Pfizer

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

Chest pain; shortness of breath and difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date (AFib, diagnosed around 10 years ago), pulmonary issues from an unknown date and unknown if ongoing (pulmonary issues started within the last year), bad heart from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced chest pain, shortness of breath and difficulty breathing on an unspecified date. The patient further reported that she has a lot of the symptoms that she lives with daily, she has a bad heart, has A Fib, has a pulmonary doctor and she discussed this with her doctor and they told her to go ahead and get the vaccination, so she went ahead with the vaccine, about 3-4 days later, got these chest pains, she has not had any chest pains connected to her Afib before, she also had shortness of breath and difficulty breathing 3-4 days after the vaccination, when she sat down and waited for this to pass, when it did pass, does not know if it was 5 min or 10 minutes, when that went away she felt very good. The patient also reported that she has not had any more chest pains since the first episode, she is still struggling with the difficulty breathing but unsure if this is just her body and prior conditions or due to the vaccine. Does not know what it was, thought maybe she had a heart attack, wants to know if she should go ahead and get the second vaccine. Does not want to get any of the side effects worse than what she had, states someone told her the second one hits you harder and wants to know if this is true. The patient did not recover from shortness of breath and difficulty breathing while the outcome of the rest of the events was unknown. Information on the batch number/lot number has been requested

According to medical report, Pt presented to the ED on 1/14/21 w/ cc of SOB for 1 day. She received her COVID-19 vaccine on 1/9/21. Pt stated that she developed a dry hacking cough 2 days prior to the vaccine on 1/7/21. Over the last few days prior to admission, she developed generalized weakness, SOB, loss of sense of taste and smell w/ associated decreased appetite and nausea ultimately SOB in the24 hours prior to admission. Final Diagnosis- acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Pt died on 2/3/21. See Medical report for more information.

trouble breathing/couldn't breathe without oxygen; possible COVID-19 pneumonia; possible COVID-19 pneumonia; wouldn't eat; incoherent; thrashing around with her legs, would not settle down/legs were thrashing around; persistent UTI; aspiration pneumonia; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for the mother. A 90-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech) (lot# EL3249), intramuscular in right upper arm, on 14Jan2021 between 12:00 PM to 12:30 PM , at single dose, for COVID-19 immunisation. She was monitored for an hour after vaccine. Medical history included penicillin allergy, ongoing vascular dementia, cardiac pacemaker insertion, congestive heart failure. There were no concomitant medications. The patient previously took ciprofloxacin and experienced drug hypersensitivity and rash (she took the prescribed dose and immediately broke out after, all over her body), codeine and experienced drug hypersensitivity, neomycin and experienced drug hypersensitivity, neosporine and experienced drug hypersensitivity. The patient experienced aspiration pneumonia in Jan2021 with outcome of unknown, wouldn't eat on 17Jan2021 with outcome of unknown, trouble breathing/couldn't breathe without oxygen on 21Jan2021 with outcome of unknown, incoherent on 15Jan2021 with outcome of unknown, thrashing around with her legs, would not settle down/legs were thrashing around on 15Jan2021 with outcome of unknown, persistent urinary tract infection (UTI) on an unspecified date in Jan2021 with outcome of unknown. The events were considered serious as caused patient's hospitalization. Clinical course: on 15Jan2021 night the patient started thrashing around with her legs, would not settle down, she was incoherent. On 17Jan2021, when she woke up, she was completely incoherent and would not eat. On 17Jan2021 she was taken to the emergency room (ER), and was diagnosed with aspiration pneumonia and persistent urinary tract infection (UTI). The patient was admitted on 17Jan2021 and she was treated. On 18Jan2021 patient got better, they put her on a bunch of antibiotics. On 19Jan2021 patient walked the halls, she wasn't incoherent. She was going to get PT/OT, speech therapy. The patient was discharged on 20Jan2021 and was taken to rehab type place (near the hospital), she was fine. However over the night she got worse. She became incoherent again and couldn't breathe without oxygen (21Jan2021). On 21Jan2021 the patient was sent back to ER due to trouble breathing. The reporter stated that something happened at nursing home and the patient went bonkers. She was admitted again (still ongoing) and put to intensive care unit (ICU) for treatment. The patient underwent lab tests and procedures which included cardiac function test: nothing wrong with heart in Jan2021, chest x-ray: concerning for possible Covid pneumonia on 17Jan2021 (transvenous pacemaker is present some peripheral, increased entity present Concerning for possible COVID pneumonia), CT scan: no evidence of pleural effusion or pneumothorax in Jan2021, COVID-19 virus test: negative in Jan2021 (2 times during the ER trips). Therapeutic measures were taken as a result of the events and included treatment with unspecified antibiotics.

2 days later pt developed shortness of breath. Went to ER. Had mobitz 2 heart block and required emergency pacemaker placement

pt stated that she had SOB, muscle aches, diarrhea, nauseated for about 2 days. Pt is now feeling better and has not contacted PCP.

C/o problem breathing. Pursing lips Hx of COPD CHF lungs sound tight. EMS Eval done. Had client in wheelchair told to remove mask. Inhaler at home. EMS encouraged client to go with them to hospital numerous times. Client and her husband refused. Client stated had a bad Experience at hospital last visit and refuse to go. Client assisted to bathrooms and had episode of SOB yet refused hospital. Client went home with husband against EMS advice.

