Pfizer

Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21

stated she felt broke, clarified she was having all over joint pain that was very bad; no control of her kidneys/she has messed the bed up twice since yesterday; This is a spontaneous report from a contactable consumer, reporting for herself. A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing urinary incontinence (stated she has always had a little trouble). There were no concomitant medications. The patient got a shot yesterday, 14Jan2021, stated she felt broke, clarified she was having all over joint pain that was very bad, stated she has no control of kidneys, states she has always had a little trouble, but since yesterday it just wont stop, stated she has messed the bed up twice since yesterday. She was taking Tylenol for the pain and that was all she knows to do. She was encouraged to reach out to her HCP for any medical advice if she has concerns. The outcome of the events was not recovered. Information on the batch/lot number has been requested.

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.

Day After - severe headache, 2 days after headache continues, itchy scalp, day 3 rash visible at hair line headache continues, more confusion than normal, day 4 on site nurses check rash and think it is dermatitis, day 5 continues to get work nurse practitioner was to visit next day, day 6 NP thinks that she has UTI and sends her to hospital (2/11/21). Hospital determines - Rash is Shingles, UTI present, - MRSA is now present in shingles which is on right back of head and right neck and face. Next Sepsis is diagnosed. Since 2/11/21 patient was not conscious. 2/20/21 famiy is notified that she should be moved to Hospice. Moved to hospice on 2/20/21. The patient, my mother, died on 2/23/21 official cause of death is UTI.

Confusion that appeared to be a stroke but turned out to be swelling in the brain; caused memory loss/confusion, weakness of muscles, bladder retention issues treated with antibiotics/ 8 day stay in the hospital currently needs PT and OT to try to get back to her baseline

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

3/24 arm pain, 3/25 rt shoulder and back pain, Tylenol given, 3/25 body aches and tired, Tylenol given 3/25 visit with dr to discuss pain- urinalysis ordered, later Tylenol and biofreeze, temp of 101 noted. 3/26 urinalysis results returned- NNO---- later 3/26This nurse is called to resident's room. Resident noted to have emesis of all bile, pale and lethargic. Complaints of not feeling well. Temp: 102.0, tympanic. Call placed to MA help nurse to update. Await call back .3/30 to dr again, confusion and bp issuesMercy ER, admit to hospital dx of cholecystitis.

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.

She doesn't know what she weighs, it is going down so fast; She has a urine problem and urinates often; Don't have any appetite now/lost her appetite, even for water; Loose bowels; Voice is so dry/voice had also been affected; having a sleep problem, sleeping has been very bad; This is a spontaneous report from a contactable consumer (the patient). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199) via an unspecified route of administration on 10Mar2021 at age of 90-year-old at single dose for COVID-19 immunisation. Medical history included the patient had cancer about 10 years ago, it went away and then it came back. Caller reported that it started showing up on her mammogram again. Concomitant medication included anastrozole taken for neoplasm malignant from 10Jan2021. Caller reported side effects from the Pfizer COVID vaccine. Caller stated that she didn't know if it was the vaccine or because of the cancer she has, but she didn't have any appetite now (onset date 24Mar2021). She was eating all right and taking the cancer drug, but on 24Mar2021 (reported as "about 2 weeks after the Pfizer COVID vaccine on 10Mar2021"), she lost her appetite, even for water. Caller reported that she could go two days without eating anything. At the same time she was having loose bowels. She didn't know if the loose bowels was from the medicine she was taking or something else. Her voice had also been affected, it was so dry, she couldn't even talk. The caller also reported that that she didn't know what she weighs, it was going down so fast because she was not eating since an unspecified date. Caller not sure about weight. Caller stated that she was having a sleep problem, sleeping has been very bad. Everything started about 2 weeks after she got the first Pfizer COVID vaccine on the 10Mar2021. Caller was supposed to go back for her second Pfizer COVID vaccine on the 31Mar2021, but on the 24Mar2021 she started having trouble with eating and sleep and loose bowels. Since symptoms started after her Pfizer COVID vaccine dose on 10Mar2021, she decided not to go back on 31Mar2021 for the second dose. Caller reported that she ate 2 French fries since 07Apr2021 (yesterday), from a sandwich she ordered yesterday but didn't eat the sandwich. Caller clarified that she couldn't even eat the 2 French fries and hasn't had anything since then. For loose bowels: caller reported that she had a urine problem and urinates often since an unspecified date. Caller stated that when she went to urinate and when she barely presses down, she would have a bowel movement, but it was very watery and loose, not a formed bowel movement. She talked to her cancer doctor and her regular doctor who both told her to go to the hospital but she did not go. For dry voice: caller reported that she didn't know if it was acid coming up in her mouth or just dry mouth. Caller didn't know what it was, if she kept her mouth closed and didn't talk and didn't get any air, it was not as bad. Caller reported that trying to talk was bad and it had recently gotten a little worse. The patient wasn't having these symptoms before she took the vaccine. The outcome of "she doesn't know what she weighs, it is going down so fast" and "she has a urine problem and urinates often" was unknown, the outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

