Pfizer

3:07 pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats remained low for next 36 hours ( patient on Hospice care ) expired 6:22 am 1-8-21

Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP, Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine "administered without complications." Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI Bleed in the death note from 01/10/2021

Patient remains hospitalized but respiratory symptoms are improving, AST/ALT are down-trending, & PT/INR returned to normal. Symptoms: Bleeding, Abnormal INR & ElevatedLiverEnzymes

Per EMS, the patient was last seen walking and talking to wife 10 minutes prior to EMS arrival. EMS reports via patients wife, that patient was upstairs to change for his doctor appointment then patient's wife found him down. The patient received his COVID-19 vaccine on 1/25/21. EMS states they gave 5 rounds of EPI then patient moved into vfib then was shocked once but returned to asystole. In ED, the patient initially in asystole CPR was started immediately. The patient was given 3 rounds EPI, 1 round bicarb. The patient stayed in PEA throughout. Patient was given tPA. Patient continued to be in asystole and time of death was called at 11:35 am.

Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling "bad" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival. Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.

HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and ACLS guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and ACLS guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.

Patient presented for second COVID vaccine (1st dose given 1/21/21). While in observation, patient started feeling chest & throat tightness. Nurse in observation reports pt looked anxious. EMS was called over. EMS assessed patient and advised transfer to emergency department. Patient was taken to ER. At the ER, patient was diagnosed with chest tightness and shortness of breath. He received 325 mg of aspirin. EKG showed rate 63, no ST-T changes, no ectopy, normal PR & QRS intervals with rhythm atrial fibrillation. No epinephrine was given in the field (at vaccination site) or while in the ER. Patient was in NSR at time of discharge with recommendation for close cardiac follow up.

Patient received initial COVID vaccine on 2/11/2021 at Clinic. Direct observation for 15 minutes and no documentation noting an adverse reaction. On 2/14/2021 was diagnosed with Sepsis secondary to pneumonia, started on antibiotic therapy, cardiac arrested, and expired on 2/14/2021 while at Hospital.

Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.

BECAME VERY, VERY COLD AND HAD VERY BAD SHAKES. SIMILAR TO ANTIPHLAXIS REACTION I HAD TO 2 ANTIBIOTICS- CIPRO & METRONADOZLE. WENT TO BED WITH CLOTHES ON AND SEVERAL BLANKETS. LASTED 5-6 HRS. NEXT DAY WORN OUT. 3RD DAY FEELING BETTER. I DID NOT HAVE SWELLING OR CLOSURE OF MY THROAT. I DID NOT SEE A DOCTOR .

Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and "losing stamina". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later.

DEATH Narrative: patient's wife reported he had gone in an outside hospital, had held his brilinta as advised anticipating shoulder surgery "and he threw a big clot and died."

Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14. Was admitted to Hospital. Found to be COVID +, required O2 per NC 2-3 L for approx 24 hours. Was found to have NSTEMI. Was transferred for speciality/cardiology care at General Hospital. Was on heparin gtt. Cardiology-no intervention. Was not treated for COVID and was discharged to home on 2/16. Was unable to care for himself at home and was readmitted with in hours. He has failed discharge twice and is being now discharged to SNF

Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positive ultrasound exam.

THE PATIENT HAD PASSED AWAY AND WAS UNABLE TO GET HIS SECOND SHOT TO COMPLETE THE SERIES. WE ARE UNSURE IF THE VACCINE WAS RELATED TO HIM PASSING.

intraparenchymal hemorrhage, right occiput; This is a spontaneous report from a contactable nurse (patient). This nurse reported that a 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) at the age of 76-years, via an unspecified route of administration on 04Feb2021 17:30 at single dose for COVID-19 immunisation, in hospital. Medical history included MGUS; thyroid nodule; hyperlipidemia; single episode A fib. Patient had no known allergies, no COVID-19 prior vaccination, no other vaccine in four weeks. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin; colecalciferol (VIT D3); cyanocobalamin (VIT B12); rivaroxaban (XARELTO). The patient historically received first single dose of BNT162B2 (lot number: EL3247) at the age of 76-years on 14Jan2021 05:45 PM for COVID-19 immunisation. On 09Mar2021, the patient experienced intraparenchymal hemorrhage, right occiput. This adverse event resulted in emergency room/department or urgent care, 5 days of hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient received XARELTO reversal and osmotic fluids to reduce brain s as treatments. The patient underwent lab tests and procedures, which included on 11Mar2021, COVID-19 test (Nasal Swab) was negative. Outcome of the event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Minor Stroke affecting the right side (hand and leg). Went to emergency room Monday and Tuesday (3/1/21)

He had his Vivid shot and awoke blind in left eye 4 hours later. Went to ER and then on Friday went to eye Dr. at clinic.

2/17 received 1st dose vaccine, Pfizer 2/20-3/9 admitted. Found to have seizures (twitching of upper extremities, aphasia). 2/24 RML pneumonia. Found to have MSSA bacteremia and bacteriuria. Transition from vanco/pip-tazo to cefazolin Mental status improved and he was sent on cefazolin which he was to complete on 3/26/21. Was not sent out on seizure prophylaxis. 3/23 second dose Moderna. Had recurrent seizure on 3/27. Evidence of post central stroke. Expressive and receptive aphasia.

blood pressure dropped really low; pulse went really high; heart rate went up; atrial fibrillation; his blood pressure and pulse have remained erratic; his blood pressure and pulse have remained erratic; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 10:30 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), at the age of 76-years at vaccination, as SINGLE DOSE for COVID-19 immunisation . Medical history included congestive heart failure, aortic valve replacement couple of years ago. Concomitant medication includes aspirin 325mg once per day by mouth. On 05Mar2021, the patient went into Afib, his heart rate went up and the next day on 06Mar2021, his blood pressure dropped really low but his pulse went really high and carried it that way for a few days and then he went pretty much back to normal. On 05Mar2021, the patient experienced atrial fibrillation for 22 hours and since that time his blood pressure and pulse have remained erratic. The reporter stated that the patient has returned to normal and his pulse is still a little high and his pulse used to run in the 70's and maybe 80 but today (15Mar2021), the pulse was still 95; on 06Mar2021, the patient took his blood pressure twice and is not sure at what time he checked it but one time it was 98/65 and the pulse was 114 at that time and the other time the blood pressure was 88/59 and the pulse was 115. States the patient's blood pressure pretty much turned back to normal on 10Mar2021 and the blood pressure started being normal on 10Mar2021. On 15Mar20021, the patient's blood pressure was 140/76 and the pulse is still real high at 95 today and he weighs himself, takes his blood sugar and blood pressure every day. Regarding the treatment, the reporter and the patient saw the patient's cardiologist this past Friday 12Mar2021 and put the patient on Metoprolol and the blood thinner Eliquis; states the patient was just taking a whole Aspirin and had previously had aortic valve replacement a couple of years ago and the HCP reduced his aspirin dose down to a low dose of Aspirin and then put him on the Eliquis at the HCP appointment. The reporter stated, for the Metoprolol and Eliquis she does not know the dosages or frequency of how the patient takes them at this time; states she has no lot numbers for the Metoprolol, Eliquis or Aspirin to provide as they are not with her at this time. The outcome of the event his blood pressure and pulse have remained erratic was not recovered; while the other events was recovered. Treatment has been given for the events.

death Narrative: not thought to be associated with the covid vaccine, had clear other reasons for demise

On December 30th my father tested positive for COVID. He was reported asymptomatic by the care facility staff. He was given vaccine on Jan 14th and began feeling ill that evening. The morning of the Jan 15th the nursing facility had my father admitted to emergency and then to ICU. He stayed in the hospital for 10-14 days and then was released on hospice at the senior care facility. He passed away on Jan 31st. I'm not sure if the sudden change in my father's health was due or made worse due to the COVID vaccine as the hospital was treating several symptoms, but the timing seems suspicious. I have also not been able to get an explanation for why he was given a vaccine if he tested positive. I do not know which vaccine was given, but needed to select one to submit the form.

DVT L leg, possible PE; DVT L leg, possible PE; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 09Mar2021 (at the age of 76 years old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took NSAIDS. The patient experienced DVT L leg, possible PE on 12Mar2021. Treatment given included Eliquis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was recovering. Information on the batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events deep vein thrombosis and possible pulmonary embolism occurred in a plausible temporal relationship. 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.

During my annual physical scheduled on 03/10/2021 at approx 11:00AM, my Primary Care Physician, listened to my heart and commented that it was irregular. He had his nurse take an ECG and after his review he said that I had new onset Atrial Fibrillation. He prescribed the blood thinner, Eliquis 5mg twice daily, and recommended that I schedule an appointment with my Cardiologist. I had an appointment with cardiologist on 03/17/2021 and he confirmed my Atrial Fibrillation. He scheduled me for a Transthoracic Echo (TTE) Complete with PRN definity on 04/08/2021 which was completed. It must be noted that annual visits to my three doctors over a past period of 5 years, never showed that I had an irregular heartbeat or Atrial Fibrillation prior to its first discovery by PCP on 03/10/2021, exactly one week after my second Pfizer Covid 19 vaccination.

D69.6 - Thrombocytopenia (CMS/HCC) U07.1 - COVID-19 D72.819 - Leukopenia R77.8 - Elevated troponin I level J18.9 - Multifocal pneumonia U07.1, J12.82 - Pneumonia due to COVID-19 virus

Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS.

Patient hospitalized with covid-19 late November of 2020. Then received 2 doses of Pfizer vaccine on 1/13 and 2/2 of 2021. He has myelodysplasia and is receiving Vidaza. He was admitted on 3/19/21 with PNA symptoms. last cycle of Vidaza was 2/22/21-3/2/21. he tested positive for SARS-CoV-2 RNA x2 on admission. Uncertain if delayed shedding or reinfection. CXR with LUL Pneumonia. WBC 0.5, ANC 0, Procalcitonin initially 1.14 peaked next day at 14.7. patient was initiated on dexamethasone, piperacillin-tazobactam, and doxycycline. clinically felt to be more of a bacterial process, but could not rule out COVID-19 re-infection.

Ischemic stroke with paralysis on left side of body, impaired speech, swallowing, cognitive functioning

After the first vaccine: Leg pain, foot pain, chest pain. Four days after vaccine, the chest pain was so bad that my dad went to ER and had a Pulmonary Embolism . He was hospitalized two nights. After the second vaccine: right leg pain, weakness in both legs. Three days after the second dose, my dad had a stroke.

Had average Saturday at home, no illness. Layed in bed talking. Became nauseated, got up to vomit. Went back to bed, talking again. Said something wasn't right. Massive Heart Attack and Immediate Death. Police arrive in 2 minutes to begin CPR. Medic soon after. Efforts to resuscitate unsuccessful.

The day after my second shot I went into Atrial Fibrillation. This lasted for 6 days. I have never been diagnosed with this, but have had infrequent bouts with PVC's. Diagnosis was made at Hospital ER a few days after onset of symptoms. Visited my Cardiologist about a week after that, but by then my symptoms had disappeared. It is now about 3 months after this episode and I have had no irregular heartbeats since.

developed a thrombosis on the left arm; varicose veins on the arm; whole arm is swollen; veins are swollen; burning pain in left lung, and it goes up to the breast and lymph nodes/ discomfort on left side Lung; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; has tenderness near the wrist and elbow, clarifying the inside of the elbow; felt numbness in the left arm; hot flashes; This is a spontaneous report from a contactable consumer (patient) and physician. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart conditions, he has had 2 heart attacks in the past, the first one was 21 years ago, and the second was 2 years ago. Concomitant medications included all his regular medications, nothing new; (also reported as No other products). Patient previously received BNT162B2 first dose on 13Feb2021 administered in left arm for COVID-19 immunization. Patient developed varicose veins a month after he received both his shots for Pfizer's COVID vaccine. Caller stated veins are swollen. It's coming down some, but patient need to know what medications could take or not take. On the left arm right inside of his elbow, he started getting some pattern of varicose veins. It was tender to some degree and people told him to massage it and put a warm pad on it. Seems like the veins were going to pop out. Patient stated he received his vaccine at a hospital. On 03May2021, reported patient was calling in regards to a covid vaccine. He developed a thrombosis on the left arm, it was varicose veins on the arm and the whole arm is swollen, it was still swollen but it was coming down. He had been using a heat pad. Initially after 2 weeks from when he got the shot he wasn't concerned, he went to the doctor and they gave him Cat scan, Ultra sound, and blood test and did not find a blood clot. He added that he had discomfort on left side Lung, but he had discomfort several years ago, an MRI in the past that showed he has a spot in the lungs, but they didn't think it was progressing. With this thing in the past 3-5 weeks he has burning pain in left lung, and it went up to the breast and lymph nodes, it is sensitive there, he has no idea what it is. Caller was asked to clarify since he stated that he had a thrombosis but all tests show no blood clot. Caller stated that he thought Thrombosis meant when the veins are popping out and gives impression of varicose veins. He had tenderness near the wrist and elbow, clarifying the inside of the elbow. If looking at the arm from the elbow up little, it looked like worms coming out, it was veins or arteries showing. The varicose veins appearance was more pronounced close to surface initially but is now minimizing. First dose date on 13Feb2021. He was not concerned after the first dose, he was fine, he thought it was a good product and it still is. Second dose date on 10Mar2021. After the second dose he felt numbness in the left arm and hot flashes, he looked down and saw the varicose veins. He did go see the primary care doctor. He also saw his heart doctor but that was an already scheduled appointment, he did not schedule it because of this situation. the heart doctor said to put a warm pad on the arm and lift the arm up over the head every so often. Caller did not have his covid vaccine card, caller stated that he has miss placed it. He found some paper but it only has his ID number and "LHDSER" on it. He received the vaccine in the left arm both times. All symptoms occurred on the left side. He recieved the vaccine in a hospital. Patient asked to refer to his primary care doctor as he has all the results for the tests. Investigation included CAT scan normal; Ultrasound normal; Blood test normal and MRI abnormal which showed spots in the lungs on unspecified date. The event outcome for all events was unknown. Information for batch/ lot number has been requested.

Chief Complaint Patient presents with ? Cough ? Shortness of Breath HPI is a 76 y.o. male presenting to the ED for assessment of approximately 2 weeks of shortness of breath and cough that has been progressively worsening. Patient's wife did test positive for COVID-19 2 weeks ago. At this time patient has been taking over-the-counter cough and cold medications with no relief of symptoms. Patient does have a history of atrial fibrillation. Patient does take Lopressor daily. At this time patient denies any headache dizziness confusion chest pain nausea vomiting diarrhea abdominal pain dysuria rashes leg pain leg swelling. PCP: , DO

ED to Hosp-Admission Discharged 5/4/2021 - 5/10/2021 (6 days) Treatment team COVID-19 Principal problem Hospital Course HPI: Please see H&P for details Hospital Course: 76-year-old gentleman was admitted to hospital because of COVID-19 pneumonia and respiratory failure with hypoxemia secondary to it. He was placed on oxygen which was titrated. He was started on remdesivir and finished the course. Initially his condition got worsened and ID was consulted and he was given Tocilizumab. He also was started on dexamethasone from day 1. His condition has improved significantly. He is requiring 2 L of nasal cannula. At this point he is going to finish his course of dexamethasone as outpatient and he will be discharged home with oxygen. He was also educated about proning and he is very good at this. He also had remote patient monitoring arranged. He is going to follow-up with his PCP. Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) COVID-19 Yes Depressive disorder Yes Type 2 diabetes mellitus (CMS/HCC) Yes Chronic lymphoid leukemia in remission (CMS/HCC) Yes Pneumonia Unknown Acute respiratory failure with hypoxia (CMS/HCC) Yes

03/18/2021 FIRST COVID19 VACCINE 04/08/2021 SECOND COVID19 VACCINE 04/09/2021 FELT DIZZY AND FAINTED BREIFLY IN THE MORNING 05/03/2021 AT NIGHT, SLUGISH SPEACH, DIZZY, HIGH BLOOD PRESSURE 05/04/2021 WENT TO EMERGENCY ROOM AND HOSPITAIZED (STROKE)

3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had fallen and could not get up. He was brought to the emergency room, and a trauma evaluation was negative. He was found to have a severe junctional bradycardia with a heart rate in the 20s and systolic blood pressures in the 60s. In addition, he was found to have a creatinine now of greater than 5 when his previously had been in the low 1s. Patient admitted with junctional bradycardia, acute renal failure, hypotension, cardiogenic shock, and acute hypoxemic respiratory failure with high O2 needs. PMH significant for CAD, pulmonary HTN, aortic stenosis, obstructive lung disease, and chronic hypoxia. This patient has been made DNR/DNI over the weekend which is quite appropriate. Patient was found to be unresponsive with fixed/dilated pupils, absent heart and breath sounds, no respiratory effort, absent pulses, and no response to painful stimuli. Patient was pronounced deceased on 03/10/2021 at 0405.

ED to Hosp-Admission Discharged 4/28/2021 - 5/4/2021 (6 days) CRNP Last attending ? Treatment team COVID-19 virus infection Principal problem HPI: For complete history and physical see the H&P dictated by Dr. on 4/28/2021. This is a 76-year-old male who presented to the emergency department with upper respiratory symptoms for three days. He reports having cough, sneezing, runny nose and poor appetite. His caregiver had Covid recently and he was exposed. He was admitted for further evaluation and treatment. Hospital Course: Patient was admitted inpatient to the medical surgical floor. He was not on telemetry. Patient reports that his caregiver had recently tested positive for Covid and he was exposed. He has been having upper respiratory symptoms including cough, sneezing, and runny nose. His COVID-19 test was positive. He was started on the COVID-19 treatment protocol which included IV remdesivir and IV dexamethasone. He underwent a CT scan of the chest which showed small patchy areas of groundglass infiltrates in the peripheral portions of the left and right upper lobes and also the posterior aspects of the right lung base. These findings are probably due to pneumonia. Hospital course consisted of gentle hydration with IV normal saline. He was also started on antibiotic therapy oral azithromycin and IV Rocephin. He had completed the course of antibiotics while on the unit, therefore, at the time of discharge no antibiotics were prescribed. He initially was hypoxic and started on nasal cannula oxygen to maintain pulse oximetry greater than 92%. Eventually, oxygen was weaned and pulse oximetry on room air has remained in the 95-96% range. He has a history of diabetes mellitus and while on the unit blood glucose levels have fluctuated. His point-of-care glucose have been in the 80-500 range. He has had numerous episodes of hypoglycemia and insulin has been adjusted. The fluctuations of the blood glucose levels may be secondary to IV dexamethasone. At the time of discharge he will continue dexamethasone 6mg daily for the next three days. He was advised to increase insulin 70/25 insulin five units daily for the next thre days. After that time he can return to his normal dose of insulin. He also had been treated with IV remdesivir and had completed the 5-day course. On examination today he has been asymptomatic. He denies any chest pain, dyspnea, abdominal pain, nausea, or vomiting. The initial lab studies showed an elevated creatinine level, although he has a history of chronic kidney disease. At the time of discharge the creatinine level trended downward and he was advised to follow-up with the primary care provider for possible repeat BMP in 1 to 2 weeks. All other lab studies have been within normal limits. The systolic blood pressure has been in the 120-150 range. The most recent systolic blood pressure was 151/66 mmHg with a heart rate of 66 bpm. He denies any lightheadedness or dizziness. He was advised to continue all of his current medications. While on the unit he was in isolation secondary to COVID-19. At the time of discharge he should maintain social distancing/isolation, mask wearing and good handwashing. He will will need to follow-up with the primary care provider. He was also advised if the oxygen level dips below 89% he will need to return to the emergency department. At this time he is resting comfortably, offers no complaints and is stable for discharge. Patient is alert, oriented answering all questions appropriately. He is continent of bowel and bladder. Heis able to make his own decisions. He is able to performhis own ADLs. . At this time he is in agreement with the plan and feels comfortable to be discharged home. Thank you.

AFIB incident . Dr. sent me to ER for cardizem and EKG. Have been on Metoprolol 25mg twice a day along with Eliquis 5mg twice a day. Prior to the vaccination had no heart condition.

I had a severe reaction to my 2nd Pfizer shot with projectile diarrhea for 3+ days! This seems unlikely since it occurred 9 days after the shot but there's no other explanation. This left me so dehydrated that I went into AFIB and had to visit Emergency Room.

diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot. The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered and outcome for other events was unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter

Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021

7/3/2021 7:23:41 AM > phone call from Officer pt deceased. discussed with wife. she heard him make a loud breathing noise at 3am and then could not wake him. had been feeling well with no complaints. planned to run a road race this Sunday. offered support. pls mark chart and then FYI to Dr.

The day after getting the vaccine I went into atrial fibrillation and I have never been diagnosed with that before, so I went to the ER in hospital and got that diagnosis. They did a blood panel, and everything was ok, and an EKG which they used to diagnosed A fib. About a week after I saw my cardiologist and the atrial fibrillation had resolved itself, I was in A fib for about 5 or 6 days. I was in sinus rhythm now. The cardiologist increased my Metoprolol a little bit, I was taking amount twice a day and we increased that to other amount twice a day. I have not been in A fib ever since; I have been in sinus rhythm almost for 6 months now.

After the first vaccine he suffered a massive brain bleed. Then in the nursing home he contracted Covid-19 and was in Hospital Heart Transplant unit for 6 days. After 4 or 5 days back in the nursing home he contacted Covid-2 pneumonia. His balance is off he has memory loss and a lot more.

TIA - Transcient Ischemic attach; Both vaccines was administered on same day; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (at the age of 76-year-old) (Batch/Lot Number: E200187) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 10May2021 13:00 (Batch/Lot Number: EW0167) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included glaucoma and cardiac disorder. Concomitant medication included acetylsalicylic acid (ASPIRINA); carvedilol (CARVEDILOL) and furosemide taken for an unspecified indication, start and stop date were not reported. On 04Jun2021 13:00 the patient was hospitalized for tia - transcient ischemic attach for 2 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Patient do not have any allergies. Patient tested positive post vaccination. Patient received treatment for adverse event as Physical Therapy. Post vaccination the patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jun2021. The outcome of event was recovered and unknown for both vaccines was administered on same day. Follow-up actions are needed. Further information has been requested.

patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020

Possible seizer, unknown at this time, aprox 1hr and 20min after vac given. Passed away aprox 2hrs after vac.

Patient arrived at ER with complaints of CPR in progress. Per EMS, patient became short of breath while performing yard work on 1/26/2021. At arrival, patient was in fine v fib with a total of 6 shocks delivered along with 300 mg amiodarone followed by 150 mg amiodarone, 1 amp epinephrine and 2 epinephrine drips adminstered en route to ED. CPR initiated at 1755 and EMS reports asystole at 1829. TOD 1909 pronounced by ED DO Dx: Cardiac arrest

Narrative: See "Other Relevant History" in Section 6 above Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib Treatment:

Narrative: See "Other Relevant History" in Section 6 above Other Relevant Hx: 76yo man with a history of for C5 tetraplegia 2/2 cervical stenosis leading to neurogenic bowel/bladder (chronic suprapubic catheter) and chronic respiratory failure with tracheostomy, severe dysphagia s/p G tube placement and multiple aspiration pneumonias, COPD GOLD III, hx MRSA bacteremia (7/2018) and E coli bacteremia (12/2019). Patient transferred from Spinal Cord Injury until to ICU on 1/11/2021 due to worsneing dyspnea, hypoxia (80s) and tachycardia and was found to have acute hypoxic respiratory failure likely 2/2 multifocal pneumonia. CXR findings of "There is interval increase in patchy airspace infiltrates and consolidation in bilateral lungs concerning for pneumonia" Patient was started on vancomycin and pip/tazo on 1/11 and tracheal aspirate cultures were obtained for VAP diagnosis which ultimately grew Serratia liquifaciens and Proteus mirabilis. Infectious Diseases was consulted who recommended a switch to ertapenem therapy for a total 10 day course for VAP. UCx/BCx remained negative. On 1/20, a therapeutic bronchoscopy was completed with cultures growing Stenotrophomonas maltophilia and pan-S Klebsiella pneumoniae. The following day a chest tube was inserted and the course of ertapenem completed but vancomycin was continued. By 1/22, patient developed shock liver with ALT/AST 2135/1579 from normal range the day prior and SCr increased to 1.3 from baseline 0.7/cystatin C of 2.46 up from 1.15. Levofloxacin was added for Stenotrophomonas coverage. By 1/25, patient's clinical status continued to decline and Cardiology was consulted for new onset Afib with RVR. Discussion was documented with patient's family who requested DNR. Patient passed away in the early AM on 1/26. Demise does not appear to be related to COVID-19 vaccination but occurred in recent timeframe. Symptoms: ElevatedLiverEnzymes & death, pneumonia, afib

Thrombocytopenia, SkinRash, Rash & ElevatedBunSCr Narrative: Petichial rash. Patient had IV contrast dye 1/19 no reaction. Patient on Apixiban for a. fib.

Patient was vaccinated at 11:30am. By 7pm he started presenting symptoms of fatigue, chest pain. Patient urinated and defecated in himself. Was not feeling well. Patient died at 10:30pm.

Client was administered the vaccine while symptomatic (01/25/21) although client did not know he was symptomatic for COVID-19. He had been exposed to a family member who had tested positive and should have been in quarantine but wasn't either because it was not felt he was considered a close contact by his family opinion or his family member never notified public health of this close contact...?. Clinet had presented to the ED following day after vaccination for shortness of breath and fatigue and an antigen test showed he was positive for COVID-19. He was sent home that same day 01/26/21. He was back in ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on ventilator. He passed away on 02/09/2021 (date of death was per his wife).

This patient received his 2nd dose of Pfizer vaccine yesterday. Today, he had focal weakness and difficulty walking and was transferred for suspected stroke.

I am 77 yrs old, male , , 150# and 5ft 6inches...Within 24 hours of receiving the shot, my body thru-up clots in my left leg. and I spent 4 days in the hospital ( 3 days in surgical ICU), breaking up the clots to save the leg. This is too much of a coincidence to ignore and I will not receive the 2nd shot.

Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.

Shortness of Breath causes by multiple large blood clots, put on blood thinners, seems to be fine, but has follow up appointment in March

2-3 weeks after COVID vaccination, patient presented to hospital with anemia and thrombocytopenia and intracranial hemorrhage. L axillary mass (same side as Pfizer vaccine admin site) found on exam. Bone marrow biopsy demonstrated Burkitt's Lymphoma. He is undergoing treatment at hospital

1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed. 2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and life support guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and life support guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.

Pulmonary Embolism right lung and blood clot in right leg. No travel or other events or activities are known that might have contributed to blood clots in leg and lung. Symtoms of embolism first appeared about 10 days following 2nd dose of Pfizer vaccine.

11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms worsened. Admitted to medical center for cath and stint placement.

2/9 received 2nd vaccine in series. 2/10 mild headache and fatigue. 2/11 worsening headache, extreme fatigue, and general malaise. In bed except for bathroom use and minimal food consumption starting 2/11 until hospitalization on 2/17/2021.

Sudden development of rash all over body, flushed face, tired, weak, headache, temperature 97.8, blood pressure 108 over65, pulse 75. Sat down, took prednisone 20 mg and benedryl. Symptoms lasted for a couple of hours. Rash took several hours to reduce. Continued prednisone overnight. Next morning seemed very improved. IT TRULY SEEMED LIKE AN ANAPHALXIS REACTION. Waiting for Health Dept. nurse manager to call back. As noted, this Anaphalixis occurred 72 hours after the vaccination.

Patient described the event as "severe anaphylaxis" that included redness all over the body and a rash on the face, with a strange feeling in the esophagus but no trouble breathing. The patient self-medicated with prednisone and did not seek medical care. Symptoms resolved later the same day they appeared. The patient indicated he had an appointment unrelated to this event scheduled with his primary care physician on March 3, 2021, and was advised to discuss the reaction with the physician at this appointment.

Patient passed away 24 hours after receipt of 1st Dose Pfizer vaccine. Provider does not feel death was due to vaccination. but underlying conditions. No immediate side effects noted from vaccination.

Patient received the first shot on 2/17/21. Nothing seemed unusual during the following days; no complaining of soreness or anything. He hadn't introduce any new medicine or food into his routine. On the morning of 2/21/21, he woke up around 5 AM as usual. He spoke with his wife for a bit. Around 7:00 AM, he started having trouble breathing. He asked for help from family members. 911 was called. EMT's preformed heart compressions for about 45 minutes before pronouncing patient deceased. During EMT's initial encounter, EMT's struggled getting a tube down patient's throat due to his tongue being swallon

Two days after receiving the vaccine the patient began experiencing shortness of breath. One week after onset of symptoms he presented to the hospital and was diagnosed with submassive pulmonary embolism. He underwent IR suction thrombectomy which removed 30% of the PE burden and spent two days in the ICU. He has now been transferred to the floor.

The patient is a 77-year-old male with T2DM (not on medications), gout, and HTN who received the first dose of the Pfizer COVID-19 vaccine on 2/14. On 2/17 (three days after vaccination), he sought care in the emergency department for chest pain that worsened when he was supine and shortness of breath. EKG in the emergency room showed STEMI and troponin levels were normal. He was transferred to a different facility for cardiac catheterization. Cath showed mild circumflex disease and a stent was placed. He was diagnosed with pericarditis at that time (elevated inflammatory markers ESR/CRP). He was discharged home post cath on Plavix/ASA. He had an echocardiogram at his PCP?s office on 2/25, results still pending (as of 3/10). 2/25 ? televist with cardiologist who concurred with pericarditis, maybe mild coronary artery disease (follow-up scheduled 3/11). 3/3 chest pain symptom improved further, no cough, improved shortness of breath. Medications at home: statin, previously colchine for gout, likely BP medication (PCP will send records) Allergies: None known. Vaccine Indication: Age >75

Patient went in to atypical rhythm junctions rhythm and atrial flutter and fib which was difficult to control. Our cardiologist says she?s been seeing a number of these post vaccine

3 days after 1st shot, I suffered a stroke; This is a spontaneous report from a contactable consumer (patient himself). This 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 02Feb2021 at 09:30 AM (at the age of 77-year old) at single dose for COVID-19 immunization. Relevant medical history included type 2 diabetes, kidney disease, heart failure, cutaneous T-cell lymphoma (CTCL) and allergy to lisinopril. Concomitant medications included atorvastatin (LIPITOR), metformin, losartan, potassium and acetylsalicylic acid (ASPIRIN). On 05Feb2021 at 01:30 PM, after 3 days from the first dose of vaccine, the patient experienced a stroke that resulted in hospitalization for 4 days. Treatment included CAT scan, MRI (with unknown results) and intravenous blood thinner. The outcome of the event was recovering. The event was serious due to hospitalization and life threatening illness (immediate risk of death from the event). Information on the lot/batch number has been requested.

Death Narrative: Patient received first COVID vaccine does on 3/13/21 at 07:53 without complications. Home telehealth nurse informed by family member on 3/18/21 the patient passed away on 3/13/21 at approximately 1300. Per medical record documentation, "Patient had been at facility getting COVID vaccine that morning at 0800, came home and was taking out his garbage when he started to stumble and fell to his knee, a neighbor saw and assisted patient up and was walking with him back to the apartment when "...he stopped breathing and feel over, dead." Per medical record review, patient had several co-morbidities including hypertension, hyperlipidemia, chronic hyponatremia, alcohol abuse, alcoholic fatty liver, chronic thrombocytopenia, and GERD.

Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day: severe weakness, unable to ambulate, follow directions, mumbling, sleepy, incontinent. Taken to ER - CT of head, EKG, Chest Xray, Labs, UA. Radiologist diagnosis start of Right lower lobe pneumonia. Given IV antibiotic and admitted to hospital. Admission MD thinks no pneumonia with profound weakness. Improved next day and discharged. Same evening as discharge had expressive aphasia. Next day speech normal again and weakness gone. Admitting physician said had another dementia patient with same symptoms and cleared in a couple of days.

72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.

Two blood clots in left leg; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunisation. Medical history included back disorder, ATTR amyloidosis, and allergies: caffeine from an unknown date. Concomitant medication included allopurinol (ELAVIL); meloxicam; tizanidine; tafamidis (VYNDAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), on 05Feb2021, administration time: 06:00 PM, vaccine location: Left arm for COVID-19 immunisation. The patient experienced two blood clots in left leg on 03Mar2021 23:00. Treatment for the event includes Aspirin. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The outcome of the event was resolved on an unspecified date.

left leg was cold/left foot was 79-82 degrees Celsius; blood clots in his left leg/he had three/first one on 02Mar, second one 13Mar and the third one yesterday; he had the Pfizer vaccine on 15Feb and 26Feb; he had the Pfizer vaccine on 15Feb and 26Feb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation; tafamidis (VYNDAMAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient took the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Feb2021 at age of 77 years old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient taking Vyndamax medication who stated that he had experienced blood clot in his left leg. Clarified that he had the Pfizer vaccine on 15Feb2021 and 26Feb2021. Clarified that on 02Mar2021 that he had blood clots in his left leg. Stated that he had three. Stated that he had the first one on 02Mar2021, second one 13Mar2021 and the third one yesterday (15Mar2021). Stated that he was told left leg was cold. Stated that he took his temperature with a thermometer and his left foot was 79-82 degrees Celsius. Stated that the right foot is 95-96 degrees Celsius. Stated that he filled it out for the Covid vaccination. Stated that he reported Vyndalink when it asked what other medications that he took. The action taken in response to the events for tafamidis was unknown. The outcome of events was unknown.

PT devolved occulsive DVT to left femoral vein; This is a spontaneous report received from a contactable physician. A 77-year-old male patient received second dose of BNT162B2 (Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 24Mar2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included azithromycin (Z-PAK) taken for an unspecified indication, start and stop date were not reported. The patient experienced "devolved occulsive DVT to left femoral vein" on 24Mar2021 with outcome of unknown. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of occulsive dvt to left femoral vein which included apixaban (ELIQUIS). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event "occlusive DVT to left femoral pain" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient went to physical therapy on that day. Then when he came home I could barely get him out of the car. patient could barely walk and talking made little sense. He could not stand on his own. He was taken to emergency room by rescue squad. I thought he was having a stroke.

Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died.

Timeline of events: o No concerns in the past month. o Usual state of health on Friday 4/9/2021 o Received Pfizer vaccine at event on 4/9/2021 o Fatigue, poor PO intake and myalgia on Saturday, 4/10/2021; Received Tylenol at 1 pm o Texted Primary Community Nurse (PCN) (not on call), on Saturday, to share above. PCN followed up Sunday morning and reassured them. o Last seen alive Sunday night, not well from vaccine but does not seem like family was concerned enough to page on call team o Monday morning- found dead in rigor mortis o Cause of death: deemed sudden cardiac death. Etiology unclear. o Unexpected death.

The patient was admitted to hospital from 2/24/2021 until 3/6/2021 for AMS, diagnosed with UTI. He had an MRI on 3/3/2021 that incidentally showed a nonocclusive thrombus in the right dural venous sigmoid sinus, which extends to the right jugular vein. He is being treated with apixaban. It is unclear if this is coincidental or somehow related to the vaccine.

4/14/21: onset of right leg swelling from the knee down that was painless. Calf circumference of the right leg had increased to 2cm greater than the left. No fever, chest pain, or difficulty breathing.

Death Narrative: Patient was not previously COVID-19 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 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.

Patient came to hospital on April 23, 2021 with shortness of breath and a productive cough, very weak and debilitated. Patient was diagnosed with pneumonia and required 2 liters of oxygen. Patient also has mild tremors and family states that this is new. Patient received the first dose of the COVID vaccine 10 days prior to admission on April 13, 2021.

Death Narrative: Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.

