Pfizer

Patient noted to have a change in status at 11:23PM that night. Her oxygen saturation had dropped from normal on room air to 82% and required oxygen. She was also noted to be lethargic with altered mental status and not responding verbally. She then began to mottle. Her oxygen saturation worsened to 51% on 4Liters of oxygen by the next day and she expired on 1/14/21.

Family member reported that after receving first injection patient went home and a few hours later became lethargic to the point where she did not know she had an injection, could not answer questions and could not feed herself. Patient had extreme lethargy and did fall once. This lasted 24 hours.

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.

02/04/2021 2:15pm Felt Buzzed.. Energized ..Up lifted in Spirit 02/05/2021 2:00am Set up to go restroom.. slight Forehead Headache.. upon standing Dizzy unstable. Weak.. Used walk and furniture for support.. after seated on the toilet head pain increased.. Felt Nausea (did not Vomit)..headache passed.. returned to bedroom. This took 35 minutes 02/05/2021 2:35am seated on the bed.. felt Dry throat.. smelled Feverish ..Aches in Legs ..Right hand up to shoulder Stiffness(10minute duration).. 02/05/2021 3:00am felt fatigued.. feel asleep 02/05/2021 9:00am Awoke no issues.. 02/05/2021 10:30am Injection site left arm itchy.. no swelling .. no bruising.. tender to touch.. itchy sensation over full body

Having more severe stomach pain than normal. Interfering with ability to sleep at night. Visited urgent care this morning because of the pain.

The next day, patient was found down by children (lives alone.) Was confused, had had fecal incontinence many hours earlier (dried) . Neither syncope nor fecal incontinence had occurred before. Previously managed to walk w walker or holding on, do her own basic ADLs (toilet, use microwave, eat.) Now bed bound and requires 24 hour care, unable to stand even with assistance/PT. Mental state has returned to baseline. Spent a week in rehab but could barely comply w PT instructions due to pain/dizziness.

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.

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

The evening of the administration hands started to tingle, lasted about half hour. The next morning felt fine at noon the second day started with violent shaking chills which lasted one hour, at that time it slowly started to stop but felt icy cold with sweating. Took 2 tablets of advil 200mg at the beginning of shaking. After shaking slowed down could not talk, stand or hold up hands; she was drooling barely could swallow. She just wanted to lay down and sleep. This lasted about 30-45 minutes. Hands turned BLUE to her wrists lasting 15 minutes. Resolved without intervention. Very tired that evening. Slept for 12 hours. Back to normal the next day.

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

3/24 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.

Delusions; Hallucinations; Psychosis; Cognitively, she is very bad; Dysphagia; Aphasia; Extreme lethargy; Brain fog; Confusion; Slurring speech to the point where it was very slurred; This is a spontaneous report from a contactable consumer (patient's granddaughter). A 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, on 18Feb2021 at 10:50 AM, at a single dose, for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including type 2 diabetes diagnosed years ago), and obesity. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 24Jan2021 at 90 years of age for COVID-19 immunization. There was no prescriber for the vaccine. About a week ago (Mar2021), the patient started experiencing delusions and hallucinations. The patient was currently hospitalized. These came on quickly, no definitive diagnosis. Over the last 2 months (2021), the patient slowly started slurring speech to the point where it was very slurred. In 2021, they took her to the emergency room (ER) and they did a battery of test including computerized tomography (CT) scan, blood test, urine, and magnetic resonance imaging (MRI) of brain. They were thinking maybe she might have had a small stroke but did not find anything. On Sunday (14Mar2021; within the last 2 weeks), the patient also had brain fog, and a little confusion, but was still there. The patient had no cognitive issues of any sort. On Tuesday (16Mar2021), the patient called and said there were some men at her house. The patient had the police go over and they said there was no one there and she started to say other things that did not make sense. On Wednesday (17Mar2021) at 03:00, the patient's granddaughter got a call from EMS that the patient reported someone broke into her home, stole her TV, and raped her. This was not true. By Wednesday (17Mar2021), the patient was in full blown psychosis with hallucinations, and delusions. The patient was hospitalized on Wednesday (17Mar2021) and the delusions, psychosis and hallucinations began between Sunday to Wednesday (Mar2021). The patient's granddaughter believes it all occurred after the vaccine. It was around the same time frame. The patient's granddaughter would notice a word here and there where the patient was slurring. The patient's granddaughter did not know if the patient was being lazy or tired and it gradually progressed. The patient's current state is in a very bad spot - cognitively, she is very bad (started on an unspecified date). The patient now has aphasia and extreme lethargy from 18Mar2021, and dysphagia from 22Mar2021. This has all progressed since she has been in the hospital. The psychosis came out of nowhere. The patient was on a whole laundry list of medications and does not know if they were relevant to this. The patient had just recently started experiencing some extreme changes to herself to the point where she is hospitalized. The medical team is not finding anything wrong with the patient medically. The patient has developed some psychosis and there is nothing else that has happened that would have caused it. The patient had both doses of her COVID-19 vaccine. The patient's granddaughter was trying to research it to see if has been reported by anyone else. The patient's granddaughter considered the events as non-serious. The patient had not recovered from the events.

Stroke. ER treatment. Hospitalization. Skilled Nursing Facility. Symptoms: Weakness/fell to the floor/terrible bruises entire left side of body/slurred speech/confusion. Treatment: TPA administered. Hospitalized for 10 days, followed by continuing stay in skilled nursing facility.

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.

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.

Dehydrated; Lost her electrolytes; Her lips were cracked; Eczema; exhausted and she couldn't leave the bed; Hallucinating; Violent dreams; Strange aches in one of her arms and one ear; Strange aches in one of her arms and one ear; Has not had the same energy; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9261; Expiration Date: May2021) at the age of 90-years-old as single dose for covid-19 immunization. Medical history included allergies to Shellfish, penicillin, sulfa, mercury, and latex, the patient has been tested positive on 08Jan2021 for covid-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: EL9261; Expiration Date: May2021) on 26Jan2021 at the age of 90-years-old for covid-19 immunization and experienced exhausted, weak, so lethargic she could barely move, had chills, and she lost her sense of taste. For second dose: Most of these symptoms began on 16Feb2021 around 6:00 - 7:00 pm. The patient was exhausted and she couldn't leave the bed, started 16Feb2021, improved. The patient was hallucinating, started 16Feb2021, improved. The patient had chills, started 16Feb2021, improved. On an unknown date in Feb2021, the patient was dehydrated to the point to where her lips were cracked, the patient was so dehydrated and couldn't get enough water she drank so much water that she lost her electrolytes which was why she was hospitalized. The patient was hospitalized on 28Feb2021 and released on 01Mar2021, they gave her an IV for treatment. The patient had violent dreams, started 16Feb2021, improved. The patient had strange aches in one of her arms and one ear, started 16Feb2021, improved. The patient has not had the same energy since the shots on 16Feb2021, she's going to physical therapy for this. The patient had eczema, started 28Feb2021, ongoing. The outcome of the events eczema was not recovered, the outcome of the event dehydrated, lost her electrolytes and lips were cracked and 'has not had the same energy' was unknown, the outcome of the other events Hallucinating, Violent dreams, 'Strange aches in one of her arms and one ear', 'exhausted and she couldn't leave the bed' was recovering.

Pfizer-BioNTech Covid 19 Vaccine EUA Reaction: shooting pain in arm that was injected, tired and cold, unable to sleep on arm due to pain

Felt the pinch of the needle; She hasn't had anything happen, she has not felt different what so ever; This is a spontaneous report from a contactable consumer (patient herself). This 90-year-old healthy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0185), via an unspecified route of administration on 26May2021 10:00 (this past Wednesday) (age at vaccination: 90 years) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179) on 05May2021 for COVID-19 immunization. On 26May2021, the patient experienced felt the pinch of the needle, she hasn't had anything happen, she has not felt different whatsoever. She keeps waiting for the other shoe to drop. She wants to know if this has been reported before. Patient said that she got the shot Wednesday morning and now it is Friday morning and she has not had anything happen, she has not felt different what so ever and she wondered if this is normal because she has not felt anything, nothing at all. She said that was so complicated she just wants to know if this is normal. The outcome of the events was unknown. Follow up needed, further information has been requested.

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.

The first vaccine was administered on December 30, 2020 from a local pharmacy. She was diagnosed with COVID on January 3. She was in and out of ER for 3 days, when we finally took her home and got hospice care. On January 19, 2021 Dr's office told us that she could get the 2nd vaccine the next day. She received the 2nd vaccine on January 20, 2021 from a local pharmacy. On January 21 she became disoriented and was sleeping most of the time, by Friday, January 22, she could not walk and was incoherent most of the time. The evening of January 22, we presume she had a stroke, but was not officially diagnosed. Her oxygen level dropped to 42 and her blood pressure was 287/182 with seizures that lasted about 1 minute. She died on January 29, 2021.

7:00PM fatigued, burning up fever 100., ibuprofen/tylenol dose; Sunday afternoon nausea, loss control of body, anxious, feeling of fainting, unable to move-paralyzed, pressed button for medical help, ambulance arrived, pt transported to ER -- 102. temp ambulance, RN at hosp temp 98., pt was shaky, 8:30PM erratic heartbeat per admitting doctor - pt admitted. Pt PCP/Cardiologist contacted, kept on heart monitor, pt discharged Monday afternoon. 1/14/21 chest pain, nausea, 102. fever. symptoms

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.

