breath$ Hypoxic$ Lethargic within minutes became unresponsive and died.$	$Nausea$ Vomiting$ Diarrhea on 2/19$	$Macular Degeneration$ HTN$No Known Allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055203-1$	$1055203-1$	$Began having SOB and cough on 2/18/21$ the day after his first vaccine.  Had a routine physician appointment for diabetes on 2/15/21 with no documentation of these complaints.   Presented to the hospital on 2/23$ soon after required intubation. Admitted with severe pneumonia$ diffuse colitis$ and sepsis.   Condition continued to worsen until patient passed away on 2/24/21 @ 1632.$	$No current illness for this event.$	$Essential hypertension$ benign  ? Other and unspecified hyperlipidemia  ? Hypertrophy of prostate without urinary obstruction and other lower urinary tract symptoms (LUTS)  ? Injury of left rotator cuff  ? Adhesive capsulitis of left shoulder  ? Suppurative otitis media of both ears  ? Bronchitis$ acute  ? Acute myeloid leukemia in remission   ? Type 2 diabetes mellitus without complication   ? Acute midline low back pain without sciatica  ? Sinistrocardia  ? Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene$ with long-term current use of insulin   ? Thrombocytopenia   ? Splenomegaly  ? Cirrhosis of liver without ascites   ? Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene$ with long-term current use of insulin   ?$Cat hair extract$ Pollen extract$ Mold and Smuts$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055267-1$	$1055267-1$	$Death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055341-1$	$1055341-1$	$Sudden death two weeks after first dose of vaccine was administered. No previous symptoms or signs. Family opted not to do an autopsy so cause of death (stroke or heart attack) not known.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1055830-1$	$1055830-1$	$Febrile peak 39.5 ¦ C in the evening following vaccination$ yielding to paracetamol; This is a spontaneous report from a contactable physician downloaded from the regulatory authority; BE-FAMHP-DHH-N2021-76313$ received from Regulatory Authority.  A 73-year-old female patient received the 1st dose of BNT162B2 (COMIRNATY$ lot number: EM0477) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included combined spinal cord sclerosis$ extra-pyramidal syndrome of the Parkinsonian type$  gastric adenocarcinoma of the diffuse linite-type$ total gastrectomy$ Hashimoto's thyroiditis$ peripheral arteriopathy$ perforation of gastrectomy suture in Nov2020$ laparotomy$ septic and intensive care stay marked by: shock secondary to peritonitis$ atrial fibrillation$ mixed respiratory failure on acute respiratory distress syndrome (ARDS) and bilateral pleural effusions$ acute renal failure$ discharged from hospital on 22Jan and admission to rest and care home. Concomitant medications included paracetamol$ levothyroxine sodium (EUTHYROX)$ benserazide hydrochloride/levodopa (PROLOPA)$ rosuvastatin calcium (CRESTOR)$ acetylsalicylic acid (ASAFLOW)$ hydrochlorothiazide/olmesartan medoxomil (BELSAR PLUS). The patient experienced fever on 28Jan2021. The patient died on 29Jan2021. The autopsy was performed. Relatedness of drug to reaction/event fever was possible.   Reporter's comments: Treatment - Yes Paracetamol$ Evolution of the ADR - Death. This was a normal build$ fragile patient (according to the clinical frailty scale$ score of 7-8)$ no longer autonomous. The patient ahd feverish peak at 39.5 ¦ C in the early evening$ giving way to paracetamol. Passage of the nurse around 11 pm: afebrile$ calm patient$ no sign of particular worry. Death on 29Jan: no precise explanation for the death or autopsy. Given the fragile state of the patient and her clinical history (hospitalization in intensive care for several weeks at the end of 2020)$ the notifier considered the death to be natural.  No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Febrile peak 39.5 ¦ C in the evening following vaccination$ yielding to paracetamol$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Acute renal failure; Adenocarcinoma gastric; Arteriopathy (peripheral arteriopathy); Atrial fibrillation; Extrapyramidal syndrome; Hashimoto's thyroiditis; Hospitalization; Laparotomy; Perforation (In November 2020$ perforation of gastrectomy suture); Respiratory failure; Septic shock (septic shock secondary to peritonitis); Total gastrectomy; Vertebral sclerosis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1056660-1$	$1056660-1$	$Cardiac Event MI or Stroke; Cardiac Event MI or Stroke; This is a spontaneous report from a contactable consumer (Son in law). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration at left arm on 17Feb2021 14:00 at single dose for covid-19 immunisation. Medical history included atrial fibrillation (AFib)$ prostate cancer Survivor. Concomitant medication included alirocumab (PRALUENT)$ escitalopram oxalate (LEXAPRO)$ apixaban (ELIQUIS)$ nitroglycerin and Ca channel blocker. The patient received the first dose of BNT162B2 on an unknown date for covid-19 immunisation. The patient experienced cardiac event myocardial infarction (MI) or stroke on 17Feb2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment received for the events. Prior to vaccination$ the patient was not diagnosed with COVID-19 and since the vaccination$ the patient was not been tested for COVID-19. The patient died on 19Feb2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The reporter didn't know if this was associated or not. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardiac Event MI or Stroke; Cardiac Event MI or Stroke$	$No current illness for this event.$	$Medical History/Concurrent Conditions: AFib; Prostate cancer (Survivor)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1056845-1$	$1056845-1$	$Three days after second COVID-19 vaccine$ patient became lethargic.  Due to advance directive that instructed that no life saving interventions to take place$ patient continued to decline and expired on 29 January 2021.$	$Patient diagnosed with COVID-19 on 25 November.  Mild symptoms.  Tested negative within two weeks.  Patient had significant Alzheimer's disease$ but not life threatening.  Other co-morbid conditions that were managed through medication.  Facility administered first dose of COVID-19 shortly after Christmas and second dose on 29 January.$	$See above.  Recommend FDA contact facility for medical records.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057348-1$	$1057348-1$	$Extreme Fatigue$ slurring speech$ unable to stand$ eat.  Death on 2/5/21$	$congestive heart failure$	$congestive heart failure$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1057956-1$	$1057956-1$	$Heard through a family member had some feeling badly and some respiratory symptoms. We do not have any real information. This is a coroners case.$	$unknown$	$unknown$unknown$ not reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058171-1$	$1058171-1$	$Death$	$No current illness for this event.$	$Pacemaker$ high blood pressure$ kidney disease$ dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058190-1$	$1058190-1$	$On the evening of 2/23/221 at 9:00 pm$ resident reported feeling SOB$ BP 80/44$ Pulse 53$ O2Sat 95% on 3L oxygen$ hands cold$ pulse weak. Temp 92.5F MD notified. EMS activated. EMS arrival and HR 20. Family refused transport to ER. Resident expired at 2:40 am on 2/24/21 Meds continued: duloextine$ VITd2$hydralazine$ synthroid$ lisinopril$ mag ox$ folplex$ pantoprazole$ potassium chloride$ ellipta$ ensure$ hydrocortisone cream$ boost$ deprox$ xanax$ morphine$ lorazepam$ tylenol$ albuterol inhlation$ ventolin inh.$	$acute polynephritis$ acute kidney failure$	$HTN$ hypothyroidism$ afib$ COPD$ alopecia$anxiety disorder$ depression$ GERD$ hyperlipidemia$pcn$ doxycycline$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058192-1$	$1058192-1$	$2/24/21 Patient Died.  02/23/21. Patient came to ED for weakness/falls. Patient had fallen on 02/21 and 02/23. UA was done in LTC$ and he was started on ciprofloxacin 02/22/21. Treatment was to put patient on comfort cares (morphine + lorazepam)$	$UTI on 02/21.  02/23 ED visit: AKI$ HTN$ Fall/weakness$ NSTEMI$ sepsis with hypoxic resp. failure.$	$Obstructive bladder$ GERD$ HTN$ Hypothyroidism$ Malignant neoplasm of prostate$ hyperlipidemia$ Type 2 DM$ Vit D deficiency$ osteoarthritis$ peripheral edema$ Diabetic neuropathy.$etodolac. reaction unknown.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058266-1$	$1058266-1$	$Pale$ not eating$ no urine output$	$Lewy-Body dementia$	$Lewy-Body Dementia$Carbidopa/Levodopa$ penicillin$ Pramipexole$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058793-1$	$1058793-1$	$Pt had only complained of a sore arm after receiving the vaccine- pt died on 2/25/21 from what they feel was a massive heart attack- unsure if related to vaccine at all$	$diabetes- type 2 High bp$	$diabetes- type 2 High bp$unsure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1058845-1$	$1058845-1$	$$Pfizer-BioNTech COVID- 19 Vaccine EUA  Patient received COVID-19 Vaccine dose #2 on February 24$ 2021. On February 25th at 10:36 AM$Patient's son called physician to report some side effects to second dose of Covid vaccine. She had diarrhea when she came home yesterday. Son has been up all night with her as patient has had a $$hacking cough$feels terrible$ and now has had diarrhea x2$$. Patient has taken Advil and will be taking tylenol periodically through out the day for her side effects. Patients son notified physician at 09:55 AM on February 26 that the patient has expired.$$	$No current illness for this event.$	$Generalized anxiety disorder; Restless legs syndrome; Mixed diabetic hyperlipidemia associated with type 2 diabetes; Allergic rhinitis; CKD stage 3 due to type 2 DM; GERD with esophagitis; Hypertension in Stage 3 CKD; Lumbar Spondylosis; Major Depression; Mixed incontinence; Obstructive sleep apnea on CPAP; Osteoarthritis; History of renal cell carcinoma; Type 2 diabetes mellitus; venous stasis dermatitis bilateral lower extremities; venous insufficiency; Vaginal atrophy; Gastroparesis; Insomnia; Acquired hypothyroidism; Recurrent UTI; Oropharyngeal dysphagia; S/P repair of paraoesophageal hernia; lactose intolerance; Sensorineural hearing loss bilaterally.$Citalopram - itching; Seasonal allergic rhinitis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059001-1$	$1059001-1$	$Patient had declining health for the past 6 months$ dementia and unable to walk. Patient had decreased appetite starting 1/1/21. After 1st vaccine shot patient appetite decreased further. After 2nd vaccine shot patient fatigue increased to the point where she could not get out of bed and had minimal appetite. Patient passed away 10 days after receiving 2nd shot on 2/22/21. Patient did not go to ED and was not hospitalized.$	$Had declining health for the past 6 months$ dementia$ unable to walk. Decrease appetite after 1/1/21.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059344-1$	$1059344-1$	$death 2/25/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059621-1$	$1059621-1$	$1/14/21 - Resident complained of SOB. SPO2 66% on RA$ vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID results. Resident transferred to COVID wing. Family (HCP) updated and declined transfer to hospital Resident continued with fever$ hypoxia and lethargy. Family elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM.$	$Obesity$ Diabetes Type 2$ Heart Failure$ Bipolar Edema$ CVA$ GERD$ Cardiomegaly$	$See above$Daptomycin$ Penicillin$ Vancomycin$ Cipro$ Cubicin$ Rocephine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059623-1$	$1059623-1$	$Possible Stroke per Medical examiner but Reported symptoms after covid vaccine 2/11 therefore being considered poss Covid vaccine related also. No hospitalization prior to death. (Symptoms reported to office 2/17) Fatigue$ decreased appetite-$	$0 Nothing Acute Reported$	$Arthritis; Atrial fibrillation; Bleeding of eye$ right; Cardiomyopathy; CHF (congestive heart failure); Claustrophobia; Coronary artery disease; Dizzy spells; Fractures; Head injury; Heart attack; Hyperlipidemia; Hypertension; Panic attacks; Pneumonia; Prostate cancer; Renal insufficiency; Venous insufficiency$Penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1059745-1$	$1059745-1$	$Per Patients Wife  - Same day - Flu like symptoms$ Nausea$ Headache.  Restless that night.  Next day - Weak$ shortness of breath.  Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated.  Patient passed away around 11 AM the day after vaccination.$	$No current illness for this event.$	$$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060080-1$	$1060080-1$	$Death$	$none$	$osteoporosis$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060520-1$	$1060520-1$	$Pt expired 11 days after receiving vaccine. No indication his passing was related to the vaccine.  Narrative: No updated notes regarding cause of death. Patient's wife called to notify the facility of his passing on 1/26/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060522-1$	$1060522-1$	$death Narrative: 86 year old MALE with PMH of Afib s/p AICD/PPM$ HFrEF (EF< 20% 10/2019)$ DM2$ HTN$ HLD$ BPH$ Depression. Was stable and feeling well when he was administered Covid-19 vaccine on 02/17/2021- Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); PFR; Lot#; EL9267; Exp Date:05/31/2021 Administration Anatomic site: Right Deltoid; Pt was monitored for 30 minutes after administration and had no adverse effects. He was called later in the day and reports he feels well and has had no adverse reactions$ he endorsed his arm is a little sore at injection site. ON 02/19/2021- his dghter found him on the floor$ next to his bed$ dead. She reported on 2/19/2021- that she was out with him to dinner on 2/18/2021$ and he stated he did not feel well$ that his insides did not feel right. He proceeded to have dinner and 2 drinks. HE was doing ok$ when she took him home.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060523-1$	$1060523-1$	$contracted covid after first dose Narrative: First covid vaccine dose 12/31/2020$ tested positive for covid 1/7/2021$ died from complications 1/25/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060524-1$	$1060524-1$	$Death$ unknown cause Narrative: Patient received COVID19 vaccine on 2/23/2021 at 14:27. On 2/24/21$ patient's family found patient deceased at 12:08am. The local coroner had called the MC to let us know on 2/24/21 at 12:55am. Coroner did not suspect foul play.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060528-1$	$1060528-1$	$Death due to underlying condition for hospice pt. Narrative: This was a 95 yo patient residing at home with daughter. Patient reported to PCP on 1/4 c/o poor appetite and weight loss. Daughter reported that patient was very frail and requested a hospice referral. Outside medical records indicate that patient was dx with pneumatosis of the cecum and peritonitis. Patient also had severe atherosclerotic disease with near complete occlusion of the infrarenal abdominal aorta. Due to age and frailty$ patient was placed in hospice care where he passed away on 1/22/21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1060833-1$	$1060833-1$	$Severe headache$ nausea and vomiting$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1061064-1$	$1061064-1$	$Unable to breathe and died. Doctors unable to save her upon arrival$	$Bacterial infection$	$Depression$ anxiety$ and pain in joints from arthritis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1061226-1$	$1061226-1$	$death$	$progressive supra nuclear palsy$	$PSP HTN$penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1061303-1$	$1061303-1$	$Death.  Patient was found unresponsive in the morning hours after her shot.$	$No current illness for this event.$	$Pace maker$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1063174-1$	$1063174-1$	$Narrative:  Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR$ fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1065920-1$	$1065920-1$	$$never woke up after arrival; Suffered with vascular dementia; Death cause: Covid/Tested positive to Covid 31Jan$ tested due to increased lethargy; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient received the vaccine at nursing home/senior living facility. Medical history included dementia$ hypertension$ past strokes. The patient was exposed to asymptotic staff member on or prior to 25Jan2021. The patient had no known allergy. No COVID prior vaccination. Concomitant medication included lisinopril. No other vaccine was received in four weeks. The patient was tested positive to COVID on 31Jan2021$ tested due to increased lethargy started from 26Jan2021. The patient suffered with vascular dementia. She was ambulatory up to 31Jan2021. The patient was sent to hospice that evening on 31Jan2021 to quarantine$ never woke up after arrival. Palliative Care started 02Feb2021$ the patient expired 12Feb2021. Cause of death was COVID. The patient did not receive treatment for events. The autopsy was not performed. The outcome of events $$never woke up$ vascular dementia$$ was unknown.   Information on Lot /Batch Number has been requested.; Reported Cause(s) of Death: Death cause: Covid$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Dementia; Exposure to COVID-19 (on or prior to 25Jan2021); Hypertension; Stroke$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1066209-1$	$1066209-1$	$[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria$ dysphagia and bilateral arm weakness and incoordiantion$ worse on right. MRI brain was negative for acute stroke and MRI cervical$ showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.$	$No current illness for this event.$	$Hx of CLL and possible CSF involvement$ also hx of Rheumatoid arthritis.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1062260-1$	$1062260-1$	$Developed acute facial droop and slurred speech 2h after 1st dose of the vaccine on 2/17$ found with R MCA stroke. Then became unresponsive on 2/27 and was found with an acute L MCA stroke. Was transferred from another hospital$ was not a candidate for intervention$ and was made comfort and died on 2/28$	$No current illness for this event.$	$hypotension$ HLD$ permanent AF on warfarin$ thyroiditis$ TIA$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063522-1$	$1063522-1$	$1. Fatigue ? day 1 - Tuesday 2. Loss of appetite ? day 1 Tuesday 3. Fever 102.0 ? day 2 - Wednesday 4. Chills ? day 2 - - Wednesday 5. Weak ? day 2 - - Wednesday 6. Non-ambulatory (unusual) ? day 2 - - Wednesday 7. Two emergency service ambulance assessment ? day 2 - - Wednesday 8. Symptoms improved ? day 3  - Thursday 9. Ambulatory  - day 3 - Thursday 10. Symptoms worsened ? day 4 - Friday 11. Chills ? day 4 - Friday 12. Non-ambulatory again ? day 4 - Friday 13. Fever 102.0 ? day 4 - Friday 14. Left side flank pain ? day 4 - Friday 15. CPR and declared decease at home by paramedics - day 5 - Saturday morning @ 1:32am$	$No new or acute illnesses reported within the last month$	$1. Multiple myeloma 2. Atrial Fibrillation 3. COPD ? Emphysema/Asthma 4. Congested Heart Failure 5. Macular degeneration 6. Normal Sp02 ? 90%-92%$1. Entresto$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063674-1$	$1063674-1$	$EMS responded to a call at his home; he was found unresponsive by family slumped over in a chair$	$unknown$	$diabetes$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1063980-1$	$1063980-1$	$1/26 /2021 - pt went to ER for chest pain 2/9/2021 - pt received Pfizer COVID vaccine 1st dose 2/17/2021 - cardiac arrest with death$	$Mildly enlarged cardiomediastinal silhouette.   went to the ER on 1/26$ 15 days prior to vaccine.  c/o episodes of 4/10 midsternal nonradiating chest pain$ first at noon after eating and second episode woke her from sleep at 0400$	$HTN$ DM type 2$ CKD IV$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1064646-1$	$1064646-1$	$Minor arm pain on 2nd day of each vaccine Diarrhea 3 days after 2nd vaccine Massive heart attack (left ventricle) 8 days (2/24/21) after vaccine Home hospice 3:30pm 2/24/21 Stopped breathing 5:45 am$ pronounced dead at 8:22 am on 2/25/21$	$No current illness for this event.$	$High blood pressure Stroke 2017 and 2019$Shrimp  Hydrochlorothiazide$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1065551-1$	$1065551-1$	$$Pt received 2nd Pfizer BioNTech Covid 19 EUA vaccine @1:50 pm; Pt released from Observation @2:09 pm. Approximately 2:18 pm RN called to parking  lot and observed pt having difficulties. Called for EMS & crash cart. Vitals taken 2:20 BP 83/55$ no respirations noted$ pt unresponsive. AED attached.  EMS arrived 2:22 and took over care of pt. and transported @2:40 pm to Hospital. Per wife$ pt has history of PE in Oct. 2020$ HTN$ diabetes with insulin pump$ obesity$ gastroparesis$ home oxygen and uses motorized scooter. Wife also said pt had allergy to iodine not previously reported$ and MD had stopped Zarelto subsequent to 1st Pfizer vaccine 2/8/21 $$due to  breathing difficulty$$. Patient was  unable to be resuscitated.  Time of death 14:59.$$	$Diabetes$ HTN$ obesity$	$Diabetes$ HTN$ obesity$ history of MI @ 2011$ PE 10/2020$ gastroparesis$ on home oxygen$None reported$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066107-1$	$1066107-1$	$death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066126-1$	$1066126-1$	$death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066178-1$	$1066178-1$	$Caller is nephew of patient. Patient was admitted to Hospital on 2/15/21 with Covid like symptoms and decreased O2 sat. He tested positive for Covid 2/15/21. Treated with Remdesivir. Patient status continued to decline and he passed away in hospital 2/22/21 0612.$	$No current illness for this event.$	$CAD$ HTN$ Basal Cell CA$ cancerous appendix removed 1 month ago$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066289-1$	$1066289-1$	$death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066322-1$	$1066322-1$	$Patient was vaccinated approx 9a. Later that evening$ patient was having trouble breathing so they called son who lives down the road to come$ 20 mins after the call the patient has passed. Per medical examiner$ pt died due to possible PE$ MI$ or his aortic aneurysm ruptured.$	$multiple heart issues$	$multiple heart issues$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1066332-1$	$1066332-1$	$death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068308-1$	$1068308-1$	$cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion; On 21Feb he went to the ER after vomiting and passing out; On 21Feb he went to the ER after vomiting and passing out; On 19Feb$ he began to feel ill again with a fever. He felt worse on 20Feb; On 19Feb$ he began to feel ill again with a fever. He felt worse on 20Feb; fever; headache; stomach upset; This is a spontaneous report from a contactable consumer reporting for the father:  A 75-year-old male patient received the 1st dose of bnt162b2 (BNT162B2$ Lot # EL3428) at single dose at left arm on 03Feb2021 for Covid-19 immunisation. Medical history included type 2 diabetes mellitus. No known allergies. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included amitriptyline hydrochloride (manufacturer unknown) 10 mg$ atorvastatin (manufacturer unknown) 20 mg$ dutasteride (manufacturer unknown) 0.5 mg$ linaclotide (LINZESS) 290 mcg$ gabapentin (manufacturer unknown) 300 mg$ montelukast (manufacturer unknown) 10 mg$ ramipril (manufacturer unknown) 5 mg$ insulin degludec (TRESIBA) 100 unit/ml$ liraglutide (VICTOZA) 18 mg/3ml solution. No other vaccine in 4 weeks. The patient experienced cardiac arrest due to pericardial effusion on 21Feb2021 14:15$ fever on 13Feb2021$ headache on 13Feb2021$ stomach upset on 13Feb2021$ on 19feb$ he began to feel ill again with a fever$ he felt worse on 20feb on 19Feb2021$ on 21feb he went to the ER after vomiting and passing out on 21Feb2021.  Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of cardiac arrest due to pericardial effusion.  Course of events: In Feb2021$ 10 days after his 1st injection$ the patient developed fever$ headache$ and stomach upset. He went for a rapid Covid-19 test (nasal swab) and it was negative on 11Feb2021. The doctor told him he might be having a delayed reaction to the vaccination. After a couple of days$ he improved. On 19Feb2021$ he began to feel ill again with a fever. He felt worse on 20Feb2021. On 21Feb2021 he went to the ER after vomiting and passing out and received treatment: IV fluids$ diagnostic testing at ER. Rapid Covid test (nasal swab) at ER came back negative again on 21Feb2021. His heart arrested suddenly and he could not be resuscitated. CT scan results$ that came back after death$ showed Covid like pneumonia and pericardial effusion. The patient died on 21Feb2021 14:15. Cause of death was cardiac arrest due to pericardial effusion. An autopsy was not performed. The outcome of cardiac arrest due to pericardial effusion was fatal$ of fever$ headache$ stomach upset was recovering$ of he began to feel ill again with a fever$ he felt worse was not recovered$ of he went to the ER after vomiting and passing out was unknown.; Reported Cause(s) of Death: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Type 2 diabetes mellitus$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068549-1$	$1068549-1$	$2/13/21 Patient had covid like symptoms 2/15/21 Patient admitted to Hospital with covid like sx and decreased O2 sat; tested positive for Covid on 2/15/21; treated with Remdesivir and convalesent Plasma. Sx worsened and patient died 2/26/21..$	$No current illness for this event.$	$Obesity$ Lung disease$ DM type 2$ spinal stenosis$ OA$ essential tremor$ sleep apnea$ glaucoma$ Hashimoto thyroid disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068700-1$	$1068700-1$	$Patient passed away 24 hours after receipt of 1st Dose Pfizer vaccine.  Provider does not feel death was due to vaccination. but underlying conditions. No immediate side effects noted from vaccination.$	$Known pneumothorax w/ chest tube placement after percutaneous lung biopsy;$	$current smoker; severe emphysema ; enlarging lung nodules w/ avidity; IA Lung CA with right lower lobectomy;$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068761-1$	$1068761-1$	$DEATH Narrative: patient was placed on hospice care following vaccine$ unclear cause of death$ not documented$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068762-1$	$1068762-1$	$$DEATH Narrative: patient's wife reported he had gone in an outside hospital$ had held his brilinta as advised anticipating shoulder surgery $$and he threw a big clot and died.$$$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068850-1$	$1068850-1$	$Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that patient had received dose #2 of Pfizer COVID vaccine$ and later that evening experienced a seizure and expired.$	$No current illness for this event.$	$Cardiomegaly$ Hypertension$ BK virus nephropathy$ Acute Kidney Inj.$ Chronic pain$ Kidney Transplant$ (cont.) Anemia of chronic disease$ Immunosuppression$ Arthritis$ Depression$ Spinal stenosis$ cytomegalovirus infection$ degenerative joint disease.$Vancomycin (itching)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068883-1$	$1068883-1$	$DEATH Narrative:  PATIENT PASSED AWAY WHILE ON HOSPICE CARE$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068886-1$	$1068886-1$	$DEATH Narrative: Pt he reports he developed chills SOB body aches the same night as receiving the COVID vaccine on 1.26.2021-pt is currently reporting CheSt tightness and SOB Admitted to hosp: ICU with Bilateral Pulmonary Emboli$ LLE DVT$ NSTEMI$ Arrhythmia.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068889-1$	$1068889-1$	$death Narrative: no other details available$ as nothing documented in record$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069235-1$	$1069235-1$	$Death$	$Dementia$ Anxiety$ Hypokalemia$ Peripheral Vascular disease$ HTN$ Absence of part of Lung Z90.2$ BPH$ Hypomagnesemia$$	$Dementia$ Anxiety$ Hypokalemia$ Peripheral Vascular disease$ HTN$ Absence of part of Lung Z90.2$ BPH$ Hypomagnesemia$$Amoxicillin$ Azithromycin$ Notriptyline$ Augmentin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069263-1$	$1069263-1$	$DIED$	$DIABETIS$	$NA$NA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069743-1$	$1069743-1$	$Cardiac arrest- death$	$none reported$	$A-fib$ DM$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1069876-1$	$1069876-1$	$Vaccinated 2/20. At that time$ had symptoms of incarcerated hernia$ went to ED for evaluation. Not felt to warrant hospital admission. Returned two days later with agitation$ altered mental status$ and incarceration. Went to OR$ uncomplicated hernia repair. Postoperatively$ did not recover mental status. Went into arrythmias POD 4$ hypotension ensued$ had multiple interventions and evaluations without satisfying answers for clinical course.$	$Incarcerated ventral/incisional hernia$	$CAD$ Hep C wiht cirrhosis$ CKD$ CHF$ COPD$ HTN$ chronic pain$ hypothyroidism$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071741-1$	$1071741-1$	$He started vomiting 2 days later. we suspect he was having stool issues as well. he vomited blood at some point over the weekend. there was black vomit right before he passed. from 2am-6am he was wheezing and rattling and then he passed at approximately 6am 3/1/2021 at home. EMS did come and try to revive him and were unsuccessful.$	$No$	$High Blood Pressure Prostate cancer in the  past Non-insulin diabetic Coronary Artery Disease  Aortic Stenosis$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1071863-1$	$1071863-1$	$Patient$ age 101$ was having a period of declining health prior to vaccine administration.  This continued after the vaccine to include increased pain$ inability to swallow and ultimately Patient passed away on 1/9/2021.  The physician does not believe this is due to vaccine administration$ however family asked that this information be reported for record keeping.$	$Dementia$ health decline$	$chronic gout$ renal impairment$ ischemic cardiomyopathy$No known allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1072763-1$	$1072763-1$	$The same day that the person was vaccinated he started feeling dizzy and had difficulty breathing.  He was hospitalized from February 5 to February 23.  Patient died in the hospital on February 23$ 2021$	$The patient was convalescent from COVID-19$ his first positive PCR  COVID-19 test was on December 23$ 2020.  The patient was hospitalize on December 22$ 2020 and was check out on December 25$ 2020.$	$Diabetes and AIDS$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1072993-1$	$1072993-1$	$Day After - severe headache$ 2 days after headache continues$ itchy scalp$  day 3 rash visible at hair line  headache continues$ more confusion than normal$  day 4 on site nurses check rash and think it is dermatitis$  day 5 continues to get work nurse practitioner was to visit next day$  day 6 NP thinks that she has UTI and sends her to hospital (2/11/21).  Hospital determines - Rash is Shingles$  UTI present$   -  MRSA is now present in shingles which is on right back of head and right neck and face.  Next Sepsis is diagnosed.    Since 2/11/21 patient was not conscious.  2/20/21 famiy is notified that she should be moved to Hospice.  Moved to hospice on 2/20/21.  The patient$ my mother$ died on 2/23/21 official cause of death is UTI.$	$Tic Douloureux$ arthritis$ anxiety$	$Tic Douloureux$ arthritis$ anxiety$Sulfur$ laytex$ pennecillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073128-1$	$1073128-1$	$Expired within 30days of vaccination.  Received vaccine 1/22/21 did not have any complaints$ during a bed check she was found on the floor with no apparent injury$ no pulse or respirations.$	$Fall at home with arm fracture$ placed in Memory Care$	$Cardiac History$ pacemaker$Unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073252-1$	$1073252-1$	$Death within 30 days of vaccine$	$No current illness for this event.$	$5/18/2020 Diagnosed with invasive ductal carcinoma of the breast$ elected not to treat$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073283-1$	$1073283-1$	$Death within 30 days of vaccination$	$2/2/21 New diagnosis of breast cancer and sarcoma left thigh and CT positive for 9mm Right middle lobe nodule$ no treatments started prior to vaccine.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073812-1$	$1073812-1$	$DEATH Narrative: PT WAS PLACED ON HOSPICE ON 1/21/2021$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073814-1$	$1073814-1$	$DEATH Narrative: NO ADDITIONAL DETAIL PROVIDED OTHER THAN PATIENT DIED AT HOME$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073815-1$	$1073815-1$	$DEATH Narrative: NO DETAILS PROVIDED$ NO NOTE REGARDING DEATH$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1073816-1$	$1073816-1$	$RESPIRATORY FAILURE Narrative: PT PASSED AWAY WHILE IN THE HOSPITAL$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0928062-1$	$0928062-1$	$vomiting later on 01/05/21.  Lethargy and hypoxia in pm of 01/06/21.  Hypotension am of 01/07/21.  Hospitalized$ intubated$ cardiac arrest$ died 01/07/21.$	$Parkinson's Disease with advanced dementia$ dysphagia.  Alcoholism in remission.  HTN.  BPH.  GERD$	$Parkinson's Disease with advanced dementia$ dysphagia.  Alcoholism in remission.  HTN.  BPH.  GERD$angioedema due to ACE and ARB meds$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0943266-1$	$0943266-1$	$Initial pain in back of head and extreme headache. Some vomiting.  At emergency$ went into coma and was intubated.  Hole drilled in skull to relieve pressure.  MRI taken.  Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial symptoms.$	$No current illness for this event.$	$Arthritis$ high blood pressure$Penicillin$ Sulfa$ Gluten$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0955390-1$	$0955390-1$	$Resident received vaccination on January 15$ 2021.  She was found unresponsive with shallow respirations on the morning of January 16$ 2021 and was sent to ER via ambulance.  The resident was admitted to medical center ICU where she passed away later that day.$	$unknown$	$unknown$unknown$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0959179-1$	$0959179-1$	$Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021$ patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated$ but the patient suffered PEA vs VFib. At the time of transfer$ patient was on vasopressin$ norepinephrine$ and epinephrine. The patient had an EF of 40-45% and elevated troponins.  Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states$ but wanted to make sure reporting was made available.$	$No current illness for this event.$	$Type 2 DM$ Diabetic neuropathy/nephropathy$ CKD Stage 3$ Hyperlipidemia$ Hypertension$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0961010-1$	$0961010-1$	$Resident returned to the memory support unit at 1500.  Resident was than toileted and transferred in to bed per his request.  At 1515 resident was observed face down beside bed$ resident sustained a 1inX1in eccyhmotic/hematoma to the forehead. Neuro Checks with in normal limes Vital signs: 100/52$ 100$ 97.2$ 28.  Resident sent to ED for further medical evaluation via EMS.$	$n/a$	$encephalopathy; gastritis unspecified with bleeding; essential primary HTN; benign prostatic hyperplasia without lower urinary tract sx; hypothyroidism; hyperlipidemia; spinal stenosis; sacral and sacro ccygeal region; anxiety; atrial fibrillation; GERD without esophagitis; edema unspecified; weakness; dementia; hammer toe acquired right foot$Hydralazine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Jan.$ 2021$	$2021/01$	$0972392-1$	$0972392-1$	$Patient sent to hospital 1/2 and 1/5.  Returned both times to nursing home covid unit without a hospital admission.  Resident had been diagnosed with COVID later in the day on 12/30$ when routine testing PCR results returned to facility$ after resident had already had her first covid vaccination on 12/30/20 in the morning.  Resident continued decline$ was again sent to hospital on 1/24/21$ and expired in hospital 1/25/21.$	$Left femur fx 12-7-20 UTI 12-7-20$	$Diabetes Type 1 Rheumatoid Arthritis GERD HTN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$0998637-1$	$0998637-1$	$Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest.$	$No known acute illness$	$Macular degeneration Dislipidemia$None noted$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$1019548-1$	$1019548-1$	$$Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea$ she had a negative work up$ felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of $$feeling sick$$.  she had fatigue$ chills$ decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities$ sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure$ pneumonia$ and DIC>$$	$No current illness for this event.$	$CVA$ hypertension$ pulmonary hypertension$ GERD$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$1036182-1$	$1036182-1$	$$Patient received 2nd dose of the COVID-19 Pfizer vaccine$ was observed in office x 15+ minutes$ and released home. Pt and his son exited the building and when they got to the car$ the pt shouted out $$oh no!$$ and collapsed to the ground. The patient was unconscious experiencing agonal respirations$ and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known  Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival$ he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads $$Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm.  Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture.  Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag.  Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation.$$ The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021.$$	$Unknown$	$Not verified. Problem list in EMR includes: Cerebellar ataxia Noted 7/28/2017$ Parkinson's disease  Noted 10/11/2019$ Peripheral polyneuropathy Noted 7/29/2017$ Lumbar radiculopathy Noted 10/29/2020$ Throat clearing Noted 1/22/2018$ Oropharyngeal dysphagia Noted 10/11/2019$  Aortic ectasia Noted 10/6/2019$ Anterior communicating artery aneurysm Noted 7/28/2017$ Essential hypertension Noted 7/28/2017$  Constipation Noted 10/23/2019$ Nocturia Noted 10/11/2019$ Dupuytren's disease of palm of both hands Noted 10/11/2019$ Alcohol intake above recommended sensible limits with complication Noted 7/29/2017$ Major depressive disorder$ single episode$ mild Noted 10/11/2019$ Hoarseness Noted 1/22/2018.$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$1036479-1$	$1036479-1$	$Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021.  Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.$	$Fell 2/4 and struck abdomen and ribs with large amount bruising Brought to ER 2/7 due to increased shortness of breath since COVID vaccine.  Patient was admitted with CHF$ hypoxia$ possible aspiration pneumonia; NSTEMI (refused transfer for cardiology).$	$Dementia; CABG; HTN; MI; esophageal varices; Former smoker; liver cirrhosis; absent kidney$Sulfa and vicodin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Feb.$ 2021$	$2021/02$	$1043302-1$	$1043302-1$	$My dad received the Pfizer vaccination on 2/5/21.  