It started with swelling, redness, and heat at injection site pretty soon after the injection on Friday 5/21. By Sunday, 5/23, patient had instability when standing and walking; her dementia had gotten worse; there was edema in her whole right arm; and she started having tremors. She was brought to Hospital by ambulance that afternoon and has since had decreased appetite and thirst; continuing swelling at injection site and in her whole right arm; terrible tremors; very low oxygen levels; and is almost comatose. The doctors there have said her kidney function has dropped to unacceptable levels and they are also monitoring her heart. She has been put on hospice care as of this time, 5/26.

01/11/2021- Found lying on bed in apartment, incontinent, lethargic, unable to respond to questions, unable to do hand grasps. sent to hospital. 01/14/2021- remains in hospital- confusion and disorientation continues, poor verbal skills, limited ability to feed self, out of bed to sit in chair. uncertain of return to facility status.

kidneys weren't acting/kidney issues; not having the feeling to urinate; Light-headed; This is a spontaneous report from a contactable consumer (reported for herself). A 91-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3248; expiration date: not known), via an unspecified route of administration in the left arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and blood thinner. Concomitant medication included apixaban (ELIQUIS) for blood thinner. The patient is asking if there were any reports of adverse events with kidneys and the vaccine. She received the 1st shot last Thursday (07Jan2021) and told that yesterday (10Jan2021), she had an episode where kidneys weren't acting. She also mentioned that she is on a blood thinner, ELIQUIS. She is due to receive the 2nd shot on 28Jan2021. She said that she wouldn't want to receive the 2nd dose if this was related to her adverse reaction. The issue with the kidney started after on 10Jan2021, yesterday she was really having problems, she went to church then came home by that time she would have to go to the bathroom, but she did not go, she ended up cooking dinner which was 3 hours later, she was noticing that she was not urinating. She drank some Gatorade and that made it little better, she is wondering if it's a side effect. On 10Jan2021, when she noticed the kidney issues, she did not know for certain if it started before that, she didn't pay attention. Also, yesterday (10Jan2021), she got sick in which she had to grab the counter, she felt bad, she wasn't dizzy, but felt light-headed. The symptom of not having the feeling to urinate had improved a little today but she is concerned and wanted to know if this was a side effect. Her being light-headed only occurred on 10Jan2021, it was a onetime occurrence yesterday. However, she was also just sitting around, laying around, after that yesterday. The outcome of the event 'light-headed' was unknown; while outcome of other events was recovering.

Resident reported feeling unusual and fuzzy/Frequent Urination. Resident started antibiotic for Urinary Track Infection

patient presented to ED with weakness, altered mental status. Admitted to the hospital with urosepsis, acute on chronic kidney injury, elevated lactate and BNP