Less than 30 minutes after receiving vaccine patient reported some itchiness on right arm as well as some light-headedness and an "odd" feeling on her right side only. Blood pressure was 126/68mmHg. Recommended water and some food if possible. Patient's symptoms resolved on their own after patient had lunch - did not report any new or worsening symptoms roughly an hour after vaccine administered. No medications were given to patient to treat symptoms.

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 with severe dementia developed nausea, dizziness and diaphoresis; acute distress. No chest pain or dyspnea noted. 3:49 P 56, 144/78, PO2 99% 3:54 P 34 164/58, O2 99% Exam CVS- irregular rhythm, systolic ejection murmur Care taken over by EMS and transported to Hospital

On 1/28/2021, 3 days after her injection my mom started feeling unwell. She felt dizzy, drowsy and had no energy (fatigued). This went on for 4 days (until 1/31/2021). She called a nurse at her facility morning of 1/31/2021, who told her it was most likely a side effect from the vaccine. My mom did not feel reassured and called the front desk at her facility. Eventually 911 was called, the paramedics came afternoon of 1/31/2021 and they told her her blood pressure was not quite right, and if she wanted to go to the hospital. She said no. She was less upset though. She still didn't feel "normal" until 2/2/2021. She is prone to panic and PTSD if things don't feel right.

tingling around the mouth area and lips; her mouth or lips were moving in a way that she had no control over/It was just a feeling she was having; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE)Lot # EL3247, via an unspecified route of administration on 19Jan2021 18:00 at single dose at left shoulder for covid-19 immunisation. Medical history included osteoporosis from Aug2020, rash on her legs from Aug2020, (lower leg below the knee, she was using a steroid but she had stopped as she was told not to use it too often by her doctor and just use Vaseline to keep the skin moist. She was asked if she had used any steroids but she hadn't used it in the past week and maybe only once in the previous week but couldn't be certain it wasn't in the last 10 days. She resisted the urge to use Mometasone 0.01 as it damaged the skin.); allergies to Sulfa a few years before. The patient reported her daughter who died at 41 years old of breast cancer. There were no concomitant medications. There was no additional vaccines administered on same date of BNT162B2 and no prior vaccinations within 4 weeks.The patient previously took brimonidine tartrate/timolol maleate (COMBIGAN) a few years before and experienced allergies, the eye drops didn't her any good at all and was told not to use it anymore. She previously received flu shot most every year and never had a problem. She stated that evening on 19Jan2021 she felt fine and then the next morning on 20Jan2021 she experienced tingling around the mouth area and lips. Almost as though her mouth or lips were moving in a way that she had no control over. She looked in the mirror and saw no evidence of it moving but could feel it moving. It was just a feeling she was having. The feeling was about the same. The first 2 days was on just the right side but she has had now had 2 occasions where it was on the left side. This was not constant, just occasionally during the day. She wanted to know if this was a known side effect and will it go away. She wanted to know if she should receive the second dose of the vaccine considering these side effects.The outcome of the events was not resolved.

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.

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

very acute confusion; marked confusion; never had it before; completely out of character; This is a spontaneous report from a contactable Nurse (patients daughter). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 05Feb2021 at 14:30 PM (at the age of 91-year-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), in Jan2021 for COVID-19 immunization and experienced minor soreness and nausea; the Flu vaccine and experienced aches, chills, fever, and once even had a red streak up and down the injection site arm. On 05Feb2021, immediately after received the second shot, the patient experienced very acute confusion; marked confusion, that lasted about an hour; she had never had it before; it was also reported that it was completely out of character. The nurse informed that her mother had never had marked confusion before and since it did pass, the nurse feels it's medically significant. It was reported that the patient was observed for 15 minutes and then got up and went back to her apartment. In that period of time when in there, no one noticed what happened in that few minutes. The nurse reported her mother's neighbor was who called her. The nurse was on the way to pick up her mother anyway because she knew there was always a chance of side effects with older people. The nurse had just driven up within that 15 minutes when the neighbor called stating the patient was confused. This was completely out of character for her. When she picked up her mother she took her to the emergency room which is maybe 20 minutes away and didn't have the petal to the metal. On the way to emergency room could see her mother starting to clear up. She had her down in the car in about 10 minutes, 20 minutes driving to emergency room, so a total of 45 minutes to hour. They asked questions and within the hour her mother was okay, it was scary. The clinical outcome of very acute confusion and completely out of character was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the events "acute confusion; marked confusion, that lasted about an hour; she had never had it before; it was also reported that it was completely out of character" with BNT162b2 can not be completely exclucded. 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.

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.

Received vaccine at a different facility (CVS) on 2/10/2021 and presented to this facility ED 02/11/2021 from facility with confusion. CT negative, UTI present but present prior to visit. antibiotics for UTI, discharge back to facility.

Blood sugar has gone up/Blood sugar started increasing; Burning in chest; Had trouble keeping head up; Nauseous; Pain between shoulder blades; Pain at injection site; Did not feel good; Heartburn; Bones hurt worse than usual; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, Expiration Date: 31May2021) intramuscularly, administered in left arm on 12Feb2021 at 14:55 (at age of 91 years old) at a single dose for COVID-19 immunization. Medical history included type 2 diabetes (Diagnosed 15-16 years before this reporting), high blood pressure prior to that. She lost a lot of weight since she found out she was diabetic, which was prior to getting vaccine, around 15-16 years before this reporting. She lost 50 lbs in 15 years. It has been gradually. She gets Prolia shots and did not get one this month. She has scoliosis and osteoporosis and that was one of the things that happened. She had previously broken her shoulder blade and some ribs on her right side. She confirmed that she broke it over a year before this reporting. She has a yellow mark and a little reddish mark that looks like someone hit you. It is still there and it is a fading black and blue mark and does not hurt any more. She takes blood pressure medicine. She does not take diabetic medication. She did in the past, but it caused her ankles to swell and then she started controlling it with diet. She was right handed and had trouble trying to do things with her left hand. This started prior to the vaccine. Family medical history included: Family heart issues and diabetes. Heart disease and cancer in the family. There were no concomitant medications. The patient previously took Prolia for back problems. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261, Expiration Date: 31May2021) on 22Jan2021 at age of 91 years old at a single dose for COVID-19 immunization. She didn't have any problems after the first COVID-19 Vaccine. No additional Vaccines administered on same date of the Pfizer Suspect. The patient experienced blood sugar has gone up/blood sugar started increasing on 15Feb2021 at 08:00, pain at injection site on 12Feb2021 at 14:55, pain between shoulder blades on 12Feb2021 at 20:30 to 21:30, had trouble keeping head up on 13Feb2021 at 07:30, nauseous on 13Feb2021 at 07:30, burning in chest on 13Feb2021 at 08:30, did not feel good on 12Feb2021 at 08:30, heartburn on 12Feb2021 at 08:30, bones hurt worse than usual on 12Feb2021 at 07:30. She has stated her blood sugar has gone up since she's received the second dose of Pfizer's COVID vaccine on 12Feb2021. Blood sugar started increasing was reported as worsened. She was type 2 diabetic and does not take any medicine. She got second shot on 12Feb2021, and her sugar was 89, then she started not feeling good the day after. On 15Feb2021, she was checking it and it was 119. On 16Feb2021, it was 145. On 17Feb2021, it was 144, and 18Feb2021, it was 145. She had never had them this high. It does not mention it can do anything to your sugar. She does not know her height. Last she was measured was 4'6"-4'7". Her highest was 5 feet. This was prior to the vaccine. She said her weight was between 80-85 lbs. The second shot hurt when they gave it to her. About 6 hours later, it felt like she was hit by lightning between her shoulder blades. She had previously broken her shoulder blade and some ribs on her right side. That has been bothering her and it felt worse when she got the vaccine and she could hardly lift her head up. The pain went from her left shoulder blade to right shoulder blade and stopped right away and then it felt like a lightening thing. She had trouble keeping her head up. She still has trouble with shoulders and is putting heating pads on them. She felt nauseous off and on. Her bones usually hurt, but after the second injection they hurt worse. As long as she puts heat on them, it feels better. The second dose feel like it hit the bone. The first one did not feel that way. The outcome of the event "Blood sugar increased, Chest burning, Feeling abnormal, Heartburn, Bone pain" was not recovered, for events "Shoulder blade pain, Heaviness of head, Nauseous" was recovering, for event "Vaccination site pain" was unknown.

feeling tired; feel a little "whoo"; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 22Jan2021 08:00 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other vaccine on the same day of COVID-19 vaccine. On 22Jan2021, after vaccination patient experienced feeling tired and feel a little whoo. The events were considered as non-serious. The outcome of the events was recovering. information about lot/batch number has been requested.