Difficulty breathing; Low blood pressure; This is a spontaneous report from a contactable consumer (patient). This 90-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201) via an unspecified route of administration in the right arm on 25Feb2021 at single dose for COVID-19. Medical history included Known allergies: Sulfa drugs, Afib, Diabetes, Meniere disease. The patient had COVID prior vaccination. Concomitant medications included amlodipine, celecoxib (CELEB), metformin, pravastatin, warfarin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) in the left arm on 04Feb2021 12:00 PM for COVID-19. The patient experienced difficulty breathing, low blood pressure on 26Feb2021 02:30 AM. The patient was admitted to Hospital. Life support IV in neck to maintain blood pressure. Treatment including high flow oxygen, life support IV to maintain BP was received for events. AE resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient had no COVID tested post vaccination. Outcome of the events was unknown.

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

Shortness of breath, anxiety, BP 227/104 (pulse 69), O2 sat 98%. BP eventually went down (not listed in report).

Patient required hospitalization for COVID-19 Seen at an urgent care 2/24 for sore throat. Clinically dx'd w/strep and started on cefuroxime and prednisone Continued to decline with anorexia, dry cough , mild sore throat and weakness. Was taken to ED 2/27 and diagnosed with COVID pneumonia. Had mild hypoxemia requiring oxygen. She was admitted from 2/27-3/3. She was treated with 3 doses of IV dexamethasone and Remdesivir. Because of the length of time from second vaccination ID was consulted. They SARS-CoV-2 IgG testing. Pt was negative. Therefore the pt was treated with one unit of convalescent plasma on 3/1 for passive immunity. She was able to be weaned off oxygen on 3/1 and was discharged on 3/3 Additionally her SARS-CoV-2 nasal swab was sent to the health department for genetic sequencing

3/30/21 ER HPIHPI Patient is a 90 y.o. female who presents with with complaint of weakness and poor appetite. Patient also complained of cough productive of brownish sputum. Patient got her 1st Pfizer vaccine for coronavirus on the 18th of March (3/19) and tested positive on the 20 (3/21)March 2021. Patient was admitted to the hospital treated and discharged on the 26th of March. Patient has no fever or chills, no shortness of breath, no chest pain, no nausea vomiting, no headache or dizziness. Patient says she is weak in both legs and afraid of falling Admitted inpatient to Hospital 3/31 Dx: Pneumonia d/t Covid-19

Patient presented to the ED with CC of weakness. N/V, fever and SOB requiring oxygen. Mild left shift of total WBC, SARS-Cov-2 swab positive, CXR noted mild pulmonary vascular congestion and small bilateral pleural effusions. elevated troponins with no chest pain. diuresis was given and patient had improvement of symptoms of SOB. Patient was discharged to maintain isolation.

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

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

Tired. Slept for while after shot, then a few hrs later, Pressure in chest followed by a feeling that I must breathe deliberately for myself or I might not breathe automatically. Did deep breathing, watched and wondered when I should get help. Realized I could help myself and began using acupuncture and applied kinesiology points. After a time, breathing slowly retuned to normal. Very, very tired.Next 2 days, balance poor. Actually fell before I realized how woozy I was. Hit head on wall, but not knocked out. After balance recovered, still very tired after 10 days, but not as bad. Memory worse. Hoping all will improve.

Client was feeling al little bit anxious about vaccination symptoms and stating that she was having difficulty breathing. Pt. instructed on relaxation, breathing techniques. Pt. fully recovered.

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

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

Patient reports elevated blood glucose readings into the "200's," shortness of breath and fatigue within 24 hours of receiving the Pfizer COVID-19 vaccine.

Patient complained of dizziness during the 15 min observation period post-vaccination. Patient requested water which was provided. Patient complained she had difficulty swallowing and shortness of breath. Patient was sent to the onsite Emergency Department. Patient was place in bed in supine position. Symptoms resolved. No further treatment was provided.

This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021), via an unspecified route of administration on 21Jan2021, 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included oesophageal dilation procedure from 11Jan2021 to an unknown date and had trouble swallowing from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received the first dose of the vaccine on 21Jan2021 and everything was pretty good. Nothing bothered her until yesterday, Sunday morning. Her throat is not sore but swollen. She feels it is in her tonsils, like her tonsils are swollen. When she gets ready to swallow it is hard sometimes, she can swallow but it feels like something is in the back of her throat like her tonsils are swollen. She has had headaches off and on. She asked if these were normal symptoms after the vaccine. Reported her second COVID-19 Vaccine is scheduled for 11Feb2021 at 9:30AM. Reported she had 3 negative COVID-19 virus tests before. She said each time she had the COVID-19 virus test done was before a scheduled procedure. She said her last negative COVID-19 virus test was on 08Jan2021 before a procedure on 11Jan2021. She clarified she had trouble swallowing and had an esophageal dilation on 11Jan2021. She said she was put to sleep for the procedure. Clarified she has had an off and on headache, a sore throat that feels like her tonsils are swollen, and a pain that shoots through her ear occasionally. She said all her symptoms started late on Saturday (23Jan2021) or early Sunday (24Jan2021). Reported she took 1 Tylenol Extra Strength 500mg capsule yesterday evening (24Jan2021). She said she does not have the box with the UPC number for the Tylenol Extra Strength 500mg capsule, providing: Lot Number: PBA023, and Expiration Date: Dec2022. Reported she left her COVID-19 vaccine paperwork at her daughter's house. She said her daughter read some of the COVID-19 vaccine side effects over the phone to her, but sore throat wasn't one of the listed vaccine side effects. She said she was calling Pfizer to find out if a sore throat was a side effect of the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jan2021. More information available (Y/N): No. Therapeutic measures were taken as a result of throat is not sore but swollen, headaches off and on and pain that shoots through her ear occasionally. The outcome of the event "throat is not sore but swollen", "headaches off and on" and "pain that shoots through her ear occasionally" was not recovered while of the other events was unknown.

