Pfizer

MORNING AFTER VACCINATION, DEVELOPED VOMITING, DIARRHEA, HEADACHE, LOWER BACK PAIN, LEG PAIN, AND RASPY VOICE. WENT TO ER ON 1/21/21

Left Arm pain; This is a spontaneous report from a contactable consumer. A 90-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283 expired date 30Apr2021 in left arm via an unspecified route of administration on 10Jan2021 at a single dose for COVID-19 immunisation. Medical history included arthritis. Concomitant medications were not provided. On 11-JAN-2021 the patient experienced pain in her left arm. She would like to know if she can use a heating pad on it. The event outcome is not recovered and action taken is not applicable.

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.

1/27 at approx 11:30 Patient started with chills and muscle cramping during dialysis. After returning home took 2 -500mg acetaminophen and approx 2:30pm had more chills, body shakes, muscle/leg cramping, all over muscle aches, headache, weakness, arm numbness and tingling. Temp taken and was afebrile. Temp taken at 6pm and afebrile and symptoms of chills, weakness, headache, muscle aches, tingling in fingers.

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

Pfizer-BioNTech COVID- 19 Vaccine EUA Patient experienced change in speech and jerky movements on way home from COVID-19 vaccine. Presented to ED. Patient diagnosed with Acute CVA (cerebrovascular accident). Patient discharged on 1/31/2021.

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

90 YEARS OLD: 1st Dose of Pfizer Vaccine did NOT produce any side effects that I am aware of. However, the 2nd Dose of Pfizer Vaccine produced side effects about 3 hours after the injection. Reactions were arm sore, tiredness, body ache, headache; no diarrhea, temp not taken - went to bed and slept. These side effects continuing February 6 and February 7. February 7 taking Tylenol to help with aches and pains. This report was written on February 7 at 1:30 pm with side effects continuing.

Systemic: Other- per Nurse Practioner , patient seemed like a "zombie" with blank stares and not responsive

At 10:33 am Patient pushed her pendant for staff, staff arrived to her apartment and Patient was found unresponsive in her bathroom. Patient received her second COVID-19 Pfizer vaccine about 75 minuets prior to this, she had no adverse reaction's within the first hour of receiving the second dose. CPR was started until paramedics arrived, they took over and tried to resuscitate. Patient was pronounced dead at 11:33 am at scene.

Resident c/o itchiness & pain in R upper arm where injection site was located, about 48 hrs after injection. Noted 12cm x 6 cm swelling, redness at injection site. MD aware.. Ice pack given for relief and effective.

Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient's son). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on 24Jan2021 13:30 at a single dose for COVID-19 immunization. The patient had no medical history and family medical history. There were no concomitant medications. On 24Jan2021, the patient experienced sore arm and tiredness. Right after the vaccine she noticed her arm was sore. Later she also felt a tiredness. She was scheduled to receive the second dose 14Feb2021, but she was unsure if she will get it. The events did not require a visit to physician or ER. There were no additional vaccines administered on same date of Pfizer suspect. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was in a hospital. No relevant tests done. The event sore arm recovered on 28Jan2021, while the event tiredness on 26Jan2021.

Patient had increased weakness and ended up in the emergency room department. It took one clinical observer and one volunteer to get her moved. Son reported he could not get her into the house alone , and she was definitely weaker than normal.

Patient was feeling extremely fatigued after the vaccine. Patient also was shivering and said she felt cold. Her blood pressure was 107/78. Her mental state did not seem far from normal. She was taken home by her son.

syncope followed by ER visit w/ many negative tests. persistent weakness, apathy and loss of appetite

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

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.

sciatic nerve pain; fever; every nerve in my body, fingers, buttocks was in pain; sweating; Dry cough; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 18Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took gabapentin and felt burning in her feet and couldn't sleep at night. Historical vaccine includes flu vaccine. One time when she had the flu shot 64, she had a reaction to it. She said had the same reaction with COVID-19 vaccine. On 29Jan2021, every nerve in her body, fingers, buttocks was in pain, in the middle of the night woke up and she was sweating. It all lasted for a day and a half, by the next day it has diminished. She was also coughing, dry cough. It happened all at one. All at once, she could hardly get out of bed. She couldn't touch her body the night of the 29Jan2021. She also has sciatic nerve pain. It hurt so bad she couldn't handle it. The nerves in her hands, fingers, buttocks, and legs just hurt. That lasted the night until noon. Sunday morning it was gone. She clarified the hurting and not being able to get out of bed started the 30Jan2021, but was gone by Sunday. The pain in her buttocks and hands started to slowly go away. She thinks when she woke up soaking wet that she had had a fever that broke (29Jan2021). She woke up Saturday morning with the nerves and the pain. By Sunday late evening, it was starting to diminish. Her next vaccine was next Monday. Her legs aren't moving as fast at 90 years old. The outcome of the events sweating and fever was recovered on 30Jan2021; cough recovered on 31Jan2021; nerve pain and sciatic nerve pain recovered on Jan2021. Information about lot/batch number has been requested.

Approximately 2 days after receiving her vaccine, she began to develop swelling and tender spots on both legs, mostly around the knees. These spots continued to grow in size, swelling and got more red in color. She developed more around the ankles. Edema of both legs worsened. approximately 20 days after receiving the vaccination she developed a similar spot over the right thumb. She also complained of scratchy throat, especially when lying down at night although she is noted to have chronic allergies. On March 25, she was re-evaluated. Given that her symptoms were worsening, and lab tests were abnormal she was treated with prednisone.

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

Covid vaccine monitoring documentation. 90 yof patient presented to ED 3/4/21 at 1233 unresponsive via EMS due to cardiac arrest. BP documented 82/43 at 1233, pulse 49. Prior to arrival, patient had been in bathroom and had syncopal event. Patient lived with family. EMS began CPR and administered doses of Epi. Documentation also stated patient?s family member said patient received their 2nd covid vaccine 5 days prior and has not been okay since. After arrival to ED, patient was intubated, cardiac ultrasound showed no cardiac activity and no pericardial fluid. Patient received sodium bicarbonate and calcium chloride. Patient expired in the ED department at 03/04/2021 12:51. Per Death Summary Form clinical diagnosis cardiopulmonary arrest, clinical impression of cause of death or terminal events leading to death, possible myocardial infarction. Pfizer EL9265 on 1/30/21, Pfizer EL9266 on 2/20/21.

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.

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

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.

feel very weak; unstable walking; I am wondering; feel very weak, unstable walking and I don't know if it may be in my stomach too, I am feeling upset feeling in my stomach; This is a spontaneous report from a contactable consumer (Patient herself). A 90-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not reported, Expiration date: 31May2021) via unspecified route of administration on 02Feb2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history was not reported. Concomitant medication included vitamins. The patient stated I am wondering; feel very weak, unstable walking and I don't know if it may be in my stomach too, I am feeling upset feeling in my stomach. The patient did not receive treatment medication. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Patient tested positive for COVID on 12/30/2020. She did not experience COVID symptoms; however, at that time her dementia and weakness progressed. She passed away on 02/12/2021 at the nursing home facility.

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.

only had a sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Daughter) reported for a 90-year-old female patient (mother) received second dose in left arm on 13Feb2021 at single dose for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (Lot Number: EL1283) on 21Jan2021. The patient reported that her mother received the 2nd dose of vaccine 3 weeks and 2 days (2 days late) on 13Feb2021. Patient only had a sore arm, no other symptoms, no treatment received. The outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up (22Mar2021): New information reported from a contactable consumer included: add event "only had a sore arm", remove event "Received the 2nd dose of vaccine 3weeks and 2 days". No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Might have Guillain-Barre Syndrome; her mother's legs "went numb and weak"; her mother's legs "went numb and weak"; her speech started to slur; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received BNT162B2 (Solution for injection) via an unspecified route of administration on 30Mar2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. It was reported that upon returning home after the vaccination, her mother was unable to get out of the car under her own power, with the caller reporting her mother's legs "went numb and weak". Later on that day, her speech started to slur. They had contacted their family physician who thinks her mother Might have Guillain-Barre Syndrome. The outcome of the events was unknown. Information about lot/batch number has been requested.

