Pfizer

Patient c/o light headedness/dizziness during post - vaccine monitoring. BP: 89/56 P: 72 SpO2: 96% on RA. Patient monitored for extended time. 2:50pm Patient verbalized resolved symptoms, BP: 114/70 P: 75 Sp)2 100% RA. Patient assisted to vehicle and d/c home.

Assessment: Individual stated he was feeling lightheaded approximately four minutes after receiving his first dose of the Pfizer vaccine via IM injection in his upper arm. Individual was seated at the time and was about to move from the vaccination station to the check out desk. PT attempted to stand and said, ?Oh, I don?t feel so good?, after which vaccinator inquired with PT on what was wrong. After a brief assessment, notified personnel of the situation. Individual remained with the vaccinator, who obtained a set of vital signs and continued an assessment. Vitals: (as I recollect, I gave the post it to the check out staffers who monitored the individual prior to his departure) BP: 126/54, P: 78, RR: 18, pale and sweating across his brow area. Denied chest pain, difficulty breathing, nausea, tingling, headache, stated only symptom was lightheaded ness which was dissipating. Provided the individual with bottled water to sip on, which he did. Individual?s last oral intake was at ~0845 PTA at the clinic, a normal breakfast of eggs, toast and coffee. Individual stated he had several cups of coffee but had not had anything else to drink that morning. Individual receives dialysis three days per week. He had an appointment Wednesday, next appointment is Friday. Individual did not have anyone driving him to the clinic, stated he would be fine and did not have anyone to come pick him up. He stated he was feeling better already. After approximately 8 additional minutes, individual stated he thought he could get up and move to the check out station. Individual was able to stand an ambulate to the check out line. Upon arrival at check out, transferred the individual to the check out personnel and Exit workers to monitor the individual?s condition for the remainder of the 30 minutes.

Administered COCID vaccine , pt felt lightheaded , wife said he always does this then he proceeded to slide out of the chair, unsure if he lost conscience, called for help and Pharmacist who responded, pt hypertensive do called EMS, Fire Dept responded as well as EMS and it was decided he needed to be transported for further evaluation

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

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.

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.

About 4-5 hours following injection, started to feel tired and achy. Went home to bed, slept for several hours. Woke up, went to sleep again. Woke in the middle of the night feeling urgent pressure to urinate. Rose to go to bathroom, became dizzy, fell and lost bladder control. Returned to bed with help from spouse. Measured fever of 100.2. Awoke in the morning feeling some better. By mid morning was sitting up in house. Fever and aches were dissipating. By evening felt normal except for fatigue.

Upon going to bed I started getting vertigo like room was spinning. thislasted in the evening for about 4 days. It appeared to have stopped ad then after taking second dose the same thing occured. I am not sure if this is related to the vaccine or not but seemed suspicious that it occured again after second injection

soreness on left shoulder; stomach spasm; vertigo; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (lot number: ek4176), via an unspecified route of administration in left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included glaucoma, gastrooesophageal reflux disease (GERD), benign prostatic hyperplasia (Bhp), and cholesterol. Concomitant medications included tamsulosin, metoprolol, and travoprost. Patient experienced soreness on left shoulder, stomach spasm and vertigo started on day 4 of vaccine on 15Jan2021 21:30. Patient went to hospital ER on tenth day after vaccine and released from hospital ER after 2.5 hours. AE result in: Emergency room/department or urgent care. Treatment was not received for these events. Outcome of the events was resolving.

on 1/25 patient experienced dizziness, nausea and vomiting, dizziness worsened the next day. Nausea improved within a day and dizziness resolved fully in one week. According to records reviewed "LINQ device and showed mild arrhythmia but no Afib" MRI brain 1/26/2021: Tiny acute lacunar infarct in the left posterior medulla.

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.

