Pfizer

ON 1/28/21, REPORTED FEELING WEAK, WITH LOW GRADE FEVER AND CHILLS. STILL FELT WEAK ON 1/29 AND 1/30. EVENING OF 1/30 HE WAS FOUND IN HIS APARTMENT FEELING WEAK AND WITH SHORTNESS OF BREATH. WAS TRANSPORTED TO MEDICAL CENTER BY AMBULANCE AND ADMITTED FOR OBSERVATION.

Temp 103.5 temporal, myalgia, SOB, loss of balance, SpO2 85% RA lying down Symptoms appear to be resolving this AM. Sp02 98% on 2L O2. Temp 98 temporal - at 7:45am

Coughing; wheezing; shortness of breath; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 90 years, first dose on 19Jan2021 09:00 (lot number: EK4176) and second dose on 09Feb2021 (lot number EL9261); via unspecified routes of administration on the left arm at single doses for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included losartan, terazosin, melatonin, glipizide, linagliptin (TRAJENTA), clopidogrel bisulfate (PLAVIX), clopidogrel bisulfate, citalopram, zinc, famotidine, amino acids nos (PROTINEX) and colecalciferol (VITAMIN D). On 20Jan2021, the patient experienced coughing, wheezing and shortness of breath. The patient was taken to the ER and put in the hospital for five days (date of hospitalization was unknown). Treatment received by the patient was unknown. Lab data includes COVID test: Unknown results on an unspecified date. The outcome of the events was recovered with sequelae on an unspecified date.

Within 10 minutes my father developed shortness of breath, diaphoresis, elevated blood pressure, and elevated blood sugar. His blood sugar was 318. My father is a type ll diabetic and has never had a blood sugar over 200. His blood pressure was elevated at 160/90 and it normally runs 120/70. Symptoms resolved within about 2 hours.

Pt tested positive for COVID after receiving both vaccines. Pt developed respiratory distress requiring supplemental oxygen.

After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well as progression in memory loss and confusion. His oxygen levels decreased and his blood work showed low platelets, so he was admitted to hospital on March22-23. Discharged with recommendations to see hematologist. Bone marrow biopsy indicated a very rare form of leukemia (Hairy Cell ). Cancer likely not a cause of vaccine of course, but suspected low blood platelets and exacerbation of COPD?

shortness of breath; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX support. A 90-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (at the age of 90-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath on an unspecified date. The event was considered serious as medically significant. The outcome of unknown. He decided to skip second dose. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

