Pfizer

Nurse wanted this rxn reported. The patient had severe chills. The nurse said this is not normal for this patient.

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

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.

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

Super tired/exhausted; This is a spontaneous report from a contactable consumer (patient). This 90-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiry date unknown), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included blood cholesterol abnormal and thyroid disorder. Concomitant medications included levothyroxine for thyroid, atorvastatin for cholesterol, and unspecified vitamins. When she got the first dose of the vaccine, she felt fine when she got it in the morning and then she felt super tired later in the evening. She went to bed about an hour early as she was just exhausted. She stated that at her age, she was always tired in the evening but she was just exhausted that evening. She got "no temperature". The patient felt fine/normal the next day. She felt as good as she usually did. She did not receive treatment for the event. Due date for the second dose was reported as 28Jan2021. Outcome of the event was recovered on 07Jan2021.

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.

Approx 10-15 minutes after receiving the vaccine, client reports dizziness and lightheadedness. Vitals monitored. Client had removed her Clonidine patch the day before due to vaccine, and was instructed this was not necessary. Vitals stable, released to her son that was with her. Now c/o Headache and dizziness, but she thinks it may be related to her ear problems.

1st dose, tired about 5 HR after vaccine. Tired 2nd day after 1st dose. 2nd dose was 4 1/2hr ago, so far no symptoms. Bed rest.

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 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.

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

Patient reported 5 days of joint pain and fatigue after the second covid vaccination Did not seek medical advise, symptoms resolved on their own after 5 days with rest, hydration

I felt sickish at stomach. Did not vomit but not hungry. Excessive amount of gas on stomach. Some coughing. My normal temperature is 96 or 97 but it measured 99 degrees then. This could have been a touch of something else but since it followed the shot, I felt that it was the probable source. I was also very tired. It lasted about 4 days.

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.

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

11:11 After vaccination patient started to feel headache pain that radiates down to her chest. Began feeling chest pressure that doesn't radiate anywhere else. Patient stated that pressure is 7/10 pain. At 11:20 patient stated that "Headache is now gone but chest pressure remains the same." Daughter is with patient, poor historian on history and medication. Patient does have history of having Covid in December 2020 with hospitalization. Patient had similar event while hospitalized when given "certain medication" and it caused chest pressure which prompted medical staff to stop. EMS was called to come assess patient's need for higher level of care. Upon arrival, patient stated that pressure still "remained the same". After further assessment and EKG, decision was made to take patient to Hospital Emergency Dept for further treatment. Daughter made aware of decision and left with patient.

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.

Patient began to complain about secretions on 2/1 and phlegm for days post vaccine. Following that she complained of upset stomach upset and large mucus. Loose stool followed on day 6 post vaccine, with continued large amounts of mucus.

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

Patient received 2nd dose Pfizer Covid-19 vaccine on 3/2 then developed positive Covid-19 test on 3/23. Had fever but also confirmed E Coli bactremia.

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.

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

02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic. She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on 3/12, poor PO intake and weight loss. 3/23 Resident passed.

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.

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.

Chills; Achy; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received second dose (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in the right arm on 15Feb2021 (age at vaccination was 90 years) as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history and concomitant medications were not reported. Historical included first dose of bnt162b2 (lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration, administered in the right arm on 25Jan2021 and experienced diverticulitis. The patient experienced chills and achy on 16Feb2021 12:00 with outcome of recovered on 16Feb2021 19:00. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.

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

5/2/2021 - productive persistent cough and poor appetite. Received physician order to transfer to Hospital for evaluation.

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

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

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

Blisters (size of a quarter) keep breaking out on legs. A lot of them break out repeatedly in the same spot. They are painful and she feels fatigue with them. She has been given a topical cream. (Fluorouracil) The cream does not seem to do anything. She has been to the hospital, primary doctor and dermatologist. Blisters continue to break out everyday. In addition, she was diagnosed with Macular Degeneration in her right eye.

