Pfizer

mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; myalgia (was reported as worsened); Arthralgia; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; This is a spontaneous report from a contactable physician (patient). A 76-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose on deltoid Right for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 8 years ago). There were no concomitant medications. Patient developed myalgia on 27Dec2020 and arthralgia on 28Dec2020. Patient also experience ten days later and still having pain/ started in neck and migrated to his back, the buttocks and gluteal and quadriceps area in Dec2020. He had labs a few days ago. He had a mild elevation of his sed rate and leukocytosis. Events myalgia and arthralgia considered serious due to medically significant. Outcome of events myalgia (was reported as worsened) and arthralgia was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the events myalgia and arthralgia are possibly related to suspect bnt162b2 administration. 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.

Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state the day after vaccination

Sore and tender right arm, chills, muscle ache, joint pain, some nausea, fatigue starting at about 6 PM EST on 1/13/21, worse on 1/14/21 until around 5 PM EST, better on 1/15/21 with some fatigue, but all symptoms recurring again that evening starting around 7 PM EST. I took Tylenol 325 mg around 10 PM EST and went to bed and feel normal so far today 1/16/21.

Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; Joints hurt; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 12:00 on arm Left at single dose for covid-19 immunisation. Lot number is EL3, then a number he cannot read, followed by 46. Medical history included type 2 diabetic. No concomitant medications. His joints hurt on 11Jan2021 in later afternoon. It is not worse, but not better. On 12Jan2021, chills and Woke up during night completely ice cold. Had to get a blanket and finally went back to sleep. Feels weak. Doesn't know what happened. Still feels chill. After midnight on the 12Jan2021. Is a little bit better. He was really sore in injection arm on 11Jan2021. Outcome of the event Joints hurt was not recovered. Outcome of the events Chills and completely ice cold was recovering. Outcome of the event Really sore in injection arm was not recovered. Outcome of the event Weak was unknown. Information about lot/batch number has been requested.

Fatigue; mild soreness/arm sore/soreness in the arm; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 04Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation, naproxen sodium (ALEVE), via an unspecified route of administration on 04Jan2021 at an unspecified dose and frequency for an unspecified indication. Medical history included blood pressure abnormal, blood uric acid abnormal, hypersensitivity, blood cholesterol abnormal, all from an unknown date and unknown if ongoing. Concomitant medication included alopurinol (ALOPURINOL), 300mg take once daily by mouth for Uric acid, amlodipine besilate (AMLODIPINE BESILATE) 10mg; take once daily by mouth for blood pressure, atorvastatin calcium (ATORVASTATIN CALCIUM) 20mg; take one half daily by mouth for cholesterol, cetirizine (CETIRIZINE) 10mg take once daily as needed for allergy, omeprazole (OMEPRAZOLE) 20mg; take one twice daily by mouth for uric acid, losartan (LOSARTAN), 100mg; take once daily by mouth for Blood pressure. The patient called regarding the Pfizer COVID 19 vaccine. He received his first dose of the vaccine at the a Hospital. He added he had just taken Aleve before the vaccination. Then he was reading in his heart magazine and it said it could effect the efficacy of the shot if you take aspirin or ibuprofen. He was asking for more information about that and was it okay that he took Aleve. He clarified he received the first dose of the Pfizer COVID 19 vaccine on 04Jan2021 at 15:00 PM in the left arm. He took the Aleve at 08:00 04Jan2021. He reports he had no pain the first day, no soreness in the arm or anything. The next day he had mild soreness in arm like the flu or pneumonia shot. On the third day he was a little fatigued. But by the fourth day he was able to take his usual walk of three or four miles without being winded and he was fine. He was planning for the second dose 25Jan2021 at 15:00. The outcome of the event pain in extremity was recovered on 06Jan2021 and the event fatigue was recovered on 07Jan2021.

He is also experiencing coughing; all I wanna do is sleep; Had aches and pains; He also has joint pain and pain in his right arm, hand, and wrist area; He also has joint pain and pain in his right arm, hand, and wrist area; Diarrhea; He is also very fatigued and does not want to get out of bed and that he is so tired; off and on headaches; This is a spontaneous report from contactable consumers. A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 11:28 (also reported as about 1130) at a single dose on left arm for COVID-19 immunization. Medical history included pulmonary fibrosis from 2014 and ongoing, ongoing type 2 diabetes mellitus (Diagnosed probably in 1996-1997; under control). The patient previously had pneumonia shot in 2020 and flu shot in 2020 (few months ago in Oct2020/Nov2020) both for immunization. The patient's concomitant medications were not reported. The patient experienced diarrhea, very fatigued and does not want to get out of bed and that he is so tired, and off and on headaches, all on 07Jan2021. He also has joint pain and pain in his right arm, hand, and wrist area on 11Jan2021. He experienced coughing, somnolence, and had aches and pains on an unspecified date. Patient received the vaccine last Wednesday. He experienced diarrhea (on Thursday and Friday, went away then came back on Yesterday), had aches and pains, and severe fatigue (all I wanna do is sleep). Today he said that he wasn't having diarrhea that can be attributed to him not eating much yet, a few aches and pains, very tired, and a minor headache. He was asking how long do these symptoms usually last. Patient received it last Wednesday 06Jan2021 at about 1130. He said that he has been experiencing side effects, not severe, but on Thursday 07Jan2021 and Friday 08Jan2021, he had diarrhea. He said that on Saturday 09Jan2021 the diarrhea let up and Sunday 10Jan2021 was ok, but yesterday 11Jan2021 the diarrhea was bad. He said that he is also very fatigued ("severe fatigue (all I wanna do is sleep)") on 07Jan2021 and does not want to get out of bed and that he is so tired. He has had no fever, but has had off and on headaches. He said that he also has joint pain and pain in his right arm, hand, and wrist area. He said that it is hard to pick up a cup or glass because of the pain. He said that he got the injection in the left arm. He said that he is also experiencing coughing, but stated that he does have pulmonary fibrosis and it could be that. Diarrhea: patient said that his diarrhea is improved as of today 12Jan2021. Fatigued: he said that he noticed it on 07Jan2021, it subsided Saturday 09Jan2021 and Sunday 10Jan2021, but yesterday and today 12Jan2021 it is very prominent and he is very tired. Headaches: He said that the headaches are not severe, but they were there. He said that the headaches are not there today. Pain in the arm, hand, and wrist area: He said that he noticed the pain yesterday and stated that it is slightly worse. Coughing: He said that he coughs due to the pulmonary fibrosis too and sometimes it is a lot and sometimes it is a little bit. He said that he has to get his second dose on 27Jan2021 at 1500. He stated that his brother died of Covid last Thursday. The outcome of event diarrhea was recovering, of "he is also very fatigued and does not want to get out of bed and that he is so tired", "he also has joint pain and pain in his right arm, hand, and wrist area", and "coughing" was not recovered, of "off and on headaches" was recovered on 11Jan2021, of the events "all i wanna do is sleep" and "had aches and pains" was unknown. No relevant tests. No prior vaccinations within 4 weeks. No family medical history relevant to AE.

Shakiness; Chills; Feeling jittery; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 76-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer BioNtech Covid-19 vaccine) via unknown route of adminsitration on 15Jan2021 11:30AM on left upper arm at a single dose for covid-19 immunization(lives in senior center and because of his age). Medical history and concomitant medications were none. He is a little shaky, but not had any dizziness or anything. He wanted to make sure it's okay and not interfere with him getting the next dose. Is this normal. Has also had a few chills, but not feeling too bad. Is a little jittery, but is staring to feel better. He did not receive any other vaccines the same time or 4 weeks prior. Did get a flu shot last October (Oct2020) with no problems or reaction. States no history of problems with vaccines in past. Vaccination Facility Type was unknown. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)) was none. AE(s) following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The events started from 15Jan2021 with outcome of not recovered. Information on the lot/batch number has been requested.

Tingling, numbness in face, arms, hands and down front of both legs. Started second day after shot and starts first thing in morning, continues throughout day and subsides in evening. I?m in my eight day and problem continues. Made calls to my oncologist and MD and solution or advice received as of this time.

Wife states day after injection client began coughing, weak, pain in joint, tires easily. Returns to bed at least two times per day, feel rested but upon rising to side of bed becomes weak again. Complaining of shortness of breath. Concerned about COVID infection; states had three negative tests with last test being in December. Was evaluated by Dr. with Family Medicine (his primary care provider was not available) and was prescribed Prednisone 20 mg QD x 5 days and Erythromycin 250 mg QD x 5 days; both have been completed. During office visit lungs were evaluated and reported as clear; physician mentioned a COVID test but none was obtained. Has continual cough with asthma, but feels symptoms have gotten worse since the COVID vaccine; "can't get his strength back". States the weakness, cough, shortness of breath, and joint pain have remained the same since first day noticed and has not seen any improvement since completing Prednisone and Erythromycin. Not on O2; states O2 sat is around 98 - 99%; uses a C Pap Machine. Wished to schedule a COVID test; appointment given for 2/3/2021. Denies dyspnea beyond usual SOB; instructed to seek emergency care if symptoms worsen; indicated understood and would do so if needed.

Immediate warm flushing sensation lasting a couple seconds/coincident with change in taste to a metallic taste. Lasted only a few seconds.

1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982 Patient was feeling well the day of vaccine and reports no recent illness, no adverse events to first injection in COVID vaccine series. 20 minutes later developed dizziness and nausea. Within hours noticed LUE weakness. Weakness has progressed over last two days to severe left upper extremity and left lower extremity weakness with inability to walk. No sensory deficits. Some urinary retention. Hyperreflexia on examination with upgoing toe on left. Presentation consistent with transverse myelitis. Patient remains hospitalized at this time, starting treatment with IV solumedrol for clinical transverse myelitis. Workup remains in process

Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling "bad" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival. Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.

Severe headache, body aches, slight nausea,, complete fatigue unable to function, chills, fever101.6 (highest) total feeling of unwell

BELLS PALSY SYMPTOMS ON LEFT SIDE OF FACE . Start PredniSONE Tablet, 20 MG, 3 tablets, Orally, Once a day, 7 days, 21 Tablet, Refills 0 Start Valacyclovir HCl Tablet, 1 GM, 1 tablet, Orally, Three times a day, 7 days, 21 Tablet, Refills 0

diaphoresis, flushing, anxiety Narrative: Began feeling symptoms during monitoring period-mildly diaphoretic, dizzy, flushing upon standing. Was anxious about second vaccine. Received monitoring of vital signs for additional 15 min and water provided. Released to home.

little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night; allergies due to the pollen; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer reporting for himself. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history reported as none. Family history included wife who passed away 2.5 years before, on an unspecified date and his daughter and her (daughter) son, who lives with the patient, tested positive for COVID virus. There were no concomitant medications. The patient experienced little bit of fever, allergies, and feeling unwell, but described as not horribly bad. Patient stated he is ok and doesn't think it has anything to do with the COVID-19 Vaccine. He stated that he thinks it is just allergies due to the pollen. Patient was taking two to three Ibuprofen once or twice a day when he goes to sleep. He has been perspiring quite a bit at night, which he stated was ok. Aside from that he was pretty much ok. He doesn't get second dose until 15Feb2021. Stated we have come a long way from beginnings of time where people would just die. He asked if he should get tested. Patient was advised to follow up with his primary care physician. He stated his symptoms began in the evening of 16Jan2021 at 8pm. He started getting a little feverish and sluggish. He took three Ibuprofen. He thought he lost some weight with the COVID-19 Vaccine. Weight was between 169-170lbs on 16Jan2021. The patient operates a daycare center with children. He was not taking any medication except for the Ibuprofen. He is very active and runs a business. Only thing is, he is sad because he does not have his wife with him. He stated everything was fine. He wanted to know if it was possible one can get the COVID virus even with the injection. He asked about the second COVID-19 Vaccine and what does the first dose do. Treatment included ibuprofen for little bit of fever, sluggish, and Feeling unwell. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of fever, sluggish, weight decreased, night sweats and feeling unwell due to temporal relationship Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of pollen allergy, which likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.

1. At approx 11PM , Tues. my left arm started to hurt and was a bit stiff. By 6AM, my neck was stiff and I could not move left arm because of pain. I went to bed and when I got up Wed at about 1:30pm, I experienced a lot of pain in my joints and I could not get out bed. I also felt light headed. This lasted the whole day and night. I slept most of the day. The next day, Thur, I was better however, my joints were still hurting. Saturday morning it appears that I was ok.

Fever to 100 degrees F., shaking teeth rattling chills, headache , myalgia, sore muscles, fatigue, joint pains and insomnia

Patient went to Emergency Room @ 5PM day following vaccine with difficulty moving eyes and drooping cheek.

Bell's palsy; This is a spontaneous report from a contactable physician reported for self. This 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 10:50 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. None additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Cardiac disorder from Jun1990, Type 1 diabetes mellitus from 2000, Heart Attack from Jun1990. Concomitant drugs were none. He said he has a question. He stated he got his first dose of the COVID-19 Vaccine on 04Jan2021 and woke up 9 days later on 13Jan2021 with Bell's Palsy, which was medically significant. He said he was not sure if he should get his second COVID-19 Vaccine shot that was scheduled for Monday, 25Jan2021. He asked if Bell's Palsy has been a reported side effect of the COVID-19 Vaccine. He said he refuses to take steroids for the Bell's Palsy. He said he had an incident in 2019 where he was prescribed steroids for an arthritic condition, and he ended up septic. No treatments were received. Outcome of the event was resolving. Drug result by physician was related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported Bell's Palsy 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.

Burning sensation on upper right back which moved to shoulder and right front upper chest. Elevated blood pressure. Went ER on 01292021. Resolved on own by 01312021

HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and ACLS guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and ACLS guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.

On Saturday 2/6/21 in the morning on the left side under armpit felt like he had a pulled muscle or something. It eventually radiated over up into the left quadrant of his chest where he could not push down on it. It was extremely painful by Monday. He has a history of esophageal spasms and exacerbated them to where he thought he was having a heart attack. He called his Cardiologist and told him to go to the ER. He went to the hospital Monday evening, he had two EKG's, had blood drawn 3 times, did sonograms looking for blood clots. He did inform them that he had the vaccine on Friday and they told him it was due to that. He went to nuclear medicine to get his lung checked for blood clots as well. All tests were negative. He saw his PCP today who told him that the lymph nodes were affected due to the vaccine. He has improved greatly, still has some slight discomfort which his PCP said would go away in time.

Pain the underneath part of left arm, pain in tendon of left ankle and rash on left side around to the middle of back which itches severely and is very tired

very bad abdomen pain and back kidney area pain chills and weakness for 24 hours and still four days later very week and unable to do much activity

Pt sts feeling flush post receiving vaccinations. Pt vital signs were within normal limits. Pt refused treatement or tx.

Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.

Bells Palsy - Left sided; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9263) intramuscular in left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included DMII (Type II diabetes mellitus), Parkinson's disease, and CAD (coronary artery disease). Concomitant medications were not reported. The patient previously took metformin and experienced allergy. Prior to vaccination, patient was not diagnosed with COVID-19; and since vaccination, patient has not been tested. Facility where the most recent COVID-19 vaccine was administered: Other (Public Health Department). On 24Jan2021, the patient experienced Bells Palsy - Left sided. The event required physician office visit (Doctor or other healthcare professional office/clinic visit). No treatment was received for the event. Outcome of the event was unknown.

dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

BECAME VERY, VERY COLD AND HAD VERY BAD SHAKES. SIMILAR TO ANTIPHLAXIS REACTION I HAD TO 2 ANTIBIOTICS- CIPRO & METRONADOZLE. WENT TO BED WITH CLOTHES ON AND SEVERAL BLANKETS. LASTED 5-6 HRS. NEXT DAY WORN OUT. 3RD DAY FEELING BETTER. I DID NOT HAVE SWELLING OR CLOSURE OF MY THROAT. I DID NOT SEE A DOCTOR .

High Fever, shakes, chills, headache Feb 17 p.m. - Feb 18 plus all over ache. Tylenol time release. Felt good on Feb 19.

RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKNESS, FATIGUE. , AND NAUSEA/VOMITING/DIARRHEA AND BEING UNABLE TO EAT SINCE YESTERDAY. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL WITH DIAGNOSIS OF ELEVATED TROPONIN AND GENERALIZED WEAKNESS.

Severe shaking. Chills, headache,acute srvere sharp pain in both feet . Began after a short sleep period. Lasted for 3 hours. Then wesknesd and headache tiredness until bedtime the next eve. No isdued after 2nnd night sleep.

Developed quite a bit of pain in the tip of left index finger. Also, have slight numbness feeling there.

Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and "losing stamina". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later.

Bell's Palsy - L facial droop; This is a spontaneous report from a contactable physician. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176), intramuscularly on 22Jan2021 at 08:00 am on the left arm at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 2), hypertension (HTN), hypersensitivity lung disease (HLD), and hepatitis C (Hep C) s/p treatment, all from an unknown date. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (ASA), gabapentin, lisinopril, and an unspecified statin from unknown dates and indication. No other vaccines were received in four weeks. On 27Jan2021, it was reported that the patent experienced Bell's palsy - L facial droop which resulted in emergency room visit and required treatment of "Pred". The patient had no COVID prior to vaccination and was tested post vaccination on 27Jan2021 via nasal swab which had a negative result. The patient received the vaccine in a hospital. The outcome of the event was reported as recovering.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event Bell's palsy cannot be excluded, due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

18-20 hours after receiving the injection he noticed that "his heart would beat "hard"/heart beating fast; about 18 to 20 hours later the next morning he was experiencing something like a palpitation; arm hurt that night and the next morning/sore arm of course; This is a spontaneous report from a contactable consumer (patients wife). A 76-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261) , via an unspecified route of administration on 21Jan2021 at 14:30 (at the age of 76-years-old) in the left arm as SINGLE DOSE for covid-19 vaccination. Medical history included cardiac murmur and Type 2 Diabetic. There were no concomitant medications. On 21Jan2021 the patient experienced arm hurt that night and the next morning/sore arm, and On 22Jan2021, 18-20 hours after receiving the injection he noticed that 'his heart would beat hard' /heart beating fast/he was experiencing something like a palpitation. Report described that it is like when you get scared. This Happens 2-3 times a day and it is not constant. The patient went to his primary care physician on Friday for a 'routinely scheduled annual check up' and mentioned this to her at his appointment. His provider encouraged him to call Pfizer and report these symptoms. His doctor is going to continue to follow up with him and if the problem persists do further tests. Lab data included heart rate on 22Jan2021 18-20 hours after injection his heart would beat hard /would be fast/something like a palpitation. The clinical outcome of heart beating fast was not recovered while palpitations and arm pain were unknown.

Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored; extremely tired; muscle pain, aches; extreme chills/shivering; shaking; Joint pain; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL3248, expiry date not reported), via an unspecified route of administration on 02Feb2021 11:00 at a single dose in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation (reported he has had no occurrence for 3-4 years); and high blood pressure and high cholesterol, both from an unknown date and unknown if ongoing; and pneumonia. Concomitant medications included that patient was also taking high blood pressure medication and high cholesterol medication. When asking for the Lot number, reporter explained "his card was in his wallet but she gave her lot and said it was the same, they got the shot at the same time, within 5 minutes of each other". Patient previously took amoxicillin for pneumonia from 09Jan2021 to 13Jan2021, reported as he took this for 5 days and stopped. This was reported as "It was noted that he had pneumonia and got an antibiotic that he took for 5 days. It was amoxicillin and was started on 09Jan2021" (pending clarification). Reporter also stated that she was not sure if it was a Pfizer vaccine but patient did have a mild reaction to the first shingles vaccine (unspecified) but this lasted only 24 hours. Reporter, a wife calling for her husband (patient), was reporting on the COVID vaccine and who explained he was having symptoms and wanted to report this but also has a question on what to do. Patient was extremely tired. This was noticed on the 3rd day after the shot. This would be Friday 05Feb2021 and it was the same since starting. There were moments when he has rested and showered where he felt better but then it went down again. The patient had muscle pain, aches on 05Feb2021, this would be Friday, and it came and went but was about the same. Patient had extreme chills on 05Feb2021, and he was still shaking now (05Feb2021). It was a little better during the day, maybe because he was moving around but last night he was shivering and shaking for 3 hours and she could not get him warm even with the heating pad. Patient also had joint pain on 05Feb2021 and it was the same since starting. Patient had fever that probably started Sunday, 07Feb2021 wherein few hours ago, it was 102.00 but she got it down to about 100.2 now, it has increased and was the reason she called today. Patient's belly was swollen since 05Feb2021 and it was the same since starting. She remarked she was not sure if this was where lymph nodes were or not and the cause of the swelling. It was also explained that due to hurting, it was hard for him to breath. When he moved and exerted, his breathing was labored. This would be Friday, 05Feb2021 and it is the same since starting. Yesterday, patient went to his primary doctor. He was supposed to do blood work but couldn't due to his fever. The doctor prescribed him an anti-inflammatory called Etodolac 500mg. It was by Taro Pharmacutal US (there was no Lot or expiry). He took one at 7pm and was to take them twice a day, took another a little while ago. Reporter explained she has heard stories where the second dose is worse, and wanted to know if that is true. She also wanted to know if the product Etodolac, has side effects that are similar to what patient was experiencing, and wouldn't taking that make the side effects double worse. Therapeutic measures were taken as a result of the events extreme chills/shivering, shaking, joint pain, and fever. The events extremely tired, muscle pain, aches, extreme chills, shaking, joint pain, fever, belly was swollen, hurting, and "hard for him to breath/moved and exerted, his breathing was labored" were not recovered

Weak clogged up, my hands were numb and chills, fever, nausea, feeling unwell, my nose feels swollen, runny nose, my lymphoids are swollen, im tired. Joint pain, and just drowsy, slight headache at time. Slight case of constipation

Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.

Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events "Bell's Palsy/drooping of his face and mouth" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for "Bell's Palsy/drooping of his face and mouth" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of " Bell's Palsy/drooping of his face and mouth", swallowing issues, chewing issues, weak, "tired / does not have stamina" was not resolved; bloody nose was resolved on Feb2021; "vertigo (dizzy / lightheaded)" was resolved on 17Feb2021.

Within 1 hr pain in right leg above knee; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Feb2021 07:45 at single dose for at left arm covid-19 immunisation. Medical history included type 2 diabetes, heart surgery in 2017, spinal stenosis, high blood pressure. Concomitant medications within 2 weeks of vaccination included metformin, metoprolol, gabapentin, glipizide, warfarin, acetylsalicylic acid (ASPIR). The patient experienced within 1 hr pain in right leg above knee on 12Feb2021 08:30 with outcome of not recovered. Patient didn't receive treatment for the event. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious. Information on the lot/batch number has been requested.

Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14. Was admitted to Hospital. Found to be COVID +, required O2 per NC 2-3 L for approx 24 hours. Was found to have NSTEMI. Was transferred for speciality/cardiology care at General Hospital. Was on heparin gtt. Cardiology-no intervention. Was not treated for COVID and was discharged to home on 2/16. Was unable to care for himself at home and was readmitted with in hours. He has failed discharge twice and is being now discharged to SNF

he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE

Loss of taste and smell. Sore neck, shoulder, arm on side vaccination was given. Generalized body aches. Congestion, extreme fatigue and chills all lasting for 3-4 days.

I felt great after my vaccine until midnight that same day. My legs from the knees down including my feet were painfully cold as if they were on dry ice. I didn't get much sleep that night, but the next morning at 2:00 a.m. the pain was gone. I was just extremely fatigued which was a symptom I expected. I don't know what to think of the first symptom but wanted you to know. Thank you.

Client verbalized feeling very weak after receiving the vaccine. According to client he is diabetic and did not absorb anything to eat prior to receiving the vaccine. Client was given a bottle of water and evaluated by Fire Rescue. Client's spouse accompanied home and he was released by paramedic at 9:40 am. Per Paramedic no further evaluation needed.

Numbness and tingling in right leg about 4 days after 2nd vaccination, moved to right foot. Then moved to left foot but didn't affect left leg.. Feet are cold now, legs are okay now, just the feet. Hands, lips, & tongue, & face feel numb and tingly too. Spoke with Dr on phone. Client stated he took Tylenol for a couple of days after vaccination. Stated injection site is black & blue. Client still dealing with numbness & tingling. Waiting to speak with Dr again. Phone call to office.

Sudden loss of strength in left hand/arm involving wrist extention and radial deviation and grip strength. Normal range of motion is still present but stregth is significantly diminished and has reurtned only minimally. Right arm is normal.

Patient was admitted to the Neuro ICU in critical condition. He is there currently on 4 seizure medications AND INTUBATED WITH GENERAL ANESTHESIA TO CONTROL THE SEIZURES. All diagnostic tests including MRI's, CT scans, laboratory tests, Spinal taps are negative. He was presented and they can arrive at no diagnosis!!!!! He has no history of a seizure disorder.

I developed stomach, intestinal pain, cramps. A continuous aching with a sharp pain about every 20 - 35 minutes. Lasting 36 hours. This was in my lower abdomen below belly button on the left side. Really quiet frightening, in that this was not in any material regarding side affects. I considered the emergency room Saturday night but didn't t go. Began to subside Sunday afternoon, leaving me sore to the touch. Only a little tenderness remains in the area. I have seen no physicians. I cannot speak to any permanent damage.

Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positive ultrasound exam.

symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore muscles in neck and shoulder; watery eyes; muscle aches; pains; problems in sleeping; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This is a spontaneous report from a contactable consumer (the patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration, in the left arm on 01Feb2021 at 14:30 (at the age of 76-years) as a single dose for COVID-19 immunization. Medical history included chronic asthma, nasal polyps, vestibular schwannoma, alopecia, gastrooesophageal reflux disease. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 07:00 AM, the patient experienced symptoms of bell palsy, numbness of upper and lower lip on right side, sore muscles in neck and shoulder, watery eyes, muscle aches, pain, problems in sleeping. He felt the symptoms after the first dose. The patient visited the emergency room/ department or urgent care due to the events. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.

76 YO M C/O LEFT SIDE RING AND LITTLE FINGER HAS GONE NUMB AFTER COVID 19 SHOT (PFIZER) WHILE WAITING IN THE OBSERVATION AREA. PT HAS NO OTHER C/OOR SX. NUMBNESS IS IMPROVING AFTER MOVING ARM AROUND. DENIES ALL SX RELATIVE TO ALLERGIC/ANAPHYLACTIC REACTIONS.FOUND ABOVE PT SITTING A/O X4, NO DISTRESS, CX - GOOD RESP EFFORT, WITHOUT C/O. EXTREM - GOOD PMS X4 WITH EXCEPTION OF LITTLE AND RING FINGER OFLEFT HAND. R/O TEMPORARY NUMBNESS OF RING AND LITTLE FINGER OF LEFT HAND SECONDARY TO ULNAR NERVE COMPRESSION. EXAM, T&R WITH INSTRUCTIONS TO FOLLOW UP IF NUMBNESS DOESNT GO AWAY.

Pain in left calf Had ultrasound on left leg 3-16-2021 DX: hematoma left leg Told to apply hotpack q20 min off & on

Left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well; Left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well; This is a spontaneous report from a contactable consumer (the patient). A 77-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Feb2021 at 13:00 (at the age of 76-year-old) as a single dose for COVID-19 immunization. Medical history included heart condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021, the patient experienced left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well. The patient did not receive any treatment for the events. The clinical outcome of the "left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well" was not resolved. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Pains in hips and hands, lesser pains and some stiffness in other joints and muscles. This is typical of when I get viral diseases such as colds and flu, except that there were no cold symptoms in my head. First noticed when I awoke the day after my second shot and lasted into late afternoon. OK after that.

Resident entered the Observation, with daughter at side and stated that patient is feeling dizzy, staff lowered patient to chair in sitting position, BP 122/81, P64, R24, O2 sats 94 on room air, resident became slightly unresponsive, BS 109, EMS here, O2 at 100% Endtidal NC, with O2 sats at 92%, HR 42, BP 90/48, P45, IV fluids NS in progress flowing via 20 guage, 911 call. 14:42- 911 here, patient assessed, BP 92/51, P60, R22 patient fully aroused, was taken to hospital at 14:52, family will follow to ER.

Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.

Total body pain followed by extreme chills then feverish then uncontrollable tremors accompanied by unable to keep my balance(had to hold on to desk )then massive amounts of nasal mucous all in about a 9 0 minute time period then just headache and fatigue - felt fine 90 mins after headache and fatigue

12h after COVID vaccination awoke with severe bilateral muscle/buttock/leg pain, nausea, vomiting and ultimately some confusion and disorientation with possible left sided focal neurologic deficits. Sodium initially 127 on admission, but may have been artifact, as simultaneous venous blood gas electrolytes showed 135. On following day had platelet count of 115k, repeated at 90k

2/17 received 1st dose vaccine, Pfizer 2/20-3/9 admitted. Found to have seizures (twitching of upper extremities, aphasia). 2/24 RML pneumonia. Found to have MSSA bacteremia and bacteriuria. Transition from vanco/pip-tazo to cefazolin Mental status improved and he was sent on cefazolin which he was to complete on 3/26/21. Was not sent out on seizure prophylaxis. 3/23 second dose Moderna. Had recurrent seizure on 3/27. Evidence of post central stroke. Expressive and receptive aphasia.

Witness seizure activity by the patient's wife and observation clinical (RN) staff. Per the patient's wife this type of seizure happens on a regular basis. The patient was seated at the time of the seizure and did not fall from the chair. The patient was transported to the ER for evaluation and post seizure activity monitoring.

onset of chills around 10 pm, poor sleep due to chills. next day weak, tired. achy. fever of 103. chills and fever continued through next day. feeling better on 04/02/2021. still weak. was hospitalized in October 2021 for five days due to COVID.

Blood pressure spike 10 minutes after shot. 6 hours later had intense burning of nerve bundles down arms and legs for 2 hours. After that had 1 hour of uncontolled severe shaking and shivering . Next day felt fine. Afew days started noticing LOW FREQUENCY INTERMITTANT TINNITUS THAT IS A HUM, BUT ONLY IF I AM AROUND HIGH VOLTAGE POWER TRANSMISSION LINES AND POWER TRANSFORMERS . HEAR IT IN MY HOME WHICH IS 1000 FEET FROM HIGH VOLTAGE LINES 24/7 SINCE DAY 2-4 OF DOSE #1. Can hear it in other enclosed areas, but doesn't seem to happen AS MUCH outdoors, although if I am within 1000 feet of high voltage lines I will hear it UNLESS there are many trees to block the EMF's or HUM between me and the source. SOUNDS CRAZY, BUT IS TRUE FOR PAST 3 MONTHS 24/7 AND HAS RUINED MY LIFE BECAUSE I CANNOT SLEEP AND SLEEPING PILLS DON'T WORK. HAS DISRUPTED MY SLEEP CENTER SOMEHOW. ALL OF THIS IS SINCE FIRST COIVD19 SHOT ! HAVE HAD #2 SHOT AND WILL NEVER GET ANOTHER !

At 30 mins he began shaking and appeared to pass out for a moment. He became confused. This morning he had fever, oxygen was low, not speaking not walking.

sore left arm, little bit swollen; sore left arm, little bit swollen; covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid; This is a spontaneous report from a contactable other hcp (Nurse). A 76-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm on an unspecified date (Batch/Lot Number: EM9809) as 0.3 mL, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EL3249) via intramuscular in left deltoid on 18Jan2021, unknown time as single dose for covid-19 immunisation. On 08Feb2021, covid vaccine was administered in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid and on 09Feb2021, sore left arm, little bit swollen. Clinical course of the events includes, someone at a vaccine clinic, the second dose of the covid vaccine was administered very low in the arm. States the injection probably did not go into the deltoid, probably went in the bicep. She is asking if the injection would need to be repeated. She wants to know if the vaccines will need to be repeated. She also had a sore left arm and it was little bit swollen which started on the morning of 09Feb2021. The outcome for the event covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid was unknown and for the events sore left arm, little bit swollen was not recovered.

slightly sore arm; This is a spontaneous report from a contactable pharmacist in response to a healthcare professional letter. A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EM9809) intramuscularly in the upper left arm on 10Feb2021 at 15:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number EL1289) on 19Jan2021 at 10:30 (at the age of 76-years-old) for COVID-19 immunisation and experienced sore arm, headache, and slight sinus headache. On an unspecified date, the patient experienced slightly sore arm which lasted one day post-vaccination. The outcome of slightly sore arm was recovered on an unspecified date.

Vaccine kicked my Restless Leg Syndrome into high gear, making it impossible to sleep. Did not sleep for 2 nights in a row, until finally the reaction started to subside. Also, the vaccine gave me a minor case of hives rash. This has not subsided yet. But the RLS is NOT a minor problem, it is major, to me.

Vasovagal/pre-syncopal event. Accompanied by paresthesia/ weakness/ blurred vision/ lightheadedness.;a seizure-like episode followed' patient was transported to ER via EMS.

Fatigue; Pain in arm; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration in right arm on 23Jan2021 at 10:30 as a single dose for COVID-19 immunisation. The patient's medical history included diabetic type 2, stent from an unspecified date in Dec2019, sulfa allergies. Concomitant medications included metformin (Strength: 500 mg) at four times a day, buspirone (Strength: 10 mg) at thrice a day, sitagliptin phosphate (JANUVIA, Strength: 50 mg), hyoscyamine sulfate (OSCIMIN, Strength: 0.125 mg), lisinopril (Strength: 5 mg) at once a day (bedtime) for BP (blood pressure), silodosin (Strength: 8 mg) at once a day (bedtime), simvastatin (ZOCOR, Strength: 40 mg) at once a day (bedtime), fish oil (Strength: 1000 mg) at twice a day, zinc (Formulation: Tablet) at once a day (in the morning), vitamin D3, cyanocobalamin (B12 20 MIL, Strength: 1000 mg) at once a day, allium sativum bulb (GARLIC EXTRACT) at 1 DF (Dosage Form), once a day (1 pill, once a day), ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 NOS, vitamin d NOS, vitamin e NOS, vitamin k NOS, xantofyl, zinc (MEN 50+) at once a day, ubidecarenone (COQ-10, Strength: 200 mg) at once a day, exenatide (BYDUREON PEN, Formulation: Injection) at weekly (once a week on Monday) for diabetes, doxepin (Strength: 10 mg) at twice a day (bedtime). Family history was none. The patient did not receive prior vaccinations (within 4 weeks). The patient experienced pain in arm on 23Jan2021, fatigue on 24Jan2021. The patient did not require the initiation of new medication / other treatment / procedure for the events. Relevant tests was none. The outcome of the event fatigue was not recovered and recovered on an unspecified date in 2021 for the other event.

It was itchy like crazy; both of his arms are as stiff and achy at the top; both of his arms are as stiff and achy at the top; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9263) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had two side effects and the second shot would be coming up and he was nervous about what he should do. The main side effect is that they put a band aid on where injection was to protect site. The next morning, he took it off and on the edge of the band aid, there was a red dot about 1/8 to 1/4 inch around. It was itchy like crazy, he did not scratch it. That dot was staying there. The doctor told him not to do anything to it and just put a little bacitracin on it. He did not provide any information for the Bacitracin such as a dose, lot or expiration. The next side effect was both of his arms which was stiff and achy at the top. The injection arm feels exactly like the right, but only the left one got the injection. He would like to know if he should be concerned with second dose or not. The outcome of the events was unknown.

paralysis of right side of face (Bell's Palsy); This is a spontaneous report received from a contactable consumer (patient himself). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EMe205) via an unspecified route of administration in left arm on 09Mar2021 at 17:15 (at the age of 76-year-old) as a single dose for COVID-19 immunization. The patient's medical history included ADM II. The patient did not have allergies to medications, food, or other products. Concomitant medications included insulin, carvedilol, furosemide, clopidogrel, simvastatin (SIMVAS); All received 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 has not been tested for COVID-19 since the vaccination. The patient experienced paralysis of right side of face (Bell's Palsy) on 11Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The event was considered as serious (disability or permanent damage) by the consumer. The patient was treated with physical therapy - heat, vibration for the adverse event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

4/3 = SATURDAY - 12:30 AM , USED 2 ACETAMINOPHEN PM ( This what i use nightly ) 6:30 AM , CHILLS (FEVER) LASTED COUPLE OF HOURS TIRED NO ENERGY , NO FOOD UNTILL DINNER TIME , WAS TOLD I LOOKED PALE , ** THAT SATURDAY AFTERNOON I WAS SMELLING AN ODOR LIKE GARBAGE, WIFE SAID SHE DIDN'T SMELL ANYTHING, LASTED FOR A FEW HOURS.??? 4/4 = SUNDAY - STILL LOW ENERGY. EVERY MORNING FOR PAST 20 YEARS I RINSE EYES WITH SALINE SOLUTION. I SKIPPED SATURDAY, TRIED SUNDAY & MY EYES STARTED BURNING, TRIED A DIFFERENT BOTTLE STILL BURNING, HAD TO STOP. 4/5 = MONDAY - FEELING BETTER & EYES RINSED WITH NO PROBLEM .???

Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalance; unable to move legs; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received bnt162b2 (Pfizer, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 06:00 to 16Feb2021 06:00 (at the time of 76-yers-old) as single dose for covid-19 immunisation. Medical history included ongoing parkinsonism, high blood pressure and asthma. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR); losartan, omeprazole, dopamine and silodosin (RAPAFLO). The patient previously took bnt162b2 for covid-19 immunisation (Covid 19;Pfizer,Lot unknown; time; 05:00 AM, Vaccine location; left arm, dose; 01). The patient had worsening parkinson's symptoms. 2 days post vaccine, unable to move legs. cough lasted 3 weeks, and experienced headaches. Patient continues to feel week and has imbalance. Also had a case of diverticulitis on 18Feb2021. The event diverticulitis was considered as medically significant. The patient not received treatment for the adverse events. The outcome of events was resolved with sequel on 2021 (unspecified date). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Woke up with very stiff neck Neck sprain, subsequent encounter Breast pain in male Unclear etiology, no obvious mass on exam no axillary adenopathy, mamogram pending Patient's axillary and shoulder pain may be secondary to Covid vaccination.

Patient received 1st Covid-19 Pfiser Vaccine shot on Thursday February 11, 2021. Patient received the 2nd Covid-19 Pfiser Vaccine on Thursday, March 4, 2021. 7 days after second vaccine shot on Thursday, March 11, 2021, patient showed some symptoms of a itchy-horsed throat & a slight dry cough. Called doctors - they said nothing to worry about, drink hot fluids and take couch drops. It went away in 2-3 days. Exactly 4 weeks after second Covid-19 Pfiser vaccine on Thursday, April 1st 2021, patient was sent to the ER for a seizure.

patient reported numbness in right side of face and tooth pain on the day after his covid-19 immunization. His prescriber evaluated him today and said he has a sinus infection with mild bells palsey. Unsure if related to immunization.

His arm was sore; Nausea; Headache; Fatigue; This is different feeling than what he normally feels; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, Expiration Date: 31May2021) via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Medical history included diabetes mellitus. On 04Feb2021 the patient experienced his arm was sore, nausea, headache, fatigue. On an unspecified date Feb 2021, the patient experienced this is different feeling than what he normally feels. The reporter stated, Yes, he takes a lot, I would rather not because its lot he is diabetic and he takes blood thinner and statin and its very long list, but these are different so those, the reason I called because this is different feeling than what he normally feels when he gets ups in the morning, and that's why I thought maybe it because of Covid. The patient underwent lab tests and procedures which included glycosylated hemoglobin, diabetes, I do I have to look up the result and the date, the date was 30Jan and it was blood draw for his A1C. The outcome of event different feeling than what he normally feels was unknown and other outcome of the events was not recovered.

Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926), via unspecified route of administration in left arm on 18Feb2021at 08:30 as a single dose for COVID-19 immunization. The patient medical history included Hypertension, hyperlipidemia, acid reflux. The patient concomitant medication included fenofibrate, atorvastatin, atenolol, lisinopril. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient has allergic to cephalosporins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient experienced headache, nausea, diarrhea, weakness, fatigue, 99.5 temp. The patient did not receive any treatment for the events. The outcome of the events Headache, nausea, diarrhea, weakness, fatigue, 99.5 temp was recovered.

Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; temperature of 99.5; discolored (orange) urine.; 1st day - sore arm only.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 32 48), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 17:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. No known allergies were reported. Concomitant medications included atorvastatin calcium 40 mg, Metoprolol succinate 25 mg, Colecalciferol (D3) 25. 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. Since vaccination patient was not tested for covid-19. On 30Jan2021, first day after vaccination, the patient had sore arm only. On 31Jan2021 at 10:00 pm, 27 hours later of vaccination, patient experienced nausea, headache, muscle ache, temperature of 99.5 and discoloured (orange) urine. The events were considered nonserious. Patient could not eat all next day and slept around the clock, drank a little bit of bubbly water. After 48 he later patient began to feel a little better and ate some grapes. The patient had not yet recovered from the events.

stomach aches; he's got the shakes; his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore; Diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 25Dec2020 (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as single dose for an unspecified indication. Medical history included myocardial infarction from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already), cardiac operation from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already) rhinorrhoea from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 28Dec2020, the patient experienced diarrhea, stomach aches, he's got the shakes, his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore. Patient says the 25th of last month, 25Dec he got his first shot, that was 14 days ago and 3 days after he got diarrhea it was pretty severe but then that cleared up and he was ok for few days and then he got stomach aches, the stomach aches woke him up at 5o'clock in the morning and then he had the stomach ache 03Feb. It was 3 times he had the stomach aches. Today he's got the shakes but he also has Parkinson's so a lot of things amplify his Parkinson's, so he is not overly concerned about the shaky thing. shaky thing happens periodically to him but it is pretty bad today. What he did to rectify is he took his normal medicine and he has taken an antacid on those days when he had the stomach ache and one other thing, the second thing was the stomach aches and also his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore and he is having a runny nose, the runny nose is the last thing but at the same time the runny nose was happening prior to taking the shot so that might not be related. He is calling to see if those things are associated with the vaccine. During that time period of time he took his temperature and he did not have a fever at any time. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.

Ischemic stroke with paralysis on left side of body, impaired speech, swallowing, cognitive functioning

After the first vaccine: Leg pain, foot pain, chest pain. Four days after vaccine, the chest pain was so bad that my dad went to ER and had a Pulmonary Embolism . He was hospitalized two nights. After the second vaccine: right leg pain, weakness in both legs. Three days after the second dose, my dad had a stroke.

I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours; have to go to bed and sleep for about 3 hours; Feeling weaker; Fatigue; This is a spontaneous report from two contactable consumer (patient's partner and patient). A 76-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982) via an unspecified route of administration on 04Jan2021 (76-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included sick. Other products were reported as no. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269) via an unspecified route of administration on 04Feb2021 (77-year-old at vaccination) at a single dose for COVID-19 immunization. Consumer stated, "I hope you can, what's happening is I had my COVID shot on my last one on 04Feb2021 (further clarification unknown) and before that even I was sick ( Intent: medical history) and then now it's been 4 months later. This happen to start when I felt before I had the shot. I was like feeling weaker and weaker, there was no strength and then now I am totally fatigue (the start date of the feeling of weakness and fatigue was stated as "That's going to be hard, it's probably, it was in January. I want to look at this. January, probably, in the beginning of January maybe you can say 5th or something like that"), I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours. So, I am looking to you for some help or what can I do." No treatment received. The report was reported as non-serious. The patient was still feeling weak, he was little bit better but he was still very worried about it. The outcome of event feeling weak was resolving, and of other events was unknown. No Follow-up attempts are needed. No further information expected.

temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fever 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.

severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash is located.; Elevated heart beat, feels flushed; Elevated heart beat, feels flushed; Itching; Broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in left arm on 20Apr2021 10:00 (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included ongoing diabetic reported as 10 years ago. No other products. No investigation assessment. No prior vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 20Apr2021 after 10 am, patient experienced broke out in a rash, it improved when he took his medication, that he was given in the hospital, but then the rash came back as the medications wears off. About a half hour after the vaccine on 20Apr2021 10:30, patient had itching, when he took the medicine it helped the itching, but as the medicine wears off, the itching came back, with a vengeance. He went to the emergency room, yesterday for treatment. He was released and made contact with his family physician. He was taking Famotidine 20 mg by mouth once a day, and Benadryl every 25 mg, 2 pills, by mouth every 4 hours. He had some relief with these medications, but then started to feel the events as he got closer to taking his next dose. An hour or so after the initial shot on 20Apr2021 11:00 and then at the hospital, patient had elevated heartbeat, felt flushed. He seemed ok, but he wasn't sure, what his heart rate was, as he felt flushed once in a while. This morning on 21Apr2021, skin was starting to blister, like a poison ivy breakout, where the rash was located, it was about the same as when he took the medicine it helped, but as the medicine wears off, it came back. He had severe allergic reactions. Events required a visit to emergency room and physician office. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on 19Mar2021, the patient experienced left kneecap went numb/started to come back, but just a little bit around the edge of the kneecap (hypoesthesia); on an unspecified date, the patient experienced knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning, knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning (gait disturbance), back pain, starting in the lower back and it kept getting worse, up my back, pain the size of a dime, like where your kidney is, lasting about 30 seconds, then it would wrap around to my appendix, bothered me all day (back pain), soreness to their arm where the injection was given. The clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Acute pancreatitis; No appetite/he was starving himself to death; he lost all use of his extremities; Still not eating and is so weak/No energy/he still has no strength; Whole balance everything was off/His balance is horrible; he took 2 bites of food and vomited; Dizziness; Still not eating and is so weak; Affected his memory; This is a spontaneous report from a contactable consumer (patient wife). A 76-year-old male patient received second dose of BNT162B2 (mRNA PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262; 76-year age at the time of vaccination), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Medical history included allergy, blood pressure, kidney patient (on dialysis three times a week, so he was a kidney patient). Concomitant medication(s) included Insulin aspart (NOVOLOG) (He takes Insulin with each meal he takes 6 units of NovoLog with his Demeter 6 units), Amlodipine besilate (5 mg tablet) taken for Blood pressure as 5 mg (one tablet on Saturday and Sunday, Tuesday and Thursday), Atorvastatin (40 mg tablet), 40 mg daily, Acetylsalicylic acid (BABY ASPIRIN) daily, Cetirizine (5 mg tablets) for Allergy at 5 mg daily, Ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE) daily (1 pill daily), Docusate (DOCUSATE capsule) by oral 1 DF, 2x/day (One capsule by mouth twice a day), Fish oil (100 mg capsule) 100 mg, 2x/day orally, insulin glargine 1x/day (At bed time he takes 8 units of his Insulin glargine), Vitamin B complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) and vitamin D3 daily; patient was taking other medications for kidney. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3302; 76 Year age at time vaccination) on 21Jan2021 for COVID-19 immunization and experienced lost his appetite right away, extremely volatile vomiting, lost control of all of his extremities, this has all affected his memory, acute pancreatitis, barely moving, balance was horrible/his whole balance everything was off; had no strength. It was reported patient received his 1st Pfizer vaccine shot on 21Jan2021. He "lost his appetite right away and wasn't eating." Then on 29Jan2021 he took 2 bites of a meal, and "had extremely volatile vomiting and lost control of all of his extremities. My daughter had to help me get him up from the floor." the next day "he was able stand up and use the restroom by himself. This has all affected his memory, he cannot do his medications alone anymore and he cannot take care of himself." 09Feb2021 he received the 2nd vaccine dose. "Again that night he took 2 bites of food and vomited. The next day, he still had no appetite, he took shower and then went to bed with dizziness (10Feb2021) and no energy." stated she took him to the (hospital name) on 12Feb2021 and he was admitted to the (hospital name) with "acute pancreatitis (Feb2021) and was released on the 17Feb2021. They should have kept him longer, because he is still not eating and is so weak (Feb2021), I am worried." Further stated, " He had his first shot of the Pfizer on 21Jan2021 and then he violently threw up on the 29Jan2021 and from that's when on he had no appetite, I couldn't get him to eat anything. And then he had his second shot on the 09Feb2021. On Thursday, the 11Feb2021 he violently threw up again after taking two bites of food. And then on the 12Feb2021 I took him over to the (hospital name) because after when he vomited; he lost all use of his extremities (Feb2021). My daughter and I were having to pick him up of the floor, the Friday night 24 hours it was just horrible. Saturday morning he had gotten use of his extremities back but I mean barely moving and still very, his whole balance everything was off (Feb2021). Now when I took him into the hospital they diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday the 12Feb2021 and they released him on the 17Feb2021. And he still has no strength (Feb2021). His balance is horrible. It was affecting, whatever it is affecting his memory. the medical records when he went in the hospital and everything if they would like. They have no idea why he came down with acute pancreatitis and he never had any pain with it. They said we are amazed that he was not in severe pain, never any pain. I want to find out if they feel that it had anything to do with the vaccine and if it did if there's anything we can do to improve because he is terribly, terribly getting worse." also stated, "He started experiencing the problems right with in that time period of him getting both shots." Also reported, Affected his memory in Feb2021. Reporter stated, "Because I didn't know, he was starving himself to death (in Feb2021) he couldn't hold anything down. He wouldn't eat and when I went (incomplete sentence)" The seriousness was reported as hospitalization for the events Acute pancreatitis; Appetite lost; Muscle disorder; Asthenia. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021191555 Same reporter/patient/product, Different dose/AE

sore arm other than injection site; light headedness; mild diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received first dose of bnt162b2(BNT162B2; formulation: solution for injection; Lot number el9264) via an intramuscular route of administration in left arm on 27Jan2021 at 03:00 PM (Age at vaccination: 76) as single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products and the patient received other medications within 2 weeks of vaccination, but unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 09:00 PM (the date of the vaccination), the patient experienced sore arm other than injection site, light headedness, mild diarrhea. The patient did not received treatment for the adverse event. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.

shoulder pain; My husband had a sore arm; This is a spontaneous report from a contactable Consumer. This Consumer reported that a 76-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 25Jan2021 as 1 ST DOSE, UNKNOWN for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She stated that her husband experienced only shoulder pain. She stated my husband had a sore arm, he (Husband) was fine, he was good with it he just had a sore. The outcome of the events was unknown.

developed a thrombosis on the left arm; varicose veins on the arm; whole arm is swollen; veins are swollen; burning pain in left lung, and it goes up to the breast and lymph nodes/ discomfort on left side Lung; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; has tenderness near the wrist and elbow, clarifying the inside of the elbow; felt numbness in the left arm; hot flashes; This is a spontaneous report from a contactable consumer (patient) and physician. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart conditions, he has had 2 heart attacks in the past, the first one was 21 years ago, and the second was 2 years ago. Concomitant medications included all his regular medications, nothing new; (also reported as No other products). Patient previously received BNT162B2 first dose on 13Feb2021 administered in left arm for COVID-19 immunization. Patient developed varicose veins a month after he received both his shots for Pfizer's COVID vaccine. Caller stated veins are swollen. It's coming down some, but patient need to know what medications could take or not take. On the left arm right inside of his elbow, he started getting some pattern of varicose veins. It was tender to some degree and people told him to massage it and put a warm pad on it. Seems like the veins were going to pop out. Patient stated he received his vaccine at a hospital. On 03May2021, reported patient was calling in regards to a covid vaccine. He developed a thrombosis on the left arm, it was varicose veins on the arm and the whole arm is swollen, it was still swollen but it was coming down. He had been using a heat pad. Initially after 2 weeks from when he got the shot he wasn't concerned, he went to the doctor and they gave him Cat scan, Ultra sound, and blood test and did not find a blood clot. He added that he had discomfort on left side Lung, but he had discomfort several years ago, an MRI in the past that showed he has a spot in the lungs, but they didn't think it was progressing. With this thing in the past 3-5 weeks he has burning pain in left lung, and it went up to the breast and lymph nodes, it is sensitive there, he has no idea what it is. Caller was asked to clarify since he stated that he had a thrombosis but all tests show no blood clot. Caller stated that he thought Thrombosis meant when the veins are popping out and gives impression of varicose veins. He had tenderness near the wrist and elbow, clarifying the inside of the elbow. If looking at the arm from the elbow up little, it looked like worms coming out, it was veins or arteries showing. The varicose veins appearance was more pronounced close to surface initially but is now minimizing. First dose date on 13Feb2021. He was not concerned after the first dose, he was fine, he thought it was a good product and it still is. Second dose date on 10Mar2021. After the second dose he felt numbness in the left arm and hot flashes, he looked down and saw the varicose veins. He did go see the primary care doctor. He also saw his heart doctor but that was an already scheduled appointment, he did not schedule it because of this situation. the heart doctor said to put a warm pad on the arm and lift the arm up over the head every so often. Caller did not have his covid vaccine card, caller stated that he has miss placed it. He found some paper but it only has his ID number and "LHDSER" on it. He received the vaccine in the left arm both times. All symptoms occurred on the left side. He recieved the vaccine in a hospital. Patient asked to refer to his primary care doctor as he has all the results for the tests. Investigation included CAT scan normal; Ultrasound normal; Blood test normal and MRI abnormal which showed spots in the lungs on unspecified date. The event outcome for all events was unknown. Information for batch/ lot number has been requested.

Chills for two days after the first vaccine. rash on right foot and right arm after the second vaccine which lasted several days and then dried up. At that point I had cold sweats and chills which started today about 10 AM. I texted Dr. who advised me that the rash should disappear in a few days. She was correct and a couple of days later texted that she had no concerns about the cold sweat and chills.

03/18/2021 FIRST COVID19 VACCINE 04/08/2021 SECOND COVID19 VACCINE 04/09/2021 FELT DIZZY AND FAINTED BREIFLY IN THE MORNING 05/03/2021 AT NIGHT, SLUGISH SPEACH, DIZZY, HIGH BLOOD PRESSURE 05/04/2021 WENT TO EMERGENCY ROOM AND HOSPITAIZED (STROKE)

3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had fallen and could not get up. He was brought to the emergency room, and a trauma evaluation was negative. He was found to have a severe junctional bradycardia with a heart rate in the 20s and systolic blood pressures in the 60s. In addition, he was found to have a creatinine now of greater than 5 when his previously had been in the low 1s. Patient admitted with junctional bradycardia, acute renal failure, hypotension, cardiogenic shock, and acute hypoxemic respiratory failure with high O2 needs. PMH significant for CAD, pulmonary HTN, aortic stenosis, obstructive lung disease, and chronic hypoxia. This patient has been made DNR/DNI over the weekend which is quite appropriate. Patient was found to be unresponsive with fixed/dilated pupils, absent heart and breath sounds, no respiratory effort, absent pulses, and no response to painful stimuli. Patient was pronounced deceased on 03/10/2021 at 0405.

jaw bone like what hooks onto his head gets achy; it gets achy and is weird; terrible muscle pain and joint pain; little shaky when getting out of the chair; terrible muscle pain and joint pain; his hands joint do not work right; This is a spontaneous report received from a contactable consumer or other non hcp (patient himself). A 76-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EP7534, Expiration date: Unknown), via an unspecified route of administration in Arm Left on 18Mar2021 10:30 as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There were no prior vaccinations within 4 weeks and no adverse events prior vaccination. There was no family history relevant to adverse events. The patient previously received first dose was received in his left shoulder as an injection on 25Feb2021 10:30 and the lot number is EN6200. On 19Mar2021, the patient experienced terrible muscle pain and joint pain, little shaky when getting out of the chair, on unspecified date in Apr2021, experienced jawbone like what hooks onto his head gets achy, it gets achy and is weird and on unspecified date in 2021, experienced his hands joint do not work right.. It was stated that he was calling to report what has happened to him from the second shot. The patient stated he got the shot on 18Mar2021 and when he woke up in the next morning he had terrible muscle pain and joint pain so he decided to call his doctor. The patient stated he could not get a hold of his doctor but the information that was given to the caller was provided from the nursing staff. It was stated that before he got the COVID shot he was working out with weights in the fitness center and doing really good and now he was fighting a battle. The patient stated also his jawbone like what hooks onto his head gets achy. The patient stated that mostly the joint pain was in his shoulders. It was stated he was sitting down on his chair and he used to be able to get up real easy but he now he was a little shaky when getting out of the chair now. The patient stated also his hands joint do not work right but he bought some stuff to rub on them which seems to help a little bit, but he has never had any of this before. It was stated he was working out, handling barbells, and for an old guy people would be surprised what he was lifting and he had no problems and stated for example if he goes to eat a breakfast meal with the egg, sausage, and biscuit he can barely open his mouth enough to eat it. The patient stated this started probably at the end of April. It was stated this is no 24 hours a day but he had it this morning and it gets achy and was weird. It was stated that eventually he will go back to the dentist since the dentist has a machine to take a picture of his jaw since he has not gone yet because of COVID but once he gets all this squared away he will go to dentist so they can take that picture. It was stated he was able to squat down towards the floor and go way down all the way down and pop right up and stated he knows he could not do that in the last couple of weeks anyway but he has not tried it since he has had trouble getting out of chair. It was clarified that this started as an introduction the day after getting the second shot on 19Mar2021 and it was still going on. It was stated he was not sure if it is getting worse or not since he has not followed it like a documentary. It was stated the doctor told him to take Tylenol and he has never had anything like this happen to him. It was stated what the doctor relayed to him was to go get a Tylenol rapid release and he takes two pills which is 1,000mg and he takes this 3 times a day and has a schedule knowing it was not recommended to take more than the 3,000 since the doctor was not wanting him to go over 4,000mg because effect the kidneys or liver. It was stated but he had not talked face to face with his doctor and he needs to get an appointment with his doctor but there is a wait and probably won't be able to see him for about a month. The outcome of the events terrible muscle pain and joint pain, jawbone like what hooks onto his head gets achy were not recovered and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

nausea; Headache; Fatigue; different feeling than what he normally feels; His arm was sore; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Feb2021 14:02 (at the age of 76-year-old) (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes from 1996. The patient's concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9264) administered in the right arm on 02Feb2021 (at the age of 76-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization where patient also experienced his arm was sore. On 24Feb2021, the patient experienced nausea, headache, fatigue, different feeling than what he normally feels, and his arm was sore. The onset time for the events headache and nausea was at 09:00. The patient was admitted to the hospital due to the events nausea, headache, fatigue, and different feeling than what he normally feels. The events did not require emergency room and physician office visit. There was no treatment received for all events. On an unspecified date, the patient recovered from all events. Follow-up attempts are needed. Further information has been requested.

left arm to be a bit sore; tiny little headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), on 16Mar2021 at 13:00, after lunch (at the age of 76-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was in good health for age 76, as reported. The patient played semi pro sports. The patient received the first dose of BNT162b2 (lot number: EN6200) on 23Feb2021, at the age of 76-years-old, for COVID-19 immunisation. The patient experienced his left arm to be a bit sore and just one tiny little headache in Mar2021. He had no fever or other possible side effects. Patient asked if drinking alcohol had any effect a few hours later the vaccine. He clarified he was not drunk; only for a couple of glasses of wine/beers. The patient clarified that he had a couple of glasses of wine with dinner and had no reaction. He was speaking about having a couple of glasses of wine with dinner and the pharmacist told him that he was pretty sure that would be fine to do. Patient stated he had a lady friend coming over the night of the report and she was getting her 2nd Pfizer vaccine on that day and he was convinced that a glass of wine would not hurt. The patient asked when after the shot you would have the highest level of protection and how long after the 2nd booster of BNT162b2 he would be best protected and if it would be in another week or 2 weeks before full protection occurred. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Multiple episodes of tachycardia (60+ since 2/28/2021) with accompanying symptoms of flushing labored breathing and triggering of bowels.