The pain went down his left shoulder and back/he developed pain down his right side of his shoulder, and down in his hips/His left ankle, right side heel, and shoulders also hurt.; The pain went down his left shoulder and back; he was having problems breathing/difficulty breathing; possibly a swollen lymph node on his trachea; His left ankle, right side heel, and shoulders also hurt.; He has had pains in different parts of his body that last for 2-3 days and then some place else starts to hurt.; chills; His wife took his temperature and it was 100.3./He has weird fevers for one day with no other symptoms.; jaw pain; Dates for COVID vaccine: (Start: 5Feb2021 Stop: 16Feb2021), first dose on 5Feb2021 and second dose on 16Feb2021; Dates for COVID vaccine: (Start: 5Feb2021 Stop: 16Feb2021), first dose on 5Feb2021 and second dose on 16Feb2021; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 (Lot Number: EL9267) (at age of 90-year-old) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included ongoing atrial fibrillation, stent placement from 19Jun2020 and ongoing (successful in the descending aorta), and ongoing Heart problems. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2, administered in Arm Right on 05Feb2021(Lot: EL9263) (at age of 89-year-old) for covid-19 immunisation. The patient would like to talk to an individual regarding his side effects he has been having since his two COVID vaccinations in Feb 2021. Ten days after the second inoculation on 26Feb2021, he woke in the middle of the night with jaw pain. He was in great pain. The pain went down his left shoulder and back . His wife said that morning that those were signs of heart problems. He does have Atrial Fibrillation, and he had a stent placed 19 Jun 2020. He went to the emergency room where they checked him out for heart problems. He had a clean bill of health. They sent him home, and told him to take Tylenol for the pain. The Tylenol certainly helps. It took whatever number of days for it to subside. It subsided for 2 weeks, but then he developed pain down his right side of his shoulder, and down in his hips. Once again they figured they better get back to the ER. They did EKG and a X-ray. There was absolutely nothing wrong with his stent. They told him just to continue with Tylenol to control the pain. He went a third time to the emergency room because he was having problems breathing. The emergency room put him through the COVID entry at Kaiser because of the difficulty breathing. They re did all the previous work, and did a scan of his lung to check for blood clots. He thinks they did that because 6 people died from blood clots from Johnsons and Johnson. They wanted to see if there were blood clots, but there were no blood clots. They told him he needed to make an appointment with his primary who then referred him to a Cardiologist. On 11May2021, he saw his primary doctor who ordered another scan because they found possibly a swollen lymph node on his trachea. The doctor measured that, and said to wait a month to do that again. To see any change in it. On the 26 May 2021, he has his next appointment to get that rechecked. He hasn't had a comfortable day since this started. He has had pains in different parts of his body that last for 2-3 days and then some place else starts to hurt. His left ankle, right side heel, and shoulders also hurt. The pain was under control if he takes ibuprofen, but his doctor advised him against too much of that because of his kidneys. It was very effective. The Tylenol works to some extent, but not like the Ibuprofen. He is just living with it day to day. He can play tennis some days. One day he played tennis and came home with chills. His wife took his temperature and it was 100.3. In the last week and half this has happened two times. After the second shot this has happened probably four times. He has weird fevers for one day with no other symptoms. Ever since 26Feb2021, it has been on a daily basis that some place else hurts. One subsides , but another pain starts up elsewhere. If that is not happening, then his whole demeaner is dead. He is just not comfortable and sitting around he feels like he was wasting what life he has left. He used to be a PE teacher. He has always been in good physical condition. He was 5k and walking 5ks every 4th of Jul. He would compete. He prepared for this 90 birthday/ His goal was to do a 5k in under 60 minutes. He worked out like always , and played tennis 3 days a week to prepare. He also played ball. He likes to walk run 2-3 miles most days. He did his 5k in 52minutes, and he was celebrating. Then ten days later this all started happening. The patient/caller has been tested for COVID, and it was negative. The aches and pains were moving around. He was still having breathing difficulties. Sometimes he can't talk because of the breathing. It just goes away. If it is something like the tumor or a node on the trachea wouldn't it be happening all the time? Sometimes he can't talk because the breathing is bad. It comes and goes. It is more often recently. It is like all the sudden he can't breath and can't talk. That started right at the beginning. It has gotten progressively worse. He took Tylenol to help the pain in his body. Nothing has helped his breathing. He tried antihistamines to see if maybe it was hay fever or something , but there was no difference. He didn't know where to go from here. He was feeling horrible. He was just waiting on 26 May2021, for the second scan without color of thorax to see those results. The patient said he didn't have questions. The outcome of events was unknown.

I get all sorts of pain; Fever of 101.3F; Slight shortness of breath; Confusion; Extreme fatigue and weakness.; Extreme fatigue and weakness.; This is a spontaneous report from two contactable consumers (one is the patient). This 90-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6200), via an unknown route in the left arm, on 20Feb2021 at single dose for COVID-19 immunization, administered at Public Health Clinic/(Name) facility. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262) as single dose on 30Jan2021 for COVID-19 immunization. No other vaccine was received in four weeks. Relevant medical history included melanoma, lung cancer, peripheral neuropathy, arthritis and heart failure. Past drug history included allergy to penicillin. Relevant concomitant medications included spironolactone and bumetanide. On 22Feb2021, the patient experienced extreme fatigue and weakness, confusion and slight shortness of breath. He had fever of 101.3F five days after second dose of vaccine. The patient stated, 'I get all sorts of pain'. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the events. The outcome of the event 'I get all sorts of pain' was unknown while the outcome of the remaining events was not recovered. No follow-up attempts are needed. No further information is expected.

