Pfizer

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

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

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.

Systemic: Other- pt had history of copd and DNR on file. approx 3 1/2hr after vaccine pt had sob and lowo2 sat, emergency services called, pt passed on their arrival.staff felt due to pt existing condition

Pfizer-BioNTech COVID- 19 Vaccine EUA Patient experienced change in speech and jerky movements on way home from COVID-19 vaccine. Presented to ED. Patient diagnosed with Acute CVA (cerebrovascular accident). Patient discharged on 1/31/2021.

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.

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.

Bleeding; seeping from lower leg; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the right arm, on 03Feb2021 10:30, at a single dose, for COVID-19 immunization. Medical history included breast cancer and chronic obstructive pulmonary disease (COPD). The patient has no known allergies. The patient has many unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in other facility. On 03Feb2021, at 11:00 A.M., the patient experienced bleeding/seeping from lower leg. The patient did not receive treatment for the events. Outcome of the events not recovered. Information about lot/batch number has been requested.

Patient was admitted and treated for severe PE and DVT, as well as hypoxia and paroxysmal SVT. Pt was discharged to inpatient rehab when stable

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.

3/6/2021 Expired at facility receiving Hospice Services since 8/1/2020. Hx Covid-19 June 2020. Prior to death: Resident began refusing meals and failing overall. On, 2/18 began with jaundiced skin, no other symptoms. ADPOA, Hospice APRN and MD updated. Comfort measures maintained as resident continued to have slow decline.

Chief Complaint: CHF exacerbation, atrial fibrillation Source of History: Patient History The patient is a 90 y.o. female with a past medical history notable for CHF, atrial fibrillation, arthritis, reflux, hypertension. The patient presents for evaluation of Worsening issues of shortness of breath in addition to fluid overload and swelling. Patient was also having rapid heart rate. Patient was recently stopped on her Cardizem as they thought that this was causing worsening swelling. Patient was set up for an outpatient echocardiogram however had not Got that completed yet. Patient notes that since diuresis patient is feeling much better. Patient is unsure about changes of heart medications. Patient did have close follow-up with Cardiology. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/12/21 remains admitted at Hospital - in patient

Thrombocytopenia and Presence of Schistocytes Thrombocytopenia and anemia–CBC reports schistocytes although this was not quantified, worrisome for microangiopathic hemolytic anemia (MAHA), such as TTP– anemia and thrombocytopenia both improving, in this case it is a resolving etiology, such as adverse effect from vaccine - remained conservative - consider reporting as vaccine side efffect as the vaccine is the most likely cause due to temporal relationship - monitor Thrombocytopenia – etiology is unclear but there is possibility related to drugs or Covid-19 Pfizer Vaccine she received

Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Coroners Office contacted Pharmacy on 3/21/21 to report a patient who had recieved a dose of the covid vaccine on 3/18/21 and was founded deceased on 3/20/2021

Covid vaccine monitoring documentation. 90 yof patient presented to ED 3/4/21 at 1233 unresponsive via EMS due to cardiac arrest. BP documented 82/43 at 1233, pulse 49. Prior to arrival, patient had been in bathroom and had syncopal event. Patient lived with family. EMS began CPR and administered doses of Epi. Documentation also stated patient?s family member said patient received their 2nd covid vaccine 5 days prior and has not been okay since. After arrival to ED, patient was intubated, cardiac ultrasound showed no cardiac activity and no pericardial fluid. Patient received sodium bicarbonate and calcium chloride. Patient expired in the ED department at 03/04/2021 12:51. Per Death Summary Form clinical diagnosis cardiopulmonary arrest, clinical impression of cause of death or terminal events leading to death, possible myocardial infarction. Pfizer EL9265 on 1/30/21, Pfizer EL9266 on 2/20/21.

Patient tested positive for COVID on 12/30/2020. She did not experience COVID symptoms; however, at that time her dementia and weakness progressed. She passed away on 02/12/2021 at the nursing home facility.

Patient presented to hospital 4/6/21 with rectal bleeding and subacute dysnpea on exertion/fatigue over the preceding several weeks and was found to have immune thrombocytopenic purpura (ITP) w/ platelet count of 1000. Anticoagulation was reversed (on warfarin at home for history of PE). Platelet count responded to steroids and TPO-agonists per typical ITP treatment. Incidentally, the patient was found to have H. pylori stool antigen + and commenced with quadruple therapy for this. Platelet counts continue to improve slowly w/ treatment.

Stroke. ER treatment. Hospitalization. Skilled Nursing Facility. Symptoms: Weakness/fell to the floor/terrible bruises entire left side of body/slurred speech/confusion. Treatment: TPA administered. Hospitalized for 10 days, followed by continuing stay in skilled nursing facility.

02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic. She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on 3/12, poor PO intake and weight loss. 3/23 Resident passed.

Resident have had multiple PNA tx with IM Rocephin and IV Zosyn, Difficulty in swallowing, Elevated HCV RNA, 02/15 PCR Quant, ER visit following weakness and involuntary UE movements/jerking. Elevated amonia levels controlled with use of Lactulose. 02/22/2021 RUE and RLE extensive DVT. Worsening pressure wound and development of arterial wounds. Admitted to Hospice on 03/31/2021. Resident deceased on 04/03/2021.

This 90 year old white female received the Pfizer Covid shot on 3/25/21 and went to the ED on 4/27/21 and was admitted on 4/27/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

Pt received both vaccines of Pfizer. Pt was admitted to the hospital on 6/15 for SOB/dyspnea. SOB contributed to CHF exacerbation. COVID was incidental. No COVID treatments so far during admission.

The first vaccine was administered on December 30, 2020 from a local pharmacy. She was diagnosed with COVID on January 3. She was in and out of ER for 3 days, when we finally took her home and got hospice care. On January 19, 2021 Dr's office told us that she could get the 2nd vaccine the next day. She received the 2nd vaccine on January 20, 2021 from a local pharmacy. On January 21 she became disoriented and was sleeping most of the time, by Friday, January 22, she could not walk and was incoherent most of the time. The evening of January 22, we presume she had a stroke, but was not officially diagnosed. Her oxygen level dropped to 42 and her blood pressure was 287/182 with seizures that lasted about 1 minute. She died on January 29, 2021.

RLE edema started on 6-30-2021. Extensive RLE deep vein thrombosis was diagnosed through the ER. Due to the extensive DVT, this has been growing for longer than the symptoms have shown.