She got her 2nd vaccine, and almost immediately into her shoulder had pain in her shoulder blade and into her neck and had a lymph node on the right side of her chin/upper neck, then she has another one that is smaller and back further, and possibly a third one that is almost to the right side of her neck, tiny in nature. None on the left side at all. She felt that they would eventually go away and didn't do anything about it. She went to see her Dr., and he did a neck scan on 4/7/21, and reported that it was not cancer and told her to watch it, but if they were there in 4 months that they would have to be removed, they are still there. They have not changed in size. She has not gotten any more either. She definitely can feel the two and the third one is there but tiny. Her arm is still very sore at the site of the shot at the muscle. Almost daily at the site it gets very very sore and she gets chills and has to lie down due to exhaustion that lasts about 40 minutes and has to go lay down and then she gets back up once the chills pass. She was having it every day at noon almost every day, and still continues pretty much on a daily basis, but the arm is still very sore.

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.

extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 90-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the right arm on 04Mar2021 at 13:30 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma. Concomitant medications included timolol maleate, dorzolamide hydrochloride (COSOPT), tafluprost (ZIOPTAN), losartan (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), simvastatin (ZOCOR) and vitamin d (MANUFACTURER UNKNOWN); all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9810), via an unspecified route of administration in the right arm on 11Feb2021 at 02:30 (at the age of 90-years old) as a single dose for COVID-19 immunisation and betahistine mesilate (DARVON) and indometacin (INDOCIN) on an unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 06Mar2021, the patient experienced extreme fatigue since the second dose. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of extreme fatigue was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

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.

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.

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

Immediately, felt burning at injection site, then mild headache, lips tingling. . About 40 minutes later, lips and tongue swelling, and uncomfortable swallowing.

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

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

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

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.

Ears blocked, pressure in head, loss of hearing. Next day -pain in abdomine followed by diahrea - general not feeing well,

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.

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.

Ongoing decline overall. Remained on Hospice with increased lethargy documented on 1/20/21 and progressively worsening thereafter.

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.

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

Patient had declining health for the past 6 months, dementia and unable to walk. Patient had decreased appetite starting 1/1/21. After 1st vaccine shot patient appetite decreased further. After 2nd vaccine shot patient fatigue increased to the point where she could not get out of bed and had minimal appetite. Patient passed away 10 days after receiving 2nd shot on 2/22/21. Patient did not go to ED and was not hospitalized.

Nausea; Diarrhea; Kind of not feeling good; Throwing up; This is a spontaneous report received from a contactable consumer (patient's daughter). A 91-year-old (also reported as 92-year-old) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), intramuscular on the right arm, on 25Jan2021 19:00, at single dose, to prevent covid/COVID-19 immunization. There were no medical history and concomitant medications. It was reported that the patient had the first shot of the vaccine on 25Jan2021 at 19:00 (yesterday). The patient was surprised that the shot did not hurt going in and she was not having any pain in the arm. On 26Jan2021 (this morning), the patient was experiencing nausea, diarrhea, was throwing up and was feeling kind of not good. The patient stated that the side effects were ongoing. No treatment was given for the events. The outcome of the events was not resolved. Information about batch/lot number has been requested.

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,

On 2/9/21 patient received her first vaccination in her right arm. She only had a mild headache that afternoon that Tylenol took care of. On 3/2/21, patient received her second vaccination in her right arm. That same afternoon she had a mild headache that Tylenol took care of. On the evening of 3/6 she noticed a slight itchiness on her arm near the injection site. She took 1 24hr Fexofenadine and rubbed 1% hydrocortisone on the affected area. The following day, on 3/7 she noticed the swelling spread and the itchiness was worse and she took another Fexofenadine and used the 1% Hydrocortisone. As of today, 3/9 the itchiness is slightly better but the swelling & red area is still present.

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.