On 1/9/2021 observed with elevated respirations of 38-42 per minute, BP manually 72/50. pulse is jumping rapidly between 110-16 bpm. oxygen sat 76% RA, resident refusing oxygen at first attempt, allowed oxygen to be placed, is now 84% on 4L. resident shaking head yes that he is hurting, and yes that he would take medication for pain. Dr. notified, branch block. Received order for morphine 2mg per hr as needed for elevated respirations and pain. Dr. also gave orders to D/C Tamsulosin and finasteride. Resident continue with decreased O2 sats and elevated respirations. Absence of vital signs on 1/10/21 at 826PM.

RECEIVED COVID VACCINES ON 01/20/21 AND 02/10/21. 2/11/21 EMS CALLED BY FAMILY FOR ALTERED MENTAL STATUS AND ACCUCHECK OF 40 AND TAKEN TO ER HAD NEGATIVE COVID PCR ON 02/11/21 DIAGNOSED IN ER ADMITTED TO HOSPITAL INPATIENT WITH HYPOGLYCEMIA DUE TO DMII, AMS, UTI, AND PLEURAL EFFUSION

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

Pain in his lower extremities and torso. Pain on breathing inspiration, and observed with a nosebleed.

Patient was seen and examined at the bedside. The patient is a 91 yr/o male with a history of CHF, NSVT, aortic stenosis, atrial fibrillation, HTN, hypothyroidism, DM2 who presents to the emergency room with complaints of chest pain and worsening shortness of breath. He reports he got his second Covid vaccine yesterday and was feeling well until about 1 AM when he woke up acutely short of breath. His wife checked his oxygen and reports he was 90% on his home 2 L. He felt he could not breathe unless he was sitting straight up. He changed over to his CPAP and was able to breathe and fall asleep comfortably. Today throughout the day his shortness of breath has persisted and he was due to see his cardiologist so they went to his appointment. While at the appointment he developed substernal chest pressure. It did not radiate. It resolved with 2 sublingual nitroglycerin. Patient was transferred to the emergency room for further evaluation. Patient denies any fever or chills. He has a chronic cough with clear sputum unchanged. He reports worsening lower extremity edema over the past few days. He reports he has been taking all of his cardiac medications as prescribed. Work-up in the emergency room concerning for acute on chronic CHF exacerbation. Troponins mildly elevated but are plateaued. No further chest pain while in the emergency room. Patient to be admitted for further evaluation and treatment

Patient tested positive for COVID 19 by PCR on 4/15/21; >2 weeks after 2nd dose Symptoms started 4/3/21; now w/ SOB w/ exertion, cough, chills, diarrhea, fatigue, chest pain/tightness, fever.

About 10 minutes after the vaccine the patient complained of headache/lightheadedness. We supplied the patient with a bottled water and he drank some. About 3 minutes later the patient complained of not feeling well/right. His eyes then rolled back in his head and he began to shake. He did slump to the side in his wheelchair. He was breathing although it seemed a bit labored. He was not responsive verbally when w asked him if he was ok. After about 2 minutes, the episode seemed to end. He moved and straightened up. His eyes opened and he was able to answer questions. He complained of feeling tired. He wanted to lay down and he said his stomach was a bit upset. 911 was called while the patient was not responding. They arrived after he awakened. He was given oxygen and eventually placed on a gurney and taken to the ER.

Lungs filled up - CT scan looked like glass - similar to COVID19 patients Had multiple COVID 19 tests all negative o2 levels very low in hospital for 12 nights to stablezize

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

Patient developed shortness of breath, fever, chills and was diagnosed COVID positive on July 3, 2021. Patient was admitted to hospital and received tocilizumab and remdesivir. He received dexamethasone however this caused him hallucinations. He initially required oxygen however he was weaned off to roomair. He did receive antibiotics for possible pneumonia which he has now completed. Patient also takes Coumadin for atrial fibrillation. On 7/12, he transitioned another Hospital for swing bed for reconditioning. He was ultimately discharged to home to his nursing facility on 7/17.

