Pfizer

Lethargy, chills, shaking, pale, slightly tachycardic. Afebrile initially then fever presented after about an hour to 103.3

PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS.

per staff at facility patient died 24 hours post vaccination. Please contact Director of Nursing for further details.

Presented with stroke like symptoms at 10:30, right sided weakness and slurred speach. 911 was call, patient was transported to hospital. Per ED note, patient experienced TIA which resolved, actue exacerbation of CHF. Patient was admitted. Discharge summary on 1/22 indicates same diagnosis, plan was home with hospice. Family notified hospital on 1/25 that patient had expired on 1/23 at home.

Abnormal chest x-ray; Altered mental status, unspecified altered mental status type; Arrhythmia; Bradycardia; CHF (congestive heart failure); Cardiac arrhythmia, unspecified cardiac arrhythmia type; Essential hypertension; Heart failure with preserved ejection fraction, unspecified HF chronicity; Hypothermia, initial encounter; Pneumonia of right middle lobe due to infectious organism; Right middle lobe pneumonia

On 2/5/2021 resident noted to be azotemic. Creatinine up to 3.8 and BUN in 80's. He was started on NS hydration. On 2/7/2021 he was noted without VS, per MD notes, possible VF arrest, renal failure; death unclear exact cause.

Uncle received vaccine on 2/9/21 at 11:30am. Had acute myocardial infarction on 2/10/21 at 08:30am where he proceeded to fall and fracture hip. Transported to emergency department and treated for AMI. Stabilized and taken for surgery to repair hip fracture. To be discharged on 2/15/21 to rehabilitation facility. Up until this point he was very healthy and active, despite his age, living unassisted at home.

2/24/21 Patient Died. 02/23/21. Patient came to ED for weakness/falls. Patient had fallen on 02/21 and 02/23. UA was done in LTC, and he was started on ciprofloxacin 02/22/21. Treatment was to put patient on comfort cares (morphine + lorazepam)

Called patient to refill medication and spoke with daughter. She stated that her father had passed away last week.

Caller is nephew of patient. Patient was admitted to Hospital on 2/15/21 with Covid like symptoms and decreased O2 sat. He tested positive for Covid 2/15/21. Treated with Remdesivir. Patient status continued to decline and he passed away in hospital 2/22/21 0612.

caller (son) stayed w/ the pt for about an hour after he received the vax and the pt stated the only symptoms at that time was some achiness on the arm around the injection site. Son went home after that. He tried to contact him on 3/1/2021 but wasn't able to reach him. On 3/2/21 the brother tried to contact him and wasn't able to reach him. They contacted the police dept on 3/2/2021 around 8:00 AM to do a well check. Pt was found on the couch like he had fallen asleep but was deceased. They suspect he probably expired on 3/1/2021. No autopsy will be conducted per the son.

Severe abdominal pain unable to eat or sleep for 36 hours. He went by ambulance to the Hospital emergency room. They tried to pump his stomach but he aspirated and and went into cardiac arrest. He was revived but never regained consciousness. (The ICU Dr said that he had blood clots in his abdomen from a recent stroke. We were unaware of him having a stroke other than in 2026. The same Dr. said that he had necrosis in his lungs from aspirating. The necrosis was from his bowel dying) He was put on a ventilator and given drugs to increase his heart rate. On 3-5-21 the heart drugs were reduced and he died. I was with him when he recieved the vaccination and he was healthy, just old. I think that the shot killed him.

@nd dose Pfizer on March 27 without immediate problems. Had sudden collapse on March 29, found to have large intracerebral hemorrhage; at local hospital after discussion placed on comfort measures only; died 04/02/2021

Death Hypokalemia LBBB (left bundle branch block) Pneumonia Anemia Hypoxia Fever Multifocal pneumonia Pneumonia due to COVID-19 virus2.82 Sepsis

PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT RECEIVED FIRST DOSE OF VACCINE ON 2/8/21. PATIENT REPORTEDLY PASSED AWAY ON 2/13/21 AT 7AM IN NURSING FACILITY. Record of death states CHF as principle cause of death and Stage IV CKD as contributory cause of death.

Death Narrative: Patient was previously tested COVID-19 positive on 3/2/2021, but did not have any other predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted with afib with RVR on 2/17/21 and was having a HFrEF exacerbation. HR was controlled during admission and he was discharged on 2/19/21. Patient was hospitalized 4 more times over the next two months for cardiac symptoms with last hospitalization occurring 4/12/21 for hypotension/tachycardia and decompensated heart failure. Patient never recovered and transitioned to hospice before passing on 4/16/21. Patient had a PMH significant for afib s/p DCCV on eliquis, CKD, HFpEF on home O2 2L, PMR on prednisone, known R pleural effusion, Covid PNA in 11/2020 and chronic foley

Swollen left leg noticed on 3-19-2021 as a result of blood clots identified by ultra sound on 03-31-2021

I COULDN"T WRITE DOWN WHAT WE WENT THROUGH . DOCTORS SAID THE VACCINE STIMULATE A CELL THAT MIGHT NEVER BE SEEN IF HE DID NOT HAVE VACCINE. HE WAS A VETERINARIAN UNTIL AFTER THE SECOND SHOT HEALTHY WALKING 2 MILES 3 TO 4 TIMES DAILY ETC ETC DID THE VACCINE SO WE COULD GO ON VACATION....ENTERED HOSPITAL AND WITH ALL THE DOCTORS SAYING HE WILL BE ALRIGHT IN A FEW DAYS OUR VACATION TURNED OUT TO BE A 15,000DOLLAR FUNERAL THEN DIED

Patient presented to the ED and was subsequently hospitalized with acute respiratory failure with hypoxia within 6 weeks of receiving COVID vaccination.

Patient was a healthy, active man, walked the dog 2x a day, wrote about classical music, etc. until 02/23-26/2021: Atrial fibrillation episodes that would not resolve themselves; 03/03/2021: Cardioversion at Hospital which did not work; medications were changed or adjusted over the next weeks, Metoprolo tartrate 25mg was added 03/10/2021. Patient was anxious, napped during the day, couldn't sleep at night, couldn't concentrate on anything for any length of time, breathing irregular, had no energy to walk; 03/11-16/2021: in Hospital 04-10-14/2021: in Medical Center, for ablation and pacemaker. Great improvement, had more energy, was ale to drive again but was not back to his active self pre- 02/23/2021. Medications as of 04/27/2021 were Allopurinal 300mg daily; Atorvastatin 10mg, daily; Eliquis 5mg 2x a day; Furosemide 20mg daily; Melatonin 10mg, daily; Metoprolol succinate ER 50mg daily; Valsartan 40mg, daily; Adult 50+ Eye Health, daily; multivitamin, 1 daily; Docusate sodium 50mg as needed. By 05/26/2021, the patient is once again sleeping off and on during the day, has no energy, coughs more, can't concentrate, has lost his appetite, is anxious and discouraged. His speech is often muffled instead of clearly enunciated as is his wont. The medications have been adjusted again: as of 06/07/2021, Metoprolol 200mg, daily; Furosemide 40mg daily; the other medications remain the same. The patient, over the more than 3 months, has had xrays, electrocardiagrams, CT scans; bloodwork done. The question is: is it possible that these seemingly uncontrolable atrial fibrillation episodes are an adverse reaction to the second Pfizer vaccine? Has research been done on the vaccine and cardiac problems?