Pt received first dose of Pfizer COVID-19 at Vaccine Clinic 2/3/2021. Patient had previously tested positive for COVID at a community testing center on 10/2/2020, but is outside of the 90 day window where retesting is not recommendation. Pt began having headache and dizziness 2/21/2021, BP checked at home and was very elevated. Presented to ED and was diagnosed with hypertensive urgency, then admitted. Pt tested for COVID via PCR, positive.

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/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.

Pt reported feeling faint approx 10 min after receiving vaccine. He disclosed that he had not eaten anything before the vaccination. Monitoring revealed BP of 150/74, HR 52, O2 93%. He felt better after 10 min and was released to self. In follow-up he stated he went home and had something to eat and felt much better. Only sequela was pain at site if injection.

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

Took Covid vaccine February 28, 2021, lack of sleep that night and next 2 nights. On March 3, 2021, about 12:30 am was sleepwalking until 7 am next morning. Kept getting up and going to bed about ever 10 to 15 minutes. Fell on his back once but did not wake up. Next morning (9 am), March 4, 2021, had bad taste in mouth. Rinsed mouth with mouthwash which helped. Was not hungry for breakfast. went back to bed at 10 am. got up at 10:30 am and said he felt bloated. gave him Pepto Bismol and he went back to bed. Slept approximately 3 hours. Ate soup and sandwich with no problem. was alert and at 100%. Said he felt good and didn't remember anything from previous night.

1. room spinning dizziness on Sunday, March 7th, at 5:30 PM. Lasted for about 3 minutes. 2. same dizziness but shorter duration 3 times on March 12th, at 5:30 pm and even shorter at about 8:30 pm.

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.

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.

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

Same evening of vaccine injection 3/24 - chills and severe headache and extreme fatigue. Overnight - nausea, vomiting and fever 102.6. Next morning 3/25, woke up and tried to get out of bed. Legs were so weak they gave out and I fell out of bed on the floor. I had no strength to get back up to get on the bed. My wife could not lift me, so she called 911 for a "lift assist". Paramedics were told I received the 2nd dose of the Covid vaccine the day before, so they picked me up off of the floor and put me back in bed. They took my vitals - blood pressure was 116/73 and temperature was still 102.6. Paramedics offered to take me to the hospital but I refused. Paramedics told my wife that if my breathing became labored, she should get me to the ER or call 911 again. I was not able to get out of bed the whole day on Thursday 3/25, because I was so weak I could not stand up, and I also had body aches and had to use a urinal because I could not walk to the bathroom. My wife gave me Tylenol and the fever finally broke late evening of Thursday 3/25 and I started to feel a little bit better. I had not eaten all day, but my wife made sure I stayed hydrated with water. On Friday morning 3/26 I was able to sit up on the side of the bed, and I was able to walk with the assistance of a cane to the bathroom. Extreme fatigue affected me all day Friday, but I did feel better. Fever did not come back after it broke. Saturday 3/27 - still experiencing extreme fatigue, but feel better overall.

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.

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

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.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Severe, Additional Details: Patient received vaccine, came back after 10 minutes and said he didnt feel good. Sitting BP was 232/112. 6 minutes later it was 245/119. Patient stayed seated, 5 minutes later BP was 247-132 HR 84. Called 911 and EMS responded and brought patient out on stretcher. He remainder conscious the entire time.

Patient tested Positive for COVID 19 by PCR on 4/17/21. Had received 2nd Pfizer dose on 3/19/21. Patient admitted to hospital due to fall, tested for COVID d/t hospital admission. Patient admitted to non-productive cough for approximately 1 month but denied other COVID symptoms. Did receive monoclonal antibody infusion on 4/22/21.

1st shot, none. 2nd shot, 22Feb21 fatigue joint and wound soreness. Soon diminished.. But, I got shot through my throat and shoulder in RVN ?68 and a deep gash to my inner right forearm 11Sep01 exposing my bones and severed arteries. 2 months later I still feel tightness/constriction, soreness in my lower throat and upper lungs when I breath deeply such as running, exercising or sex to the point I have to slow down. Also my right forearm is no longer sore but still feels a little swollen.