Pain in the left arm between the elbow and the shoulder; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration, administered in Left arm on an unspecified date in Jan2021 at 10:30 or 11:00 (at the age of 76-years-old) as dose 1, single dose for covid-19 immunisation. Medical history included, patient was tested for covid months ago, prior to receiving the pfizer covid 19 shots and tested negative at that time. Patient's medical history including any illness at time of vaccination were none. Family medical history relevant to adverse events were none. Relevant tests were none. There were no concomitant medications. The patient previously took flu shot over the years and experienced the same sensation (pain) in his arm, only worse occurred. The patient is unable to provide NDC/lot/expiration for the flu shot. There was no antipyretic use around the date(s) of vaccination. The patient stated that he was for the most part a healthy person. History of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was not reported. Are there predisposing factors? Unknown/no/ yes (e.g. Immunosuppression, contact with other infected persons) if yes, please specify: not that the patient knows of. Prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines were none. Additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect were none. There was no investigation assessment. On an unspecified date in Jan2021, the patient experienced pain in his left arm between the elbow and the shoulder, began about two hours after he received both the first and second dose pfizer covid 19 shot. The caller states the pain in the left arm between the elbow and shoulder has gone away. The caller states the pain in the arm went away completely after both doses of the pfizer covid 19 shots. Adverse events required a visit to to urgent care. He stated there were no emergency room visits. The patient underwent lab tests and procedures which included covid (sars-cov-2 test): negative on an unspecified date. Is there a Product Complaint: Yes, description of complaint was the caller received both doses of the Pfizer Covid 19 Vaccine and tested positive for Covid. Product strength and count size dispensed: N/A. Additional lot numbers: The caller states his wife has this information with her and the caller has no clue, the caller states Pfizer should be able to look this information up. The caller states his wife is not available for the next 4 or five hours. The caller is unable to provide this information for the first or second dose received of the Pfizer Covid 19 shots. The outcome of event was recovered on an unspecified date in 2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733594 similar report from same reporter

Patient received entire vial of undiluted vaccine. Patient being monitored for adverse effects while inpatient. Patient received vaccine while admitted for other medical conditions. Currently experiencing weakness and generalized pain.

diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot. The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered and outcome for other events was unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter

Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021

Chest pain; Tingling Pins and Needles All Over his body/pins and needles all over his skin; This is a spontaneous report from contactable consumer via Medical Information Team. A 76-year-old male patient (Husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 17Feb2021 09:00 (at the age of 76-year-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced tingling pins and needles all over his body, pins and needles all over his skin. On an unspecified date, the patient experienced chest pain. Reporter stated that this morning it was only on his left arm where he got his vaccine. February 2021. She explained her husband had "pins and needles all over his skin", and in the morning it was limited to his left arm, where he received the vaccine. She added she experienced "chest pain" the Friday following the injection, which lasted for 4 days. She had a phone consultation with her cardiologist who said it was "fine and muscle pain". She mentioned their second dose was scheduled on 10Mar2021 and asked if they should receive it. She also reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained: one died after the vaccine; the second, in her sixties, died of a heart after the vaccine; and the third, in her fifties, died after experiencing chest pain for 2 weeks post vaccination. She explained she had no additional details on these adverse events. Her husband had pins and needles all over his skin the day after, and it was just in left arm where he had the COVAX. She said he tried to ask the HCP about it, but the HCP would not answer them and told them to call. She had chest pain 4 days after receiving the COVAX and her cardiologist told her it was just muscle pain. She did not have it. Patient was not visited to Emergency Room and physician Office. No vaccine was administered Prior Vaccinations (within 4 weeks). No treatment was given for the events. Outcome of the event chest pain was recovered on an unspecified date, and tingling pins and needles all over his body and pins and needles all over his skin was recovering. Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.

kept going back and wanting to go to sleep; Fever; weak; chills were real bad, it made him shake; pulse has been high ever since the shot; has the thing you put on finger to read oxygen, it was 92 one time; arm sore; This is a spontaneous report from a contactable consumer(patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 11Feb2021 (at12:00) (Batch/Lot Number: EN9581) as Dose Number Unknown, 0.3ML Single for Covid-19 immunization. Medical history included Gastroesophageal reflux disease, Blood cholesterol; Only takes acid reflux and cholesterol medicine and Covid-19 From an unknown date and unknown if ongoing. The patients' concomitant medications were not reported. The patient experienced Arm sore on 11Feb2021, Fever on 12Feb2021 at 05:48, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, weak on 12Feb2021, Kept going back and wanting to go to sleep on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 101 on 12Feb2021, Body temperature: 101.6 on 12Feb2021, Body temperature: 100.3 on 12Feb2021, Heart rate: high on 12Feb2021, Oxygen saturation: 96-98 on 12Feb2021, Oxygen saturation: was like 92 one time on 12Feb2021. There was no Assessment. A query was raised to confirm Patient's last name and then the response was received After listening to the recording. The outcome of event for Arm, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, and Kept going back and wanting to go to sleep sore was unknown. The outcome for event Fever and weak was resolving. Follow-up attempts are completed. No further information is expected.

sleepy; soreness around the arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 77-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER6955, Expiration Date- Jun2021) via an unspecified route of administration in left arm on 05Apr2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in left arm on 03May2021 as dose 2, single (at the age of 76-years-old) for COVID-19 immunization. Patient medical history included ongoing seasonal allergies, never had an actual diagnosis. He thought there was something wrong with his lungs and said that he was wheezing and the doctor prescribed him something that he did not want to take. Picked up leaves and his throat constricted on him and he said that he diagnosed himself. The concomitant medications were not reported. On an unspecified date in 2021, patient stated he has had both doses of the Pfizer COVID-19 vaccine and reported that the vaccine made him sleepy. He stated he would sleep for 3 to 4 hours after the vaccine. He reported soreness around the arm. He stated he felt great after the nap. He stated he took the Pfizer covid 19 vaccine and feels more at ease now. He stated that his eyes were bad prior to the vaccine and it had no effect on his eyes. He does not like taking medication, but every once in a while would take Benadryl for his allergies. It might have been that he just laid down after the vaccine. He said that he is a old man and can sleep all of the time. The outcome of the events was unknown. Follow up are attempts needed. Further information is expected.

within a week of the second shot the patient began to have problems with both legs, such as burning in both legs, continued weakness, and when he walks his feet want to go in one direction and he wants to go in another. It is now July 25, 2021 and his legs are no better.

Flu like symptoms, chills, shakiness, stuffy sinuses and moderate fatigue. Occurred 24 hours after injection and, with the exception of fatigue, have abated for the most part on day two following injection. I received my shot at hospital. It was the Pfizer formula. Injection site upper left shoulder.

sore arm/soreness in the arm; a little swelling, slight swelling/there was a little swelling where it was injected; This is a spontaneous report from a contactable consumer (patient). This reporter reported similar events for two patients. This is 1st of 2 reports. A 77-year-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 11Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Family Medical History was None. The patient previously had pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. He went to the clinic and they gave him something and it went away and he was told not to get another one. It was about 8-9 years ago. The patient's concomitant medications were not reported. The patient experienced sore arm and a little swelling, slight swelling on 11Jan2021. The patient noticed the soreness in the arm about 2-3 hours after getting the shot, but it was getting better, but there was a little swelling where it was injected. There was slight swelling, but not much. The outcome of event "sore arm/soreness in the arm" was unknown; of event "a little swelling, slight swelling/there was a little swelling where it was injected" was not recovered. Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026404 same reporter/product, different patient.

No reaction originally; but 10 days after receiving the PFIZER-BioNTech COVID 19 Vaccine EUA I had severe pain in my left (vaccine site) upper arm muscle and shoulder joint; and was unable to lift my arm up away from my left hip. I have been experiencing these severe symptoms since the 10th day after receiving the COVID Vaccine (now the 12th dasys after the vaccine)

Patient received unknown covid vaccine 1/20/21, sometime before or after became Covid PCR+. 3 days later developed encephalopathy, was quite agitated, walking around hospital naked. He had LP which ruled out infection and CT imaging to rule out CVA. Improved after 24 hrs with supportive care, pt returned to mental status baseline

Day of injection (01/28/2021) plus 3 hours Approx 12 noon. 4 bouts of Diarrhea lasting several hours. Two days post injection (01/30/2021) 11:A.M. 2 bouts of Diarrhea over two hour period. Two days post injection (01/30/2021) 10:00 P.M. Broke out in a full body sweat, weakness with heart rate 120 bpm. Cooled off by using cool wet towels and rested for two hours. Heart rate down to 75bpm. Heart felt like skipping beats for another hour. Now Sunday morning (01/31/2021) and feel normal

intense itching/ itching on his hips and on his back; gets red whenever he scratches it; after the injection his arm got a little sore; Feels like it is hot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246, expiry: 30Apr2021) intramuscularly into the left arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history included nerve damage, brain damage, disability from 1997, anxiety, major severe depression, occupational exposure to heavy metal uranium, chronic obstructive pulmonary disease (COPD), early stage emphysema and diabetes. Concomitant medication includes unspecified medications for brain damage, anxiety and major severe depression. It was reported that after the injection, his arm got a little sore on 06Jan2021. On 13Jan2021, patient experienced intense itching; further reported as itching on his hips and on his back which gets red whenever he scratches it. It was also reported that the more he would scratch it, the more intense the itching would get. On an unspecified date in Jan2021, the patient also feels like it is hot. The patient applied EUCERIN cream and CORTISONE 10 for the events "intense itching/ itching on his hips and on his back" and "gets red whenever he scratches it". The patient was scheduled for his second dose on 27Jan2021. Outcome of event "intense itching/ itching on his hips and on his back" was not recovered while for the events "after the injection, his arm got a little sore", "gets red whenever he scratches it" and "feels like it is hot" was unknown.

he doesn't have any energy, he is real low on energy; real sick; tired; freezing to death; Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Jan2021at single dose for COVID-19 immunization. Medical history includes hearing aids user from unknown date. There were no concomitant medications. On 17Jan2021 Sunday, the patient was freezing to death, had chills and diarrhea and still has them right now. The patient was fully aware that second dose is on 04Feb2021, and wants to know more information, is this going to continue, etc. The patient stated he was real sick, but while being sick, he read the papers, and it actually told him, this was supposed to happen. He was supposed to have chills and fever and all that, and by golly his body has done a good job of that. The real thing is, he is fine with taking it again, but after such a reaction, he wants to know if it is safe to take it again. The patient stated he lost one of his hearing aids, he needs to have another one sent, he had a terrible day yesterday. His symptoms came on in the middle of night, got in clothes stayed in bed. He has no primary care doctor, he has one here but doesn't know if he wants to mess with him. For events freezing to death and chills outcome was the he feels good, he was not chilling or doing anything anymore, but one thing that is bothering him, he doesn't have any energy, he was real low on energy. The freezing to death and chills started leaving yesterday morning, and went away over the day, he is just kind of down with it, just tired. He doesn't know why. The diarrhea didn't hang around a long time. The outcome of the events freezing to death, chills and diarrhea was recovered on unspecified date. The outcome of the remaining events was unknown. Information on the Lot/Batch number has been requested.

Tired; Arm hurt a bit; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 18Jan2021 at 14:30, at a single dose, for COVID-19 immunization; and ibuprofen (ADVIL; Strength: 200 mg, Lot Number: DC5474, Expiration Date: May2022), via an unspecified route of administration, on 18Jan2021, at 400 mg, single, as premedication. The patient's medical history and concomitant medications were not reported. The patient's wife was told by a nurse to give ibuprofen before the patient's first shot. So, the patient's wife told the patient to take ibuprofen before the COVID-19 vaccine shot and he took two 200 mg ibuprofen before the vaccine. The patient's wife feels guilty because she doesn't know if the patient is protected or not. The patient's wife gave the patient two ibuprofen before the COVID-19 shot. On 18Jan2021, the patient felt a bit tired and his arm hurt a bit, but he was fine the next morning (19Jan2021). He only felt a little tired that day and the next day, he felt great. It was further reported that the patient's wife gets allergy shots from a nurse, and the nurse told her to take ibuprofen before the COVID-19 vaccine shot. The patient never takes ibuprofen and the patient's wife can't believe she told him to take it. She had a friend who said ibuprofen could minimize the effectiveness of the shot. So, she was asking if the patient should have another shot since he took ibuprofen before his vaccine. It was a very bad advice because the patient's wife just learnt she shouldn't have. The patient's wife wanted him to have a little reaction as she thinks the vaccine is not going to be effective; asked if the patient should take an additional shot. The patient is scheduled for the second dose of the COVID-19 vaccine on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable; and for ibuprofen was post-therapy. The patient recovered from the events on 19Jan2021. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

fever 102-chills- unable to walk-disorientated-loss of appetite-dizzy- we had to take him to his Dr in a wheelchair on Monday ,February the 1st. Doctor put him on covid meds and he is still to this date (Feb. 6th) still weak . we had a covid test done and it was negative.

Very Sore upper left arm with deep bruises covering significant part of upper left arm below injection site.

2 days after the shot I woke up and I had a hard time moving my mouth and my bottom lip was completely swollen. Its still puffy and very very red.

Patient began experiencing left facial droop on 1/31/2021. Diagnosed with bell's palsy on 2/1/2021 and started on antiviral, PPI, and steroids.

Left arm (arm that received injection) was slightly painful when used to left or push push a snow shovel for two (2) days. 3 day was fine. On 3rd day, Sat. 2/6/2021, felt a bit tired and listless most of the day. Next day felt 100%

Events: Soar arm, chills, slight fever, aching muscles and joints Treatment: Tylenol Outcome: Resolved in two days

This patient received his 2nd dose of Pfizer vaccine yesterday. Today, he had focal weakness and difficulty walking and was transferred for suspected stroke.

ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.

Hypothermia/A temperature of 93.7 orally/temperature was 92.7/went down to 93.2 degrees; Chills; The arm he received the injection in was tender however progressed to mild to moderately painful/arm was suddenly painful; Shaking; Injection site tenderness; This is a spontaneous report from a contactable physician (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9262, expiry: unknown), via an unspecified route of administration in the left arm on 26Jan2021 15:30 at a single dose for protection from the virus at the Physician Office. Medical history included type 2 diabetes mellitus from 2011 and ongoing. The patient also thought he had a Covid respiratory infection in Feb2020. He had a prolonged moderate to severe respiratory infection. He thought at first that he had the flu, but he had a flu shot. He thinks he had Covid. He had antibody studies in May2020 (last spring) that were negative. The patient has no concomitant medications. The patient previously had influenza vaccine (flu shot). The patient reported hypothermia after getting the first dose of the Pfizer Covid 19 vaccine. On the same day of vaccination (26Jan2021), he had injection site tenderness. The next day, (27Jan2021), his arm was suddenly painful; he began to have chills 29 hours after receiving the vaccine (27Jan2021) and was shaking. He also had a temperature of 93.7 orally, confirmed with two different digital thermometers. He took his temperature with a new electronic thermometer that he purchased at a pharmacy. His temperature was 92.7 on 27Jan2021. He repeated it with another electronic thermometer. The first evening (27Jan2021), his temperature went to 96.5 to 98 degrees. Then it went down to 93.2 degrees. He covered up with blankets and his temperature increased and the chills stopped. He stated that this was hypothermia. He had low temperatures the following day (28Jan2021) as well, his temperature was 93-94 degrees. His temperature was 93.7 degrees. Other times he checked his temperature and it was 96.5 degrees. When his temperature was low the first time, it only lasted for about three hours. The second time it happened he went to bed and covered up. It lasted for an hour or two. He noticed it again two days ago. The patient also stated the arm he received the injection in was tender however progressed to mild to moderately painful when he experienced the chills and low temperatures. The arm tenderness after getting the vaccine was very mild. He noticed it when he rolled over on his arm. He took some Tylenol for it. His son is an internist. He said the hypothermia was medically significant. His son also said hypothermia is equivalent to a fever in the elderly. The patient wanted to know if there have been any reports of hypothermia after the administration of the vaccine. He has concerns about this occurring after the second dose. He is scheduled to receive the second dose on 15Feb2021 or 16Feb2021. The outcome of the event hypothermia was recovered on 30Jan2021 and pain in arm recovered on 27Jan2021. The outcome of the other events was unknown. The events hypothermia, arm pain and injections site tenderness were assessed as related to BNT16B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported hypothermia and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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.

1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed. 2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and life support guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and life support guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.

11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms worsened. Admitted to medical center for cath and stint placement.

Arm is very sore; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration in left arm on 27Jan2021 10:00 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included metformin. The patient experienced arm is very sore on 27Jan2021. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Sudden development of rash all over body, flushed face, tired, weak, headache, temperature 97.8, blood pressure 108 over65, pulse 75. Sat down, took prednisone 20 mg and benedryl. Symptoms lasted for a couple of hours. Rash took several hours to reduce. Continued prednisone overnight. Next morning seemed very improved. IT TRULY SEEMED LIKE AN ANAPHALXIS REACTION. Waiting for Health Dept. nurse manager to call back. As noted, this Anaphalixis occurred 72 hours after the vaccination.

had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an asthma attack.; Felt like something was stuck in his throat; He feels tired now; vomited lying down; Right now his throat is burning; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient woke up and had severe acid reflux, trouble breathing for about 15 minutes, couldn't catch his breath, was wheezing and sounded like an asthma attack. He felt like something was stuck in his throat. It cleared in 10 seconds and he could breathe and swallow fine. He took a Benadryl as treatment and drank water. He also felt tired. The patient further reported that he had the covid vaccine shot. He did not know if he was having a reaction, but he was taking a nap, and he guessed he regurgitated. He had a difficult time catching his breath, it was like it was stuck in the throat. He vomited lying down. He felt the stomach acid come up into mouth after he was able to breath better. But before he was not breathing at all. This never happened before. He was lying flat, he guessed he threw up. He had a large lunch, maybe too large. It was like he was getting something caught in in throat. The patient also reported that his throat was burning and mentioned that he slept on a triangular pillow. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.

About 24 hours after the injection, I had extreme fatigue and difficulty getting out of bed. along with body aches in both arms and a seizure like blank stare and couldn't move my arms and legs for a short time. Briefly I had shakes in both arms but no fever, chills, or headache. By the next morning the injection arm (left) was achy with no other prominent symptoms.

Patient presented to ED with weakness, black stool and was found to have erosive gastritis with PUD. Multiple polyps on colonoscopy. Per , hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

During post vaccination observation period complaint of dizzy, warm, clammy and hypertensive BP 180/96. While being observed complaint of chest pain, transferred to ED. EKG and lab work within normal limits, Observed an additional hour with symptom relief and discharged to home.

Following Dose 1, Right Arm became sore at injection site for 4 days, at which time Right armpit became very tender touch and was swollen about size of silver dollar, approx. 1/2 inch thick. Soreness at injection site subsided over the next 17 days, but tenderness in armpit only diminished slightly. Following Dose 2, Right Arm was once again sore at injection site for about 4 days, but tenderness to the right armpit became more pronounced, with swelling increasing to the size of a hockey puck. Size of swelling was easily visible to the eye. Armpit became more tender to the touch, and has diminished only slightly in size,, as of this reporting. Mass remains soft to the feel, but easily defined in size and location. I have taken OTC pain killers to help with the discomfort. Will continue to monitor its progress, unless notified otherwise. Do not anticipate seeing my physician at this point. Have consulted the Web, and have noted that this is a lesser side effect of this vaccine, if swelling remains localized to the injection site. Thought I should report this side effect only because of the size of the swelling that occured.

1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.

Patient awoke at 01:30 am on 1/31/21 with abdominal cramps, nausea, diarrhea x 3 stools, and chills with rigors. 01/31/2021 03:22 presented to ED for assessment with complaints of abdominal pain and shaking; 01/31/2021 06:29 patient discharged from ED - symptoms resolved; ED Tx consisted of Acetaminophen 1gm IV x 1 dose; chest x- ray (neg); CBC (WBC 12.9); CMP (AST 77, ALT 94); Respiratory Panel 2.1 IVD (BIOFIRE) - Negative; EKG - A-fib rate 108;

Entire core hurt. Loss of appetite. Fatigue. Joint ache. Mild headache. Second day less severe. Third day weakness and fatigue.

low temperature (96.5); Chills; slight tremors; soreness at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration on 10Feb2021 08:15 at age of 77-years-old at arm left at single dose for COVID-19 immunisation. Medical history included bladder cancer, high blood pressure and no known allergies. Concomitant medication included allopurinol, amlodipine, valsartan, indapamide, atorvastatin (LIPITOR), pregabalin (LYRICA), metformin hydrochloride (MEDFORMIN), metoprolol succinate (TOPROL) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 18Jan2021 at age of 77-years-old for COVID-19 immunisation. The patient experienced chills, low temperature (96.5) and slight tremors, soreness at injection site on 10Feb2021 06:00 (as reported). No treatment was received for the adverse events. The events outcome was recovered on an unspecified date in Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.

Almost immediately felt swelling at the injection site, which I felt as being normal. Next day when I woke up felt a slight headache , abnormal vision issues that included sparkles, blurred vision and a general tiredness. Did not feel refreshed as I normally do when I wake up in the morning. As the day went on sparkles and vision issues remained and headache got worse. Went to bed earlier than normal and next day when woke up the symptoms got worse, I felt like I had a migraine. Vision issues persisted. Laid down around 11AM and took a nap and when I woke up I noticed a blotch in my left eye reminiscent of the shape of a fish (looked like a shark) and it had different colors. Bright yellow and black almost kind of an iridescent green and orange. The shape was still just the colors were different. I panicked and called the optometrist and explained what happened. They wanted to see me right away. I was able to be seen in the afternoon. They looked at it, did two tests and came with the diagnosis of a branch retinal artery occlusion. I visited my neuro- ophthalmologist on 01/28 and he confirmed the diagnosis had previously given. He then ordered fedrate and a couple of other tests. They also did a visual acuity in the left eye (20/30) and color vision (8/8 normal) and color plates and intraocular pressure (16 OS)

Awakening on Saturday, March 13, I saw blood on my pillow and a pee spot on the bed (my first time for either). I could barely get out of bed (an awkward rollover did it). My tongue was numb (still is) and raw from the presumed chewing on it. Walking was slow and painful as all muscles hurt. If I sneezed or coughed, my back would hurt. Those last problems are still true. I periodically cough up phlegm and lacking a good place to spit it out, I just swallow it. I have for the first time in my life been using a walker for stability. Right arm is almost useless due to pain.

chief complaint of lightheadedness and an upset stomach onset this morning. Patient states that yesterday he had his second Pfizer COVID shot. Afterward he felt fine but this morning woke up with an upset stomach, lightheadedness and felt clammy. He describes the upset stomach as feeling hungry. The lightheadedness is described as, "my stomach felt off, which made me feel sick and off". His wife called EMS for the patient to be evaluated as he has a cardiac history. At this time he has no lightheadedness but his stomach is still upset, like "I need to eat". Received pepcid and NS 1000 mL

Progressive Left arm pain/shoulder soreness that began 5 days prior to hospital presentation. Seen in ambulatory clinic 7 days prior to presentation, given ibuprofen and percocet without relief. New swelling and erythema brought pt to hospital. Around time of vaccination, the pt was using triamcinolone for left forearm rash (described as small, more-spotty and resolved quickly). MRI revealed an abscess (10 x 6.8 x 1 cm) deep to the deltoid muscle and along the lateral aspect of the left proximal humerus. He also has another abscess within the posterior deltoid muscle (3.1 x 2.1 x 2.8 cm). There is surrounding myositis, fasciitis and cellulitis.

dehydrated and then he stayed in the hospital for some time; said patient has Covid; severe reaction to the vaccine/severe allergic reaction to the vaccine; high fever/get real hot/running a 103.1; sweating; UTI; could not breathe and he was struggling to breathe; Moaning; diarrhea; chills; shaking all over; severe headache; started throwing up; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202 and expiry date: unknown), via an unspecified route of administration on 26Feb2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma and stage 4 kidney disease. The patient's concomitant medications were not reported. On 27Feb2021 (Saturday), patient was not feeling well and on 28Feb2021, he had diarrhea, chills, shaking all over, severe headache and started throwing up. Reporter stated patient had all the symptoms of the reactions and then "you go again to the serious, more dangerous symptoms, he has all of them". Throwing up, fever, chills, diarrhea and then he get real hot and then he started sweating and it was another day on 01Mar2021. On Monday (01Mar2021), reporter called to take patient to the hospital with high fever. The ambulance put him on IV and oxygen right away. They gave him fluids and were monitoring everything because he was dehydrated and then he stayed in the hospital for some time. He had x-rays, they monitored his blood pressure and heart rate, and the doctor was concerned about his heart rate and blood pressure. Doctor decided to check his urine and he did and he had a UTI on 01Mar2021, and so he gave him antibiotics for that (treatment unspecified). Patient seemed to be better after having the fluids and everything so they let him come home. During the night on 01Mar2021, he had another attack and it was the same thing that he had before. The shaking and the chills the fever and throwing up and the doctor said that it was a reaction from having the vaccination and reporter just wanted to report that he did and reported actually thought he was going to die. Reporter tried to call again the ambulance since she thought that he was not going to make it. The doctor put on the report and he did not put on there that he was in there because of suspected of (incomplete sentence) and then told the reporter himself that he had a reaction from the vaccine. The report stated that patient was in for a UT, but the reporter stated that, once does not call an ambulance for a UTI and she (reporter), have UTI's all the time. After the reporter got the patient home, he was even much worse. Patient could not breathe and he was struggling to breathe on 01Mar2021. He was shivering, shaking, having diarrhea, throwing up, soaking wet, and she had to change his clothes twice, and his fever was 103.1 F around 2:00 or 3:00 in the morning of 02Mar2021. The pharmacist gave medicine for vomiting. Reporter called the hospital and the nurses were busy and they could not take it so 24 hour nurse called. She was finally able to get him comfortable enough that she didn't have to call again. She thought she was going lose him. She said she felt twice he was going to die, when she called. At the hospital they told him he was having a severe reaction to the vaccine but also had a UTI and they gave him antibiotics. Patient contacted her nephew who is a medic in the military and RN and he said patient has Covid and thinks reporter has Covid too because the virus was in the vaccine. The nephew explained that patient just could not fight it off and said the vaccine acts like that. It made sense because it is inhibit in it then your body will learn to fight it off, like if you come in contact with it and that makes sense but the woman never explained. The nephew further stated to reported that patient's immune system or whatever was not able to fight it off. So, he said he has to have Covid and when patient heard that after all they had fought to stay away from it and then what were they supposed to do. Patient got the vaccine and ended up with it and that is what reporter have found out and it was very disturbing. Patient was running a 103.1 earlier on the night of 02Mar2021. He was moaning a little bit on Mar2021. Reporter thought patient had severe allergic reaction to the vaccine because he had all the symptoms and stated there was no doubt in her mind (referring to it being an allergic reaction) as it was too soon after the vaccine. Outcome of the event of dehydration was recovering, while for the remaining events was unknown. Reporter was asking if patient should take the second shot.

Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day: severe weakness, unable to ambulate, follow directions, mumbling, sleepy, incontinent. Taken to ER - CT of head, EKG, Chest Xray, Labs, UA. Radiologist diagnosis start of Right lower lobe pneumonia. Given IV antibiotic and admitted to hospital. Admission MD thinks no pneumonia with profound weakness. Improved next day and discharged. Same evening as discharge had expressive aphasia. Next day speech normal again and weakness gone. Admitting physician said had another dementia patient with same symptoms and cleared in a couple of days.

Patient received a vaccine at museum sight on 03/23/2021 at 0130 pm according to fiancé. Around 1:30 the next day, his fiance tried to call him and she stated that his voice was garbled, she found him face down with his chin on the table, covered with his own feces and urine. EMS notes that upon their arrival the pt had a right sided facial droop along with some contracture to his left side. Pt was originally awake and confused as he gradually became unresponsive and is only responsive to pain of sternal rub. He has no history of stroke. Pt's BP was noted to be 88/50's en route.

72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.

Pain shoots up his leg; hard for him to walk; tenderness in the back of his calf and thigh/the back of his left leg above the knee and back of his calf feels a little weird, tender; Pain in the bottom of his heel; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 77-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), via an intramuscular route of administration in the left arm on 28Jan2021 at 9:30 (at the age of 77-years-old) as a single dose for COVID-19 vaccination. Medical history included low iron from unspecified date to ongoing (diagnosed about two years ago). Concomitant medication included iron infusion taking for about 2 years, they cannot seem to straighten it out, states it is uncurable. He had too many red blood cells due to bone marrow, he got on iron infusions, and if his red blood cells gets to high, then they will perform phlebotomy to have them taken out. This was his second year receiving the infusions. He goes in once a week and they test him and sometimes he was able to get the infusion and sometimes he had to wait till the next week. Stated they took a pint of blood out of him about a week and a half ago. He goes every Thursday and his red blood cell count was 15.7. The weight of the patient was 205-206. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 28Jan2021, the patient had no problem with his arm, not really too many problems at all, except after he got home, the back of his left leg above the knee and back of his calf feels a little weird, tender. Stated he had a crazy feeling on the bottom of his heel, it was killing him, he can barely walk, he did not have this prior to getting the vaccine. He was worried about getting the second dose. Advised to contact hcp. Him and his wife have their second shot scheduled for 28Feb2021. He was told that it can be given up to 4 days ahead or anytime after. He read that Pfizer recommends 21 days between doses The feeling in his heel has stayed the same. States he slept ok. He does had a bad back. When he woke up and tried to put the weight on his left leg he can walk a couple of steps and his heel was killing him. Pain shooted up his leg. It was hard for him to walk. The back of his knee and calf are not really that bad, but he can feel it, he can barely walk. Caller asked have there been any reports of this and how long does it take for the pain to disappear. Caller stated the clinic where they received the vaccine told them the second dose can be scheduled 4 days before 21 days or a week or so after 21 days. Caller also asked if that was going to cause a problem if the second dose is scheduled 28 days after dose 1? they responded saying that "The Pfizer-BioNTech COVID-19 Vaccine vaccination series was 2 doses given 3 weeks apart. This was how Pfizer-BioNTech studied the vaccine. Provided disclaimers that Pfizer was unable to speak outside of the EUA fact sheet and Pfizer was independent of a company guidelines and recommendations. He hoped the heel pain was going to go away and it was something from the vaccine, not something else. The outcome of the event was not recovered.

left leg was cold/left foot was 79-82 degrees Celsius; blood clots in his left leg/he had three/first one on 02Mar, second one 13Mar and the third one yesterday; he had the Pfizer vaccine on 15Feb and 26Feb; he had the Pfizer vaccine on 15Feb and 26Feb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation; tafamidis (VYNDAMAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient took the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Feb2021 at age of 77 years old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient taking Vyndamax medication who stated that he had experienced blood clot in his left leg. Clarified that he had the Pfizer vaccine on 15Feb2021 and 26Feb2021. Clarified that on 02Mar2021 that he had blood clots in his left leg. Stated that he had three. Stated that he had the first one on 02Mar2021, second one 13Mar2021 and the third one yesterday (15Mar2021). Stated that he was told left leg was cold. Stated that he took his temperature with a thermometer and his left foot was 79-82 degrees Celsius. Stated that the right foot is 95-96 degrees Celsius. Stated that he filled it out for the Covid vaccination. Stated that he reported Vyndalink when it asked what other medications that he took. The action taken in response to the events for tafamidis was unknown. The outcome of events was unknown.

Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatigue with temperature up to 99.2F and patient insists his basal core temp is 97.5F. Received his second vaccine on 04 Mar 2021 with temp < 100F therefore staff encouraged him that he had no contraindication. Same day, noted aches, pains, N/V, decreased appetite, loss of taste. Subsequently noted increased temperature up to 100.4F (single true fever) on 09 Mar 2021. Developed cough on 13 Mar 2021. His remaining symptoms are fatigue, loss of taste, decreased energy. The patient also noticed acute onset Rt chest wall pain after an episode of coughing ? states that it feels like a similar episode previously with known prior Dx of rib fracture. Not worse with exertion or relieved by rest. Not associated with meals. Worse with contact and position changes. He is taking ASA-325, 2 tabs each morning for pain, then 2 x 200mg Motrin tablets at night.

Extreme pain around hip, lower left front torso first night; subsequently, very sore left leg front of thigh ever since and unable to sleep.

Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example; Pain into shoulder area, deltoid muscle nearly totally paralyzed; pain down arm to elbow; This is a spontaneous report from a contactable Physician (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263; expiration date: unknown), via an unspecified route of administration on right arm on 21Jan2021 at 14:30 (02:30 PM) at the age of 77 years old at a single dose for COVID-19 immunisation. Medical history included S/P CABG in 2015, S/P ruptured appdx in 2007. He was asymptomatic, major operations (laparotomy and open-heart surgery) and a retired surgeon. He was still solo skydiving from 14,000 feet with no problems. Allergies were none. Concomitant medications included losartan, metoprolol, vit D (ergocalciferol), aspirin (acetylsalicylic acid) and lipitor (atorvaostatin). It was reported that no problems at all until approximately 10 hours post injection. The most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example. Pain into shoulder area, deltoid muscle nearly totally paralyzed, pain down arm to elbow. Got one hour of sleep that night. Amazingly, at about 11 a.m. the next morning while still in severe pain (R arm) all symptoms immediately disappeared. Like a switch was thrown. Two major operations in patient life (laparotomy and open heart surgery) and patient also a retired surgeon. Patient was not exaggerating the degree of this pain in the right arm. Have felt great ever since and would get Shot # 2 tomorrow. The events onset date reported as 21Jan2021 11:30 PM. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the events. The patient recovered from all the events on an unspecified date in 2021.; Sender's Comments: Based on temporal association and known vaccine safety profile, the reported events are assessed as related to BNT162B2 vaccine. 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 RAs, Ethics Committees, and Investigators, as appropriate.

weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.

Hospitalized on 30Jan2021 for COVID pneumonia; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Weakness; confusion; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 18Jan2021 at 14:00 (at the age of 77-year-old) as a single dose for COVID-19 immunization. The patient's medical history included AFib, high blood pressure. Concomitant medications included apixaban (ELIQUIS), hydrazaline hydrochloride (APRESOLINE), losartan potassium (COZAAR) and metoprolol; All received within 2 weeks of vaccination. The patient previously took lisinopril and experienced known allergies: Lisinopril. Allergies to medications, food, or other products: Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient been tested for COVID-19 was unknown. The patient did not receive other vaccine in four weeks. Hospitalized on 30Jan2021 for COVID pneumonia which occurred on 24Jan2021 at 08:00 AM and put on ventilator on 05Feb2021. 18 days on ventilator, ICU and released to hospital. On 17Mar2021 admitted to hospital for speech, occupational, and physical therapy. Cannot support standing and walking and vocal cords not fully closed yet on 24Jan2021 at 08:00 AM. Weakness and some confusion on 24Jan2021 at 08:00 AM. The adverse events resulted in emergency room/department or urgent care. The patient was hospitalized for 55 days. The events were considered as serious (hospitalization and disability or permanent damage) by the consumer. The patient was treated with medications and ventilator for the adverse events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.

Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died.

Patient went to physical therapy on that day. Then when he came home I could barely get him out of the car. patient could barely walk and talking made little sense. He could not stand on his own. He was taken to emergency room by rescue squad. I thought he was having a stroke.

vertigo is debilitating. Caller wanted to know if there have been reports of vertigo; he could not drive. Caller stated he was ok when laying on the couch but when he got up he could not walk without falling down; vertigo is debilitating. Caller wanted to know if there have been reports of vertigo/Vertigo; staggering and unable to walk on his own without someone helping him; complain of being dizzy/slight dizziness/dizziness; This is a spontaneous report from a contactable consumer (wife) on behalf of a 77 years-old male patient. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on arm Left on 3Mar2021 at single dose for COVID-19 immunization. The patient medical history included ongoing Peritoneal dialysis from 2018, ongoing Heart bypass from Jan2019. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17mar2021 or 18Mar2021, the patient complained of being dizzy. By 20Mar2021 he was staggering and unable to walk on his own without someone helping him and ongoing vertigo from 20Mar 2021 and reported as vertigo worsened. By 21Mar2021 he could not drive. The patient was ok when laying on the couch but when he got up he could not walk without falling down. The patient had extreme vertigo that started about 2 weeks after the vaccine and is debilitating. The patient is just under 6 feet, he shrunk a little. The events dizziness resulted in hospitalization from an unspecified date. The event vertigo resulted in ER visit and hospitalized from 22Mar2021 to 28Mar2021. The lab test included CT scan and MRI, results: negative; He also had lab tests, but nothing showed a reason why he has the vertigo. No further details provided about lab work. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.

Fever; nightsweats; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), gout, and lung cancer (remission). Patient has no COVID-19 prior to vaccination. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever and nightsweats on 01Apr2021. The patient was hospitalized for fever and nightsweats for 3 days. The outcome of the events was recovered. Information about lot/batch number has been requested.

Patient came to hospital on April 23, 2021 with shortness of breath and a productive cough, very weak and debilitated. Patient was diagnosed with pneumonia and required 2 liters of oxygen. Patient also has mild tremors and family states that this is new. Patient received the first dose of the COVID vaccine 10 days prior to admission on April 13, 2021.

Reports achey on Wednesday after the shot, by midnight reports severe pain in the neck, down into chest, down arm and down scapula. Sought treatment Thursday morning around 8:30am at ER in. Patient was admitted. Discharged Tuesday 5-4. Hospital tried pain medications and muscle relaxants (chewable baby aspirin, morphine, benadryl (after reaction to morhphine) norco, dilaudid, toradol, valium, oxycodone and flexeril. Sent home with diclofenac gel, and hydrocodone/apap.

No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 12:45 as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included ezetimibe, tamsulosin, amlodipine, sumatriptan, finasteride and tadalafil. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 at 01:00 PM, patient experienced no energy, no appetite, hot & cold, body aches. very hoarse, coughing-No fever. On 25Jan2021, the patient was tested negative for COVID-19 via nasal swab. No treatment was received for the adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

I63.81 - Other cerebral infarction due to occlusion or stenosis of small artery R29.810 - Facial weakness I63.81 - Left sided lacunar stroke

he started having pain in his right arm, from elbow to shoulder. He still has it on and off; This is a spontaneous report from a contactable consumer reporting for himself. A 77-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 15Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Apr2021, he started having pain in his arm, from elbow to shoulder. He still has it on and off. When it goes away it's only for a little bit. He received the shot in his left arm and the pain is in his right arm. The event had not resolved yet at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

shingles; so he thought it was just a pulled muscle; Back pain; soreness in the arm; This is a spontaneous report from a contactable other health professional via the Pfizer-sponsored program. A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 77-years-old), administered in Arm Left on 26Jan2021 13:30 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Medical history included penicillin allergy. It's been 25-30 years ago and he can't take it. He gets swollen and hives and sick. There were no concomitant medications. The patient previously received a shingles shot about 5-6 years ago and flu shot Nov2020. The patient experienced soreness in the arm on 26Jan2021, back pain on 30Jan2021, so he thought it was just a pulled muscle on Feb2021, shingles on 15Feb2021. The patient received the first COVID shot on 26Jan2021 and didn't really have a reaction, but soreness in the arm a couple of days. He then started having back pain and he is a very active person so he didn't think anything of it. Spouse told him that he needs to see the doctor because she thought he had shingles. They do not know if it's associated to the COVID shot or not. They need to also cancel his appointment for tomorrow because the doctor does not want him to get his second COVID shot since he is on medication for the shingles. Mentions again, his arm was a little sore, but then 4 days after that he had back pain. He is an exceptionally active person, and excavation construction worker and still works and so he thought it was just a pulled muscle. Then a few days later, pain was awful and area was sensitive to touch and it looked a little swollen and he had nothing else. A couple days later he kept saying it bothered him and it was all the way around to his side. It was fine at first it started with a little rash and so he went to the doctor today and diagnosed with shingles. Therapeutic measures were taken as a result of shingles which included valacyclovir (Was given Valacyclovir 1 gram tablet to take three times daily to help the shingles). Adverse events required a visit to Physician Office. The outcome of the event "soreness in the arm" was recovered on 28Jan2021, for Back pain and shingles was not recovered, for "so he thought it was just a pulled muscle" was unknown. No other vaccines given the same day or 4 weeks prior. No problem with vaccines in past. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Herpes zoster,sorenessin the arm,backpain,pulled muscle cannot be excluded.But also consider.medical history of allergic drug history and other relevant medical history.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.

flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing toes red swollen painful; appearing toes red swollen painful; elbow hip pain covid; This is a spontaneous report from a contactable other hcp (patient). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: el3247), via an unspecified route of administration in arm left on 19Jan2021 at 08:30 AM as single dose for COVID-19 immunisation. Medical history included htn (hypertension). Patient had allergy from Indocin. Concomitant medication included (other medications the patient received within 2 weeks of vaccination) lisinopril (LISINOPRIL). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:30, the patient experienced flushed, elbow hip pain covid appearing toes red swollen painful still on day 8. The events were considered as non-serious. Patient reported no for seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was received for the adverse event (home care). The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.

red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin.; feel something under skin; looked like red rash broke out on his thighs and seemed like the shingles; looked like red rash broke out on his thighs and seemed like the shingles; muscle spasms on the left side of his back; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; 2nd dose, 3 mg single; This is a spontaneous report from a contactable consumer (who is also the patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm, on 01Mar2021 (also reported as 02Mar2021) a little before 10:00 close to an hour after arriving at 09:00, as 2nd dose, 3 mg single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), administered in the left arm shoulder, at 0.3 mg, for COVID-19 immunization. On 02Mar2021, the patient started having muscle spasms in the lower part of his back. The patient clarified that the muscle spasm was on the left side of his back which was the same side as the vaccination. On the same day, 02Mar2021, the patient experienced stiffness and it was hard to straighten up, it was catching in his left hip and lower part of his back and it was pretty severe. On 05Mar2021, the patient could feel something under his skin that looked like red rash broke out on his thighs and seemed like the shingles or something and he didn't know what that was. He stated that he saw red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin. The patient was recovering from muscle spasms, stiffness, and joint stiffness. The outcome of the remaining events was not recovered.

This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 13Feb2021 11:30 at 77 years old as 2nd dose, single for COVID-19 immunization. Medical history included hypertension from an unknown date. No medications received within 2 weeks of vaccination. No other vaccine received within 4 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose BNT162B2 on an unspecified date (lot number: EN6200) for COVID-19 immunization on the left arm. On 14Apr2021, it was reported that patient had lost energy to get out of bed. Patient was transported to the emergency room with fevers and altered mental status. The patient was admitted in the hospital for 6 days from 14Apr2021 to 20Apr2021. The reporter considered the events to have caused disability. The patient received an unspecified treatment. Multiple tests were done to the patient on an unspecified date with unknown result. The patient had a COVID-19 test post vaccination via nasal swab on 15Apr2021 with a negative result. The outcome of the events was recovering.

Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.

Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 rounds of epinephrine, In ED unresponsive, placed on a ventilator, required high doses epi to maintain perfusing blood pressure. Has acute kidney injury with hyperkalemia, shock liver and severe metabolic acidosis with arterial pH 7.04. CT of the head showed early findings of anoxic brain injury. Admitted to ICU and treated with aggressively with vasopressors, bicarbonate drip, heparin drip and empiric broad spectrum antibiotics. Very poor medical and neurologic prognosis, discussed with family and patient was transitioned to comfort care and passed away on 03/21/21 at 1626

Was living happily and independently in a retirement community. After the second dose because losing his memory, focus, depression, followed by 2 strokes, brain bleed, blood clots, seizures, and a Dx of Parkinson's and Parkinson's dementia. He saw doctors monthly and never had any signs of any of these things.

I started having numbness in my feet and tingling in my legs, especially my left leg. I went to the ER and they admitted me. I was in the hospital for 3 days. They ran a bunch of tests and they referred me to a specialist. I was diagnosed with some type of a neuropathy. He advised me not to get the second shot.

77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intubated/sedated on admission - he was recently admitted, and had prolonged hospital stay (4/30 - 5/10) after orthopedic intervention / ORIF 4/30 Rt hip Fracture- s/p. - Acute hypoxic and hypercarbic respiratory failure, on mechanical ventilation - Bibasilar infiltrates, Lt > Rt, will small bilateral pleural effusions, HCAP - COVID PNA - Small bilateral pleural effusions - Encephalopathy - A-Fib - HFrEF, EF 45%, Mild MR - Acute on CKD - UTI

2 weeks after second shot pt. experienced: feet burning, hand burning, night sweats, chest pain, can't do flight of stairs without being out of breath, sore joints, fatigue

around 05/30/2021 started experiencing numbness and pain on left arm, along with chest pain. patient was hospitalized at local medical center for 1 week.

spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right. The patient had lab tests and procedures which included blood pressure measurement: 190/80. The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks". He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day. He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine. Information about Lot Batch number has been requested.

medical hx for atrial fibrillation, chf, hx of cardiac arrest, CAD, hypertension, prostate cancer, hypothyroidism, presents to ER after an episode of inability to move for over one hour, unable to move extremeties but was able to talk. reported that had a cough on friday but no sob or hypoxia and did not report fever or chills to hospital, although did report those to investigator. Discharged on 6/3/2021. symptoms of fever, chills, runny nose/congestion, sore throat and cough began on 5/25, none of these symptoms present upon hospitalization on 6/1/21.

Fever; Dizziness; gland under arm was painful; muscle cramping in legs; This is a spontaneous report from a contactable consumer (Patient reported for himself). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 77-year-old), as First dose, single for Age/COVID-19 immunisation in clinic; warfarin, via oral route of administration from an unspecified date since 15-20 years ago (Batch/Lot number was not reported) and ongoing, at 7.5 mg, daily, (7.5mg by mouth daily) for Blood thinner (anticoagulant therapy). Medical history included cardiac disorder(bad heart) ,back disorder(bad back that is full of metal) from an unknown date and unknown if ongoing. No investigation assessment. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on same date of the Pfizer vaccine received. No history of all previous immunization with the Pfizer vaccine considered as suspect. Vaccine did not administer at military facility. The patient forgot and did not tell vaccine administrator that he was on a blood thinner prior to getting the vaccine and received the COVID-19 vaccine on Tuesday at clinic. He did not read the papers at first. Later he saw on the papers something that he did not tell them. "What does he need to do." On 03Feb2021, the patient had a fever of 100 degrees,It was down to 98.9 degrees ,He was dizzy. The gland under his arm was painful. He had muscle cramping in his legs. Adverse event did not require a visit to emergency room/physician office. The patient underwent lab tests and procedures which included on 03Feb2021, body temperature: 100 degrees and body temperature: 98.9 degrees. No relevant tests were performed. Therapeutic measure the patient took "Tylenol" as a result of fever, dizziness, gland under arm was painful, muscle cramping in legs and it helped. No product complaint was reported. The outcome of the event gland under arm was painful was resolved on 03Feb2021, outcome of the event fever was resolved on 04Feb2021 and outcome of the events dizziness and muscle cramping in legs was resolving. Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected.

I was fine just had some discomfort in my arm and I took some Tylenol and I was fine. My husband also had the same reaction/just a little soreness in his arm; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's husband). This is second case out of the two cases. A 77-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021 as unknown, single dose for COVID-19 immunisation. Medical history included myocardial infarction : Mild heart attack , blood pressure abnormal from an unknown date. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced discomfort in the arm, had a little soreness in the arm. Additional Information was reported by the reporter that patient had Mild heart attack last Sep but now he is fit as fiddle and also reported that her husband, I don't know if it's same. Yes his is same, it says lot number, product name, EN5318. Reporter also stated that "Well because we are old. Outcome of the event was recovered on an unspecified date. Follow up (04Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a 77-year-old patient (Reporter's husband) that included patient's weight, height, medical history, product batch no, product start date, event with outcome. Follow-up attempts are completed. No further information is expected.

Night of first injection my dad said he missed his bed and fell on the floor and laid in the floor and couldn?t move for an hour. The day after second injection he almost passed out and we went to the ER. He was sent back home. Now he has been diagnosed with Parkinson?s disease. He has low Vitamin D. He is anemic and his iron is so low he is receiving 2 iron infusions. He has blood that has showed up in his stool and is having a colonoscopy on July 15th. He stays very dizzy and weak. He also has problems now with his eyesight.

Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight. Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16. 4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.

Tachycardia; elevated pulse; High Blood Pressure; Hot flash; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), via an unspecified route of administration, administered in right arm on 25Jan2021 13:45 (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, asthma and hypertension. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination (not reported details of medications). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jan2021 14:30, the patient experienced hot flash in the face within 45 minutes of the shot. On 26Jan2021 02:45, the patient had tachycardia and high blood pressure which started at approximately 13 hours after the shot. High Blood pressure remained for about the next six days, but the elevated pulse has continued. The adverse event resulted patient to doctor or other healthcare professional office/clinic visit. The patient received treatment - increase in blood pressure medication. Outcome of the event elevated pulse was not recovered and the outcome for other events was recovered with sequel. Follow-up attempts are completed. No further information was expected.

slight headache; muscle cramps; lymph node pain under arm; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Feb2021 at 13:30(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart attack and bypass surgery. The patient had a history of allergy to ciprofloxacin (CIPRO). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), montelukast sodium (VICTOR) and metoprolol succinate (METOPROLOL) all for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 05Feb2021 at 14:00(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021, the patient experienced slight headache for a month which was still continuing, muscle cramps for 2 days and had lymph node pain under arm when lying on side with arm under body which started two weeks after shot and continued for several weeks. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscle cramps was resolved on 20210226. The clinical outcome of the events slight headache and lymph node pain under arm were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

My trigeminal neuralgia became more intense with pain to right side of face; My trigeminal neuralgia became more intense with pain to right side of face; pain was too intense; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) dose 2 via an unspecified route of administration in left arm on 08Jun2021 11:30 (age at vaccination was 77-year-old) for covid-19 immunization. The patient had no known allergies. Medical history included heart diabetes, DVT (deep vein thrombosis), PAD (peripheral arterial occlusive disease), trigeminal neuralgia. Patient previously received dose 1 (Lot number and Expiry date was not reported) via an unspecified route administration in left arm on 18May 11.30 AM as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Concomitant medications received within 2 weeks of vaccination was atorvastatin (ATORVASTATIN), cholecalciferol (CHOLECALCIFEROL), gabapentin (GABAPENTIN), glimepiride (GLIMEPIRIDE). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Jun2021 patient experienced trigeminal neuralgia became more intense with pain to right side of face, notified Doctor of pain and made 3 trips to ER 2 by ambulance as the pain was too intense. Treatment received for the events was oxycodone, morpheein, Vicodin. Since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not resolved. Information on the lot/batch number has been requested. Additional information is expected.

The symptoms were ever pain in my chest, great discomfort allowing only one sitting position on the ground, inability to walk more than about 50 feet without resting. After three attempts to walk, I could no longer continue. I was the beginning of a myocardial infarction. It was four hours before a rescue team could get me to the hospital.

Painful lower left torso and waist and too sore to sleep; Sore left leg; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient had no known 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. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021, the patient experienced extremely painful lower left torso and waist, then very sore left leg which continued through whole day and at the time of this report and was too sore to sleep. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included steroid PAK and tylenol. The clinical outcome of the events too sore to sleep, sore left leg, painful lower left torso and waist was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Sore arm; slightly swollen two months after second vaccination; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male 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 18Feb2021 at 10:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and cholesterol. The past drug included ALEEVE for unknown indication, from an unknown date. The patient received unspecified medication within two weeks prior to the vaccination. The patient previously 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 28Jan2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 1900, the patient experienced sore arm and slightly swollen arm. The patient was concerned with length of time, since it continued to the present -May1. The events resulted in doctor or other healthcare professional office/clinic visit. On 01May2021, the patient underwent COVID test (nasal swab) and the result was negative. The clinical outcome of the event sore arm and swollen arm was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 31Dec2020 11:00 AM via unknown route of administration at single dose for COVID-19 immunization. Medical history included high blood pressure, but went up and down and had to readjust. His BP was high and not sure how long it was that way. Concomitant medications included unspecified blood pressure medications. There were no known allergies. Patient went to ER left side of face sagging. They did MRI it showed he had stroke. It Happened before 4pm that same day as vaccine on 31Dec2020 02:00 PM. And it Happened between 2-4 pm. Patient received treatment. Patient had ER test blood, cat scan, MRI. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. This case was assessed non-serious by reporter. And the events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.

Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills; Tested positive for COVID-19; Hypotensive; Achy; Severe achy cramps/Severe cramps all over body; This is a spontaneous report from a contactable nephrologist (patient himself). This 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 78-year-old. The patient was diabetic and hypertensive. Additional medical history included hyperlipidaemia. No relevant concomitant medications were provided. On 18Dec2020, the patient developed severe achy cramps/severe cramps all over body. On 19Dec2020, the patient developed achy. On 20Dec2020, the patient was dehydrated and hypotensive, he had also chills. On unknown date, blood pressure was down to 76/50. His symptoms for COVID were severe achy cramps, hypotension, and dehydration. On 20Dec2020, COVID-19 test was positive. On 21Dec2020, the patient was given monoclonal antibodies. A computerized tomogram (CT) of the lungs was performed on 21Dec2020 and it was ok. A week later (Dec2020), he had a repeat CT which showed increased infiltrates of 10 to 15%. He then started on dexamethasone, apixaban (ELIQUIS) and the rest of the things. He had a repeat CT on 05Jan2021 which showed resolution of the infiltrates; most of the lesions went gone. CT results had improved significantly. The patient underwent a second COVID test a week ago which was still positive. He had a third COVID on 06Jan2021, but results were not available yet. The patient queried if he can proceed with second dose planned on 07Jan2021 or if he should wait. The clinical outcome was recovered for the event 'severe achy cramps/severe cramps all over body' on 19Dec2020, for 'dehydration/dehydrated' on 20Dec2020, for 'chills' on unknown date in Dec2020, for 'achy' on 30Dec2020, for 'hypotensive' on 20Dec2020; the outcome of the event 'CT showed increased infiltrates 10-15%' was recovering; the outcome for 'Tested positive for COVID-19' was unknown. The reporter considered the events 'achy' and 'severe achy cramps/severe cramps all over body' serious because causing disability; the events 'tested positive for COVID-19', 'dehydration/dehydrated', 'chills' and 'hypotensive' were considered medically significant. The reporter considered the events 'Tested positive for COVID-19', 'CT showed increased infiltrates 10-15%' and 'dehydrated/dehydration' unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. Case will be reassessed when new information is received. 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.

little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient was found unresponsive and pronounced dead later that day.

I had no reaction for approximately 4 hours after my vaccination. Then I got the shakes and all the muscles in my body seemed to be vibrating. I could still walk but found a comfortable chair. The shakes would rise and fall in amplitude causing my hands and legs to oscillate then recede after about 30 seconds. This lasted for about 20-25 minutes and simply went away and has not recurred. I have had no other symptoms. As chills were a listed side effect, I assumed at first that it was chills or some variant but I was not cold. It was the chills without an apparent temperature effect although I did not measure my temperature.

On 1/18/21, received the vaccine at 1007. At 1035 while working with PT, he became very fatigued and short of breath. Pulse ox was 96%. At 1105, he began shaking uncontrollably and projectile vomiting. BP 100/62, P-100, temp 96.0. 1230: temp 99.0 and still shaking. 1315: temp 100.1, shaking less. 1500: temp 102.0 no other symptoms. 1600: Temp 101.3 no other symptoms. 2000: Temp 99.3 no other symptoms. Temp continued to normalize through the night. Doing well and back to baseline on 1/19/21.

hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypotension, and c/f new oxygen requirement and admitted to acute care ward on 1/14/21. Tachycardia resolved w/ fluids. Patient was ruled out for PE and infectious workup negative. Fevers, hypoxia resolved overnight. Medicine Team felt symptoms were side effects from COVID vaccine (2nd dose received 1/13). He was treated for possible cellulitis at L shin wound (warm and tender to touch with mild erythema, without fluctuation) with 14-day cephalexin course, however cellulitis not deemed severe and unlikely contributing. Regarding urinary retention, the Discharge Summary stated, "Urinary retention seemed new in the last day. Pt on condom cath during admission, urinating well." Discharged 1/15/21 and returned to facility.

perfuse sweating; mild tenderness of arm; Muscle pain; Chills; Weakness; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) intramuscular at single dose at left deltoid on 11Jan2021 around 13:00 for covid-19 immunisation, administered at hospital. Medical history was none, he was basically healthy. There were no concomitant medications. No prior vaccinations (within 4 weeks), but the patient received the 1st dose of bnt162b2 (BNT162B2) at single dose exactly 3 weeks before 1st dose on 21Dec2020 for covid-19 immunisation. No additional vaccines administered on same date of bnt162b2. The patient began to have muscle pain, chills, and weakness about 8 hours or so after the 2nd vaccine on 11Jan2021. He states these symptoms have maybe gotten a little better, but have been continuing on for 2-3 days now. He is also experiencing perfuse sweating during 13Jan2021night. Right now, he was not experiencing this. Maybe a little bit, but not much. The caller experienced mild tenderness of arm on 12Jan2021: he explained when you press his arm, it hurts a little bit. No events required a visit to Emergency Room or Physician Office. The outcome of muscle pain was and perfuse sweating was unknown, of chills, weakness was recovering, of mild tenderness of arm was not recovered. The patient was his own primary doctor. The reporter considered all events as medically significant and he believed these symptoms are related to receiving the vaccine because he stated he was okay before that. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event muscle pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Resident displayed tachycardia, diaphoresis, severe weakness - transfer to hospital from skilled facility

I started having pain in my left shoulder across my back and down my arm into my left hand. It is getting progressively getting worse. both shoulders are so painful and I cannot grip anything in my left hand. My fingers on my left hand are going numb. I've been alternating taking tylenol and ibuprofen but they are not helping at all.