Resident admitted to Hospital on 6/29/2021 for hemiplegia. Diagnosed with a cerebral infarct. Resulting aphasia and right hemiplegia.

SUSPECTED CVA; BRADYCARDIA; FACIAL DROOP; SLURRED SPEECH; WEAKNESS; DYSARTHRIA; ALTERED MENTAL STATUS; HYPERTENSION;HYPOKALEMIA; ISCHEMIC CARDIOMYOPATHY; LEFT BRANCH BUNDLE BLOCK; RHEUMATOID ARTHRITIS; RIGHT SIDED WEAKNESS; TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY STARTED ON 7/4/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/8/21. CARDIAC ARREST; ACUTE ENCEPHALOPATHY; ALTERED MENTAL STATUS STARTED ON 7/9/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/12/21.

Patient experienced a heart attack 5 days after Covid 19 Injection and then a Stroke. Hospitalized for 3 weeks and had 2 months of Rehab.

Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021

The patient was observed to be lethargic on 1/29/21 at 1515. BP-80/50, P-75, RR-27, T-100.1. He was given a bolus of NS 150 mlx2. and Rocephin 1 gram IM.

DIAGNOSIS: #1. CVA #2. Aphasia, acute Number 3. Change in mental status, acute ASSESSMENT/PLAN/DECISION MAKING: Spoke with radiologist informed me that patient had a deep ischemic or infarct change in his corona radiata area which is common in patients with covid 19 infection or vaccination, which patient had a day and a half ago after lengthy discussion with wife, she informed me that patient would not want CPR and he had a stroke in the past and does not want to go to another city as he is 91 years old and therefore not a candidate for thrombolysis and also this was a wakeup stroke and so we do not know his exact time of onset, and she states that they simply want to be treated here for comfort care.

Patient (now deceased) received 1st dose of Pfizer-BioNTech vaccine around December 21, 2020 and was noticed to be scratching, fatigued, and unresponsive by a family member on December 24, 2020. He received the second dose of the same vaccine around January 22, 2021. Pockmarks and bleeding scratch marks were noted by a family member on the patient's face prior to this second dose. On January 28, 2021 a family member was alerted that the patient was suffering from severe bullous pemphigoid- a skin condition that has never been experienced by the patient, has been reported to be related to COVID-19 viral infection, and to T-cell responses promoted by vaccines. A corticosteroid was given, but did not work. Blisters developed to the point hands had to be dressed.

Patient was not seen at our facilities prior to or after COVID-19 vaccination. Patient received first dose on 1/23/2021 and as reported by the family member, patient expired on 2/5/21. Symptoms were reported to have stared on 2/1/2021, 9 days after receiving the first dose with a drop in oxygen levels and fever. He was reported to also have a history of chronic lung disease. Patient's family member to be contacted if necessary.

Emergency room HPI Patient is a 91 y.o. male who presents from nursing home with positive coronavirus a and flu A positive tests. Test was done yesterday. Patient sent to ER because of low oxygen saturation. Patient unable to answer or respond to questions. No fever or chills, no cough or shortness of breath and no complaint of pain when patient was moved around. Oxygen saturation on presentation was 89% on room air and went up to 93% on 4 L of oxygen admission: HPI: Patient is a 91 y.o. male with a history of severe dementia and severe COPD. He currently resides at Rehab. He had a routine coronavirus (COVID-19) test yesterday that was positive. Then, today he started having increasing oxygen requirement. He was not responding to his typical breathing treatments or oxygen and so they sent him in. In the ER he was found to be in some respiratory distress and did require increased oxygen concentration. Once they got him calm down, his oxygen saturation state over 90% with 4 L. His ABG did show an oxygen Saturation of 86% on 4 L. The patient reportedly had coronavirus (COVID-19) several months ago, but then did test positive for both coronavirus (COVID-19) and influenza on rapid testing at the nursing home yesterday. The patient is being admitted due to his increasing oxygen requirement and respiratory distress

Patient presented to ED for DVTs, currently being treated with warfarin and heparin bridge. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Patient became acutely ill on 1/15/21 with recurrent pneumonia, treated with Augmentin. Pt became progressively worse on the next 48-72 hours, treatment goals changed to palliative-focused, and all treatments withdrawn. Patient died on 1/22/21.

Patient fractured his hip and 2/22, underwent hip surgery, discharged to but readmitted with R lower DVT and bilateral pulmonary emboli.. Treated with IV heparin. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

Client received Pfizer vaccine lot number EL9265 IM left deltoid on 2/1/21 and then received Moderna vaccine lot 03120A left deltoid on 2/20/21. His neice states he has not had any reactions initial reactions with the vaccine. She reports he was on hospice due to Congestive Heart Failure and died on 3/5/21

Only received 1st round dosage of COVID vaccination, he seemed to handle vaccination okay. On January 17, 2021, he tested COVID positive on a resident screening test done in response to an employee positive case in days previous to the residents testing. Fifteen days after his first innoculation,his AM nurse found him non-responsive on early vital checks. Vitals at that time were normal range. The facility physician was contacted and advised that he should be taken to Emergency Room at local hospital for further evaluation. Blood work was taken and ER DR diagnosed Heart enzymes elevated indicating a heart attack. Advised additional testing should be done, and that monoclonal antibody treatment wasn't an option due to time lapse since diagnosis of COVID, The option of comfort care was chosen as the treatment plan.