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

Not been able to walk; Motor skills diminished; Speech has also been deterred; She is in bed right now, can't move; She is not responding; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on 30Mar2021 on right arm at a single dose for COVID-19 immunisation. Medical history included Blood pressure high, heart condition, diverticulitis, ongoing constipation and ongoing pain. Concomitant medications included clonidine (tablet, 0.1 mg) at 0.1 mg, once a day, duloxetine (capsule, 20 mg), orally at 20 mg, two times a day (one in morning and one in evening), simvastatin (tablet, 10 mg), at 10 mg, once a day (at bed time once a day), doxazosin (tablet, 4 mg) at 4 mg, two times a day, carvedilol (tablet) at 3.125 mg, twice a day (takes half a tablet twice a day one in the morning one in the evening half, they cut in half), lisinopril (tablet, 5 mg) at 5 mg, once a day, paracetamol (TYLENOL, tablet, 500 mg) at 500 mg, as needed (takes one in the morning and one in the evening or as needed if she is in pain) for pain, acetylsalicylic acid (ASPIRIN, tablet, 81 mg) at 81 mg, once a day, iron (tablet, 65 mg) at 65 mg, two times a day, bisacodyl (tablet, 5 mg) as needed for the constipation and geri-Kot 8.6 mg, tablet as needed for the constipation. Reporter stated, "he just wanted to call on behalf of his mom. She took the vaccination on the 30Mar2021 and her side effects has been, she has not been able to walk and so right after the shot we brought her home and immediately after that her motor skills diminished. So, She was in bed and can't move on an unspecified date in 2021. He had called the doctor and let them know what her prognosis is. Her speech has also been deterred on an unspecified date in 2021. She was due for the second shot, he was scared for her to get the second shot because he doesn't know if she is going to recuperate from the first shot, she is due 27Apr2021. Needed to report this information on what her prognosis is, was very scared and patient was not responding on an unspecified date in 2021 and reported that don't know what to do. It reported that, her primary doctor gives her lab and her kidney doctor takes lab. The patient had not recovered from the events not been able to walk and she is in bed right now, can't move and the outcome of the other events was unknown. Information on the lot/batch number has been requested.

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.

sore arm; tiny little cough; This is a spontaneous report received from a contactable consumer (patient). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date (reported "on Friday") (at the age of 90-year-old), at single dose, for COVID-19 immunization. Medical history included she was just getting over COVID-19. Concomitant medications were not reported. The patient experienced sore arm. It was reported the second dose scheduled four weeks after first dose. Patient was 90 and she could not even remember the phone number a while ago. She just got over COVID 1 or 2 months ago. She was still kind of getting over it, didn't get over it right away. She had the first one and it was fine, she had a little sore arm and the usual. Patient asked if she would need to get the 2 shots since she had COVID. Her appointment was for 07May2021. She didn't know if anyone every really gets over COVID. It hangs on for awhile. She wanted to get what she needs, but if she didn't need it she won't get it. The smell, tiny little cough, different things. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Reactions were arm sore; Tiredness; Body ache; headache; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) dose 2 via an unspecified route of administration, administered in right arm on 05Feb2021at 15:30 as single dose for covid-19 immunization. historical vaccine include dose 1 via an unspecified route of administration, administered on 14Jan2021, (at the age of 90 years-of-old). Medical history included Heart failure, Chronic high blood pressure, Obesity, Kidney Disease, penicillin, sulfa, dairy allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Aldactone, Bystolic, Lisinopril, Zetia, and Cymbalta. The patient stated that 1st Dose was on 14Jan2021, of Pfizer Vaccine did NOT produce any side effects that she was aware of. However, the 2nd Dose on 05Feb2021 07:00pm, of Pfizer Vaccine produced side effects about 3 hours after the injection. Reactions were arm sore, tiredness, body ache, head-ache; no diarrhea, temp not taken and went to bed and slept. These side effects continuing February 6 and February 7. On February 7 took Tylenol to help with aches and pains. She stated that the side effects were continuing. The outcome of the events was reported as not recovered. Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected

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

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

Diarrhea; Sore arm; This is a spontaneous report from a A contactable consumer (patient neighbour) reported that a 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC, lot, Expiry Date: Not provided), via an unspecified route of administration, on an unknown date (age at vaccination 90-year-old) as unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced diarrhea and sore arm. Reporter states as, her old neighbour said she got Pfizer and she had diarrhea too. the patient had diarrhea and sore arm. The patient got hers, so patient was the first round of people. she doesn't think she has enough information to complete a report for her. The patient told her that she barely made it home in time before the symptoms started. Outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

Constant burning, throbbing pain in R calf unrelieved by acetaminophen or naproxen; different from arthritis in her knee.

Shaking, almost spasm type shaking. Weakness in her legs. progressing to abd. pain, cough, headache, nausea

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.

Fine in Am. Started complaining of stomach pain in afternoon. Had dinner around 6 pm & threw up part of it along with clear mucus and all the water she drank. After that it was all clear mucus off & on through the night. Has had this episode before but only lasting a few minutes never this long! Tried to give water but kept coming back up. Meanwhile pain in stomach (pelvic area) was getting worse. Called 911 at 2 AM (see line 19). Sometime after 911 left, the clear mucus started coming at a faster rate. Had bowel movement around 6 AM but said no relief in stomach pain. Called at 8Am. Could not come til between 12-1 PM. Seemed weak and very tired so let sleep. Around 10-10:30 AM could not wake her up. Called 911 again. This time it was cardiac arrest and they could not revive her.

nausea; dizziness; blurred vision; stomach is starting to hurt; I am unable to function in a normal capacity/could not get out of the bed.; sick; Im not alert long enough; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) received from a Pfizer colleague. A 90-yerar-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 27Feb2021 (lot number: EN6198) at dose 1, single, then second dose on 20Mar2021 (lot number: EP1534, batch number: EP7534) at dose 2, single; both via an unspecified route of administration at the age of 90-years-old for COVID-19 immunisation. Medical history included glaucoma and brain tumor. The patient has no previous vaccinations within 4 weeks. Concomitant medications were reported as none. Historical vaccine included flu vaccine back when the patient was a teenager and experienced allergic reaction that broke out with a rash, shaking, and itching. On 27Feb2021, after the vaccination of the Pfizer COVID vaccine, the patient experienced bad reactions daily. The symptoms include nausea, dizziness, and blurred vision. The patient has been unable to work because of it. These events caused the patient to seek medical attention from her primary care provider and vision care provider. The patient has a history of glaucoma, making it very difficult. The patient had to get a CT scan on an unspecified date because her doctor thought that a tumor may have come back to her brain, but the result of the CT scan was clear, and the tumor was not back. As a result, the doctor prescribed medication for dizziness (taken 3 times per day) and nausea (taken as needed). The patient stated that she was unable to function in a normal capacity from an unspecified date in 2021 without the daily treatment medications and still the treatment medications were not always effective in reducing the symptoms. The patient stated that the nausea was getting worse every day. At 5am, it woke her up and she took the pill and lasted a couple of hours but it came back and took another pill. The patient was taking ondansetron 4 mg orodispersible tablet taken under the tongue. On an unspecified date in 2021, the patient's stomach was starting to hurt and takes another pill for this. The patient reported that her ophthalmologist did the examination on an unspecified date in 2021 and stated that this examination had no difference from the previous examination on an unspecified date. The patient stated that her daughter also had the vaccine and had a sore arm for two or three days. The patient also reported that she could not get out of the bed. She had a blurred vision and cannot read without a magnifying glass. It was terrible and the patient had never been this way. The patient takes a medication for the blurred vision and it doesn't last. The patient cannot function, and her doctor already knows this. The patient will see her doctor again on the 26th. On an unspecified date in 2021, the patient was sick all day because of the nausea. The patient had 4 doses of medication and it did not last anytime. On an unspecified date in 2021, the patient was not alert long enough. Yesterday, the patient's nausea woke her up at 5am. She took a pill under the tongue, and before 8am, nausea attacked her again in a couple of hours and all day long. All day yesterday, the patient was nauseated like a morning sickness when pregnant. The nausea quieted down after the patient took a tea but started again after lunch. The patient stayed sitting all day. The patient reported that she experienced the same events after the second dose. The events nausea, dizziness, and blurred vision resulted to physician office visit. Outcome of the events alertness decreased, nausea, dizziness, and blurred vision was not recovered, and for other events was unknown.

neuropathy in feet; Weakness in legs; This is a spontaneous report from a non-contactable physician. A 90-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EL9262) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date. There was unspecified concomitant medications in two weeks. The patient previously received the first dose of bnt162b2 intramuscularly on 23Jan2021 (lot number: el8982) for covid-19 immunization at age of 89 years old. The patient experienced neuropathy in feet and weakness in legs on an unspecified date. No treatment received for the events. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of BNT162B2 to the development of neuropathy in feet and weakness in legs 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.

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.

Chest pain; Dehydration; Elevated troponin; Encephalopathy, metabolic; Hypernatremia; Troponin I above reference range; Uremia; Weak; Weakness

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.

She went limp and slumped in my arms at 9:30 am the day after her 2nd injection, so almost 24 hours later. Blood pressure, pulse and respiration were absolutely normal. But she was unable to speak for the rest of the day, she would open her mouth but could not get any words out. She also was extremely fatigued and slept most of the day, had no grip in her hands and was very stiff when she was able to get up. Had a slight fever, which went down after taking 1/4 of a Tylenol. No pain in the arm at the injection site and also no redness or swelling. So the know side effects of fatigue and muscle/joint pain hit her very hard. She is much better today, 24 hours after experiencing the side effects.