This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.

flu; flu like symptoms; fever; vomiting; diarrhea; malaise; dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Mar2021 at 10:00 am (at the age of 76 years old) (Lot Number: El9266, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included prostate cancer. No known allergies. Concomitant medications included levetiracetam (KEPPRA); ascorbic acid (VIT C); acetylsalicylic acid (BABY ASPIRIN); calcium, colecalciferol (CALCIUM +D3). The patient also received first dose of BNT162B2 on 11Feb2021 at 14:00 (at the age of 76 years old; lot number: El3246, unknown expiration) in left arm for COVID-19 immunization. On 05Mar2021, after 2nd shot, the patient just feeling flu like symptoms. He was hospitalized on 26Mar2021 in an emergency situation with fever, vomiting, diarrhea (which started on 04Mar2021). The patient was released from hospital on 29Mar2021 with diagnosis of flu (unspecified date). The patient still experiencing malaise (unspecified date) and dizziness on 14Apr2021. The patient received antibiotics and diarrhea medication. The events flu like symptoms, fever, vomiting, diarrhea, and flu resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and had nasal and throat swab on 18Mar2021 with negative result. The patient had not yet recovered from flu like symptoms and malaise, while unknown outcome for the remaining events. The events flu like symptoms, fever, vomiting, diarrhea, and flu were assessed as serious (hospitalization). No follow-up attempts are possible. No further information is expected.

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.

Feb 3, 2021. Five days after first vaccination, had severe dizziness upon awakening. Could barely stand up. Dizziness and lightheadedness has persisted on and off for almost two months. Felt much better for about 3 weeks and then it re-occurred and continues to this day (5/3/21). On the evening of 4/29/21, actually passed out and hit the floor incurring head laceration. Epley procedures have had no effect. Doctors have not found cause. Cardiologist has me starting on a monitor, but I'm sure that's not the issue. Dizziness comes and goes and is not always present. Have never experienced these symptoms before. No history of vestibular problems. Very distressing.

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.

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)

Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; Slight dizziness when tying shoes getting out of bed for four days though Alpine skiing each of those days then fifth day dizzy almost staggering all day; high blood pressure; This is a spontaneous report from a non-contactable consumer (Patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported), via an unspecified route of administration, administered in left arm on 20Jan2021 at 15:30 (at the age of 76-years-old) as an unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no other vaccine within four weeks prior vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021 at 07:00 (next day after vaccination), patient experienced slight dizziness when tying shoes getting out of bed for four days though alpine skiing each of those days then fifth day dizzy almost staggering all day and high blood pressure. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of all the events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

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.

hearing loss; my nose started to run non stop; type of vertigo symptom's; This is a spontaneous report from a contactable other HCP (patient herself). This 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number el3249), via an unknown route, on 01Feb2021 (at the age of 76-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided) on unknown date for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included lisinopril and atorvastatin. The patient received the last shot on 01Feb2021. The next day ''my nose started to run nonstop''. The runny nose lasted for about 6 days. The next thing that happened was a type of vertigo symptom's that lasted for 4 days. On 12Feb2021 ''I woke up and could not hear out of my left ear''. The hearing loss was trying to come back but did not. The events required a physician office visit. She was treated for the events. On 23Mar2021, the patient performed a hearing test, but results were not provided. On 12Apr2021, a nasal swab was done and resulted negative. The patient had recovered from 'my nose started to run non stop' on 08Feb2021 and from 'type of vertigo symptom's' on 06Feb2021. The outcome of 'hearing loss' was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

extreme muscular fatigue/discomfort on exercise, "trigger finger" in both hands, diarrhea, sometimes explosive. Course - persisting since mid-April - unresolving muscular fatigue, continuing bilateral joint stiffness in hands, left thumb continues to have trigger finger.