After receiving injection, waited 30 mins before leaving hospital, when walking to car experienced shortness of breath like I'd run a mile. Breathing so heavily, when I got to car, had to wait 5 mins before I caught my breath. Stopped for errand & had same experience. No other symptoms until next night at 012:15 on 01/24/21 when i woke with shortness of breath, clammy, nausea, heart skipping beats, BP 178/106. Went to ER. Had EKG, check xray,troponin levels checked 6 hrs apart. All were negative. Released. Since that time, I continue to have: chills, no temp, shortness of breath, fatigue, mild headache, sore throat, runny nose, occasional nausea. Went for Covid test 02/04/21 Results were negative. Just began feeling more normal today--2 weeks after innoculation.

Patient presented with night sweats and shortness of breath the day after receiving the second dose of the COVID vaccine. Initially presented to his PCP and received levaquin for presumed PNA, but subsequently presented to the ED with persistent SOB and fatigue. Admitted to the ICU on AIRVO for high O2 requirements. Chest CT showing dense ground-glass opacities with interlobular septal thickening and mild crazy paving pattern. Currently admitted and undergoing workup.

Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, nausea, hyperglycemia, uncontrollable diarrhea, polyuria, insomnia. Event lasted 32 hours. Slept 16 hours of that time, interrupted 11 times due to polyuria and diarrhea. Lost 5 lbs. Have not felt this sick in at least 20 years - not for any bout of influenza, But it only lasted a day. Took no medication including ibuprofen or acetaminophen. Completely recovered

chills; body aches; fever of 102.9; extreme weakness; dizzy; This is a spontaneous report from a contactable consumer reported for himself. This 78-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 22Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included Seizures, low white cell count, enlarged prostate and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 08:00 AM (reported as 18 hours after injection), the patient experienced chills, body aches, fever of 102.9, extreme weakness, dizzy. At 4 am on 25Jan2021 the fever broke and now he was ok. No treatment received for the adverse event. Outcome of the events chills, body aches, extreme weakness and dizzy was recovered on an unspecified date, of the event fever of 102.9 was recovered on 25Jan2021. Since the vaccination, the patient had not been tested for COVID-19. Seriousness criteria was reported as non-serious. Information on the lot/batch number has been requested.

chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during the night waking often; Sweat profusely during the night waking often; Had difficulty breathing somewhat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration (left arm), on 18Jan2021 09:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included rosuvastatin, and metoprolol succinate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), vaccine location left arm, on 28Dec2020 08:30 AM, for covid-19 immunization at a hospital at 78-years-old. Four days after the second injection, on 22Jan2021 10:00 mid-morning, the patient started with severe chills and shakes, temps ranging from 98.3-102.9 thru the day and into bedtime, sweat profusely during the night waking often, and had difficulty breathing somewhat. By mid-day the next day, the patient was without any more symptoms. The patient did not receive any treatment for these events. The patient recovered from the events on 23Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.

His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261 with Expiration Date 31May2021), via intramuscular, on 22Jan2021 (at 09:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included ongoing restless legs syndrome and ongoing acid reflux. Relevant concomitant medications included omeprazole ongoing from an unknown date for acid reflux and gabapentin ongoing from an unknown date for restless legs syndrome. Her husband had the injection on Friday 22Jan2021. The next morning his left foot was swollen up really bad, red and tender and he could not walk on it. He has had problems like that before and he had it checked and was told it is not gout. It did not go away and she called the nurse on Sunday morning, and the nurse did not think it was a reaction and told her that a lot of times it is swelling in the lymph nodes. He was advised to go and see a podiatrist on Monday. He saw the podiatrist yesterday morning and the podiatrist gave him a one injection that contained Lidocaine, dexamethasone, and depomederol. After injection, the swelling right down and his foot was ok. The patient went to go get the Moderna injection and she asked those giving the injection if it was ok for her husband to get that injection from the podiatrist. She was told that people are not supposed to take paracetamol (TYLENOL) or ibuprofen. She was told that they did not think it was a good idea for her husband to get that injection from the podiatrist and it may have wiped out the benefit of the Pfizer COVID VACCINE. His foot was 95% recovered, he could walk on it and the swelling was down. The patient was recovering from the events.

Tingling and numbness within one hour. That subsided after another 30 minutes but then I lost control of thumb and pointer finger. That loss of control/strength has continued until today(2/11/2021). I tend to drop things from my left hand.

The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.

We feel as if the vaccine completely counteracted with his Parkinson's medication. Patient was hallucinating for 2 days, completely unaware of surroundings, making non sensical words, mumbling, showing Parkinson side affects such as hand wringing, not able to balance, walk, completely different than his normal self. Side affects wore off in about 36 hours.

Injection site developed numbness and tingling of left arm that began 45-60 minutes after reciving the vaccine on 2/8/2021. Resolved within an hour or so, then no strength between thumb and index finger. Symptoms resolved that night. On 2/10/2021 patient had difficulty picking up things and had less strength than usual. Patient stated he felt clumsy.

At around 9am, my husband started shaking and reported he was very cold. The shaking was spontaneous and I covered him with electric blanket and within 30 minutes the shaking stopped and he was no longer cold

myalgia/arthralgia, significant weakness followed by reactivation of rapid ventricular rate w/ his chronic Atrial Fib leading to angina and hospitalization w/i 2 days of vaccine. symptoms have not yet recovered, resulting in SNF placement

Flushed, nauseous, serious headache and extremely tired within first hour after receiving the injection. took 2 Ibuprofen and laid down. Ate supper with the family, headache still really bad. Stepped outside for a few minutes and my heart began to race wildly. Called hospital after I couldn't get it to calm down with breathing technique after trying for 40 minutes. Too many bpm for me to count myself.

Patient received his first dose of vaccine on 2/10 at 11:30am. (His 2nd is scheduled for 3/3) He started with sx ~13 hrs later - He started drifting out of consciousness, then had labored breathing through night rendering him unable to sleep. After getting up in the morning, his breathing was better but he felt lightheaded/weak through the day. By the next morning (Friday 2/12), he was so bad next morning that wife called 911 - He reports that he was there and then not there and was losing track of train of thought. He was taken to ER via EMS, where his HR was initially 15 - He was admitted to hospital - initially a temporary pacer was placed, then a permanent one on Monday, 2/22. He has had other episodes like this in past 13 mos. PCP referred him to neurologist and EENT. Neurology work-up, including MRI and 72 hr EEG were unremarkable, although he learned retrospectively that there was a time during EEG where HR was only 35. EENT found no auditory or other issues . *MD in ER told him that if issues were not neuro in nature, they were probably cardiac.

My dad (78 year old male) received the second Pfizer Covid19 vaccine shot on Wednesday, Jan 27 that night he started experiencing trouble breathing, Fatigue, chills, night sweats, etc. He was admitted to the hospital on Wed, Feb 3. CT scan showed he has an infection and inflammation of the lungs. Today is day 6 of hospitalization, and he has not improved despite many antibiotics, steroids, IVIG and oxygen. He is also in year two of remission from Multiple Myeloma so he is immunocompromised.

sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for different patient. This is the first of two reports. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included egg allergy, bladder cancer and surgery. There were no concomitant medications. It was reported that the patient had a sore arm after getting the shot. The outcome of the event was recovered on an unspecified date in Jan2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106756 same drug, same event and different patient

Appox. 16 hours after injection I started shivering and cold sweats. was weak. and just out of it. Went to bed and by mid afternoon shivers were gone as well as sweating. Slept all day and into the evening, by 10pm or so all seemed back to normal. Mid afternoon I sat up on the edge of the bed to go to the bathroom and passed out falling on my left knee (bad one) and hit my forehead on the bathroom door scraping and bruising same above left eye brow. Walking with pain in left knee but getting better daily.

Bell's Palsy caused the side of my face to swell up and droop on one side; Eyes have been bothering him and he is blinking; Can't talk very good because his lips are swelled up/hard to talk; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9809/expiration date: not provided), via intramuscular route of administration, on 04-FEB-2021 at 14:30 (at the age of 78 years old) 0.3mL as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included patient was diabetic since an unknown date and has psoriatic arthritis. Concomitant medication included infliximab (REMICADE) infusion every 8 weeks for psoriatic arthritis and cetirizine hydrochloride (EQUATE ALLERGY RELIEF). The patient had infliximab infusion the morning of 04Feb2021, prior to receiving the vaccination and was told that infliximab would not be a problem with receiving the vaccination on the same day. On 07Feb2021, the patient went to the emergency room due to Bell's palsy, which was described as swelling of lips, nose, mouth, and side of face and stated that he can't talk very good because his lips are swelled up/hard to talk and his eyes have been bothering him and he is blinking. The patient stated, "I went to the emergency room at a hospital and what they said is totally unrelated to the COVID shot I got. In the meantime, few days after I had the shot, I had somehow got Bell's palsy caused the side of my face to swell up and droop on one side. I just wanted to get back to you so you knew that was not some reaction to the COVID shot, it was something else." Treatment for the event Bell's palsy included took Allergy Relief Equate 25mg ultra tablet and another allergy pill and it did not help swelling of lips, nose, mouth, and side of face. Relevant tests included blood work on an unspecified date in 2021 "two weeks ago" that was all good. The outcome of the events Bell's palsy, eyes have been bothering him and he is blinking and hard to talk was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Felt as though truck kept turning over, but it was all in his head; Felt as though truck kept turning over, but it was all in his head; Was hot and everything; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: PK12ER/EL9261; Expiration date was not reported) on 26Jan2021 (11:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization/to not get COVID at the public health department. The patient had no relevant medical history and concomitant medications. The patient had no history of problems with vaccines in the past. On 27Jan2021, the patient had felt as though a truck kept turning over, but it was all in his head; and was "hot and everything". The outcome of the events, 'felt as though a truck kept turning over, but it was all in his head' and '"hot and everything"', was recovering.

11 Hours later ambulance called Taken to hospital C/O of left shoulder arm chest pain ,significant dizziness, unable to stand without falling over

First day: lethargy all day. Second day, 2-28 starting c 10PM got the shivers and shakes,, had trouble standing. Lasted c one and a half hours. I lay down, it finally stopped

2nd SHOT Thur Feb. 18, 2021 2:30pm Fri. Feb 19 6:00 p.m Chills! Sun. Feb 21 lost taste Fri Feb 26 extreme weakness in legs Otho has had side effects THAT OTHERS HAVE NOT REPORTED. Otho received the first Pfizer shot on January 28, 2021 and only suffered a small ache in his arm. Otho received the second shot of Phizer on February 1 8, 2021 adminsted at the same location. Day 1 arm a little uncomftable Day 2 6:00 pm extreme chills Day 3 chills gone, tired, weak Day 4 LOST SENSE OF TASTE Day 9 Legs so weak, could not walk without a walker Day 13 TODAY Still very weak and still connot taste. Otho is a male age 78 yrs. Usually very active. He does suffer from Carcinod Caner of many years. We did visit with our doctor. He prescribed to take two Ibuprifen morning and night to help with inflammation. And if Legs weakness increases to get back to him.

The patient woke up with severe pain in his leg, a flare of a previous nerve pain issue he was having. He had taken percocet to help with the pain and went to bed. His wife called and she was informed to have him take ibuprofen 400-600 mg every 6 hours to help suppress an inflammatory response that could be increasing the pain he is experiencing.

shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318, via an unspecified route of administration in the right arm on 08Feb2021 at 11:45 (at the age of 78-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). 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. Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit. No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.

Patient's wife reported that he broke both of his shoulders four days after his first vaccine. He had a seizure and fell off the bed breaking his shoulders. No hx of seizures, TBI or stroke. His wife stated they were told by the PCP he could get the second dose of the vaccine. None of these records are accessible by the vaccinating site. No known ED visit or hospitalization related to the event.

During administration of vaccine, pt. turned head away from vaccinator and did not answer any questions would not respond to his name. A rapid response was called and pt. transported via ambulance to ER. Pt. had a history of seizures. "Not controlled with medications" per pt. Pt. discharged stable.

Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was slurred he fell and was unable to walk good his body was pulling to one side. His left arm was numb . I called ambulance he was taken to hospital diagnosed with a stroke. Now in rehab

About just after one this morning my whole body began to convulse violently. I am sure it lasted for more than a minute or two. I woke up feeling very tired. I woke up feeling that I ma have had a heart attack.

lethargic, like a big fog hit me, loss of energy, loss of balance heavy red ichy rash developed over arms, chest, waist, REALLY ITCHY Prescriptions taken: Levocetirizin E5 mg --1 tablet daily; Hydroxyzine HCL 25mg --two tablets at bedtime, 1 tab every 8 hours as needed

possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over weakness; Blood sugar over 400; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9261), via an unspecified route of administration on 02Feb2021 at 16:30 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included esophagectomy on an unspecified date. The patient previously took morphine (UNKNOWN MANUFACTURER) and adhesive tape (UNKNOWN MANUFACTURER and experienced allergy. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284) on 05Jan2021 at 16:30. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12 MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), magnesium oxide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), "orevastatin" (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), co-q10 (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) multivitamin (MANUFACTURER UNKNOWN), turmeric curcumin (MANUFACTURER UNKNOWN), vitamin d-3, b-12-E (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), dicyclomine (MANUFACTURER UNKNOWN) all from unknown indications from unknown dates and unknown if ongoing. On 16Feb2021 at 09:00, the patient experienced all over body aches, extreme all over weakness, blood sugar over 400 and hemoglobin dropping rapidly. The patient was taken to the Emergency Room and was hospitalized. The patient received treatment for the events which included an infusion of iron for dropping hemoglobin and infusion antibiotic for possible infection around "hvalve." Lab data included a nasal swab SARS-COV 2 test on 16Feb2021 which was negative. The clinical outcomes of the events hemoglobin dropping rapidly, generalized aching, extreme weakness, blood sugar increased and possible infection were unknown. It was also reported that since the vaccination, the patient had been tested for COVID-19 (on 16Feb2021) and it was negative.

Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient?s wife reported that she notice he was slurring his speech and had some confusion prior to getting vaccinated. They contemplated seeking medical care but wanted to get the vaccinated first. After receiving the vaccine, the vaccine recipient was reported to have fell back in his chair and began seizing. EMS responded and treated the patient. They have no history of seizures. They were transported to emergency department at e Regional Medical Center. The patient was admitted to the intensive care unit for further work up and currently present.

Exacerbation of myasthenia gravis that had been stable for 10 years. Increasing weakness and respiratory difficulties within 72 hours of vaccination. Required intubation and mechanical ventilation which continues

Flu-like symptoms beginning 12 hours after the 2nd dose. Joint aches, mild headache, low-grade fever lasting ~24 hours. Symptoms abated after 24 hours and gone by 48 hours after the administration of the 2nd dose or 36 hours after I became symptomatic. NO symptoms other than a slightly sore arm after the 1st dose.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting body aches, heaches, and chills since receiving vaccination five days prior. No shortness of breath, chest pain, vomiting, or diarrhea. Patient was not in distress or ill-appearing: normal breath sounds (no wheezing, rhonchi, or rales). Five days after clinic visit (ten days after vaccination) patient's wife and daughter reported patient had poor appetite and feeling worse since clinic visit: weakness, pain all over, decreased oral intake, and cough with phlegm. Advised to go to the emergency room immediately. Patient's daughter reported the next day patient admitted to another facility and COVID-19 test was positive.

Severe hypoglycemia with blurred vision and neuropathy in legs roughly couple hours after receiving vaccine

Collapsed in house; Chills; Total Weakness; Memory problems; Racing heart beat; This is a spontaneous report from a contactable consumer. A 78-year-old male consumer reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 23Feb2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had Covid prior vaccination. No other medical history. Concomitant drugs were unknown. On 23Feb2021 at 04:00 PM the patient experienced chills, total weakness, memory problems, collapsed in house and racing heart beat. The patient was hospitalized, he was in hospital 4th day now. Cannot get out of bed or walk. the patient was treated with Physical Therapy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223394 similar report from same reporter

fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, high blood pressure, TIA, CVA, aneurysm

Arm pain described as sharp/nerve related worst around day 4 after vaccination. somewhat improved after 3 weeks. Reduced range of motion. Reported to pcp, pcp thinks vaccine was placed improperly

Patient is a 78-year-old male with history of COPD, paroxysmal atrial fibrillation, ischemic cardiomyopathy, type 2 diabetes mellitus, status post mitral valve replacement with metallic valve on Coumadin, stage II: CAD status post LAR. Presented to Hospital campus on account of severe shortness of breath in a patient with significant weakness. Patient has had significant shortness of breath progressively worsening. Patient was just discharged from this facility on 03/17/2021. The patient was admitted on 03/05/201 on account of shortness of breath. During the admission, patient had a multiloculated right-sided pleural effusion requiring video-assisted thoracoscopy and evacuation of hemothorax. Associated with chest wall mass. Subsequent biopsy revealed evidence of small cell carcinoma. The patient was seen by oncology during that admission with a Mediport put in place. With plans to follow-up with oncology outpatient for continued management and to hopefully initiate chemotherapy. There was also concern for acute congestive heart failure and required diuresis. Echocardiogram was showing EF of 40% at the time. Now, patient is presented to the emergency room on account of significant weakness in the patient well developed worsening shortness of breath over the last couple of days. Patient was still short of breath and weak he could not even get up the toilet seat. When EMS saw the patient he was satting 80% on room air and required 6 L via nasal cannula. Did not complain of any chest pain or cough with this finding. Neither did he complain of any fever. In the emergency room, patient was tachypneic and slightly tachycardic. Lab work shows lactic acid of 2.3 glucose of 302 and creatinine of 1.90. The patient's BNP was 1170 with GFR of 34. Patient INR was 4.5. Chest x-ray shows Trace right pleural effusion. No pneumothorax. With concern for pneumonia patient was given azithromycin and Unasyn. Also with concern for possible CHF patient was given Bumex.

Shortness of breath/out of breath; Breathing very heavily as if I had been running; Nausea; My body was clammy all over; Blood pressure was 178/106; Tightness in my chest; Kept taking deep breaths, with an overall feeling of weakness; Feel unwell with cold like symptoms, including chills; Feel unwell with cold like symptoms, including chills; feel unwell with cold like symptoms, including chills; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot Number: EL3302) at single dose for covid-19 immunisation. Medical history included Heart stent placed in 2016, high blood pressure, enlarged prostate. Concomitant medication included rivaroxaban (XARELTO); metoprolol; losartan; aspirin [acetylsalicylic acid]. The patient previously took finasteride, dutasteride and experienced Known allergies. It was reported that on 24Jan2021 00:15/12:15 AM patient had shortness of breath within 30 minutes of receiving the injection, and was breathing very heavily as if I had been running. By the time I got to the car, I was totally out of breath. Any slight exertion over the next week would bring this on. The day after the injection on the morning of 24Jan2021 I awakened with nausea, my body was clammy all over, Blood pressure was 178/106, tightness in my chest, and kept taking deep breaths, with an overall feeling of weakness. Went to the ER ,and was checked out and released after all tests were neg. for a heart problem. I continued to feel unwell with cold like symptoms, including chills. Adverse event treatment was emergency room protocol for a suspected heart attack, Patient did not had covid prior vaccination, Patient did not tested covid post vaccination. Outcome of the all events was recovering.

H & P states m, 2 weeks after second vaccine, developed myalgias, arthralgias, swelling and generalized weakness, seen in clinic and started on oral corticosteriods, 9/19 to ER and admitted , given IV,,,,,,,, fluids, steriods. co of increased joint pain, and swelling of upper extremities

He received his vaccine, and immediately he could taste it in his mouth. About 5-6 days later his normal routine was to work outside and noticed that he had lost his energy issue, and had this issue in the past when his pacemaker was out of wack. As the month went on it got worse and worse. In March he was out cleaning up the yard and as he worked it got worse and worse. He would have to work for 5 and sit down for a minute. He has hyperventilation syndrome and diagnosed back in 1980 and has been under control, this is one thing that always happens, which seems to be an ongoing problem that he's having. His settings on his pacemaker seem to be OK. He was sitting on his couch and watching a race on 3/8/21 and got a shock coming up from the bottom part of his head, through his chest and out through his right eye, this was less than 2 seconds. This was an event, but not a hard "mule" kick event. He wasn't doing anything to get the shock. The defibrillator is connected to the bottom part of his heart. He has a logic system and had an episode of 190-200 BPM which was at the top part of his heart. He had all of his equipment checked out yesterday, but they could not give him an answer why he got a shock. He now has to set up an appointment with his cardiologist to see tomorrow. He has had the pacemaker for 6-7 years now and the device goes into the device clinic and he gets reports regarding this information. They device people said there was no registration that he had any event.

Pt presented to ED on 3/9 with R eye pain and blurred vision, plus R-sided facial dropping which started that morning. Physical exam positive for facial asymmetry. Per ED provider note: "Pt now with clear R-sided 7th nerve palsy compared to arrival when lower portion was more pronounced.... Labs largely unremarkable.... Overall, exam at this point most consistent with Bell's palsy. Will start on prednisone, acyclovir, eye patch, and artificial tears."

20 hours after Pfizer immunization C/O left hand pain with dime size hard lump located on palm of hand.

3 days after second Pfizer shot right foot swelled up with pain. Two days later pain shot up right leg and to hip. Intense pain for about 5 days similar to when I had back surgery about 27 years ago. Since then leg and hip pain subsided but my right foot still feels swollen and painful at night and in the morning. Gets better temporarily walking on it during day but feel like there is a stiff pad below the skin on my foot . Had a similar reaction with second pneumonia shot in October where I got spasms in lower back and then right leg started to collapse but only lasted then for about 5 minutes with no long term effects/

myalgias, chills, weakness, nausea. He cannot vomit secondary to history of Nissen fundoplication. In the middle of the night on 3/28 he got up to go to the bathroom and was too weak to get off the toilet - to the point where he had to lower himself to the ground, so EMS was notified and reportedly found him with a fever of 104 Fahrenheit. Hospitalization x2 days. Discharge home.

fast heartbeat; dizziness; weakness; slow thinking; very tired; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion because of chronotropic incompetence. 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 vitamins and zolpidem tartrate (AMBIEN), both were taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 18Jan2021 14:00 as a single dose for COVID-19 immunization and experienced sweating, chills and tired. On an unspecified date in Feb2021 after receiving the second dose, the patient experienced fast heartbeat, dizziness, weakness, very tired and slow thinking. No treatment was received for the adverse events. The clinical outcome of the fast heartbeat, dizziness, weakness, very tired and slow thinking was unknown.

I couldn't move for about 4 hours, I was slight paralyzed laying on the floor; IV (intravenous) by needle; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (BNT162B2), dose 2 intravenous (at the age of 78-years-old), administered in Deltoid Left (reported as left shoulder) on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 78-years-old), administered on 22Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient stated, "I received my second Pfizer shot (captured as Unspecified medication) on Monday (15Mar2021) and on Monday night (15Mar2021) I woke up on the floor and I couldn't move for about 4 hours, now finally got back into the bed by 5 o'clock in the morning and I was slight paralyzed laying on the floor and I felt it. You may did know about this because it is probably related to the vaccine. They have improved drastically (events), after yesterday I tried to get some sleep because I laid on the floor for 4 hours, but today I feel alright." The route of administration was "IV (intravenous) by needle." No treatment received for the events. The outcome of the events "I couldn't move for about 4 hours, I was slight paralyzed laying on the floor" was recovered on an unspecified date. The event Paralyzed was considered as serious (medically significant). Information about Batch/Lot number has been requested.

CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown. Information on the lot/batch number has been requested.

Collapse of lung; Diarrhea; very weak; lost his appetite; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 03Mar2021 (Batch/Lot Number: EL9261) at single dose (at the age of 78 years old) for COVID-19 immunisation. The patient medical history included had vascular problems in his legs, and his legs were very clogged. The doctors couldn't do anything and tried to do a catheterization. Thyroid was not okay, and now his doctor increased his thyroid medication. The reporter blamed the hospital for doing something wrong when her husband was there the last time. She said the hospital made a mistake and gave her husband the wrong medication. She said the first time her husband was at the hospital, the hospital didn't give her husband his thyroid medicine. She said the second time, the hospital gave her husband the wrong dose of medication. Concomitant medications were not reported. The patient previously took BNT162B2 (lot number: EN9581) dose 1 on 10Feb2021 for COVID-19 immunisation. The patient previously took flu vaccines in Sep2020. On Mar2021, the reporter's husband was okay at first. She said now her husband had diarrhea and pooped in his clothes. She said her husband was very weak and lost his appetite. She clarified her husband's symptoms started probably 2 weeks ago, and her husband was worse, and like a different person now. She said her husband used to eat at the table, and now he just sits in his chair, and after 5:00PM he wants to go to bed. She said she was not sure if her husband's symptoms were related to the COVID-19 Vaccine. She said her husband was supposed to have heart bypass surgery on Monday (22Mar2021), and his surgeon called on Saturday night (20Mar2021) and called off her husband's surgery. She said the surgeon said her husband had a collapsed lung. She said her husband had a chest x-ray in late Feb2021 and his lungs were clear. She said everything that happened to her husband, happened after he had his second dose of the COVID-19 Vaccine. She said she was not sure if her husband's collapsed lung (19Mar2021) was related to his second COVID-19 Vaccine. She said before getting the COVID-19 Vaccine, her husband did not have a problem with his lungs. She said her husband's surgeon can't figure out why her husband's lung collapsed. She said she can't prove his collapsed lung was a side effect of the COVID-19 Vaccine, but her husband never had sick lungs in his life. She said she knows her husband doesn't have the COVID-19 Virus because he had to be tested on Saturday (20Mar2021) for the COVID-19 Virus before he could have his surgery on Monday (22Mar2021). She said her husband's COVID-19 Virus test was negative Saturday, but he has all these problems. The patient's wife was afraid to give her husband Pepto Bismol, so she didn't give her husband anything. She said her husband has an appointment on Thursday (25Mar2021) with his primary care doctor to talk about his symptoms. The outcome of collapsed lung was unknown and other events were not recovered.

eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.

about a week after shot developed severe facial pain, felt to have trigeminal neuralgia got temporal artery biopsy negative develop FUO hospitalized 4/8 to present

He began showing dementia like behaviors within 24 hours of receiving 2nd Pfizer vaccine. To be clear, not referring to forgetfullness, referring to full on, can't remember names children or grandchildren, up to and including 'word salad' related symptoms. On a 04/07/2021 follow up he was given 'SLUMS' test and scored 24 of 30, yet struggled to recall appropriate words in the appropriate context. Ex. degrees for years of age, check for the word 'injection', coinciding with circular coversations, where the same topic is repeated numerous times in a conversation, without recollection...

Received his vaccine, he had soreness in the arm, but nothing else. On 3/3/21 he went to hospital ER with diagnosis of kidney stones, had a morphine injection, Flomax and a prescription for Oxycontin and Flomax. At that time he was experiencing also in his right eye swelling and it was reddish, and there was an itching around the eye, and there was a couple blotches on top of his head and his cheek, but did not mention it as he was there for kidney stones. On 3/9/2021 he saw a Urologist, Dr. and that morning he passed a kidney stone. The urologist took an x-ray and did not see any more. The eye then became an issue on 3/9/21 and he made an appointment to see the eye Dr., Dr. at Eye institute on 3/11/21 @ 9:00 AM. The doctor diagnosed shingles on the face and right eye, and she put him on 2 medications (Durezol ophthalmic drops). He is still on that medication still 4/16/21. The other medication that they prescribed for him was Valacyclovir which he took 3 times a day, they reduced it from 1000 mg to 500 mg twice a day. The swelling of the eye itself has gone down a little bit. He is still seeing the eye doctor, and has a FU on 5/5/21 as it is getting better but still has symptoms. He did get a single dose Shingrix shot a couple of years ago.

Pt is GCS 15 and A&Ox4. Skin is P/W/D to pt ethnicity. Neuro intact and PERRLA. Respirations are regular/equal and non-labored. pt states he's had left sided facial droop for 2 days and a sore throat for 5 days. pt denies any other symptoms at this time. pt appears to have bells palsy. Dr. was contacted and she ruled out a stroke. Symptoms started 1 week after the completion of vaccine.

pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Medical history included osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) and finasteride (PROSCAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left arm (Vax site) migrated down to elbow & forearm on 27Mar2021 with outcome of recovered. The patient received treatment: ibuprofen. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

from office visit 4-19-21: Chief Complaint Patient presents with ? Facial Droop started yesterday. ? Neck Pain right side. Yesterday noticed a facial droop without any arm weakness or change in gait. No headaches. Using some artificial tears but eye is getting more red and matting of eyelashes. Having more right rhinorrhea, but that's been a chronic issues. Feels like hearing is off in his right ear. More neck soreness on the right.

Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: S/P PROSTATE CANCER, TAKES LUPON INJECTION EVERY 6 MONTHS AND IS NOT SURE IF THIS DATA HAS SOMETHING TO DO WITH HIS PROLONGED SYMPTOMS, NEXT DOSE OF LUPON DUE IN A COUPLE OF WEEKS FROM TODAY.

severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; rheumatism; sciatica; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 05Jan2021 03:30 as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. Concomitant medications included sotalol (SOTALOL), Olmesartan (OLMESARTAN), Amlodipine (AMLODIPINE), tamsulosin (TAMSULOSIN). On 06Jan2021 at 09:00 the patient experienced severe pain in back and right-side thigh, knee and leg, rheumatism, sciatica. Pain started within one day of shot and has not stopped. I have never experienced this before now. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107296 same reporter/ drug/ AE, different patient

Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.

Progressive lower extremity weakness with markedly diminished reflex: Per the history it appears that patient has had a progressive course of this problem over the last 1 week. His symptomatology is mostly consistent with gait ataxia with some lower extremity weakness. He mentions that his weakness of the lower extremities became more and more pronounced towards the end of the week when he would start trembling in his legs whenever standing for some time. Although he had some numbness and tingling few days ago but that does not seem to be the predominant symptoms. There was no preceding symptoms of any viremia prior to this. Although he has Covid in January, however he did not have cough expectorations upper respiratory infection or any diarrhea in the last 1 month. He has not been exposed to any new pets or any new medications. His clinical exam suggest a lower extremity weakness more proximal than distal although there appears to be some sensory sparing. He has diminished reflexes all over including absent reflexes in his lower extremities and many of the upper extremities. His imaging study did not show any specific etiology for the cause of his problem. He does not have any spinal etiology and his exam does not show any upper motor type of involvement. His spinal fluid shows a high protein with no cells consistent with cytoalbuminogenic dissociation. So he definitely fits with the diagnosis of acute immune mediated demyelinating polyneuropathy or Guillain-Barré syndrome. On IVIG therapy. Overall appears to be some improved however not still able to walk.

Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination.

Arm was sore. I started taking Advil the evening of 5-4-21. The next morning, I woke up with chills and weakness. I was unable to lift arm to shoulder without discomfort. I took more Advil. I had a 101.5 fever. I actually felt worse than I did when I had COVID back on 12-10-20. I spent the next 4 hours in bed. I got up at 11:00 am and went to the couch to lie down for most of the day. I started feeling slightly better around 5:00 pm. I had dinner and laid around. I went to bed at 10:00 pm. Everything lasted a period of 23 hours. I'm feeling back normal today.

muscle weakness and cramping and overall fatigue and chest pains still continuing after a month and a half

A little over a week ago I was admitted to a local hospital having been diagnosed with Guillain?Barré syndrome, a debilitating condition where the body?s auto immune system attacks the nervous system resulting in peripheral numbness in one?s hands, feet and legs. This condition was diagnosed by a neurologist. Following his diagnosis, I spent 8 days in the Hospital and was treated for 5 days with a daily dose of 400ml of immune globulin (IVIG) to rebuild the damage to my nervous system. On April 10, I began to feel the onset of Guillain Barré syndrome as the bottoms of my feet suddenly began to tingle and feel numb. The next day I tripped while returning our waste management garbage cans to our garage. Fell face forward onto the driveway and was bruised pretty bad. The next day my BP zoomed to 224/160. 911 was called and I was taken to our local hospital fearing and thinking that I was having a heart attack. I spent 4 days in the hospital being checked for a possible heart attack and all the while my Guillain Barré syndrome was progressing undiagnosed. I was discharged and instructed to see a neurologist for the tingling and numbness in my hands, legs and feet. Within 15 minutes of the neurologist consult, a few days following my discharge, I was told I had Guillain Barré syndrome and get to a hospital. I left his office and went straight to the emergency room and I spent the next 8 days there and was discharged Tuesday, 4 May 2021. Several hospital neurologists treating me believed the vaccination triggered the syndrome as do I. It's not being widely reported even though there have been several Facebook postings of people saying the same thing as me.

On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.

3/3/2021 Chief Complaint Patient presents with ? Covid-19 Screening diarrhea, weakness, fatigue. wife is positive. Clinical Support 3/5/2021 COVID-19 virus infection Dx Medication Infusion Reason for Visit Encounter Date: 3/5/2021 ? ? Signed Arrived to the ambulatory infusion site alone via car. Reports intermittent diarrhea, dry nonproductive cough, fatigue.

first shoulder and arm pain later in day post vaccine, subsequent neck pain on the left and eventually right neck pain. Admitted with neck pain. MRI cervical 4/18 with: Zones of anterior epidural thickening and enhancement causing ventral flattening of the thecal sac without cord compression or superimposed epidural fluid collection from the C4-5 through the C6-7 disc space levels. Additional zone of edema and enhancement within the prevertebral soft tissues along the anterior margin of the left longus coli musculature from the C2-C5 levels again without superimposed fluid collection. Given history of fever and neck pain is findings could be consistent with epidural cellulitis as well as prevertebral cellulitis. No evidence for superimposed abscess. Recommend correlation to CRP level in white blood cell count with differential. No evidence for displaced fluid or disc space enhancement to suggest concomitant discitis.

difficulty breathing; pneumonia; human immunodeficiency virus; pain in arm, neck and back; pain in arm, neck and back; pain in arm, neck and back; FACILITATED COLLECT This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3841481-00). A non-contactable consumer (patient) reported for himself that a 78-year-old male patient received bnt162b2 (Pfizer, Batch/Lot number was not reported), intramuscular on 12Mar2021 as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose for moderate to severe chronic plaque psoriasis, psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced difficulty breathing on an unspecified date, pneumonia in Mar2021, pain in arm, neck and back in Mar2021, human immunodeficiency virus on an unspecified date. The events difficulty breathing and pneumonia were reported as serious per hospitalization, event human immunodeficiency virus was serious per medically significant. The patient took covid-19 vaccine and afterwards had pain in arm, neck and back and could not breathe. He went to emergency room and was hospitalized due to difficulty breathing and was diagnosed with pneumonia. He did not know if this was due to vaccine and would not be taking second vaccine shot per his primary physician. He also had human immunodeficiency virus. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 12Mar2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. The outcome of events for difficulty breathing was unknown, for other events was resolving. The reporter's causality for the event(s) of Pneumonia, Pain in arm, Human Immunodeficiency virus, Pain in Back and Pain in neck with adalimumab was no reasonable possibility. Causality for all events with COVID-19 vaccine was not reported. The reporter's assessment of the causal relationship of all events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Information on batch/lot number has been requested.; Sender's Comments: Based on known disease pathophysiology, the reported event of Human Immunodeficiency virus , pneumonia and dyspnea is assessed as not related to suspected product bnt162b2 vaccine and the events pneumonia and dyspnea are more likely due to underlying medical condition of chronic plaque psoriasis. However the reported events of Pain in extremities ,Pain in Back and Pain in neck is assessed as related due to close temporal association with the suspect product. However, more information is required on date of HIV infection deducted to properly assess the case. The case will be reevaluated should additional information become available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.

Stroke, Hemmoragic Numbness, tingling on left side Went to emergency room at the Hospital Forwarded by ambulance to different Hospital Placed in Nuerology Intensive Care Unit (ICU) at hospital Released from ICU to Nuerology ward Released from Nuerology ward to Rehab Unit Released from Rehab to home for outpatient rehab

Light headedness/ Dizzy; Equilibrium was way off/ he was wobbly; Nauseous; Mild case of vertigo; he ached; felt terrible/ yucky feeling; Stayed down all the day/ he was wobbly; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Jan2021 17:20 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included tinnitus, Blood pressure, Gout, Cholesterol, Acid Reflux. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for blood pressure abnormal from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for gout from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. No prior vaccinations within 4 weeks. No history of previous immunizations with the Pfizer vaccine considered as suspect, this was the first dose. No additional vaccine administered on same date of the Pfizer suspect. On 13Jan2021, the patient received the vaccine. He clarified the reaction as, on Saturday 23Jan2021 all of a sudden it was quick he got real light headed, dizzy, he felt like his equilibrium was way off. He felt like he had a mild case of vertigo. He was wobbly, he ached, and felt terrible. It was a yucky feeling. He also felt nauseous, and it went away soon as he ate. He had never had a feeling like that before. He stayed down all day. He noticed all these events that occurred on Saturday 23Jan2021 started late morning around 10-11 in the morning. By the afternoon he was on his back for the rest of the day. It knocked him for a loop. Sunday 24Jan2021 he woke up and felt a little better. He still had some of the symptoms, but they were milder and kept getting milder through out the day. By Sunday afternoon they were almost gone and by Monday 25Jan2021 he felt normal and great. Tuesday 26Jan2021 these same feelings hit him again, but not the same way and was not as bad. Then 27Jan2021, they were gone and he felt fine. He went to the doctor's office yesterday (27Jan2021). The doctor thought he was having an inner ear problem. He has a history of tinnitus and the doctor thought this was causing the light vertigo symptoms. He was light headed, wobbly. He was prescribed Meclizine-25mg one tablet by mouth three time a day. Now, today, 28Jan2021, he woke up this morning and he had the same feelings again. He was wobbly. He had the same feelings that he experienced on Saturday 23Jan2021. However, they were milder. He felt like it is a little vertigo. He did not feel stable. He had never had anything like this happen before. The patient stated he is pretty healthy for his age. he is very active. He usually plays golf, but has not recently. The patient believes he is having a reaction from vaccine, he is not sure, but he is having some of the symptoms. The doctor provided him with medication, but he has not started it yet. He does not know if he should. Caller is thinking these events are related to the shot. He is due to get his second shot on 03Feb2021. Outcome of the events was not recovered.

An extremely sore area on right arm. Unable to lift above should height. Has persisted since inoculation on 2/25/2021

Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down; felt so weak that he could not lift himself to get up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2020 to an unknown date; he also mentioned that he had COVID-19 back in July but has already recovered. The patient's concomitant medications were not reported. On an unspecified date in Jan 2021, the following day, he woke up and his tongue was swollen. He got excited and called doctor and he went in. He went to get dressed and as he went in, he fell down. Then he is trying to get up and cannot get up. He layed there for 1/2 hour. He could not get up. He was trying and trying. His wife had to call neighbors to help him get up. He did not want to go to the hospital and wait for 2-3 hours. He took some Benadryl and a couple of Aspirin and fell asleep. The following day when he woke up, his mouth was not swollen and he was able to get up and around. His muscles hurt and he felt like a weakling. The clinical outcome of tongue became swollen, fell down, felt so weak that he could not lift himself to get up was resolved and the outcome of other events was unknown. He is scheduled to get second dose on 24Feb2021. He would like to know if he should get it or not. He was an EMT in Fire Department before he retired. That day when it happened, he really felt old. No further details provided. The seriousness of the events was reported as non-serious. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

loss of appetite; fatigue/completely drained/ragged tired; he got sick the next day/has been sick; whenever he tried to do something, he will break out in a cold sweat; This is a spontaneous report from a contactable consumer other non-health professional (patient) via medical information team. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: Unknown, Expiration date: Unknown), via unspecified route of administration on left arm on 28Jan2021 (age at vaccination 78-year-old) at 1st dose, single for covid immunization. The patient had no medical history. There were no other products. On 28Jan2021 patient took 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 29Jan2021 (day after) the patient experienced loss of appetite, fatigue, and completely drained. Reportedly on 29Jan2021 patient had been sick. The patient experienced ragged tired, totally drained, and whenever he tried to do something, he will break out in a cold sweat. Patient stated that he got a COVID shot on 28Jan2021 (last Thursday), and he had been sick ever since. Patient stated that the sickness does not seem to be going away, it was about the same, it did not seem to be getting any better. Patient was wondering how long this is supposed to last, and if there was something he could do. Patient wanted to know how long he will be experiencing these symptoms. The case was assessed as non-serious as per reporter. No investigation assessment was done. Reporter confirmed that he had no other vaccines on the same day as his COVID vaccine. Reporter did not have his COVID Vaccination card with him at the time to provide Lot number. The outcome of the event was not recovered for sick and unknown for all other events. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

That evening he called me and told me his groin area was hurting and I went over to his house. He said he was having a hard time standing up. His groin and down his leg. He never had complained about it before. I took him to ER Hospital and they checked him out and verbally talked to him. The doctor told him to take Tylenol and told him to go home. He had that pain for about two hours.

Dizziness; loss of balance resulting in falling; Chills; fatigue; sleepiness; diarrhea; Loss of strength; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number = unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 01:00pm (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, shingles (15 years ago) and anemia. The patient was allergic to codeine. Concomitant medications included vitamin b12, c, d3, iron and Tylenol (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. On 05Mar2021 at 1:00 PM, the patient experienced dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite. On 06Mar2021, the patient underwent COVID-19 virus test (nasal swab type) and the result reported as negative. Adverse events resulted in emergency room/department or urgent care. Clinical outcome of the events dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite was reported as not recovered. Information about lot number cannot be obtained and no further information is expected.

unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; This is a spontaneous report from a contactable consumer. This 78-year-old male consumer (Patient) reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL 9264 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EL 9264) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included, chronic kidney disease, coronary artery disease, hypothyroidism, hypertension from an unknown date and unknown if ongoing. No known allergies were reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), dose number; 1 on 18Jan2021 at 09:30 am at left arm for covid-19 immunization. Facility type vaccine was reported as other. The patient did not receive any other vaccines within 4 weeks. Concomitant medications (Other medications in two weeks) included allopurinol taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID), eicosatetraenoic acid ethyl ester (VASCEPA), rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 the patient experienced unsteady on feet, almost "tipsy", as if returning to land after being on boat, have been experiencing for 4-5 days. 2 others, not related, with same approx schedules, experiencing same feelings. No treatment was given for the AE. If covid prior vaccination: No, If covid tested post vaccination: No. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.

He was living independently in a retirement home. They administered the vaccine. Since the jab he has been diagnosed with Parkinson's, Parkinson's dementia, Suffered two strokes and we were recently told he now suffers from seizures and will require medication for the rest of his life AND 24 hr. Care.

During rounds at 10pm, CNA observed resident unresponsive. Nurse was immediately called, who in turn call the code. Nursing staff responded and started CPR. A total of 16 rounds of compressions and shocked x 2, prior to Paramedics taking over 10 minutes later. They continued CPR for another 10 minutes before resident was pronounced dead.

major seizure within minutes of receiving shot; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at 14:00 (at the age of 78 years), in left arm, for COVID-19 immunization. The first dose of BNT162B2 was given on 12Feb2021 at 12:00 PM in left arm (at the age of 78 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified statin drug and blood pressure medicine. On 05Mar2021 the patient experienced major seizure within minutes of receiving shot. The event required Emergency room/department or urgent care and ended up on ventilator in ICU. Treatment received included lorazepam (ATIVAN), intubation, ventilator, CT scan, MRI, EEG. The event was reported as serious as required hospitalization for 6 days and was life-threatening. Event outcome was unknown. Information on the lot/batch number has been requested.

The patient is a 78-year-old male who presents to the hospital with weakness and fever 1 day following his second COVID-19 vaccine. Noted o have a transient thrombocytopenia. Presented with severe weakness and unable to get up. He was able to provide some history. His wife provided additional history. He received second dose of mRNA vaccine on 6/5. Developed weakness afterwards and brought to the hospital for further evaluation. Admitted with dehydration low-grade temperatures. Tmax 100.4. Denies bleeding.

Blood clots in left leg from groin area to knee area. Swollen and painful left leg. Prescribed Eliquis blood thinner. Currently in treatment phase with symptoms basically the same.

This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot Number: EN6203) age at vaccination of 78-years-old, as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included hypersensitivity from an unknown date and unknown if ongoing (Erythromycin and iodine contrast fluid). Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported. After 5 weeks from vaccination the patient still experienced pain in upper arm, severe pain in left shoulder with limited use of arm/inability to freely move arm. Physician Office Visit was required and MD prescribed lidocaine patch (that not help) and now patient was taking Prednisone pack. May require orthopedic intervention. The patient was not recovered from the events.

hardly a sore arm; This is a spontaneous report from a contactable consumer (patient himself). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318, Expiration Date: 31May2021) as unknown, single for COVID-19 immunisation. Medical history was none and there were no concomitant medications. On an unspecified date of Feb2021, the patient experienced hardly a sore arm. The patient thought it was a good idea to get the vaccine. He did not have anything except hardly a sore arm. The patient underwent lab tests and procedures which included sars-cov-2 test: positive, for it hadn't been 90 days since he had COVID that he got the vaccine on an unspecified date of Dec2020. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21 with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions. Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion. It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment. He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home. There was no fever no hemoptysis chest pain or pleuritic pain. Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen. He had a CT of the abdomen and pelvis which was negative for any malignant spread. Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21

Skin started itching everywhere; Skin started feeling sunburned everywhere; Some little raised bumps on his stomach like a little area of that itched/On his stomach he had the little welts that started to itch; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:00 (at the age of 78 years old) (Batch/Lot Number: EN6201; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EL3249; Expiration Date: Jun2021) as single dose for COVID-19 immunisation and experienced itching all over his body. States he took Benadryl regularly for the side effects but after 4-5 hours of taking the Benadryl, his symptoms returned. After a few days the itchiness resolved. States he went to allergist and received a prescription for prednisone, epipen and Benadryl with instructions for use by allergist. He was instructed to take Benadryl prior to the 2nd shot of the vaccine. He was instructed to take Benadryl if reaction post vaccine shot was mild and instructed to use epipen and call if he had a bad reaction. Also instructed to take Prednisone if Benadryl was not working. Received his second vaccine shot yesterday and, in the afternoon, developed a sun burning sensation on his skin in addition to itchiness and a welt on his stomach. The patient took Benadryl and within 30 mins symptoms resolved. He had had to take Benadryl regularly (every 4-5 hours) as his symptoms returned about 4 hours after a dose of Benadryl. States he has not needed the epipen or prednisone and would like to know if Benadryl deactivates effectiveness of vaccine. The patient wanted Pfizer to conduct clinical trials/have information on how antihistamines may interfere with the vaccine and asked if there is a blood test he can take after a period after the second vaccine dose to determine effectiveness of the vaccine. Concerned about his reaction as wondering if he should avoid the vaccine if a booster is indicated down the road and especially if his reaction is consider serious reactions and asked about the half-life. This consumer called to ask if Benadryl he has taken would affect the efficacy of the Pfizer COVID-19 Vaccine that he has been administered. He has allergies so he took a Benadryl approximately 2 hours before being administered the vaccine around 11:00. After second dose was administered, he felt ok, he waited on site for about 30 minutes for monitoring like you are supposed to. About 2 hours after vaccine was administered his skin started feeling sunburned everywhere and skin started itching everywhere. In response to events he took another Benadryl. About 30 minutes after taking Benadryl the events went away. About 4-5 hours later the events came back the same way as when they started. He had some little raised bumps on his stomach like a little area of that that itched. His body itched all over but it felt horrible sunburned. He took another Benadryl and in about 30 minutes the events kind of cleared up, it was good. About 4 hours after that the Benadryl wore off, the events came back so he took another Benadryl. Today the events are ongoing but a lot milder than it was on 17Feb2021. It seemed like every 4-5 hours the events would come back but milder today. His question is since he had to take Benadryl or he would have been itching all over the place; and he did not want to go to emergency room which he probably would have had to if he had not taken the Benadryl; and he would like an answer, not a maybe; since he had to take Benadryl and taken Benadryl again today and got the Pfizer COVID-19 Vaccine shot yesterday, is the Benadryl counteracting the efficacy of the Pfizer COVID-19 Vaccine. He has had no other vaccines or immunizations other than the first dose of Pfizer COVID-19 Vaccine. He took Benadryl pill 2 hours before he went for the second dose of Pfizer COVID-19 Vaccine; had the second dose of Pfizer COVID-19 Vaccine shot, nothing happened until he would say maybe around 13:00; because he waited 30 minutes after the shot; got in the car and came home. Around 13:00 he started getting the itchiness but this time his skin felt like it was sunburned everywhere. He was not out in the sun, it is snowing there, there are clouds, no sun; skin all over felt like it was sunburned. On his stomach he had the little welts that started to itch; He took Benadryl. He did not want to use the Epi-Pen because the allergist said he had to call # if he used the Epi-Pen and he did not want to do that. Benadryl cleared it up; did not make it go away; about 4 hours later events started back; so he took Benadryl again; and about 4 hours later events came right back; it did that all night. Today, right now, he took a Benadryl let's say about 4-5 hours ago and events are not coming back like that. If events do not come back, he probably won't take another Benadryl. Events are a lot milder now, seems like they are going away. The Benadryl works. His concern is because he did hear on TV from one of those TV doctors on one of those daily regular daily talk shows that his idea was, and caller reported it is unknown how accurate the information is; but the doctor said avoid taking medications like Aspirin, Tylenol or antihistamines, all that stuff when you get your shot because it could affect the efficacy of the shot. Caller is not sure he is right; because his allergist just said take the Benadryl in case of anaphylactic shock which he did not have. Would like to know if this a waste of all this stuff he did because what they did now was he interfered with the action of the vaccine. No other vaccines were administered on same date with the Pfizer vaccine considered as suspect. The adverse events required visit to Physician office and not required to visit Emergency room and was not hospitalized. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.

Parsonage-turner syndrome; pain along inner arm; numbness on his left side of this hand; numbness on thumb and index finger; His wrist dropped in his left hand.; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 12Feb2021 18:30 (78-years-old at the age of vaccination), (Batch/Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, Coronary artery disease, High blood pressure, prostate cancer, a little arthritis from an unknown date and unknown if ongoing. Concomitant medication included metformin taken for diabetes mellitus from an unspecified start date and ongoing; metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]) taken for diabetes mellitus from an unspecified start date and ongoing; amlodipine taken for hypertension from an unspecified start date and ongoing; atorvastatin taken for coronary artery disease from an unspecified start date and ongoing; metoprolol taken for hypertension from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN 81) taken for coronary artery disease from an unspecified start date and ongoing. Patient reported that received both doses of the Pfizer covid vaccine. Diagnosed with possible Parsonage-Turner syndrome: Had the test done last week and the report received today mentioned this. His doctor mentioned the high likelihood that it may have a connection to the vaccination. The test was 10 days ago. Has had the symptoms since about 03Feb2021. Had the last dose, the second dose, 12Feb2021. He developed pain in the arm, not at the injection site, but along the inner arm. The next day he developed numbness in the left side of the hand, in the middle and ring finger. A couple of days later he developed the same thing on the thumb and index finger. A few days later, he woke up in the night and had wrist drop in the left hand. He recovered most strength of muscles and was able to lift the fingers. Within the next few days, he recovered his strength in his muscles. The numbness continued to be there but slowly showing some improvement. He still had little patches of it. Had the test done last week, it was a nerve conduction EMG. Was initially shocked that this was all of a sudden happening. He knew it was not life threatening. Of course, we know these days doctors are not like they used to be. It took a long time to get an Appointment. Got an appointment more than a week later with the neurologist. A week later, they got the tests. The patient underwent lab tests and procedures which included electromyogram: possible parsonage-turner syndrome on 25May2021 possible Parsonage-Turner Syndrome. The clinical outcome of the events numbness on thumb and index finger, numbness on his left side of this hand was recovering, remaining all were unknown. No follow-up attempts are possible. No further information is expected. Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.

sore arm; slight headache; flu like feelings; right shoulder became extremely sore for several days (unable to use right arm).; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included dislocated shoulder. The patient was allergic to sulfa and sun screen. Concomitant medications included benazepril (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 17:30 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. The patient previously received lidocaine (MANUFACTURER UNKNOWN) and epinephrine (MANUFACTURER UNKNOWN); and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-1. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced sore arm, slight headache and flu like feelings for several days. In addition, the right shoulder became extremely sore for several days (unable to use right arm). It was reported that the right shoulder dislocated 3 times beginning in 1965 through 1996 and the shoulder was almost completely normal after 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of sore arm, slight headache, flu like feelings and right shoulder became extremely sore for several days (unable to use right arm) was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Received covid shots. Within in a few hours developed severe all body muscle cramping, pain and nausea. Extreme symptoms of gout w/pain and cramping in feet / ankles. Did not eat for 4 days - fatigue, low energy. these symptoms lasted for 4 days. After the second shot on 6-3-21 - Became weak and ill the next day and was taken home from work with extreme pain in right foot and knees. Extensive all over body painful muscle cramping, weakness. Fatigue. To this day has not been able to carry on his normal walking routine. Had consulted with physician.

experiencing in his left arm where the bump is a sensation of being red/ redness, heat and itching are in the location of the injection; redness, heat and itching are in the location of the injection/ feels hot; intermittent itchiness/ redness, heat and itching are in the location of the injection; it was just sort of like rash; it's a delayed allergic reaction; I have only minor discomfort; Pfizer Covid-19 vaccine that was given at an angle and a bump occurred; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL0261; NDC number, UPC number and expiry date: unknown) via an unspecified route of administration in left arm on 05Feb2021 (age at the time of vaccination was 78-year-old) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and epilepsy both from an unknown date and unknown if ongoing. The patient had low level of sodium in his system because of phenobarbital. The patient's wife had metaplastic breast cancer and passed away 12 years ago. The patient's concomitant medications included phenobarbital; phenytoin (DILANTIN [PHENYTOIN]); riboflavin (VITAMIN B 2); cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]); vitamin D3; vitamin C [ascorbic acid]; tocopherol (VITAMIN E [TOCOPHEROL]); colecalciferol (VITAMIN D [COLECALCIFEROL]); calcium; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176; NDC number and expiry date: not reported) on 15Jan2021 for COVID-19 immunization and experienced dizziness, headache and chest discomfort. The patient received second dose and reported that the injection was given at an angle and then there was bulb (bump) on his arm for 4 months. In Jul2021, the patient had feeling of sensation in his arm, feeling of the thing red, felt hot and had inter massive itchiness. The patient reported that the redness, heat and itching were in the location of the injection (area was in the upper portion of his left arm, almost by his shoulder). At first, the patient didn't really give it much attention because it was just sort of like rash and then it started becoming little bit attended and becoming little bit like heat there, the patient had no fever at all during the whole period. He had only minor discomfort and itching. The patient asked if anyone had experienced the sides effects which the patient felt at the injection site (feeling hot and intermittent itchiness). The events were reported as non-serious. The patient found an article on news entitled rare COVID arm phenomenon, a harmless immune response to vaccination, and the patient said that the article was talking about COVID arm, about where in 1st trial 344 people had the COVID arm but in the 2nd trial 64 people had COVID arm but this was the late body reaction that initially occur 10 to 14 days after the injection. The patient got 4 rounds of house treatment. The patient had been to safety and medical information. The patient had an article that he found online that covers all the symptoms that he had, that indicates that it was a delayed allergic reaction and that was the minor incidence and its extremely rare even on the global level. The patient reported that it occurred within the company Moderna, the other vaccine company like Pfizer that produced the 1st 2 vaccine. It was kind of same technology that they use, and the indication was that it will go away if an individual basically takes an aspirin or some anti-inflammatory for a few days. The patient was concerned about it because the way the owner of report said that the initial allergic reaction occurs with people within 10 to 14 days, the patient was 4 months after the effect and had symptoms. The patient explained the way he received injection. The patient reported that they may have given him the vaccine at an angle which created a small pocket through the medicine to stay into regional muscle and later it was released into his system and the patient experienced side effect, that was the minor side effect by description and he had an article that he can refer and even had a quotation medical journal of medicine, what they called a COVID arm phenomenon. The patient gave the reference of the website to other two ladies, where the rare phenomenon called the Covid arm was listed in detail. The patient further stated left upper right arm almost at the shoulder level. The patient did not receive any treatment medication. Investigations was not reported. The outcome of all the events was unknown.

This patient received a full, diluted multi-dose vial of the Pfizer COVID-19 vaccine instead of the single dose of .3mL. The patient was notified on Friday July 23, two days after receiving shot and reported a sore arm, but did not feel it was anything beyond what was expected.

Low energy/weakness; loss appetite; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 15:30 (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were other concomitant medications in two weeks. The patient experienced low energy/weakness, loss appetite on 05Mar2021. The events resulted in emergency room visit, and were serious per hospitalization and disability. The patient was hospitalized for low energy/weakness and loss appetite for 12 days. The patient underwent lab tests and procedures which included Nasal Swab (covid test): unknown results on an unspecified date. Therapeutic measures were taken as a result of the events with Plasma exchange. The outcome of the events was resolving. Follow-up attempts are completed. No further information is expected.

Caller received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs / numbness in his feet / numbness in his knees; when he pinches his skin in his left leg and some parts of his body, he doesn't feel the pinch; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0196, Expiration Date was not reported), via an unspecified route of administration on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (Lot number: EW0196) received on an unspecified date (at the age of 78-years-old) for COVID-19 immunization. Patient states that, the person at the pharmacy told him to mention that he was calling in regards to the Pfizer BioNTech COVID vaccine EUA although his card after both doses has EW0196. Patient received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs, feet, and knees. Patient states when pinching his left leg and other parts of his body he doesn't feel the pinch. Patient would like to know if this is a common side effect, if there have been any other reports of this side effect, if this side effect will go away in a couple weeks on its own without having to go get medication for it. No information in PI regarding numbness in legs, feet, and knees being reported as a side effect, when pinching the left leg and other parts of the body not feeling the pinch. Patient confirms he received the Pfizer Covid 19 Vaccine. Additonal information is expected.