This 77 year old male received the Covid shot on 1/27/21 and went to the ED on 2/1/21 and was admitted on 2/2/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome) Pneumonia, unspecified organism Acute kidney failure, unspecified

I63.81 - Other cerebral infarction due to occlusion or stenosis of small artery R29.810 - Facial weakness I63.81 - Left sided lacunar stroke

Blood clot in leg - first dose; This is a spontaneous report received from a contactable consumer, the patient. A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: CR2613), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 77-years-old) as a single dose for COVID-19 immunization. Medical history included broke femur of right leg on 09Nov2020 and hospitalized from 09Nov2020 until 15Nov2020 or 16Nov2020, surgery to repair broken right femur on 12Nov2020, rehabilitation following hospital discharge and got out of the rehab facility on 14Dec2020, been in either a walker or a wheelchair and still not fully recovered (ongoing); chronic obstructive pulmonary disease (COPD), asthma diagnosed at least 13-14 years ago, bronchitis, all ongoing from an unspecified date diagnosed at least 13-14 years ago. Concomitant medications were not reported. There were no other vaccinations within 4 weeks of the vaccine. On an unspecified date, the patient experienced a blood clot in the leg. The clinical course was follows: After he was discharged from rehab, the patient went to his own family doctor on 30Mar2021 because his ankle and leg were still swollen. The physician sent him to have a vascular done, on an unspecified date after 30Mar2021, with unknown results. The patient reported that the physician determined that he had blood clots in his leg. The patient was sent to the emergency room and started "that stuff" for about a week until he went to a regular vascular doctor and the physician determined what the patient should be doing. The patient reported that he was diagnosed with the blood clots after he got out of rehab. The patient received apixaban (ELIQUIS) from Apr2021 for blood clot in leg. The clinical outcome of blood clot in leg was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021478767 same patient, different dose/event

Severe clots on right thigh rushed to urgent care and urgent care referred me to emergency Hospital. Was hospitalized for 5 nights with severe swelling on right thigh. The swelling has since abated but has still not subsided. Feel still very heavy on right thigh.

Patient received both doses of Pfizer vaccine (#1 on 2/9/21, #2 on 3/2/21) and was fully vaccinated when he presented to the ED on 5/9/21 w/ 3 week h/o cough, shortness of breath,. Tested positive for COVID19 by PCR on 5/10/21. Patient treated w/ Remdesivir, Dexamethasone, and convalescent plasma. Was on ventilator. Expired on 5/16/21 due to Acute Respiratory Failure with Hypoxia, Pneumonia due to COVID-19.

Pt with history of recovered Covid, developed sudden absominal pain, distention, emesis, diagnosed with bowel infarct and pneumonia, one day after 1st covid vaccine. Died 1/5/21 in hospice.

First dose given 2/9/2021 see further information below. Date of death 5/16/2021. Hospital 5/8/2021 to 5/16/2021

Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 rounds of epinephrine, In ED unresponsive, placed on a ventilator, required high doses epi to maintain perfusing blood pressure. Has acute kidney injury with hyperkalemia, shock liver and severe metabolic acidosis with arterial pH 7.04. CT of the head showed early findings of anoxic brain injury. Admitted to ICU and treated with aggressively with vasopressors, bicarbonate drip, heparin drip and empiric broad spectrum antibiotics. Very poor medical and neurologic prognosis, discussed with family and patient was transitioned to comfort care and passed away on 03/21/21 at 1626

A-fib; renal dysfunction; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration in Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included carbidopa and levodopa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In Mar2021, the patient experienced onset of A-fib and resultant renal dysfunction shortly after injection. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Cardioversion and medical management for the event A-fib. The outcome of the events was recovered on unspecified date. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of Atrial Fibrillation and Renal Impairment and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.

Pt w/no significant PMH p/w worsening symptoms over 10 days of cough, general malaise, nausea, poor oral intake, and sore throat. On admission, was hypoxic on RA & generally ill appearing. CXR showed poss viral pneumonia consistent w/COVID-19 and COVID test was positive despite having received Pfizer vaccine on 01/15 & 2/8/21. Was admitted for acute hypoxic resp failure secondary to COVID and given 3L O2, dexamethasone and remdesivir. Was ultimately discharged 3 days later w/follow-up.

Was living happily and independently in a retirement community. After the second dose because losing his memory, focus, depression, followed by 2 strokes, brain bleed, blood clots, seizures, and a Dx of Parkinson's and Parkinson's dementia. He saw doctors monthly and never had any signs of any of these things.

Case developed extreme fatigue and disorientation resulting in a fall. Case was taken by ambulance to Hospital. Case suffered a stroke, admitted to hospital 06/02, then into ICU 06/07/2021.

Patient received Pfizer COVID-19 vaccine on 1/24/21 (first dose) and 2/5/21 (second dose). Patient tested positive for COVID on 5/22/21, hospitalized on 5/22/21 for acute respiratory failure with hypoxia and passed away on 5/29/21: Preliminary cause of death: Respiratory failure with hypoxia Diagnoses contributing to death: SARS-CoV-2 respiratory infection COVID-19 vaccination breakthrough infection (Pfizer vaccine) Rheumatoid arthritis on methotrexate Anemia Hypertension Obesity

I had the vaccine on 01/16/2021 and my heart stopped. I had a long period of Atrial fibrillation, my heart will stop for 8 seconds and then it will start again. I had like 3 or 4 fainting episodes. Since then, I have had a heart pacer implanted. They put a Halter monitor to check my heart behavior. I was already under treatment for the fibrillation but this was an exaggeration of this problem. My cardiologist told me to come in because I had the monitor and they saw that my heart was stopping so I went in since it was an emergency. They kept me in the hospital for 3 days because they wanted to keep me in observation before they put the pace maker in.

77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intubated/sedated on admission - he was recently admitted, and had prolonged hospital stay (4/30 - 5/10) after orthopedic intervention / ORIF 4/30 Rt hip Fracture- s/p. - Acute hypoxic and hypercarbic respiratory failure, on mechanical ventilation - Bibasilar infiltrates, Lt > Rt, will small bilateral pleural effusions, HCAP - COVID PNA - Small bilateral pleural effusions - Encephalopathy - A-Fib - HFrEF, EF 45%, Mild MR - Acute on CKD - UTI

Overnight I developed very significant headaches (hardly ever had a headache before); in a few days I developed edema of my ankles and feet; checked blood pressure after a few days and it was very elevated; Took Tylenol for headaches (not very effective); Doctor had me move from 20mg Olmesartan to 40mg Olmesartan with 25mg hydrochlorothiazide which controlled my blood pressure and eliminated the lower extremity edema. When my blood pressure became dangerously low, I was moved back to just 20mg Olmesartan. Atrial fibrillation had been controlled prior to the vaccination with Multaq. For two days after the vaccination I had A-fib, then it went away. I have been monitoring my blood pressure and EKG since and the A-fib is becoming increasingly common, so that now I seldom had sinus rhythm.

Death 5/30/2021 Causes of death listed on death certificate 1. respiratory failure 2. covid pneumonia

Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight. Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16. 4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.

Was currently w/hospice care. 5/25/2021 exhibited symptoms nausea/emesis. Seen by MD. Treated for symptoms. continued to decline consistent w/ dx. End of life care with nitro prn, oxygen continued and emotional support followed and he expired 5/27/2021 at facility.

The symptoms were ever pain in my chest, great discomfort allowing only one sitting position on the ground, inability to walk more than about 50 feet without resting. After three attempts to walk, I could no longer continue. I was the beginning of a myocardial infarction. It was four hours before a rescue team could get me to the hospital.

Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 31Dec2020 11:00 AM via unknown route of administration at single dose for COVID-19 immunization. Medical history included high blood pressure, but went up and down and had to readjust. His BP was high and not sure how long it was that way. Concomitant medications included unspecified blood pressure medications. There were no known allergies. Patient went to ER left side of face sagging. They did MRI it showed he had stroke. It Happened before 4pm that same day as vaccine on 31Dec2020 02:00 PM. And it Happened between 2-4 pm. Patient received treatment. Patient had ER test blood, cat scan, MRI. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. This case was assessed non-serious by reporter. And the events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.

little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient was found unresponsive and pronounced dead later that day.

New onset atrial fibrillation that resolved in 1-2 hours after treatment in ER with Amlodipine and Metaprolol. Observed overnight. No symptoms since.

Myocardial infarction Narrative: PMH significant for aortic valve stenosis, mitral valve stenosis, CKD, CHF, DM, HTN, obesity, hypothyroidism and dyslipidemia. Per report from primary care - the patients wife reports that the patient went on Saturday (1/30/21 - about 1050) morning to receive his COVID vaccine. He returned home and told her about the experience and denied any side effects. He then proceeded to sit in his easy chair for a while and around 1:30, she asked him if he wanted any lunch. The patient's wife reports he "grumbled" at her, and then got up to go to the bathroom. She then heard a loud crash and found him lying on the floor of the bathroom, with his head knocking hole in the wall as he fell. She could not detect a pulse. She called 911 and began compressions. First responders to the scene likewise tried to revive him but were not successful in her efforts. Per primary care documentation - Uncertain if related to Pfizer vaccine; vaccine administered on 1/30/21 and approximately 3 hours later suffered fatal MI at home.

The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.

Patient found deceased at home on 2/15/2021. There was no known cause of death with no significant medical history.

Pt. was hospitalized with acute hypoxic respiratory failure due to severe COVID-19 complicated by acute kidney injury and exacerbation of heart failure on 2/8/2021.

myalgia/arthralgia, significant weakness followed by reactivation of rapid ventricular rate w/ his chronic Atrial Fib leading to angina and hospitalization w/i 2 days of vaccine. symptoms have not yet recovered, resulting in SNF placement

Patient is positive for COVID-19 and being admitted to the hospital. Patient received dose 1 of the vaccine on 2/11/21 and began feeling ill several days before presentation to the ED. He is unable to pinpoint an exact date but states it has been a few days that he has felt unwell. Presentation to the ED was on 2/23/21 and his oxygen saturation on presentation was in the 80s with mild confusion. Patient is requiring supplementary oxygen. The patient is receiving dexamethasone.

My dad (78 year old male) received the second Pfizer Covid19 vaccine shot on Wednesday, Jan 27 that night he started experiencing trouble breathing, Fatigue, chills, night sweats, etc. He was admitted to the hospital on Wed, Feb 3. CT scan showed he has an infection and inflammation of the lungs. Today is day 6 of hospitalization, and he has not improved despite many antibiotics, steroids, IVIG and oxygen. He is also in year two of remission from Multiple Myeloma so he is immunocompromised.

Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was slurred he fell and was unable to walk good his body was pulling to one side. His left arm was numb . I called ambulance he was taken to hospital diagnosed with a stroke. Now in rehab

pneumonia; strange dreams; While there I went into AFIB; I had a dry cough that I attributed to several bouts of dry heaves; I had a dry cough that I attributed to several bouts of dry heaves; This is spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (lot number EN5318), via an unspecified route of administration in right arm on 08Feb2021 11:45 at single dose for covid-19 immunization. The patient had no relevant medical history. Concomitant medication included metoprolol, lisinopril, atorvastatin (LIPITOR). The patient experienced pneumonia on 10Feb2021, while there he went into AFIB (atrial fibrillation) on 19Feb2021, he had a dry cough that he attributed to several bouts of dry heaves on 10Feb2021, strange dreams on an unspecified date. The event pneumonia was reported as serious per hospitalization. The patient was hospitalized for pneumonia from 19Feb2021 to 21Feb2021. Previously reported side effects along with strange dreams and he would also like to mention a couple of more issues. Throughout 10Feb2021 and 14Feb2021 adverse reaction period he had a dry cough that he attributed to several bouts of dry heaves, Since the cough continued and he wasn't feeling better he went to emergency care facility on the 19th and he was diagnosed with pneumonia and went to the hospital and was admitted. While there he went into AFIB. Pneumonia was located in left lower lobe (infectious organism). Discharged from hospital on 21Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization for 2 days. The patient underwent lab tests and procedures which included covid test nasal swab: negative on 20Feb2021. Therapeutic measures were taken as a result of pneumonia and cough. Treatment included antibiotics. The outcome of events for pneumonia was resolving, for dry cough was not resolved, for other events was unknown. Facility type vaccine: Nursing Home/Senior Living Facility. No other vaccine in four weeks. No covid prior vaccination. Covid test post vaccination: Covid test type post vaccination Nasal Swab, covid test date 20Feb2021, covid test result negative. Not known allergy.

PER MEDICAL RECORDS PATIENT PRESENTED TO ER VIA EMS REPORTING INTERMITTENT CHEST PAIN, FEELING LIKE HIS HEART WAS STOPPING.

patient began to have left sided chest pain which radiated to left arm. stated sharp pain but also belt like pressure. does not have history of similar chest pain. he also described dizziness and SOB, but additional questioning suggests this is his baseline. 12 lead showed a fib. patient denies history of similar. patient given ASA and transported to ED for additional work-up for his chest pain

On evening of vaccine, he began to run high fever of 101.5. next day 102. 3 with extended chills, Doctor was called and patient was told to take Tylenol, On second time Doctor was called, he was told to alternate Tylenol with ibuphrofen. Fever came down on 2/28 started back up on 3/2 , went to Er ON 3/4 FOR BREATHING ISSUES, a blood infection was found, went back to ER ON 3/8 FOR ANTIBIOTIC,( DOCTOR HAD WANTED HIM ADMITTED,THIS WAS NOT COMMUNICATED) , next day was admitted to Providence Hospital for IV antibiotics, dismissed from Providence on 3/13, with antibiotics infusion to continue at home.

fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, high blood pressure, TIA, CVA, aneurysm

Death Narrative: Patient died at home on 2/11/21, two days after receipt of the Pfizer COVID19 vaccine. Reviewed death certificate and cause of death is listed as chronic systolic heart failure and pulmonary hypertension. That is all the information that I have.

During my earlier years working in an industrial area I had inhaled asbestos which caused me to have plural thickening in my lungs. Every year since that diagnosis I have been required to annual Pulmanary (lung and heart) testing. On February 11th I had my 30th annual Pulmonary exam consisting of EKG, Stress Test, and Chest X-ray. As in the past, results were all good. On March 3rd I had my 1st Pfizer vaccination. Five days later on March 8th I collapsed, was taken to the hospital by ambulance having suffered a massive Pulmonary Embolism affecting my heart and right lung. During my 2 hour operation, Surgeons used a flexible suction tube inserted thru my groan to remove a large blood clot (embolectomy). Pieces totaling about 14cm long, 2cm wide and 1/2 cm thick. I was discharged 3 days later and instructed to take blood thinning medication probably for the rest of my life. I am now 78 years old.

Patient passed away unrelated to covid vaccine Narrative: The patient had new onset of CHF,A.fib and hx f COPD. Patient was admitted to hospital on 1/21 and Patient discharge against medical advise on 1/22. Patient aware of risk including early death and increased morbidity but patient still wanted to leave. Patient received the first dose of Pfizer vaccine on 1/19 and no adverse reaction was reported. Patient presented to ER for shortness of breath and chest pain and was admitted on 1/29. Patient passed away on 1/31. No indication that death was related to COVID 19 vaccination.

Case tested positive for COVID-19 on 3/1/2021 by rapid antigen and then again on 3/3/2021 by PCR. Case was admitted to hospital on 3/3/2021 for shortness of breath and occult infection. Case was previously admitted and discharged from hospital on 2/22/2021 after a lumbar compression fracture. Case had monoclonal antibody infusions; was afebrile and denied chills, but had a dry cough. Case was a previous smoker, quit 2 years prior. Case developed pneumonia. Case required supplemental oxygen.

Patient died in his sleep the night of getting dose 1 COVID -19 he had a massive heart attack and died

Patient presented to SJMC in Brainerd by private car, 3/23/21 DOA. Family with patient wanted no resuscitation. Patient pronounced deceased 2:49 pm.

The patient presented to the ED with complaints of fatigue. The patient was found to have an NSTEMI and suspected pneumonia on x-ray. The patient was started on a heparin drip, ceftriaxone, and azithromycin. BP was 176/101, pulse 93, O2 sat of 95% and temp 99.3 F. Patient is being admitted to the hospital for continued treatment of NSTEMI.

Multiple pulmonary embolism 100 degree fever Chills incontinence Gout Blood Uric Acid Increase Shortness of breath

Death Dehydration Community acquired pneumonia Closed head injury, initial encounter Fall at home, initial encounter Acute hypoxemic respiratory failure

This 78 year old male received the Covid shot on 2/26/2021 and died the next day on 2/27/21. 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.

Death Narrative: Patient was not previously COVID-19 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. No notes detailing the circumstances the death of the patient. Patient had issues controlling his blood pressure in the prior 6 months with an average BP of 150/68 and systolic blood pressure readings >200 at times, Other comorbidities include anemia, DM2, Afib on pradaxa, cardiac pacemaker, and HLD.

This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19. 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. Other diagnoses include: J18.9 - Pneumonia R77.8 - Elevated troponin

Pt presented with SOB and leg swelling and found to have RLE DVT. He was admitted and started on anticoagulation

Fever greater than 103; body aches; chills; extreme fatigue; severe headache; gradually increasing back pain Back pain increased every day. About 3 weeks after vaccine shot, he went to doctor. Back pain continued til he was bedridden bc of severe pain. Went to ER March 22. Tests showed cancer in lungs and hip. Died April 10

Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.

Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination.

My father suffered a heart attack due to blood clots clogging the artery to his heart. He coded and was resuscitated and had four stents installed after the blockage was cleared. He had a second heart attack several days later when the stents clogged and had to be cleared. He was hospitalized for several days for each heart attack.

After receiving the injection, patient had not been feeling well. Low appetite, lightheaded, fatigued, difficulty breathing. They had been traveling and returned on 3/7. He was tested for covid and the test was positive. He presented to the ED on 3/25/21 and was subsequently admitted to the hospital for 4 days with pneumonia.

Pt had covid19 in 11/2020, now with immediate onset of sepsis of unclear source after 1 dose Pfizer vaccine as well as rapid atrial fibrillation and heart failure

On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.

DVT was twice as bad; death/natural process; This is a spontaneous report from a contactable Nurse reporting for reporter's husband. A 78-year-old male patient received bnt162b2 (reported as COVID vaccine), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as 2nd dose, single (at the age of 78-year-old) for COVID-19 immunisation. Medical history included diabetes, Liver cirrhosis, thrombocytopenia, Kidney stone, sarcoidosis, blood pressure abnormal, high cholesterol, pacemaker and they putted the IVC filter for blood clot. Concomitant medications included insulin, simvastatin, hydrochlorothiazide and omeprazole (PROTONIX), all taken for an unspecified indication, start and stop date were not reported; and carvedilol (COREG) taken for blood pressure, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN6201; Expiration Date: 30Jun2021) on 27Feb2021 at the age of 78-year-old for COVID-19 immunization and experienced pulmonary embolism and deep vein thrombosis (DVT) on 12Mar2021, and went into the hospital 12Mar2021. Then the patient had the second COVID shot on 20Mar2021 and the reporter had taken him right back into the hospital couple days later because the DVT got twice as worst. The patient experienced DVT was twice as bad on an unspecified date in Mar2021, which required hospitalization on 22Mar2021. The patient underwent lab tests, he had lab tests on 22Mar2021 when he went in and he probably had them on 23rd and 24th of Mar2021. The reporter didn't know what all the lab tests were done in the hospital. The patient died on 12Apr2021. The reporter stated they put Reason of death as natural process because she sent him in the Hospice. An autopsy was not performed. The outcome of event DVT was unknown. The reporter considered there was a causal relationship, when he got his second COVID shot on 20Mar2021 and then he went back in the hospital on 22Mar2021 and the DVT was twice as bad.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported DVT. 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/natural process

Patient presented to the ED and was subsequently hospitalized for left-sided nontraumatic intracerebral hemorrhage. He is currently admitted for rehab.

ED to Hosp-Admission Discharged 3/28/2021 - 4/2/2021 (5 days) Treatment team. Acute hypoxemic respiratory failure due to COVID-19 Principal problem Discharge Summary (Physician) Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 3/28/2021 PCP: (doctor) Length of Stay: 5 Days Discharging provider: (doctor) Discharge Date: 4/2/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 Yes Cardiomyopathy Yes Obstructive sleep apnea syndrome Yes Essential hypertension Yes Type 2 diabetes mellitus Yes Presence of automatic (implantable) cardiac defibrillator Unknown Pneumonia due to 2019 novel coronavirus Yes Stage 4 chronic kidney disease Yes Pneumonia of both lungs due to infectious organism, unspecified part of lung Yes Atrial fibrillation with rapid ventricular response Yes NSTEMI (non-ST elevated myocardial infarction) Yes Hospital Course: Patient is a pleasant 79-year-old male admitted due to acute hypoxic respiratory secondary COVID-19 pneumonia. He was continued on dexamethasone for the COVID-19 pneumonia however the medicine was relatively contraindicated due to renal failure. Patient was seen by cardiology continued on aspirin beta-blocker and statin for non-STEMI and already was anticoagulated with Xarelto which is continued. Patient's oxygenation requirements did improve and he was set up for home oxygen prior to discharge. Patient was continue with PT and OT and slowly did well he was doing well clinically at this time may be discharged home for convalescence as per protocol. Patient may follow-up with PCP and specialist as noted

Patient presented to the ER on 3/28/2021 with shortness of breath and lower extremity edema and complaining of lower back pain. O2 sat high 80s on room air. Worsening renal failure since last discharge from hospital on 3/23/2021. Patient was readmitted to hospital from skilled care facility after being discharged 5 days prior with acute on chronic stage IV kidney disease as well as acute on chronic diastolic heart failure and had slowly worsening with renal dysfunction and growing concern for dialysis. Patient had developed a cough, a fever up to 101, and 1 questionable sewed of either hemoptysis or hematemesis since being discharged to skilled nursing facility on 3/23/2021. Patient was transitioned to the hospice team and expired on 4/2/2021.

ED to Hosp-Admission Discharged 4/16/2021 - 4/19/2021 (3 days) Hospital Doctor Last attending - Treatment team COVID-19 Principal problem Medical Problems Hospital Problems POA * (Principal) COVID-19 Yes Hypercholesterolemia Yes Hypertension Yes Type 2 diabetes mellitus Yes Major depressive disorder Unknown Acute respiratory failure with hypoxia Unknown Hypertensive urgency Unknown Presenting Problem/History of Present Illness/Reason for Admission COVID-19 Hospital Course (Patient) is a 78 y.o. male with medical history of hypertension, type 2 diabetes on insulin, and hyperlipidemia presents with SOB and she was admitted for acute hypoxic respiratory failure with sepsis .Patient was diagnosed with Covid on 4/15 and repeat COVID-19 was positive on admission. Acute hypoxic respiratory failure likely from COVID-19-improving o On admission satting low 90% ,required supplemental oxygen, normal lactic acid & CRP, elevated LDH 263 o CXR (4/16/21): mild basilar atelectasis. o Continue remdesivir (4/16-4/21, Day 4) and dexamethasone (4/16-) since O2 sat <94% on room air, requiring supplemental oxygen o Patient currently satting 95-97% on 2 L nasal cannula. Bedside study does not qualify patient for home oxygen while resting and/or ambulating. PT recommends safe discharge home. Patient clinically stable to be discharged home today. Patient to follow-up with PCP. Sepsis likely from COVID-19 -resolved o On admission HR >90, RR >20 + source of infection COVID= sepsis, procalcitonin neg- antibiotics not indicated Elevated D-dimer likely from SARs-COV-2 o On admission D-dimer elevated 0.59, patient was tachycardic o CTA significant for No pulmonary embolism. No lung consolidation. Hypodense renal lesions. Hypertensive urgency - resolved Essential hypertension o On admission BP >180/120 o Continue home losartan and amlodipine. Diabetes mellitus type 2 o A1c (11/18/20):7.9, repeat A1c 6.7 (4/17) o Home meds metformin 500 BID, Novolin 70-30 : 40 unit AM, 75 unit PM. Home novolin 70-30 = lispro 34 units, glargine 80 unit approximately o Started SSI, lispro TID 5 units, Glargine 10 units BID, confirmed dose with pharmacy based on his home Novolin 70-30 conversion. Patient to continue home medications and follow-up with PCP. MDD-Continue home paroxetine, venlafaxine Hyperlipidemia - Continue home statin Treatments: steroids: Dexamethasone 6 mg and remdesivir 100 mg, benzonatate capsule 100 mg Procedures: None Consults: pulmonary/intensive care Pertinent Test Results: CXR: There is mild atelectasis at the lung bases. There is no effusion or pneumothorax. The cardiac silhouette is normal size. The trachea is midline. The osseous mineralization is normal. CTA: IMPRESSION: 1. No pulmonary embolism. 2. No lung consolidation. 3. Hypodense renal lesions as described above. ED to Hosp-Admission Discharged 4/26/2021 - 5/6/2021 (10 days) Hospital Doctor Last attending ? Treatment team Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present Principal problem HPI: (Patient) is a 78 y.o. male with past medical history of T2DM, HTN, HLD, and depression/anxiety who presented to the ED on 4/26 with COVID pneumonia and acute bilateral PE. Orthostatic Hypotension. Improved with IV fluids. No orthostasis this morning. TTE done yesterday showing preserved EF. Acute hypoxemic respiratory failure secondary to Covid 19 Pneumonia with some contribution from PE. Patien.t now on room air. Patient completed Remdesivir. Completed 10 days of Dexamethasone. He will be transitioned to prednisone 20 mg daily for 7 days, 10 mg daily for 7 days then 5 mg daily for 7 days. He was givenTocilizumab: 8 mg/kg, 4/29. He is not a candidate for convalescent plasma. Acute bilateral PE: Mild clot burden without evidence of RV strain. Was initially started on therapeutic Lovenox, transitioned to Eliquis 4/29. Eliquis priced and affordable to the patient. T2DM: On lantus 23 units nightly and Humalog to 10 units with meals HTN: Continue losartan and amlodipine with holding parameters HLD: Continue statin Depression with anxiety: Continue paroxetine and Effexor BPH: Continue Flomax Suspected OSA: Per his daughter concern for OSA. Will need outpatient sleep study.

difficulty breathing; pneumonia; human immunodeficiency virus; pain in arm, neck and back; pain in arm, neck and back; pain in arm, neck and back; FACILITATED COLLECT This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3841481-00). A non-contactable consumer (patient) reported for himself that a 78-year-old male patient received bnt162b2 (Pfizer, Batch/Lot number was not reported), intramuscular on 12Mar2021 as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose for moderate to severe chronic plaque psoriasis, psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced difficulty breathing on an unspecified date, pneumonia in Mar2021, pain in arm, neck and back in Mar2021, human immunodeficiency virus on an unspecified date. The events difficulty breathing and pneumonia were reported as serious per hospitalization, event human immunodeficiency virus was serious per medically significant. The patient took covid-19 vaccine and afterwards had pain in arm, neck and back and could not breathe. He went to emergency room and was hospitalized due to difficulty breathing and was diagnosed with pneumonia. He did not know if this was due to vaccine and would not be taking second vaccine shot per his primary physician. He also had human immunodeficiency virus. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 12Mar2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. The outcome of events for difficulty breathing was unknown, for other events was resolving. The reporter's causality for the event(s) of Pneumonia, Pain in arm, Human Immunodeficiency virus, Pain in Back and Pain in neck with adalimumab was no reasonable possibility. Causality for all events with COVID-19 vaccine was not reported. The reporter's assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on batch/lot number has been requested.; Sender's Comments: Based on known disease pathophysiology, the reported event of Human Immunodeficiency virus , pneumonia and dyspnea is assessed as not related to suspected product bnt162b2 vaccine and the events pneumonia and dyspnea are more likely due to underlying medical condition of chronic plaque psoriasis. However the reported events of Pain in extremities ,Pain in Back and Pain in neck is assessed as related due to close temporal association with the suspect product. However, more information is required on date of HIV infection deducted to properly assess the case. The case will be reevaluated should additional information become available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.

Starting day of first shot on March 6 (and in the three weeks between first and second shot on March 27), I began having atrial fibrillation/flutter episodes twice a week for about four hours per episode. After second shot, episodes averaged four per week for six weeks. I went to the ER April 4 and was referred to electrophysiologist. I saw electrophysiologist on April 15, he immediately scheduled me for double cardiac ablation. I had this procedure on May 7, whereupon my episodes ceased.

Worsening heart function; increased sx PVC burden and runs of VT. Drop in LVEF from 40% to 15%. Worsening CHF sx. Occured after the second COVID 19 Pfizer vaccine dose

78y.o. male with a past medical history of COPD, DM II, and HTN who presented to the hospital's emergency department from an extended care facility. Patient was recently hospitalized and treated with IV antibiotics for HCAP. Patient tested positive for COVID on 3/24/2021. EKG was negative for ischemic signs but patient had an elevated troponin. CXR showed right pleural effusion. Patient was admitted with COVID-19 pneumonia and severe respiratory failure. Patient's oxygenation continued to deteriorate despite Remdesivir, decadron and lovenox. Patient went into respiratory failure and expired from progressive respiratory failure.

Pulmonary embolism; DVT; This is a spontaneous report from a contactable nurse (patient's wife). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration on 27Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included diabetes mellitus, Liver cirrhosis, thrombocytopenia, kidney stone, sarcoidosis, blood pressure (unspecified condition) and high cholesterol and a pacemaker (cardiac pacemaker insertion). Concomitant medications included insulin (manufacturer unknown), simvastatin (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), carvedilol (COREG) taken for blood pressure, and omeprazole (PROTONIX). On 12Mar2021, the patient developed pulmonary embolism and DVT (deep vein thrombosis) that requiring a hospitalization on 12Mar2021. The nurse reported, "He went into the hospital 12Mar2021 that's when they find out he had pulmonary embolism and DVT. They putted the IVC filter for blood clot." On 12Mar2021, the patient was hospitalized for pulmonary embolism and DVT. Therapeutic measures were taken as a result of pulmonary embolism and DVT. The clinical outcome of the events pulmonary embolism and DVT was unknown. Additional information has been requested and will be provided as it becomes available.; Sender's Comments: Based on available information and known drug profile it is unlikely that the reported pulmonary embolism and DVT (deep vein thrombosis) were causally related to BNT162b2 . These are intercurrent medical conditions. Case will be reassessed if additional 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.,Linked Report(s) : US-PFIZER INC-2021528357 same patient/reporter, different vaccine dose with different events separated by time gap.

started seeing strange things- saw things that weren't there. The yellow wall in his bedroom came up but had all kinds of art work on it, the ceiling and doors too; couldn't remember things; Weird things happened in my brain; lost his vision while driving; CT scan it did show hardening of the arteries in his brain ,was told had a TIA (Transient Ischemic Attack) or some kind of a stroke; had issues with confusion as well; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 06Apr2021 as 2nd dose, single dose (at the age of 78-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 as 1st dose for COVID-19 immunization. On 02May2021 (26 days later), patient lost his vision while driving and it came back good enough to drive within a half hour (medically significant) and when it recovered on 02May2021, patient started seeing strange things, saw things that were not there. The yellow wall in his bedroom came up but had all kinds of artwork on it, the ceiling and doors too (medically significant), patient couldn't remember things, had weird things happened in his brain. Patient stated that it didn't go away entirely until about 10 days later. Patient also had issues with confusion as well. Patient stated that he thinks he was back to normal now. A computed tomography (CT) scan was completed a week or so earlier and it did show hardening of the arteries in his brain. Patient saw his primary care physician and was referred to a neurologist. On unspecified date of May-2021, patient was told he had a transient ischemic attack (TIA) or some kind of a stroke (medically significant). Patient had a Magnetic resonance elastography (MRE) (like a Magnetic resonance imaging (MRI) of the brain) yesterday (27May2021), but it had not been read yet. Patient asked if he was the only one that had done this or had other people had this problem, even two or three people or he was an isolated case and in response it was stated that, unable to find information about his symptoms in resources and the Product Information (PI) for the vaccine does not contain information reporting his symptoms (vision loss, memory loss, confusion, hallucinations) as side effects of the vaccine. The outcome of had a TIA (Transient Ischemic Attack) or some kind of a stroke was unknown, for lost his vision while driving was recovered on 02May2021 while recovered for rest of the events on May2021. Information about lot/batch number is requested.

He was living independently in a retirement home. They administered the vaccine. Since the jab he has been diagnosed with Parkinson's, Parkinson's dementia, Suffered two strokes and we were recently told he now suffers from seizures and will require medication for the rest of his life AND 24 hr. Care.

During rounds at 10pm, CNA observed resident unresponsive. Nurse was immediately called, who in turn call the code. Nursing staff responded and started CPR. A total of 16 rounds of compressions and shocked x 2, prior to Paramedics taking over 10 minutes later. They continued CPR for another 10 minutes before resident was pronounced dead.

The patient is a 78-year-old male who presents to the hospital with weakness and fever 1 day following his second COVID-19 vaccine. Noted o have a transient thrombocytopenia. Presented with severe weakness and unable to get up. He was able to provide some history. His wife provided additional history. He received second dose of mRNA vaccine on 6/5. Developed weakness afterwards and brought to the hospital for further evaluation. Admitted with dehydration low-grade temperatures. Tmax 100.4. Denies bleeding.

Blood clots in left leg from groin area to knee area. Swollen and painful left leg. Prescribed Eliquis blood thinner. Currently in treatment phase with symptoms basically the same.

Symptom onset 4/12, hospital admission date 4/19, died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to COVID-19, hepatic encephalopathy, liver cirrhosis

Patient stated after receiving his second covid vaccine on 06/15 he started having visual changes, which was confirmed a stroke on 06/25 by MRI. Patient stated he noticed his stroke symptoms after receiving his second vaccine.

Patient was Positive for Covid-19 in September 2020, repeat testing in October showed negative result. Patient was vaccinated on 2/24/21 and 3/17/21 with Pfizer-BioNTech COVID-19 vaccine. Patient developed COVID 19 on 6/20/21, and was hospitalized for acute respiratory failure. Patient was intubated and required pressor support with norepinephrine and an IABP.

Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21 with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions. Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion. It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment. He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home. There was no fever no hemoptysis chest pain or pleuritic pain. Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen. He had a CT of the abdomen and pelvis which was negative for any malignant spread. Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21

Legs and feet swelled suddenly and dramatically. Cardiologist described it as possible myocarditis and congestive heart failure.

This is a patient who presented to the ED with a cc of dyspnea and was found to have left central main pulm artery/left upper lobe/left lower lobe PE's and also has a large clot in transient in his RV. There is no provoking risk factor that I can clearly identify (no recent surgeries, trauma, immobilization, or active cancer). He does have a remote cancer hx of bladder cancer in 2015. He is a former smoker 20+ years ago. However, he is at risk for VTE events by being a ERSD patient and also there's increased risk for VTE for pts >70yo. His COVID vaccination a few months ago is a potential contributing risk factor, will report to VAERS

first signs of were in last week of February and first week of march. approximately 5 times between Feb 21 and April 15 I had what I thought to be indigestion, constant belching with a little pain in center of stomach area, these symptoms disapeared after a few hours and tums. All started in early morning around 630 am. On April 15 it happened again but continued all day, went to urgent care at around 330n they did egg which was fine but advised going to emergency room for better tests,

loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia.

Patient received COVID-19 vaccination on 1/14/2021. On 1/17/2021, patient was transferred to Hospital s/p multiple cardiac arrests. Patient was hyperkalemic and in acute renal failure at time of transfer. Hyperkalemia was treated, but the patient suffered PEA vs VFib. At the time of transfer, patient was on vasopressin, norepinephrine, and epinephrine. The patient had an EF of 40-45% and elevated troponins. Patient was made DNR and placed on comfort care. Patient passed away on 1/18/2021. Ultimately we suspect that the patients condition was a direct result of his underlying disease states, but wanted to make sure reporting was made available.

Dizziness, nausea, irregular HR. EKC revealed AF. Drank full glass of red wine at 2 AM on the day of the vaccine. Went to the ED

(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous production. (02/16-17/2021) : death possibly during the night

Death, unknown cause Narrative: Patient received COVID19 vaccine on 2/23/2021 at 14:27. On 2/24/21, patient's family found patient deceased at 12:08am. The local coroner had called the MC to let us know on 2/24/21 at 12:55am. Coroner did not suspect foul play.

1st dose vaccine 2/23/21; EMS called after pt fell at home 2/25/21; taken to ED and admitted to hospital DX: 1. Right-sided nontraumatic intracerebral hemorrhage, unspecified cerebral location (CMS/HCC) I61.9 431 2. Long term (current) use of anticoagulants Z79.01 V58.61 3. Sensory neglect (left sided) R41.4 781.8 currently still admitted to hospital at the time of this report

The same day that the person was vaccinated he started feeling dizzy and had difficulty breathing. He was hospitalized from February 5 to February 23. Patient died in the hospital on February 23, 2021

Severe thrombocytopenia; This is a spontaneous report from a contactable Nurse. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient had known allergies: methotrexate. There were no concomitant medications. No other vaccine in four weeks. The patient experienced severe thrombocytopenia on 17Feb2021. The event 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 was hospitalized for severe thrombocytopenia for 2 days. Patient was referred to hematology proactive for severe thrombocytopenia, likely ITP. Platelet (Plts) 5 and then 1. He was sent to the Emergency room (ED) and received plt transfusion w/ minimal effect. He was started on Intravenous Immune Globulin (IVIG) as well as high dose steroids. Plts currently w/i normal range after above treatment. The outcome of event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association, the Company assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported event Severe thrombocytopenia. 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.