Fine in Am. Started complaining of stomach pain in afternoon. Had dinner around 6 pm & threw up part of it along with clear mucus and all the water she drank. After that it was all clear mucus off & on through the night. Has had this episode before but only lasting a few minutes never this long! Tried to give water but kept coming back up. Meanwhile pain in stomach (pelvic area) was getting worse. Called 911 at 2 AM (see line 19). Sometime after 911 left, the clear mucus started coming at a faster rate. Had bowel movement around 6 AM but said no relief in stomach pain. Called at 8Am. Could not come til between 12-1 PM. Seemed weak and very tired so let sleep. Around 10-10:30 AM could not wake her up. Called 911 again. This time it was cardiac arrest and they could not revive her.

Admitted 4/1/2021 and discharged to Sunrise assisted living 5/14/21. Return admission to Hospital from hospital 7/17/21 w/dx R femur fracture under Hospice Comfort Care for end of life. Expired at facility 7/18/21 at hospital.

presented to the ED 1/5/21 with syncope 1 hour after receiving COVID vaccine found to have acute hypoxic resp failure at rest. Per family patient's pulse ox low with exertion at baseline for the past couple of months, but she always recovers to above 90%. She was discharged home with home health with oxygen 1/19/21

Had swelling in leg for a couple of days prior to the early morning of 1/31 where the knee and entire lower leg was swollen and painful and made it very painful to walk. After sending photo to primary care physician had mom evaluated for a blood clot. It was determined based on blood test, vascular ultrasound that right non occlusive (mid) Femoral vein DVT.

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

Extreme difficulty breathing upon exertion, collapsed shortly after walking started, loss of conciousness, and death

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.

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.

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

Systemic: Made aware of patient passing away on 3/1 per letter from Corporate legal team. Patient passed away on 2/14. Vaccine 1st dose given 1/29/21.-Severe

Acute myocardial infarction, NSTEMI, Atrial flutter, extreme weakness inability to get out of bed, headache, dizziness , nausea/vomitting,

SYNCOPE, fall, head contusion FATIGUE DIARRHEA Pneumonia due to SARS-associated coronavirus Diverticulitis Hyponatremia Hypoxia Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC)

Death SHORTNESS OF BREATH Hyponatremia Atrial fibrillation (CMS/HCC) Generalized weakness SIADH (syndrome of inappropriate ADH production) (CMS/HCC) Pleural effusion on right Syndrome of inappropriate secretion of antidiuretic hormone Sick sinus syndrome

Pt had her 2nd pfizer covid 19 vaccination on 3/30/2021. Hospitalized 4/21 for b/l pneumonia and sepsis. blood cx neg, covid/flu neg. procalcitonin <0.4 treated with antibiotics, ivf. discharged home 4/24/2021

Unexplained hoarseness at 7:00 am 02/06/2021 and cough at 0:700 pm on 02/06/2021. Fall (first time ever), followed vomiting, and choking at 2:00 pm 02/07/2021. Ambulance called recorded vitals 97.5 Temp 102/70 BP, 98 HR at 2:51 pm at home and 146/90 BP 102 HR at 3:09 pm enroute to hospital; pt pointed to hip pain and answered questions in native language Polish (although pt spoke English). Pt delivered alert and kicking blankets off legs inside emergency room. Emergency room staff failed to communicate with pt. Pt was discovered unresponsive 20 minutes later when staff arrived to take admission vitals. Pt passed 02/07/2021 in ER. No causeof death given by ER doctor to family.

patient's son called pharmacy on 5/4/21, stating patient had a stroke and is in hospice care now. un-sure if it is vaccine related or not however in light of johnson and johnson news we wanted to report this

Patient presented to ED for abdominal pain, nausea and vomiting. during CT of the abdomen and pelvis a finding suspicious for DVT in the left external iliac vein and left common femoral vein. External venous doppler was done to confirm DVT. impression : Acute DVT throughout the left lower extremity extending from the left lower calf to the left common femoral vein. Patient has been admitted to Medical floor for care

Pt. Passed away in her sleep at night following receiving her 2nd Covid vaccination earlier in the day.

92 year female admitted to hospital for fall on 5/24/2021. Unknown exposures in 14 days prior. Pfizer vaccine 2/25/2021 & 3/19/2021. PCR positive 5/24/2021. Transferred to hospice on 29th. Passed on 5/30/2021. Diagnosis at time of death: ARF on chronic with hypoxia, hematoma anterior chest wall left hip and upper thigh, suspected mild heart failure preserved ejection fraction, mechanical fall, delirium, bilateral PNA, pulmonary HTN, acute encephalopathy.

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

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.

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.

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.

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.

DX: CVA History The patient is a 92 y.o. female with a past medical history notable for History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

The patient has developed an acute deep venous thrombosis in the right popliteal and trifurcation vessels of the calf. She has an elevated d-dimer of 14,738 and acute hypoxic respiratory failure due to pulmonary embolism.

Death felt a little sick 1 day after shot 2/28/21, felt worse next day 3/1/21 was weak, she was found dead am 3/2/21 on the floor in her bedroom 1/2 way between bathroom and bed.

DVT in right leg discovered after swollen foot on 2/25/2021 via ultrasound. Clot extends from mid thigh to mid calf. Placed on Xarelto 15 mg 2x/day until next imaging appointment on March 30, 2021. First incident of blood clot for mother.

Patient was taken by ambulance to E.R. 3 days after injection with bleeding from the nose and blood in stool. Spent 10 days in hospital. Returned to ER a few days later with fluid leaking from arms and legs. Diagnosed with congestive heart failure. Sent home under Hospice. Returned to ER, by ambulance, 36 hrs. later. Still weeping from skin and placed in ICU. on Bipap machine . Transferred that evening to medical Care Center where she passed away on March 3, 2021.

DAY AFTER, PT COMPLAINED OF PAIN IN LEFT COLLAR BONE. PATIENT DECLINED IN FUNCTION OVER NEXT 11 DAYS. HOSPICE WAS CONSULTED AND PT PASSED ON 2/23/21

After vaccine was administered patient was seemingly fine until a loss of consciousness/mini stroke on Jan 16 (5 days after vaccine) causing a fall and massive stroke on Jan 22 (11 days after vaccine) that left patient unresponsive and on life support until family decided to stop services and begin hospice care with no fluids or food until death

Found in chair lethargic less than 48 hours after her first civid vaccine by facility staff where she lives in an independent living facility. Nursing staff felt she had a stroke with right sided weakness. Slurred speech, weak, unable to walk without two person assistance. Patient was under hospice care so hospitalization was given.

TIA 3/16/2021 and moderate stroke on 3/18/2021 resulting in ischemic area left temporal and occipital lobe. Injury affecting speech, memory, and cognitive abilities. unable to live independently as prior to the event.