Patient stated "I feel some pressure like I need to burp." Patient was taken back to medic area where vital signs and EKG were done. Manual v/s 138/98, O2 98%, HR 70, EKG results normal. Patient burped and stated, "I feel better now." EMT released patient to go home.

Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.

Chills, loss of taste and smell, weakness, shallow breathing Narrative: Patient referred to facility ER for COVID- 19 testing and evaluation of symptoms

Started with severe myalgias, back pain, leg pain and fever T 104 He was taken to Urgent Care with Covid neg, Influenza A/B neg. UA and CXR negative Symptoms lasted 72 hours He has never had fever before and he is 79 years old.

Area of facial numbness about 2 inches in diameter on left mandibular distribution. No motor loss. Persistent to present, unchanged.

Seizure Activity: Nursing assessment: 1/28/2021 17:55 Staff asked writer to check on resident, stating that there was something wrong with him. Resident found sitting up in wheelchair. Resident noted to be nonverbal, making small jerking movements with upper extremities and head articulated to the left. As writer attempted to assess pupils, resident squeezed eyes shut and grimaced. Resident did squeeze with both hands, equal strength. VS: 94, 16, 138/86, 97% on RA. Resident put into bed with assist of two staff and hoyer lift. MD notified: 1/28/2021 18:10 Return phone call received from Physician. Advised to continue to monitor and OK to send to ED if resident representative wants further evaluation done. Nursing assessment: 1/28/2021 18:35 Resident found to be alert and smiling at this time. Resident speech is garbled per baseline. VS: 111, 20, 129/77, 100% on RA. Resident able to follow commands. ROM equal with strength at baseline. No incontinence noted. Resident noted to be fatigued. Start of episode of seizure-like activity not witnessed. The time between first found by staff to noted resolution was approximately 40 minutes. No further seizure episodes noted. No previous hx of seizure activity.

At just after 5 o'clock, pt received his 1st dose of the COVID-19 vaccine and about 10 minutes later he began to feel flushed in his face. This was associated with some chest tightness as well. He was referred to the emergency department. He had no difficulty breathing and did not feel like his throat is closing. He had no rash anywhere else on his body but does feel like his face is redder than usual. His symptoms have not been associated with shortness of breath and has no abdominal pain. Upon presentation to emergency department, the patient was hypertensive to the 220s but his vital signs were otherwise within normal limits. Physical exam was fairly unremarkable with exception of some mild redness of the bilateral cheeks. He had no rash there is no evidence of airway compromise or wheezing. Low concern for acute anaphylactoid reaction. Patient was given diphenhydramine. Symptoms resolved and patient was discharged home.

2 days after vaccine - left sided weakness in arm and leg, speech/swallowing impairment. ER then 3 days in hospital- home with walker, assistance and home health.

(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous production. (02/16-17/2021) : death possibly during the night

On February 18 or 19, noticed a 5 mm. purpuric skin lesion on right hand, not painful. On about February 19, perhaps in the evening, noted varied perhaps 5 mm discolorations on ankles that in retrospect were probably resolved mild purpuric lesions. On the same evening, noted very mild tenderness in the calf (soleus muscle) regions bilaterally feeling like mild muscle fatigue. On February 21 at about 6 AM, before showering, noted bright cherry red lesions on/under skin of both ankles and more severely on the posterior calf of both lower legs above the calf tenderness. The skin was flat and not tender. Calf tenderness was slightly worse (though still mild). Lesions turned purpuric, fading in hours.

Patient states since he got the first dose of Pfizer vaccine on 2/3 and the second on 2/17. He has gained almost 20 pounds since taking the first shot. Patient states he has gained right around 20 pounds since getting the first shot of the Pfizer vaccine. States he had some shortness of breath right after receiving the first dose of vaccine, but that has cleared. Felt achy and stiff and sore after the second injection. Follow up with patient on 2/20/21 F/U with caller - He was advised at ER that he had excessive fluid retention; no other issues were identified. He was advised to increase his furosemide dose from 20mg twice daily to 40mg twice daily for 5 days. He continues to feel tired and weak, with slight shortness of breath. Confirmed with caller that his 2 vaccinations were separated by only 14 days.

on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time

"Pfizer-BioNTech COVID-19 Vaccine EUA" Exagerrated numness on the left side of my face from ear to mouth

whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; having trouble bending his right elbow; This is a spontaneous report from two contactable consumers via the Pfizer-sponsored program. A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiration date 31May2021) on his left arm, intramuscular on 21Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included ongoing congestive heart failure, ongoing type two diabetes, ongoing hypertension, transient ischemic attack, gout, depression and anxiety. Concomitant medication included allopurinol for Gout, ongoing spironolactone for Hypertension, buspirone hydrochloride anxiety and depression, ongoing finasteride, ongoing glipizide for type two diabetes, ongoing valsartan for Hypertension, ongoing apixaban for transient ischemic attack, ongoing doxazosin mesylate for Hypertension, ongoing loperamide, ongoing vitamin d3, ongoing pravastatin sodium, ongoing furosemide for Congestive heart failure and ongoing carvedilol for Hypertension. On Friday afternoon or evening, the patient was having trouble bending his right elbow. When he got up in the morning, his whole elbow 3 to 4 inches either way was swollen a lot and very painful. During the course of the day, it went down his arm and into his right hand. At its height it looked like a surgical glove that gets blown up for kids. It was very painful. Treatment: declines any Outcome: His elbow is still slightly swollen, not much pain at all He puts his glasses on to read the card. The outcome of the events was unknown.

1st dose vaccine 2/23/21; EMS called after pt fell at home 2/25/21; taken to ED and admitted to hospital DX: 1. Right-sided nontraumatic intracerebral hemorrhage, unspecified cerebral location (CMS/HCC) I61.9 431 2. Long term (current) use of anticoagulants Z79.01 V58.61 3. Sensory neglect (left sided) R41.4 781.8 currently still admitted to hospital at the time of this report

Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so weak he couldn't stand up out of a chair; felt really bad; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; EL3247), via an unspecified route of administration in the left arm near the shoulder on 16Jan2021 at about 2-3:00 PM as a single dose for COVID-19 immunization (also reported as to protect himself; hopefully). The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines on the same day as BNT162B2 or even four weeks prior and had no problems with vaccines in the past. The patient experienced fever, chills, extreme weakness; so weak he couldn't stand up out of a chair, and felt really bad on 26Jan2021. He had a fever a little over 100 degrees, extreme weakness. He was so week he couldn't stand up out of a chair. He also had chills and just felt really bad. The patient thinks he was over it, he hoped. The events did not require any visit to the Emergency Room or Physician's office. Outcome of the events was recovering.

Initially mild pain and tenderness Left arm shoulder muscle. On third day after second vaccination, should symptoms gone but I started to develop diffuse myalgias. By 4th day, began having problems with my memory. I could not figure out some instructions on a computer program. I had some trouble recognizing a common object in my hand. Then mild ataxia. Excessive sleepiness in 2-3 hour intervals. On 8th day, developed abdominal pain similar to diverticulitis. And became very constipated. I had forgotten to take the Parnate and missed two doses. I had forgotten to take Metamucil and Miralax. these led to the constipation and abdominal pain. On advice of psychopharmacologist, I resumed Parnate and started to feel better. I resumed laxatives and good effect. Abdominal symptoms abated in two additional days. I had gone to ER but seen only informally by my medical friends. After 3 hour, and getting better, I left. Blood tests were normal. No exam. Since 02/27/2021, I have felt perfectly normal. Recovered.

feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients

right sided facial palsy, consistent with Bell's palsy, grade 3 treatment with prednisone and valacyclovir for 7 days with improvement to grade 2 by 1 week

a little bit of itching; kind of hives; uncomfortable at times, at his feet, and ankles; he has rashes; terrible skin; This is a spontaneous report from a contactable consumer (reporting for himself). A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history Ablation surgery. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of itching, kind of hives, he did not break out, he was uncomfortable at times, at his feet, and ankles. The patient has rashes, and terrible skin. The outcome of the events was unknown.

slight fatigue the next day; some left arm soreness; This is a spontaneous report from a contactable consumer (reported for himself). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 9261, expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, a-fib, small stroke 5 years ago and some weakness from that (stroke). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included atenolol, amlodipine, warfarin, and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 26Jan2021, patient experienced slight fatigue the next day (as reported) and some left arm soreness. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue and left arm soreness was recovered in Jan2021.

23 Hours after the injection, a mild muscular pain started on the mid left arm , within minutes it became evident on the entire left arm and it extended across from to right shoulder arm. The pain included a burning sensation, being extremely intense (using the standard pain scale I was way over 10) At first it appear to be a heart attack. I never had any cardiac issues. The pain lasted approximately 30 minutes. Second event started on Sunday, 7 at 10 : AM same location, and intensity.

Right Hand swollen and fingers tingle. Unable to hold fork for the past 4 days. Plenty of pain. 1st shot 3 weeks ago attacked my upper leg muscles - front and back- and shoulders - both sides. Even though rules say not to get 2nd shot if an allergic reaction is still viable, I didn't know this was an allergy reaction. Thusly, I got the 2nd shot. Sorta wish I hadn't. My original e-report # is 327694

Pain developed in right arm at injection site. Pain very slowly diminished for 10 days. First day temperature of 101.3F. Very debilitating, making it difficult to dress and to sleep. Hand to take anti anxiety drugs to help sleep for 8 days. I had COVID -19 and was hospitalized from Nov.16 to Dec. 4 2020. Then 2 weeks in bed before able to walk downstairs. Not a pleasant experience!

increased heart rate/slight increase in his blood pressure and heart rate post vaccination/a 97 heart rate; feel very weak; blood pressure is steady now but pulse is always elevated/slight increase in his blood pressure and heart rate post vaccination/It was 139 over 78 with a 61 heart rate/Next morning at 10 am my blood pressure was 139 over 95; tired; I think I had a reaction to it; This is a spontaneous report from a contactable consumer (patient). A 79-(unit: unknown)-old male patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, NDC number, UPC number and Expiry Date: unknown), via an unspecified route of administration on 28Jan2021 13:00 at single dose for covid-19 immunisation at the vaccination facility. COVID Vaccine was a Pfizer product. COVID Vaccine manufacturer was unspecified. Reason for no lot number of COVID Vaccine stated by consumer as he don't know. He stated "I had little card Pfizer EN5318 (further not clarified). There is another number here, I think it D-6152061100." Medical history included a heart disease (A-Fib) (Intent: History) for which the patient takes Eliquis, losartan ,metoprolol and pravastatin and a heart condition. Concomitant medication included apixaban (ELIQUIS), losartan, metoprolol, pravastatin; all for A-Fib. Caller (patient) stated "I receive my first dose of Pfizer COVID-19 vaccine on 28Jan2021. I felt really tired (in Jan2021) for a week after receiving the vaccine. I have a heart disease (A-Fib) for which I take Eliquis, losartan, metoprolol and pravastatin." He noticed a slight increase in his blood pressure and heart rate post vaccination. He had the tendency to monitor his blood pressure and heart rate on regular basis but had been monitoring closely post vaccination. His normal vital signs were around Blood pressure:120/70 to 80 and Heart Rate: 50 -60. However he noticed his BP was high as 139/95 (in 2021) and heart rate 95-103 (in 2021) which is not his normal. His blood pressure is steady now but pulse is always elevated. On 11Feb2021 patient stated "Started to feel very weak. My blood pressure had gone up; Blood pressure was 139 over 95. Heart rate almost doubled: 97 heart rate. Patient stated, "I took the COVID first shot and my age is 79. I took the first shot of the COVID Vaccine on 28Jan2021, around 1 pm in the afternoon at the vaccination facility (a 2 year college, they were doing it outside of the college). I think I had a reaction to it (in 2021). Normally my blood pressure is 110 to 125 on top and I don't know 65 up to 80 on the bottom and my heart is normally between 50 to 65. That's my normal heart rate. I am pretty healthy and I do a lot exercise and lot of power walking, so my heart rate is 'not so' low. That afternoon (28Jan2021) I walk, my power walk training miles. I started to feel very weak and at night I took my blood pressure it wasn't too bad. It was 139 over 78 with a 61 heart rate and then next morning I woke up and my blood pressure had gone up to medically and heart rate almost doubled. Next morning (29Jan2021) at 10 am my blood pressure was 139 over 95 and a 97 heart rate. It kind of continued, I have been writing this all down and monitoring it and blood pressure has come down to some degree but my heart rate continue to be elevated but my blood pressure like this morning, I do in January because I have heart condition and I have Afib (Intent: History). I took the Pfizer vaccine." I am scheduled to get the second dose on the 18th and I am concern about the elevation of my heart rate and elevation of my blood pressure." Outcome of event 'tired' was recovered in 2021; 'Blood pressure raised' was unknown; 'Heart rate increased' was not recovered; 'feel very weak' was unknown; 'I think I had a reaction to it' was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

When he raises his left arm where the vaccine was given, he feels a twinge of pain/lifts his arm over his head he feels the twinge of pain; When he raises his left arm where the vaccine was given he feels a twinge of pain where that was, and a kind of numbness; when he exercises it and swings his left arm, then he feels a bit tightness; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021, at single dose, to prevent COVID, at a hospital. Medical history included lung cancer (19-year lung cancer survivor), mild heart attack in 2011, aortic valve replacement in 2013 and a heart issue. Concomitant medications were not reported. Historical vaccine included influenza vaccine received on 06Nov2020 for immunization. The patient reported that on he had the first vaccine shot on 19Jan2021 (10 days ago) and on 20Jan2021, when he raised his left arm where the vaccine was given, he felt a twinge of pain where that was, and a kind of numbness, it was nothing that restricts him in any way, but when he exercised in the morning and lifted his arm over his head he felt the twinge of pain, which was something he never experienced with the flu vaccine or any other vaccines. He wondered if it had something to do with this vaccine. He has not treated it, it has not bothered him much. He stated he feels it when he exercises it and swings his left arm, then he feels a bit tightness or a twinge of pain. He says it does not restrict him or cause him to cry out or anything. The patient also reported that he is scheduled for the second dose on 09Feb2021 and stated that he needs to get a dental procedure done on 04Feb2021 and needs to take amoxicillin for it due to past heart issue. The patient wanted to know if it is okay to take amoxicillin and was wondering if this medication will interfere with the second dose. He also asked if he should cancel the dental procedure. The patient mentioned that he had his annual wellness visit on an unspecified date and they did a lipid profile (unknown results) but it was not relevant in his opinion. The outcome of the events was unknown.

Patient experienced a witnessed tonic clonic seizure on 3/12 /21 at 5:30am. Seizure lasted for 3 minutes. He was post-ictal for approximately 15-20 minutes afterwards. No prior history of seizure. He was taken for further evaluation.

Bell's Palsy, treated on 2/21/2021 with Prednisone and Valacyclovir for 7 days, will take several months to see if improvement in facial nerves/muscles.

MUSCLE TIGHTNESS AND LOSS OF SENSATION IN LEFT ARM FOR LAST 3 WEEKS. SAME ARE AS VACCINATION WAS DONE.

diagnosed as having AFIB.; light headed; I had some aches; I was completely down in bed with no energy/physically weak; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6202), via an unspecified route of administration administered in left arm on 23Feb2021 00:15 as SINGLE DOSE for COVID-19 immunisation. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included atenolol, oxybutynin, and tamsulosin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (at the age of 79-year-old) for COVID-19 immunisation. The patient stated that in the past her pulse rate was in the low 60's. The patient lost energy gradually from 23Feb2021 until 26Feb2021 and 27Feb2021. The patient was completely down in bed with no energy. The patient had some aches on 25Feb2021 at 07:00 AM, but the pulse rate went up to 80 to 100. The patient went to the Cardiologist he believes on 08Mar2021 and was diagnosed as having atrial fibrillation (AFIB) on 08Mar2021. The patient was being treated for AFIB now and have been light headed and physically weak since 25Feb2021 at 07:00 AM. Therapeutic measures were taken as a result of diagnosed as having afib. The patient had not yet recovered from the events.

Loss of energy; Loss of energy; Headache; very tired; arm sore; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 12:05 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient previously administered first of BNT162B2 on13Jan2021 for covid-19 immunisation and experienced Headache, loss of taste, very tired, arm sore. The patient experienced headache, very tired, arm sore, loss of energy on 03Feb2021 and patient again experienced loss of energy on 04Feb2021. The patient did not received any treatment for the events. The outcome of the events arm sore was reported as unknown and other events was reported as Recovered. Information of Lot/ Batch number have been requested.

COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.

Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.

sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021. No follow-up attempts are possible. No further information is expected.

Seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration in right arm on 11Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and COVID-19 (if COVID prior vaccination: Yes). No known allergies. Concomitant medications included metformin; insulin lispro (HUMALOG); metoprolol; amlodipine; atorvastatin; vitamin D; and pioglitazone. The patient also received first dose of BNT162B2 on 18Feb2021 at 01:00 pm (at the age of 79 years old) for COVID-19 immunisation. On 13Mar2021 at 12:00am, the patient experienced seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there. Patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedures which included COVID test: negative on 13Mar2021. The event resulted in emergency room/department or urgent care visit. The patient received treatment for the event. The patient had not yet recovered from the event. The event was assessed as serious (hospitalization). Information on the lot/batch number has been requested.

Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back pain and wanted to go back to bed and she noted he was extremely sweaty at that time. He was lifted back to bed and was reportioned several times because he could not get comfortable. She went to get him a drink from the kitchen and heard a guttural sound and rushed back to find him unresponsive and blue in color. She called "911" and patient was dead upon arrival (and a DNR) so the Medical examiner arrived and pronounced him dead. She states sx started at about 4pm and he was pronounced dead at about 5pm. Medical examiner determined a heart attack cause of death. The family not sure that the vaccination had anything to do with death but wanted it to be reported.

I need to talk with someone re: effects getting shots Before getting the shots I was walking 3-5 miles a day, going to the gym 5-7 times a week, playing tennis 5 nights a week and getting up before 7 am Now, I don't want together out of bed. every joint in my body aches, I have no energy, my hands are swollen and i have no stamina when I tr to go to the gym or play tennis I hurt so bas the I do not want to play I have gone from being active and strong to being totally depressed because of the constant pain that I am in

suddenly began shaking horribly from head to feet/shaking of his hands; freezing; My walking is not as good as before; This is spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration on 01Mar2021 at 12:45 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stem cell transplant; then soon after GBS from an unknown date and was diagnosed with COVID-19 from an unknown date. No allergies to medications, food, or other products. Concomitant medications included levothyroxine; rosuvastatin; telmisartan; and metformin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) on 08Feb2021 at 12:45 pm in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 at 21:30, patient was getting ready for bed but suddenly began shaking horribly from head to feet and was freezing. His wife put him in bed with six blankets but he was still freezing. His wife brought him to the ER. Upon arrival at the ER, it was noted that the shaking was gone but the shaking of his hands remain that he could not put a spoon of sugar in his coffee cup without spilling it and stated that his walking is not as good as before. The patient was hospitalized due to the events for 2 days. The events were considered serious for disability. Therapeutic measures were taken as a result of the events (needles were placed on both legs as reported) and MRI was performed. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel on an unspecified date.

Extreme Fatigue, sore feet, legs , hips, lower back, mid back, upper back neck into skull ........knees , shoulders , hands , fingers , wrists....Have not been seen by Dr...his office told me there was nothing they could do ......situation has not improved and doing normal things hurt like hell ...getting up and sitting down painful, getting in and out of car hurts .......I need and use a cane to walk.......how long does this side effect go on?????

wheezing in the morning; shortness of breathe in-between all the other symptoms; bronchitis; hot flashes/warm flush; lack of appetite; trouble walking; uneasiness in the stomach; feeling of warmth; achiness; feeling so bad; nausea; Fatigue; he got extremely cold; not feeling well/feel lousy/sick; My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little; chills/Shivering; shaking uncontrollably; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, dose 2, administered in Arm Right on 11Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization. Medical history included prostate cancer from an unknown date and unknown if ongoing and major radial prostatectomy from 04Feb2021 to an unknown date. The patient previously received first dose of BNT162B2 (lot number: EN9581) on 17Feb2021 for COVID-19 immunisation and experienced chills, low grade fever and fatigue. There were no concomitant medications. The patient got the second dose of BNT162B2. The patient was fine, had no problems until 15Mar20201 (4 days afterwards), the patient stated, "I started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. I wouldn't be calling you but this has not subsided. It's been 3 weeks now and I'm not feeling well. It ebbs and tides. I've been taking a diary. I went to the ER last Monday because I was wheezing in the morning and had shortness of breathe in between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder with unknown results. They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels. I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday. Please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice, that I'm not nuts, something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took BNT162B2 vaccine. I need someone to get back to me." After the second dose of BNT162B2, the patient has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer COVID-19 vaccine that would be causing his symptoms. The events hasn't gone away, it's now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. He would like to know if this is normal and have others reports this? The First time he experienced the chills and fatigue it was on 18Feb2021. Then the second time the chills, fever, fatigue, and nausea started on 15Mar2021. The events were described, "Fever: It is not as steady, when it ticks up, it is never going past 100F, it's been like 98 and 99, that's when he starts to feeling so bad. He provides todays temperatures, this morning 97.5F he usually runs low, then about 10AM 97.7, then at 11AM 98F, then an hour ago it was 98.8F and he can feel the difference. Nausea: It occurs when the temperature ticks up, it's not really nausea but its uneasiness in the stomach, not necessarily nausea but he feels no appetite. It has the Same pattern as the fever. Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. On 21Mar2021 he went to the ER because he was feeling so bad, there was a little bit of wheezing and shortness of breath, they did lab work and a chest X-ray, they sent him home with an antibiotic and a steroid inhaler. The chest X-ray showed Bronchitis. Blood work results are Unknown. He clarifies that the ER sent him home the same day after 9 hours, he was not admitted to the hospital. When queried if he had a physician office visits he states that he had 2 "Tele-med" appointments with the Primary Care doctor. He has no Allergies. The outcome of the event fever and nausea was not recovered while the outcome of the event fatigue was recovering; and the outcome of the rest of the events was unknown.

Patient presented to a doctor's appointment with complaints of blood in stool as well as a sore arm ever since his COVID vaccination.

Covid positive 4/19/2021, off balance, weak/tired, trouble hearing, cannot taste, cough, runny nose, reports not short of breath but breathing heavy, fever comes and goes,

Bells Palsy, started 5/4/21. 1st dose of pfizer vaccine given on 4/14/21. Had been due for second dose on 5/5/21 but will be delayed by a couple of weeks or will switch to J&J.

Initially had chills, myalgia, and weakness. Symptoms worsened with fever and ongoing headache that lasted for 2 weeks. Developed visual disturbances. Was admitted twice and ultimately diagnosed with giant cell arteritis

swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip; swollen gland he noticed on the left side; the swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days,his upper lip irritated on inside for a day or 2,; swelling that occurred in his mouth/1st occurrence of swelling was like golf ball size, it was visible; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 11:00 (at 79-years age) as single dose for covid-19 immunisation. Medical history included diabetes and hypertension (he was diabetic and was on blood pressure medication, but both his hypertension was under control, and his diabetes, sure his A1C is higher than it should be but was under control with oral medication), root canal infection (though this was contributed to the root canal which he had on 29Jan2021, the root canal was on the lower left of the mouth, tooth number 20). Patient provided relevant Family medical History of Hypertension. Concomitant Medications: He was just taking his general medications, like his maintenance medication, nothing out of the normal. He had no other vaccines on the same day as the covid vaccine or in the 4 weeks prior. He had no positive covid or antibody test prior to the first dose (he had never had a test).On 08Feb2021, the patient had the 1st occurrence of swelling was like golf ball size, it was visible, but it went away after 3-4 hours and he didn't have to take anything. Then on the 11Feb2021, the patient woke up at 4:30AM, experienced the swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip, it gave him a distorted appearance, it was severe. The swelling in the mouth, that wound up settling in upper lip which was the 2nd occurrence in a 3-day period. The first occurrence was swelling, not as severe, in the lower inside of the mouth in the lower right inside of the gum, the swelling appearance from the outside, though this was contributed to the root canal (had on 29Jan2021). The swelling in the mouth from 08Feb2021 subsided for him in 3-4 hours. He called endodontist, and told her about the second swelling, she said to come in and look at it, that was on 11Feb2021, she took X-rays and result was normal, she said it was not connected to the root canal and told him to contact his Primary and go from there, he agreed with her because he did not feel any type of sensitivity. On 11Feb2021, patient then called the Primary Care doctor, told how he developed the swelling, and the primary care said that he would rather see an ENT specialist and he got an appointment with the ENT that same day 11Feb2021 at 15:00 in the afternoon. The patient went to see him, the ENT checked his mouth out, checked his nose and throat, he did not know what it was stemming from, and said he will put him on an antibiotic. On 11Feb2021, the ENT said that the patient did had a swollen gland he noticed on the left side. The swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days, his upper lip irritated on inside for a day or 2, but it lasted till about the 13Feb2021. On 11Feb2021 (5 days ago), the patient was put on an antibiotic for swelling that occurred in his mouth which was Clindamycin HCL 300mg, 3 pills a day with his last 2 pills of antibiotics falls same day (18Feb2021) as his second vaccine dose was scheduled on Thursday (18Feb2021; appeared to be scheduled outside of the 21-day recommendation). Patient felt like he was sort of on edge for another occurrence possibly happening. Being on the antibiotic, maybe this was some type of infection. The ENT told honestly that he didn't know why this happened, but if it happened again, he might have a CT scan for the suspect salivary gland, maybe it was clogged or there was an infection in the gland. He asked if he should take the pills or reschedule the vaccine dose and if it was ok to receive the second shot while on this antibiotic (his prescribing doctor couldn't give an answer). On 18Feb2021, the patient was due to have booster. Patient would have 2 pills left on the 18Feb2021, after that he was finished. Therapeutic measures of antibiotic were taken as a result of swelling that occurred in his mouth (mouth swelling). He did not have to go to the emergency room for the mouth swelling but he has visited the physician's office. The outcome for swelling in the mouth and lips was recovered on 13Feb2021 (Duration 5 Day); outcome for swollen gland was unknown. Follow up (16Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported patient information, new event information.

Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Patient with new onset of severe dizziness after his first COVID19 vaccine. Pt began having dizziness and then felt nauseated, weak, and diaphoretic. Patient left ED.

Diagnnosis: Bell's Palsy, right ear ache, right peripheral facial palsy, and corneal injury. March 29 to April first. Treatment by Opthomologist: eye drops every hour and eye lubricant before bed.

Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a 79-year-old male patient (husband). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in deltoid right on 26Jan2021 15:00 as unknown, single for covid-19 immunisation. Relevant medical history and concurrent conditions: diabetes type 2, Hypertension, Stroke(Other Conditions: he has completely recovered), incipient Parkinson's disease(Other Conditions: this was minor and he has very little to no symptoms, Congestive heart failure was ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): The only vaccine they get was the flu shot and has had to have things like typhoid, the shots needed for international travel. He has had a never had a reaction to a vaccine that she knows about and they had been married over 50 years. No additional vaccines administered on same date of the Pfizer Suspect. No Emergency Room and Physician Office visited. Prior Vaccinations (within 4 weeks) was none. AEs following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination) was no. Family Medical History Relevant to AEs was no Relevant Tests was no. Time the Vaccination Was Given was 3pm. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right deltoid. On26Jan2021, the patient experienced, sore arm. No other Products. Investigation Assessment was no. Additional Context: Caller, reporting COVID vaccine and who has a question. She explains her and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm, but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could affect the efficacy of the vaccine. She wants to know does it affect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. Prescribing Healthcare: no address, phone or email are known. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not get through the day without the Tylenol. Today, she is a little tired, but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really yucky. She was healthy. On 28Jan2021, the outcome of event was recovered Follow-up (07May2021): Follow-up attempts completed. No further information expected.

embolic stroke; blood clot; His major issue was speech and wasn't able to formulate any words; left sided weakness on his leg; This is a spontaneous report from a contactable nurse (patient's daughter). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 79-years-old) for COVID-19 immunisation. Medical history included transient ischaemic attack (TIA) from 2019 to an unknown date, mild hypertension, idiopathic neuropathy: in the left leg, started in the beginning of the year from 2019, melanoma removed in the 1970s, enlarged prostate, neuropathy, cholesterol and fluid retention. Ongoing concomitant medications included tamsulosin taken for enlarged prostate; gabapentin taken for neuropathy; candesartan taken for hypertension; pravastatin taken for cholesterol; acetylsalicylic acid (BABY ASPIRIN); and furosemide (LASIX [FUROSEMIDE]) taken for fluid retention. The patient has been taking all of his meds for quite some time, over 5 years. The patient did not have prior vaccinations within 4 weeks. The patient received the first dose of BNT162B2 on 09Mar2021 10:30 for COVID-19 immunization. The patient completed the Pfizer COVID vaccine series, the second shot was on 30Mar2021. On 09Apr2021, the patient had an embolic stroke. The patient's daughter stated that the patient has a history of TIA in 2019 and was concerned. She does not know if it was related. She added it might be that if people have previous risk, there may be some precautions, like to take a full dose of aspirin before, a week before. She sent an e-mail last 05May2021 and hasn't gotten a response back. The patient went to the ER due to embolic stroke and was in the hospital Friday (09Apr2021) through Wednesday. The patient went to the stroke rehab center for 3 weeks. The daughter clarified that the patient was in the hospital until 14 or 15Apr2021 before being transferred (also reported as 5 or 6 days and in rehab for three weeks). Then was discharged last 06May2021. The patient's condition seemed to be getting better. His major issue was speech and wasn't able to formulate any words. He was able to speak now. His rehab would be a lot of neurological rehab and speech therapy. The patient previously had left sided weakness on his leg from some random thing that happened. It didn't seem to get worse. It really affected his speech and cognition. The patient's daughter thought that the embolic stroke was related to the Pfizer Covid vaccine and added that thought was in some way but cannot say in what way. She thought that it exacerbated some type of blood clotting. She stated that he never had blood clotting issues before and was the type of person that would take a baby aspirin and get a nose bleed, he was the opposite of a clotter. An MRI in the hospital showed blood clot and stroke. He had blood work but does not know what it showed and presumed he was fine (unknown results). He has never really had any kind of blood work issues and does not know why he was on cholesterol medication. The patient required emergency room visit for embolic stroke. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported "embolic stroke" cannot be excluded. Previous medical history and Old age is a risk factor for the onset of stroke. 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.

right wrist was "quite sore and painful"/left wrist then "started swelling and being painful"; carpal tunnel; feeling anxious; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap/ was hotter than a firecracker; arm was so sore he couldn't pick it up straight in the air; trouble walking; right shoulder was swollen; left knee is swollen real bad; right shoulder was pretty sore and is getting worst all the time; left knee was "sore"; right wrist twice as thick as [his] left one/left wrist then "started swelling and being painful"; This is a spontaneous report from a contactable consumer, the patient. This 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in Apr2021 (at the age of 79-years-old) as a single dose for the corona virus, to get rid of it/ it's supposed to be sure he didn't get it. Patient had no medical history. There was no relevant family medical history. There were no additional vaccines administered on same date of the COVID-vaccine. Patient had no adverse events following prior vaccinations. He remembers his first polio shot he got that back in the early 50's and his second shot was a cube of sugar, called the salt vaccine. Stated he's been getting vaccines for a long time and he never had any trouble with any of them. The patient previously received the initial dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in 2021 (March or April) in the left arm which was deemed invalid by the vaccination provider due to temperature related issues (i.e wasn't cold enough). He explained he received a letter informing him of this incident and recommending a replacement dose (which he thinks was on 06Apr2021). About 2 to 3 weeks before he got his first COVID shot, he got a flu shot in his left arm, about 4 or 5 inches above where he got his COVID shot. The patient's concomitant medications were not specified. He reported that the second vaccine (BNT162b2) caused him problems. On 06May2021, he woke up with his right wrist twice as thick as his left one, it was swollen real bad. The right wrist was quite sore and painful. He didn't know if he was getting carpal tunnel or what it was, so he went to the ER about it and they gave him three different kinds of pills, two of which included tramadol 50mg one every day and ibuprofen 400 mg. The ER couldn't determine the cause for his reaction. About 3-4 days after taking the prescribed medication, his reaction subsided quite a bit and was not nearly as hurtful, but his left wrist then started swelling and being painful/sore. Therefore, he continued to take his medication and it improved. It was like that for a couple/ three days, and it calmed down. He thought he was okay 2-3 days ago, but this morning (14May2021), his right shoulder was swollen and pretty sore and was getting worse; he was in so much pain, so sore he could hardly even move his arm, he couldn't pick it up straight in the air, couldn't get his elbow up past his ear. The patient also reported that when he got off his bed, his left knee was sore and it felt like a fire underneath his kneecap and he was having trouble walking. The left knee was swollen real bad and was hotter than a firecracker. Thus, he went back to taking his pill again. The knee pain started the morning of 14May2021 about the same time it seemed and has worsened, and he took a 400mg ibuprofen and the other pill he's taking, "100 mg doxycycline or something". Patient hadn't been doing much since, he was feeling kind of laid up, he had thought it was all done with yesterday (13May2021). He stated he's been hearing things about allergic reactions to this COVID shot, was sure that a lot of people are having complaints of allergic reactions, and was sure he's not the only one who has had a problem like this. He asked if there was anything he can take to block it because he is sure when this calms down after a week or whatever, it will be his in his right knee or left shoulder or wrists or ankles and he's 100% it's about that COVID shot. He stated he's never had arthritis before. He stated that he has never had any problems like this before. He is supposed to go see his doctor in a week or two. He tried to call the doctor to make an appointment, but he figured he would wait a couple days, but he is hurting bad today (14May2021), and he hasn't been to anybody yet except for the ER. The patient stated it looks like the vaccine is methodically causing this spread into his body. He also reported that it feels warm outside of his left wrist, towards the edge of it and all the way to the joint of the little finger and he thinks the swelling will start again. He expressed feeling anxious about his reactions. He asked if there were any kinds of pills he could take to block the effects of the vaccine from working in his body. He stated it seems like it's going from one area to the next and it seems like it's going through his joints and he doesn't like that. His left wrist still got a little bit of soreness in the back near the joint, but doesn't appear to be swollen. Regarding the right wrist, he has recovered completely, it feels better; doesn't feel any soreness in any place and doesn't look swollen. The clinical outcome of right wrist twice as thick/left wrist started swelling recovered on unspecified date; left wrist painful/sore not recovered; right shoulder is so sore not recovered; left knee was sore not recovered; anxious was unknown; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap was unknown; left knee is swollen not recovered; arm was so sore unknown; carpal tunnel unknown; trouble walking unknown; right shoulder was swollen was not recovered. The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551521 same patient/reporter/drug with different AE/time gap.

dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of 79-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) on 31Jan2021 (reported as yesterday morning (Sunday)) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Jan2021 (reported as starting last night), the patient experienced dizziness/when he stands up, can't move right away. He has to wait until the dizziness goes away/dizzy feeling like he a concussion. This morning he was having the dizzy feeling like he a concussion. He wants to know, if this could be a side effect. He sat and waited for 15 minutes after with no reaction. The outcome of all the events was unknown. There was no product quality complaint (PQC) present. Information on the lot/batch number has been requested. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Two weeks and one day after receiving second dose of COVID19 vaccine, patient experienced extreme sharp pain in injection arm (left arm: injection site, shoulder and elbow) as well as muscle in opposite leg and hip that prevented him from walking. Pain has minimized since then (report is one week after incident) but patient still feels some minor pain, and says he will report to his primary care provider if symptoms persist for one week. Patient took aspirin for pain, which helped.

Patient presented to the ED with dehydration, elevated lactic acid and seizure, and was subsequently hospitalized for elevated troponin and seizure. This is within 6 weeks of receiving second covid vaccination.

Pt had 1st Pfizer Covid 19 vaccine on 3/5/21 and 2nd Pfizer Covid 19 vaccine on 4/2/21. He started to have mild muscle pain just before the 2nd vaccine and continued. Few days after the 2nd vaccine, his muscle pain got worse. He went to a pain clinic from 4/5/21 to 4/9/21. He stopped going there because his muscle pain got worse and he could not walk or move. On 4/16, he made an appointment to see Dr. (orthopedic) and Dr. could not see anything wrong with the X-ray. Dr. said he had a similar case with other patients and pain shots will not fix it. Pt saw PCP (his main doctor) on 6/7/21 and told him he still has muscle pain with muscle spasm and he cannot move or walk. PCP told him to exercise. Pt is still in serious muscle pain and he is homebound from 4/9/21 to now. He cannot walk or move. His symptoms have not improved at all. We do not know what to do because his muscle pain won?t go away for about 4 months now.

a shooting pain started up into his knee and it just aches all the time; It is irritated where he cannot wear a shoe now/He cannot get up and out of chair/ He cannot do anything; Everything was normal except for that same mass in his foot; he has a soft tumor on both feet/ the tumor is sticking out; his foot started hurting/his right foot is having pain/ the pain is starting to get worse; now I can't walk; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 09:00 (at the age of 79-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included foot tumor. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EL9265) via an unspecified route of administration, administered in arm left on 29Jan2021 09:00 as single dose for COVID-19 immunization. The patient reported he has a soft tumor on both feet/ the tumor is sticking out, his foot started hurting/his right foot is having pain/ the pain is starting to get worse, now I can't walk, it is irritated where he cannot wear a shoe now/he cannot get up and out of chair/ he cannot do anything, everything was normal except for that same mass in his foot on an unspecified date in 2021, a shooting pain started up into his knee and it just aches all the time on 26Apr2021. AE resulted to visit physician office. Patient is a consumer, asking what do I do or what can I take to make this pain go away. Patient reported that he received both doses of the Pfizer covid vaccine, his first dose in January and his second dose February 1. Patient reported that around the same time that he got his shots his foot started hurting and now I can't walk. Patient reported that he has a soft tumor on both feet but his right foot is having pain, the tumor is sticking out and the pain is starting to get worse. Patient reported that nothing works to take the pain away. Patient reported that he saw his doctor a while back but reports that back then the pain wasn't as bad, they did x-rays and nothing was wrong. Patient reported that now the pain is terrible. Soon after having the COVID vaccine shot in Jan 2021, patient started having foot problems on his right foot. Patient did have a preexisting soft tumor in that foot. It is irritated where he cannot wear a shoe now. Patient can't stand or walk on it. It is constantly aching. A couple of days ago, a shooting pain started up into his knee and it just aches all the time. Patient was wondering if this is one of the side effects. Patient wants to find out if it is caused by the vaccine. Patient had a x-ray three weeks ago, and there was nothing wrong with his foot. Patient had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Patient thinks the vaccine affected the mass. Patient can't walk on his foot it just aches. Patient foot became irritated in Jan 2021. It was irritating. It has worsened. The shooting pain up to his knee started 26 Apr 2021. Patient just drove to the hospital today to get information and the pain shot up a little bit today. Even when patient is sitting in a chair he has aching and shooting pains in his foot. Patient went to the store in pain. Patient cannot do anything, cannot get up and out of chair, can't turn around with his foot on the floor. The patient underwent lab tests and procedures which included x-ray was normal -he had a x-ray three weeks ago, and there was nothing wrong with his foot. He had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Outcome of the event a shooting pain started up into his knee and it just aches all the time was not recovered, and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.

Clients wife called to report adverse event. Wife reported client having episodes of lungs feeling like they are burning, experiencing shortness of air when walking thirty to forty feet, and elevated blood pressure at times of episode. Wife reported she has called primary care provider to let doctor know. Doctor referred client to see his lung doctor as soon as possible. Wife reports they are in another state working on their farm and is having trouble getting client to cooperate to go to doctor. Clients wife reported primary care provider recommended going to ER as soon as client experiences any of those symptoms again. Educated wife the importance of listening to providers recommendations. Clients wife reported client using his own CPAP machine when episode occurs and it does bring some relief to symptoms.

Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pressure declined, diarrhea, vomiting, injection sight swollen, disoriented, shakes, was freezing, uncontrollable bowls, unknown substance coming from mouth, loss of strength in arm

depressed; he was freezing and was shivering; he was freezing and was shivering; blood pressure was a little high; pulse was high; Nauseated; slept a lot; feeling tired; chills; high fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient wife). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: EN5318), intramuscularly, administered in Arm Left on 03Feb2021 08:00 as 1st dose, single for covid-19 vaccination (79 years old when vaccinated). Medical history included ongoing High blood pressure, additional Information for Other Conditions: Diagnosed years ago, ongoing CAC score high from 2018, ongoing urinary tract disorder from 2007- She said that he takes urinary medication, nephrolithiasis and also felt like it was like when he had a kidney stone. She said that he does not have a kidney stone. She said that he was really sick and hospitalized with the kidney stone. The patient's concomitant medications were not reported. Patient did not receive any other prior Vaccinations within 4 weeks Shingles vaccine, 2nd dose, No manufacturer or lot number at the time of the call, Intramuscular injection, Left arm 1 previous dose, given 2.5 weeks prior to the Covid vaccine at the beginning of Jan2021.It was reported that, Consumer called on behalf of her husband, who had his 1st dose of the Pfizer Covid vaccine last Wednesday morning (03Feb2021). He then started experiencing symptoms yesterday (on 04Feb2021) and last night he started feeling tired, had chills, high fever and muscle aches which was worried. She said that everything was ok until yesterday other than being tired, he had no reaction and no real soreness in his arm. Yesterday he was really tired and slept a lot and at about 20:30 he yelled out he was freezing and was shivering felt like it was like when he had a kidney stone, that he does not have a kidney stone. She said that his fever spiked really high, and he was treated with Tylenol and it came down. His highest temperature was 102. When he first got up this morning(05Feb2021), his temperature was normal, but within the next hour it went to 101.9 at 10:00, then to over 101, and then it came back down to 100. It maintained during the night, he had some muscle aches now, he was a little bit nauseated, but that has gone away also, and the Nausea did not last very long. The blood pressure was a little high and his pulse little high, but the blood pressure is better. His next appointment for his 2nd dose of the Covid-19 Vaccine is 24Feb2021. She said that he takes high blood pressure medication. urinary medication, and cholesterol medication. He had been a little depressed because of Covid and he is taking antidepressant medication, but it should be temporary. Therapeutic measures were taken Tylenol as a result of high fever, blood pressure was a little high, depressed. The outcome of the events Fatigue, chills and Nausea, feeling cold were resolved; for Fever, Muscle ache, pulse was high, Myalgia, Hypertension, Depression mood were not recovered, blood pressure was a little high was recovering was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

On 03/27/2021 I had the second dose and 3 weeks later I started to have a swollen hand and painful wrist and hand and I was unable to pick up things. I decided to go to the doctor and he gave me injections in the wrist and they did some x-rays. The second time I visited the doctor they diagnosed me with Rheumatoid arthritis in the hand and wrist in the same arm I had the injection. And they put me on prednisone.

AFib; His voice is hoarse today.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Feb2021 19:00 (Batch/Lot Number: EN6201) as dose 2, single for covid-19 immunisation. Patient age at vaccination was 79 years old. Medical history included ongoing COPD (chronic obstructive pulmonary disease), ongoing emphysema, ongoing high blood pressure (he couldn't say, it has to have been a good 15 years he has had it), ongoing high cholesterol (he had it for over 10 years), ongoing Low red blood cell count (depending on his blood count, they give him either a Vitamin B shot or Procrit), ongoing idiopathic pulmonary fibrosis. Both of his parents had type 2 diabetes, and he had type 2 diabetes. Historical vaccine included 1st dose of BNT162B2 (Lot no: EL9263) on 25Jan2021 at 19:00 in left arm for COVID-19 Immunization and flu shot back on October for immunization. Concomitant medications included prednisone (It was for his lungs (unspecific). It was prescribed by his lung doctor. It affected the immune system. He took 10mg. He was taking 5mg then they changed it to 10mg about a month ago. He had taken it for maybe 1 and a half to 2 years); epoetin alfa (PROCRIT) taken for red blood cell count decreased, he only took it as needed when his count was below 10. He had not taken it in 6 months; losartan taken for high blood pressure, from May2021 and ongoing (It was new, he started it about a month ago); amlodipine taken for high blood pressure from May2021 and ongoing (He had been taking it for about a month); atorvastatin taken for blood cholesterol increased from an unspecified start date and ongoing (He had taken it for a couple years); nintedanib esilate (OFEV) taken for idiopathic pulmonary fibrosis from an unspecified start date and ongoing (He had been on it for about a year). The patient experienced AFib on an unspecified date with outcome of recovered. His voice was hoarse today (21Jun2021) with outcome of unknown. He stated he spent 4 days in the hospital and got his rhythm back to normal after 2 days. They put him on apixaban (ELIQUIS), which was a blood thinner. The AFib has resolved, he had no problem with it anymore. The patient underwent lab tests which included COVID-19 antibody test: negative on both 09Jun2021 and 16Jun2021. His HCP told him it was due to prednisone that lowers his immune system.

Chronic Orthostatic Hypotension; Chronic Pain in the Arm that got the shot still; Dizziness; Cannot walk without support and fall to my knees to prevent falling; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 12:00 (at the age of 79-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included seizure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included midodrine; levetiracetam; doxazosin; finasteride, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right in Feb2021 at 12.00 (at the age of 79-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation. Since 15Apr2021, 12:00 PM, the patient experienced chronic orthostatic hypotension, chronic pain in the arm that got the shot still, dizziness, cannot walk without support and fall to my knees to prevent falling. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hosp, Disability or permanent damage. The patient was hospitalized for 10 days. The patient received treatment for AE, adjusted medications. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. Information on lot/batch number has been requested.

1 significant episode of asymptomatic Supraventricular tachycardia; transient ischemic attack; seizure-like shaking; shaking episode arms going up and down; extremely tired; This is a spontaneous report from a contactable physician (patient himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) at the age of 79-year-old male as single dose for covid-19 immunisation. Medical history included ongoing diabetes type two from 30 years, ongoing hypertension from 15 or 20 years ago, depression from 20 years ago, hyperlipidemia from 15 to 20 years, orthostatic hypertension (had it off and on for years; but it got bad in the last couple of months), pain and radiculopathy. Concomitant medication included metformin (1000 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); glipizide (4 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); lisinopril (10 mg) taken for hypertension from Mar2021 and ongoing; duloxetine (60 mg) taken for depression and pain from an unspecified start date and ongoing (taking for years); gabapentin (NEURONTIN) taken for radiculopathy, start and stop date were not reported. The patient previously took flu shot for immunization and took dose 1 of bnt162b2 in Jan2021 for Covid-19 immunization at the age of 79-year-old. Physician was calling regarding the Pfizer BioNTech COVID 19 vaccine. He had a very strange experience; added he was a physician and in reasonable good health. He had mild side effects, not much; the one side effect he did have was one week after the second shot he and his wife both felt extremely tired the whole day from Feb 2021. Physician mentioned that 4-6 weeks after getting the 2nd dose, he had a 3-5 minute episode of seizure-like shaking, shaking episode arms going up and down on 21Mar2021 and that he was just blankly staring and non-responsive. He had no other symptoms to suggest a seizure; no biting; no urination. This episode lasted three to five minutes. During the episode his wife said he was just staring ahead and he was non responsive to his wife who was only six inches away speaking to him. Then he started to vaguely he heard his wife's voice in the distance and then he woke up and then he was fine. Later that day he was hospitalized, they did a work up and discharged him about 4 days later. While in the hospital he thought he had a Blood work, CAT Scan; MRI; holter monitor; EEG but they were all normal. He had no other complications and the effect completely went away. Adds he was completely recovered when it went away. At discharge they put him baby aspirin, 81mg enteric coated aspirin once daily, and gave him a tentative diagnosis of transient ischemic attack (TIA). This further resulted to being hospitalized for 3 days but his physicians were not able to see anything significant on his MRI, 72 hours EEGs and telemetry tests (everything was normal). However, during his out-patient visit, his physician mentioned that he had 1 significant episode of asymptomatic Supraventricular tachycardia that may be causing the seizure (inconclusive). They further specified to him that it was not much of a tonic clonic seizure. He also verified that he only had 1 episode of the mentioned event, no other side effects experience and been feeling fine since then. After discharge he had a work up on the outside including a 72 hour EEG; 72 hour holter with the only thing that was abnormal that one run of 3 beat supraventricular tachycardia that was asymptomatic. His doctor put him on Metoprolol 12 mg once daily at night by mouth to help prevent arrhythmias as well as control his blood pressure. He had previously taken lisinopril. He added the only thing he knew that he never had anything like this before in his life. Patient mentions he was at a good weight now as he lost 40 pounds last year for his daughter's wedding. He added sometime in the last 6 to 8 months he had severe left side radiculopathy and was taking small dose of gabapentin. He did not remember if it happened before or after the vaccine but he went to see a pain specialist. The medication worked and he tapered it down and discontinued it. It may have been before the vaccine, he is unsure. But the medication worked like a miracle as he had intractable pain down his leg. All events resulted in emergency room. In line with this, he would like to know in relevance to the news of Pfizer releasing a possible booster dose, if there are any reports of anything that may be related to seizure and/or Transient ischemic attack (TIA) of cardiac origin or a like. Extremely tired was reported as non-serious, other events was serious and caused hospital from 21Mar2021 to 24Mar2021. Outcome shaking episode arms going up and down was recovered on 21Mar2021, of extremely tired was recovered in 2021, of other events was unknown.; Sender's Comments: There is no reasonable possibility that the events supraventricular tachycardia, seizure, tremor, and transient ischemic attack happening 4-6 weeks after vaccination were related to BNT162b2. It is more likely to be complications of pre-existing conditions of hypertension, hyperlipidemia, and diabetes. Advanced age may have been contributory as well. 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.

79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission

Development of Bells Palsy approximately 48 hours after initial (dose 1) vaccination with Pfizer vaccine.

I received a call from the pharmacist at the clinic at 10:30 am on 1/8/2021, to let me know that a staff member at the facility we were at on Tuesday 1/5/2021 developed Bell's Palsy on 1/7/2021. Half of his face went numb and they feared the patient had a stroke. They rushed the patient to urgent care where it was determined it was Bell's Palsy and NOT a stroke. The patient is back home and recovering well.

shaking, altered consciousness Narrative: One day after pt received his first covid vaccine, pt experienced upper extremity shaking leading to ED visit and subsequent hospitalization with concern for seizure. Examination and labs were not consistent with seizure. He had features of lewy body disease and parkinsonism. Labs were significant for leukocytosis, but pt had no other signs/symptoms of infection or findings to indicate a source of infection. Pt referred to Neurology.

Tiredness, loss of appetite, coughing, nausea, Arm ache, excessive thirst, some sweating. NO high temperature.

Hypoxia; Shortness of breath; Viral pneumonia; COVID-19; Weakness. COVID+ 1/7; Pt had Telephone encounter 1/1 reporting mild symptoms (fever, cough). Possibly infected prior to vaccination; still admitted

Patient reports intermittent left land paresthesias lasting about 10 minutes with a glove distribution just in the hand initially on 1/16/21. On 1/18/21, patient had symptoms lasting about 4 hours and could not pick up objects. By the time he came to the ER for this, symptoms had resolved. On Tues, 1/19, patient went skeet shooting and experienced an episode of numbness involving the entire left arm from shoulder to fingertips, involuntary hand movements, and left cheek twitching. These symptoms lasted about 10 minutes. Patient also reported dysarthria, slurred speech, strange sensation on left side of face, and facial asymmetry. His wife reports his voice was a whisper and patient's left arm was dangling at his side. Reports voice feeling weak along with these symptoms.

Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."

1:32 Shivering and fatigue, chills; BP: 132/35, O2: 97%, HR: 70, Temp: 98.4, Med team alerted; Non-verbal at baseline, hands cold, wearing gloves; (Given warm compress for hands) 1:43: Back to baseline per family, BP: 131/54, MAP: 67, continued observation 1:50: Observation ended, left with 2 family members

he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the virus; My eyes are hurting; no matter which way I turned it was hurting, knees, everything was hurting really bad/aches and pain; dizzy/dizziness; weak; muscle pain; joint pain/back knees elbow joint pain; fever; headaches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, lot number EL1283) , via an unspecified route of administration on 17Jan2021 01:15 at single dose for covid-19 immunisation. Medical history included open heart surgery 11 years ago, covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient received bnt162b2 yesterday, with no problems. However today (18Jan2021), in 15 minutes after waking up at 11, he had the chills really bad, that went away, then he went to sleep again and woke up and he had all the symptoms on the paperwork, he had dizziness, headache, he's hardly ever had a headache ever. He had aches and pain. Caller states that he was just asking right now about another company, and their vaccine in started with an M, and her daughter is at a girls home, because she has a epileptic type thing, and this particular shot, that started with M, the nurse called over, and the problems that he is having he explained to the nurse is like when he had the virus previously about in Jul2020, when he had the virus he was in hospital for a week, because he had to get rid of the virus, and they got him out of that. Now he took this shot yesterday and the next day is when he got all these symptoms, he's tired, cant walk, muscle pain, had chills not any more, pain in the knees, everywhere really, he couldn't get any position to go back to sleep, his back knees elbow joint pain. Since he had these things, the nurse at the girls home, told his wife if having these problems he can take 300 mg of Zinc, 1000mg of Vitamin C, and 2000IU or Vitamin D, the same thing, that amount, he asks will it over come the symptoms. Another person felt good after getting those, it helped him he does state however that is what the person took when he actually had the Covid 19 Virus. Caller states that he received paperwork after the vaccine from the (State), it has a bunch of blocks asking if he has this or that symptom. His First dose was 17Jan2021 at 1:15, then on 07Feb2021 if this Second Dose. All the side effects started Today 18Jan2021. His doctor said he's in good health. He did have open heart surgery 11 years ago. The patient reported he is 5 feet 8 and a half inches, he is shrinking. He stated, "I was good until this morning, it hit me like I had the virus. The product they gave me at the (State) was the Pfizer-biontech vaccine. I had all the symptoms except vomiting/throwing up. I got all the other symptoms. no matter which way I turned it was hurting, knees, everything was hurting really bad. I was dizzy and weak so I don't want to walk around too much. I had muscle pain, joint pain, fever, headaches, chills, never went away. I hurt everywhere. I am really weak. My eyes are hurting. My daughter is in a girls home (paralysis problem). They had the vaccine from the another company and they have heard so many negative stuff so they decided they did not want to, when my wife told her I was having these problems. I had the virus 4 months, the nurse told me to take 300mg of zinc, 1000mg vitamin C and 2000mg vitamin D (the person took that when he had the disease). Should I take this stuff? Is there any information on that? what's in this? protein? my wife got the disease. They said she had enough antibodies. How long is the immunity? When does it start?" The outcome of the event chills was resolved, of other events was unknown.

Noticed facial drooping on the left side starting on Friday night and symptoms increasing. Went to urgent care on Monday morning. facial drooping increased over the weekend also lift eye was irritated from lack of moister and did not close or blink without extra effort. wore a patch and lubricated over the weekend. Diagnosed as Bellys Palsy at Lander urgent care medical clinic. Prescribed course of prednisone. Also Erythromycin op mgigm oin akor for the left eye and wear a patch until eye will blink and close normally.

Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.

On the 3rd day after vaccination, the patient developed mild malaise. As the day progressed, there was increasing difficulty moving and talking. That night the patient began hallucinating,. Later at night the patient awoke and couldn't move at all. By the morning, things were better and patient could get out of bed and eat. Ity sounds like a dopamine reaction which the aptient has previosuly expeicned, however, there was no irregularity in L-dopa dosing.

Bell's Palsy right side of face; This is a spontaneous report from a contactable physician and consumer. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via intramuscular first dose on 12Jan2021 14.00 at a single dose for COVID-19 immunisation. The patient medical history included DM (diabetes mellitus), hypertension, CAD (Coronary artery disease) and Atrial Fib (Atrial fibrillation). The patient concomitant medication was not reported. The patient visited physician office and it was reported that patient experienced bell's palsy right side of face on 27Jan2021 06.00. The patient did not receive therapeutic measures for the event. The patient did not have COVID prior vaccination and not tested COVID post vaccination. The patient had not received any vaccine in four weeks (as reported). The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNt162B2 on reported event 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.

At 1200 it was noted resident had a small emisis. Resident responded minimally to this writer verbally and does track writer with his eyes. Respirations are noted to be labored. Respirations 32. Mouth cleaned, no obstruction noted. Oxygen applied via nonbreather at 5L. Temp 91.3, pulse weak and thready, BP 98/50 on R)arm, Pulse 90. Resident is very weak, pale diaphoretic. Resident shaking and jerking. Initially unable to obtain pulse ox. Emergency services contacted. At 1212PM BS 135 BP to R)arm 108/68, Sats 99% on 5L nonrebreather, respirations are even and unlabored 18. Resident is noted to open eyes and communicate. Dr.is notified and okays sending resident to ER. Wife notified of pt condition by staff she will meet at ER. EMS arrives and transports resident to ER 1223 and RN gives report to the ER.

Later in evening I had intense muscle pain in legs and chills. It progressed later in that day to a piercing headache and 100 degree fever. Ibuprofin helped to lessen the pain. The following day the pain was greatly improved but I was very lethargic and tired.

Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and released home. Pt and his son exited the building and when they got to the car, the pt shouted out "oh no!" and collapsed to the ground. The patient was unconscious experiencing agonal respirations, and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival, he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads "Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm. Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture. Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag. Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation." The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021.

Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient found unresponsive sitting in recliner and breathing. Vitals normal. After 5min sternum rub patient became conscious and stated he could hear being spoken to but could not respond. Felt weak rest of the day. Although this occurred several days later there were 3 patients at same facility experiencing similar issues on same day

Pt experienced chest pain while waiting in line for vaccine. 5 out of 10 chest pain persisted post vaccination. Reported feeling nervous, anxious, cold sweats. Pt with hx of HTN, on cardizem. Denied hx of afib. Denied other past medical hx. Pt with elevated BP 160s with labile pulse, ranging from 30-80s. O2sat 99%. Pt escorted to ED.