She got the first Covid-19 vaccine yesterday and the nurse that had to put it in her, she felt it and it hurt.; really aching there in her left arm and shoulder high up; this morning and last night and didn't sleep good at all; couldn't even take off her pajama top; really aching there in her left arm and shoulder high up; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included history of atrial fibrillation real bad where her heart has leaky valves and takes a lot of medicines. The patient's concomitant medications included unspecified medications for atrial fibrillation which were considered as co suspects. Caller states she needs to know. She got the first Covid-19 vaccine yesterday (09Feb2021) and the nurse that had to put it in her, she felt it and it hurt. Her other friends said they couldn't tell they were getting a shot, but she did and it hurt. Where she went to get it was organized and wonderful and she got the shot about 12:00. Before it got to 6pm she was really aching there in her left arm and shoulder high up. Instead of a soreness she had pain. Had pain this morning and last night and didn't sleep good at all and couldn't even take off her pajama top. It was reported that she has history of atrial fibrillation real bad where her heart has leaky valves and takes a lot of medicines. She has some Tylenol in the house but does not know with her heart condition if it is alright to take the Tylenol for the pain or should she not take it. Has not taken any pain killers last night for fear of not knowing what it would do. The facility where she had the shot she was taken to since she does not drive and it was very well organized and all. Was very glad to get this vaccine and if people in the county can take it eventually it can be cured. Again, mentions having so many friends say they didn't have any problems and not to worry about getting the shot and she was filled with so much hope. The literature says you can have some joint pains and tiredness and her problem is wondering if she can take Tylenol to ease the pain. No further details provided. Outcome of the events was unknown. Information on the lot/batch number is requested.

she feels like she is another world and has to lay down frequently; she feels like she is another world and has to lay down frequently; She has been experiencing intermittent dizziness; she feels like everything is a blur; injection arm is "black and blue."; This is a spontaneous report from a contactable consumer (patient) reported that a 91-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 28Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She has been experiencing intermittent dizziness, she feels like everything is a blur, she feels like she is another world and has to lay down frequently, vaccination site bruising on an unspecified date. Her injection arm is "black and blue." She wants to know if this is normal after the vaccine, she states she is going to an eye doctor appointment tomorrow 20Mar2021. No PQC involved. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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.

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

adverse events: headache, general body ache, unable to sleep due to pain treatments: advil capsules, relaxation, lying down Outcome: all pain resolved after 24 hours.

Pt had mild dementia prior to vaccine. Was able to walk, toilet herself, feed herself,. After Vaccine pt became bedbound within 12 hours, markedly confused, and anorexic

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.

DX: Ileus Chief Complaint: Coffee-ground emesis, bowel obstruction Source of History: Patient History The patient is a 92 y.o. female with a past medical history notable for COPD, dementia, history of DVT, reflux, hypertension, hypothyroidism, recent small bowel obstruction. The patient presents for evaluation of Worsening issues of coffee-ground emesis once more. This is very similar patient's last hospitalization were patient required NG to and monitoring for blood loss. Patient continues to be confused and not a good source of history. Staff notes that patient started this 1 day prior at skilled care facility was sent into the ER. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient shows no signs of any pain or discomfort

feelings of unease developed about 22 hours post vaccine,, abour 2:30 pm, series of five vomits took place, ending around 6pm. One diarrhea event at around 3 pm. No fever, no appetite. Feeling weak, tired. Worry of dehydration. Given small sips of water with diluted lemon/lime soda every 10 minutes ore so for two hours at least beginning at 7:30 pm.

she had not been eating properly; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; On helping up she was confused but otherwise ok; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (Formulation: Solution for injection, Lot number: EK1768), via an unspecified route of administration, on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included t2diabetes, hypertension, arthritis, previous episodes of falling. The patient's concomitant medications included rampril, glimepiride, gabapentin, sitagliptin, atorvastatin, tolterodine l-tartrate (PREBLACON) all at unspecified doses. It was reported that on 16Jan2021 at around 6pm she was found lying on floor of her house - likely having been there for 3 hours. On helping up she was confused but otherwise ok (as reported). She remained ok for several hours before going to bed. Next morning found lying on the floor of the bathroom. It was reported that ambulance was called but did not go to hospital due to COVID risk and overcrowding. It was reported that blood sample was taken on an unknown date in 2021 and analysed. The doctor called and reported no abnormal findings in blood sample. Suggested possibility that she had not been eating properly. The outcome of the event she had not been eating properly was unknown, while for other events was recovering. The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Syncope cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

her mother didn't want anything to eat; her mother wasn't making any sense when she talked; Dizzy; Weakness; shaky; stomach became upset; her mother had a pretty severe headache come on; Nose bleeds; Blood pressure increased; her mother's comprehension is not at the same level as prior to being hospitalized; This is a spontaneous report from a contactable consumer. A 92-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 15Feb2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure high, high cholesterol. Caller stated her mother has had high blood pressure for around 15 years. She said her mother's blood pressure medicine has changed over the years, providing her current blood pressure medication as: Ramipril 2.5mg capsule, once a day, Bisoprolol 5mg tablet, once a day. Reported her mother has had high cholesterol for at least 30 years. She said her mother's cholesterol is controlled with Simvastatin 40 mg, once a day. She said her mother has been on Simvastatin for at least 10 years and her mother's Simvastatin dose has been bumped up gradually over that time. She said the Simvastatin 40mg is dispensed in a pharmacy bottle with no NDC, Lot, and expiration date. Concomitant medication included omeprazole (OMEPRAZOLE), simvastatin (SIMVASTATIN) for high cholesterol, ramipril (RAMIPRIL) for blood pressure high, bisoprolol (BISOPROLOL) for blood pressure high. The patient experienced nose bleeds on 18Feb2021 with outcome of recovered on 22Feb2021, her mother had a pretty severe headache come on on 18Feb2021 with outcome of not recovered, blood pressure increased on 18Feb2021 with outcome of recovering, dizzy on 20Feb2021 with outcome of unknown, weakness on 20Feb2021 with outcome of not recovered, shaky on 20Feb2021 with outcome of unknown, stomach became upset on 20Feb2020 with outcome unknown, her mother didn't want anything to eat on 21Feb2021 with outcome of unknown, her mother wasn't making any sense when she talked on 21Feb2021 with outcome of not recovered, her mother's comprehension is not at the same level as prior to being hospitalized on an unknown date with outcome unknown. The patient was hospitalized from 21Feb2021 to an unknown date. Reporting on her 92 years old mother who received her first Pfizer COVID-19 Vaccine dose last Monday, 15Feb2021. She said the first couple days her mother was fine after receiving the COVID-19 Vaccine. She said on Thursday, 18Feb2021, her mother had a pretty severe headache come on. She said her mother normally doesn't have headaches. She said her mother began having nose bleeds that started on Thursday (18Feb2021), and continued on Friday (19Feb2021), and Saturday (20Feb2021). She said her mother's blood pressure was up during that time, as well. She said on Saturday night (20Feb2021) at 9:00 PM she took her mother to the Emergency Room because her mother's blood pressure was very high. She said a CT scan of her mother's head was done and was negative for a stroke. She said her mother was kept in the Emergency Room and monitored. She said her mother's blood pressure was gotten under control with given blood pressure lowering medication in the Emergency Room and her mother was discharged home at around midnight. She said she does not know the name, dose, NDC, Lot, and Expiration Date for the blood pressure medication. Reported her mother takes Warfarin for blood clots. She clarified her mother is monitored monthly and her mother's Warfarin is adjusted accordingly. She said her mother takes a Warfarin 1mg tablet daily on Monday through Friday, and a 1/2 Warfarin 1mg tablet (0.5mg) on Saturday and Sunday. She said the Warfarin is dispensed in a pharmacy bottle with no NDC, Lot, and Expiration Date. She said her mother has been on Warfarin for around 20 years, since her mother had a blood clot. Reported her mother takes a stomach medication, clarified as Omeprazole 20mg capsule once a day. She said her mother has been on Omeprazole for years. She said the Omeprazole 20mg capsule was dispensed in a pharmacy bottle with no NDC, Lot and Expiration Date. She said her mother's stomach had been fine. She said her mother didn't get sick to her stomach, until the night she was released from the Emergency Room (20Feb2021). She said when her mother sat up and tried to stand while she was in the Emergency Room on Saturday night (20Feb2021), her mother was dizzy, and felt weak and shaky. She said her mother was given some orange juice and peanut butter crackers at the time. She said her mother's stomach became upset then. She said she thinks her mother's stomach upset had more to do with having the orange juice and peanut butter crackers than anything else. She said her mother has never had nose bleeds or headaches before. She said her mother has blood pressure issues that she takes blood pressure medicine for. She said she thinks the COVID-19 Vaccine may have exasperated her mother's issues. Reported on Sunday (21Feb2021), her mother didn't seem much better to her. She said her mother's blood pressure was up, her mother was dizzy, weak and had a bad headache. She said her mother has a healthy appetite for 92 years old and her mother didn't want anything to eat. She said she ended up calling 911 because her mother wasn't making any sense when she talked. She clarified her mother was picked up by the ambulance at 9:00PM on Sunday (21Feb2021); and admitted to the hospital. She said her mother is still in the hospital as of today, Tuesday, 23Feb2021. She said her mother had a CT scan, a MRI, and an EEG. She said the CT scan, and MRI were negative, and the EEG results were not back yet. She said her mother may be released home today, 23Feb2021, depending on the EEG results. Reported her mother has never had nose bleeds or headaches before. Reported on Sunday, 21Feb2021, she took her mother's blood pressure. She said her mother was very weak and incoherent. She said her mother was unable to comprehend the way she usually does. Reported her mother has had no more nose bleeds since yesterday 22Feb2021. She said her mother is still quite weak, but her blood pressure is now under control. She said her mother has been on a stroke watch while at the hospital, and her mother has not been allowed to get up out of bed as of last night (21Feb2021). She said the hospital staff are supposed to let her mother walk today (23Feb2021) to see if her mother's blood pressure stays stabilized. She said her mother's comprehension is not at the same level as prior to being hospitalized. She clarified her mother still drives a car at 92 years old and takes care of her own check book. She said she doesn't know if her mother will still be able to do that at this time. Reported her mother was checked for a UTI while at the hospital. She said the hospital went ahead and treated her mother for a UTI without knowing if her mother had a UTI. She said because her mother is elderly, a lot of times the elderly have UTIs. She said the hospital didn't want to waste time and went ahead and treated her mother for a UTI because her mother hadn't been on antibiotics recently. The caller stated she did not have any information on the medications her mother has been given while at the hospital. Reported at first she did not think her mother's symptoms had to do with her mother's first COVID-19 Vaccine dose, but then there was a new part to her mother's story that made her think her mother's symptoms had to do with the COVID-19 Vaccine. Caller stated she is apprehensive for her mother to go get her second COVID-19 Vaccine shot. The patient underwent lab tests and procedures which included blood pressure abnormal: up on 18Feb2021, Head CT: negative on Feb2021, Head CT: negative for stroke on 20Feb2021, EEG: unknown results on Feb2021, MRI brain: negative on Feb2021. Therapeutic measures were taken as a result of nose bleeds, blood pressure increased, dizzy, weakness, shaky.