she couldn't urine/She couldn't urinate anymore; she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out; Always had burning on bottom of her foot/she felt like her body was burning up in side/Felt like she was burning alive; Had a fever every day and every night/Temperature was 100 degrees; she has an infection in her bladder; feel like I am dying/had a very strange feeling in her body/Something was going across the top and right side like a fluid was flowing or something strange; sweating/wet, perspiring all night./Got all wet with perspiration; gotten more sick; weak; tired; headache; lost a little weight; Eats very little now; afraid; pain was around the bottom of the foot now it's on top of the foot and goes up to knee; uncomfortable; sneezes; diarrhea; cramps; constipation; colon cancer; doesn't think the needle went in all of the way when the nurse administered her vaccine; shingles; Post herpetic neuralgia/the post-herpetic neuralgia was on her whole foot; pain at the bottom of my foot; impact on the nervous system; This is a spontaneous report from a contactable consumer (patient). This 91-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via an unspecified route of administration on 02Feb2021 at single dose in the left arm for COVID-19 immunization. The patient medical history included high blood pressure, kidney cancer, cancer in her bladder 20 years ago and coughing. The patient's concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), losartan potassium for blood pressure, metoprolol succinate for blood pressure, amlodipine for blood pressure, acetylsalicylic acid (ASPIRIN 81). Patient had cancer in her bladder 20 years ago. That was taken care of. Had kidney cancer because her husband used to smoke and blow it in her face. Had rare type of kidney cancer. It was removed. Treated for bladder cancer. Patient has had no problem ever since and that was more than 18 years ago. Patient had a fever, headache, and was very tired. Burning up on side of the body and she got all wet. This was not normal and she felt like she was dying. Patient stated she had shingles and developed post herpetic neuralgia. Patient always had pain at the bottom of her foot but it was getting worse after she received the first dose of Pfizer COVID-19 vaccine. Patient noticed the liquid going thru arm to chest and in straight line to her leg, like a science fiction movie with an injection of some kind. The doctor thought the vaccine might have an impact on the nervous system and spike the symptoms of post herpetic neuralgia. Patient spoke to her doctor but nobody knows anything. Nobody was willing to help her. Patient felt like she was dying. She didn't want to die. Patient feel the symptoms are getting worst. She was burning up inside. Her pain was around the bottom of the foot now it's on top of the foot and goes up to knee. Patient was not blaming anybody but she thought it was the vaccine. Patient was sweating, wet, perspiring all night. The symptoms usually occur at night. Patient wanted to know if these symptoms were associated with the vaccine. Patient also mentioned she developed a bladder infection for which she was taking antibiotics. Patient had Pfizer vaccine on 02Feb2021, about 5 days ago. Patient followed instructions before vaccine. Doctor said to take paracetamol (TYLENOL) before the vaccine for a headache. Patient did that. Patient had injection and told to wait for 15 minutes before she went home. About 5 minutes, she was relaxed and sitting down. Vaccination given in left arm. All of a sudden she had a very strange feeling in her body on 02Feb2021. Something was going across the top and right side like a fluid was flowing or something strange. Then it felt like a straight line down her right foot and it stopped. Was a feeling like maybe the liquid of the vaccine went that way. Didn't have a vein going that way. Patient was afraid. She went home and didn't remember the next thing that happened. Every night she has gotten more sick. Patient had a feeling in her foot where she had shingles a few years ago. After shingles had post-herpetic neuralgia. Patient always had burning on bottom of her foot and would put it in ice water. Patient could handle that because it was just uncomfortable. After injection, she got so bad, the post-herpetic neuralgia was on her whole foot and it started to burn. It went up a little towards the knee or higher. Yesterday, at times, it quickly went over to the left leg. Patient had a fever every day and every night. Patient took paracetamol to cut the fever. Patient was coughing on call but stated that was nothing and the coughing was something she had. Every night she felt like her body was burning up in side. Felt like she was burning alive. Got all wet with perspiration. She changed clothes and every night it got worse. Patient called emergency, they listened to her, stating they have never heard of anything like this. Asked patient if she wanted to go to emergency. She stated ok. The doctor listened to her story and told her it was weird. Doctor told her to give it a few more days to up to eight days. Doctor wanted her to get a urine test, but she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out and it was brown. Not normal urine. Next day patient called 911. She wanted to be assured she was not dying at home. Did have room available at the hospital. Patient had to sit in a wheelchair and there was no bed for her to lie down in. Last time she was admitted from the emergency. Next day she came home and had to call emergency again. Really thought she was burning up. Patient didn't want to go to the hospital and suffered at home. Next night and third night was so bad. Patient couldn't urinate anymore. She had a fever, but not a high fever, because the paracetamol cut the fever. Temperature was 100 degrees. On the inside she thought she was being burned up a live. Never got better, always got worse. Yesterday, she was in the hospital all day. Now she has an infection in her bladder. Was put on a machine and everything. Had a long procedure, and got the urine going. Patient didn't miss not urinating. Has accidents like when she sneezes or cough. Usually gets up 2-3 times at night to urinate. When she finally realized she couldn't urinate, the doctor kept her there for a long time, eight hours. Was put on the machine, thought she may need a catheter. Her bladder was massaged in order to get her to urinate. Patient only had the left kidney. Correct problem about the urine. Doctor told her to make sure she goes back for second dose on 23Feb2021, but she was afraid. In the morning she was a little better, couldn't handle this. Patient was very weak and tired. One night she was in the emergency and didn't sleep because of the procedures. Patient didn't think the needle went in all of the way when the nurse administered her vaccine. Sensation started on the left, went across her chest, straight down like an arrow. Like something was trickling down to the end of her foot and stopped. Patient had symptoms every night since. So severe patient thought she was burning up. Patient got worse every night and didn't get any better. Patient said feeling at COVID-19 Vaccine injection site was not a natural thing. Last time she was in the hospital her blood pressure went up to 184. After COVID-19 Vaccine patient lost a little weight. Same time had this problem, was seeing a doctor with a colon specialty. Had so much constipation for a long time and tried to correct it with mediation. Medication was too strong and gave her diarrhea. Doctor thought maybe she had colon cancer. Stopped the medication. Wasn't 100% healthy, but that was just cramps. Patient eats very little now, not very hungry. Patient feels good in her bowels after something good from a restaurant. Patient attempted to clarify the medication that was too strong. She stated it was over the counter. She stated it was something that had to be mixed. She was supposed to take a cap full and mix it with 8 ounces of liquid. Needed something to make her have a bowel movement. Only took it for two days. Was way before the vaccine. It was too strong and she stopped it. Patient took a probiotic. After that patient was given gas relief medication called: Gas Relief Extra Strength Simethicone, 125mg. Provided: V11496, MSRS 53041 REV 0417, and 883928. Patient no longer has constipation. Now it is the opposite. Now bowel movements are soft and pasty. Patient tried a stool softener that didn't work, was worthless. Was over the counter. Patient didn't take stool softeners after the COVID-19 Vaccine. All the events started from Feb2021. Outcome of the events was unknown.