Fever (up to 102 F); headache; mental confusion; lack of responsive speech or delay in responding to questions. Symptoms began around 11:30 a.m. on Feb. 21. Administered one Tylenol at 2:30 p.m. on Feb. 21. By 6 p.m. on Feb. 21, the fever and headache abated. But confusion and lack of speech continues to Feb. 22 (10:30 a.m.) as I prepare this report.

1st dose vaccine 1/30/21; 2nd dose vaccine 2/20/21; new onset weakness 2/21/21; fell at home and seen in ED and admitted to hospital 2/22/21 Dx on admission: 1. Hypoxia 2. Elevated troponin 3. Elevated brain natriuretic peptide (BNP) level 4. Generalized weakness 5. Closed head injury, initial encounter

Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.

sudden extreme pain in right shoulder radiating in arm pit and to clavicle area. Unable to extend or lift right arm and no strength to lift object. Felt swelling in nymph node area under arm and in neck. Totally immobile arm on day 8; improvement and dissipation on day 9. Today, day 10 no after effects; back to normal. Treated the pain and discomfort with Tylenol extra strength.

2-22-21 JOINTS ON RT SIDE PAINFUL - NECK, SHOULDER, ELBOW, WRIST, HIP AND KNEE. HAS BEEN TAKING TYLENOL AND USING ICE PACKS WITH TEMPORARY RELIEF - ADVISED TO CALL PCP FOR EVALUATION 2/23/21. 2-24-21 8:30AM TC - PT STATES HE FEELS BETTER TODAY. PCP GAVE HIM A STEROID SHOT AND RX FOR PREDNISONE.

Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.

Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair ×2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. The peripheral blood leukocyte count measured 3.5 x10e3/µL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/µL. A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. Total CK measured 1424 U/L. The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness. He was taken to the hospital by emergency medical services. A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/µL for an ANC of 0.8 x10e3/µL. Hemoglobin was 8.1 g/dL and platelets 111 x10e3/µL. A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. AST was 174, ALT 91 and alkaline phosphatase 93 U/L. The lactic acid level of the venous blood was 2.1 mmol per liter. A repeat total CK was 4631 U/L. Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. LDH measured 838 U/L. A ferritin level was 3464 nanograms/mL. A test for COVID-19 (SARS-CoV-2) was negative. A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. A head CT showed no acute abnormality. An abdominopelvic CT without contrast was limited by motion artifact. No acute intra-abdominal or pelvic finding was noted. Nonspecific soft tissue stranding was seen in the right inguinal region. There was no soft tissue gas or drainable fluid collection. Cultures of specimens of the blood were obtained. The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. The E. coli isolate has since been determined to be pansusceptible. A MRSA PCR of the nares was negative. He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25. Surgical consultation was pursued. They did not feel that he had necrotizing fasciitis. The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.

weakness, fall Narrative: Pt with history of CAD (s/p PCI mid and prox RCA in 2006, on ASA/Plavix; CABG, AVR), afib, GERD, HTN, HLD, hypothyroidism, BPH, diverticulosis, aortic stenosis, small fiber neuropathy (since 2010), lumbar stenosis at S1. Also, pt presented to outside ED on 12/26/20 for increasing falls and weakness over one week and was admitted to outside hospital 12/26/20 for generalized weakness, dehydration, hyponatremia all secondary to covid 10 infection. Hospital course included sepsis due to covid 19, elevated liver enzymes, acute kidney injury. Pt discharged 12/29/2021. After first COVID vaccine 2/12/2021, patient experienced fever x 1 day, weakness, and fall. Presented to outside ED 2/13/21 abd was admitted for critical illness myopathy 2/2 recent COVID infection +/-COVID vaccination. Pt was discharged 2/18/2021.

'Severe stiff neck from 2/4 to3/10, with shoulder muscle aches, vague headache, and slight "fuzzy" feeling and fatigue. By 3/1, I also had thigh and buttock ache with effort and left TMJ pain. On 3/2, I saw Dr. My sed rate was 24. She made a diagnosis of probable PMR and prescribed prednisone. After I single dose, my symptoms almost magically abated and I was almost normal. On 3/11, the only residual symptom with soreness with with extreme neck rotation. On clinical grounds, this confirms the diagnosis of PMR. I assume treatment will continue for several weeks.

79 yo woman received Pfizer Covid vaccine #1 on 2/23/21. She has been experiencing diffuse body pain-especially her hands. Patient had a ground level fall requiring sutures for a head lac on 1/25/21. The diffuse body aches and pains seem to pre-date the vaccine. Certainly, vaccine related reactions such as myalgias can be expected from the vaccine and may have exacerbated her symptoms. MD recommended, based on the above, for patient to receive the 2nd dose of Pfizer vaccine. However, patient can be reassured that she can safely get the second covid vaccine to finish her immunization. She may take pain medication as needed after the vaccine is given to relieve pain.

Pt presented to the ED with right-sided facial drooping and was diagnosed with Ball's Palsy. Pt was prescribed prednisone in the ED. Evaluated today at our office and was prescribed valtrex. Currently experiencing right eye dryness and irritation.

Muscle ache; Spasms/buttock spasms/ muscle cramps; Injection site hurt; walking difficulty; walking painful; both legs are hurting; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3242), via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 80 years-old) as a single dose for COVID-19 immunization. Ongoing relevant medical history included myopathy, neuropathy, neurological issues, and chronic pain. Additional medical history included the patient also had spinal cord surgery several years ago and sensation issues for a lot of years. The patient's concomitant medications were not reported. On an unknown date the patient experienced muscle ache, muscle spasms, injection site hurt bit, walking difficulty and walking painful. On 10Feb2021 the patient experienced both legs are hurting. The patient reported that they had the first vaccine on the 06Feb2021 and the injection site hurt a little bit and a couple of days went by and then the patient had the muscle aches and all of a sudden it was severe with muscle cramps and spasms from the buttocks down the leg on the left side. The patient stated that now both legs are hurting a lot from about 10Feb2021. The patient stated that he could barely walk and it was very painful to walk. The patient stated he was using a walker, cane, and holding onto objects when walking. The patient said it is a little better, but the patient still has to take baby steps and the patient is currently having a buttock spasms. The patient stated they have the second appointment 27Feb2021 and the patient is leery of taking the second dose as the patient has not been able to function for the last 2.5 weeks and is not sure about getting the second dose. The clinical outcome of the muscle ache, injection site hurt, walking difficulty, walking painful and both legs are hurting was unknown. The outcome of the event muscle spasms/buttock spasms/ muscle cramps was not recovered.

Shaking Uncontrollably, Sweats, Dry mouth, sore all over, injection site was swollen, memory loss, confusion

During the evening of March 26, 2021 at home I could not pronounce words to describe something on TV. This condition lasted only a few minuted.

Received 1st Pfizer dose 3/2/2021, on 3/4 pm he started not feeling well. On 3/5 he slept through the day and was not feeling well. He reported his legs and back were hurting, and he had difficulty walking due to problems with his balance. He got up at 9pm and fell in the bathroom. He was dizzy. His wife assisted him back to bed. He was not able to sit, he would fall over. On 3/6 his balance was still off. His wife assisted him to the car and took him to the Hospital. They treated him for dehydration and discharged him. On 3/7 he developed a rash over his body, "big red spots". 3/8 his wife called the physician , who saw him the following day, on 3/9. He was advised not to take the 2nd Pfizer vaccine. The rash lasted 5-6 days. At the time of this report, his symptoms have resolved. His wife reports she completed a VAERS. His report number is 346254

Woke up the day after the vaccine was administered (2nd Dose) and legs were weak ("muscles felt like jelly"). The next day I developed aches in lower extremities. The third day, I went to the emergency room and was given a muscle relaxer. This has not relieved the pain. The pain has now moved into my ankle joints and it is very painful to walk. I visited my doctor on the seventh day and was given a pain killer, Meloxicam (15mg), and this is relieving some of the pain when I walk.

Patient, of 80-year-old male, with significant past medical history of hypertension, paroxysmal atrial fibrillation, hyperlipidemia, coronary artery disease s/p stent, and BPH. Patient comes from urgent care after being found hypoxic. He refers that for the last 3 weeks felt weak, with loss of appetite and poor oral intake. He went to a to the urgent care to get it evaluated and he could get some IV fluid because he felt dehydrated. Patient refers that in the past when he gets severely dehydrated had episodes loss of conscious and this time he wanted to avoid that. He states that on February 4th got tested positive for COVID-19 because his fiancee tested positive the previous day. He quarantined and was asymptomatic. On February 27nd got first dose of COVID-19 vaccine. But since he tested positive feels that has no energy. Besides this patient denies fever chills shortness of breath, chest pain, abdominal pain, diarrhea nausea, vomiting, headache, lightheadedness, loss of sense of smell or taste.

Fever for 3 days, Shortness of breath and Weakness increasingly, Dizziness, became very pale, and so on... Visited PCP on March 24, 2021 . Blood work showed 4.8 Hemoglobin. Was hospitalized on March 25, 2021. Diagnosis - Autoimmune Hemolytic Anemia due to IgG.

My Husband and I received the same day a strong pain in our left arms. The next day my husband complained about pain in his entire body and weakness, and I had the same. In the evening he collapsed falling out of his wheelchair. He tried for an hour to sit down back in his wheelchair with my help, but he couldn't. He agreed that I call 911. Two nurses took him to Emergency Room at Hospital and didn't allow me to go with him. In the morning on Saturday, he was transferred to Room at Hospital and the next day to the Intensive Care Room, where he sadly passed away on Tuesday April 13 at 4:22 am.

At some time after the vaccines were given I started having muscle aches and pains throughout my body. Thighs, calves, butt, hips, biceps, forearms, and inside area between bicep and lower arm (opposite side of elbow) which would keep me awake at night due to the pain. That pain was only at night, the other pains were during the day and most times would last the whole day, but other times would lessen as the day went on. I still cannot sleep on my left side, due to hip and arm pain, but the very painful left arm pain persists as described above even when sleeping on my right side. I still have these pains as of the date of this writing, April 17, 2021.

Patient has left arm numbness after his 2nd pfizer covid vaccine. He states that exercise helps. It is not a pins/needles feeling, but more of a whole arm numbness, Patient reports that it happens every other day. Pt states it did not happen between his first and second dose; it started only after his second dose.

Presented to ER via private vehicle with complaints of general malaise, weakness, "not feeling good" beginning the morning before (04/16/2021), complaints not more specific. Associated symptoms included encephalopathy, lethargy, anorexia, progressively unsteady gait. Wife denied nausea, vomiting, diarrhea, fever, bloody stools, difficulty/painful urination. Diagnosed with thrombotic thrombocytopenic purpura with an initial hemoglobin of 4.8g/dL, hematocrit 14.2%, platelet count 6000uL, PT 12.2sec, INR 1.2, BUN 75mg/dL, creatinine 2.4 mg/dL, total bilirubin 3.3 mg/dL, direct bilirubin 0.60mg/dL, troponin 3.81ng/mL, and ADAMTS13 activity <2.0. He received 2 units PRBC, 2 units platelets, and plasmapheresis was initiated. As of today, he has had 5 consecutive days of plasmapheresis. Repeat laboratory evaluation this morning hemoglobin 8.8, hematocrit 28.4, platelet count 97000, BUN 35, creatinine 1.5, total bilirubin 1.3. Now awake, alert, and oriented. Eating and ambulating with physical therapy

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild

Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins. Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure. Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP. Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021.

Pain in my right arm and shoulder, pain in my right wrist, paiin my my thighs and hanstring, pain in my kness

Reaction was more intense, but of shorter duration than the reaction to the first shot on 4/15/2021 (lot # ER8729) I experienced weakness, dizziness and remained in bed until 5 PM on Saturday 5/8/2021, the day after the shot. This time, there was no pain, swelling, or redness at the shot location on my right arm. I experienced a loss of appetite, slight headache and some groin aches through most of the day on Saturday. I'm feeling much better today, Sunday 5/9/2021. Side effects from the first shot lasted a full two days

Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd COVID vaccination on Feb 26th when he began to have bilateral knee and LE pain. He then was having difficulty walking for a couple of weeks. The leg pain was not constant, but he did fatigue easily with walking. On 3/11 he had his lower dentures placed and that evening/early morning of 3/12 he apparently fell. Patient does not remember anything about the fall - he cannot recall when he fell, how he fell, or any of his symptoms leading up to the fall. Patient remembers being on the floor and attempting to get up but was too weak. He has rug burns on his forearms from attempting to get up. He was hospitalized on 3/13 for dehydration, traumatic rhabdomyolysis, and w/u following fall. Despite very stable labs prior to 1st dose of vaccination on 2/5/21, following vaccination he has had significant and substained leukocytosis as well as transfusion dependent anemia that has not resolved at the time of the reporting (5/13/21). He remains at a skilled nursing facility due to debility.

Two right MCA ischemic strokes occurring 3-5 days after each dose of Pfizer vaccine. Both episodes he presented with by waking up with acute left arm weakness, numbness and dysarthria. Both episodes happened a few days after COVID vaccine (Covid #2 was administered 4/27). Previous Right MCA stroke from 4/11 was fully worked up. The etiology of this stroke was cryptogenic. TSH from 4/11 was 2.57 and T4 was 0.69. Hgb A1c on 4/11 was noted to be 5.6%. LDL on 4/11 was noted to be 73. MRI brain 4/11/2021 showed multifocal small acute infarcts in the right cerebral cortical/subcortical and periventricular matter infarcts, favored to be embolic. CTA head and neck from 4/11 showed no evidence of large vessel occlusion. Ultrasound of bilateral lower extremities on 4/12 was negative for DVT. ECHO on 4/12 was positive for PFO with an WF > 55%, mild LVH and no thrombus. He also has an atrial septal aneurysm. Cardiac MRI was negative for thrombus. He was discharged on 4/14 with 30 day Holter monitor to evaluate for AFIB.

dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Arm soreness after each dose was given/ Severe pain in legs; was 187 pounds and now down to 170; fell and busted his spleen; fell and busted his spleen; started peeing; developed blisters in his mouth and on his tongue; developed blisters in his mouth and on his tongue; Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine; mouth was also full of saliva, started slobbering and couldn't stop; Pain in shoulder/ Severe pain in joints; Severe diarrhea; having problems with words; had some problems with his balance; couldn't hardly walk because of his balance; Has no taste of food; Mouth Burning; break out with bumps around mouth; Scrotum blood blisters; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in left arm on 17Apr2021 (Batch/Lot Number: EW0171) as 3rd dose, single for covid-19 immunisation. Ongoing medical history included diagnosed with vertigo 5 years ago but had vertigo long before that, diagnosed with COPD, emphysema, asthma 12 years ago, Congestive heart failure after having a heart attack in Nov2018, stomach problem (had gastric bypass back in the 80's), had Pacemaker in 2020. Patient does take medications, but is unable to provide details. Patient received flu shot in Nov2020. No Prior Vaccinations within 4 weeks. Patient had first dose on 02Feb2021, second dose on 05Mar2021, and Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine on 17Apr2021. He had gone to Vaccination facility to get a B12 shot and the staff messed up and gave him the Covid-19 vaccine. He states he had arm soreness after each dose was given. On the night of 17Apr2021 after the third dose, pain in his shoulder began, the pain lasted about 3 days and had intensified a little more from the previous dose of the Covid-19 vaccine. When he woke up on 21Apr2021, his mouth was also full of saliva, he started slobbering and couldn't stop. On 22Apr2021 or 23Apr2021, he began experiencing severe diarrhea he began and having problems with words, he knew what he wants to say but it just doesn't come out. About 23Apr2021 or 24Apr2021, he began experiencing problems with his balance. He had vertigo for a long time and has always had some problems with his balance, couldn't hardly walk because of his balance, but the problems with his balance have intensified to where he needs someone to help him stand up now. On 24Apr2021 when he first gets up in the morning, he developed blisters in his mouth and on his tongue. On 27Apr2021 he began having problems with control, and started peeing all over himself, he didn't take his water pill on 27Apr2021 because he was going out and he still peed all over himself, he has been wearing adult diapers so that he doesn't mess himself again. On 04May2021 night, he fell and busted his spleen. And on an unspecified date in Apr2021, has no taste of food, Mouth Burning and break out with bumps around mouth. Scrotum blood blisters. Severe pain in legs and joints. He was 187 pounds and now down to 170. Patient received fourth injection on 21Apr2021 in left arm, but he is unsure if he received a B12 shot or something else. Attempts were made to clarify if the patient received 3 or 4 doses of the Covid-19 vaccine. Patient had blood tests, an EKG, and X-rays with unknown results, his heart looked good. The outcome of events was unknown.

his neck was stiff; it was very, very cold; a lot of pressure on his eyes; pain in arm the injection was given in; I got a lot of headaches and I still have them./unbelievable headaches; More back pain than usual; My blood pressure went up a little bit but not much; This is a spontaneous report from a contactable consumer (patient). Follow-up information received on 17Feb2021 was processed together with initial information. A 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: UNKNOWN), via an intramuscular route on 08Feb2021 (at the age of 80-years-old) as single dose in the left arm for covid-19 immunization. The patient medical history included and back pain. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced blood pressure went up, More back pain than usual and on unspecified date experienced Stiff neck, Headache, pain in arm the injection was given in, pressure on his eyes, cold. The clinical course of the event was as follows: blood pressure went up a little bit but not much. It was reported that blood pressure was up which he was told by the nurse was normal. It was just a little bit high. The nurse at the facility said it was not that concerning and that it was fine. The facility let him stay a half an hour and then he was able to driven home. He hadn't wanted to stayed long because it was very, very cold. He had a lot of back pain. He does have back pain all the time, but not that much. It was more back pain than usual. The pain in his back increased/doubled, and the pain is still high. He clarifies he has had problems with his backed and have had backed pain normally, but after the shot it was liked a lot of pain in his backed and his neck was stiff very, very stiff hasn't knew if it's from vaccine or what. Patient stated that before the vaccine, he was okay and was able to worked in his house and outside. He believes the stiff neck began after 2 or 3 days of receiving the vaccine and it have had worsened. Patient stated that pain in his armed where he received the shot went away completely. He clarifies further the pain in his armed went away the second day. He got a lot of headaches and he still had them. The headaches began right away, and the headaches still c continued. He mentions the headache got a little better last night. He was really worried about it and hadn't knew what to did. It was reported that he told his son everything and his son said to not went to hospital because there was a lot of people that had been in contact with covid and it's going to have been worse. He states his son told him to drink a lot of water and saw if he got better. He did that and he did got a little better but not that much. Patient mentions that he had a lot of pressure on his eyes. The patient did not went to emergency room because he was told it was normal to had headaches but they went away and his should went away in 2-3 days. His armed where he received the vaccine was also okay the next day. The patient did not visit to physician office. Patient mentions that he took blood pressure medication, and everything was under controlled and he took 10mg of a cholesterol medication. Patient declined to include these medications for the report, stating he gave all of this information at the facility he received the vaccine at. He had to filled the paperwork out. He confirms he hasn't had any NDC, lot number or expiry date for these medications at this time. It was reported that patient had a blood tests done about 3 weeks before he received the vaccine and the doctor said everything was okay at the time. The outcome of the events headache was recovering, backed pain and neck was stiff was not recovered and other events was unknown.

Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol. He states he feels like he has no power when he walks. No chest pain. No fevers. He also notes slight diarrhea. Patient denies any Covid contacts. There are no other modifying factors or associated symptoms

Headache; I was weak; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiry Date/ UPC/ NDC number: Unknown), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for covid-19 immunisation. Patient's age at vaccination was 80 years. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient experienced headache and i was weak on 02Mar2021. Additional Context received as, the patient stated, "I got the vaccine, I got the first shot last month and I got the second shot on 01Mar (clarified as 01Mar2021), and I feel nothing on the 02Mar2021, I was okay. Then on 02Mar (not clarified), all of a sudden, I get a headache, not so bad but still a headache and today, in the afternoon, I was weak. I thought I had a fever but I have no fever, I just have a headache but now it is going away. Today, when I wake up, it was fading away and I got it in vaccination facility. When probed to clarify if consumer want to know that headache wais related to the Covid vaccine, consumer stated, as yes. For treatment in response to events, the patient stated, that was yesterday, today, I feel little better. No, I did not take anything. Outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.

Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 07:30am, at the hospital, (at the age of 80-years-old) as single dose for Covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin (about 21 years old, Inflammation and redness, system gets flush), sulfonamide derivatives. The patient previously took aspirin (e.c.), keflex, sulfur, cellcept and experienced hypersensitivity to all. Concomitant medication included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient had inflammation on face, red as a beet, (dermatitis) (non-serious) on an unspecified date with outcome of unknown , malaise (non-serious) on an unspecified date with outcome of unknown, had arm hurt, left arm (pain in extremity) (non-serious) on an unspecified date with outcome of unknown , headache (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , dizziness (non-serious) on an unspecified date with outcome of unknown. The clinical course was as follows, at about 4pm the patient went outside, he "felt flushed, but didn't look in the mirror a friend told me to put sunblock on. I looked at my face and saw my face beet red. I just laid down, my arm felt bad, like a Charlie horse, like someone smacked me in the arm." Caller states his symptoms are, "basically inflammation through the body, then headache, weakness, dizziness, malaise, one good thing, no fever or nausea. Some uneasiness, vacillation, physical weakness. The patient don't drink alcohol, drink water and took Tylenol after the vaccine. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.

Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordinarily sleepy, stopped gregarious talking and only responded to questions asked, became extremely confused, eventually losing his ability to walk, talk, and swallow. All occurring in short order. ER twice, hospitalized twice, rehabilitation twice. As yet, no formal diagnosis despite three hospitals seeing my father and testing him extensively.

R29.810 - Facial droop I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) J18.9 - Pneumonia, unspecified organism

Approximately one month after second dose of Pfizer injection patient began to have shoulder joint pain, progressing to hand and then opposite shoulder. Has persisted greater than 3 months. New onset/diagnosis rheumatoid arthritis, connective tissue disorder. Patient states he has had similar pain and swelling in joints in the past that resolves quickly, however states this pain and swelling is severe and persistent now three months

Pt had a spontaneous brain hemorrhage, leading to his death. Pt was found by his wife at approximately 0800, slumped over in the corner of the room, pt was brought into the ER unresponsive. Pt died 4 hours later.

Extreme tiredness, aching legs, pains across whole of chest, swollen left foot, shortness of breath , "pins and needles" in bothe hands at the same time as each other, loss of balance when walking, stomach pains only in the evening after eating a Small amount of food as I have put on weight recently even though I am eating the same amount ( less recently as above) as normal for the last 70 years.

81-year-old male with a history of stage IV renal disease, breast carcinoma status post mastectomy last year, hypertension, diabetes, hyperlipidemia presents to the ED via EMS complaining of general weakness and tiredness. Patient also had 2 episodes of vomiting prior to arrival to the ED (one time this morning, and one time on the EMS ride). He denies any abdominal pain, he denies any fever, he denies any chest pain, denies diarrhea or urinary symptoms. Of note, pt is 3 days post op from left upper extremity AV graft placement. Denies any pain or excessive bleeding at the site, but site is noted to be bruised appearing. He had lung infiltrates. He has been on doxycycline. He was also found to be positive for Covid 19. He was seen by multiple consultant including nephrologist, cardiologist, infectious disease specialist., Diabetes management, vascular surgery, Pulmonology. Due to his comorbidities, he was given bamlanivimab 700, etesevimab 1400 mg monoclonal antibody infusion on 4/29/2021.

is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse; he has lost some weight; He is having trouble with his memory; is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse/He has pain down his right side into his crotch and down his leg; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: 2L3247) intramuscularly into the right arm on 20Jan2021 15:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient's medical history included diabetic, COPD, prostrate cancer. He has a hard time breathing and was on oxygen. Concomitant medications were not reported. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN5318) intramuscularly into the right arm on 17Feb2021 10:30 AM as single dose for COVID-19 immunisation. On an unspecified date, the reporter stated that her husband had the first dose of the Pfizer covid 19 vaccine on 20Jan2021 and was in a lot pain going down the right side into his crotch and legs and screams out in pain. Pain was getting worse and wanted to know if this was a side effect of the vaccine. He was not getting the second dose of the Pfizer covid 19 vaccine because of the adverse event he experienced with the first dose. He was on oxygen and had to carry an oxygen tank. He was due to get the second shot on Wednesday. She wanted to check and make sure. It may be a muscle thing. It seems to be getting worse and worse. He can hardly get up. He cannot hardly sleep in the bed. He does not want to get the next shot and his left side be in pain. Then he would not be able to do anything. He had lost some weight around 230 pounds. He has the first stages of Alzheimer's and clarified that has not been diagnosed yet with Alzheimer's. He had a test a couple years ago and it was normal. He was having trouble with his memory. He got the flu shot on 01Sep2020. He takes two cases full of medication. He was diabetic. He took shots in his stomach. It was changed over. No further details provided. Pain on right side started two days later. She does not know, but was assuming it was the muscle, going to be a little sore. It had progressively worsened. He could hardly move to go to the bathroom. He had prostate cancer a few years ago and has to wear underpants. He cannot bend over to put on his underpants or socks. He screams in pain. He does not do well with pain. No prior vaccinations within 4 weeks. Relevant tests included X-Ray on 26Feb2021 with unknown results. Outcome was unknown for all the events. Follow-up attempts are completed. No further information was expected.

coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the touch/ couldn't get warm; tired; Didn't feel good; just wanted to stay down and didn't want to get up/ just couldn't wake up; eat very little and he didn't like to eat; color was off, looked grey; Pressure in lower stomach; Lost weight; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient of unspecified age and gender received the first/second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via intramuscular at left arm on 02Feb2021 10:00 (80-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included Stents from 2005 (a stent placed in 2005; a heart attack in 2017 and additional 5 stents were placed in 2017; a stent placed in his neck in Nov2019); Heart attack from 2017; Reaction to contrast dye from 2005 (has a reaction to the dye that they use for stents; had a stent placed in 2005 and had a reaction to the dye then; a mild heart attack in 2017 and did stents; once again had a reaction to the contrast dye); Sensitivity to bug bites (When the patient got big bites, you would think someone had beat him he had so many knots; the last few years the patient's reaction to bug bites got much worse); High blood pressure. Additional information for other conditions: The patient was very highly allergic or has a reaction to the dye that they use for stents. The patient had some heart stents and he had bad reactions to the contrast used. The patient was allergic to different things. The patient couldn't take codeine. When the patient got big bites, you would think someone had beat him he had so many knots. Reaction to contrast dye: the patient's physicians then wanted to do imaging with contrast dye on the patient's neck. Physician put the patient on a cocktail for 24-48 hours before the stent was placed and the patient still had a reaction. The patient was given a cocktail of Benadryl and 2 other medications that she cannot remember. The patient's reaction to the dye was not as bad as the first 2 but he still had one. The patient had the stent placed in his neck in Nov2019. The patient still had a reaction to the contrast dye, a mild reaction, even with the cocktail. The reaction was enough the patient was told to continue taking the medication afterward. The patient always carried a nitro bottle in his pocked but he never took any of them. They asked how the nitro tablets were and they were powder. They were blessed as far as the patient's heart. Concomitant medications included cetirizine taken for allergy problems; amlodipine taken for high blood pressure for years; acetylsalicylic acid (ASPIRIN) (for the arteries, just to keep the blood thin, the patient began taking aspirin after experiencing side effects from Effient). The patient previously received codeine and experienced sensitivity (Couldn't take codeine, goes way back, 40-50 years). The patient previously received prasugrel hydrochloride (EFFIENT) from 2017 and experienced shortness of breath (The patient was put on Effient after his stent placement in 2017. Doctor took the patient off of Effient and instructed him to just take aspirin because the patient was showing side effects of shortness of breath and different things. Doctor informed the patient that he would rather the patient just take Aspirin than have the side effects from Effient). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 12Jan2021 (80-year-old at time of vaccination) for COVID-19 immunisation and experienced "so excited" (the patient was so excited after the first shot of the COVID-19 vaccine). The patient previously received tetanus vaccine toxoid (TETANUS) shot for immunisation (20 years ago at least) and experienced "Couldn't move arm, arm swelled and turned red and was messed up for a while". Prior vaccinations within 4 weeks was none. Patient's wife reported that she and her husband (the patient) took the COVID-19 vaccines on 12Jan2021 and 02Feb2021. After his second dose, the patient kept telling her that he didn't feel good and that he was tired (from 03Feb2021). The patient just did not feel good. The patient was cold and so cold to the touch (from 03Feb2021). On 03Feb2021, he was dragging. The patient just wanted to stay down and didn't want to get up. She asked the patient if this was going to keep him in the room all day. The patient replied that he just couldn't wake up. The patient was tired and cold and couldn't get warm. The patient lost 30 pounds (in Feb2021) after he got the second dose of the COVID-19 vaccine. The patient walked around holding his pants up. The patient would eat very little and he didn't like to eat. When he was weighed at the doctor on Friday 02Apr2021, he weighed 136 pounds fully clothed. The patient normally weighed 150-160 pounds. The patient had lost a lot of weight. The patient's color was off, stating that one of her friends said the patient looked grey. The patient experienced pressure in lower stomach (in Feb2021). The patient told her that in his lower stomach, he described it as pressure, and the patient thought he was just kind of sore from coughing from the sinus infection. The patient couldn't stand clothes to touch him and would cut holes in his underwear elastic so that it wouldn't press into him. The patient went to the doctor twice from the time he took the second shot of the COVID-19 vaccine to his death (on 04Apr2021). The patient went to the clinic. The clinic thought the patient had a sinus infection (from 27Mar2021) and gave him a shot that would make him feel good. The patient got a shot on 27Mar2021. She wasn't sure what the shot was and she didn't get a print out. They treated the sinus infection with amoxicillin-clavulanate (875mg-125mg, manufacturer is Teun). The amoxicillin hadn't worked well and the patient went back to the clinic a second time on Friday, 02Apr2021. When the patient went to the doctor on 02Apr2021, they were unable to get a register on the finger pulse-ox monitor. The patient's physician did an X-ray (on 02Apr2021) and the X-ray was perfectly fine (normal). Nothing showed up on the X-ray at all. The patient passed away easter Sunday morning (04Apr2021). The cause of death listed on the patient's death certificate is due to consequence or problem of pulmonary embolism (from 04Apr2021), respiratory impairment. The patient did not receive an autopsy. The family didn't feel the need and the staff didn't even ask if the family wanted an autopsy. "When you live to be 80 years old, you're blessed." HCP: The patient's heart doctor did not see the patient on 04Apr2021 before he died. The last time the patient saw the doctor was Dec2020. The wife reported that she is not complaining, the patient made the decision to take the shot, she is just concerned that the patient had something that could help someone else. The wife stated she was not trying to complain at all, she took the COVID-19 vaccine right beside him and had no consequences. She didn't even have a sore arm. The family is just concerned that there is an ingredient in the COVID-19 vaccine or something that could trigger that in them. Yesterday, 23Jun2021, they were showing a lady on TV that was so sick (unable to provide details). "The patient" (unknown to which patient this is referring) got the shot and ended up in the hospital with side effects. The wife reported that's why she wanted to let Pfizer know about her husband. She was just reporting the patient's symptoms and was not wanting to hurt anyone's feelings in the world. She is not blaming the COVID-19 vaccine for the patient's death, and stated that it could have been his heart or more anything. She just felt like she needed to let pfizer know some of the side effects the patient was having that didn't start until after the second COVID-19 shot. The wife unable to provide the NDC number, lot number, or expiry date of the patient's COVID-19 vaccines. She does not have the information but her son does have that if Pfizer wanted to call and talk to him. The adverse events did not require a visit to emergency room; the adverse events requiref a visit to physician office (The patient went to the clinic 27Mar2021 and went back 02Apr2021 for Sinus infection). Therapeutic measures were taken as a result of the event sinus infection and included a shot and amoxicillin-clavulanate. The outcome of the event pulmonary embolism/ respiratory impairment was fatal; outcome of other events was unknown. The patient died on 04Apr2021. No autopsy was done. The cause of death was pulmonary embolism/ respiratory impairment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pulmonary embolism/ respiratory impairment

Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. An 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ED7534) via an unknown route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 80-years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema, angina, diabetes, hypertension and COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included potassium (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 09:00, the patient experienced headache, fever, chills, shakes, body aches, muscle arches, fatigue and shortness of breath. Any therapeutic measures were not taken as a result of events. 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 the events body aches, chills, fatigue, fever, headache, muscle aches, shakes and shortness of breath was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

No adverse event after the vaccination in March. Case went for his Dialysis (at a separated private setting for their covid patients) on 6/29/2021. Was supposed to have dialysis tx on 6/26 but that one got cancelled due to his sxs and subsequent test. After dialysis session on 6/29, case was disoriented (more than usual after tx), hard to direct/assist in transfer, decreased coordination at home, diarrhea. Family tried to care for him but by next day 6/30 (Wed) realized it was more serious, and via ambulance went to the hospital and admitted on 6/30/2021 through 7/7/2021. Was in ICU but not ventilated. DIscharged to an extended care facility on 7/8/2021.

Sour tongue; sour taste in my mouth 24 hours a day; Diarrhea like symptoms; Tiredness; Occasional tingling in my fingertips; Mouth irritation; This is a spontaneous report form a contactable consumer. This 80-year-old male patient reported for himself stating that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration into the left arm on 11Mar2021 14:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Have a surgery but have seem to get a clean health, thinks that all was good. He has no other health problems really, nothing other the old age, no problems. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop dates were not reported, takes one of them every day. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration into the left arm on 18Feb2021 16:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. On 11Mar2021, the patient experienced mouth irritation. On an unspecified date, he experienced sour tongue; sour taste in his mouth 24 hours a day, diarrhoea like symptoms, tiredness and occasional tingling in his fingertips. The patient underwent lab tests which showed magnetic resonance imaging on 10Jun2021 and positron emission tomogram on 15Jun2021, both as negative, they could not find any cancer, correct. He spoke to several doctors since his changes of taste were occurring and had constant mouth irritation, sour tongue since, third week from his first COVID shot. Did not know how to describe it but it was a sour taste in his mouth 24 hours a day and it seems to he does not know what else to say about it expect talked to doctor several times and couples of other specialists that he has been seeing and they think it possible that it could be linked to the COVID shot since it was the sourness that he feels in his mouth was one of the symptoms of COVID. He had a couple of other side effects but few weeks ago they went away, for about a month from that day he was going to call loose bowels, not terrible but diarrhoea like symptoms and they lasted probably 3 weeks. Had tiredness that he experienced and was not experiencing now. Seemed to be quite good about that and occasional tingling in his fingertips but that seems to be helped, it was almost gone but once in a while. Those all sort occurred at same time but the sour taste in his mouth and tongue was constant or just do not go away. No other medical conditions. Treatment for event included that he went to doctor several times and he just suggested nothing to do about it.no prior vaccination. He was thrilled that he was able to get through there that day. Outcome was not resolved for event sour tongue; sour taste in my mouth 24 hours a day and was unknown for rest of the events.

tired and fatigue, soreness in arm on first day, diarrhea,sore knee, magnified any type of pain he initially had:shoulder pain as well

Slurred speech started morning of 1/8 and patient went to ED after dialysis appointment. Admitted for TIA (transient ischemic attack). Discharged home on 1/10 with follow up appts with Neurology.

The patient began experiencing trouble breathing and weakness a few hours after administration of the vaccine. He was recovering from a kidney infection, so it is unknown what the cause of the symptoms originated from. It was determined to involve EMS, and they came and picked him up at the Long Term Care facility and took him to the hospital.

(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home.

Patient had full body hives starting on 1/25/2021 (mainly on arms) Hoarseness in throat and congestion Child treated with Benadryl Advised treatment from PCP was/is as of 1/28/2021 Zyrtec 10 mg AM + pepcid 20 mg AM Zyrtec 10 mg PM + pepcid 20 mg PM Limit benadryl but if give it then only at night and replace it for the zyrtec

the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; This is a spontaneous report from a contactable consumer reporting for the father. An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:45 at single dose in right arm because of his age group /mass senior vaccination order. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included blood pressure medicine since recent years. The patient previously had a flu shot (INFLUENZA VACCINE) but had that in early Nov2020. He kept saying it was the shot, but that he was fine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient got vaccinated with the Pfizer COVID vaccine on 14Jan2021. He was feeling great with no problems. He sat and waited 15 minutes, and felt fine. When they were driving home after breakfast, her mother said she was talking asking him a question, and he wouldn't respond. Her father could hear her mother asking the question, but he said he could not think of what he wanted to say. He told her he couldn't think of what he was thinking on 14Jan2021. It probably started 1 hour to 1 hour 15 minutes after vaccination, and lasted 15-20 minutes. He kept trying to think of stuff. He kept repeating this for a little bit. His wife thought he was just trying to think of something, but couldn't remember. He was 81. He was very healthy and in shape. He still rides his bike every day. He walks in the morning to play golf too. When they got home and woke up from the nap, and he felt fine. He did say it was the weirdest thing, and that it had to have come from the shot. Since then, he has felt perfectly fine. He had nothing more going on that would indicate any side effect. Her concern was that it sounded like possibly a mini stroke. Upon checking with an HCP (Healthcare professional), the doctor was concerned that it might be a mini stroke and scheduled him for a CAT (Computerised axial tomography) scan. He kept saying it had to be the shot because he has been fine ever since. He had no issues with soreness at site or anything. He didn't have a prescribing doctor. He was driving when it happened. He didn't have a slur or anything. His second appointment is on the 04Feb2021. The event did not require a visit to Emergency Room, but required a visit to Physician Office in the morning of 18Jan2021. The outcome of the event couldn't think of what he wanted to say was recovered, and of the other event was unknown. Information on lot/batch number has been requested.

not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle pains; headache; joint pain; chills; Injection site pain on left arm; body slightly warm/felt slightly warm; This is a spontaneous report from a contactable consumer (Patient's wife). A 81 years old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247 or EL3427), via an unspecified route of administration at Arm Left on 21Jan2021 09:33 at the 81 years old at single dose for COVID-19 immunization. The medical history was none. The family medical history was none. The concomitant medications included warfarin from Mar2012 for Atrial fibrillation( AFib) and standard medications . The patient was not feeling well. All occurred on 21Jan2021 18:00, the patient developed symptoms, such as aches all over his body, aches all over with muscles pains with muscle pains, headache, joint pain, chills, injection site pain on left arm, body slightly warm, felt slightly warm, feeling unwell. He had chills all night and could not get warm. The reporter had not taken the patient's temperature yet. The patient takes regular medications. The patient was on warfarin and standard medications. The reporter stated the vaccine cards were mixed up because they did not write their names on them and the vaccine lot numbers looks like they were mixed up. Someone probably made a mistake because one says EL3247 and the other says EL3427, so she is not sure which it is. The handwriting is different on the cards. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was not Emergency Room Visit or physician's office required Prior Vaccinations (within 4 weeks). The outcome of the event was not recovered.

lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight. Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills. Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge. The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.

Resident found on floor beside chair, unable to rouse. Blood Sugar upon paramedics arrival to facility of 66, blood sugar reported by hospital upon emergency department arrival of 18. Emergency Department discovered Urinary Tract Infection present, resident admitted to hospital and discharged from hospital to rehabilitation skilled nursing facility.

non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; This is a spontaneous report from a contactable other health professional. An 81-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3249), intramuscular in left arm on 22Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Parkinson's disease, post polio syndrome, Alzheimer's disease, atrial fibrillation, benign prostatic hyperplasia, right knee replacement, sleep apnoea, restless legs syndrome, covid-19 prior to vaccination. Concomitant medication included carbidopa monohydrate, levodopa (CARB/LEVO), cephalexin (unknown manufacturer), cetirizine (unknown manufacturer), citalopram (unknown manufacturer), donepezil (unknown manufacturer), etodolac (unknown manufacturer), finasteride (unknown manufacturer), furosemide (unknown manufacturer), metoprolol (unknown manufacturer), omeprazole (unknown manufacturer), oxybutynin (unknown manufacturer), senna alexandrina leaf (unknown manufacturer), tamsulosin (unknown manufacturer). The patient experienced had vaccine on friday and on sunday had neurological symptoms, non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused on 24Jan2021 14:00 with outcome of recovered in Jan2021. The patient was sent to ER and CVA/TIA were ruled out. Has no history of seizure disorder. Returned and had 1 more episode later in the day. Vitals were all within his normal limits. ER physician felt was possible reaction to vaccine. The patient was not treated due to the events. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.

High fever at night (up to 103.9) persisting from January 30 until present, night sweats, chills. Lower fever during the day (100- 101.4)

Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral.

Received first COVID vaccine today and started having throat tightening, SOB, flushing, and tremors in his hands. Had a syncopal episode and chest pressure. Went to ER on 2/20/21

Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for which he self catheterizes twice daily, as well as recently diagnosed atrial fibrillation that presents complaining of increasing weakness and falls. Patient fell 2/18 pm trying to get out of bed and he took about 20 minutes to get himself to a position where he could pull himself back up. Again 2/19 he was trying to get up and his legs were too weak to carry him and he fell to the ground. He needed assistance to get up and family asked him to come to emergency room for evaluation. He has been feeling poorly for about a month, with poor appetite and has lost about 15 pounds. He is not nauseated or short of breath and has no cough. He was apparently treated for UTI about 4 to 6 weeks ago after a visit to urgent care. He has since been to a different urgent care and was diagnosed with atrial fibrillation which was new in onset and was referred to a cardiologist who is planning to do a stress test in a few weeks. I believe he is on Eliquis now. In ER he was found to have significant pyuria and bacteriuria and was given a dose of Rocephin. Renal function shows worsening from levels in December although it is pretty stable over the past month from looking through other labs.

The patient developed sudden onset nausea, diaphoresis and hypotension and shaking. Symptoms improved with IV fluids and rest. She was hospitalized 2 days.

Client c/o generalized weakness, stated that symptom began immediately after receiving vaccine. Client was seen by EMS and assessment rendered. Vitals are BP 177/87, HR 66, O2 97. Client express that symptoms decrease and cleared to go home by EMS.

1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospital from ED DX: Acute respiratory failure with hypoxia ; Pleural effusion, left; Community acquired pneumonia of right lung, unspecified part of lung currently admitted to hospital during time of this report.

patient reported feeling dizzy and weak, admitted to local hospital. Continued to be weak and dizzy for several weeks Narrative: Patient reported not eating breakfast the day of his first vaccine, 02/7/21. He stated he waited the full observation time and upon leaving was told if he had any symptoms/side effects to call 911 or go to the ED. On his way home he pulled over because he was very dizzy and felt like passing out. Stated almost called but instead proceeded to drive to the ED. There he was admitted for cardiac workup. He states he continued to be weak and dizzy for several weeks, just now feeling better in the past week. He is currently wearing a holter at home. He reports never having any other reaction to any other drug or vaccine. States "that was a powerful shot"

injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur). Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.

81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, presents to the ER with change in mental status. Patient was otherwise in his usually state of health. He got his 2nd COVID-19 vaccine on 3/5. His wife noticed on Sunday, he started acting strangely, more confused. He was given his remote, and forgotten how to use it. He came to the hospital; has progressively gotten weaker, unable to walk, swallow, severe dysphagia, pupil unreactive, patient staring at ceiling. CT head; normal; CXR is normal. Platelets: 91,000.

patient reported me to his primary care provider he got his covid 19 vaccine Pfizer through department of health, he was diagnosed of Bells palsy thereafter and treated

he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.

4 intermittent episodes of blurred vision/unclear speech/unsteady gait/slight confusion lasting 30-45mins in past 9 days.

Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care.

Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased

Patient waited the 15 minutes in front of the pharmacy and then started shopping in the store and passed out on one aisle in the store. I was called to look at patient and they had already placed him in a chair and he was alert but weak and was able to answer questions coherently. His son that was with him call EMS to come. I called the son later in the day to see how everything was going and the son said that EMS told him all vitals were normal and he did not go with them. He then told me that his dad and him were having dinner at the time I called and that he felt fine. He also said his dad did not have breakfast that morning which could have contributed to it since he had T2DM.

Site: Pain at Injection Site-Mild, Systemic: Severe pain in right arm (non vaccine arm) with sever joint pain also-Severe, Systemic: Joint Pain-Severe, Additional Details: Severe pain in opposite arm with severe joint pain

Pt here for covid vaccine. Received Pfizer at 800am. Was in observation area and RN noticed that pt was experiencing SOB at approx 811am . Upon questioning Pt stated this was his normal breathing and needed to use inhaler. Pt stated he has been experiencing this SOB for several weeks. Used inhaler was stared was feeling better. RN went to get grandson from parking lot, he stated that pt was SOB this AM when he picked him up. Pt was being questioned by RN when he became diaphoretic and less responsive. 911 called at 819am. VS attempted difficult to get BP via dianamap. Pulse was present. 4L O2 placed on pt . Pox per dianamap was in the 60's. Paramedics arrived at approx 823 am and left at approx 826am . Pt opened eyes and responded to name on way out to ambulance.

muscle tenderness; stiffness in his upper shoulder and the neck; stiff neck and shoulder; local light pain; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL9261, expiration date: unknown), via an unspecified route of administration in the left arm on 21Jan2021at 12:50 as a SINGLE DOSE for COVID-19 immunization. Medical history included back pain and arthritis. Concomitant medications include propafenone taking for more 5 year still ongoing for indication atrial fibrillation and dutasteride taking for a year and half still ongoing for indication prostate. No history of all previous immunization with Pfizer vaccine and no prior vaccination in four weeks. On 21Jan2021, received first dose of the vaccine about 2 and a half weeks ago. He stated, it went fine but the day after, on 22jan2021 had some muscle tenderness (local light pain) and stiff neck and shoulder developed that was pretty mild but it was still going. It's about 2 and a half weeks now. In the morning it was maybe a tad more stiff mostly on left arm, it improved some when walking around and with exercising so he doesn't have to take medication. He stated, when you don't move it doesn't hurt, it's when you move the neck muscle that it was sore but not much at all. At his age you have back pain and a little arthritis. It was strange that it started the day of or day after. He stated he did report just a bit of local pain but only when you touch the area and a very mild muscle pain, but it has continued and he doesn't know if it was related. He asked if this was related to the vaccine and how long this typically lasts. Mentioned he has had this pain before but he feels that he has avoided exercise or yoga or anything that would cause it now. he does have arthritis in his back. He was scheduled to receive the second dose of the vaccine on 11Feb2021. He didn't receive any treatment for the events. The clinical outcome of the events was still unsure if he had this before vaccine or not and its persisting.The outcome of all events were not recovered.

The patient has been tired since the vaccine was given. The patient slept for 3 hours after vaccination and was nevertheless tired. His forehead looked hot.

difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown. Information on the lot/batch number has been requested.

history is a bit complex. I had had occassional r shoulder pain in the past without a diagnosis or specific Rx. 2 days before 2nd dose, i b raised upper L ulna. 2 days post 2nd dose, rather severe olecranon pain developed dwith expuisite tenderness and mild swelling, but no fever. Subsequently over a period of days and weeks, I developed worsening right and then left shoulder and some neck pain and some additional hip and other pain. Shoulder tyenderness was diffuse and mostly muscular, Siginficant limitations of ROM withinability to raise arms. Pain was worst at night and on awakening with some relief with acetaminophen (no NSAIDS as on Xarelto).

Approximately one hour after the shot, I felt a little weird. About 3 hours after shot, having just walked up stairs, I felt dizzy. I had to hold a table to prevent falling. I felt so dizzy I couldn?t see. Since then I have walked up stairs, slowly, and have not felt dizzy. Also my left arm is sore.

Shortly after the vaccine I developed red, burning hot feet which persisted off and on for about 3 months. My dermatologist diagnosed me with Erythromelalgia and perscribed Neurotin and finally within the last 10 days since the vaccination has the symptoms finally has seem to be getting better and are diminshing It generally occurs at night but happens periodically throughtout the day as well.

Got worse and the leg swelled and was also having foot swelling because blood flow wasn't there; sore arm; blood clot; pain behind left knee; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in right shoulder on 23Feb2021 (Batch/Lot Number: EN6202) (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, stage 3 renal failure (was not bad, was in stage 5 couple of years ago, was a month or so away from full failure, was in the hospital and had dialysis, was able to get reversed with medication and diet), high blood pressure, and blood cholesterol increased/high cholesterol. The reporter stated that with regards to patient's height, he shrunk a little. Patient had no prior vaccinations within 4 weeks, didn't get flu shots. Concomitant medications include about 12 other unspecified drugs, takes statins, has high blood pressure and high cholesterol. Patient started experiencing pain behind his left knee about 6 or 7 days later in Mar2021 (also reported as 04 or 05Apr2021, pending clarification). By that Sunday, it had gotten worse. The leg swelled and was also having foot swelling because blood flow wasn't there. There was no TIA's no stroke, no heart racing, no sweating, was all pain. Got leg up and kept elevated until they could get to the doctor and get imaging. Patient went Monday 08Mar2021 to see the doctor. Patient was brought to the doctor and was then sent to the imaging place. Radiology read the imaging around 5:15pm on the Monday, 08Mar2021. The radiologist said there was 2.5" blood clot behind the left knee. He had never had a blood clot before. Patient was then sent to the Emergency Room at (Name) Hospital, in (Name) where they live. Was kept there several hours. Did a lot more blood tests. He was immediately put on 10mg ELIQUIS 10mg, once in the morning, and once at night. He is now taking 5mg Eliquis in the morning, and 5mg at night. He has not had any of these problems before the Pfizer shot. The reporter knew that not a lot had been reported. It seemed it should be safe. The correlation and timing having the shot on 23Feb2021 and all of a sudden a week and a half later this happened. It was 10 days later. There was nothing they can do about it. Just continuing with the ELIQUIS, trying to dissolve the blood clot, will be staying on it for 4 to 6 months. It was a pretty big blood clot and were worried about it breaking up and traveling. The patient had no other symptoms, had a sore arm, that was it. Patient going back to (Name) 01Jun2021 and he will have another CT scan or ultra sound when they get back. The reporter did not want to need to get the leg amputated. Patient was only in the ER, was not admitted to the hospital. Patient was concerned because of his age. If it doesn't dissolve, they know there will be a lot more trouble. The event of pain left knee, blood clot and sore arm required a visit to the emergency room and physician's office. The patient received the second dose of BNT162B2 on 01Apr2021 (lot number: ER8730) in the right arm. The outcome of events was unknown.

pain in chest; pain in neck and back; pain in neck and back; sneezes; Feels when muscles are contracting; felt a little nagging; Was like a very dull irritation in the right side of the neck. Was probably the lymph node; Was like a very dull irritation in the right side of the neck. Was probably the lymph node.; coughs; very mild sore arm; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 81-year-old on 27Mar2021 (Lot Number: EP6955) as single dose for COVID-19 immunisation. Medical history included cancer from 2018 (started out with BCG treatments, where they insert bacteria into the bladder); Had another form of immunotherapy that didn't work too well for him and the cancer kept growing chemotherapy; Had a couple of operations and surgeries where the doctor removed it all but it came back. Best reaction was chemotherapy (It stopped the bleeding and was working on the cancer). Last one was 15Feb2021. Was getting blood work for every treatment. Had to miss one of the treatments due to low platelets. Has a chest port for treatments and blood work. Was very conscious before having chemo. It is kind of a rough thing to kill cancer but also kills good cells too. Definitely worked on killing the cancer for a while; the last treatment was 15Feb2021. Stage 4 was taking chemo. Had bladder cancer (which got out of the bladder and started spreading in to the lymph system), Height: used to be 5'7", is now maybe 5"4". The caller remarks that when he started with chemotherapy. he also lost a lot of weight. Weight: When he went in for last appointment it was 129 or 130 pounds. The patient's concomitant medications were not reported. The patient previously took chemotherapy nos from unknown date to 15Feb2021 for cancer. The patient experienced pain in neck and back on 28Mar2021, pain in chest on 29Mar2021. Caller stating that he and his wife had shot number one 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm and he had the same reaction. Was a very mild sore arm in 2021. On day 2 or 3 on the right side of the neck, had felt a little nagging in Mar2021 and slight pain, especially when he moved and felt it around his back. It is just starting to go away now at 3 weeks. Around the back, around the perimeter and when he coughs in Mar2021, he can feel it in his chest. He is scheduled for the second shot. Is wondering if the second shot will have those symptoms. It's not like it is anything severe, it is just nagging. What worries is him, is that it lasted this long. Is a cancer patient and had last chemotherapy 15Feb2021. His oncologist said to go ahead and take the shot because he really needs the protection. It was asked what if he has the same reaction again. Will go on website but wanted to find out what other people are experiencing and whether or not to take the second shot. Wants to take it for protection. Really wants to take the shot on Tuesday. Pain in neck and back: Only when he coughs, is more of an ache. Started day 2 after vaccine on 28Mar2021. Was like a very dull irritation in the right side of the neck in Mar2021. Was probably the lymph node in Mar2021. Pain in chest: When he sneezes in Mar2021, there is a sharp pain, all around the perimeter of his chest. Is gone as soon as he stops coughing. Feels when muscles are contracting in Mar2021. Started day 3 after getting the vaccine on 29Mar2021. Stage 4 was taking chemo. Had bladder cancer, which got out of the bladder and started spreading in to the lymph system. Wants to be put on immunotherapy but can't until he is finished with his shots. If he gets the immunotherapy and if he has a reaction, would have to use steroids and they do not want to do that with the vaccine. The doctor wanted to start him earlier on the immunotherapy but thought it was important to get the vaccine first, that taken care of. The pain is only sharp if he lifts something. Otherwise, it is just dull. He knows it is there. It is not completely gone. This morning was the best that he had. Really got good sleep last night. The best since it has happened. When he sneezes, he can kind of feel it around his chest, just around the perimeter of the muscles. Treatment: The first couple of days, just put up with it. Took Tylenol one day and then on another day. Takes at bedtime. Does not like taking Tylenol because it effects his liver. If he doesn't need it, he doesn't take it. In the last week, every night he has been less and less bothered by how he slept. Last night he didn't even know he had it, the pain, and slept really well. Have not taken any meds, just Tylenol on day 4 and 5 to help sleep. Therapeutic measures were taken as a result of events. The outcome of events very mild sore arm, sneezes and feels when muscles are contracting was unknown. The outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.

Client was feeling generally weak, off balance and chilled starting on 5/1. Subsequently, he developed body aches and a non productive cough. He has no sore throat, chest pain, or shortness of breath. On 5/4 the client presented to the emergency department with generalized weakness, lightheadedness, chills, cough, and fever. He received Tylenol and IV fluids while in the ER. Covid test was negative. Client admitted to hospital for further evaluation.

This 81 year old white male received the Pfizer Covid shot on 2/20/21 and went to the ED on 4/10/21 and was admitted on 4/10/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) unable to speak

Increased confusion/dizziness today. Increased weakness. Withdrawn affect. Incontinent of urine/stool.

muscle pain in my chest and going down my rib cage; feet felt like ice; Calf muscle also hurt; could not find a comfortable way to sit or lie down; muscles still tingle a little bit; lost my appetite; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old male patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 02Feb2021 15:30 ((age at vaccination 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included myelitis transverse. I had Transverse Myelitis 70 Years ago at age 12. No other allergies were reported. No covid was reported prior to vaccination. The patient's concomitant medications were not reported. No other vaccination in four weeks and no other medications in two weeks. On 11Feb2021 20:30, the patient experienced muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The patient underwent lab tests and procedures which included sars-cov-1 test: unknown on 14Feb2021. Therapeutic measures were taken as a result of muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The outcome of event was Not recovered/Not resolved.

1) I had L elbow injury a few days before 2nd injoction (ind 02/26/2021. 2) Some hast history of vague R shoulder pain- intermittent 3) Severe L elbow pain, swelling, tenderness a few days post 2nd shot. Probable olecranon bursitis and bone bruise. 4) Severe bilateral shoulder, neck, arm pain 8/10 most severe at night interfering with sleep and morning. Inability to raise arms. Significant malaise. Some improvement w acetaminophen. Saw dr. Elevated CRP and ESR . Began Prednisone 20mg/day with dramatic improvement within hours.

Systemic: slight numbness left leg,patient was able to walk-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient complained of slight numbness in his left leg after the shot. according to daughter he sometimes gets numbness in his leg. it has happened before, just not with a vaccine.