Narrative: 79 yo patient with history of stroke, hypertension, prostate cancer. Hospitalized for acute CVA on 3/2 after receiving first dose of Pfizer vaccine on 2/27.

Patient experienced a witnessed tonic clonic seizure on 3/12 /21 at 5:30am. Seizure lasted for 3 minutes. He was post-ictal for approximately 15-20 minutes afterwards. No prior history of seizure. He was taken for further evaluation.

79 yo with HFpEF, CKD, neurogenic bladder with chronic indwelling Foley admitted to Facility 01/21/21-01/28/21 with recurrent c. difficile/sepsis. Received COVID vaccine on 2/3/21 as outpatietn. Readmitted to Facility on 02/16/21 with sepsis with E. coli BSI from GU source, recurrent/persistent c. difficile colitis. Worsening sepsis. Family transitioned goals from full code to DNR/DNI and then to CMO. Patient expired 02/18/2021.

diagnosed as having AFIB.; light headed; I had some aches; I was completely down in bed with no energy/physically weak; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6202), via an unspecified route of administration administered in left arm on 23Feb2021 00:15 as SINGLE DOSE for COVID-19 immunisation. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included atenolol, oxybutynin, and tamsulosin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (at the age of 79-year-old) for COVID-19 immunisation. The patient stated that in the past her pulse rate was in the low 60's. The patient lost energy gradually from 23Feb2021 until 26Feb2021 and 27Feb2021. The patient was completely down in bed with no energy. The patient had some aches on 25Feb2021 at 07:00 AM, but the pulse rate went up to 80 to 100. The patient went to the Cardiologist he believes on 08Mar2021 and was diagnosed as having atrial fibrillation (AFIB) on 08Mar2021. The patient was being treated for AFIB now and have been light headed and physically weak since 25Feb2021 at 07:00 AM. Therapeutic measures were taken as a result of diagnosed as having afib. The patient had not yet recovered from the events.

COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.

Male patient who to the hospital on 3/15/2021 due to 10 days of shortness of breath on exertion and right-sided chest pain. He went to his PCP for follow-up and had a CT PE study today which was positive for right upper lobe and right lower lobe pulmonary embolism. He notes that he received a 2nd 5 0 COVID-19 vaccination on March 6th and since then has not felt well, feeling short of breath and generally fatigued. He notes that he has not been very active since receiving the vaccine. CT PE study showed an increased RV to LV ratio 1.2. He had no elevation in his troponin or BNP. His echocardiogram showed an EF of 60% and there were no wall motion abnormalities and grade 1 diastolic dysfunction. Patient would prefer Eliquis at this time. He will need a 6 month course of Eliquis. Given the setting of recent COVID vaccination and recent decreased mobility as possible provoking factors, this will be treated as a provoked pulmonary embolus. Per hospital COVID vaccine protocol, patient presentation will be reported to pharmacy for FDA reporting.

Patient developed substernal chest pressure and lightheadedness prompting visit to the ER where he was found to have a STEMI and developed Vfib arrest and had cardioversion x 2. Patient was found to have an inferior wall MI. Mechanical thrombectomy was performed for a thrombotic occlusion of the mid-distal RCA and DES X 1 placed. Significant CAD was present in the proximal-mid LAD and proximal-mid left circumflex.

Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back pain and wanted to go back to bed and she noted he was extremely sweaty at that time. He was lifted back to bed and was reportioned several times because he could not get comfortable. She went to get him a drink from the kitchen and heard a guttural sound and rushed back to find him unresponsive and blue in color. She called "911" and patient was dead upon arrival (and a DNR) so the Medical examiner arrived and pronounced him dead. She states sx started at about 4pm and he was pronounced dead at about 5pm. Medical examiner determined a heart attack cause of death. The family not sure that the vaccination had anything to do with death but wanted it to be reported.

Sudden Death; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6199) and second dose (lot: ER8730); both via an unspecified route of administration into the right arm on 28Mar2021 12:00 for COVID-19 immunization. Medical history included coronary artery disease (CAD), hypertension, parkinson's disease, abdominal aortic aneurysm, cerebral aneurysm and arthritis. Concomitant medications included paracetamol (TYLENOL) taken for arthritis and a pill for his hypertension. It was reported that the first and second dose of vaccine was administered on 28Mar2021 12:00 PM. The patient's sudden death on 30Mar2021 15:30 was also reported. An autopsy was not performed. The patient was not diagnosed with COVID-19 prior to vaccination. Further information has been requested.; Reported Cause(s) of Death: Sudden Death

PCP notes in progress notes upon the patient return on 1/12/2021 Hospital course CT head/CTA neck/CT perfusion studies concern for possible right ICA and MCA thrombus, transferred to neuro ICU. TPA ( s/p alteplase). CTA shows >90% R ICA stenosis. Vascular consulted. Started on AC (heparin, plavix and loaded with brillanta). Pt underwent R TCAR (Transcarotid Artery Revascularization) on 1/11. No post-op complication. pt stable/neurologically intact. Pt offers no acute concerns. pleasant, pain is controlled. No CP, sob, palpitation. neck incision CDI. HR and BP controlled. He is happy to back to the rehab. CEREBRAL INFARCTION DUE TO UNSPECIFIED OCCLUSION OR STENOSIS OF RIGHT CAROTID ARTERIES

Developed fever, nausea and vomiting about 24 hours later. Symptoms lasted two days and began to subside, at which time shortness of breath began. Patient drove himself to the hospital for evaluation and treatment on Saturday, March 27th where he collapsed in cardiac arrest. he was resuscitated and stabilized on life support. He died of multiple organ failure on Monday March 29th. The official diagnosis was Severe Septic Shock. It is unclear if any infective agent was identified. It should be noted that sepsis is a condition in which immune dysregulation is inherent and includes cytokine storm activity. The possible correlation between vaccination and the subsequent development of sepsis should be investigated.

This 79 year old white male received the Covid shot on 2/16/21 and went to the ED on 2/21/21 and was admitted on 2/21/21 after a fall with rib fractures and traumatic hematoma. He went to the ED again on 4/27/21 and was admitted with Abdonminal aortic aneurysm and died on 4/28/21 . 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.

Woke up in the middle of the night dizzy on the evening of 3/11/21,started vomiting blood, syncope, when woke up had altered mental state, when reoriented he was able to call EMS, taken to hospital where he was diagnosed with an abdominal clot size of a grapefruit

history of hypertension, mild cognitive impairment. Prior COVID pneumonia treated as an outpatient November 2020. Completed dose 2 of Pfizer vaccine 4/11 with progressive fatigue low-grade fevers and white count of 14 CRP elevated at 4 (see this would equate to a CRP of 40 with most other lab references) on 04/27. He was admitted and treated for community-acquired pneumonia with ceftriaxone and azithromycin. He was discharged 04/30 and then presented again 5/5 with progressive right greater than left consolidative ground-glass opacities and hypoxemic respiratory failure requiring up to FiO2 80% of high-flow nasal cannula. Infectious workup has been negative. He has been too unstable to bronch. COVID-19 testing has been negative. He was started on high-dose steroids 5/8 with stability and slow gradual improvement.

Inpatient Discharge Summary Admission Date: 3/22/2021 Discharge Date: 3/27/2021 Principal Problem: COVID-19 virus infection Hospital Course s a 79 y.o. male who presented to the hospital with a complaint of 1 week of shortness of breath and fever. He was managed for- COVID19 pneumonia with acute hypoxic respiratory failure, POA - CTA negative for PE; there is evidence of COVID19 pneumonia - given a unit of convalescent plasma - Remdesivir daily x 5 days (last day 3/26) -Will be sent on 4 days of Decadron to finish total of 10 days of Decadron. - inflammatory markers have improved - procalcitonin is negative x 2 - Mucinex/is/opep - wean oxygen as able, encourage patient to prone. - patient weaned down to room air. Home oxygen evaluation was done he did not qualify for O2 at home. AKI - Cr 1.36 upon presentation, improved to 1.0. - avoid nephrotoxic agents- d/c mobic. Did get contrast on 3/23 - continue to monitor renal function 5 beat run vtach - Patient does have hx of osa and was using CPAP machine - electrolytes were normal - continue telemetry monitoring - discussed outpatient ECHO Transaminitis - ?secondary to remdesivir vs covid virus Commend to repeat the LFTs in 3 days and follow the results with the PCP.

Patient presented to the ED on 4/22/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were: Severe sepsis (HCC) due to pneumonia causing acute on chronic hypoxic respiratory failure and hypotension that resolved with fluids. He also presented to the ED on 5/13/21 and was subsequently hospitalized for sepsis secondary to UTI.

heart inflammation, heart went into atrial fibrillation again, suspected myocarditis (symptoms within short time of second shot) Observation of EKG on Apple watch showed atrial fibrillation (after four years of normal readings)

Non traumatic insidious stroke right brain leaving left side paralysis; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 13:45 (lot number: EL9262) at 2nd dose, single for COVID-19 immunization. Medical history included coronary artery bypass grafting (CABG). Concomitant medications included metoprolol, atorvastatin (reported as 'atorvasten'), tamsulosin, and clopidogrel (reported as 'clopidigrol'), all taken for unspecified indications, start and stop dates were not reported, these medications were received by the patient within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in arm left on 07Jan2021 13:30 (lot number: EL3246) at 1st dose, single for COVID-19 immunization. The patient experienced non traumatic insidious stroke right brain leaving left side paralysis on 15Feb2021 12:30. The event reported assessed as serious which required hospitalization and resulted to disability. Hospitalization: 28 days. The event resulted to emergency room/department or urgent care. Treatment received included intensive care unit (ICU) care (1 week) and rehab hospital (3 weeks). The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination (unknown result on an unspecified date). The patient also underwent nasal swab on 22Feb2021 with negative result. The outcome of the event was recovering. Follow-up information has been requested.

embolic stroke; blood clot; His major issue was speech and wasn't able to formulate any words; left sided weakness on his leg; This is a spontaneous report from a contactable nurse (patient's daughter). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 79-years-old) for COVID-19 immunisation. Medical history included transient ischaemic attack (TIA) from 2019 to an unknown date, mild hypertension, idiopathic neuropathy: in the left leg, started in the beginning of the year from 2019, melanoma removed in the 1970s, enlarged prostate, neuropathy, cholesterol and fluid retention. Ongoing concomitant medications included tamsulosin taken for enlarged prostate; gabapentin taken for neuropathy; candesartan taken for hypertension; pravastatin taken for cholesterol; acetylsalicylic acid (BABY ASPIRIN); and furosemide (LASIX [FUROSEMIDE]) taken for fluid retention. The patient has been taking all of his meds for quite some time, over 5 years. The patient did not have prior vaccinations within 4 weeks. The patient received the first dose of BNT162B2 on 09Mar2021 10:30 for COVID-19 immunization. The patient completed the Pfizer COVID vaccine series, the second shot was on 30Mar2021. On 09Apr2021, the patient had an embolic stroke. The patient's daughter stated that the patient has a history of TIA in 2019 and was concerned. She does not know if it was related. She added it might be that if people have previous risk, there may be some precautions, like to take a full dose of aspirin before, a week before. She sent an e-mail last 05May2021 and hasn't gotten a response back. The patient went to the ER due to embolic stroke and was in the hospital Friday (09Apr2021) through Wednesday. The patient went to the stroke rehab center for 3 weeks. The daughter clarified that the patient was in the hospital until 14 or 15Apr2021 before being transferred (also reported as 5 or 6 days and in rehab for three weeks). Then was discharged last 06May2021. The patient's condition seemed to be getting better. His major issue was speech and wasn't able to formulate any words. He was able to speak now. His rehab would be a lot of neurological rehab and speech therapy. The patient previously had left sided weakness on his leg from some random thing that happened. It didn't seem to get worse. It really affected his speech and cognition. The patient's daughter thought that the embolic stroke was related to the Pfizer Covid vaccine and added that thought was in some way but cannot say in what way. She thought that it exacerbated some type of blood clotting. She stated that he never had blood clotting issues before and was the type of person that would take a baby aspirin and get a nose bleed, he was the opposite of a clotter. An MRI in the hospital showed blood clot and stroke. He had blood work but does not know what it showed and presumed he was fine (unknown results). He has never really had any kind of blood work issues and does not know why he was on cholesterol medication. The patient required emergency room visit for embolic stroke. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported "embolic stroke" cannot be excluded. Previous medical history and Old age is a risk factor for the onset of stroke. 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.

Pt received vaccine 3/3/2021. Pt began with congestion and shortness of breath 03/17/2021. Pt admitted to hospital 3/23/2021 with DVT and PE. Pt was fully ambulatory and no recent procedures prior to this

Crisis Hypertension, Thrombocytopenia with internal bleeding from stomach and intestines (replaced 4 pints of blood), shortness of breath.

AFib; His voice is hoarse today.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Feb2021 19:00 (Batch/Lot Number: EN6201) as dose 2, single for covid-19 immunisation. Patient age at vaccination was 79 years old. Medical history included ongoing COPD (chronic obstructive pulmonary disease), ongoing emphysema, ongoing high blood pressure (he couldn't say, it has to have been a good 15 years he has had it), ongoing high cholesterol (he had it for over 10 years), ongoing Low red blood cell count (depending on his blood count, they give him either a Vitamin B shot or Procrit), ongoing idiopathic pulmonary fibrosis. Both of his parents had type 2 diabetes, and he had type 2 diabetes. Historical vaccine included 1st dose of BNT162B2 (Lot no: EL9263) on 25Jan2021 at 19:00 in left arm for COVID-19 Immunization and flu shot back on October for immunization. Concomitant medications included prednisone (It was for his lungs (unspecific). It was prescribed by his lung doctor. It affected the immune system. He took 10mg. He was taking 5mg then they changed it to 10mg about a month ago. He had taken it for maybe 1 and a half to 2 years); epoetin alfa (PROCRIT) taken for red blood cell count decreased, he only took it as needed when his count was below 10. He had not taken it in 6 months; losartan taken for high blood pressure, from May2021 and ongoing (It was new, he started it about a month ago); amlodipine taken for high blood pressure from May2021 and ongoing (He had been taking it for about a month); atorvastatin taken for blood cholesterol increased from an unspecified start date and ongoing (He had taken it for a couple years); nintedanib esilate (OFEV) taken for idiopathic pulmonary fibrosis from an unspecified start date and ongoing (He had been on it for about a year). The patient experienced AFib on an unspecified date with outcome of recovered. His voice was hoarse today (21Jun2021) with outcome of unknown. He stated he spent 4 days in the hospital and got his rhythm back to normal after 2 days. They put him on apixaban (ELIQUIS), which was a blood thinner. The AFib has resolved, he had no problem with it anymore. The patient underwent lab tests which included COVID-19 antibody test: negative on both 09Jun2021 and 16Jun2021. His HCP told him it was due to prednisone that lowers his immune system.

Patient hospitalized due to hypoxia, shortness of breath and dry cough. Arrived on 15L and put on BiPAP at 100%

Atrial fibrillation; pericarditis; low grade myocarditis; he was still having chest discomfort.; pleuritic chest pain; This is a spontaneous report from a contactable physician. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: not reported), via an unspecified route of administration on 12Jan2021 (at the age of 79-years-old) as dose 1, single, and via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hyperlipidemia; ongoing Presume erectile dysfunction. Concomitant medications included rosuvastatin (ROSUVASTATIN) taken for hyperlipidemia; tadalafil (CIALIS) taken for erectile dysfunction. On 03Jun2021 the patient experienced atrial fibrillation. On Jun2021 the patient experienced pericarditis, low grade myocarditis. on 02Jun2021 the patient experienced pleuritic chest pain, on 10Jun2021 the patient experienced he was still having chest discomfort. The patient underwent lab tests and procedures which included C-reactive protein increased: 65.2 on 03Jun2021 upper limit of normal is less than 8 , C-reactive protein increased: 74 on 10Jun2021, C-reactive protein increased: 65.1 on 16Jun2021, sedimentation rate: 80 on an unspecified date, sedimentation rate: 25 on 10Jun2021, sedimentation rate: extremely high on 24Jun2021, troponin: elevated on 03Jun2021, troponin: normal on 10Jun2021 .Therapeutic measures were taken as a result of atrial fibrillation, pericarditis, low grade myocarditis , pleuritic chest pain, he was still having chest discomfort. Treatment included on 24Jun2021 primary/internist started patient on steroids which caller clarified as being Prednisone 20mg because he was not feeling well and a sedimentation rate came back quote: extremely high; Eliquis 5mg twice daily with the atrial fibrillation; When caller first met the patient, he started Motrin and Colchicine-which caller clarified as they gave him Mitigare which caller believes is the same thing as Colchicine: 0.6 twice daily. The outcome of events was not resolved. Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited information currently available, the causal association between the event Pericarditis, myocarditis and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Atrial fibrilation, Chest pain, Chest discomfort and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

1 significant episode of asymptomatic Supraventricular tachycardia; transient ischemic attack; seizure-like shaking; shaking episode arms going up and down; extremely tired; This is a spontaneous report from a contactable physician (patient himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) at the age of 79-year-old male as single dose for covid-19 immunisation. Medical history included ongoing diabetes type two from 30 years, ongoing hypertension from 15 or 20 years ago, depression from 20 years ago, hyperlipidemia from 15 to 20 years, orthostatic hypertension (had it off and on for years; but it got bad in the last couple of months), pain and radiculopathy. Concomitant medication included metformin (1000 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); glipizide (4 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); lisinopril (10 mg) taken for hypertension from Mar2021 and ongoing; duloxetine (60 mg) taken for depression and pain from an unspecified start date and ongoing (taking for years); gabapentin (NEURONTIN) taken for radiculopathy, start and stop date were not reported. The patient previously took flu shot for immunization and took dose 1 of bnt162b2 in Jan2021 for Covid-19 immunization at the age of 79-year-old. Physician was calling regarding the Pfizer BioNTech COVID 19 vaccine. He had a very strange experience; added he was a physician and in reasonable good health. He had mild side effects, not much; the one side effect he did have was one week after the second shot he and his wife both felt extremely tired the whole day from Feb 2021. Physician mentioned that 4-6 weeks after getting the 2nd dose, he had a 3-5 minute episode of seizure-like shaking, shaking episode arms going up and down on 21Mar2021 and that he was just blankly staring and non-responsive. He had no other symptoms to suggest a seizure; no biting; no urination. This episode lasted three to five minutes. During the episode his wife said he was just staring ahead and he was non responsive to his wife who was only six inches away speaking to him. Then he started to vaguely he heard his wife's voice in the distance and then he woke up and then he was fine. Later that day he was hospitalized, they did a work up and discharged him about 4 days later. While in the hospital he thought he had a Blood work, CAT Scan; MRI; holter monitor; EEG but they were all normal. He had no other complications and the effect completely went away. Adds he was completely recovered when it went away. At discharge they put him baby aspirin, 81mg enteric coated aspirin once daily, and gave him a tentative diagnosis of transient ischemic attack (TIA). This further resulted to being hospitalized for 3 days but his physicians were not able to see anything significant on his MRI, 72 hours EEGs and telemetry tests (everything was normal). However, during his out-patient visit, his physician mentioned that he had 1 significant episode of asymptomatic Supraventricular tachycardia that may be causing the seizure (inconclusive). They further specified to him that it was not much of a tonic clonic seizure. He also verified that he only had 1 episode of the mentioned event, no other side effects experience and been feeling fine since then. After discharge he had a work up on the outside including a 72 hour EEG; 72 hour holter with the only thing that was abnormal that one run of 3 beat supraventricular tachycardia that was asymptomatic. His doctor put him on Metoprolol 12 mg once daily at night by mouth to help prevent arrhythmias as well as control his blood pressure. He had previously taken lisinopril. He added the only thing he knew that he never had anything like this before in his life. Patient mentions he was at a good weight now as he lost 40 pounds last year for his daughter's wedding. He added sometime in the last 6 to 8 months he had severe left side radiculopathy and was taking small dose of gabapentin. He did not remember if it happened before or after the vaccine but he went to see a pain specialist. The medication worked and he tapered it down and discontinued it. It may have been before the vaccine, he is unsure. But the medication worked like a miracle as he had intractable pain down his leg. All events resulted in emergency room. In line with this, he would like to know in relevance to the news of Pfizer releasing a possible booster dose, if there are any reports of anything that may be related to seizure and/or Transient ischemic attack (TIA) of cardiac origin or a like. Extremely tired was reported as non-serious, other events was serious and caused hospital from 21Mar2021 to 24Mar2021. Outcome shaking episode arms going up and down was recovered on 21Mar2021, of extremely tired was recovered in 2021, of other events was unknown.; Sender's Comments: There is no reasonable possibility that the events supraventricular tachycardia, seizure, tremor, and transient ischemic attack happening 4-6 weeks after vaccination were related to BNT162b2. It is more likely to be complications of pre-existing conditions of hypertension, hyperlipidemia, and diabetes. Advanced age may have been contributory as well. 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.

Within 2 days of second shot, Patient exhibited extreme fatigue. This continued for the next several weeks culminating with the inability to move which resulted in admission to Hospital the week of 2/22/21. After weeks to stabilize vital systems, a diagnosis of multiple myeloma was obtained. Patient continued to decline until multiple organ failure occurred within 30 days of admission. Death occurred on 3/25/21. It is not clear whether the vaccine potentially caused and/or exacerbated a previously undiagnosed condition (multiple myeloma). However, the proximity of an immune cell related cancer which resulted in rapid decline and death within 60 days of vaccination should be noted in case there are any other previously undiagnosed blood cancers being found in newly vaccinated individuals.

79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission

80YO male who htn, cva, epilepsy, ckd, cerebral avm s/p repair, cad s/p cab, cva (left sided hemiplegia) , hx of prostate cancer recent admission for pna on abx presents to ED on 1/11 with dizziness, hypoxia. CT with Bilateral PE "Large bilateral pulmonary artery emboli in the right and left main pulmonary artery extending into the right and left main pulmonary artery branches bilaterally. Findings are associated with right-sided heart strain." "Patchy alveolar airspace disease within the lungs highly suspicious for COVID pneumonia" Covid negative. Patients wife recovered from Covid-19 infection within last month. Patent thus far has tested negative. Doppler lower extremity revealed Acute occlusive vein thrombosis of the entire course of the gastrocnemius vein and soleal vein. Patient received covid vaccine on 1/4/21. Patient has several risk factors for clot - age, previous CVA, hx of prostate cancer. Also had positive covid exposure though tested negative

We do not believe that the patient's death was an adverse event from the vaccine. Patient received COVID vaccine from Pfizer Dose #1 12/19/2020 (lot # EK5730) and Dose #2 1/7/2021 (lot # EL1284). No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction. Patient died 1/10/2021 from chronic respiratory failure and congestive heart failure after recent aspiration pneumonia requiring hospitalization. Death was anticipated and not sudden. We were told to report his death to VAERS even though his death was anticipated and not related to his vaccination.

Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."

Acute Gastrointestinal Bleeding per rectum with massive bloody diarrhea, transfer to Emergency room by EMS with IV placement and fluid resuscitation, vital signs unstable, emergency assessment and massive transfusion over next 4 hours of 4 units of PRBC and 2 units platelets, dual 16 gauge IV's, intrarterial line. ER Summary available and can be scanned and sent. Low HgB, Low platelets in 60 k range and multiple consultants and diagnositcs

Patient received first dose of the COVID-19 Moderna vaccine on 1/19/2021 at an outside facility (no lot #, route, or site available to me in electronic charting). Pt began having hypoxia, SOB, and a dusky appearance of extremities on 1/29/2021 and was brought by EMS to our hospital. PT is a DNR and family had been looking into a hospice sign up due to dementia and general decline in the weeks prior to hospitalization. Pt tested positive on admission for COVID-19 via PCR test on 1/29/2021. Pt continued to have respiratory decline, was put on comfort care per wishes of family/advanced directives, and he passed away the evening of 1/30.

Patient scheduled, arrived and consented to receive the first dose of the Pfizer Covid vaccine on Thursday Feb 4,2021 around noon. Patient received his vaccine and was directed to an observation seating area, accompanied by his wife and completed at least 15 minutes of observation prior to being released home. When patient stood up from his chair to exit the clinic , he fell and hit his head on the floor which caused substantial bleeding. He was immediately attended to and transported to the Emergency Dept on the campus of this vaccination site for treatment.

Patient reported to Emergency room on 01/23/2021 with complaint of nausea. According to ER record patient reported he received a COVID 19 vaccine Pfizer the day before. Work up in the ER (CT ABD PELVIS) reveal a clotted of SMA. CT CHEST REVEALED BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE STATE HOSPITAL. HE WAS SCHEDULED FOR EMERGENT VASCULAR SURGERY WHICH WAS CANCELLED AS THE PATIENT DIED SHORTLY AFTER HIS ARRIVAL.

Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and released home. Pt and his son exited the building and when they got to the car, the pt shouted out "oh no!" and collapsed to the ground. The patient was unconscious experiencing agonal respirations, and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival, he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads "Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm. Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture. Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag. Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation." The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021.

Resident with acute onset of SOA this AM with Sao2 of 65%. Transfered to ER with diagnosis of bilateral pulmonary embolism

Severe thrombocytopenia. Administration of dexamethasone and IVIG immune globulin. Petechiae over bilateral lower extremities and feet. Ecchymosis.

Patient was found on bathroom floor by spouse @ approximately 02:30 am (2.5 days after receiving 2nd dose of Covid-19 vaccine). He had fallen and had an obvious head injury & demonstrated altered mentation from usual baseline. Family utilized 911 to transport him to local ED. He was febrile upon arrival to ED and admitted for severe sepsis with unknown etiology. He was found to have positive SIRS criteria and elevated LA. He was admitted to hospital and received IV antibiotics for 11 days (spent 7 days as an inpatient and completed remaining infusions in home environment)

Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.

Admitted to hospital on 2/28/21 for covid pneumonia and acute hypoxic respiratory failure, covid test positive. receiving dexamethasone 6 mg BID and received 1 dose of actemra. concern for bacterial infection.

weakness, fall Narrative: Pt with history of CAD (s/p PCI mid and prox RCA in 2006, on ASA/Plavix; CABG, AVR), afib, GERD, HTN, HLD, hypothyroidism, BPH, diverticulosis, aortic stenosis, small fiber neuropathy (since 2010), lumbar stenosis at S1. Also, pt presented to outside ED on 12/26/20 for increasing falls and weakness over one week and was admitted to outside hospital 12/26/20 for generalized weakness, dehydration, hyponatremia all secondary to covid 10 infection. Hospital course included sepsis due to covid 19, elevated liver enzymes, acute kidney injury. Pt discharged 12/29/2021. After first COVID vaccine 2/12/2021, patient experienced fever x 1 day, weakness, and fall. Presented to outside ED 2/13/21 abd was admitted for critical illness myopathy 2/2 recent COVID infection +/-COVID vaccination. Pt was discharged 2/18/2021.

Patient had sudden cardiac arrest; currently on a ventilator with very poor prognosis 3/11/21; 1st COVID vaccine given 3/2/21

the night after receiving this 2nd COVID vaccination, I returned to active Afib and started in active Afib status for 9 1/2 days. Since then I have had 2-4 days where no Afib (irregular heartbeat) was recorded, but the past week irregular heartbeat has been recorded each time I took my blood pressure (using an Omron series BP monitor).I can feel my heart flutter often and I am very short of breath, where I cannot walk over a block without getting out of breath.

until the vein opened up and was squirting out blood; until the vein opened up and was squirting out blood; a severe itching rash; This is a spontaneous report from a contactable consumer. An 80-year-old male patient (reporter husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 29Jan2021 12:00 at SINGLE DOSE in left arm for COVID-19 immunisation. Medical history included ongoing asthma Onset Date: Probably about 20 years ago, ongoing chronic obstructive pulmonary disease Onset Date: Probably about 20 years ago, ongoing overweight Illness/AE: Little overweight. There was none family medical history relevant to AEs. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot number: EC3246) on 08Jan2021 in Left arm for COVID-19 immunization. The patient experienced a severe itching rash on 01Feb2021 with the outcome not recovered. Area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood on 24Feb2021 with unknown outcome. The rash hasn't gotten worse, and it is staying the same. The AEs require a visit to: Emergency Room and Physician Office. The patient underwent lab tests and procedures which included biopsy: unknown results on 25Feb2021, Bloodwork: Nothing showed up on this test. This is a non-serious report. The outcome of event a severe itching rash was not recovered, outcome of the other events was unknown. This consumer reported she and her husband were administered second dose of Pfizer COVID-19 Vaccine on 29Jan2021. Her husband apparently has had a reaction of very itchy rash to the Pfizer COVID-19 Vaccine. She reported that the patient saw the Dermatologist and the Dermatologist thinks the Reaction of very itchy rash is a reaction to the Pfizer COVID-19 Vaccine. Regarding testing/investigations related to this report caller provided that the primary care physician ordered bloodwork and nothing showed up in that. Biopsy was taken 25Feb2021 to see if reaction of very itchy rash is related to the Pfizer COVID-19 Vaccine When queried if any adverse event required Emergency room visit, physician's office visit or hospitalization caller reported that the patient was seen in the emergency room, but not admitted to the hospital on 24Feb2021 related to patient's event of area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood event-they got that situated in the emergency room. Emergency room staff were the ones that recommended that the patient start Claritin. Dermatologist office visit was regarding the reaction of very itchy rash. The patient is taking Claritin and using Calamine lotion or Calamine spray for these events. Reaction assessed: Reaction of very itchy rash, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.

Deceased Narrative: Patient was a 79 yr old male with a PMH of metastatic rectal cancer with colostomy s/p chemo with RT in 2015-16 with recurrence in 2020, was on holiday from palliative chemo since 9/23/20 due to chemo-related toxicity. Patient was admitted back to Facility on 10/08 for RLE pain ins/o increased weakness and functional decline. Patient decided to transition to hospice care and was admitted to Facility 10/13 for end life care, where he continuously showed signs of functional decline.

Received vac. on 2/10/2021 and on 2/15/2021 had a stroke with no warning. Hospital and Rehab ever since.

STEMI; This is a spontaneous report from a contactable healthcare professional. An 80-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscularly, administered in the left arm on 29Mar2021 13:30 (at the age of 80 years old) at a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, asthma, chronic kidney disease (CKD) 3, all from an unknown date and unknown if ongoing. Concomitant medications included tamsulosin, amlodipine, doxazosin mesilate (CARDURA), albuterol [salbutamol], umeclidinium bromide (INCRUSE ELLIPTA) atorvastatin (LIPITOR) and montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient previously took enalapril and augmentin [amoxicillin; clavulanic acid] and experienced allergies with both. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), intramuscularly, administered in the left arm on 05Mar2021 13:00 (at the age of 80 years old) at a single dose for COVID-19 immunization. The patient experienced ST-elevation myocardial infarction (STEMI) on 31Mar2021. The event was reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization (also reported as number of days hospitalization: 0; pending clarification) and was reported as life threatening. Treatment included cardiac catheterization. There was no other vaccine in four weeks. It was unknown if the patient had COVID prior vaccination and was not COVID tested post vaccination. The outcome of the event was recovering. Information on the batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

My Husband and I received the same day a strong pain in our left arms. The next day my husband complained about pain in his entire body and weakness, and I had the same. In the evening he collapsed falling out of his wheelchair. He tried for an hour to sit down back in his wheelchair with my help, but he couldn't. He agreed that I call 911. Two nurses took him to Emergency Room at Hospital and didn't allow me to go with him. In the morning on Saturday, he was transferred to Room at Hospital and the next day to the Intensive Care Room, where he sadly passed away on Tuesday April 13 at 4:22 am.

not feeling well and short of breath on 2/11/21, 2/12/21 more short of breath ambulance came. Went into PEA in ambulance with CPR. They gave TPA for suspected blood clot. He initially improved. He did not recover and died 4/4/21. He spent the entire time in hospital or TCU with complications. We brought him home 4/2 to die at home.

This 80 year old white male received the Covid shot on 4/8/21 and died on 4/18/21. 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 presneted to the ED and was subsequently hospitalized for NSTEMI on 3/24/21 as well as 4/12/21.

Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins. Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure. Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP. Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021.

First dose covid vaccine given 1/28/21, second dose given 2/18/21. Admitted for bilateral pulmonary emboli to hospital on 4/25/21. From H&P "He reports that he woke up this morning and then subsequently started developing left-sided chest discomfort, it was pleuritic in nature. It is sometimes worse with position. He traveled to the Emergency Room where he was found to be mildly hypoxemic. He underwent workup to include a CT angiogram, which revealed multiple predominantly small peripheral bilateral pulmonary emboli with borderline dilation of the main pulmonary artery and slightly greater than 1:1 right to left ratio. He subsequently was felt to be appropriate for admission because of his underlying hypoxemia. He denies any unilateral weakness or stroke symptoms. He does have a patent foramen ovale. He also reports no history of calf discomfort. With the exception of being sedentary because of the pandemic, he has not traveled anywhere in a car or in a plane in the last 6-12 weeks." treatment: enoxaparin 1mg/kg SQ Q12h starting 4/25 @1659, changed to apixaban 10 mg PO Q12h 4/26 at 1756.

The medical investigator was contacted regarding the death of this 80 year old man within hours of receiving his first dose of the Pfizer vaccine for COVID-19. Little information is known about the facility and actual vaccination administered at the time of this report. However, patient was reported by his next-of-kin to be an otherwise healthy 80 year old without COVID-19 symptoms. He did have a tobacco smoking history. By postmortem computed tomography scans, patient was found to have evidence of catastrophic complications of cardiovascular disease, with apparent aortic dissection and large blood collections in the left chest cavity as well as the pericardial sac. In my medical opinion, these findings were most consistent with a complication of his underlying cardiovascular disease.

Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd COVID vaccination on Feb 26th when he began to have bilateral knee and LE pain. He then was having difficulty walking for a couple of weeks. The leg pain was not constant, but he did fatigue easily with walking. On 3/11 he had his lower dentures placed and that evening/early morning of 3/12 he apparently fell. Patient does not remember anything about the fall - he cannot recall when he fell, how he fell, or any of his symptoms leading up to the fall. Patient remembers being on the floor and attempting to get up but was too weak. He has rug burns on his forearms from attempting to get up. He was hospitalized on 3/13 for dehydration, traumatic rhabdomyolysis, and w/u following fall. Despite very stable labs prior to 1st dose of vaccination on 2/5/21, following vaccination he has had significant and substained leukocytosis as well as transfusion dependent anemia that has not resolved at the time of the reporting (5/13/21). He remains at a skilled nursing facility due to debility.

Altered mental status, confusion, subdural hematoma. Was lifeflighted to Clinic and remained there about 5 weeks, developed a stage IV pressure ulcer on buttock. Diagnosed with multi organ failure. Went to a SNF for rehab after being discharged. Wife said then patient received 2nd dose of vaccine about 2 weeks ago and is currently at Hosptial in town for a GI bleed, passing frank blood and clots. He was admitted 5/9/21. Patient is still confused and lethargic. Before the vaccine, he was taking care of his farm and home. Now he doesn?t even know his wife or what is going on.