He was admitted into the hospital the next day for C-Diff bacterial infection.  He had been on dialysis treatments for kidney failure treatment since 2017 and had recently been diagnosed with stage 3 colon cancer in June 2020.  He had completed his final treatment of chemotherapy on 2/4/21 and several weeks prior had been determined cancer free.  On Tuesday 2/9/21 he was released from the hospital and went home.  Early Thursday morning 2/11/21 @ approximately 1:30 am CST his eyes rolled back in head and he stopped breathing and was non responsive.  My mother called 911 and attempted CPR.  Paramedics arrived and were able to successfully get a pulse then transferred him to the hospital.  He was put on a ventilator @ the hospital and then transferred to a different hospital a few hours later.  He lost pulse/heartbeat several times @ the 2nd hospital he was transferred to.  We were not allowed to travel with him or see him b/c of all of the COVID restrictions.  We were communicating with the ICU doctor by phone who ultimately communicated to us that there was nothing further that could be done to save his life. He subsequently passed away @ approximately 8:55 am CST on 2/11/21.$	$No current illness for this event.$	$Kidney failure - dialysis treatment 3x per week Recently recovered from stage 3 colon cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$1 day$	$1$	$Mar.$ 2021$	$2021/03$	$1073682-1$	$1073682-1$	$pulmonary edema; Low heart rate; chest pain; This is a spontaneous report from a contactable pharmacist. An 80-years-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ intramuscular in left arm on 28Jan2021 at single dose for COVID-19 Immunisation. Medical history included dementia$ high blood pressure$ COVID prior vaccination. He had no known allergies. Concomitant medication included diltiazem hydrochloride (CARDIZEM)$ anastrozole (ARIMIDEX)$ simvastatin and lorazepam. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 (at the age of 80-years-old) at single dose for COVID-19 Immunization. There was no other vaccine received in four weeks. The patient experienced pulmonary edema$ low heart rate and chest pain on 26Feb2021. The events resulted in hospitalization and patient died. The patient was hospitalized from 26Feb2021 for 1 day. Treatment received for the events included Epinephrine$ morphine$ nitroglycerine. The patient underwent lab tests and procedures which included Covid test Nasal Swab post vaccination on 26Feb2021 indicated Negative. The patient died on 26Feb2021. An autopsy was not performed.  information on the lot/batch number has been requested.; Sender's Comments: Pulmonary edema$ low heart rate$ and chest pain$ all reported as fatal$ are deemed unrelated to BNT162B2 vaccine$ being rather accidental occurrences$ likely favored by the patient's age and by the mentioned high blood pressure$ known risk factor for  cardiovascular diseases.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: Low heart rate; pulmonary edema; chest pain$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Blood pressure high; COVID-19; Dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Jan.$ 2021$	$2021/01$	$0948150-1$	$0948150-1$	$increase weakness and fatigue$ weakness in extremities$ incontinent$ jerky arm movements$ within first 24 hours$ continue to decline sent to hospital returned weaker$ within 24 hrs hours BP dropped$ low pulse  oximeter reading$ diaphoretic$ lung sounds diminished$ loss consciousness and passed away. 01-12-2021$	$pneumonia$$	$A-FIB; HYPERCHOLESTEROLEMIA; CKD 3; BPH; DEPRESSION; CERVICAL DISC DISORDER; SPINAL STENOSIS; BLADDER; COPD$ibuprofen$sulfa antibiotics$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Jan.$ 2021$	$2021/01$	$0951101-1$	$0951101-1$	$PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE$ PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE$ ACUTE KIDNEY INJURY$ ABNORMAL LFTS.$	$No current illness for this event.$	$hypertension$ dementia$ osteoarthritis$ diverticulosis$tramadol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Jan.$ 2021$	$2021/01$	$0953922-1$	$0953922-1$	$The day following the vaccine$ the patient complained of throat issues and anxiety.  This was not new... however .  That evening he reported difficulty breathing and was placed on oxygen; a COVID test was performed and was negative.   On 12/30/2020$ patient complained of sternal pressure and was transferred to the hospital.  The patient died 12/31/2020 and records obtained from the hospital indicated the patient died from a massive myocardial infarction.$	$Diabetes$ COPD$ Chrone's Disease$ DJD$ OSA$ PTSD$ GERD$ HLD$ Depression$ HTN$ lobectomy 3/4/2019$ cancer$	$See above$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Jan.$ 2021$	$2021/01$	$0987789-1$	$0987789-1$	$REC'D CALL FROM PT'S DAUGHTER$ HER FATHER WAS VACCINATED ON 1/22/21$ WOKE UP 1/23/21 WAS SHORT OF BREATH AND DIZZY. PT PRESENTED TO ED OF LOCAL HOSPITAL AND WAS ADMITTED$ PT PASSED ON 1/25/21. DAUGHTER STATES THAT FAMILY AND DOCTORS AGREE THAT THE VACCINE DID NOT CONTRIBUTE TOWARDS PT'S DEATH$ BUT FELT IT NEEDED TO BE REPORTED.  PT'S DAUGHTER CONTACTED THIS RN AT LOCAL HEALTH DEPARTMENT TO REPORT TO VAERS.$	$UNKNOWN$	$UNKNOWN$UNKNOWN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$0992082-1$	$0992082-1$	$Resident was noted on 1/25 with an increased functional decline as she would not feed herself with utensils$ but would eat finger foods if placed in her hand. She was started on Rocephin IM for possible infections. Labs had been obtained on 1/21/21$ unremarkable for CBC and CMP. 75$000 colony count on urine. On 1/26/21 she was noted with right sided weakness and further decline. She was sent to Hospital for further evaluation. We were notified that she expired on 1/28/2021. Resident had been noted with a decline in function about 2 weeks earlier when she would not stand or transfer any longer. She was still responsive$ taking meds$ and feeding herself until 1/26/21. Further information on admitting diagnoses and progress notes from hospital have not been available to date.$	$None$	$Supraventricular Tachycardia$ cerebral palsey$ epilepsy$$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$0993028-1$	$0993028-1$	$On 1/9/21-Diaphoresis$ O2 90%$ respirations 22$ increased weakness$ wheezing bilaterally. Send to ER for evaluation and treatment. She was sent to ER$ where she was admitted for 2 days$ then expired there on 1/11/21$	$C-diff$	$COPD$ HTN$ DM II$ CAD$ Acute kidney failure$ CHF$ GERD$ Adult failure to thrive$$metoprolol$ demerol$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1024817-1$	$1024817-1$	$Patient was coded and expired Code Blue:  Patient was in dialysis$ after 30 minutes his sbp dropped to 60s he was given 4 albumin. Patient who was responsive before that became unresponsive$ had seizure like activity$ lost pulse and spontaneous breathing.  HD stopped. Code called. Cpr started.  A few minutes into cpr patient  started to profusely bleed - gi bleed and ventilation became very hard.$ intubation was very difficult and ventilation hard as we suctioned large amounts of aspirated blood. Patient was eventually intubated. More than 8 doses of epi ws given$ sodium bicarbonate * 2 given with continuous  cpr. It was mostly PEA with one shockable rhythym. And shock delivered for vfib.   patient continued to profusely bleed$ og insertion was not successful and effective ventilation was very tough due to massive aspiration$. Possible variceal rupture with cpr from his cirrhosis is likely scenario.  After 30 minutes of unsuccessful ventilation and acls protocol. Code was stopped.$	$NIDDM$ HTN$ CAD s/p CABG x4v$ liver cirrhosis$ ESRD on HD$ cataracts$ dysarthria$ PAD s/p angioplasty 2020 bilateral lower extremity$	$social history of alcohol abuse$Ampicillin sodium$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1026045-1$	$1026045-1$	$On 2/7/21 resident complainted of not feeling well$ nausea$ vomiting and weakness sent to ER passed away.$	$COPD$	$COPD$ history of stroke$Sulfa$ Hydroxizine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1026980-1$	$1026980-1$	$Patient reported to Emergency room on 01/23/2021 with complaint of nausea. According to ER record patient reported he received a COVID 19 vaccine Pfizer the day before.   Work up in the ER (CT ABD PELVIS) reveal a clotted of SMA. CT CHEST REVEALED  BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE STATE HOSPITAL. HE WAS SCHEDULED FOR EMERGENT VASCULAR SURGERY WHICH WAS CANCELLED AS THE PATIENT DIED SHORTLY AFTER HIS ARRIVAL.$	$NONE$	$DIABETES$ MOOD DISORDER$ ELEV CHOL$ CAD$ HTN$ BPH$ DIABETIC NEUROPATHY$  ENVIROMENTAL ALLERGIES$ LOW VIT D$ HYPOGONADISM$ GERD$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1027258-1$	$1027258-1$	$Resident was given the Pfizer vaccine on January 22$ 2021$ nausea and shortness of breath was taken to the Hospital on the 23rd of January and passed on the 24$ 2021$	$kidney failure$ diabetic$	$congestive heart failure$ dialysis$no$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1037051-1$	$1037051-1$	$Diarrhea $ fatigue on 2/10 Fall 2/12 out to hospital Resident Expired 2/14$	$Pyelonephritis$ Nephrostomy in 2019$	$HTN$ ASTHMA$Ampicillin$ Penicillin$ shellfish$seafood$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1041191-1$	$1041191-1$	$Decedent had unwitnessed fall out of wheelchair 1/25/21 around 9:43am$ denied head strike$ pain$ discomfort. Around 10:02pm$ 1/25/21$ decedent noted to have slurred speech and fluctuating HR$ transported to Hospital and made cmo.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1041784-1$	$1041784-1$	$On the 25th he was home alone$ he called 911 and let them know he thought he was having a stroke. EMS arrived and transported him to Hospital. It was massive stroke$ he was not able to comprehend anything$ he was put into Hospice the following day and passed away on the 27th. There was no autopsy preformed.$	$No current illness for this event.$	$A stroke a year and half before$ AVM$ Arthritis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Feb.$ 2021$	$2021/02$	$1052645-1$	$1052645-1$	$Cardiogenic shock occurred on 2/10/2021$  approximately 12 hours after patient received her 12th dose of pemetrexed/pembrolizumab and 4 days after COVID vaccine. Coronary angiography was done on 2/10/2021 and no significant coronary narrowing or blockage were noted. Baseline troponin on 2/10/21 was 0.02 and later on 2/10/21$ troponins were 9.99 & 25.27. Creatinine increase from 1.2 to 3.4 within 24hours$ and AST/ALT increased from 23 & 31 to  4$220 & 4$786 respectively on 2/11. Patient expired on 02/11/2021.$	$Stage IV adenocarcinoma of lung$	$Stage IV adenocarcinoma of lung diagnosed on 05/19/2020$Latex$ penicillin$ sertraline$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Mar.$ 2021$	$2021/03$	$1065435-1$	$1065435-1$	$blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contactable consumer.   An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3248)$ via an unspecified route of administration at single dose in the left arm on 19Jan2021 14:00 for covid-19 immunisation. Medical history included heart problems$ pacemaker. Concomitant medication included heparin.  The patient experienced death cause: heart problems on 20Jan2021$ blood clot  on an unspecified date with outcome of unknown that required hospitalization$ tired on 19Jan2021 with outcome of unknown$ nauseous on 19Jan2021 with outcome of unknown. The patient was hospitalized for blood clot from 16Jan2021 to 18Jan2021. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: The patient was tired and nauseous about 3 hours after her vaccine. She had been in the hospital 16Jan2021 to 18Jan2021 for a blood clot. The patient died at her home on 20Jan2021 between 4 and 7 pm. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination$ the patient was not diagnosed with COVID-19 and since the vaccination$ the patient had not been tested for COVID-19.; Reported Cause(s) of Death: death cause: Heart Problems$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Heart disorder; Pacemaker insertion (cardiac)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$2 days$	$2$	$Mar.$ 2021$	$2021/03$	$1072218-1$	$1072218-1$	$Patient hospitalized for NSTEMI (from 2/18/2021 to 2/20/2021) and discharged on hospice/comfort care. Patient died 2/21/2021.$	$No current illness for this event.$	$angina pectoris$ coronary artery disease$ epistaxis$ gout$ hyperlipidemia$ hypertension$ idiopathic pulmonary fibrosis$ lymphoma$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$3 days$	$3$	$Jan.$ 2021$	$2021/01$	$0968846-1$	$0968846-1$	$Within 15 minutes of the injection$ the individual became aphasia and stroke like symptoms. She was taken to the ER where she was later diagnosed with a cerebral hemorrhage and passed away.$	$None$	$Hypertension$Dust mites and outdoor allergens$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$3 days$	$3$	$Jan.$ 2021$	$2021/01$	$0970618-1$	$0970618-1$	$SON SAID PATIENT WAS FOUND UNRESPONSIVE AND CALLED 911$	$UNKNOWN$	$UNKNOWN$UNKNOWN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$3 days$	$3$	$Jan.$ 2021$	$2021/01$	$0986672-1$	$0986672-1$	$Patient tested Covid positive$ cough$ low oxygen levels$ COVID Pneumonia$ patient is now deceased$	$none$	$CVA$ seizures$ Lung nodule$iodine          topical betadine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$0992734-1$	$0992734-1$	$1st COVID immunization 1/7/2021$  COIVD positive results on 1/16/21$   1/24/21 O2 sats decreased to 78%$ 1/24/21 reveived the Bamlanivimab infusion 50 ml/hr. 1/24/20 chest x ray 1/24/21 She was sent to hospital and admitted. 1/27/2021 Expired$	$Rheumatoid Arthritis$ overactive bladder$ glaucoma$ major depressive disorder$ Alzheimers Disease$ polyneuropathy$$	$Rheumatoid Arthritis$ overactive bladder$ glaucoma$ major depressive disorder$ Alzheimers Disease$ polyneuropathy$$codeine$ penicillin$ enbrel$ septra$ sulfa antibiotics$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1017509-1$	$1017509-1$	$Day after receiving the vaccine$ the patient complained of abdominal pain which worsened over the day.  She went to the ED and was hospitalized.  Abdominal pain complaints increased and continued$ she decompensated rapidly$ was intubated and subsequently died 3 days later.  Imaging results showed$ progressive ovarian cancer in the bowels.  Blood culture revealed that she had E.Coli in her blood.  It is thought that this is NOT related to the vaccine.$	$Advanced Ovarian Cancer$	$spinal stenosis$penicillins$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$4 days$	$4$	$Jan.$ 2021$	$2021/01$	$0984617-1$	$0984617-1$	$Patient passed su hospital on 23Jan2021 stopped breathing; complained of not feeling well; had an inflamed gall bladder; This is a spontaneous report from a contactable consumer. A 98-year-old female patient received bnt162b2 (BNT162B2$ PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EL8982 and expiry date unknown)$ via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication reported as has received other medications (unspecified) within 2 weeks. The patient passed in hospital on 23Jan2021 with stopped breathing. Day after vaccine on 17Jan2021$ the patient complained of not feeling well$ went to hospital where was told she had an inflamed gall bladder. The events caused patient hospitalization for 4 days. The cause of death reported as stopped breathing. It was unknown if autopsy done. Prior to vaccination$ the patient not diagnosed with COVID-19. The outcome of the event breathing arrested was fatal$ outcome of the other events was unknown.; Reported Cause(s) of Death: Stopped breathing$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$4 days$	$4$	$Jan.$ 2021$	$2021/01$	$0985367-1$	$0985367-1$	$TESTED POSITIVE FOR COVID-19 1-7-2021$ TRANFERRED TO HOSPITAL ON 1-18-2021. HE READMITTED TO THE FACILITY ON 1-21-2021 WITH HOSPICE SERVICES AND EXPIRED ON 1-25-2021.$	$COVID-19 + DAY AFTER THE FIRST DOSE OF THE VACCINE$	$PARKINSON'S DISEASE  HTN BPH CROHN'S DEMENTIA  ANXIETY OA DDD ALLERGIC RHINITIS  VITAMIN D DEFICIENCY$ATIVAN  GEODON$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1051666-1$	$1051666-1$	$Pt presented to ER with SOB on 01-29-2021. He was admitted to Healthcare with acute CHF exacerbation$ elevated lactate$ anemia and elevated d-dimer. Pt reports getting SOB getting up to go to the bathroom.  Pt was intubated. He developed pulmonary edema. Pt expired on 02-02-2021 at 10:13 PM.$	$None$	$CHF$DM2$OSA$HTN$Diabetic Neuropathy$ CKD3$Heparin$Cipro$Imdur$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$4 days$	$4$	$Feb.$ 2021$	$2021/02$	$1054434-1$	$1054434-1$	$Patient reported to emergency room on 2/20 with increasing of shortness of breath$ quantitated unable to walk from room to room in his house. Patient was admitted.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$0995641-1$	$0995641-1$	$Resident was hospitalized for confusion$ and hypotension and increased weakness; resident proceeded to have a NSTEMI and died on 5th day in hospital on 1/31/2021.$	$No active illnesses at time of vaccination or 1 month prior to vaccination; was diagnosed with UTI between vaccination and date of death.$	$Malignant neoplasm of prostate$ Hypothyroidism$ Type 2 Diabetes Mellitus$ Hyperlipidemia$ Multiple Sclerosis$ Neuropathy$ Essential primary hypertension$ Atrial Fibrillation$ Heart Failure$ Peripheral Vascular Disease$ Constipation$ Weakness$ Dry mouth$ Personal history of Urinary Tract Infections$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$1048687-1$	$1048687-1$	$stroke; This is a spontaneous report from a contactable consumer reported for father. An 87-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: el9261) via an unspecified route of administration on 22Jan2021 at 10:45 AM at single dose for covid-19 immunisation. Medical history was unknown. Concomitant medications included other medications in two weeks in medical records. The patient had no other vaccine in four weeks. The patient had a stroke around 9 pm after receiving vaccine on same day (22Jan2021). At 10:50 that morning$ he died on 27Jan2021. AE resulted in emergency room/department or urgent care$ hospitalization. The patient had hospitalization for 5 days. The patient had no Covid prior vaccination$ no Covid tested post vaccination$ no known allergies. The patient had other medical history (unspecified). It was unknown whether the autopsy was performed. Outcome of the event was fatal.; Reported Cause(s) of Death: stroke$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$5 days$	$5$	$Feb.$ 2021$	$2021/02$	$1059421-1$	$1059421-1$	$After the second vaccine dose she reported not feeling well with unspecified symptoms for a few days. On February 18th$ 2021 she visited her doctor with numbness in her hand. They thought it may be carpal tunnel and sent her home. The morning or March 18th $ 2021 she had a severe stroke and was transferred to Hospital and then to other hospital. She was in the hospital until Tuesday March 23rd when she was transferred back to her home for hospice care. She died on March 26th$ 2021.$	$None$	$Arthritis - Macular Degeneration$None Known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Jan.$ 2021$	$2021/01$	$0966856-1$	$0966856-1$	$Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19  outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline$ but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital  At no time during the hospital stay has she been more than minimal responsive.   She need O2 for Comfort   but on CXR and CT cardiopulmonary imagining  was clear. Discharge note stated that he was requiring supplemental oxygen$ but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely$ this disease set her level of function back to the point that she was no longer eating and drinking$ and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis.  On 1/12/2021 family made patient a DNR  and IVF were stopped and switched to comforted care.  Patient expired 1/13/21$	$unk$	$renal   AND   Alzheimer's$unk$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Jan.$ 2021$	$2021/01$	$0969488-1$	$0969488-1$	$Fatigue$ muscle aches$  vomiting$ hematoma$	$Covid 19$	$hypertension$No$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$0998175-1$	$0998175-1$	$Resident vaccinated-1/7/21 Resident covid positive 1/11/21 Resident covid PNA-1/12/21 Resident hospitalized 1/16/21 Resident deceased 1/20/21$	$No$	$MAJOR DEPRESSIVE DISORDER$ RECURRENT$ SEVERE WITH PSYCHOTIC SYMPTOMS   UNSPECIFIED PSYCHOSIS NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION   MILD COGNITIVE IMPAIRMENT$ SO STATED       GENERALIZED ANXIETY DISORDER   ESSENTIAL (PRIMARY) HYPERTENSION   TYPE 2 DIABETES MELLITUS WITHOUT COMPLICATIONS   AGE-RELATED OSTEOPOROSIS WITHOUT CURRENT PATHOLOGICAL FRACTURE       OTHER ALLERGIC RHINITIS   OTHER IRRITABLE BOWEL SYNDROME   PNEUMONIA DUE TO CORONAVIRUS DISEASE 2019       COVID-19   BACTERIAL INTESTINAL INFECTION$ UNSPECIFIED       HYPOKALEMIA   UNSPECIFIED SYMPTOMS AND SIGNS INVOLVING COGNITIVE FUNCTIONS AND AWARENESS   OTHER SEBORRHEIC KERATOSIS       HYPERLIPIDEMIA$ UNSPECIFIED   AGORAPHOBIA WITH PANIC DISORDER   PRESENCE OF RIGHT ARTIFICIAL HIP JOINT   ACQUIRED ABSENCE OF BOTH CERVIX AND UTERUS       ACQUIRED ABSENCE OF OTHER ORGANS       CYST OF KIDNEY$ ACQUIRED   NEOPLASM OF UNCERTAIN BEHAVIOR OF LIVER$ GALLBLADDER AND BILE DUCTS   OTHER SLEEP DISORDERS   PURE HYPERGLYCERIDEMIA   SPONDYLOSIS WITHOUT MYELOPATHY OR RADICULOPATHY$ SITE UNSPECIFIED$Penicillin$ Pravastatin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1014659-1$	$1014659-1$	$Four days after being vaccinated$ she developed pneumonia and died 8 days later.$	$No current illness for this event.$	$hypothyroidism$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1028476-1$	$1028476-1$	$She started having breathing problems/heart attack appearance. on 1/22/21 and went to the ER. Upon admittance was told it was an anaphylactic shock from the Covid shot. They kept her in ICU and released her 1/23/21. At 12:45 am on 1/24/21 she passed out and we called the ambulance. Hospital admitted her and worked through multiple organ failure issues and thought her numbers were under control. She was released on 1/27/21 and was driving on 1/28/21 around 4:15 pm and appears to have had heart failure and had a wreck. She passed away that day.$	$No current illness for this event.$	$A fib$ type 2 diabetes$ obesity$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1033102-1$	$1033102-1$	$Patient received first dose of vaccine on 1/7/21 at a community Public Health clinic.  On 1/29/21 he received a second dose at the community Public Health clinic.  On 2/5/21$ the patient presented to the ED with complaints of shortness of breath worsening over the last 2 weeks.  Patient reported that he had decreased exercise capacity and increased coughing with sputum production intermittently.  Patient reported that he had been feeling chilled$ but no fevers. Patient was admitted and treated with Decadron and Remdesivir.  Patient experienced increased oxygen requirement.  Patient was a DNI and did not want to be on life support.  After discussion with the patient and family$ patient was moved to comfort care. passed away on 2/11/21.$	$No current illness for this event.$	$CAD$ CKD$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1035539-1$	$1035539-1$	$Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot# EL3249)$ via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization.  Medical history included hypertension$ hyperlipidemia$ OA (osteoarthritis)$ cognitive impairment. No other vaccine in four weeks was administrated.  Concomitant medication in two weeks included atorvastatin$ aspirin$ calcium$ gabapentin$ losartan and memantine hydrochloride (NAMENDA).  The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021$ no bleeding or bruising from injection. On 31Jan2021 19:00$ patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care$ hospitalization$ life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions$ bone marrow biopsy$ cytogenetic testing$ antibiotics$ intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cognitive impairment; Hyperlipidemia; Hypertension; Osteoarthritis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1040183-1$	$1040183-1$	$$Patient had swelling around her jaw after her second shot of the covid $ Pfizer vaccine ( .5 ml IM)  on the Friday morning$ January 29th$ I took her to a follow up appointment with the cardiologist  at 3:00 pm$  as a follow up to a small heart attack event with hospitalization two weeks previously$ at the cardiologist she was given the ok/all is well. That next morning early$ she had a 911 event at her assisted living apartment and was sent back to the hospital$ having had another heart attack. Patient died on the following Thursday$ February 4$ 2021. I do not know if the vaccination had any cause for my mothers death; but I feel it is necessary to report this series of heart attacks after she received the pfizer vaccine. Her Certificate of Death records the cause of death as $$Coronary Artery Disease$$0$$	$CHF$	$CHF$ Diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Feb.$ 2021$	$2021/02$	$1048688-1$	$1048688-1$	$My mother had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine; Cerebral infarction; This is a spontaneous report from a contactable consumer (reporting for mother). A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number and expiry date unknown as not available or provided to reporter at the time of report completion) via an unspecified route of administration on 27Jan2021 in right arm at single dose for COVID-19 immunization. Medical history included coronary artery disease and hypertension. There were no concomitant medications. The patient was not pregnant. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not have covid tested post vaccination. The patient had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine and was hospitalized due to stroke for 6 days from Jan2021. The patient then experienced cerebral infarction in 2021 and died due to it on 04Feb2021. Treatment received for events stroke and cerebral infarction included tPA injection. The outcome of events stroke and cerebral infarction was fatal. An autopsy was not performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Coronary artery disease; Hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Mar.$ 2021$	$2021/03$	$1067090-1$	$1067090-1$	$within 24 hours after her second injection she developed chills$ had a syncopal episode and had$ difficulty breathing. this progressed over the next day when she had a second syncopal episode and her dyspnea and confusion worsened  EMT was called and she was brought to the hospital. she was in flash  pulmonary edema and with her history of severe aortic stenosis she was admitted to the cardiac icu.  she had no prior history up to that time of pulmonary edema and was functioning without distress in her home. she had a history of covid in early april$ manifesting primarily as severe confusion$ from which she recovered.$	$aortic stenosis severe mild hypertension peripheral vascular disease stable$	$aortic stenosis glaucoma macular degeneration mild hypertension senile dementia$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$6 days$	$6$	$Mar.$ 2021$	$2021/03$	$1072166-1$	$1072166-1$	$Patient hospitalized with shortness of breath and pneumonia (from 2/15/2021 to 2/21/2021) and patient died at another facility on 3/2/2021.$	$paraviral pneumonia$	$atrial fibrillation$ bladder cancer$ aortic dissection$ hypertension$ spinal cord stroke$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$7 days$	$7$	$Feb.$ 2021$	$2021/02$	$0995460-1$	$0995460-1$	$Vaccine-1/7 Covid positive-1/10 Hospitalized-1/17 Deceased-1/25$	$N/A Covid positive on 1/10 Hospitalized 1/16 Deceased 1/25$	$HEMIPLEGIA AND HEMIPARESIS FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE AFFECTING RIGHT DOMINANT SIDE (I69.951) WEAKNESS (R53.1) UNSPECIFIED DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE (F03.90) PNEUMONIA$ UNSPECIFIED ORGANISM (J18.9) UNSPECIFIED ABNORMALITIES OF GAIT AND MOBILITY (R26.9) HEART FAILURE$ UNSPECIFIED (I50.9) CHRONIC OBSTRUCTIVE PULMONARY DISEASE$ UNSPECIFIED (J44.9) ENCOUNTER FOR SURGICAL AFTERCARE FOLLOWING SURGERY ON THE DIGESTIVE SYSTEM (Z48.815) ATHEROSCLEROTIC HEART DISEASE OF NATIVE CORONARY ARTERY WITHOUT ANGINA PECTORIS (I25.10) ESSENTIAL (PRIMARY) HYPERTENSION (I10) ACUTE EMBOLISM AND THROMBOSIS OF DEEP VEINS OF RIGHT UPPER EXTREMITY (I82.621) APHASIA FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE (I69.920) DYSPHAGIA FOLLOWING UNSPECIFIED CEREBROVASCULAR DISEASE (I69.991) FLUID OVERLOAD$ UNSPECIFIED (E87.70) DYSPHAGIA$ OROPHARYNGEAL PHASE (R13.12) COVID-19 (U07.1) SPONDYLOLYSIS$ CERVICAL REGION (M43.02) HYPERLIPIDEMIA$ UNSPECIFIED (E78.5) PNEUMONIA$ UNSPECIFIED ORGANISM (J18.9) VITAMIN D DEFICIENCY$ UNSPECIFIED (E55.9) CELLULITIS OF RIGHT UPPER LIMB (L03.113) ENCOUNTER FOR ATTENTION TO COLOSTOMY (Z43.3) INCONTINENCE WITHOUT SENSORY AWARENESS (N39.42) OTHER PULMONARY EMBOLISM WITHOUT ACUTE COR PULMONALE (I26.99) OTHER SPECIFIED SOFT TISSUE DISORDERS (M79.89) OTHER SPECIFIED SYMPTOMS AND SIGNS INVOLVING THE DIGESTIVE SYSTEM AND ABDOMEN (R19.8) VASCULAR DISORDER OF INTESTINE$ UNSPECIFIED (K55.9) DYSPHAGIA$ UNSPECIFIED (R13.10) HYPOKALEMIA (E87.6) GASTRO-ESOPHAGEAL REFLUX DISEASE WITHOUT ESOPHAGITIS (K21.9) OTHER DYSPHAGIA (R13.19) VERTEBRO-BASILAR ARTERY SYNDROME (G45.0) ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTIONS AND CONDUCT (F43.25) BENIGN NEOPLASM OF COLON$ UNSPECIFIED (D12.6) CEREBROVASCULAR DISEASE$ UNSPECIFIED (I67.9) DISORDER OF KIDNEY AND URETER$ UNSPECIFIED (N28.9) HEMATEMESIS (K92.0) HYPOTHYROIDISM$ UNSPECIFIED (E03.9) LONG TERM (CURRENT) USE OF ANTICOAGULANTS (Z79.01) METABOLIC ENCEPHALOPATHY (G93.41) OTHER HYPERLIPIDEMIA (E78.4) OTHER SPECIFIED MENTAL DISORDERS DUE TO KNOWN PHYSIOLOGICAL CONDITION (F06.8) PERSONAL HISTORY OF OTHER VENOUS THROMBOSIS AND EMBOLISM (Z86.718) PERSONAL HISTORY OF TRANSIENT ISCHEMIC ATTACK (TIA)$ AND CEREBRAL INFARCTION WITHOUT RESIDUAL DEFICITS (Z86.73) RESPIRATORY FAILURE$ UNSPECIFIED$ UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA (J96.90) DIFFICULTY IN WALKING$ NOT ELSEWHERE CLASSIFIED (R26.2) PNEUMONIA$ UNSPECIFIED ORGANISM (J18.9)$Vancomycin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$8 days$	$8$	$Feb.$ 2021$	$2021/02$	$1035850-1$	$1035850-1$	$Patient woke up on the morning of 2/6 with symptoms of a stroke.  Rushed to hospital where clot found in brain.  Recovered from initial stroke but then had another major stroke on 2/8 and never recovered.$	$Sinus Infection being treated with steroids and antibiotics$	$Asthma Allergies Chronic Sinus infections Depression History of heart attack$Aspirin Erythromycin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$8 days$	$8$	$Feb.$ 2021$	$2021/02$	$1045842-1$	$1045842-1$	$A few days after the vaccination my father had a sore throat and slight cough.  This progressed into pneumonia like symptoms and he died on 2/11/21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$9 days$	$9$	$Feb.$ 2021$	$2021/02$	$1020816-1$	$1020816-1$	$Pt with acute resp failure$ COVID PNA$ that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior toa admit$ then shortly after progressed with other covid symptoms and was admitted. She decompensated while intp and was transferred to ICU for rising O2 needs$ ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed$ hemodynamics deteriorated. Pt passed soon after(2/2).$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$9 days$	$9$	$Feb.$ 2021$	$2021/02$	$1035553-1$	$1035553-1$	$Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure$ COVID pneumonia; acute resp failure$ COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist.  A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247)$ intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure$ COVID pneumonia$ that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit$ then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs$ ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed$ hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association$ the causal relationship between bnt162b2 and the events death$ COVID-19 pneumonia$ acute respiratory failure$ hypotension$ abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: Pt passed soon after$	$Suspected COVID-19$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$9 days$	$9$	$Feb.$ 2021$	$2021/02$	$1044459-1$	$1044459-1$	$Grandmother had trouble breathing the night she got the vaccine. She went to the hospital. They found pneumonia and a partial bowel obstruction. The obstruction cleared but she died from the pneumonia on 2/16/21.$	$None$	$High blood pressure Dementia  Spinal stenosis$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Jan.$ 2021$	$2021/01$	$0971676-1$	$0971676-1$	$muscle aches-increased pain to lower back$	$HYPERLIPIDEMIA$ UNSPECIFIED(E78.5)$ CHRONIC OBSTRUCTIVE PULMONARY DISEASE$ UNSPECIFIED(J44.9)$ VASCULAR DEMENTIA WITHOUT BEHAVIORAL DISTURBANCE(F01.50)$ OTHER SPECIFIED ANXIETY DISORDERS(F41.8)$ VENTRAL HERNIA WITHOUT OBSTRUCTION OR GANGRENE(K43.9)$ NONINFECTIVE GASTROENTERITIS AND COLITIS$ UNSPECIFIED(K52.9)$ CHRONIC VASCULAR DISORDERS OF INTESTINE (K55.1)$ SACROCOCCYGEAL DISORDERS$ NOT ELSEWHERE CLASSIFIED(M53.3)$ OTHER SPECIFIED DISORDERS OF BONE DENSITY AND STRUCTURE$ UNSPECIFIED SITE(M85.80)$ PERSONAL HISTORY OF OTHER VENOUS THROMBOSIS AND EMBOLISM(Z86.718)$ PRESENCE OF INTRAOCULAR LENS(Z96.1)$ ANEMIA$ UNSPECIFIED(D64.9)$ DISORDER OF WHITE BLOOD CELLS$ UNSPECIFIED(D72.9)$ IRRITABLE BOWEL SYNDROME(K58)$ ABDOMINAL AORTIC ANEURYSM$ WITHOU$	$see #11$hydrocodone$ metformin$ niacin$ Aricept$ lipitor$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1017563-1$	$1017563-1$	$Patient got the injection and quickly developed a fever and felt weak.  Family was contacted and he was sent to Hospital.$	$arthritis$ heart issues$	$neuropathy pain$none that we know of$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1019911-1$	$1019911-1$	$Client was administered the vaccine while symptomatic (01/25/21) although client did not know he was symptomatic for COVID-19. He had been exposed to a family member who had tested positive and should have been in quarantine but wasn't either because it was not felt he was considered a close contact  by his family opinion or his family member never notified public health of this close contact...?. Clinet had presented to the ED following day after vaccination for shortness of breath and fatigue and an antigen test showed he was positive for COVID-19. He was sent home that same day 01/26/21. He was back in ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on ventilator. He passed away on 02/09/2021 (date of death was per his wife).$	$Tested positive for COVID-19 on 01/26/2021 (Antigen positive) - presented to ED due to shortness of breath and fatigue$	$Active Problems Noted Date Hypokalemia 1/28/21  Pneumonia due to COVID-19 virus 1/28/21  Acute hypoxemic respiratory failure 1/28/21  Stone of salivary gland or duct 1/8/21  Recurrent major depressive disorder$ in partial remission 1/7/21  Secondary hyperparathyroidism of renal origin 1/7/21  Abnormal blood smear 7/22/20  Alkaline reflux gastritis 1/2/20  Severe obesity (BMI 35.0-39.9) with comorbidity 12/20/18  Type 2 diabetes mellitus with diabetic neuropathy$ without long-term current use of insulin 12/20/18  Morbid obesity due to excess calories 6/18/18  Psoriasis 12/13/17  Proteinuria 10/20/17  Bilateral leg edema 12/5/16  Hypertriglyceridemia 6/27/16  Essential hypertension with goal blood pressure less than 130/85 6/27/16  Anxiety$ generalized 6/27/16  Hypothyroid 11/24/14  Aortic valve replaced 7/7/14  Pulmonary emphysema 1/22/09  Obstructive sleep apnea syndrome 8/4/1943   Resolved Problems Noted Date Resolved Date Other chest pain 10/29/19 10/30/19  Chest pain 10/29/19 10/30/19  Type 2 diabetes mellitus without complication$ without long-term current use of insulin 6/24/19 7/6/20  Sialadenitis 1/4/19 1/2/20  Obesity (BMI 35.0-39.9 without comorbidity) 12/20/18 1/29/21  Abdominal pain 11/21/18 1/2/20  Type 1 diabetes mellitus with stage 3 chronic kidney disease 6/18/18 6/18/18  CKD (chronic kidney disease) stage 3$ GFR 30-59 ml/min 10/20/17 1/2/20  Sarcoidosis of lung 6/27/16 6/26/20  Uncontrolled type 2 diabetes mellitus with stage 3 chronic kidney disease$ without long-term current use of insulin 6/27/16 12/13/17  Overview:  Recent onset HbA1C 4/21/16 11.9. Last FBS-110 5/17/16 Diabetic eye exam 9/23/16 no diabetic retinopathy. fup one year. Hypothyroidism (acquired) 6/27/16 12/13/17  Exertional dyspnea 6/27/16 6/26/20  Tobacco abuse 11/19/08 9/23/11  documented as of this encounter (statuses as of 01/29/2021) Patient Active Problem List  Diagnosis  ? Obstructive sleep apnea syndrome  ? Pulmonary emphysema (*)  ? Aortic valve replaced  ? Hypothyroid  ? Hypertriglyceridemia  ? Essential hypertension with goal blood pressure less than 130/85  ? Anxiety$ generalized  ? Bilateral leg edema  ? Proteinuria  ? Psoriasis  ? Morbid obesity due to excess calories (*)  ? Obesity (BMI 35.0-39.9 without comorbidity)  ? Severe obesity (BMI 35.0-39.9) with comorbidity (*)  ? Type 2 diabetes mellitus with diabetic neuropathy$ without long-term current use of insulin (*)  ? Alkaline reflux gastritis  ? Abnormal blood smear  ? Recurrent major depressive disorder$ in partial remission (*)  ? Secondary hyperparathyroidism of renal origin (*)  ? Stone of salivary gland or duct  ? Hypokalemia  ? COVID-19 virus infection  ? Acute hypoxemic respiratory failure (*)   Past Medical History:  Diagnosis Date  ? Anxiety  ? Arthritis  ? Asthma  ? Back pain  ? Chronic kidney disease$ stage II (mild) 10/20/2017  ? Dependent edema  ? DJD (degenerative joint disease)  ? Gastritis  ? Glucose intolerance (impaired glucose tolerance)  ? History of pulmonary function tests 10/20/2010   showing decreased lung flow consistent with normal variant versus mild obstruction and emphysema  ? History of stress test 12/2009   Normal  ? Hyperlipidemia  ? Hypothyroid   Previously had hyperthyroidism  ? Kidney stone 05/1999   Right  ? Proteinuria 10/20/2017  ? Psoriasis  ? Sarcoidosis  ? Sleep apnea   Past Surgical History:  Procedure Laterality Date  ? AORTIC VALVE REPLACEMENT 05/2001   #25 St. Jude's aortic valve replacement  ? APPENDECTOMY 1960's  ? CHOLECYSTECTOMY 1994  ? COLONOSCOPY 2010  ? COLONOSCOPY FLX DX W/COLLJ SPEC WHEN PFRMD N/A 11/21/2018   COLONOSCOPY with hot polypectomy snare   ? OTHER SURGICAL HISTORY 09/2018   spot removed from left arm  ? TOTAL KNEE ARTHROPLASTY Right 11/19/2012    ? UPPER GI ENDOSCOPY$DIAGNOSIS N/A 11/21/2018   EGD with cold biopsies performed  ? WISDOM TOOTH EXTRACTION$Review of patient's allergies indicates: Allergies  Allergen Reactions  ? Other [Uncoded Nonscreenable Allergen] Rash   Neoprene$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1034182-1$	$1034182-1$	$Approximately 2 weeks post vaccination developed rapid AF$ CHF.  Admitted to Medical Center.  Discharged home on hospice.  Patient died at home on 2/13/2021.  