Resident was given the Pfizer vaccine on January 22, 2021, nausea and shortness of breath was taken to the Hospital on the 23rd of January and passed on the 24, 2021

COVID vaccination clinic received Pfizer vaccination at 1015, started with shortness of breath and a different feeling in her chest at 1022. Removed mask, inspected oral airway, no swelling noted. Individual talking and answering questions. BP 138/68, pulse 78, respiratory rate 20, oxygen sat 96% RA. Benadryl 25 mg orally administered 1025. Remained at bedside, granddaughter also at bedside. 1031 verbalizes feeling better. 1033 pulse 61, Pulse Ox on room air 98%. verbalizing wanting to leave, go home. 1045 left with granddaughter.

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

Within 15-minutes of vaccination, the patient reported SOB and felt that they were having difficulty taking deep enough breaths. EMS evaluated patient on-site. Patient was hypertensive (182/89) with a FSBG of 85 mg/dL. 12-lead EKG was unremarkable with sinus bradycardia without ectopy. ETCO2 values are within normal limits with square waveform. EMS transported patient to hospital. On arrival, patient noted her condition was probably due to anxiety and left without seeing a physician.

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

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

Pt received Pfizer vaccine x2 on 2/14/21 at 1/24/21. Pt found to be COVID + on 5/4. Pt admitted to the hospital on 5/3/21 d/t a fall which currently treating for UTI. Currently asxmatic COVID and not hypoxic.

Patient was confusing but it sounds like she developed an asthma exacerbation 3 days after Covid vaccine. Resolved with her normal inhalers and she may have used albuterol more often than usual. She cannot tell us how long it took for the symptoms to resolve. She dealt with the symptoms at home and told me about it 2 months later at a routine and unrelated office visit.

closing of the throat; This is a spontaneous report from a contactable consumer. A 91-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (at the age of 91-year-old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient has been tested for COVID-19. On an unspecified date after second dose, the patient experienced a sensation of the closing of the throat. The patient called 911 and EMTs came to assist. She declined going to the hospital and stayed with her daughter that night for observation. The symptoms subsided by the next day. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

1/27/2021 01:30 NURSE CALLED TO 3RD FLOOR UNIT BY CNA FOR EMERGENT SITUATION IN PROGRESS. FOUND RESIDENT BENT OVER FORWARD IN CHAIR AT BEDSIDE GASPING FOR AIR, RESIDENT STATES "HELP I CAN'T BREATHE, RESIDENT IS PALE IN COLOR AND STATES SHE IS WEAK IN STAMINA, VS 97.9 70 24 168/50 SPO2 87% ON RA, O2 APPLIED AT 2L NC, RESIDENT STATES SHE WANTS TO GO TO HOSPITAL, SHE STATES SHE IS AFRAID SHE IS GOING TO DIE. CALL PLACED TO EXCHANGE TO INFORM ON CALL MD, NP RETURNED CALL AND GAVE NEW ORDERS FOR STAT LABS, CXR, AND BREATHING TX, AND INCREASE O2 TO 6 LITERS, RESIDENT STATES NO I WANT TO GO TO THE HOSPITAL NOW, ON CALL N.P. INFORMED AND AGREES WITH RESIDENT TO SEND OUT. O2 SATS DECREASING WITH 6L TO HIGH 70'S LOW 80'S, AMBULANCE CALLED, POA NOTIFIED, ON CALL NURSE MANAGER NOTIFIED, REPORT CALLED TO HOSPITAL 1/27/2021 02:00 AMBULANCE ARRIVED AND RESIDENT PLACED ON NON REBREATHER MASK SHE IS SAYING I TOOK THE SECOND SHOT OF COVID-19 VACCINE AND SHE FEELS SHE IS HAVING A REACTION TO IT. TRANSPORTED TO AMBULANCE VIA GURNEY 1/27/2021 03:17 HOSPITAL CALLED FACILITY WITH UPDATE, RESIDENT IS POSITIVE FOR COVID-19, SHE IS BEING ADMITTED FOR RESPIRATORY DISTRESS AND WILL BE PLACED ON BIPAP OR INTUBATED IF NO IMPROVEMENT IN BREATHING. ON CALL MANAGER UPDATED, HOSPITAL CALLING POA TO UPDATE

Pfizer-BioNTech COVID-19 Vaccine EUA: One day after vaccination patient reported left arm and chest pain (over pacemaker), shortness of breath, and nausea resulting in poor oral intake. Initial vital signs in the emergency department within normal ranges except blood pressure 135/60 mmHg. No fever, cough, or dermatologic symptoms reported or noted. Only neurological symptom noted was lightheadedness. Patient administered aspirin, antibiotics, intravenous fluids, and acetaminophen and observed overnight. Pain improved with acetaminophen. Vitals were within normal ranges during observation period and symptoms resolved. Cardiology evaluated patient, determined pacemaker functioning appropriately, and patient discharged to home stable.