This is a spontaneous report received from a contactable consumer (patient). This is the first case out of the two cases. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via an unspecified route of administration on 01Apr2021 as a 2nd dose, single for COVID-19 immunisation. The patient's medical history included arthritis, from an unspecified date and unknown if ongoing. Past drug event included prednisone for arthritis, the patient had been taking it for 25 years. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration on 10Mar2021 as a 1st dose, single for COVID-19 immunisation. The patient's age at vaccination was 81 years. The patient's concomitant medications were not reported. It was reported that, the patient and his wife, both had their shots which had been Pfizer. Stated that, the patient don't know the dates of when his wife had her list. Stated that, they have both come down with like Sciatica pain, both in their right knees both of them and they had been trying also pain medication. It seemed really strange of both of them, both of them had the same shots and both of them came down with the same pain. Stated that, he have had sciatica before that only way back when the patient was younger and driving long distances and sometimes after sitting in, the patient was having this problem and he actually have some homeopathic drops and stuff that he got from a natural doctor stuff (unspecified medication). He usually used that but he was feeling the affect in this they doesn't feel the affect in this sciatica. Stated that, he remember a Pfizer community and he told his doctor about that was happening. He was talking to a pharmacist the other day and he told the patient to call you guys and give you the information. He don't know email and stuff at all, he was not on internet and all that, so he don't know his wife's. Stated that, he just changed to a new medication that pharmacist told him about, it's a diclofenac something. Stated that, he had the container, he had been taking several different pain medication such as Lidocaine and this morning at 6 O'clock just a few hours ago, he started with this new medication that the pharmacist recommended that was diclofenac sodium topical gel 1%. It's for sciatica pain and arthritis. Stated that, when probed for any vaccination prior to the first shot was reported as no, nothing recently, he don't know. Stated that, weight, he don't weight himself fair enough, he think he was still pretty close to 155 pounds (further not clarified hence, not captured in tab). Stated that, it would just be a guess but he think it seemed like it was really close to when he had his second shot but he can't tell the exact date and unable to remember his wife's. Stated that, it doesn't show any expiration date. The investigation assessment was reported as no. The outcome of the event was unknown.

impacted with fecal matter / Fecal impaction; feelings of heat in the butt area, specifically on the tailbone of his "butt" / Feels like butt is heating up on bottom; numbness / the area also feels numb; feelings of heat in the butt area/ heats up very hot and it hurts; This is a spontaneous report from a contactable consumer (patient). A 81-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736; Expiration Date: Jul2021), via an unspecified route of administration, at the age of 81-year-old administered in arm left (reported as left shoulder) on 29Apr2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing high blood pressure (diagnosed about 20 years prior to this report), ongoing diabetes (diagnosed about 3 years prior to this report). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications included insulin taken for diabetes from an unspecified start date and ongoing; hydrochlorothiazide, losartan potassium (HYZAAR) taken for high blood pressure from an unspecified start date and ongoing. Prior Vaccinations (within 4 weeks), there was no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received Flu Vaccine and experienced Shoulder pain for 6 months. The patient asking if the side effects he has been experiencing have been reported. The patient received his first dose of the Pfizer BioNTech COVID 19 Vaccine on 29 Apr 2021. A day after, he gradually became impacted with fecal matter on 30Apr2021. He was taken to the emergency room and was given an enema and stool softener. He mentioned that he was still currently having problems using the restroom. The patient added that he also has "feelings of heat in the butt area", specifically on the tailbone of his "butt" in Apr2021. When he starts walking around, it "heats up very hot and it hurts" in Apr2021. The patient also reported numbness in Apr2021. The patient mentioned that because of the side effects he has been experiencing, he was opting not to receive the second dose. He mentioned that he has been doing frequent visits to the doctor because of his MRI (Magnetic resonance imaging) and colonoscopy." The patient stated he had fecal impaction right after the shot on 29 Apr 2021. Stated it was probably a day or so later. He was gradually becoming impacted. After a week it got so bad he went to the Emergency Room. They gave him an enema and told him to take stool softeners. The patient stated that he still has this problem. He said it feels like his butt was heating up on the bottom, an area about the size of a pie pan, when he was walking around. States that it is the stool building up inside of him and he cannot get it out. Stated the area also feels numb at times. When he walks around a bit it feels like its heating up and started to hurt. He suspected that this was a side effect from the first dose of the vaccine. He stated he was not going to get the second dose. The patient stated he continues to take the stool softeners, Metamucil, and eats a lot of prunes. The event fecal impaction and feels like butt is heating up on bottom required a visit to Emergency Room. The patient stated that if he didn't think it might be required to travel he would not have gotten the vaccine. The patient denied any labs or testing related to these events. The outcome of events impacted with fecal matter / Fecal impaction; feelings of heat in the butt area, specifically on the tailbone of his "butt" / Feels like butt is heating up on bottom was not recovered and others was unknown.

February 9,2021 I went see my caediologist complaining shortness of breath and little energy. We laid rhis off to lack of excercise due ro quarantine from Covid. By April 6 I was so short of breath,my wife insisted that I see my PCP. He found that my O2 was at 77%, he immediately called my cardiologist and explained my symptoms which resulted in my hospitalization. After six days of testing, the diagnosis being "Acute respiratory failure with hypoxia (HCC) J96. and Diastolic dysfuntion (151.89)

PT ADMITTED TO HOSPITAL FOR COVID PNEUMONIA ON 6/17/21. RECIEVED PFIZER VACCINES ON 1/29/21 AND 2/24/21 (UNSURE WHERE THESE WERE RECEIVED). 1.5 WEEK HISTORY OF DECLINE IN FUNCTION INCREASED CONFUSION, CHRONIC PAINS, DECREASED ENERGY, SUBJECTIVE CHILLS, CONGESTION AND DECREASED APPETITE. SAT 89% ON RA UPON ARRIVAL. PUT ON 8L/NASAL CANNULA. REMOTE HX OF LYMPHOMA S/P RADIATION AND CHEMO 3 YEARS AGO. WILL GET REMDESIVIR AND DEXAMETHASONE HERE

This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in right arm for COVID-19 immunisation at the age of 81-year-old. Medical history included hypertension, atrial fibrillation. Concomitant medications included losartan, amlodipine, metoprolol, apixaban (ELIQUIS). Historical vaccine included first administration of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunization. On unknown date, blood cholesterol resulted a little bit high. On unknown date, the patient experienced little spot on arm got bigger and started to swell, It got worse, patient had red splotches down my arm, down my wrist, underarm, and then even on side of body; on the other arm a few spots, he had soreness in that arm, the patient might have shingles, doctor gave the patient medication (Unspecified Medication); it did not do anything, the splotches actually got a little bit worse, right arm has 3 splotches on it, one in muscle area on upper arm, down elbow is another red spot, right down the elbow another one; other one has a lot of them; It was getting a little bit itchy. The outcome of the events was unknown.

Fully vaccinated patient hospitalized with positive COVID PCR. Patient admitted from ED after a fall at home on 05/20/21 which patient attributed to weakness. COVID swab in ED for admission testing was positive for COVID. Weakness only notable symptom at that time. Patient d/c'd home and readmitted on 05/28/21 per recommendation of Homecare due to increased shortness of breath and O2 in 70's. Chest X-ray showed PNA. Patient discharged with Homecare on 06/02/21.

81 yo male patient with a history of leukemia, diabetes, renal failure, htn, hyperlipidemia, and nephrolithiasis presents with increasing weakness over the last several days. The patient states that he received his second pfizer covid vaccination on Monday. Since then has felt weak and tired. Has been short of breath with any exertion. No fever or chills. No chest pain. Has had a cough when he breathes through his mouth. He states he is only short of breath when he breathes through his mouth. No nausea or vomiting. Had one episode of diarrhea. No blood in the stool or black stool. No abdominal pain. No urinary symptoms. Has been eating. Has been exposed to a known covid positive contact at home between

Patient not feeling well, decrease in oral intake, general weakness, abdominal pain, nausia. Diagnose with moderate to high grade small bowel obstruction. Patient was given IV fluid, Zofran, Steroids and pain meds. Patient still in hospital

First dose 08JAN2021 and second 29JAN2021. Husband tested positive 02JUL2021; Patient received both doses of the covid vaccine. Patient tested positive for covid.; not feeling too good; body aches; weak; chills; listless; restless; This is a spontaneous report from contactable consumer (Patient's wife). An 82-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 08:00 (Batch/Lot Number: EJ168) as dose 1, single, second dose on 29Jan2021 (Batch/Lot Number: EL9263) (at the age of 81-year-old) as dose 2, single, both administered in arm for covid-19 immunisation. Medical history included heart problems, leaky mitral valve, patient is waiting to do heart surgery, they are waiting for a new micro valve catheter. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for Blood pressure; lisinopril (LISINOPRIL) taken for Blood pressure; simvastatin (SIMVASTATIN); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); ascorbic acid (VIT C); cyanocobalamin (VIT B12); finasteride (FINASTERIDE). None prior vaccinations within 4 weeks. Patient had Rapid covid test positive on 02Jul2021. Patient was not feeling too good, had body aches and was weak, and chills, listless, and felt weak. After a week of still not feeling great, and being restless. The events not required emergency room visit or physician office visit. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

been tired, with decreased energy; been tired, with decreased energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Novartis. (Manu-facturer Control No:NUS2021US104132_NC). A 81-year-old age male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. No medical history reported. No concomitant medication reported. Patient reported that he had been tired, with decreased energy and stated that these symptoms began after he received the COVID-19 vaccine in April. The outcome of Events was unknown. Information on Lot/Batch number has been requested

palpitations, dizziness, chills and "wet from head to toe". Note; patient did not eat yet today and arrived at 5am.

Clammy; feels heated from the waste up; Chills; 98.8 degrees/mostly hot on the inside; kidney trouble; Creatinine high; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration in left arm on 06Jan2021 12:00 at single dose for COVID-19 immunization. Medical history included gout from Dec2020 and ongoing. Concomitant medication included probenecid tablet from 29Dec2020 and ongoing, allopurinol tablet from 15Dec2020 and ongoing, both for Gout. Prior Vaccinations (within 4 weeks): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Vaccination Facility Type: Public Health Dept. Vaccine Administered at Military Facility: No. Reported her husband had Gout, and was prescribed 2 pills. She clarified her husband was diagnosed with Gout in Dec2020. She said her husband had a doctor's appointment on 13Dec2020, and on 15Dec2020, he got a prescription for Allopurinol 100mg, once a day. She said the Allopurinol is dispensed in a pharmacy bottle and does not have the NDC, Lot & Expiration Date. She said the word "Accord" appeared after the dose, and may be the name of the Allopurinol manufacturer. She said on 29Dec2020, her husband went to the Emergency Room because he had real bad pain in his legs and feet. She said her husband was prescribed an additional Gout medicine, Probenecid, at that time. She said she doesn't know the Probenecid dose, but he takes it once a day. She didn't have the Probenecid NDC, Lot, and Expiration Date listed on the pharmacy bottle. Her husband received his first dose of the COVID-19 Vaccine on 06Jan2021. And on 07Jan2021, he got chills, felt hot on the inside, and was clammy. He felt heated from the waste up. She said her husband said inside his body feels hot. She said she checked his temperature a while ago, and his temperature was 98.8 degrees. She said her husband said if he could just cool his brain, he could cool himself down. She clarified on 07Jan2021, her husband got chills, felt hot on the inside, and was clammy. She stated her husband is mostly hot on the inside now. Reported her husband had an x-ray of his leg recently, and blood work to check his creatinine. She said her husband's creatinine was high, saying her husband has kidney trouble. No further details provided. Any AE require a visit to: Emergency Room: No, Physician Office: No. The patient underwent lab tests and procedures which included creatinine: high in Jan2021, body temperature: 98.8 in Jan2021, x-ray of his leg: unknown result. Treatment: Declined any. The outcome of the events clammy and felt heated from the waste up was not recovered, for the event chills was recovering, for the other events was unknown.

Systemic: Pt monitored by nursing for 30min after inj,pt was stable/no reaction.At ~1hr post inj pt was unresponsive.Pt was a hospice/dnr per director

I still have uncomfortable feeling in my arm/I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful; I have severe pain in my arm/it started hurting and then it continued to get worse and worse and it was severe; It was the worst pain I have ever had and I could not move my arm; It continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad/I could not sleep on the right side or on a left side; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), via an unspecified route of administration (left arm) first dose on 30Dec2020 10:30 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that I had the vaccine back a week and half ago on 30Dec2020 and was due to get the booster this month and wanted to report severe pain arm for two days. The patient stated that he had many vaccine (Unspecified Vaccine) over the years and have never had anything that hurts so bad after about six hours. The patient just wanted to know that was that normal. Consumer further stated, "I took the vaccine about 10:30 in the morning and about four hours later, it started getting sore but that thing was normal you know some vaccines (Unspecified Vaccine) do that but along with that it started hurting about four hours after the vaccine and it continued to get worse and that night I went to bed and I cannot sleep, it hurts so bad. The patient even have thoughts about getting up and go in to the emergency room. It was the worst pain I have ever had and I could not move my arm. I could not sleep on the right side or on a left side and all I did was take Tylenol as prescribed and that helped a little bit but not much but I did not go to the emergency room, I am not going to do that but I felt like it because it hurts so bad but I made it through the night and next day it continued to hurt really bad. I just keep taking Tylenol every four hours and that continued for two days and then finally I was able to raise my arm up above my head without little pain, it was discomfort, but it was not hurting so bad." The patient stated that the event started about two hours later it started, it started hurting and then it continued to get worse and worse and it was severe, that is the reason why I am calling that it was severe. I wanted a shot or morphine to relieve myself that how bad it was." (no clarified further). The patient stated that the vaccine was given in my left arm only about one inch below the top of my shoulder which I think that might have been the problem, I don't know if you can answer that or not but I have never received the vaccine or shot anywhere near that area, it is always three or four inches down in my muscle, on my arm either on left or right, this was given in my left arm but this was given almost in my joint I am wondering if that would cause pain." The patient stated it was given only one inch below the tip above shoulder may be that is causing so much pain." The patient just wanted to report the severe pain, that was for two whole days and then it was subsided and it lasted for four days and I still have uncomfortable feeling in my arm. I was finally able to raise it above my head, my left arm, after two days but it was not comfortable to do it, it was painful." The outcome of the events was unknown. Information on the lot/batch number has been requested.

DAY OF VACCINATION, DEVELOPED COLD-LIKE SYMPTOMS. TESTED POSITIVE FOR COVID ON 1/27/21 AND COMPLAINED OF EXTREME FATIGUE, WEAKNESS, DIZZINESS, SINUS CONGESTION, CHEST, CONGESTION, AND COUGH.

DEVELOPED COLD SYMPTOMS ON DAY OF VACCINATION. DAY AFTER, TESTED POSITIVE FOR COVID AND COMPLAINED OF EXTREME WEAKNESS, FATIGUE, DIZZINESS, CHEST CONGESTION, AND COUGH.

Given vaccine in AM, had adverse reaction around 1430 when he was found unresponsive and in respiratory distress

hearing is off/his ears feel like they're full of water so he can't really hear; lost his voice; dizziness/Really dizzy; bottom of the feet is tingling; Slightly blurry vision; This is a spontaneous report from a contactable consumer (caregiver). An 82-years-old male patient (Father) received first dose of BNT162B2 (BNT162B2, lot number: EL1283), via an unspecified route of administration in left arm on 24Jan2021 13:30 at SINGLE DOSE as Scared to death to get COVID. Medical history included ongoing High blood pressure. Family history included Father died of melanoma. Concomitant medication included ongoing lisinopril (strength: 10mg) for High blood pressure. Caller stated her father received the pfizer covid vaccine first dose on this Monday and have weird side effects, he lost his voice, dizziness/ Really dizzy, hearing is off/ Ears feel like they're full of water so he can't really hear, bottom of the feet is tingling/ tingling in his feet and slightly blurry vision. Caller wanted to know if it is normal. Caller also said safety department told her to speak to quality department about the shot her farther received is it a bad batch or not. No visit to Emergency Room and Physician Office. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.

Vaccinated on Feb 2, slight pain in the side of injection for two days, Then on Feb 9 (5 days after injection) strong gradually increasing pain in R leg at hip and knee (medial side) - these parts were painful previously but not as strong pain as it is now. Using ibuprofen 200mg two tablets (400mg) twice a day with 80 % relief, strong pain during walk, but still worse during the night - difficult to find right position to reduce pain.

WOKE UP AT 3:00 A.M. WITH INTENSE PAIN IN ARM OF THE INJECTION AND SHIVERING. TOOK ACETAMINOPHEN AND BUNDLED UP. GOT UP ABOUT 9:00 A.M. AND TOOK IBUPROFEN EVERY 4 HOURS UNTIL BEDTIME. WAS SORE, COLD AND ACHEY FOR REST OF DAY. SLEPT GOOD THAT NIGHT. IT WAS ALL OVER WHEN I WOKE UP THE SECOND MORNING AFTER INJECTION

Patient developed persistent fevers and weakness and loss of appetite that continued for about 3 weeks after getting the vaccine. There was a delay of about a day from getting the vaccine that he developed symptoms. He came to the hospital at today, 2/23/2021 because of the persistence of his symptoms. Vitals were stable and within normal range, but he had elevated creatinine to 1.66, unknown baseline. Troponin was also elevated to 0.08 without symptoms of ischemic heart disease. EKG was normal.

Pt with no previous history of abdominal aortic aneurysm presented to ER on 02.20.2021 with abdominal pain, weakness and BP of 50/30 via EMS. Abdominal pain started on 02.19.2021 approx 10:00 PM. Pain was described as severe in the left flank, radiating into the lower abdomen and worsened through the night. EMS was called around 11 AM. Pt CT Abd/Pelvis angiography shown Ruptured abdominal aortic aneurysm measuring up to 7.9 cm in diameter and 9.8 cm in length with active extravasation of IV contrast. Large volume of predominantly retroperitoneal hemorrhage. Pt was flown hospital for surgical intervention after being given 2 units of O neg blood with 2 L normal saline.

Woke at midnight the following day with chills headache and shaking.Very fatigued. No fever. Rested the next day .felt better no fever.but still tired.Next day. (Fri) woke up with swollen neck gland on the left side.Still tired but improving

2/25 - loss of taste 2/26 - dizziness/woozy, severe flu like symptoms all day (no energy, ache) 2/27 - continuing dizziness, minimal energy 2/28 - continuing dizziness, wheezing/trouble catching breath (needed oxygen to calm)

1-21-21. Got first COIVID-19 vaccination at 7:15 AM (Phizer). No reaction whatsoever. Pfizer Lot:EL3249 2-11-21. Got second vaccination at 7:05 AM. Felt normal all day. Pfizer Lot:EL9264 2-12-21. Felt good early. Played tennis and worked out. About 2 PM, started feeling very poorly. Took 90 minute nap. Woke up nauseous and dizzy. Threw up several times. Could not drink or eat dinner. 2-13-21, Continued to feel badly. Threw up after arising. Couild not drink or eat breakfast. About 1:30 PM, was able to keep yogurt and cottage cheese down. Nibbled off and on. Ate light supper. 2-14-21. Woke up dizzy. Was able to eat normally. Still felt badly. Had bad headache (very unusual for me) before supper. Ate normal supper. Canceled tennis for following week. 2-15-21. Started feeling much better than day before. 2-16-21. Felt much better than the day before. 2-17-21. Best day since 2-11 ? the last 5 days. 2-18-21. Began to feel rocky. Slightly dizzy. Low energy 2-19-21. Felt worse than the day before. Low energy, short dizzy spells, little appetite. 2-20-21. Felt really bad. Very dizzy all day. Drippy nose for 5 hours, but nose okay by bedtime. Very tired all day. 2-21-21. Felt a little better. Still dizzy when I got up. Recovered enough to go to church at 10 AM. Note that it had been 10 days (at 7:05 AM) since I had my second shot. 2-22-21. Got up to the bathroom at 2 AM. Was dizzy. Got back to sleep until 6:30 AM. Was and am better than the last 4-5 days. Still feel a little shaky if I move quickly or get up out of my chair quickly. Very tired all day. 2-23-21, Doing better. Still wobbly on my feet. Only mildly dizzy. 2-24-21. Best day since 2-17. Still a little weak. Worked out in the late AM. 2-25-21. Felt a little dizzy in the AM. Better after lunch. Did light workout. Good day overall. Felt fine. 2-26-21. Felt good in the AM. Worked out. Feeling stronger than yesterday even. 2-27-21. Felt good 2-28-21. Felt tired all day 3-1-21. Did not sleep well. Worked out in the AM and then was very tired. Felt a little dizzy after returning home from the gym. Took short nap before lunch and am doing better in the PM.

Diarrhea; his arm was a little sore; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date: unknown) at the vaccination age of 82-year-old intramuscularly in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 vaccination (COVID-19 immunization). The patient's medical history and concomitant medications were none. The patient did not received other vaccine within 4 weeks prior to vaccination. The wife reported that her husband got the first dose of the Covid-19 Vaccine on 25Jan2021 about 14:00 and did not have any reaction except his arm was a little sore on 25Jan2021 18:00. It is sore if he rubs the area, but has gotten better She said that last night, he developed diarrhea at about 22:30 26Jan2021. She inquired if this is a coincidence, he got the diarrhea or is it a side effect from the shot. She added that the diarrhea started about 36 hours after he got the first dose. He had the diarrhea at 22:30 26Jan2021, he had it again at 02:00 27Jan2021, and again at 07:00 27Jan2021 and he has not had it since. She said that her husband was saying he thinks it was getting better. She mentioned that after he received the vaccine, they waited for 15 minutes to make sure there was no reaction. She added that the vaccination facility type was health department drive through vaccination. The adverse events did not require emergency room or physician office visit. The outcome of the event was recovering.

Right arm achy/a little achy/only his arm was achy/arm only hurt when he was lying on it; Right ear ache and bumps around ear lobe/ear started hurting/earache/behind his ear started hurting. Going online and believes irritation could be from the masks worn for COVID-19.; Back of his ear was red and swollen/around left ear lobe it is bump and red; Back of his ear was red and swollen/around left ear lobe it is bump and red; Back of his ear was red and swollen/around left ear lobe it is bump and red; Tingling to his ear; lesions are at the top of his ear near his hairline; This is a spontaneous report received from a contactable consumer (patient). An 82-year-old male patient received the first shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 11:10, at single dose, for COVID-19 immunization/Want to live, at the hospital. Medical history included being allergic to cats; had triple bypass and valve, had allergies his whole life and had shrunk. Concomitant medications included unspecified allergy pills which the patient takes all year round. The patient previously took amoxicillin and reported that he was immune to it and it did not work; reported that he has taken azithromycin before when he goes to the dentist he has to take azithromycin. On 25Jan2021, the patient took his first COVID-19 vaccine shot. On the same day, the patient was a little achy. He took Tylenol every 5 hours afterwards and iced it and then had had no problem. He woke up the next morning (26Jan2021) perfectly fine. The patient clarified that only his arm was achy, his right arm was achy, and it only hurt when he was lying on it. But then on Wednesday night or Thursday morning (Jan2021), the patient had tingling to his ear and the back of his ear was red and swollen. He reported that "behind his ear started hurting". He also had right earache and bumps around ear lobe. He reported he had little bumps or lesions which were at the top of his ear near his hairline. The patient went to his pharmacist to get their opinion and was given Aquaphor ointment for pain relief, but he reported that it made the area behind his ear worse, so he went back to using the antibiotic ointment and stated that "the cold pack helped the most". The patient reported had doctor's appointment on 01Feb2021 at 12 and the doctor gave him azithromycin tablets, 6 tablets. He also reported that he has an unopened box of Azithromycin tablets USP which he has not taken and will not without doctor's permission. He went online and believes this irritation behind the ear could be from the masks worn for COVID-19 and stated that the KN-95 masks were kind of tight. He stated he now has the thing on the back of his neck to help with the mask. The patient also reported that he doesn't have fever or temperature and he has no cold. The patient was scheduled to receive his second shot two weeks from the time of the report and wanted to know if he can take antibiotics and then get the second shot. The patient recovered from pain in arm on 26Jan2021; and has not recovered from the remaining events.; Sender's Comments: Event ear pain represents an intercurrent medical condition and unrelated to BNT162B2 .

moderate pain in left knee, left thigh, and left hip (the vaccine shot was in my left arm) and the pain continued for weeks and is still happening. Doctor recommended Tylenol, Ibuprophen which did not help. Orthopedist recommended Cortisone injection in 3 weeks from now.

started with a sore arm, Tuesday pain radiated to chest. Pain pressure in chest come and go. Wednesday pain got worse. Thursday I felt dizzy and I felt short of breath. Chest area felt like bruised pain

82-year-old male who presents after getting dizzy and weak just prior to arrival. Patient was receiving his first dose of COVID. Pt's blood pressure was checked and was found to be 78 systolic. On arrival patient's BP was 91. Patient states that when he gets up he can still dizzy however while in bed patient currently asymptomatic this time. According to the patient's failure member he has been dizzy and increasingly dizzy over the past few days.

wasn't able to sleep; felt like he was in a refrigerator; shaking; lower back pain; The patient reported receiving the Pfizer vaccine in his right arm; right arm/shoulder pain; right arm/shoulder pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Feb2021 at a single dose on the right arm for COVID-19 immunization. The patient also started to receive mirtazapine (MIRTAZAPINE, 50 mg, Capsule, soft), via an unspecified route of administration, from an unspecified date at 50 mg, once a day for sleep. Medical history included sleep (disorder). Concomitant medications included aspirin [acetylsalicylic acid], calcium, escitalopram, finasteride, lamotrigine, simvastatin, tamsulosin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient reported receiving the Pfizer vaccine in his right arm on 06Feb2021. That evening he took his nightly medication and went to bed at 11:30 pm. He stated he wasn't able to sleep because he felt like he was in a refrigerator and he was shaking. He had lower back pain, right arm/shoulder pain, and went to the bathroom 5 times (all on an unspecified date in Feb2021), which was not normal for him. The patient added that it was the second dosage of the Pfizer (Covid-19 Vaccine) her received on 06Feb2021. And he had some negative response: a little pain in his shoulder but the worst thing that happened, he went to bed 11:30 did not sleep at all. At 11:30 night, he took his medication (Mirtazapine) and went to bed. He was shaking and he had to put another blanket on himself. Eventually, it was okay, but the problem is he was not able to sleep all night, from 11:30 to 9' O clock this morning (07Feb2021). Consumer stated, "Yesterday my wife and I had the second dose of the Pfizer and I had really strange reaction and I will tell you what it was. Last night at about 11:30 I took my night medicine (later clarified as Mirtazapine), I went to bedroom, I started shaking all over. And the worst part is from 11:30 to 10 o' clock this morning, I was not able to sleep. There is slight pain in my shoulder". When confirmed if the consumer wanted to report the same or have any questions, consumer stated, "No, we have no problem with temperature is fine, the oxygen is fine. Just I don't understand why in fact the medication (mirtazapine) is to induce sleeping, use to for sleep within half hour but it didn't help. I wanted to know what happened. So, this will eventually go away?" The action taken in response to the events for mirtazapine was unknown. Outcome of the events was unknown. Information on batch number has been requested.

Seizure followed by Acute encephalopathy a few hours after receiving 2nd dose of Pfizer COVId-19 vaccine. COPVID-19 PCR testing positive on admission. Ongoing encephalopathy and patient made Comfort care. EEG showed no overt siezures.

Patient was found unresponsive by family members in the early morning on 2/23/2021. Patient passed away.

On Saturday patient woke up saying he was in extreme pain with his left arm. At 5 o'clock that night he lost his equilibran and I had to call 911. They came and after an initial examination took him to Hospital's emergency room. They did c-scans, MRI. and they said that a blood clog was showing in his brain and that he had atrium filibration of his heart. His vision has been affected, though the hospital thinks it will improve. The left side of his body is not function right and he needs a walker to walk. He has been in ICU since Sunday. This is late Tuesday.

seen in office for appointment by Dr. on 3/22/21: arthritis of hand (Bilateral) bilateral hand swelling and MCP joint swelling symptoms worsening each day per patient suspect rheumatoid arthritis even with negative rheumatoid factor will recheck labs today and refer patient to rheumatology for further work up patient to start prednisone 7.5 mg every day x 30 days used in the decision making process Send for rheumatology referral Check ANA multiplex w/reflex 11 Ab cascade Check cyclic citrullinated peptide (ccp) Ab (IgG) Check rheumatoid factor Check C-reactive protein Check sed rate Start predniSONE 5 mg tablet 1.5 tablets every day for 30 days tendonitis of left shoulder limited range of motion, tenderness pain since administration of Pfizer covid vaccine in January patient agrees to steroid injection to area patient reports improvement post injection used in the decision making process Start Kenalog 40 mg/mL suspension for injection 1 cc kenalog and 2 cc xylocaine to L shoulder Send for physical therapy referral hypothyroidism denies worsening symptoms or side effects will check lab today continue current treatment used in the decision making process Check TSH hypertensive disorder blood pressure within normal limits patient denies side effects continue current treatment used in the decision making process hyperlipidemia denies side effects continue current treatment used in the decision making process celiac disease denies worsening symptoms continue current treatment neoplasm of prostate followed by oncology--reviewed records congestive heart failure followed by cardiology--records reviewed overweight BMI 27.8 + hypertension, hyperlipidemia, CHF weight maintained since last visit continue current efforts--diet and exercise History of Present Illness pt is here for pain to hands pt states he is having pain to left arm where he had covid vaccine. pt thinks that pain and swelling to hands begin after he got the covid vaccine. pain level is 10/10 pt finds swelling is worse in the mornings pt is also having trouble walking established pt pain in right hand pain of left shoulder joint Kenalog 40 mg/mL suspension for injection hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight pain in right hand ketorolac 60 mg/2 mL intramuscular solution ANA screen, ifa, w/refl titer and pattern C-reactive protein cyclic citrullinated peptide (ccp) Ab (IgG) rheumatoid factor hypertensive disorder hyperlipidemia neoplasm of prostate congestive heart failure cervico-occipital neuralgia celiac disease body mass index 25-29 - overweight overweight intolerant of cold CBC (includes diff/plt) comprehensive metabolic panel TSH w/reflex to FT4 T3, free

1/15 through 1/19 Pt was hospitalized for COVID symptoms and diagnosed COVID +. received remdesivir and plasma on 1/15. 1/19 discharged home and doing well until 2/12 2/11 received pfizer vaccine 2/12 readmitted to hospital after being found unresponsive at home, sats 35%, rales, temp 103.8, CXR infiltrates, placed on PR mask then BIPAP- diagnosed with cytokine storm possibly from vaccine. 2/13 sats 78% on BIPAP, sweating, rapid response called and stabilized 2/16 pt found with left sided weakness, droop and left arm flaccid. CT scan revealed ischemic stroke 2/17 6L salter lab remain weak on left side 2/19 increased to 10L salter lab 2/20 possible aspiration - worsening sats 2/21 continues to have decreased sats PR mask at 15L. then back on BIPAP 2/22 discussion with family about poor prognosis. DNR comfort. 2/23 Pt passed away

Systemic: Weakness-Severe, Additional Details: AFTER 20 MINUTES WAITING TIME THE PATIENT WAS LEAVING THE STORE WHEN FELT AND BECOME UNRESPONSIVE, 911 WAS CALLED AND PATIENT TRANSPORTED TO MEDICAL CENTER. NO MORE INFORMATION KNOW

At 3:00 pm the following day(03/24/21) after covid-19 vaccine #2 was administered (03/23/21), patient was at grocery store and experienced severe entire back pain that lasted until around 8:00pm, patient was then in bed at 8:00pm, tried to get out of bed, legs went numb and weak and gave out, arms started feeling numb as well. Patient reports his son helped him back to bed and patient fell asleep, slept through the night and the next day 03/25/21 all of patient's reported symptoms were gone.

83 yo F presents to the ER on 1/30/21 with complaints of worsening SOB and weakness. She was diagnosed with COVID-19 in 1/22/21, 7 days after receiving the first dose of COVID-19 vaccine. She had a fall on 1/25/21 and was evaluated in the ER, where she was placed on steroids and oxygen at home. She was admitted on 1/30/21 for hypoxia, generalized weakness, and A-Fib with RVR. Patient required oxygen supplementation and was treated with IV dexamethasone and inhaled budesonide. She also received treatment for afib/RVR with improvement upon treatment. Patient was discharged on 2/1/21 with recommendations to transfer to skilled nursing facility.

DVT -- leg pain began the day after vaccination, patient was seen in the ER a week later and diagnosed with right leg DVT. Started treatment with Eliquis.

10 days after his 2nd Pfizer COVID-19 vaccine, patient developed upper extremity weakness and paraesthesia. From the discharge summary: Pt had his second dose of Pfizer vaccine on 02/18/2021. The patient complained of new onset of bilateral upper extremity tingling, numbness and weakness since 02/28/2021. The patient denied lower extremity paraesthesia or weakness. He has a history of chronic low back pain. He denied any neck pain, back pain or radiation sensation. He has no sphincter dysfunction or incontinence. He has been using walker in the past. Dr. of neurology did a nerve conduction and EMG recently. The study showed the evidence of peripheral demyelination, peripheral neuropathy. The patient was admitted for possible spinal tap and IVIG treatment. The patient had a ground level fall 7 to 8 days ago. He denied fever, chills, headache, dizziness, shortness of breath, chest pain, palpitation, abdominal discomfort, diarrhea, UTI symptoms or coughing. Pt had his last dose of IVIG yesterday. No side effects. Motor weakness improving and UE paresthesia nearly resolved. No side effects to IVIG. BMP normal. Patient symptoms improved after 5 days of IVIG and he was discharged after being in the hospital 7 days

After the 2nd dose my arm was very sore (muscle ache) and fever; After the 2nd dose my arm was very sore (muscle ache) and fever; My arm was very sore; The initial case was missing the following minimum criteria: identifiable patient. Upon receipt of follow-up information on 29Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that, A 82-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection), dose 2 intramuscular, administered in Arm Left on 22Feb2021 15:30 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) from 2000 and ongoing Enlarged Prostate from 2000. Historical vaccine included bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: EL5982) dose 1 Intramuscular, administered in Left Upper Arm on 02Feb2021 1:10 PM for COVID-19 immunisation. Concomitant medication included tiotropium bromide (SPIRIVA) taken for chronic obstructive pulmonary disease from 2000, salbutamol (ALBUTEROL HFA) taken for chronic obstructive pulmonary disease from 2000 and ongoing, budesonide, formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease from 2000 and ongoing, terazosin (TERAZOSIN) taken for prostatomegaly from 2000 and ongoing and finasteride (FINASTERIDE) taken for prostatomegaly from 2000 and ongoing. The patient experienced after the 2nd dose my arm was very sore (muscle ache) and fever and my arm was very sore on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included positron emission tomogram: unknown on 22Feb2021 Slightly radioactive spinal fluid culture. Outcome of the events was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.

Rapid COVID test was positive/Next day long test came back negative and was quickly moved out of the COVID-19 unit; Hemoglobin Anemia; difficulty breathing; fast heartbeat; dizziness; weakness; tiredness; over all feeling of unwell.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 10:00 (Lot Number: EN6198) as SINGLE DOSE for COVID-19 immunization. Medical history included lower left lung lobectomy in Mar2019 and cancer in May-Jul2019 treated with chemotherapy 4x. The patient previously had first dose of BNT162B2 in the left arm on 26Feb2021 10:00, lot number: EN5318 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 06:00, 1 day later had side effects of tiredness and over all feeling of unwell. On 22Mar2021, 3 days later, the patient had additional side effects of difficulty breathing, fast heartbeat,dizziness and weakness. On the 6th day, the patient went to ER 26Mar2021, the patient was admitted to the hospital. Rapid COVID-19 test was positive and sent to COVID-19 unit. Next day long test came back negative and was quickly moved out of the COVID-19 unit. The patient was diagnosed with hemoglobin anemia. Over all, hemoglobin dropped from normal base line of 14 to 6.1. The patient was given 2 units of blood, was given a shot of prednisone and then put on 60 mg of prednisone daily. Release from hospital after 6 days with hemoglobin of 9.9. Still being followed by doctor and follow up blood work. Continuing 60mg of prednisone daily until hemoglobin reaches normal range. If prednisone does not work, next step is an infusion of Rituxan. The patient underwent lab tests and procedures which included haemoglobin: 9.9 on unspecified date, haemoglobin: dropped from normal base line of 14 to 6.1 on 27Mar2021, long test: negative on 27Mar2021 and Nasal swab/Rapid test: positive on 26Mar2021. All events were reported as life threatening. The outcome of the events was recovered with lasting effect

This morning my temp rose to about 99. this morning my temp rose to 100 (normal 97.5), Had chills, shakes Went away after 5 hours 9last night my temp rose to 100

in april 2021 i suddenly came down with pain in legs and arms went to urgent care the symptons are that of polymyaliga and now on prednisone

felt very tired/feeling exhausted/tiredness; Headache; muscle and joint pains; muscle and joint pains; Hot Flashes; Chills/cold chills; nauseous; he felt so hot; thought he had a fever; cramping all through the night to the point he wanted to cry; Couldn't Sleep; He specified the pain was in his hands, legs, feet/sore arm; weakness to the point he couldn't get up to go to the bathroom.; Feeling unwell; Dizzy; but everything else was sore too; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as "EUO150"/"LU0150"), via an unspecified route of administration, administered in arm left on 13Apr2021 11:15 (at the age of 82-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included blood pressure, allergy, glucose-6-phosphate dehydrogenase deficiency (G6PD), liver genetic deficiency, and had allergy mice, cat, dust and trees. The patient previously took sulphur and aspirin and makes him bleed because his blood was already thin. Concomitant medications included amlodipine taken for blood pressure; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergy; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication; all were start and stop date were not reported. An 82-year-old caller received the first dose of the Pfizer-BioNTech COVID-19 vaccine yesterday (13Apr2021), around 11:15 am. He added he was monitored for 15 minutes post injection and then used the public transportation to run some errands and return home. He said he received the injection on his left arm had soreness in this arm after vaccination. He explained around 3-3:30 pm he was walking to get the bus and then felt very tired to the point he wanted to sit on the pavement. He also described it as feeling exhausted. He explained he was so tired on the bus that he was falling asleep and almost missed his stop. He said he also began having joint and muscle pain on the bus. He specified he got home around 4 pm and he then experienced tiredness, headaches, muscle and joint pains, hot flashes, chills, and felt nauseous but didn't vomit. He specified he felt so hot, he had to turn off the heat and remove his clothes, but then he had chills/cold chills and had to turn the heat back on and thought he had a fever. He said around 11 o'clock he had appetite. He added he had cramping all through the night to the point he wanted to cry. He couldn't sleep. He specified the pain was in his hands, legs, feet, and joints. He also said he felt tired like he had worked for 12,000 hours and was not able to move. He said he had weakness to the point he couldn't get up to go to the bathroom. He said he had the headaches all through the night. He was feeling unwell, dizzy. He explained he felt like he was going to die; he was worried about his body. He said he still feels tired. They told him he would only have a sore arm, which he did, but everything else was sore too until about 08:00 today (14Apr2021). He explained that he didn't have all these issues before vaccination. He explained how disappointed he was with his reaction to the vaccine given that he was reluctant to the unapproved vaccine at beginning because he wasn't the person that take a lot of injection and medications, and so finally after his primary physician to influence him to get the vaccine. He mentioned he lives alone, healthy, vegetarian, never smoked, never took recreational drugs, does acupuncture, and takes little medications. He explained most people and his acupuncture doctor said he shouldn't get much reaction from the first dose and the reactions to the second dose are more prevalent. He added he was told that people have mainly experienced soreness in their arm after this vaccination with the first dose. He asked if his symptoms were reported after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. Everyone told him the first vaccine is a whiz. That it was easy. The second vaccine is the one that have side effects on. He also stated that he almost called to get an ambulance to take him to the hospital. Said that if he had these reactions with the first one, he does not want to take the second vaccine. Sometimes he regret that he have taken it now because he did not expect all of this to happen to him and they just told him that he will have a sore arm on left arm. He was in kind of shock to experience all of this and he was G6PD (Intent: History). He cannot take Sulfur and Aspirin because that makes him bleed because his blood was already thin but that would be no problem also have a liver genetic deficiency (Intent: History). He was allergic to mice, cat, dust and trees (Intent: History). So, he told all what he had that they knew in the beginning they said none of those things will affect. He take B12 (Intent: History) too once a month, he get injection for allergies for his cats and trees and grass once a month but they told him none of the things will affect him. The outcome of the events was unknown. Information about the lot/batch number has been requested.

pain in the joints of the feet, ankles, and wrist; pain happened on the right hand and feet; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing gout. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number: not reported) as SINGLE DOSE for COVID-19 immunization. On an unspecified date, the patient reported that in the last couple of days he had pain in the joints of the feet, ankles, and wrist and also mentioned that the vast majority of the unusual pain happened on the right hand and feet. Reporter asked what medication he can take for the joint pain and asked how long the possible side effect would last. The outcome was unknown for the reported events. No follow-up attempts are possible; information about batch number cannot be obtained.

On April 24, patient started not feeling well while away from home in the early afternoon. Later noticed some balance issues and some memory problems. The next day, balance issues continued and had noticeable mouth drooping on left side first noticed by daughter who was visiting and son-in-law. Was taken to the hospital and diagnosed with a stroke.

left hand went numb,Left wrist and hand had numbness before going to sleep; This is a spontaneous report from a contactable consumer. A 82-Year-old male patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:30 as single dose for covid-19 immunisation. Medical history included diabetes, hypertension, Cured cancer, hayfever allergy. Concomitant medications included Metformin HCL, Vit D3, Vit B12. No other vaccine in four weeks. The patient reported on 16Feb2021 18:30, left hand went numb. Left wrist and hand had numbness before going to sleep on 18Feb2021. No numbness on 19th. Outcome of event was recovered on 19Feb2021. Information of lot/batch number has been requested.

sore arm hours after shot; fatigue/tired; runny nose; coughing/slight cough; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm 05Feb2021 11:15 (82-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included diverticulitis (surgery), kidney cancer small area excised, and prostate cancer radiated. There were no known allergies. Concomitant medications in two weeks included allopurinol, fenofibrate, tamsulosin, and amlodipine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 15Jan2021 11:15 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. On 05Feb2021 15:00, patient experienced sore arm hours after shot, fatigue, runny nose, coughing, no temperature the next day. Symptoms abated second day after shot. Still tired and a slight cough. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test for COVID-19 post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Too nervous about second dose of Covid-19 vaccine to drive to vaccination facility; A little shaky; This is a spontaneous report received from a contactable consumer (patient's wife). A 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, in left arm on 19Jan2021 10:20 (at 82-years age) as single dose for covid-19 immunisation. Medical history included high cholesterol a long time ago, at least 10 or 15 years, high blood pressure a long time ago, at least 10 or 15 years, high triglycerides a long time ago, at least 10 or 15 years. Concomitant medication(s) included hydrochlorothiazide(HYDROCHLOROTHIAZIDE) taken for high blood pressure from an unspecified start date to Apr2021; eicosapentaenoic acid ethyl ester (VASCEPA) taken for high triglycerides from an unspecified start date to Apr2021; atorvastatin (ATORVASTATIN) taken for high cholesterol from an unspecified start date to Apr2021 and Multi vitamin. Patient underwent laboratory test including a CT scan and MRI, a spinal tap on the patient, and all the tests the medical staff could possibly run to try to find out what the problem was with the patient and the doctors didn't find anything on 2021. On 19Jan2021 patient experienced a little shaky following his first dose of the Covid-19 vaccine and patient was too nervous about second dose of Covid-19 vaccine to drive to vaccination facility on Feb2021. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Covid-19 vaccine might have jump started Alzheimer's; Altered mental status; Patient meant he saw things, he talked to people and he was terrible; Depression; Shaking; Went berserk / He is just crazy. Saying and seeing things that was not there; This is a spontaneous report a contactable consumer (wife). An 82 years old male patient (Height: 170 cm and Weight: 66.68 kg) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6201) intramuscularly, in the right arm, at single dose, on 13Feb2021 at 10:20, for COVID-19 immunization. Relevant medical history included high cholesterol, high triglycerides and high blood pressure, all from an unspecified date, all diagnosed at least 10 or 15 years and acid reflux (esophageal), from an unspecified date. The patient previously, on 19Jan2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EL3249) at single dose, in the left arm, for COVID-19 immunization. After the first dose, the patient experienced shaking ("the patient was a little shaky following the first dose of the Covid-19 vaccine on 19Jan2021, but it was nothing major") and was nervous ("the wife reported that when it was time to get the second dose on 13Feb2021, the patient was so nervous to get the shot that he was too nervous to drive"). Concomitant medications included hydrochlorothiazide 12.5 mg, once daily, in the morning, from an unspecified date to Apr2021, for high blood pressure; eicosapentaenoic acid ethyl ester (VASCEPA) 1 mg, twice daily, from an unspecified date to Apr2021, for blood triglycerides; atorvastatin 40 mg, once daily, from an unspecified date to Apr2021, for blood cholesterol; omeprazole from an unspecified date, for an unknown indication; colecalciferol (VITAMIN D (colecalciferol)) from an unspecified date, for an unknown indication and an unspecified multi vitamins. On 13Feb2021, the patient experienced altered mental status, illusion ("patient meant he saw things, he talked to people and he was terrible. He was saying people called to him. He wanted to go outside; vision illusions like people were calling him to come outside"), depression, shaking and he was feeling abnormal ("he went berserk. He was just crazy. Said and saw things that was not there. Patient was hearing people calling him to go outside"). The patient might have Alzheimer's. Patient's wife reported that the physician stated that the Covid-19 vaccine might have jump started Alzheimer's. Treatment was received. Patient was prescribed donepezil, ondansetron, quetiapine, escitalopram, trazodone, and sertraline after he went berserk to help with altered mental status. None of the medications worked. Patient also received risperidone. Patient's wife reported that even with the risperidone, the patient was not his complete self like he was before he received the Covid-19 vaccine. Risperidone helped some. Relevant laboratory tests, performed on an unspecified date, in 2021, included: computerised tomogram head (CT brain scan) normal, lumbar puncture (Spinal tap) normal, and magnetic resonance imaging head (MRI brain) normal. Clinical outcome of the events was unknown at time of this report.

pain; low energy; mild headache; mild nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: E99261), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 (at the age 82-year-old) as SINGLE DOSE for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced mild headache and mild nausea on 02Feb2021, low energy on 03Feb2021, pain on an unspecified date. Reporter stated that "He is calling about the covid 19 vaccine. He had his first shot yesterday afternoon at 2. He slept great. He had a mild headache last night and mild nausea. This morning he got breakfast, and it wasn't excruciation but still felt pain, as well as the nausea, and his energy level was not normal. As far as the headache, would it be okay to take Tylenol, and for the nausea can he take Phenergan or Dramamine, its not extreme but just uncomfortable. His First Dose of the Covid Vaccine was on 02Feb2021 at 2PM or 2:05PM. The mild headache started last night the same day. The Nausea started last night was mild, on the same day also. The energy level being low started today 03Feb2021". Caller confirms that "after the onset of events he took 2 tylenol last night at 7. He had a little sinus problem and took 1 of coricidin hbp sinus over the counter medication last night. Taking both together made him anxious. Thats why he is calling to find out in the morning. He does not want to take things close together". Outcome of the event pain was unknown and other were not recovered. Follow-up attempts are completed. No further information is expected.

Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; Severe cramp, left leg on 18Feb2021 atleast 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting abt1hr.Cramps lasted approx.3-5 Min.each time; This is a spontaneous report from a contactable consumer (patient). An 82-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) administered in right arm via an unknown route of administration on 14Feb2021 at 09:45 am as SINGLE DOSE for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medications in two weeks included Esomeprazole (ESOMEPRAZOLE), Simvastatin (SIMVASTATIN), Ramipril (RAMIPRIL), Amlodipine (AMLODIPINE). Prior vaccination, patient was not diagnosed with covid. On 18Feb2021 at 15:30 pm, the patient experienced severe cramp, left leg at least 4 separate times in afternoon followed by cramps both legs simultaneously with warm feeling right toes lasting about 1 hr. cramps lasted approximately 3-5 minutes each time. The outcome of the events was unknown. No other vaccine was received in four weeks. Post vaccination, the patient was not tested for covid. The patient had known allergies only to Typhus vaccine many years ago.

see above....chills lasted for months until hot weather started, headaches still on going taking asprin each morning, weak and getting weaker, fatigue use to walk 6 or 7 miles 4 or 5 times a week now 2 or 3 miles twice a week and feeling tired

Patient presented to the ED and was subsequently hospitalized for right sided weakness and dysarthria within 6 weeks of receiving COVID vaccination.

the arm he had the shot in, he has loose skin under the arm; he feels numb under the bottom of his feet; numbness under his feet but today it is more pronounced; This is a spontaneous report from a contactable consumer or other non hcp. An 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 05Feb2021 (82-years-old at the time of vaccination) as a SINGLE DOSE for COVID-19 immunization. The reported indication was reported as that is what was offered. The patient's medical history included stents in his heart and back condition. The patient's concomitant medications were not reported. The patient reported that skin from his elbow to his armpit is more "flabby" than normal and he has "numbness under" his feet. He also reports having a prior injury, degenerative disc, in his back that sometimes causes numbness under his feet but today it is more pronounced. On 05Feb2021, the patient experienced having a problem with his arm he had the shot in, he has loose skin under the arm, he feels numb under the bottom of his feet. The outcome of the event the arm he had the shot in, he has loose skin under the arm was recovering and other events was not recovered. Follow-up (05Feb2021): Upon follow up, new information included: Age at time of onset of reaction/event details, patient details, adverse event details, medical history details, Event onset details, Lot details. Follow-up attempts are completed. No further information is expected.

Develop rash front of his left arm the injection on the side, the rash is on front kind of even where the injection was given; Pain in his left arm; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Started having a lot of pain in his shoulder, left elbow and it radiated down into his finger; Left elbow swelled; This is a spontaneous report from a contactable consumer (patient's wife). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9261), via an unspecified route of administration, administered in arm left on 04Feb2021 (at the age 82-years-old) as 2nd dose single for COVID-19 immunization. Medical history included hypertension (20 Years ago, patient don't know the exact date, at least 20 years ago), cardiac pacemaker insertion from Feb2020, bypass heart surgery on an unspecified date in 2006, neuropathy (patient did not remember its diagnosis date, patient only had bypass and to put in 2 stents). Concomitant medications included hydrochlorothiazide (Tablet) (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg (25 mg, 2 tablets per day) daily for hypertension; metoprolol (MANUFACTURER UNKNOWN), orally on an unspecified date at 25 mg twice a day for unknown indication; duloxetine (MANUFACTURER UNKNOWN), orally on an unspecified date at 30 mg once a day for unknown indication; hydralazine (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg thrice a day for unknown indication; furosemide (MANUFACTURER UNKNOWN), orally on an unspecified date at 80 mg once a day for unknown indication; rivaroxaban (XARELTO) (MANUFACTURER UNKNOWN), orally on an unspecified date at 50 mg once a day for unknown indication; ezetimibe (MANUFACTURER UNKNOWN), orally on an unspecified date at 10 mg once a day for unknown indication; clopidogrel (MANUFACTURER UNKNOWN), orally on an unspecified date at 75 mg once a day for unknown indication. Vaccination Facility at the doctor's office. The patient experienced started a lot of pain in shoulder, left elbow and it radiated down into finger on an unspecified date in 2021. 3 days age develop rash front of left arm the injection on the side, the rash was on front kind of even where the injection was given on 14Mar2021 (reporter stated that, read moderna (not clarified) had a problem with rash). Pain in left arm on an unspecified date in 2021. Event start date, it would had couple of weeks after the 04Feb2021 and patient had the rash right now. Probed for events start date, reporter stated, That one was about two weeks ago, everything was in left arm. When probed still having the problems (event), reporter stated, that was better but yes patient had still left, it improved but patient still have it, it progress started about 3 days ago. On an unspecified date, the patient underwent lab tests and procedures which included blood test they were fine, patient was almost fine had routine blood work done but now had not anything. Any treatment for the event, reporter stated, For the rash patient not had any treatment for, the pain in arm and everything the orthopedic doctor gave a shot of cortisone to see if that might have (treatment) and that was on 01Mar2021. When probed for cortisone dose (treatment), reporter stated, I have no idea, I don't know about that. Patient probed for cortisone dose (treatment), reporter had no idea and do not know about that. When probed for cortisone shot (treatment) site of injection, reporter stated, would be on left shoulder and frequency, just once. The clinical outcome of the event pain in arm was recovering and rest of the events were unknown. No follow-up attempts are possible. No further information is expected.

The patient lost the use of his legs completely; Bedridden; sores on his rear end and heels; cuts on his left arm; The patient started walking very very slow that afternoon and the next couple of days; Fell; Loss of mobility; This is a spontaneous report from a contactable consumer. This consumer reported for an 82-year-old male patient (husband) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6206) on 10Mar2021 at single dose for COVID-19 immunisation (82-year-old at vaccination). Relevant history included Neuropathy (Diagnosed over 10 years ago), lewy body Parkinson's (Diagnosed about 5 years ago), Open heart surgery (Over 10 years ago). Relevant concomitant drugs included Gabapentin for Neuropathy peripheral, Allopurinol for Gout, Modafinil CCL, Donepezil for Parkinson's disease, Carbidopa for Parkinson's disease, atorvastatin, 'tamiflosin' and potassium cloride 40. The patient previously the first dose of BNT162B2 (lot EN 6200) for COVID-19 immunisation on 17Feb2021. The events happened after the second dose of the vaccine. At that time the patient was able to get in the truck. The patient started walking very very slow that afternoon on 10Mar2021 and the next couple of days. The patient fell on 10Mar2021, 18Mar2021, 19Mar2021, 20Mar2021, 02May2021, and 02Jun2021. The patient lost the use of his legs completely. The patient was bedridden for 2 weeks. The patient had to get a hospital bed and lost a lot of his ability to get around. Prior to the vaccine, the patient was able to take a shower with an aid, walk to the truck and get in it, walk with a walker, walk 5 laps in his home with a walker per physical therapy, walk outside in the neighborhood for 30-40 minutes with his walker, could go to a restaurant and could sleep in a normal bed. After receiving the vaccine the patient's movements became slower the second and third day. The patient had one shower and sat down and couldn't get up so the aid had to take off her clothes and get him up and out. The patient was completely bedridden by day 6 and 7. The patient cannot enter their truck. They had to install a ramp from the kitchen into the garage for $2600. Since the patient couldn't get up, can't walk, and is bedridden he had to get a hospital bed. Medicare demands before you get a hospital bed and everything the doctor has to see the patient face to face. The patient didn't break anything, he has just lost the use of his legs. On 18Mar2021 they got the patient a hospital bed for $175 a month plus a $35 service fee. On 01Mar2021 a doctor came to the house and saw the patient and put it into Medicare. On 04Apr2021 a ramp was installed. The patient uses cab and a wheelchair at their expense. The filling fell out of the patient's tooth and he had to go to the dentist. They purchased a new bed mattress. They had to purchase an 18 inch wide wheelchair because the other one didn't fit in their house. Medicare is paying for physical therapy 2 days a week and they pay out of pocket $65 on Fridays. They pay an aid out of pocket 7 days a week. The caller called their regular doctor to see if he could get them a hospital bed. The caller didn't want to take the patient to the hospital because of COVID. The caller contacted the patient's ### for physical therapy and the doctor said he couldn't do it. The patient is now being seen at the ####. Since everyone is a #####, no one knows anything about this. The caller thinks the vaccine must hit the patient's nervous system. The patient's legs just give way. The patient can walk the length of the hospital bed to his lift chair. The patient had sores on his rear end and heels so they decided to put him back in his lift chair. The aids clean the patient in the morning then he eats, watches TV, the caller puts him in the lift chair where his feet are not touching anything. The patient's feet were healed last week (as reported). The patient has cuts on his left arm from his fall on 02Jun2021. The patient was so weak he had to start using a wheelchair instead of a walker, just of a couple days later. The caller will never have the patient get another shot because she doesn't want anything to happen to the patient. The patient is just quiet now and not sociable and stays quiet because of this. The patient has had blood work twice and a chest x-ray. The patient's blood pressure was always high. The patient was never admitted to the hospital as a patient for any of this. The outcome of events The patient lost the use of his legs completely, walking very very slow was not resolved, the outcome of events Fell, Loss of mobility was resolving. The outcome of other events was unknown.

Really tired for 3 weeks following the shot; Sick; Weak; Sleepy and couldn't stay awake; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date, at the age of 82-years-old, as single dose for COVID-19 immunisation. Medical history included ongoing blood pressure; suffered from cramps (ongoing). The patient was in good health Family medical history was none. Concomitant medication included blood pressure medication for blood pressure from an unspecified date and ongoing. No additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations (within 4 weeks). It was reported that the patient was really tired for 3 weeks following the shot. He was sick and weak. He was sleepy and just could not stay awake. Right after the patient got the shot, his symptoms started. The patient did not go to the doctor or the ER. He just got through it. He had no relevant tests done. Outcome of the events was unknown. Information on lot/batch number has been requested.

Pt. states about 3 months after receiving second Covid vaccine started having shoulder, hip and thigh pain. Went to several different doctors - orthopedic, PCP and got referred to a rheumatologist. After several months, finally got diagnosed with polymyalgia rheumatica. States symptoms have improved since being on Prednisone 12.5 mg PO daily. Pt. states sister was also diagnosed with same condition after receiving her Covid Moderna vaccine.

issues with his memory and being more confused/Confusion; tiredness/Fatigue; He feels like he is not getting enough oxygen, has had a cough, runny nose, issues with his memory and being more confused; cough; runny nose; Having problems with memory; Not Feeling Right; Muscle pain; Pain areas have been more painful/pain; Sore arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EJ1685 then says someone changed the 5 to a 6), via an unspecified route of administration in left arm (left shoulder) on 05Jan2021 (at the age of 82 years old) as single for covid-19 immunisation. Medical history included he had two ablations, close together 4 years ago, blood pressure issues from Dec2020 and ongoing, ongoing thyroid condition from several years, ongoing acid reflux, has been on medication on and off for this condition for 5-10 years. Concomitant medications included levothyroxine sodium, 75 mcg once a day for thyroid disorder taking this medication for several years; losartan, 0.5 mg once a day per for blood pressure abnormal from Dec2020 and ongoing, he used to take half a tablet; started taking a full tablet 08Mar2021; omeprazole, 40 mg twice a day for acid reflux, he has been on and off this medication for 5-10 years. Started taking it regularly in the past year. Also increased it to twice a day in the past year. He was on Eliquis for blood thinning. He was started it 01Mar2021. He had been on hit previously for quite a while and had an ablation and was able to stop taking it. Blood pressure went up so he was put back on it in Mar2021, before then he had taken it about 2-3 years ago. He currently takes 5 mg twice a day. Caller also mentions unspecified vitamins and herbs; no further information provided by the caller. The patient previously received flu and tetanus vaccines in Oct2020 and shingles vaccine in Aug2019. The patient did not receive additional vaccines on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The month ago (or more) he has been experienced tiredness, fatigue, pain, although he stated that he always has some kind of pain because he was 82 year old but it has been worse in the past 2 weeks. He felt like he was not getting enough oxygen, had a cough, runny nose, issues with his memory and being more confused. He stated that the tiredness and fatigue started out as intermittent about a month ago and said that it would "come and go" but now in the past couple of weeks it has been much more frequent. He also stated that he has been experienced a runny nose, cough and congestion for the past couple of weeks. He stated that since he got it; and for about a month or two, he has not been feeling right. He has tiredness, fatigue, all of his pain areas have been more painful, muscle pain. He doesn't seem to be getting enough oxygen; he really has to suck in air. His overall biggest problem was the fatigue. He stated that right after the shot he had no issues other than soreness in his arm on Jan2021; he has been going down hill since then. Tiredness and fatigue it has gotten worse gradually. It started a month or more ago. It has gotten worse over the last 2-3 weeks. He has pain all the time, he was 82 year old and something that always bothering him. Increased in pains started along with the tiredness and has also gotten worse over the last 2-3 weeks. He stated that his tiredness and fatigue was intermittent, but now it was more frequent. Before he had more good days than bad days. Now he has more bad days than good days. His feeling of not getting enough oxygen also went along with the tiredness. It has also gotten worse over the last 2-3 weeks. Cough and runny nose seem like it started in the last few weeks and has gotten worse. He has difficulty in answering the questions because his memory has been giving him problems and he's been confused more for about a month or so. It was gotten worse. The patient received second dose of the Covid vaccine (Lot Number: EL3249) on 26Jan2021, He was pretty sure that it was given in his left shoulder. He would like to know if he should go back to the VA where he received the Pfizer COVID-19 vaccine to be evaluated for these symptoms. The patient did not visit to emergency room or physician office. No family medical history relevant to adverse events was provided and no relevant tests were performed. The outcome of sore arm was recovered on an unspecified date in Jan2021, while with other event was not recovered. Information about Lot/Batch Number has been Requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.