lost strength in left thigh and then all the muscle seemed to melt away in about a week. Still can not support self from left knee, it gives out and I fall

he had to have passed out; he defecated himself among other things; could not move; the fatigue.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a 76-year-old elderly male received the second dose of BNT162b2 (solution for injection; Lot EWO187 expiry information not provided) as a single dose via an unspecified route on an 19May2021 (at 76 years-old) for COVID-19 immunization. Relevant medical history included ongoing Type V hyperlipidaemia (12Aug2020), ongoing Coronary artery disease (31Oct2018), ongoing elevated Prostatic specific antigen (PSA; 10Jun2014), ongoing extradural extramedullary spinal tumor (04Apr2018), ongoing Dizziness (04Apr2018), ongoing Obesity (03Mar2021), Acute kidney injury (AKI), swelling of joint right upper arm, urinary tract infection associated with indwelling catheter (05Jun2020), pneumonia due to COVID-19 virus (hospitalized for two and one half months; 26Apr2020-02Jun2020), pneumonia due to COVID-19 virus (05Jun2020), restless leg syndrome, depression, and Atrial fibrillation (Afib), stent in his heart, and chest pain. Concomitant medications included pramipexole dihydrochloride for restless leg syndrome from unspecified date; venlafaxine hcl for depression from 1992; atorvastatin calcium (LIPITOR) for unspecified indication from unspecified date; SOTALOL for Afib from an unspecified date; tamsulosin hydrochloride (FLOMAX) for unspecified indication from unspecified date; apixaban (ELIQUIS) for unspecified indication from unspecified date; and esomeprazole magnesium (NEXIUM) for unspecified indication from 1998. The patient also received unspecified concomitant medications for the stent in his heart though he could not recall the name. The patient received the first dose of BNT162b2 (solution for injection; Lot EWO171 expiry information not provided) as a single dose in the left upper arm an 19Apr2021 (at 76 years-old) for COVID-19 immunization and experienced no adverse effect. The patient reported that on 19May2021 when he got home, he passed out and had to be taken by ambulance. When questioned, the reporter stated he had to have passed out. The patient reported that de does not really know, except he could not move; described as 'had a heck of a time moving'. The patient reported that he literally defecated himself among other things. The patient reported that his neighbor heard him screaming and called an ambulance who took the patient to the hospital, the emergency hospital and then the hospital itself. The patient reported that he was hospitalized from 21May2021 to 24May2021. The patient yawned and stated that this was another problem, the fatigue. The outcome of the events passed out, defecated himself, and could not move was recovering. The outcome of the fatigue was unknown.