The patient received vaccine on 3/25 (2nd dose in series). The patient was a 911 call 3/31 with death at home (natural causes) 6 days after vaccine receipt

Asymptomatic Thrombocytopenia noted on routine labs prior to second vaccination. Still requires hematology follow-up and immunosuppression.

Hospital admission due to COVID-19 positive result. Patient tested positive on 4/7/2021. Patient was hypoxic and had a cough on admission. Patient was diagnosed with COVID pneumonia, was given Remdesivir and decradon. Patient was discharged on 4/17/2021

Presented to ED on 1/12/21 slowly worsening constant myalgias, generalized weakness where she couldn't walk, dry cough. Per daughter not acting herself and more confused. Clinical impressions included hypoxia, COVID-19. Pt is s/p her first dose of vaccine and this precludes plasma. Supportive care steroids and doxy. Family faxed DNR on 1/12/21 at 2225. Remdesivir given 1/13/21 at 1am. 1/13/21 note at 1:30am: Pt's O2 sat fluctuating btw 80%-90%. Increased NC success pt O2 sat continues to decrease. NRB 15L in place O2 Sat 90%. Pt became pulseless and expired at 0451.

Patient presented to the ED and subsequently hospitalized for CVA within 6 weeks of receiving COVID vaccination.

This 92 year old female received the Covid shot on 3/16/21 and went to the ED on 4/2/21 and was admitted on 4/2/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) E87.1 - Hypo-osmolality and hyponatremia

patient with hx of thrombocytopenia received vaccine and presented to hospital with thrombocytopenia with platelet count of 6

Death; my question is, why wouldn't the CDC want to investigate/autopsy any individual who has an adverse event??? The body was sent to mortuary without autopsy, as the family wouldn't want one done at their expense. However, it would seem feasible that the CDC would see this as an opportunity to add to the available statistics on vaccine recipients. Its unknown whether the vaccine contributed to the adverse outcome, but given that this person had the vaccine recently, it should have been investigated. It seems there should be a protocol for Drs and medical examiners to note ALL conditions in the patient not just cause of death, if vaccinated within a few months to a year. It just seems like good research opportunities to me, and I have to wonder why it isn't being done.

Patient admitted on 7/5/21 from nursing home with acute hypoxic respiratory failure. Patient diagnosed with COVID pneumonia and CHF exacerbation. Patient was treated with oxygen, steroids, and remdesivir, Patient returned to baseline and was discharged on 7/8/21.

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 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.

Stroke within 48 hours of shot on 1/22/2021. L sided weakness, facial droop, slurred speech, confusion, . to this writing (2/4/2021), symptoms persist.

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.

My mother died on February 19, 2021. She had her 2nd dose vaccine on 2/11, on 2/12 it was noted that she was not able to walk, on 2/13 she was walking at 30%, on 2/14 she was walking with difficulty, on Monday 2/15 she was throwing up violently and her blood pressure dropped, so she was sent to Clinic. My sister was told she was just constipated and she had A Fib (never reported before to us). My sister was then told on 2/16 early a.m. that she had a blood clot that destroyed her colon. Due to age surgery would likely not be successful. She then died on the Friday. We are reporting in the event that the Pfizer vaccine was somehow a contributing factor to the A fib or to the Clot. She has no history of A fib or clotting prior to this incident. She was 93, and did have dementia, but was able to eat normal foods prior to this. What was unusual was the challenge in walking the day after the shot. Other than that no difference was observed until the day she was admitted to the hospital emergency room. She was a resident at Assisted Living, Memory Care, and that is where she received the vaccine. The mailing address I provided is her mailing address prior to death.

This 93 year old white female hospice patient received the Covid shot on 1/20/2021 and went to the ED on 3/12 for COPD exacerbation, shortness of breath and extremity weakness. She returned to the ED on 3/13/21 and was admitted for generalized weakness and dehydration. The patient subsequently died on 4/13/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

died; administered in Left leg; This is a spontaneous report from a contactable consumer reported for patient (mother). A 93-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Mar2021 administered in Left leg at single dose for COVID-19 immunisation. No other vaccine in four weeks. Medical history included COPD, aortic stenosis, mild dementia, no known allergies. Concomitant medications in two weeks included donepezil, acetylsalicylic acid (ASPIRIN), ascorbic acid/ergocalciferol/nicotinamide/retinol/riboflavin/thiamine hydrochloride (VITAMINS), Blood Pressure Meds. Historical Vaccine included the first dose of BNT162B2 (lot number EL1283) in the right arm on 26Jan2021 09:15 (at the age of 93-years-old) as a single dose for COVID-19 immunization and experienced prolonged tiredness, increased weakness, dragging right foot when walks, little more trouble swallowing pills than before on 27Jan2021. The patient died three weeks later on 29Mar2021, she received treatment included ambulance. Care providers thought rapid decline after vaccine. The death cause was unknown, no autopsy was performed. No COVID prior vaccination, no COVID tested post vaccination. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died

acute hypoxic respiratory failure, severe sepsis, acute COPD exacerbation, secondary to COVID-19 pneumonia. remdesivir Solu-Medrol 40 mg IV

Likely vaginal bleeding first noticed from stain on bed pad on 4/21/2021 and blood drops on toilet seat. Seen again a week later. Also apparent bruises to hand and wrist of unknown origin.

-Resident was admitted to facility on 4/14/2021 from hospital. Resident had been vaccinated prior to admission to facility on 3/10/21 and 3/29/21 which was given at another clinic/facility. Resident had history of (+) COVID-19 test results on 1/2021 and 4/9/2021 (Test done at facility). Facility is still doing a weekly routine COVID-19 Testing/Surveillance and on 4/21/20, resident was incidentally found to be still (+) COVID-19 (PCR Test). During that positive result (test date:4/21/21) the resident was asymptomatic at that time, and, Quarantine period completed 5/6/21. Resident expired on 5/19/2021

She received her first COVID vaccine on 1-13-21 and her second on on 2-3-21. She was hospitalized for shortness of breath and multiple subsegmental pulomnary emboli without acute cor pulmonnale. Other active hospital problems were: acute hypoxemic respiratory failure due to CVOID-19, acute kidney injury, lower limb ischemia. Patient was admitted to the hospital on 6-22-21 and tested positive for COVID-19 on 6-30-21. Patient was put on comfort measures on 7-9-21 and died at the facility on 7-12-21.

admitted to hospital 1/11/2020 with Acute respiratory failure with hypoxemia; Iron deficiency; SOB (shortness of breath); Symptomatic anemia; still admitted

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.

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.