91 yo father received vaccine, was mobile and alert before first shot, but required wheelchair by second vaccination due to being weak. After second vaccination, was not able to stand or move after 36 hrs, at which point he was taken to the hospital. At hospital, all vital signs were good except an MRI showed cancer in spine. Shot was given 3/1 and my father passed on 3/18. Obviously this shot did not cause metastatic cancer, but I believe it did induce an inflammatory response of some kind that caused it to progress extremely quickly.

pneumonia; kidney failure; This is a spontaneous report received from a contactable consumer. A 91-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208), parenteral in left arm on 17Mar2021 (at the age of 91-year-old) at single dose for COVID-19 immunsation. The patient's medical history included prostate cancer, heart disease, Alzheimer. The patient's concomitant medications included leuprorelin acetate (LUPRON) injection, via parenteral route of administration in location reported as stomach from 10Mar2021 for prostate cancer. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM6203), parenteral in left arm on 24Feb2021 (at the age of 91-year-old) at single dose for COVID-19 immunisation. It was reported that patient began feeling sick after injection. He progressively worsened and he was admitted to the hospital on 31Mar2021 with pneumonia and kidney failure. He was put on a ventilator and received dialysis along with antibiotics. Adverse events start date was reported as 18Mar2021. Adverse events were reported as serious as resulted in emergency room/department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The number of days of hospitalization was reported as 6. Adverse events treatment was reported as ventilator, dialysis, and medications. The patient underwent lab tests and procedure which included COVID test post vaccination (unknown) on 31Mar2021. The outcome of the events was not resolved.

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 and suffered cardiac arrest at home on 2/25/21. Patient had afib w/ a pacemaker, cardiomyopathy, CKD4, and PVD.

This 91 year old white male received the Covid shot on 2/19/21 and subsequently died on 3/21/21. 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..

Felt a little off; Pneumonia; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 16Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history included deaf. Concomitant medications were not reported. Reporter stated that a week and a half after his first vaccine he had pneumonia (Mar2021); but that they didn't think it was related to the vaccine. The patient also felt a little off on 16Mar2021 and required a visit to the emergency room and physician office. The facility where the vaccine was administered was in a clinic. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no family medical history relevant to events and no relevant tests done. Outcome of the event pneumonia was unknown while not recovered for the other event. The reporter mentioned that they didn't think that pneumonia was related to the vaccine. Information about the Lot/batch number has been requested.; Sender's Comments: Based on available information, pneumonia is assessed as unrelated to BNT162B2, this is an intercurrent medical condition. Potential contributors include patient's advanced age as the risk for infections is higher in this population. Case will be reassessed if additional information is received

Patient hospitalized on 4/15/2021 after being fully vaccinated. Tested positive on 4/19/2021. Patient died on 4/27/2021.

stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; right arm, soreness in arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm/ with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; General body weakness; This is a spontaneous report received from a contactable consumer (patient). A 91-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 91-year-old, via an unspecified route of administration, administered in arm right on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included arthritis. Known allergies: amoxicillin. Concomitant medication included verapamil HCL; furosemide, potassium chloride (LASIX + K); colecalciferol (VIT.D3); magnesium oxide (MAGOX); atorvastatin calcium; warfarin. The patient previously received the first dose of BNT162B2 on 28Jan2021 at the age of 91-year-old for COVID-19 Immunisation, no issues whatsoever. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021 on 24Feb2021 02:00, right arm, soreness in arm on 21Feb2021 , neck and shoulder pain began along with weakness in right arm on 21Feb2021, general body weakness on 21Feb2021. Adverse events resulted in emergency room/department or urgent care, hospitalization (in 2021 for 3 days), life threatening, disability or permanent damage. It was unknown whether treatment received for the events. The patient underwent lab tests and procedures which included Covid test type post vaccination: blood test: negative in 2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After the first dose my father got what the eye doctor thought was pink eye. After treating him it didn't clear up. It was later diagnosed as herpes of the eye and he became blind in one eye. Shortly afterwards I read an article from researchers who stated they had found fragments of the herpes virus in the vaccine. After the second vaccine he was fine one day and 2 days later started having seizures. He was hospitalized for the seizures. His personality totally changed. He no longer recognized my sister. He also became hostile which is not the person he was. He was released from the hospital and brought to a new facility. Then the lights went out. he just stared off into space. A day later he was dead.

Patient admitted to hospital on 03/24/2021 for high fever and shortness of breath; these symptoms began in 3/17. Patient tested positive for COVID-19 on 03/21/2021 and again on 03/24/2021 despite being fully vaccinated against COVID-19. Patient died on 04/19/2021. COVID-19 is listed on the death certificate. Death Certificate Information: Part I Cause of Death: A. Acute Hypoxic Respiratory Failure B. Suspected pulmonary embolism Part II: Significant Other Conditions: COVID 19 subacutely

91 y/o male, BMI 38, PMHx CHF, dementia, HTN, and paroxysmal Afib, admitted for acute onset altered mental status, SOB, Covid19, and pulmonary edema on 4/12/21. No reports of fever but tested positive for Covid19. Chest x-ray presents cardiomegaly with bibasilar opacities suggesting atelectasis and/or pneumonia. Covid treated with supportive care. Discharged home with hospice on 4/14/21.

Patient stated he wasn't feeling well on January 25, 2021, wasn't eating and complained of abdominal pain. Patient noted to have indigestion and was constipated. Meds provided and labs ordered. On morning of January 26, 2021, patient became weak, lethargic and hypoxic and was sent to emergency department around 0700 hours on January 26, 2021. At approximately 1100 hours, emergency physician notified this writer that patient was not going to overcome his illness and would be placed on comfort care. At approximately 1130 hours, this writer was notified that patient had passed away from multi-organ failure.

Patient got the injection and quickly developed a fever and felt weak. Family was contacted and he was sent to Hospital.

Ischemic stroke on Saturday morning following vaccine Thursday. Symptoms were muscle weakness and inability to speak

Patient had no adverse events during the observation period after vaccine. He was conscious and having conversation with facility staff. He was observed for 15 minutes at least. When the facility staff returned later, approximately 60 to 90 minutes, patient had passed away.

92 year-old male with PMHx of vascular dementia, BPH, MDD, sleep disturbance , basal cell carcinoma of neck, osteoarthritis, BLE edema, Guillain-Barre syndrome 30 years prior, s/p COVID positive on 1/11/21 and received IV Bamlanivimab. Sent to hospital on 2/2/21 for altered mental status, generalized weakness with inability to lift bilateral UE and difficulty moving his BLE. He was treated for UTI with 7 days of Cefepime for Morganella Morganii. He was followed by neurology with MRI of the brain and CT of the spine without acute findings. Lumbar puncture unable to be obtained. He received 5 day course of IVIG for presumed Guillain-Barre . EMG showed generalized sensory motor polyneuropathy both axon loss and demyelinating type severe in degree. However, he did not recover from his GBS symptoms, was transferred back to the nursing home and died on 2/15/2021.