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

Felt like his throat was closing. He was given 25mg benadryl and then developed dizziness, heart racing, chest pain, shortness of breath, jaw pain. Was in SVT on arrival to ED

After getting the second vaccine on the 5th of March at 7 PM, he couldn't breath that night during the night, so had to get out of bed to sit up and short of breath a good portion of Saturday.... also unable to control bowels which is unusual for him and pooped in his pants which was awful for him. He felt dizzy and tired all Saturday and Sunday. Doing better as of Monday the 8th. He had no adverse affects from the first dose.

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

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

92 y.o. male patient with past medical history of Factor V with history of pulmonary embolism who presented with shortness of breath and cough. He was vaccinated for COVID-19 with his first shot on 2/3 followed by 2/27 with the Pfizer vaccine. He reported his symptoms started on 4/3. Family members including wife (also vaccinated) all had similar symptoms, they had all tested positive for COVID-19 on 4/6. He reports having diarrhea, nausea, shortness of breath and cough. No chest pain. Work up in the ED revealed a WBC of 16.1 and infiltrates on CXR. Patient is admitted to hospital starting 4/9/21 and currently still here as of today 4/30/21.

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

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

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

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

Client reports he received 1st dose of COVID-19 vaccination early January, 2021, shortly after became SOB, continued for 3 weeks, worsening in the last week with increased weakness and lethargy, and received 2nd dose on 2/2/2021, and was seen by his PCP, PA Cerner on 2/3/21, sent to to the ED of Hospital was admitted for 2 days

Prt received 2nd dose of Covid 2/4 and 2/5 was found to have significant short of breath with RR 40, temp 103 and 02 sat 80%. prt was sent to hospital where he was tested positive for Covid and started treatment with Decardron and Remedesivir and on BIPAP mask to help with breathing and prt response to the treatment and able to discahrged after 3 days hospitalization He was hospitalized from 2/5-2/08 and discharged

Patient received his second dose of the Pfizer vaccine. He was accompanied by his daughter. Per daughter prior to receiving his vaccine he was his "normal" self. He was sitting in a chair next to the vaccinator. He did walk in with a walker and minimal assistance from his daughter. He did have a gait belt on around his waist. When I came to patient he was looking straight ahead with his left eye open - right eye s/p surgery to his right eye per daughter. He did not respond to questions asked. His daughter stated mentally he is normally intact. His pulse was faint but palpable. His color was pale with slight dusky skin to hands. 911 was called. Undetectable blood pressure initially with his faint pulse. Initially his heart rate was 105. He was shallow breathing. BP was undetectable sitting - with oxygenation low 80's on room air. He was lifted to a bed/cart with legs elevated. He was given supplemental oxygen. After laying down with legs up he started to look around. He was able to tell me his name and respond to questions. His blood pressure was 117/68 with heart rate 55 and oxygenation on 6L nasal cannula 87-88%. Patient's daughter stated that patient was recently at hospital with low blood pressure and questionable seizure activity. No obvious seizure activity noted today. Parametics - updated with patient history and events. Blood sugar checked at 183. Patient neurologically improved with ability to state name, his daughters name and his age. No injury noted. Dr phoned and updated on patient condition and events. Patient transported without injury on oxygen. Two daughters with patient to emergency room. Pt being evaluated by cardio on admission for sycope/possible seizure. Still admitted