This is a spontaneous report from a contactable Consumer. A 91-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249, Expiry Date 31May2021 ), at single dose into the left arm on 20Jan2021 at 11:30 am for COVID-19 immunization. Medical history included problem with gallbladder in the last 4 months. Concomitant drugs were none. The patient had never problem with flu and shingles shot. On 20Jan2021, the day of vaccination the patient felt fine and told everyone it was a breeze. On 21Jan2021 morning she was getting ready to go to the store at 1130am, it was about 24 hours after getting the shot, and she felt dizzy, achy, her eyes ached and were weak, she felt feverish but had no fever and was a bit nauseated. The patient also reported loss appetite the same day. On 22Jan2021 around 11am she felt a little better. She checked her temperature and blood pressure normal. She has had a little nausea in the evening and was dizzy. On 23Jan2021 she felt a little weak but felt better and her appetite was better. At the time of reporting the outcome of the events was unknown.

left side of her head is hurting/the whole left side of her head hurts from her temple to her chin; in pain; migraine; This is a spontaneous report from Pfizer Sponsored program,received by a contactable consumer (patient's daughter). A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 21Jan2021 at a single dose for COVID-19 immunisation. Relevant medical history included some dementia. (ongoing). No relevant concomitant medications were provided. She said her mother had no side effects at the time she received the COVID-19 Vaccine. She said her mother's arm didn't even hurt. She said her mother (who lives with her) woke up this morning (25Jan2021) around 4:30AM to go to bathroom, and then went back to bed. Caller stated she, herself, had left her house around 7:00AM this morning to go shopping, and when she got back from shopping 25 minutes later, her husband said her mother was in pain, left side of her head is hurting and he gave her mother a couple of paracetamol (TYLENOL). She said her mother told her the whole left side of her head hurts from her temple to her chin. Her mother was talking fine, and her mother was able to lift both her arms up, so she didn't think her mother had a stroke. She said for the past 20 minutes her mother has been laying back down and seemed to be doing better. The reporter stated that her mother could be having a migraine. She asked if anyone has previously reported to Pfizer developing a headache 4 days after receiving the COVID-19 Vaccine. The outcome of the events was unknown. Information about batch/lot number has been requested.

Had swelling in leg for a couple of days prior to the early morning of 1/31 where the knee and entire lower leg was swollen and painful and made it very painful to walk. After sending photo to primary care physician had mom evaluated for a blood clot. It was determined based on blood test, vascular ultrasound that right non occlusive (mid) Femoral vein DVT.

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

On Feb 3 woke up very dizzy, lightheaded, arm pain. Feb 9th developed rash on both arms from elbows to hands, extremely itchy and also had a large blister develop on left arm.

She had the vaccine on Thursday and no visible side effects. On Saturday she was very weak and had to be lowered to the ground. She was drooling and staring vacantly and was not responding to questions. This lasted for a bit. I called the ambulance which took her to the hospital. They hydrated her and sent her home with no idea what caused it. The next day she was sitting on the toilet and passed out with her eyes closed. She started drooling. I again called the EMTs and they came. She had come to and they said she fainted and it was probably because she was having a bowel movement. This has not happened before or since these two episodes. I do not know if she should get the next shot.

After the second vaccine dose she reported not feeling well with unspecified symptoms for a few days. On February 18th, 2021 she visited her doctor with numbness in her hand. They thought it may be carpal tunnel and sent her home. The morning or March 18th , 2021 she had a severe stroke and was transferred to Hospital and then to other hospital. She was in the hospital until Tuesday March 23rd when she was transferred back to her home for hospice care. She died on March 26th, 2021.

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.

Acute myocardial infarction, NSTEMI, Atrial flutter, extreme weakness inability to get out of bed, headache, dizziness , nausea/vomitting,

Pt received the vaccine around 1200 PM. Around 1400 pt lost consciousness and became unresponsive and hypotensive with systolic BP at 90 per EMS. Pt was unconscious and unresponsive for approximately 10-15 minutes. Pt regained consciousness spontaneously and her BP slowly returned to normal over the next 3 hours.

I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; torn rotator cuff; I have a slight headache in the back of my head too; 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 VACCINE) (Lot number EL9262), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included High blood pressure. Concomitant medication included olmesartan medoxomil for high blood pressure and pravastatin sodium. The patient stated she was 91 years old and that was why she got the first shot of the Covid19 vaccine Pfizer about 10 days ago (27Jan2021). Last night (05Feb2021) she had such pain all night and she still had it. It was all around her neck and up to the top of the ears and then her right shoulder down the front and to the back, she had a torn rotator cuff there and all the way down to her fingertips she had pain. Event onset last night, during the night. Like 9 days well, coming into the 10th day. She did not know why she have it. It was fine until last night and now it was terrible. She had a slight headache in the back of her head too on an unspecified date in 2021. She had been taking Tylenol and put some Icy Hot, you rub it on when you have pain but it did not do anything. She wanted to know will she get the same type of reaction when she get the second shot. There was no expiration date on it. There was nothing else. The outcome of the event slight headache in the back of head was unknown and the outcome of the other events was not recovered.

3/16/2021 Reaction from Pfizer second shot: I received the second Pfizer vaccine on Tuesday, February 23rd, 2021 around 1PM. Early Wednesday morning I developed Gastric reflux which I never had before. As the day progressed I had severe abdominal pain that lasted throughout the day, also something I never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday I developed black diarrhea that continued all day. By Sunday I was so weak that a nurse came and sent me to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday when the severe pain began. After release from the 4 day hospital stay, I was sent to our health clinic for 6 days to regain some strength. Since I never had ulcers, I firmly believe that everything was activated on Tuesday when I received the second Pfizer vaccine shot. Please advise on your perspective of my situation. Is what I have described similar to others who have reported vaccine side-effects? Thanks and be well.

By Sunday I was so weak; I developed black diarrhea; Wednesday (day after vaccine) I developed Gastric reflux which I never had before.; As the day progressed I had severe abdominal pain that lasted throughout the day; Nausea set in late that evening; bleeding ulcer; 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) on 23Feb2021 13:00 at single dose for COVID-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility (as reported). Medical history included high blood pressure, aortic valve replacement and stent placement, 1 kidney, cancer 12 years ago (2009). Patient was not pregnant, no known allergies. No covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was yes (blood pressure medication). Concomitant medications included unspecified blood pressure medication. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on an unspecified date for COVID-19 immunisation. Patient reported that on Wednesday (day after vaccine) (24Feb2021) she developed gastric reflux which she never had before (24Feb2021 08:00). As the day progressed she had severe abdominal pain that lasted throughout the day, also something she never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday (26Feb2021) she developed black diarrhea that continued all day. By Sunday (28Feb2021) she was so weak that a Harrogate (senior living complex) nurse came and sent her to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday (24Feb2021) when the severe pain began. After release from the 4 day (as reported) hospital stay, patient was sent to health clinic for 6 days to regain some strength. Since she never had ulcers, she firmly believed that everything was activated on Tuesday when she received the second Pfizer vaccine shot. Adverse events resulted in: Emergency room/department or urgent care, Hospitalization (as reported), Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3 (as reported). Treatment included blood transfusions and intravenous (IV). The outcome of the events was recovered. Information of lot/batch number has been requested.

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

Patient recieved covid vaccine #2 4/7/2021. Of note first dose was Moderna, second dose was Pfizer. Tested +Covid 4/15/2021, admitted to hospital with weakness.

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

Pt received first dose of COVID-19 vaccine on 5/8/21, pt later became ill with COVID19, presenting to ED for testing on 5/22/2021 but was not admitted at this time because symptoms were more mild and manageable at home. Returned to ED on 5/26 and at this time was admitted for weakness and hypoxemia related to COVID pneumonia. Discharged 6/1/2021

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.

Facial drooping occurred on 1/3/2021, patient sent to ER and returned with diagnosis of Bels Palsy on 1/4/2021

Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.

1/3/2021 developed facial drooping later to be diagnosed by ER on 1/4/2021 as Bels Palsy status post COVID-19 Vaccine administered on 12/28/2020. The long-term outcome is unknown. The patient returned to the center and was doing well.

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

Patient tested positive for COVID-19 by rapid test on 1/6/21. She began to demonstrate a dry cough on 1/11/21. On 1/12/21 at 1723 her oxygen saturation dropped to 79% and oxygen was applied at 4L per nasal cannula. On 1/19/21 at 2130 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.

Resident received vaccination at 9:12 am, she was monitored and checked at the 15 minute interval 9:27 am, reassessed, vitals were fine. Within 20 (9:32 am) minutes of receiving the vaccine she was unresponsive, pupils were fixed at 9:45 am, no vital signs noted; hospice came out and reported her time of death 10:21 am. This person was on hospice.

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

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.

faint; slightly dizzy; weak; This is a spontaneous report from a contactable nurse (patient). A 92-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL9262), intramuscular in the left arm on 01Feb2021 12:30 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 02Feb2021 16:00, the patient faint, slightly dizzy, weak and had to grab counter. Within 5-10 minutes it was gone and she was feeling fine. The patient added that it would have been serious if she hit the floor, but she did not. The outcome of the events was recovered on 02Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events faint, slightly dizzy and weak with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient reported numbness in left arm/hand that spread to right side of the body over several days. She also reported mild swelling of her face. She went to her primary care doctor who did not prescribe or provide any treatments but told her to monitor the situation and go to the emergency room if she experiences any difficulty breathing. She reported no issues breathing, and the numbness has lessened.