This individual received the first dose of the Covid-19 Pfizer vaccine on 3/4/21 and a few days later passed away on 03/07/21.

pneumonia; urinary tract infection; Shortness of breath; Currently critically ill; This is a spontaneous report from a contactable consumer reporting for himself. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6203/expiration date: not provided), via an unspecified route of administration, on 03Mar2021 at 10:00 (at the age of 92 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included congestive heart failure, pace-maker to treat congestive heart failure, ongoing and consistent treatment for high cholesterol, high blood pressure, and shell fish allergy. Concomitant medication included levotyroxine, atrovastatine, amniodarone, and wafarin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 at 04:15, the patient experienced shortness of breath and needed to be hospitalized with pneumonia and urinary tract infection. The patient was currently critically ill. The events required an emergency room visit and hospitalization. It was unknown if any treatment was received. The outcome of the events shortness of breath, pneumonia, urinary tract infection, and ill was unknown. Since the vaccination, the patient had been tested for COVID-19 on 06Mar2021, with a negative result.

Shingles and Hospitalization within 30 days of vaccination. 2/18/21 PCP ordered outpt wound for shingles and unstageable decubitis ulcer (unknown onset date of shingles). Seen in ER on 2/19 and admitted discharged to rehab unit on 2/23/21. reported 1-2 week history of generalized weakness and frequent falls, poor oral intake and shingles. 2/19/21 pt c/o heart racing and irregular. Found to be in Afib with RVR. 2nd dose of Pfizer given 3/19/2021 went to ER 3/24 for pneumonia.

respiratory arrest, cardiac arrest Narrative: Patient died 1 day after receiving 2nd dose of COVID vaccine in his bed at home. Paramedics arrived but were not able to resuscitate.

Pulmonary Embolism in right lung; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9267), via an unspecified route of administration, administered in right arm on 16Feb2021 at 12:45 PM at the age of 92-years-old as single dose for COVID-19 immunization. Facility type vaccine was reported as Other. The patient had no other vaccine in four weeks. The patient's medical history included known allergies to penicillin and sulfa drugs. Concomitant medications included fluoxetine, cyanocobalamin (B12-VITAMIN), and fish oil (OMEGA 3); all taken for unspecified indications, start and stop dates were not reported (reported as other medications in two weeks). The patient previously took potassium iodate and experienced allergies. The patient previously received the first dose of BNT162B2 in the right arm on 26Jan2021 at 12:45 PM (lot number: EL9261) at the age of 92-years-old for COVID-19 immunization. The patient experienced pulmonary embolism in right lung on 07Mar2021 at 09:00 AM. The event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for pulmonary embolism in right lung for 2 days in 2021. The patient received treatment for the event which included heparin. The patient had no COVID prior the vaccination and was not tested for COVID post vaccination. The outcome of the event was recovering.

Patient had two ED visits 3/9/21 and 3/11/21, then presented to the ED on 3/28/21 where he was subsequently hospitalized with severe sepsis.

Patient was a well and active 92 year old man, who walked 2 miles daily with a walker. He received Covid vaccine dose 1 on 11 Jan. On or before 30 Jan, he noted pains in one leg while walking. Newly dilated veins on the lower leg were noted. On feb 2 a doppler US revealed a superficial saphenous vein venous thrombosis, also new onset A flutter. Aspirin begun. On Feb 5 he woke with a cold foot (same side) and was found to have an arterial thrombus from SFA through distal posterial tibial. He underwent emergency thrombectomy, went to rehab for recovery, on Feb 23 suffered intracranial hemorrhage and died on Mar 10.

This 92 year old white male received the Covid shot on 2/23/21 and went to the ED and admitted on 5/3/21 and again to ED and admitted on 5/5/21 with the following diagnoses listed below. I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) CHEST PAIN

PER SPOUSE, HE HAD A CUT ON HIS LEG THAT DID NOT STOP BLEEDING. THEY WENT TO CLINIC TO GET IT CAUTERIZED. DAY LATER HIS BODY HAD MULTIPLE BRUISES, THEN HE WAS EVEN BLEEDING FROM HIS PENIS. AT HOSPITAL THEY TOLD HIM HE HAD LOW PLATELETS AND WAS BLEEDING OUT. HE WENT INTO HOSPICE AND PASSED AWAY ON 5/8/2021

The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was "abnormal" how he was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was found without a pulse, respirations, or blood pressure at 1:54 pm. He was a DNR.

tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing

My father was in weak condition to begin with. He didn't get out of bed for the next few days after receiving the vaccine. The little amount that he ate was consumed in bed. He began aspirating his food which lead to pneumonia. He wasn't strong enough to fight off the pneumonia even with antibiotics. He died on 1/23/21. While he might have passed soon in any case, I believe that the vaccine may possibly have increased his weakness/exhaustion thereby hastening his demise.

general malaise , Fatigue, poor interest in activities , hypoactivity, pulmonary embolism Narrative: Patient transferred to ER for evaluation. Physician at facility reported marked deterioration, hypoactivity and slow mentation s/p COVID vaccine second dose 1/8/21. Cough also reported x 1 week. Patient evaluated at ER on 1/20/21 and admitted to internal medicine ward with diagnosis impression pulmonary emboli, aspiration pneumonia and urinary tract infection.

Pt from home via EMS. Pt reports increased weakness since getting the covid vaccine on the 24th. Pt is normally ambulatory at baseline, but has not been able to get around his house. Pt was found to be 83% on RA and was audibly wheezing per EMS. No history of respiratory issues. Denies fever, but has had a productive cough. A&O x4. Pt received Duoneb treatment in route. Acute respiratory failure with hypoxia , Pneumonia due to COVID-19 virus , Elevated LFTs. Patient admitted to hospital on 2/3 and is still inpatient

death Narrative: 92 yo male seen in clinic on 12/30/2020 for transfusion, hbg 6.9. PMH includes HLD, CKD, myelodysplastic syndrome, DM, prostate cancer, HTN. Pt also received COVID19 Pfizer vaccine the same day. The patient denied any prior severereaction to this vaccine or its components. Post-transfusion, patient had a mechanical fall (per patient he was seated and used the cane to help him stand. However the cane slipped on the floor causing the patient to fall, patient hit his head and injured his right hip, no loss of consciousness at the time). Rapid response team was called and patient was admitted to the ED. Pt was found to have subcapital right femoral neck fracture, scalp contusion, and TBI (per ED provider's note). Ortho evaluated and said patient wasn't a surgical candidate. During his hospitalization, patient tested positive for COVID19 on 1/12/2021, pt was asymptomatic at the time. On 1/13/2021, pt exhibited mild URI symptoms, no respiratory distress. He was started on cetirizine, Montelukast, albuterol, and inhaled steroids to manage his symptoms. Dexamethasone was started on 1/14/2021. Chest Xray was ordered on 1/17/2021, pt's respiratory was slowly getting worse, resting O2 sats were in the high 80s and low 90s with IS. On 1/18/2021, CXR shows patchy bilateral airspace opacities suspious for pneumonia of bacterial or viral etiology. Pt was started on remdesivir 01/18/2021 (5 doses, from 1/18-1/22/2021). Pt required 5-6 LPM of oxygen at rest. Pt was then transferred to the ICU. His oxygen demand continued to increase and his condition worsened. On 2/14/2021, pt started to desat into the 70s on max high flow. Patient/family agree to comfort care. Medical cause of death was listed as "acute hypoxic respiratory failure due to COVID19." Patient expired 1/24/2021.