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

Dizzy; not feeling well; Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head/a "shush"ing sound, like steam evaporating from a teakettle letting out steam; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown),via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 91-years-old) as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies.The vaccine was administered at a Nursing Home/ Facility. Concomitant medications included macrogol 3350 (MIRALAX) and losartan potassium (LOSARTAN POTASSIUM) 25 mg. Historical Vaccine includes BNT162B2, Dose 1; Administration date: 06Jan2021 at 03:00, Lot Number Not Provided, in the left arm. On 31Jan2021 at 12:00 the patient experienced dizziness, malaise and tinnitus. 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. The clinical course was reported as follows. About 4 days after Second shot, on '31JAN2021 at 12:00' patient started to get dizzy and not feeling well. Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head. It is like a "shush"ing sound, like steam evaporating from a teakettle letting out steam. This has been for 2 weeks. The patient went to the Emergency Room and/or Doctors Office and was checked, vital signs normal, had scan of head and stomach, EKG and bloodwork. No treatment was given for the events.The noise has never subsided in the past 3 weeks. . The patient underwent lab tests and procedures which included blood test: unknown results on and unknown date, electrocardiogram: unknown results on an unknown date, Scan of head and stomach unknown results on an unknown date and vital signs measurement: normal on an unknown date. The clinical outcome of the event dizzy, malaise and tinnitus was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

SYNCOPE, fall, head contusion FATIGUE DIARRHEA Pneumonia due to SARS-associated coronavirus Diverticulitis Hyponatremia Hypoxia Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC)

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

Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4/six days running a 100degree fever; my blood pressure went to 170/100; my oxygen dropped to 88%; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient (non-pregnant) received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in right arm on 02Feb2021 09:45 AM (at the age of 91-year-old) as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease/COPD, asthma, hypertension. The patient has no known allergies. Concomitant medications were not reported. Patient took unspecified other medications within two weeks of vaccination. No other vaccine in four weeks. Patient was not tested positive for Covid prior vaccination. On 22Feb2021 at 10:15 AM, the patient experienced vomiting, blood pressure went to 170/100 and oxygen dropped to 88%. She was in bed end of the care of her daughter for six days running a 100 degree fever. Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested positive for Covid post vaccination. No treatment was taken for events. Outcome of events was recovered in 2021. Information about lot/batch number has been requested.

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.

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

LAb work discovered on 4-23-2021, physician called and reported that red blood cells and platelets were very low. After a second blood test 10 days later, doctor reported that blood transfusion may be necessary. Transfusion was not received. At that time, bone marrow biopsy was ordered by hematologist. Blood condition had changed to myelofibrosis. Additional testing pending CAT scan and ultrasound for thrombosis lower extremities. Continue to suffer from extreme fatigue and feeling of despair.

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

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

Patient 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.

passed away; cough; This is a spontaneous report from a contactable consumer, the patient's daughter. A 92-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 in the left arm on 13Jan2021 at 11:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization. Ongoing medical history included nursing home resident, admitted to hospice on 13Jan2021 (prior to vaccination), and oxygen supplementation (due to low oxygen levels) from a few days prior to the vaccine (Jan2021). Other relevant medical history included congestive heart failure from Dec2020 and sulfa allergy. Prior to the vaccination, the patient was tested numerous times (as reported) for COVID-19 and was negative. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. A few days before the vaccination, her oxygen level had gone down, and she had been placed on oxygen. Prior to receiving the vaccine, the patient was reported as being 'fine'. On 13Jan2021, the patient received the vaccine at 11:00. The patient coughed maybe 5 or 6 times and then dropped her head. Resuscitation was not performed as patient had a do not resuscitate (DNR) order. The patient passed away on 13Jan2021 at 13:05. The cause of death was not reported. An autopsy was not performed. The clinical outcome of the cough was unknown at the time of death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away

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

Resident coughing in dining room, staff suctioned, physician stated to transfer via 911 to hospital, 6:33 PM. Hospital notified Nursing Home staff resident passed away at 8:25 PM. No adverse reaction noted to the Covid vaccine 24 hours after each dose at Nursing Home. There was no airway obstruction, cardiorespiratory arrest, death was natural at hospital.

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.

fever; chills; headache; fatigue; This is a spontaneous report from Pfizer via a contactable consumer (mother). A 92-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 92-years-old), via an unspecified route of administration on 21Jan2021 as a single dose for covid-19 immunization. The patient has no medical history and Is not taking any concomitant medications. On 26Jan2021, she experienced fever, chills, headache, and fatigue. The clinical outcome of the events fever, chills, headache, fatigue was not recovered. Information on Lot/Batch has been requested.