Feeling tired with flu like symptoms; Chills; Experienced clots when blowing his nose; Feel bad; sore; Very tired; Sore; Leg pains; neck pain; shoulder pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 82-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: unknown) via an unspecified route of administration on 20May2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient Medical history included Heart attack from an unknown date and unknown if ongoing Verbatim: Heart attack, diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes. Concomitant medication(s) included carvedilol (CARVEDILOL AL) taken for an unspecified indication, Metformin taken for an unspecified indication, furosemide sodium (FUROSEMIDE AL) taken for an unspecified indication, tamsulosin taken for an unspecified indication, glipizide (GLIPIZIDE) taken for diabetes mellitus and finasteride (FINASTERIDE) taken for an unspecified indication start and stop date were not reported. On an unspecified date patient experienced Feeling tired with flu like symptoms, Chills, clots when blowing his nose, feel bad, Leg pains, the neck, shoulder, Sore. it was reported that after administration of vaccine patient started to feel bad, this was a first shot, leg pains, the neck, shoulder and chills on an unspecified date yesterday he started to feel a little better, today even had some breakfast and a little lunch and hour and half ago he stared to get chill again real cold and real achy again in his legs and So he kind of bunded up and he took two Tylenol, Confirmed Tylenol as treatment for the side effects He had the blow his nose constantly and he has been getting the 3 good size clots coming out of his wrong side of his nose on an unspecified date kind of blackish and blood and blood on the other side of his nose also. His only problem is his legs, he thinks he got neuropathy (Further clarification unknown), people make this know that some old guy hardly walk believe he just concerned that it might be a side effect and real sick and dying. The outcome of events was Unknown. Follow-up attempts have been completed and no further information is expected

CC: shakiness made pt felt as though pt was about to faint or blackout but didn't actually happen. per nurse report, it was how pt felt but didn't actually happen so pt was fine when the nurse checked back again after an hour later.

on 1/14/2021 out for appointment with family. Returned cold, clammy,m lethargic, thick tongue. POx = 84% on room air. pulse = 44, BP = 110/46. Blood sugar = 120. No fever. No signs/symptoms prior to this

When given vaccine patient felt a moment of shortness of breath, advised the staff also had flushing Benadyl 25 mg given to patient. Patient waited 30 minutes. all vitals were normal patient escorted to his car, drove home.

around noontime on 1/22 I suddenly felt weak and woozy and started to fall. Had to grab counter to stay from falling. Problem lasted for about a half hour. But a certain amount of weakness persisted and is still with me. Had one other wooziness episode on 1/24 at about the same time. This is new to me and may not be a reaction to the vaccination.

My legs were very weak. When I got out of the car, I could not stand and I fell . This happened twice within an hour. I hurt my right foot when someone was trying to get me up.

01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.

Client received the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Plans were for Hospice services. Client tested positive for COVID-19 by rapid testing on 1/8/21. On 1/10/21 at 0900 Client was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.

bronchitis; Arm soreness; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: A3246/H3246, via an unspecified route of administration from 12Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included asthma and ongoing cough. There were no concomitant medications. The patient had a minor cough and was spitting up phlegm but had no temperature before he got the vaccine. The patient had bronchitis but no virus currently. He still has a bit of cough. He wanted to know if it gets worse was, he allowed to take an antibiotic and if taking antibiotics or prednisone will interfere with the vaccine as he already received the first dose. He was asking if it got worse, should he wait five more days and then go to the doctor. He wanted to know if prednisone affects the vaccine. The only side effect of COVID-19 Vaccine was his arm was hurting for about four to five hours on 12Jan2021, but that was it. The patient took two Tylenol. Arm soreness went away maybe five to seven hours later. The outcome of the event arm soreness was recovered while bronchitis was unknown. Information on the lot/ batch number has been requested.

On 1/26/2021, resident had an elevated blood pressure of 183/102 and he was cold and clammy. Resident sent to ER via 911. He was sent home that same day. On 1/27/2021, resident found sitting in his apartment with a facial droop, slightly slurred speech and left sided weakness. Resident had also fallen the previous night and on the morning of 1/27/2021. Resident transported to the ER for evaluation and treatment and was admitted with diagnosis of TIA; rule out stroke.

Arm very sore chills for one night fever for one night loss of appetite general feeling of not feeling well general feeling of fatigue second day/ feeling slightly better but not back to normal

Could not walk, legs weak and not able to walk up stairs. Called physician who took him off his Statin and ran a series of blood tests. Call physician and saw him two days later. Ordered brain MRI and two days of nerve mapping of his legs and upper body. Waiting for final results.

Pt is on hospice services for 5 months for CVD/CVA. On 2/8/21 pts dtr called to report new onset seizure (no hx of seizures). Per dtr report only change in pts condition is that he rcvd the COVID vaccine on Saturday 2/6/21. Dtr called 911 due to severity of seizure.

About 6 hours later I fell. My legs could not hold me up. Next day I felt very weak, If I had to walk I had to hold on furniture, a general body weakness. At this time, pretty well recovered. The doctor sent in for full blood workup and chest scan and a brain scan and also the virus test.

feeling bad; Had no energy; everything spins inside the room/ went black; everything spins inside the room/ went black; This is a spontaneous report from a contactable consumer reporting for himself. An 83-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer- BioNTech, lot# lot# EL1284), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing wheelchair user, blood pressure abnormal and prostate infection. Patient's body weight was 218-220 pounds. Concomitant medications included acetylsalicylic acid (ASPIRIN) for many years at 1 DF daily, an unspecified prostate medication and an unspecified drug for blood pressure at 20 mg, another unspecified drug that is mixed and eye drops. The patient experienced feeling bad, had no energy, everything spins inside the room/ went black all in Feb2021 with outcome of unknown.

Sore arm; I had a little bit of a rash on my shoulder; Back is full of pimples, red pimples, like red marks; Back is full of pimples, red pimples, like red marks and they itch; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284 and expiry date unknown), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure, gout, and rash on the penis area. Concomitant medications included tacrolimus for rash on the penis area, allopurinol for gout, amlodipine for blood pressure, benazepril, hydrochlorothiazide, metoprolol, and unspecified vitamins. The patient has not had laboratory in the past two weeks but last month, and the everything was fine. On an unspecified date in Jan2021, the patient had sore arm. On an unspecified date in Jan2021, the patient noticed that he had a little bit of a rash on his shoulder but then he looked at his back and it is full of pimples, red pimples, like red marks and they itch. It is on the upper part of the back, around the middle. The patient did not take anything for said events. As they were on his back, he didn't notice them until last night (unspecified date in Jan2021), they started to itch a little bit. So, they could have been there for 2 or 3 days. The patient stated that the only thing he can think of is that it might be from the vaccine. Due date for the next shot is on 08Feb2021. Outcome of the events was unknown.

Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with AST/ALT in the 900s, T bili of 10, creatinine of 1.7. CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction.

Pfizer-BioNTech COVID-19 Vaccine EUA Patient presented to the ER on 2/14/21 after experiencing night sweats, fevers, urinary incontinence, flank pain, and generalized fatigue for 5 days. Admitted and treated empirically for sepsis. No source of infection found, fevers continued on IV antibiotics.

Fever of 101, chills and profound weakness. Patient was unable to ambulate. Patient was admitted due to these symptoms

neuralgia on the right side of the head down the ear 5 days after the vaccine; has not seen the doctor (2/26/2021)

The pains across his body keeps getting worse, the pains got a little better Saturday but then Saturday night it got pretty bad.; Loss of taste; difficulty talking; Friday night the same thing happened except the pains were a little higher and above his belly button; pain across body; little bit of soreness in left arm; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL9261, exp. unknown) , intramuscular on left arm on 21Jan2021 08:30 at single dose covid-19 immunization at a clinic. Medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine 100mcg once a day for thyroid. The patient experienced little bit of soreness in left arm (non-serious) on 21Jan2021 with outcome of recovered, pain across body (non-serious) on 28Jan2021 20:00 with outcome of recovering , the pains across his body keeps getting worse/the pains got a little better Saturday but then Saturday night it got pretty bad (condition aggravated) (non-serious) on an unspecified date with outcome of unknown, loss of taste (non-serious) on 01Feb2021 with outcome of unknown, difficulty talking (non-serious) on 31Jan2021 with outcome of not recovered , pains were a little higher and above his belly button (non-serious) on 29Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included thyroid function test was low on Sep2020 (levothyroxine was changed to 125mcg from 112mcg), thyroid function test was back towards normal but had not quite reached it on Nov2020 (new dose of 100mcg tablet once a day), thyroid function test was unknown on 25Jan2021 but was on 100mcg of levothyroxine once a day. Therapeutic measures were taken as a result of little bit of soreness in left arm and pain across body included Tylelol (acetaminophen).

On the 2nd day, I got chills, exhaustion, headaches, dizziness & weakness in the legs and coordination walking.

Cardiac arrest Narrative: An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.

Didn't realize what was going on; Whole body felt like itching, whole body was just feeling funny; Feet are numb and cold; Feet are numb and cold; Ended up in the emergency room because I was having some problems with chest pain; heart problems; Sick all day Saturday, all day Sunday, and most of Monday; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male (also age at vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right (reported as Right upper arm) on 27Feb2021 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunization. Medical history reported that "I have had one stent and one angioplasty done. Stent was done last year in 2020 and angioplasty was done in '1990' (not confirmed)." The patient also added "I gained a bunch of weight when I had my thyroid removed." The patient previously took the first dose of bnt162b2 on unspecified date for Covid-19 immunization. For the concomitant medication the patient stated, "Yes, I am taking medications." (specified medications not reported/ provided). It was reported by the patient that, "I got this, my second COVID-19 Vaccine shot Saturday morning. All day Saturday (27Feb2021), all day Sunday and most of Monday, I was so sick, I didn't realize what was going on. Yesterday (02Mar2021), I ended up in the emergency room because I was having some problems with chest pain. So, I presume this is all connected to the second shot I got." It was added by the patient, "I am asking question. About an hour or less than an hour ago I woke up, and my whole body felt like it was itching. I mean my whole body was just feeling funny. I was itching all over, that went away, I took a pill a while ago for that. 'Lorazepam' (not confirmed over the call), it's a nerve, anxiety pill and it kind of helped. But right now, my feet are numb and cold." For the laboratory test the patient stated that, "Yes they did a lab test on me yesterday (02Mar2021) as I went to the emergency room with some heart problems. They did blood work, that's all they did." The patient reported for the results, "They said everything was fine." The outcome of the events was unknown. The patient explained that "No, I didn't take any medication for that." However treatment was received for Whole body felt like itching, whole body was just feeling funny.

Arm soreness Joint pain shoulder pain stiff neck involuntary sleep leg cramps taking Tylenol, trying to stay hydrated, making doctor apt.

Blood in stool; Diarrhea; Severe weakness; Dizziness; Slurred speech; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at a single dose for covid-19 immunization. Medical history included ongoing high blood pressure and enlarged prostate. Concomitant medications included lisinopril taken for high blood pressure from an unspecified date and ongoing; tamsulosin taken for enlarged prostate; and amlodipine taken for high blood pressure. The patient had side effects: blood in stool, coupled with diarrhea on 02Mar2021, severe weakness and dizziness on 01Mar2021, and slurred speech in2021. The patient felt fine during the day and was able to exercise and it was in the evening of 01Mar2021, that he started to feel the weakness and dizziness. It was followed by diarrhea and he started to get some blood in his stool. The patient's daughter took him to the hospital on 07Mar2021. They were still diagnosing him now. The patient's daughter said that he was still having the weakness, but he has not really eaten anything. Outcome of events blood in stool, severe weakness and diarrhea was not recovered, reported as ongoing; event dizziness was recovered on 04Mar2021; outcome of other event was unknown. The patient was hospitalized from 07Mar2021 and ongoing for the event blood in stool. Information on lot/batch number has been requested.

Dizzy, throwing up, sore arm, chills, sweats, headaches, loss of appetite, could not stand due to dizzy or open eyes, temperature variance from 97 to 100.

Pt sts to nurse that he "feels weak" 20 minutes after receiving vaccine. Radial pulse 67 and slightly irregular. Day was very warm and patient sitting in very warm vehicle. EMS called. Patient transported to hospital.. Remained awake and alert. No syncope, shortness of breath or chest pain.

Resident began to feel ill at 2:30 am the night after he received 2nd dose of COVID vaccine. Suffered from weakness, chills, and nausea. Felt ill for approximately 2 days, but then symptoms subsided.

my left arch was very painful; not able to walk very well; This is a spontaneous report from a contactable 83-year-old male consumer (patient) reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 11Feb2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Known allergies included only dogs and cats. On 11Feb2021, hour after the vaccination, the patient experienced left arch was very painful and he was not able to walk very well. The patient did not take any treatment for the events. The outcome of the evets was resolved on an unknown date. Information on Lot /Batch Number has been requested.

rash or hives on whole body. Red blotchy marks. felt like pins jabbing; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; rash or hives on whole body. red blotchy marks. felt like pins jabbing.; This is a spontaneous report from a contactable consumer (patient, self-reported). An 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN9581 and expiry date was provided), via an unspecified route of administration, in the left arm, on 22Feb2021 at 08:30 AM (at the age of 83-years-old) as a single dose for covid-19 immunisation, at hospital. The patient had no known allergies. Medical history included cancer and finished chemo on 13Jan2021 (start date was unspecified date). The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 22Feb2021 at 13:00 on same day (as reported), the patient experienced rash or hives on whole body, red blotchy marks and felt like pins jabbing. The patient was treated with Cetirizine (ZYRTEC) 1/day, diphenhydramine (BENADRYL) 25mg at bedtime and acetaminophen (TYLENOL). The clinical outcome of the events was recovering.

Had very little pain at the injection site; severe pain in my left shoulder; could not raise my left arm to the side without severe pain; This is a spontaneous report from a contactable consumer patient(himself). A 83-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on left arm on 27Jan2021 04:30 PM as single dose for COVID-19 immunization. Patient medical history included diabetic, high blood pressure, overweight from unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient didn't have allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not tested for COVID-19 since the post vaccination. The Patient concomitant medication were not reported. Patient took unspecified other medications in two weeks. The patient experienced very little pain at the injection site on 1Feb2021 at 7:00 AM. After about 3 days he awoke with severe pain in his left shoulder and patient could not raise left arm to the side without severe pain in Feb2021. It seemed to be concentrated in the rotor cuff muscle. Patient not received treatment for the adverse events. The outcome of event was recovering.

Got first pfizer vaccine 4/7. Started to feel pain in right calf 4/9. Went to emergency room Hospital, 4/14 where after an ultrasound was diagnosed with blood clot in saphenous vein. Repeated ultrasound per primary care recommendation 4/21, no changes in size were noticed. Currently taking Advil.

Pain commenced in left arm Sunday evening about 7:00 P.M. . Thinking it may be a precursor to a heart attack visited Hospital. Following extensive tests to eliminate a heart problem it was determined the pain may be due to the Covid injection as no other untoward experience had taken place in that arm. Sunday night the pain was so intense the nursing staff administered morphine twice to achieve relief. Pain continued Monday and Tuesday, but is somewhat subdued by Tylenol. . Upon palpation of the left arm at singular site invokes extreme pain. The entire arm aches and feels "heavy."

Description of incident: Following administration of second COVID-19 vaccine, patient was sitting in the observation area for his 15 minute watch time. Staff noticed the patient was passed his wait time and noticed the patient was unresponsive in his chair. RN alerted critical response team and patient was brought back to the triage area outside of the gymnasium. Patient was somewhat more responsive to his name upon arrival to triage area. Blood pressure taken at 1435 and blood pressure was found to be 61/38 with a map of 45, taken on the right upper arm. Patient was immediately placed in the recliner and reclined with legs elevated. Per vaccinating RN, the patient was alert and oriented and speaking clearly when vaccine was administered. Initial Vitals at 1435. Blood pressure: 61/38 map 45 on right upper extremity with adult regular cuff. Pulse: 66; Respirations: 18; O2 saturation: 74% on room air. Patient placed on 15 liters of oxygen via non-rebreather mask. EMS called at 1437. Vital signs at 1438. Blood pressure: 96/56 map 69 on right upper arm with adult cuff. Pulse: 62; Respirations: 18; O2 saturation: 100% on non-rebreather. Clinical response team called, NP at side of recliner assessing patient. Vitals at 1440: Blood pressure: 104/61 right upper extremity with adult cuff. Pulse: 61; Respirations: 18; O2 saturations: 100% on 15 L non-rebreather mask. Vitals at 1442: Blood pressure: 104/59 map 74; Pulse: 59; Respirations: 18; O2 saturations: 100% on non-rebreather mask. EMS arrived to the triage room at 1446. Vitals at 1448: Blood pressure: 107/60 map of 76. On adult cuff right upper extremity. Pulse: 64; Respirations: 18; O2 saturations: 100% on non-rebreather mask. Blood glucose taken: 111. Orders initiated per RN protocol: None, protocol not warranted. Oxygen placed on patient via non-rebreather mask. Patient not wanting to go to the hospital, patient's daughter is on the phone trying to convince him to go to the hospital to be checked out. Patient stating "I just really want to go home." Patient's wife is here as well trying to convince him to go to the hospital. Patient attached to EMS monitors upon arrival at 1446. Vital signs at 1510: Blood pressure 153/80 map 108 on right upper extremity, adult regular cuff. Heart rate: 69; Respiratory rate: 18; O2 saturation level: 99% on room air. Vitals signs sitting at 1516: Blood pressure: adult regular cuff RUE 134/76 map 95; Heart rate: 76. Respirations: 18; O2 saturations: 99% on room air. Vital signs standing: Blood pressure: 156/79 map 104 adult regular cuff on RUE. Heart rate: 76; Respirations: 18; O2 saturations:99% on room air. Patient's daughter, here now at 1520 and speaking with patient and convincing him to go the hospital to be checked out. Patient now at 1531 agreeing to go to the hospital. Patient able to stand and transfer himself to the ambulance gurney. Patient outcome: Patient transferred via EMS to Hospital at 1534. Patient left vaccine clinic via ambulance at 1534.

PT HOSPITALIZED 4/26/21 WITH COVID-19 AFTER BEING FULLY VACCINATED. ACUTE ENCEPHALOPATHY DUE TO COVID-10. TREATED WITH DEXAMETHASONE. DISCHARGED FROM HOSPITAL, ON 4/29/21

Arm soreness Joint pain shoulder pain stiff neck involantary sleep leg cramps taking Tylenol, trying to stay hydrated, making doctor appmt. Went to ER because of hand and foot swelling. Diagnosed with Poly Myalgia rheumatica or PMR. Being treated at this time by Dr.

potential interaction between the COVID-19 virus and the virus affecting his cancer; small pain in [his] arm; This is a spontaneous report from a contactable consumer reported for himself. A 83 years old male patient received the Second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on 12Feb2021 for COVID-19 immunisation. Patient historical vaccine included received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on unspecified date as 1st dose single for COVID-19 immunisation. Patient medical history included has rare cancer called classic Kaposi sarcoma. Patient concomitant medication was not reported which was associated with a virus. Patient explained that this virus lived dormant in his body but last year, his immunes system became weak, and the virus activated. Patient added that it manifested as a lesion on his skin and his current prognosis is of 5 years. Patient stated he needs to start chemotherapy, yet after researching he found opposing recommendations as to when he should start his treatment following the COVID-19 vaccination. Patient added he also found a recent publication from a scientist in (publication name) stipulating a potential interaction between the COVID-19 virus and the virus affecting his cancer. Patient said based on this article the cancer virus may be activated by the COVID-19 virus; and wants to make Pfizer aware of it. Patient asked for general recommendation on how long to wait before starting chemotherapy. Patient mentioned speaking with HCP, including physicians and his wife but would like to get our perspective. He also reported having small pain in his arm after the second dose of vaccination and he took Tylenol, and it was fine now. The outcome was unknown for potential interaction between the COVID-19 virus and the virus affecting his cancer and recovered for pain in his arm. Failed to offer warm transfer to DSU. E-transmitting AE. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

4 days after receiving the vaccine the patients arm swelled up and was painful. Arm is bruised from deltoid to above the elbow . Purple and yellow bruises are still visible 3 weeks later. Patient did see physician and physician advised patient to receive the second dose

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were weakness, elevated CPK, anemia, non-traumatic rhabdomyolysis.

Chills; Fever; Weakness; I had couple of days when I had cough at night and little bit of this and that; I am worrying about the reaction because I didn't realize that I probably had Covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive; Muscle ache; Tired; I had like laryngitis type like my vocal cords were little bit swelled; Aches; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 12Apr2021 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure and mild case of COVID-19 both from an unknown date. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date was not reported. On an unspecified date, the patient experienced chills, fever, weakness, i had couple of days when i had cough at night and little bit of this and that, I am worrying about the reaction because I didn't realize that I probably had covid antibodies from the mild case that I had and then the shot hit me, was really bit apprehensive, muscle ache, tired, I had like laryngitis type like my vocal cords were little bit swelled and aches. It was reported that the patient had his first Pfizer shot last week and Monday, he had quite a reaction about four to five hours later and had chills, fever and weakness and so forth. He called one of the pharmacists about it and was asked if he had COVID before. The patient said that he was checked in for that but last month or so and was not checked down but he had couple of days when he had cough at night and little bit of this and that and he suspected that he might have something. The patient had COVID before he got the first shot within 5 or 30 days and that is why he got that reaction when that shot hit him. Now, the patient was concerned about the second shot, like if he will have a problem with that too, he was worrying to go to from about 2 or 3 days for that shot which was scheduled for next Monday, believed it is 3rd of May. The patient was really bit apprehensive about getting the shot simply because they usually recommend 90 days, in other words, after someone had COVID, to not get vaccination until at least 90 days afterwards. So, he was not sure what to do. The patient took as recommended for the fever, he took Tylenol and it was helpful as far as the aches, muscle ache and all that. Also, he was still very tired and the fever that he got after the shot was only for one day or he got it that night and lasted maybe till the next day and he was sure that it's going to come down and he will feel better. The weakness that linked, had a cough anyway, was going through this cough a little bit and had muscle ache. He also had like laryngitis type like his vocal cords were little bit swelled but was now getting better and it took like a good week like week and a half and that's why he was concerned about the second shot. The patient thought what he was hoping to do, was to stop a week or two and give it a little bit of time because he may be close to the 90 day window, it appeared the best way to do that but he thought that it was what the experts should be able to tell him. The patient underwent lab tests and procedures which included COVID-19 virus test: No- Negative on 23Feb2021. Therapeutic measures were taken as a result of events fever, muscle ache and aches included TYLENOL. The outcome of the event I had like laryngitis type like his vocal cords were little bit swelled was recovering and the outcome of all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Six days after 2nd Pfizer shot I woke at 2:00 am with intense pain in left arm and shoulder. Left arm had very limited motion, could not lift arm . Also had general pain in legs and right arm. Dr. gave me cortisone shot in left arm on May 7th , provided relief for one week. The ongoing pain and restricted motion in my left shoulder have continued for the past eleven weeks. Had MRI scan this week.

Pt states he had his 2nd Covid vaccination at his County Health Department on 6/10/21 and later the same day he began having significant difficulty breathing. He did not seek treatment and it resolved 24 hours later. he also claims he had significant pain in arm that vaccination was given in. Both symptoms have resolved.

The patient states a couple days after his second Covid Pfizer vaccination he started to experience pain inside his arm. He has a bruise next to where the vaccination was given. He has limited range of motion in the left arm.

For the past several weeks I have been experiencing terrible pain and stiffness in my shoulders and legs. The X-Rays taken show mild arthritis, but I did not feel this discomfort until the past several weeks. Just want to check if the vaccine could have caused it.

Numbness and pain in both arms and into right hand and unable to write (patient is right hand dominate). Symptoms, pain, nerve damage, and inability to use bilateral upper extremities latest for three days!

Presented to hospital for increased SoB and weakness. Diagnosed with COVID-19 on 7/8. Discharged home on 2L O2 and dexamethasone. On 7/12 presented again with hypoxia, elevated WBC/ D-dimer. O2 titrated to 5 L NC and transferred to our facility on 7/12. Oxygen requirement continued to increase and patient admitted to ICU on 7/14. Currently receiving dexamethasone and received tocilizumab 7/13. Received remdesivir initially but was discontinued on transition to HFNC> Currently on HFNC w/NRB 50 L at 90%

83-year-old male with past medical history significant for coronary artery disease with MI, CABG, atrial fibrillation, and COPD, who came to the hospital with shortness of breath. Upon arrival at the ED on June 12, 2021, the patient was in severe respiratory distress with oxygen saturation in around 70s. The patient was intubated for respiratory distress. The patient had recent angiogram with 2 stents placement. The patient was admitted to the ICU with acute hypoxic respiratory failure/ventilator-dependent respiratory failure, pleural effusion, possible pneumonia with sepsis, hypotension, and urinary retention. Critical Care, Cardiology, and Infectious Disease were consulted. Urology was consulted for the patient for urinary retention. The patient went to the OR for urinary retention and urethral stricture. The patient had transurethral incision of the vesical neck contracture. Foley catheter was placed. Infectious Disease was consulted for evaluation of the patient for positive COVID-19 infection. Infectious Disease recommended to continue COVID-19 isolation precautions, anticoagulation and steroids. The patient was seen and examined on June 15. At that time, Neurology was consulted for patient's seizure. Neurology saw the patient and recommended CT of the brain, which showed no acute intracranial process and EEG for further evaluation. Cardiology was consulted for evaluation of the patient for STEMI type 2. The patient had 2D with ejection fraction of 60%. The patient was on aspirin and Plavix. The patient had a recent stent placement. The patient was seen and examined on June 22, 2021. At that time, the patient was successfully extubated to nasal cannula. The patient was improving. The patient had IV antibiotics for suspected pneumococcal bacteremia and hospital-acquired pneumonia. Infectious Disease was following the patient. The patient was seen and examined on June 28. At that time, IR was consulted per Pulmonary request for thoracentesis. IR requested to hold Plavix for the procedure. The patient went to the procedure on June 29. The patient had 300 mL blood-tinged right thoracentesis done. The patient was seen and examined on July 3, 2021. At that time, the patient was lying down in the bed, no acute distress noted. The patient denied any chest pain or shortness of breath. The patient was status post thoracentesis. Infectious Disease was following the patient and IV antibiotics recommended. The patient was status post pneumococcal pneumonia with septicemia, bronchitis. At that time, Infectious Disease was okay to discharge the patient on p.o. antibiotics for 5 more days. The patient was discharged on July 3, 2021, in stable condition to subacute rehab with advice to continue outpatient followup for further medical care. The patient was stable at discharge.

Pt.received a Pfizer Covid vaccination but was supposed to receive a Shingrix vaccine. He received his Covid series (Moderna) 1/22/21 and 2/19/21. This was a third Covid vaccine and unnecessary. He experienced a sore arm for approximately 2 days. He did not experience fatigue or headache. He did experience chills and hotness (fever?) for 3 days. His doctor was notified by me, pharmacist and he recommended the shingrix shot 2 weeks after this Covid shot. He is not currently experiencing side effects.

increase weakness and fatigue, weakness in extremities, incontinent, jerky arm movements, within first 24 hours, continue to decline sent to hospital returned weaker, within 24 hrs hours BP dropped, low pulse oximeter reading, diaphoretic, lung sounds diminished, loss consciousness and passed away. 01-12-2021

painful hip; sore arm; This is a spontaneous report from a contactable consumer (Patient's wife). A 84-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at single dose (Left arm) for COVID-19 immunization (for coronavirus). The patient medical history was not reported. There were no concomitant medications. The reporter was calling about the Covid-19 vaccine. The reporter stated that her husband had a sore arm from the covid-19 vaccine on an unspecified date and that he had a different reaction. She said that he ended up with a painful hip and it was a side effect that was listed on the paperwork. She said that he is in really good shape for his age and that he is much better now. She said that he has very little soreness in his arm still. The pain in his hip has resolved. The outcome of the event painful hip was recovered and sore arm was recovering. Information on the Lot/Batch number has been requested.

The following morning, he experienced headache and loose stools./had really loose stool and was squirting liquid/ diarrhea; The following morning, he experienced headache and loose stools.; arm soreness; He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on left arm on 12Jan2021 at a single dose for COVID-19 vaccination. Medical history included Chronic obstructive pulmonary disease (COPD) (he has had it for years. He says he uses a machine when he goes to bed, a mask). The patient's concomitant medications were not reported. The patient previously took flu shot (unspecified) one injection a few (also reported as 3) weeks ago. The patient received the Pfizer-BioNTech COVID-19 vaccine on 12Jan2021 in the evening about 05:30-06:00PM. The following morning on 13Jan2021, he experienced headache and loose stools. The loose stools were described as "squirting" of over the next 5 days and then the loose stools started to improve. He says starting Wednesday he had really loose stool and was squirting liquid and it has bad for about 3 days. He says Saturday he started having loose, real loose stools, not squirting, but this has gone through to today. He says he still has a feeling kind of like he needs to go to the bathroom all the time. He says he never had a loose stool as far back as he can remember before, he didn't take anything for it, his doctor isn't giving the vaccine so he didn't contact him. He says he also didn't want to mess up by taking anything. He was squirting and had loose stool Wednesday morning and then that continued until today, he was not squirting, was having very loose stool, that was better, since he was not squirting. He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom. The headache gradually improved after the initial injection and he only has a little headache left currently. Patient had a headache the first couple of days, it was real light until now, he was still kind of not back to normal. He wanted to know if this will go away, since he is due for next virus shot in a week or so and was kind of dubious about taking it. On unspecified date in Jan2021, the patient had arm soreness that went away and was gone, he was sore for a couple days. The outcome of the events diarrhea and headache was recovering; event "He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom" was not recovered; and arm soreness was recovered in Jan2021.

At midnight started with chills, shaking in his shoes. Got up the next morning, was not feeling good. Went out for a little while and realized that he was cold. Went to bed for about 30 hours with a little nausea, but not feeling right. Took Tylenol every 6-7 hours during that interval of time. Feels good now.

patient arm hurt/very sore; swollen very hard; arm hurt and it was warm; very painful for him to touch where the injection went in; not comfortable; This is a spontaneous report from a contactable consumer (patient wife). An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, patient arm hurt, started to feel pain on 22Jan2021 and in the morning his arm was very swollen and very sore. He got up in the middle of the night and he said that his arm was swollen, and it was warm and swollen very hard, and 5 days later, the arm was still hard and warm and it was still very painful for him to touch where the injection went in. Caller was very concerned that this point that 5 days later could the shot gone in and then not gone anywhere just be sitting in that muscle. Patient can't touch it because it hurt too much. It was reported patient was not comfortable. Outcome of events was unknown.

Within 12 hours after vaccination, I became hot and sweating with pain all over my body. I went to bed at 7 pm and stayed in bed until noon the next day. The pain and sweats were 90% gone by that time. Total hours in pain+ was about 12 hours.

pins and needles in the feet, toes, bottom of the feet; it's just uncomfortable and the bottom of my feet; My wife says it can be Psoriasis; This is a spontaneous report from a contactable consumer (patient). A 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination, the patient park the car and all of a sudden he started to get like pins and needles they used to call in old days in his feet, in his toes. Last time he had this something like this years ago, he sat in the car too long. So, he loosen up his snickers and all and sat there, everything else was all right, a lady came over 15 minutes later and she said okay they can go. So the patient said he got some pins and needles in his feet, before he said the lady said "huh, are you having trouble breathing or anything", the patient said no he felt fine. So let they go home, and then the patient went home it's at night when he was laying down he didn't get much reaction and all. So he went up to the doctor she looked at up a few things and opened few things and the patient didn't think the doctor really had an answer for it. It was scheduled to go Monday again for the second it was still there. The patient didn't know it was probably kind of nerve reaction and all and his wife said it could be psoriasis, he never had this, it was not aggravating it's only when he walked he forgot he even had it . It's just uncomfortable and the bottom of his feet. He never had any reaction to any shot whether it was shingles or pneumonia, flu shots or whatever. The outcome of events was unknown. Information on the batch number/lot number has been requested

felt weak; Dysentery; violently sick; throwing up; dehydrated; dry heaving; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E18982, expiration date was not reported), intramuscular on the left arm (also reported as left shoulder) on 15Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that the patient was taking an unspecified blood thinner and other unspecified products. It was reported that patient got the first dose on 15Jan2021 and everything was fine. The following Friday, exactly a week later, on 22Jan2021 at 930am he got violently sick as far as throwing up and dysentery. He was asking if it could be from the shot. He got sick and was heaving for 7 hours, then he was dry heaving after throwing up so much, it was green bile. He knew he was getting dehydrated and drank a bottle of Pedialyte at 7pm that night. He had to stay a half hour after getting the vaccine since they wanted to monitor him a little longer since he takes blood thinners an other crap. He did not specify the other medications that he takes. On Saturday he felt fine but he felt weak. The patient recovered from dysentery and throwing up on 23Jan2021, while outcome of the remaining events was unknown.

Chorea type movements (intermittent twitching/spasms) of the right upper and lower extremities began at 3PM two days after the second Covid-19 Vaccination. My grandfather then presented to the ED for further evaluation. Work-up included a CT scan of the head (negative for acute CVA or acute hemorrhage), UA (negative for infection) and BMP/CBC (unremarkable). Physician ruled out acute causes of symptoms, diagnosed patient with acute choreo vs dystonia, and advised follow-up with PCP. My grandfather followed up with PCP the day after presenting to the ED day 3 after second covid-19 shot) and felt symptoms might be related to the second covid shot.

At midnight developed heart burn, low BP but normal O2; at 4am took Antacid then felt better and BP was normal. Then around 7am asked to go to ER because the discomfort became pain and moved to the side. Went to ER, mild Cardiac issue and at 3pm had heart attack and passed away.

A short time after the injection a tingley, prickley feeling went down both arms and legs to my hands and feet. I felt normal otherwise. The intensity varies but is always there. My doctor could find no serious problem and suggested a possible B12 connection and ordered a blood test. The test showed my B12 went from around 200 to over 1000.

my temperature and it's at 99.3 F/a little fever; weak; I didn't have appetite; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9264) via an unspecified route of administration on the left arm on 08Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS) via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included afib and heart rate (abnormal). Concomitant medication included propranolol hydrochloride (MANOPROLOL) for afib. The patient previously received first dose of BNT162B2 on 18Jan2021 for COVID-19 immunization (lot: EL1283 on the left arm) and experienced a little bit of soreness at the injection site. The patient took his temperature and it was at 99.3 F. Patient asked, "Is that within range? Can I take Tylenol?" The patient stated that when he first got his shot of the Pfizer Covid Vaccine at the (Hospital name) in (City name) he didn't have any problems or didn't experience any side effects. Then after receiving his 2nd shot on 08Feb2021, he mentioned that he started having trouble. On 10Feb2021, he started to experience some side effects and stated, "I was as weak as I could be, I didn't have appetite and I had a little fever. I just feel super weak but not like if you have corona. Now, I can sleep under oxygen and it doesn't bother me anymore and when I get up I don't need oxygen anymore and I can breathe freely." Wanted to know how long will his symptoms last. He was as weak as a rag, has a little fever that comes and goes, does not go over 101, stated he was taking Eliquis does not know if that was important or not, slept with oxygen but has not had any trouble breathing. Wondering if this was standard. The action taken for apixaban was unknown. Outcome of the event 'didn't have appetite' was unknown and not recovered for the other events.

Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Symptoms similar to thrush of mouth; I have sore throat and all inside my mouth is sore, my tongue is sore; Headache; Eyes are sore; Soreness in arm; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), via an unspecified route of administration on the upper right arm, first dose at age 84 years on 15Jan2021, at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient had the COVID Vaccination on the 15Jan2021 and he had minor soreness in his arm for 2 days and it went away, it was gone by the 18Jan2021. On 23Jan2021, he started with the symptoms similar to the thrush of the mouth and he went to the doctor 27Jan2021 and they told him it was not thrush because he did not have the white coating in his mouth, and thought it was reaction to the Covid-19 Vaccination (Covid-19 Vaccine by Pfizer) and he has a sore throat and all inside his mouth is sore, his tongue is sore he has headache and his eyes are sore. Patient's doctor told him to take Vitamin C and Vitamin D and Zinc, and he took his first dose this morning 27Jan2021, after breakfast which are Vitamin C and Vitamin D, but he haven't taken the Zinc yet. The outcome of the event soreness in arm was recovered on 18Jan2021, while for the rest of the events, it was unknown.

congestion in his chest; real deep coughing; hurting at the base of his neck/his shoulders were hurting from his neck down his arms to his elbow; dysentery; felt a little unwell; when he gets up, his back is giving him trouble; he can't stand up long because of the weakness; body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall; he can't stand up that well; his head was hurting in the back of it; his shoulders were hurting from his neck down his arms to his elbow; his shoulders were hurting from his neck down his arms to his elbow; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Feb2021 (at the age of 84 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported he came home after getting his shot, and he felt a little unwell but it was no too bad (04Feb2021). Then, on 11Feb2021, he started having dysentery. On 12Feb2021, he got congestion in his chest and a real deep coughing, and then he started hurting at the base of his neck. The patient used a chest rub which helped break up some of the congestion, but he is still coughing. On unspecified date in Feb2021, the patient also experienced his head was hurting in the back of it, and his shoulders were hurting from his neck down his arms to his elbow; his shoulders had been hurting so bad, he thought they would come off. Now (Feb2021), when he gets up, his back is giving him trouble, and he can't stand up long because of the weakness. His body also seemed to want to walk backward on his heels when he stands up and he is wanting to fall (Feb2021). The patient has been taking his dog out every morning, but it is hard to do that now because he can't stand up that well (Feb2021). Therapeutic measure was taken as a result of the event congestion in his chest. Outcome of the event real deep coughing was not recovered while outcome of all the other events was unknown. Information on the lot/batch number has been requested.

Chills; fever and a temperature (unspecified); Tiredness; Weak; This is a spontaneous report from a contactable consumer. An 84-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9262, expiry date unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter and the patient got the vaccine and it was reported that the patient got side effects on 30Jan2021. The patient got lot of chills, had fever and a temperature (unspecified). The patient also had tiredness and was very weak. He had to go to the bed in the afternoon and that was 24 hours later. The outcome of the events was unknown.

Patient presented to the ED reporting that he was feeling "real weak". In the ED, he was found to be hypoxic, tachycardic, and hypothermic with a temperature of 93.2. Pt has history of COPD (on chronic oxygen), HTN, CAD, atrial fibrillation, spinal stenosis, bilateral pleural effusions requiring thoracentesis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

Severe weakness 3 days after vaccine (3/5), to the point I which patient could not stand. Presented to hospital 6 days after vaccine (3/8). Hospital workup notable for CPK 45,720 U/L with CRP 109 (3/8) and low-grade fever (3/9). Negative infectious workup so far (BCx, Biofire, COVID PCR, UA without WBCs, no leukocytosis). He also had new thrombocytopenia to 84 (3/8), but possibly due to rifampin for LTBI. He remains admitted at this time, receiving fluids for rhabdo, undergoing further infectious and rheumatologic workup.

Injection in left arm at 4:15 pm. on Friday 3/5/2021. At 9pm, 3/5/2021 he complained of chest pain and was taken by ambulance to Medical Center Emergency Room. He was diagnosed with gallstones and discharged at approx 4:00 am on 3/6/2021. He found non responsive at home shortly thereafter.

arm soreness 2nd shot; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9243), via an unspecified route of administration on 02Feb2021 at the age of 84-year-old in Left Arm at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 84 years old on 12Jan2021 for Covid-19 immunization and the following morning on 13Jan2021, he experienced headache and loose stools/ had really loose stool and was squirting liquid/diarrhea. The patient experienced arm soreness on an unspecified date which the patient was admitted to hospital. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021050412 Same patient/drug, different dose

Received 2nd dose of covid19 vaccine on Wednesday 3-24-2021, felt fine Thursday, Friday loss of appetite tired, Saturday lethargic could barely function on his own. Sunday morning lethargic, weak, could not walk very well, complained of shortness of breath. Called 911 and took to emergency room. White blood count off, platelet level low, 14,000

Injection SUNDAY. within 2 hrs of the 2nd injection, he was amazed to no longer feeling the chronic pain throughout his shoulder. MONDAY: The following evening (after supper) he experienced severe light-headedness, followed by violent, prolonged projectile vomiting, during which, his eyes rolled back and he passed out while continuing to vomit. Low BP. transported to hospital; CT scan showed perforated esophagus, air in chest lining. 2nd CT: air and fluid spread to neck area, bowel obstruction/infection. TUESDAY: 5am: Transferred to hospice ward, unresponsive. Tuesday, 2:20pm: died.

Starting evening of 3/18 noticed right side of face was numb. It continued to worsen during day on 3/19. Went to ER, Sat. AM and was admitted same day. Tests were run and it was determined no Stroke had happened and the was told it was Bells Palsey. Spent 2 days in hospital while they ran more tests. Numbness continues.

extreme weakness beginning 3 days after shot; difficulty standing and walking; brain fog - often did not know where I was; could not understand what people were saying. This gradiually improved, but as of 4/7/21 much weakness remains. Hard to stay awake, but that is improving. Felt sicker than I ever have.

Presented to urgent care on 4/10/21 with fever, chills, weakness, and cough. Was tested for COVID-19 and diagnosed with pneumonia. Patient then presented to ED on 4/11/21 with the same symptoms and was admitted to hospital for further care.

The information was presented by his granddaughter. He was scheduled to come in for his second vaccination with his granddaughter on 4/14/21, however, he passed away on 4/13/21. His granddaughter stated he experienced a severe nose bleed just under a week post vaccination (1st dose/Pfizer). The nose bleed lasted a few hours and had to be controlled by the Hospital. The incident reoccurred a week later and again, the bleeding had to be controlled by nasal clamp and lasted for a few hours. The patient began having pain in his stomach and feet, and stayed pale and nauseous. On 4/13/21 the patient was found in his bed saturated in blood and had soiled himself. His family called EMS and the patient went to Hospital. The patient coded and was not revived. The granddaughter stated that he had an enlarge prostate that was discovered during one of his hospital visits in the past 3 weeks.

I didn't feel anything the rest of the day, but the next morning I felt that feeling tingling through my arm and it was there every day and wouldn't go away, it was the feeling like when you hit your elbow and it tingles but this was constant. The last few days it's moved up to around the shoulder, and I did have a lump that would come up for a few days but it's gone down.

Patient is an 84 year old male with a PMH of psoriasis, DM2 on insulin, HTN, HLD, who was admitted on 2/9/2021 with COVID-19 pna, weakness, and AKI. Pneumonia due to COVID-19 likely had concurrent bacterial infection present. Patient received 5 days of IV dexamethasone and ceftriaxone during admission. He was not a candidate for remdesivir. On day of discharge, chest x-ray showed persisting infiltrates and pt was discahrged with additional 5 days of oral dexamethasone. Patient discharged to home on 2/16/2021

WEAKNESS, SHORTNESS OF BREATH, NASAL CONGESTION, DEATH Narrative: Patient died after COVID vaccine dose #1 01/07 visit for chemo, stable 01/21 visit for chemo, stable 01/27 hematology visit d/t rash, likely heat rash 02/09 chemo for multiple myeloma, reports fatigue but no dyspnea 02/10 COVID vaccine dose #1 03/02 chest xray with concern for bilateral pneumonia, treated with antibiotics 03/08 pt having pain in back of the neck 03/09 pt having shortness of breath, transported to hospital with persistent generalized weakness with body ache and shortness of breath; diagnosis: atypical pneumonia, viral vs. bacterial, acute dyspnea with hypoxia, nonproductive cough, chest congestion, headache, and malaise 03/25 pt passed away COVID vaccination not likely contributor to patient's death, but is more likely due to advanced age (83 y/o) and comorbidities, especially active multiple myeloma, receiving chemo. No immediate reaction after first vaccination. Hospitalized a month after vaccine and illness persisted, leading to patient's passint. No COVID infection documented.

Presents with dyspnea for a few days. Pt was tested positive for COVID 19 one wk ago (outside health system). Pt also c/o L arm numbness. Pt denied f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to have hypoxic O2 sat at 89% and was put 2L NC. Pt got loading dose of ASA and dexamethasone (7 day course), completed 5 day course of remdesivir and received tocilizumab due to increased oxygen requirements. Pt also has mildly elevated troponin and cardiology was consulted in ED. St elevation noted 4/20 AM, heparin bolus given for acute coronary syndrome and ticagrelor LD. Left heart cath on 4/20/21 showed 3 vessel disease but due to difficulty revascularizing LAD in setting of worsening K+, Bicarb, S no further revasc attempts were made. Upon return to MICU, pt found to be hypotensive and bradycardic. PEA arrest. Family contacted during code and in agreement to transition to comfort measures.

her husband was really sick; he is still weak from it; horrible diarrhea; vomiting; This is a spontaneous report from a contactable Consumer. A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration in right arm on 03Feb2021 (at 84-years age) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter confirms that her husband received no other vaccines on the same day as the COVID vaccine. On 04Feb2021, the patient received the first dose of the vaccine and experienced diarrhea and vomiting on. The reporter wants to know if the patient could get this after the second dose, too. The reporter also enquired if someone does not have side effects from the first dose, could they get them from the second dose and wants to know what would happen if she delayed her second dose. Two weeks after receiving the first dose patient had a very bad reaction. The reporter wants to know if her husband would experience the same if he received the second dose. The reporter states that her husband no longer has the vomiting and diarrhea, but he was still weak from it. The patient took Imodium AD, because he could not leave the house to see his doctor, because the diarrhea was so severe. The outcome of event diarrhea and vomiting was resolved on 14Feb2021, for weakness was not resolved and for illness was unknown.

Presented to ED following witnessed seizure in setting of COVID+ and BG <50. Given dextrose. COVID treated with dexamethasone and antithrombotic - aspirin 81 mg and intermediate dosing of enoxaparin. Hospital course complicated by UTI. Discharged back.

He presented to the ED with Bell's palsy on 5/12. He had left-sided facial drooping when he woke up at 6 am. He was hospitalized overnight for hospitalization and was started on prednisone.

Day after 2nd vaccination. Legs felt unbalanced (rubbery feelings). Stability compromised - looks like he is drunk when he is walking. 2 days after 2nd dose - fingers became numb both hands. Patient reports he: Called CDC about it. Saw PCP and ran some tests, but no answers. Dr. Called a neurologist - don't want to see him unless referred by a PCP. Seeing another neurologist on 7th of June.

Hospital 5/22 thru 5/24/2021 Dx: UTI/ Weakness/ Right Pleural Effusion Covid Positive (5/22/2021) ED to Hosp-Admission Discharged 5/22/2021 - 5/24/2021 (2 days) Treatment team UTI (urinary tract infection) with pyuria Hospital Problem List Generalized weakness Resolved Pleural effusion on right Resolved UTI (urinary tract infection) with pyuria Resolved Lack of appetite Resolved UTI (urinary tract infection) Resolved Constipation Resolved Intractable vomiting with nausea Resolved

pain in his left wrist; arm pain and swelling to left arm; arm pain and swelling to left arm; swollen under side of his arm where he got the vaccine injected; pain in his left wrist, which was the same arm that he received his injection; This is a spontaneous report from a contactable consumer, the patient. A 84-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 13Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9262), via an unspecified route of administration, administered in left arm on 23Jan2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, occasionally rapid heart beat, blood cholesterol abnormal, cardiac operation (9 years ago, macular degeneration (in each eye and puts eyedrops in and occasionally they give him injections). Concomitant medication(s) included atorvastatin (LIPITOR [ATORVASTATIN]; 10mg everyday) taken for blood cholesterol abnormal; estradiol (ESTROGEN; 10mg everyday). The patient did not have any other recent vaccinations or started any new medications. The patient reported practically had no symptoms with either shot. After his first dose he had one day where his blood pressure went very low but by the time he talked to his cardiologist it had gone back to normal and was taking pills, it was under control. Yesterday afternoon he experienced pain in his left wrist, which was the same arm that he received his injection, and describes the pain as not too bad. He states that when he uses his wrist in certain positions, the pain "shoots up." This morning on the lower part of his left arm ("not the top where I got the injection") he has "slight pain." He says this morning his upper arm on the underside where he got it on the left side is swollen. He says he would like to know can it be from vaccine, though maybe he could have strained his wrist, it happened yesterday evening, he had wrist pain and swollen under side of his arm where he got the vaccine injected. He says yesterday late afternoon was the first time, it could be something else, it was the same arm this morning he has a little pain to his upper arm that was not on injection side but below, under it. The patient did not received any treatment, it was not serious pain, it was low level pain, when he uses his wrist and turns it, it comes in more prominent. He says it was not pain that bothers him, if it was not related to the vaccine then he most likely strained his arm. No follow-up attempts are possible. No further information is expected.

84 y/o M PMHx of non-hodgkin's lymphoma, adenocarcinoma of the colon (1996) and type 2 DM, presented ED 4/17 with complaints of weakness x 1 week. He reported some Memory loss but denied fever/chills, coughing, dyspnea or fever. Admitted for UTI. On 4/19 patient developed fever, tested positive COVID, started on decadron and remdesivir, pulmonology consulted. 5/1 increasing O2 requirements, prompting transfer to ICU. Mental status improved. 5/3: Fluctuant FiO2 requirements. Transferred to the floor and back to the ICU for hypoxemia. Intubated 5/7. Pt with worsening AKI, metabolic acidosis and shock in the evening of 5/8. Daughter on 5/9 and pt made a DNR. Worsening shock, metabolic acidosis and MODS. Decision to dc to hospice

The next day after the vaccine, I could not stand, no balance and drooping on right side of face. My spouse called 911 and thought I was having a stroke. I was admitted to the hospital. I had numerous blood work done and tests done and was diagnosed with TIA transient ischaemic attack and to follow up with a neurologist. I was in the hospital 3 days. I am being followed by the neurologist. I still have balance issues and the facial drooping is gone.

Patient admitted to hospital with positive COVID test after being fully vaccinated. Patient admitted to hospital on 06/15/2021 with right sided facial droop and right sided weakness. Initial admission test was "NOT detected." Patient with chronic cough since April. Was tested for COVID (NOT detected) on 04/20/21, and chest X-ray completed unremarkable for infectious process. Cough continued, patient seen again by PCP on 06/10 for cough. No further COVID testing at that time. Patient is fully vaccinated (Pfizer 1/18/21 and 02/08/21). No new or worsening symptoms during hospitalization related to COVID. Discharged to rehab (PT) facility once out of potential infectious period.

Patient admitted to hospital 7/28/21 diagnosed with COVID-19. Symptoms started 7/18/2021 and positive Covid-19 test 7/21/21. Repeat Covid-19 test on 7/28/21 to confirm diagnosis. Patient reports symptoms of nausea, nasal drainage, cough with yellow-green sputum, increasing SOB, generalized weakness, dry heaves.

Pfizer-BioNTech COVID19 dose #1 given IM LD at 10:30AM 1/27/21. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting. While seated, vital signs were taken- BP 148/76, HR 73, O2 98%. No falls or medication administered. EMS arrived around 11:10am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on EMS assessment, recommenedation was to go to the ER. Patient brought to Sharp Memorial Hospital by EMS staff at 11:20am, spouse was present and in agreement.

Heart stopped; Could not swallow; This is a spontaneous report from a contactable nurse (patient's wife). An 85-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure abnormal (verbatim: blood pressure) from an unknown date and unknown if ongoing, neuropathy from an unknown date and unknown if ongoing, weight issue from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, walker user from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes from an unspecified date to an unspecified date; and he was taking a long acting one as well. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates ("had flu shots before with no reactions and everything, nothing before"). On 24Jan2021, the patient's heart stopped (death, medically significant), and could not swallow (medically significant). The clinical course was reported as follows: The patient's wife stated the patient was taking insulin aspart (NOVOLOG) and he was taking a long acting one as well. The reporter, the patient's wife and a retired registered nurse (RN) stated, her husband (patient) just died and she thought he died from the COVID vaccine (later clarified the reason of death was-heart stopped). The patient had the vaccine on 21Jan2021, which was on a Thursday, and he was fine. On the following Sunday around 1:30 (on 24Jan2021), the patient was feeling a little weak, however, the patient's wife thought maybe his blood sugar was low. The patient's wife checked, and the patient's blood sugar was 91. The patient's wife went to get some yogurt to feed him in order to get his blood sugar up a little; "which was a normal thing for him, it was not that low for him." Then, suddenly, the patient fell, and the patient's wife could not get a pulse or anything. The patient's wife called an unspecified number and she started compressions; however, he was dead. The patient's wife stated the patient just had his heart test, a three hour long one, and it was "perfect three weeks ago." The patient had just gone to the doctor the other day and his blood pressure was "fine and everything." The patient's wife stated that other than his diabetes, "which he had for (sentence incomplete)." Regarding lab tests, the patient's wife stated, "No, he had it before but not in the last two weeks. He was going for one because we just went to the doctor last week and he was going to call yesterday to make the appointment request to get his blood work done. Blood work has been good except his A1C was always high, but other than that everything was good" (as reported). Regarding causality, the patient's wife stated, "I do, because he was fine until about half an hour before he died. He said to me, I feel a little weak today and then I was talking to him that your upper body strength is really good and then I said, we just have to work on your weight a little more because he did have neuropathy. And then, I went out of the room and all of a sudden I just heard him fall and that is when I just went in to check his blood sugar and it was 91 and I got him yogurt and he started eating that and then that was it, he started spitting it out and he said, I could not swallow and that was it, he just died." The patient's wife further added, "I just wanted other people to know that things like this happen and I am sure it was from that because he was healthy as could be. He was walking with his walker, the day before outside and he felt fine." The clinical outcome of the event, heart stopped, was fatal. The clinical outcome of the event, could not swallow, was unknown. The patient died on 24Jan2021 due to "heart stopped." An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart stopped

3 days after the shot he started getting flu-like symptoms. This included headache, diarrhea, tiredness, weakness, severe muscle aches, loss of appetite. Contacted his cancer dr. and was told to stop the Calquence for 3 days, drink 8 - 8oz of water a day (which he could not do and threw up after drinking), and to start taking Immodium, which he did.

Patient had R sided facial droop and slurring of speech at 9:30 AM 1/21/2021. Sent to Hospital where he was found to have CVA, with complete occlusion of the R vertebral artery from the origin of distal V3 segment.

unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient had no energy in the first 24 hours and then began a steady decline that started with vomiting after 48 hours, then an inability to swallow and ultimately the patients death on 2/5/21.

No adverse effects for the first two weeks. The morning of 2/7/21 he claimed he was not able to sleep the night before. He was cold, but only wanted something cold to drink. He was not able to get through his normal morning routine. By 8 am we was beginning to get confused and weaker. By 9 am he vomited and was not able to stand up or walk. The confusion was increasing. We called 911. When they arrived he had chills and was agitated. He did not have a fever at that time. He was transported to the emergency room. We were not able to accompany him there, but were told he was confused, agitated and combatant. His fever was up to 101 degrees. The started him on antibiotics and began tests. He tested negative for COVID and the flu. By that evening they diagnosed him with viral meningitis and admitted him to the hospital. The next day we were told that they had ruled out viral meningitis as well as other infections. The infectious disease doctor said that all tests had come back negative, but they were continuing to give him antibiotics. A neurologist and cardiologist were called in and they were not able to find anything either. He did complain of chest pains, but it was determined that it might be heart burn. They did see a sign of Afib, but test were not conclusive. On Friday, Feb. 12th he was sent home with antibiotics and heart medicines. The confusion has improved, but he is very weak and not mobile without assistance.

DIRECTLY FOLLOWING ADMINISTRATION Involuntary shaking in both arms for 2-3 hrs (severe). Not just trembles Fatigue to near incapacitation (severe) Muscular movement unresponsive Unable to stand, sit up right, raise arms Incontinence Confusion, non-responsive, fog 101.3 F temperature Strained breathing

Headache, worsening of his neurologic status, dizziness, change in gait, shuffling feet, then unable to walk, more sleepy, unable to move extremities, unable to speak, tremors

Resident rec'd COVID vaccine #2 on 02/02/2021 and was hospitalized on 02/03/2021. Diagnosed with UTI & Metabolic Encephalopathy. He was re-admitted to facility on 02/05/2021. On 02/08/2021 resident was found to be unresponsive with small amount of tan emesis in mouth and on bed. CPR initiated and resident was transferred to ER. ER MD notified facility that resident had died.

had trouble with his stomach in the bowels while sleeping; arm sore; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that his arm was sore the first night (23Jan2021) and did not take anything for it. On Monday night (25Jan2021), he had trouble with stomach in bowels while sleeping. He wanted to know if this was an occurrence from the vaccine or if it was a random occurrence. In all things that he read, diarrhea like symptoms were not mentioned. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Developed Belle's Palsy within 48 hours; This is a spontaneous report from contactable consumers. An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 03Feb2021 16:00 at single dose (left arm) for COVID-19 immunisation. Medical history included prostate cancer from 1994. The patient was not diagnosed with covid prior vaccination and since the vaccination, patient was not covid tested. Patient was not aware of any known allergies. Concomitant medication included bisoprolol. The patient did not receive no other vaccine in four weeks prior to Covid vaccine. On 05Feb2021, 15:00, the patient developed bell's palsy within 48 hours. The patient was treated with a prescription of prednisone 5mg. The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of event was not recovered. Information on the Lot/batch number has been requested.

Within 36 hours, 2/27 my knees swelled and I was unable to walk. On Sunday we went to The ER near where we were and had x-rays and ultrasound of my knee. Dr. took a fluid sample for culture but said it looked clear. I have no history of arthritis nor any injury. I am an avid bike rider and suddenly cannot stand on my feet due to extreme pain.