Pfizer-BioNTech COVID-19 Vaccine EUA Received dose #1 in drive thru vaccine clinic and reports shortness of breath, lightheadedness, left hand tingling post vaccination on right arm. Taken to ED for further assessment. Pt has COPD but patient feels these symptoms are different. After some time, daughter feels patient is back to baseline. ED visit on 2/12/21 (12:03p - 15:02p)

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

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient recieved vaccine and was helped to observation area. About 3-5 minutes after vaccination the patient told her son that she felt hot and then her head slumped forward. She became unresponsive to verbal/ physical stimulation. Patient vomited and would have fallen out of her chair if she had not been caught. She also made some noises from her throat that sounded concerning. EMS was immediatly called and epinephrine administration was attempted. Epi not given. Pt recovered and taken to ER.

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

RESIDENT COMPLAINED OF CHEST PRESSURE AND DIFFICULTY BREATHING ABOUT 1 HOUR AFTER VACCINE ADMINISTRATION. SENT TO HOSPITAL FOR EVALUATION. RETURNED HOME 2 HOURS LATER. SPOKE WITH RESIDENT AT 830am ON 1/7/21 AND SHE REPORTED SHE FELT FINE AND FELT SHE MAY HAVE HAD A PANIC ATTACK. SPOKE WITH RESIENT AT 830AM ON 1/8/21 AND SHE REPORTED SHE FEELS FINE.

Systemic: Generalized Body Aches -Medium, Systemic: Nausea-Medium, Systemic: Light-headedness and difficulty breathing-Medium

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild

Injection site became pink, 3X5 inches, the day following the shot. On 2.11.2021, about 55 hours after vaccination #2, pt developed generalized weakness, nausea, and then vomited. She was taken to bed, where she rested poorly and only dozed off for 1-2 minutes at a time and was mumbling words. She continued with generalized weakness, nausea with dry heaves, a sensation of marked shortness of breath, and inability to stand without support. Complained of feeling hot and then cold. Appeared pale and lethargic, skin clammy and complained of difficulty breathing and was irritable. Lung sounds -clear, no wheezing despite being unable to speak more than a few words at time. Vitals at 10:00pm: HR 62, pulse weak, O2 sat 92% (normal for her), temp 101.7F (her normal temp is 95-96). Given a Tylenol extra strength 500mg, 2.5 mg Prednisone, increased O2 nasal canula to 3-4 L/min, and cold compresses to reduce fever and discomfort. Vitals at 10:15p: HR 93, O2 sat 92%, BP 131/59. Discussed going to the ER, but decided to wait until the morning if not better. Symptoms continued until ~ 2am, when she was able to fall deep asleep for 4 hours. Awoke and felt better, able to walk, but still a bit weak and short of breath. By noon Feb 12 she felt mostly back to normal.

garbled speech; spasms; Mouth/lips twitching/twitching; arms rigid up toward face; lips blue; rapid breathing; deep sleep after; glazed look; not responding; bite tongue; This is a spontaneous report received from a contactable healthcare professional also reported as a nurse. A 93-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN5318) intramuscular, administered in Arm Left on 28Feb2021 at 14:30 as SINGLE DOSE for covid-19 immunisation Facility where the most recent COVID-19 vaccine was administered was a Home/Facility. Medical history included cerebrovascular accident 'CVA 8 months ago' from Jul2020 to an unknown date , atrial fibrillation from an unknown date and unknown if ongoing. The patient has no known allergies. Historical Vaccine included BNT162B2 Dose 1, Lot number EL9621, Administration date 07Feb2021 at 14:00, Intramuscular, in the Left arm for Covid-19 immunization. Concomitant medication included asa (ASA); levothyroxine (LEVOTHYROXINE);metoprolol (METOPROLOL); bupropion (BUPROPION); docusate sodium (COLACE); apixaban (ELIQUIS); iron (IRON); latanoprost (LATANOPROST); omeprazole (PROTONIX [OMEPRAZOLE]); timolol (TIMOLOL); paracetamol (TYLENOL). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 2021, The patient experienced spasms, mouth/lips twitching/twitching,arms rigid up toward face, lips blue, rapid breathing, deep sleep after, glazed look, not responding, bite tongue and on Mar2021 garbled speech. on Mar2021. The events Mouth/lips twitching,arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, garbled speech was considered Disabling/Incapacitating. Clinical course was reported as follows Mouth/lips twitching, arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, same repeated 4 hours later and then again 1 hour after that. next day garbled speech, not exhausted and stayed in bed 4 days. It was unknown if treatment was give for the events. The clinical outcome of the events was recovered with sequelae. .

She has COPD. She is a little more out of breath than usual. It is more pronounced late in the day. First day at 7 pm. I put her to bed because she was exhausted. Second day. Became worse at 10 pm. I think it?s at its worst when she has sat the longest.

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

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

breathing needs oxygen now; rash on legs; fever; This is a spontaneous report from a contactable consumer (patient). A 93-year-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269, expiration date not provided), via an unspecified route of administration in arm left on 08Feb2021 at 04:00 (age at vaccination 93-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient received facility type vaccine in the Hospital. The patient was not pregnant at the time of vaccination. The medical history included high blood pressure and she had an open-heart surgery. The patient had COVID prior to vaccination. The concomitant medication included amlodipine, pantoprazole, clopidogrel and atorvastatin. Patient did not receive other vaccine in four weeks of vaccination. The patient stated the other medications received in two weeks included amlodipine, pantoprazole, clopidogrel and atorvastatin. The COVID was not tested post vaccination. On 12Feb2021, patient's breathing needs oxygen now, rash on legs and fever. It was unknown if the patient received any treatment. The outcome of events was not recovered. The explicit consent was obtained as yes. Follow-up attempts completed. No further information expected.