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.

Altered mental status R77.8 - Elevated troponin N39.0, R31.9 - Urinary tract infection with hematuria, site unspecified D64.9 - Anemia, unspecified type R40.2431 - Glasgow coma scale total score 3-8, in the field (EMT or ambulance) (CMS/HCC)

gets confused and her personality changes; gets argumentative; burning urination/UTI; burning urination/UTI; diarrhea; chills; 99.7 degree Fever; shaking; feeling tired/Tired rest of day; This is a spontaneous report from a contactable consumer (Caregiver called in behalf of her mother in law (Patient)). A 91-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205, Expiration date was not reported), dose 1 via an un-specified route of administration, administered in Arm Right on 06Mar2021 13:00 (At the age of 91-years-old) as single for COVID-19 immunisation. The patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She has Congestive Heart failure and a lot of allergies. Diagnosed with allergies over the years. Not to any vaccine. Arthritis diagnosed 10 years ago. She is on medication for Cholesterol- Diagnosed for that is unknown. more than 4 years. On an unspecified date the patient fell and broke her hip last summer they had caretakers for her (She had the fall be-fore the vaccine. It was last summer, but it does not have anything to do with the vaccine. No further details provided.); Family medical history: none. The patient Concomitant medications included warfarin (2mg a day, It changes based on her INR. No further details) taken for Blood thinner (She has been on it for at least 4 years). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced during the night chills on 07Mar2021 03:00 She did not notice anymore chills, diarrhea on 11Mar2021 19:00, burning urination/UTI (Urinary Tract Infection) on 17Mar2021 08:00, feeling tired/Tired rest of day on 07Mar2021, During the night 99.7-degree fever on 07Mar2021 03:00, shaking on 07Mar2021 03:00. Reporter not sure if patient can get to her appointment for the 2nd dose on 27Mar2021. Patient was visibly shaking when she woke up at 3am and did not wake reporter up until 6am. she had 4 good days and then had diarrhea. She had another good day and then went into a UTI. She does not know if they had anything to do with it or not. she gets confused and her personality changes. With her UTI, patient gets confused and her personality changes. She gets argumentative. With her heart failure and age, it was good for her to have the vaccine. She has had congestive heart failure for years and is on blood thinners. She also takes 10 other medications. She takes blood pressure medications and vitamins. She did not think they were relevant. No further details provided. If she wants to reschedule, does she need to wait a certain number of days after she finishes the CIPRO. 17Mar2021, she asked for a specimen cup and took a urine sample to their office. The patient under-went lab tests and procedures which included body temperature was 99.7 degree on 07Mar2021 (03:00). Patient received treatment of tylenol for chills, 99.7-degree fever. Tylenol as part of her nor-mal regimen. On 18Mar2021, she knew that she had it (UTI) and she called the doctor and he gave her Cipro (ciprofloxacin) antibiotic (it was in a pharmacy vial. Unknown dose), which she has been on since 18Mar2021. She was tired the rest of the say day. She takes Tylenol as part of her normal regimen. No further details provided on the Tylenol. She did not notice anymore chills. There was not a prescriber. She had it at (Pharmacy name). It was reported that the patient was tired and wanted to reschedule her appointment for second shot. Patient will be on the CIPRO until 28Mar2021. Her next shot would have been 27Mar2021. Reporter wanted to know if the ciprofloxacin will have an effect on the vaccine. Asking if ciprofloxacin will have an interaction with the COVID 19 vaccine. Reported does not want the patient to go through with getting the shot if it will not be any good. Reporter stated that, Tired rest of day - Unable to confirm start time. She never recovered from fever and diarrhea (it was off and on until 15Mar2021) and was tired the rest of the day. She later stated fever and diarrhea were improved. The outcome of event shaking, she gets confused and her personality changes, She gets argumentative were unknown; outcome of rest of all events were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.