right arm swelling immediately after injection. followed by bilateral lower leg edema, chills and body aches that continued daily at 2 weeks post immunization admin 2/4/21 treated with dexamethasone 6mg PO x 7 days- this resolved his s/s 2/13/21 patient passed away at facility

Patient received first dose of vaccine on 1/7/21 at a community Public Health clinic. On 1/29/21 he received a second dose at the community Public Health clinic. On 2/5/21, the patient presented to the ED with complaints of shortness of breath worsening over the last 2 weeks. Patient reported that he had decreased exercise capacity and increased coughing with sputum production intermittently. Patient reported that he had been feeling chilled, but no fevers. Patient was admitted and treated with Decadron and Remdesivir. Patient experienced increased oxygen requirement. Patient was a DNI and did not want to be on life support. After discussion with the patient and family, patient was moved to comfort care. passed away on 2/11/21.

hospitalized with extensive bilateral pulmonary emboli and right leg deep vein thrombosis after 1st vaccine dose. Required high-flow nasal canula for oxygen support. ultimately discharged on hospice

Daughter of decedent reported that he quickly declined within 2 weeks of receiving vaccine and developed shortness of breath. Decedent received vaccine 1/30/2021 and died 2/15/2021. Only received first dose of series.

contracted covid after first dose Narrative: First covid vaccine dose 12/31/2020, tested positive for covid 1/7/2021, died from complications 1/25/2021

Low platelets, thrombocytopenia, bleeding from mouth, large bruising, purpura, petechiae, rash of pinpoint-sized reddish-purple spots on lower legs. Treated with at least 2x2 units of platelets, IVIG for several days (at least), diagnosed as ITP, immune thrombocytopenia. Developed aspirational pneumonia in hospital. Admitted with platelets at 1x10^9/L; discharged on day 5 with 79x10^9/L. Patient had ITP 10 years earlier and was recovered from it.

WE CALLED PATIENT ON 3/2/21 BECAUSE HE HAD NOT SHOWED UP FOR HIS 2ND DOSE. THE PERSON WHO ANSWERED THE PHONE NOTIFIED US THAT PATIENT PASSED AWAY AT MEDICAL CENTER ON 2/13/21.

death Narrative: Pt has been declining prior to starting COVID vaccine doses; then he got COVID after first dose (VAER reported); and then was admitted to hospice for dyspnea, chronic pain, pressure ulcers, urinary incontinence with foley catheter in place, bedbound, dysphagia.

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was 92 and a resident at facility when he passed away. Patient has been LTC resident since 2/15/2019 and received hospice services prior to receiving first Pfizer vaccine dose. Patient receiving hospice care for terminal colon cancer.

Cause of death is believed to be a fatal arrhythmia resulting from advanced old age and aggravated by sepsis due to COVID-19 infection along with gastroenteritis. The death was natural and not unexpected. Tobacco is not believed to have contributed to t

Received 2nd shot on April 14. He was functioning normally until he woke up on April 25. Symptoms were chest pain, trouble breathing, lethargic, very pale, cold to the touch, vomiting with blood in vomit. PT was taken to the ER where he passed away later that night.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Additional Details: Patient passed away on 4/23/21 and had blood clots throughout body. Patient did not have any other symptoms that were reported. Patients family requested a VAERS report be submitted.

N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified K92.2 - Acute lower GI bleeding K92.2 - GI bleed

ED to Hosp-Admission Discharged 3/31/2021 - 4/12/2021 (12 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Date: 4/12/2021 DOB: 1/13/1928 Admission Date: 3/31/2021 MRN: 000452141 Length of stay: 12 Days Admission diagnosis: POA * (Principal) Pneumonia due to COVID-19 virus Yes HPI: Patient is an 93 y.o. male presenting to ED on 3/31/21 with worsening shortness of breath with fever occasional cough, and fatigue. He just received his second dose of his covid vaccination 3//26. Hospital Course: Patient was admitted to receive treatment for COVID 19 infection. On presentation he was hypoxic requiring supplemental oxygen, he was in Afib RVR. He received experimental treatment with plasma, remdesivir, and dexamethasone. He had a AKI in setting of infection that improved, and his lasix was added back. He has CKD3, would recommend re-check cr in 3 days after discharge. He did develop acute urinary retention that required a foley to be placed. Void trail in hospital was unsuccessful, suspect relatedd to weakness/poor endurance. Can considner ongoing voiding trails as his health improves and or outpatient urology consult. Paroxysmal Afib in the setting of viral infection, with fluids and increasing metoprolol rates improved. Once he recovers from Afib can consider MCOT to evaluate Afib burden, continue ASA Covid pneumonia Acute hypoxic respiratory failure, from COVID Pneumonia Received convalescent plasma Received Dexamethasone 10 day course Completed remdesivir 5-day course on 4/4/21 Oxygen Requirement continues at 2 L nasal cannula Inflammatory markers trended down He was vaccinated SECOND INJECTION on 3/26. Acute kidney injury on chronic kidney disease stage IV Creatinine improved with IVF did upwardly trend again likley from acute urine retention Cautiously watch Cr while on Lasix, consider checking CR/BUN in 3 days Monitor creatinine, avoid nephrotoxins Discharged with foley, continue Flomax. Consider voiding trails at SNF and/or urology consult Paroxysmal atrial fibrillation -new onset Metoprolol tartrate increased during hospitalization patient will benefit from outpatient event monitor to determine A. fib burden once he recovers from Covid, to be arranged by PCP continue aspirin

Starting having trouble breathing 1 week later 2 weeks later diagnosed with pneumonia 10 days later admitted to hospital with interstitial lung disease (never before diagnosed with that) Needed 24/7 oxygen Passed away May 10/21

Pt received both doses of the Pfizer COVID-19 vaccine, on 2/18/2021 and 3/10/2021. On 7/12/2021, pt presented to our ED for "feeling crumy" with a decline in ADLs. Pt tested positive for COVID 19 via PCR. Chest Xray positive for pneumonia, suspected UTI also contributing. Pt admitted to inpatient due to weakness and suspected underlying infection.