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

pain in right elbow and both knees; pain in right elbow and both knees; fell down; he has had chronic pain in his knees prior to receiving the vaccine, however, it has gotten worse; had a problem in his left back, and then went to his left shoulder; had a problem in his left back, and then went to his left shoulder; bedridden; knees have gotten weaker; more scared; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical in-formation team. Pfizer sponsored program (CEP ID: 159558). A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0176) via an unspecified route of administration and administered in right arm on 01Jun2021 10:00 (at 76 years old) as dose 1, single for COVID-19 immunization in pharmacy. The patient medical history included ongoing high blood pressure diagnosed maybe over 10 years ago. The patient concomitant medication include allium sativum (KYOLIC) taken for high blood pressure 2 tablets, formula 100, 600 mg (It was a cardiovascular formula. He substituted this because he did not like what he was taking before); vita-min c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for something i guess for cold (been taking all his life) 500 mg; fish oil (OMEGA 3 [FISH OIL]) taken for something that builds you up (started taking years ago) at 100 mg once daily. The patient did not had any AE(s) following prior vaccinations, no other vaccinations within four weeks prior to the first administration date of the suspect vaccine, no family medical history relevant and no relevant tests. There was no history of all previous immuniza-tion with the Pfizer vaccine considered as suspect. On 02Jun2021 (in the morning when he tried to get out of the bed) patient experienced pain in right elbow and pain in both knees after 1st dose and last-ed days, then weeks, and continues to on and off. Tried getting out of bed and he fell down and went to the hospital. Patient stated that he has had chronic pain in his knees prior to receiving the vaccine, however, it has gotten worse since the vaccine. Reported that on an unknown date in 2021 he had a problem in his left back, and then went to his left shoulder and that he was "practically bedridden for days, and then weeks after the first dose, things have been different since the Pfizer shot and my knees have gotten weaker". Patient provided information that he does take a ginger supplement in the mornings. Next morning patient did not use a full breakfast, he wanted to know if he had done some-thing to make his body feel different. Patient stated that he was more scared now than he was before the shot because he does not know if he was protected. The reporter said that he expects that pain and aches could be symptoms of the Pfizer shot but he did not know if this experience was normal. Patient was supposed to get the second COVID vaccine on 22Jun2021, but he had pain 3 days after the received the first shot. He stated the pain was in his right elbow and both of his knees. He mentioned that he missed his second dose because he went to the hospital to get checked out. Patient wanted to know why he had been experiencing this pain for 3 weeks now and would like to know if it was ok or if he was in danger. Patient confirmed that he went to the hospital because of everything that was hap-pening to him. He stated one night, a Thursday, before he went to the hospital, which was the follow-ing week, all of the sudden woke up and had to go to the bathroom. He tried to get out of bed and he fell. He could not get up off of the floor, because his knees were not strong enough to push himself up. He told the hospital everything that happened to him. Patient stated the problem started after the first shot. They proceeded to give him a scan for his brain and his back. After, they wanted to scan his knees. He told them he came from an (withheld) where he played soccer and rode bikes. He has had problems with his knees bothering him, but not both knees at the same time. He said they wanted to scan his knees. He told them he had problems before and he uses hot water and salt, and his knees were fine. He does not think his knees are the problem, he has a different problem. They said fine, you do not want it, fine. Then they said they would do a chest scan. He has not had any problem for three weeks. No problem with breathing or anything. He wanted to find out what happened after he got the shot. Patient stated he was never in immediate pain. He had pain with movement. For three weeks he was only going to the toilet. He almost fell on the toilet and could not get up because his knees were so weak. He had to take like 10-15 minutes trying to get off of the toilet. Patient stated now he was sitting, his knees have no pain. But when he gets up he knows his knees will hurt. Pain on his right elbow, clarified that the pain in his elbow started on 2Jun2021. Patient was using his elbow to push himself up from lying down, and said very very rarely he has any problem in his elbow. His elbow was okay after a couple of days. If he was in bed he usually uses his elbows to roll over. Stated that he has recovered about 95%. He stated he was 76 years old, he was not young anymore. Patient con-firmed his elbow and knees began to hurt after receiving the first COVID-19 vaccination. He stated it was debilitating when he was trying to get out of bed or sit or stand up. It was immediate, but not the day that he got the vaccine. It was all around him trying to get out of bed and do certain thing that he needed to do and he found that he could not get out of bed; unable to clarify further. Patient unable to provide start date. knee pain: He said it is not causing any irritational pain when he is sitting down. When he tries to get up he can feel the stiffness in his knees. At that point he knows there is a problem in his knees. Patient stated when he went to the hospital they told him they were going to take some blood. He turned away from what they were doing and they gave him some kind of intravenous. He was in the hospital for over an hour. After he questioned them about the first test, and there was no problem. When they said they were going to do his knees and his chest, which was a complete set of tests that they were doing, it has nothing to do with what he was experiencing. He thought he was ex-periencing something from Covid and he was wanting to know if he was going to die. They did not seem to care about what his problem was. He thought COVID had a system where people would be tested for reactions and things like that. Has had problems with his knees off and on maybe once or twice a year but has never gone to the hospital for them. Sometimes his brain does what it wants to do. There was no additional vaccines administered on same date of the Pfizer suspect. Patient visited the emergency room. The patient underwent lab tests and procedures which included chest scan, scan brain on an unknown date with unknown results. The outcome of event pain in right elbow was recovering and pain in both knees and fell down was recovering, outcome of event pain in right elbow and both knees was not recovered, outcome of events had a problem in his left back, and then went to his left shoulder, gotten worse, bedridden, knees have gotten weaker and more scared was unknown. Follow-up attempts are completed. No further information is expected.