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

Patient presented to ED 2/6/21 with rash on abdomen/chest with pruritus for past 1 day. Denies nausea/vomiting, chest pain, dyspnea, dizziness, cough. Received COVID vaccine and also prescribed Bactrim on 2/4/21. Also presented with acute renal failure, hyponatremia. It is likely that all these events are due to Bactrim but we are reporting to VAERS given patient received vaccine at same time. Patient has been treated with hydration with normal saline, Solu-Medrol, Pepcid, and cetirizine, Calamine lotion, sodium chloride tablets. Symptoms of rash have improved and sodium is improving.

Resident had slight/slow decline in health prior to vaccine but continued to be able to walk around with walker at community. The day of the vaccine she had a fever. 2 days after vaccine resident did not get out of bed all day and refused to eat. She had small amounts of orange juice as her blood sugar level was low due to not eating. Resident was diagnosed with a UTI and began an oral antibiotic. 3 days after and on day 5 after vaccine resident began feeling weak and had a fall on each day. The following day again resident spent the day in bed. The next day she was quite restless, was on the edge of her bed attempting to self transfer often throughout the day. Resident continued to be restless on the 10th of Feb, had further decline on the 11th of Feb. Resident passed away early the AM of Feb. 12th.

2/21 patient presented for leg weakness. Patient had UTI on work up treated with antibiotics. Patient discharged 2/22. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

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.

Disoriented; Urinary tract infection; Shingles/rash; Complaining of pain and burning; Complaining of pain and burning; she was not feeling that well; lose her mental faculties; This is a spontaneous report from a contactable pharmacist. A 94-year-old female patient (reporter's mother) receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 07Jan2021 (around 3:15 PM to 3:20 PM) at 0.3 mL, single (0.3ml dose injection in right arm) for COVID-19 immunization. Medical history included blood pressure, cholesterol, blood thinner and fluid. The patient historical vaccine included varicella zoster vaccine live (ZOSTAVAX) for immunization. There was no history of all previous immunization with the Pfizer vaccine considered as suspect as this was the first dose. The patient had no prior Vaccinations within 4 weeks. Concomitant medications included ongoing apixaban (ELIQUIS) for blood thinner, ongoing furosemide (LASIX) for fluid, valsartan for blood pressure, ongoing pravastatin for cholesterol. The reporter was calling because her mother had the COVID-19 Vaccine on 07Jan2021, it was on a Thursday. By that Friday (08Jan2021) she was not feeling that well. Caller stated she did not know if what occurred had any correlation to the vaccine, but she wanted to report these details in case this started to be came a problem. Her mother is 94 years old and was in very good shape. However, now she was in the hospital completely disoriented. Since getting the vaccine she had subsequently broke out with shingles two days after getting the vaccine on 09Jan2021. Caller reiterated she was not saying this had anything to do with the vaccine, but she just wanted to reported these events. Caller initially stated it was unknown why patient was admitted to the hospital. She went on to explain her mother, the patient, was complaining of pain and burning. She started complaining of this pain and burning in the evening like around 5PM (on 08Jan2021 17:00). She later broke out into shingles. Caller mentioned patient has not had the SHINGRIX vaccine yet. However, she did have the older vaccine, ZOSTAVAX. Caller confirmed patient received the ZOSTAVAX years before. Patient went to the Emergency Room the first time on 09Jan2021 due to complaining of pain and burning and they could not find anything wrong with her. They checked her vitals and ran several tests and it all came back fine. They then sent her home. Patient went back to the Emergency Room on 10Jan2021 and completed another battery of test, labs, checked vitals, had chest x-ray, and cat scan at this time they could not diagnose with Shingles. On 11Jan2021, the patient had an appointment with her Primary Doctor and he did not find anything wrong. Patient came home with caller's sister and she was helping her get undressed. That was when the sister noticed a rash on the patient's body. The rash broke out on her body on Monday 11Jan2021. They tried to call the doctor that night, but did not get a response. On Tuesday 12Jan2021 they took the patient to urgent care and that was when she was formally diagnosed with Shingles. She was started on medication for the Shingles, Acyclovir, and sent home. They also thought she had a slight Urinary Tract Infection. She was started on CIPRO for the urinary tract infection. Patient was home for a couple of days in Jan2021 and she was not getting any better. She was then starting to lose her mental faculties. They thought this was from the urinary tract infection. Caller clarified the patient was then admitted to the hospital on 16Jan2021 due being disoriented. For causality assessment, it was mentioned that it is so coincidental this happened right after getting the vaccine. She was healthy and then it was like a snowball. The outcome of the events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