93 Male vaccinated Pfizer 1/06/2021 & 1/28/2021. Symptom onset 4/30/2021 - SOA, fatigue. Taken to ER 5/10/2021 for blurry vision. Diagnosed with COVID 4/30/2021. Started dexamethasone. Patient claims left eye problems secondary to dexamethasone. Discharged and final diagnosis at time of death 5/24/2021 - COVID-19 with PNA

Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He did say that he felt tired, but he often complained of feeling tired over time.

This is a 94-year-old male who is brought in by ambulance after being found on the floor with unknown downtime. He was in asystole upon EMS arrival. He remains in asystole. No advanced airway is in place. The patient is getting compressions from Lucas device upon arrival. It was reported that he was last talked to by family at 2 PM. The patient got his SARS-CoV-2 vaccination this morning. The patient is evaluated emergently. CPR was ongoing with 3 rounds of epinephrine given. The patient remains in asystole. He has rigor mortis. The patient's pupils are fixed and dilated. The patient has compressions paused and ultrasound is used to evaluate for cardiac activity. None is detected. The patient has no electrical activity on monitor. The patient's time of death is 2113.

The vaccine was given on Monday. Tuesday afternoon he developed weakness in both legs and could not stand up. This was a new development; he had neuropathy in one leg but he had been able to stand up and walk three hours before. He was helped to the bathroom. He said he felt better and might want to stand up again. He was helped to bed. He was found dead around 5:30 Wednesday morning. He was 94 years old and had a lot of medical conditions. No one has indicated his death had anything to do with the vaccine. I'm sure it's just a coincidence that he died so soon after receiving the vaccine

Pt with underlying COPD and chronic respiratory failure requiring BIPAP. Pt had cardiopulmonary arrest on 2/24/21 and died as a result. Pt was overall palliative-focused plan of care.

Patient became ill with pneumonia on 1/29/21 and then recurrent pneumonia on 2/10/21. Pt's plan of care was subsequently changed to comfort-focused on 2/11/21 and patient was deceased that same day.

started him on his oxygen; O2 went from 85 to 98; bp 155; notably shuffled; became non-responsive; looks like he is having a stroke; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Feb2021 13:45 (at 94-year-old) at single dose (Arm Right) for COVID-19 immunization. Vaccination facility type is clinic. Medical history included congestive heart failure, early stages dementia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 04Feb2021 (at 93-year-old) on right arm for COVID-19 immunization. The patient had no covid prior vaccination. Patient has no known allergies. The patient (father) seemed to be doing fine until 19:45 on 26Feb2021 roughly 30 hours after vaccination. He has early stages dementia, so if he was feeling ill he didn't report anything, and they didn't notice anything. He got up from the table, notably shuffled the 10 feet to the bathroom, sat down on the toilet before we could "pull down his pants", and then became non-responsive. The reporter said to her son it looks like he is having a stroke. They got him onto the floor. started him on his oxygen concentrator (usually used only at night), O2 went from 85 to 98; bp 155 from an unspecified date. after a while he came to. he is dnr, dni, so they didn't call an ambulance. Eventually they got him up. no signs of stroke. He does have congestive heart failure. This has never happened before, and he has no history of falling. Daughter was reporting the next morning. He has not yet been awake since this occurred. it is now 8am 27Feb2021. Covid was not tested post vaccination. The outcome of the event o2 went from 85 to 98 was recovered, while for other events was unknown. Information on the lot/batch number has been requested.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was community acquired pneumonia.

Pt had long complicated course spanning almost a month. He was initially admitted for right intertrochanteric hip fracture (following a fall at home) for which he required surgery. Also had bacterial pneumonia and received Zosyn. He was close to discharge at 1 point but then had Covid testing done which came back positive. He gradually worsened from there with acute hypoxic respiratory failure and very poor oral intake. He had multiple episode of hypoglycemia and required D5. He was made care only but improved on his own and was back on medical Mx. It did not last long and he again became very tachypnic in 60s and hypoglycemic. He was made care again. Pt passed away peacefully with his daughter at the bedside on 3/11/21 at 11 AM Causes of Death: 1. Cardiopulmonary arrest due to reason #2 2. Failure to thrive due to reason #3 3. Old age and COVID-19 No autopsy performed.

Within two hours of the vaccine, my father was unable to walk, suffered severe weakness, and had severe shortness of breath. The weakness, inability to walk, and shortness of breath lasted in a severe state for 48 hours. After that, he continued to be unable to walk, suffered weakness and had shortness of breath until he died. He never recovered the strength and vitality he had prior to the 2nd vaccine. That 2nd shot shortened his life and killed him.

4/22/2021 Tested positive for Covid-19 discovered during Universal Swabbing on Specific Unit. Resident was asymptomatic. COVID-19 screening were completed every 4 hours. 5/3/2021 COVID-19 screening revealed runny nose, declining meds and combative. Urine tea colored and foul smelling, Poor PO Intake. 5/4/2021 resident appeared uncomfortable and distressed with increased respiratory rate. Morphine and Ativan given for comfort measures. 5/5/2021 Deceased.

Had a stroke 3 days after round one of Covid vaccine and subsequently died the next week due to complications of stroke. Upon admission to hospital, was in afib.

L hand edema, hematoma which burst and caused bleeding sending pt to the ER for pressure dressing and 2 stitches. L hand and arm progressively got more edematous and bruised looking (severely black/blue/purple) and the hand continued to bleed and swell on 2/6/21. Severe arterial and venous issues and apparent blood clots. On 2/7/21 there were also lumps noted on left inner thigh. Pt. stopped eating or drinking on 2/8/21 and expired on 2/12/21.

Death due to underlying condition for hospice pt. Narrative: This was a 95 yo patient residing at home with daughter. Patient reported to PCP on 1/4 c/o poor appetite and weight loss. Daughter reported that patient was very frail and requested a hospice referral. Outside medical records indicate that patient was dx with pneumatosis of the cecum and peritonitis. Patient also had severe atherosclerotic disease with near complete occlusion of the infrarenal abdominal aorta. Due to age and frailty, patient was placed in hospice care where he passed away on 1/22/21.

Deceased Narrative: Patient was outpatient, there is no information about reactions, underlying or active conditions between the time they came in for their first Pfizer dose and their death.

3 days after vaccination, person was somewhat disoriented. 4th day after vaccination, patient fell, hit head and developed subdural hematoma from which he subsequently died.