Reported to this reporter at second dose clinic on 2/16/21.  Other details not known.  Unknown if related to vaccine.$	$OSA started on oxygen at night Dysphagia - work up$	$Sleep apnea Joint inflammation Hypoxia Past history of MI Hyperlipidemia Back pain Alcohol abuse Hearing loss Nodular hyperplasia of the prostate Asthma  TIA Atrial fibrillation$ new onset$None Known$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1055298-1$	$1055298-1$	$Emergency Room HPI: The patient is a 71 y.o. female with a PMH notable for COPD$ hypertension and anxiety and depression who presented on 2/6/2021 for evaluation of shortness of breath. Patient presented to our emergency room yesterday morning from local nursing facility rehab nursing staff reported that she had had a increased shortness of breath for the last 3 days she has been diagnosed with COVID-19 on 2-2-2021.  Patient has also received both COVID-19 vaccines.  Patient presented to the emergency room with labored respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to our emergency room patient's temperature 101.6¦$ pulse 169$ respirations 40 to blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather.  Patient received a chest x-ray that showed chronic emphysema and fibrotic changes in the lung no acute processes identified.  Patient's white count 12.8$ glucose 197$ creatinine 1.2$ lactic acid 4.6$ cardiac enzymes negative$ D-dimer 1180$ patient has urine culture pending.  Patient has received about 3 L normal saline boluses patient was having hypotension 86/52.  Patient also received IV acetaminophen a 1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback.  Patient was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19 and sepsis  2/12 admit Brief history and initial physical exam: Patient is a 71 year old long-term resident of Rehab and Healthcare.  Unfortunately$ she contracted coronavirus (COVID-19) at the nursing home.  Her respiratory status started to decompensate and so she was brought into the hospital.  Initial workup showed significant bilateral pleural effusions and ground-glass opacity of both lungs.  She had a significant supplemental oxygen requirement.  She was admitted for further evaluation and treatment. ل Hospital course: The patient was admitted and started on IV Remdesivir.  She was given IV Decadron.  She was given immune support vitamins.  Despite this$ her sepsis worsened.  When it became apparent that the patient was not going to recover$ her daughter did make her comfort care only and hospice was consulted.  The patient was found to be appropriate for general inpatient hospice and was made comfort care.  Her requirement for morphine and Ativan did slowly rise.  Eventually$ the patient did succumb to her respiratory failure.  Time of death was called at 10:00 p.m. on February 15$ 2021 ل Discharge Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to acute respiratory failure secondary to coronavirus (COVID-19) pneumonia ل Disposition: Deceased$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Feb.$ 2021$	$2021/02$	$1057082-1$	$1057082-1$	$Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE$ productive cough$ H/A$ N/V$ profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization$ has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.$	$unknown$	$Arthritis$ Afib$ chronic anticoagulation$ chronic back pain$ coronary arteriosclerosis$ DM$ GERD$ HLD$ HTN$ kidney stone$ PVD$ stroke$Pneumococcal vaccine - rash$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$10-14 days$	$10-14$	$Mar.$ 2021$	$2021/03$	$1066906-1$	$1066906-1$	$92 year-old male with PMHx of vascular dementia$ BPH$ MDD$ sleep disturbance $ basal cell carcinoma of neck$ osteoarthritis$ BLE edema$ Guillain-Barre syndrome 30 years prior$ s/p COVID positive on 1/11/21 and received IV Bamlanivimab.  Sent to hospital on 2/2/21 for altered mental status$ generalized weakness with inability to lift bilateral UE and difficulty moving his BLE.  He was treated for UTI with 7 days of Cefepime for Morganella Morganii.  He was followed by neurology with MRI of the brain and CT of the spine without acute findings.  Lumbar puncture unable to be obtained.  He received 5 day course of  IVIG for presumed Guillain-Barre .  EMG showed generalized sensory motor polyneuropathy both axon loss and demyelinating type severe in degree.  However$ he did not recover from his GBS symptoms$ was transferred back to the nursing home and died on 2/15/2021.$	$Dementia with behavioral disturbances.$	$1.  CAD  2.  Leg edema  3.  BPH 4.  Vascular dementia  5.  MDD/behavioral disturbances  6.  Sleep wake disturbance  7.  Hx BCC posterior neck 8.  B/L hips and right knee OA  9.  Hyponatremia$No known allergies.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$15-30 days$	$15-30$	$Feb.$ 2021$	$2021/02$	$0992238-1$	$0992238-1$	$Tested positive for COVID19 on 12-30-2020$ Admitted to Hospital on 1/5/2021 with active COVID$ Patient died 1/29/2021.$	$No current illness for this event.$	$ischemic heart disease hypertension diabetes mellitus type 2 gastroesophageal reflux disease  hyperlipidemia obstructive sleep apnea obesity$Plavix$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$15-30 days$	$15-30$	$Feb.$ 2021$	$2021/02$	$1002808-1$	$1002808-1$	$According to medical report$ Pt presented to the ED on 1/14/21 w/ cc of SOB for 1 day.  She received her COVID-19 vaccine on 1/9/21.  Pt stated that she developed a dry hacking cough 2 days prior to the vaccine on 1/7/21.  Over the last few days prior to admission$ she developed generalized weakness$ SOB$ loss of sense of taste and smell w/ associated decreased appetite and nausea ultimately SOB in the24 hours prior to admission.    Final Diagnosis- acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Pt died on 2/3/21. See Medical report for more information.$	$Diabetes$ hypertension$	$IBS$ GERD$ overweight$ scoliosis$ Macular degeneration$ sciatica$ umbilical hernia$ RBBB$ Others listed$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$15-30 days$	$15-30$	$Feb.$ 2021$	$2021/02$	$1036935-1$	$1036935-1$	$unkown$	$Treatment for recent eye procedure. Took blood pressure med$ lasix$ albuterol inhaler$ oxygen at night time$ antibiotic eye drops$ pain med as needed.  Received B12 injection once month. Took folic acid$ used nasal spray$ probiotic$	$Diastolic heart failure Edema to lower extremities Anemia Hyperparathyroidism due to rental insufficiency Chronic Kidney disease stg. 3 & 4 Chronic hyponatremia Essential hypertension Hx. of pacemaker$ breasts lumpectomy$Dairy products Tetracycline$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0921175-1$	$0921175-1$	$Resident received Covid Vaccine$ noted after 30 mins with labored breathing BP 161/77$ HR 116$ R 38$ T 101.4$$	$CHF$ COPD$ DM$ heart failure$ anemia$ sleep apnea$	$CHF$ COPD$ DM$ heart failure$ anemia$ sleep apnea$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0926462-1$	$0926462-1$	$Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021$	$dementia$ Upper gastrointestinal bleed$	$Advanced dementia$ Parkinson's' disease $chronic kidney disease$ sciatica$ hyperlipidemia$no known food or medication allergies$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0926568-1$	$0926568-1$	$patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020$	$chronic medical problems as noted below$	$dementia$ peripheral vascular disease$ COPD$ hypertension$ GERD$ S/P CVA with stent of left carotid $right common iliac and right external iliac arteries$ CDK$diabetes$clopidigrel$ sulfa$ vicodin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0946225-1$	$0946225-1$	$At approximately 10:30pm on 1/14/2021$ resident was noted to have a rash on her face$ hands$ arms$ and chest. VS:100.2$ 113$ 20$108/59$ 84% room air. applied nasal cannula at 4-L$ telephoned Physician orders 6mg Decadron one time order$ a second set of Vitals $ reads 99.3$ 110$ 20$ 106/60$ 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021$ resident congested and coughing. BP 151/70$ pulse 124$ temp 98.1 forehead$ resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away.$	$No current illness for this event.$	$Dx with Covid-19 on 12/11/2020$  PERIPHERAL VASCULAR DISEASES$ SCHIZOAFFECTIVE DISORDER$ BIPOLAR DISORDER$  EPILEPSY$  HYPERLIPIDEMIA$  SECONDARY PARKINSONISM$ MAJOR DEPRESSIVE DISORDER$  ANXIETY DISORDER$ HYPOTHYROIDISM$ HYPERTENSION$  OBESITY$ and UNSPECIFIED CHRONIC BRONCHITIS$$Lithium$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0954251-1$	$0954251-1$	$71 year old woman at rehabilitation center for physical therapy with history of cirrhosis of the liver$ asthma$ and heart condition was tested for COVID-19 on 01/07/21$ received 1st dose of Pfizer COVID-19 vaccine on 01/08/21$ positive test result for COVID-19 received on 01/09/21.  She was sent to the hospital and admitted  on 01/12/21 after O2 was 70% and was in a confused state.   Patient passed away on 01/17/21.$	$Cirrhosis of the liver$ asthma$ heart condition$	$Cirrhosis of the liver$ asthma$ heart condition$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0959929-1$	$0959929-1$	$$Narrative:  Patient seen in ED 1-17-21 with c/c of $$bloated with epigastric pain$$. Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX)$ and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009$ PAF$ and HTN). Regarding ER visit for epigastric pain$ nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day$ and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day$ Monday 1-18-21$ patient's caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been $$feeling kind of bad all day$$. Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL$ CXR unremarkable for infection$ UA neg for bacteria$ LFTs WNL$ blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21$ but around 13:00 began rapidly declining (confusion$ unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report.$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0962390-1$	$0962390-1$	$Admitted to hospital after vaccination with Acute hypoxemic respiratory failure$ Septic shock;  Aneurysm of arteriovenous dialysis fistula; expired 1/16/2021$	$intestinal adhesions with obstruction; Intestinal adhesions with partial obstruction; S/P colon resection; SBO (small bowel obstruction)$	$chronic renal failure$ stage 5; Dilated cardiomyopathy; end stage renal disease on dialysis;  End stage heart failure$ASPIRIN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0962827-1$	$0962827-1$	$Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF$ P 80$ diabetes mellitus$ HTN$ hyperlipidemia$ CKD stage 3$ has been complaining of generalized weakness$ fatigue$ decreased appetite for the past few days.  She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the hospital$ condition clinically deteriorated.  Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30 p.m. earlier today.  Preliminary cause of death:  Hypoglycemia induced lactic acidosis.$	$No current illness for this event.$	$chronic combined CHF$ diabetes mellitus$ HTN$ hyperlipidemia$ CKD stage 3$ATORVASTATIN; CODEINE; DOXY$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0963057-1$	$0963057-1$	$presented to ED 1/9/21 with abdominal pain$ progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline$ palliative care had been consulted on end of life care. Patient expired 1/17/21$	$No current illness for this event.$	$hypertension$ hypothyroidism$ emphysema$ CKD 3$ and history of breast cancer$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0972049-1$	$0972049-1$	$5 days after application of second dose$ patient developed oculogyric crisis with oropharyngeal automatisms (schmatzautomatismen) i.e. parkinsonoid at 9:00 a.m and was seen by me the following day at 01:00 a.m. patient was delivered to neurology unit of ameos klinikum bernburg (section 14 for follow-up). at nursing home$ no vaccination documents could be retrieved. any other immunization status unknown. pantoprazole seems not to be attributable. once-in-a-lifetime entity. I think the report is valid. Poor data at nursing home. There is ZERO vaccination documentation on-site. Only the Pfizer/Biontec vaccine is available at time of vaccination.$	$--$	$Diabetes$ Hypertension$ Apoplect.- Insult 2019$--$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0975184-1$	$0975184-1$	$The patient had a heart attack and died at a local hospital morning of 1/19/2021.$	$none$	$Heart disease Mild stroke about a year ago$none$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0975744-1$	$0975744-1$	$See initial report$	$The resident was febrile on 1/9/2021 after receiving the Pfizer vaccine on 1/7/2021. On 1/9/2021 UA$ CBC$ and CMP ordered indicating she had UTI. SARS-CoV-2 testing was performed using POCT GeneXpert on 1/9/2021. No SARS-CoV-2 was detected. The resident continued to decline and on 1/15/2021 she became tachycardiac and was having trouble breathing. She was transferred to ER where she later died.$	$Dementia$ Hyperlipidemia$ HTN$ Hypothyroidism$ left femur fracture$ hx of COVID-19$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$0992063-1$	$0992063-1$	$Patient received first dose of the COVID-19 Moderna vaccine on 1/19/2021 at an outside facility (no lot #$ route$ or site available to me in electronic charting).  Pt began having hypoxia$ SOB$ and a dusky appearance of extremities on 1/29/2021 and was brought by EMS to our hospital.  PT is a DNR and family had been looking into a hospice sign up due to dementia and general decline in the weeks prior to hospitalization.  Pt tested positive on admission for COVID-19 via PCR test on 1/29/2021.  Pt continued to have respiratory decline$ was put on comfort care per wishes of family/advanced directives$ and he passed away the evening of 1/30.$	$No current illness for this event.$	$Vascular dementia$ swelling of left lower extremity (chronic)$ subclinical hypothyroidism$ STEMI (2014)$  rheumatoid arthritis$ postinflammatory pulmonary fibrosis$ posterior tibial tendon dysfunction$ paroxsymal atrial fibrillation$ osteoporosis$ OSA on CPAP$ microscopic colitis$ interstitial lung disease$ hypertension$ hx of squamous cell carcinoma of skin$ hx of basal cell carcinoma$ hearing loss$ gout$ GERD$  dyspnea on exertion$ dyslipidemia$ diverticulitis$ HX of CVA$ COPD$ chronic heart failure w. preserved ejection fraction$ chronic back pain$ carotid artery stenosis$ CAD$ BPH$ Barrett's esophagus$ asthma$ anxiety$ allergic rhinitis$ actinic keratosis.$$Amoxicillin (N&V)$ $$poison ivy/treatments$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$0997571-1$	$0997571-1$	$BRAIN BLEED$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$0999480-1$	$0999480-1$	$Ventricular fibrillation; This is a spontaneous report from a non-contactable physician downloaded from the database [Regulatory Authority number DE-DCGMA-21187603].  An 85-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY)$ intramuscular$ on 31Dec2020$ at single dose$ for COVID-19 immunisation. Medical history included ongoing Parkinson's disease$ hypertensive crisis (unknown if ongoing)$ ongoing cardiac failure chronic$ infarct myocardial (not ongoing)$ stethalgia (unknown if ongoing)$ ongoing dementia$ ongoing chronic renal insufficiency$ bundle branch block left (unknown if ongoing). Concomitant medications were not reported. The patient experienced ventricular fibrillation on 18Jan2021. Shocking and cardiopulmonary resuscitation (CPR) were performed. The patient was hospitalized due to the event in Jan2021. The patient died on 19Jan2021 due to multimorbidity$ cardiac arrhythmia and ventricular fibrillation. It was not reported if an autopsy was performed.  Reporter comment: Measures: Initial restoration of the circulation after shocking and CPR on 18Jan2021. No resuscitation measures$ no artificial ventilation and no intensive medical therapy desired on the part of the family. Thus regular ward. Development of aspiration pneumonia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ventricular fibrillation; Multimorbidity; Cardiac arrhythmia$	$Cardiac failure chronic; Chronic renal insufficiency; Dementia; Parkinson's disease$	$Medical History/Concurrent Conditions: Bundle branch block left; Hypertensive crisis; Infarct myocardial; Stethalgia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1000670-1$	$1000670-1$	$she was hurting at her chest/ Chest pain; on her left arm hurt real bad that's what the clot on her left arm; on her left arm hurt real bad that's what the clot on her left arm; She passed away; heart attack; This is a spontaneous report from a contactable consumer.  An 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus$ for which she was taking a pill like an hour before she would take her meal. On Monday (Jan2021) the patient experienced was hurting at her chest/ chest pain$ her left arm hurt real bad as she had a blockage in her left arm/clot on her left arm$ and they wanted to put in a stent and after the surgery it went well and she all go home in two days. The patient was hospitalized in Jan2021 due to the events. She had a heart attack and that the chamber between the dividers had a hole in it and her heart tissue was too thin so much thin she couldn't repair it. The patient passed away on 26Jan2021. The patient was tested negative for COVID-19 on unknown date.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed away$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1002255-1$	$1002255-1$	$Death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1019661-1$	$1019661-1$	$Patient admitted to hospital evening of 2/7/21 with acute ischemic stroke and received tenectaplase.  Diagnosis Left MCA stroke.  Reporting event given was just over 24 hours after first COVID vaccine dose.$	$hip replacement$ HLD$ HTN$ atherosclerotic heart disease$ cataract surgery$	$hip replacement$ HLD$ HTN$ atherosclerotic heart disease$ cataract surgery$NKA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1024343-1$	$1024343-1$	$PATIENT ARRIVED TO ED ON 2/9 IN FULL CARDIAC ARREST$	$No current illness for this event.$	$LUPUS$ERYTHROMYCIN$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1026492-1$	$1026492-1$	$The individual received the vaccine around 12:00pm on 02/11/21. Around 9pm the individual went to lay down on the couch at home and started to have difficulty breathing. Within 30 minutes the individual became week and unresponsive. She was transported to the hospital where she was pronounced deceased at 11:44 pm on 02/11/21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1028166-1$	$1028166-1$	$Patient was found unresponsive on her kitchen floor about 9:45 AM on February 10$ 2021 approximately 18 hours after receiving her first Covid-19 vaccination. Exact time of the event is unknown. She was known to get up between 6:30 and 7:30 AM. It appeared that she had not eaten breakfast nor taken any medication that morning. She was taken by ambulance to Medical Center where a CT scan showed an unrecoverable massive brain hemorrhage. She died at approximately 3:50 PM after the respirator was removed. She was sent to the local Medical Examiner afterwards.$	$Glaucoma$ corneal virus in right eye$ IBS$	$IBS with Constipation/Diarrhea$ atrial fibrillation$ heart failure$ and osteoporosis. Had a known brain aneurysm that had been scanned annually which showed no signs of change. Dr. was her primary care physician and has most of her medical records. CNA gave her cardiology care. Endocrinologist$ treated her osteoporosis and gave her a Prolia injection twice yearly. Her newest medication was Acyclovir$ 800mg$ 4x Daily prescribed by doctor for her right eye.$ALLERGIC to monopril$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1035546-1$	$1035546-1$	$Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2$ Manufacturer Pfizer-BioNTech)$ via an unspecified route of administration$ on 16Jan2021$ at single dose$ for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized  due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all.  The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age$	$Hypertension (Took medication)$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1036731-1$	$1036731-1$	$SOB$ DOE$ oxygen desaturation$ nausea. Ems transport to ER for eval$	$CHF$ venous stasis ulcers$	$HTN$ polycythemia vera$ anxiety disorder$ ataxia$ backache unspecified chronicity$ hyperlipidemia$ seizure d/o$ h/o skin cancer$ osteoporosis$ incontinence$ arthralgias$ dizziness and giddiness$Novacaine$ ampicillin$ sulfa$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1037865-1$	$1037865-1$	$respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care$ hospitalization$ and patient died.  No follow-up attempts are possible$ information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome$ and the administration of COVID 19 vaccine$ BNT162B2$ based on the reasonable temporal association.  More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to RA$ IEC$ as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1041990-1$	$1041990-1$	$PATIENT WAS ADMITTED TO ER FOR  ALTERED MENTAL STATUS  / UTI  SEPSIS  WITH SEPTIC SHOCK / COVID AND COVID   PNA   PATIENT WAS ADMITTED TO ICU AND DIED .   POA WISH TO WITHDRAWL EXTRME MEASURES$	$Covid  IN NOVEMBER$	$CKD $ CAD WITH STATUS POST  CABG $ HTN  HYPOTHYROIDISM$ DEMENTIA AND RECURRENT UTI$nkda$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1051675-1$	$1051675-1$	$$Patient passed away on 2/1/21 at the Health System. She was there for congestive heart failure (CHF) which had been a problem for her since contracting COVID-19 (symptoms began 10/29/20 and tested positive 10/30/20). She had been to see her medical provider several times after her isolation period as well as a few trips to the hospital for$ what they called $$CHF flare-ups$$. Her last hospitalization began on January 30$ 2021. Her social worker reported on t1/31/21 that $$she would likely be returning in another day or two$$0$$	$congestive heart failure$	$congestive heart failure$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1054114-1$	$1054114-1$	$Patient was hospitalized 15 days after receiving vaccine. Admission was not due to vaccine and was admitted for acute ascites and patient had reported fever and hypoxia. Patients admission resulted in death 7 days after being admitted to hospital.$	$No current illness for this event.$	$$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1059356-1$	$1059356-1$	$Pt fell within 24 hours after vaccine. was sent to hospital. pt was  found to be hypoxic with multifocal opacities on CT scan$	$UTI$	$Afib$ CHF$ Alzheimer's$ bradycardia ( officially diagnosed march 2019)$sulfa$ pet dander$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$65+ years$	$65+$	$Unknown$	$U$	$Mar.$ 2021$	$2021/03$	$1068884-1$	$1068884-1$	$DEATH Narrative:  Presented to ED via EMS c/o increasing shortness of breath$ O2 sat mid to high 80s on 4L. When EMS arrived $ pt was in distress$ intubated by EMS and transported to ED. Pt had a PEA arrest en route but resuscitated w/ return of spontaneous circulation after receiving a dose of epinephrine and chest compressions. Pt was hypotensive on arrival to ED. He was started on sepsis protocol $ volume resuscitation and empiric antibiotics. Once stabilized$ he was admitted to icu at hospital. Removed from respirator 2/22/21$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0908245-1$	$0908245-1$	$Asystole; Circulatory collapse; This is a spontaneous report from a contactable pharmacist received from Agency and downloaded from the Regulatory Authority-WEB GB-MHRA-WEBCOVID-20201214111558$ Safety Report Unique Identifier GB-MHRA-ADR 24542972 and EU-EC-10007191566 received via Regulatory Authority.   An adult female patient received bnt162b2 (batch/lot number not provided)$ via an unspecified route of administration on 13Dec2020 at single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medication included sildenafil$ acetylsalicylic acid$ allopurinol$ levothyroxine$ spironolactone$ amiloride hydrochloride$ furosemide and desogestrel. The patient experienced asystole on 13Dec2020$ circulatory collapse on 13Dec2020. The patient died due to asystole and circulatory collapse on 13Dec2020. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Information about batch number is not obtainable. No further information is expected.; Reported Cause(s) of Death: circulatory collapse; Asystole$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0918721-1$	$0918721-1$	$cardiac arrest; heart failure; did not feel well$ lost consciousness and died; did not feel well$ lost consciousness and died; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 28Dec2020 08:30 at single dose for covid-19 immunisation.  Medical history included suffered from the past from heart attacks$ active heart disease$ malignant disease.  The patient's concomitant medications were not reported.  A man of 75 years old$ who suffers from many different background diseases$ died (this morning 28Dec2020) from cardiac arrest$ two hours after he received the injection. The man received the injection at 8.30am$ and after he was feeling okay he was released to go home. After a while when he was home he did not feel well$ lost consciousness and died$ and he was pronounced dead from heart failure. The patient died on 28Dec2020.  It was not reported if an autopsy was performed. The outcome of the event cardiac arrest and heart failure was fatal while the outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : IL-PFIZER INC-2020517177 same reporter$ same vaccine$ reporting similar events in different patients.; Reported Cause(s) of Death: heart failure; cardiac arrest$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cancer (NOS); Heart disease$ unspecified; Heart failure$ unspecified$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Dec.$ 2020$	$2020/12$	$0918722-1$	$0918722-1$	$found dead in his bed; This is a spontaneous report from a contactable healthcare professional received via the Ministry of Health department of epidemiology. The department of epidemiology reported similar events for two patients. This is the second of two reports.  A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4175)$ via an unspecified route of administration on 24Dec2020 as a single dose for COVID-19 immunization.  Medical history included schizophrenia$ very heavy smoker for almost 50 years$ emphysema$ and tumor resection in the bladder.  The patient's concomitant medications were not reported.  On 28Dec2020$ the patient was found dead in his bed. It was reported that the patient did not have any complaints in the days following the vaccination. Then$ on 28Dec2020$ the patient was found dead. The cause of death was unknown. It was not reported if an autopsy was performed.; Sender's Comments: A reasonable possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until further information regarding clinical course and death cause is provided. Of note$ the patient did not have any complaints in the days following the vaccination. The case was confounded by the patient's underlying conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.$Linked Report(s) : IL-PFIZER INC-2020517122 same reporter$ same vaccine$ reporting similar events in different patients.; Reported Cause(s) of Death: found dead in his bed$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Bladder tumor resection; Emphysema; Heavy smoker (for almost 50 years); Schizophrenia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0923219-1$	$0923219-1$	$Sudden death; This is a spontaneous report from a contactable physician and consumer.    A 41-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: UNKNOWN)$ via an unspecified route of administration on 30Dec2020 at 0.3 mL single dose for COVID-19 immunisation.  Medical history included hypertension.  The patient's concomitant medications were not reported.  On 01Jan2021$ the patient experienced sudden death. The clinical course was as follows: The patient didn't experience any adverse event at the moment of inoculation with COVID-19 vaccine or the following days. On 01Jan2021$ at lunch time$ two days after receiving the vaccine$ the patient was found unresponsive in her bed by her partner. The cause of death was unknown. It was reported that an autopsy would be performed in the next days; the results were not yet available.  The lot number for the vaccine$ BNT162B2$ was not provided and will be requested during follow up.; Sender's Comments: The reported information is limited and does not allow a meaningful assessment of the case. It will be reassessed upon receipt of follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to regulatory authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: Sudden death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0929016-1$	$0929016-1$	$Death; Loose stools; Vomited; This is a spontaneous report from a contactable other healthcare professional by Pfizer from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20201230164020.   An elderly female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH$ Batch: EJ1677$ Expiration date: Feb2021) via an unspecified route on 29Dec2020 at single dose for Covid-19 vaccination. Medical history included dementia and a history of urinary tract infection and delirium$ all from an unknown date and unknown of ongoing. Concomitant medication included influenza vaccine (INFLUENZA VIRUS$ Batch: 4924B1A) for influenza immunization. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. No known allergies. The patient had not tested positive for COVID-19 since having the vaccine. On the 29Dec2020 the patient experienced loose stools and vomited. The patient underwent lab tests and procedures which included COVID-19 virus test: no -negative on 08Dec2020. The patient died on the 30Dec2020 at 11:25 am in the morning. It was unknown if a postmortem was going to be carried out$ after talking to the general practice surgery they advised that the general practitioner was only passed notification of the patient's death that afternoon (04Jan2021). It was advised that they may go to the coroner but couldn't give a definitive answer until the general practitioner had looked at the notification. It was not reported if an autopsy was performed.   No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Delirium (History of); Dementia; Urinary tract infection (History of)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0929027-1$	$0929027-1$	$At night they found him lifeless. Probably following acute MI; pain in the arm and swelling in the arm of vaccination; pain in the arm and swelling in the arm of vaccination; This is a spontaneous report from a contactable other healthcare professional via Division of Health. The other healthcare professional reported similar events for three patients. This is the second of three reports.  A male patient of an unspecified age received BNT162B2 (lot# EK4175)$ via an unspecified route of administration on 25Dec2020 at single dose for Covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) with smoking background$ atrial fibrillation$ aortic stenosis$ diabetes with damage to all target organs (nephropathy$ retinopathy$ neuropathy)$ carotid stenosis$ deep vein thrombosis (DVT) history$ history of alcohol use with hepatitis$ history of Hodgkin's lymphoma after successful chemotherapy treatment$ got around on a scooter. The patient's concomitant medications were not reported. The patient was vaccinated on 25Dec2020 and passed away at home on 28Dec2020. Before his death$ according to his daughter$ he complained about pain in the arm and swelling in the arm of vaccination on an unspecified date of Dec2020. At night they found him lifeless. Probably following acute myocardial infarction (MI). The outcome of pain in the arm and swelling in the arm of vaccination was unknown$ acute MI was fatal. It was not reported if an autopsy was performed.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Fatal acute myocardial infarction is more likely attributed to the patient underlying medical conditions including vascular stenosis and diabetes with complications.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate$Linked Report(s) : IL-PFIZER INC-2020519349 same reporter/product$ similar event$ different patient;IL-PFIZER INC-2021009752 same reporter/product$ similar event$ different patient; Reported Cause(s) of Death: acute MI$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Alcohol use; Aortic stenosis; Atrial fibrillation; Carotid artery stenosis; Chemotherapy; COPD; Diabetes; Diabetic nephropathy; Diabetic neuropathy; Diabetic retinopathy; DVT; Hepatitis; Hodgkin's lymphoma; Mobility decreased; Smoker$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0930431-1$	$0930431-1$	$Cardiac event$ 2 days after vaccination$ patient expired.$	$none$	$Aortic Stenosis$ Status post Tavr procedure$ Hypothyroidism$ Hypertension$ Thoracogenic Scoliosis$ Polymyalgia Rheumatica$ Heart Valve Replacement$ Hyperparathyroidism$None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0933230-1$	$0933230-1$	$Death within 24 hours after dose; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority (GB-MHRA-EYC 00236003 and GB-MHRA-ADR 24545815).  A 78-year-old male patient received BNT162B2 (COMIRNATY)$ via an unspecified route of administration$ on 20Dec2020 at 16:00 as a single dose for COVID-19 immunization. Medical history included cardiac disease and lung disease. The patient had no known allergies. Concomitant medications included an unspecified hypertensive taken for hypertension$ an unspecified drug for ischaemic heart disease$ and an unspecified drug for chronic obstructive pulmonary disease (COPD). The patient experienced death within 24 hours after dose on 21Dec2020. The event was reported as fatal. The clinical course was reported as follows: The patient was observed for 15 minutes after the dose was given and had no side effects. In the evening$ the patient felt well. The patient received the vaccination as he was a high risk patient$ elderly$ and with a background of cardiac and lung disease. The clinical outcome of death within 24 hours after dose was fatal. The patient died on 21Dec2020. The cause of death was unexplained. It was unknown if an autopsy was performed. The reporter assessed the causality between the vaccination and death as unlikely.  No follow-up attempts possible; information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Death unexplained$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cardiac disorder; Lung disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0933232-1$	$0933232-1$	$Death; Head ache and dizziness; Head ache and dizziness; Spitting  blood; Vomiting blood; Nose bleed; This is a spontaneous report a contactable consumer downloaded from the Regulatory Authority(GB-MHRA-WEBCOVID-20201220100831 and GB-MHRA-ADR 24545199).   A male patient of an unspecified age received BNT162B2 (COMIRNATY)$ via an unspecified route of administration$ on 17Dec2020 as a single dose for COVID-19 immunisation. Medical history included vitamin D3 deficiency and asthma. Concomitant medications included colecalciferol (MANUFACTURER UNKNOWN) for vitamin deficiency and salbutamol sulfate (VENTOLINE) for asthma. The patient experienced nose bleed on 17Dec2020$ head ache and dizziness$ spitting blood$ and vomiting blood on 18Dec2020$ and death on 20Dec2020. All of the events were reported as fatal. It was reported that a healthcare professional advised the patient to take unspecified pain medication after explaining mild and strong side effects to help with pain. The patient underwent lab tests and procedures which included COVID-19 virus test: No - negative COVID-19 test on an unspecified date. Therapeutic measures were taken as a result of nose bleed$ head ache and dizziness$ spitting blood$ and vomiting blood as aforementioned. The clinical outcome of nose bleed$ head ache and dizziness$ spitting blood$ vomiting blood$ and death was fatal. The patient died on 20Dec2020. The cause of death was unexplained. It was not reported if an autopsy was performed. It was also reported that since the vaccination$ the patient had not been tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death unexplained$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Asthma; Vitamin D3 deficiency$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934465-1$	$0934465-1$	$patient died after collapsing in his home several hours after he received the vaccine; patient died after collapsing in his home several hours after he received the vaccine; The initial case was missing the following minimum criteria: the reporter does not have first-hand knowledge of the reported events and was not identifiable. Upon receipt of follow-up information on 06Jan2021$ this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional via regulatory Authority.  The regulatory authority reported similar events for three patients. This is the first of three reports.  An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK4237)$ via an unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization.  Medical history included dementia$ cardiac background with pacemaker$ atrial fibrillation$ heart failure$ and penicillin allergy. The patient was not allergic to polyethylene glycol.  The patient's concomitant medications were not reported.  On 29Dec2020$ the patient died after collapsing in his home several hours after he received the vaccine.  Outcome of collapsing was not recovered.  The patient had no pulse when he arrived at the hospital.  It was not reported if an autopsy was performed.  The cause of death was unknown.    Follow-up attempts are completed. No further information is expected.; Sender's Comments: The advance old patient had underlying cardiac background with pacemaker$ atrial fibrillation and heart failure$ therefore the pre-existing cardiovascular medical conditions more likely provide explanations for collapsing lead to the patient death.   More information especially death cause and autopsy results are needed for further meaningful assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.$Linked Report(s) : IL-PFIZER INC-2021009752 same reporter$ product$ similar event$ different patient;IL-PFIZER INC-2021009751 same reporter$ product$ similar event$ different patient; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac disorder; Cardiac pacemaker insertion; Dementia; Heart failure; Penicillin allergy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934763-1$	$0934763-1$	$$Sudden death; This is a spontaneous report downloaded from the regulatory authority DK-DKMA-WBS-0028211. Report was received from a contactable nurse via regulatory authority. A 94-years-old female patient received BNT162B2 (COMIRNATY) (Lot # EJ6797$ exp date 30Apr2021)$ via intramuscular on 30Dec2020 at first single dose for covid-19 immunization. Medical history included ongoing periodic obstipation (periodic treated)$ ongoing dementia$ ongoing atrial fibrillation$ ongoing depression$ tibia fracture from 01Nov2020 (treated conservatively). Concomitant medication included apixaban (ELIQUIS) from 09Apr2018 to unknown date for atrial fibrillation$ sertraline from 20Jun2018 to unknown date for depression. The patient had not received BNT162B2 before. The patient experienced sudden death on 01Jan2021. There was no immediate illness until the time of vaccination and the nurse described that she $$seemed like herself and fresh$$. The ADRs were by the reporter reported as fatal. Reported cause of death: Unknown caused of death$ sudden death. No treatment due to the death was described. There is no information regarding test results. An autopsy was not performed.    