No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m. Contacted Primary Care Physician in early a.m. and had office visit. Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw at Imaging Services. X-ray showed arthritis and began taking prescription.

No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m. Contacted Primary Care Physician, Dr. (Internal Medicine) in early a.m. and had office visit. Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw. X-ray showed arthritis and began taking prescription. On Wednesday, February 24, As day progresses, pain is now continuous. Thursday, February 25, Pain is throughout the day behind right ear/neck area. Late afternoon into evening, a small amount of rash has now developed on back area and side area of neck. Lymph node is swollen on right side back of neck. More pain behind ear. Pain is more severe late into evening. Trouble sleeping. Took Cefdinir as prescribed. Friday, February 26, contacted Dr. due to small amount of rash appearing on right side of face, right shoulder blade, behind neck, behind ear, and into hairline along with continued pain. Dr. diagnosed shingles over the phone. He prescribed medication for shingles and pain. Antibiotics were no longer taken. Shingles - Valacyclovir 1gm tablets. Pain - Aceteminophen/COD #3 as needed. Pain is more severe. Pain radiating into right ear. Can't sleep. From February 26 to March 5 shingles medication was taken daily. Additional rash developed. Pain was more severe/continued and trouble sleeping. From February 26 to March 4 pain medication was taken on Tuesday, March 2 and Thursday, March 4. One pill only to assist with sleeping. Monday, March 1, reported situation to Pfizer over the phone. Information on when to discontinue shingles & pain medication was obtained from Pfizer, and doctor prior to receiving second shot on Wednesday, March 10, at 9:30 same location as first shot. Shingles medication was finished on Friday, March 5. Pain medication was stopped on Friday, March 5 until after second shot. Pain medication resumed on Friday, March 12 and continues only as needed. Normally just one pill. As of Tuesday, March 23, rash, pain, swollen lymph node seems to be starting to improve.

Extreme joint pain for over three weeks. Knee joints, SI Joint, inner thighs, and even arms on certain days. Extreme fatigue. Mental fogginess.

TIA 3/16/2021 and moderate stroke on 3/18/2021 resulting in ischemic area left temporal and occipital lobe. Injury affecting speech, memory, and cognitive abilities. unable to live independently as prior to the event.

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.

My Mom went from being able to walk fine on her own to suddenly being confined to a wheelchair because she could not walk after the 2nd vaccine. She was lethargic, weak, sleepy & in excruciating nerve pain throughout her body. Her doctors office said to let her get plenty of rest, fluids, & to take Tylenol for pain. She had previously had only mild cognitive impairment, which seems to have become accelerated & she is much more confused. Because she was sleeping & not eating & drinking enough, she then became dehydrated. She was then admitted to the Emergency Room Hospital

Presented to ED on 1/12/21 slowly worsening constant myalgias, generalized weakness where she couldn't walk, dry cough. Per daughter not acting herself and more confused. Clinical impressions included hypoxia, COVID-19. Pt is s/p her first dose of vaccine and this precludes plasma. Supportive care steroids and doxy. Family faxed DNR on 1/12/21 at 2225. Remdesivir given 1/13/21 at 1am. 1/13/21 note at 1:30am: Pt's O2 sat fluctuating btw 80%-90%. Increased NC success pt O2 sat continues to decrease. NRB 15L in place O2 Sat 90%. Pt became pulseless and expired at 0451.

nervous; easily startled with any quick noise; she has awoken with a very bad startle in the night; depressed; Feeling jittery; woke up on 09Apr2021 around 7 AM, she was on some kind of a high; tiredness/body was tired; head felt a little different, fuzzy; couldn't sleep that well at night; headache; This is a spontaneous report from a contactable consumer reported for herself. A 93-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) via an unspecified route of administration in the left upper arm on 08Apr2021 14:00 at single dose for COVID-19 immunization. Medical history included ongoing acid reflux which was bad enough that she would upchuck in the morning, light stroke from 2019 that she did not need to go to rehab and made a complete recovery, ongoing thyroid problem diagnosed 10 years ago, low on vitamin D which was brought up to normal with a special medication and then she was advised to take vitamin D every day, ongoing chronic urinary tract infections hospitalized and with treatments. Concomitant medications included omeprazole from a couple of years ago and ongoing for acid reflux, levothyroxine ongoing from maybe 8 years ago for thyroid problem, vitamin D3 ongoing for low on vitamin D, sulfamethoxazole/trimethoprim (SMZ-TMP) ongoing from at least 12 years ago for chronic urinary tract infections as prophylaxis, atorvastatin ongoing for a light stroke, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing for a light stroke. The patient reported that she took SMZ-TMP for her chronic urinary tract infections as prophylaxis. Her physician had informed her that your body builds up immunity to the antibiotics and you can still get urinary tract infections. Caller reported that when she gets a urinary tract infection while taking the SMZ-TMP, she has to take something different and then switch back to it. The patient was recently on a different kind of antibiotic for a urinary tract infection, but she cannot remember the name. That evening the patient went to bed and stated "my head felt a little different, fuzzy, I couldn't sleep that well at night on 09Apr2021. I woke up the next morning and felt high as a kite." She stated this lasted all day and said, "my body was tired but I couldn't sleep and take my normal nap. I couldn't sleep at night, I woke with a jerk and a start." This happened 3 times that night. On 10Apr2021 she started to feel very depressed and she had a headache. A couple days ago, the depression lifted but then she felt jittery/nervous and easily startled with any quick noise. She stated that she remained easily startled and wanted to know what the vaccine was doing to her body that would cause this side effect? She reported she had been to her MD and they did not recommend anything. The patient been taking store brand Extra Strength Pain Reliever Acetaminophen 500 mg tablets for her headache. She had been taking 2 or 3 tablets per day. The patient stated she wasn't sure about getting the second dose of the vaccine with her side effects from the first. The patient had a very bad reaction to the 1st dose, that it's a week later and she's still not completely over her reaction. The patient reported that she got the Covid-19 vaccine, came home and felt fine during the evening on 08Apr2021. Right before she went to bed around 9 PM on 08Apr2021, her head didn't feel quite right and felt kind of fuzzy. The patient reported that everybody and all of her friends had been tired the next day following the Covid-19 vaccine so the caller thought that maybe the tiredness was starting. Details not provided for her friends that felt tired. The patient reported that she didn't sleep too well the night of 08Apr2021 but it wasn't anything outstanding. When she woke up on 09Apr2021 around 7 AM, she was on some kind of a high. She was flying high like a kite instead of being tired after sleeping poorly the night before. The flying high feeling went on and on. The patient reported that her schedule was to have lunch around noon, at 1 PM sit in her chair and read for a bit, and then take a nap. She never had any trouble and she was always ready for a nap. On 09Apr2021 she sat in her chair and was wide awake. She thought there was no way that she could go to sleep and she gave up taking a nap. The patient reported that she was flying high all day. She went to bed on 09Apr2021 and thought to herself that she was very tired and that she would surly get a good night's sleep. She did not sleep well, that her body was tired but her mind was fully alert and wide awake. She didn't get sleep at all, except that her body was so tired that the patient would doze off and wake up with a start. She didn't usually wake up with a start and a jerk. After she awoke with a start on the night of 09Apr2021, she thought that she had slept for an hour. She looked at the clock and she had only dozed off for 5 minutes. She laid in bed and tried to relax. Her body was tired but her mind was full speed ahead. She dozed off again on the night of 09Apr2021 and that the same thing happened, the patient dozed off for 5 minutes and then jerked awake. The patient reported that she had 3 episodes on the night of 09Apr2021 of falling asleep and then jerking awake. She finally fell asleep around 4 in the morning on 10Apr2021 until 6 AM when she was awake again. She woke up and realized that she had plunged into a very bad depression. This was very troublesome as she was a person with very good spirits that other people mention. She was in a deep depression and was just very concerned about that. The depression went on through the day and it just lasted and lasted. The depression finally seemed to get a little better but not right away. She thought it was almost 2 days that the depression lasted. Because of all of these side effects, it had bothered her mind so much that she can't really keep track of days and times so well. The last 2 days, when she felt like her spirits were coming up but not quite back up to the top yet, she got the jitters. She had just a very nervous feeling of jitters that as still kind of with her. The last 2 nights (13Apr2021 and 14Apr2021), she had awoken with a very bad startle in the night. Last night, 14Apr2021, she experienced a very bad startle again. She was not over the jitters because she never woke up with a jerk and startle and just frightened. She was very concerned and there was no way she can get the second dose of the Covid-19 vaccine. She hadn't even gotten past the depression yet into the jitters. She made an appointment with her doctor and that her doctor kind of blew it off in a way that they're really pushing for all of them to get the vaccination. The patient reported that she called Pfizer when she had the high and crash into depression. She going to cancel the appointment for her second dose of the Pfizer Covid-19 vaccine. The patient reported that she has never taken an illegal drug in her life, but she had heard stories of what a drug high felt like. She had heard details of what it felt like to get really high and then the crash and to have cravings for the drug. The patient reported that there as apparently some kind of medication in the Covid-19 vaccination that affected her like some kind of not very good drug. The patient reported that she didn't feel quite so nervous and jittery at time of call on 15Apr2021. The jitters were better but still occurring. The depressed feeling was still present a little, but it was a lot better than it was. She was not sure that her spirits were right up to the tip top as usual. The patient reported that given a little time, maybe in a day or two her spirits will be up at the top again. The patient reported that the jittery feeling caused her to startle at unexpected noises. She had been startled quickly and easily and having quite the startle reaction. That's not like her to startle so easily. The patient reported that the headache hadn't been extreme but it's been there. At the time of reporting she felt like her headache was a lot better than it was. She was pretty sure that she reported this AE to the first Pfizer agent that she spoke with. The patient had 2 heart tests done and that everything came back fine and that she was in good health. She was concerned that the vaccine may have affected her brain, heart, or organs. Before she got the Covid-19 vaccine, she was feeling so good. The patient inquired if she had this bad of a reaction maybe it's doing something to her inside organs that no one knows about, how would she know. Outcome of the event Feeling jittery was recovered on 11Apr2021, of the event depressed Was recovering, of the other events was unknown. No follow-up attempts are needed. No further information is expected.