Patient seen at my office 3/18/2021 (ambulatory). Had dose 2 on 3/19/21. The next morning around 5am (3/20), he had difficulty get to bathroom. Was holding onto the sink because his legs would not work. Family had to help him use bathroom and get him back into bed. Family got him bedside commode that day and even then had severe weakness like a "bowl of jelly". Had mild cough and neighbor listened to lungs and was clear. Cough cleared and had labored breathing intermittently. His breathing became more labored and he slept a lot and then breathing "kind of erratic" and then breathing slowed down and got slower and slower until he stopped breathing altogether. Passed on 3/21/2021.

Per family and health department report, patient died at home. No treatment or assessment performed. Patient family reports death caused by complications r/t bladder cancer. No further details released.

Patient continued to deteriorate after second dose of vaccine with progressive weakness and shortness of breath. When he presented to the emergency room he had new onset cardiomegaly and heart failure. Patient also developed new onset atrial flutter but had bradycardia due to AV heart block.

Came in ED due to a fall and rhabdo. Found to have NSTEMI Monitored symptoms. started on plavix and switched statin to atorvastatin and metoprolol tartrate to succinate discharged home

The resident was found deceased a little less than 12 hours following COVID vaccination, and he had had some changes over the last 2 days. He was 96 and had been on hospice care for a little while. Noone noticed any side effects from vaccine after it was given

PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21. PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE. HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT. HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND. HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS. EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING. EMS NOTED URINARY BAG HAD GROSS HEMATURIA. PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT. PATIENT COMPLAINS OF PENILE PAIN. NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA. ASSESSMENT UPON ADMIT: *CONTINUATION SEE BELOW PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21. PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE. HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT. HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND. HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS. EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING. EMS NOTED URINARY BAG HAD GROSS HEMATURIA. PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT. PATIENT COMPLAINS OF PENILE PAIN. NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA. ASSESSMENT UPON ADMIT: THROMBOCYTOPENIA (PRESUMED ITP, CAUSE? VACCINE?), DEXAMETHASONE 20MG PO DAILY. AMINOCAPROIC ACID 5GM IVPB X1 DOSE, 1 UNIT FFP, 2 UNITS PLTS PHERESED

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 95 and admitted to ED on 2/26/21 with leg edema and diarrhea. Had periods of bradycardia in the 40s during admission. Diagnosis was heart failure exacerbation which caused a significant decline in his condition resulting in eventual palliative care before his death. Notable comorbidities include CAD s/p cabg, T2DM, HFrEF, CKD, HTN, recurrent UTIs.

COVID-19 infection with pneumonia: Present on admission. Patient was treated with remdesivir and convalescent plasma.

died; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A 97-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 at 97-years-old at a single dose for COVID-19 immunization; administered by the nursing home. Medical history included glaucoma from an unknown date and unknown if ongoing. Concomitant medications included: "used a sav for skin tears", and "eye drops for glaucoma" from an unknown date to an unknown date. On 07Jan2021, the patient experienced: tested positive for COVID (medically significant). The patient died (death, medically significant) on 17Jan2021. The clinical course was reported as follows: The reporter stated that in regard to the patient's height and weight: "was probably getting down to about five foot eight. Shrinking." The reporter stated that If she remembered correctly, they were trying to maintain the patient's weight 135 to 136 pounds. The reporter stated that her father was in a nursing home. The patient received his first dose of the COVID vaccine on 30Dec2020. The patient died on 17Jan2021. The reporter stated that she "wanted Pfizer to know that the little old people in the nursing might not be strong enough for the vaccine." The reporter stated that she was "not calling to complaining." The reporter stated that there was nothing wrong with her dad. He was elderly with no health issues. "He was literally on no medications. The only reason he was in the nursing home was because he was afraid to walk." The reporter stated that she received a call about giving the patient the vaccine and she said yes because she wanted him to have the vaccine. One week after the vaccine, the patient tested positive for COVID "like all the other people" (no further details provided). The reporter stated that her dad had no symptoms of COVID. The director of nursing said the patient was doing so well. The patient ate his lunch, he laid down for nap, and at 14:30 he was gone. The patient "went peacefully in his sleep." The reporter then again stated that the patient literally had nothing wrong with him. "They were shocked. They fed him and he took a nap. He was sleeping, but it was eternally." The reporter stated that, "it might not have been the Pfizer vaccine, maybe his heart wore out." In regard to an autopsy: the reporter stated that they would get it done if needed. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021. History of all previous immunization with the Pfizer vaccine considered as suspect: none. It was unknown if there were additional vaccines administered on the same date of the Pfizer suspect, but the reporter doubted it. There were no prior vaccinations within 4 weeks. There were no adverse events following the prior vaccinations. The clinical outcome of the event, died, was fatal. The clinical outcome of the event, tested positive for COVID, was unknown. The patient died on 17Jan2021 due to an unknown cause of death. An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: died

COVID-19; Chronic heart failure with preserved ejection fraction; Elevated brain natriuretic peptide (BNP) level; Fatigue; Hypokalemia; Hyponatremia; Need for vaccination

Death 2 days later; This is a spontaneous report from a contactable Other HCP. A 97-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular in the left arm on 18Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included prostate cancer, macular degeneration, type 2 diabetes, atrial fibrillation. No known allergies. Concomitant medications included glipizide, warfarin and metformin in two weeks. The patient had no other vaccine in four weeks. The patient experienced death on 20Jan2021 at 09:00 PM. Death cause was undetermined. No autopsy was performed. No treatment was received for AE. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the event was fatal.; Sender's Comments: Event unknown cause of death is assessed as Related until sufficient information is available to confirm an unrelated cause of death or if there is sufficient information to allow an unrelated causality assessment. Case will be reassessed when follow-up information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death 2 days later

Early in the shift on January 31 resident was noticed to be more tired than usual and was not eating well. Lung sounds were crackly and resident was found to be hypotensive. He was evaluated in emergency department. He was diagnosed with pneumonia. Received a loading dose of antibiotic and returned to facility.

On 01 February 2021 a 97 year old male was administered the Pfizer COVID vaccine. Side effects began as fatigue and difficulty communicating. On 08 February 2021 the male became bedridden and developed a fever with chills. Over the next few days he struggled to eat, drink, and eventually to breath. The 97 year old died 25 February 2021.

Pfizer-BioNTech COVID-19 Vaccine treatment under Emergency Use Authorization(EUA): The decedent received their vaccine and had no reaction. He was found dead in bed the next morning.

Breakthrough case: Patient was hospitalized on 4/2021 after developing acute hypoxemic respiratory failure. Per limited notes, he first tested positive for Covid on 4/13/21 and was transferred to a dedicated Covid facility. His status worsened and he was admitted to the hospital on 4/20/21.