Causality: The doctor who issued the death certificate does not suspect that it is the COVID-19 vaccine that is the cause of her death. She slept quietly in$ and was old. Due to reporting obligation this case is reported.  If the regulatory authority receives supplemental significant information regarding this case the case will be re-submitted.; Reported Cause(s) of Death: Sudden death; Unknown cause of death$$	$Atrial fibrillation; Dementia; Depression; Obstipation (Periodic treated)$	$Medical History/Concurrent Conditions: Tibia fracture (conservative treatment)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934764-1$	$0934764-1$	$Hypoxic respiratory failure; Dyspnea exacerbated; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB DK-DKMA-WBS-0028232. The report was received from a contactable physician via The Medicines Agency (MA). A 45-year-old male patient received BNT162B2 (COMIRNATY) (Lot #: EJ6797$ Expiration Date: 30Apr2021)$ via intramuscular on 30Dec2020 at single dose for Covid-19 vaccination. Medical history included ongoing treatment noncompliance$ ongoing alcohol abuse chronic$ ongoing psychosis$ dyspnoea from 20Dec2020 and ongoing$ ongoing hallucination$ ongoing tobacco abuse$ ongoing paranoid schizophrenia$ chronic obstructive airways disease exacerbated from Aug2020 and ongoing$ chronic obstructive airways disease exacerbated from Nov2020 to an unknown date (not ongoing)$ hypoxic down to 60 % from 20Dec2020 and ongoing$ Amphetamine abuse (not ongoing)$ ongoing pain$ ongoing opioid abuse$ ongoing anxiety$ and ongoing insomnia. There is no information regarding past medication. Concomitant medication included prednisolone (PREDNISOLON ACTAVIS) from 20Nov2020 for Chronic obstructive airways disease$ ipratropium bromide$ salbutamol sulfate (IPRAMOL) from 20Nov2020 for Chronic obstructive airways disease exacerbated$ orphenadrine hydrochloride (LYSANTIN) from 02Dec2019 to 03Jan2021 for Anxiety aggravated$ quetiapine fumarate (QUETIAPIN ACCORD) from 16Dec2020 to 03Jan2021 for Psychiatric symptom$ salbutamol sulfate (VENTOLINE) from 03Nov2018 for Chronic obstruct airways disease$ paracetamol (PARACETAMOL ORIFARM) from 30Nov2020 to 03Jan2021 for Pain$ quetiapine fumarate (QUETIAPIN ARROW) from 15Aug2020 to 03Jan2021 for Psychiatric symptom$ buprenorphine hydrochloride$ naloxone hydrochloride (BUPRENORPHINE/NALOXONE MYLAN) from 29Jun2020 to 03Jan2021 for Opioid abuse$ paliperidone palmitate (XEPLION) from 19Dec2019 to 03Jan2021 for Psychiatric disorder prophylaxis$ fluticasone furoate$ umeclidinium bromide$ vilanterol trifenatate (TRELEGY ELLIPTA) from 04Jul2019 to Jul2019 for Chronic obstruct airways disease$ promethazine hydrochloride (PHENERGAN) from 24Sep2020 to 03Jan2021 for Insomnia. The patient experienced hypoxic respiratory failure on 31Dec2020$ dyspnea exacerbated on 31Dec2020. Patient treatment: On the 31Dec2020 it is recorded that the patient did not want resuscitation in the event of cardiac arrest or respiratory treatment in the event of respiratory failure. Initially the patient did not want to transfer to somatic treatment. But because of anxiety after dyspnoea the patient got treatment with oxygen. On 01Jan2021 the patient denied again treatment despite clear indication for oxygen therapy and COPD exacerbations treatment with ipratropium bromide and salbutamol sulfate (IPRAMOL) and inhalations. On 02Jan2021 the patient received oxygen-treatment$ but the patient did not want further somatic treatment. It was stated in the patient journal that the patient did not want treatment and that in the given situation there was nothing more to do. Therefore the patient was returned to department with palliative treatment in the form of oxygen$ midazolam subcutaneous (S.C.) and morphine S.C. On the 03Jan2021 the patient's respiration was calm. The patient was unreachable. At 14:00 he was restless and got palliative treatment with midazolam and morphine. The patient underwent lab tests and procedures which included c-reactive protein: normal on an unspecified date$ 16 on 27Dec2020$ fibrin D dimer: normal on 31Dec2020$ fluid balance assessment: normal on 27Dec2020$ forced expiratory volume (FEV 1): 37 % on 2018$ hepatic enzyme: normal  on 27Dec2020$ oxygen saturation: 64 % on an unspecified date$ 60 % on 20Dec2020$ 58 % on 27Dec2020$ 62 % on 31Dec2020$ 35 % (in the ambulance) on 31Dec2020$ 100 % (on oxygen-treatment) on 31Dec2020$ 40-60% on 02Jan2021 12:47 pm$ 58 % (in the ambulance) on 02Jan2021 09:00 am$ 30 % on 02Jan2021 04:24 am$ 99 % (on oxygen-treatment) on 02Jan2021$ PCO2 up to 12.8 (Unit not specified) on an unspecified date$ PO2 Down to 4.8 (Unit not specified) on an unspecified date. The patient died on 03Jan2021.  An autopsy was not performed. The outcome of the events was fatal.  Causality: The reporter assessed that even though the patient's symptoms have occurred long before the vaccination$ it can not be ruled out that the patient's dyspnoea and hypoxia due to COPD have been aggravated by the vaccine.  If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted.; Reported Cause(s) of Death: Dyspnea exacerbated; Hypoxic respiratory failure$	$Alcohol abuse chronic; Anxiety; Chronic obstructive airways disease exacerbated; Dyspnoea; Hallucination; Hypoxic (Hypoxic down to 60 %); Insomnia; Opioid abuse; Pain; Paranoid schizophrenia; Psychosis; Tobacco abuse; Treatment noncompliance$	$Medical History/Concurrent Conditions: Amphetamine abuse; Chronic obstructive airways disease exacerbated$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934765-1$	$0934765-1$	$Dyspnoea; suspected pulmonary edema; This is a spontaneous report downloaded from the regulatory authority DK-DKMA-WBS-0028304. Report was received from a contactable physician via from the regulatory authority. An 80-year-old female patient received bnt162b2 (COMIRNATY$ lot EJ6797$ expiration date 30Apr2021)$ intramuscularly on 03Jan2021 at single dose for covid-19 immunisation. Medical history included dementia with lewy bodies from an unknown date and unknown if ongoing$ osteoporosis from an unknown date and unknown if ongoing$ hypertension from an unknown date and unknown if ongoing. No previous drug was given. The patient's concomitant medications were not reported. On 04Jan2021 around 12$ approximately 25 hours after the vaccination the patient developed dyspnoea and pulmonary edema. 4 hours later she died. The patient did not experience any allergic symptoms. Events reported as dyspnoea and suspected pulmonary edema. The ADRs were by the reporter reported as fatal. No treatment due to the ADRs was reported. Reported cause of death was pulmonary edema. Outcome of event dyspnoea also reported as not recovered. There was no information regarding test results. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Pulmonary edema; Dyspnoea$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Dementia with Lewy bodies; Hypertension; Osteoporosis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934826-1$	$0934826-1$	$Death; This is a spontaneous report from a contactable consumer and a physician downloaded from the Regulatory Authority number GB-MHRA-WEBCOVID-20201222043330 and Safety Report Unique Identifier GB-MHRA-ADR 24545938.   A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ Solution for injection$ LOT: EJ0553) via an unspecified route of administration on 20Dec2020 around 15:45 at single dose in left upper arm for COVID-19 vaccination. The patient ongoing medical history included Depression$ Hypertension$ chronic obstructive pulmonary disease and ischaemic heart disease.  Patient is not enrolled in clinical trial. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken for Depression. The patient was taking unspecified concomitant medications for hypertension$ chronic obstructive pulmonary disease (COPD) and ischaemic heart disease. The patient experienced death in Dec2020 (reported as in the evening of the 20Dec2020 or morning of 21Dec2020). Specifically$ it was reported that the patient had the first dose of the vaccine at around 15:45 on 20Dec2020 and was observed for 15 minutes after with no side effects$ the patient then left the site with family member. He was well that evening$ he lived alone but spoke on the phone in the evening and felt well. On the 21Dec2020$ after went to check on him and he was found in his bed passed away. When seeing the body$ it was assumed that he had passed away in the evening of the 20Dec2020 or morning of 21Dec2020. Although unlikely$ it was less than 24 hours after taking the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient was found dead in his flat the next day on 21Dec2020 by next of kin. He was dropped of home by family after the vaccination$ he spoke to his family on the night after having the vaccination and told them he was feeling fine and was going to bed. He did not respond to telephone calls the next day (on Monday 21Dec2020) so the family went over to his flat and found he had passed away. The patient was registered at another surgery. Screening questions were asked$ no contra indication found. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death$	$Chronic obstructive pulmonary disease; Depression; Hypertension; Ischaemic heart disease$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0934966-1$	$0934966-1$	$COVID-19; COVID-19; Pneumonia; respiratory failure; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical history included Alzheimer's and others. No known allergies. Concomitant medications included unspecified medications. The reporter's mother in law was tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On 02Jan2021$ she received the first dose of Pfizer vaccine. On 04Jan2020$ she developed a high fever$ needed oxygen and was positive for COVID-19. Date of death was 04Jan2021. The cause of her death was listed as pneumonia$ respiratory failure and COVID-19. No autopsy performed. No treatment received. No one knew if the vaccination contributed to her death. It was hard to know if her death was due to the administration of the vaccine or it exacerbated the COVID19 symptoms which led to her death. Since this was unknown$ it could have been a possibility. The reporter wanted to give us this information because we might want to consider having high risk population$ patients with underlying conditions$ older population tested for COVID-19 prior to the vaccination$ as this is not currently a recommendation or a requirement. All is very new and they are all learning so the reporter wanted to share this information with us. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There are medications the patient received within 2 weeks of vaccination. Prior to vaccination$ the patient was not diagnosed with COVID-19. Since the vaccination$ the patient has been tested for COVID-19. The outcome of the events was fatal.   Information about Lot/Batch has been requested.; Sender's Comments: The association between the fatal event lack of effect (pneumonia$ respiratory failure and COVID-19) with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to regulatory authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: Pneumonia$ respiratory failure and COVID-19; Pneumonia$ respiratory failure and COVID-19; Pneumonia$ respiratory failure and COVID-19; Pneumonia$ respiratory failure and COVID-19$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Alzheimer's disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0936170-1$	$0936170-1$	$Myocardial infarct; Circulatory collapse; This is a spontaneous report from a contactable physician from the regulatory authroity. The regulatory authority report number is GB-MHRA-ADR 24553112 and GB-MHRA-WEBCOVID-20210104143047.  An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1688)$ via an unspecified route of administration$ on 31Dec2020 at a single dose for COVID-19 vaccination. Medical history included mitral valve incompetence from 08May2020$ myocardial ischaemia from 07May2020$ acute myocardial infarction from 07May2020$ cataract from 29Nov2019$ chronic kidney disease from 03Oct2013$ colitis ischaemic from 23May2013$ basal cell carcinoma from 20Apr2012$ transurethral bladder resection on 06Sep2005$ neoplasm malignant (other/unspecified site) from 16Aug2005$ debridement (arthroscopic debridement of patella) on 12Jan2005$ and essential hypertension from 2005. The patient had not had symptoms associated with COVID-19. The patient was not been tested/or had an inconclusive test for COVID-19. The patient was not enrolled in clinical trial. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN)$ atorvastatin (MANUFACTURER UNKNOWN)$ betamethasone valerate (BETNOVATE)$ bisoprolol (MANUFACTURER UNKNOWN)$ furosemide (MANUFACTURER UNKNOWN)$ glyceryl trinitrate (MANUFACTURER UNKNOWN)$ loperamide (MANUFACTURER UNKNOWN)$ omeprazole (MANUFACTURER UNKNOWN)$ phenoxymethylpenicillin (MANUFACTURER UNKNOWN)$ and ramipril (MANUFACTURER UNKNOWN).  The patient experienced myocardial infarct and circulatory collapse on 31Dec2020. The event$ myocardial infarct$ was reported as fatal. It was reported that the patient collapsed at home the evening after vaccination. The clinical outcome of myocardial infarct was fatal and of circulatory collapse was not recovered. The patient died on 31Dec2020. The cause of death was reported as myocardial infarct. It was unknown if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Acute myocardial infarction; Basal cell carcinoma; Cataract; Chronic kidney disease; Colitis ischaemic; Debridement (Arthroscopic debridement of patella); Essential hypertension; Mitral valve incompetence; Myocardial ischaemia; Neoplasm malignant (other/unspecified site); Transurethral bladder resection; Comments: Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0938038-1$	$0938038-1$	$Acute cardio-respiratory event and died a few hours later; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210107093111. Safety Report Unique Identifier GB-MHRA-ADR 24565959.  An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose$ on 04Jan2021$ for COVID-19 immunisation. Patient was elderly and frail and gradually declining in mobility$ communication and memory over the last 12 months. Relevant medical history also included vascular dementia form an unspecified date and unknown if ongoing. Concomitant medications were unknown. Patient was not enrolled in clinical trial.  COVID-19 virus test was performed twice on an unspecified date$ in Dec2020 and on 18Dec2020 and the results were negative. On 04Jan2021$ at 06:00 PM$ the patient experienced acute cardio-respiratory event and died a few hours later. It was unknown if autopsy was done. Since the vaccination$ the patient has not been tested for COVID-19. Patient did not have symptoms associated with COVID-19. The patient was kept comfortable in the nursing home in these last few hours. There was no way to know whether the vaccine was to blame at all$ it was unlikely.   No follow-up attempts are possible$ information about lot number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory failure$	$Communication disorder NOS; Frailty; Memory impairment; Mobility decreased$	$Medical History/Concurrent Conditions: Vascular dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0939332-1$	$0939332-1$	$Death; Malaise; Vomiting; This is a spontaneous report received from a contactable physician  from the Regulatory Agency (RA). The Regulatory Authority report number is GB-MHRA-WEBCOVID-20210105172532$ Safety Report Unique Identifier GB-MHRA-ADR 24558660. An 81-year-old female patient received bnt162b2 (BNT162B2) (lot# EJ1688)$ via an unspecified route of administration$ on 30Dec2020$ at single dose$ for COVID-19 immunisation. Medical history included vascular dementia (advanced dementia)$ dementia Alzheimer's type (vascular and Alzheimer's mixed dementia)$ oral intake reduced (patient known to not be eating or drinking)$ fluid intake reduced$ (patient known to not be eating or drinking)$ general physical health deterioration (patient known to be declining); all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death on 03Jan2021$ malaise on 01Jan2021 with fatal outcome$ vomiting on 01Jan2021 with fatal outcome. It was reported that 48 hours after vaccination the patient became unwell$ vomited and then died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Dec2020. Patient has been not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. It was not known whether vaccine caused reaction.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Malaise; Vomiting; Death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Dementia Alzheimer's type (Vascular and Alzheimer's mixed dementia); Fluid intake reduced (patient known to not be eating or drinking); General physical health deterioration (Patient known to be declining); Oral intake reduced (patient known to not be eating or drinking); Vascular dementia (advanced dementia)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0939334-1$	$0939334-1$	$breathless on exertion; This is a spontaneous report received from a contactable other health professional received from the United Kingdom's Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-ADR 24561910$ other case identifier number: GB-MHRA-WEBCOVID-20210106094618. An 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE$ Batch/lot no: EJ1688)$ via an unspecified route of administration on 30Dec2020 single dose for covid-19 immunisation. Medical history included Bowen's disease$ basal cell carcinoma$ chronic kidney disease and essential hypertension$ all unknown if ongoing. Concomitant medication included alfacalcidol (unknown manufacturer)$ amlodipine (unknown manufacturer)$ atorvastatin (unknown manufacturer)$ clopidogrel (unknown manufacturer)$ prazosin (unknown manufacturer)$ sodium bicarbonate (unknown manufacturer)$ folic acid (unknown manufacturer)$ furosemide (unknown manufacturer). The patient experienced breathless on exertion on 02Jan2021. The patient died on 02Jan2021 due to the event. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unknown date. It was not reported if an autopsy was performed.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dyspnoea exertional$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Basal cell carcinoma; Bowen's disease; Chronic kidney disease; Essential hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940902-1$	$0940902-1$	$$Death 2 hours after vaccination in a retirement home; This is a spontaneous report from a contactable physician.  A patient of unspecified age and gender received BNT162B2 (COMIRNATY; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ6796)$ via an unspecified route of administration on 08Jan2021 as first single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Jan2021$ at 19:24$ death 2 hours after vaccination in a retirement home  was noted.  The patient died on 08Jan2021.  It was not reported if an autopsy was performed.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case.  The event $$death$$ is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information$ particularly the clinical course before death$ complete medical history and concomitant medication and autopsy report$ becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: Death 2 hours after vaccination in a retirement home$$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940935-1$	$0940935-1$	$Death; Vomiting; This is a spontaneous report from a contactable other health professional from the  Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 24573192. An elderly female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: BJ1688 and EJ1688; as reported)$ via an unspecified route of administration on 05Jan2021 at 12:26 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient had not had symptoms associated with COVID-19; and was not enrolled in the clinical trial. On 05Jan2021 at 12:51$ the patient experienced vomiting (non-serious); 25 minutes post vaccine (had further vomiting episodes). On 07Jan2021 at 01:00$ the patient experienced death; which caused death$ and was medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date.  The clinical outcome of the event$ vomiting$ was unknown. The clinical outcome of the event$ death$ was fatal. The patient died on 07Jan2021 at 01:00 due to unknown cause of death.  An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death$	$No current illness for this event.$	$Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940940-1$	$0940940-1$	$heart pain; cardiac and respiratory arrest; cardiac and respiratory arrest; This is a spontaneous report from a contactable consumer or other non hcp received via regulatory authority. This consumer reported different fatal events for four patients. This is the first of four reports. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EK4175) via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunisation. Medical history included Nursing background$ cardiac$ intended for valve replacement surgery$ diabetes mellitus (DM). The patient's concomitant medications were not reported. The patient was vaccinated on 03Jan2021 with the first dose. From the moment of the vaccine he complained about heart pain. Cardiopulmonary resuscitation (CPR) was performed by the persons on call without an electric shock$ emergency services arrived after 5 minutes$ resuscitation continued asystole on the monitor$ received 4 doses of adrenaline IV$ respiration through mask and ambu. After 20 minutes of resuscitation pupils do not respond to light$ without heart sounds. The patient died from cardiac and respiratory arrest in Jan2021. It was not reported if an autopsy was performed. The outcome of event heart pain was unknown.; Sender's Comments: Linked Report(s) : IL-PFIZER INC-2021019632 Same reporter$ same product$ different patient/events.;IL-PFIZER INC-2021019633 Same reporter$ same product$ different patient/events.;IL-PFIZER INC-2021019634 Same reporter$ same product$ different patient/events.; Reported Cause(s) of Death: cardiac and respiratory arrest; cardiac and respiratory arrest$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cardiac disorder (intended for valve replacement surgery); Diabetes mellitus; Mobility decreased$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0940941-1$	$0940941-1$	$felt bad; This is a spontaneous report from a contactable consumer. This consumer reported different fatal events for four patients.This is the fourth of four reports. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK4238) via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history included oncological patient$ diabetes$ hypercholesterolemia$ osteoarthrosis. Concomitant medications were not reported. The patient went out for work a day after he received the vaccine$ he felt bad on 08Jan2021 and MDA was called$ shortly afterwards his death was determined by MDA. The date of death was on 08Jan2021. The cause of death was felt bad. The outcome of event was fatal. It was unknown if an autopsy was performed.; Sender's Comments: Linked Report(s) : IL-PFIZER INC-2021019507 Same reporter$ same product$ different patient/events; Reported Cause(s) of Death: felt bad$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cancer; Diabetes; Hypercholesterolemia; Osteoarthrosis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0941174-1$	$0941174-1$	$first death case due to Covid-19 vaccination in this country/deterioration in the general condition; stomach was hard and caused pain under pressure; Urethral and abdominal pain; abdominal pain/stomach was hard and caused pain under pressure; restless; his blood pressure dropped; pulse increased; This case was originally submitted under WWID AT-PFIZER INC-2020519756. Upon follow-up$ reporter with regulatory authority was considered as primary reporter; as a result of this update case is being resubmitted under new WWID CH-PFIZER INC- 2021017201. As a consequence$ this follow-up report will be indicated as an initial report.   This is a spontaneous report from six contactable consumers and a contactable other health professional. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; COMIRNATY)$ via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 vaccination. Medical history included dementia and urinary tract infection from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The resident had previously reacted negatively to a flu vaccine and therefore no further vaccinations were recommended. The patient experienced urethral and abdominal pain$ restless$ his blood pressure dropped$ pulse increased all on 26Dec2020$ deterioration in the general condition and death on 29Dec2020. On Christmas Eve$ the residents of a nursing home for dementia were vaccinated with the Pfizer/Biontech vaccine. The affected$ otherwise healthy resident$ suffered from pain in the urethra and abdomen two days later. The examination by the home doctor revealed a decrease in blood pressure and an increase in the pulse on 26Dec2020. At the last consultation on Sunday evening$ 27Dec2020$ the patient was stable with persistent sensitivity to pressure of the abdomen. The family doctor in charge examined the patient one last time on Sunday evening$ 27Dec2020. He was calm$ but his stomach was hard and caused pain under pressure. The following day$ the management of the institution did not report back to the home doctor. On the morning of 29Dec2020$ the nursing home informed the doctor about a deterioration of the general condition. By the time the doctor was called back the same morning$ the patient had already died$ vaccinated on Christmas Eve and dead five days later. The patient underwent lab tests and procedures also included home doctor examination: condition was stable with persistent sensitivity to pressure of the abdomen on 27Dec2020. The patient died on 29Dec2020$ which was the first death case due to COVID-19 vaccination in this country. It was not reported if an autopsy was performed. The news of the death of a 91-year-old person after he was vaccinated against COVID-19 is circulating on social media channels and information platforms. Investigations by the health authorities have shown that due to the medical history and the course of the disease$ a connection between death and the COVID-19 vaccination is unlikely. Neither the medical history nor the acute course of the disease suggest a direct causal connection between the COVID-19 vaccination and death. The comprehensive information available indicates the pre-existing diseases as a natural cause of death. This was also noted on the death certificate. It soon became clear that the home physician$ who had implied a connection between vaccination and the death of his elderly patient$ was himself. Quoted from the medical record and message spread by email$ it was possibly overlooked that patient had symptoms of a urinary tract infection and did not prescribe antibiotics.  Event occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  Information on the Lot/Batch number has been requested.  Follow-up (05Jan2021): New information received from Pfizer Employee$ who sent a follow-up from another source included medical history urinary tract infection and cause of death updated.  Information on the Lot/Batch number has been requested.  Follow-up (08Jan2021): New information received clarified that Reporter with regulatory authority is to be considered as primary reporter.   Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information available$ a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. However patient old age of 91 years and other underlying medical conditions could have played a contributory role. Further information including autopsy reports would be helpful for a meaningful medical assessment  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators as appropriate.; Reported Cause(s) of Death: first death case due to Covid-19 vaccination in this country/deterioration in the general condition$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Dementia; Urinary tract infection$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944114-1$	$0944114-1$	$Sudden death; This is a spontaneous report from a contactable physician from the regulatory authority. The regulatory authority report number is GB-MHRA-ADR 24556755.   An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0553)$ via an unspecified route of administration on 19Dec2020 as single dose for  COVID-19 immunization.  Medical history included Waldenstrom's macroglobulinemia for Waldenstrom's macroglobulinaemia$ memory impairment$ with recent memory problems$ cerebrovascular accident $ with previous CVA$ joint swelling $ reported as slight ankle swelling awaiting head CT scan and bloods$  oesophagitis$ and cholesterol$ all from an unknown date and unknown if ongoing.  Concomitant medication included acetylsalicylic acid (MANUFACTURER UNKNOWN) for Waldenstrom's macroglobulinaemia$ lansoprazol (MANUFACTURER UNKNOWN) for oesophagitis$ simvastatin (MANUFACTURER UNKNOWN) for blood cholesterol.  The patient had sudden death on 29Dec2020. The patient died on 29Dec2020.  It was not reported if an autopsy was performed. The reporter did not think the COVID vaccination caused the patients  death; It did not appear to be related. The patient was seen by the physician on the 24th (not otherwise specified)$ and was fine.  The patients son also saw the patient on the 28th (not otherwise specified) and also fine with no side effects from the jab.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently provided$ the company considers the patient death is unrelated to the vaccine use;  the advance old patient having multiple pre-existing medical conditions including Waldenstrom's macroglobulinaemia and cerebrovascular accident$ which more likely led the patient to sudden death.; Reported Cause(s) of Death: Sudden death unexplained$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Ankle swelling (slight ankle swelling awaiting head ct scan and bloods.); Cerebrovascular accident (previous CVA.); Cholesterol; Memory impairment (Recent memory problems.); Oesophagitis; Waldenstrom's macroglobulinemia; Comments: Patient has not had symptoms associated with COVID-19 Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944121-1$	$0944121-1$	$Cardiac arrest; This is a spontaneous report from a contactable physician. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-20210105171610$ Safety Report Unique Identifier GB-MHRA-ADR 24558665.   A male patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine)$ via an unspecified route of administration on 23Dec2020$ at single dose for covid-19 vaccination. Medical history included ongoing dementia$ and cardiac pacemaker insertion on an unknown date. Patient has not had symptoms associated with COVID-19. Unsure if patient was enrolled in clinical trial. The patient's concomitant medications were not reported. The patient experienced cardiac arrest on 31Dec2020. Had spontaneous cardiac arrest 9 days (to be clarified) after vaccination doubtful implicated but new vaccine of course. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unspecified date. The patient died of cardiac arrest on 31Dec2020. It was not reported if an autopsy was performed.  Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest$	$Dementia$	$Medical History/Concurrent Conditions: Cardiac pacemaker insertion; Comments: Patient has not had symptoms associated with COVID-19 Unsure if patient is enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0944154-1$	$0944154-1$	$This is a spontaneous report from a contactable consumer. This consumer reported different fatal events for four patients. This is the second of four reports. An 82-year-old female patient in a nursing home received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4238) via an unspecified route of administration on 04-Jan-2021 at a single dose for COVID-19 immunisation. Medical history included background of asthma$ dementia$ depression$ gastrointestinal and heart failure. Concomitant medications were not reported. 4 Hours after the receipt of the vaccine$ she was found in her room on the floor with a bruise on her forehead apparently from a fall$ CPR was performed by nursing home staff. Staff performed CPR$ asystole without heart sounds$ CPR continued for 23 minutes without any change and death was declared. The events occurred in Jan 2021. The date of death was in Jan 2021. The outcome of events was fatal. It was unknown if an autopsy was performed. Sender's Comments: Linked Report(s): IL-PFIZER INC-2021019507 Same reporter$ same product$ different patient/events; Reported Cause(s) of Death: was found in her room on the floor with a bruise on her forehead apparently from a fall; was found in her room on the floor with a bruise on her forehead apparently from a fall.$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Asthma; Dementia; Depression; Gastrointestinal disorder; Heart failure; Living in nursing home$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0945725-1$	$0945725-1$	$$heart failure; Death; feeling sick; changes with speech and mobility; changes with speech and mobility; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210111094207$ Safety Report Unique Identifier: GB-MHRA-ADR 24577774. A 97-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1688)$ via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 10Jan2021$ the patient experienced feeling sick (medically significant)$ changes with speech and mobility (speech disorder) (medically significant). On 11Jan2021$ the patient experienced death (death$ medically significant). On an unspecified date$ the patient experienced heart failure (death$ medically significant). The clinical course was reported as follows: $$The resident had got heart failure.$$ The patient was feeling sick on 10Jan2021 and was concerned as there were changes with speech and mobility. Emergency was called$ and the ambulance arrived. It was stated the sats were low and blood pressure was low. The ambulance crew called for an out of hours general practitioner (GP) to come and see the patient.  The out of hours general practitioner (GP) visited on 10Jan2021 and advised $$she maybe poorly due to having the Covid-19 vaccine$$ that was administered on the 08Jan2021. The resident passed away at 07:20 on morning 11Jan2021. The patient had not tested positive for COVID-19 since having the vaccine. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial.  The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative COVID-19 test on an unspecified date$ oxygen saturation (sats): low on 10Jan2021$ blood pressure: low   on 10Jan2021. The clinical outcome of the event$ death and heart failure$ was fatal. The clinical outcome of the event$ feeling sick and changes with speech and mobility$ was unknown. The patient died on 11Jan2021 due to heart failure. It was unknown if an autopsy was performed.   No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: heart failure$$	$No current illness for this event.$	$Comments: The resident had got heart failure. The out of hours GP visited 10/01/2021 and advised she maybe poorly due to having the Covid-19 vaccine. The resident passed away at 7.20am this morning 11/01/2021 Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947270-1$	$0947270-1$	$patient died while there were no other complaints at that time; This is a spontaneous report received from a contactable consumer (Pfizer colleague). A 99-year-old female patient received bnt162b2 (COMIRNATY)$ via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient died 3 days after the vaccination while there were no other complaints at that time on 10Jan2021. The patient died on 10Jan2021. It was not reported if an autopsy was performed. The family assessed there was a causal relationship with the vaccine.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died 3 days after the vaccination while there were no other complaints$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947332-1$	$0947332-1$	$Died in sleep; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number was GB-MHRA-ADR 24556999 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210105122200.  An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1688)$ via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 vaccination.  Medical history included craniotomy in 2019$ acute subdural haematoma in 2019$ and ongoing bedridden following a craniotomy for an acute subdural haematoma from 2019. The patient was not enrolled in clinical trial.  Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN)$ cetirizine (MANUFACTURER UNKNOWN)$ ferrous sulfate (MANUFACTURER UNKNOWN)$ finasteride (MANUFACTURER UNKNOWN)$ flucloxacillin (MANUFACTURER UNKNOWN)$ colecalciferol (FULTIUM D3)$ gabapentin (MANUFACTURER UNKNOWN)$ hypromellose (MANUFACTURER UNKNOWN)$ levothyroxine sodium (MANUFACTURER UNKNOWN)$ betamethasone dipropionate/clotrimazole (LOTRIDERM) $ macrogol (MANUFACTURER UNKNOWN)$ tramadol hydrochloride (MAROL)$ omeprazole (MANUFACTURER UNKNOWN)$ oxybutynin (MANUFACTURER UNKNOWN)$ paracetamol (MANUFACTURER UNKNOWN)$ senna spp. (MANUFACTURER UNKNOWN)$ and influenza vaccine inact sag 4v (FLUCELVAX TETRA).  On 05Jan2021$ the patient died in his sleep. The clinical course was as follows: The patient had not had symptoms associated with COVID-19. The patient received the vaccination on 31Dec2020. The patient had tested negative for COVID-19 since having the vaccine on an unknown date.  There were no other reactions noted but the patient died in his sleep overnight on 05Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Died in sleep$	$Bedridden (Patient bed bound following a craniotomy for an acute subdural haematoma in 2019)$	$Medical History/Concurrent Conditions: Acute subdural haematoma; Craniotomy; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947362-1$	$0947362-1$	$Death; Unresponsive to stimuli; This is a spontaneous report received from a contactable physician by Pfizer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106141652 and GB-MHRA-ADR 24563112. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number EJ1688) via unspecified route of administration on 30Dec2020 at single dose for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Patient has not been tested/or has had an inconclusive test for COVID-19. Patient is not enrolled in clinical trial. Medical history included ongoing asthenia$ ongoing Parkinson's disease and ongoing dementia with Lewy bodies. The patient experienced unresponsive to stimuli on 31Dec2020$ death on 01Jan2021. The reporter described that this lady was extremely frail with a history of Parkinson's and Lewy Body dementia.  