The patient is having a hard time hearing me, she is hard of hearing in one ear; the pain was radiating in her ear and behind there; Rash/She still has the rash all over/ rash is behind ear, all down the back side of her neck, side of the neck up to hairline/right side of face/collar bone and little on back; swelling in the lymph nodes behind her right ear; trouble sleeping; sharp pain that would come and go behind her right ear/Ear pain was reported as worsened.; pretty big blotches; arthritis; shingles; This is a spontaneous report from a contactable consumer (patient's son). A 92-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm up at the top on 13Feb2021 at 10:00 or 10:15 (Lot Number: EN6200) (at age 92 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received shingles shot for immunization. The patient's son said that a week and a half after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, the patient developed shingles and severe pain. He wanted to know if his mother should still go ahead and receive the 2nd dose. If so, how long does she have to wait to receive it. He said his mother received the 1st dose on 13Feb2021, and was scheduled for the 2nd dose on 01Mar2021 or 10Mar2021. After the shot, a week and a half later (Feb2021), the patient got what the doctor thinks is shingles. The reporter and patient didn't know if she should get the second vaccine. The shot was not given by her doctor or at his office. The patient was healthy before and she's in quite a bit of pain, should she get the next shot because she's worried about it. The patient's second dose was scheduled already on 10Mar2021 but hasn't been able to get a hold of the place when calling them. The patient had the shot on 13Feb2021, on Monday 22Feb2021 the patient had sharp pain that would come and go behind her right ear. Patient stated she hates the pain. The patient had swelling in the lymph nodes behind her right ear a couple of days later. On 23Feb2021 the pain continued off and on behind the patient's right ear and she was having trouble sleeping. On 24Feb2021, the patient went to the doctor and he prescribed antibiotics because he wasn't sure that's what it was. There were no spots on the patient yet, the patient had more pain than before in the back, but she did not have a rash or swollen lymph nodes. The patient's lymph nodes were swollen in the back of her neck Thursday night (25Feb2021). The pain continued, it was more severe. The patient developed a rash on Thursday (25Feb2021). Friday the doctor prescribed the medicine for shingles. On 28Feb2021, the pain was radiating in her ear and behind there, you'll see her wince. The patient didn't get red blotches yet. Monday and Tuesday the pain was sharp, kind of sticks and then it was gone, it came and went, yesterday it was constant all day and Saturday it wasn't constant. Saturday the pain was constant. Thursday you could feel the knots in the lymph nodes, they have gone down some today. There is a little improvement in the patient's ear lymph node swelling. The patient has ear pain. The doctor looked in the patient's ear on Wednesday the 24th, the pain radiates, on the outside and the inside, it's just pain, shoots there and behind there. The pain has gotten worse over the week. The pain is intermittent, not constant and when it comes it's really sharp, she's had more over the weekend where its coming more often. The patient was having trouble sleeping starting Tuesday evening, it was fair but by Wednesday the trouble sleeping wasn't bad yet, the patient was still able to sleep, she has had to sleep sitting up, but by Wednesday, she hasn't been able to sleep well. The patient states that she has slept better now that she's on medication, last night was the first time she slept well. The shot was given in the left arm, all of this is on the right side. The patient has had no vaccines before, she wasn't sick before this. She still has the rash all over, the rash is behind the patient's ear, all down the back side of her neck, side of the neck, up into her hairline slightly, on the right side of her face, on her collar bone, and a little on her back. People say they got a bad case. No further clarification provided. Reports these are pretty big blotches (Feb2021). The rash was about the same, between Thursday, Friday and Saturday the patient developed more of them. With the rash, the reporter noticed more on Friday and Saturday. Today the rash is there but it has not changed. For her history, the reporter stated she's on normal medication, she didn't have anything before this. The patient is not in a nursing home, resides in her own home, not in a facility, she's is able bodied to stay at home. The patient is mentally alert, walks with a cane when needed, she does everything on her own. The patient's doctor sent her for x-rays behind her right ear and face, facial, shoulder, and behind the ear area, behind the neck area on 24Feb2021. The patient's doctor's office called and said it showed arthritis. The reporter states that this pain is not from the arthritis. The caller mentions that the patient got a shingles shot, it was a one-time shot, and she did not have a reaction to it. The patient was having a hard time hearing, she is hard of hearing in one ear. The patient was recovering from trouble sleeping and swelling in the lymph nodes behind her right ear; not recovered ear pain and rash; while unknown for the rest of the events.

Immediate fatigue that has persisted for months. I fall asleep all the time since getting the vaccine and feel unstable. This is a sudden change upon getting the second dose. Also this week pain in left arm and chest, severe pain in heart area but a strong pulse.. My body does not feel normal. I began to notice something was really wrong within two days of getting the second shot.

Resident with physical decline prior to vaccination. Noted with fever, t. 100.6 after 24 hours, and t. 99.2 in 48 hours post vaccine with increasing physical decline with confusion. Sent to hospital for evaluation.

ADVERSE REACTION REPORTED AS TEMPERATURE OF 100.0, CONFUSION, AND VERTIGO. PATIENT WAS TAKEN TO HOSPITAL, UNAWARE OF CURRENT STATUS, TREATMENTS, OR OUTCOME.

Symptoms: Headache, dizziness, feeling spaced out, and head fullness. BP elevated 152/75. Resolved on its own after 30 minutes from injection time.

Pt. reported feeling "different", dizzy, notified. BP 200/110, HR 78, SO2 98% Called PCP and pt was taken to ER.

Stroke within 48 hours of shot on 1/22/2021. L sided weakness, facial droop, slurred speech, confusion, . to this writing (2/4/2021), symptoms persist.

headache; pain in arm; Aches/pain; Pain injection site; feeling like her whole body is burning up, hot feeling; could not sleep all night/did not sleep last night; tired; feeling like she has a fever/felt warm and feverish/temperature it was 98; chills; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283) intramuscular injection in right upper arm, near her shoulder on 21Jan2021 10:00 AM at single dose for preventative. Medical history and concomitant medication were none. patient reported side effects to the pfizer vaccine after the first dose last Thursday 21Jan2021. Caller reported headache, chills, pain in arm and feeling like she has a fever. Caller stated pfizer should have two dose, one for small people and one for large people. Reporter asked what the timing of the second dose of Pfizer-BioNTech COVID-19 vaccine is and if she could receive it earlier or later than 3 weeks. Caller stated she received the first Pfizer dose on 21Jan2021 and her second dose is on 18Feb2021. She is calling about the Pfizer BioNtech Covid vaccine. She had the vaccine last Thursday on 21Jan2021. She started having the usual aches, headaches, and pain. On Saturday (23Jan2021) she started getting chills and by the evening she felt warm and feverish, when she checked her temperature it was 98. Last night, she felt like her body was burning up but her temperature was 98. She felt miserable and could not sleep all night. States she attributed it to the vaccine since she was feeling ok prior to the vaccine. She is asking if she should get the second dose. Weight: 95 to 98 pounds, she suggests that those that are smaller like her be given a smaller dose since she weighs so little. She is nervous about getting the second dose which is scheduled on 18Feb2021. She felt like she was burning up and it drained her. She keeps taking her temperature but she does not have a fever. She did not sleep last night. She feels better today. She is aching a bit today but not as much as she did. She is tired since she did not sleep last night. She still has the chills. States it is weird since she feels like she has a high temperature but does not have a high temperature or fever. She hears that there is usually not side effects with the first injection and usually there are side effects with the second injection. She did not feel the vaccine when it was administered. Her chills on Sunday was really bad and today it is better. The burning up/ hot feeling started gradually on Saturday and then on Sunday it got worse. She does not feel as hot and it has improved right now. it was also reported pain in injection site. Relevant Tests was none. no AEs following prior vaccinations. The last outcome of did not sleep last night and tired was unknown, of the events was recovering. It was a non-serious report. Event were not required a visit to Emergency Room nor Physician Office.

Patient developed unsteadiness two days after the vaccine, and became progressively delirious, then obtunded and was placed on comfort care thereafter.