4/30/21 Patient presents to the ED w/complaint of SOB x 2 days. He had rales on exam and RA pulse ox was 88-90%. Troponin was elevated and EKG showed lateral ST-T wave changes. Pt was admitted for COVID and NSTEMI. NSTEMI Hx of CAD sp CABG Presented with dyspnea, Trop of 382, trended up to 859, now trending down CXR with findings of pulmonary edema Started on lovenox, aspirin, coreg, statin Cardiology consulted TTE showed EF 50 %, normal diastolic dysfunction, moderate AV stenosis S/P Cardiac cath 5/3 with severe disease of SVG to Diag with successful PCI Continue aspirin, plavix, statin, coreg Follow up with cardiac rehab once he has completed quarantine 10 days after 4/29 Pulmonary Edema Acute HFpEF CXR with findings of mild/early bilateral pulmonary edema. NT ProBNP of 3081 Started on IV lasix and improved Lasix stopped 5/3 due to improvement in symptoms and worsening Na TTE as above Monitor intake and output COVID 19 infection Symptoms of exertional SOB of 2 days Diagnosed on 4/29 Has received two doses of Pfizer Vaccine, last dose 1 month ago per patient CXR Low lung volume examination with findings suggestive of mild/early bilateral pulmonary edema. Was on 2L oxygen, now on RA after diuresis Doubt symptoms are due to COVID-19 and suspect more likely cardiac in origin given rapid improvement of oxygen status with dose of lasix Inflammatory markers also not elevated held off on decadron and remdesivir due to patient not requiring oxygen Complete 10 days of quarantine Patient was discharged home on 5/5/21

Two right MCA ischemic strokes occurring 3-5 days after each dose of Pfizer vaccine. Both episodes he presented with by waking up with acute left arm weakness, numbness and dysarthria. Both episodes happened a few days after COVID vaccine (Covid #2 was administered 4/27). Previous Right MCA stroke from 4/11 was fully worked up. The etiology of this stroke was cryptogenic. TSH from 4/11 was 2.57 and T4 was 0.69. Hgb A1c on 4/11 was noted to be 5.6%. LDL on 4/11 was noted to be 73. MRI brain 4/11/2021 showed multifocal small acute infarcts in the right cerebral cortical/subcortical and periventricular matter infarcts, favored to be embolic. CTA head and neck from 4/11 showed no evidence of large vessel occlusion. Ultrasound of bilateral lower extremities on 4/12 was negative for DVT. ECHO on 4/12 was positive for PFO with an WF > 55%, mild LVH and no thrombus. He also has an atrial septal aneurysm. Cardiac MRI was negative for thrombus. He was discharged on 4/14 with 30 day Holter monitor to evaluate for AFIB.

headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old male 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 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown. Upon follow-up on 16Apr2021: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Office Visit 3/23/2021 Urgent Care PA-C Family Medicine 2019 novel coronavirus disease (COVID-19) Dx Covid-19 Screening Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/23/2021 ? ? Signed Cosigned by: MD at 3/24/2021 4:39 PM Expand AllCollapse All MDM Number of Diagnoses or Management Options 2019 novel coronavirus disease (COVID-19): Diagnosis management comments: Patient is an 80-year-old male with history of atrial fibrillation and positive POCT COVID-19. 6 days of symptoms. Excellent candidate for antibody therapy. The health system treatment navigator was notified of this and will schedule him for antibody infusion treatment. Patient is stable at present with no severe or concerning symptoms at this time. Tylenol/continued Eliquis recommended. Clinical Support 3/24/2021 Health system RN COVID-19 virus infection Dx Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/24/2021 ? ? Signed Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions ED to Hosp-Admission Discharged 3/25/2021 - 3/26/2021 (39 hours) Hospital MD Last attending ? Treatment team COVID-19 Principal problem Chronic anticoagulation Persistent atrial fibrillation (CMS/HCC) COVID-19 Confusion Hypoxemia Hospital Course: In his hospital stay we managed his medical issues as follows; Confusion/Syncope in the setting of COVID-19 infection Chronic atrial fibrillation/sinus node dysfunction Hypertension Prediabetes Patient received first dose of vaccination on 3/16 and afterwards started having muscle aches and body pains, later on found out to be having Covid 19+ test, he might be having Covid infection before vaccination as well and symptoms showed with vaccination. On 3/24 he was found out to be having confusion, family called EMS. They tried to debride patient on his feet and he collapsed for about 10 seconds. He did mention that he usually get dizziness/lightheadedness upon standing from bed. Although patient has a history of A. fib but remained rate controlled during hospital stay, we held his antihypertensives including HCTZ and ARBwhile continued his Eliquis. I believe his syncope was likely due to dehydration with decreased oral intake in the setting of acute illness with COVID-19 symptoms. Before discharge is blood pressure was rising so his ARB were restarted while decision regarding HCTZ will be made by primary care physician. In regard to his COVID-19 infection, initially was started on 2 L of supplemental oxygen but his oxygen demand decreased rapidly and most of the time he remained room air, he was not showing any dyspnea, cough, fever or any other generalized symptoms of Covid 19 infection. He did get plasma and remdesivir while inpatient, decision was made to discharge him on 3/26 as patient was symptom-free. He also had received first dose of vaccination. I believe that he would need further remdesivir. We will continue him on steroids for now after completion of dexamethasone for next 8 days he can recent resume his home medication of prednisone.

NIECE CALLED TO LET US KNOW PATIENT EXPIRED 3 DAYS POST VACCINE SHOT. NIECE STATED PATIENT HAD BREATHING ISSUES AND NOTES MENTION HEART ISSUES.

Muscle ache, loss of smell and taste The PUI started feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a loss of appetite due to his loss of taste/smell. The patient is currently undergoing chemo therapy and is most likely the reason why he still got sick with COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA

Patient presented to the ED on 5/5 after being sent by his PCP after an ultrasound in the office showed a DVT along with patient's complaint of shortness of breath. Patient denied history of DVT/PE. In the ED, CTA-PE showed bilateral pulmonary embolic disease and Ultrasound confirmed acute right lower extremity DVT. Patient was started on a heparin drip and then switched to enoxaparin 1 mg/kg every 12 hours per pulmonary. Hematology/Oncology was consulted and determined that acute bilateral PE likely provoked by recent vaccination with the second dose of the Pfizer vaccine. Patient was switched to rivaroxaban 20 mg daily prior to discharge for planned duration of 3 months.

COVID-19 - patient admitted for 5 days of shortness of breath. Tested COVID+ upon admission, Received vaccine in March. Patient admitted 5/25, still inpatient but improving. Allergies (drug/food and reaction):NKDA Date of Vaccination:02/03/2021 and 02/25/2021 Dose: 1 and 2 Vaccine Manufacturer: Pfizer Lot #: 1st dose 2/3 Lot # EL9269 2nd dose 2/25 Lot # EN6203 Clinic Administering Vaccine: Healthcare Injection site: L deltoid Description of event/reaction: Pt was hospitalized for COVID-19 after receiving vaccination Date of Clinic Visit or Hospitalization: 5/24/2021 Reason for clinic visit or hospitalization: hypoxia COVID-19 positive test result: Yes ; if Yes, date 5/22/2021 Plans to monitor (include medications if prescribed):Treatment with dexamethasone, remdesivir, tocilizumab

R29.810 - Facial droop I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) J18.9 - Pneumonia, unspecified organism

Pt had a spontaneous brain hemorrhage, leading to his death. Pt was found by his wife at approximately 0800, slumped over in the corner of the room, pt was brought into the ER unresponsive. Pt died 4 hours later.

ED to Hosp-Admission Discharged 6/18/2021 - 6/19/2021 (17 hours) Hospital MD Last attending ? Treatment team Musculoskeletal chest pain Principal problem Hospitalist Medicine History and Physical Date: 6/18/2021 Admission Date: 6/18/2021 PCP: MD DOB: 3/16/1940 Hospitalist: MD Assessment/Plan Medical Problems Hospital Problems POA * (Principal) Atrial fibrillation with RVR (CMS/HCC) Yes COVID toes Yes Angina of effort (CMS/HCC) Yes Atrial fibrillation (CMS/HCC) Yes Medical Problems Plan: 1. Will be admitted to icu because of angina like smptoms montor 2.repat tropon 3. Check bmp bnp and echo in am 3.check tsh mag 4.covid precautions5. Cardiology and ID consut in am if needed VTE prophylaxis: already on eliquis avoid nsaids because he is on eliquis will try tylenol if needed morphine for severe pain Full Code History of Present Illness Pt. is an 81yr male. Very pleasant male with history of choronic afi on eliquis history of hypertenson hyperchol Had ultrasound of the carotid arteris which showed stenosis Today he was mowing lawn developed left sided cheestpain pressure with no radiation to the neck arm s shoulder he was not diaphoretic. No fever chills or cough his covid is postive denies nausea vomiting or abdominal pain Came to the ER initially he was tachycardic with heart rate of 136 ekg showed right bundle with A-fib His initial troponin is negative less than 0.03 Has wbc cont of 11.8 hb 14.3 hct Normal platelets 188 na 142 k4.0 cl 110 c02 223 bun 17 cr 1.07 ast 15 alt 16 blood sugar of 148 Continue with chestpressure little anxious sats stable Considered his multiple risk factors and rapid a fib on arrival therefore he will be admitted in icu And montor his oxygen sats in case if it get rapid may need iv blocker or amiodarone Family history father died at the age of 63 from cAD /MI Mother died of old age at 93 Assessment Review of Systems Constitutional: Negative for activity change, appetite change, chills, diaphoresis, fatigue, fever and unexpected weight change. HENT: Positive for trouble swallowing. Negative for congestion, ear discharge, mouth sores, sinus pressure, sinus pain, sore throat and voice change. Eyes: Positive for visual disturbance. Negative for photophobia, pain and redness. Respiratory: Positive for chest tightness and shortness of breath. Negative for apnea, cough, choking and wheezing. Cardiovascular: Positive for chest pain and palpitations. Negative for leg swelling. Gastrointestinal: Negative for blood in stool, diarrhea, nausea and vomiting. Endocrine: Negative for cold intolerance, heat intolerance, polydipsia and polyphagia. Genitourinary: Negative for difficulty urinating, flank pain and hematuria. Musculoskeletal: Positive for arthralgias. Negative for back pain, gait problem, joint swelling, myalgias, neck pain and neck stiffness. Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches. Negative for dizziness, tremors, seizures, syncope, facial asymmetry, speech difficulty, weakness and numbness. Psychiatric/Behavioral: Negative for agitation and behavioral problems. Past Medical, Social and Family History Medical History No past medical history on file. Surgical History No past surgical history on file. Social History Socioeconomic History ? Marital status: Married Spouse name: Not on file ? Number of children: Not on file ? Years of education: Not on file ? Highest education level: Not on file Occupational History ? Not on file Tobacco Use ? Smoking status: Not on file Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Other Topics Concern ? Not on file Social History Narrative ? Not on file Social Determinants of Health Financial Resource Strain: ? Difficulty of Paying Living Expenses: Food Insecurity: ? Worried About Running Out of Food in the Last Year: ? Ran Out of Food in the Last Year: Transportation Needs: ? Lack of Transportation (Medical): ? Lack of Transportation (Non-Medical): Physical Activity: ? Days of Exercise per Week: ? Minutes of Exercise per Session: Stress: ? Feeling of Stress : Social Connections: ? Frequency of Communication with Friends and Family: ? Frequency of Social Gatherings with Friends and Family: ? Attends Religious Services: ? Active Member of Clubs or Organizations: ? Attends Club or Organization Meetings: ? Marital Status: Intimate Partner Violence: ? Fear of Current or Ex-Partner: ? Emotionally Abused: ? Physically Abused: ? Sexually Abused: No family history on file. Allergies and Medications No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider apixaban (ELIQUIS) 5 mg tablet Take 5 mg by mouth 2 (two) times a day Yes Provider, Historical, MD atorvastatin (LIPITOR) 10 mg tablet Take 10 mg by mouth at bedtime 5/20/21 Yes Provider, Historical, MD clonazePAM (KlonoPIN) 0.5 mg tablet Take 0.5 mg by mouth at bedtime 6/14/21 Yes Provider, Historical, MD metoprolol succinate XL (TOPROL-XL) 25 mg 24 hr tablet Take 12.5 mg by mouth daily 6/2/21 Yes Provider, Historical, MD NIFEdipine XL (PROCARDIA XL) 30 mg 24 hr tablet Take 30 mg by mouth daily 6/12/21 Yes Provider, Historical, MD omeprazole (PriLOSEC) 40 mg capsule Take 40 mg by mouth daily 5/26/21 Yes Provider, Historical, MD tamsulosin (FLOMAX) 0.4 mg capsule Take 0.4 mg by mouth daily 4/26/21 Yes Provider, Historical, MD Objective Objective Current Min/Max Temperature: 36.1 °C (97 °F) Temp Min: 36.1 °C (97 °F) Max: 36.1 °C (97 °F) Heart Rate: 99 Pulse Min: 80 Max: 116 Resp: 18 Resp Min: 18 Max: 18 BP: (!) 148/89 BP Min: 121/103 Max: 148/89 SpO2: 96 % SpO2 Min: 94 % Max: 98 % No intake/output data recorded. Weight: Wt Readings from Last 1 Encounters: 06/18/21 75.8 kg (167 lb 1.7 oz) Physical Exam Physical Exam Vitals reviewed. Constitutional: Appearance: He is well-developed. He is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Neck: Vascular: No hepatojugular reflux or JVD. Trachea: No tracheal deviation. Cardiovascular: Rate and Rhythm: Rhythm irregular. Pulmonary: Effort: Pulmonary effort is normal. No accessory muscle usage. Breath sounds: Normal breath sounds. No stridor. Abdominal: General: Bowel sounds are normal. There is no abdominal bruit. Palpations: Abdomen is soft. There is no splenomegaly. Tenderness: There is no abdominal tenderness. There is no rebound. Musculoskeletal: Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not cyanotic or pale. Findings: No rash. Nails: There is no clubbing. Neurological: General: No focal deficit present. Mental Status: He is alert. Cranial Nerves: No cranial nerve deficit. Motor: Weakness present. Psychiatric: Mood and Affect: Mood is anxious. Signed, MD Hospitalist Medicine 6/18/2021 10:08 PM

coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the touch/ couldn't get warm; tired; Didn't feel good; just wanted to stay down and didn't want to get up/ just couldn't wake up; eat very little and he didn't like to eat; color was off, looked grey; Pressure in lower stomach; Lost weight; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient of unspecified age and gender received the first/second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via intramuscular at left arm on 02Feb2021 10:00 (80-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included Stents from 2005 (a stent placed in 2005; a heart attack in 2017 and additional 5 stents were placed in 2017; a stent placed in his neck in Nov2019); Heart attack from 2017; Reaction to contrast dye from 2005 (has a reaction to the dye that they use for stents; had a stent placed in 2005 and had a reaction to the dye then; a mild heart attack in 2017 and did stents; once again had a reaction to the contrast dye); Sensitivity to bug bites (When the patient got big bites, you would think someone had beat him he had so many knots; the last few years the patient's reaction to bug bites got much worse); High blood pressure. Additional information for other conditions: The patient was very highly allergic or has a reaction to the dye that they use for stents. The patient had some heart stents and he had bad reactions to the contrast used. The patient was allergic to different things. The patient couldn't take codeine. When the patient got big bites, you would think someone had beat him he had so many knots. Reaction to contrast dye: the patient's physicians then wanted to do imaging with contrast dye on the patient's neck. Physician put the patient on a cocktail for 24-48 hours before the stent was placed and the patient still had a reaction. The patient was given a cocktail of Benadryl and 2 other medications that she cannot remember. The patient's reaction to the dye was not as bad as the first 2 but he still had one. The patient had the stent placed in his neck in Nov2019. The patient still had a reaction to the contrast dye, a mild reaction, even with the cocktail. The reaction was enough the patient was told to continue taking the medication afterward. The patient always carried a nitro bottle in his pocked but he never took any of them. They asked how the nitro tablets were and they were powder. They were blessed as far as the patient's heart. Concomitant medications included cetirizine taken for allergy problems; amlodipine taken for high blood pressure for years; acetylsalicylic acid (ASPIRIN) (for the arteries, just to keep the blood thin, the patient began taking aspirin after experiencing side effects from Effient). The patient previously received codeine and experienced sensitivity (Couldn't take codeine, goes way back, 40-50 years). The patient previously received prasugrel hydrochloride (EFFIENT) from 2017 and experienced shortness of breath (The patient was put on Effient after his stent placement in 2017. Doctor took the patient off of Effient and instructed him to just take aspirin because the patient was showing side effects of shortness of breath and different things. Doctor informed the patient that he would rather the patient just take Aspirin than have the side effects from Effient). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 12Jan2021 (80-year-old at time of vaccination) for COVID-19 immunisation and experienced "so excited" (the patient was so excited after the first shot of the COVID-19 vaccine). The patient previously received tetanus vaccine toxoid (TETANUS) shot for immunisation (20 years ago at least) and experienced "Couldn't move arm, arm swelled and turned red and was messed up for a while". Prior vaccinations within 4 weeks was none. Patient's wife reported that she and her husband (the patient) took the COVID-19 vaccines on 12Jan2021 and 02Feb2021. After his second dose, the patient kept telling her that he didn't feel good and that he was tired (from 03Feb2021). The patient just did not feel good. The patient was cold and so cold to the touch (from 03Feb2021). On 03Feb2021, he was dragging. The patient just wanted to stay down and didn't want to get up. She asked the patient if this was going to keep him in the room all day. The patient replied that he just couldn't wake up. The patient was tired and cold and couldn't get warm. The patient lost 30 pounds (in Feb2021) after he got the second dose of the COVID-19 vaccine. The patient walked around holding his pants up. The patient would eat very little and he didn't like to eat. When he was weighed at the doctor on Friday 02Apr2021, he weighed 136 pounds fully clothed. The patient normally weighed 150-160 pounds. The patient had lost a lot of weight. The patient's color was off, stating that one of her friends said the patient looked grey. The patient experienced pressure in lower stomach (in Feb2021). The patient told her that in his lower stomach, he described it as pressure, and the patient thought he was just kind of sore from coughing from the sinus infection. The patient couldn't stand clothes to touch him and would cut holes in his underwear elastic so that it wouldn't press into him. The patient went to the doctor twice from the time he took the second shot of the COVID-19 vaccine to his death (on 04Apr2021). The patient went to the clinic. The clinic thought the patient had a sinus infection (from 27Mar2021) and gave him a shot that would make him feel good. The patient got a shot on 27Mar2021. She wasn't sure what the shot was and she didn't get a print out. They treated the sinus infection with amoxicillin-clavulanate (875mg-125mg, manufacturer is Teun). The amoxicillin hadn't worked well and the patient went back to the clinic a second time on Friday, 02Apr2021. When the patient went to the doctor on 02Apr2021, they were unable to get a register on the finger pulse-ox monitor. The patient's physician did an X-ray (on 02Apr2021) and the X-ray was perfectly fine (normal). Nothing showed up on the X-ray at all. The patient passed away easter Sunday morning (04Apr2021). The cause of death listed on the patient's death certificate is due to consequence or problem of pulmonary embolism (from 04Apr2021), respiratory impairment. The patient did not receive an autopsy. The family didn't feel the need and the staff didn't even ask if the family wanted an autopsy. "When you live to be 80 years old, you're blessed." HCP: The patient's heart doctor did not see the patient on 04Apr2021 before he died. The last time the patient saw the doctor was Dec2020. The wife reported that she is not complaining, the patient made the decision to take the shot, she is just concerned that the patient had something that could help someone else. The wife stated she was not trying to complain at all, she took the COVID-19 vaccine right beside him and had no consequences. She didn't even have a sore arm. The family is just concerned that there is an ingredient in the COVID-19 vaccine or something that could trigger that in them. Yesterday, 23Jun2021, they were showing a lady on TV that was so sick (unable to provide details). "The patient" (unknown to which patient this is referring) got the shot and ended up in the hospital with side effects. The wife reported that's why she wanted to let Pfizer know about her husband. She was just reporting the patient's symptoms and was not wanting to hurt anyone's feelings in the world. She is not blaming the COVID-19 vaccine for the patient's death, and stated that it could have been his heart or more anything. She just felt like she needed to let pfizer know some of the side effects the patient was having that didn't start until after the second COVID-19 shot. The wife unable to provide the NDC number, lot number, or expiry date of the patient's COVID-19 vaccines. She does not have the information but her son does have that if Pfizer wanted to call and talk to him. The adverse events did not require a visit to emergency room; the adverse events requiref a visit to physician office (The patient went to the clinic 27Mar2021 and went back 02Apr2021 for Sinus infection). Therapeutic measures were taken as a result of the event sinus infection and included a shot and amoxicillin-clavulanate. The outcome of the event pulmonary embolism/ respiratory impairment was fatal; outcome of other events was unknown. The patient died on 04Apr2021. No autopsy was done. The cause of death was pulmonary embolism/ respiratory impairment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pulmonary embolism/ respiratory impairment

Within a few minutes of his 2nd dose, he said his throat felt tight like it was closing. I alerted staff. They checked his blood pressure. 155/50. Made us wait another 20 minutes and my dad said he felt better after drinking water. Once we got home he said he felt brain fog and a bit dizzy. He passed away on May 4th, 2021. 3 days after his 2nd dose of Pfizer. It was ruled a heart attack.

Pt on hospice in facility for severe cardiomyopathy unable to perform interventions received vaccine without adverse sequelae died 5 days later. Reporting as required. Narrative: Reporting as required patient death 5 days after immunization with Pfizer vaccine. However, no adverse sequelae were noted to the vaccine in the 15minute observation period, nor in the days following the immunization related to the vaccine. The patient denied any prior severe reaction to this vaccine or its components, and the patient gave verbal consent to receive the vaccine. Patient had been in the facility on hospice since 11/18/20 for severe decompensated HF and newly diagnosed cardiomyopathy, unable to perform interventions, also LE ischemic wounds with very poor potential to heal due to advanced PVD.

patient passed away after receiving the Covid vaccine; This is a spontaneous report from a contactable nurse. An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization. There was no medical history and no concomitant medications. On 08Jan2021, the patient passed away after receiving the COVID vaccine. The patient died on 08Jan2021. An autopsy was not performed. Investigations indicate that unspecified labs were done, but nothing two weeks prior; no further details were provided. The patient received the first dose the day prior. The reporting nurse discussed it with the medical director, and he thought that he potentially passed away from the COVID vaccine. The relatedness of the event to the suspect vaccine was reported as related by the reporting nurse per The Agency. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the limited information available, it is medically not possible to make meaningful causality assessment, it is unlikely the vaccine could have contributed to the death of the patient based on the known safety profile. However case will be reevaluated when additional information is received during the follow-up The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Stated that the patient passed away after receiving the Covid vaccine

patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.

Chest pain; LBBB (left bundle branch block); NSTEMI (non-ST elevated myocardial infarction); angioplasty & bypass done 1/11/21; discharged home 1/12/21 with referral to radiation oncology and f/u with interventional cardiology.

Slurred speech started morning of 1/8 and patient went to ED after dialysis appointment. Admitted for TIA (transient ischemic attack). Discharged home on 1/10 with follow up appts with Neurology.

Admitted to hospital after vaccination with Acute hypoxemic respiratory failure, Septic shock; Aneurysm of arteriovenous dialysis fistula; expired 1/16/2021

(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home.

hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason. Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.

in addition to above, pt had the following diagnosis: portal HTN, abnormal blood chem, essential tremor, depressive disorder, abnormal glucose tolerance test, hyperlipidemia, hypothyroidism, insomnia, localized osteoarthrosis, calculus of kidney, pancytopenia, odule on liver, hepatocellular CA, hyotension, hypovolemia, hepatorenal syndrome additional meds: zoloft, aldactone, thiamine,demadex, ultram, kenalog, vitamins, bactroban ung

Possible transverse myelitis developing 2 days after vaccine injection. Death on day 9 after vaccination

Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

On 2/4/21, at around 3:00pm he began feeling very tired and he began burping in the evening. The following morning, he woke up early and was still burping and not feeling well. At around 5:00am, he collapsed. My mother called 9-1-1 and began giving CPR. The parademics arrived and tried to revive him, and transported him to the hospital but at 6:11am, he was pronounced dead of a heart attack. He was healthy.

Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral.

Stroke; like he had a film over his eye, it was cloudy, like a cloudy day; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL1283 and expiry date: 30Apr2021) solution for injection, intramuscular in left arm on 18Jan2021 13:10 at a single dose for Covid-19 immunization. Medical history included chicken pox, measles, and mumps (had chicken pox vaccine, measles, and mumps when he was younger, and he got the flu shot for flu). The patient's concomitant medications were not reported. The next day (19Jan2021) after receiving the injection, patient reported it was like he had a film over his eye, it was cloudy, like a cloudy day. This went on for a couple of days before it improved. There was still a little bit in his left eye, but he can read and it has improved. He can see now and his eyes were improving. He found out that he had a stroke on 28Jan2021. He did not go to the hospital. He does not think the stroke affected anything else. He was supposed to have an MRI sometime this week. He went to the eye doctor and the eye doctor was the one that discovered the stroke and his eye doctor sent the report over to his primary office. He had a vision field test which was how the stroke was diagnosed. He was taking a baby aspirin and he will be put on a blood thinner called Plavix. He has not started Plavix yet, he has to go pick it up. Outcome of the event stroke was unknown while the other events was recovering. No follow-up activities are needed. No further information is expected.

Anaphylaxis symptoms began approximately 6-7minutes post vaccination with patient having difficulty breathing, palor, lethargy, sweating, and stating throat was closing/tightening-patient immediately given epi and ems called...patients symptoms improved significantly in about 2 minutes post epi and ems arrived within 11 minutes and took over patients care..patient transported to local ER per EMS for further evaluation and treatment

1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospital from ED DX: Acute respiratory failure with hypoxia ; Pleural effusion, left; Community acquired pneumonia of right lung, unspecified part of lung currently admitted to hospital during time of this report.

Patient has history of COVID19 infection on November 2020. He received first dose of pfizer COVID 19 vaccine on 2/2/21. Six days later on 2/8/21, the patient presented to the ED with complaints of cough, dyspnea, and vomiting. Patient was breathing on room-air, blood pressure was stable, and he wasn't febrile. Patient was admitted for bilateral pneumonia. Initial COVID test on 2/9/21 was negative and patient received 7 days of antibiotic therapy. Throughout the patient's stay, his respiratory function was stable on room air. Patient was to be discharged at the end of the antibiotic therapy but a follow-up COVID PCR test on 2/17 resulted POSITIVE. Patient's s/s for infection were already improving and the providers held off on discharging to be sure the patient was asymptomatic for COVID 19. Patient was uneventfully discharged on 2/26/21 for a total stay of 18 days.

Patient hospitalized 2/18/21, second dose was scheduled for 2/23/21. Patient expired in hospital 2/27/21.

Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care.

Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased

NO IMMEDIATE LOCAL REACTION, NO REACTION 30MINUTES LATER. FOUND FOAMING AT THE MOUTH NEXT MORNING. PRONOUNCED DEAD AT HOSPITAL.

shortness of breath Hypoxia Pneumonia of both lungs due to infectious organism, unspecified part of lung History of COVID-19

Patient developed a syncopal episode one day following the vaccine. Without warning, he fell to the ground, losing control of bowel and bladder, although no seizure activity noted at the time. He transiently lost consciousness and then woke up confused and combative. Brought to emergency room and admitted with multiple rib fractures. Initial brain imaging was negative but 24 hours later, noted to have small hemorrhagic brain contusion in left frontal/temporal region and a small subdural hematoma. One day later, there was not noted to be any extension of the hemorrhage/hematoma.

Sudden onset of Atrial Fibrillation within 2 minutes; This is a spontaneous report from a contactable physician (patient). This 81-years-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EN6206, on 05Mar2021 10:45 in right arm as a single dose (at the age of 81 years) for COVID-19 immunization. The patient had dose 1 of BNT162B2 for COVID-19 immunization, Lot number EL9261, on 05Feb2021 10:45, in Left arm. Relevant medical history included GERD (gastrooesophageal reflux disease). There were no allergies reported. Concomitant medication included Omeprazole, Ursodiol, fexofenadine hydrochloride (Allegra), diphenhydramine hydrochloride (Benadryl). The patient had no other vaccine in four weeks. The patient experienced sudden onset of Atrial Fibrillation within approximately 2 minutes on 05Mar2021 reported as 10:45. The patient was seen at the physician's office. Treatment included EKG; Xeralto anticoagulant. The patient did not have COVID prior to vaccination and was not tested post vaccination. The outcome of sudden onset of Atrial Fibrillation was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event cannot be completely ruled out given the implied temporal association. However, underlying medical conditions may provide the alternate explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Pfizer COVID -19 Vaccine EUA Patient's wife reported to facility, upon contacting for 2nd dose appointment, that the patient passed away from COVID-19. This patient did not pass away at facility, as there are no records of this patient in our EHR. Per patient?s wife, patient was vaccinated on 2/3/21 at the clinic with the initial Pfizer COVID-19 vaccine. The patient passed away on 2/22/21 from COVID-19 (3 weeks after the initial dose, but prior to the booster dose). Pfizer/BioNtech NDC# 59267-1000-2 Pfizer/BioNtech Lot # EL9269 Lot Exp: 05/30/2021 Site: left Deltoid Time of vaccination: 2/3/2021 6:15:53 PM

Death Narrative: Death on 12/22/20. 1st dose administered 5 days prior to serious event. Patient passed of chronic illness while in facility. There are no indications that death was related to the vaccine.

No adverse events reported while client observed after vaccination. Received voice message on 4/6 from daughter that client had died several hours after receiving vaccine. Also reported he had underlying health issues so unsure of cause. I made telephone call to daughter on 4/6. Daughter was wanting report made and plans to do so with additional health information included. I informed daughter I would be making a report also.

On February 20, 2021 in the early evening my husband began to experience chest pain and pressure, took Tylenol, however did not relay the symptoms to me. About 6:50 AM on February 21, 2021 told me that he did not feel well, had chest pain and pressure in his chest. An ambulance was called and my husband was transported to the Hospital. I was contacted by the treating physician and was told that my husband suffered with a Pulmonary Embolysm (sp?). He was started on Heparin and admitted to the hospital. Later that evening his medication was changed to Eloquis. He was released from hospital the following evening. He has since followed up with his primary care.

Lung blood clot found after emergency room visit experiencing shortness of breath 03/04. Tennis ball size neck lymph node swelling starting 02/25. Joint pain and swelling starting 2/22

Patient received his 2nd dose of the Pfizer vaccine at on Monday, February 15. That evening, he experienced visual disturbances with slightly blurred vision. Not thinking anything of it at the time, the vision cleared, and he continued about their evening/week without telling anyone of his visual disturbances. On Sunday, February 21, he experienced additional visual disturbances including double vision and dizziness, and we had him visit a local ER for evaluation. He was discharged with a diagnosis of dehydration and vertigo. No scans were performed. The visual disturbances cleared up the following week and the only persistent symptom was a slight dizziness. An eye exam was performed on Friday, February 26 with no problems found. An MRI was performed on March 3, and he was diagnosed with the below conditions. Impression (3/3/2021) 1. Small acute to subacute infarcts in the left splenium of the corpus callosum and parasagittal left occipital lobe. 2. Trace subarachnoid hemorrhage in the parasagittal left parietal lobe. 3. Mild chronic microvascular ischemic disease. He was admitted to the hospital and remained there until Saturday, March 6. Follow-up scans and testing were performed with no underlying reason for the stroke being determined. Prior to the stroke, he had been a very active individual with osteoarthritis as is only health complaint. He was not on any prescription medication prior to the stroke. While in the hospital, the tests for high blood pressure, high cholesterol (LDL 92 MG/DL), sugar inadequacies (glucose 93 mg/dl, A1C 5.7%), etc. came back without major concerns. His follow-up CT scans also did not reveal the stroke shown on the MRI. No inquiry was made by any of his doctors or hospital staff as to his COVID vaccination status/dates to even consider the connection. Below are the results of the last CT scans: Impression (3/4/2021) 1. Age-related volume loss and white matter disease similar to prior exams. 2. Small infarct seen on MRI are not well seen on CT. 3. No acute intracranial abnormality demonstrated on the CT scan. Impression (3/5/2021) 1. No evidence of acute infarct or intracranial hemorrhage. No significant change. 2. Periventricular white matter disease is likely secondary to chronic small vessel ischemic changes.

Multiple blood clots, bleeding, hematoma, bleeding events after heparin, swelling in lower body, gangrene in both feet, double below knee amputation, situation ongoing, still in hospital.

Janssen COVID-19 Vaccine EUA; patient reports intermittent blurry vision and fatigue after vaccination. Presents to infusion center for chemotherapy, experienced blurred vision, found to be hypotensive and bradycardic, and transferred immediately to emergency department (ED). In the ED diagnosed with acute left lower lobe segmental pulmonary embolism and thrombocytopenia. Admitting to hospital for further management.

Death Narrative: Patient was not previously COVID-19 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 80 and discharged on 2/17/21 with hospice after falling and suffering a subdural hematoma. Patient was likely reaching end of life from metastatic prostate cancer before fall.

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

Got worse and the leg swelled and was also having foot swelling because blood flow wasn't there; sore arm; blood clot; pain behind left knee; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right shoulder on 23Feb2021 (Batch/Lot Number: EN6202) (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, stage 3 renal failure (was not bad, was in stage 5 couple of years ago, was a month or so away from full failure, was in the hospital and had dialysis, was able to get reversed with medication and diet), high blood pressure, and blood cholesterol increased/high cholesterol. The reporter stated that with regards to patient's height, he shrunk a little. Patient had no prior vaccinations within 4 weeks, didn't get flu shots. Concomitant medications include about 12 other unspecified drugs, takes statins, has high blood pressure and high cholesterol. Patient started experiencing pain behind his left knee about 6 or 7 days later in Mar2021 (also reported as 04 or 05Apr2021, pending clarification). By that Sunday, it had gotten worse. The leg swelled and was also having foot swelling because blood flow wasn't there. There was no TIA's no stroke, no heart racing, no sweating, was all pain. Got leg up and kept elevated until they could get to the doctor and get imaging. Patient went Monday 08Mar2021 to see the doctor. Patient was brought to the doctor and was then sent to the imaging place. Radiology read the imaging around 5:15pm on the Monday, 08Mar2021. The radiologist said there was 2.5" blood clot behind the left knee. He had never had a blood clot before. Patient was then sent to the Emergency Room at (Name) Hospital, in (Name) where they live. Was kept there several hours. Did a lot more blood tests. He was immediately put on 10mg ELIQUIS 10mg, once in the morning, and once at night. He is now taking 5mg Eliquis in the morning, and 5mg at night. He has not had any of these problems before the Pfizer shot. The reporter knew that not a lot had been reported. It seemed it should be safe. The correlation and timing having the shot on 23Feb2021 and all of a sudden a week and a half later this happened. It was 10 days later. There was nothing they can do about it. Just continuing with the ELIQUIS, trying to dissolve the blood clot, will be staying on it for 4 to 6 months. It was a pretty big blood clot and were worried about it breaking up and traveling. The patient had no other symptoms, had a sore arm, that was it. Patient going back to (Name) 01Jun2021 and he will have another CT scan or ultra sound when they get back. The reporter did not want to need to get the leg amputated. Patient was only in the ER, was not admitted to the hospital. Patient was concerned because of his age. If it doesn't dissolve, they know there will be a lot more trouble. The event of pain left knee, blood clot and sore arm required a visit to the emergency room and physician's office. The patient received the second dose of BNT162B2 on 01Apr2021 (lot number: ER8730) in the right arm. The outcome of events was unknown.

Acute respiratory failure due to COVID-19 (CMS/HCC) SOB Severe sepsis (CMS/HCC) Hyperlipidemia IV remdesivir IV dexamethasone

This 81 year old white male received the Covid shot on 3/11/21 and went to the ED on 4/2 and was admitted on 4/4 with shortness of breath, pericardial effusion, pulmonary edema, CHF and again to the ED on 4/30 and admitted on 4/30 with abdominal pain, hypoatremia, renal insufficiency and again to the ED on 5/1 with pericardial effusion and died on 5/4/21.

This 81 year old white male received the Pfizer Covid shot on 2/20/21 and went to the ED on 4/10/21 and was admitted on 4/10/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) unable to speak

This 81 year old male received the Pfizer Covid shot on 3/01/21 and went to the ED on 3/20/21 and was admitted on 3/20/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

Patient developed chest pain late March. Duration of 1-2 days. No medical follow-up. Patient developed chest pain and difficulty breathing 26 Apr. He reported to a facility like Urgent Care. HCP recommended CXR which revealed questionable findings. HCP recommended hospital visit but patient did not go that day. Instead patient called ambulance to home the next morning and was transferred to the local hospital. Chief complaint chest pain and difficulty breathing. Bloodwork ruled out myocardial infarction. Various other assessments done over the first three days of hospitalization, including a CT scan which purportedly showed about a pulmonary emboli. Most (if not all) of the emboli were in the right lung and were small and fixed/immobile. At least one was larger. Patient was started on heparin . Echocardiogram workup ruled out presence of DVT in the legs. Patient was discharged after 13-14 days in the hospital.

Patient received COVID vaccine #1 on 3/25/21 and #2 on 4/17/2021. He had CBC done on 3/3/21 which showed normal CBC with WBC 4.4 and platelet 172K. On 5/3/2021 with routine CBC, it showed WBC 2.3 and platelet 10K. On 5/7/2021, WBC 0.3 and platelet 16K. Methotrexate was D/C'd then. He was given dexamethasone 40mg daily for 4 days for presumed ITP, completed on 5/10/2021. On 5/12/2021, WBC 2.9 and platelet 122K. Methotrexate still on hold.