After the first vaccine he suffered a massive brain bleed. Then in the nursing home he contracted Covid-19 and was in Hospital Heart Transplant unit for 6 days. After 4 or 5 days back in the nursing home he contacted Covid-2 pneumonia. His balance is off he has memory loss and a lot more.

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.

vomited; nausea/ felt sick to his stomach; felt woozy; didn't feel well; right deltoid soreness; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received the first dose of BNT162B2 (Lot: EH9899), via an unspecified route of administration in deltoid right, on 24Dec2020 11:30 at single dose for COVID -19 immunization. Medical history included pulmonary embolism half a dozen years ago. He has had no problems with Deep Vein Thrombosis or pulmonary emboli since then, since half a dozen years. He has had a battery of lab tests 2 months ago, his blood glucose was high, it was 106 mg. The potassium was ok. He has had no issues with vaccines in the past. He had an antibody test last Jul2020 because he had bacterial lower urinary tract prostate infection. Concomitant medication included rivaroxaban (XARELTO) at 10 mg a day and cefalexin sodium (CEPHALEXIN) at 500 mg three times a day, well approximately 3, sometimes he forget a dose. The physician reported possible side effects of Covid vaccine. The physician received the vaccine on 24Dec2020 at 11:30 in the late morning and felt fine. He woke up on 25Dec2020 and at 2:30AM he was sick to his stomach and vomited and didn't feel well the rest of the day. Since then he had been okay, he had occasional nausea and vomiting. He clarified that on 24Dec2020, in the late evening, his appetite which was usual, was robust. Then on 25Dec2020 at 2:30 in the morning he vomited, and had no trouble since then. From what he read, nausea and vomiting are observed following the injection. On 24Dec2020 just before bed, he had a light supper, his appetite was robust, then unexpectedly he woke up sick to his stomach and went back to bed on 25Dec2020. He clarified that he had not vomited since the one episode on 25Dec2020. He also added that he has not been nauseous since then. Caller also added that he felt a little woozy on Holiday 25Dec2020, it only lasted up until the evening of 25Dec2020. He had the 1 episode vomiting on 25Dec2020 and felt woozy until late evening of 25Dec2020. His right deltoid where he received the vaccine was a little bit sore on 24Dec2020, and he was still having a little bit of soreness, it is slight, not very tender, he is unable to do usual morning exercises with out noticing the discomfort, the exercise he is doing is chin ups, the soreness is not intense and it never was. The lab test in 2020 included Height: under 5 feet 5 inches. Weight: about 165lbs or 167lbs. He had no positive test for COVID prior to the vaccine. All the tests were negative. The 1st one was nasopharyngeal, and all the next ones after were nasal swabs. He thought they are all reverse transcriptase tests. The last time he had a COVID test they did a nasal swab, it was this morning, and before that was last Monday or Tuesday, but he thought more so Monday. He had one PCR test. The outcome of the events vomited, nausea and felt woozy was recovered on 25Dec2020. The outcome of the event right deltoid soreness was recovering. The outcome of the other event was unknown. The 2nd dose for Covid vaccine was schedule for 14Jan2021.