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

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

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

The vaccine (#2 in series) was administered in the drive through clinic. During the 15 minute waiting period, the patient developed headache, then began to have chest pressure and shortness of breath. She was given depo medrol 80 and benadryl 50mg. She was further evaluated and found to have blood pressure of 200/100 and oxygen saturation was 80 % . She was transferred right away to ambulance and transported to ER. She was able to stand on her own to transfer to the gurney to be transported. We have not been able to have follow up as of yet; she is not a patient of Health Center so records have not come to me (nor can they be released to me) from the hospital. We are continuing to try to reach the patient or her family to follow up on this case. I will update this report as more information becomes available to me. * the Regional Covid-19 Vaccine Clinic is a collaborative effort of Health Center, the Health Dept, Regional Hospital, and Pharmacy. Vaccines are given to all qualified residents, so the patients coming through on a certain day may or may not be the patients of the physicians working that day.

Received first vaccination on Feb. 4, noted decreased activity approximately 3-4 days after receiving vaccination. As time went on begin to stay in the bed more and more. Complaint feeling tire and unable to walk short distance without getting out of breath. Decreased strength and increased fatigue. Feb. 25 received second vaccination approximated 3-4 days after receiving vaccine, became very unbalanced, and falling. became short of breath while without any activity. Went to physician on 03/04/2021 Hemoglobin 7.5 was hospitalized had to receive multiple blood transfusion.

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

Tested positive at hospital during outbreak on 4/27, hospital reporting cold-like symptoms until 05/06 when patient was noted to be hypoxic (70% O2 saturation on RA). Patient presented to ED with tachypnea and dyspnea. O2 saturations in ED were in the low 90% and patient did require oxygen supplementation after admission. Received dexamethasone, no remdesivir given time course. Has required HFNC up to 40L/80%. Currently weaning oxygen but still admitted.

Patient fully vaccinated 1/23/26. COVID-19 symptom onset 6/28/21, COVID-19 test positive at Maples Nursing Home 6/30/21, patient hospitalized for COVID-19 infection at Sturdy Memorial Hospital 7/1/21 and required oxygen support, Decadron, and Remdesivir therapy.

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

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

Resident received vaccination on January 15, 2021. She was found unresponsive with shallow respirations on the morning of January 16, 2021 and was sent to ER via ambulance. The resident was admitted to medical center ICU where she passed away later that day.

At approximately 12:15 pm the resident had a brief unresponsive episode that resolved quickly. Her Vital signs were stable and her mentation was at baseline. Later that evening approximately 10 pm she had labored respirations, shortness of breath, lethargy with bilateral crackles, Oxygen desaturated to 76% on room air, tachycardia and hypotension. She expired at 6:30 a.m. the following day.

After sitting in the observation area for 15 minutes she was ambulating to leave the clinic when suddenly noted feelings of air hunger and pressure on her chest. Said she just "felt funny". Was taken to triage room where her O2 levels, pulse, and BP were monitored. O2 level 98-99%, Pulse 65-69 bpm, BP around 160/60. After being allowed to remove her mask and have some water she stated she felt better. Was monitored for 15-20 more minutes during which time BP remained around 160/60. Eventually stated that feeling of air hunger and chest pressure had resolved and she was allowed to leave the facility . No other symptoms noted. Felt fine the rest of the day. No other symptoms noted the following day.

Coughing; Wheezing; Vomiting; Loss of appetite; This is a spontaneous report from a contactable consumer (daughter) reported for her mother that a 95-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left upper arm, on 20Jan2021 at single dose for covid-19 immunization. Medical history included atrial fibrillation in last 2 months in 2020 and ongoing; pacemaker inserted from 2020 to 2020, inserted about 2 months ago, also mentioned approximately Oct2020. She just had her second follow-up related to this day before getting first dose of Pfizer COVID-19 Vaccine. No notable results or information from that follow-up appointment. broken hip in Oct2020 and surgery for broken hip performed on 27Oct2020. The patient's concomitant medications were not reported. This daughter is the caregiver for her mother but is not a healthcare professional. She reported her mother was administered the first dose of Pfizer COVID-19 Vaccine on 20Jan2021. Starting 22Jan2021 around 08:45 she had onset of coughing; wheezing; vomiting; and loss of appetite. She wanted to know if these events could be related to the Pfizer COVID-19 Vaccine. Events outcome described as improved; the patient's nurse reported to daughter that they have subsided at this time. No adverse events required a visit to emergency room or physician office. No additional vaccines administered on same date of the Pfizer suspect. Patient did not have any vaccinations within four weeks prior to the first administration date of the suspect vaccine. Outcome of the events was recovering. Information on the lot/batch number has been requested.

Expired within 30days of vaccination. Received vaccine 1/22/21 did not have any complaints, during a bed check she was found on the floor with no apparent injury, no pulse or respirations.