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

Disorientated; in a lot of pain in his chest and rib area; in a lot of pain in his chest and rib area; hurt to breathe and move; shaken up; Short of breath/It hurt to breathe; Concomitant medication:ongoing prednisone for immunotherapy; Concomitant medication:ongoing prednisone for immunotherapy; This is a spontaneous report from a contactable nurse. A 93-year-old male patient (reporter's father) received first does of BNT162B2 (Lot#: EN5318), via intramuscular on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included ongoing prostate cancer metastatic diagnosed a few years ago and immunotherapy. Concomitant medication included ongoing abiraterone acetate (ZYTIGA) at 1g, once a day for prostate cancer and ongoing prednisone at 5 mg, tablet, twice a day, by mouth for immunotherapy. The caller stated she is reporting a reaction her father had to Pfizer's COVID-19 vaccine. The patient experienced disorientated, in a lot of pain in his chest and rib area, hurt to breathe and move and short of breath/it hurt to breathe on 29Jan2021. The reporter seriousness for the events was medically significant. The events didn't require a visit to emergency room or physician office. The patient did go to urgent care. The caller explained her father became disoriented. He received the first vaccine on 28Jan2021. The next day, her father began to move his car around 12 pm and he became disoriented and stated he wasn't going to drive. Caller stated they were not aware of this disorientation until Friday, 29Jan2021. Her father was not sleeping and was up the night before because he was in a lot of pain in his chest and rib area. It hurt to breathe. He was short of breath. It hurt to move. Caller clarified further her woke up feeling so bad he thought he was going downhill. He thought his cancer got worse over night. He told the caller's brother after he became so disorientated that he was no longer going to drive because he was so shaken up. He was taken to urgent care on Friday, 29Jan2021. He was prescribed Naproxen, 500 mg Friday evening and he slept all night for the first night in years. He usually gets up in the middle of the night to use the bathroom. He woke up on Saturday morning, 30Jan2021, and he was feeling 100% better. He recovered completely. He was up moving around and in no pain. Caller verified she has no NDC, Lot number and expiry date for the Naproxen her father was prescribed. She didn't see any of that written on the discharge papers, that may be with the pharmacy. She wanted to put a chest x-ray was done. He has Metastatic Prostate Cancer and the pain was coming from the lesions on his lung and rib. Caller explained the Chest X-Ray showed the mets (metastasis) but no new lesions, no infiltrates or anything. It showed nothing related to the COVID-19 vaccine.The patient underwent lab tests and procedures which included Chest X-ray: showed the mets (metastasis) but no new lesions, no infiltrates or anything on 29Jan2021 and EKG: essentially normal on 29Jan2021. The outcome of the events disorientated, in a lot of pain in his chest and rib area, hurt to breathe, shaken up and move and short of breath/it hurt to breathe was recovered on 30Jan2021. The reporter's assessment for all the events was related.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to all events disorientation, chest pain, musculoskeletal chest pain, movement disorder, shaking, and shortness of breath cannot be excluded. The ongoing prostate cancer metastatic status and immunotherapy may be major cofounders. 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.

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

Pt reported sudden onset of shortness of breath and general weakness. symptoms resolved in less than 5 minutes with no treatment. BP 126/74, HR 76 strong and regular, RR 16, Skin PWD. PT denied further treatment.

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

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

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

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

stated when he took the shot that he is breathing harder than he was before; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 19Jan2021 (age at vaccination 93-year-old) at 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hearing problem, hearing aid user, amyloidosis. The patient's past drug included Coumadin and Vyndamax. The patient's concomitant medications were not reported. On an unspecified date, the patient stated that he had a Pfizer shot on 19Jan and is due to get another on 09Feb. he is 93 years of age. He stated that he was diagnosed with amyloidosis and was using a Pfizer medication called Vyndamax to help him keep the protein off the major parts of his body. He took the shot that he was breathing harder than he was before. He wanted to know if this is possible and also stated that he had a hearing problem and hearing aids before the shot. Stated that he was diagnosed with amyloidosis and taking Coumadin and Vyndamax before the shot. The outcome of events was unknown. Reporter details: Stated that he was going for medicine many years ago but ended up in business. Follow-up (01Feb2021): New information received from a contactable consumer. Follow-up (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. Information on the lot/batch number has been requested.