94 yo F presented from assist living with slur speech for 1 day, last seen well on 1/30. Pt has a PMH of dementia (Baseline, she will keep saying, "help me, help me", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed. According to patient's daughter, she saw her January 30, she was doing okay after the vaccine. On 1/31 when the daughter called her on the phone, she knows she has some slurred speech, when she saw patient in the facility, she noticed her gait becomes unsteady. She decided to bring her to the hospital. 1/30, she noticed the patient has spilled up some water, otherwise denies fever, chills, shortness of breath, pain, chronically, she has constipations taking laxative. In the ED, pt was afebrile, 36.1, heart rate 85, blood pressure 130/61, respiratory rate 18, saturations 98 on room air. Labs shows, sodium 134, potassium 3.6, bicarb 28, BUN 18, creatinine 0.97, glucose 119, WBC 12.5, hemoglobin 11.8, platelet 239. PT INR 1.09, COVID negative. CT head suggestive of subacute infarct. Possible including small vessel ischemic changes. Chest xray questionable patchy left retrocardiac atelectasis or pneumonia. EKG shows atrial fibrillation's heart rate 71, QTc 610. Case was discussed with neurology in the ED, patient was not a TPA or embolectomy candidate. CT head suggestive of acute/subacute cerebellar infarct. Patient does not have any residual or sensory deficit except expressive aphasia. Neuro saw patient, mentioned patient appears to have had a stroke that by the CAT scan criteria is already subacute. The patient was admitted on the stroke pathway. The patient has new onset atrial fibrillation and therefore should be considered for anticoagulation. The patient cannot have an MRI of the brain due to her spinal cord stimulator but given that the stroke is already subacute on the CT without any signs of hemorrhagic conversion she could be started on this at this point. If she gets started on anticoagulation the aspirin should be stopped. If the patient cannot go on anticoagulation or does not want to then she might be a candidate for dual antiplatelet therapy for secondary stroke prevention. 2D echo shows normal ejection fraction of the left ventricle estimated at 70 to 75%. Regional wall motion abnormality was not observed. Right ventricle systolic function is normal. Moderate aortic stenosis. Cardio was consulted for anticoagulation, From cardioembolic prevention standpoint, anticoagulation is recommended to prevent CVA. However, she has significant risks for bleeding given recent vaginal bleeding (investigation not pursued to spare her comfort), age, comorbidities, etc. Again, further discussion between family and primary team is required regarding risks vs benefits. Was evaluated by speech-language pathology present minimal oral dysphagia no overt clinical signs of aspiration, recommended to continue with NDD 2 diet/thin liquid. Patient was discharged to ECF.

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

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".

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

Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events.

passed away; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 94-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient passed away on an unspecified date. It was unknown if an autopsy was performed. The reporter said that patient died because she is 94 years old and not with the vaccine. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, this female patient death is attributed to her advanced age (94 years old) and assessed unrelated to BNT162B2 vaccine.; Reported Cause(s) of Death: passed away

pt received her 2nd pfizer covid 19 vaccination on 4/1/21. she presented to the er on 4/16 with family with c/o 3 days of poor oral intake, diarrhea, weakness and confusion. family reported deterioration over the last 2 weeks. she was initially hemodynamically stable in the ER initially then became bradycardic and hypotensive. oxymask was placed. blood work revealed neutrophilia, anemia, mildly elevated ast and a markedly elevated troponin. she was admitted with non ST elevation MI, acute encephalopathy which ultimately progressed to coma, acute renal failure, progressive thrombocytopenia. cardiology saw her. she was started on a heparin drip. infectious cause for her symptoms was not found. her ef was 40% on echo. she expired on 4/20/2021.

Patient admitted on 03/25/2021 through the emergency department for complaint of shortness of breath she was a resident of a Nursing Facility. Her oxygen saturations were into 80%. Patient was poor historian her daughter at the bedside provided most history. Patient with recent admissions for coronavirus on 03/03/2021 and then again on 03/05/2021 for post coronavirus pneumonia. Throughout hospitalization patient with poor appetite, on 03/28/2021 noted to be somnolent, additional blood cultures and labs checked. Patient continue to decline, refused medications. Minimal responsiveness on 04/01/2021. Had episode of PAF on 4/1/21, renal dosed Eliquis per Cardiology. Service discussed with family multiple times about code status, he continued to be on decided home willing to change code status. Patient remained on high-flow oxygen and not eating. Patient very anxious increase work of breathing. Patient died on 04/03/2021.

This 94 year old female received the Covid shot on 4/13/21 and went to the ED on 4/16/21 and was admitted on 4/16/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC)

Pt had acute ischemic stroke involving right vertebral artery 16 days after dose number one of Pfizer vaccine. She developed sudden dizziness and loss of leg strength, fell to floor. it took 7 hours until she was found and taken to hospital, so did not receive TPA. CTA on 2/27/2021 showed occluded V4 segment of rt vertebral artery. residual deficits currently include imbalance, loss of lower extremity strength (now in wheelchair), loss of hearing and discordant occular movement.

Resident continued to progressively decline and was receiving Hospice services. Family and MD declined 2nd Covid vaccine on 5/3. Resident passed away peacefully on 5/11/2021.

Mom was fine day of incident. After caregiver left, I come to her home around 6, but lost my keys and didn't get there until about 7pm and found her blacked out and appeared to be passed away and dead weight on the floor. Called paramedics and took her to hospital admitted to ICU told she had profuse bleeding around the brain and something to do with her heart and she wouldn't make it through the night and she was in a coma.. Somehow, the neurosurgeon and staff saved her life. She is now in a skilled nursing home. Can't walk without walker and assistance and can't return home.

Patient died due to COVID-19 illness after being fully vaccinated. no one believes the death to be related to the vaccine.

Stable at time of vaccine 1/15/21 and 2/5/21, Transferred to ER for pocketing food, Left facial drooping and left sided weakness on 7/4/21. Returned from hospital 7/14/21 w/gastrostomy nutritional status and hospice care. She expired w/end of life hospice care in place on 7/15/21.

Congestion Shortness of breath Tachycardia Transferred out 911. Per hospital, patient had a myocardial infarction, is unresponsive, and on hospice services.

she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; This is a spontaneous report from a contactable nurse. A 95-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration on 06Jan2021 at 15:00 at SINGLE DOSE at deltoid for COVID-19 immunization. The patient received first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration date : 31Mar20221, on 16Dec2020. Medical history included : cardiac failure congestive, hypertension, cardiac murmur .There were no concomitant medications. The patient previously took cymbalta , vasotec and zocor and experienced drug hypersensitivity. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.This nurse,worker at a skilled nursing facility, reported that this patient with a history of heart failure, received her second dose of the Pfizer-BioNTech Covid-19 vaccine yesterday, 06Jan2021, at 3pm. At 7am on 07Jan2021 she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive. Patient was stable prior to vaccination, but will now be transferred to hospice care. The nurse added the patient had the second COVID vaccine on 06Jan2021 yesterday and has now been transport to hospital due to a drastic decline after the shot. It was explained that this morning around 7 am she was transferred to the hospital. She was experiencing tachycardia, shortness of breath, and congestion. The events started this morning around 6-6:30am. The patient was admitted to the hospital. The shot was given at the facility. She received it at 3pm on 06Jan2021, First dose was on 16Dec2020.The caller relays she didn't know how aggressive the hospital will be for the patient. She was a full code when left and now a DNR and is unresponsive. The patient will be going on hospice care. The causality was reported as related. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tachycardia, shortness of breath, congestion, unresponsive, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of cardiac failure congestive, hypertension, cardiac murmur are confounding factors. 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.