THE NIGHT OF VACC DAY, C/O SEVERE INJ ARM PAIN. THE FOLLOWING DAY, HE BEGAN DISPLAYING VERBAL AGGRESSION AND OUTBURST TOWARDS STAFF WHICH IS OUT OF NORMAL FOR HIM, INCREASED DIFF REMEMBERING SHORT TERM, C/O DIZZINESS AND SEVERE HEADACHE RATED 10/10 ON PAIN SCALE NOT RELIEVED WITH SEVERAL DOSES OF PAIN MEDS AND RANDOM DIZZINESS

THE NIGHT OF VACCINATION DAY, RESIDENT BEGAN C/O SEVERE PAIN IN THE INJECTION ARM. THE DAY AFTER THE VACCINE, HE BEGAN HAVING MOOD ISSUES, VERBAL AGGRESSION/OUTBURSTS (ABNORMAL FOR THIS RESIDENT), DIZZINESS AND A SEVERE HEADACHE HE RATED AT 10/10 PER PAIN SCALE THAT DID NOT RESOLVE WITH SEVERAL DOSES OF PAIN MEDS.

Rather sudden onset of severe weakness of legs and unable to stand up from chair without assistance of wife or walker

Patient states that he had vaccine on 1/13/21. He presented to the clinic 4 days later on 1/17/21 with light headedness, nausea and elevated BP 160/88 and upon recheck 175/100. There is H/O HTN but on medication he has not been this elevated in years.

Pt received injection, immediately became dizzy, mildly anxious. Dizziness lasted, 5-6 minutes and resolved without any intervention. Pt monitored for 30 minutes, ambulated out of clinic independently.

PATIENT RECIEVED INJECITON, AND WITHING 30 SECONDS BECAME DIZZY. PT C/O DIZZINESS FOR 5-6 MINUTES. AND DIZZINESS RESOLVED SPONTANEOUSLY. NO TREATMENT NEEDED

Approximately 8 hours after shot I suddenly had dizzy feeling, my eyes became crossed, could not focus my eyes, everything was a blur. I could think correct and carry on a conversation. Took 2 Ibuprofen, drank 8oz of water and laid down for a half hour or so. After about 40 minutes my eyes started coming back in focus. My left eye was not seeing some cobweb stands but eventually stopped and became normal. I then ate some food and everything seemed to be ok. As I write this 5 hours after the above incident nothing more has happened. My arm does not hurt either. No other symptoms of any kind are occurring.

He woke up could not walk; dizziness; lots of difficulty walking; This is a spontaneous report from a contactable consumer (patient's daughter) A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 13Jan2021 at 15:00 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included borderline diabetic. It was also informed that patient had a little bit of cognitive decline predating the vaccine and he didn't drive. Concomitant medications were not reported. On 14Jan2021 the patient woke up and could not walk. On the same day (14Jan2021) the patient also experienced dizziness and lots of difficulty walking. He was admitted to hospital on 14Jan2021. Reported the CT was clean, chest x ray was clean and blood work was fine. Patient was planning to receive the next dose of vaccine on 03Feb2021. At the time of the reporting the patient was recovering from dizziness and had not yet recovered from other reported events. Information about lot/batch number has been requested.

Patient began complaining of dizziness and changes in vision (but no loss of consciousness) following 1st dose of COVID-19 vaccine. Patient was also diaphoretic and hypotensive with blood pressures of 82/57, 80/36 mmHg. No wheezing or respiratory distress were noted, and the patient did not endorse any changes in sensation/tingling/itching to face, lip or mouth. Patient was taken to the ED for monitoring. Workup in the ED was negative, and the patient was discharged home.

light headed/ when he got out of bed that he was lightheaded; wobbly on my feet; where he had knee surgery he always has pain but there was additional pain/ Clarified that the pain from knee surgery is joint pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 at a single dose for COVID-19. Medical history included knee surgery from 2010. There were no concomitant medications. The patient reported, "After I got my first dose of the vaccine, I felt light headed, wobbly on my feet, and had additional pain where I had knee surgery in the past. Is this normal?" He had a question about vaccine which he got last Monday 11Jan2021. Stated that he had no symptoms when he got the shot. On 11Jan2021, he was light headed and wobbly on his feet. Stated that where he had knee surgery he always has pain but there was additional pain. Stated that the symptoms lasted 4.5 days and went away. Wondered if anyone else had experienced this. Stated that he called his doctor and the CDC. Stated that this is his first shot. Clarified that the pain from knee surgery is joint pain. Stated that he had knee surgery the last time in 2010. Stated that when he got out of bed that he was lightheaded. Stated that it lasted Tuesday into early Saturday. Stated that lightheaded (dizzy) and wobbly on his feet resolved on Saturday morning. No treatment was received for the events. Outcome of the events 'light headed/ when he got out of bed that he was lightheaded' and wobbly on my feet was recovered on 16Jan2021, while recovering for the other event.