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.

injection site started itching; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; Strange area around injection site about size of silver dollar, red around outer rim and kind of orangeish colored in the middle; feel extremely unwell; feverish 97.5-97.6 degrees Fahrenheit; tired; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (upper arm) on 20Jan2021 11:00 (at the age of 92years) at single dose for Covid-19 immunization. Medical history included breast cancer, second right breast lumpectomy related to breast cancer from 16Oct2020 to an unknown date, first right breast lumpectomy related to breast cancer on an unknown date (done about 3-4 years prior to second right breast lumpectomy related to breast cancer), on blood thinner, allergic to the statins and allergy to unknown product (She was once given something, some medication for her heart, but about 5- 6 weeks later she developed a reaction to it so she was taken off the medication but does not remember the name of the drug.) The patient would consider herself obese at this weight, but that is probably because she was always very thin historically; her doctor has never diagnosed her as being obese or advised her to lose weight. The patient's daughter had a very, very aggressive form of breast cancer-she is deceased 11 years. Patient's younger sister had breast cancer; there is a lot of breast cancer on her husband's side- his mother, sister, niece all had breast cancer, they have a big history of breast cancer; other types of cancer in patient's family include her mother who died of pancreatic cancer in her 80s; and her dad had prostate cancer but he was in his upper 80s; and patient's older sister died of leukemia. Concomitant medications included warfarin from an unspecified date at 5 mg (daily x 2 days/week) then 2.5 mg (daily x remaining 5 days/week) as blood thinner and metoprolol from an unspecified date at 25 mg, 2x/day (morning and evening) for an unspecified indication. The patient previously had Flu shot. The patient reported that she got on last Thursday (21Jan2021) the first dose of the Covid 19 vaccine at 11 o'clock. She did not feel anything wrong at the moment (also reported as she had no immediate reaction at all). A couple of days after (About maybe 2-3 days later sort of in the middle of the day, not the morning) she started to feel extremely unwell, feverish (although thermometer did not indicate any raise) tired and malaise she was really surprised because it occurred that long after administration. She took Tylenol and she was looking to know if this has been reported as a side effect of the vaccine and how to treat it. She was very concerned about it because she has never had an adverse event with any vaccine or inoculation before. She takes a yearly flu shot and never had any reaction. Feverish: She has taken her body temperature with her digital thermometer which does not show a fever, it shows like 97.5-97.6 degrees Fahrenheit so not a fever; but she feels feverish. On 26Jan2021 the injection site started itching and she looked at site which is way up high so she can't turn her neck that way; but found a strange area around the injection site that is about the size of a silver dollar, red around the outer rim and kind of orangeish colored in the middle. She has never had that occur before, and the skin in the middle of the area, the orangeish colored area has no pain. She reported that there was a mass of people at the location where she was administered the Pfizer COVID-19 Vaccine. There were hundreds of people there when she was for inoculation event so she is wondering if she could have picked up COVID while there. She called to ask about these events related to the product. She has no major allergies. The patient underwent lab tests and procedures on an unspecified date which included body temperature: 97.5-97.6-degree Fahrenheit. The outcome of events was unknown. Information on the lot/batch number has been requested.

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.

Headache; This is a spontaneous report from a contactable consumer (patient). A 92-years-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number; NDC number; Expiry Date: Unknown), via an unspecified route of administration on left arm on 02Feb2021 at single dose (shot left upper arm once) to prevent the virus (covid-19 immunization). It was unspecified whether Covid shot a Pfizer product. Covid shot manufacturer was unspecified. No Lot number of Covid shot since complainant does not have the product with them at the time of call. Medical history included ongoing high blood pressure (stated that she has had it for many years), and the patient was a handicapped (walked with a walker before the shot). There was no concomitant medication. Caller (patient) stated that "she had her first shot on Tuesday. She developed a headache this afternoon (04Feb2021). Patient was unsure if this was related the shot. She wanted to know if she can take Tylenol or something. She read that she cannot take Tylenol or aspirin. Clarified that it was the Covid shot." Patient was a handicapped and walked with a walker before the shot. Stated that "the brochure that they gave her recommended not taking Tylenol or aspirin. Wanted to know how long that will last that she cannot take Tylenol or aspirin. It has been two days since the shot." The patient experienced headache on 04Feb2021. Age at time of onset of event was 92 year. No investigation assessment. The outcome of event headache was recovered on 04Feb2021. Information regarding Lot/batch number has been requested.