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

DX: CVA History The patient is a 92 y.o. female with a past medical history notable for History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

15 minutes after receiving vaccine, she noticed legs becoming more numb than usual and difficult to move them. Had to have additional assistance ambulating, getting out of chair, getting into bed unable to raise legs into bed, assistance in the bathroom, had to hold onto her to stabilize.. This lasted for 30 hours with gradual resolution of symptoms. she remains with her usual neuropathy at this time.

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.

The patient began experiencing headache the evening of receiving vaccine (02/25/2021). She reports awakening the following morning with left upper and lower extremity pain and weakness and was unable to ambulate. She also reported some slurring of speech. These symptoms lasted for a few hours and then resolved. Headache, left-sided pain and weakness and slurring of speech have resolved.

Death felt a little sick 1 day after shot 2/28/21, felt worse next day 3/1/21 was weak, she was found dead am 3/2/21 on the floor in her bedroom 1/2 way between bathroom and bed.

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.

Leg Pain 03/03/2021 Erratic BP episode 03/11/2021 9:00am BP 202/117, P78 After 15 minutes BP 108/65, P77 10:00am BP 172/86, P79 12:00 pm BP 138/75, P79 Dr. was called and is having us monitor her.

After vaccine was administered patient was seemingly fine until a loss of consciousness/mini stroke on Jan 16 (5 days after vaccine) causing a fall and massive stroke on Jan 22 (11 days after vaccine) that left patient unresponsive and on life support until family decided to stop services and begin hospice care with no fluids or food until death

Found in chair lethargic less than 48 hours after her first civid vaccine by facility staff where she lives in an independent living facility. Nursing staff felt she had a stroke with right sided weakness. Slurred speech, weak, unable to walk without two person assistance. Patient was under hospice care so hospitalization was given.

13 days post vaccination patient wakes up with a slight itch in here ears. By 4pm she reports a sudden hearing loss in her right ear. On day 14 she proceeds to get very weak with vertigo, nausea, and anorexia. No temp or other signs of illness. On day 15 we take her to ER and work up was negative. On day 16 we take her to ENT no explanation of the sudden hearing loss but is told she is totally deaf in the right ear and needs a hearing aid in the left. She did not have this prior to the vaccination and it was a sudden onset.

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.

Patient received vaccination with no immediate reaction. Approximately 3-5 minutes later after the patient was helped to the observation area, the patient told her son that she was very hot. Her head then slumped forward and she became unresponsive to verbal and physical stimulation. Patient also threw up while unresponsive. She almost fell out of her chair onto the floor, but was caught before hand. When patient became unresponsive, emergency medical services was contacted and a dose of epinephrine was going to be administered. The training EpiPen was used so a dose was not administered. Patient recovered within a couple of minutes and paramedics arrived to evaluate patient.

Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine. The outcome of the events "Her health has declined each day" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done. Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine

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

Pt received COVID Pfizer vaccine on 4/3/21. Pt tested positive for COVID on 4/14/21. Pt hospitalized on 4/14/21 for weakness d/t COVID

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.

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.

felling dizziness; nausea; not feeling strong; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization and lubiprostone (AMITIZA) , via an unspecified route of administration from Dec2020 to an unspecified date at 1 DF, 2x/day as laxative..Medical history included:TIA started in Dec2020, bowel problem, fell (she fell about 3 weeks before she got the Pfizer COVID-19 shot) and some memory loss ( not serious).She wanted to know if she should receive her second dose of the COVID-19 vaccine if she was presenting the following side effects: felling dizziness, nausea and not feeling strong. She was currently taking Amitiza as a laxative. She believed these side effects were not related to the administration of the first dose of the vaccine and were rather common conditions for her age , she also stated that she did not have any "negative feelings" with the first shot of the vaccine. Consumer said she had an appointment today for her second shot of the Pfizer COVID-19 vaccine and got a letter yesterday that said she could get it at 03:00PM today at the center where she got the first vaccination. She said that they gave the shot in her left arm for her first vaccination. She said it was very common at this age that she very often didn't feel well, and she was on a new laxative that might be causing some upset. She said she had no fever, she was not nauseated, she had no headache, there was nothing wrong. However the outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dizziness, nausea and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Further details about the patient's medical history, concomitant conditions and the events would be helpful. The contributory role of the concomitant laxative also cannot be excluded. This case will be reassessed once additional information becomes available. 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.

Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF, P 80, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3, has been complaining of generalized weakness, fatigue, decreased appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the hospital, condition clinically deteriorated. Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30 p.m. earlier today. Preliminary cause of death: Hypoglycemia induced lactic acidosis.

On 01/19/2021 patient was observed to have a slight right facial droop and slight slurred speech, hand grips were equal, pupils equal and reactive, she had difficulty moving her right leg. 911 activated due to possible CVA, admitted to the hospital , a MRI was done to rule out a stroke. Readmitted 1/20/21 with the diagnosis of probable Bell's Palsey. The patient is stable medically at this time. Facial droop remains at this time, she is able to swallow without difficulty.

Normally, patient has neuropathy but it has never been this bad before and it has never been that high up.; Terrible cramps in both legs and thighs; This is a spontaneous report from a contactable consumer who reported for herself, a 93-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration on 15Jan2021, at the age of 93 years, at a single dose for COVID-19 immunization. Medical history included diabetes and neuropathy, both ongoing. Concomitant medications included unspecified medicines including one for diabetes. The patient stated that she received her shot yesterday, 15Jan2021 and last night, same day of vaccination 15Jan2021, she had terrible cramps in both legs and thighs and was just wondering if that was one of the symptoms. Normally, patient has neuropathy but it has never been this bad before and it has never been that high up (15Jan2021). The outcome of the events was unknown.

During injection she felt it burning; Her Blood Pressure went up to 255; She felt weakness and Nausea; Became unaware of her surroundings.

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.

Resident on Hospice. 1/18 Hand Shaky. 1/19- Covid +19. 1/20 Desat 85% on RA, provided 2L O2 supplement= 97% 1/20 congestive cough, 1/28- RR-28;1/29- Hypoglycemia 1/30-NPO. 1/30-resident passed away.

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.

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

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.

Patient became dizzy, tachycardic and hot after getting her second COVID vaccine. She was monitored and discharged home with her daughter, who is her caregiver.

Prolonged tiredness; increased weakness; dragging right foot when walks; little more trouble swallowing pills than before; little more trouble swallowing pills than before; This is a spontaneous report from a contactable consumer (the patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration in the right arm on 26Jan2021 09:15 (at the age of 93-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: aortic stenosis, COPD (chronic obstructive pulmonary disease), blood pressure medications, and trouble swallowing pills. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021, the patient experienced prolonged tiredness, increased weakness, dragging right foot when walks, little more trouble swallowing pills than before. No treatment was received for the events. The clinical outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

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.

Severe attack of Trigeminal Neuralgia requiring being transported to ER via ambulance. Began having attack during the early hours of the morning, 10 days after the 2nd vaccine. She had her first episode of Trigeminal Neuralgia on 1/8/21 and was doing well being treated with Homeopathic remedy Magnesia Phosphorica. Because Bells Palsy has been connected to the vaccine we are concerned that the 2nd vaccine could have exasperated her underlying problem of Trigeminal Neuralgia. Because her attack required treatment to the ER and caused her to require being treated with Carbamazepine we felt it was important to report this incident to you.

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

Patient received vaccine and approximately 30 minutes afterwards began experiencing tongue swelling, bilateral hip, knee, leg and shoulder pain, and dizziness.

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.

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

She doesn't remember exactly when it started, approximately within 24 hours of vaccination Nerve pain in hands and feet, pins and needles feeling Worse after second vaccine Stiffness ongoing PCP started on Gabapentin to help with pain

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

The patient presents with generalized weakness and fever. She has been feeling weak in general for past 2 days. She developed fever (103F) today. She also has a decrease appetite. She does not have any pain. She denies any chest pain, headache, sore throat, abdominal pain. She denies any cough, shortness of breath, vomiting, diarrhea, or dysuria. She does not have any sick contact. She received Pfizer COVID-19 vaccination about a week ago. Since then, she has been feeling slightly weak and fatigued.. Given fluids and discharged to home stable.

Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands./tingling in hands; both legs swelled some; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in right arm on 03Feb2021 as single dose for COVID-19 immunisation. The patient had no medial history or concomitant medications. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 as 1st dose, single dose for COVID-19 immunisation. On 04Feb2021, the patient's both legs became numb from the knee down, they swelled some, but numb as they can be and experienced tingling in her hands. The numbness in her legs got real bad in the night of 04Feb2021. On the morning of 05Feb2021, the legs were still partially numb but not as numb as in the night of 04Feb2021. The fingers were also numb on both hands. The tingling was just in her fingers. The patient was wondering if these were after effects of the vaccine. She didn't have a prescribing doctor and was advised by her doctors to get it though. She wanted to know if this was one of the side effects. She stated that she know no other reason other than this that she would get this reaction. Outcome of the events Legs are numb/numbness in legs from knees down/ Fingers were also numb on both hands/tingling in hands was not recovered while that of the event both legs swelled some was recovering. Follow-up attempts are completed. No further information is expected.

a sore arm for a few days with both doses in the left arm; This is a spontaneous report from a contactable consumer (patient) or other non HCP via agency. A 93-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EN6208, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Mar2021 14:00 (at the age of 93-years-old) as 1st dose, single for covid-19 immunisation. Medical history included ongoing high blood pressure, cardiac stent, ongoing non-hodgkin's lymphoma. concomitant medications caller takes medicine but does not think they are relevant to this report. She does take medicine for her blood pressure. The patient previously took flu vaccine and experienced sore arm. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EP7533; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 09Apr2021 14:00 (at the age of 93-years-old) as second dose, single for covid-19 immunisation. She reports she did have a sore arm with both of her Covid 19 vaccines. On 19Mar2021, the patient experienced a sore arm after first dose. On 09Apr2021 the patient experienced a sore arm after second dose. Sars-CoV-2 antibody test came back that she has no antibodies after receiving both Covid 19 vaccines and she may not be getting the benefit of the Covid 19 vaccine because of her Non-Hodgkin's Lymphoma. Patient thought everything was fine. On 26 APR 2021, she had appointment with her oncologist, she has non-Hodgkin lymphoma, more or less in remission not getting treatments for 4- 6 months, she goes for complete blood test and visit with him. On that blood test, he added a SARS COV-2, antibody, LQG spike semi, quantitative. Took a few days before she could call him back from results of the particular test, it turns out that no antibodies were found. Her PCP on vacation, spoke to her 10May2021, she told her you have no immunity. and said, if you want you can come in and get the Moderna shot, you can get it here. because her Oncologist, said to not take any more tests, until you see her 14Jun2021 and we will take another blood test. The patient has been staying out of Restaurants, really staying away from people, wearing a mask. She went to her oncologist for a regular visit and her doctor did a complete blood test including the Sars-Cov2 antibody test. She had her second Covid 19 vaccine on 09Apr2021 and her appointment with her oncologist was on 26Apr2021. She was concerned because the Sars-Cov-2 antibody test came back that she has no antibodies. Her blood work was sent. She called her primary care doctor, and that doctor reviewed her blood work and confirmed that she had no Covid 19 antibodies. She hope's she was wrong. She has no immunity even though she had both her Covid 19 vaccines. She called the CDC, and the CDC said the Sars-CoV-2 antibody test wasn't a responsible test and she shouldn't have even taken the antibody test. She called her primary care doctor, and her primary care doctor offered the Moderna Covid 19 vaccine to her or another Covid 19 antibody test. She was not going to mix the Covid 19 vaccines. and her oncologist told her not to get any more blood tests until her next follow up visit on 14Jun2021. She was not sure if she even wants to take another antibody test. She was very unsure of what to do next. Her primary care doctor also said she may not be getting the benefit of the Covid 19 vaccine because of her Non-Hodgkin's Lymphoma. She does have Non-Hodgkin's Lymphoma, it's in remission. She was not getting active treatments. She sees her oncologist every two months and gets blood taken. She asked the health department where and she was told she should only get her Covid 19 vaccines in a hospital setting. She finally found that was giving the Covid 19 vaccines, so she was happy to go and get her vaccine. When probing The sore arm only lasted about 2-3 days with both doses; it was not terrible. She was just conscious that her arm was sore. The patient underwent lab tests and procedures which included complete blood test: results unspecified on 26Apr2021, sars-cov-2 antibody test: negative on 26Apr2021. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Patient reports severe worsening of carpal tunnel syndrome after first dose of COVID-19 vaccine, has been persistent for past 4 months, not improving

they were told they were getting the Moderna vaccination but she was given the paperwork for the Pfizer Covid 19 vaccine; sore arm/arm is continuing to hurt and her lump is bigger and now it's getting red; increased redness at the injection site; The pain is also described as hurting up into the shoulder; arm is continuing to hurt and her lump is bigger and now it's getting red; arm is getting redder and larger and it hurts up into her shoulder and down to her elbow; arm is getting redder and larger and it hurts up into her shoulder and down to her elbow; mother has back problem and she is having back pain now too; This is a spontaneous report from a contactable consumer (Patients daughter) reporting for her mother. A 93-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 22Mar2021 11:30 (at the age of 93 years) as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at dose number unknown, single for an unspecified indication. Medical history included dementia (Verbatim: dementia), myocardial infarction (Verbatim: 4 heart attacks), stroke (Verbatim: 4 strokes), angioplasty (Verbatim: 9 angioplasties), angiogram (Verbatim: reaction to the dye when she gets the angiograms), mother has back problem, thyroid. On an unspecified date concomitant medication(s) included ongoing warfarin (WARFARIN); unspecified thyroid medication(0.075mg) she doesn't think her mother needs her thyroid medication anymore, but the caller needs her thyroid medication because she doesn't have a thyroid. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced they were told they were getting the moderna vaccination but she was given the paperwork for the pfizer covid 19 vaccine, sore arm/arm is continuing to hurt and her lump is bigger and now it's getting red and ongoing, increased redness at the injection site, the pain is also described as hurting up into the shoulder and ongoing, arm is continuing to hurt and her lump is bigger and now it's getting red, arm is getting redder and larger and it hurts up into her shoulder and down to her elbow, mother has back problem and she is having back pain now too. Reporter stated, she wanted to know if her mother should take the second dose of the Pfizer COVID-19 vaccine since she has had these side effects after receiving the first dose, she should use hot or cold packs to help her mother's arm pain from the Pfizer COVID-19 vaccine injection, how long she can expect her mother's side effects to last after receiving the first dose of the Pfizer COVID-19 vaccine. She states it's difficult to determine exactly how painful her mother's arm is because of her limited cognition and ability to describe the pain, also states that at times the mother will refuse to use her arm and other times she will use it as if there is no problem. Her mother does have a pacemaker and defibrillator and the facility was advised of that before her mother had the Covid 19 vaccine. She reports that they were told they were getting the Moderna vaccination but she was given the paperwork for the Pfizer Covid 19 vaccine. She's assuming since she had received the Pfizer paperwork that she and her mother had received the Pfizer Covid vaccine. Patient asking why her arm is sore and with her age and her dementia a few years ago her mother wouldn't have been complaining. She would have been different. She would have thought that her arm soreness was just part of the vaccine. Now reporter is concerned. She just wanted to call and check because her mother keeps holding her arm. Yesterday she put ice on it and she doesn't know if she should have done that. The caller reports she tries not to take her mother out because of Covid 19. She does go to the heart doctor because she's on the blood thinners and has the pace maker and defibrillator. Her mother has a tendency to get any infection easier now. Patient acts like a child sometimes in showing her arm and complaining about it. Daughter doesn't remember when her mother's arm started hurting. She remembers her mom saying there was a lump in her arm and the felt her own arm and felt a little lump in her arm too. Patient had open heart surgery also and the doctor went in and put a clamp on her leaking valve in her heart. She did have a reaction to an antibiotic during that time. reporter doesn't recall the name of the antibiotic. She reports it was done intravenously and her mother came out red as a beet, reporter states because of the Covid 19 you have to be in bad shape to go to the emergency room. The outcome of event arm is continuing to hurt and her lump is bigger and now it's getting red, arm is getting redder and larger and it hurts up into her shoulder and down to her elbow was not recovered rest of all event outcome was unknown. Description of complaint: Caller reports her mother is on Warfarin and occasionally the doctor has to change it up a little bit. The warfarin is in a pharmacy bottle. TARO is the manufacturer. Caller does not see an NDC/Lot/Expiry. No follow-up attempts are possible. Information on lot/batch number cannot be obtained.

1:45 PM flushing with headache Blood Pressure: 120/64; Pulse 80; Pulse Ox: 98% 1:55 PM Blood Pressure 170/90; Pulse 84: Pulse Ox: 98% Resident up and walking 2:05 PM Slight headache Blood Pressure 130-70; Pulse 78; Pulse Ox: 98%

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.

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

emergency room HPI A 94 y.o. female who presents with complaint of generalized weakness for one week. She had her first covid vaccination one week ago also. She denies fever, chills, body aches, dyspnea, cough, nausea, emesis, abdominal pain, diarrhea, urinary tract symptoms. She does have some anorexia.

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.

2 days following her Pfizer shot, patients face started burning all over and became bright red. Redness and pain continues but has lessened some to date (3/31/21). Face started to peel a couple of days ago and is continuing to peel. Patient describes it as a very intense sunburn, but she has not been out in the sun. Patient is now on day 12 of reaction.

started with dizziness, nausea, abd pain on 3/29/2021. treated conservatively. seen in office on 3/31/2021. She started improving the morning of 4/1/2021. Developed Left Bells Palsy on the afternoon of 4/1/2021. Seen in office on 4/2/2021

Patient experienced generalized weakness, nasal congestion and decreased appetite on 4/14/21 and was tested for COVID-19 infection. Symptoms worsened and patient presented to emergency department. Patient was admitted to hospital for treatment of COVID-19 pneumonia.

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.