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

can barely walk; upper respiratory problems; Sinus infection; has not been well/ bad shape/ can't be out of bed for 2 seconds with out having to get back into bed/ wasn't feeling good/ not feeling well; chills; fever as high as 104.5; nasal congestion; upper respiratory difficulty breathing/ can't breathe through her nose; non-productive cough; breathing rapid; Arm pain/ sore arm around the injection site; This is a spontaneous report from a contactable consumer (Caregiver/ Patient's daughter). A 95-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 14:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021. The patient was reported to have possible side effects that was getting worse. The patient had "chills, fever, nasal congestion, upper respiratory difficulty breathing, non-productive cough." On Monday evening, 29Mar2021, the patient was brought to the hospital but tests showed that "everything looked good" (chest x-ray etc.) Last night, the patient's temperature reached 104 F and was given paracetamol (TYLENOL). The patient mentioned that she was "breathing rapid," and that she "coughs when she takes a breath." Reporter asked if patient can be given an antihistamine; or something to help with the upper respiratory concern (nose blockage, upper respiratory breathing). The patient had not been well. They spent Monday evening and all night and in the morning at the hospital. They did X-rays and lab work and everything else. The doctors couldn't find anything wrong with her and stated that it's got to be the vaccine. She was really in bad shape at this point. She can't be out of bed for 2 seconds without having to get back into bed. She was having a upper respiratory thing going on. She had a fever as high as 104.5 last night. The fever was last night and she got paracetamol (TYLENOL) for that and brought it down. It did respond. The patient stated she can't breathe through her nose and she has upper respiratory problems. The problem was when they went to the hospital, they didn't find signs of infections, all normal across the board. The patient doesn't fake it, she was a feisty elderly lady. She walks up the hill every day. She was independent. Normally, she can walk and walks very well without any assistance. The patient now can barely walk. She can barely walk to the toilet without holding on to anything. She was constantly complaining about chills. Reporter wanted to know what can they do and not do and what should the doctors be looking at. They kind of just threw up their hands as this was side effects of the vaccine, but the patient was alarming on Monday night and even more alarming right now. The patient was in bad shape. She wasn't feeling good on Saturday night, but not too bad on Friday night. Reporter asked her mom how she felt on Friday. Reporter told her mom to put in her hearing aids, that would probably help. Reporter further explained that patient had a sore arm around the injection site and that she might not have been feeling that great. On Saturday, she was not feeling well and started to have a fever, sinus infection and upper respiratory problems. The patient stated that she finally identified it. Reporter confirmed the fever, sinus infection, and upper respiratory problems started on 27Mar2021 towards the late afternoon she was progressively getting worse. Fever, sinus infection, chills, upper respiratory problems all have worsened. The reporter stated that her mother's (patient's) arm pain got better on Sunday and was now gone. On Saturday, her arm hurt from her shoulder to her elbow, it did get worse. However, a the next day it was gone pretty much. Monday in the emergency room, they did labs for her kidney, liver and were looking for infection. They did not find anything came up normal on everything. Today, the reporter thinks patient was worse. She doesn't want to come out of bed at all. She was laying there like a lump, whining and crying which she has never done. She was probably going to take her to the hospital again and they were not going to do anything again. She stated that something got to change, They haven't had that conversation about going to the hospital. She was going to go downhill if this continues, it had gone downhill at this point. Reporter confirmed that patient has recovered completely from the arm pain while outcome of remaining events was not recovered. Information about the lot/batch number has been requested.

Severe shortness of breath, administered inhaler, hydralazine with no improvement. Dr. notified. Sent to ER

Patient began to demonstrate a cough the evening of 1/5/2021, after receiving the COVID-19 vaccine earlier in the afternoon. A rapid COVID-19 test was performed and was positive. She began to demonstrate shortness of breath with exertion on 1/7/21, and lethargy on 1/12/21. Appetite and oral intake began to decline on 1/12/21, and Oxygen saturation dropped on 1/16/21 to 82%, and oxygen was initiated at 3L per nasal cannula. On 1/19/21 at 0414 patient was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.

Grandmother had trouble breathing the night she got the vaccine. She went to the hospital. They found pneumonia and a partial bowel obstruction. The obstruction cleared but she died from the pneumonia on 2/16/21.

Sudden dizziness while standing outdoors; extreme chills; heavy breathing difficulty; Nearly fell over; This is a spontaneous report was received from a contactable consumer (patient). A 96-years-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 27Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included allergies to medications, food, or other products maybe penicillin. Concomitant medications included lovastatin, thyroid patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 11:00AM, the patient had experienced sudden dizziness while standing outdoors 48 hours after vaccine injection, extreme chills, and heavy breathing difficulty. Nearly fell over but son caught her. Treatment received for the adverse event are unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