Patient got second dose of the vaccine on 2/4/2021. He was diagnosed with COVID 19 on 5/15/2021 (he was negative on 3/19/2021). He was hypoxic, developed changed in mental status. Died on 5/16/2021

admitted 5/5/21 with increased sob/cough/aches and pains. Dx with COVID 19 pneumonia on 5/1 . temp 98.3

Resident received vaccine at 10am and was observed for 15 minutes post vaccine with no reaction noted. Pre and post vitals were at baseline. Upon rounds at 12pm, nurse noted resident with increased respirations and an elevated temperature (Resp 40, Temp 103.5). Nurse notified nursing supervisor and MD called. Patient was transferred via 911 to Hospital at 12:25pm.

Patient brought to ED due to what he described as indigestion not improving over time. Diagnosed with ST elevation MI on EKG. 4 stents were placed in the RCA, EF at 50%. Given Brilenta and admitted to ICU. Discharged and placed on atorvastatin and ticagrelor.

About 2 weeks after receiving the vaccine, the patient started developing progressive shortness of breath. He obtained a CT chest which showed bilateral pleural effusions and congestive heart failure. Patient was evaluated in emergency room at hospital and treated with IV lasix for acute on chronic heart failure. However, his symptoms were progressing. Currently, he is hospitalized with suspicion of myocarditis / cardiomyopathy.

Symptom onset began on 4/29/2021. Tested (+) on 4/29/2021. Symptoms included fatigue, congestion, cough. Case was interviewed by public health department on 5/3/2021 and family reported he was in hospital and was admitted on 4/30/2021. Deceased as of 5/14/2021. Unknown if in ICU or mechanically ventilated.

February 9,2021 I went see my caediologist complaining shortness of breath and little energy. We laid rhis off to lack of excercise due ro quarantine from Covid. By April 6 I was so short of breath,my wife insisted that I see my PCP. He found that my O2 was at 77%, he immediately called my cardiologist and explained my symptoms which resulted in my hospitalization. After six days of testing, the diagnosis being "Acute respiratory failure with hypoxia (HCC) J96. and Diastolic dysfuntion (151.89)

Death 5/26/2021 Causes of death listed on death certificate: 1. COVID 19 pneumonia 2. acute respiratory distress syndrome due to COVID 19 3. Acute heart failure with reduced ejection fraction 4. aspergillus pneumonia 5. history of prostate cancer, history hypertension

Fully vaccinated patient hospitalized with positive COVID PCR. Patient admitted from ED after a fall at home on 05/20/21 which patient attributed to weakness. COVID swab in ED for admission testing was positive for COVID. Weakness only notable symptom at that time. Patient d/c'd home and readmitted on 05/28/21 per recommendation of Homecare due to increased shortness of breath and O2 in 70's. Chest X-ray showed PNA. Patient discharged with Homecare on 06/02/21.

All events took place: Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure. PDF Continuation field did not permit entering text, see attached Continuation Page.

Patient presented to the ER on 7/7/21 with hematuria and was found to have acute kidney injury. Patient was recently diagnosed with a PE and bilateral DVT 4 weeks PTA and was on Eliquis for these. Patient also has a history of lung cancer and COPD and is chronically on 4L O2 at home. A foley was placed by Urology in the ER and Eliquis was held due hematuria and changed to heparin drip upon admission. In the ER, patient was tested for COVID per policy, and was found to be positive on 7/7/21 despite being fully vaccinated (1/24/21 and 2/14/21). Patient was admitted for further work-up and has not been started on COVID treatment due to patient being asymptomatic for COVID. Pt's chest X-ray was negative for pneumonia.

Pt had his Pfizer COVID vaccinations at Medical Center on 2/23/21 and 3/16/21. on 6/8/21 he presented to the office for an apt for Pulsatile tinnitus in right ear x 2 weeks. Pt was examined and Doctor ordered a CBC and MRI with constrast, ENT referral to be scheduled. Pt to start Fluticasone nasal spray. :Pt referred to Neuroradiology

resident expired; This is a spontaneous report from a contactable healthcare professional. An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0140), intramuscular in the left arm on 05Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia. Known allergies was none. The patient took unspecified concomitant medication. On 11Jan2021, the resident expired. The patient underwent lab tests and procedures which included nasal swab: negative on 09Jan2021. There was no treatment given for the event. The patient died on 11Jan2021. An autopsy was not performed.; Sender's Comments: Lacking information on the cause of patient's demise, the Company cannot completely exclude a causal relationship between COVID 19 vaccine, BNT162B2, and patient's death of unknown cause, as a cautionary measure and for reporting purposes. The patient's pre-existing medical condition of metabolic encephalopathy from, failure to thrive (FTT), diabetes mellitus (DM) 2 , chronic obstructive pulmonary disease (COPD), arthritis, weakness, hyperlipidemia, chronic kidney disease (CKD), dementia may have provided the contribution to the event in this 82-year-old male patient. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: resident expired

Per Nursing Staff- patient died within 24 hours of receiving the vaccine. patient has hospice. Please contact director of nursing for more details.

Patient had fall x 2 with or without sycnope (conflicting documentation) with humeral fracture after recieving the vaccine. Workup demonstrated PE and DVT (appears PE was not submassive/massive, unlikely it directly precipitated fall/ syncope)

Acute on chronic respiratory failure with hypoxemia; Acute urinary retention; Arterial leg ulcer; Cardiac rhythm disorder or disturbance or change; Chest discomfort; Chest pain; SOB (shortness of breath)

Approximately 2 weeks post vaccination developed rapid AF, CHF. Admitted to Medical Center. Discharged home on hospice. Patient died at home on 2/13/2021. Reported to this reporter at second dose clinic on 2/16/21. Other details not known. Unknown if related to vaccine.

passed away; This is a spontaneous report from a contactable consumer (patient's granddaughter). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581), via an unspecified route of administration on 08Feb2021 at 14:30 into right arm at single dose for COVID Prevention. Medical history included Heart valve replacement from 5 years before 09Feb2021 (2016), on Oxygen at night (reporter did not know the liter amount that the patient used at night). The patient's concomitant medications were not reported. Patient had no other vaccines on the same day as the COVID vaccine. It was reported that patient received his first dose of the Pfizer vaccine around 14:30 on 08Feb2021 and he was fine before that, and by 16:30, he had passed away on 08Feb2021. Reporter reported that the cause of death was unknown at this time and that the family would be having an autopsy performed but that it had not yet been performed. No investigation assessment could provide. The patient died on 08Feb2021 at 16:30. An autopsy was not performed.; Reported Cause(s) of Death: passed away

Discussed with ER provider last night about this patient. The abdominal findings and mild elevation of WBC gave us a hope to manage it with antibiotics alone because of his age, COPD, AAA. He was admitted to be kept NPO, and IV Zosyn was started. The understanding was to reassess the patient this morning and make appropriate decision Surgeon's H&P 1/10/21, Admitted from ER: Admitted with sudden onset of right lower abdominal pain started yesterday morning. Not associated with vomitings, diarrhea, fever Was seen in ER last night WBC 13K and CT scan showed appendicitis with multiple appendicoliths. This morning he is having pain, slightly worse. Not hungry WBC 11.3K. Afebrile

Diagnosed with CML few months ago and taking Dasatinib daily with great response and normalized WBCs. Had second dose of Pfizer vaccine 2/2. Blood work on 2-5 WBCs 150K and 2/6 bilateral blood clots in legs which then became pulmonary blood clots.

DEATH Narrative: patient was placed on hospice care following vaccine, unclear cause of death, not documented

bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; bilateral blood clots in legs that then went to lungs then went into BLAST crisis; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; Patient with myeloid leukaemia (CML) and WBCs abnormal received BNT162B2; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 02Feb2021, 13:00PM (at 82 years old) at a single dose for COVID-19 immunization. The patient was vaccinated in the Nursing Home/Senior Living Facility. The patient's medical history included myeloid leukaemia (CML) diagnosed a few months earlier, WBCs abnormal, blood pressure, and heart surgery valve repair. The patient has no known allergies. Concomitant medications included atorvastatin, carvedilol, vitamin d nos, dasatinib monohydrate (SPRYCEL) from an unknown date to help get WBCs back in normal range; cyanocobalamin (VITAMIN B12), and cetirizine hydrochloride (ZYRTEC), all were received within 2 weeks of vaccination. At 82 years old, the patient received the first dose of BNT162B2 (lot number and expiration date unknown) via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination and did not receive any other vaccines within 4 weeks prior to BNT162B2. It was unknown if patient was tested for COVID post vaccination. On Friday (unknown date in Feb2021), patient's WBC was 150,000 and on Saturday (unknown date in Feb2021), patient had bilateral blood clots in legs that then went to lungs then went into BLAST crisis. The adverse events resulted in emergency room/department or urgent care as well as hospitalization due to life threatening illness (immediate risk of death from the events). The patient was hospitalized for 12 days. Therapeutic measures which include steroids, blood thinners, and lots of other meds were administered. Outcome of the events "patient's WBC was 150,000" and "bilateral blood clots in legs that then went to lungs then went into BLAST crisis" was recovering. Information on the lot/ batch number has been requested.

Patient hospitalized for NSTEMI (from 2/18/2021 to 2/20/2021) and discharged on hospice/comfort care. Patient died 2/21/2021.

pulmonary embolism; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after 1st dose; This is a spontaneous report from a non-contactable other healthcare professional. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was admitted with pulmonary embolism and Covid 19 PCR positive (Igg also positive) with chest x-ray consistent with Covid pneumonia, 2 weeks after the 1st dose of Pfizer vaccine. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject product contributed to the events. The reported events may likely represent intercurrent medical conditions. Pulmonary embolism is known to be a potential complication of COVID 19 infection, including COVID 19 associated pneumonia. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including pulmonary angiogram, VQ scan and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient presented to ED for on/off SOB the past few days. Required O2 60% FiO2. Acute on chronic CHF exacerbation. Treated with Lasix. Patient is currently improved and planned discharge.

Severe shortness of breath, and decrease in oxygen saturation to 61%, 2 weeks after second Covid Vaccine dose. He was rushed to the hospital and was diagnosed with pulmonary embolism and received oxygen therapy. He also received Lovenox injections and then apixaban orally.

D= decedent D received the second dose of the COVID vaccine on 3/10/21 @ 10:45AM. His daughter, ************, transported him to the Pharmacy appointment. She notes that D did not have any complaints before or after the appointment?specifically she denies observing any weakness, dizziness, cough, and fever. D went on to have an uneventful day with normal appetite and bedtime. ************ also mentions that there were no adverse reactions following the first dose either. The next morning (3/11/21) at 6am the decedent?s wife found him in bed ?looking around the room? with gurgling agonal breathing. No seizure activity reported.

Patient was found unresponsive by family members in the early morning on 2/23/2021. Patient passed away.

On Saturday patient woke up saying he was in extreme pain with his left arm. At 5 o'clock that night he lost his equilibran and I had to call 911. They came and after an initial examination took him to Hospital's emergency room. They did c-scans, MRI. and they said that a blood clog was showing in his brain and that he had atrium filibration of his heart. His vision has been affected, though the hospital thinks it will improve. The left side of his body is not function right and he needs a walker to walk. He has been in ICU since Sunday. This is late Tuesday.

Patient presented to the ER on 3/2 for urinary frequency and lower abdominal pain. He was hospitalized at Medical Center- on 3/2/2021 for small bowel obstruction and acute kidney injury. Patient passed on 3/2/2021.

patient experienced TMI approx 2 hours post vacc presneted with loss of balance and listed to right. diagnosed by MRI the next day.

seen in office for appointment by Dr. on 3/22/21: arthritis of hand (Bilateral) bilateral hand swelling and MCP joint swelling symptoms worsening each day per patient suspect rheumatoid arthritis even with negative rheumatoid factor will recheck labs today and refer patient to rheumatology for further work up patient to start prednisone 7.5 mg every day x 30 days used in the decision making process Send for rheumatology referral Check ANA multiplex w/reflex 11 Ab cascade Check cyclic citrullinated peptide (ccp) Ab (IgG) Check rheumatoid factor Check C-reactive protein Check sed rate Start predniSONE 5 mg tablet 1.5 tablets every day for 30 days tendonitis of left shoulder limited range of motion, tenderness pain since administration of Pfizer covid vaccine in January patient agrees to steroid injection to area patient reports improvement post injection used in the decision making process Start Kenalog 40 mg/mL suspension for injection 1 cc kenalog and 2 cc xylocaine to L shoulder Send for physical therapy referral hypothyroidism denies worsening symptoms or side effects will check lab today continue current treatment used in the decision making process Check TSH hypertensive disorder blood pressure within normal limits patient denies side effects continue current treatment used in the decision making process hyperlipidemia denies side effects continue current treatment used in the decision making process celiac disease denies worsening symptoms continue current treatment neoplasm of prostate followed by oncology--reviewed records congestive heart failure followed by cardiology--records reviewed overweight BMI 27.8 + hypertension, hyperlipidemia, CHF weight maintained since last visit continue current efforts--diet and exercise History of Present Illness pt is here for pain to hands pt states he is having pain to left arm where he had covid vaccine. pt thinks that pain and swelling to hands begin after he got the covid vaccine. pain level is 10/10 pt finds swelling is worse in the mornings pt is also having trouble walking established pt pain in right hand pain of left shoulder joint Kenalog 40 mg/mL suspension for injection hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight pain in right hand ketorolac 60 mg/2 mL intramuscular solution ANA screen, ifa, w/refl titer and pattern C-reactive protein cyclic citrullinated peptide (ccp) Ab (IgG) rheumatoid factor hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight intolerant of cold CBC (includes diff/plt) comprehensive metabolic panel TSH w/reflex to FT4 T3, free

Atrial fibrillation; Cardiomyopathy; Mixed hyperlipidemia; This is a spontaneous report from a contactable consumer. This consumer reported the same events for himself and two other patients. This is the first of three cases. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 04Mar2021 and first dose on 27Jan2021 (batch/lot numbers not reported); both via unspecified routes of administration as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes. Concomitant medications were not specified and reported that they were too many to list, also he has quite a list of prescription. The patient stated since he has gotten both COVID shots and it was found out after going to the doctor and to a cardiologist that he was the third person that has been diagnosed with atrial fibrillation from taking the COVID shots and since he was the third person that they had recently after both shots, he thought he should call the toll number and report side effects after taking the vaccine. Consumer confirmed the date for diagnosis of atrial fibrillation as 08Mar2021 and stated primary care doctor, he went for his quarterly visit and she gave him an EKG and it showed this the fibrillation and he was immediately sent to a cardiologist who confirmed it after a second EKG and echocardiogram had both of those. Consumer stated it said atrial fibrillation, cardiomyopathy and mixed hyperlipidemia whatever that was, he has a print out of the diagnosis from the cardiologist in his hand. Consumer stated date of test was yesterday, 08Mar2021. Consumer stated he was given a new medicine Eliquis 5 mg twice a day as treatment. Consumer stated he just wanted to report this, since the doctor yesterday told him that he was the third patient that had both shots and came back with this. The outcome of the events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021274387 Same reporter and drug, similar event, different patient;US-PFIZER INC-2021316269 Same reporter and drug, similar event, different patient

1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away

Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a "blockage in his throat". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report "cause of death is anaphylaxis", and pt would be an OME case.

I went to hospital on 04Feb2021 and was diagnosed with TIA.; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 03Feb2021 (Batch/Lot Number: EM9810, expiry date not reported) as SINGLE DOSE for covid-19 immunization. Medical history included atrial fibrillation (Afib), high blood pressure, pacemaker, type 2 diabetes and high cholesterol. Concomitant medications included apixaban (ELIQUIS), metformin (METFORMIN), levothyroxine sodium (SYNTHROID) and valsartan (VALSARTAN). The patient reported "I went to hospital on 04feb2021 and was diagnosed with tia. (transient ischaemic attack)" on 04Feb2021. The patient was hospitalized for the event from 04Feb2021 to an unknown date. The patient received first dose of BNT162B2 on 14Jan2021 First dose (lot number EL3248, vaccine location= Left arm). Therapeutic measures were taken which was reported as AE treatment Jardiance. Outcome of the event was recovered.

83 yo F presents to the ER on 1/30/21 with complaints of worsening SOB and weakness. She was diagnosed with COVID-19 in 1/22/21, 7 days after receiving the first dose of COVID-19 vaccine. She had a fall on 1/25/21 and was evaluated in the ER, where she was placed on steroids and oxygen at home. She was admitted on 1/30/21 for hypoxia, generalized weakness, and A-Fib with RVR. Patient required oxygen supplementation and was treated with IV dexamethasone and inhaled budesonide. She also received treatment for afib/RVR with improvement upon treatment. Patient was discharged on 2/1/21 with recommendations to transfer to skilled nursing facility.

Patient was admitted to hospital for chest pain and was found to have a NSTEMI. Upon screening for hospital admission, was found to be COVID-19 positive. He was asymptomatic and was not treated for infection.

DVT -- leg pain began the day after vaccination, patient was seen in the ER a week later and diagnosed with right leg DVT. Started treatment with Eliquis.

Pfizer COVID-19 Vaccine EUA Patient received vaccine dose #1 on 1/14/2021 and Dose #2 on 1/31/2021. Patient presented to ED on 2/1/2021 with complaints of acute mental status change. He was recently diagnosed with enterocoal/pseudomonas UTI four days prior to presenting to ED and was being treated with Augmentin and Levaquin. Patient screened positive for COVID-19, with the sample analyzed using PCR or equivalent. Patient suffered a cardiac arrest on 2/7/2021 x3, developed three pressor shock, and required maximum ventilator settings. Patient subsequently expired.

Patient began to experience breathlessness after receiving vaccine. His SOB continued to worsen. On the 13th, the patient reported to the ER. The patient was discharged from the hospital with a diagnosis of CHF exacerbation

received second covid vaccine on 3/2/2021. Admitted to hospital on 3/27/21 with shortness of breath and expired on 4/12/2021.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was new onset atrial fibrillation.

On April 24, patient started not feeling well while away from home in the early afternoon. Later noticed some balance issues and some memory problems. The next day, balance issues continued and had noticeable mouth drooping on left side first noticed by daughter who was visiting and son-in-law. Was taken to the hospital and diagnosed with a stroke.

Fever Cellulitis Elevated troponin Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present"

After my father received the second COVID vaccination he started complaining of headaches. He had lung cancer, but he was in good condition. Within weeks his health deteriorated and when we bought him for a scan the beginning of March he had two small brain bleeds. The cancer had spread to the brain and he had a mass. They put a shunt in on March 18th because they said he had fluid, and this was the only treatment. Ten days later he was back in the hospital and after a week we had to take him home on hospice. I think the vaccine could of escalated his cancer this rapidly. Especially because he had two brain bleeds.

pt received pfizer #2 on 2/20. on ~3/7 family noticed that he was waking up at night more than his usual. They noticed that the patient was more lethargic and was starting to have visual hallucinations. Reportedly, the patient never endorsed any fevers or chills, neither did he complain of headaches. He also reported that the patient had been having a nonproductive cough since 3/3, constipation around this time. he was admitted 3/10 with altered mental status, respiratory failure s/p intubation. difficult LP, no cell count, had elevated protein. hospital course complicated by delirium, gout flare. he was empirically treated with broad spectrum abx bacterial and viral meningitis, completed 5/6, without significant improvement in mental status. repeat LP concerning for possible autoimmune encephalitis, started on steroids.

The patient, began suffering from extreme fatigue about 4 weeks ago and has now been admitted on an emergency basis to Hospital. He has blood clots in his lungs and his heart rate is sustained at approximately 140 beats per minute. No cause for the clots has been determined as of yet and the possibility of the COVID 19 vaccine causing the clots as an adverse effect can not be ruled out. This case needs to be investigated. Patient is still in the hospital as of 5/18/2021.

COVID-19 SOB (shortness of breath) Cough Suspected COVID-19 virus infection Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Initial Patient Assessment Ordering Prescriber has completed required FDA EUA elements. COVID-19 Positive Result Date (and on chart/file): 5/8/21 Start of Symptoms Date: 5/6/21 Meets Criteria: ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease ED to Hosp-Admission Discharged 5/10/2021 - 5/18/2021 (8 days) Treatment team Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Principal problem Discharge Summary Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: DO Primary Care Physician at Discharge: MD Admission Date: 5/10/2021 Discharge Date: 5/18/2021 Discharge Diagnosis Medical Problems Hospital Problems POA * (Principal) Sepsis due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (CMS/HCC) Yes Overview Signed 5/14/2021 10:50 AM 05/11/2021 Dexamethasone 05/11/2021 Remdesivir Essential hypertension Yes CLL (chronic lymphocytic leukemia) (CMS/HCC) Yes OSA (obstructive sleep apnea) Yes Persistent atrial fibrillation (CMS/HCC) Yes DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 82-year-old male with past medical history significant for CLL, obstructive sleep apnea, obesity and persistent atrial fibrillation who presented to the ER on 5/10 for evaluation of progressively worsening shortness of breath after recently being diagnosed with Covid?19. ER work-up concerning for severe sepsis with acute hypoxic respiratory failure for which he was admitted to the PCU under the hospitalist service. Hospital Course He was treated with dexamethasone and remdesivir but remained hypoxic requiring alternating trials of high flow nasal cannula and BiPAP for which pulmonology was consulted on 5/12. Unfortunately, he did not tolerate prone positioning. Despite his advanced age and several risk factors, he slowly but surely progressed from a pulmonary standpoint. He was weaned off high flow oxygen 2 days ago and deemed stable for downgrade to MedSurg with telemetry at that time. Since then he has continued to recover well, now requiring 6 L of oxygen with activity and 4 L at all other times. He is anxious to be discharged home and appears medically stable to do so with home health care services, remote patient monitoring and outpatient pulmonology follow-up with PAL as prior to hospitalization. Prior to discharge, all questions were answered and patient and his son expressed understanding, appreciation and agreement with the discharge plan at this time. Treatments: IV hydration, analgesia: acetaminophen, cardiac meds: metoprolol, furosemide and aldactone, anticoagulation: eliquis, steroids: dexamethasone, respiratory therapy: O2 and remdesivir

This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included dementia and he shrunk he is 5'9" or 5'8". Concomitant medication(s) included warfarin sodium (COUMADIN), at 4 mg once daily in the evening 6 days per week, On Fridays he takes 6 mg once in the evening. Patient's wife says her husband had one vaccination, the Pfizer vaccine and a week later her ended up in the hospital. They had to postpone his second dose because he ended up in the hospital but they have the second one coming up on the 14May2021 and she is scared for him to get it, he is adamant he is going to take it. He was taking her to the doctor for a problem she had and he told her he could not go to the bathroom and she was like what, because he has a stoma bag and she looked and it was plugged with a blood clot, he couldn't open it and drain it so she told him to get in the shower and take it off and put a new one on and she was pulling it off, it was full of blood and there was a big huge, like real liver sized clot came out of his stoma bag. She went to get the stoma bag after the thing came off she grabbed it and got it in the bag and took it out. He was taken to the hospital by the paramedics and he spent 3 days in the hospital. He is 83 now but this happened the week before his birthday, he was 82 when they noticed the blood in his stoma bad, he was a week away from 83. She provides his height and says he shrunk he is 5'9" or 5'8". She does not remember the date of the first dose. She says his birthday was 18Apr2021. She thinks he was admitted to the hospital on 12Apr2021 and he got the first dose the week before that. She thinks it was 12Apr2021 that he was admitted because it was just before birthday first dose week prior to that. They never made the connection. She thinks he ended up in the hospital on a Tuesday and she is trying to count from his birthday 18Apr2021, she thinks he got to come home on Thursday, 15Apr2021. She believes he went in on 12Apr2021 and was discharged on 15Apr2021, he was there 3 days. No further information provided. Her husband is not there with her. She does not have his vaccine card to provide NDC lot expiration or dose amount. he may not even have his vaccine card because he has dementia. No further information provided. He hardly takes any mediation He takes Coumadin he takes 1 per day except Fridays he takes 2, she thinks it's 4 mg and he takes 2 at night everyday except Friday he takes 3. she was guessing. She has one there called Atorvastatin that says it is for Lipitor, so that is not it. She sees Glipizide. No further information provided. She says she found the Coumadin, they are 2mg tablets and he takes 2 at night. She says the dose is not written on there because they call him every 3 weeks because he has to have a blood draw. He takes 2 tablets at night 6 days per week. She clarifies he takes 4 mg once daily in the evening 6 days per week and on Friday he takes 6 mg once in the evening. They just got report for that and it was 1.8 which is a little bit low but he lost blood and had to have a transfusion while in the hospital. It is in a white plastic bottle they got it from (Name). NDC 0093-1713-01 she does not see anything else. She thinks the pharmacy label is wrapped almost all the way around the bottle but she does not see lot number expiration. She sees they ordered it 11Feb2021 and she has a quantity that is it. Treatment received and outcome was unknown. Information on the lot/batch number has been requested.

Patient hospitalized. Patient died after testing positive for COVID-19. Admitted to hospital 4/2/2021 for right flank pain. Tested positive on 4/1/2021. Died 4/29/2021

No access to SIH documentation: 4/6/21 Occult blood positive - Cancer Center 4/27/21 Dx Melena, Medical Center, VCE, EDG/upper enteroscopy and colonoscopy discussed / ordered? - wife cancelled? 5/17 ER - Admission: falls, bruising abdomen, pelvic area, right back, buttock - Hospital 5/29/21 ER - Admission: The patient is a 82 y.o. male with a PMH notable for uro lift on 05/26/2021, BPH, CAD, diabetes, atrial fibrillation, hypertension, and CABG who presented on 5/29/2021 for evaluation of catheter problems. Patient presented to our emergency room with complaints of leaking around his catheter. Patient had a uro left done on Wednesday 05/26/2021. Wife and patient stated they went back yesterday due to the catheter was clogging up with clots and they replaced catheter. Patient stated he has been urinating clear but around the catheter and none has been going into his leg bag. Patient wife states that he has not taken his diuretic all day because he was worried about taking it since urine was not going into the Foley catheter bag. Upon arrival to the emergency room patient's temperature 98°, pulse 83, respirations 18, blood pressure 153/77 oxygen saturation 100%. Hemoglobin 8.8, glucose 285, BUN 24, sodium 134, INR 1.3, BNP 1460, urinalysis has culture pending. The emergency room called Dr and he requested that the patient be placed in observation here to assure that anemia is not worsening, CHF improves and patient is able to void on his own without retention. Patient received Lasix 40 mg IV push in the emergency room. Patient was admitted observation status for further treatment and evaluation systolic congestive heart failure, acute post hemorrhagic anemia, anticoagulant induced hematuria. Upon entering the patient's room this morning patient is resting in bed in no acute distress. Patient is alert and oriented x3. Patient states he is voiding without any difficulty from having Foley catheter removed. Patient states he came to the ER because he did not take his diuretics due to he was peeing around the catheter and then of his urine was going in Foley catheter bag. Patient denies any increase in shortness of breath, chest pain or any weight gain. Explained to patient that he is going to be here for the next day receiving IV diuretics to see if we can get swelling decreased on bilateral lower extremities and to continue monitoring his urine for blood and checking his hemoglobin. Rounds made with another Dr.

Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) unknown dose number, via an unspecified route of administration, administered in arm on an unspecified date (Batch/Lot number was not reported) (at age 82 years old) as single dose for covid-19 immunisation. There was no relevant medical history. The patient's concomitant medication was not reported. The reporter wanted to report a possible connection to an adverse event from the Pfizer COVID vaccine. The patient had the vaccine in either January or February and last week he had a heart attack. The reporter stated that he was okay. He was not completely "out of the woods" right now but he was extremely healthy and what had happened was kind of unusual. After this, the patient was given some kind of statin (unspecified). Since the heart attack, he had a lot of tests but the reporter didn't know. As for the treatment, the reporter responded that "Yes, they are having there. They are under the care of doctor now." Outcome of the event was unknown. Information about lot/batch number has been requested.

Death 4/21/2021 Causes of death listed on death certificate: 1) Acute respiratory failure (onset interval 1 week) 2) COVID Pneumonia (onset interval 1 week) Other: acute on chronic congestive heart failure

SKYLINE ICU DOD 5/2/21 VENT REQUIRED14 DAYS, PNEUMONIA, ARDS, HX OF HTN, CAD, THROMBOCYTOPENIA, HYPOCALCEMIA, HX of TIA and Cereb Infarc with resid dysphgagia, Major Depressive Disorder single episode unspecified

Pfizer Dose #1 - Jan 22, 2021 - Symptom: arm pain, fatigue Pfizer Dose #2 - Feb 16, 2021 (11:57am) - Death approximately 12 hours later before 1am 02/17/2021.

Rash: all over his body, like measles, on his back, arms, and legs/ terrible measle like rash all over my body except for my face; The itching was so bad that I scratched myself to the point of drawing blood; Itching, worse itching he ever experienced/ intense itching all over my body/worse itching/ itching was so bad; they called it, Dermatitis.; he thought he was having a stroke.; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. An 82-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6208; NDC/expiration: unknown) via an unspecified route of administration, administered at arm right on 22Mar2021 at 10:00 (at the age of 82-years-old) as dose 2, single for covid-19 immunization. Medical history included ongoing high blood pressure diagnosed many years ago, ongoing high cholesterol which was diagnosed around the same that his high blood pressure, ongoing type 2 diabetes mellitus diagnosed when he was in his 20's and he does not take any medications for his type 2 diabetes. The patient did not receive other products. No investigation assessment was reported. He stated several family members had the Moderna Covid vaccine, and they had some negative reactions. There were no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any prior vaccinations (within 4 weeks prior to the COVID vaccine) and no adverse events were reported following prior vaccinations. Family medical history relevant to adverse event was not provided. His other family members had flu like symptoms, and they were all females. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included rosuvastatin calcium (CRESTOR); losartan (LOSARTAN); propranolol; primidone (MYSOLINE) and acetylsalicylic acid (ASPIRIN (E.C.)) all taken for an unspecified indication, start and stop date were not reported. He had been taking the same medications for years and never had any negative reactions. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EN6200; expiry date: unknown), via unspecified route of administration, administered on right arm on 01Mar2021 at 10:00 for COVID-19 immunization. The patient experienced terrible reaction 3 weeks after the second vaccine. He woke up in the morning, turned on light and saw that he had rash all over his body (except for face), like measles, on his back, arms, and legs, intense itching all over body, worse itching he ever experienced in his life on 11Apr2021. The itching was so bad that he scratched himself to the point of drawing blood. He thought he was having a stroke. When he went to urgent care, he was treated with 2 injections Benadryl and steroid (Lot or expiration date was unknown). He was also treated with Pepcid. The injections did not help his symptoms. In the urgent care they didn't knew what the rash was and later clarified that they called it dermatitis. He stated that the staff did not thought that it was not related to the vaccine. He reclarified that when he was at urgent care, the staff told him that he should feel better in the evening, but by midnight, he decided to go to the emergency room. In the emergency room, he was given Tagamet, Hydroxyzine, and Prednisone. The rash went away and reported that itching was present, but not as bad as it was before. He reported that he took Hydroxyzine as prescribed, and after about 20 minutes, his itching diminishes but then in the evening he started to itch again. Later in the report it was mentioned that for some days he only has to take it once a day and sometimes he can skip a day when he was not itching. He was treated and released from the emergency room. The patient went to dermatologist and neurologist and no one could tell him why he had itching, no one had come up with a treatment as he was still itching. The patient stated that he called because he was reading information about the side effects and learned that the vaccine may cause a rash. Relevant tests were reported as none. Device date was reported as 22Jun2021. The outcome of the rash was recovered completely in 2021, for scratch and pruritus was not resolved and for stroke and dermatitis was unknown.

Dx: Pericarditis s/s: Dyspnea on exertion, edema, fever/chills unknown symptom onset date, patient poor historian. diagnosed with pericardial effusion, suspect pericarditis. viral panel negative. etiology not defined defined as acute on chronic dyspnea and acute CHF

I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

1/11/21 at 8:57 Resident with fever and at 11 am saturation down to 83 O2 to 10 liters. Resident continued to decline until CTB on 1/14/2021 at 1325

01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.

LEFT SHOULDER STARTED HURTING ON THE FOLLOWING THURSDAY MORNING, WAS IN UPPER CHEST AREA BY THE SAME EVENING. FOLLOWING MORNING INCREASE IN TEMPERATURE. TOOK TO EMERGENCY ROOM FRIDAY EVENING, DIAGNOSED WITH PNEUMONIA. LEVAQUIN PRESCRIBED. SATURDAY COVID19 TEST NEGATIVE. INCREASE IN CHEST DISCOMFORT NEXT FEW DAYS, NO TEMPERATURE. TEMPERATURE OVER 99 AGAIN ON 1/26/2021, TOP PORTION OF CHEST, NECK AREA HURTING, WOKE AT 10:30 PM COMPLETELY DRENCHED. 1/27/2021 AM FEELING A LITTLE BETTER.

LEFT SHOULDER PAIN STARTED MORNING OF 1/22/21, INCREASED PAIN WITHIN THE NEXT 24 HOURS AND INCREASE IN TEMPERATURE. TOOK TO ER ON 1/22/21 AFTER TEMPERATURE 100.4. DIAGNOSED WITH PNEUMONIA, LOWER LEFT LUNG. LEVAQUIN PRESCRIBED. COVID-19 TEST ON 1/23/21 BOTH RAPID AND PCR NEGATIVE. INCREASE CHEST PAIN OVER NEXT FEW DAYS, NOT TEMPERATURE AGAIN UNTIL EVENING OF 1/26/21. AWOKE FROM SLEEP AT 10:30PM ON 1/26/21 DRENCHED. 1/27/21 FEELING BETTER IN THE AM, BUT STILL EXPERIENCING CHEST DISCOMFORT.

TESTED POSITIVE FOR COVID-19 1-7-2021, TRANFERRED TO HOSPITAL ON 1-18-2021. HE READMITTED TO THE FACILITY ON 1-21-2021 WITH HOSPICE SERVICES AND EXPIRED ON 1-25-2021.

On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy. Resident sent to ER via 911. He was sent home that same day. On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness. Resident had also fallen the previous night and on the morning of 1/27/2021. Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of TIA; rule out stroke.

Patient that received his first dose of Pfizer vaccine on 2/1/2021 passed away on 2/2/2021. No further information is available at this time.

Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with AST/ALT in the 900s, T bili of 10, creatinine of 1.7. CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction.

Sent to ER 1/14/2021 due to drop in blood pressure with LOC during dialysis. Imaging revealed right lower lobe pneumonia given script for amoxicillin. According to staff patient was on dialysis had pneumonia and was on hospice, dialysis stopped resulting in death.

Pfizer-BioNTech COVID-19 Vaccine EUA Patient presented to the ER on 2/14/21 after experiencing night sweats, fevers, urinary incontinence, flank pain, and generalized fatigue for 5 days. Admitted and treated empirically for sepsis. No source of infection found, fevers continued on IV antibiotics.

RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/12/21 ON 02/20/21 REPORTED TO ED AFTER BECOMING LIGHT HEADED AND HAVING A SYNCOPAL EPISODE. REPORTED SOME SOA ON EXERTION THAT DEVELOPED EARLIER THAT DAY. ON 02/20/21 PT ADMITTED INPATIENT TO HSOPITAL WITH DIAGNOSIS OF SYNCOPE AND COLLAPSE, AOMMUNITY AQUIRED PNEUMONIA, ACUTE COLITIS, AND LEUKOCYTOSIS.

Resident is a Hospice patient. On 1-23-2021 am shift resident was observed by nursing have chest congestion and had a emesis times 1 with SOB, Zofran 4 mg was given. HOB (02 sats 88%) was elevated resident on 02 via nasal canula with 02 sat now @ 90% . no respiratory distress noted. MD was called with response pending for orders. @ 1400 resident with no signs of life. vs 90%-24-97/71-97.6. Hospice on site and time of death 1436

Pt received vaccine on 1/29/2021 and died on 2/13/2021. Wife called agency and noted the pt received his 1st dose of vaccine and was having "side effects and began declining". It is unknown what side effects he was having.

Pulmonary Embolism suffered on 2/13/2021. Hospitalized at Medical Center. Discharged on 2/20/2021. Still recovering.

Patient was vaccinated approx 9a. Later that evening, patient was having trouble breathing so they called son who lives down the road to come, 20 mins after the call the patient has passed. Per medical examiner, pt died due to possible PE, MI, or his aortic aneurysm ruptured.

He started vomiting 2 days later. we suspect he was having stool issues as well. he vomited blood at some point over the weekend. there was black vomit right before he passed. from 2am-6am he was wheezing and rattling and then he passed at approximately 6am 3/1/2021 at home. EMS did come and try to revive him and were unsuccessful.