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

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

Pt had acute ischemic stroke involving right vertebral artery 16 days after dose number one of Pfizer vaccine. She developed sudden dizziness and loss of leg strength, fell to floor. it took 7 hours until she was found and taken to hospital, so did not receive TPA. CTA on 2/27/2021 showed occluded V4 segment of rt vertebral artery. residual deficits currently include imbalance, loss of lower extremity strength (now in wheelchair), loss of hearing and discordant occular movement.

Patient presented on 07/15/2021 with a four day history of feeling cold all the time. Also has a cough, fatigue, mild sore throat, and nasal congestion.

Stable at time of vaccine 1/15/21 and 2/5/21, Transferred to ER for pocketing food, Left facial drooping and left sided weakness on 7/4/21. Returned from hospital 7/14/21 w/gastrostomy nutritional status and hospice care. She expired w/end of life hospice care in place on 7/15/21.

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

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

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

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

She began exhibiting seizure like activity, admitted to hospital and observation and since has returned to the facility.

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

DEVELOPED FATIGUE, WEAKNESS. NORMALLY AMBULATES WITH A WALKER, BUT REQUIRED A 2-ASSIST WITH TRANSFER AND USING A WHEEL CHAIR. WAITING FOR GUIDANCE FROM PCP.

Getting hot and cold; Gets hot and sweaty; Does not feel like doing anything, feels lazy; Hungry and eating like crazy/has been more hungry and eating more; This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246, expiration date: 30Jan2021) via an unspecified route of administration on the right arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included walks with a walker, both knees replaced a year ago on 11Mar2020 (prior to receiving the vaccine), she had the mucus in her throat and a little bit of a cough prior to getting the vaccine. She had allergies. She normally has the mucus and cough in the morning when she gets up. She is also blowing her nose a lot. There were no concomitant medications. The patient was starting to get hot and cold. She was unsure if she has a fever as she does not have anything to measure it with. She gets hot and sweaty. She feels good but is hungry and eating like crazy on 09Jan2021. She is talking and breathing fine. Getting hot and cold and hot and sweaty: Happened a few days after the vaccine. She was unsure what day, maybe the day before yesterday, or yesterday and today. Yesterday she took a shower and she also took some guaifenesin (MUCINEX). This made her feel better. For example, she had lunch a while ago and she did not feel like doing anything. She felt lazy. She usually swims at 6 AM Monday, Wednesday, and Friday, and she did not go. Her friend said this was not like her. She also did not want to shower yesterday. She kept putting it off and then she finally showered and felt terrific. Her body felt like her body. She has always been a good eater, but since the vaccine she has been more hungry and eating more. Right now, she is starting to get warm as she is talking. It will go away and come back a little while later. Outcome of the events 'getting hot and cold' and 'gets hot and sweaty' was recovering and not recovered for the other events.

Patient did not have any issues until 1/29/21 at around 8:40 AM (the day after vaccination). Her symptoms are: Pale, lethargic, hypotension, slurred speech, unable to verbalize, and weak. Her blood pressure was found to be 68/34. Pulse was 66, O2 93, and temperature was 98.6 degrees F. EMT was called and the resident was sent out. Hospital has been called and they are unknown what is going on and unsure if the resident will be admitted or not.

very weak; couldn't stand or walk; couldn't stand or walk; fever; could barely speak; lethargic; fell into a deep sleep; This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 19Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included AFIB, chronic anemia, hip surgery in Aug2020 (recovering) and diagnosed with COVID-19 (prior to vaccination). Concomitant medication included levothyroxine sodium (L-THYROXINE), omeprazole (PRILOSEC), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS); sodium chloride; ferrous sulfate; folic acid; vitamin D3; guaifenesin (MUCINEX) and clarithromycin (CLARITINE) reported as 'Claratinde'. Approximately 22 hours after injection, on 20Jan2021 03:30 PM patient became very weak, couldn't stand or walk, had a fever, could barely speak, lethargic and fell into a deep sleep. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.

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.

today, the foot is swollen; unusual pain on her left foot that has been worsening; This is a spontaneous report from a contactable consumer (patient's daughter). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm, on 22Jan2021, at the age of 95 years, at a single dose for COVID-19 immunization. Medical history included congestive heart failure diagnosed a year and a half ago, reported as "October last year"; blood pressure abnormal (reported as blood pressure), pain and headaches. Patient had no prior vaccinations within 4 weeks. Concomitant medications included metoprolol 50 mg tablet for blood pressure; amlodipine for blood pressure; and tramadol 50 mg tablet for pain and headaches, patient has been on this about a year and a half. It was reported patient gets anxiety from her concomitant medications. The reporter stated that her mother, the patient, received the first dose of the COVID-19 vaccine on the left arm, last Friday, on 22Jan2021. She explained the next day, Saturday (23Jan2021), her mother experienced some unusual pain on her left foot that has been worsening and today, 26Jan2021, the foot was swollen. She asked if her mother's experience was a reported side effect to the vaccine. The reporter added that yesterday, 25Jan2021, the pain was not quite as bad, but today, 26Jan2021, it has worsened and was now swollen. The reporter clarified again it was just her left foot, not her whole leg, and stated it was just odd. The events were reported as non-serious, and did not require a visit to Emergency Room nor the Physician Office. The outcome of the events was not recovered, reported as worsened.

Patient was found unresponsive on her kitchen floor about 9:45 AM on February 10, 2021 approximately 18 hours after receiving her first Covid-19 vaccination. Exact time of the event is unknown. She was known to get up between 6:30 and 7:30 AM. It appeared that she had not eaten breakfast nor taken any medication that morning. She was taken by ambulance to Medical Center where a CT scan showed an unrecoverable massive brain hemorrhage. She died at approximately 3:50 PM after the respirator was removed. She was sent to the local Medical Examiner afterwards.

heart attack; became ill; I became nauseous; vomiting; dry heaves; dizzy; tingling in my face and right hand; right hand didn't feel like I could get up on my own; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 10:15 at SINGLE DOSE in left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) with lot number: EL3249 on 20Jan2021 in right arm. After receiving the 2nd dose on 10Feb2021, the patient became ill on 11Feb2021, while sitting on the toilet, she became nauseous and vomiting repeatedly even dry heaves also then became dizzy and felt a tingling in my face and right hand didn't feel like the patient could get up on her own so the patient's son and daughter assisted her to her bed. She didn't know what was wrong and her daughter thought it was a side effect of the vaccine and called the nurse on call. After arriving at the emergency and was examined the patient was told she was being kept for observation since she had just had the vaccine. The patient was later told she also had a mild heart attack and to her knowledge I never had any heart issues. She could then no longer use her walker to walk because she couldn't bear weight on her right hand. She was hospitalized for 8 days and transferred to rehab and I'm still in rehab. The events were assessed as serious (hospitalized and disability). The outcome of the events was not recovered. The patient received treatment for the events.

Patient reported GI distress, overheating, and tremor after approximately 5 minutes post vaccination.

a bruise on her ankle and it split open; a bruise on her ankle it split open; soreness of her arm where she got the injection after the first dose; back spasms pain; back spasms pain; This is a spontaneous report from a contactable consumer (the patient) via the Pfizer-sponsored program. A 95-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (at the age of 95-year-old) as single dose for COVID-19 immunization. Medical history included using a wheelchair. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced soreness of her arm where she got the injection after the first dose at 12 noon and then at 10 pm she had the pain. On an unspecified date, she had a bruise on her ankle and it split open so she put POLYSPORIN (bacitracin and polymyxin B) on it. Then she bruised it again on her wheelchair. She also reported experiencing bad back spasms pain for 3-4 days which happens periodically (unspecified date). The clinical outcomes of the soreness of her arm where she got the injection, back spasms pain and a bruise on her ankle it split open were unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

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.

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

Hives on back, arm and shoulder blade that are itchy and burning sometimes; Hives on back, arm and shoulder blade that are itchy and burning sometimes; Hives on back, arm and shoulder blade that are itchy and burning sometimes; This is a spontaneous report from a contactable consumer. A 95-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for Injection; Lot number: Unknown) via an unknown route of administration in the left arm on 29Jan2021 at 11:00 as single dose for COVID-19 immunization. The patient medical history included allergies to Penicillin, Bactrim and cholesterol medicines. The patient previously received the first dose of bnt162b2, via an unknown route of administration in the left arm on 07Jan2021 at 12:00 as single dose for COVID-19 immunization and experienced rash and hives on stomach, hip arm and shoulder blades on 11Jan2021 at 09:00 (the events resulted in doctor or other healthcare professional office/clinic visit and outcome was not recovered). The patient was healthy. The patients concomitant medications was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 29Jan2021, at 11:45, the patient developed hives on back, arm and shoulder blade that are itchy and burning sometimes. It was two weeks since second vaccine and it was still bothering the patient. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the events to be non-serious. The outcome for the events was not recovered. Information on lot/batch number has been requested.