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.

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.

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

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.

96 yo F presents with with thrombocytopenia, suspected ITP. Pt had the Pfizer COVID vaccine approx 4 weeks ago. She initially developed an itchy rash on her lower/mid back. Over the last 2 weeks, she also developed increased bruising/purpura on her flank/hip and LEs. Her son, a radiologist, came to town late last week and noted that in addition to bruising, she had what appeared to be petechiae on her LEs. Son had her skip her 2nd dose of vaccine (scheduled for Friday) and took pt to PCP for blood work. CBC apparently showed PLT of 9k so pt went to ER. Repeat PLT was 11k and pt was admitted overnight. She received dex 40 mg IV x 1 on 2/20/21. Repeat PLT today is 11k. Family reports she had normal blood work including CBC about 1 year ago. No active bleeding. No change in mental status No recent viral or bacterial infection. She otherwise feels well. No history of blood disorders or ITP. No history of autoimmune disease.

Notified on 2/24/2021 that patient passed away on 2/14/2021. Other cause of death - non-covid -19 related

Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment. The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021. Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Patient is not a patient of our clinic. When called to confirm appointment for second dose, we were notified patient was deceased.

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.

heart attack; became ill; I became nauseous; vomiting; dry heaves; dizzy; tingling in my face and right hand; right hand didn't feel like I could get up on my own; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 10:15 at SINGLE DOSE in left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) with lot number: EL3249 on 20Jan2021 in right arm. After receiving the 2nd dose on 10Feb2021, the patient became ill on 11Feb2021, while sitting on the toilet, she became nauseous and vomiting repeatedly even dry heaves also then became dizzy and felt a tingling in my face and right hand didn't feel like the patient could get up on her own so the patient's son and daughter assisted her to her bed. She didn't know what was wrong and her daughter thought it was a side effect of the vaccine and called the nurse on call. After arriving at the emergency and was examined the patient was told she was being kept for observation since she had just had the vaccine. The patient was later told she also had a mild heart attack and to her knowledge I never had any heart issues. She could then no longer use her walker to walk because she couldn't bear weight on her right hand. She was hospitalized for 8 days and transferred to rehab and I'm still in rehab. The events were assessed as serious (hospitalized and disability). The outcome of the events was not recovered. The patient received treatment for the events.

After many residents being vaccinated starting 01/07/2021 1st dose and 1/28/2021 2nd dose ; on 03/01/2021 an outbreak of Covid positive tests was noted. Residents and staff were sent away to a Covid designated facility and staff to home. My mother was one of these tested positive and I brought her to my home on 3/2/2021 instead of her being sent 2 hrs away. She was asymptomatic ,On 03/07/2021 she developed pneumonia and a UTI. She stayed in hospital 1 wk & 1 wk in another rehab. She is still not recovered.

Brain bleeding; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Right on 19Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 for covid-19 immunization (lot number: EN6198; location: Right arm) The patient experienced brain bleeding on 21Mar2021 19:30. The patient was hospitalized for brain bleeding for 11 days on an unspecified date. The event was also assessed as life-threatening by the reporter. The patient underwent lab tests and procedures which included nasal swab: unknown on an unspecified date. Treatment for the event was reported as unknown. Outcome of the event was not recovered.

Patient presented after falling on February 5 with injury to her scalp. She apparently also fell on 2/4/21. Family was uncertain as to whether patient loss consciousness. According to family, patient has been weak over the last day or 2 with no other complaints aside from some diarrhea. EMS was notified PM Feb 5, and the patient was found to have atrial fibrillation with elevated heart rate to the 160s and hypoxic to the low 80% range on room air. She had a low-grade temperature and elevated respiratory rate according to EMS. Evaluation in the ED demonstrated bilateral chest infiltrates on chest x-ray (right greater than left), elevated heart rate with atrial fibrillation, and back pain. Imaging demonstrated a T11 compression fracture (possibly new), elevated pro-calcitonin (2.80 ng/mL) and elevated troponin (1.45 ng/mL). Her venous blood gas showed mild hypoxemia (7.39/25/41/33/57), and head CT did not show acute changes and her cervical CT was negative for fracture. Pelvic x-ray did not show fracture. She was covid positive. Admitted for acute hypoxemic respiratory failure and severe sepsis secondary to COVID-19 pneumonia and acute metabolic encephalopathy. Received 3 days of remdesivir and 4 days of IV dexamethasone. Also ceftriaxone was given 4 days for possible UTI. Goal of care switched to inpatient hospice on 2/8/21.

Presented to ED with UTI symptoms with apparent septicemia. COVID-19 test upon hospital admission was (+). Patient had low O2 sats on RA at 88%. She also reported chills, fever and myalgias and cough. Denied SOB.

This 95 year old female received the Pfizer Covid shot on 2/20/21 and went to the ED on 3/16/21 and was admitted on 3/16/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

On May 14, 2021, at 9:30 p.m., patient was found on the floor by caretakers who had her taken to the Emergency Dept. She exhibited signs of a stroke; her left side was paralyzed. A CT scan of her brain was done, which showed a blood clot in her brain, which caused the stroke. She was taken to medical center, where she remains as of today, June 3, 2021. She remains paralyzed on her left side so she is unable to walk, or to use her left arm, or to swallow without aspirating food into her lungs. Potentially we have found a care facility and hope that she will be moved there within a few days. Of all the people I know, patient is the last person I would expect to have a stroke. She has always had good blood, a strong heart, strong bones, has never smoked or drank, has never been overweight, and has always worked hard and exercised daily. Her internal organs are all strong and well-functioning. She has had two CT scans of her brain within the last couple of years, the last one near the end of 2020, and they were both clear. These scans were done following falls which she took. She had the the COVID-19 on January 23 and February 17 of 2021 and had a stroke on May 14, 2021. There is no doubt in my mind that her stroke was caused by these injections. She will never recover from this event and will probably get pneumonia, which will bring about her death!