9 days after receiving vaccine, pt developed rapid onset of ascending paralysis. No use of legs, minimal use of right arm. Limited use of left arm. Repiratory difficulty/failure.

my AFib kicked in and lasted for over a week; my AFib kicked in and lasted for over a week; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9269), via an unspecified route of administration from 08Feb2021 08:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 06:45 AM (also at age of 83 years old) on left arm for covid-19 immunization with lot number EK9231. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation from an unknown date. Concomitant medication included apixaban (ELIQUIS). After the second dose, on 08Feb2021 08:45 AM, patient's AFib kicked in and lasted for over a week. Patient didn't received treatment for the event. The outcome of event was recovering.

severe allergic drainage from nasal cavity into chest; had pneumonia; collapse of the right middle lobe; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 30Jan2021 at 12:00 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and rosuvastatin. The patient developed shortness of breath and severe allergic drainage from nasal cavity into chest. Cough has ensued. Went to medical doctor (MD) today (13Feb2021 at 21:00) and received chest Xray and office said he had pneumonia with collapse of the right middle lobe. The patient underwent lab tests and procedures which included sars-cov-2 test: pending on 23Feb2021, heart rate: 78 and oxygen saturation (pulse oximeter registering): 91-94 on an unspecified date. The patient was prescribed with antibiotic pending result of COVID test. The outcome of the events was not recovered.

Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.

Deceased Narrative: Patient was a 82 yo male with multiple co-morbidities consisting of AF (on warfarin), prio PE, HFrEF, CAD, HTN, mixed CSA/OSA, hypothyroidism, COPD and GERD. Patient was admitted to facility on 7/12/20 after he was found down in his home for 3 days, dx with right MCA ischemic stroke with hemorrhagic conversion. Etiology of CVA was presumed to be secondary to AF/warfarin failure. No treatment with tPA or thrombectomy was initiated as he was outside the window for intervention. Patient was also found to have bilateral DVTs. Patient was then admitted to facility 08/14/20 for end of life care.

Shortness of breath sepsis AKI (acute kidney injury) (CMS/HCC) Atrial fibrillation with rapid ventricular response (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Pneumonia of both lower lobes due to infectious organism

cardiac arrhythmia; Atrial fibrillation; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received the first dose of bnt162b2 (BNT162B2, Batch/Lot Number: EL8932), via an unspecified route of administration, administered in the left arm on 21Jan2021 as a single dose for covid-19 immunization. The patient's medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing , Defibrillator/pacemaker insertion from 2015 to an unknown date. Concomitant medication included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. The next day after 1st dose the patient experienced a 7hr period of atrial fibrillation (all recorded on a cardiac monitor), he stated he was dizzy, light headedness and periods of shortness of breath. He just became aware of this cardiac arrhythmia from his Cardiologist. He has an internal heart monitor and the Doctor was able to see this report. He was now taking medication for A-FIB. It was reported that patient never had it until the night he got the shot. The outcome of the events was unknown.

Death Narrative: Death on 03/04/21. 2nd dose of the vaccine was given 2 months before severe event. There is no indication that death was related to the vaccine. Patient was admitted to facility for hospice care when he passed.

Pt developed dyspnea and decompensated due to underlying metastatic adenocarcinoma of lung and large pericardial effusion which caused cardiac tamponade ultimately causing him to succumb.

Patient's immune thrombocytopenia was quiescent 15 months but relapsed 2 weeks after receiving first and only dose of Pfizer Covid vaccine. Non-critical GI bleed. Also neutropenia. Treated with IVIG and high dose prednisone with response.

Patient's spouse called on 4-13-21 to cancel second dose appointment due to her husbands death on 4-9-21. Spouse states unsure of cause awaiting autopsy results. He received the vaccine on Wednesday 4-7-21 and his wife said he was fine that night and worked in the yard the following day in the morning and early afternoon. Thursday night/Friday morning she noticed he was thrashing in his sleep and making "weird sounds".

Immune thrombocytopenic purpura; ITP; acute bleeding and thrombocytopenia; uncontrollable bleeding that did not stop; This is a spontaneous report from a Pfizer-sponsored. A contactable physician (anesthesiologist) reported that an 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 25Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Mar2021, the patient developed immune thrombocytopenic purpura (ITP) after getting or receiving the COVID-19 vaccine. The physician would like to know the protocol of that. The patient got his vaccination, on Thursday before the reporting (25Mar2021). And the patient was admitted to the hospital 48 hours later on Saturday (27Mar2021) with acute bleeding and thrombocytopenia. The patient went to the hospital with uncontrollable bleeding that did not stop. The physician was interested if the company had any internal protocol for treatment of ITP occurring acute onset after the Pfizer COVID-19 vaccine. The physician was trying to get some information to help some rheumatologist who can't seem to be finding things on the information on treating this. The physician was not here to blame anybody for it and from what he/she read, there are like 150 cases around the world with thrombocytopenia after the COVID-19 vaccine from totally different manufacturers (further clarification unknown). The physician had read a many couple case reports of different individual, people have tried for that but he/she was just interested if the company had any inhouse information for the treatment protocols for acute thrombocytopenia after the Pfizer COVID-19 vaccination. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information provided and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Immune thrombocytopenic purpura. 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.

A FIb kicked in/A Fib again; Meniere's attack/light headed and get winded very easily; This is a spontaneous report from a contactable consumer (patient and his spouse). An 83-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2), intramuscular administered on arm left on 08Feb2021 08:00 (Batch/Lot Number: EL9269; Expiration Date: 02Feb2021) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing atrial fibrillation (AFib) and he had maybe once or twice a week but never felt it (before Pfizer shot), ongoing hypertension, and Meniere's disease which had attacks several times a year and since he lost his hearing in his right ear the attacks were minor (he felt a little nauseous, similar to having a minor hang over and with a louder than normal ringing in his right ear -tinnitus). Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation from 2016 (reported as 5 years ago) and ongoing; and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension from 2011 (reported as 10 years ago) and ongoing. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Before the shots, he had an AFib attack maybe once or twice a week never felt it. He mentioned that the only way he knew he had it was using his fitness watch and take his pulse before several times a day (unknown results) and before he exercise (he will not exercise if he was in Afib but it always went away overnight). His doctor recommends staying hydrated and will see a cardiologist if it does not stabilize. After his first vaccine shot on 21Jan2021 06:45 (Batch/Lot Number: EK9231) intramuscular administered on arm left and while he was at his car, the was in Afib which lasted for 5 days (26Jan2021) which was unprecedented. After about five days, his pulse stabilized and was back to normal having AFib again maybe only once a week (AER 2021194945). Then, the patient received the 2nd dose on 08Feb2021. By 08:45, the patient was in AFib again for five days (13Feb2021) when it cleared but then it came back almost immediately for another two days and he was not back to normal even after 7 days. The patient also had Meniere's attack the same time (08Feb2021 08:45) with the Afib he had. He was little lightheaded and get winded very easily during that time and recovered by 13Feb2021 (same time with the Afib). The event of Afib noted on 08Feb2021 was persistent/Significant disability/Incapacity and did not received any treatment. No follow up attempts are needed. No further information is expected.

Got first pfizer vaccine 4/7. Started to feel pain in right calf 4/9. Went to emergency room Hospital, 4/14 where after an ultrasound was diagnosed with blood clot in saphenous vein. Repeated ultrasound per primary care recommendation 4/21, no changes in size were noticed. Currently taking Advil.

Patient presented to the ED and was subsequently admitted for TIA on 2/21/2021. He also had an ED visit on 3/10/21 for peripheral edema.

This 83 year old black male received the Covid shot on 03/22/2021 and went to the ED on 4/5/21 and was admitted on 4/8/21 with CHF, bilateral lower extremity edema, chronic kidney disease and died on 5/1/21 . 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.

BRIEF OVERVIEW: Primary Care Provider at Discharge: DO Admission Date: 5/5/2021 Discharge Date:5/6/2021 Active Hospital Problems Diagnosis Date Noted POA ? Essential hypertension 05/06/2021 Yes ? Pulmonary embolism on right (HCC) 05/05/2021 Yes ? Right flank pain 05/05/2021 Yes ? Hypokalemia 05/05/2021 Yes ? Uncomplicated alcohol dependence (HCC) 05/05/2021 Yes Resolved Hospital Problems No resolved problems to display. CONSULTS: None INPATIENT PROCEDURES: None DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Patient is a 83 y.o. male with Hx of HTN who presents today with complaint of right sided flank pain, with radiations into the right side of his back and right side of his chest. The pain is worse with movement and deep inspiration. He denies palpitations and shortness of breath. He has no previous HX of VTE. He denies fever, chills, cough, nasal congestion, and sore throat. He denies abdominal pain, N/V, and changes in bowel movements. The patient is a limited historian. He is oriented x4 on admission, but states that he has had difficulty with his memory over the past 2-3 years. He lives alone in an apartment. In the emergency department the patient's vital signs were stable. Labs revealed a potassium of 3.3. AST was 52 and ALT 61. White blood cell count was 11.13. Troponin was negative and BNP was within normal limits. Lactic acid was 1.5. UA showed trace blood. EKG showed normal sinus rhythm with PACs. CTA the thorax abdomen and pelvis showed acute pulmonary emboli involving the segmental subsegmental arteries of the upper and lower lobes. There is no evidence of heart strain. He was admitted for observation due to severe pain, and was given IV fentanyl. Echocardiogram showed: The left ventricular ejection fraction is 67%. No regional wall motion abnormalities noted. The right ventricular size, thickness, and function are normal. The estimated right ventricular systolic pressure is 36 mmHg. The inferior vena cava was not visualized during the exam. There is no comparison study available. He was started on Eliquis 10 mg bid for 7 days, than 5 mg bid for total of 3 months. He should follow up with PCP in 1 week and should check CBC and BMP on 5/10/21. He should also follow up with pulmonologist in 2-3 months. He had Pfizer COVID-19 vaccine on 2/18/21 and 3/18/21. There is remote possibility that this PE could be related to COVID-19 vaccine, so this was reported to Vaccine Adverse Event Reporting System (VAERS). He had mild hypokalemia due to HCTZ, and required K-dur supplement. HCTZ was switched to Maxzide 25/37.5 mg daily. Rechecked K was normal 3.9. BMP should be checked in 1 week. Also he is drinking little bit too much alcohol, 4 alcoholic drinks every night. He was instructed to cut alcohol drinking to </=2 alcoholic drink a day. His daughter was updated over the phone.

Presented to ED ~ 12 hours after receiving 2nd Covid vaccine. Chief Complaint: FEVER. (Pt had second COVID vaccine around noon. He presents via ambulance " feeling terrible" with fever, malaise. He is somewhat confused and uncomfortable here. Daughter in law here). No muscle aches, chest pain or cough. He has had loss of appetite. He has had dyspnea (chronic). He has had altered mental status (mild confusion). He has had skin rash (chronic LE). Pt was kept for observation x3. He was given IV fluids and a started 4.5 gm of Zosyn (Piperacillin Sod-Tazobactam So). Diagnosed with pneumonia - switched to oral augmentin at discharge. On home oxygen.

Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction ABNORMAL LAB BACK PAIN

Patient presented to the ED with acute coronary syndrome and was subsequently hospitalized, diagnosed with NSTEMI. This was within 6 weeks of receiving COVID vaccination.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were weakness, elevated CPK, anemia, non-traumatic rhabdomyolysis.

Patient received what he believes was the Pfizer covid-19 vaccine x 2 in March 2021. He generally felt poorly since receiving the vaccine and was eventually tested for covid-19 in mid-May 2021 as an outpatient, which was positive. He was admitted to hospital on 5/23/21 with pneumonia. Transferred to Bigger hospital on 5/26/21 for ICU care.

Admitted to hospital on 5/2/2021 due to hypoxia and ultimately intubated. Family moved to comfort care and he died on 5/2/2021 at 10am.

Pt w/hx significant for B-cell lymphoma & interstitial lung dx (on 4L O2 at baseline) p/w 5 day hx of SOB, cough, congestion, and diarrhea. COVID test was positive (6/15) despite receiving Pfizer vaccines (1/15 & 2/6). Was admitted for acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. Received dexamethasone, plasma, and tocilizumab during admission with improvement, however, pt is still hospitalized and feels SOB w/any exertion and desaturates w/cough.

R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

Patient hospitalized for atrial fibrillation with RVR and underwent a cardioversion within 6 weeks of receiving COVID vaccination.

Patient is an 83 year old male admitted with COVID respiratory failure who has end stage COPD. His condition declined throughout hospitalization and expired 7/2/2021.

~5 months following vaccination, COVID-19 infection: Abnormal CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive; Patient died as result of illness 4 days after admittance to hospital from nursing home.

Presented to hospital for increased SoB and weakness. Diagnosed with COVID-19 on 7/8. Discharged home on 2L O2 and dexamethasone. On 7/12 presented again with hypoxia, elevated WBC/ D-dimer. O2 titrated to 5 L NC and transferred to our facility on 7/12. Oxygen requirement continued to increase and patient admitted to ICU on 7/14. Currently receiving dexamethasone and received tocilizumab 7/13. Received remdesivir initially but was discontinued on transition to HFNC> Currently on HFNC w/NRB 50 L at 90%

83-year-old male with past medical history significant for coronary artery disease with MI, CABG, atrial fibrillation, and COPD, who came to the hospital with shortness of breath. Upon arrival at the ED on June 12, 2021, the patient was in severe respiratory distress with oxygen saturation in around 70s. The patient was intubated for respiratory distress. The patient had recent angiogram with 2 stents placement. The patient was admitted to the ICU with acute hypoxic respiratory failure/ventilator-dependent respiratory failure, pleural effusion, possible pneumonia with sepsis, hypotension, and urinary retention. Critical Care, Cardiology, and Infectious Disease were consulted. Urology was consulted for the patient for urinary retention. The patient went to the OR for urinary retention and urethral stricture. The patient had transurethral incision of the vesical neck contracture. Foley catheter was placed. Infectious Disease was consulted for evaluation of the patient for positive COVID-19 infection. Infectious Disease recommended to continue COVID-19 isolation precautions, anticoagulation and steroids. The patient was seen and examined on June 15. At that time, Neurology was consulted for patient's seizure. Neurology saw the patient and recommended CT of the brain, which showed no acute intracranial process and EEG for further evaluation. Cardiology was consulted for evaluation of the patient for STEMI type 2. The patient had 2D with ejection fraction of 60%. The patient was on aspirin and Plavix. The patient had a recent stent placement. The patient was seen and examined on June 22, 2021. At that time, the patient was successfully extubated to nasal cannula. The patient was improving. The patient had IV antibiotics for suspected pneumococcal bacteremia and hospital-acquired pneumonia. Infectious Disease was following the patient. The patient was seen and examined on June 28. At that time, IR was consulted per Pulmonary request for thoracentesis. IR requested to hold Plavix for the procedure. The patient went to the procedure on June 29. The patient had 300 mL blood-tinged right thoracentesis done. The patient was seen and examined on July 3, 2021. At that time, the patient was lying down in the bed, no acute distress noted. The patient denied any chest pain or shortness of breath. The patient was status post thoracentesis. Infectious Disease was following the patient and IV antibiotics recommended. The patient was status post pneumococcal pneumonia with septicemia, bronchitis. At that time, Infectious Disease was okay to discharge the patient on p.o. antibiotics for 5 more days. The patient was discharged on July 3, 2021, in stable condition to subacute rehab with advice to continue outpatient followup for further medical care. The patient was stable at discharge.

Lethargy/Fatigue, fever/chills, acute chest pain or pressure, Exertional chest gas and pressure occurring in the last week or so Pericardila effusion was present in echo May be alternative cause/etiology for diagnosis--but not identified in report Complex medical history in 83 yr old male including Paroxysmal Atrial Fibrilation, HTN, dilated aorta, s/p prostate cancer, recent hernia surgery (1 week prior) with new signs of inflammation of pericardium after vaccination. Was also treated for possible UTI due to hematuria and fever

1 week of nausea, vomiting, and diarrhea and worsening dyspnea. His respiratory status decompensated since admission. He was initially on 2-3 L nasal cannula and then worsened to needing BiPAP at 100% FiO2. Even with that, his SpO2 was between 88-90%. He was transferred to another hospital for further management.

increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021

Paroxysmal atrial fibrillation 4 hrs after vaccine administration. Symptoms: palpitations, dyspnea, throat tightness, fatigue

Narrative: Please note that patient is a hospice patient. Death occurred 10 days post vaccination. Providers do not believe that there was a correlation. Facility requires that we reports all death even if we suspect no correlation between death and vaccine. Symptoms: & death

~2 weeks after 1st dose, patient suffered cerebral hemorrhage. Was also on Eliquis. Received KCentra.

CC:full arrest HPI:HPI and ROS limited due to patient's condition. History is via EMS, medical record, and son. Per Son patient had Covid vaccine on Saturday morning. Slept all day Sunday. Woke up Sunday night a bit "like coming out of a deep sleep per son, around 10 pm. Shortly after that patient was having a hard time breathing. Emergency called. Arrested around the time EMS arrived. King airway, I/O and CPR initiated. Patient has been in v fib. Was shocked multiple times, given 4 rounds of epi, bicarb and amiodarone. ACLS continued on arrival. Multiple rounds of epi, and attempted defib. Patient given epi, bicarb. Rhythms included fine v fib, asystole, and PEA. Unrecoverable with no cardiac motion. Time of death 11:50 pm.

Excessively tired during the week after the first vaccine. One week after an undiagnosed episodic atrial fibrillation was discovered when treating a stroke. Causation not researched.

Patient admitted to hospital evening of 2/7/21 with acute ischemic stroke and received tenectaplase. Diagnosis Left MCA stroke. Reporting event given was just over 24 hours after first COVID vaccine dose.

Shortness of Breath, Continuous Coughing with blood tinged spit, Blood Pressure 200/100, Oxygen level 84 began around 5:00 am with paramedics arriving and transporting to the hospital around 7:00 am.

At midnight developed heart burn, low BP but normal O2; at 4am took Antacid then felt better and BP was normal. Then around 7am asked to go to ER because the discomfort became pain and moved to the side. Went to ER, mild Cardiac issue and at 3pm had heart attack and passed away.

Development of chest pain and dyspnea. Large pleural and pericardial effusions requiring drainage. No evidence of CHF by echo or BNP. Fluid was found to be exudative rather than transudative. No growth of infectious agents found to be causal. ESR and CPR extremely elevated. All self resolving after thoracentesis and pericardiocentesis.

Pt. recieved COVID vaccine on 6 Feb @0730 and presented to the hospital with chest pain & quesionable stroke. + CT and transferred to another hospital @ 1430, appears CVA (cerebral vascular accident); Cardioembolic stroke; Cerebrovascular accident (CVA), unspecified mechanism; TIA (transient ischemic attack). He was discharged on 10 Feb. Home course unknown

Systemic: Allergic: Anaphylaxis-Severe, Additional Details: Patient taken to emergency medical facility.

Patient went into rapid afib at around 8 pm (6 hours after vaccination) Rate up to 180-190. Became hypotensive with BP as low as 76/56. Went to ER. Hospitalized overnight for observation

Severe weakness 3 days after vaccine (3/5), to the point I which patient could not stand. Presented to hospital 6 days after vaccine (3/8). Hospital workup notable for CPK 45,720 U/L with CRP 109 (3/8) and low-grade fever (3/9). Negative infectious workup so far (BCx, Biofire, COVID PCR, UA without WBCs, no leukocytosis). He also had new thrombocytopenia to 84 (3/8), but possibly due to rifampin for LTBI. He remains admitted at this time, receiving fluids for rhabdo, undergoing further infectious and rheumatologic workup.

On 3/11/2021 the patient presented to the ED with worsening afib and SOB for 4 days prior. He also reported neck and shoulder pain. His afib medications were adjusted and the symptoms resolved.

The patient presented to the ED on 3/11/2021 with fatigue for a few weeks, and recent abdomen pain. The patient was found to be hyponatremic and there was also evidence of a CVA on MRI findings.

03/16/2021: Presented to the emergency department with substernal chest pain/pressure. Patient was admitted for non-ST elevation MI, and currently awaiting cardiac catheterization.

Death Narrative: Patient was outpatient. There was no information or document notes about reactions, underlying or active conditions between the time patient came in for the first Pfizer dose and their death.

03/14/2021: Presented to the emergency department due to fall which occurred prior to arrival. Patient states he climbed up his attic, lost balance came down rolling the stairs and hit the back of his head. He did not lose consciousness, but is taking a blood thinner. The patient is currently still admitted with subarachnoid hemorrhage and pelvic hematoma.

Patient had unexplained asystolic cardiac arrest 3 days after second Pfizer shot was administered. No recent illnesses or complaints, no fevers.

Injection SUNDAY. within 2 hrs of the 2nd injection, he was amazed to no longer feeling the chronic pain throughout his shoulder. MONDAY: The following evening (after supper) he experienced severe light-headedness, followed by violent, prolonged projectile vomiting, during which, his eyes rolled back and he passed out while continuing to vomit. Low BP. transported to hospital; CT scan showed perforated esophagus, air in chest lining. 2nd CT: air and fluid spread to neck area, bowel obstruction/infection. TUESDAY: 5am: Transferred to hospice ward, unresponsive. Tuesday, 2:20pm: died.

heart attack; This is a spontaneous report from a contactable consumer. A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE (at age of 84 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart attack on an unspecified date within 15 minutes after taking the Pfizer COVID-19 vaccine. Outcome of the event heart attack was unknown.

Respiratory distress, Atrial fibrillation, Acute Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine, antibiotics

Presented to urgent care on 4/10/21 with fever, chills, weakness, and cough. Was tested for COVID-19 and diagnosed with pneumonia. Patient then presented to ED on 4/11/21 with the same symptoms and was admitted to hospital for further care.

The information was presented by his granddaughter. He was scheduled to come in for his second vaccination with his granddaughter on 4/14/21, however, he passed away on 4/13/21. His granddaughter stated he experienced a severe nose bleed just under a week post vaccination (1st dose/Pfizer). The nose bleed lasted a few hours and had to be controlled by the Hospital. The incident reoccurred a week later and again, the bleeding had to be controlled by nasal clamp and lasted for a few hours. The patient began having pain in his stomach and feet, and stayed pale and nauseous. On 4/13/21 the patient was found in his bed saturated in blood and had soiled himself. His family called EMS and the patient went to Hospital. The patient coded and was not revived. The granddaughter stated that he had an enlarge prostate that was discovered during one of his hospital visits in the past 3 weeks.

WEAKNESS, SHORTNESS OF BREATH, NASAL CONGESTION, DEATH Narrative: Patient died after COVID vaccine dose #1 01/07 visit for chemo, stable 01/21 visit for chemo, stable 01/27 hematology visit d/t rash, likely heat rash 02/09 chemo for multiple myeloma, reports fatigue but no dyspnea 02/10 COVID vaccine dose #1 03/02 chest xray with concern for bilateral pneumonia, treated with antibiotics 03/08 pt having pain in back of the neck 03/09 pt having shortness of breath, transported to hospital with persistent generalized weakness with body ache and shortness of breath; diagnosis: atypical pneumonia, viral vs. bacterial, acute dyspnea with hypoxia, nonproductive cough, chest congestion, headache, and malaise 03/25 pt passed away COVID vaccination not likely contributor to patient's death, but is more likely due to advanced age (83 y/o) and comorbidities, especially active multiple myeloma, receiving chemo. No immediate reaction after first vaccination. Hospitalized a month after vaccine and illness persisted, leading to patient's passint. No COVID infection documented.

Presents with dyspnea for a few days. Pt was tested positive for COVID 19 one wk ago (outside health system). Pt also c/o L arm numbness. Pt denied f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to have hypoxic O2 sat at 89% and was put 2L NC. Pt got loading dose of ASA and dexamethasone (7 day course), completed 5 day course of remdesivir and received tocilizumab due to increased oxygen requirements. Pt also has mildly elevated troponin and cardiology was consulted in ED. St elevation noted 4/20 AM, heparin bolus given for acute coronary syndrome and ticagrelor LD. Left heart cath on 4/20/21 showed 3 vessel disease but due to difficulty revascularizing LAD in setting of worsening K+, Bicarb, S no further revasc attempts were made. Upon return to MICU, pt found to be hypotensive and bradycardic. PEA arrest. Family contacted during code and in agreement to transition to comfort measures.

3/30- Resident was sent to ER was found to have acute CVA, R vertebral occlusion, carotid stenosis, 17mm lung mass suspicious for malignancy, family opted for palliative and or Hospice. 4/03-re-admitted to the facility. 4/14 Admitted to Hopsice. Resident deceased on 4/16.

went on Saturday afternoon to the Arena where the 2nd dose was given. On Sunday afternoon he was not feeling well, achy, and by evening slightly light headed. Monday morning he had worsened, and tried to stand, and collapses, the home health nurse called for an ambulance. By mid afternoon on Monday March 1st he was blue around the lips and skin, doctor worked to try and stabilize him throughout the evening, until his heart stopped at 1:30am on March 2nd.

Patient presented to the ED and was subsequently hospitalized with a pulmonary embolism within 6 weeks of receiving COVID vaccination. Patient also hospitalized on 3/12/21.

stroke; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient has no known allergies and no covid prior vaccination. Concomitant medications included clopidogrel bisulfate, amlodipine, vitamin d [vitamin d nos] and "levoth" (as reported). The patient has no other vaccine in four weeks. On 21Feb2021 at 12 AM, the patient had a bad stroke "14 days" after he's first shot. They think it's the vaccine. The event resulted in hospitalization for 25 days and disability or permanent damage. The patient was covid tested post vaccination via nasal swab on 17Mar2021 which was negative. The outcome of the event was not recovered. Information on the Lot/batch number has been requested.

Patient developed shortness of breath and "barky cough" 5 days after first COVID 19 vaccination. Chest imaging revealed pulmonary embolism. Patient was hospitalized for 4 days and discharged on anticoagulation.

Hospital admission on 03/22/2021, dx COVID+ with acute respiratory failure, acute embolism and thrombosis of unspecified deep veins of unspecified lower extremity.

Hospital 5/22 thru 5/24/2021 Dx: UTI/ Weakness/ Right Pleural Effusion Covid Positive (5/22/2021) ED to Hosp-Admission Discharged 5/22/2021 - 5/24/2021 (2 days) Treatment team UTI (urinary tract infection) with pyuria Hospital Problem List Generalized weakness Resolved Pleural effusion on right Resolved UTI (urinary tract infection) with pyuria Resolved Lack of appetite Resolved UTI (urinary tract infection) Resolved Constipation Resolved Intractable vomiting with nausea Resolved

Pt R hand and foot started swelling 4/20/2021, 2 days after Pfizer shot, on 4/18. Pt admitted to Hospital 4/23-4/25/2021. Pt was diagnosed with cellulitis and treated with IV antibiotics. Pt also treated for exacerbation of CHF and COPD. Pt re-hospitalized 5/7-5/12/21 for COPD and CHF exacerbation, a-fib with RVR, acute respiratory failure with hypoxia, and gout of R wrist Pt went to STR from 5/12-5/18/2021

Patient presented to the ED with shortness of breath and was subsequently hospitalized for elevated troponin, pneumonia and palpitations. She was in the ICU for 9 hours before being transferred to the cardiology floor.

The next day after the vaccine, I could not stand, no balance and drooping on right side of face. My spouse called 911 and thought I was having a stroke. I was admitted to the hospital. I had numerous blood work done and tests done and was diagnosed with TIA transient ischaemic attack and to follow up with a neurologist. I was in the hospital 3 days. I am being followed by the neurologist. I still have balance issues and the facial drooping is gone.

Death: 4/22/2021 Causes of death listed on death certificate: 1) Respiratory failure 2) Emphysema Other: Covid-19 pneumonia, diabetes

Death 4/21/2021 Causes of death listed on death certificate: 1) respiratory failure 2) covid 19 pneumonia

Patient presented to emergency department with complaints of worsened shortness of breath and lower extremity edema on 6/22/2021. He was admitted for further management of CHF exacerbation. During screening for placement to post acute rehab facility, patient was found to be COVID-19 positive on 6/29/2021. He was treated for COVID-19 infection in April of 2021. He is still admitted at time of writing.

N17.9 - Acute kidney failure, unspecified I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)

From EMR: Immediate cause of death: acute hypoxemic respiratory failure (2 days from onset to death) Secondary conditions leading to death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA Died of COVID-19 illness on 06/13/2021

85 yo M with past medical history significant for diabetes mellitus type II and hypertension, received Pfizer vaccine in April/May. He presented to the hospital with fever and chills x 2 days but reports no other symptoms. He was found to be COVID positive and with RLL pneumonia on imaging

nose bleed; Atrial Fibrillation; hypertension; This is spontaneous report from a contactable consumer or other non HCP. The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 19Jul2021, this case now contains all required information to be considered valid. A 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: unknown), via unspecified route of administration in the right Arm, on 28Jan2021 at 12:00 PM, (at the age of 84-year-old) as dose 1, single for COVID-19 Immunisation. Medical history included blood too thin to coagulate. Concomitant medications included warfarin taken for Blood too thin to coagulate start and stop date was not reported, acetylsalicylic acid (ASPIRIN 81) taken for unspecified indication start and stop date was not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302), via unspecified route of administration in the left shoulder, on 19Mar2021 at 11:00 AM, as dose 2, single for COVID-19 Immunisation. On 10Feb2021 at 07:15 PM, the patient experienced nosebleed. On an unknown date, the patient experienced hypertension and atrial Fibrillation. The patient visited 3 times to emergency room for bleeding and received two transfusions to stop bleeding and kept in hospital until 19Feb2021. On an unknown date, the patient transferred to ENT physician. It was reported that he was hospitalized and couldn't make it to appointment for second dose on 26Feb2021. Prior vaccinations within 4 weeks were none. The patient was visiting her primary care physician and cardiologist regularly. The outcome of the events were not recovered. Information about lot/batch number has been requested. Follow-up (19Jul2021): The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (19Jul2021), this case now contains all required information to be considered valid. new information added which included suspect product detail, event detail, Patient age at time of vaccination, patient medical history was updated. Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.

vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died 01/07/21.

REC'D CALL FROM PT'S DAUGHTER, HER FATHER WAS VACCINATED ON 1/22/21, WOKE UP 1/23/21 WAS SHORT OF BREATH AND DIZZY. PT PRESENTED TO ED OF LOCAL HOSPITAL AND WAS ADMITTED, PT PASSED ON 1/25/21. DAUGHTER STATES THAT FAMILY AND DOCTORS AGREE THAT THE VACCINE DID NOT CONTRIBUTE TOWARDS PT'S DEATH, BUT FELT IT NEEDED TO BE REPORTED. PT'S DAUGHTER CONTACTED THIS RN AT LOCAL HEALTH DEPARTMENT TO REPORT TO VAERS.

Heart stopped; Could not swallow; This is a spontaneous report from a contactable nurse (patient's wife). An 85-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure abnormal (verbatim: blood pressure) from an unknown date and unknown if ongoing, neuropathy from an unknown date and unknown if ongoing, weight issue from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, walker user from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes from an unspecified date to an unspecified date; and he was taking a long acting one as well. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates ("had flu shots before with no reactions and everything, nothing before"). On 24Jan2021, the patient's heart stopped (death, medically significant), and could not swallow (medically significant). The clinical course was reported as follows: The patient's wife stated the patient was taking insulin aspart (NOVOLOG) and he was taking a long acting one as well. The reporter, the patient's wife and a retired registered nurse (RN) stated, her husband (patient) just died and she thought he died from the COVID vaccine (later clarified the reason of death was-heart stopped). The patient had the vaccine on 21Jan2021, which was on a Thursday, and he was fine. On the following Sunday around 1:30 (on 24Jan2021), the patient was feeling a little weak, however, the patient's wife thought maybe his blood sugar was low. The patient's wife checked, and the patient's blood sugar was 91. The patient's wife went to get some yogurt to feed him in order to get his blood sugar up a little; "which was a normal thing for him, it was not that low for him." Then, suddenly, the patient fell, and the patient's wife could not get a pulse or anything. The patient's wife called an unspecified number and she started compressions; however, he was dead. The patient's wife stated the patient just had his heart test, a three hour long one, and it was "perfect three weeks ago." The patient had just gone to the doctor the other day and his blood pressure was "fine and everything." The patient's wife stated that other than his diabetes, "which he had for (sentence incomplete)." Regarding lab tests, the patient's wife stated, "No, he had it before but not in the last two weeks. He was going for one because we just went to the doctor last week and he was going to call yesterday to make the appointment request to get his blood work done. Blood work has been good except his A1C was always high, but other than that everything was good" (as reported). Regarding causality, the patient's wife stated, "I do, because he was fine until about half an hour before he died. He said to me, I feel a little weak today and then I was talking to him that your upper body strength is really good and then I said, we just have to work on your weight a little more because he did have neuropathy. And then, I went out of the room and all of a sudden I just heard him fall and that is when I just went in to check his blood sugar and it was 91 and I got him yogurt and he started eating that and then that was it, he started spitting it out and he said, I could not swallow and that was it, he just died." The patient's wife further added, "I just wanted other people to know that things like this happen and I am sure it was from that because he was healthy as could be. He was walking with his walker, the day before outside and he felt fine." The clinical outcome of the event, heart stopped, was fatal. The clinical outcome of the event, could not swallow, was unknown. The patient died on 24Jan2021 due to "heart stopped." An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart stopped

1/14/2021-0545, blood noted left and right ear. 0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.

Patient had R sided facial droop and slurring of speech at 9:30 AM 1/21/2021. Sent to Hospital where he was found to have CVA, with complete occlusion of the R vertebral artery from the origin of distal V3 segment.

Patient had no energy in the first 24 hours and then began a steady decline that started with vomiting after 48 hours, then an inability to swallow and ultimately the patients death on 2/5/21.

No adverse effects for the first two weeks. The morning of 2/7/21 he claimed he was not able to sleep the night before. He was cold, but only wanted something cold to drink. He was not able to get through his normal morning routine. By 8 am we was beginning to get confused and weaker. By 9 am he vomited and was not able to stand up or walk. The confusion was increasing. We called 911. When they arrived he had chills and was agitated. He did not have a fever at that time. He was transported to the emergency room. We were not able to accompany him there, but were told he was confused, agitated and combatant. His fever was up to 101 degrees. The started him on antibiotics and began tests. He tested negative for COVID and the flu. By that evening they diagnosed him with viral meningitis and admitted him to the hospital. The next day we were told that they had ruled out viral meningitis as well as other infections. The infectious disease doctor said that all tests had come back negative, but they were continuing to give him antibiotics. A neurologist and cardiologist were called in and they were not able to find anything either. He did complain of chest pains, but it was determined that it might be heart burn. They did see a sign of Afib, but test were not conclusive. On Friday, Feb. 12th he was sent home with antibiotics and heart medicines. The confusion has improved, but he is very weak and not mobile without assistance.

Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes)

Received 2nd dose of COVID19 Pfizer vaccine at 1103 am on 2/19/21, was last seen at 1159, found around 1615 by kitchen staff who were serving dinner.

Feb 9, patient was light-headed, as if he was going to faint. He did not have appetite. Evening of Feb 9, started vomiting large amounts of blood. Ambulance took him to hospital. CT scans showed abnormally enlarged pancreas. Patient aspirated blood and was put on a ventilator for 48 hrs. Endoscopic ultrasound showed ulcers in stomach that appear to have been bleeding, which were clipped and shot with epinephrine. After being treated for ulcers, patient developed blood clots in leg and lungs. It is almost two weeks since initial emergency, and patient is still showing sings of internal bleeding (low blood pressure, low hemoglobin, blood in stool). Still no firm explanation for continued bleeding. Before adverse event on Feb 9, patient did not report other symptoms from shot, however, he did show unusual signs of large bruising on his arm. Patient is currently at Hospital. Blood thinners are being discontinued, but patient still has blood clots.

Pt presented to ER with SOB on 01-29-2021. He was admitted to Healthcare with acute CHF exacerbation, elevated lactate, anemia and elevated d-dimer. Pt reports getting SOB getting up to go to the bathroom. Pt was intubated. He developed pulmonary edema. Pt expired on 02-02-2021 at 10:13 PM.

Resident rec'd COVID vaccine #2 on 02/02/2021 and was hospitalized on 02/03/2021. Diagnosed with UTI & Metabolic Encephalopathy. He was re-admitted to facility on 02/05/2021. On 02/08/2021 resident was found to be unresponsive with small amount of tan emesis in mouth and on bed. CPR initiated and resident was transferred to ER. ER MD notified facility that resident had died.