However$ on the day that she received the injection she was not acutely unwell. The reporter visited her the following day (31Dec2020) and found her unresponsive and clearly dying. On examination she had no signs of sepsis$ she had no fever$ her chest was clear and she had no difficulty breathing. She died the next day 01Jan2021. This could simply be a coincidence of course but this was a sudden change after receiving the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 01Jan2021.   No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death; Unresponsive to stimuli$	$Dementia with Lewy bodies; Frailty; Parkinson's disease$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0947363-1$	$0947363-1$	$Death; Acidosis; Acute kidney injury; Blood creatine phosphokinase increased; Circulatory collapse; This is a spontaneous report from a contactable physician. This is a report received from the Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 24563115.    An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ0724-L456)$ via an unspecified route of administration on 22Dec2020$ as single dose for covid-19 immunization.  Medical history included ongoing chronic kidney disease$ ongoing diabetes mellitus$ well controlled for 8 year and gout from an unknown date.  Concomitant medication included allopurinol (MANUFACTURER UNKNOWN) for gout$ felodipine (MANUFACTURER UNKNOWN) for hypertension$ metformin (MANUFACTURER UNKNOWN) for diabetes mellitus$ ramipril (MANUFACTURER UNKNOWN) for hypertension$ simvastatin (MANUFACTURER UNKNOWN) for diabetes mellitus.  The patient experienced death on 31Dec2020 ( reported as diabetes mellitus inadequate control)$ acidosis on 31Dec2020$ which was medically significant with outcome of not recovered; acute kidney injury on 31Dec2020$ which was medically significant with outcome of not recovered;  blood creatine phosphokinase increased on 31Dec2020$  which was medically significant with outcome of not recovered; circulatory collapse on 31Dec2020$ which was medically significant with outcome of not recovered. The events were acidosis$ acute kidney injury$  blood creatine phosphokinase increased and circulatory collapse  were  serious as they were medically significant. The patient underwent lab tests and procedures which included creatine kinase$ which was significantly raised on 31Dec2020$ and blood glucose was 43 on 31Dec2020.  Details were as follows: Had vaccine on 22Dec2020. Attended A+E via ambulance after being found on floor 31Dec2020. The patient was found to have extremely high sugars (43) and was acidotic. Acute kidney injury and creatine kinase significantly raised were noted. The patient died on 31Dec2020.  It was not reported if an autopsy was performed. Cause of death$ was put down as diabetes$ but the physician indicated concert as the patients diabetes had been well controlled for eight years. Obviously not an immediate reaction but concerned as to unexpected death. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in a clinical trial.; Reported Cause(s) of Death: Diabetes mellitus inadequate control; Diabetes mellitus$	$Chronic kidney disease stage 3; Diabetic (well controlled for 8 years)$	$Medical History/Concurrent Conditions: Gout$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0952914-1$	$0952914-1$	$Death (death certificate: uncertain type of death); evening vomiting; This is a spontaneous report from a non-contactable physician the Regulatory Authority. This is a report received from the Regulatory Authority. Regulatory authority report number was DE-PEI-CADRPEI-2021011672.  A 79-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EJ6796)$ intramuscular on 30Dec2020 as a single dose for COVID-19 immunization.  Medical history included especially autoimmune encephalopathy of paraneoplastic origin and suspected urothelial carcinoma of the bladder.  The patient's concomitant medications were not reported.  The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) on 03Dec2020 for immunization and was tolerated. On 31Dec2020 (also reported as 30Dec2020)$ the patient developed evening vomiting which was dark in color and most likely food related. On 31Dec2020 at 04:35$ the patient died. It was not reported if an autopsy was performed. The clinical outcome of vomiting was reported as fatal; however$ the cause of death was reported as unknown cause of death. The vomiting and unknown cause of death were reported as medially significant and fatal.   No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Autoimmune encephalopathy (Especially autoimmune encephalopathy of paraneoplastic origin); Urothelial carcinoma bladder$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953012-1$	$0953012-1$	$further sickness; vomited; felt unwell; Sudden death unexplained; slightly sore arm; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-20210108094947 & GB-MHRA-ADR 24571609.   A 93-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)$ via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization.  Medical history included residential care home resident$ vascular dementia with frailty$ type 2 diabetes mellitus (DM) from 2006 to an unknown date$ essential hypertension from 2006 to an unknown date$ claudication in legs from 2006 to an unknown date. The patient's concomitant medications were not reported. The patient had not had symptoms associated with COVID-19 and is not enrolled in a clinical trial.  The patient experienced slightly sore arm on 05Jan2021$ sudden death unexplained on 07Jan2021 and vomited and felt unwell on 07Jan2021 10:00 PM and further sickness on 07Jan2021 10:15 PM. The patient was entirely well after vaccine apart from a slightly sore arm that resolved. On 07Jan2021$ 2 days after the vaccine administration$ the patient vomited and felt unwell at 10:00 PM.  Observation was stable$ then further sickness at 10:15pm.  Thereafter slumped to the side and died peacefully. There were no signs of other allergic reaction.  The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 06Jan2021.  The outcome of sudden death unexplained was fatal$ of slightly sore arm was recovered in Jan2021 and of vomited$ felt unwell and further sickness was unknown.  The patient died on 07Jan2021.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death unexplained$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Claudication; Essential hypertension; Living in residential institution; Type 2 diabetes mellitus; Vascular dementia (Vascular dementia with frailty); Comments: Residential care home resident$ Vascular dementia with frailty$ 2006 Type 2 DM$ 2006 Essentia hypertension$ 2006 Claudication in legs Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953036-1$	$0953036-1$	$Death; The initial case was missing the following minimum criteria: reporter with first-hand knowledge.  Upon receipt of follow-up information on 14Jan2021 this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician downloaded from the regulatory authority. This is a report received from the regulatory authority. Regulatory authority report number was IS-IMA-1518.  A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EJ6796)$ via an unspecified route of administration on 29Dec2020 as a single dose for COVID-19 immunization.  Medical history included hypermobility syndrome$ consciousness decreased$ pain$ and Parkinson's disease.  The patient's concomitant medications were not reported.  On 01Jan2021$ the patient died.  The clinical course was as follows: The patient had impaired consciousness for a few days. On 29Dec2020 the patient was vaccinated with BNT162B2. On 31Dec2020 end-of-life care was initiated. The patient's condition was worsening with hypermobility$ dementia and pain (not otherwise specified). The patient had impaired consciousness for the past 6 days. The patient passed away on 01Jan2021. The cause of death was unknown.   It was not reported if an autopsy was performed. The physician did not consider that there was a reason to suspect a causal association between the death and the vaccination; however$ in the light of the circumstances it was reported.; Sender's Comments: The association between the event death with BNT162b2 can not be fully excluded based on the temporal relationship and the limited information available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to regulatory authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Consciousness decreased; Hypermobility syndrome; Pain NOS; Parkinson's disease$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953037-1$	$0953037-1$	$Death; The initial case was missing the following minimum criteria: (no first-hand knowledge). Upon receipt of follow-up information on (14Jan2021)$ this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable physician and healthcare professional. This is a report downloaded from the regulatory authority. The regulatory authority report number  IS-IMA-1491.  An 88-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6796$ Expiration date 30Apr2021)$ via an unspecified route of administration on 30Dec2020  as single dose for covid-19 immunization.  Medical history included pneumonia$ chronic obstructive pulmonary disease and dementia from an unknown date$ and not ongoing.  Concomitant medication included vitamin b complex (MANUFACTURER UNKNOWN)$ ergocalciferol (VIT D)$ enalapril (MANUFACTURER UNKNOWN)$ ciprofloxacin (MANUFACTURER UNKNOWN)$ risperidone (RISPERIDON KRKA) $ bifidobacterium animalis$ lactobacillus acidophilus (ACIDOPHILUS BIFIDUS)$ escitalopram (MANUFACTURER UNKNOWN)$ metoprolol (MANUFACTURER UNKNOWN)$ mirabegron (BETMIGA)$ oxazepam (SOBRIL) $ quetiapine (MANUFACTURER UNKNOWN)$ cyanocobalamin (BETOLVEX [CYANOCOBALAMIN])$ folic acid (MANUFACTURER UNKNOWN)$ amlodipine (AMLODIPIN)$ estradiol (VAGIFEM)$ vitamins nos (also reported as Vitaplus)$ Magical mouthwash$ B-kombin$ Progastro.  The patient experienced worsening of condition on  31Dec2020$ which was serious as it was life-threatening and had fatal outcome; the patient experienced death on 01Jan2021. The patient died on 01Jan2021. Details were as follows: patient was diagnosed with pneumonia 1.5 weeks prior to immunization with BNT162B2. The patients condition had deteriorated for the past days and weeks. The patient was vaccinated on 30Dec2020$ and on 30Dec2020 . The patient condition continued to worsen. On 01Jan2021$ the patient passed away. It was not reported if an autopsy was performed.  Reporter's comments: There is not an obvious causal association between the death and immunisation with Comirnaty due to worsening of the patients condition prior to immunisation.; Sender's Comments: Based on the close temporal relationship$ the association between the event death with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to regulatory authorities$ Ethics Committees$ and Investigators$ as appropriate.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: COPD; Dementia; Pneumonia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953450-1$	$0953450-1$	$Exitus letalis; Influenza like illness; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) WEB (DE-PEI-CADRPEI-2020011585).  A 93-year-old male patient received BNT162B2 (COMIRNATY)$ intramuscularly$ on 28Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension arterial. The patient's concomitant medications were not reported. The patient experienced influenza like illness and exitus letalis on 29Dec2020$ which were reported as medically significant and fatal. It was reported that two days after vaccination$ the patient developed influenza like illness (previously asymptomatic) and then found lifeless the following day (as reported). The clinical outcome of influenza like illness and exitus letalis was fatal. The patient died on 29Dec2020. The cause of death was influenza like illness (reported as unknown cause of death). It was unknown if an autopsy was performed. The causality assessment to both of the events was reported as unclassifiable by Regulatory Authority.   No follow-up attempts possible; information about batch number cannot be obtained.; Reporter's Comments: Previously asymptomatic$ then found lifeless the following day.; Reported Cause(s) of Death: Influenza like illness$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Hypertension arterial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953468-1$	$0953468-1$	$patient passed away 4 days after receiving vaccination$ not known if related but patient was seen 2 days before at the surgery and was fit and well at that time. Death was unexpected.; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority$ RA.  Regulatory authority report number was GB-MHRA-ADR 24546873 with Safety Report Unique Identifier of GB-MHRA-EYC 00236252.  A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ0553)$ intramuscular on 17Dec2020 as 0.3 ml single dose for COVID-19 immunisation.  Medical history included cataract operation on 23Oct2020$ intraocular lens implant on 23Oct2020$ atrial fibrillation from 10May2018 and unknown if ongoing$ ventricular tachycardia from 11Sep2003 and unknown if ongoing$ polymyalgia rheumatica from 31Mar2008 and unknown if ongoing$ total prosthetic replacement of left hip joint using cement on 24Feb2011$ total prosthetic replacement of left knee joint using cement on 28Nov2011$ osteoarthritis of right knee from 02Jul2012 and unknown if ongoing$ prostate cancer from 28Feb2017 and unknown if ongoing$ pressure sore from 01Sep2017 and unknown if ongoing$ postoperative care from 10Jan2018 and unknown if ongoing$ left inguinal hernia from 07Jun2017 and unknown if ongoing$ urine retention from 11Nov2016 to 04Feb2017$ transurethral prostatectomy from 17Feb2017 to 13May2017$ total knee replacement on 26Oct2018 to 18Jan2019 (as reported)$ high frequency ablation from 03Jul2019 to 25Sep2019$ and wound dressing from 03Jan2019 and unknown if ongoing.  Concomitant medications included apixaban (MANUFACTURER UNKNOWN)$ paracetamol (MANUFACTURER UNKNOWN)$ propafenone (MANUFACTURER UNKNOWN)$ and zopiclone (MANUFACTURER UNKNOWN).  The patient previously took codeine (MANUFACTURER UNKNOWN) from 29Oct2018 to an unknown date for an unknown indication and experienced adverse reaction.  In Dec2020 (reported as 4 days after the vaccination)$ the patient passed away. It was not known if it was related to the vaccine but the patient was seen 2 days before at the surgery and was fit and well at that time. The death was unexpected. An autopsy was performed$ and the results were not provided.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Atrial fibrillation; Cataract extraction; Intraocular lens implant; Left inguinal hernia; Osteoarthritis knee (right knee); Polymyalgia rheumatica; Postoperative care (Postop wound management gen secondary care done by practice); Pressure sore; Prostate cancer; Radiofrequency ablation (Radiofrequency ablation of varicose vein of leg); Retention urine; Total hip replacement (Total prosthetic replacement of hip joint using cement - left.); Total knee replacement (Total prosthetic replacement of knee joint using cement - left.); Total knee replacement (Primary total knee replacement NEC); Transurethral prostatectomy (Bladder outlet and prostate operations); Ventricular tachycardia; Wound dressing$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953471-1$	$0953471-1$	$Death within 24 hours of vaccine; Livedo reticularis; Hypotension; Respiratory rate increased; Peripheral coldness; Loss of consciousness; This is a spontaneous report from a  contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00236256.    An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)$ subcutaneous on 20Dec2020 at first single dose for covid-19 immunization.  Medical history included malaise from Dec2020$ Started 2 days prior to vaccine; cold sweat from Dec2020$ started 2 days prior to vaccine;  dyspnoea from Dec2020$ started 2 days prior to vaccine; feeling cold from Dec2020$ started 2 days prior to vaccine;  lethargy from Dec2020$ started 2 days prior to vaccine; hyperhidrosis from Dec2020$ started 2 days prior to vaccine$ peripheral vascular disorder from 1982$ peripheral ischaemia from 1982$ Critical left foot ischemia;  essential hypertension from 2003;  myocardial ischaemia from 2005; Chronic kidney disease from 2006; myelopathy from 2007; Acute myocardial infarction in 2012; Mitral valve incompetence in 2012; Cardiac failure in 2013; Post thrombotic syndrome in 2015; Vascular dementia in 2017; Aortic stenosis in 2017; humerus fracture in 2019$ Closed fracture distal right humerus; Postmenopausal haemorrhage 2019$ unidentified cause; abdominal abscess in Jul2020$ chronic$ .  Concomitant medication included acetylsalicylic acid (ASPIRIN)$ atorvastatin (MANUFACTURER UNKNOWN)$ bisoprolol fumarate (MANUFACTURER UNKNOWN)$ bumetanide (MANUFACTURER UNKNOWN)$ codeine phosphate$ paracetamol (CO-CODAMOL) $ colecalciferol (MANUFACTURER UNKNOWN)$ dimeticone (MANUFACTURER UNKNOWN)$ docusate sodium (MANUFACTURER UNKNOWN)$ doxycycline hyclate (MANUFACTURER UNKNOWN)$ glyceryl triacetate (MANUFACTURER UNKNOWN)$ isosorbide mononitrate (MANUFACTURER UNKNOWN)$ macrogol 3350$ potassium chloride$ sodium bicarbonate$ sodium chloride (LAXIDO)$ melatonin (MANUFACTURER UNKNOWN)$ macrogol (MICRALAX MACROGOL)$ paracetamol (MANUFACTURER UNKNOWN)$ senna spp. (SENNA SPP.)$ tramadol hydrochloride (MANUFACTURER UNKNOWN).  The patient previously took trimethoprim$ penicillin and ace inhibitors and angiotensin ii receptor blockers and experienced adverse drug reaction$ not specified.  On 21Dec2020$ the patient experienced death within 24 hours of vaccine$ livedo reticularis$ hypotension$ respiratory rate increased$ peripheral coldness$ loss of consciousness. The events were serious as it lead to death.  The patient underwent lab tests and procedures which included body temperature  of 38.1 on 21Dec2020. The patient died on 21Dec2020.  It was not reported if an autopsy was performed. Details were as follows: Death within 24 hours of first vaccination dose occured. Patient had been unwell two days prior to the vaccination. New onset dyspnoea at rest and lethargy were noted. No fever at that time was noted. Noted to be cold$ clammy and sweaty and this persisted for the following two or three days. No doctor notified of these developments. Over the following two days patient remained in a similar condition. She remained cold$ clammy and dyspnoeic. Few observations appear to have been taken over this time; I do not know if she was fevered at any point due to lack of data. She was administered her first Covid-19 vaccine dose on 20Dec2020. On the morning of 21Dec2020$ she was found unrousable in bed. Paramedics were called. She was noted to be cold and mottled$ temperature was  38.1$ low blood pressure (BP) and high respiratory rate. She died a couple of hours later. The case was reported  to the procurator fiscal (PF) as cause of death was unknown$ and death happened within 24 hours of a new vaccine$ also with some concerns over patient care after she became unwell$ not notifying general practitioner (GP) of deterioration in health. Post mortem was agreed by PF$ but date not known. The other outcome for death within 24 hours of first vaccination dose was not known (NK) if death caused by vaccine. The patient was unwell prior to the dose. Cause of death  was reported as unknown. The reporter did not know if the Pfizer COVID-19 vaccine caused or accelerated or contributed to this patient's death.  The patient's deterioration was not informed  until after her death.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Abdominal abscess (Chronic); Aortic stenosis; Cervical myelopathy; Chronic kidney disease stage 3; Clammy (Started 2 days prior to vaccine); Dyspnoea (Started 2 days prior to vaccine); Essential hypertension; Feeling cold (Started 2 days prior to vaccine); Fracture of humerus (Closed fracture distal right humerus); Heart failure; Ischaemic foot (Critical left foot ischamia); Ischaemic heart disease; Lethargy (Started 2 days prior to vaccine); Lipodermatosclerosis; Mitral incompetence; Non STEMI (Acute); Peripheral vascular disease; Postmenopausal bleeding (Unidentified cause); Sweaty (Started 2 days prior to vaccine); Unwell (Started 2 days prior to vaccine); Vascular dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953488-1$	$0953488-1$	$Unknown cause of death; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number was GB-MHRA-ADR 24569457 with Safety Report Unique Identifier of GB-MHRA-WEBCOVID-20210107171332.    An 80-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1688)$ via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunisation.  Medical history was not reported.  It was unknown if the patient had had symptoms associated with COVID-19. The patient was not enrolled in the clinical trial. Concomitant medications included edoxaban (MANUFACTURER UNKNOWN) taken for blood caffeine (as reported) from 06Dec2019 and unknown if ongoing.  The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunization and had no known adverse effects. On 07Jan2021$ the patient died due to an unknown cause of death. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0953501-1$	$0953501-1$	$cardiac arrest; suddenly went funny colour$ odd noise$ and fell back in chair; suddenly went funny colour$ odd noise$ and fell back in chair; Death; This is a spontaneous report received from a contactable physician from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-20210109135858 and GB-MHRA-ADR 24575544.  An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ0553)$ via an unspecified route of administration$ on 16Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included amlodipine besilate (ISTIN)$ propranolol (MANUFACTURER UNKNOWN) taken for anxiety from 17Dec2020$ levothyroxine (MANUFACTURER UNKNOWN)$ and ramipril (MANUFACTURER UNKNOWN).  The patient previously received the influenza vaccine (reported as flu vaccine; MANUFACTURER UNKNOWN) for immunization on 07Oct2020. The patient suddenly went funny colour$ odd noise$ and fell back in chair and experienced cardiac arrest on an unspecified date. The patient experienced death on 21Dec2020$ which was reported as fatal. The clinical course was reported as follows: The patient was well and suddenly went funny colour$ odd noise$ and fell back in chair. The emergency services were called and taken in cardiac arrest. The patient died in the emergency department. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The clinical outcome of suddenly went funny colour$ odd noise$ and fell back in chair was unknown and of cardiac arrest and death was fatal. The patient died on 21Dec2020. The cause of death was reported as cardiac arrest. It was unknown if an autopsy was performed. It was also reported that since the vaccination$ the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0955204-1$	$0955204-1$	$Our friend passed away 6 days after receiving the first dose of the Pfizer vaccine. He experienced a general weakness on the evening prior to hid death.$	$No current illness for this event.$	$Psoriasis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0963902-1$	$0963902-1$	$Death; This is a spontaneous report from four non-contactable consumers via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms.    A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)$ via an unspecified route of administration$ on 28Dec2020 at a single dose for COVID-19 immunization.  Ongoing medical history included Alzheimer's Disease$ encephalopathy$ hypertension$ acute kidney failure$ urinary retention and recent urinary tract infection (UTI)$ all from an unspecified date.  Concomitant medication included acetaminophen (MANUFACTURER UNKNOWN)$ bisacodyl (MANUFACTURER UNKNOWN)$ bupropion (MANUFACTURER UNKNOWN)$ escitalopram (MANUFACTURER UNKNOWN)$ hydrocodone bitartrate$ paracetamol (HYDROCODONE/ACETAMINOPHEN)$ loperamide (MANUFACTURER UNKNOWN)$ ondansetron (MANUFACTURER UNKNOWN)$ senna alexandrina (SENNA PLUS)$ vitamin d3 (MANUFACTURER UNKNOWN).  The patient had no known drug allergies. The patient experienced death on 30Dec2020.  The vaccine was given on 28Dec2020 with no adverse events and no issues on 29Dec2020.  The patient died on 30Dec2020$ at approximately 2:00 AM.   It was unknown if an autopsy was performed.  It was unknown if the event was related to the suspect drug$ the administrator marked as natural causes.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death$	$Acute kidney failure; Alzheimer's disease; Encephalopathy; Hypertension; Urinary retention; UTI$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965457-1$	$0965457-1$	$DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authorityy -WEB NO-NOMAADVRE-FHI-2021-Urpw8$ Safety Report Unique Identifier NO-NOMAADVRE-E2B_00013915.  An 82-years-old female patient received first dose of bnt162b2 (COMIRNATY)$ intramuscular on 05Jan2021 11:30 at single dose for Covid-19 immunisation. Medical history included cognitive deterioration (advanced/severe cognitive impairment)$ general physical condition decreased$ reduced general condition and living in nursing home$ all ongoing. The patient's concomitant medications included buprenorphine (NORSPAN) from 07Dec2020 for pain$ sodium picosulfate (LAXOBERAL) from 10Dec2020 for constipation$ bisacodyl (DULCOLAX) from 26Nov2020 for constipation. Patient had gradually declining functional level and general condition/AT over several months. Vaccinated with bnt162b2 on 05Jan2021 and died on 11Jan2021. It was not reported if an autopsy was performed. The Regulatory Authority assessed the causality between bnt162b2 and the event death as Possible.  Comment: Based on the information in the report it is likely that the underlying diseases is the cause of the death. However$ there is a temporal correlation and it cannot be entirely ruled out that the vaccine could have contributed to the worsening of the patient's underlying diseases. It can also be that the event had a completely different cause which coincidentally developed after the vaccination. Based on the criteria from WHO we assess the causal relationship between Comirnaty and death as Possible. Meaning$ a reaction$ including pathological lab samples$ that happens in a temporal correlation to the use of a pharmaceutical but which could also be caused by underlying disease$ other pharmaceuticals or chemicals. Based on the given criteria the report is assessed as serious. Reported Cause(s) of Death: Death.$	$Cognitive deterioration (advanced/severe cognitive impairment.); General physical condition decreased; Living in nursing home; Reduced general condition$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0965547-1$	$0965547-1$	$resident coded and expired; This is a spontaneous report from a non-contactable consumer via Pfizer Sponsored Program.  A 63-year-old male patient received the 1st dose of bnt162b2 (BNT162B2$ Lot # EH9899) intramuscular at single dose at left arm on 28Dec2020 for Covid-19 immunisation.  Medical history included no current Illness$ no known allergies$ but preexisting conditions: dysphagia$ violent behaviors$ depressive disorder$ schizophrenia$ aspiration$ gastrooesophageal reflux disease (GERD)$ hyperlipidaemia$ bipolar disorder$ rectal bleeding$ hypertension. The patient had no birth defect. Concomitant medication included asa (ASA) at 81mg$ lisinopril (LISINOPRIL) at 10mg daily$ ferrous sulfate (FERROUS SULFATE) at 325 (unit unknown)$ olanzapine (ZYPREXA) at 20mg$ morniflumate (FLOMAX [MORNIFLUMATE]) at 0.4 (unit unknown)$ famotidine (FAMOTIDINE) at 20mg$ ascorbic acid (VIT C)$ carbamazepine (CARBAMAZEPINE) at 250mg bid$ valproate semisodium (DEPAKOTE) at 750mg bid$ metformin (METFORMIN) at 1000 (unit unknown) bid$ sertraline (SERTRALINE) at 100 (unit unknown) bid$ albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL])$ buspirone hydrochloride (BUSPAR) at 10mg tid$ polycarbophil calcium (FIBERCON).  The patient died on 29Dec2020. The patient had no ER or Doctor visit and was not hospitalized. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: resident coded and expired$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Aspiration; Bipolar disorder; Depressive disorder; Dysphagia; GERD; Hyperlipidemia; Hypertension; Rectal bleeding; Schizophrenia; Violent behavior$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0970042-1$	$0970042-1$	$patient passed away with in 90 minutes of getting vaccine; This is a spontaneous report from three non-contactable consumer reporting on behalf of the patient via a Pfizer sponsored program$ Corporate (Pfizer) Social Media Platforms. A 90 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection$ lot number: EL0142$ unknown expiration)$ via an unspecified route of administration in right arm (reported as AR) on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient was a nursing home patient and received the first dose of COVID vaccine on 30Dec2020. The patient was monitored for 15 minutes after getting shot. Staff reported that the patient was 15 days post COVID. The patient passed away with in 90 minutes of getting vaccine on 30Dec2020.  The patient did not require office/ ER visit.  An autopsy was not performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Patient passed away with in 90 minutes of getting vaccine$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0970044-1$	$0970044-1$	$reported causes of death :circulatory collapse; asystole; reported causes of death :circulatory collapse; asystole; This is a spontaneous report from a Pfizer-sponsored program received from the Regulatory Authority-WEB GB-MHRA-WEBCOVID-20201214111558$ satety Report unique Identifier GB-MHRA-ADR 24542972 and EU-EC-10007191566 received via Regulatory Authority 908245. A contactable pharmacist and three consumers reported that an adult female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 13Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included acetylsalicylic acid$ amiloride HCl$ allopurinol$ desogestrel$ furosemide$ levothyroxine$ sildenafil$ and spironolactone. The patient experienced circulatory collapse and asystole on 13Dec2020.  The patient died due to asystole and circulatory collapse on 13Dec2020. It was unknown if an autopsy was performed.   No follow-up attempts are possible$ information about lot/batch number cannot be obtained. No further information Is expected.; Sender's Comments: The information available is limited and does not allow a meaningful case evaluation. However$ based solely on a close chronological association (same day) a causal relationship between events circulatory collapse and cardiac arrest and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.; Reported Cause(s) of Death: reported causes of death :circulatory collapse; asystole; reported causes of death :circulatory collapse; asystole$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0971559-1$	$0971559-1$	$her mother passed away 7-8 days after receiving the vaccine; This is a spontaneous report from a contactable consumer$ the daughter of the patient.  A female patient of an unspecified age received the first dose of COVID-19 mRNA VACCINE (MANUFACTURER UNKNOWN)$ via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 19Jan2021 about 7-8 days after receiving the vaccine$ the patient passed away. The patient was fine before she received the vaccine and then passed away 7-8 days later.  The cause of death was not reported.   It was not reported if an autopsy was performed. The reporter thought her mother's death had everything to do with the COVID-19 vaccine.  The lot number for the vaccine was not provided and will be requested during follow up.; Reported Cause(s) of Death: Death$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0986123-1$	$0986123-1$	$passed away-heart attack; This is a spontaneous report from a contactable consumer$ the daughter of the patient from a Pfizer Sponsored program Pfizer First Connect.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN)$ via an unspecified route of administration on 19Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 24Jan2021$ the patient passed away due to a heart attack.  It was not reported if an autopsy was performed.   The lot number for the vaccine$ BNT162B2$ was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away-heart attack$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999464-1$	$0999464-1$	$Found dead a few days later; This is a spontaneous report from a contactable physician downloaded from the  (MA) Agency-WEB AT-BASGAGES-2021-00453.  A 73-year-old male patient received bnt162b2 (COMIRNATY; Lot # EJ6797) vaccine$ via an unspecified route of administration on 13Jan2021 12:00 at single dose for Covid-19 immunisation.  Medical history included Type II diabetes mellitus (continuing)$ Chronic eczema$ Hyperuricaemia (continuing)$ Ulcus cruris (2019)$ Peripheral arterial occlusive disease Fontaine stage IV$ Peripheral arterial occlusive disease Fontaine stage III$ Popliteal stenosis$ Percutaneous transluminal coronary angioplasty in Jun20008 and Jan2009$  Below knee amputation (1999)$ Osteomyelitis of the foot(2008)$ Cholecystitis chronic Cholecystolithiasis$ Esophageal varices$ Hypothyreosis$ Iron deficiency anaemia$ Adipositas$  Hypercholesteraemia$  Carotid artery stenosis Arterial hypertension$ Renal insufficiency. Concomitant medication included candesartan cilexetil (BLOPRESS)$ clopidogrel besylate (CLOPIDOGREL GENERICON)$ cetirizine (CETIRIZINE)$ insulin aspart$ insulin aspart protamine (crystalline) (NOVOMIX)$ hyaluronate sodium (GENTEAL HA) $ retinol palmitate (VITA POS)$ melaleuca alternifolia oil (TEEBAUM OEL)$ amlodipine mesilate (AMLODIPIN GENERICON)$ betamethasone dipropionate$ gentamicin sulfate (DIPROGENTA)$ methylprednisolone (URBASON [METHYLPREDNISOLONE]) $ febuxostat (ADENURIC)$ glycine max seed oil (BALNEUM HERMAL)$ hydroxyzine hydrochloride (ATARAX [HYDROXYZINE HYDROCHLORIDE])$ pantoprazole (PANTOLOC [PANTOPRAZOLE]).  The patient  found dead on Jan2021 a few days after receiving the vaccine.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Dec2020$ Sars-cov-2 test: negative on 04Nov2020. An autopsy was not performed.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cause of death not specified$	$Adipositas (Adipositas); Arterial hypertension (essential (primary) hypertension); Carotid artery stenosis (stenosis of the carotid artery near the outlet); Cholecystitis chronic (chron. Cholecystitis and Pericholecystitis); Hypercholesteraemia (Hypercholesterinaemia); Hyperuricaemia; Type II diabetes mellitus (DM Typ II)$	$Medical History/Concurrent Conditions: Below knee amputation (status post. lower leg Amputation left); Cholecystolithiasis; Chronic eczema; Esophageal varices; Hypothyreosis (latent hypothyroidism); Iron deficiency anaemia (Iron deficiency anemia); Osteomyelitis of the foot (status post Osteomyelitis cakcaneus right); Percutaneous transluminal coronary angioplasty; Peripheral arterial occlusive disease Fontaine stage III (Peripheral artery disease right with popliteal stenosis right); Peripheral arterial occlusive disease Fontaine stage IV (Peripheral artery disease IV left of the US type); Popliteal stenosis; Renal insufficiency (status post acute renal insufficiency under NSAIDs$ ACE inhibitors$ oral antidiabetic drugs); Ulcus cruris (Ulcus cruris calcanei dx  rez Ulcera heel right and amputation stump left)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999465-1$	$0999465-1$	$Letal death; This is a spontaneous report from a contactable healthcare professional downloaded from the database AT-BASGAGES-2021-00612. An 85-year-old female patient started to receive the first dose of BNT162B2 (COMIRNATY$ lot: EL1491)$ intramuscularly on 19Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing depression$ hypovitaminosis D$ vitamin A deficiency$ sleep disorder$ and hiatus hernia. Concomitant medications included quetiapine fumarate (SEROQUEL)$ and candesartan cilexetil (CANDEBLO). On 21Jan2021$ the patient experienced Death NOS (letal death). Outcome of the event was fatal.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Letal death$	$Depression (Depression); Hiatus hernia (Hiatal hernia); Hypovitaminosis D (AD hypovitaminosis); Sleep disorder; Vitamin A deficiency (AD hypovitaminosis)$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999467-1$	$0999467-1$	$Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the database. Regulatory Authority number BE-FAMHP-DHH-N2021-75590. A 72-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EM0477)$ via an unspecified route of administration$ on 16Jan2021$ at single dose$ for COVID-19 immunisation. The patient's medical history was not reported.  Concomitant medications included venlafaxine (unknown manufacturer)$ calcium carbonate (unknown manufacturer)$ acetylsalicylic acid (ASAFLOW)$ diltiazem (unknown manufacturer)$ pantoprazole (unknown manufacturer)$ methylprednisolone acetate (MEDROL)$ olmesartan (unknown manufacturer)$ amlodipine besilate (AMLOR)$ simvastatin (ZOCOR). The patient experienced cardio-respiratory arrest  on 17Jan2021 with fatal outcome the same day. Patient had cardiopulmonary respiratory arrest at home at the end of 17Jan2021 evening and died at the hospital at 11:40 PM. Therapeutic measures were taken as a result the event and included cardiopulmonary resuscitation. It was not reported if an autopsy was performed. Patient's notes: pulmonary fibrosis and severe deterioration of general condition.  Reporter's comment: patient had cardiopulmonary respiratory arrest on 17Jan2021 at home at the end of the evening$ died at the hospital at 11:40 p.m. (i.e.> 30 hours after vaccination)   No follow-up attempts are possible. No further information is expected.; Reporter's Comments: Patient had cardiopulmonary respiratory arrest on 17Jan2021 at home at the end of the evening$ died at the hospital at 11:40 p.m. (i.e.> 30 hours after vaccination). ADR treatment: Yes: Cardiopulmonary resuscitation.; Reported Cause(s) of Death: Cardio-respiratory arrest$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999468-1$	$0999468-1$	$Agitation; restlessness; This is as spontaneous report from a contactable physician received from the Regulatory Authority$ downloaded from the database (regulatory authority report number BE-FAMHP-DHH-N2021-75638). A 92-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included venous ulcer$ pulmonary embolism$ atrial fibrillation and dementia. The patient had a BMI around 30. Concomitant medications were not reported. On 16Jan2021$ the patient experienced restlessness with outcome of unknown and agitation and on 18Jan2021 she died. The reporter specified that her son died of COVID a few months earlier and since then she has shown a let-down and a will not to live anymore. She was vaccinated on 15Jan2021 and started showing signs of restlessness on 16Jan2021 evening. No fever or diarrhea. The outcome of the event agitation was reported as fatal. An autopsy was not performed. Reporter's comment: 92-year-old patient. BMI +/- 30. Important medical history: Venous ulcer$ pulmonary embolism$ atrial fibrillation$ dementia. Her son died of covid a few months earlier and since then she has shown a let-down and a will not to live anymore. She was vaccinated on Friday and started showing signs of restlessness on Saturday evening. No fever or diarrhea.  