March 22 and March 23, 2021 belly pain, nausea, vomiting of digested blood (emesis appeared as coffee grounds), not able to keep ingested food down. Stool appeared normal as solid brown without red, black or tarryness. March 24 nausea/vomiting resolved but remaining anorexic. March 27 urine now appears darker (possibly due to dehydration). Patient remains anorexic so not eating well, minimal drinking, urine remains darkish. April 2 urine now with frank blood. Blood not rectal as patient has colostomy and not vaginal as patient Hx of hysterectomy. April 2-4 frank red blood. April 4 now urine burgundy. April 6 urine now cola-colored. Seen by physician. No UTI.

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

Unable to write as normal next day Mental decline and unable to care for herself Hospitalized 2 weeks later for dehydration Noticed reddened and painful R arm down to elbow Now back in hospital 5/18/21 with unresponsiveness, UTI and dehyration

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

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

Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should report

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

Emergency visit to Medical Center on 6/6/2021 at 1659. Reason for visit was fever. Active administrations include sodium chloride 0.9 % injection 2 mL EVERY 12 HOURS SCHEDULED, Intracatheter, first dose on 6/6/21 at 2100 and PRN flush of sodium chloride 0.9% to flush tubing. Inactive administrations include acetaminophen (TYLENOL) tablet 1,000 mg ONCE PRN, Oral, Fever, Starting Sun 6/6/21 at 1716, For 1 dose; Cefepime (MAXIPIME) 1,000 mg in sodium chloride 0.9 % 100 mL IVPB, 1,000 mg ONCE, Intravenous, Administer over 30 Minutes, Sun 6/6/21 at 1752, For 1 dose, * MINIBAG PLUS - Mixed before hanging; sodium chloride (NORMAL SALINE) 0.9 % bolus 1,000 mL ONCE, Intravenous, Administer over 15 Minutes, Sun 6/6/21 at 1718, For 1 dose, Administer for Sepsis Fluid Challenge.

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

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

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.

101 Y year old female with PMH significant for hypertension, CKD, hyperlipidemia, COVID + on 7/8/21 (reportedly got 2 doses of vaccine, though only have 1 documented in EMR) who presents with COVID pneumonia. ý Pt went to out of town for July 4th weekend. COVID + on 7/8/21. Housemate noticed pt seemed sicker upon returning with more fatigue, sleeping more, sinus congestion, intermittent cough. Denies any fevers, chills, chest pain, sob, abd pain, n/v/d, dysuria, loss of smell/taste. States that she got both her vaccine shots outside of clinic (Pfizer), but can't remember the date. Pt admitted on 7/10/21. Pt was found to be hypoxic and was treated with decadron. She was not a candidate for remdesivir due to low GFR. She was given lasix to alleviate leg swelling which improved. On date of discharge patient is afebrile and no longer requiring supplemental O2. She is to remain isolated until 7/20/2021