Grandfather died within a week and a half after his vaccination; This is a spontaneous report from a contactable consumer. This the first case out of six cases. Patients grandson reported for the patient (reporters grandfather) that a 97-year-old male (same age during vaccination) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021, as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. Reporter stated that So, he doesnt exactly know. His grandfather was the first phase to get the Pfizer vaccination (Confirmed as Pfizer Covid 19 vaccine) back in March (Further not clarified). He was in a residential home with 5 other elderly residents with him. They all got vaccinated with the first Pfizer shot (Confirmed as Covid 19 vaccine) and they all died within the 5 weeks after their first shot. Honestly the only thing that he can pinpoint with my aunt and other people and loved ones we have talked to come together because only two of the residents were on hospice and the other people were not on hospice. They should not have died they just died. he doesnt know if it was a side effect, he knows if it was a reaction but all of the six residents that got vaccinated died within their first vaccination shot. Within the 5 weeks after the first vaccination. He was not sure other residents got the second vaccination, but his grandfather died 09Feb2021. Reporter stated he only have detail for his grandfather and other residents, and they died in their sleep supposedly. They died in their sleep. Both of them died in their sleep (Further not clarified hence not captured in tab). He just feels, his grandfather was not on hospice he was healthy considering the underlying problem that they had but they were supposed to get vaccinated with the Moderna and the day that we got there they changed the vaccination to Pfizer. So, they had the on-duty nurse there to answer any of the questions that we had. We asked then all the questions we had. We felt ok with it, everybody got vaccinated that day. My grandfather died within a week and a half after his after vaccination. So, he didnt get the second and by the middle of march their resident also died. The only thing I can tie to it is the first dose of Pfizer vaccination. Regarding Height and weight reporter stated he do not know exact. he wont say he was 5 (feet) 8 (inches) when he passed away, he believed either between 115 (pounds) and 120 (pounds) when he passed away. Outcome of the event was fatal. Information related Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021618004 same reporter/SD/AE, different patients;US-PFIZER INC-2021616779 same reporter/SD/AE, different patients;US-PFIZER INC-2021617301 same reporter/drug/AE, different patients;US-PFIZER INC-2021616796 same reporter/SD/AE, different patients;US-PFIZER INC-2021616788 same reporter/SD/AE, different patients; Reported Cause(s) of Death: Grandfather died within a week and a half after his vaccination

5/3/21 this gentleman reported several days of Left lower leg pain. Ultrasound completed positive for left lower leg DVT. Pt was on chronic Coumadin therapy at that time with therapeutic PT/INR 2.7. Symptoms progressed and ongoing despite initiation of Eliquis. On 6/8/21 he underwent placement of IVC filter to protect from further clotting injury.

97 Male PCR positive 4/28/2021. Vaccinated with Pfizer 1/6/2021 & 1/28/2021. Hospitalized 4/28/2021- 5/6/2021 for COVID PNA & fatigue, SOA, diarrhea. Placed on Rocephin for UTI. Required more than 4L of oxygen, decreased appetite. Developed hematuria due to Pseudomonas. Transferred. Passed away 5/13/2021.

OBJECTIVE: Patient found deceased on March 26, 2021, less than one week post vaccination with Pfizer-BioNTech COVID19 vaccine dose #1. Found by daughter who is also RN and caregiver. Patient found with black tongue protruding slightly from open mouth. Three days post vaccine date and for three days patient found mouth-breathing heavily. When patient?s attention was called to his breathing he immediately resumed normal breathing. Also three days post vaccine date and for three days patient had loosened waist belt and offered complaint of feeling full. Also, Patient was more talkative during the week following vaccination. SUBJECTIVE: Perhaps related to anxiety. OBJECTIVE: Patient had eaten only one avocado per day for his remaining two days of life. Patient had history of stoicism and was known to downplay or deny deviations in physical well-being.

Major Complex Seizure with post-ictal period of 2 hours, occurring 3 hours after receiving injection. 16 days later on March 6, 2021 was unable to void, sustained breathing difficulty with peripheral edema. Received diuretic from Nurse,. Indwelling Catheter was inserted. On day 17, after receiving Corvid Vaccine, DECEASED on March 7, 2021 at home. Sustained Complex Seizure 6 hours prior. Death Certificate ruling Cause of Death as Cardiac Arrhythmias.

Decedent had unwitnessed fall out of wheelchair 1/25/21 around 9:43am, denied head strike, pain, discomfort. Around 10:02pm, 1/25/21, decedent noted to have slurred speech and fluctuating HR, transported to Hospital and made cmo.

Death Narrative: admitted to hospital on 12/29/20 due to Covid-19 PNA. PMH includes MRSA+, CHF, COPD, HTN, HDL, Meniere's. 1/12 DC to NH where he rec vaccine. 2/7 pt passed away at NH 2/7/21.

100 year old patient in reasonable health (reading, socializing, doing Zoom calls, etc.) took second Pfizer vaccine on February 5, 2021. On the morning of February 22, 2021 the patient suffered a major hemorrhagic stroke. He suffered severe paralysis, could not speak, and suffered from severe pain. Within 24 hours he was moved to Hospice Care. A day later on February 24, 2021 he died.

NA- patient refused second dose of vaccine - Patient condition at time of death Chronic Conditions Renal failure Advanced age 100 y/o Cardiopulmonary arrest secondary to Covid 19

Adverse reaction to the vaccine started with variable weakness beginning 1/29/2021. On 1/30/21 around 8:30pm, he needed assistance in the bathroom related to weakness and had what was later identified as a stroke with left side weakness and slurred speech. In accordance with his wishes, he had care at home. Due to his advanced age and frailty, a CT scan was not pursued. The 325 mg of aspirin that he was previously taking daily was discontinued. After the stroke, he needed total care. Hospice was established at home. Nursing assistant care was delivered by daughter. Death followed 9 days later (2/9/2021).

Patient contracted covid 2 months after receiving the full vaccine series. He was admitted the hospital and subsequently passed away. Variant testing was conducted (results are pending) and antibody testing was done. Antibody testing showed no antibodies were produced in response to the vaccine.

Pt received his 2nd pfizer covid 19 vaccine on March 11 (the lot number was not written on the card unfortunately) and was hospitalized from 5/21-6/4 with new onset profound hypotension and new onset atrial fibrillation with a bradycardic rate.,requiring ICU admission and pressor support. He presented with a fall and was found to be profoundly hypotensive. Sepsis was ruled out and the cause was unclear. He was eventually started on midodrine . He did not require any rate controlling medication. His daughter did not want anticoagulation ordered due to risk outweighing benefit. He was diagnosed with new autonomic dysfunction and new atrial fibrillation and discharged home on 6/4/21

Patient presented to the ED and was subsequently hospitalized with CVA. This is within 6 weeks of receiving COVID vaccination.