In the 2-3 days before the date specified, patient was very tired and went to bed early. On the date specified she couldn't function and didn't get out of bed. She was so weak she didn't call back or answer the phone when the call dropped. She was confused and said she didn't feel right and didn't know what was wrong. No pain reported.

Exhaustion- continuing Chills-continuing Severe Mental Fog- some improvement Loss of taste- somewhat better Loss of Appetite- some improvement in the last few days Overly cold in general Generally debilitated - continuing

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.

Patient stated that she felt anxious and nervous, heart racing. Blood pressure initially 197/102, HR: 99, spo2: 98%, RR: 17, TEMP: 97.4 T, Skin color pink warm and dry. Patient awake alert and oriented x3. Heart rate and rhythm regular. B/L BS CTAwith good aeration. At 0956, BP 207/110, HR: 100. AT 1000, B/P 191/100. PCP's office contacted to notify, message left with nurse. Patient placed in supine position B/p : 210/90 at 1010, at that time, EMS activated, 1020: B/ P: 190/ 100, at 1039, B/ P 175/93. Patient stated that she felt better. Upon EMS arrival at B/P 154/94. Patient decided not to see medical attention and wished to go home with daughter.

sleeping for 20 hours for four days after vaccine, low grade fever, chills, intense pain in right hip and left leg -intensification of arthritis pain, inability to walk on own, swollen left ankle due to inflammation, glucosed level increased for 1 1/2 weeks levels 171 to 261, brain fog , unable to do puzzles (puzzles helps with dementia. Symptoms subsided after 2 weeks and 1 day; brain fog still subsiding, almost back to level before vaccination.

1/21/2021 First dose: 1/23/2021 adverse reaction: Headache, Chills, Pain in Arm, Feeling like a fever all night long but no fever, no sleep aches/pains, burning up, hot feeling, very tired, shuffling, 2/18/2021 Second Dose: 3/01/21 adverse reaction: As experienced and seen by daughter: Extreme fatigue, shuffling, some confusion and memory affected ( did not know how to use credit card- BEFORE shot never an issue with her shopping or paying her bills on her own) , difficulty with making a decision, slept more, tired when walking (used to walk an hour - could only do 20 min if that) NO dementia associated with my mother. Was able to function fully

WORSENING delirium in addition to her memory loss since being admitted to Hospital (APRIL 2021 and May 2021). Workup at the hospital was negative for infectious process, dehydration or stroke. She was discharged to geriatric psych facility for 1 week, with no improvement in symptoms. Family has seen symptoms of delirium prior to hospitalization, such as hallucinations and paranoia. Since these hospitalizations patient is experiencing further paranoia, refusing to eat or take medications provided by her sons, as she thinks they are "trying to poison me". Her first hospitalization was within 24hrs of first injection, the second hospitalization was within 24hrs of her second injection

PATIENT WAS OBSERVED SLOUCHING OVER IN HER CHAIR AND WHEN STAFF TRIED TO SPEAK TO HER SHE WAS UNRESPONSIVE BUT BREATHING, NONCOHEARANT. 02 WAS 83-90, PULSE 115, BP 93/53. EMS WAS CALLED AND SHE WAS TRANSPORTED TO THE ER IMMEDIATLY. ER PHYSICIAN WAS UNSURE IF THE MENTAL STATUS CHANGE WAS FROM VACCINE OR POSSIBLE UTI. ATTMEPTED TO OBTAIN A URINE SAMPLE AND STARTED EMPIRIC ANTIBIOTICS.

over about an hour increasingly achy, arm pain, fever, nausea, high blood pressure, lower lip numb (sometimes a sign of a TIA), some confusion (sometimes the sign of a TIA) The severe nausea came in waves, lasted a couple of hours and cleared by Midnight before she went to sleep.

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.

32 hours post vaccine 8 hours of severe body ache, unsteady walking, sleeplessness 2 aspirin taken 4 hours apart symptoms reduced significantly at 8 hour mark

elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm; is real tired and she even slept 14 hours last night; is real tired and she even slept 14 hours last night; This is a spontaneous report from a contactable Consumer (patient's husband). A 94-year-old female patient received the first dose bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249), via an unspecified route of administration (right arm) on 21Jan2021 at SINGLE DOSE (arm right) for covid-19 immunisation. Medical history included left shoulder pain (on medication for years) from an unspecified date, and elbow that she fell on two weeks before on Jan2021. Concomitant medication included hydrocodone for left shoulder pain. On 24Jan2021, the patient experienced real tired and she even slept 14 hours the night before. Reporter was wondering if tiredness is a side effect of the product. The patient also had an elbow that she fell on two weeks before on Jan2021, and three days after getting the vaccine (24Jan2021), that elbow started hurting more, and it was on the same arm as the side she got the injection on, the right arm. The reporter was unsure of the lot number reported as E13249 or EL3249 (unsure which lot number is his, and which is the one his wife received). The patient received no other vaccines on the same day as the COVID vaccine. Outcome of the event "elbow starting hurting more, and it was on the same arm as the side she got the injection on, the right arm" was not recovered. Outcome of events "is real tired and she even slept 14 hours last night" was unknown.

Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events.

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.

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.

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

disoriented a little; Has been terribly sick, almost continually; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; eye sight went; hearing was not good to begin with but now her hearing is much worse; hearing was not good to begin with but now her hearing is much worse; Of course, is kind of out of it and doesn't know exactly what to say even though knows what wants to say; has no energy; terribly congested; has cough that turns into a violent sneeze, a couple sneezes; has cough that turns into a violent sneeze, a couple sneezes; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; hurts so bad; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 (Lot Number: EW0151) as dose 2, single at the age of 94-years-old for covid-19 immunization. The patient medical history included: ongoing hearing was not good. There were no concomitant medications. The patient received the first dose of bnt162b2 (Lot Number: PN6208) on 10Mar2021 in left upper arm for covid-19 immunization. The patient will be 95 years old in just a few more days. The patient received the second dose on 08Apr2021. The patient was fine until about Dec2020. The patient had been terribly, terribly sick almost continually. The patient took half a pill Fenofibrate a day. The patient is going to be 95 years old very soon and the patient had always been very, very active. The patient was never sick. All of a sudden, the patient had shut down to almost nothing. The patient had no energy. The patient hurt so bad, whole body had been so sick and can do very little and had to rest. The patient hurts mostly in her back and her legs and had difficulty walking. This began a month ago, everything began a month ago. The patient's whole system is out of whack. The patient will have all kinds of time to get to the bottom of this. The patient was just at the primary care physician's office yesterday, 15Jul2021 and the physician was at the whit end. The patient was terribly congested, had cough that turned into a violent sneeze, a couple sneezes. The patient had a runny nose and all the symptoms of a bad cold but the patient didn't think she really had a cold. The patient clarified congestion and sneezing began a month ago. Patient stated everything occurring began a month ago. The patient's eye sight and hearing went at the same time, really bad. This began about a month ago. Everything all of a sudden happened over night. The patient felt great and was doing yard work and very, very active almost 95 year old. The patient is down to zero now. The patient stated her eye sight is worsening. The patient stated her hearing was not good to begin with but now her hearing is much worse. Of course the patient is kind of out of it and didn't know exactly what to say even though the patient knew what she wants to say. The patient is disoriented a little. The patient stated all of this began a month ago. The patient stated all of these symptoms did not come gradually, it was like overnight. The patient got up and everything was there at once, not one think after another. Everything was there when the patient got up, the patient was a different person. Outcome of the events eye sight went and hearing went was not recovered, of other events was unknown.

Delirium, confusion, anxiety, and depression Nausea, no appetite headache, body aches pale, flushed cheeks Low blood pressure

Hypertension, possibly associated with orthostasis and lack of sleep. At 11:45, patient reported dizziness when standing after receiving the vaccine. Manual BP of 160/100. Atypical pulse of 128 BPM. Patient was reseated and monitored, PCP was called.

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.

Dizziness and weakness resulting in a fall the evening of the vaccination. Paramedics were called, but patient was not transported to the hospital. Vital signs were okay. Extreme fatigue and continued dizziness for several days. Increased brain fog and confusion.

acute and progressive onset of confusion, agitation, disorientation - no focal neurologic signs or somatic complaints - difficulty wiht attntion, concentration, focusing on conversation - oriented x 3 but confused why she was where she knew where she was 9 her home), aware of people and names,

Extreme fatigue & lethargy. Unable to do much at all. Stated she didn't know she would feel this bad or would not have taken vax. Really felt "terrible".

Had no memory of what transpired during the episode; extremely weak; almost catatonic; lost control of bowel and bladder; lost control of bowel and bladder; couldn't write; slept for almost 24hrs/ Very sleep; This is a spontaneous report received from a contactable consumer (patient) and contactable nurse. A 95-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3302), via an unspecified route of administration on Arm Left on 09Feb2021 17:30 as single dose for COVID-19 immunisation. Medical history included chronic anemia and AFIB (atrial fibrillation. The patient known allergies was reported as none. Concomitant medications included levothyroxine sodium (L-THYROXINE); omeprazole; acetylsalicylic acid (ASPIRIN) at 81 mg; calcium carbonate, magnesium carbonate (TUMS) and iron; all are received within two weeks of vaccination. The patient was not received other vaccines within four weeks. The patient had no COVID prior to vaccination. The patient was not tested COVID post vaccination. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261) on 19Jan2021 17:30 on left arm for COVID-19 immunization. On 10Feb2021, after 20+ hours, the patient became extremely weak, almost catatonic, lost control of bowel and bladder, couldn't write, slept for almost 24 hrs. Improved next day and restored almost 90% by 2nd day. Had no memory of what transpired during the episode. The nurse further stated that, 20hrs after each shot, she become very sleep, weak, lost bladder control, and didn't want to communicate. The patient was not received any treatment for the events. The outcome of the events was reported as recovered on Feb2021. The Nurse considered the Pfizer product had a casual effect to the adverse event.