fatigue; unable to get up on his own; heavy breathing; thick mucus; increased confusion; Weakness; severe muscle weakness; unable to sleep; aches and pains; arm was sore; This is a spontaneous report from a contactable consumer (patient's son). A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown) via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 (at the age of 93-year-old) as 1st dose, single dose for COVID-19 immunization in hospital. Medical history included muscle relaxant, blood pressure or cholesterol and broken neck from 1978 to an unknown date and unknown if ongoing. Concomitant medications included ongoing atorvastatin calcium 10mg taken once daily by mouth for blood pressure or cholesterol taking for a while, ongoing propafenone hydrochloride 150mg taken one twice daily by mouth, taking for a while, ongoing baclofen 10mg taken one five times daily by mouth as muscle relaxant taking for years, ongoing diltiazem HCL 180mg taken once daily by mouth, taking for long time, ongoing mirtazapine 30mg taken one at bedtime by mouth, taking for a while, ongoing citalopram HBR 20mg take once daily by mouth, taking for a while. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced unable to sleep, aches and pains, arm was sore, on 25Jan2021, experienced weakness, severe muscle weakness, on 26Jan2021, experienced increased confusion and on an unspecified date, experienced fatigue, unable to get up on his own, heavy breathing and thick mucus. But his father has tremendously decreased. Mentions his father was previously independent, using a walker, going to exercise class by himself and totally fine. Now after receiving the vaccine his father is unable to sleep, has aches and pains, was experiencing increased confusion and profound weakness. Adds his father can't get up on his own and has to be guided to use the walker if he can get up. They did call his HCP and were advised not to get the second dose and to make sure patient was eating and drinking. He was scheduled to receive the second dose on 14Feb2021 but he was unsure if he will get it. Adds his father had been water walking everyday and this wasn't like him. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

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

Admitted to hospital on 2/24/21 with shortness of breath, lower extremity edema, coagulopathy. Hx of CHF. COVID test negative

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

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

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

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

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

EM reported to emergency department on 3/29 with complaints of abdomianl pain, dirrhea, body aches , fatigue, weakness, hypoxia, headache and shortness of breath Admitted to Hospital 3/29 and discharged 4/1

Patient tested positive for COVID 19 on 5/21/2021, then admitted to Medical Center on 5/30/2021 with worsening dyspnea, cough and fevers. Remains admitted as of 6/8/2021. Had received Pfizer vaccination at the Vaccination Center Dose #1 in February 2021 Dose #2 on 3/17/2021

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

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

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

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

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

Patient was brought into the ER with weakness, confusion and decreased appetite for days after testing positive for COVID19 on 2/6. Patient's wife had a fall on 2/2, patient helped his wife and again had recurrent fall and finally took to hospital on 2/5 where she was tested positive for COVID 19 and passed away on 2/5. Patient received his first dose of COVID-19 vaccine on 1/29/2021. Patient's daughter was concerned about patient's confusion, breathing and decreased energy levels and recommended to come to hospital for evaluation. Daughter report that she noticed mild fever, cough and some diarrhea on 2/6 when she came to check on him after her mother tested positive on 2/5. She thinks he might have symptoms 1-2

This is a 98y.o. male with past medical history of s/p covid on 4/20/21 and treated with antibodies and received pfizer x2, dementia, aortic aneurysm, MI s/p AICD, a fib hypothyroidism, presents to ED via EMS. Patient is alert and oriented to person and place but not time. He does not know why he is at the hospital or who called 911 or why they called. Most of history was obtained from son. He states that this morning the facility noticed that he was more confused than usual and that he seemed short of breath. When they checked his vitals his blood pressure was low an his oxygen saturation was low. Per EMS report he was short of breath while walking to the common area and his fingers turned blue. EMS sheet 104/54 and spo2 94% on room air. Patient states that he has no complaints. He denies any shortness of breath currently, chest pain, abdominal pain, diarrhea, melena, hematochezia, palpitations. He does admit to some back pain when laying too long. Son stated that he is supposed to see his cardiologist Dr. for his defibrillator having "weird signals". Son states that he usually aspirates once a meal when asked if patient has been coughing at all.

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