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.

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

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

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

Hospital admission due to COVID-19 positive result. Patient tested positive on 4/7/2021. Patient was hypoxic and had a cough on admission. Patient was diagnosed with COVID pneumonia, was given Remdesivir and decradon. Patient was discharged on 4/17/2021

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.

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

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

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

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.

bad headache for 2 days, stomach ache for half day the first day , chills off and on the second day, muscular aches the second day, extreme fatigue for 2 days.

Chills began the same evening of vaccine. Nausea, loss of appetite, fatigue, started the following morning. Some mild diarrhea lingered two days following vaccine.

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.

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

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

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.

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

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

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.

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

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

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.

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

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%

Site: Pain at Injection Site-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Headache-Severe, Systemic: Severe drop in blood pressure, pulse, and o-sat-Severe

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.

pt states no symptoms until 1/29 pt stated she woke up w/ fever and did not feel. Pt called her PCP and spoke to the nurse and was told to rest and drink fluids and call if symptoms got worse.

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.

1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.

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

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

Cough; This is a spontaneous report from a consumer (patient). A 94-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number not reported), via an unspecified route of administration in the right arm on 26Jan2021 12:00 PM at SINGLE DOSE for COVID-19 immunization. The patient is vaccinated at a public health department. The patient is not pregnant. No other vaccines in four weeks. No COVID prior to vaccination and not COVID tested post vaccination. Medical history included High blood pressure, High Cholesterol both from unknown and if ongoing. Concomitant medication included amlodipine and simvastatin (reported as other medications in two weeks). It was reported that the patient experienced cough on 27Jan2021 at 12:00 PM. No treatment was given. The outcome of the event was not recovered. Information about Batch/Lot number has been requested

Client reported a metallic taste in her mouth, heaviness in her chest, headache, lightheadedness. On site EMS attended to client. B/P 130/70, EKG done-normal sinus rhythm. Client declined to be transported to the hospital. Client monitored for 30 minutes, reported that she felt "a little better" and wanted to go home. Client driven off site by her daughter. Client and daughter encouraged to call 911 in case of emergency and follow up with primary doctor. Verbalized understanding.

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

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.

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

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

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

Chills but no fever; Headaches for one and a half weeks; Dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 94-year-old female consumer reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 06Feb2021 12:00 AM (at the age of 94-years-old) at single dose for COVID-19 immunization. medical history included Allergies to Penicillin. Concomitant drugs were unknown. On 08Feb2021 the patient had chills but no fever. Headaches for one and a half weeks and Dizziness. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

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.

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.

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.

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

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.

assessed patient, auscultated normal lung sounds, chest tightness described from patient. Cough observed which was not normal for patient then 911 was called. paramedics arrived on scene, further assessed patient. Patient taken on stretcher by paramedics

Jan. 21, 2021, first shot. No side effects directly following it, but 10 lays later on about Jan. 31 suffered mild body aches and fatigue for 24 hours. No fever. Feb. 18, 2021, second shot. No side effects directly following it, but 4 days later on about Feb. 22 suffered sudden chills and fatigue for 24 hours. No fever. Complete recovery in both instances.

Headache. More likely due to high BP than vaccine, but had headache for 3 days after first vaccine dose.

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

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.

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

Friday the 26th Headache, fever of 100, and extremely runny nose all day Monday the 29th extreme tiredness all day, late afternoon spike in blood pressure (169/90)

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

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

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.

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

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.

Temp of 100.1 and unproductive cough on 1/17; temp of 100.4 1/28; O2 desaturation 88% on RA 1/28; Diagnosed with Covid-19 on 1/18/2021 Patient passed away on 1/29/2021

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

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.

There were no symptoms experienced on the first vaccination given on 1/14/2021. The second vaccination was given on 2/4/2021, the following day (2/5/2021) patient complained of fatigue and nauseau. In the evening she went into cardiac arrest and died.