Narrative: Patient received COVID/Pfizer #1 2/10/21 in L deltoid. (Patient home bound). On 2/12/21 reported left flank rash. 2/13 rash spread to entire abdomen/chest and UEs. Continued with fluctuations in BP/HR, fluid retention. On 2/16 labs ordered and Medrol dose pack. seen in home on 2/19 by MD - RUE swelling; diffuse rash over entire body; additional labs ordered (order to home infusion company). Patient passed in AM of 2/20/21. Reported no urine output the prior evening. Additional labs not performed due to death of patient prior to lab company arrival.

DEATH Narrative: Presented to ED via EMS c/o increasing shortness of breath, O2 sat mid to high 80s on 4L. When EMS arrived , pt was in distress, intubated by EMS and transported to ED. Pt had a PEA arrest en route but resuscitated w/ return of spontaneous circulation after receiving a dose of epinephrine and chest compressions. Pt was hypotensive on arrival to ED. He was started on sepsis protocol , volume resuscitation and empiric antibiotics. Once stabilized, he was admitted to icu at hospital. Removed from respirator 2/22/21

Pt tested positive for COVID on 2/6/2021. Deceased on 2/15/21. Not marked COVID death on death certificate.

The patient had possible syncopal episode and an increased white blood count with lactic acidosis on admission. He is currently still in hospital and had delirium and acute hypercapnic respiratory failure requiring BiPAP ventilatory support.

85 year old male who presents with 2 episodes loose black stools, weakness, decreased appetite, increased lethargy and subjective fever today, 02/22. Again admitted and had further rheumatological and infectious work up with negative results He was initially admitted to Hospital on 02/12 with fatigue, atypical chest pain, melena. He had received 2nd dose of Pfizer vaccine on 02/10. He was hospitalized from 02/12-02/15 and thought to have viral pericarditis. Diagnosis at discharge: SIRS DUE TO NONINFECTIOUS PROCESS W ACUTE ORGAN DYSFUNCTION. He was started on celebrex in addition to the the colchicine as an anti-inflammatory. After initiation of the anti inflammatory medications, patient's fever resolved, he started feeling better and his inflammatory markers decreased. He was monitored for another days and was feeling better. He is therefore being discharged home. In view of the negative work up, there is suspicion that these may be a hyper inflammatory response to the COVID vaccine since his symptoms were temporally related.

Patient passed away unrelated to covid vaccine Narrative: The patient had Alzheimer dementia and acute on chronic renal failure. Patient received first dose of Pfizer vaccine on 1/13/2021 and second Pfizer vaccine on 2/2/2021. No adverse reaction was reported. Patient was recently admitted for LE edema and increasing SOB. Patient passed away on 3/8/2021 in hospital. No indication that death was related to COVID 19 vaccination.

Patient passed away unrelated to covid vaccine Narrative: The patient had prostate cancer, Merkle cell carcinoma and clear cell carcinoma of kidney. Patient has been placed on hospice care. Patient received the first dose of Pfizer on 2/1 and no adverse reaction was reported. Patient passed away on 2/5. No indication that death was related to COVID 19 vaccination.

TIA- mini stroke; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 12:00 PM (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril. On 27Feb2021 14:00, the patient experienced TIA- mini stroke. The AE resulted in Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Feb2021. Therapeutic measures were taken as a result of tia- mini stroke. The outcome of the event was recovered.

UNKNOWN. PT'S WIFE CALLED US TODAY 3/30/2021 TO INFORM US THAT PATIENT PASSED AWAY ON 3/29/2021 DUE TO MASSIVE HEART ATTACKED

My father received his first Pfizer vaccine on 02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted several hours. They tested him for Covid and did a chest x-ray. Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5 days and was then released to nursing home for physical and occupational therapy. He was very weak and on days experienced what they called Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to his apartment, with extended visiting nurse therapy. On 3/10/21, was the first visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health Care. She checked his vitals. She said his blood pressure was good, lungs sounded good and oxygen level was 98. She said he was doing good and that she would not need to continue to come out and check on him weekly. She left. At 2:30 the same day, a Physical Therapist from Home Health Care came. She asked him lots of questions and adjusted my fathers' walker for him. He showed her how he was doing using the walker. Walked approximately 15-20 feet in his apartment. She checked his vitals before she left. His oxygen level was now at 91. She had him take a few deep breathes until his oxygen level was up to 93. She left and said she would be back on Friday the 12th to begin the actual physical therapy then. Within 10 minutes after she left my father started shaking uncontrollably and was having difficulties breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the way down to 74. They took him to the ER. When getting him out of ambulance he began vomiting. Vomiting lasted for hours just like when he went to the hospital back in February. They tried 3 different drugs to control the nausea. They did EKG, chest and abdomen scans. Was found that he had multiple blood clots and inflammation in his lungs and a bacterial infection in his blood. After testing, bacteria was found to be E Coli. Treated him with heparin for clots and antibiotics for infection and had him on oxygen in nose. Every day thereafter, he felt worse. They switched him to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked him up to a BiPap oxygen machine because his oxygen levels were dropping too low. We were then told by the lung doctor, that the damage to his lungs was extreme and that the next step would be to put him on a ventilator and feeding tube. My father did not want this per his will and his discussion with Dr earlier in the week. Dr indicated that he would not get better just being on the BiPap machine and we then chose to have them take him off of the machine because he did not want to go on life support. My father passed away on Sunday, March 14th around 6:30pm.

Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: CAREGIVER REPORTED PATIENT STOPPED EATING AND HAD FEVER OF 101, FEVER WENT DOWN AFTER A DAY OR SO BUT CONTINUED NOT TO EAT-Severe, Additional Details: CAREGIVER REPORTED PT HAD FEVER AND LOSS OF APPETITE AFTER FIRST DOSE, QUESTIONED IF SECOND DOSE IS APPRORPIATE. PER THE CDC GUIDELINES THE PATIENT DID NOT HAVE A SEVERE ALLRGIC REACTON TO THE VACCINE AND THEREFOR SHOULD PROCEED WITH SECOND DOSE. CAREGIVERS STATES TOOK A WHILE FOR PT TO REGAIN APPETITE AFTER THE FIRST DOSE. SECOND DOSE HE HAD FEVER OF 101 FOR ABOUT 1 DAY BUT LOST APPETITE AND NEVER REGAINED. PASSED AWAY ON THE 24TH OF MARCH. CAREGIVER STATES PT WAS \"STRIVING\" PRIOR TO 2ND DOSE

The patient presented for his second Pfizer Covid-19 vaccination on 28MAR2021. On his way into the Vaccination Center, he was blown over by high winds sustaining a blow to his right forehead with small abrasion and a 3x4cm subcutaneous hematoma. He was assisted to a wheel chair and brought into the EMT booth for further assessment. He was awake and alert and oriented during his time with us. He never lost consciousness . He vigorously requested to receive the Covid-19 vaccination which we complied with. Due to the mechanism of injury and use of an anticoagulant, he was subsequently transfered to Hospital for further assessment and care. We heard on 4/3/21 of his death.

Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.

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 84 and receiving palliative care for metastatic prostate cancer. Comorbidities include T2DM, HTN, MI s/p PCI, and CKD.

Pt presented to ED at the recommendation of the PCP for low hemoglobin where he reported having increased generalized weakness for the past month, dyspnea on exertion, occasional lightheadedness. On arrival to ED was found to be hypotensive, with elevated WBC count, mildly elevated lactic acid level, and anemic at Hgb 7.5. An incidental finding of a positive COVID-19 nasal swab was found despite receiving Pfizer COVID vaccinations on 1/30/21 and 2/20/21. Pt admitted for additional management of sepsis, hypotension potentially secondary to COVID-19 infection and/or RLL developing pneumonia. Pt currently still hospitalized with worsening acute respiratory failure due to COVID and acute pulmonary embolism.

Father received 2nd vaccine and died two days later of heart failure. Was not in critical condition prior to the vaccine.

This 85 year old white male hospice patient received the Covid shot on 2/16/21 and went to the ED on 2/21/21 and was admitted on 2/22/21 with altered mental status, pneumonia, severe sepsis, bladder cancer, UTI, dementia 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.

This 85 year old white male received the vaccine on 2/19/21 and went to the ED on 4/05 and was admitted with generalized weakness, hyponatremia, fever and elevated bilirubin. On 04/16/21, he went to the ED and was admitted to the hospital on 4/17 with poor appetite and hospital admission dx of ketonuria, leukocytosis, renal insufficiency, elevated troponin, hematuria, generalized weakness and died on 4/19/2021. 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.

Thrombocytopenia 14000 on admission. Was at the dentist day before and had cleaning No bleeding at that time. Most recent platelet count in computer in 2017 was 144,000. patient had BMB showing Amegaryocyte no schistocytes Was treated with steroids IVIG no improvement. Had Nplate 4/14/2021 and 4/21/2021 no improvement.. Had also HLA match platelet transfusion for platelet < 10,000. Today 04/22/2021 platelet count 4,000

Patient presented to the ED on 4/20 after near syncopal episode. Found to have submassive saddle PE with bilateral DVTs. No prior hx of coagulopathys.

new onset of Pericardial effusion and tamponade of unknown etiology extensive infectious disease evaluation was negative. after second vaccine; severe fever chills and hypotension.

As per nursing notes documented on 4/22/21 at 6:17 am, resident observed in bed with no respirations at around 5:10 am. Patient completed a 7 days course of Levaquin for UTI. Patient was on Vancomycin IV 750 mg every 12 hours and Zosyn 2.25 mg every 6 hours for possible pneumonia.

Admit 5/23. Vaccine 1/16, 2/10. H/O CAD, CHF, previous strokes. Presented to ED from NH with AMS, fever. COVID+. CXR shows no infiltrates. No supplemental O2. Also found to have acuta CVA. Palliative care consulted, family agreed to hospice. DC'd to Hospice.

Bleed; Hemoglobin and it had dropped to 6.1; 2nd dose- He was extremely exhausted/weariness/tired feeling; This is a spontaneous report from a contactable consumer (patient's wife). An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 85-years-old via an unspecified route of administration, administered in arm left on 15Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus, cancer removed from his buttocks (It was either a basal or a squamous and they did not feel it was bad and they had removed it all) on an unspecified date, he has had a stent put in on an unknown date, Had surgery for a valve replacement on an unknown date, heart disorder (He is on a lot of medications) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 85-years-old on 24Feb2021 and experienced he was tired a little bit. After the second dose on 15Mar2021 her husband and her were extremely exhausted, not sleepy, just tired. They were told to expect that though. He was extremely exhausted and this began soon after the COVID vaccine fairly early in the day. Her and her husband came home soon afterwards and looked at each other and said that they were tired and it was not sleepiness, it was not like they needed a nap. It was profound tiredness and exhaustion. Her husband had it more so but they were both in bed for a couple hours. Neither had pain in the injection site though. This lasted for several hours into the evening. Adds that for her husband 1st dose he did not have any effects basically but for his 2nd dose he did have the weariness, not sleepiness, just a tired feeling for several hours. He was just resting and he was also in the hospital but it was for another event not because of the COVID vaccine. She says that it was frightening, he went to the doctor for a routine check up he has had a stent put in and had surgery for a valve replacement at the beginning of the year and also he has had a cancer removed from his buttocks at the beginning of the year. But during his regular check in they did his hemoglobin and it had dropped to 6.1 on 20May2021, and the doctor said that they were going to call an ambulance and her husband said he was going to drive to the hospital since he was only 2 to 3 minutes from there. They admitted him and he was in for 3 days. They can not find the bleed site and they did an endoscopy and they are waiting for him to have an outpatient colonoscopy. They can not figure out the bleed and where it is coming from. He is currently been resting but it is frightening because it was out of the blue. Caller confirms that the stent, cancer and the valve replacement were all prior to the COVID vaccine. The patient was hospitalized for hemoglobin and it had dropped to 6.1 (haemoglobin decreased) and bleed from 20May2021 to 22May2021. The patient underwent lab tests and procedures which included endoscopy: unknown results on May2021, haemoglobin: 6.1 on 20May2021. The patient recovered from fatigue on 15Mar2021 while the outcome of the other events was unknown. Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021595342 same patient, and vaccine, similar event, first dose

Bronchial pneumonia; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727 and expiration date not provided), via an unspecified route of administration, on 25Apr2021 (at the age of 85-year-old), at single dose, for COVID-19 immunization. Medical history included diabetes, high blood pressure. Concomitant medications included lisinopril; amlodipine; insulin glargine (LANTUS); nefazodone hydrochloride (NOVO - NEFAZODONE-5HT2), it was reported "Novo was whatever it was when patient take his reading anywhere to 2 to 15". The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient experienced bronchial pneumonia (medically significant) in May2021. Patient got his second shot on 25Apr2021 and about may be not quite 2 weeks later patient had bronchial pneumonia that just about killed him and he was just wondering if that could be a possibility that he got that because other than that he was pretty healthy. No treatment received for event. The outcome of event was unknown.

Fever, discomfort, restlessness. Administered Tylenol at Dr's instruction; He collapsed and died. He first reported nausea occurring around 4 am on 2/25/21 and was uncomfortable all day. He felt worse that evening and was showing a fever. He was given Tylenol around 10 pm on 2/25/21. He fell asleep around 2:00 am on 2/26/21 and woke up around 3:00 or 3:15. He had a drink of water then collapsed. I performed chest compressions until the EMTs arrived but he was likely dead by the time they arrived.

Severe cough, shortness of breath, exhaustion leading to emergency room visit followed by hospitalization wherein it was discovered Pt was diagnosed with acute congestive heart failure. Prior to this vaccine he was living alone, preparing meals, driving to errands, etc. Over the following few weeks after release he became unable to live at home so he was moved to an assisted living facility where he rapidly declined and was put on hospice less than 2 weeks after his second Covid shot on 3/2/21 (Lot EN9581) (which he only took because his doctor pressured him). He died on 6/2/21 of heart failure.

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/29/21 after the completion of a full Pfizer vaccine series (Dose 1 on 1/24 and Dose 2 on 2/14). The patient later died on 5/04/21. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, IMMUNOCOMPROMISED CONDITION. Comments:05/04/21:Patient was admitted to the hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic respiratory failure requiring intubation. Despite maximum therapies, the patient's respiratory status did not improve. He remained mechanically ventilated from 4/29 through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient died at 10:45.

Patient started to become progressively weaker within 3-4 days after getting vaccine. Family members became concerned and started taking him to doctor -- primary and oncologist and cardiologist -- they ordered multiple tests and could find nothing. No sign of cancer which had been in remission for months. Patient became progressively weaker over the next 2 weeks, was hospitalized, became unable to get out of bed; hospice was called, and he died May 13. No explanation could be offered by his doctors.

Shortness of breath, low blood oxygen which gotten increasingly worse the days following first vaccine. Went to ER two days after vaccine as symptoms continued to get worse and was placed on oxygen full time. Had a portable oxygen machine. Was also placed on hospice care March 18, 2021; 3 days after 1st vaccine. He had a stable bill of health on Feb 4,2021. Dizziness, fainting and falling down days after second vaccine on March 8 2021. Was in and out of urgent care, ER and assisted care as symptoms and health rapidly deteriorated. He died May 1, 2021

Fatigue, chills, fever, exhaustion. The following Sunday, 9 days after his second dose he went to bed and never woke up.

Patient diagnosed with COVID on 6/6/21. Patient was fully vaccinated. Patient admitted to our hospital with respiratory failure and COVID-19 pneumonia on 6/9/21. Patient was treated with oxygen, remdesivir, dexamethasone, and antibiotics. His pneumonia progressed, oxygen requirements increased, and chest xray showed worsening airspace opacities and decreased aeration. Patient's code status was updated to DNR/DNI per family request. Patient's condition continued to deteriorate and patient expired on 6/13/21.

Patient was not previously COVID-19 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. Likely comorbidities that were related to death was End Stage Renal Disease

RECEIVED FIRST DOSE OF PFIZER COVID VACCINE ON 02/03/21. REPORTED ER FALLING ON ICE WITH RIGHT HIP PAIN. ALSO HIT HEAD. IS ON BLOOD THINNER. IN ER O2 SAT DROPPED AND WAS PLACED ON 4L OXYGEN. ADMITTED INPATIENT AFTER BEING DIAGNOSED WITH HYPOXIA, CHF, AND PELVIC FRACTURE

The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.

Patient passed away from chronic respiratory failure with cardiogenic shock 24 hours from 2nd dose of vaccine. Patient with longstanding history of pulmonary HTN and heart failure with desire for comfort care only. Entering into VAERS out of abundance of caution.

Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.

elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired. he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot. had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later. -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis. important to note that he had a covid vaccine just a few hours from collapsing and dying.

Patient was found sitting in his driveway around 4pm, dizzy with incontinent stool and vomiting. He was brought to ED where he was found to have skull fracture and SAH. Patient was admitted to the hospital . Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

Patient had been feeling dyspneic for 1.5 weeks to 1 month prior to his death on 2/28/21. He received vaccine on 2/25/21. On his family found him leaning on the couch with eyes rolled back and foaming at the mouth. He was making noises (like grunting sounds?). EMS was called. He had cardiac arrest while in ambulance enroute to EMS. Resuscitation efforts continued in ED. Family was informed about his status and resuscitation efforts were stopped.

Patient passed away unrelated to covid vaccination Narrative: The patient had rectal cancer with metastases and stage 4 chronic kidney disease. Has been placed on palliative care. Patient received his first dose of Pfizer vaccine on 12/22 and second dose of Pfizer on 1/12. No adverse reaction related to vaccination was reported. Patient passed away on 1/17. Patient's daughter had concern that his rapid decline over the past few days may have been related to COVID vaccine. Attending explained that patient's clinical changes are more consistent with decline due to an end of life status. No indication that death was related to COVID 19 vaccination.

Patient passed away unrelated to covid vaccination Narrative: The patient with PMHx significant for afib s/p failed ablation, chronic hep B, heart failure and skin cancer. Patient received his first dose of Pfizer on 1/14 and second dose of Pfizer on 2/4. Patient's wife notified facility that patient had passed away at his residence on 3/9 due to metastasized cancer. Cause of death is not related to COVID 19 vaccination.

2/27/21 hpi86 y.o. male with a past medical history notable for Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline. Hospital Course: patient was admitted to the hospital for worsening dehydration and finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment. 3/20/21 readmission acute renal failure

The background is he was hospitalized for 5 days in November 2020 for coronavirus, admitted with fever, chill, weakness, and inability to walk. Discharged with 3 weeks physical therapy to regain his strength. First vaccine on 2/4/2021 and within 24 hours experienced similar symptoms, profound weakness and fever. Second vaccine on 2/25/2021 and within 12 hours he was unable to walk, with weakness, fever, and confusion. He was taken by ambulance to the hospital on 2/26/2021. I did question his internist and the person at HealthCare facility on whether or not to proceed given prior reactions. During this admission determined to have heart attack with cardiac cath and stent placement. Brain MRI showed new 1cm occipital left infarct and developing pneumonia. Started on anticoagulation with Plavix and ASA 81mg. Readmitted to the hospital on 3/8/2021 with suspected GI bleed. Had colonoscopy and endoscopy with gastric erosion cauterized.

your head is bleeding; My wife heard my fall; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 08Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 for COVID-19 immunization and experienced fall, felt dizzy and cut on his head. On Tuesday, 16Feb2021, the patient went to bathroom and the patient next remembered he was on his bed (3 yards away). Patient's wife heard his fall and came into the bedroom and she said that patient's head is bleeding. He had no recollection of episode. EMT arrived and patient was hospitalized on 16Feb2021. 5 staples were put in his head in hospital. On Tuesday and Wednesday (16Feb2021 and 17Feb2021), scan of his head was done, loop recorder inserted in his chest, ultrasound of carotids, echo cardiogram and pharmacologic stress test were also performed. On Wednesday 17Feb2021 17:30, the patient discharged from hospital. On 24Feb2021, chest incision was checked by technician and on 02Mar2021, staples were removed in hospital. The outcome of the events was unknown. Information on the lot/batch number has been requested.

I thought I was having a heart attack; I had severe left arm pain; I didn't get much sleep that night; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration at left upper arm on 08Mar2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib) and high blood pressure. Concomitant medications included unspecified medications. The patient was taking loads of medications. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and reported that he had no problems with the first dose. The patient experienced severe left arm pain at the arm where the shot was given on 08Mar2021, the night after he received his second COVID vaccine dose. He almost called a number because he thought he was having a heart attack. What he did was he got up to walk around and the pain went away and when he sat down on his recliner, the pain came back so he didn't get much sleep that night. He was fine the next day. The patient took an ASPIRIN 325 mg coated pill because he thought he might be having a heart attack. If he had known, he would have taken the vaccine on his right arm. His arm hurt the night of 08Mar2021 until 6:00 AM the following day. The patient then stated that his recommendation was to tell the people who are administering the shot that a left arm pain may possibly occur because anybody who has the left arm hurting is afraid and can think they have a heart attack. The outcome of the event pain in arm was recovered on 09Mar2021 at 06:00 AM, and recovered on 09Mar2021 for all other events.

SHORTNESS OF BREATH Pleural effusion Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC) DEATH

The first doze made him tired and got back pain. Went to his Primary Doctor to see if it is okay to get the second dose. He got his blood work done, echo Cardiogram and all the necessary test have been done and he is okay to proceed by his Doctor. On the fourth day after he get the second dose of Pfizer-BioNTEch, in the afternoon, he couldn't get up from his bed that he had lay down. He experienced slur, facial droop and left side hand weekness. We called the paramedics right away and they checked him and took him to the nearest Emergency Hospital. They ran tests, did CT scan and diagnosed him with Ischemic Stroke on his right side which has effect on the left side of his body for facial droop and weekness and not being able to get up. He was threated with Mechanical Thromboctomy to remove the blood clot. He stayed in the hospital for 8 days and is bed bound up until now and is transferred to a re-hab. He still can't stand. Today is the 27th day since the adverse reaction started. His left hand has improved a little bit.

Stroke like symptom- babble; could not form words to communicate to wife or EMT; 24 hrs before he didn't feel well nothing in particular-no headache, no stomach issue, no fever, no tremors or motor skill issues.; This is a spontaneous report received from a contactable consumer (patient). An 86-year- old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 18Feb2021 as a single dose and first dose on 28Jan2021 as a single dose and both the doses (at the age of 86-years-old) for COVID-19 immunisation. The patient medical history included Prior stroke, Kidney disease and inactive pituitary gland. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received concomitant medication within two weeks of vaccination (names not specified). The patient did not receive any vaccine within 4 weeks prior to the vaccine. On 09Mar2021, the patient had stroke like symptom- babble, could not form words to communicate to wife or EMT and he didn't feel well on an unknown date in Mar2021 (24 hrs before) (as reported). It was reported that patient had no headache, no stomach issue, no fever, no tremors or motor skill issues. The patient visited emergency room and was hospitalised on an unknown date in Mar2021 for the events Stroke like symptom- babble, could not form words to communicate to wife or EMT for 2 days. Therapeutic measures were taken as a result of events stroke like symptom- babble, could not form words to communicate to wife or EMT. The patient had undergone laboratory test and procedures on an unknown date in Mar2021 includes EKG, heart CT, monitored blood, a full MRI (next morning) and the results were not reported. The outcome of the events Stroke like symptom- babble, could not form words to communicate to wife or EMT was recovered on an unknown date in Mar2021 while for another event was unknown. Information about batch number and lot number is requested.

Suffered a stroke 1 to 1.5 hours after vaccination. He was driving when according to my grandmother he couldn't deccelerate and was having trouble communicating. Grandmother had to take control of the wheel and somehow stop the car by driving it off the road. Patient was combative with healthcare and had to be restrained and was confused about why he was there. he no longer remembers the events that lead to his hospitalization.

pt came into the office with symptoms of left lower extremity swelling/edema. Ultrasound was done that determined patient is Positive for acute deep vein thrombosis of the left femoral and left popliteal veins. Pt placed on Eliquis right away.

possible heart attack; High pain in left arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in left arm on 08Feb2021 13:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from 2010 to an unknown date, hypertension from 1971 to an unknown date, both knees replace from May2011 to an unknown date, left shoulder replaced from Nov2011 to an unknown date, left eye cataract removal from Jun2013 to an unknown date, right eye cataract removal from Oct2013 to an unknown date, L4 & L5 disc repair from Aug2014 to an unknown date, Gall bladder removed from Sep2014 to an unknown date, Right shoulder, Kidney disorder, cramps, Virus fighter, Heart disorder, eye disorder, General Health, Blood thinner, R. shoulder pain, sleep disorder, constipation, Clear vessels. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. The patient experienced possible heart attack on 08Feb2021 with outcome of not recovered, high pain in left arm on 08Feb2021 with outcome of not recovered. High pain in left arm-possible heart attack on 08Feb2021. Reported it was not caused by shot, but result is possible pitched nerve- X-ray and CT scan Being done. AE required Scheduled X-Ray and then CT scan on neck. Treatment included the event did require the initiation of new medication/other treatment/procedure. Seriousness criteria reported as not serious. COVID-19 testing had not been conducted.; Sender's Comments: A contributory role of the vaccine BNT162B2 to the event possible heart attack cannot be fully excluded based on the temporal relationship. Patient's advanced age, underlying hypertension, atrial fibrillation, kidney disorder and other comorbidities provide alternate explanation for the event. Case will be reassessed if additional 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.,Linked Report(s) : US-PFIZER INC-2021277193 same patient, same product (second dose), similar events.

Patient complained of chest heaviness and fatigue at bedtime 6 days after receiving the first dose of the Pfizer COVID vaccine. Patient planned to go to the doctor in the morning, but died while sleeping.

Patient tested positive for Covid; Patient tested positive for Covid; The patient died; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on Feb2021 (Batch/Lot Number: En6303) as single dose, and dose 2 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: Ep7534) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient tested positive for COVID on 08Apr2021 which resulted in Emergency room/department or urgent care, and hospitalization for 3 days. Treatment included high flow oxygen, doxycycline, inhalers, and Rocephin. The patient underwent lab tests and procedures which included Nasal Swab: positive on 08Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: The patient died

86y.o. male with history of hypertension, Diabetes mellitus type II, OSA (uses 2L of O2 at home), CAD, cardiomyopathy, CVA with right hemiparesis, gout, GERD, and depression who presents to the hospital on 4/27/2021 for shortness of breath that has been worsening over the past week. Patient positive for COVID on 4/26/21 when he presented to the ED with fever, cough, and chronic toe infection. Patient had no hypoxia or increased work of breathing and was discharged from ED with doxycyline for his toe infection. Patient reports that he returned to ED due to family concern over symptoms. In ED, patient became hypotensive and was given 30 mL/kg bolus by ideal body weight. Patient remained hypotensive and central line placed in ED for possible vasopressors. Patient is on his home oxygen of 2L and has no increased requirements. Patient in ICU for sepsis and hypotension that responded to IV fluids.

This 86 year old male received the Covid shot on 2/17/21 and went to the ED on 4/20 with abnormal lab of hypercalcemia and again on 4/25 with altered mental status and was admitted on 4/25 and died on 4/25/21. 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.

small blood clot in brain; This is a spontaneous report from a contactable consumer (patient). A 86-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Type two diabetes b, covid prior vaccination in 2021, blood clot in lung. Concomitant medication included exenatide (BYETTA). The patient previously received the first dose of bnt162b2, via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient experienced small blood clot in brain on 09Apr2021. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (4 days), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient received the treatment Heparin for event. Covid test post vaccination (Blood test) was negative on 12Apr2021. The outcome of the event was not recovered. Information on Lot/Batch number has been requested.

I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC)

This 86 year old male received the Covid shot on 1/20/21 and went to the ED on 1/23/21 and was admitted on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs

J18.9 - Left lower lobe pneumonia I48.91 - Atrial fibrillation with RVR (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) N30.01 - Acute cystitis with hematuria

On 3/20 this patient started exhibiting right sided facial droop and paralysis of right arm and leg, dysphagia. On 3/25 he was discharged from the hospital on hospice.

March 5th Ultrasound revealed Severe DVT in left leg. Emergency room March 5th prescribed Eliquis 10mg twice daily. May 24, 2021 blood work showed elevated Ddimer. Dr requested another Ultrasound, May 27, 2021 Severe DVT not responding to blood thinners. May 30, 2021 Dr. switched to Xerelto 20mg. June 3, 2021 Dr. determined that patient has developed Chronic DVT and will continue to follow up with Blood work and Blood thinners. Next appointment is June 11, 2021.

presented to the ED with generalized weakness progressing to fever, cough, dyspnea, myalgia, pneumonia. admitted to Hospital

The patient received his first dose of Pfizer COVID vaccine 6/9/21 at pharmacy. He was then admitted 6/20/21 at hospital with abdominal pain, sepsis and a suspected aspiration event and expired on 6/23/21. This was felt by the treating physicians to be most likely not related to or associated with the vaccine, but given the close proximity it was asked that this be reported.

Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.

Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized for 2 weeks. Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus. Micro vascular ischemic changes. Critical test result of acute stroke.

86 year old pleasant gentleman with a history of coronary artery disease (noted on MPS in 2003, unclear if prior intervention), hx of SSS with PPM, type 2 DM, ischemic CM with EF of 41%, chronic kidney disease with a baseline Cr 1.5 - 1.9, hx of popliteal artery embolism felt to cardioembolic in origin (in setting of cardiomyopathy) on lifelong coumadin, and chronic thrombocytopenia with baseline plts of 100s. He has been admitted for acute respiratory failure due to COVID pneumonia. There may also be a component of pulmonary edema given elevated BNP. Plan: 1. Acute Resp Failure/COVID-19 Disease - - Symptom onset on 07/15. COVID positive on 07/17. Last fever on 07/15 o Pt has been started on Remdesivir on 07/20. He is to have a 5 day course. o Continue decadron 6 mg daily - started on 07/20, will continue for 10 days o Trend LFT's and chemistry daily as he is on remdesivir. Hold Remdesivir if ALT >10xULN or CrCl<30 o Continue awake proning: 2 hrs prone, 1 hr left, 1 hr right and back to prone. Limit the hrs supine. Explained in detail to patient who understands and is agreeable. o May use MDIs as needed for bronchospasm o Check d-dimer, ferritin, ESR, and CRP every other day. If rising will need to consider CTA/LE doppler o Monitor I/O and make sure patient is net negative. Continue bumex home dose for now per patient request. Will increase tomorrow UOP not adequate. o Continue Coumadin for prophylaxis active bleeding o Nasal Cannula 3 liters. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% o Pepcid for GI prophylaxis o Continue isolation in hospital per Regional/Local ID guidance.

Massive Brain hemorrhage. Collapsed on 4 Feb 2021. Air medevac to Hospital. Life support removed on 07 Feb 2021

a possible transient ischaemic attack; the patient began retaining water; This is a spontaneous report from a non-contactable consumer (patient). An 87-year-old male patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 for Covid-19 immunisation. Medical history included mitral valve replacement, pacemaker. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included blood thinner, atorvastatin calcium (STATIN), lisinopril (manufacturer unknown), warfarin (manufacturer unknown). No other vaccine received in four weeks. In 2021 a few days after 1st vaccination the patient began retaining water. On 04Feb2021 the patient was hospitalized for a possible transient ischemic attack. The patient was hospitalized for a possible transient ischaemic attack and began retaining water from 04Feb2021 to an unknown date. Therapeutic measures were taken as a result of events. The outcome of unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

death Narrative: 86 year old MALE with PMH of Afib s/p AICD/PPM, HFrEF (EF< 20% 10/2019), DM2, HTN, HLD, BPH, Depression. Was stable and feeling well when he was administered Covid-19 vaccine on 02/17/2021- Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); PFR; Lot#; EL9267; Exp Date:05/31/2021 Administration Anatomic site: Right Deltoid; Pt was monitored for 30 minutes after administration and had no adverse effects. He was called later in the day and reports he feels well and has had no adverse reactions, he endorsed his arm is a little sore at injection site. ON 02/19/2021- his dghter found him on the floor, next to his bed, dead. She reported on 2/19/2021- that she was out with him to dinner on 2/18/2021, and he stated he did not feel well, that his insides did not feel right. He proceeded to have dinner and 2 drinks. HE was doing ok, when she took him home.

Patient received both doses of Pfizer vaccine. Patient reports around 5 days after the vaccine, experienced shortness of breath, generalized weakness. On admission (about 10 days after completion of vaccination), patient is diagnosed covid-19 pneumonia with covid pcr positive and chest x ray consistent with pneumonia.

Pt expired 11 days after receiving vaccine. No indication his passing was related to the vaccine. Narrative: No updated notes regarding cause of death. Patient's wife called to notify the facility of his passing on 1/26/2021

[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.

Patient hospitalized with shortness of breath and pneumonia (from 2/15/2021 to 2/21/2021) and patient died at another facility on 3/2/2021.

I was disoriented, didn't know where I was, I had no hand/eye coordination, difficulty with numbers and letters and showed slight cognitative impairment. I called the hospital and was told it would get better in 24 hrs but it didn't so I went to the ED and was admitted from 01/14/2021 through 01/17/2021 with a diagnosis of having a stroke. I am currently going for cognitative therapy.

After patient received 1st dose of COVID vaccine, voiced complaints of CHF exacerbation. Was admitted for diuresis and symptom management.

Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery Altered mental status Anemia Renal insufficiency

1 week after second dose I developed a blood clot behind my left knee, in hospital for 9 days; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:00 (Lot Number: EN6201) as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, controlled from an unknown date and unknown if ongoing and penicillin allergy from an unknown date and unknown if ongoing. The patient previously had first dose of BNT162B2 in the left arm (lot number: EL3244) on 20Jan2021 for COVID-19 immunization. Concomitant medications included apixaban (ELIQUIS), metformin, caredevil and fish oil; all taken for an unspecified indication, start and stop date were not reported. On 24Feb2021 12:00 PM, it was reported that the patient 1 week after second dose, developed a blood clot behind left knee, in hospital for 9 days that also resulted in emergency room/department or urgent care. The event was treated with blood thinners. The patient had no COVID prior to vaccination and has not tested for COVID post vaccination. The outcome of the event was recovering.

FALLS, CHEST PAIN, HEMORRAHAGIC CONTUSION, COVID, PNEUMONIA, HYPOXIC RESPIRATORY FAILURE Narrative: 2/22/2021 Patient presented to hospital with multiple complaints. He was reporting falls, chest pain, his wife was diagnosed with Covid. While he was there, he was found to have hemorrhagic contusion in the right frontoparietal region with minimal surrounding edema, Covid, pneumonia, elevated troponin. He was accepted in transfer by trauma surgeon Dr. and arrives with no complaints. 2/26/2021 Patient died after code blue was called Death Diagnosis: s/p fall with head trauma Focal area right intracranial hemorrhage per initial CT - serial CT head showing stability Acute hypoxic respiratory failure secondary to COVID-19 viral illness COVID-19 viral illness Acute chest pain, improved Elevated troponin, suspected type 2 NSTEMI Elevated D-dimer - V/Q scan with intermittent probability PE Acute kidney injury on CKD, improving unlikely that vaccine contributed to patient's death.

an 87 year old male with ESRD on PD, pAfib, CAD, HTN, HLD, hypothyroidism, who was brought in after a witness cardiac arrest. Patient apparently received the first dose of the Covid vaccine (pfizer) at around 11 am. He was doing fine the rest of the day until later in the evening when he had shortness of breath without chest pain, abdominal pain, nausea, vomiting. Upon EMS arrival, the patient appeared to have some agonal breathing and then went down, was in PEA arrest, received CPR with 1 dose of calcium, 1 dose of bicarbonate, and 3 doses of epinephrine with return of spontaneous circulation. Upon arrival in the ED, patient had an intraosseous line, on dopamine for soft blood pressure. Patient has been successfully intubated.

My Father starting experiencing all the side affects - chills/shaking/loss of energy /fever and passed away - the day after having the shot.

He sees a cardiologist every 6 months for pacemaker check , pacemaker was placed over 20 years ago for slow heart rate. Been seeing cardiologist for over 20 years. Now first visit since vaccine and he has Atrial fibrillation. Never had it before. Today there is reporting possible link between vaccine and myocarditis. I look up can myocarditis cause Atrial Fibrillation.. answer YES.

Per patient's Daughter the patient developed blood clots in his small intestine on 4/13/2021 and died 4/22/21 with physicians unable to explain how or why he developed these clots while on apixaban. She requested his case be reported and reviewed in hopes it helps make the vaccines safer if that was what caused the clots.