No follow-up attempts are possible$ information about batch number cannot be obtained.; Reporter's Comments: 92-year-old patient. BMI +/- 30. Important medical history: Venous ulcer$ pulmonary embolism$ atrial fibrillation$ dementia. Her son died of covid a few months earlier and since then she has shown a let-down and a will not to live anymore. She was vaccinated on Friday and started showing signs of restlessness on Saturday evening. No fever or diarrhea.; Reported Cause(s) of Death: Agitation$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Pulmonary embolism; Venous ulceration$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999469-1$	$0999469-1$	$Diabetic complication; Renal insufficiency; Cardiac insufficiency; This is a spontaneous report from a contactable other HCP received via Regulatory Authority downloaded from the database (EMA) BE-FAMHP-DHH-N2021-75648.  A 60-year-old male patient received the first dose of BNT162B2 (COMIRNATY$ lot number EM0477) via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 vaccination. The patient's medical history included cardiac insufficiency$ renal insufficiency and diabetic complication. The patient suffered from cardiac insufficiency$ renal insufficiency and diabetic complication during treatment with BNT162B2. The patient died on 14Jan2021. It was not reported if an autopsy was performed. The outcome of the events cardiac insufficiency$ renal insufficiency and diabetic complication was fatal.  Reporter's comment: The problems were also there before the vaccination$ so probably not linked.  No follow-up attempts are possible. No further information is expected.; Reporter's Comments: The problems were also there before the vaccination$ so probably not linked.; Reported Cause(s) of Death: cardiac insufficiency; renal insufficiency; diabetic complication$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cardiac insufficiency; Diabetic complication; Renal insufficiency$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999495-1$	$0999495-1$	$Death; Blood pressure cannot be measured; Renal failure/Medical history included chronic renal insufficiency; Vomiting; unresponsive; Personality change; Nausea; This is a spontaneous report from a non-contactable downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number IS DE-PEI-PEI2021001511.    A female patient of an unspecified age received BNT162B2 (COMIRNATY; Lot number EM0477)$ via an unspecified route of administration on 19Jan2021 as single dose for covid-19 immunization.  Medical history included chronic renal insufficiency$ osteoporosis$ femoral neck fracture from and atrial fibrillation from unknown dates and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient experienced the following events$ which were serious as they lead to death: vomiting on 20Jan2021; unresponsive on 20Jan2021; personality change on 20Jan2021; nausea on 20Jan2021; death on 21Jan2021; blood pressure cannot be measured on 21Jan2021; renal failure on 21Jan2021.  Details were as follows: On 20Jan2021$ after vaccination$ the patient developed nausea$ vomiting$ personality change$ unresponsive to verbal stimuli and blood pressure immeasurable$ renal failure and unknown cause of death$ lasting for unknown duration.  The patient died on 21Jan2021.  It was not reported if an autopsy was performed. Death cause was reported as renal failure.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Renal failure$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal insufficiency; Femoral neck fracture; Osteoporosis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999507-1$	$0999507-1$	$Pyrexia; Skin blotches; Dyspnoea; General physical health deterioration; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB FI-FIMEA-20210194. A 93-year-old male patient received bnt162b2 (COMIRNATY)$ intramuscular on 08Jan2021 at single dose for covid-19 immunisation.  The patient medical history included Alzheimer's disease (2014). Hypothyroidism$ diverticulosis$ large inguinal hernia on the right. In 2011 chronic subdural hematomas were treated x3. 2013 cholecystitis. In 2016 hospitalization due to suspected biliary pancreatitis. In 2017 anemia$ intestinal bleeding. In 2019 pneumonia and lower limb thrombus. Due to dementia in a nursing home from 7/15. Diarrhea symptom for years with drug trials. Diarrhea worsened in the fall and since then varied with occasional severe diarrhea that worsened general well-being. Eating and drinking have become bad and food has not been absorbed. Started with Entocort 9 mg and hidrasec 5.1.2021$ by the end of the week diarrhea clearly decreased. Concomitant medication included sertraline$ risperidone (RISPERDAL)$ budesonide (ENTOCORT)$ oxazepam (OPAMOX)$ pantoprazole sodium sesquihydrate (SOMAC)$ racecadotril (HIDRASEC)$ levothyroxine sodium (THYROXIN).  The patient experienced pyrexia (death) on 09Jan2021$ skin blotches (death) on 09Jan2021$ dyspnoea (death) on 09Jan2021$ general physical health deterioration (death) on 09Jan2021.  Received the COVID vaccine on 8.1$ after a couple of hours later there was shortness of breath and spotted areas in the legs. General condition stabilized$ breathing calmed down$ and an ambulance checked the situation. Quick-crp 5$ no fever. Fallen asleep. The next day 9.1. in the morning refreshed$ came back to be a former self and ate normal lunch in the dayroom sitting in a G-chair. In the afternoon fever ad 37.9$ general condition worsened$ breathing became difficult again$ stayed in bed$ and has no longer taken anything orally. The patient died on 12Jan2021.  It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Alzheimer's disease; Anemia; Biliary pancreatitis (In 2016 hospitalization due to suspected biliary pancreatitis.); Cholecystitis; Dementia (Due to dementia in a nursing home from 7/15.); Diarrhea; Diverticulosis; Hypothyroidism; Inguinal hernia; Intestinal bleeding; Pneumonia; Subdural hematoma (In 2011 chronic subdural hematomas were treated x3.); Thrombus$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999508-1$	$0999508-1$	$Oxygen saturation decreased; This is a spontaneous report from a contactable physician downloaded from the  Agency. The regulatory authority report number is FR-AFSSAPS-CF20210094.  A 93-years-old female patient received the first dose of bnt162b2 (COMIRNATY$ batch/lot number EJ6796) $ intramuscular at left arm on 21Jan2021 2pm at 0.3 mL$ single for covid-19 immunization.  Medical history included ongoing hyperthyroidism$ ongoing supraventricular tachyarrhythmia$ ongoing hypertension arterial. No history of Covid-19. The patient's concomitant medications were not reported.  The patient experienced oxygen saturation decreased on 22Jan2021 with outcome of fatal. Lab data included within 24 hours after the injection$ on 22Jan2021 an oxygen desaturation occured at level 88% (usually around 91-92%)$ demanding oxygen in the evening$ saturation at level 80%. The patient died on 23Jan2021 in the morning. It was not reported if an autopsy was performed. The cause of death was oxygen saturation decreased.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Oxygen saturation decreased$	$Hypertension arterial; Hyperthyroidism; Supraventricular tachyarrhythmia$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999509-1$	$0999509-1$	$Death unexplained/sudden death; This is a spontaneous report from a contactable physician downloaded from the AGENCY -WEB FR-AFSSAPS-PA20210105.    A 70-year-old female patient received bnt162b2 (COMIRNATY) (lot number EF6795)$ intramuscular on 20Jan2021 15:05 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Medical history included syndrome sicca; endobrachyoesophagus; respiratory failure with fibrosing interstitial lung diseases under NIV and O2$ essential hypertension (primary); stroke$ not specified as being hemorrhagic or by infarction; vertebral compression; all from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified medication. On 21Jan2021$ sudden death of the resident in the morning at 10:10 a.m. Normal checking vital signs before and after vaccination$ patient on 2.5L of O2 started on the day before vaccination (patient was regularly on O2). Patient in her usual state in the morning after getting up$ took her medication in the morning. Nurse put her aerosol on and a few minutes later when another nurse was checking vital signs$ a resident found in cardio-respiratory arrest$ sitting leaning on her bed. The patient died on 21Jan2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained/sudden death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Compression of fractured vertebra; Endobrachyoesophagus; Essential hypertension (primary); Failure respiratory; Progressive fibrosing interstitial lung disease (under NIV and O2); Stroke (not specified as being hemorrhagic or by infarction); Syndrome sicca$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999514-1$	$0999514-1$	$Cardiac arrest; a sore arm; tired; Bradycardia; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number GB-MHRA-ADR 24646306.  A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EK4243)$ via an unspecified route of administration at single dose on 19Jan2021 at 16:35 for Covid-19 immunisation. Medical history included ongoing left ventricular hypertrophy$ ongoing atrial dilation$ palpitations from Dec2020 and ongoing $ sars-cov-2 test positive in Dec2020$ magnetic resonance imaging heart (results awaited$ specialist informed). Concomitant medications were not reported. The patient experienced bradycardia on an unspecified date in Jan2021 with outcome of not recovered$ pain in extremity on 19Jan2021 with outcome of not recovered$ fatigue on 19Jan2021 with outcome of not recovered$ cardiac arrest (death) on 20Jan2021. The patient underwent lab tests and procedures which included biopsy muscle: heart muscle biopsies awaited on unknwn date$ heart rate: 29  on 20Jan2021. Therapeutic measures were taken as a result of fatigue. The patient died on 20Jan2021.  An autopsy was performed and results were not provided. The patient was extremely fit$ ultra marathon runner who was complaining only of a sore arm of day of vaccination (19Jan2021) although tired so slept in separate room to wife. 'Garmin' notes profound bradycardia 29 with heart stopping 03:10 i.e. no signs anaphylaxis. Impression: Presumption is cardiac cause$ probably unrelated to Covid vaccination. Post Mortem results to follow: Post Mortem result on Friday 22nd January 2021: inconclusive.  Cardiologist has suggested that an inflammatory response to vaccine may be a cause. He is now liaising with pathologist and heart muscle biopsies awaited  6/52.  No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest$	$Dilatation atrial; Left ventricular hypertrophy; Palpitations$	$Medical History/Concurrent Conditions: Cardiac MRI (results awaited$ specialist informed); SARS-CoV-2 test positive$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999520-1$	$0999520-1$	$Cardiac arrest; Weakness of leg; Chest pain; Anal incontinence/faecal/ urinary incontinence; Urinary incontinence; Dyspnoea/breathlessness; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EMIS-418-7f3e7af1-1ad3-4f0d-a96f-732929335a69 and GB-MHRA-ADR 24654897. A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ intramuscular on 22Jan2021 at single dose for COVID-19 immunisation. Medical history included gout from 11Jan2021 and ongoing$ gout from 23Dec2020 and ongoing$ ongoing dementia$ ongoing cardiac failure$ ongoing depression$ caregiver from 28Oct2020 and ongoing (Has a carer)$ dyspnoea from 01Sep2020 and ongoing$ dyspnoea from 21Aug2020 and ongoing$ dyspnoea from 13Aug2020 and ongoing$ Dyspnoea from 29Jul2020 and ongoing$ ongoing Chronic obstructive pulmonary disease$ Ex-tobacco user from 22Jul2020 and ongoing$ Hepatic steatosis from 13May2020 and ongoing$ Cerumen removal from 09Mar2020 and ongoing. Concomitant medication included allopurinol from 23Dec2020 for Gout$ dosulepin from 11Nov2020 to 24Dec2020$ duloxetine from 18Dec2020 for Depression$ prednisolone from 23Dec2020$ promethazine hydrochloride from 11Nov2020. The patient previously took ANGIOTENSIN II ANTAGONIST NOS and experienced drug intolerance. The patient has some chest pain after the vaccination in Jan2021. Then developed bilateral weakness of legs on 22Jan2021 with faecal/ urinary incontinence. Didn't seek medical advice until 26Jan2021 when concerned about his breathlessness in Jan2021. Called ambulance but arrested and died. The patient experienced Anal incontinence/ faecal/ urinary incontinence in Jan2021. The patient died due to Cardiac arrest on 26Jan2021.  An autopsy was not performed. The outcome of Weakness of leg was not recovered$ of other events were unknown. Lab data included blood pressure measurement on 21Aug2020$ Blood test$ blood pressure measurement$ Heart rate$ Full blood count$ White blood cell count $ Red blood cell count (red blood cell distibution width measured)$ Haemoglobin (Estimation)$ Mean cell haemoglobin$ Haematocrit$ Mean cell volume$ Platelet count$ Plateletcrit$ Mean platelet volume$ Platelet distribution width$ Neutrophil count$ Lymphocyte count$ Monocyte count$ Eosinophil count$ Basophil count$ Liver function test$ Blood albumin$ Blood bilirubin$ Blood alkaline phosphatase$ Alanine aminotransferase$ Blood urea$ Blood electrolytes$ Blood sodium$ Blood potassium$ Blood creatinine$ Glomerular filtration rate (Estimated)$ Blood thyroid stimulating hormone$ Blood folate$ Serum N-terminal pro B-type natriuretic peptide concentration$ Glycosylated haemoglobin (Haemoglobin A1c level) on 18Aug2020$ Blood pressure measurement$ Oxygen saturation (Peripheral oxygen saturation) on 29Jul2020$ Computerised tomogram abdomen on 05Mar2020.  No follow up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest$	$Caregiver (Has a carer); Chronic obstructive pulmonary disease; Dementia; Depressive disorder; Dyspnea; Ear wax removal; Ex-smoker; Gout; Heart failure; Hepatic steatosis$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999779-1$	$0999779-1$	$dead; This is a spontaneous report from a contactable physician received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101271121343780$ Safety Report Unique Identifier GB-MHRA-ADR 24653881.  A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0739) via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history included small cerebrovascular accident (CVA) from 06Jan2021 which had recovered. The patient's concomitant medications were not reported. The patient was found dead by wife in morning on 25Jan2021. Awaiting Coroners PM. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. It was not reported if an autopsy was performed. The outcome of the event was fatal. The reporter considered the suspect product had an unknown relationship with cause of death.  No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: dead$	$No current illness for this event.$	$Medical History/Concurrent Conditions: CVA; Comments: small CVA 6/1/21$ COVID imm 20/1/21$ found dead by wife in morning 25/1/21. Awaiting Coroners PM Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999780-1$	$0999780-1$	$after vaccine tired$ not eating and went steadily downhill$ leading to death; after vaccine tired$ not eating and went steadily downhill$ leading to death; This is a spontaneous report from a contactable physician (patient's daughter).  This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101271354304610$ Safety Report Unique Identifier GB-MHRA-ADR 24654845.  A 99-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EE8493)$ via an unspecified route of administration at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included previous surgery for coronary artery stenosis. Patient was independently active and mobile. Concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 28Dec2020 for Covid-19 immunisation without problems. The patient experienced after vaccine$ on 20Jan2021 tired$ not eating and went steadily downhill$ leading to death. The patient died on 25Jan2021. It was not reported if an autopsy was performed. The events were assessed by the reporter as fatal and life threatening.  The patient had not been tested for COVID-19 since the vaccination.  The patient had not been tested positive for COVID-19 since the vaccination. The patient had not had symptoms associated with COVID-19. The patient was not enrolled in a clinical trial. The daughter notes steady decline in health after second vaccine. Managed by being nursed at home. However as clearly dying$ moved to ED where she passed away. No investigations conducted: clinical diagnosis. Daughter is a consultant respiratory physician.  No follow-up attempts possible; information regarding batch/lot for first dose cannot be obtained; No further information expected.; Reported Cause(s) of Death: Appetite absent; TIREDNESS$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Coronary artery stenosis; Comments: Patient was independently active and mobile. Has had previous surgery for coronary artery stenosis  Had first covid injection 28th Dec 2020 without problems. Had second vaccine$ 19th Jan 2021  but after vaccine tired$ not eating and went steadily downhill$ leading to death on 25th Jan 2021  Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999799-1$	$0999799-1$	$Death sudden; cardiac arrest; Dyspnea; Dysphoria; This is a spontaneous report from a non-contactable consumer via local legal and a contactable pharmacist downloaded from the Medicines Agency (MA) -WEB (GR-GREOF-20210423).  An 87-year-old female patient received BNT162B2 (COMIRNATY; Lot number: EJ6795)$ intramuscularly$ on 20Jan2021 at 15:00 at a single dose for COVID-19 vaccination. The patient had no medical history. It was reported that the medical history was free of any chronic cardiac$ pulmonary$ renal$ or other  metabolic disease. The patient had no history of anaphylactic medical events. The patient's concomitant medications were not reported. The patient was not taking long-term anticoagulant therapy or aspirin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccinations 15 days prior to the vaccine. The patient experienced death sudden$ cardiac arrest$ dyspnea$ and dysphoria on 21Jan2021$ which were reported as medically significant and fatal. She was not admitted to the hospital but got in contact with her private medical doctor. The clinical outcome of all of the events was fatal. The patient died on 21Jan2021. The causes of death were reported as death sudden$ cardiac arrest$ dyspnea$ and dysphoria. It was not reported if an autopsy was performed.  No follow-up attempts possible. No further information expected.  Follow-up (28Jan2021): The initial case was missing the following minimum criteria: reporter with first-hand knowledge (initially: non-contactable consumer via local legal). Upon receipt of follow-up information on 28Jan2021$ this case now contains all required information to be considered valid.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac arrest; dyspnea; sudden death; dysphoria$	$No current illness for this event.$	$Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999864-1$	$0999864-1$	$MULTIORGAN FAILURE; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB [NO-NOMAADVRE-FHI-2021-Uedy8]$ Sender's (Case) Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00014172. A 75-year-old male patient received the first dose of BNT162B2 (COMIRNATY$ Lot#: EJ 6795) at single dose in arm left on 08Jan2021 at 10:15 for COVID-19 immunisation. Medical history included patient was multimorbid nursing home resident in the 70s (living in nursing home); with chronic renal failure stage 5; well-functioning peritoneal dialysis last couple of years and spontaneous residual diuresis until recently; gradually declining general condition (reduced general condition); malnutrition for several weeks prior to vaccination with the covid-19 vaccine; multiple episodes with near-syncope and syncope$ ECOG score 3; multimorbidity; bedridden. Concomitant medication was not reported. Patient experienced multiorgan failure on 10Jan2021 that resulting death on 13Jan2021. Two days after vaccination$ the patient had greatly reduced general condition$ bedridden$ no food intake and did not take his medication$ no diuresis$ somnolent$ confused$ no fever. ECOG score 4. Assessed as irreversible condition and preterminal status. Dialysis was terminated in consultation with a renal physician. Transition to palliative care phase. The man died on day 5 after vaccination. It was not reported if an autopsy was performed or not. The outcome of event was fatal.  Reporting physician and attending nephrologist and infectious disease specialist at hospital saw no connection with the current incident and vaccination with the covid-19 vaccine.  Reporter's causality assessment: COMIRNATY/Multiorgan failure: Unlikely  Sender's Comments: Based on the information in the report$ only the reporter's causality assessment is registered. Reporter has stated that there is no suspicion of a connection with vaccination$ and therefore a causal connection with vaccination is considered unlikely. Based on the information in the report$ we agree that another cause$ other than the vaccine$ must be considered a cause of multi-organ failure. Since the patient died$ the report is classified as serious.  No follow-up attempts are possible. No further information expected.; Sender's Comments: There is not a reasonable possibility that event multiorgan failure is related to BNT162B2.  The patient had multiple underlying diseases$ which predisposed the elderly patient to developing the event.; Reported Cause(s) of Death: MULTIORGAN FAILURE$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Bedridden; Chronic renal failure; Living in nursing home; Malnutrition; Multimorbidity; Peritoneal dialysis; Reduced general condition; Syncope$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$0999870-1$	$0999870-1$	$Death; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. The regulatory authority report number is PT-INFARMED-E202101-1056.   An elderly male patient received BNT162B2 (COMIRNATY; Lot number unknown)$ intramuscular on 06Jan2021 at 0.3 mL$ single for covid-19 immunization.  The patient's medical history  was noted as  previous history of a patient with multimorbidity$ bedridden in  a nursing home since an unspecified date. The patient's concomitant medications were not reported. The patient experienced death on 07Jan2021.  Details were as follows: the case refers to an elderly patient who died associated with the use of BNT162B2 $ as a first  dose. The adverse reaction (ADR) appeared one day after the single administration of the suspected drug. The patient died on 07Jan2021.  It was not reported if an autopsy was performed.  The cause of death was reported as  cardiorespiratory arrest.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cardiopulmonary arrest$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Bedridden (in Nursing Home); Living in nursing home (bedridden)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000247-1$	$1000247-1$	$died; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB [AT-BASGAGES-2021-00572].  A 86-year-old female patient received BNT162B2 (COMIRNATY) on Jan2021 Intramuscular at single dose for COVID-19 immunisation. The patient's medical history included: Dementia (continuing)$ Ataxia (continuing)$ Transient ischaemic attack (TIA)$ Struma nodosa (continuing). Concomitant medication was not reported. The patient died a few days after receiving the Covid vaccination on 25Jan2021. It was unknown if autopsy was done.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death$	$Ataxia (Ataxia); Dementia (Dementia); Struma nodosa (Struma nodos)$	$Medical History/Concurrent Conditions: TIA (Status post TIA)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000250-1$	$1000250-1$	$Sudden death; Vomit was found near the body.; This is a spontaneous report from contactable physician downloaded from the Agency (EMA) Agency-WEB BE-FAMHP-DHH-N2021-75651.  A 80-year-old female patient received bnt162b2 (COMIRNATY$ PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation.  The patient medical history included wheelchair-bound (Parkinson's$ Parkinson's dementia)$ hip fracture in Oct2020 and mentally deteriorating so requiring care. Concomitant medication included cyanocobalamin$ folic acid$ pyridoxine hydrochloride (TRIBVIT)$ carvedilol (CARVEDILOL)$ calcium carbonate$ colecalciferol (D VITAL FORTE)$ haloperidol (HALDOL)$ sertraline (SERTRALINE)$ l-thyroxine [levothyroxine] (L-THYROXINE [LEVOTHYROXINE])$ nadroparin calcium (FRAXIPARINE)$ clonazepam (RIVOTRIL)$ pantoprazole (PANTOPRAZOLE)$ acetylsalicylic acid (DOMINAL [ACETYLSALICYLIC ACID])$ caffeine$ paracetamol (ALGOSTASE)$ fentanyl (DUROGESIC)$ macrogol 3350$ potassium chloride$ sodium bicarbonate$ sodium chloride (LAXIDO). The patient experienced sudden death on 19Jan2021. The patient died on 19Jan2021. An autopsy was not performed. Outcome of the event was fatal.  Reporter's comment: Reporter does not know if death is due to vaccination$ but rather thinks not because of 'time to onset' of 11 days. Cause of death is unknown$ however. Vomit was found near the body.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Hip fracture; Mental deterioration (requiring care); Parkinson's disease; Wheelchair user$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000251-1$	$1000251-1$	$General physical health deterioration; Cardiac failure; Lung edema; Cardiovascular disorder; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB BE-FAMHP-DHH-N2021-75687. A contactable physician reported that a 85 years old female patient received first dose BNT162B2 (COMIRNATY)$ via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 vaccination. The medical history included hypertension$ osteoporosis. Concomitant drugs were escitalopram (strength 10 mg)$ bumetanide (BURINEX$ strength 1 mg)$ edoxaban tosilate (LIXIANA$ strength 60 mg) and amlodipine besilate(AMLOR$ strength 10 mg).On 20Jan2021 the patient suffered from cardiovascular disorder$ lung edema$ cardiac failure and general physical health deterioration during treatment with BNT162B2. The patient died on 20Jan2021. It's unknown if an autopsy was performed. The cause of death was cardiovascular disorder$ lung edema$ cardiac failure and general physical health deterioration. The outcome of events was fatal.  Reporter Comment: no really obvious side effects after vaccination. earlier further deterioration (so this already deteriorated before vaccination)  No follow-up attempts are possible. No further information is expected.; Reporter's Comments: no really obvious side effects after vaccination. earlier further deterioration (so this already deteriorated before vaccination); Reported Cause(s) of Death: General physical health deterioration; Cardiac failure; Lung edema; Cardiovascular disorder$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Hypertension; Osteoporosis; Comments: Hypertension$ Osteoporosis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000268-1$	$1000268-1$	$Vomiting/food vomit; suspected heart attack; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) WEB ES-AEMPS-726097. An 80-years-old male patient received bnt162b2 (COMIRNATY)$ intramuscular on 04Jan2021 at 0.3 mL$ single for covid-19 immunisation.  Medical history included Mixed vascular and Lewy body dementia$ with severe and rapidly progressive cognitive deterioration and with behavioral and psychological symptoms of dementia in treatment with trazodone$ quetiapine$ and lorazepam. Rivastigmine was not tolerated in July 2019. Cerebral vascular disease. Multiinfarction. Lacunar stroke Aug2019. Chronic obstructive pulmonary disease (COPD). Diabetes Mellitus II. Negative PCR 15Dec2020. Rapid Antigen Test screening 21Dec2020 negative. Concomitant medication included trazodone$ quetiapine$ lorazepam$ all for dementia. Since the day of the vaccination$ he has not presented new symptoms to his usual one. On the night of 12Jan2021$ he developed food vomit and died 10 minutes later. They report suspected heart attack. It was unknown whether an autopsy has been performed.  No follow-up attempts are possible$ information on batch numbers cannot be obtained.; Reported Cause(s) of Death: Vomiting/food vomit; suspected heart attack$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cerebrovascular disorder; COPD; Dementia with Lewy bodies; Infarction; Lacunar stroke; Mixed dementia; Type II diabetes mellitus$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000275-1$	$1000275-1$	$$Death unexplained/massive pulmonary embolism in the context of neoplastic COVID +; Massive stroke related to intracardiac thrombus; massive pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR performed: positive/CT scan compatible with covid 19 infection; massive pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR performed: positive/CT scan compatible with covid 19 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB$ FR-AFSSAPS-DJ20210104.  A 75-year-old female patient received bnt162b2 (COMIRNATY$ lot number: EM0477)$ via intramuscular on 14Jan2021 at single dose for COVID-19 vaccination. Medical history included stage IIIB colon adenocarcinoma- (pT3N1aM0) from Aug2020 and unknown if it was ongoing with rectosigmoid resection on 27Aug2020 and ileostomy closure on 09Oct2020. HTA (arterial hypertension)$ ACFA (complete arrhythmia by atrial fibrillation)$ Non-insulin-dependant diabetes$ Dyslipidemia$ Obstructive pyelonephritis in renal colic$ Hypothyroidism$ right acoustic neuroma (operated on in 2014 with sequelae facial palsy)$ and all unknown if they were ongoing and notion of allergy to iodine. The patient followed in particular for an adenocarcinoma of the colon treated with simplified LV5FU2 (cisplatin$ 5-fluorouracil$ leucovorin) as an adjuvant with a 4th treatment carried out in a day hospital on 14Dec2020. The patient is non-DPD deficient. The patient lives at home with her husband$ a household helper$ a nurse who comes several times a week. Autonomous for toilet and meals. The report of the day hospitalization of 14Dec2020 mentioned: INTERCURE: G1 asthenia throughout the intercure$ improvement in BP$ better general condition. CLINICAL REVIEW: WHO 1-2$ BP 117/70 mmHg$ HR 102 bpm$ afebrile$ 97% AA saturation. Weight 62 kg stable. Normal clinical examination. She received her cure of LV5FU2. She was hospitalized on 17Dec2020 for a stroke in the territory of the right posterior cerebral artery$ with thrombus in P1$ not revascularized (fall from her bed at 6 a.m.$ her husband noting a left hemicorporeal deficit and dysarthria). An MRI is immediately performed which reveals an ischemic stroke of the posterior arm of the right internal capsule and of the diffusing right internal and occipital temporal cortex. On the TOF$ we find an occlusion of the posterior cerebral artery from the beginning and an occlusion of the right internal carotid artery with slow cerebral artery and permeable middle cerebral artery. EDTSA carried out on 18Dec2020: $$The echo-Doppler anomalies presented can be compatible either: with an obliteration of the right internal carotid artery downstream of the portion visualized by echo-Doppler (which is difficult to assert because on indirect arguments)$ if this is the case$ it looks old since ''with good replacement of the cerebral arteries via the anterior communicating artery or with a stenosis of the right siphon without occlusion of the internal carotid artery explaining the velocities preserved in right MCA$$. Cerebral MRI of 21Dec2020: Ischemic stroke made up of the right posterior superficial Sylvian territory and the superficial and deep territories of the right posterior cerebral artery. Recanalization of the right internal carotid artery and the right posterior cerebral artery of fetal origin. During the stay$ she improved neurologically$ with partial regression of motor impairment$ total regression of visual impairment and dysarthria. Upon discharge$ she presented a NIHSS score of 2$ with a slight drop in her left upper limb before 10 seconds$ and sensitive extinction. There persist ataxia of the lower limbs and facial paralysis which were sequelae respectively of an old cerebellar lesion and a neuroma. The patient is anticoagulated by LMWH tinzaparin sodium (INNOHEP)$ due to the occurrence of a stroke under ELIQUIS$ her known AF$ and the neoplastic context. INNOHEP will be continued in the long term. She was leaving for her home on 24Dec2020. Patient finally admitted to Follow-up and Rehabilitation Care on 30Dec2020. Decision with the patient not to resume adjuvant chemotherapy given the loss of autonomy and an unfavorable benefit-risk balance. Similarly contraindication to any colonoscopy. Exploration of an adrenal adenoma accidentally discovered on the control hepatic MRI. Hypercalcemia on 31Dec2020 prompting the administration of Pamidronate. On 12Jan2021: Positive orthostatic hypotension test. Concomitant medications included oxazepam (SERESTA) from Dec2020$ atorvastatin calcium (ATORVASTATINE ARROW)$ tinzaparin sodium (INNOHEP) from 22Dec2020 for Atrial fibrillation$ enalapril maleate (ENALAPRIL EG)$ calcium phosphate monobasic$ magnesium glycerophosphate$ phosphoric acid$ sodium phosphate dibasic (PHOSPHONEUROS) from 19Jan2021$ bisoprolol fumarate (BISOPROLOL SANDOZ)$ pantoprazole sodium sesquihydrate (PANTOPRAZOLE MYLAN) from Dec2020$ dexamethasone from 19Jan2021$ sitagliptin (JANUVIA)$ amoxicillin$ clavulanate potassium (AUGMENTIN) from 19Jan2021$ cinacalcet hydrochloride (MIMPARA) from 12Jan2021$ apixaban (ELIQUIS)$ enalapril maleate$ lercanidipine hydrochloride (LERCAPRESS)$ esomeprazole$ macrogol 3350$ potassium chloride$ sodium bicarbonate$ sodium chloride (MOVICOL)$ alprazolam. Notification from a hospital specialist concerning this patient who died as a result of vaccination with COMIRNATY. Vaccination by COMIRNATY on 14Jan2021 with good immediate tolerance. The same day realization of a transthoracic ultrasound which was programmed: LVEF conserved at 50% in SB on an enlarged LV (SIV and PP 11mm) not dilated. Bi-atrial expansion with left atrium 86 ml / m¦ and right atrium 21 cm¦. No increase in left ventricle filling pressures. Central minimal mitral insuffisiency. Tricuspid aortic valve$ mean gradient 2 mmHg. Moderately impaired RV function$ no PH with PAPS estimated at 30-35 mmHg. Breathable dilated IVC. Free pericardium. Transesophageal echocardiography: Left auricle not free with impaired emptying rate$ no thrombus directly visualized but significant spontaneous contrast. Bubble test: No patent foramen ovale found. On 15Jan2021: Well clinically. No headache$ no cough$ no transit disorder following the Covid vaccination. Good constants$ afebrile. On 16Jan2021: Appearance of a cough. She was reviewed in hospitalization oncology day on 18Jan2021 for reassessment. CLINICAL EXAMINATION: WHO 3 with above all significant loss of autonomy. Consciousness normal$ higher functions a little slowed down and tendency to drowsiness. BP 106/67 mmHg$ HR 89 bpm$ afebrile$ 97% AA saturation. Weight 60 kg (-2 kg). Staggering walk with loss of balance$ must hold on to furniture. On 18Jan2021: No fever$ no diarrhea$ no other symptom found apart from the cough. Covid19 PCR performed: positive. On 19Jan2021: blood pressure 140/70 mmHg$ pulse 60 / min$ respiratory level: FR at 15 / min$ Rhinorrhea$ expectorating cough$ no dyspnea$ no chest pain$ no anosmia or ageusia$ asthenia$ no headache auscultation with clear reduction of MV on the left base$ elimination of vibrations and dullness therefore: possible pleural effusion. At the cardio level: no palpitation$ no sign of HF$ or sign of DVT$ regular auscultation without noticeable breath. At the digestive level: no diarrhea$ no nausea or vomiting$ no abdominal pain$ palpation within the standards. Note that the patient does not want to go to intensive care in the event of deterioration$ she does not want intubation. At the end of the morning$ episode of loss of contact with return to full consciousness for several minutes$ it is possible that she was suffering from epilepsy after his stroke with lowering of the epileptogenic threshold on COVID / fever. No brain imaging. On the other hand$ in view of the saturation: initiation of dexamethasone and AUGMENTIN + realization of an emergency chest scanner today (on 19Jan2021). CT scan compatible with covid 19 infection (minimal degree of involvement <10%). On 20Jan2021 at 11:30 am the consultation word mentions: better today$ FR at 22 / min$ no anosmia or ageusia$ no diarrhea$ no dyspnea$ no chest pain$ no sign of cardiac insufficiency no sign of DVT or VTE. Auscultation with the same anomalies as yesterday (clear drop in MV in left base) therefore monitoring. The same day on 20Jan2021$ call from a licensed nurse around 2:35 p.m. for a patient found on the ground$ not reactive. Arrival of the doctor in the room: patient in a state of clinical death$ facial cyanosis$ no pulse$ no breathing$ no heart rate. Total asystole. Time of death recorded 14:45. Most likely in no flow for 15 minutes. Patient who had refused resuscitation care yesterday in the event of degradation (refusal of CPR and intubation) so in this context no resuscitation procedure started. Opinion of the doctor in charge of the patient since entry into Follow-up and Rehabilitation Care: presence of an intracardiac thrombus with great certainty according to cardiologists. Possible cause of death: massive pulmonary embolism in the context of neoplastic COVID +$ Massive stroke related to intracardiac thrombus. Exclusive role of COVID (see respiratory distress) very unlikely because no major respiratory damage in this patient$ correct respiratory rate and saturation. AF was fairly stable (no recent ECG either). Unexplained death notified because the participatory role of the vaccine cannot be completely excluded. The patient died on 20Jan2021. An autopsy was not performed.  No follow-up attempts are possible$ no information is expected.; Reported Cause(s) of Death: massive pulmonary embolism in the context of neoplastic COVID +; Massive stroke related to intracardiac thrombus; Massive stroke related to intracardiac thrombus; massive pulmonary embolism in the context of neoplastic COVID +; massive pulmonary embo$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Acoustic neuroma (Right acoustic neuroma operated on in 2014 with sequelae facial palsy); Adenocarcinoma of colon stage III (Stage IIIB colon adenocarcinoma treated with simplified LV5FU2); AFib (ACFA (complete arrhythmia by atrial fibrillation)); Cerebral thrombosis (hospitalized on 17Dec2020  left hemicorporeal deficit and dysarthria); Dyslipidaemia; Facial palsy (Right acoustic neuroma operated on in 2014 with sequelae facial palsy); Fall (was hospitalized on 17Dec2020); Hospitalisation (improved neurologically$partial regression$total regression-visual impairment$dysarthria); Hospitalization (G1 asthenia throughout the intercure$ improvement in BP$ better general condition.); Hospitalization; Hypercalcemia (prompting the administration of Pamidronate); Hypertension arterial (HTA (arterial hypertension)); Hypothyroidism; Ileostomy; Iodine allergy; Non-insulin-dependent diabetes mellitus; Obstructive pyelonephritis (Obstructive pyelonephritis in renal colic); Recto-sigmoidectomy; Stroke (hospitalized on 17Dec2020  left hemicorporeal deficit and dysarthria); Surgery (Right acoustic neuroma operated on in 2014 with sequelae facial palsy)