02/20/21 5 days later after shot started reporting complaints. Hospital Visit with chest pains and confusion. 03/07-03/14 2021 hospital stay with encephalopathy, delirium?s, confusion. 03/20/-03/29 2021 hospital stay with hallucinations , staring and continued decline in health.

About 30 hours after receiving vaccine, resident was very emotional, called her family numerous times in the middle of the night. Was having increased weakness and hip/back pain which required use of wheelchair. She can normally ambulate with walker. Also complained of nasal congestion.

Morning following 2nd vaccination patient was confused and not able to keep herself upright in a char, stand or feed herself . All of which she could do the day before. She was sent to medical center for MRI and they found no evidence of stroke and sent her back. She was then sent to rehab where she continued to weaken and not be able to eat or drink . A week later she is now under Hospice care.

Tiredness; chills; leg weakness; confusion; This is a spontaneous report from a contactable consumer (patient). This 96-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 23Jan2021 at 12:15 PM (at the age of 96-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included atorvastatin from an unknown date for an unknown indication; atenolol from an unknown date for an unknown indication; losartan from an unknown date for an unknown indication; buspirone from an unknown date for an unknown indication; and "levot" from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to vaccination and did not have COVID prior to vaccination. On 25Jan2021 at 11:00 PM the patient experienced tiredness, chills, leg weakness, and confusion. The clinical outcomes of tiredness, chills, leg weakness and confusion were recovered in Jan2021. It was also reported the patient had not received a COVID test post-vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

2/6/21 Sent to ER for evaluation of agitation and returned a few hours later on 2/7/21 with no acute findings. 2/7/21 continued with agitation and restlessness and had psychoactive medication changes 2/8/21 Had head CT with no acute findings 2/11/21 MRI of lumbar spine with compression fx T10 2/17/21 UA and KUB done with no acute findings Multiple falls within this time frame with escalating agitation, restlessness, and insomnia. Dx psychosis and started on Seroquel 2/25/21 3/2/21 Patient died

up all night; Itching; has small bumps; some areas of redness; This is a spontaneous report from a contactable consumer. A 96-year-old female patient (Reporter's mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (they hope the mother doesn't contract COVID). Medical history included stomach issues, blood pressure, cholesterol. Concomitant medication(s) included loperamide hydrochloride (LOMOTIL) taken for stomach issues. The patient experienced itching with, has small bumps, some areas of redness; all (non-serious) on 09Feb2021 and up all night (non-serious) on 10Feb2021. Therapeutic measures were taken as a result of itching (pruritus). Additional Information for Concomitant Products Lomotil, cholesterol and one for blood pressure: Reporter declined to provide any further information for medications such as when her mother began taking these medications, the dosages, or further information related to the medications. Reporter was calling for her mother. Her mother had her initial shot on the 8th, 08Feb2021, and she got up the next morning and was complaining of itching and had some areas of redness and bumps that went around the nape of her neck. She has small bumps around her neck, under her chin, on her chest area going down mid-line- from her chin- and then down under her breast. It itches and she didn't have that before. Clarified with caller that the shot being discussed is the Pfizer COVID vaccine. Reporter said areas of itching and bumps are still there today, she wanted to wait a little bit to see how it was going to be, but her mother still has it. Her mother does have a sensitivity to medications. You know, a lot of oral medications she can't really tolerate, it bothers her stomach. She's not really allergic to anything in particular- caller asked her mother, "are you mom, no." She just wanted to clarify that information. Her mother does have a sensitive stomach, but the COVID vaccine shouldn't have anything to do with the stomach. No further details provided on the oral medications that the mother is unable to tolerate that bother her stomach. Two days ago, the caller's mother had the COVID vaccine on the 08Feb2021 and she woke up that evening. While she was going to bed she noticed she was itching. When she got up in the morning she said she was up itching all night. The reporter says, so we will say 09Feb2021 is when this all started. Reporter makes a comment that her mother is a little thing. The reporter says her mother is about 4'5" 4'6" and her mother says she is 4'9" and the reporter says well she wants to say she is 4'9". On 08Feb2021 the patient had the COVID vaccine and then she had the itching behind her ears, on her neck, across her chest, and under her breasts. Clarified the date the itching began an 09Feb2021. The patient put something on that eliminated some of the bumps and every now and then the itching and scratching will feel like she's bleeding, but she is not bleeding anywhere. The bumps are still there. They are still red, the bumps are not red, they are an irritation. Conflicting information obtained in regard to bumps, unable to clarify or obtain further details due to the reporter not wanting to complete the safety report. Some areas of redness: Reporter says it is not really red, it is more off an off-color, pinkish. Reporter states that she can tell there's an irritation on the patient's skin from itching. Up all night: The patient was up last night 10Feb2021 when she went to bed. Reporter mentioned that her mother doesn't always relay information correctly. Company agent is unable to clarify if the inability to relay information correctly began prior to receiving the COVID vaccine or after due to the reporter not wanting to complete the safety report. The patient was up all night itching the last two nights. She feels the itching and gets some relief from an ointment she is using. Reporter is not sure of the name of the ointment off hand, but the patient was provided the ointment it is from the doctor. Unable to probe for NDC, lot number, or expiry date of ointment that only provided some relief to her mother as reporter did not wish to complete the safety report. Probed for NDC, expiry date, and dosage and reporter says this information is not on the vaccination card. Caller says the lot number is an "E" and she can't make up the next letter before 9262, it's either EL or E1 and it is separated from 9262, there is a space between them. Lot number is either: EL9262 or E19262 based on information provided from the reporter. Reporter says the mother takes medications everyday. She takes ones for her blood pressure, cholesterol, and Lomotil medication for her stomach issues. Reporter asks how much longer this is going to take and what further questions will be asked. She doesn't think the rest of the report is necessary she just wanted to report that her mother had the rash and the itching. Unable to clarify information regarding said rash with the reporter as being related to the redness and bumps mentioned previously in the report or if this rash is a different event that was experienced. Medical Conditions: Unable to obtain further information due to reporter not wanting to complete the rest of the safety report. Investigations: When informing the reporter that one question that will be asked for this report is if any testing has been done to what her mother experienced, the reporter says no. Unable to clarify if this means no testing has been completed or no to the reporter not wanting to answer the question at this time since she did not want to complete the safety report. Informed caller that an additional form is part of the safety report, caller declined to complete the safety report so unable to obtain further information and confirm given information to fill out the vaccine supplemental form. Reporter calling on behalf of the side effects experienced from her mother after the COVID vaccine. For all events, outcome was not recovered, except for event up all night, outcome was unknown. Information about Batch/Lot number has been requested.

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

Uncontrollable shaking; Felt sadness; Very depressed; This is a spontaneous report from a contactable consumer (patient). A 96-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267) via an unspecified route of administration, administered in right arm on 10Feb2021 at 10:45 (at the age of 96-year-old) as dose 2 single for covid-19 immunisation in doctor's office/urgent care. Medical history included congestive heart failure, 4 way bypass. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, on an unknown date Jan2021 (four weeks prior to suspect vaccine), as dose 1 single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 17:30, the patient experienced uncontrollable shaking lasted for 3 hours, the patient felt well enough to go to bed. Patient took 2 tylenol and slept through the night until 9:00. Along with the shaking patient felt sadness and very depressed. The patient took 2 tylenol as treatment for the event uncontrollable shaking. No treatment medication was received for the events felt sadness and very depressed. Post vaccination, the patient had not tested for COVID-19. The outcome of the events was resolving. Follow-up attempts completed. No further information expected.

Already reported immediate severe weakness, lethargy, withdrawal, delirium. Now adding 4 days later ... hypotension, nausea, vomiting, diarrhea, cramps, chest pain. ER visit and 2 day hospitalization. Abdominal CT indicated intestinal inflammation in the area of the Cecum. One week of antibiotics.

On 1/29/21 patient began not feeling well and saw her provider. The doctor gave her fluids and tramadol for pain. They noticed increased confusion, but thought that could have been due to the tramadol. They also increased her gabapentin as she was experiencing nerve pain. Patient also developed a rash and was diagnosed with shingles on 2/1/21. Patient died on 2/3/21

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

One day after injection, acted the exactly the same as she did the day she was hospitalized for COVID at Hospital in Dec 2020. She had fever around 101F, was too weak to sit up or feed herself or do anything other than lay down. She did not respond to tylenol. I got a virtual visit with her doctor, to decide if to go to the e.r. and we agreed to try one more tylenol in the late afternoon and she got slightly better, so we delayed hospitalization. So after that she slowly recovered over several days. She was weak for about a week. Her doctor suggested she not get the second dose because she probably still has lots of antibodies in her and had an antibody reaction. I'm a reporting this because i want to know if people who had COVID and only one dose of vaccine with a severe COVID like reaction like this can be officially considered "immune " and get a vaccine "passport". Could you let us know.