Heart attack; a little bit of a sore arm after the first dose; This is a spontaneous report from a contactable pharmacist. An 87-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3302; Expiration Date: Jul2021), via an unspecified route of administration on 27Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing cancer, ongoing chronic obstructive pulmonary disease (COPD), and diabetes. The patient's concomitant medications were not reported. In Feb2021, the patient experienced heart attack. On an unspecified date, the patient experienced a little bit of a sore arm after the first dose. The patient stated the sore arm was mild. The patient was hospitalized due to heart attach on an unspecified date. The reporter wanted to know if the patient needed to restart the vaccine series. The patient had no prior Vaccinations (within 4 weeks) and no events following prior vaccinations. Patient was not overweight and probably 5'8" or 5'9". The reporter guessed the patient was around 160 pounds. Patient's vital signs were stable on 13Apr2021. The patient received second dose on 13Apr2021, 11:50, right arm. The reporter confirmed that the heart attack occurred before the second dose. Outcome of events was unknown.; Sender's Comments: The event myocardial infarction is likely due to an intercurrent condition given the patient's ongpoing medical history and age and not related to BNT162B2.

Death listed as a heart attack. No symptoms, but took an abnormally long nap just prior to the attack.

atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). The 87-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jan2021 19:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 87 years old. Medical history included Pacemaker for bradycardia x 20 years, myocarditis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Same meds for years. The patient experienced atrial fibrillation on an unspecified date. The event was reported as serious with seriousness criteria disability. Reported as: Been seeing a cardiologist for 20+ years every 6 months, now first visit since vaccine and now I have atrial fibrillation. A-FIB. Never had it in 87 years of life. I see a country is reporting a link between Pfizer and myocarditis.. I look up does myocarditis cause AFIB ? YES. I pray it is temporary. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient received amiodarone for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. Follow up attempts are possible, information about lot/batch number cannot be obtained.

3/26/21 Patient presented to the ED w/several days of fever, chills, body aches, SOB, and fatigue. He had a + COVID-19 test several days prior. His RA pulse ox was 83%. He was started on BiPAP, decadron and remdesivir. Acute Hypoxemic Respiratory Failure ARDS secondary to COVID-19 pneumonia Oxygen requirement improving, Antley on 4 L of oxygen Status post 10 days of dexamethasone. Status post remdesivir. Continue incentive spirometer use. Breathing treatment as needed. Ct chest- CT chest images personally reviewed and notable for chronic changes consistent with evolving ILD/fibrosis + areas of consolidation which are consistent with a bacterial pneumonia Agree with pulmonology starting patient on IV Zosyn and IV vancomycin Agree with MRSA PCR from and starting Steroids and plan on a 6 week taper. Repeat OP imaging. Patient desaturates with activity Patient was discharged on 4/21 and was readmitted on 4/22 Patient is a 87 y.o. male patient with a history of hypertension, hyperlipidemia, CLL GERD, vitamin D deficiency, with a history of TIAs who was recently admitted to Hospital with COVID-19 pneumonia requiring remdesivir and steroids. After a protracted hospitalization the patient was deconditioned and on 4/21/2021 the patient was admitted to hospital for aggressive rehabilitation. The patient had been doing well over the past week and was making good progress however today during her visit the Daughter noticed at 11 AM when she came to visit him that he is unable to speak and that his gaze is to the right and there is left facial droop. Nurse confirmed this finding had a stroke alert was called. A CT scan was completed and patient is moved to emergency room department. Upon the virtual neurologist's evaluation, patient is alert and oriented without any aphasia or dysarthria. There is no gaze deviation. Extraocular movements are full. There is no facial weakness. There is no drift in any of the extremities and there is no reported sensory loss and there is no appendicular ataxia. The neurologist reviewed the images of CT head and it showed no acute intracranial abnormality.

Patient presented to the ED on 4/2/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Patient presented to the ED on 4/9/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. He also presented to the ED on 4/21/21. He died on 4/24/21.

Patient had been isolating prior to COVID vaccinations, Received first dose on 1/21/21. Patient received COVID # 2 dose on 2/11/21. on 2/15/21 came into ED for 1930 for acute stroke symptoms. Found to have acute/early subacute infarcts right MCA, followed by left MCA, consistent with a cardioembolic etiology given the multiple vascular territory distribution in light of recent MI and intracardiac thrombus. hospital c/b intracardiac thrombus and pulmonary emobli

Patient admitted to the hospital with shortness of breath and cough after being diagnosed with pneumonia in the clinic. He was found to have Covid pneumonia and was treated with maximal support but unfortunately became profoundly delirious and developed worsening hypoxia associated with Covid pneumonia. Family was called to the bedside due to progression in his illness and concerns for cardiac dysrhythmias occurring in the setting of worsening hypoxia on maximal support. Decision was made to transition to comfort care and aggressive life-prolonging interventions were discontinued for primary focus on comfort. Patient subsequently expired at 1810 on 04/18/2021. Patient was vaccinated against COVID 19. Death Certificate Information: Part 1: Cause of Death: A. COVID B. SARS COVID 19 Part 2: Other Significant Conditions: Diabetes Mellitus Type 2, Coronary Artery Disease, Hypertension, Hyperlipidemia

Vaccine given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and sluggish and developed a rash on forearms. He was a Hospice recipient and doctor and Hospice ordered no treatment, just to continue to monitor. When no improvement of codition reported, doctor and Hospice ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on 1/4/2021

Hospice Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21 resident had decreased appetite noted in am but ate 100% of meal at dinner. 1/9/21 resident had decreased appetite with emesis x 2, loose BM x 2. Call placed to hospice. 1/10/21 5:44 am resident able to take HS meds, ingest 2 cups of shake. No emesis or loose stool noted. 12PM nurse noted resident not eating meals but ingesting milkshake and medications without any problems. Hospice contacted for change in condition. 1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am Resident had blood in stool. Resident denies any pain, on 2L of O2 for comfort.

Three hours after receiving COVID 19 vaccination, Patient oxygen level decreased to a critical level and went into cardiac arrest. Staff performed full code but was unable to bring back patient from cardiac arrest.

patient expired 1/15/2021; had been treated as outpatient for pneumonia, likely COVID-19 but no positive test result in December 2020. PMH diabetes

Had vaccine on 1/18. No reported fevers or change in functional status/fatigue. Patient appeared in usual state of health. Is ambulatory with rollator. No prior h/o DVT. Was found in bathroom after presumed fall on 1/27. When attempted to lift patient become hypotensive (40-60 systolic). hypoxic (PO would not read). Was placed on 10 L oxygen without PO reading. Sent to ED-required 15 L nonrebreather to get PO into 90s. Was diagnosed with large bilateral PEs. Found to have dvt RLE. Patient was hospitalized 4 days. His covid test was negative. He returned to facility without oxygen, on Eliquis.

Patient was administered second dose of Pfizer vaccine in Nursing Home on 2/5/2021 around noon and was found unresponsive at 5:03AM the following day 2/6/2021. Patient arrived to Hospital in cardiopulmonary arrest and was pronounced dead.

Patient died 3 days after receiving his first dose of the Covid vaccine. He saw his doctor 2 weeks prior to his death with absolutely no complaints, very healthy. He had no prior heart conditions and was pronounced dead of a heart attack.

A few days after the vaccination my father had a sore throat and slight cough. This progressed into pneumonia like symptoms and he died on 2/11/21.

Patient brought to emergency department at 2210 with concern for stroke d/t left sided weakness. Upon arrival patient appeared to have seizure like activity and was given 2mg of ativan and keppra 1000mg. Patient remained able to converse with providers during episode. Seizure activity/muscle twitching resolved after ativan/keppra administration. At the time of filing this report the patient is being admitted to the hospital.

Patient passed away in his sleep that evening after he recieved his COVI vaccine. Patient had not been ill. No other information is known.

This not a patient of our clinic. When called to confirm his second dose vaccine, is when we learned patient is deceased. Unable to reach anyone regarding date of death.

Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and loss of appetite, chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.

Patient was a patient on hospice, had terminal dx of frontal lobe dementia. NP visited with patient on 03/10/2021, notable decline/flank pain, fever 101. Patient passed away on 03/12/21, Medical Director wanted this reported to VAERS d/t the vaccination was within 72hrs of the pts death.

Patient passed away unrelated to covid vaccine Narrative: 87 YO male has relapse lung cancer and was on radiation therapy and chemotherapy in hospital. Patient received his first dose of Pfizer vaccine on 1/28/2021 (as advised 1.5 weeks after administration of chemotherapy in between cycle) and no adverse reaction was reported. Cause of death not documented. No indication that death was related to COVID 19 vaccination.

Patient was a 88 yo M who presented to hospital on 2/19/2021 with acute onset unsteadiness and trouble swallowing. The patient noted that these symptoms began on day of admission and receiving his vaccine 7 days ago in which he noticed he had increased malaise and increasing DOE/SOB. Patient was noted to be hypoxic with SpO2 in 80s increasing to 90s on 2L NC and in atrial fibrillation on admission. Patient tested positive for COVID-19 on admission and was placed on dexamethasone 6 mg daily for 4 days, ceftriaxone 2g qd for 4 days, and doxycycline bid 100mg for 4 days. Patient improved over the 6 day stay until he was stable on room air at rest and upon ambulation at which time he was discharged home on 2/25/2021.

Fever of 102 degrees Fahrenheit discovered by me when I went to awaken my husband on Saturday February 13, 2021. Two days later I discovered that he had died when I went to keep him a dose of liquid Tylenol at 4 am on February 15, 2021.

My father became weak and non-responsive in week following vaccine. Could not communicate and passed 11 days after receiving vaccine.

The weeks following vaccination, the patient felt lethargic, dizzy, unstable on his feet. Mental cognitive ability was unchanged, and he seemed to still be sharp. Up until the day of death, the patient was still active, able to drive, speak, make jokes, eat, and do everything normally. The morning of death, he had a bad fall, but couldn't recall what happened. It's assumed that a low blood pressure event, syncope, partial aneurysm, something of that nature causing temporary loss of consciousness occurred. We attended a funeral that afternoon, ate lunch, and dropped him off at his home. Sometime during that evening, he fell and died. The cause is unknown and still "undetermined" on the death certificate. (Heart attack or brain aneurysm is what I'm guessing)

Vaccine 2/7, 3/4. Admit 3/23. MD notes state wife reports pt tested COVID + right after his first shot and has tested + several times since Feb. Physician note states pt not showing any signs of COVID +, however other documentation states CXR and inflammatory markers suspicious for COVID, and COVID PNA. Treated with abx, steroids, and fluids for respiratory infection. Family opted for comfort measures and patient eventually expired.

On Sunday afternoon, March 14, I received the first dose of the Pfizer vaccination. On the morning of March 16 I had a sudden hit of fatigued and my left leg started going numb while doing some menial work in the yard, The numbness cleared when I went inside and laid down but some form of the fatigue persisted for several days. Then, on March 28, two weeks after the vaccine, I woke up to a leg severely swollen from toe to hip. I waited two days to see if it went down but it only got worse, swelling to double the size by volume. I went to the doctor and they sent me to the hospital for ultrasound, suspecting a blood clot. No blood clot was evident but there were multi swollen limp nodes in the upper leg area. The problem worsened and two days later I was sent in for a CTscan which now showed multi blood clots near the swollen limp nodes. I was barely able to walk as major pain persisted with no signs of decline. I am now on blood thinner. It has been 2 months since the vacination and my leg is still swollen the same amount (2X by volume).

My Father had been in his usual state of health when he received his first Pfizer Covid-19 shot on 1/12/2021 and his second dose on 2/2/2021. He complained of being tired and chills on 1/13/2021 and again on 1/20/2021. He was diagnosed with a UTI and placed on antibiotics on 1/27/2021. After the second covid-19 shot on 2/2/2021 my father had a change in his condition on 2/4/2021. He became very lethargic, more confused and unable to speak and was send to the Hospital. He spent from 2/4/2021 to 2/12/2021 in the hospital being treated for a UTI and also was said to have had a Transient Ischemic Attack. He went to a rehab facility for Physical Therapy from 2/12/2021 to 2/19/2021 after which he returned to the Assisted Living Facility. He had another episode of lethargy/unresponsiveness on 2/26/2021 and was once again sent to the hospital where they did not show any new findings. He spent a few days in the hospital before returning to his facility where he continued to have periodic episodes of increased lethargy/confusion and decreased eating. He was placed on Hospice and passed away on March 29th.

4/14/2021 at ~8am, Patient was out of bed and in his wheelchair and consumed 100% of his breakfast. During lunch time, he only consumed 25% of his meal. At ~2pm, patient was noted to be unresponsive. Oxygen saturation was 88% and B/P was low and oxygen was administered and Oxygen Saturation increased to 92%. The patient was placed in bed and Dr and the family were notified. The resident was continuously monitored by the Hospice nurse, who happened to be on-site and the primary nurse. At ~6:30pm it was noted that patient was having labored breathing so 0.25 ml of Morphine Sulfate Solution 20mg/ml was administered with releif. At 8:30pm, patient expired.

88 y.o. male with medical history of hypertension, dyslipidemia, sinus bradycardia, COPD ,OSA on CPAP night and AFib on Xarelto. Patient presented to the emergency room with a complaint of chest pain and worsening shortness of breath.Initial vitals in the ED showed temperature 36.1° heart rate 83 respiratory rate 20 blood pressure 150/89 SpO2 96%. CBC within normal, PT 18.8 APTT 39 D-dimer 1111, CMP showed bicarb 32 creatinine 1.39 E GFR 45 and lipase 146. Initial troponin is 53 with indeterminate to our delta, will follow-up on 6 hour delta. ProBNP 1663 with no baseline available. Patient tested negative for COVID-19. VBG showed pH 7.33 and pCO2 of 61 no baseline pCO2 available. Chest x-ray as per report no acute abnormality, personal impression increase interstitial reticular opacities suspicion of fluid overload/pulmonary edema. CT PE as per report filling defect left descending pulmonary artery consistent with acute pulmonary embolus. Patient admitted to the ICU for further monitoring and evaluation. Patient started on heparin drip, rivaroxaban factor Xa antibody sent, as per patient he was compliant with Xarelto. Vascular medicine consult done recommended to bridge with warfarin versus start Lovenox. Discussed with the patient, patient prefers warfarin. Patient was started on warfarin INR 2-3. Resumed CPAP for OSA. Venous Doppler lower extremities negative for acute DVT. TTE showed Normal left ventricular chamber size. Estimated LV ejection fraction range 55-60%. No regional wall motion abnormalities. Mildly enlarged right ventricular chamber size and mildly reduced RV systolic function. Estimated RV systolic pressure 46 mm Hg. Moderately enlarged inferior vena cava size with reduced inspiratory collapse (<50%). No hemodynamically significant valvular heart disease. Patient was started on Lasix IV; converted to oral upon discharge. Patient discharged on Lovenox and warfarin. Patient medical condition improved with medical treatment

DVT; This is a spontaneous report from a contactable consumer reporting for a patient. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation, at 88 years old. Medical history included High blood pressure from an unknown date. No COVID prior vaccination. Not tested for COVID post vaccination. No known allergies. The patient received the first dose of BNT162B2 (Lot number el9264) on 03Feb2021 for Covid-19 immunization. Concomitant medication included simvastatin (ZOCOR); terazosin; carvedilol; ranitidine, taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Lower right leg swelling was noted beginning approximately on 01Mar2021 without injury or pain that worsened through 04Mar2021. Patient was taken to ER on 05Mar2021 when DVT was diagnosed. Therapeutic measures were taken as a result of DVT includes XARELTO. Outcome of the event was recovering.

Went to ER on 4/27 with c/o chest pain (~3 day history), resolved. Returned to ER on 4/30 for chest pain- diagnosed with a small LEFT lower lobe segmental and subsegmental pulmonary embolus on CT 4/30/2021, hospitalized until 5/2/21, discharged on Eliquis, metoprolol, pantoprazole, keflex (for sore throat, negative throat cultures), metoprolol, atorvastatin, amlodipine.

History of Thrombocytopenia (low normal). Please see attached record of platlets. It appears platelets decreased below 100,000 in 8/19. Nine days after receiving immunization #2, Platelets decreased to 44, 37, 33... Although, the immunization did not cause the thrombocytopenia, I ' m wondering if it accelerated the decline. Bone Marrow Biopsy done 4/26/21 = MDS. Staging pending. My father ' s brother is 10 years younger. He has a history of normal platlets/normal hematology. He received both COVID immunizations. After routine visit to PCP, he learns his platlets are 40,000 and sent to hematologist for f/u.

88-year-old male with lymphoma that received a transfusion of 2 units of packed red blood cells prior to admission. The patient has a history of pleural effusions and he states after the blood transfusion, he became increasingly more short of breath and could not catch his air. He was dyspneic at rest and exertion. There is no cough. No fevers. He also has a history of cardiomyopathy and chest x-ray is suggestive of increasing sizes of his pleural effusions. Tested positive for COVID on 4/20/2021. Moved to hospice and expired on 4/22/2021.

ED to Hosp-Admission Discharged 4/28/2021 - 5/1/2021 (3 days) Last attending ? Treatment team Acute respiratory failure with hypoxia Principal problem Hospital Course Admission HPI: (patient) is an 88 y.o. male come to emergency room for evaluation of cough with thick yellow sputum which is going on since past 2 days. Which is progressively getting worse. Associated with some shortness of breath. On arrival of EMS patient found to have significant hypoxia with 70% at room air. He was placed on nasal cannula. Did bring him to the emergency room. Patient had a dose of Covid vaccine and is due for second dose soon. In emergency room, he was thoroughly evaluated. He found to be septic. He was given dose of IV Levaquin and Covid swab come back positive. Hospitalist service requested to admit the patient. Asking patient, is feeling little better after coming to emergency room. He is having shortness of breath with significant cough with sputum production. He felt wheezy. Denies any fever but had chills. He feels nauseated. Hospital Course: Pt was admitted to the hospital for management of acute hypoxic respiratory failure secondary to COVID-19 virus pneumonia. His breathing improved precipitously. He had resistant hypertension this admission and was started on amlodipine. He did have mild hyponatremia this admission but did not appear to have any volume overload. TSH elevated at 13.8. Will need repeat study. He did also have rising procalcitonin and received few doses of antibiotics. Lipid panel was benign. ED Discharged 5/9/2021 (58 minutes) Hospital ER Treatment team Thrush, oral Clinical impression Sore Throat Chief complaint ED Provider Notes (Physician Assistant) Emergency Medicine Cosigned by: (Doctor) at 5/9/2021 6:45 PM Attestation signed by (Doctor) at 5/9/2021 6:45 PM The patient was seen and treated primarily by the PA-C. I did not independently evaluate the patient. Chief Complaint Patient presents with ? Sore Throat HPI Patient is a very pleasant 88-year-old male with recent COVID-19 infection diagnosed on 4/28/2021 on oxygen 4L NC, who presents to the emergency department complaining of sore throat x 1 day. He states that he started yesterday with a sore throat, painful to swallow, then noticed this morning that he had twice patches on his tongue and mouth. He states he is able to tolerate food and liquid, but that it hurts to do so. He denies any fevers or chills. From a Covid perspective, he states that he would not be here if it were not for the pains and sores in his mouth/throat. He feels that his breathing is stable and he is doing well on 4 L of oxygen nasal cannula as prescribed. He has finished a course of Decadron and states he is currently on no further treatment for COVID-19. ED to Hosp-Admission Discharged 5/10/2021 - 5/13/2021 (3 days) Hospital (Doctor) Last attending ? Treatment team Aspiration pneumonia Principal problem Hospital Course Patient come to the hospital with complaining of abdominal pain and hypoxia and cough. Patient found to have a right middle lobe pneumonia. We are believing that it is aspiration pneumonia which is improving at this time. He had a recent COVID-19 infection which is resolving at this time. During course, GI, pulmonology, urology and oncology consultation obtained. Patient continued to improve clinically. Patient had a urinary retention because of the constipation. He is able to void now. Today morning, I am seeing him. He is feeling better. Is agreed to go home. I discussed with the patient's wife regarding plan. Once he fully recovered from pneumonia he need to have colonoscopy and possible biopsy of colon mass.

My father suffered an Ischemic stroke on March 2nd and died on March 9th. He was was healthy and fit up to this point and walked several times a day.

Per discharge summary, patient presented to BHL with his wife with increased shortness of breath, diarrhea and hematuria. Found to be COVID +. Patient tested positive for COVID 5/21. He has received both Pfizer vaccinations. Patient was admitted and started on treatment for Covid with remdesivir and steroids. He was continued on his home dialysis schedule. He continued to have intermittent confusion and then for the last 3 to 5 days was very confused and more unresponsive. Reviewed goals of care with wife at length and palliative care was consulted. Decision was made not to pursue feeding tube due to patient having clearly outlined his wishes and his advanced directive. Upon further discussion with family hospice was consulted and patient was transitioned to inpatient hospice

Intermittent SOB for several weeks, progressively worsening over three days prior to presentation to ED. Presented with SOB, bilateral leg swelling. CXR obtained in ED showed perihilar and RUL opacities consistent w/ multifocal pna or pulmonary venous congestion. SARS-Cov2 PCR resulted as positive. CT of chest showed bilateral pna, began treating as COVID pna with dexamethasone, lovenox. Treated for CHF exacerbation with aggressive loop diuretic therapy. Required 2Lpm O2 via nasal cannula. Discharged home after 6 days in hospital.

Death 4/26/2021 Causes of death listed on death certificate: 1) Pneumonia 2) Coronary Artery Disease Other: Covid 19

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

Death 05/24/2021 Causes of death listed on death certificate: 1) COVID 2) ATRIAL FIB 3) CKD 3 4) Hypertension

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

Patient presented to the ED and was subsequently hospitalized with closed displaced fracture of shaft of left femur. He died on 06/27/2021

loss of consciousness Narrative: Patient received COVID-19 vaccine dose #1 on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient did not experience any injection site reactions, denied pain or tenderness at injection site, no dizziness, no n/v, remained afebrile. Around 1/9/21 @1810, patient became acutely nonresponsive after being helped to the edge of bed. Per nurses, he was previously awake/alert, talking and asymptomatic. Patient is DNR/DNI but facility rapid response emergency team called d/t patient's sudden change of condition. Emergency team helped patient into lying position. Per 1/9/21 ICU emergency team note, patient appeared comfortable w/ no palpable radial pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20 pm.

Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired

The patient received his vaccine in the. morning of 1/20/2021, while getting into car to go see his pulmonologist, about 2 hours after, collapsed, unresponsive with asystolic cardiac arrest. No symptoms prior other than chronic dyspnea. No allergic type symptoms reported by family. Asystole with EMS, no response to ACLS, presented to ED, DOA.

Resident was hospitalized for confusion, and hypotension and increased weakness; resident proceeded to have a NSTEMI and died on 5th day in hospital on 1/31/2021.

death. No known symptoms or complaints. found unresponsive in bed. Released to funeral home as the Medical Examiner will not perform and autopsy. Dr. will sign the DC.

Resident developed increased confusion on 01/30/2021 that may have been related to vaccine or to residents other medical conditions including dementia, anxiety, shortness of breath, history of lung cancer, and COPD. Sustained a fall with fracture and was transferred to Hospital. Surgical intervention performed to repair hip. Resident returned to Skilled Nursing facility. Did not recover after surgery and family chose palliative measures. Resident died/ expired on 02/09/2021.

respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care, hospitalization, and patient died. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from

Right dorsal medullary stroke leading to dysphagia and left-sided sensation changes. First noticed symptoms on 2/25 but did not present to emergency room until 2/27/2021. Patient was hospitalized 2/27/2021; anticipate discharge 3/4 or 3/5 2021. Patient lost ability to swallow; requires tube feeding.

12/31/2020: vaccine given 1/17/2021: symptom onset and subsequent hospital course: dyspnea, hypoxic, tachypnea, afib w/RVR, septic, NSTEMI

Weakness (Mar 5 evening), not able to stand / walk (March 6) ending up in slurring of voice /lethargic , high BP (morning Mar.7). Called 911 and moved to ER @ Hospital. CT Scan did not show stroke, EEG showed slowness in brain activity, MRI showed minor stroke left side of brain. Low salt (124) at the time of admittance. Released from Hospital on Mar 10.

He died around 5 o clock; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Mar2021 13:00 at a single dose (lot number was reported as NEEU200, the reporter did not know if its 2 or Z) for COVID-19 immunization. Medical history allergic to Penicillin, has a long list of allergies, neck pain and sleep disorder (sleep aid). Concomitant medications included diphenhydramine hydrochloride (BENADRYL), clopidogrel bisulfate, calcitriol, melatonin (MELATONIN) taken for sleep aid, Phillips Laxative tablet Magnesium (not appropriately paraphrased and clarified, as reported), simvastatin, terazosin hydrochloride, tizanidine hydrochloride (TIZANIDINE HCL) for when he had the pain in neck (he didn't take that hardly ever), vitamin C [ascorbic acid] and Multivitamin one a day. On Friday 12Mar2021, the reporter and the patient went to get the Covid shot. Their appointment was at 12:30 but they were in line long time before they got the shot. They got the shot around 13:00 and then they have to wait 15 minutes before they could leave. They drove up, they were ready to shoot us with the needle and they asked the patient, asked was he allergic to anything and the reporter answered for him and said yes, Penicillin and other long list and then they gave him the shot. They never did go over his allergies. They got home about 13:30, so which would take us about that long to get home. The patient died around 5 o clock and the reporter didn't know if this was connected or not with his death. The patient died on 12Mar2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: This case of death was provided with minimal details and autopsy results not available. However, drug causality cannot be completely excluded for BNT162B2 injection, only due to plausible chronological relation. Otherwise, information received was so limited to prevent a thorough medical assessment for patient death. The impact of this report on the benefit/risk profile of the Pfizer drugs 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: He died around 5 o clock

CHEST PAIN SHORTNESS OF BREATH Shortness of breath Pneumonia Elevated troponin Elevated CK Acute chest pain Elevated lactic acid level Pneumonia of both lungs due to infectious organism, unspecified part of lung Ground glass opacity present on imaging of lung Leukocytosis, unspecified type Hematuria, unspecified type Sepsis

HE HAD A RECTAL BLEED AND WAS ON ELIQUIS, SO THEY STOPPED ELIQUIS, THEY SAID THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE

89 yo M presents with complaints of weakness and diarrhea for the last 3 days. He received his COVID-19 Vaccine about 10 days before presenting to hospital. Also complains of decreased appetite and oral intake, but denies any nausea or vomiting. Denies fever, chills, cough, and SOB. Patient tested positive for COVID-19 and was admitted on 01/27/2021 for dehydration, AKI, and pneumonia likely secondary to COVID-19 virus, although he did not exhibit any symptoms of SOB or cough. Patient was treated with IV fluids, Pulmicort, Decadron, Protonix, aspirin, and SQ heparin secondary to renal function. Dehydration and AKI were corrected and the patient was discharged on 01/30/2021 with no complaints of COVID symptoms and an

The way he is acting is more like he had a stroke; eyes glazed over; disoriented; felt funny; very weak; can barely stand and barely walk without human assistance and his walker; can barely stand and barely walk without human assistance and his walker; This is a spontaneous report from a contactable consumer. An 89-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 12:15 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included vascular dementia; hypertension; hypothyroidism; malignant melanoma of back (resected/in remission); bladder cancer (surgery in Nov2018/in remission); prediabetic; chronic kidney disease stage 3 due to hypertension; and sleep related hypoxia. No known allergies. Concomitant medications included donepezil taken for an unspecified indication, start and stop date were not reported; memantine taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; lovastatin taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported; and unspecified multivitamin tablet. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech COVID 19) on 26Feb2021 07:45 PM in the left arm for Covid-19 immunization. The patient has not received other vaccine in four weeks. The first day after the shot, there were not any adverse reactions. The next morning at approximately 11:00 am, the reporter found patient laying on the floor next to his bed, eyes glazed over, disoriented, and he said "he felt funny". The reporter got him sitting up leaning on the side of the bed and called. The EMT's came and checked his vitals. Within half an hour from finding the patient laying on the floor, he seemed almost back to normal. However, since he is 89 years old, the patient was transported by ambulance. Blood was drawn, a urine sample was taken, a chest Xray, and a CT scan of his head and his spine were the labs that were run. All the labs came back normal. However, once patient got home after being in the ER for 5 hours, he is very weak, can barely stand and barely walk without human assistance and his walker. The way he is acting is more like he had a stroke. Onset of the events reported as 20Mar2021 11:15 AM. The events resulted in emergency room/department or urgent care. Outcome of the events was not recovered. The patient used walker due to can barely stand and barely walk; for other events, there was no treatment given. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination.

States that his symptoms are like he had a stroke; his health declined after the shot; not eating; he is not able to walk by himself; Can't stand up on his own; Mind is not working correctly/The patient was not himself/his mind goes in and out; Speech is Difficult/he was not responding to her and his speech was bad; not feeling very well/not feeling good; Tired and Sleepy; Tired and Sleepy; Noticed patient was warm but didn't take temperature; The patient didn't receive the second shot because he has been in the hospital.; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 14:15 (Lot Number: EN6198) at the age of 89 years, as single dose for covid-19 immunisation. Medical history included pituitary gland tumour from 2018 and ongoing (it is not growing according to tests), ongoing asthma which he had for years, and ongoing low blood pressure. His blood pressure goes up and down. He has had it for a long time but started this medication 2 years ago because it was too low. Clarified that it was not taken within 2 weeks of receiving the vaccine because his blood pressure had been too high. There were no concomitant medications. The patient previously took fludrocortisone 0.1 mg once a day. The consumer (patient's wife) stated that she called on behalf of her husband. The patient was still in the hospital. The patient received the vaccine on 04Mar2021 and by 11Mar2021, the patient was in the hospital. They have not been able to find out what was wrong with him. The patient's symptoms were like he had a stroke. The patient was 89 years old, so she took him to get the shot and his health declined after the shot and he is still under the care of the (Hospital name) in (City) (State). The reporter clarified that his symptoms were that he was feeling tired and sleepy on 08Mar2021. The patient said he was not feeling good on 08Mar2021. On 11Mar2021, he was not responding to her and his speech was bad, and now he is not able to walk by himself and can't stand up on his own. This started after he received the shot. The patient didn't receive the second shot because he has been in the hospital. He was doing fine before and now he has these issues. The patient's wife (reporter) noticed the patient was a little warm but didn't take his temperature on 08Mar2021. The reporter stated that last Thursday (11Mar2021) they called the doctor and the doctor suggested taking him to the ER at the hospital. On 11Mar2021, the patient was not himself and not eating and she doesn't know what is going on with him, but he is under care at the hospital. Reporter stated the patient is doing therapy in the hospital and they are helping him to walk but he is having difficulty. She stated they keep asking if she knows what is going on, but she has no results or medical records. Reporter stated the patient's mind is not working correctly and speech was difficult for him. She clarified that he wasn't making sense sometimes and she was not able to understand him. States the patient speaks two languages but he started speaking a third language to her. She stated that his mind goes in and out. Treatment: rest and at the hospital they are doing therapy for his legs. States she will get on update on his progress on Friday. States she can't see him because of Covid restrictions. The patient did not receive any vaccines 4 weeks prior to COVID vaccine. Outcome of the events was unknown.

he felt tired the day of but continued doing his daily activities, on april 6 morning a friend couldn't reach him by phone and went to his home and found him on the floor, the hospital said he had a brain bleed, acute hypoxia, the bleed was on the left side of his brain, the doctor stated it was a cerebral bleeding that cause him to fall.

This 89 year old white male received the Pfizer Covid shot on 1/20/21 and went to the ED on 4/16/21 and was admitted on 4/16/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) R29.810 - Facial weakness

fever and generalized weakness bilateral pneumonia secondary to COVID-19 infection Failure to Thrive, Severe Sepsis antibiotics: Levaquin, ceftriaxone and Remdesivir, insulin: Humalog and respiratory therapy: O2

5/2/21 Pt was hospitalized for 2 days for COVID is a 89 y.o. male patient of , MD with history of steroid and oxygen dependent COPD with chronic hypoxic respiratory failure on 6 L, coronary artery disease, gout, hypertension, hyperlipidemia, BPH, and recent exacerbation of his COPD who presents with fevers, body aches, generalized weakness for 5 days found to have COVID-19 infection Acute on chronic hypoxic respiratory failure Due to COVID-19 infection. On home requirement of 6L NC. Expect he may have a milder course given vaccinated status (though not fully vaccinated until 5/7/21). Update 05/4/2021 Patient stated that he feels that he is back to his baseline Currently on 6 L nasal cannula oxygen His sats was~98 %t rest, with no evidence of respiratory distress Covid-19 Virus Infection Date of onset of symptoms: 4/28/21, Symptoms present on admission: fevers, myalgias, dyspnea, weakness Date of covid positive test: 5/2/21 Vaccination status: vaccinated on 4/1 and 4/23/21 but had exposure on 4/22/21 Imaging: CXR with low lung volumes with bronchovascular crowing and strandy bibasilar pneumonia with small pleural effusions Oxygen requirements on admission: 6L Current oxygen requirements: 6L Medical therapy: Received x3 doses of remdesivir while in the hospital, will complete total 10 days of dexamethasone treatment Consultants following: pulmonary Anticipated special isolation end date: 5/8/21 Generalized weakness Due to above issues -PT/OT consults COPD with chronic hypoxic respiratory failure GOLD grade 3, group D, follows with Dr. as an outpatient and recently completed a course of prednisone taper and augmentin on 5/1/21.Chronically declines PFTs in the past. He is on chronic prednisone at 5mg daily and uses 4-6L NC continuously at home. Pneumovax 2010, prevnar 2015. -Continue home spiriva, symbicort, singulair, and albuterol MDI 4x daily -ST consulted, recommended chopped/NDD 3, thin liquids -Discharge home to complete total 10 days of dexamethasone -Can restart his home prednisone afterwards

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

Death 3/30/2021 Causes of death listed on death certificate: 1) Respiratory distress 2) ITP 3) COVID 19 4) Dementia Other: acute cardiopulmonary failure

Pfizer COVID vaccine EUA Pfizer Dose 1 2/17/21 (EN6200) Pfizer Dose 2 3/11/21 (EN6208) COVID Positive 5/30/21 5/30/21: 89-year-old male with history of coronary artery disease status post stenting, most recently on 4/13/2021, hypertension, aortic stenosis, hyperlipidemia, neuropathy, peripheral vascular disease, GERD, pulmonary nodule, hard of hearing and glaucoma has presented to the emergency room at hospital with complaints of chest pain. Patient reports that his whole lower chest was hurting on and off which was sharp pain which would come and go at rest. Patient initially reported that he had the pain when he woke up today but also reported for a week he was having some pains which was not as bad as today. Patient denies having any radiation of pain other than the lower chest across. He did not have any nausea or emesis or sweating associated with it. No aggravating or alleviating factors. In the emergency room patient's initial workup with troponin and EKG were not showing any elevation in troponin and no acute ST-T changes suggesting acute ischemia. Patient's chest x-ray did show possible left lower lobe pneumonia. Patient did not have any fever or chills or cough. Patient has some baseline shortness of breath. He denied any headache, nausea or vomiting or abdominal pain or diarrhea. He had no other acute health concerns. 6/3/21: Chest pain, resolved, ACS ruled out. Patient is chest pain-free, troponins x3 normal, ACS ruled out. The chest discomfort is likely related to the pneumonia. Community-acquired pneumonia - clinically improved, on CTX Rocephin and Azithromycin. Also received vancomycin as cultures as noted below. On room air not working hard to breathe Acute episode has resolved. GPC in chains 2/2 and GPC in clusters 1/2-likely contaminant - true bacteremia vs contamination, vancomycin was initiated. Has old systolic murmur due moderate AS & AR. Low probability of IE by Modified Duke's criteria. ID was consulted Considering 2 different blood cultures Gram-positive cocci in chains and Gram-positive cocci in clusters based on ID recommendations this represented contamination rather than true infection. Follow-up blood cultures are also negative after 72 hours. Per Infectious Disease no further treatment/intervention was required. Severe AS & moderate AR: stable, plan to f/u as an out patient for evaluation of TAVR. HFmrEF 45%: stable, not in decompensation, continue GDMT. CAD s/p DES : Continue on aspirin 81 mg daily, Plavix 75 mg daily, Coreg 3.125 mg twice a day and rosuvastatin. Peripheral arterial disease : He underwent left common femoral and superficial femoral artery intervention in 2015 per records, on dual antiplatelet therapy and statin. Positive COVID 19 test- initial with PCR negative. Patient has been vaccinated. Pulmonary nodules: Patient undergoing evaluation for pulmonary nodules as an out patient.

04/12/2021 11:15am received 2nd shot, started feeling goofy, terribly sick, Collapsed in the floor passed out for 14hrs found by management, admitted to the hospital. 04/16/2021 went into Cardiac Arrest. Hospitalized 11 days/discharged 04/27/2021