her mother's body was full blown with leukemia/she wasn't responding/leukemia was back; Second dose: breathing heavy; Second dose: screaming in agony and pain because her sides were blowing up in pain; Second dose: She had no red blood cells that could provide oxygen to her organs; Second dose: weak; Second dose: overproducing of her white blood cells; Second dose: wasn't acting like herself; Second dose: more tired; Second dose: she could hardly talk; Second dose: she couldn't stand up; Second dose: she lost control of her bowels; Second dose: hollow cough; This is a spontaneous report from a contactable consumer. A 96-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Leukaemia in 2018, High blood pressure with 40 years, Diabetes in 2016, Atrial fibrillation in 2018.The patient's concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Batch/lot number: EN6199) in left arm on 07Mar2021 for COVID-19 immunization. She had just had her blood drawn in Feb2021 and her blood was ok. So on 07Mar2021 she received her first Covid 19 vaccine. At 96 years old, after the Covid 19 vaccine, her mother's body was full blown with leukemia. Radiation wasn't an option to stop the overproducing of her white blood cells. The Covid 19 vaccine just accelerated it. Maybe there are others out there in this condition and should be double checking to see if they should get the Covid 19 vaccine. On the 12Apr2021 or 13Apr2021 her mother started having a hollow cough. She wasn't congested but she continued to cough. She noticed her mother was breathing heavy and fighting to breathe on Friday, on16Apr2021. It wasn't getting any better and she thought her mother would have more trouble so she took her to the emergency room. She reported she took her mother to the hospital on 16Apr2021.She was admitted on 16Apr2021 and discharged on 18Apr2021. They gave her some oxygen and did some tests. They asked her mother if she had chronic obstructive pulmonary disease and she did not, they suggested that it was her atrial fibrillation. She has had atrial fibrillation in the past, her doctor did leave her on her atrial fibrillation medication. She can't recall the name of the atrial fibrillation medication. She was discharged home on 18Apr2021 and she was breathing ok on her own. But by that next Tuesday, 20Apr2021, she noticed her mother was declining. She wasn't acting like herself. On Wednesday, 21Apr2021, she was more tired and her difficulty breathing started back up. On Thursday, 22Apr2021, she called the ambulance to take her mother to the hospital. She could tell that her mother wasn't herself, she could hardly talk on 22Apr2021 , she couldn't stand up, she lost control of her bowels. She wasn't responding to her. The caller knew something was going on. They put oxygen on her mother and they transferred her to a cancer specialist hospital. That's when the doctor realized it was a leukoblast. Clarified with caller, leukoblast. Then her mother died. She died on 28Apr2021.The caller knows the hospital was doing tests to see what was causing her mother's pain, but she doesn't have that information. She heard the screams from her mother and there was no consoling her mother. The hospital gave her mother morphine and it didn't work. She has no product information for the morphine, it was given in the hospital. She was screaming for murder, screaming for help and was given the morphine. Within a month of receiving the Covid 19 vaccine her leukemia was back and her mother was screaming in agony and pain because her sides were blowing up in pain. Whatever the Covid 19 vaccine did in her body, her body thought it was fighting off something. She had no red blood cells that could provide oxygen to her organs. She was weak. Overproducing of her white blood cells on an unspecified date. The lab data included White blood cell count abnormal and Red blood cell count decreased. Outcome of her mother's body was full blown with leukemia/she wasn't responding was fatal, of remaining events was unknown. Treatment received for all events. The seriousness of event breathing heavy and fighting to breathe were reported as hospitalization from 16Apr2021 to 18Apr2021. The seriousness criteria of she wasn't responding was reported as hospitalization from 22Apr2021 to 28Apr2021.; Reported Cause(s) of Death: Fatal Neoplasm progression

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

On way to car patient complained to daughter of dyspnea, had to sit down No chest tightness, wheezing, or cough No nausea, lightheadedness, diaphoresis Daughter notes patient had episode of left chest pain yesterday that resolved within 15-30min No h/o asthma, lung disease, MI No code blue called or epinephrine administered before contacting this MD for evaluation

within 24 hours after her second injection she developed chills, had a syncopal episode and had, difficulty breathing. this progressed over the next day when she had a second syncopal episode and her dyspnea and confusion worsened EMT was called and she was brought to the hospital. she was in flash pulmonary edema and with her history of severe aortic stenosis she was admitted to the cardiac icu. she had no prior history up to that time of pulmonary edema and was functioning without distress in her home. she had a history of covid in early april, manifesting primarily as severe confusion, from which she recovered.

Chills, weakness, cough, runny nose, trouble breathing. Saturday the 27 is when it started, she woke with all these symptoms, she needed assistance with everything she normally does by herself ex: taking shower, getting dressed. Everyday after she got 10% better and as of this notice she still isn?t back 100%.. She better than she was but suffering from the effects. She?s not going to get second shot because she says it will kill her. I want her to get it but if the 2nd shot is worse than first I can?t in good conscience let her get it.