VS Prior to vaccine- BP 112/74, Pulse 86, Resp 16, 99% RS. 12:05-Patient received her covid-19 vaccine and went back to waiting room. Her son brought her back and said "Something isn't right". LVN, was in the room with patient. Patient was unresponsive at this time. One sternal rub was attempted without response. Code blue was called. 2L NC placed, pulse ox 93% after placement. IV placed R AC with NS running to gravity per RN. Patient slightly responded to 2nd sternal rub. 2nd IV was placed L AC by RN. Dr. S and Dr. T was present in the room along with the code team. Patient started to come to semiconsciously when EMS arrived. At this time vitals were starting to stabilize. Patient left in route to hospital. BP 96/50, Pulse 68, 93% o2 sat, 141 blood sugar when patient left per ambulance.

On May 14, 2021, at 9:30 p.m., patient was found on the floor by caretakers who had her taken to the Emergency Dept. She exhibited signs of a stroke; her left side was paralyzed. A CT scan of her brain was done, which showed a blood clot in her brain, which caused the stroke. She was taken to medical center, where she remains as of today, June 3, 2021. She remains paralyzed on her left side so she is unable to walk, or to use her left arm, or to swallow without aspirating food into her lungs. Potentially we have found a care facility and hope that she will be moved there within a few days. Of all the people I know, patient is the last person I would expect to have a stroke. She has always had good blood, a strong heart, strong bones, has never smoked or drank, has never been overweight, and has always worked hard and exercised daily. Her internal organs are all strong and well-functioning. She has had two CT scans of her brain within the last couple of years, the last one near the end of 2020, and they were both clear. These scans were done following falls which she took. She had the the COVID-19 on January 23 and February 17 of 2021 and had a stroke on May 14, 2021. There is no doubt in my mind that her stroke was caused by these injections. She will never recover from this event and will probably get pneumonia, which will bring about her death!

6/29/21: 2 days of diffuse generalized abdominal pain, nonbloody diarrhea, increased general malaise and weakness. Patient feels chills but no measured fever at home. 7/1: Temp in ED 38.5. She uses 4L of O2 at night baseline but since her COVID Dx has been using 3L in the day as well. admitted to hospital 7/1/21.

Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am.

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

presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21

This hospice patient lives in facility and our team went to give vaccinations to all elderly resident on 1/26/2021. The facility reported to our nurse that patient received Pfizer vaccine at 12;37pm and went unresponsive at 12:55pm and immediately given 1st dose of epinephrine and followed by another doe of epinephrine after (total of 2 doses was given) has an allergic reaction. Patient recovered.

I woke up in the night with severe indigestion, a pain in my left jaw and pain in the back of my ribs near my heart. It?s subsided in about one minute time. This morning I woke up with some right arm pain but it was short-lived too. I have felt fine since...

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

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.

Excerpt taken from patient's medical record notes. Recreational Therapist was in room with patient who was at baseline mentation at that time, and was getting patient a cup of tea. Rec Therapist observed patient to "all of a sudden slouch down toward left side" and became unresponsive. Therapist called for help, and Registered Nurse (RN) and Certified Nurse Aide (CNA) came into room. Patient was initially non-responsive and profusely sweating and hot to touch. Vitals were taken (see below). The patient then slowly became responsive after approximately 4 minutes and was visibly nauseous and appeared like she was going to vomit, but ultimately did not. Patient was assisted into bed, APRN was called, order for vital signs to be taken every 4 hours for 72 hours, and Electrocardiogram (EKG) to be performed. EKG results were abnormal, indicative of infarct; APRN ordered transport to Emergency Department. Patient returned from Hospital ED at approximately 10:45 PM same day (1/28/21), with transfer paperwork documenting a Hospital diagnosis of "Syncope" without any additional lab results or any new medication or treatment orders in the documentation. Follow up the next day (1/29/21) by RN at the Nursing Facility--RN logged into the Hospital medical Charting system, only to find that there was no record whatsoever of the patient being in the Emergency Department on 1/28/21--no notes, no labs, no summary from a practitioner. Patient recovered and has resumed close-to-baseline activity and functioning.

Bell's Palsy Left side-3/08/2021 Seen at Emergency Room and was given treatment of Prednisone, ValAcyclovir, and ointment to left eye at night. She experienced severe left sided neck and left ear pain on Saturday 3/06/2021 and then got drooping of left mouth and left eye around 3 pm on Sunday, 3/07/2021, and was seen at healthcare Clinic and Emergency Room 3/08/2021 2 Doses Pfizer given: #1 on 1/21/2021 and #2 on 2/11/2021

The above info is available but it is as my mothers....She had a bad reaction ( very flu like for several days). I proceeded with second shot in February....she did not feel well, but just sorta didn't want to get up anymore. She slept more and more and more. Her appetite declined. I got her up and she was ravenous. She slept more and seemed in a lethargic way to take less and less interest. She was living independently and had been most of her life. We scheduled an internist report. She passed labs with flying colors....... when you are 96 they look at everything as remarkable ( will live for 10 more years). I also was not equating any of this with the vaccine. However, we could not ignore it any longer Saturday the 4-10-21. I took her to ER. She was lucid and walking with difficulty. I took her in by ambulance as she was just saying, "I'm so week!" I'm so whoozie! On Sunday they are talking immediate intensive rehab. Neurologist leave for 5 days and in next 48 hours she becomes 200% less. First delusional, then sleeps all day. He showed me an MRI that to a layperson looked like little hives all over the brain ( I had also gotten hives from somewhere on my skin that I originally equated with Covid but no one thought so. I have also had the two shots.) One week out I was looking at Hospic eand long term care placement. Yesterday they couldn't get a diagnosis for Hospice ( the person sent to sign her up). I thought what? After all these tests and maybe it is cardio, maybe it is exchemic strokes, they don't have a diagnosis because she hasn't changed much since 2017? We have to take this totally fine independent woman and in one week say, "She has Dementia?" It's possible but what caused it? It's not age......we live until we are 110. Yes, that MRI showed me little formations of clotting all over ( no major bleed if any in a lobe). Over the last week I have been looking at her health and how we just slowly went downhill. It's easy to blame a vaccine, but still..........I am saying that there were NO OTHER reasons other than she didn't seem to tolerate the shots well........first was acute, and the second was long term and slow...........

Disabling muscle spasms in right to center neck and upper shoulder/back; This is a spontaneous report from a contactable consumer (patient). A 96-year-old non- pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 96-year-old via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included High blood pressure. No known allergies. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks. Concomitant drug included unspecified other medications in two weeks. The patient experienced disabling muscle spasms in right to center neck and upper shoulder/back on unspecified date, resulted in Emergency room/department or urgent care, hospitalization and disability. Treatment was included OTC pain reliever. The outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

broke her hip; She described her mother-in-law as being frail and explained she fell; She described her mother-in-law as being frail and explained she fell; This is a spontaneous report from a contactable consumer (reporting for her mother-in-law) via the Pfizer-sponsored program. A 96-Year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 02Mar2021 (received at 96-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter described her mother-in-law as being frail and explained she fell, broke her hip, and had a hip surgery after getting vaccination. She added that her mother-in-law is now in a rehabilitation center. She asked what the longest interval is allowed for getting the second dose of the vaccine. She also asked if the vaccination series will need to be repeated when the second dose if given past 6 weeks. Therapeutic measures were taken as a result of broke her hip (hip fracture). Outcome of the events was unknown. Information on the lot/batch 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

feeling cold; stomach pains; coldness was in hands and feet; headache; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EW0164 and Expiration Date was not reported), via an unspecified route of administration in Arm on 16Apr2021, as 1st dose, single dose for COVID-19 immunization. Medical history included hypertension from Oct2009 and ongoing, cardiac disorder from Oct2009 to an unknown date, myocardial infarction from an unknown date and unknown if ongoing, stent placement from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS); metoprolol (METOPROLOL); simvastatin (SIMVASTATIN); isosorbide (ISOSORBIDE); acetylsalicylic acid (ASPIRINE) all taken for an unspecified indication from an unspecified start date and ongoing. It was reported that within the week prior (Prior to death), she complained of being cold, and had stomach pain, coldness was in hands and feet, she also mentioned headache. The outcome of the events was unknow. Follow up needed, further information has been requested.

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.

swelling and pain in the arm. The swollen spot was sizable for her small arms. There was no evidence of bruising or bleeding under the skin and no redness just swelling. We placed an ice pack on her arm for about 15 minutes and the swelling did go down some. By 5 pm the swelling was gone.

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.

Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as "Couldn't speak, slurring words, stuttering, couldn't formulate a sentence" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021.   Information of lot/batch number has been requested.

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

Joint pain in arms and back, increased pulse, (120-135) slight fever 100.4 - my temperature is usually around 97, the next morning temperature was 94.4. cough. These symptoms lasted, off and on for about a week. I had fever once. Feeling limp as a rag. No energy.