While receiving Hospice care, tested positive for COVID illness, prior fully vaccinated status noted. Remained at baseline w/overall status during covid illness, asymptomatic for covid illness. Following completion of covid illness recovery, continued to decline as observed during extended hospice care. End of life progressed with overall decline and she expired 6/8/21 at facility.

Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am.

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

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

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

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.

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.

Excerpt taken from patient's medical record notes. Recreational Therapist was in room with patient who was at baseline mentation at that time, and was getting patient a cup of tea. Rec Therapist observed patient to "all of a sudden slouch down toward left side" and became unresponsive. Therapist called for help, and Registered Nurse (RN) and Certified Nurse Aide (CNA) came into room. Patient was initially non-responsive and profusely sweating and hot to touch. Vitals were taken (see below). The patient then slowly became responsive after approximately 4 minutes and was visibly nauseous and appeared like she was going to vomit, but ultimately did not. Patient was assisted into bed, APRN was called, order for vital signs to be taken every 4 hours for 72 hours, and Electrocardiogram (EKG) to be performed. EKG results were abnormal, indicative of infarct; APRN ordered transport to Emergency Department. Patient returned from Hospital ED at approximately 10:45 PM same day (1/28/21), with transfer paperwork documenting a Hospital diagnosis of "Syncope" without any additional lab results or any new medication or treatment orders in the documentation. Follow up the next day (1/29/21) by RN at the Nursing Facility--RN logged into the Hospital medical Charting system, only to find that there was no record whatsoever of the patient being in the Emergency Department on 1/28/21--no notes, no labs, no summary from a practitioner. Patient recovered and has resumed close-to-baseline activity and functioning.

2/6/21 Sent to ER for evaluation of agitation and returned a few hours later on 2/7/21 with no acute findings. 2/7/21 continued with agitation and restlessness and had psychoactive medication changes 2/8/21 Had head CT with no acute findings 2/11/21 MRI of lumbar spine with compression fx T10 2/17/21 UA and KUB done with no acute findings Multiple falls within this time frame with escalating agitation, restlessness, and insomnia. Dx psychosis and started on Seroquel 2/25/21 3/2/21 Patient died

There were no symptoms experienced on the first vaccination given on 1/14/2021. The second vaccination was given on 2/4/2021, the following day (2/5/2021) patient complained of fatigue and nauseau. In the evening she went into cardiac arrest and died.

Pt tested positive for COVID on 2/15/21. She passed away on 02/23/21. Not listed as COVID death on death certificate.

Patient contracted COVID-19 after receiving two doses of Pfizer vaccine. Date of admission approximately 10 week post vaccination. Dates of vaccination unable to be verified as City Immunization Record unable to match with patient. Patient was vaccinated at the a facility. Patient was admitted on 3/31/2021 with ~ 4 days of cough and decreased appetite, found to be COVID positive with pneumonia. Patient received supplemental oxygen, decadron and completed a course of remdesivir. She has improved clinically and was discharged on room air.

The above info is available but it is as my mothers....She had a bad reaction ( very flu like for several days). I proceeded with second shot in February....she did not feel well, but just sorta didn't want to get up anymore. She slept more and more and more. Her appetite declined. I got her up and she was ravenous. She slept more and seemed in a lethargic way to take less and less interest. She was living independently and had been most of her life. We scheduled an internist report. She passed labs with flying colors....... when you are 96 they look at everything as remarkable ( will live for 10 more years). I also was not equating any of this with the vaccine. However, we could not ignore it any longer Saturday the 4-10-21. I took her to ER. She was lucid and walking with difficulty. I took her in by ambulance as she was just saying, "I'm so week!" I'm so whoozie! On Sunday they are talking immediate intensive rehab. Neurologist leave for 5 days and in next 48 hours she becomes 200% less. First delusional, then sleeps all day. He showed me an MRI that to a layperson looked like little hives all over the brain ( I had also gotten hives from somewhere on my skin that I originally equated with Covid but no one thought so. I have also had the two shots.) One week out I was looking at Hospic eand long term care placement. Yesterday they couldn't get a diagnosis for Hospice ( the person sent to sign her up). I thought what? After all these tests and maybe it is cardio, maybe it is exchemic strokes, they don't have a diagnosis because she hasn't changed much since 2017? We have to take this totally fine independent woman and in one week say, "She has Dementia?" It's possible but what caused it? It's not age......we live until we are 110. Yes, that MRI showed me little formations of clotting all over ( no major bleed if any in a lobe). Over the last week I have been looking at her health and how we just slowly went downhill. It's easy to blame a vaccine, but still..........I am saying that there were NO OTHER reasons other than she didn't seem to tolerate the shots well........first was acute, and the second was long term and slow...........

Congestive Heart Failure decline, AFib w/RVR, hospitalization, Respiratory decline, Cardiac decline, possible UTI, Hospice Care, continued decline, expired.

blood clot in her leg; blood clot in her leg; Cardiac arrest; Heart attack; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 29Jan2021 (Lot Number: EL9265) as SINGLE DOSE for COVID-19 immunization. Medical history included blood clots in her legs from an unknown date and unknown if ongoing , diabetec, bone infection, surgery and anemic; all from an unknown date and unknown if ongoing; and a family history of gangrene from an unknown date and unknown if ongoing of her mother. Concomitant medications included apixaban (ELIQUIS) taken as blood thinner and furosemide (FUROSEMIDE) taken for an unspecified indication; both start and stop date were not reported. The patient previously had BNT162B2 (Lot Number: EL1283) dose 1 on 08Jan2021 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient died due to a heart attack and cardiac arrest. The patient developed a blood clot in her leg and had to have her leg taken off. The date of surgery was 05Feb2021, not early Mar2021 like was originally stated at the hospital. The patient was admitted either on 01Feb2021 or 02Feb2021 and discharged on 23Feb2021. They had a bunch of bad weather and then they put the patient in the nursing facility for about a month and when she was brought home she had a heart attack and died due to cardiac arrest. She doesn't know about the blood clot and this being related to the COVID vaccines but the patient had surgery a week after she had her second shot. The heart attack was on 15Mar2021. The patient had a history of blood clots in her legs before and she had problems with that so that might of made it worse but she doesn't know for sure. The patient died on 15Mar2021. An autopsy was not performed. The outcome of the event blood clot in her leg was unknown. No follow-up attempts are possible; information about lot/batch number has been obtained.; Reported Cause(s) of Death: heart attack; cardiac arrest

This 96 year old female received the Covid shot on 4/10/21 and went to the ED on 4/16/21 and was admitted on 4/17/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)

she passed away last night; She reported no side effects other than being tired.; This is a spontaneous report from a contactable consumer. A 96-years-old female patient (reporter's mother) received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included high blood pressure, heart disease, stent in heart. The patient was not pregnant. There was no known allergy. Concomitant medications included blood pressure and other medications. The patient previously received first dose bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation. Patient received her second Pfizer vaccine on 07May2021. She reported no side effects other than being tired. It may not be related to the vaccine, but she passed away last night. Note that she had heart issues. The adverse events resulted in Emergency room/department or urgent care. Treatment for the adverse events included CPR and other life saving measures. There was no Covid prior vaccination. The patient was not Covid tested post vaccination. Death cause was unknown; may be listed as heart attack (as reported). The outcome of event Tiredness was unknown. The patient died on 09May2021. An autopsy was not performed. Information about lot/batch has been requested.; Reported Cause(s) of Death: she passed away last night

Patient was fully vaccinated. Doses on 1/14/21 and 2/4/21. Diagnosed with COVID-19 on 6/21/2021 and passed away on 7/3/2021.