85 year old male who presents with 2 episodes loose black stools, weakness, decreased appetite, increased lethargy and subjective fever today, 02/22. Again admitted and had further rheumatological and infectious work up with negative results He was initially admitted to Hospital on 02/12 with fatigue, atypical chest pain, melena. He had received 2nd dose of Pfizer vaccine on 02/10. He was hospitalized from 02/12-02/15 and thought to have viral pericarditis. Diagnosis at discharge: SIRS DUE TO NONINFECTIOUS PROCESS W ACUTE ORGAN DYSFUNCTION. He was started on celebrex in addition to the the colchicine as an anti-inflammatory. After initiation of the anti inflammatory medications, patient's fever resolved, he started feeling better and his inflammatory markers decreased. He was monitored for another days and was feeling better. He is therefore being discharged home. In view of the negative work up, there is suspicion that these may be a hyper inflammatory response to the COVID vaccine since his symptoms were temporally related.

I experience muscle pain in my upper back muscles, both sides. When I moved my head, I felp sharp stabbing pains which made me shout. I could not sleep much on March 8 evening. The pain persisted all day Tuesday March 9, 2021. I called my ortho doctor and made a morning appointment for March 10, 2021 at 8:15am. I did not sleep much on evening of March 9. On Wednesday March 10 I went to the doctor. On this morning, the upper back muscles were OK, and the pain and spasms wer now in the neck. I could hardly move my head up or down and left and right. Dr. perscribed Methylprednazolone (4mg, 6-5-4-3-2-1 doses) and cyclobenzaprine 5mg (3x daily). after 1 day and 1 dose, I feel I can movemy head a little farther without the stabbing pain.

Extreme exhaustion and weakness. Loss of appetite. Incontinence. Inability to participate in activities of daily living. Possible stroke. Amnesia. Delerium. Visited Dr on March 1st. Bloodwork taken. Bloodwork showed high white blood cell count. On 3/2/21, Doctor advised patient to go to ER but patient refused. Urine sample dropped off on 3/3/21. Urinalysis showed bacteria in urine. Doctor prescribed cephalexin for possible UTI and ordered brain MRI without contrast. Patient is still exhausted and sleeping a great deal. Appetite is improving. Additional information for Item 18: Patient cannot remember any events between February 24-March 9, 2021. MRI done on 3/12/21. Waiting on results of MRI. Switched primary care on 3/12/21.

Patient is experiencing numbness of the left side of his lower lip/chin since COVID19 vaccine. On exam, he has no cranial nerve deficits but has a patch of subjective numbness involving the above area. Tongue is not involved. Entire dermatome of the Mandibular branch of the L Trigeminal nerve does NOT appear to be involved. There is no swelling. There is no pain currently. Need to assume that this is a vaccine reaction.

Patient received dose around 9 AM on 3/16/2021 and felt fine the rest of the day. On 3/17/2021, patient was so weak he fell at home and could not get himself back up. A friend was called who was able to help the patient up off the ground and got him a walker to use. Patient was able to get around using the walker, but then fell again around 20:00 on 3/17/21. He called 911 because he could not get himself up off the ground and EMS brought him to the hospital. Patient denied other symptoms other than new onset BLE weakness. Patient worked with PT/OT next morning and was able to walk 400 feet on level terrain and safely ascend/descend 4 steps with rails.

about 15 hours after dose of vaccine his daughter could hear him carrying on, and was standing but not responding to verbal cues. He was confused, wet himself, and still doesnt remember anything about the event or the ambulance ride. He would not and could not walk, and was sweating, breathing labored, they called 911. went to hospital and was admitted friday morning and was released monday. patient states his body was in pain from head to toe. His daughter stated he received antibiotics and fluids and is not sure what else. Patient is home now and is doing better.

Patient called morning of 3/22/21 reporting pain/soreness in right leg and joints starting day of vaccination (3/19/21). Patient routinely wears support hose on legs but indicates his wife finding bruising on back of his right knee. Also, beginning of today (3/22/21) patient states having right-side face tenderness and soreness starting at top of head, down the face, neck, shoulder, and into chest area, making it difficult to chew. Pharmacist on duty told patient to go to the ER as soon as possible. Going to call patient to check in this afternoon.

Patient reports that the morning after his 2nd vaccine on 2/26/21, he experienced severe lack of energy, with lightheadedness and N/V. He reports that symptoms lasted 2-3 days. He reported adverse reaction on 3/22/21 to his nurse

My father received his first Pfizer vaccine on 02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted several hours. They tested him for Covid and did a chest x-ray. Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5 days and was then released to nursing home for physical and occupational therapy. He was very weak and on days experienced what they called Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to his apartment, with extended visiting nurse therapy. On 3/10/21, was the first visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health Care. She checked his vitals. She said his blood pressure was good, lungs sounded good and oxygen level was 98. She said he was doing good and that she would not need to continue to come out and check on him weekly. She left. At 2:30 the same day, a Physical Therapist from Home Health Care came. She asked him lots of questions and adjusted my fathers' walker for him. He showed her how he was doing using the walker. Walked approximately 15-20 feet in his apartment. She checked his vitals before she left. His oxygen level was now at 91. She had him take a few deep breathes until his oxygen level was up to 93. She left and said she would be back on Friday the 12th to begin the actual physical therapy then. Within 10 minutes after she left my father started shaking uncontrollably and was having difficulties breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the way down to 74. They took him to the ER. When getting him out of ambulance he began vomiting. Vomiting lasted for hours just like when he went to the hospital back in February. They tried 3 different drugs to control the nausea. They did EKG, chest and abdomen scans. Was found that he had multiple blood clots and inflammation in his lungs and a bacterial infection in his blood. After testing, bacteria was found to be E Coli. Treated him with heparin for clots and antibiotics for infection and had him on oxygen in nose. Every day thereafter, he felt worse. They switched him to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked him up to a BiPap oxygen machine because his oxygen levels were dropping too low. We were then told by the lung doctor, that the damage to his lungs was extreme and that the next step would be to put him on a ventilator and feeding tube. My father did not want this per his will and his discussion with Dr earlier in the week. Dr indicated that he would not get better just being on the BiPap machine and we then chose to have them take him off of the machine because he did not want to go on life support. My father passed away on Sunday, March 14th around 6:30pm.

Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.

Pt fainted 10 min after receiving vaccine.He was talking to his friend who brought him in to the clinic when event happened.Pt fell from the chair, did not remember what happened.Initial BP is elevated,HR elevated,pt was pale and clammy and diaphoretic,O2 100%.Pt monitored for 30 min BP and HR stabilized. Pt was comfortable going home.

When I smile, only the right side of my face reacts. The left side of my face does not react at all. I thought I had a stroke, so I went to the emergency room after two days of being unable to move the left side of my face. They diagnosed it as Bell's palsy and prescribed prednisone (deltasone), 10 Mg tablets for 9 days.

PMH of CAD, HTN, DM2, atrial fibrillation on Eliquis who was last seen normal at 2330. Family heard a thud in pt's bedroom and found him on the ground with left gaze. EMS called, placed pt on a C-collar and brought to ED as a stroke code activation. On presentation, pt with left gaze and right hemiparesis and LLE weakness. He was non-verbal and not following commands. Head CT showed no acute hemorrhage. CTA with perfusion did not show a large vessel occlusion or significant hypoperfusion. Clinical picture suspicious for ictal event so he admitted to the NSICU for further workup.

Patient came in for vaccine with his son. During the screening, the patient's son answered all of the questions regarding the patient. The patient's son denied any previous serious reactions to medications including the components to the vaccine. Only medical condition the patient's son mentioned was hypertension. The patient was vaccinated, and appeared fine. Once he got to the waiting area, he stated, "I feel hot." His coat was removed, the manager was notified,. We gave the patient something to drink, a snack, and a cold icepack. Once the patient's condition continued to decline, vital signs were assessed. Blood pressure was 140/110, pulse oximetry was 87% on room air, and patient was placed on oxygen. I notified the manager to go grab the doctor as I was helping the patient. The doctor brought a glucometer to make sure the patient was not hypoglycemic, and the result was 117 mg/dL. At this point the patient was diaphoretic, and complaining of pain in his abdomen. He also complained of nausea. The squad was alerted, and came to get the patient. At this point the patient's pulse ox was 53% on 6L of oxygen. Patient's family was present with the patient, and the patient was then transported to the hospital via EMS.

Systemic: Fainting / Unresponsive-Severe, Additional Details: according to daughter patient crashed about 1 hour after receiving vaccine, taken to hospital in diabetic coma with glucosse level of 20..hospital trying to rule out TIA

Pt presented to ED at the recommendation of the PCP for low hemoglobin where he reported having increased generalized weakness for the past month, dyspnea on exertion, occasional lightheadedness. On arrival to ED was found to be hypotensive, with elevated WBC count, mildly elevated lactic acid level, and anemic at Hgb 7.5. An incidental finding of a positive COVID-19 nasal swab was found despite receiving Pfizer COVID vaccinations on 1/30/21 and 2/20/21. Pt admitted for additional management of sepsis, hypotension potentially secondary to COVID-19 infection and/or RLL developing pneumonia. Pt currently still hospitalized with worsening acute respiratory failure due to COVID and acute pulmonary embolism.

This 85 year old white male received the vaccine on 2/19/21 and went to the ED on 4/05 and was admitted with generalized weakness, hyponatremia, fever and elevated bilirubin. On 04/16/21, he went to the ED and was admitted to the hospital on 4/17 with poor appetite and hospital admission dx of ketonuria, leukocytosis, renal insufficiency, elevated troponin, hematuria, generalized weakness and died on 4/19/2021. 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.

Itching; Aches and pains; Pins and needles; This is a spontaneous report from a contactable consumer (reporting for herself). A 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25Feb2021 12:00 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation (85-year age at Vaccination). The patient medical history was none. The patient had no previous allergies. Patient states he has a pacemaker and has a stent in his heart. Both have been there for over 10 years. The patient's concomitant medications include carvedilol (COREG) at 25 mg, twice a day taken for cardiac disorder (He has been taking this for years). It was reported that patient previously took first dose of bnt162b2 (Lot number: EM9809, Expiry date: 30Jun2021) 04Feb2021 11:00. It was reported that during that night he was getting aches and pains, he took Tylenol and was fine for a while week. The week after that, he started to get pins and needles all over his body, and itching. He states it did not want to go away. Sometimes it was better, sometimes it was worse. The doctor gave him antihistamines, but it did not go away. All the doctor's say they have never heard of it, no one knows what it was. He read some place that they have few cases like this. He was just trying to find out what he should do. He was itching all the time and got pins and needles. The antihistamine helps, but it comes back. It has been over a month now, almost 2 months. He asks what he should do. He had seen a cardiologist, urologist, and his regular doctor. In the beginning he had itchiness and pins and needles all the time, but now it was on and off. For example right now he did not have it but when he woke up this morning it was there. He tried different soaps and different shampoos, just in case that was it. He even took off some of the medications for a couple days to be sure it was one of them but no. He was almost 100% sure it was it, he never had this before. Started the night of the shot. It got a little better in the night. The next morning he took Tylenol and felt better and thought it was all over. It was then explained that it started again about a week or so later and now he has it all the time. Itchiness began a week or a week or a half. Then says it could have been 2 weeks later. The symptoms are on and off. For the aches and pains he took Tylenol and it went away. The doctor that prescribed Coreg said he never had anyone having trouble taking this medication with the vaccine. He never heard of that. That was the first thing he asked. Outcome of the event Aches and pains was recovered on 26Feb2021. Outcome of the other events was not recovered. No follow-up attempts are needed. No further information is expected

bent over to look up and almost blacked out; swimmy headedness was really more noticeable after second shot; sensation in equilibrium or vision or whatever; weakness; felt different/really knew something was wrong/something is not right; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 09Feb2021 (Lot Number: EM9810) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2, at the age of 85-year-old, via an unspecified route of administration, administered in Left arm on 20Jan2021 (lot number: EL3302) as single dose for covid-19 immunization and experienced Vertigo, felt peculiar, nausea, dizziness/swimmy headed. The patient previously received the flu shot for immunization and experienced Sore arm. He is 85 and not familiar with all the goings on today but heard a report the other day and did not know there was such a thing as Vertigo. He thought that was just a movie. When he took the shot at (place name) in (county name) on 20Jan2021, soon thereafter, not that day but maybe next, he felt peculiar. It was just uneasiness and he did not feel right. That went on and on 09Feb2021, he got second shot and he got swimmy headed, but it has continued on since then and probably gotten worse, especially when he gets up in the morning. He has to hold on until he gets balanced or coordinated. It just doesn't seem right After he gets up and gets going, it is not as prevalent. But then sometimes it strikes him and he is just completely out of it. He later stated the peculiar feeling and swimmy headedness started the same day as the first injection, but he just did not really pay attention to it and thought it was just one of those things that you accept with getting older. Wife and he both went and he thought his feelings were merely from excitement or depletion or exhaustion. He felt like he had weakness and he just felt different. He got it at noon and waited for 15 minutes. Because of the events around him at the time, it did not register with him because it was the stress of driving 30 miles through expressway. Old people aren't used to driving that far. It got worse after the second shot and then he really knew something was wrong. When you are old, you have these feelings and pains and aches and all that stuff, and you just accept it as being old. It did not register with him until a couple of weeks ago when he heard it on TV about Vertigo and he said that is what he has. The swimmy headedness was really more noticeable after second shot, it brought it on stronger. He does not complain about things and thought it may just be getting old. He said it just kept on and getting a little worse and worse. Then he said something is not right and one day he bent over to look up and almost blacked out because of sensation in equilibrium or vision or whatever. He got scared and that was a couple of weeks ago. (name) was not cognizant of what was going on until he heard on television about Vertigo. One of the news channel mentioned or somebody mentioned it. It was just general things. He confirmed it was regarding someone who had gotten Vertigo after getting the vaccine but did not have a particular person to report on. NO ER or physician's office required. The outcome of the event dizziness aggravated and Weakness was not recovered, other events was unknown.

Patient presented to the ER on 2/3/2021 with a seizure 2 weeks after his Pfizer vaccination, and was found to have striking inflammatory lesions on MRI that we presume are related to inflammatory CAA. We placed him on steroids and his edema has resolved. He feels back to his baseline. We're uncertain to what degree the induction of an inflammatory response by the vaccine might have precipitated this event (of course it did not precipitate his CAA) but to be on the safe side, we stated that he should not get his second COVID vaccination.

Woke with fever at 1AM after receiving the shot at 11AM the previous day (14 hours later). Was moaning from discomfort. Don?t know his exact temperature until the next morning when daughter was called. Fever was 101.1 at 9AM. He was hardly communicative and close to unconscious until 7PM the day after the 2nd dose was administered. Consistently improved after 7PM.

Fever, discomfort, restlessness. Administered Tylenol at Dr's instruction; He collapsed and died. He first reported nausea occurring around 4 am on 2/25/21 and was uncomfortable all day. He felt worse that evening and was showing a fever. He was given Tylenol around 10 pm on 2/25/21. He fell asleep around 2:00 am on 2/26/21 and woke up around 3:00 or 3:15. He had a drink of water then collapsed. I performed chest compressions until the EMTs arrived but he was likely dead by the time they arrived.

Patient started to become progressively weaker within 3-4 days after getting vaccine. Family members became concerned and started taking him to doctor -- primary and oncologist and cardiologist -- they ordered multiple tests and could find nothing. No sign of cancer which had been in remission for months. Patient became progressively weaker over the next 2 weeks, was hospitalized, became unable to get out of bed; hospice was called, and he died May 13. No explanation could be offered by his doctors.

severe neurological effects twitching loss of use of left side mental state declined he completely changed 8 days after his second dose he went from being independent and working to now needing 24 hour care

Patient presents to ED with 2-3 weeks of weakness, fatigue, anorexia. No known Covid exposures. Cough, productive at times. CT scan shows extensive lung infiltrate consistent with COVID per note.

he was 6 feet but had shrunk a little; fever of 100.9; chills; pain around pacemaker in chest; lower back pain; had a sore arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: 3L3246) on right arm on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history included 3 heart attacks in the past and pacemaker from an unspecified date. Concomitant medications were not reported. The patient had a reaction to the Covid vaccine he received on 05Jan2021, stated he had a sore arm the next day 06Jan2021 that had resolved. Stated last night on 07Jan2021, he had a fever of 100.9 and chills and mild pain around pacemaker area in his chest and lower back pain. Stated he treated the fever and chills and pain with Tylenol and stated it had improved. The patient stated he was 6 feet but had shrunk a little on an unspecified date. The outcome of the event had a sore arm was recovered on 07Jan2021, for the event he was 6 feet but had shrunk a little was unknown, while other events were recovering.

Vaccine was administered on 1/12/21 at Memory Care. On 1/15/21 at 12:30 he developed slurred speech at his facility and slumped to his left side. Out of concern for stroke he was sent by ambulance to Hospital. There he was found to have no evidence of stroke on MRI or CT angiogram. He was admitted to the hospital due to fever and elevated inflammatory markers (ferritin, CRP) and transaminases. He was found to have a positive SARS-CoV-2 PCR and IgG. His symptoms resolved the following morning and may have represented a TIA. He had many markers consistent with COVID-19 and his CT pulmonary angiogram did show ground glass opacities but no pulmonary embolism. It was difficult to assess if this was a reinfection with COVID-19, persistent PCR positivity from November, or an adverse event to the vaccine.

right hand swelling, right knee swelling, right ankle swelling, facial swelling of left cheek Narrative: Following 1st COVID-19 vaccine dose on 12/17/20, patient seen at Emergency Department on 12/21/20- 12/22/20 for eval of new left cheek swelling and right hand/ankle swelling. Hand x-ray did not show signs of fracture, head CT did not show any signs of new strokes, and labs showed mild BNP elevation. Per ED note, "Based on the patient history, physical, and initial vital signs - the patient's initial presentation is concerning for heart failure/volume overload->pulmonary edema and bilateral pedal edema." He received ipratropium neb x1 and returned to facility. Neurology consulted (12/22/20), "It is difficult to determine whether the patient has a new facial palsy or whether this is recrudescence of his previous stroke deficits. Given the swelling of his left face it is quite possible that there is inflammation causing some partial left facial nerve dysfunction that would not include the forehead. The pattern of weakness is, however, also consistent with what would be expected from his documented right MCA stroke. At this point it is appropriate to consider this a possible complication of his vaccination (Bell's palsy has been reported in some after Covid19 vaccination). However, I would not recommend any specific treatment for the facial weakness as the etiology is still somewhat unclear." Patient admitted to hospital 1/2/21-1/8/21 for mild hypothermia with possible AMS and found to have adenovirus. Head CT negative for CVA. Sepsis/toxic/metabolic w/u was unrevealing. Given IVF for diarrhea; C diff negative. Discharged to facility. Patient received 2nd COVID-19 pfizer vaccine on 1/13/21 in Right Deltoid w/o complications (lot#: EK9231, exp. 04/30/2021)

Bell?s palsy on left side (onset 01/24) T/t Valacylovir 1000 mg PO TID x 1 week and prednisone 60 mg PO Daily x 1 week.

Lying in bed after midnight I got so cold my whole body was shaking. I had flannel sheets, an electric blanket on #4 and a heavy down comforter over me. I was still shivering and my teeth were chattering. Never been that cold in my life. It is now 9:00 a.m. I am still cold but not shivering. Also feel weak.

pain in right groin; difficulty walking; arm soreness; redness on the toe of his left foot; This is a spontaneous report from a contactable consumer (patient himself). An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1284, expiration date was unknown), via an unspecified route of administration on the left arm on 16Jan2021 at a single dose for COVID-19 immunization; it was offered to him and he was in the Phase 1B category. Relevant medical history included ongoing type 2 diabetes mellitus, which was diagnosed 10-15 years prior reporting, had a watchman procedure on an unspecified date, and had used a cane to walk before. Concomitant medication included clopidogrel as a blood thinner from 15Jan2021 and ongoing, which he would take for 6 months. The patient previously took apixaban (ELIQUIS). It was reported that he had a watchman procedure and they took him off of apixaban and started him on clopidogrel. In 6 months, he would not have to take any blood thinners and would make an appointment with his physician. On 18Jan2021, at noon, the patient was experiencing pain in his right groin. As the day progressed it got worse. By night (18Jan2021), he was in extreme pain and had difficulty walking. He had to use a walker to walk. It had let up, but he still had pain in the groin of his right leg. The patient was asking if there were certain doctors that could assist him with this problem. He was no longer using a walker. He was using a cane instead. He used a cane to walk with before this, but not for this reason. He never had any real serious aching. He had a little soreness in his arm on an unspecified date in Jan2021, but nothing out of the ordinary. He didn't know his arm was sore until he rubbed it. He though it might have been on Sunday when he noticed it. He was not sure. Prior to this, he had redness on the toe of his left foot on an unspecified date in Jan2021. He was prescribed an antibiotic that he was still taking. He was unable to provide the name of the antibiotic. Therapeutic measures were taken as a result of "difficulty walking and redness on the toe of his left foot. The patient had no investigation assessment. The patient was recovering from the event "pain in right groin," he was not recovered from the event "difficulty walking," while the outcome of the events "arm soreness and redness on the toe of his left foot" was unknown.

Received Pfizer Covid Vaccine in the AM on 2/9/21. Arrived to emergency department later the same day complaining of nausea, weakness, fatigue, Vomiting, Diarrhea. Post operative diagnosis, Ischemic colon/toxic megacolon.

Patient's partner reporting patient is having difficulty with movement 1 day post vaccination. She explains that although patient is limited he is able to move and stand, walk. However, today patient unable to do that. Is having difficulty with movement and is very weak.

The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.

MORNING OF 2/17/21, DEVELOPED WEAKNESS, AND INABILITY TO STAND. GENERALIZED BODY ACHES AND PAIN, AND CONFUSION. WAS TRANSPORTED TO THE ER AND ADMITTED TO THE HOSPITAL.

hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021. The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).

Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.

Nausea Dizziness Had slight seizure (lasted approximately 5 seconds- arms up and shaking, eyes closed, fell back in chair) Cold sweats (still nauseous 3 1/2 hours after injection, unable to keep anything down (including water)

During post vaccination observation pt complaint of weakness and was hypotensive. Transported to ED, blood sugar 39, given IV fluid and food. Other lab work within normal limits, symptoms resolved and discharged to home

/o fatigue, weakness around 1330. Beginning at 1700, caller c/o stomach cramps, diarrhea & nausea. Today, c/o intermittent mild cramps. Denies any other symptoms. Advised to increase fluids if possible, continue to take normal medications as prescibed. Follow up with PCP if you symptoms get worse, or UC/ER for severe symptoms

Jittery, shaking hands, tight muscles in chest (confirmed that there were no palpitations). Going to take tylenol and call doctor in morning if not feeling better.

2/27/21 hpi86 y.o. male with a past medical history notable for Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline. Hospital Course: patient was admitted to the hospital for worsening dehydration and finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment. 3/20/21 readmission acute renal failure

The background is he was hospitalized for 5 days in November 2020 for coronavirus, admitted with fever, chill, weakness, and inability to walk. Discharged with 3 weeks physical therapy to regain his strength. First vaccine on 2/4/2021 and within 24 hours experienced similar symptoms, profound weakness and fever. Second vaccine on 2/25/2021 and within 12 hours he was unable to walk, with weakness, fever, and confusion. He was taken by ambulance to the hospital on 2/26/2021. I did question his internist and the person at HealthCare facility on whether or not to proceed given prior reactions. During this admission determined to have heart attack with cardiac cath and stent placement. Brain MRI showed new 1cm occipital left infarct and developing pneumonia. Started on anticoagulation with Plavix and ASA 81mg. Readmitted to the hospital on 3/8/2021 with suspected GI bleed. Had colonoscopy and endoscopy with gastric erosion cauterized.

Within 15-minutes of vaccination, the patient reported pruritic, erythematous hives on his face and chest. EMS evaluated the patient on-site. EMS administered 50mg IM Benadryl and placed patient on O2lpm via nasal cannula. Patient was hypertensive (161/84) with a FSBG of 134mg/dl. EMS transported the patient to Emergency Department for further evaluation. In the ED, the patient reported that after receiving the IV Benadryl, their facial flushing, redness, and hives have disappeared. The patient did continue to have some generalized itching. The patient remained hypertensive (163/83). Physician administered 20mg IV Pepcid and 125mg IV SoluMedrol. Patient reported improvement and was discharged with a diagnosis of allergic reaction - improved. Physician prescribed Benadryl 25mg PO QID, Pepcid 20mg PO BID, and Prednisone 40mg PO QD for 4-days.

I had redness, warmth, tenderness and swelling of my right leg. I was hospitalized to received IV antibiotics.

I thought I was having a heart attack; I had severe left arm pain; I didn't get much sleep that night; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration at left upper arm on 08Mar2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib) and high blood pressure. Concomitant medications included unspecified medications. The patient was taking loads of medications. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization and reported that he had no problems with the first dose. The patient experienced severe left arm pain at the arm where the shot was given on 08Mar2021, the night after he received his second COVID vaccine dose. He almost called a number because he thought he was having a heart attack. What he did was he got up to walk around and the pain went away and when he sat down on his recliner, the pain came back so he didn't get much sleep that night. He was fine the next day. The patient took an ASPIRIN 325 mg coated pill because he thought he might be having a heart attack. If he had known, he would have taken the vaccine on his right arm. His arm hurt the night of 08Mar2021 until 6:00 AM the following day. The patient then stated that his recommendation was to tell the people who are administering the shot that a left arm pain may possibly occur because anybody who has the left arm hurting is afraid and can think they have a heart attack. The outcome of the event pain in arm was recovered on 09Mar2021 at 06:00 AM, and recovered on 09Mar2021 for all other events.

03/22/21: Patient presented and was admitted through ED for pain, redness and swelling to his left lower extremity which began 2 weeks ago. Patient had left leg ischemia with rest pain and foot ulcers. patient was on outpatient antibiotic treatment for same problem. Per the EUA, hospitalization are to be reported irrespective of attribution to vaccine.

her husband's pain is more in his right elbow and right shoulder/pain is more like a joint pain; right arm pain started with the COVID-19 Vaccine injection site/pain is in his right (dominant) arm; husband is experiencing a sore arm, husband's arm has been sore as worsened; This is a spontaneous report from a contactable nurse. A 86-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), via intramuscular route of administration, administered in Arm Left on 03Feb2021 14:15 as single dose for covid-19 immunization. Medical history included was none. Concomitant medication was not reported. Upon follow-up (16Mar2021): it was reported that, first dose of Pfizer covid-19 was shot on an unspecified date at 14;15 PM via intramuscular route of administration in right arm of Batch/Lot number: EL9269. She said her husband's arm has been sore for 8 days. Her husband's arm has been sore for 8 days was reported as worsened. She said her husband tried Advil, Tylenol, hot packs, cold packs, and nothing seems to help his sore arm, and pain was in his right (dominant) arm, the pain was more in his right elbow and right shoulder, and her husband's pain is more like a joint pain. She said her husband has a high tolerance for pain, and normally doesn't take anything for pain. She said her husband can't put his jacket on because he is unable to lift his arm due to the pain in his right elbow and right shoulder. She said her husband has been trying everything, and nothing seems to help his right elbow and right shoulder pain much. Clarified her husband's right arm pain started with the COVID-19 Vaccine injection site and then the pain moved into his right shoulder and then into his right elbow. Reported her husband had a CAT scan of his head and neck on 01Feb2021 checking for blood clots. She said the results of the Head and Neck CAT (Computerised tomogram) Scan were normal. Reported her husband's second COVID-19 Vaccine dose is scheduled for 24Feb2021. The reporter classified the event husband is experiencing a sore arm and husband's arm has been sore as worsened as disability and other events was not reported and assessed the causality between the event husband is experiencing a sore arm and husband's arm has been sore as worsened the vaccines as Related. Upon follow-up, it was reported that, the patient has a very sore arm for about 8 days but then it resolved and no trouble since then. His second shot did not have much of a reaction and both are fine now. Therapeutic measures were taken as a result of husband is experiencing a sore arm and husband's arm has been sore as worsened and included treatment with ADVIL at a dose of 200 mg (Lot Number: W36210, Expiration Date: Nov2019), TYLENOL, at a dose of 500mg, hot packs and old packs. Upon follow-up (16Mar2021), the outcome for the events were recovered on 11Feb2021. Follow up (16Mar2021): This is a follow-up spontaneous report received from a contactable nurse includes, updated information about the first dose of Pfizer vaccine, route of administration for the second vaccine and the outcome for the events. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering temporal relationship and known safety profile, the reported pain in arm was likely causally related to the vaccination with BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

The first doze made him tired and got back pain. Went to his Primary Doctor to see if it is okay to get the second dose. He got his blood work done, echo Cardiogram and all the necessary test have been done and he is okay to proceed by his Doctor. On the fourth day after he get the second dose of Pfizer-BioNTEch, in the afternoon, he couldn't get up from his bed that he had lay down. He experienced slur, facial droop and left side hand weekness. We called the paramedics right away and they checked him and took him to the nearest Emergency Hospital. They ran tests, did CT scan and diagnosed him with Ischemic Stroke on his right side which has effect on the left side of his body for facial droop and weekness and not being able to get up. He was threated with Mechanical Thromboctomy to remove the blood clot. He stayed in the hospital for 8 days and is bed bound up until now and is transferred to a re-hab. He still can't stand. Today is the 27th day since the adverse reaction started. His left hand has improved a little bit.

Suffered a stroke 1 to 1.5 hours after vaccination. He was driving when according to my grandmother he couldn't deccelerate and was having trouble communicating. Grandmother had to take control of the wheel and somehow stop the car by driving it off the road. Patient was combative with healthcare and had to be restrained and was confused about why he was there. he no longer remembers the events that lead to his hospitalization.

immediate soreness at injection site and worsened as time went on. Pain severe on shoulder movements at times, arm feels asleep and a lump developed on the inner aspect of the elbow.

possible heart attack; High pain in left arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in left arm on 08Feb2021 13:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from 2010 to an unknown date, hypertension from 1971 to an unknown date, both knees replace from May2011 to an unknown date, left shoulder replaced from Nov2011 to an unknown date, left eye cataract removal from Jun2013 to an unknown date, right eye cataract removal from Oct2013 to an unknown date, L4 & L5 disc repair from Aug2014 to an unknown date, Gall bladder removed from Sep2014 to an unknown date, Right shoulder, Kidney disorder, cramps, Virus fighter, Heart disorder, eye disorder, General Health, Blood thinner, R. shoulder pain, sleep disorder, constipation, Clear vessels. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. The patient experienced possible heart attack on 08Feb2021 with outcome of not recovered, high pain in left arm on 08Feb2021 with outcome of not recovered. High pain in left arm-possible heart attack on 08Feb2021. Reported it was not caused by shot, but result is possible pitched nerve- X-ray and CT scan Being done. AE required Scheduled X-Ray and then CT scan on neck. Treatment included the event did require the initiation of new medication/other treatment/procedure. Seriousness criteria reported as not serious. COVID-19 testing had not been conducted.; Sender's Comments: A contributory role of the vaccine BNT162B2 to the event possible heart attack cannot be fully excluded based on the temporal relationship. Patient's advanced age, underlying hypertension, atrial fibrillation, kidney disorder and other comorbidities provide alternate explanation for the event. Case will be reassessed if additional information is received. 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.,Linked Report(s) : US-PFIZER INC-2021277193 same patient, same product (second dose), similar events.

He has double vision; Weakness; Tiredness; Headache; He had problem with lymph nodes; doesn't feel good; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in left shoulder on an unspecified date (at the age of 86-year-old) at SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol abnormal. Concomitant medication included lisinopril taken for blood pressure. On an unspecified date, the patient experienced he has double vision, weakness, tiredness, headache, and he had problem with lymph nodes. The reporter further stated, "Now I realize that was Wednesday, now this Wednesday afternoon it will be a week do these symptoms last these long normally I am calling because I mean he is not ready for the hospital or anything like that but he just doesn't feel good." The reporter also mentioned that the patient has no fever. The patient was afraid to get the second shot. They are scheduled for the second dose of vaccine on 06Apr2021. There was no treatment received for all events. The patient was recovering from all events.

Minimally responsive; Severe left arm pain; systemic weakness and lethargy resulting in 5 falls within the week after the shot; systemic weakness and lethargy resulting in 5 falls within the week after the shot; systemic weakness and lethargy resulting in 5 falls within the week after the shot; This is a spontaneous report from a contactable nurse. An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 86-year-old, via an unspecified route of administration, administered in left arm on 24Mar2021 (Lot Number: ER2613) as single dose for COVID-19 immunisation. Medical history included cerebrovascular disease, HTN, DMII, dementia. Concomitant medications included metformin, glimepiride, amlodipine, acetylsalicylic acid (ASPIRIN (E.C.)), senna alexandrina leaf, and vitamin D. The patient was not diagnosed with COVID-19 prior vaccination and was not tested post vaccination. The patient has no known allergies. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EN6206) at the age of 86-year-old, on 03Mar2021 11:00 AM, intramuscular at the left arm for COVID-19 immunisation. On 25Mar2021 06:00 AM, the patient experienced severe left arm pain, systemic weakness and lethargy. This resulted in 5 falls within the week after the shot on 24Mar2021. Minimally responsive on 05Apr2021 and transferred with full assist to hospital bed. Gathered family for goodbyes on 06Apr2021 as appeared terminal. On 07Apr2021 some alertness in afternoon and strength has been slowly improving as of today 12Apr2021. No treatment was received for the events. The patient was hospitalized due to the event minimally responsive on 05Apr2021. The outcome of the events was recovering.; Sender's Comments: Based on the available information, the Company considers the reported event minimally responsive is unrelated to BNT162B2 vaccination but more likely an inter-current medical condition in this 86-year-old male patient with medical history of cerebrovascular disease, HTN, DMII, dementia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient reported tingling in fingers of right hand. Started about 1 minute after vaccine administration. Patient states he has a history of a pinched nerve in his neck that affects is right hand. Patient's wife states patient turned awkwardly when getting vaccine and this may have bothered his pinched nerve. Consulted Dr and after observing patient it was recommended that he follow-up with his Primary care doctor that follows his pinched nerve.

arm got sore; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This consumer reported events for both doses of bnt162b2. This is for the second dose. This 86-year-old male patient received the second dose of bnt162b2 via unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization and reported very little arm trouble the next day (barely). After the second dose 2-3 hours later his arm got sore, all day and through the night it was sore (couldn't lay on that side). It was 3 out 10 pain. The next morning it was over. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021394788 Same patient, different dose and event.

Received 2nd vaccine on 01/24/21. woke up on 02/03/21 and could not talk or walk. Very weak. Admit to Medical Center. tx to Hospital on 02/12/21. Was treated with steroids for dx of Autoimmune Encephalitis. Tx to rehab center on 02/24/21 . discharged home 04/30/21.

This 86 year old male received the Covid shot on 3/16/21 and went to the ED on 04/19/21 and was admitted on 4/21/21 with the following diagnoses listed below. G51.0 - Bell's palsy

shortness of breath, generalized weakness, loss of taste and smell, nauseated, diarrhea or abdominal pain supplemental oxygen per hypoxia along with IV remdesivir and IV dexamethasone, Tessalon for the cough

In 2017, at 83, my dad was diagnosed with Guillain-Barre. By the time he was diagnosed he had lost all use of his legs. After 2.5 months of physical therapy he walked out of the skilled nursing facility. He continued an active life involved with family, his church and the community. He received his first Pfizer COVID shot 1/27/2021 and noticed a tingling in his fingers shortly after, but thought nothing of it. He received his second Pfizer COVID shot 2/17/2021 and began to notice a marked weakness in his legs. This was reported to Dr., who began diagnostics. He was diagnosed with Chronic inflammatory demyelinating polyneuropathy (CIPD) and IVIG

While in observation he began to get clammy and sweaty. Vital signs were obtained which revealed elevated BP. After several minutes, BP was reassessed and was still elevated. Patient was AAOx3 and had no speech difficulties. Patient reports that his baseline BP is 140/65. BP noted as 206/89. ED notified and patient transferred via wheelchair to ED.

My nervous system is a wreck; Have not slept in two days; My digestive system is unfix, I have gone to bathroom like 3 times yesterday; I feel like I wanted to throw up; discomfort; This is the spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (Pfizer vaccine; Lot number: unknown; Expiry date: Unknown), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included unspecified Diabetes. Concomitant medications included Losartan (unspecified dose) and Xarelto 20 mg. On 26Jan2021, patient experienced my nervous system is a wreck (nervous system disorder), I have not slept in two days (insomnia), my digestive system is unfix , I have gone to bathroom like 3 times yesterday(gastrointestinal disorder), I feel like I wanted to throw up (nausea), discomfort (discomfort) and I can't you know (incomplete sentence) and the patient was just trying to find out, how long this side effect would last approximately or what to do, to ease my discomfort. Therapeutic measures taken as a result of the events; Tylenol and patient regular medications were taken. The outcome of the events were not recovered. No follow up attempts are possible. No further information is expected. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

On 3/20 this patient started exhibiting right sided facial droop and paralysis of right arm and leg, dysphagia. On 3/25 he was discharged from the hospital on hospice.

She has seen that sometimes he appears to be cold and he is tired.; She has seen that sometimes he appears to be cold and he is tired.; RBC 3.80/the counts were significantly low; blood count to be low; HgB 11.3; HCT 33.8; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm left on 28Jan2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes, coronary heart disease, intestinal polyp removed from 2014 she believes it was maybe a duodenal polyp. Concomitant medication included apixaban (ELIQUIS) took since 2018 or 2019 and ongoing. The patient historical medicine includes received first dose of BNT162B2 for COVID-19 Immunisation. It was reported that her husband received the first vaccination 28Jan2021 and approximately 3 weeks later received the second vaccination. They both got it at the same time. They were pleased and had no problems. It was reported that on 11Feb2021, they went to the primary care physician for a regular follow up and her husband's blood count was low. The doctor didn't tell them about her husband's low blood count in Feb2021. He did call attention to a seriously low count this past week. Also reported that Low blood count: Results from 11Feb2021, Red blood count: 3.80, Hemoglobin: 11.3, Hematocrit: 33.8, Does not have the paperwork from the results from last week, which indicated that the counts were significantly low. Treatment: None, he is scheduled to have an endoscopy and a colonoscopy 04Jun2021. Also reported he had Second dose and Unable to read the date, stated that it looked scratchy. Stated that is was something, 1, 2021. She is pretty sure she knows it was in a 3 week period. It was administered by the Fire Dept, LOT: EN620, thinks it is a zero, or 2 zeros mushed together. First dose was in the left arm and the second dose was in the right arm. Has read about anemia recently since Friday, She has seen that sometimes he appears to be cold and he is tired. Doesn't know what fatigue is but they are not 25 any longer and things change. He sleeps well during the night. He did have a surgical procedure 16Apr2021. They released an ulnar nerve in his wrist and elbow of his left hand. The patient underwent lab tests and procedures which included blood count: low on 11Feb2021, haematocrit: 33.8 on 11Feb2021, haemoglobin: 11.3 on 11Feb2021, red blood cell count: 3.80 on 11Feb2021. Th outcome of the events was unknown.

presented to the ED with generalized weakness progressing to fever, cough, dyspnea, myalgia, pneumonia. admitted to Hospital

This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown, Expiration Date: 31Jul2021), via an unspecified route of administration, administered in left arm on 12Mar2021 at 10:00 (at the age of 86 years old) as first dose, single for COVID-19 immunization at a Senior Center. The patient has no medical history (including any illness at time of vaccination) and family medical history relevant to the adverse event. No adverse event prior to vaccination. The patient's concomitant medications were not reported. On an unspecified date in Mar 2021, the patient started having problems where he would wake up at night and his right hand would be asleep and did not think anything of it since it had happened once in a while over the years. The patient further stated that he has had numbness in his fingers and the right hand only and then would have problems during the daytime where he would be sitting around and notice like the tip of his thumb, whole hand would go numb, or two fingers would go numb that would last several minutes up to 10 mins and then would slowly disappear. The patient also reported that this started getting worse a week in a half ago or 2 weeks. On an unspecified date in Apr 2021, his whole right arm was aching really bad and that lasted for about 15, 20, or 25 minutes and that continued to get worse but had has not happened during daytime. The night before the day of the report, the patient tried using a heating pad, tried sleeping in a chair, and tried to apply vibrations since it was so bad. The patient stated this started at 2 o'clock this morning and was still hurting at 6 o'clock and he thought he would have to go to the emergency room so he got up and showered and shaved and then all the symptoms disappeared. He was back to normal and it was getting pretty bad. The patient stated that his doctor did not think it could be with the vaccine. The patient was calling to see if these symptoms had been reported since he was worried about the extreme pain in his right arm that he had when the numbness happened. The events resulted to a physician office visit. Treatment was done in response to the events which included heating pad, tried sleeping in a chair, and tried to apply vibrations. Outcome of all events was not recovered. The patient received the second dose of BNT162B2 (lot number and expiration date: unknown), via an unspecified route of administration administered in left arm on 02Apr2021 at 10:00 as single dose for COVID-19 immunization. Information on the lot/batch numbers has been requested. Further information was expected.

vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 86-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Right on 05Feb2021 14:30 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included pacemaker (Caller says this was put in about 5 years ago this coming May); Blood pressure high (Caller says this was diagnosed about 35 years ago); high cholesterol (Caller says this was diagnosed about 35 years ago) and diabetes (Caller says that he had a little sugar, but everything is under control with medication. She clarifies that at one point they said he had diabetes and his A1 sugar or A1C when it was last taken was 7.1). There were no concomitant medications. Patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9261), first dose via an unknown route of administration on 15Jan2021 (Batch/Lot number : EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 06Feb2021, the patient experienced vomiting and diarrhea and lack of energy, poor eating. The patient received treatment for diarrhoea. It was reported that Caller was calling on behalf of her 86 year old male friend. Had the second dose of the Pfizer COVID 19 vaccine on Friday, 5Feb2021. On Saturday her friend had vomiting and diarrhoea and lack of energy, poor eating. Sunday vomiting had stopped but diarrhoea continues. Took Imodium today. It was reported that consumer clarified to be the Pfizer COVID-19 vaccine, second dose. She says that he had the same shots at the same time she had them but he has had severe reactions to his. She says that they got their second dose on Friday February 5th and the next morning he had severe vomiting and diarrhoea and no energy at all. She says on Saturday the 6th he had vomiting and diarrhoea, bit on Sunday the 7th he did not vomit at all. She says he still has diarrhoea yesterday and today and he was not totally listless but he had no energy. Caller says she has been feeding him rye bread with peanut butter on it and yesterday she fed him some toast with egg on it and then a bit later vegetable soup with crackers, then later he had some popcorn. Caller says she also started him on Imodium, which he started taking today on 8Feb. Caller says she was having trouble reading the Imodium label, it was not printed. UPC: Not provided. LOT: SHF081, EXP: May2022. She says that he took his first dose so far only which was two 2mg capsules by mouth. At the time of reporting, the outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.

His blood pressure went extremely low to 88/55; heart rate went to 160; was not a place on his body that did not hurt; charley horses in his legs; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 86-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot Number: EL9264) via intramuscularly on 02Feb2021 at 08:15 as SINGLE DOSE and first dose on 14Jan2021 (Lot number: EL3248) for covid-19 immunisation.The patient's medical history included myocardial infarction (from 2002 to an unknown date Verbatim: Heart attack), prostatic operation (from 2002 to an unknown date Verbatim: Prostate surgery), knee arthroplasty (from Jun2016 to an unknown date Verbatim: Knee replacement), cataract operation (from Feb2013 to an unknown date Cataract surgery), hypertension (ongoing), cardiac disorder Heart strengthener (ongoing), anticoagulant therapy (ongoing), sinus disorder (ongoing), lung disorder (ongoing), diuretic therapy (ongoing). Concomitant medications included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; ubidecarenone (COQ-10) taken for cardiac disorder from an unspecified start date and ongoing; (ASPIRIN) taken for anticoagulant therapy from 2002 and ongoing; Ipratropium (IPRATROPIUM) taken for sinus disorder from 2019 and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for sinus disorder from 2019 and ongoing; (FLONASE) taken for sinus disorder from an unspecified start date and ongoing; (BREO) taken for lung disorder from an unspecified start date and ongoing; spironolactone (SPIRONOLACTONE) taken for diuretic therapy from Dec2020 and ongoing; guaifenesin (MUCINEX) taken for lung disorder from Jun2020 and ongoing; leuprorelin acetate (ELIGARD) taken for prostatic specific antigen, neoplasm malignant from an unspecified start date and ongoing; alirocumab (PRALUENT) taken for blood cholesterol from 2018 and ongoing; melatonin (MELATONIN) taken for sleep disorder from 2015 and ongoing. It was reported that, patient was feeling great all day on 02Feb2021. The patient went to bed around 22:00 and at midnight he woke up and there was not a place on his body that did not hurt. He spent the rest of the night hugging a heating pad and had Charlie horses in both of his legs and had to force himself to walk on them. He said that he felt like he played in the super bowl after he got up that morning. He was concerned because the next morning he started having blood pressure activity. His blood pressure went extremely low to 88/55 and heart rate was 160 beats per minute at around 08:30. He took it again at 10:00 and it was 112/75 and pulse was down to 109. It remained at that number pretty stable until around 16:00 and at that time it was like someone upstairs said he was done, he quit hurtling, his blood pressure went back to normal and he felt great again. Outcome of the events was resolved on 03Feb2021. Follow-up attempts are completed. No further information is expected.

Stroke; Couldn't walk; Blood pressure was higher than the caller had ever heard of it being; Can't walk; His legs are numb; Has no control of his legs; Heartrate was elevated; Dizziness; This is a spontaneous report from a contactable consumer (Patient's wife). An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EWO169), via left arm on 11May2021 as single dose for COVID-19 immunization. The patient's medical history included Thyroid. The patient's concomitant medications included Levothyroxine, Tamsulosin Hydrochloride (FLOMAX), Dutasteride, Aspirin81. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number ER8731), via left arm on 20Apr2021 as single dose for COVID-19 immunization. On an unknown date in 2021, the patient experienced blood pressure was higher than the caller had ever heard of it being. On 28Jun2021 he experienced dizziness and lightheadedness and last night his heartrate was elevated but that resolved when he woke up. She reports that he had an eye appointment and walked in there fine but when at home she heard a crash and she saw him with his hand out on the wall, he had not fallen but she helped him get to a chair. On 29Jun2021 patient had Elevated heartbeat 30Jun2021 he suddenly could not walk his legs were numb and he has no control of his legs. On 01Jul2021 patient could not walk, on 02Jul2021 he had Stroke. She reports that they have a zoom appointment with his doctor at 3pm but when she spoke with the nurse, she was advised to take her husband to the emergency room within the hour. They have not gone to the emergency room. She reported that there was an urgent care across the street, but she could not get him to walk to be able to get there. She reported that she heard that there were people with bell's palsy and neurological problems that got the COVID vaccine. Patient performed lab test on 29Jun2021, and 02Jul2021 blood magnesium result was unknown and blood pressure result was high. The outcome of event (Heartrate was elevated) was recovered 0n 30Jun2021 and outcome of (blood pressure increased) unknown, rest of all events were not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number and hours of operation prior to a warm transfer.

he fallen split his head open and he thought he just would go to the ER; actually fell couple of times and he finally actually fell and hit his head and was taken to the ER; on June 1st, but he still couldn't walk but they sent him home, and he could not even move his hand; elevated blood pressure, elevated sugar and elevated potassium; elevated blood pressure, elevated sugar and elevated potassium; elevated blood pressure, elevated sugar and elevated potassium; he became weaker and weaker and recently he been using walker now; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand; on June 1st, but he still couldn't walk but they sent him home, and he could not even move his hand; his weakness got worse and he couldn't even move the walker because he could not grip it with his hand/ he became weaker and weaker and recently he been using walker now; This is a spontaneous report from a contactable consumer. A 86-years-old male patient received bnt162b2 (BNT162B2, Lot number: EN6201 and Expiration date: unknown), via an unknown route of administration on 19Feb2021 (at the age of 86-years-old) as dose 2, single for covid-19 immunisation. Medical history included diabetes and hypertension. The patients concomitant medications included 3 pills one was blood pressure, one for sugar, and one for Potassium correct, he took these 3. Patient previously took first dose of bnt162b2 (Lot number: EL8982) on 23Jan2021 and on an unknown date felt very weak and walking slow. Reported said he was just calling to report the side effects that happened to my uncle, after he get the Pfizer vaccine. Well, the first weakness was in January and February they did not think too much about it because it was not one of the side effects that were told to watch out for. So, they noticed, my aunt and my cousin noticed that he was having trouble in walking and he used to walking and drive and to the church on regular basis after his first vaccine he had trouble walking and he started moving very slowly that was unlike him and he became very weak. He always has been a walker and that was not normal for him, he was very healthy. So, that was the first injection and then he got the second injection then nobody realized about you know, weakness was none that, no side effects that we talk about, you know from you providers that you read about and what was on the news. So, he got the second injection, and he became weaker and weaker and recently he been using walker now. His weakness got worsen and he could not even move the walker because he could not grip it with his hand. He could not use his hands and it got worse and he has fallen a couple of times, but they did not take him to hospital as he did not want to go to the hospital it was not until 05Apr2021 that he fallen split his head open and he thought he just would go to the ER. He fell couple of times and he finally actually fell and hit his head and was taken to the ER. From the ER he was transferred to the hospital. He was hospitalized and then they could not find anything wrong with him. He first went to the ER on 10Apr2021 at 21:30. Patient was in the hospital for three days on 14Apr2021 they transferred him to a rehab and he was there for 6 weeks and he was sent home on 01Jun2021, but he still could not walk but they sent him home and he could not even move his hand, so, he got taken back to the hospital at the hospital request on 14Jun2021, and she said to keep him bed rested at home and 2 days to be rested here that he fell or might now fell until we find care for him but we need to go back so she called 911, took him back to the hospital, second rehab and she came back to the hospital and they still could not find anything wrong with him and he got transferred on week later on 21Jun2021. Patient did not receive any other vaccine prior or during the covid vaccine. It was reported that he has both Diabetes and Hypertension but doctor was absent because he has Diabetes for about 25 years and when my aunt told them that she thought that it was related to the vaccines then they just said they have no idea. They just said they had no idea they wished what they knew what was wrong with him, because everything was normal with exception of elevated blood pressure, elevated sugar and elevated potassium. At the time of reporting, he weighed about 139 pounds. Since he has been out of hospital, he has lost about 25 pounds. Reporter stated that, she has to pay out of her pocket for his rehab because they did not know what was wrong with him and her insurance only cover certain amount of days and she was trying to figure out how she can get some assistance in paying for that rehab visit because they paid certain number of days and then she ready to go but he was not ready to come home so she had to pay out of her pocket to keep him there and also trying to see if that is something that pfizer would reimburse for. Reporter stated that, her insurance would not cover all the kind of aiding there and then they sent him home and then he had to back to his status because nurse said he should not be home he is too fragile and that was dangerous for him to keep him in the hospital, if he falls, he falls. She was asking if can either reimburse my aunt for the extra days that insurance did not cover, she had to pay out of her pocket for those because insurance did not cover everything and the doctors, nobody know what is wrong, they just says I wish I knew what was wrong, they can see that he was weak, they can see that he can not walk, he can not feed himself, so he can not be home and yet none of this happened if he did not have these vaccine. Upon follow up, reporter stated that, all events were reported yesterday, first was an ER visit, the doctor said they had no explanation, what was causing this, the weakness, he used to drive, he did daily walks, was active, it all started after the first injection, but at the time, no one knew to look for fatigue, they looked for flu like things and he fell a couple times, but he got the second shot, he got worse, and he went to ER because he fell and cracked his head on wall and cut it open, so he was taken to ER and admitted. Reporter did not know why the lady last night gave her a number that was not valid. Outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

He started walking more slow and he became very weak; He started walking more slow and he became very weak; They looked for flu like things; He fell a couple times; This is a spontaneous report from a contactable consumer. A 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 23Jan2021 (86-year-old at the time of vaccination) (Batch/Lot number: EL8982, number/Expiry date: Unknown) as single dose for Covid-19 immunization. The patient's medical history included diabetes for about 25 years and hypertension. Concomitant medication: Reporter stated, "He was on 3 pills one was for blood pressure, he took one for sugar, and one for potassium correct, he take these 3." Reporter stated: "he was calling to report the side effects that happened to the patient, after he get the Pfizer vaccine." Reporter stated, "He had his first injection and after that injection, it was noticed that he started walking more slow and he became very weak. He always had been a walker. And that was not normal for him, he was very healthy. All events were reported yesterday, first was an ER visit, the doctor said they had no explanation, they asked what is causing that, the weakness, he used to drive, he did daily walks, was active, it all started after the first injection, but at the time, no one knew to look for fatigue, they looked for flu like things, and he fell a couple times. Reporter stated, "Yes, he had both diabetes and hypertension, but doctor was absent because he had diabetes for about 25 years and when aunt told them that she thought that it was related to the vaccines then they just said they have no idea." Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

According to staff present, patient was found nonresponsive. Nurse Practitioner and RN entered room too assess resident. He was slow to respond, but appropriate. He was very warm to touch. Temp was 100.4, BP taken manually 158/78. Spo2 95% on room air. received 1st dose of vaccine yesterday 12/29/2020 at approximately 1230 pm.Chest X-ray and STAT labs were ordered. After a few minutes pt was awake and alert and oriented to person, place, and time and back to his baseline. Resident was given acetaminophen for fever.

Fell; Weakness in legs; got so weak; His legs just continued to get worse/He could not get up without help; He could not walk; This is a spontaneous report from a contactable nurse reported for her father. An 87-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular on left arm on 13Jan2021 (Time the vaccination was given: 13:00-13:15) at the age of 87-years-old at single dose for prevention because of age group. Medical history included covid-19 in Jun2020, forgetful from an unknown date, he got a little forgetful sometimes, so he may have forgotten to tell her. This occurred prior to getting the vaccine. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) was none. Family medical history was none. The patient got the Pfizer COVID vaccine last week on 13Jan2021, he was really sick in Jan2021. The patient had weak legs anyway, but he got so weak. Weakness in legs started at night on 13Jan2021, around 20:00. No emergency room (ER) or physician's office required. He never complained of any symptoms and did not know if there were other symptoms, because he did not complain. He fell on Thursday night on 14Jan2021. He got the vaccine around 1:00-1:15pm, and got so weak, that he went to the bathroom and he fell in the floor. His legs just continued to get worse. It started on Wednesday night on 13Jan2021. He could not walk in Jan2021. Thursday was the worst. By Friday, it started to get better. He did not get hospitalized. He could not get up without help. The patient had Covid 19 in Jun2020. He had a lot of symptoms after receiving the first dose of the vaccine. The reporter reported her father fell in the bathroom while brushing his teeth and her brother had to come over to get him up. The reporter was starting to wonder if he should take the second dose. The outcome of the events Weakness in legs and fell was resolving and of the other events was unknown. The reporter considered event Weakness in legs was serious due to medically significant and disabling; considered event fall was serious due to medically significant.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of the events muscular weakness, fall and gait disturbance cannot be excluded. The events are confounded by the elderly patient's underlying conditions. The impacts of this report on the benefit/risk profile of the 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.

EMS WAS CALLED PATIENT BECAME WARM BUT CLAMMY, PALE AND LETHARGIC WHEN EMS ARRIVED PATIENT WAS ALERT AND RESPONSIVE

Patient was admitted for AMS, possible UTI. Patient also tested positive for COVID-19 at this time. He stayed overnight, was felt to be stable and was discharged. He was readmitted 1 day later under observation for weakness, treated, and discharged to a nursing home

Patient received both doses of Pfizer vaccine. Patient reports around 5 days after the vaccine, experienced shortness of breath, generalized weakness. On admission (about 10 days after completion of vaccination), patient is diagnosed covid-19 pneumonia with covid pcr positive and chest x ray consistent with pneumonia.

Patient presented to ED with reports of weakness stating that he was lightheaded and felt like he was going to pass out. Also stated that he had nausea. Patient lowered himself to the ground and called his son to help and take him to the hospital. Stated that he frequently has dizziness in the mornings (for the past 5 years) and that they have increasing in frequency. On arrival to the ED, he continued to have generalized weakness and was unable to sit up.

[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.

chills; sore arm; Did not feel well during the night; This is a spontaneous report from a non-contactable consumer (non-healthcare Professional reporting for a patient). A 87-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number Unknown), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 13:15 (at the age of 87-years-old) as a single doe for covid-19 immunization The patient medical history and concomitant medications were not reported. The patient has no known allergies. 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 13Feb2021 The patient experienced chills, sore arm and did not feel well. The clinical course is as follows the patient didn't feel good during the night and had chills during the night. Feels fine 24 hours later except for a sore arm. No treatment was given for the events. The clinical outcome of the event chills, and malaise were recovering while sore arm was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Unable to stand or walk; Unable to stand or walk; Pulmonary edema weakness; Temp. 101.7; Vomiting; weakness; This is a spontaneous report received from a contactable consumer (daughter of the patient) reported for in response to HCP follow-up letter sent in cross reference case. A 87-year-old male patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 03feb2021 (formulation: Solution for injection, lot number: EIV6202) via intramuscular route of administration at single dose for covid 19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID Immunity on 06Jan2021. On 04Feb2021, the patient was unable to stand or walk. It was reported that the patient had to call all could not get off couch, no strength in his legs. All came could not stand or walk. On an unspecified date, patient had temp. 101.7, vomiting, SOB, chest X-ray showed pulmonary edema weakness. The patient received IV Lasix, one dose IV Antibiotics, physical therapy consult. On 05Feb2021 he could stand again on his own and able to walk on 06Feb2021. Discharged home on 07Feb2021. The outcome of event pulmonary edema was unknown and rest of the events was recovered on 11Feb2021. The reporter assessed the events are related to drug.

he is experiencing soreness in the arm.; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer reported for an 87-years-old male patient (husband) received first dose of BNT162B2 (solution for injection; Lot Number: EL8982) via intramuscular at left arm on 27Jan2021 12:30 PM as single dose for covid-19 immunisation. The patient medical history reported None and concomitant medications were not reported. The reporter stated that her husband received the vaccine as well he is experiencing soreness in the arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Therapeutic measures were taken for this event. The event considered non serious. The outcome of the event was unknown.