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000276-1$	$1000276-1$	$Death unexplained; asymptomatic COVID-19 (with postivie PCR test); asymptomatic COVID-19 (with postivie PCR test); This is a spontaneous report from a contactable pharmacist downloaded from the database. This is a report received from the Regulatory Authority. Regulatory authority report number was FR-AFSSAPS-DJ20210108.  An 87-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EM0477)$ intramuscular on 14Jan2021 as a single dose for COVID-19 vaccination.  Medical history included severe chronic renal failure$ arterial hypertension$ pulmonary arterial hypertension$ dyslipidemia$ heart disease$ permanent cardiac pacemaker insertion$ prostatectomy$ and chronic respiratory failure with oxygen; all from unknown dates and unknown if ongoing.  Concomitant medications included fluindione (PREVISCAN)$ furosemide (MANUFACTURER UNKNOWN)$ fluticasone propionate/salmeterol xinafoate (SERETIDE)$ bismuth subnitrate/sterculia urens (NORMACOL BISMUTH)$ oxazepam (SERESTA)$ latanoprost (MONOPROST)$ morphine sulfate (ACTISKENAN)$ bisoprolol (MANUFACTURER UNKNOWN)$ amiodarone (MANUFACTURER UNKNOWN)$ paracetamol (DOLIPRANE)$ nitrous oxide/oxygen (MANUFACTURER UNKNOWN)$ oxygen (MANUFACTURER UNKNOWN)$ and macrogol (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing.   On 20Jan2021$ the patient experienced unexplained death. The clinical course was as follows: the patient had been hospitalized since 02Dec2020 due to difficult home care (patient confined to bed) with bedsores in the heels and especially a very important sacral bedsore. It was reported that the patient had made numerous stays in this service for some time$ in particular a stay from 28Aug2020 to 22Oct2020.  In the afternoon of 14Jan2021$ the patient was vaccinated and no signs of reactogenicity were observed after vaccination. On 18Jan2021$ the COVID-19 PCR test came back positive (test carried out because other patients were positive) but the patient was not symptomatic.  On 19Jan2021$ he presented with a cough. On 20Jan2021 around midnight$ when the nurse took her turn$ the patient was sleeping$ there was nothing in particular to report. When she returned to see the patient at 5:30 a.m. taking her turn$ the nurse noticed that the patient was dead. The cause of death was unexplained and it was not reported if an autopsy was performed. The clinical outcome of asymptomatic COVID-19 was unknown at the time of death.  Chronologically$ the patient died 6 days after the COVID-19 vaccination. According to the information provided$ no therapeutic modification had been made in the days preceding the occurrence of the patient's death. On the semi logical level$ the COVID-19 test was positive on 18Jan2021. The other etiologies discussed with the doctor were a massive pulmonary embolism (but INR at 2.61 on 04Jan2021 and 2.42 on 09Jan2021) or septic shock on a sacral pressure ulcer with bone involvement. It should be noted that the patient did not present any particular sign of reactogenicity such as fever following the vaccination.    No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: unexplained death$	$Hospitalization$	$Medical History/Concurrent Conditions: Bed sore; Bedridden; Chronic respiratory failure (with oxygen); Dyslipidaemia; Heart disease$ unspecified; Hospitalization (most recent of numerous stays); Hypertension arterial; Oxygen therapy; Permanent cardiac pacemaker insertion; Prostatectomy; Pulmonary arterial hypertension; Renal failure chronic (severe)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000280-1$	$1000280-1$	$$Agitation; Tachycardia; Sudden death; Fall; This is a spontaneous report from contactable physician downloaded from the  Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-PC20210066.  An 82-year-old male patient received bnt162b2 (COMIRNATY$ lot/batch EJ6795) intramuscular at single dose on 15Jan2021 for covid-19 immunisation$ prednisolone (SOLUPRED) oral from 15Jan2021 to 15Jan2021 at 40 mg for bronchitis$ amoxicillin$ clavulanic acid (AUGMENTIN) oral from 14Jan2021 to 16Jan2021 at 2 g for bronchitis.  Medical history included effort angina (stress angina for more than 20 years)$ angioplasty on the IVA + stent in 1997$ diabetes mellitus insulin-dependent$ orthostatic hypotension (low compression refusal)$ dyslipidemia$ stent placement$ fall$ cognitive disorder$ dissociative identity disorder (DID)$ gastritis$ diverticular sigmoiditis in May2018 with enterococcal bacteremia complicated by necrotic esophagitis and shock treated in intensive care$ amputation 1st and 2nd phalanx 5th finger right hand$ bilateral hip prosthesis$ vertebral compression$ swallowing disorders. Between 27Jan20 to 28Apr2020: admitted to SSR for treatment of repeated falls (also on 11Dec2021). No brain bleeding on the CT scan. On 20Apr2020 Cardiac ultrasound: Moderately tight aortic stenosis (SA = 1.4 cm¦) and calcified. LV of normal size with slightly hypertrophied walls in a concentric way. Global systolic function of LV normal (EF = 61%). Normal LV filling pressures. Discreetly dilated OG. Normal straight cavities. Systolic PAP = 34 mmHg. Normal pericardium. On 30Apr2020 ECG: RSR at 60 / min$ full BBG already known. On 05May2020: a documented COVID infection$ non-serious form of COVID. Last COVID PCR test 14Dec2020: negative. The last blood test was carried out on 13Jan2021: Kalaemia at 4 mmol/l$ Natremia at 145 mmol/l$ Creatinemia at 67 micromol/l$ CRP at 18$ Leukocytes at 10$300 and HB at 13.4 g/dl$ platelet at 220 000$ Albuminemia at 36 g/l.  The patient's concomitant medications included as usual treatments: acetylsalicylic acid (manufacturer unknown) 75 mg 1 sachet in the morning$ for 1 month$ every day$ lansoprazole (manufacturer unknown) 15 mg mg: 1 tab in the morning$ for 1 month$ every day$ atorvastatine (manufacturer unknown) 10 mg tablet: 1 tab in the morning$ for 1 month$ every day$ paracetamol (manufacturer unknown) 500 mg: 1 morning sachet$ 1 midday sachet$ 1 evening sachet$ for 1 month$ every day if moderate to light pain$ insulin aspart (NOVORAPID) 100 IU/ml: Subcutaneous$ 8:00$ 12:00$ 18:00$ according to protocol$ for 1 month$ every day$ zopiclone (IMOVANE) 3.75 mg: 1 tab in the evening$ macrogol (MOVICOL) 13.8 g: 2 sachets in the morning$  insulin glargine (LANTUS) 100 IU/ml slow-acting solution for injection: Subcutaneous$ 20 IU in the morning$ for 1 month$ every day$ risperidone (RISPERDAL) 0.5 mg/d (date of introduction not specified).  The patient experienced fall on 15Jan2021$ agitation on 16Jan2021$ tachycardia on 16Jan2021$ sudden death on 16Jan2021. On an unknown date the patient did not eat a lot because they are dissatisfied with the mixed meals set up due to swallowing disorders.  Course of events: Due to repeated falls$ the patient cannot return home. He was hospitalized in Long Term Care while waiting for a place in Home for Senior and Dependent Persons. On 14Jan2021$ due to bronchitis with a fever (maximum 38¦C)$ the patient initiated treatment with AUGMENTIN 1g x2/day and BRICANYL aerosol. On 15Jan2021: 10:30 am administration of the COMIRNATY vaccine. Before vaccination the patient did not appear to be feverish$ pulse at 103 / min. At meals$ as at breakfast$ the patient did not eat a lot because they are dissatisfied with the mixed meals set up due to swallowing disorders. At 1:00 p.m. after the meal$ the patient falls from her chair. He rocked back. A priori no notion of head trauma. The Sa O2 was then 91%. At 4 p.m.$ as part of his bronchitis$ the patient received 40 mg of SOLUPRED. During the night of 15Jan2021 to 16Jan2021 the patient was agitated. He $$spoke until 2 am$$. He was also agitated on the morning of 16Jan2021 during his toilet and then in the afternoon. He pulled out his IV. At 8:00 a.m. pulse at 103$ BP 118/70 then at 6:00 p.m. pulse at 106/min and BP at 100/55. A BRICANYL aerosol was applied at 7 p.m.$ lasting 15 minutes. When removing the aerosol$ the patient was fine but has just eaten little with his evening meal (a small compote). Patient remained afebrile all day. DEXTRO at 23 mmol/l . At 8:25 p.m.: during his shift$ the nurse notices the patient's death in his bed. The action taken in response to the events for bnt162b2 was not applicable$ for amoxicillin$ clavulanic acid was unknown. It was not reported if an autopsy was performed. The outcome of patient did not eat a lot was unknown$ of all other events was fatal.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death; tachycardia; agitation; fall$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Angioplasty (angioplasty on the IVA + stent); Cognitive disorder (Last MMS 23/30 in Oct2019); COVID-19 (a documented COVID infection$ non-serious form of COVID); Diabetes mellitus insulin-dependent; Dissociative identity disorder (Dissociative identity disorder (DID)); Dyslipidemia; Effort angina (stress angina for more than 20 years); Enterococcal bacteremia (diverticular sigmoiditis with enterococcal bacteremia$ necrotic esophagitis and shock treated in ICU); Fall (Repeated falls 27Jan20 to 28Apr2020$ on 11Dec2021: SSR admission for treatment. CT:no brain bleeding); Finger amputation (Amputation 1st and 2nd phalanx 5th finger right hand); Gastritis; Hip prosthesis insertion (Bilateral hip prosthesis); Hypotension orthostatic (low compression refusal); Infective sigmoiditis (Diverticular sigmoiditis with enterococcal bacteremia$ necrotic esophagitis and shock treated in ICU); Intervertebral disc compression (Vertebral compression); Necrotizing esophagitis (diverticular sigmoiditis with enterococcal bacteremia$ necrotic esophagitis and shock treated in ICU); Shock (diverticular sigmoiditis with enterococcal bacteremia. necrotic esophagitis and shock treated in ICU); Stent placement (angioplasty on the IVA + stent); Swallowing disorder$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000285-1$	$1000285-1$	$Death unexplained; This is a spontaneous report from a contactable Pharmacist downloaded from the Agency  Regulatory Authority-WEB  FR-AFSSAPS-RN20210166 This is a report received from the Regulatory Authority. A 93-year-old male patient received first dose bnt162b2 (COMIRNATY$ lot/batch: EM0477) $ intramuscular on 15Jan2021 at single dose for covid-19 vaccination.  Medical history included complete tachyarrhythmia by atrial fibrillation and mitral insufficiency with a large leak which were treated with cimetidine$ movicol$ fumafer$ furosemide$ bisoprolol$ paracetamol if needed and zopiclone$ He was hospitalized on 18Dec2020 for global cardiac decompensation on mitral insufficiency and left ventricular ejection fraction at 40 percent with moderate left ventricular dysfunction (NT pro Brain Natriuretic Peptide: 17 965pg / ml) on arrhythmia complete by atrial fibrillation + pneumopathy and functional renal failure under furosemide (LASILIX)$ severe hyponatremia$ digestive haemorrhage due to probable ulcerative erosive gastritis$ severe neurocognitive troubles and difficult home maintenance$ repeated falls in the service. Sensation of discomfort without loss of consciousness on 08Jan2021 then on 14Jan2021. Cardiac decompensation table since 12Jan2021 with an increase in diuretics. Cardiac stabilized although fragile. Concomitant medication included cimetidine$ macrogol 3350/ potassium chloride/ sodium bicarbonate/ sodium chloride (MOVICOL)$ ferrous fumarate (FUMAFER)$ furosemide$ bisoprolol $ paracetamol$ zopiclone. The patient previously took furosemide (LASILIX) for functional renal failure. The patient experienced death unexplained on 19Jan2021$ it was reported that he suddenly dead on 19Jan2021 in the evening$ he was found dead reactive around 10 p.m(19Jan2021 22:00). An autopsy was not performed. The relaunched clinicians do not put forward any hypothesis on the cause of death. Lab data included an electrocardiogram was performed on 08Jan2021$ it was unchanged. Lonogram on 15Jan2021 in the morning$ stable: Na 136 mM$ K 4.6 mM$ Urea 15 mM$ creatinine 129 uM$ Albumin 29 g / l$ Haemoglobin 10.6 g / dl Leukocytes at 6.9 and C-reactive protein (CRP) 64 mg / L.    No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Decompensation cardiac (hospitalized on 18Dec2020 for global cardiac decompensation on mitral insufficiency and left ventricular ejection fraction); Fall; Functional renal failure; General discomfort (then on 14Jan2021); Haemorrhage of digestive tract; Hyponatremia; Left ventricular dysfunction (moderate); Left ventricular ejection fraction; Mitral insufficiency; Neurocognitive deficit; Pneumopathy; Tachyarrhythmia absoluta; Ulcerative gastritis$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000286-1$	$1000286-1$	$emesis/vomiting of food; Gastric volvulus; abdominal pain; This is a spontaneous report from a contactable physician from the regulatory authority FR-AFSSAPS-RN20210173  .  A 90-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY$ lot number: EM0477) via intramuscular in the left arm on 13Jan2021 at single dose for COVID-19 vaccination. Medical history included hypertension arterial$ cardiomyopathy and renal failure chronic$ no known allergy$ no history of infection with Covid-19. Long-term treatment not specified. Concomitant medications were unknown. From 16Jan2021$ the patient presented with abdominal pain with emesis/vomiting of food$ prompting hospital transfer. A gastric volvulus was highlighted$ operated urgently. The patient died despite the surgery on 21Jan2021. It was unknown if autopsy performed. Clinicians did not hypothesize the causes of death. Outcome of all events was fatal.   No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: emesis/vomiting of food; Gastric volvulus; abdominal pain$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cardiomyopathy; Hypertension arterial; Renal failure chronic$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000287-1$	$1000287-1$	$Death unexplained; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was FR-AFSSAPS-RN20210174.  A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477)$ intramuscular in the left arm on 13Jan2021 as a single dose for COVID-19 vaccination.  Medical history included ongoing nursing home resident and cutaneous ulcer in Jan2021 (biology performed on 15Jan2021 was normal). The patient's medical history and concomitant medications were not reported.  On 18Jan2021$ the patient presented with a fever without a starting point of clinical infection$ apart from a cutaneous ulcer treated at the beginning of Jan2021 without sign of recurrence. On 19Jan2021$ the patient died$ and the cause was unexplained. The clinicians did not hypothesize the causes of death. It was not reported if an autopsy was performed. The clinical outcome of the fever was not recovered at the time of death.   No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained$	$Living in nursing home$	$Medical History/Concurrent Conditions: Ulcer skin (Biology normal on 15Jan20201)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000288-1$	$1000288-1$	$positive COVID-19 virus test; COVID-19; Back pain; This is a spontaneous report received from a contactable healthcare professional by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 24648457.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)$ via an unspecified route of administration$ on 17Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 on 13Jan2021$ which was reported as fatal. The patient also experienced positive COVID-19 virus test on 13Jan2021 and back pain on 08Jan2021. The clinical course was reported as follows: The patient was admitted with back pain and multiple co-morbidities and COVID-19 virus test was negative on admission on 08Jan2021. On 13Jan2021$ the COVID-19 virus test was positive (reported as 3 weeks and 6 days after his first vaccination on 17Dec2020). The clinical outcome of positive COVID-19 virus test and COVID-19 was fatal and of back pain was unknown. The patient died on 20Jan2021. The cause of death was reported as positive COVID-19 virus test and COVID-19. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000376-1$	$1000376-1$	$SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261748200590$ Safety Report Unique Identifier GB-MHRA-ADR 24651574.  A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE$ Solution for injection$ lot/batch number and expiry date were not provided)$ via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization.  Medical history included dementia from an unknown date and unknown if ongoing$ chronic kidney disease from an unknown date and unknown if ongoing. Text for relevant medical history and concurrent conditions: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient's concomitant medications were not reported. The patient experienced SARS-COV-2 infection (death) on 28Dec2020. Reported that patient developed COVID on 28Dec2020$ died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: COVID/SARS-CoV-2 infection (Positive) on 28Dec2020$ COVID-19 virus test: NO - Negative covid-19 test on an unknown date. The patient died on 03Jan2021.  It was not reported if an autopsy was performed. The outcome of the events was fatal.  No follow-up attempts are possible$ information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Chronic kidney disease; Dementia; Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000377-1$	$1000377-1$	$Intestinal perforation; This is a spontaneous report from a contactable physician. This is a report received from the  products Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202101272220168460 and Safety Report Unique Identifier of GB-MHRA-ADR 24657435.  An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)$ via an unspecified route of administration on 14Jan2021 as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  Patient has not had symptoms associated with COVID-19$ and was not enrolled in a clinical trial. The patient experienced intestinal perforation on 15Jan2021$ which was serious as it was life threatening$ and lead to death.  Details were as follows: patient was taken to emergency (A&E) by ambulance in afternoon of 15Jan2021$ after being found at home poorly responsive$ confused and hypotensive.  The patient had been seen in the evening previously$  by her son. Covid vaccine was reported as likely not relevant. In A&E$ noted hypothermic$ hypotensive$ elevated D dimer$ elevated -reactive protein (CRP) 199$ AKI$ WCC 5.8$ diffusely tender abdomen. CXR L basal consolidation.  Air under diaphragm bilaterally seen clinically not reported. CT TAP free fluid and free intraperitoneal air indicating perforated viscus.  Likely sigmoid colon perforation and signs of diverticulitis. Patient had not tested positive for COVID-19 since the vaccination. COVID-19 virus test$ was negative on 15Jan2021. The patient died on 16Jan2021.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: The 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)$ on 14Jan2021$ and didnot have symptoms associated with COVID-19. On 15Jan2021$ she experienced intestinal perforation$ with clinical and lab findings supporting sigmoid colon perforation and signs of diverticulitis.  The fatal event was more likely an intercurrent disease$ and unlikely causally related to BNT162B2.; Reported Cause(s) of Death: Death$	$No current illness for this event.$	$Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000380-1$	$1000380-1$	$27.1; Death of unknown cause; This is a spontaneous report from a contactable physician. This is a report received from the HA. Regulatory authority report number GB-MHRA-WEBCOVID-202101280855444210$ Safety Report Unique Identifier GB-MHRA-ADR 24657685.  A 79-year-old female patient received bnt162b2 (BNT162B2)$ via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Hypertension$ OA$ Prediabetes$ Pacemaker for heart block. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included atorvastatin for hypertension from 09Jan2015$ ibuprofen for Arthritis from 07Jul2016$ omeprazole from 17Dec2019$ Ramipril for hypertension from 17Oct2014. The patient experienced death of unknown cause on 27Jan2021$ 27.1 (pruritus) on an unspecified date. The patient died on 27Jan2021. An autopsy was not performed. Referred to coroner and for post mortem examination. It would be likely that this death is cardiovascular )MI/CVA etc) but given the recent vaccination we thought it prudent to report it. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event death was fatal$ of the event pruritus was unknown.  No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Death of unknown cause$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Heart block; Hypertension; Osteoarthritis; Prediabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000389-1$	$1000389-1$	$Stroke; bleed to brain; This is a spontaneous report from a contactable consumer. This is a report received from the HA. Regulatory authority report number GB-MHRA-WEBCOVID-202101282143521990$ Safety Report Unique Identifier GB-MHRA-ADR 24663909. An 85-year-old female patient received BNT162B2$ via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included 5 years previous had urinary tract infection which led to discitis$ followed by severe osteoporosis and blood clot. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included amlodipine. The patient experienced stroke$ and bleed to brain on 16Jan2021. Patient had vaccine on the 12Jan2021 and was prior to this very fit and well. Then patient died suddenly and unexpectedly with no prior illness in the proceeding days. Post mortum stated bleed to brain. Patient had not tested positive for COVID-19 since having the vaccine. Post mortum: No signs of anaphylaxis. Outcome of the events was fatal. The patient died on 16Jan2021.  It was not reported if an autopsy was performed.  No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: stroke; bleed to brain$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Haemorrhage; Intervertebral discitis; Osteoporosis; Urinary tract infection; Comments: 5  years previous had urinary tract infection which led to discitis$ followed by severe osteoporosis and blood clot.  Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000477-1$	$1000477-1$	$STROKE/decreased consciousness and right-side paresis; This is a spontaneous report from a contactable physician downloaded from the Agency (EMA) Agency-WEB SE-MPA-2021-000972$ other case identifier: SE-MPA-1611224017780$ received from Regulatory Authority. A 72-year-old female patient received bnt162b2 (COMIRNATY$ Batch/lot number: EL1484)$ via an unspecified route of administration on Jan2021 at unknown age at single dose for covid-19 immunisation. Medical history included progression of Alzheimer's disease and hypertension. The female was living in a special care home and got infected with Covid during Christmas weekend 2020 and a few days later on 30Dec2020 she tested positive for Covid. The female had sparse infection symptoms$ no fever$ but felt more tired than usual after the covid infection. The patient's concomitant medications were not reported. The female experienced a stroke on Jan2021. The reporter stated that according to guidelines the female was vaccinated with Comirnaty in mid-Jan2021 and fell ill 5 days later$ decreased consciousness and right-side paresis. The reporter stated it was similar to a clinical picture in the event of a stroke$ unknown if it was an ischemic stroke or caused by a bleeding. The female calmly died shortly thereafter. The patient underwent lab tests and procedures which included COVID19 test: positive on 30Dec2020. The patient died on Jan2021. Outcome of the event stroke was fatal. An autopsy was not performed. The reporter stated that the probability of death caused by Comirnaty is low.   No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: stroke$	$No current illness for this event.$	$Medical History/Concurrent Conditions: COVID-19 (during Christmas weekend 2020 and tested positive for Covid); Hypertension; Infection; Progression of Alzheimer's disease; Tiredness (more tired than usual after the covid infection)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1000478-1$	$1000478-1$	$Pneumonia; cough; fever; CRP 42; had leukocytes in the urine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-1611238512515 Safety Report Unique Identifier SE-MPA-2021-001019 and received via Regulatory Authority. An 85-years-old male patient received the first dose of BNT162B2 (COMIRNATY) (lot: EJ6795) intramuscular on Jan2021 at single dose for COVID-19 immunisation. Medical history included polyneuropathy from an unknown date and unknown if ongoing$ cerebellar stroke from 2006 and unknown if ongoing$ reduced general condition from an unknown date and unknown if ongoing$ bladder catheterisation from an unknown date and unknown if ongoing$ vascular dementia from an unknown date and unknown if ongoing$ polymyalgia rheumatica from an unknown date and unknown if ongoing. Concomitant medication included memantine from 2017 to 21Jan2021$ mirtazapine from 2017 to 21Jan2021$ furosemide (LASIX RETARD) from 2006 to 21Jan2021$ acetylsalicylic acid (TROMBYL) from 2006 to 21Jan2021$ irbesartan (APROVEL) from 2006 to 21Jan2021. The patient experienced pneumonia on Jan2021. The patient lived in a service home and was vaccinated with Comirnaty in early Jan2021$ 12 days after the vaccination with Comirnaty he got a cough and one day later he got fever$ CRP 42 and got treated with ciprofloxacin. He had a negative COVID test. Next day he was out of fever and he ate breakfast$ but dies later that day (Jan2021). No reaction close to vaccine 2$ before death the patient had periods of a reduced general condition and at the time of death the patient had leukocytes in the urine$ but he also carried a catheter. The reporter states that the pneumonia is the cause of death and that the probability of death caused by Comirnaty is low. The reaction started 13 days after the vaccination with Comirnaty. It is unknown if the man has had any previous drug reactions. Event outcome for pneumonia was fatal$ for fever was recovered on Jan2021$ while for others was unknown. The patient died on Jan2021. An autopsy will not be performed.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonia$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Bladder catheterisation; Cerebellar stroke; Polymyalgia rheumatica; Polyneuropathy; Reduced general condition; Vascular dementia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1010236-1$	$1010236-1$	$death; somnolence; Pain; rale; hypertensive emergency; fatigue aggravated; This is a spontaneous report received from a contactable physician by Pfizer from the database. The regulatory authority report number is AT-BASGAGES-2021-00487.  An 83-year-old female patient received bnt162b2 (COMIRNATY)$ via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation.  Medical history included ongoing ulcus cruris$ ongoing marasmus$ ongoing dementia vascular$ Ischemia cerebral from an unknown date and unknown if ongoing$ ongoing aortic aneurysm.  The patient's concomitant medications were not reported.  On 13Jan2021 the patient experienced fatigue aggravated. On 14Jan2021 the patient experienced hypertensive emergency. On 18Jan2021 the patient experienced somnolence$ hypertensive emergency$ pain$ rale. On 19Jan2021 the patient experienced death. It was not reported if an autopsy was performed. Medication from 14Jan2021: Ringer's solution 500 ml sc because of decreased fluid absorption on 14Jan; nitrospray on 14. and 18Jan because of RR>200; 0.5 Vendal ampoules on 18. and 19Jan because of pain; 0.5 Buscopan ampoules on 18. and 19Jan because of mucus rattling. The outcome of events Pain$ Hypertensive emergency and rale was unknown$ while the outcome of the other events was fatal.  Sender Comment: Confounding factors: elderly age$ underlying weakness. Temporal relationship: 7 days between vaccination and death. The causal relationship between the product/substance COMIRNATY / TOZINAMERAN and fatigue aggravated and somnolence is assessed as unclassifiable. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. The topic will be monitored closely. Follow-up information has been requested.  No follow-up attempts possible. No further information expected.$	$Aortic aneurysm; Dementia vascular; Marasmus; Ulcus cruris$	$Medical History/Concurrent Conditions: Ischemia cerebral$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1010239-1$	$1010239-1$	$Hypoxemia; Bilateral bronchopneumonia; General physical health deterioration; Acute respiratory failure; Oxygen saturation decreased; Acute renal insufficiency; This is a spontaneous report from a contactable physician from the database$ Regulatory authority report number is BE-FAMHP-DHH-N2021-75743. A 95-year-old female patient received the first dose of bnt162b2 (COMIRNATY$ lot number: EM0477)$ via an unspecified route of administration on 15Jan2021at single dose for Covid-19 vaccination. Medical history included Stage IV chronic renal failure with probable nephroangiosclerosis$ Multiple hepatic cysts and hepatic angioma. Gastro-duodenal ulcers in 2017. Hiatus hernia with beginner Schatzky ring. Mild aortic stenosis$ moderate mitral insufficiency$ moderate tricuspid insufficiency$ Severe pulmonary arterial hypertension (57 mmHg + PVC) with hypoxemia in 2017. depression$ Involvement of the right rotator cuff without surgical sanction. Recurrent right basal bronchopneumonia favored by broncho-inhalations in 2017. Severe undernutrition in 2017. Pulmonary emphysema$ nocturnal hypoxemia with probable sleep apnea syndrome in 2017. Concomitant medications included amlodipine besilate (AMLOR)$ sertraline$ ferrous gluconate (LOSFERRON)$ acetylsalicylic acid (ASAFLOW)$ bisoprolol fumarate (ISOTEN)$ moxonidine$ lacosamide (VIMPAT)$ perindopril arginine (COVERSYL)$ omeprazole.  The patient experienced oxygen saturation decreased on 19Jan2021$ acute renal insufficiency on 19Jan2021$ hypoxemia on 21Jan2021$ bilateral bronchopneumonia on 19Jan2021$ general physical health deterioration on 19Jan2021$ acute respiratory failure on 19Jan2021. Seriousness Criteria for all events was reported as death. The outcome of the events oxygen saturation decreased$ acute renal insufficiency$ hypoxemia$ bilateral bronchopneumonia$ general physical health deterioration$ acute respiratory failure was fatal. The patient died on 21Jan2021. It was unknown if an autopsy was performed. Casual relationship between bnt162b2 (COMIRNATY) and all events per FAMHP$ WHO: unclassifiable.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: oxygen saturation decreased; acute renal insufficiency; Hypoxemia; Bilateral bronchopneumonia; General physical health deterioration; Acute respiratory failure$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Aortic stenosis (Mild); Bronchopneumonia (Recurrent$ favored by broncho-inhalations); Chronic renal failure (with probable  nephroangiosclerosis$ Stage IV); Depression; Emphysema pulmonary; Gastroduodenal ulcer; Hemangioma of liver; Hepatic cyst (Multiple); Hiatus hernia (with beginner Schatzky ring); Hypoxaemia (nocturnal$ with probable sleep apnea syndrome); Hypoxemia; Malnutrition (Severe); Mitral insufficiency (moderate); Nephroangiosclerosis (probable); Pulmonary arterial hypertension (57 mmHg + PVC  with hypoxemia$ Severe); Rotator cuff syndrome (right$ without surgical sanction); Schatzki's ring (beginner); Sleep apnea syndrome; Tricuspid insufficiency (moderate)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1031846-1$	$1031846-1$	$$Patient and her husband are elderly$ but healthy and live independently. Patient took blood pressure medicine 'off and on' according to family. She was 5'2$$$ 120 pounds and slim and healthy and active$ so was her husband$ though he had pulmonary fibrosis so they had been staying home and not attending church etc$ and masking when they did go out to protect against covid disease. They were both vaccinated with covid Pfizer vaccine (dose #1) on Thursday Feb 11. (02/11/2021) Thursday night as they went to bed they checked in with each other on how they each felt. Patient said she felt totally fine$ and her husband said his arm was a bit sore. Patient woke before her husband on Friday Feb 12$ went downstairs and$ from what the family can tell$ fixed herself a snack$ then sat on the sofa. Patient's husband found her deceased on the sofa. He called 911 and they asked him to do CPR until the paramedics arrived. Because of proximity to covid vaccine$ the ME wanted to examine the body in the home and also ordered an autopsy. Autopsy was completed on the same day as death$ Feb 12$ 2021$$	$UNK$	$HTN$ other unk$UNK$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1035552-1$	$1035552-1$	$approxmately 1:30 Pm the resident passed away; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer reported that a female patient of an unspecified age (reported as 85 without unit) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ Lot number: EL0140)$ intramuscular at left arm on 29Dec2020 11:29 at single dose for COVID-19 immunization. Medical history included dementia$ aphasia$ type 2 diabetes mellitus (DM)$ iron deficiency$ asthenia$ osteoporosis$ polyneuropathy$ anxiety$ Major depressive disorder (MDD). Concomitant medication included gabapentin$ memantine. The patient had allergies to codiene$ phenobarbital$ penicillin. The vaccine was administrated with no immediate adverse reaction at 11:29. Vaccine screening questions were completed and resident was not feeling sick and temperature was 98F. At approximately 13:30 on 29Dec2020$ the resident passed away.  It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: approxmately 1:30 Pm the resident passed away$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Anxiety; Aphasia; Asthenia; Dementia; Iron deficiency; Major depressive disorder; Osteoporosis; Penicillin allergy; Polyneuropathy; Type II diabetes mellitus$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1047571-1$	$1047571-1$	$Death after stroke .$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1056196-1$	$1056196-1$	$$He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; This is a spontaneous report from contactable pharmacist via Pfizer Sales Representative. A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number not reported)$ via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Patient had a long history of congenital heart issues. He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia. The patient's concomitant medications were not reported. Patient collapsed due to a cardiac arrest on Friday 15Jan2021 and passed away on 19Jan2021. The doctors feel that his cardiac arrest was caused by an arrhythmia. Reporter reported this through the v safe app. And received a message stating reporter would be contacted by the cdc. After patient passed away reporter replied stop to v safe. But still had not been contacted by anyone. This may or may not be related. Reporter have no way of knowing. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported $$collapsed due to a cardiac arrest$$$ $$cardiac arrest was caused by an arrhythmia$$ and the administration of COVID-19 vaccine$ BNT162B2$ based on the reasonable temporal association.  The patient's pre-existing long history of congenital heart issues might have provided alternative explanations.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to RA$ IEC$ as appropriate.; Reported Cause(s) of Death: He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan; his cardiac arrest was caused by an arrhythmia; He collapsed due to a cardiac arrest on Friday 15Jan and passed away on 19Jan$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Congenital cardiovascular disorder (He had been stable and closely monitored for the past 20 years. He had no history of arrhythmia.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1065158-1$	$1065158-1$	$death; severe headache; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program.  A male patient of an unspecified age (Age: 83$ unit: Unknown; as reported) received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:EH9899)$ intramuscularly in the left arm on 20Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient previously took azithromycin [MANUFACTURER UNKNOWN] and experienced allergy on an unspecified date.  On 22Jan2021$ the patient experienced severe headache (non-serious). On 28Jan2021$ the patient experienced death (death$ medically significant); 8 days after receiving the vaccine. The patient died on 28Jan2021 due to unknown cause of death.  It was unknown if an autopsy was performed. The clinical outcome of the event$ death$ was fatal. The clinical outcome of the event$ severe headache$ was not recovered.  No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Sulfonamide allergy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1068304-1$	$1068304-1$	$died; This is a spontaneous report from a contactable consumer reporting for a patient.  An 86-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ solution for injection)$ on 10Feb2021 at single dose for COVID-19 immunization. Concomitant medications were not reported. Relevant medical history included bacterial infection$ the patient was being treated for bacterial infection and had spent 1 week in hospital within one month prior to being dosed with vaccine. On 17Feb2021 the patient died. The cause of death was unknown. It was unknown if an autopsy was performed.   Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Bacterial infection (Patient was being treated for bacterial infection and had spent 1 week in hospital within one month prior to being dosed with vaccine.)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$None$	$None$	$Mar.$ 2021$	$2021/03$	$1070770-1$	$1070770-1$	$Maternal exposure during pregnancy; Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; This is a spontaneous report from a contactable consumer (parent).  This consumer reported information for both mother and fetus. This is a fetus report.  A patient of unspecified age and gender (fetus) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot number: EL9269)$ transplacental on 04Feb2021 at 14:00 at single dose for COVID-19 immunisation.  The patient medical history was not reported.  Concomitant medication included ergocalciferol (VIT D)$ folic acid (FOLATE)$ ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/ nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide (PRENATAL VITAMINS) and sertraline hydrochloride (ZOLOFT) at 25 mg$ all transplacental.  