First day very tired slept all the time appetite decreased Dash day after not drinking not eating complaint of headache back pain which was generalized to the whole body with her alzheimers hard to tell very weak by noon could not walk from the living room to the bathroom Not eating or drinking that day had to have Neighbor come over and help move her she slept in a reclining chair for the night ? the next day she was doing better Was in touch with the doctor ? did not take her to the clinic or to the hospital but has she been any worse we would have

prickly feelings; slept all day; felt it right to her stomach; chills; bad anxiety attack; This is a spontaneous report received from a contactable consumer (reporting on herself). A 97-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: HT6955 and Expiration date was not reported), via an unspecified route of administration in Arm Right on 20Mar2021 11:30 (at the age of 97 years-old) as SINGLE DOSE for covid-19 immunization. Medical history included cardiac murmur, chronic kidney disease, hypertension, blood pressure measurement all from an unknown date and unknown if ongoing. Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure measurement from an unspecified start date and ongoing; nifedipine (NIFEDIPINE) taken for blood pressure measurement from an unspecified start date and ongoing; losartan (LOSARTAN) taken for blood pressure measurement from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for water pill from an unspecified start date and ongoing; potassium (POTASSIUM) taken for take with the water pill from an unspecified start date and ongoing. It was reported that she got the first shot week ago; clarifies she received the first dose of the Pfizer COVID-19 vaccine on 20Mar2021 at 11:30 in the right arm. States when she got the injection she felt it right to her stomach. The next day she had chills. Patient mentions one night she woke up with a bad anxiety attack in the night, she felt another tiny anxiety attack again yesterday but she told herself you are okay. One day last week she slept all day; and then there was one night were she was just sitting there and she felt prickly feelings all over. Now she was concerned about getting the second shot and was asking how strong was that second shot with regard to her side effects. She called in before to Pfizer the second week to ask about her side effects and left a message for them to call back but no one ever called back. No reference number provided. This will be a follow up. She was planning to receive the second dose on 10Apr2021. Tests: Mentions she recently had an echocardiogram and an EKG but no results are provided. No follow-up attempts are needed. No further information is expected.

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.

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.

Increased confusion on 1/13/21 with delusions. Seen in ER. No fever. CT found mass in amdomen. Upon returnning to personal care home had a seizure. Patient on pain meds.

Stomach ache; Restless; Couldn't sleep; Headache; So hot she couldn't keep cool; This is a spontaneous report from a contactable consumer (patient). A 98-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982, expiration date not reported) via an unspecified route of administration at the left arm on 12Jan2021 15:45 at a single dose for COVID-19 immunization. The patient's medical history included arthritis, she is in a wheelchair (can't walk), gallbladder out a year ago (2020) and she her right hip replaced. No family medical history. There were no concomitant medications. The patient usually sleeps well. Clarified she received the first dose of the Pfizer COVID 19 vaccine 12Jan2021 15:45PM in the left arm. She was fine after the injection then 13Jan2021 in the afternoon she had a headache for two hours; that night she was restless and couldn't sleep; she was so hot she couldn't keep cool. Then this morning 14Jan2021 her headache is gone but she has a little stomach ache. Mentioned they haven't brought breakfast by yet and that might help. She was planning to get the next dose of the vaccine 02Feb2021. She has been living in an assisted living facility now for three years; and she can't get outside; and has not seen her family due to the virus. The facility where the vaccine was administered was in an assisted living facility. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events did not require a visit to physician or ER. No relevant tests done. Outcome of the events headache, feeling hot, restless was recovered on 14Jan2021; stomach ache was recovering and unknown for the other event.

Patient began to show muscle weakness in late afternoon on 1/31/21. On 2/1/21 she was unable to walk, not even one step. She had difficulty swallowing, was unable to feed herself, and was extremely lethargic. She was unable to remain awake all day and had to be shaken unusually hard to wake up. She appeared confused/ disoriented upon waking. She did not have a fever or report of any pain. Her BP, pulse, and O2 were all normal. She did present with any indications of a stroke. Slight improvement began late afternoon on 2/2/21. On 2/3/21 all of these conditions had disappeared and she was back to her normal self and activities.

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.

Patient is a 99yr old female who got a covid vaccine in the afternoon of 1/10/21 and woke up in the morning of 1/11/21 with altered mental status, weakness, and dysarthria. She was taken from her assisted living facility to the hospital and MRI showed a small stroke in the right medial thalamus. She was also found to have new onset atrial fibrillation. She was treated appropriately for both conditions and discharged to a skilled nursing facility on 1/13/21.

health has totally deteriorated; She sleeps, barely opens her eye; refuses to eat or drink; dizzy; didn't feel well; she can't talk, walk or anything; she can't talk, walk or anything; She is weak and frail; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and walking aid user from an unknown date and unknown (prior to the vaccine, she walked well with her walker). Concomitant medication included quetiapine. The reporter reported that the patient's health has totally deteriorated as of a few days after receiving the vaccine on 13Jan2021. She is dying. She sleeps, barely opens her eyes and refuses to eat or drink. Three days after receiving the vaccine on 13Jan2021, she said she was dizzy and didn't feel well. Now she can't talk, walk or anything. She is weak and frail. Prior to the vaccine, she walked well with her walker, ate well and had energy. The reporter visited with her and had conversations but the patient doesn't talk or respond. She is her daughter and POA. She lives in the facility due to dementia. No treatment was received for the events. The patient did not recover from the events. Information on the lot/batch number has been requested.

After 7 days following first shot some day time hullucinations and exhaustion Day after 2 nd shot slept - -14 days after this shot exhibiting exhaustion and some day time hulluciations, Exhibiting NARCOLEPSY behavior

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

confused and tired; confused and tired; ear infection as well as an ongoing infection; ear infection as well as an ongoing infection; This is as spontaneous report received from a contactable consume. A patient of 101-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: Not reported) via unspecified route on 20Jan2021 at 12:00 PM, as a single dose in the right arm for COVID-19 immunization. Patient's medical history included conjunctive heart failure, can't walk, allergies, chronic infection in hip. The patient was not allergic to medications, food and other products. Concomitant medications included spirolactone, Asprin (acetylsalicylic acid), Ceflex (cefaclor), Lasik (furosemide) and Esclaminapin. The patient did not receive other vaccines in four weeks. The patient had not diagnosed with COVID-19 prior vaccination and was not tested since the vaccination. On 28Jan2021 at 04:45 PM, 7days after the vaccination, the patient experienced confusion and tired. The patient also had ear infection along with ongoing treatment which included Keflex. The patient visited to clinic due to events. Event of ear infection was not sure if it was caused by vaccine. Outcome of events was resolved with lasting effects. Information on the lot/batch number has been requested.

on 3/16/2021 lost feeling in both legs and was unable to stand - vital signs were normal - doctor's exam at 12:30 was unremarkable - this was 18 days post injection #1 on 4/04/2021 lost feeling in both legs again, was unable to stand, B/P was 220/122, posturing on left side, disoriented - week preceding was marked by uncharacteristic disorientation and anxiety and complaints of pain to light touch on skin, - week following was characteristic of recovery from mild stroke - now mental status is returning to normal, overall strength decreased - this was 16 days post injection #2

Stroke; sitting on the floor totally disoriented; Cardiac arrest; This is a spontaneous report from a contactable consumer (patient's Daughter). A 101-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 101-year-old on 03Mar2021 at single dose for covid-19 immunisation. Medical history included glaucoma, blood pressure high, Mini stroke, her blindness was an infarct to her optic nerve, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, and obesity. Family history included Patient's sister got the vaccination and either 3 or 5 days later she passed away. There was none history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medication included metoprolol taken for high blood pressure; levothyroxine; amlodipine taken for high blood pressure; sertraline to keep her spirits up because she is old and blind; latanoprost (XALATAN); dorzolamide hydrochloride, timolol maleate (COSOPT); acetylsalicylic acid (BABY ASPIRIN); calcium (CALCIUM); vitamin C [ASCORBIC ACID]; tocopherol (VITAMIN E). Prior Vaccinations (within 4 weeks), there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient received the Flu shot every year and patient also received the shingles shot and the pneumonia shot. Reporter stated patient had lunch and was sitting in the chair so it was probably somewhere between 12 and 3pm on 09Mar2021 when she had her stroke. Reporter states when she got back home patient was on the floor totally disoriented. Above events results in Emergency Room and patient was hospitalized from 10Mar2021 to 12 Mar2021. Reporter stated that patient died in her sleep so early in the morning probably between 3am and 6am on 06Jun2021. Reported cause of death was cardiac arrest. Reporter was calling about the Pfizer COVID vaccination. Reporter was calling on behalf of her mother. Reporter believed that her mother had a reaction to the first shot. Reporter stated that her mother had a stroke 6 days after receiving the first Pfizer COVID vaccination and has since passed away. Reporter thought this was a contributing factor. Reporter states that her mother was 101 years old but was an incredibly lucid and healthy individual. Reporter states that her mother used to be 5 foot 1 inch but she was probably 4 foot 11 inches at the time of this event (09Mar2021). Reporter states at the time of this event her mother probably weighed about 133 pounds. Reporter states that she came home on 09Mar2021 and found her mother on the floor. She took her mom to the hospital on 10Mar2021 and she was diagnosed with a stroke. Her mother was hospitalized 10Mar2021 through 12Mar2021. Reporter stated that her mother went to rehab after being discharged from the hospital. Stated that her mother never came back home. Reporter states that her mother lived with her. Reporter states she looked at her labs on 01Jun2021, her labs were always good. She stated that her mother also had a cat scan with contrast in 2021, no further details provided. Reporter states that she was not saying that this product caused her death but the timing was very suspicious. The patient underwent lab tests included Fasting blood glucose: 99 on 01Jun2021, cat scan with contrast with unknown results in 2021. The outcome of events was fatal. The patient died on 06Jun2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Stroke; sitting on the floor totally disoriented; Cardiac arrest

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