Decline noted w/increased hospitalizations over months, including during time of vaccination. CHF and pulmonary edema. Hospice care initiated, end of life care, expired at facility.

Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as "Couldn't speak, slurring words, stuttering, couldn't formulate a sentence" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021.   Information of lot/batch number has been requested.

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

PRESENTED TO HOSPITAL WITH MULTIPLE SYNCOPAL EPISODES THROUGHOUT THE DAY @APPROX 7PM 2/24/21. HAD SEVERAL EPISODES OF ASYSTOLE. CURRENTLY COMPLETE HEART BLOCK. PT HAS DNR AND IS IN HOSPITAL. INFORMATIO PROVIDED BY RN

In ED on 2/25/21 Chief complaint: Patient's daughter present at bedside stating patient was not vocalizing this morning when she woke up. Patient's daughter was talking to her and she would orient to her but not answer any of her questions. EMS called and by the time they arrived patient was acting her normal self. Daughter states she has had a very difficult time managing patient's behaviors over the last several weeks and it has been getting more difficult. Daughter states that over the last several weeks her behaviors have been worsening and been more difficult to deal with. These include her getting up at night and sundowning as well as yelling and screaming during the day. Daughter states that she gets in the shouting matches with the patient during the day. Daughter breaks down and starts to cry when discussing that she thinks her mother will need long-term placement as she is having a difficult time dealing with her behaviors. Of note patient did receive second dose of Covid vaccine yesterday. -Patient has not been complaining of any symptoms over the last several days and daughter has not noticed cough or congestion or other signs of URI/illness -No focal neurologic deficits on exam -Received 1L IV NS in ED 2/26/21 Covid positive, incidental finding ? tested so she could go to nursing facility -Patient asymptomatic -Vital signs stable, afebrile -She does not need treatment at this time -She will need a repeat Covid test 14 days after the original Covid test prior to going to SNF -Plan- discharge to skilled nursing facility Discharge summary Principal Problem: Comfort measures only status Active Problems: Chronic atrial fibrillation Essential hypertension Dementia with behavioral disturbance Recurrent falls Dysphagia COVID-19 Resolved Problems: Cough with hemoptysis Leukocytosis Dehydration Inadequate oral intake Patient is a 97-year-old female with a past medical history of dementia, likely combined vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on 2/25/2021 due to behavioral disturbance as well as need for long-term care placement due to progressive dementia. She did have an incidental positive Covid test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She did not require medication or oxygen treatment for COIVD-19. She developed tachycardia/tachypnea and cough later productive for blood after suctioning attempts overnight on 2/28-3/1, which did not recur. Unfortunately, patient's overall function declined after, and she was refusing/unable to eat or drink. She was transitioned to comfort care status on 03/03/2021. She eventually slipped into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was provided. She had decreased urinary utput and respiratory function indicating expected progression. She was noted to not have a heart rate on 03/08/2021. Auscultation did not reveal any breath sounds or heart sounds; unable to palpate pulse; no pupillary response to light was seen; and patient did not respond to painful stimuli. Death was pronounced on 03/08/2021, 02:58am. Deceased 3/8/21

Developed multiple dvt and pe one week after vaccine. Patient started on heparin drip the bridged to coumidin then switched to xarelto.

This 97 year old female received the Covid shot on 2/06/21 and went to the ED and was admitted on 2/17/21 with AMS, UTI, Sepsis from e.coli, and subsequently on 3/10/21 and again on 3/24 and recevied the 2nd Covid shot on 4/9/21 and died on 4/19/21. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Patient tested positive on 04/20/2021 via PCR. Upon arriving to hospice care, patient tested positive via rapid on 04/29/2021. She died in hospice care on 05/01/2021.

PMH Afib, BiV PPM, HTN, pHTN, hypothyroidism, hemorrhoids, hearing loss, macular degeneration, squamous cell carcinoma, Parkinsons brought to ED after her caregiver found her in bed in AM w/a "dark substance in her bed" and minimally responsive. On admission vomiting x1, no cough, no SOB, abnormal CXR, covid+ Admission originally planned by IMS, but CCM asked to take over due to rapid decline.Pt w/ shallow breathing, guarded prognosis.In the morning on May 1, 2021 around 830 in the morning patient found to be without any pulse or breathing. DNR DNI with pupils fixed and dilated without any spontaneous breathing. No pulse palpated.pronounced dead at 8:30 a.m.

Patient is a 97 year old female, received first dose on 12/29/21 and second dose on 02/09/2021. Patient had previously tested positive for COVID on 12/07/2020. Patient was living in a long term care facility, when she was sent to ER for abnormal labs, where she again tested positive for COVID on 03/09/21. She did not have any symptoms of COVID. Patient was discharged back to the care facility for hospice care and died on 03/13/21.

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

I am the discharging physician and did not admit her but based off the information at admit: the patient received her Pfizer vaccine and developed nausea during her observation time but it was not significant enough to cause concern for the family. They took her home in good spirits and she appeared to be doing well until the evening when she became unresponsive. She developed high fevers and came to the ER with low normal O2 saturations and evidence of sepsis. Blood work showed a markedly elevated white count and an elevated lactic acid of 8 along with an elevated renal function and cardiac enzymes without EKG changes (multiorgan failure). Her COVID test was negative. Blood and urine cultures were negative. A CT scan of the abdomen demonstrated no acute findings but likely chronic fecal impaction. CT Head was negative for bleed or stroke. At this time is is unclear as to what was the cause of her symptoms but we believe it was presumed bacterial sepsis but this diagnosis is in question as all her cultures were unremarkable. The family opted on comfort measures rather than aggressive intervention and she was sent home with hospice. Since it occurred so closely after receiving the vaccine I think it was worthwhile to bring it to your attention.