It was reported that OB exam on 03Feb21 showed healthy baby at 7weeks 5days heartbeat detected 152 bpm; no abnormalities identified via ultrasound; labs and hormone levels all within normal ranges. No issues detected. Mother received 1st dose of vaccine on 04Feb2021. Per ultrasound on 20Feb2021$ fetus stopped growing on 09Feb2021 (8 weeks 4 days); no heartbeat detected. Miscarriage occurred on 22Feb2021. The fetus died on 22Feb2021.  It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021204433 same drug and reporter$ different patient and event; Reported Cause(s) of Death: Fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected; Mother received 1st dose of vaccine 04Feb21. Per ultrasound on 20Feb21$ fetus stopped growing on 09Feb21 (8w4d); no heartbeat detected. Miscarriage occurred 22Feb21.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0929028-1$	$0929028-1$	$SEPSIS; respiratory distress; PLEURAL EFFUSION; This is a spontaneous report received from other healthcare professional via the Division of epidemiology of the Ministry of Health. The other healthcare professional reported similar events for three patients. This is the third of three reports.   A 91-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunisation. Medical history included known background of blood pressure disease$ diabetes$ malignant bladder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was received at the emergency room 3 days after receiving the corona vaccine in Jan2021$ with fever$ vomiting more than 40 times$ in respiratory distress$ was hospitalized in internal medicine department with sepsis diagnosis due to respiratory distress and pleural effusion$ intubated$ his condition was serious$ patient passed away on 04Jan2021. Cause of death was reported as sepsis$ respiratory distress and pleural effusion. It was not reported if an autopsy was performed.  Follow-up attempts are completed. No further information is expected. Information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information currently provided$ the fatal events sepsis$ respiratory distress and pleural effusion are more likely attributed to intercurrent infectious conditions associated with the advanced old patient underlying diseases .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation$ including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review$ as well as any appropriate action in response$ will be promptly notified to Regulatory Authorities$ Ethics Committees and Investigators$ as appropriate.$Linked Report(s) : IL-PFIZER INC-2020519349 same reporter$ product$ similar event$ different patient;IL-PFIZER INC-2021009751 same reporter$ product$ similar event$ different patient; Reported Cause(s) of Death: SEPSIS; respiratory distress; PLEURAL EFFUSION$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Bladder cancer; Blood pressure abnormal; Diabetes$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0934781-1$	$0934781-1$	$Sepsis; Acute bronchopneumonia; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (GB-MHRA-EYC 00236063 and GB-MHRA-ADR 24546059).   An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ intramuscularly$ on 15Dec2020 as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included pregabalin (MANUFACTURER UNKNOWN)$ amitriptyline (MANUFACTURER UNKNOWN)$ amlodipine (MANUFACTURER UNKNOWN)$ candesartan (MANUFACTURER UNKNOWN)$ and levothyroxine (MANUFACTURER UNKNOWN). The patient experienced acute bronchopneumonia on 18Dec2020 and sepsis on an unspecified date. The events caused hospitalization and were reported as fatal. The clinical course was reported as follows: The patient was brought to the hospital by ambulance with severe sepsis and bronchopneumonia. She was resuscitated but unfortunately died shortly after arriving. The family reported that the patient received the coronavirus vaccine on 15Dec2020. It was reported that it is unclear from the family history whether she was unwell before she received the vaccine. The clinical outcome of acute bronchopneumonia and sepsis was fatal. The patient died on 19Dec2020. The cause of death was reported as acute bronchopneumonia and sepsis. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information on batch number cannot be obtained.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular the following relevant information is not available: medical history$ autopsy report.; Reported Cause(s) of Death: Sepsis; Acute bronchopneumonia$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0947357-1$	$0947357-1$	$tested Covid positive/suspected COVID-19; tested Covid positive/suspected COVID-19; Shortness of breath; Fall; This is a spontaneous report from a contactable physician from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-20210106123053. An 81-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation.  Medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection$ shortness of breath on 03Jan2021. Reaction to vaccine is none. Patient was admitted with fall and on the floor for 5 hours on 03Jan2021. He was tested COVID positive on admission on 03Jan2021. So he tested positive about two weeks after first dose of Pfizer COVID-19 vaccine.  Patient was suspected COVID-19 from 03Jan2021. The patient underwent lab test included COVID-19 virus test: Yes - Positive COVID-19 test (03Jan2021). Outcome of the events was fatal. The patient died on 03Jan2021.  It was unknown if an autopsy was performed. Cause of death reported as SARS-CoV-2 infection/suspected COVID-19$ shortness of breath and fall.   No follow-up attempts possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection/suspected COVID-19; SARS-CoV-2 infection/suspected COVID-19; shortness of breath; Fall$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Jan.$ 2021$	$2021/01$	$0958809-1$	$0958809-1$	$Hypotension/ hypotensive; Hypoxia/ hypoxic; Tachypnoea/ tachypnoeic; Unresponsive to stimuli/ unresponsive; Death; Somnolence/ Drowsy; Hypoglycaemia/ hypoglycaemic; Hypothermia/ hypothermic; Hypophagia/ reduced oral intake; Fall; Confusional state/ confused; Headache; Chills; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; feel unwell; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency$ manufacturer report number GB-MHRA-ADR 24566650. A 95-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing$ moderate aortic stenosis from an unknown date and unknown if ongoing$ pulmonary hypertension from an unknown date and unknown if ongoing$ possible papillary fibroelastoma from Jun2019 and unknown if ongoing$ non-specifically lethargic from Dec2020 and unknown if ongoing. The patient had been non-specifically lethargic for 1-2 weeks in early Dec2020. The patient's concomitant medications were not reported. In the 24-48 hours following vaccine$ developed headache and chills. Daughter thought it was all post-vaccination inflammatory response and that it would settle. Continued to feel unwell$ reduced oral intake$ 2x falls and became confused on 25Dec2020. The patient was admitted on 26Dec2020$ hypothermic. Consultant review 27Dec2020 and no diagnosis documented. Leg ulcers and bilateral leg oedema noted$ supplemental oxygen commenced due to low saturations in Dec2020. Plan was for chest x-ray$ infection screen$ COVID test. Drowsy and found to be hypoglycaemic overnight 28Dec2020 to 29Dec2020$ given intravenous treatment and blood sugars improved. National Early Warning Score (NEWS) of 14 (hypotensive$ hypoxic$ tachypnoeic$ unresponsive) on 29Dec2020 and Medical Emergency Team (MET) call put out at 06:50. By the time MET team arrived the patient had died. The patient experienced headache on Dec2020 $ chills on Dec2020$ hypophagia on 25Dec2020$ fall on 25Dec2020$ confusional state on 25Dec2020 $ hypothermia on 26Dec2020$ skin ulcer on Dec2020$ oedema peripheral on Dec2020$ oxygen saturation decreased on Dec2020$ somnolence on 28Dec2020$ hypoglycaemia on 28Dec2020$ hypotension on 29Dec2020$ hypoxia on 29Dec2020$ tachypnoea on 29Dec2020$ unresponsive to stimuli on 29Dec2020$ death on 29Dec2020 $ feel unwell on 25Dec2020. All the events except feel unwell were reported as serious as hospitalization and death. The patient underwent lab tests and procedures which included computerised tomogram head: no bleed$ C-reactive protein: 37$ echocardiogram: possible papillary fibroelastoma- not investigated in Jun2019$ white blood cell count: normal. The patient died on 29Dec2020.  An autopsy was not performed. The outcome of the event feel unwell was unknown$ while other remain events was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Headache; Chills; Fall; Hypophagia/ reduced oral intake; Confusional state/ confused; Skin ulcer/ Leg ulcers; Oedema peripheral/ bilateral leg oedema; Oxygen saturation decreased/ low saturations; Somnolence/ Drowsy; Death; Hypoglycaemia/ hypoglycaem$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Aortic stenosis (moderate); Atrial fibrillation; Cardiac valve fibroelastoma; Lethargy; Pulmonary hypertension$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$0999504-1$	$0999504-1$	$cardiorespiratory arrest; COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report a contactable pharmacist downloaded from the Agency Agency-WEB (ES-AEMPS-726724).  An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot number: J6796)$ intramuscularly in the right arm$ on 28Dec2020 at a single dose for COVID-19 immunisation. Medical history included cardiovascular disorder (excluding hypertension) and nursing home resident. The patient's concomitant medications were not reported.  The patient experienced COVID-19 pneumonia on 11Jan2021 and cardiorespiratory arrest on 24Jan2021$ which caused hospitalization and was reported as fatal. The clinical course was reported as follows: The patient was in a nursing home with no previous diagnosis or suspicion of COVID-19 and was vaccinated on 28Dec2020. On 11Jan2021$ an COVID-19 antigen test was performed with a positive result. On 12Jan2021$ the patient started to have symptoms of dyspnea$ fatigue$ oxygen saturation (SaO2): 88-89% without oxygen$ heart rate (Fc): 90 beats per minute (bpm)$ temperature: 37.5 degrees$ and vesicular murmur with crackling$ for which he was referred to the hospital. After initial improvement and maintenance of stable SaO2 with oxygen$ the patient died on 24Jan2021 due to cardiorespiratory arrest due to COVID-19 pneumonia. The patient died on 24Jan2021. The cause of death was reported as COVID-19 pneumonia and cardiorespiratory arrest. It was not reported if an autopsy was performed.  No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; cardiorespiratory arrest$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Cardiovascular disorder (excluding hypertension); Living in nursing home; Comments: Enfermedad cardiovascular (excluida la HTA)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1000256-1$	$1000256-1$	$$Deterioration in general condition; Vigilance reduction; Acute kidney failure; Fall; Epilepsy; Hypercalcemic crisis; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) WEB. The regulatory authority report number is DE-DCGMA-21187620.    A female patient of an unspecified age received BNT162B2 (COMIRNATY)$ intramuscular on 09Jan2021 as first 0.3 mL$ single for immunization.  The patient's medical history noted$ CT Throrax-Abdomen noted thickened esophagus on an unspecified date.  Concomitant medication included dimeticone$ silicon dioxide$ colloidal (LEFAX [DIMETICONE;SILICON DIOXIDE$ COLLOIDAL])$ calcium glubionate (CALCIUM-SANDOZ [CALCIUM GLUBIONATE])$ colecalciferol (DEKRISTOL)$ torasemide (MANUFACTURER UNKNOWN)$ candesartan (MANUFACTURER UNKNOWN)$ prednisolone (MANUFACTURER UNKNOWN)$ tapentadol hydrochloride (PALEXIA)$ macrogol (LAXOFALK)$ pantoprazole sodium sesquihydrate (MANUFACTURER UNKNOWN)$ bisacodyl (DULCOLAX) $ metamizole (MANUFACTURER UNKNOWN).  The patient experienced vigilance reduction$ acute kidney failure$ fall$ epilepsy$ hypercalcemic crisis on 13Jan2021; the patient also experienced deterioration in general condition on 14Jan2021. The events were serious as they involved hospitalization and lead to death. The patient underwent lab tests and procedures on an unspecified date$ which included blood calcium: 2.4 mmol/l; blood creatinine: 2.8 mg/dl; Computerised tomogram (CT) Throrax-Abdomen: thickened esophagus; parathyroid hormone: 9.0 ng/ml.  Details were as follows: after vaccination$ the patient developed general physical condition abnormal and fall and acute renal failure and hypercalcaemia and vigilance decreased and epilepsy$ lasting for eight days. The patient is dead. A diagnosis was confirmed by blood creatinine result: (2.8$ unit: mg/dl)$ calcium (result: 2.4$ unit: mmol/l).  The death cause was reported as acute renal failure. After vaccination$ the patient also developed vigilance decreased and hypercalcaemia and seizure cerebral and acute renal failure$ lasting for unknown. The patient was hospitalized$ and was dead. CT-Thorax-Abdomen without contrast medium noted possible esophageal carcinoma. Notes in the patient history noted CT Throrax-Abdomen noted thickened esophagus. Disturbance in attention$ acute kidney injury$ epilepsy$ and hypercalcaemia were reported with stop date 20Jan2021 (also reported as with fatal outcome). The causality information for BNT162B2 for all the events per attending physician/ was reported as D. Unclassifiable.   Referenced $$dekristol 1000 palexia 50$$. The reporter's commented that measures: infusion therapy to lower calcium$ prednisone IV. (50mg / d)$ calcitonin 100 IU 2x subcutaneous. A sufficiently reliable$ alternative cause for the above entities could not be found. The patient died on 20Jan2021.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Acute renal failure$$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Esophageal disorder (CT Throrax-Abdomen noted thickened esophagus)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1000375-1$	$1000375-1$	$COVID-19 pneumonia/sars-cov-2 infection/dyspnoea$ cough and pyrexia; COVID-19 pneumonia; SARS-CoV-2 infection; pyrexia; cough; Dyspnoea; This is a spontaneous report received from a contactable physician by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261732199850. Safety Report Unique Identifier GB-MHRA-ADR 24651485.   A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE$ lot# EK1768)$ via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization.  Medical history included cardiac pacemaker insertion$ hypertension$ chronic lymphocytic leukaemia$ atrial fibrillation$ type 2 diabetes mellitus$ angina pectoris$ prostate cancer$ deep vein thrombosis$ cardiac failure. Concomitant medication included allopurinol$ atorvastatin$ hydralazine$ lansoprazol$ isosorbide mononitrate (MONOMIL XL)$ rivaroxaban for atrial fibrillation. On 17Jan2021$ patient was admitted with shortness of breath/ dyspnoea$ cough and pyrexia$ he was suspected covid-19 then confirmed having sars-cov-2 infection and covid-19 pneumonia. The patient underwent lab tests included COVID-19 virus test: positive on 17Jan2021. It was not sure if he was carrying the virus at the time of vaccination. He said he didn't have any temperature at the time of the vaccination. Outcome of event covid-19 pneumonia was fatal$ sars-cov-2 infection was not recovered$ and the events pyrexia$ cough$ dyspnoea was unknown. The patient died on 21Jan2021. It was not reported if an autopsy was performed. The cause of death was covid-19 pneumonia/drug ineffective.   No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Angina pectoris; Atrial fibrillation; Cardiac pacemaker insertion (cardiac pace maker in situ); Chronic lymphocytic leukaemia; DVT; Heart failure; Hypertension; Prostate cancer; Type 2 diabetes mellitus; Comments: Patient is not enrolled in clinical trial$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1000378-1$	$1000378-1$	$lethargy; abdominal pain; vomiting; hyponatraemic; very confused; mobility issues; memory problems; urea and creatinine increasing; urea and creatinine increasing; hypotensive and unresponsive; abdominal tenderness; Intestinal perforation; This is a spontaneous report received from a contactable physician by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101272230124630. Safety Report Unique Identifier GB-MHRA-ADR 24657446.  An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)$ via unspecified route of administration on 13Jan2021 at single dose for COVID-19 Immunization. The relevant medical history included brain tumour (acoustic neuroma$ 20 years ago) and breast cancer (mastectomy$ 20 years ago). Concomitant medications were not reported. The patient experienced Intestinal perforation on 21Jan2021. It was also reported as admitted on 21Jan2021$ GP admit with abdominal pain$ off food$ vomiting and lethargy$ previous brain tumour (acoustic neuroma) and breast cancer (mastectomy) 20 years ago$ also noted to be very confused$ mild lower abdominal pain$ also mobility issues and memory problems$ CRP=18; 1/7 right in brief MMT$ sodium 117 (previously hyponatraemic) very dry AKI plan is to rehydrate$ consultant review replace electrolytes$ slight RIF tenderness$ AXR reported as NAD$ 23Jan2021. 23Jan2021 (12.43) asked to see sodium increasing but urea and creatinine increasing$ became unresponsive later that day (16.35) hypotensive and unresponsive$ diffuse abdominal tenderness$ plan is for CTTAP$ hydrocortisone$ pip/taz$ also sees later in the day$ CT abdomen showed intestinal perforation$ spoke to surgical team at CIC accepted patient$ tube$ 22.10$ further deterioration 23.57 decision to keep comfortable$ family updated on a regular basis. Following day palliative care involved and dies early hours of 25Jan2021 at 00:25. Haemoglobin remains normal throughout$ CT scan reported as unclear as to source of perforation$ lactate was slightly elevated on admission but lactate elevated 3.5; NEWS = zero on admission$ acute collapse probably reflects perforation but there was a delay in identifying cause of intra-abdominal pathology. Patient died on 25Jan2021. It was not reported if an autopsy was performed. The patient had COVID-19 virus test on 21Jan2021 showed No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event intestinal perforation was fatal$ while other events were unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: intestinal perforation$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Brain tumour (acoustic neuroma$ 20 years ago); Breast cancer (mastectomy$ 20 years ago); Mastectomy$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1000401-1$	$1000401-1$	$PANCREATITIS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (IE-HPRA-2021-063633).  A 91-year-old female patient received the first dose of BNT162B2 (COMIRNATY)$ via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. Medical history included cerebrovascular accident (CVA)$ atrial fibrillation$ artificial cardiac pacemaker user$ dementia$ pancreatitis in 2014 and COVID-19 from Apr2020. Concomitant medication included olmesartan medoxomil (OMESAR)$ lamotrigine (LAMICTAL)$ Vitamin D$ folic acid$ apixaban (ELIQUIS)$ frusemide (FRUSEMIDE)$ pravastatin$ pantoprazole sodium and venlafaxine. The patient experienced pancreatitis on 20Jan2021. The patient had experienced a previous episode of pancreatitis six years prior$ in 2014$ the cause of which was unknown. The reporter outlined it was unclear if the pancreatitis was related to COMIRNATY. The seriousness for the event was fatal and hospitalization. The patient died in Jan2021. It was not reported if an autopsy was performed.  No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: PANCREATITIS$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Atrial fibrillation; COVID-19; CVA; Dementia; Pancreatitis; Comments: Previous CVA ; AF + Pacemenker   Dementia  Previous pancreatitis 2014 ? cause  Covid 19 04/2020$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1010237-1$	$1010237-1$	$Pre-collapse symptoms; left ventricular failure; This is a spontaneous report from a contactable physician downloaded from the database [AT-BASGAGES-2021-00632] received via Regulatory Authority.  An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY) (Lot number EJ6796$ expiration date unknown)$ intramuscular on 18Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concurrent conditions included: Acute appendicitis (from 12Aug2014$ unknown if ongoing$ acute appendicitis with localized peritonitis$ open appendectomy)$ Appendectomy (from 15Jul2014$ not ongoing$ open appendectomy)$ Commotio cerebri (not ongoing$ condition after a fall with commotio cerebri)$ Extrasystoles (continuing$ SVES and VES (triples and couplets))$ Arterial hypertension (continuing)$ Diabetes mellitus (continuing)$ Normal pressure hydrocephalus (continuing$ Normal pressure cephalus- condition after lumbar puncture 2011)$ Cerebral atrophy (continuing$ cortical atrophy)$ Haematuria microscopic (unknown if ongoing$ microhematuria)$ Hypergammaglobulinaemia (unknown if ongoing)$ Lumbago (continuing$ lumbago by the spine)$ Hypoproteinaemia$ Vitamin D deficiency (continuing)$ Steatosis hepatic (continuing$ Inhomogeneous Steatosis hepatis)$ Coxarthrosis (unknown if ongoing$ Left hip joint$ increased sclerosis in the acetabular roof with bony extensions$ narrowing of the hip joint gap$ this almost completely eliminated$ bony extensions on the femoral head)$ Atrial fibrillation (continuing$ tachicardia$ atrial fibrillation)$ Electrical cardioversion (not ongoing$ condition after electric cardioversion)$ Generalised convulsion (unknown if ongoing$ SEC generalized cerebral seizure$ DD TIA with resulting epileptic seizure)$ Atrial tachycardia (unknown if ongoing$ unstable atrial tachycardia due to exsiccosis)$ Exsiccosis (unknown if ongoing)$ Electrocardiogram QTc interval prolonged (unknown if ongoing$ severely impaired QTc prolongation$ severely impaired LVEF$ severely diastolic dysfunction)$ Ejection fraction low (unknown if ongoing$ severely impaired QTc prolongation$ severely impaired LVEF$ severely diastolic dysfunction)$ Diastolic dysfunction (unknown if ongoing$ severely impaired QTc prolongation$ severely impaired LVEF$ severely diastolic dysfunction). The patient's weight and height was not reported. There's no known allergies. Concomitant medications were not reported. On 19Jan2021 19:00$ the patient experienced pre-collapse symptoms which was reported as serious due to required hospitalization. On 23Jan2021$ the patient experienced left ventricular failure which resulting in death. The outcome of the event pre-collapse symptoms was unknown$ for the event left ventricular failure was fatal. The patient died in Jan2021. Autopsy was performed. The cause of death was left heart failure according to autopsy findings from 25Jan2021$ findings are not transmitted to BASG. No evidence of adverse drug reaction from vaccination.   Causality assessment by BASGAGES: the causality of the event left heart failure with COMIRNATY was unlikely$ for the event pre-collapse symptoms with COMIRNATY was possible.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: left ventricular failure$	$Arterial hypertension (arterial hypertension); Atrial fibrillation (tachicardia$ atrial fibrillation); Cerebral atrophy (cortical atrophy); Diabetes mellitus (diabetes mellitus); Extrasystoles (SVES and VES (triples and couplets)); Lumbago (lumbago by the spine); Normal pressure hydrocephalus (Normal pressure cephalus- condition after lumbar puncture 2011); Steatosis hepatic (Inhomogeneous Steatosis hepatis); Vitamin D deficiency (Vit D deficiency)$	$Medical History/Concurrent Conditions: Acute appendicitis (acute appendicitis with localized peritonitis$ open appendectomy); Appendectomy (open appendectomy); Atrial tachycardia (unstable atrial tachycardia due to exsiccosis); Commotio cerebri (condition after a fall with commotio cerebri); Coxarthrosis (Left hip joint$ increased sclerosis in acetabular roof with bony extensions$ narrowing hip joint gap); Diastolic dysfunction (severely impaired QTc prolongation$ severely impaired LVEF$ severely diastolic dysfunction); Ejection fraction low (severely impaired QTc prolongation$ severely impaired LVEF$ severely diastolic dysfunction); Electrical cardioversion (condition after electric cardioversion); Electrocardiogram QTc interval prolonged (severely impaired QTc prolongation$ severely impaired LVEF$ severely diastolic dysfunction); Exsiccosis; Generalised convulsion (SEC generalized cerebral seizure$ DD TIA with resulting epileptic seizure); Haematuria microscopic (microhematuria); Hypergammaglobulinaemia; Hypoproteinaemia$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Feb.$ 2021$	$2021/02$	$1010238-1$	$1010238-1$	$Respiratory disorder; Unwell; Bilateral pneumonia; Dopiness; Oxygen saturation decreased; This is a spontaneous report from a contactable consumer downloaded from the database and received via Regulatory Authority BE-FAMHP-DHH-N2021-75690 .   A 90-year-old female patient received first dose of BNT162B2 (COMIRNATY) on 13Jan2021 at single dose for COVID-19 vaccination. Medical history included atrial fibrillation and overactive bladder. Concomitant medications included bisoprolol fumarate (BISOPROLOL EG)$ dexpanthenol (PANTOMED)$ quetiapine fumarate (QUETIAPINE EG)$ apixaban (ELIQUIS)$ cyanocobalamin$ pyridoxine$ thiamine (BEFACT)$ paracetamol (PARACETAMOL EG)$ amiodarone$ and spironolactone (ALDACTONE). The patient experienced Unwell$ Respiratory disorder$ Bilateral disorder$ Oxygen saturation decreased$ Dopiness on 14Jan2021. The patient was admission to hospital on 14Jan2021 and death on 16Jan2021$ probably not related to covid vaccination the day before. Treatment received included antibiotherapy$ oxygen Evolution. Lab data included blood analysis: CRP 180; leucocytes 15$000 (left shift)$ yeasts from HC.  Reporter Comment : admission to hospital on 14Jan and death on 16Jan$ probably not related to covid vaccination the day before Treatment - Yes antibiotherapy$ oxygen Evolution of the ADR - Died Examinations - blood analysis: CRP 180;  leucocytes 15$000 (left shift); yeasts from HC.  No follow-up attempts possible. No further information expected.  Lot/batch number was not provided and unable to obtain; Sender's Comments: Based on the current available information$ the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Oxygen saturation decreased; Unwell; Bilateral pneumonia; Dopiness; Oxygen saturation decreased$	$No current illness for this event.$	$Medical History/Concurrent Conditions: Atrial fibrillation; Overactive bladder$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$PFIZER\BIONTECH$	$590$	$Unknown$	$U$	$Unknown$	$U$	$Mar.$ 2021$	$2021/03$	$1068306-1$	$1068306-1$	$heart attacks; Collapse of lung; pulse was in the 130s/140s; passed away; nose and fingers turned gray and were cold to the touch; nose and fingers turned gray and were cold to the touch; his big toe had turned gray; his right foot was swollen; low grade fever; Shaking; extremely cold; This is a spontaneous report from a contactable consumer. An elderly male patient received the 2nd dose of bnt162b2 (BNT162B2$ Manufacturer Pfizer-BioNTech)$ via an unspecified route of administration$ on 18Feb2021$ at single dose$ for COVID-19 immunisation. Medical history included ongoing blood magnesium decreased (went to the hospital on 17Feb2021). Concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2$ Manufacturer Pfizer-BioNTech)$ on 27Jan2021$ for COVID-19 immunisation and experienced arm soreness. The patient experienced passed away (death$ hospitalization$ medically significant) on 23Feb2021$ heart attacks (caused hospitalization$ medically significant) on 20Feb2021 with outcome of unknown$ collapse of lung (caused hospitalization) on 20Feb2021 with outcome of unknown$ pulse was in the 130s/140s (caused hospitalization) on 19Feb2021 with outcome of unknown$ low grade fever on 18Feb2021 with outcome of recovered on 23Feb2021$ shaking on 18Feb2021 with outcome of unknown$ extremely cold on 18Feb2021 with outcome of unknown$ nose and fingers turned gray and were cold to the touch on 19Feb2021 with outcome of unknown$ his big toe had turned gray on 19Feb2021 with outcome of unknown$ his right foot was swollen on 19Feb2021 with outcome of unknown. The events his big toe had turned gray and his right foot was swollen required physician visit on 19Feb2021. They were reported as a result of the magnesium deficiency. On 19Feb2021 evening his fever increased and his nose and fingers turned gray and were cold to the touch. On 20Feb2021 he collapsed at home and was taken to the hospital by ambulance. He had several heart attacks prior to the collapse. They decided to put him in a medically induced coma and reduce his body temperature that evening and started dialysis on 21Feb2021. They returned his body to normal temperature on 23Feb2021$ his pulse was in the 130s/140s. They were starting to reduce the sedatives on 23Feb2021. The patient passed away on 23Feb2021. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: passed away$	$Magnesium low (went to the hospital on 17Feb2021)$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$UNKNOWN MANUFACTURER$	$0$	$60-64 years$	$60-64$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1001488-1$	$1001488-1$	$Patient died several days after receiving the second dose of the vaccine. See additional information sent. An autopsy has been performed and results are pending.$	$COVID infection November 2020$	$HTN$ Afib$ atherosclerotic cardiovascular disease;$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$UNKNOWN MANUFACTURER$	$0$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0956962-1$	$0956962-1$	$COVID 19 vaccine$ unknown which company  Chronically ill in a skilled nursing facility found diaphoretic$ hypotensive$ hypoxia to 85% arrived to Emergency dept in cardiac arrest Died within 65 minutes of nursing finding patient in distress Wife felt it may have been related to vaccine date of vaccination 1/6/20 hx covid 19  PNA in April 2020$	$CVA seizure disorder all chronic HTN CAD had COVID 19 in April 2020$	$as above  PAtient had accute respiratory distress followed prolptly by cardiac arrest$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$UNKNOWN MANUFACTURER$	$0$	$65+ years$	$65+$	$None$	$None$	$Jan.$ 2021$	$2021/01$	$0973957-1$	$0973957-1$	$5 days after receiving his COVID vaccination the patient had a spontaneous (nontraumatic) subarachnoid hemorrhage which was fatal. The patient had previously been stable on his coumadin dosing with therapeutic INRs for the past several months per his wife. At time of presentation his blood pressure in the ER was elevated to 223/94 and his INR was risen to 3.1$	$none$	$atrial fibrillation$ hypertension$ GERD$ prostate cancer$penicillin$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$UNKNOWN MANUFACTURER$	$0$	$65+ years$	$65+$	$None$	$None$	$Feb.$ 2021$	$2021/02$	$1036519-1$	$1036519-1$	$Received first SARS-CoV2  vaccination yesterday at local store Experienced new symptoms of chills$ nausea as well as worsening from baseline dyspnea at night. Wife states he had rough morning breathing and had sudden loss of consciousness and unresponsiveness and failed to respond to bystander CPR. He expired at his home.$	$No current illness for this event.$	$Severe COPD$ cor pulmonale$ history of pulmonary embolism$ chronic hypoxemic respiratory failure.$NKDA$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
	$UNKNOWN MANUFACTURER$	$0$	$65+ years$	$65+$	$3 days$	$3$	$Feb.$ 2021$	$2021/02$	$1015838-1$	$1015838-1$	$Patient was admitted to hospital from home in cardiac arrest. Hx of hypertension$ hyperlipidemia$ type 2 diabetes (not on insulin) and bilateral carotid artery stenosis. The patient was reportedly at his baseline health on 2/2/21. He received the 2nd dose of COVID vaccine around 1000AM on 2/2/21. Reportedly started running fever of 100.1 and chills the afternoon of 2/2/21. Around 7:00PM he started having dry cough and was complaining of breathing difficulties. He subsequently vomited multiple times (was eating pizza and aspirated) then lost consciousness. His wife called 911$ did CPR and EMS reported he in PEA at scene and was intubated. Transported to hospital. SARS CoV-2 and influenza negative.$	$No current illness for this event.$	$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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$Dataset: The Vaccine Adverse Event Reporting System (VAERS)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Query Parameters:$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Title: type$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Date Died: 2020; 2021$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Date of Onset: 2020; 2021$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Date Report Completed: 2020; 2021$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Date Report Received: 2020; 2021$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Date Vaccinated: 2020; 2021$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Vaccine Products: COVID19 VACCINE (COVID19)$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$VAERS ID: All$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Group By: Vaccine Manufacturer; Age; Days In Hospital; Month Reported; VAERS ID$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Show Totals: False$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Show Zero Values: Disabled$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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$Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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$Query Date: Mar 16$ 2021 3:35:48 PM$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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$Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Mar 16$ 2021 3:35:48 PM$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$---$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
Messages:$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$1. The full results are too long to be displayed$ only non-zero rows are available.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$2. VAERS data in CDC WONDER are updated every Friday. Hence$ results for the same query can change from week to week.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$3. These results are for 1$351 total events.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$4. When grouped by VAERS ID$ results initially don't show Events Reported$ Percent$ or totals. Use Quick or More Options to$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$restore them$ if you wish.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$5. Click on a VAERS ID to see a report containing detailed information for the event.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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Footnotes:$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$1. Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$event (possible side effect).$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
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Caveats:$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$1. <p> VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers$ vaccine$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$manufacturers$ and the public can submit reports to VAERS. While very important in monitoring vaccine safety$ VAERS reports$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$information that is incomplete$ inaccurate$ coincidental$ or unverifiable. Most reports to VAERS are voluntary$ which means they$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$should always be interpreted with these limitations in mind. </p> <p> The strengths of VAERS are that it is national in scope$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA's multi-system approach to$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$post-licensure vaccine safety monitoring$ VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$also known as $$safety signals.$$ If a safety signal is found in VAERS$ further studies can be done in safety systems such as$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$the same limitations as VAERS$ and can better assess health risks and possible connections between adverse events and a vaccine.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$</p> <p> Key considerations and limitations of VAERS data: <ul><li> Vaccine providers are encouraged to report any clinically$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$significant health problem following vaccination to VAERS$ whether or not they believe the vaccine was the cause. </li><li>$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Reports may include incomplete$ inaccurate$ coincidental and unverified information. </li><li> The number of reports alone$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$cannot be interpreted or used to reach conclusions about the existence$ severity$ frequency$ or rates of problems associated$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$with vaccines. </li><li> VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$for which data are available. </li><li> VAERS data do not represent all known safety information for a vaccine and should be$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$interpreted in the context of other scientific information. </li></ul> </p>$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$2$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$3. Some items may have more than 1 occurrence in any single event report$ such as Symptoms$ Vaccine Products$ Manufacturers$ and$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$Event Categories. If data are grouped by any of these items$ then the number in the Events Reported column may exceed the total$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$number of unique events. If percentages are shown$ then the associated percentage of total unique event reports will exceed 100%$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$in such cases. For example$ the number of Symptoms mentioned is likely to exceed the number of events reported$ because many$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report$ then the percentage of Symptoms to$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$4. Data contains VAERS reports processed as of 3/5/2021. The VAERS data in WONDER are updated weekly$ yet the VAERS system$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$receives continuous updates including revisions and new reports for preceding time periods. More information:$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$http://wonder.cdc.gov/wonder/help/vaers.html#Reporting.$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$5. For more information on how many persons have been vaccinated in the US for COVID19 to date$ see$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
$https://covid.cdc.gov/covid-data-tracker/#vaccinations/$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$