Patient contracted COVID-19 after receiving two doses of Pfizer vaccine. Date of admission approximately 10 week post vaccination. Dates of vaccination unable to be verified as City Immunization Record unable to match with patient. Patient was vaccinated at the a facility. Patient was admitted on 3/31/2021 with ~ 4 days of cough and decreased appetite, found to be COVID positive with pneumonia. Patient received supplemental oxygen, decadron and completed a course of remdesivir. She has improved clinically and was discharged on room air.

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...........

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

she passed away last night; She reported no side effects other than being tired.; This is a spontaneous report from a contactable consumer. A 96-years-old female patient (reporter's mother) received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included high blood pressure, heart disease, stent in heart. The patient was not pregnant. There was no known allergy. Concomitant medications included blood pressure and other medications. The patient previously received first dose bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation. Patient received her second Pfizer vaccine on 07May2021. She reported no side effects other than being tired. It may not be related to the vaccine, but she passed away last night. Note that she had heart issues. The adverse events resulted in Emergency room/department or urgent care. Treatment for the adverse events included CPR and other life saving measures. There was no Covid prior vaccination. The patient was not Covid tested post vaccination. Death cause was unknown; may be listed as heart attack (as reported). The outcome of event Tiredness was unknown. The patient died on 09May2021. An autopsy was not performed. Information about lot/batch has been requested.; Reported Cause(s) of Death: she passed away last night

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

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

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.

My mother collapsed the morning after her second shot.; She was non responsive; blood pressure was very high; limp, could not walk; squeezing sensation around head; Fatigue; This is a spontaneous report received 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, Batch/Lot Number: EWo191) via an unspecified route of administration, administered in Arm Left on 09Jun2021 at 01:00 PM as single dose for covid-19 immunisation at Pharmacy/drug store. Medical history included renal insufficiency and Grave's Disease. Patient had no known allergies. The patient's concomitant medications were not reported but she received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ewo176) via an unspecified route of administration, administered in Left arm on an unspecified date in May2021 at 01:00 PM covid-19 immunisation. On 10Jun2021 at 09:00, the patient collapsed the morning after her second shot, she was nonresponsive, limp, could not walk, blood pressure was very high, squeezing sensation around head (stated did not know what year it was). Ambulance was called and she was hospitalized for two days. CT scans and blood work were normal. ER (emergency room) Doctor and floor Doctor both said it was an extreme reaction to the second dose of the vaccine. Fatigue, unresponsive episodes continued for two days after she was released to home. The patient underwent lab tests and procedures which included blood pressure measurement: high, blood test: normal, computerised tomogram: normal, echocardiogram: unknown, urine analysis: unknown. Therapeutic measures were taken as a result adverse event. The outcome of events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on close temporal relationship the causal role of the vaccine cannot be excluded for the reported events. Renal insufficiency and graves disease can be contributory to event

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

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

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.

Felling ill immediately- diarrhea & loose stool for a few days, headache for a few days, muscle aches- pain in back & side (new), low grade fever daily since vaccine

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

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

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

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

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

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

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

Presented to ED with 3 week history of increased fatigue, rib pain, 3 day history of cough. Known COVID household exposure. Positive COVID-19 result by PCR after >14 days vaccination completion.

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

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.

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

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

dizziness upon awakening 2 days after receiving vaccine. Has not experienced an episode like this prior to the vaccine

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

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.

Patient did not feel well and reports general malaise day 2 and day 3 post vaccination. She noticed itching of Right Breast on Day 3 and later that evening, noticed a rash with blisters.

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

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

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%

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.

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

chill; tired; Unwell; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 99-year-old female patient (reporter's Mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter mentioned his mother experienced side effects unwell, chill, tired on an unspecified date and asked if his mother can take Tylenol. Outcome of the events was unknown. Information on the 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.

Client complained of slight headache and seen by EMT. Vital signs are 118/66, BS 118, HR 90, O2 98. Client voice that she had not eaten but decrease was felt in symptom and client cleared to go home by EMT.

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

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.

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.

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

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

Patient was hospitalized 15 days after receiving vaccine. Admission was not due to vaccine and was admitted for acute ascites and patient had reported fever and hypoxia. Patients admission resulted in death 7 days after being admitted to hospital.