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

fatigue; Eyesight; Dizzy; bell's palsy; This is a spontaneous report from a contactable consumer (patient's son). A 97-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6207) intramuscularly in the right arm on 11Mar2021 at 14:00 as a single dose for COVID-19 immunization. Patient's medical history included glaucoma for more than 25 years - 'implants caser' (as reported), thyroid disorder for more than 25 years, eye disorder, and gastrointestinal disorder. The patient had no other prior vaccinations to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6201) intramuscularly in the right arm on 18Feb2021 at 15:00 as a single dose for COVID-19 immunization and experienced cannot focus with her eyes and full body aches and pains. Ongoing concomitant medications included timolol ("Timnol") drops for the eyes since more than 5 years, levothyroxine sodium (LEVOTHYROXIN) pill for thyroid since more than 20 years, and omeprazaole pill for stomach for 5 years. One week after the second injection (Mar2021), the patient experienced Bell's Palsy at 20:30, reported as serious for important medical event. On 12Mar2021 at 22:00, patient was dizzy and 'eyesight', both events reported as non-serious. It was further described as, "She saw patient over everything so she slept. Day after 2nd she had to had most of day as too Dizzy/fatigued to be mobile. Dangling/twisting side of face last 7 days ongoing." The patient did not receive treatment for Bell's palsy, dizzy or eyesight. The clinical outcome of Bell's palsy was not recovered, of dizzy was recovering, of eyesight was recovered on unspecified date, of fatigued was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185916 Same patient, reporter, event, different vaccine dosing

AT 10:50 AM (5 MINUTES POST VACCINATION), FELT LIKE 'HEAD IS FILLING UP, MY LIPS ARE PUFFY, AND I HAVE NUMBNESS UNDER MY EYES AND NOSE'. RECEIVED BENADRYL 12.5MG AT 10:59AM. CONDITION RESOLVED BY 11:15AM. MD WAS NOTIFIED.

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.

Pfizer vaccine, she presents with tremors, hypertension, tachycardia. Pt has a h/o Afib, and she tells me that she has had tremors in her RLE x6 months or so, but that it worsened today. Denies precipitating events. She also had SBPs up to 170's (150's/90's on my interview) and is tachy to 140's in sinus tach. Denies any caffeine today or anxiety or behavioral contributors today, no pain or other stimuli. Pt admits she is feeling jittery when she talks with me, and that taking deep breaths slows her heart rate to 70's-80's. Patient has notable history of cHF with associated LE edema in the past and should strongly be considered as part of this ADE assessment.

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

Client's daughter described events to me. Stated mother experienced tingling, weakness in legs about 7-14 days after receiving 2nd Covid vaccine. Also spoke with client for a few minutes. Stated could only walk a few minutes then legs felt like they were paralyzed and became really hot feeling. States toes felt like they were curling under left foot. Daughter took mother (client) to ER on Feb. 17 (after this had been going on for 4 days). Client was not admitted to hospital. Client stated no adverse events noted with 1st Pfizer Covid Vaccination. Client & daughter stated that client had bladder infection 1 week after receiving 2nd Covid vaccination. Client states problem with legs improving each day.

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

1/24/20211 unresponsive, sent to Hospital. Admitted with diagnosis: Acute Ischemic left MCA stroke. 1/26/2021 Transferred to Hospice care. 01/30/2021 died. I don't believe the hospital was aware of her vaccination date as it is not recorded in her records, therefore I assume that a previous VAERS report has not been submitted. My relationship to the patient is that I am her daughter.

patient received the second dose of the Pfizer vaccine at 1618, ten minutes post administration, patient started to feel weakness, dizziness, chest pain

Pt. received the Covid-19 vaccine and reported symptoms of dizziness, weakness and stated "my chest hurts" within approximately 10 minutes after receiving the vaccine Vitals signs taken as recorded below 1620: BP 155/80, HR 102, O2 95% 1623: 147/59, HR 98, O2 96% 1627 148/59, HR 97, O2 97% At 1628 EMS was called because the patient continued to report chest pressure and "feeling tired". At 1632 EMS arrived and was taken to the hospital. VS at time of EMS arrival: 159/50, HR 79, O2 98%

Pt developed red, swelled, warm, painful RLE at lower leg/ankle/foot less than 24 hours, near 12-18 hours after 2nd dose.

sweats; Chills; feeling horrible; it was progression of the disease; tired; energy level was gone/wasn't strong; low fever; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patients mother). A 98-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right Arm on 17Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol, blood pressure, synthetic thyroid replacement, kidney and breast cancer survivor. Concomitant medication(s) included levothyroxine sodium (LEVOXYL) taken for thyroid therapy, start and stop date were not reported, vitamins, Cholesterol medication, Blood Pressure medication. The patient previously had a flu shot. The reporter said her 99-year-old mother received the 1st dose of the Pfizer-; had mild symptoms. Her mom is 99 and in good health. Her dad lived until 110. Her mom had first Pfizer shot through the assisted living facility on 17Jan2021. During routine testing her mom tested positive for COVID 25Jan2021. She had mild symptoms that started on the 26Jan2021. She was tired. Her energy level was gone and she had low fever. For prevention and to stay safe she had monoclonal antibodies infused on 29Jan2021. After that, she got really bad with fever and sweats. She never had trouble breathing. When taking her back from receiving the monoclonal antibodies, her mom had chills and was feeling horrible. They said it was progression of the disease. It took a month for her to get her strength back, but now she is great. She wasn't strong when she was due for second shot on 07Feb2021 and she didn't get it because they didn't want to stress her. She didn't have any stamina at that point. Now caller has been reading that some people say wait 90 days after monoclonal antibodies for the second dose. Her mom's thyroid doctor said not to give it. Her mom got better within the month, but would tire easily. She would be spent and couldn't do anymore. Now she is back to normal. She is up all day and stays up until 11PM.The outcome of the events was not reported.

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.

Developed acute facial droop and slurred speech 2h after 1st dose of the vaccine on 2/17, found with R MCA stroke. Then became unresponsive on 2/27 and was found with an acute L MCA stroke. Was transferred from another hospital, was not a candidate for intervention, and was made comfort and died on 2/28

she was dying as her blood pressure dropped to 70/40 and to come for a last visit; This is a spontaneous report from a contactable consumer. A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. Medical history included COVID in Dec2020, urinary tract infection (UTI), dehydration and Covid sickness (vomiting) (was treated earlier in month for UTI and dehydration from the Covid sickness (vomiting)). Known allergies: no. The patient's concomitant medications were not reported. After testing positive in mid December to COVID and being declared Covid free on 30Dec by the nursing staff and in good health, with normal vitals and oxygen levels, the patient was given a vaccination on 02Jan2021. In the early evening the patient's blood pressure dropped to 70/40 and the reporter was told to come for a last visit. The patient was sleeping comfortably. She did not wake up when spoke with her. No one expected her to make it through the night. The next morning she work up, ate breakfast, watched TV, got IVs and oxygen and her vitals improved significantly. Lab tests and procedures included blood pressure: 70/40 on 02Jan2021, oxygen levels: normal, COVID test: positive in Dec2020 (testing positive in mid December to COVID and being declare Covid free on 30Dec), vitals: normal; improved significantly. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been tested for COVID-19: No. AE resulted in: Life threatening illness (immediate risk of death from the event). Serious: Yes. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about lot/batch number has been requested.

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.

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

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

Resident reported feeling nauseous and wanted to vomit and did not. Had an episode of diarrhea and needed assistance as she was unable to make it to the restroom (this is not her normal) and was noted to have extremity tremors. Legs and arms were noted to be shaking and resident had c/o not being able to walk steady because of it. Resident was assisted with a shower and after relaxed with no further complaints. Was treated with PRNs for nausea with 20ml of Geri-Lanta Suspension and diarrhea with 15ml of Loperamide HCl Suspension . Pulse was noted at 101 and all other vitals WNL. Resident reported she had not consumed much fluids during the day. Was instructed on hydration and fluids were provided. Resident per post COVID-19 Vaccination protocol was administered PCR COVID test with NEGATIVE results and placed "under evaluation" status and placed in "Special Droplet/Contact Precautions." Resident reports today "feeling good" and has no further noted or reported episodes of diarrhea, nausea or extremity tremors or changes in her gait.

Patient 101 years old, nursing home resident, received vaccine 1/11, on 1/13 found on floor without obvious trauma, unresponsive. Brought to ED and was bradycardic, hypotensive, hypothermic and refractory to aggressive medical management. No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as soon as discovered.

vaccine appt 11:30 am vaccine administered 11:42 am observation 15 minutes left facility 11:57 am fine for 36 hours except pain in left arm onset of vomiting, severe stomach pain and ultimately several BMs sweats and weakness Primary Dr was called finally about 12:30 all symptoms subsided lingering abdominal pain used heating pad slept off and on in night but no further events no events today 2/14/21 other than weakness, fatigue and arm pain - light diet and hydration Dr suggested ER - didn?t want to go

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

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

Patient received vaccine at 1344.. Upon the end of observation time at 1400 patient's caretakers began to wheel the patient out. Patient's caretakers did not check in with the medical team. When they discovered she was unresponsive in wheelchair in hallway of facility they alerted the medical team. Several staff members (RN's, ER MD) at patient's side obtaining VS, changing out pts home O2 NC to a NRB mask. Patient appeared to have vomited on self before medical team arrival. Vitals taken at 14:05 BP 127/106, HR 64, SP02 89%. Emergency department team arrived. Patient transferred to gurney and taken to emergency department for treatment.