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

She has not been feeling herself; Wheezing; Mild tachycardia; Oxygen saturation drop; This is a spontaneous report from a contactable nurse (patient's son) via Pfizer sponsored program. A 97-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 97 years of age), via an unspecified route of administration, administered in arm right on 18Mar2021 10:45 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included compression fracture (fell in the driveway) from Apr2010 to an unknown date, ongoing hypertension for a long time sine 1980s and has gotten less with age; diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient has no known drug allergies and no known food allergies. Family history included cardiovascular, cholesterol, blood pressure, but nothing relevant to her situation. She was never a cigarette smoker and she had no history of smoking. Concomitant medication included atenolol taken for blood pressure from an unspecified start date and ongoing. The patient previously took atenolol for hypertension and experienced dizzy and sometimes her pulse will get a little on the higher side. She had no history of previous immunization with the Pfizer vaccine considered as suspect. She had no prior vaccinations within four weeks prior to the first administration date of the covid vaccine. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any recent vaccines for any other conditions prior to the event/s being reported. Patient received the first dose of the Pfizer COVID-19 vaccine 18Mar2021 and has yet to get the second dose. The patient experienced wheezing in the morning, mild tachycardia and Oxygen saturation drop on 15Apr2021. The patient got her first dose in Mar2021 and since then she had not been feeling herself so they waited on getting her second dose. The reporter asked if the patient can get her second dose or does she have to start all over. The patient is in a hospice, and she was at home; she can get out of the house rarely. The first dose was on 18Mar2021 and she tolerated it well. It was mentioned that she was kept in a tight bubble and anyone that comes into contact with her has to get the shot. She did about a month after her first dose experience wheezing. She never had wheezing before and she had to have oxygen, which she never had to use before. He said they had to do intermittent oxygen. She was doing ok now, and he was not sure if a month after the first dose was some kind of a reaction. The patient's first dose was on 18Mar2021 and has yet to get the second dose. He said a little less than a month later she had wheezing and that she never had wheezing and he never heard her wheezing. He said it was almost four weeks after the date of her vaccination. He said they put her on oxygen at home because her O2 saturation dropped. She was in the high 80's and she was usually in the high 90's. He said in mid Apr2021 she was in the 80's. He said the oxygen was intermittent now and they use 1L. He said he wanted to make sure her oxygen saturation stays good and that it was not life threatening. He said given her age she was dropping O2 saturations in the 80's and she was never in the 80's. She did not have her second dose and it was due 08Apr2021. He said she was doing ok, no wheezing at the time. He said with her age and hospice, he heard things on TV that there were lots of problems with the second dose any of the vaccines so they watch close. He said any contact with her is vaccinated and she stays in a tight bubble at home. He says they are being very conservative. He says she got the vaccine around 10:45am. It was mentioned that the patient was experiencing mild tachycardia. She was in the 90's or low 100's but was not sure if it was related to the wheezing or if it was the dose. He said he noticed it the first time on the same day he noticed the wheezing. He said that on 15Apr2021 her heart rate was 146 when checking oxygen saturation. He said that his mother's blood pressure was usually 115/75. He said her hypertension has gotten less with age. She has had no blood work done because of COVID or the pandemic. He says no pcp visits, only telemedicine visits. He said she has had no labs done in a long time but that they monitor every day and as long as she's eating, etc. Therapeutic measure was taken as a result of wheezing and Oxygen saturation drop wherein she was given intermittent oxygen 1L ordered by the hospice nurse. The caller says the used no inhaler or nebulizer because the oxygen brought her saturation up. He says they also gave her some cough medicine. He does not remember the name of the cough medicine. He says it was just some DM, dextromethorphan, from . The events did not result from Emergency Department, patient was not hospitalized, not admitted to an Intensive Care Unit. The patient was recovering from the events as she was getting better. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug 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 Committees, and Investigators, as appropriate.

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

Patient was admitted to medical facility on 7-12-21. She had fever, chills, nausea/vomiting, fatigue, shortness of breath, diarrhea, and light headed

Patient passed su hospital on 23Jan2021 stopped breathing; complained of not feeling well; had an inflamed gall bladder; This is a spontaneous report from a contactable consumer. A 98-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication reported as has received other medications (unspecified) within 2 weeks. The patient passed in hospital on 23Jan2021 with stopped breathing. Day after vaccine on 17Jan2021, the patient complained of not feeling well, went to hospital where was told she had an inflamed gall bladder. The events caused patient hospitalization for 4 days. The cause of death reported as stopped breathing. It was unknown if autopsy done. Prior to vaccination, the patient not diagnosed with COVID-19. The outcome of the event breathing arrested was fatal, outcome of the other events was unknown.; Reported Cause(s) of Death: Stopped breathing

Minor arm pain on 2nd day of each vaccine Diarrhea 3 days after 2nd vaccine Massive heart attack (left ventricle) 8 days (2/24/21) after vaccine Home hospice 3:30pm 2/24/21 Stopped breathing 5:45 am, pronounced dead at 8:22 am on 2/25/21

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

This 98 year old female was admitted from medical center this date to this facility due to dehydration and deconditioning. Pt has ribs 6 and 7 Fx on left side with pleural effusion.

Shortness of breath. Patient was speaking in full sentences. No other symptoms. Did not take blood pressure medication this morning. EMS arrived. Patient refused transport. Stated that BP usually runs 170s systolic. Advised to schedule appointment with PCP.

Vaccinated for Covid-19 on 1/29/2021 and 2/18/2021. Symptom onset on 6/10 with fatigue, dizziness, vomiting, abdominal pain, shortness of breath and eventually fever. Tested positive on 6/13/2021.

Patient was waiting for 15 minutes post-vaccine time in the vaccine clinic lobby and experienced shortness of breath. Patient chose to be evaluated at the facility's Emergency Department on the same site as the State's vaccine clinic. Shortness of breat stared about 15 mintues after receiving 2nd COVID vaccine today. Had shot in left deltoid. No allergic reaction the first time (with 1st vaccine in series). EKG and chest xray were completed as well as nebulizer treatment of albuterol. Patient relieved of symptoms and dismissed home.

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

Pfizer vaccine Difficulty breathing, delusions, hallucinations, combative, anger, sky rocketing blood pressure lack of motor control, weakness, inability to take care of herself, confusion to the extent of dementia. Non of these symptoms prior to vaccine

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

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

medical history most significant for hypertension, type 2 diabetes, hypothyroidism, pacemaker, who presents to the Emergency Department today due to shortness of breath that began approximately 2 days ago. The patient reports that the shortness of breath had a gradual onset and is getting worse. She normally wears 1.5 L of oxygen at night. However, she has been wearing it throughout the day. Upon EMS arrival, she was satting well. However, with any exertion, she dropped her sats for which they started her on non-rebreather. She also reports bilateral knee pain that has been chronic along with chronic back pain. She denies chest pain, abdominal pain or fevers. She is COVID vaccinated. She received her 2nd doe