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

Pt had worsening altered mental status, tachypnea, and low-grade fever on 1/13/21. Pt considered terminal status previously and comfort-focus care pursued. Suspected pneumonia vs. TIA/CVA. PO meds D/C'ed as patient could no longer swallow.

1/24/20211 unresponsive, sent to Hospital. Admitted with diagnosis: Acute Ischemic left MCA stroke. 1/26/2021 Transferred to Hospice care. 01/30/2021 died. I don't believe the hospital was aware of her vaccination date as it is not recorded in her records, therefore I assume that a previous VAERS report has not been submitted. My relationship to the patient is that I am her daughter.

Pt developed red, swelled, warm, painful RLE at lower leg/ankle/foot less than 24 hours, near 12-18 hours after 2nd dose.

Patient is a 99yr old female who got a covid vaccine in the afternoon of 1/10/21 and woke up in the morning of 1/11/21 with altered mental status, weakness, and dysarthria. She was taken from her assisted living facility to the hospital and MRI showed a small stroke in the right medial thalamus. She was also found to have new onset atrial fibrillation. She was treated appropriately for both conditions and discharged to a skilled nursing facility on 1/13/21.

on 1/26/21 Found laying on Bathroom Floor in Bedroom Apt. Complaint of Right Shoulder paiN bleeding (unknown origin) then discovered origin HANd/FiNgers. (Head on Floor towARds WALL) SeNT TO ER 1/26/21, Admitted 1/26/21 Diagnosis: AoRtic STENOSIS

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.

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.

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

episodes of 4.5 seconds with non pulse; she experienced a basal artery blood clot stroke; lightheaded; This is a spontaneous report from a contactable consumer (patient's son). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 14:30 (at the age of 100years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history was not reported. Concomitant medication included furosemide taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had medical issues starting within hours of the first dose of Covid vaccine. Prior, the patient was in independent living, no medications (as reported), walking about 1/2 daily and completely lucid. Immediately thereafter (after the vaccine, 11Jan2021 16:00), she experienced lightheaded, a hospital stay, and episodes of 4.5 seconds with non-pulse. A pacemaker was installed. During rehab, the patient experienced a basal artery blood clot stroke. The patient is still in rehab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized on an unspecified date for 8 days. Treatment received included pacemaker, numerous medicines (e.g. AFIB). The patient had Covid test post vaccination: Nasal Swab on 15Jan2021 with negative result. The outcome of events was recovering. Information about lot/batch number has been requested.

Received first dose of Pfizer vaccine in left deltoid on 4/8/21 at 7:30 am. At 10:00 am, she called her niece and complained of extreme fatigue. At 12:00 pm, she complained of worsening fatigue and blurry vision. At 3:40 pm, she complained of loss of appetite but denied fever and chills. The niece was unable to reach her by phone after 4 pm, so she came over to the decedent?s residence at 6:15 pm to check on her. The niece found her lying face up in bed ?gasping for air.? She then became unresponsive and EMS was called. The decedent was pronounced at 8:11 pm after unsuccessful resuscitative efforts. Autopsy showed hypertensive and atherosclerotic cardiovascular disease with marked partially calcific coronary atherosclerosis; marked pulmonary edema; and pleural effusions. The brain was saved for neuropathology given the history of blurry vision.

Pt. developed emesis, vomiting blood afternoon after covid vaccine. She died within a few minutes. Resuscitation not attempted due to DNR status. Had recovered from covid months before.

Death 3/25/2021 Causes of death listed on patient's death certificate: 1) COVID-19 Infection, 2) Acute Hypoxic Respiratory Failure, 3) Acute on Chronic Deconditioning

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.

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.

passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine

Dose given at 1649hrs. At 2030hrs, complaints of headache and diarrhea. At 0100hrs on 03/21, family noticed patient unresponsive and not breathing. Fire rescue called out and pronounced her at 0210hrs.

Stroke; sitting on the floor totally disoriented; Cardiac arrest; This is a spontaneous report from a contactable consumer (patient's Daughter). A 101-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 101-year-old on 03Mar2021 at single dose for covid-19 immunisation. Medical history included glaucoma, blood pressure high, Mini stroke, her blindness was an infarct to her optic nerve, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, and obesity. Family history included Patient's sister got the vaccination and either 3 or 5 days later she passed away. There was none history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medication included metoprolol taken for high blood pressure; levothyroxine; amlodipine taken for high blood pressure; sertraline to keep her spirits up because she is old and blind; latanoprost (XALATAN); dorzolamide hydrochloride, timolol maleate (COSOPT); acetylsalicylic acid (BABY ASPIRIN); calcium (CALCIUM); vitamin C [ASCORBIC ACID]; tocopherol (VITAMIN E). Prior Vaccinations (within 4 weeks), there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient received the Flu shot every year and patient also received the shingles shot and the pneumonia shot. Reporter stated patient had lunch and was sitting in the chair so it was probably somewhere between 12 and 3pm on 09Mar2021 when she had her stroke. Reporter states when she got back home patient was on the floor totally disoriented. Above events results in Emergency Room and patient was hospitalized from 10Mar2021 to 12 Mar2021. Reporter stated that patient died in her sleep so early in the morning probably between 3am and 6am on 06Jun2021. Reported cause of death was cardiac arrest. Reporter was calling about the Pfizer COVID vaccination. Reporter was calling on behalf of her mother. Reporter believed that her mother had a reaction to the first shot. Reporter stated that her mother had a stroke 6 days after receiving the first Pfizer COVID vaccination and has since passed away. Reporter thought this was a contributing factor. Reporter states that her mother was 101 years old but was an incredibly lucid and healthy individual. Reporter states that her mother used to be 5 foot 1 inch but she was probably 4 foot 11 inches at the time of this event (09Mar2021). Reporter states at the time of this event her mother probably weighed about 133 pounds. Reporter states that she came home on 09Mar2021 and found her mother on the floor. She took her mom to the hospital on 10Mar2021 and she was diagnosed with a stroke. Her mother was hospitalized 10Mar2021 through 12Mar2021. Reporter stated that her mother went to rehab after being discharged from the hospital. Stated that her mother never came back home. Reporter states that her mother lived with her. Reporter states she looked at her labs on 01Jun2021, her labs were always good. She stated that her mother also had a cat scan with contrast in 2021, no further details provided. Reporter states that she was not saying that this product caused her death but the timing was very suspicious. The patient underwent lab tests included Fasting blood glucose: 99 on 01Jun2021, cat scan with contrast with unknown results in 2021. The outcome of events was fatal. The patient died on 06Jun2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Stroke; sitting on the floor totally disoriented; Cardiac arrest

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.

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