WHEN I WAS GETTING OUT OF BED I WAS VERY DIZZY AND UNSTABLE. I SAT ON THE BED FOR ABOUT 10 MINS AND WAS ABLE TO WALK AROUND, BUT FELT LIGHT HEADED. I CHECKED MY BLOOD PRESSURE AND BLOOD SUGAR AND THEY WERE FINE. I HAVE NO PAIN. I GOT UP THIS MORNING FEB. 6 AT 6 AM. I SAT ON BED FOR A FEW MINUTES BEFORE I STOOD UP AND I FELT UNSTABLE FOR A FEW MINUTES, BUT DOG OKAY.

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.

starting at the base of head/shoulder pain goes up head, throbbing can not lift head. Taking Tylenol, applied heat pad to back of neck and head

Patient complained of feeling light headed and "weird". Patient alert and oriented. Denies n/v/d or itching. BP 147/92, HR 97, SAO2 96%. Patient reports similar feeling after annual influenza vaccine but did not require medical care. Patient requests transport to ED for further evaluation.

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

After mild and expected side effects (stomach ache, mild diarrhea, headaches, tiredness) woke up at 2 am with dizziness on rolling over in bed. Persisted into the morning on arising.

Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021. Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.

1. Pain at site of injection started about 6 hours post second vaccine injection (7-8 on a 0-10 scale) that lasted for almost 48 hours, most intense during the day following injection. No treatment for that. 2. Significant fatigue on the morning 14 hours following the injection (could have started during the night) . Difficult to maintain balance. Just rested the whole day. Unable to exercise on stationary bike. 3. Low grade fever (just under 99 F; base line for me has been 97.6 F) in the evening following injection, gone next morning. No treatment.

Exactly one week following the injection I experienced sudden onset of significant vertigo that required immediate bed rest. There was also minimal nausea and headache, intermittent. Slept well, but had a very difficult time walking from bed to toilet during early morning due to the symptoms. Slightly improved by 7 AM in the morning. Intermittent episodes of the vertigo during Friday and Saturday, decreasing in intensity. Was able to exercise on stationary bike on Friday and Saturday PM. No symptoms Sunday AM (now). Will symptoms recur?

48 hours after the 2nd dose of the COVID-19 vaccine, he had generalized body aches that had worsened, chills, agitation/anxious, dizzy, and hyperventilating/ shortness of breath. He went to the hospital with his wife on 3/1/2021. He stated "I think I'm going to die". Patient had been off Cymbalta for 3 days completely- treating neuropathy (previous daily medication that his primary physician advised him with weaning down the dose). The patient was manic and had tangential thoughts- from crying/angry to laughter. It is believed that the agitation could be due to medication withdraw.

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.

Dizziness and nausea, fever peaking at 101.4 deg, chills lasted for 2 days. Severe muscle aches, strong joint pain, persistent tiredness, bowel irritation lasted for more than 3 weeks so far. Examined by doctor but no treatment prescribed. Rash in right arm was visible on fourth day, below shoulder where second shot was received. Severe pain in left shoulder on third day, where first vaccine shot was received 3 weeks before second shot. Most symptoms are improved at this time, but still some tiredness and muscle and joint pain.

Five days after vaccine shot, patient experienced extreme dizziness which lessened each day but lasted 10 days. There were three episodes of confusion.

My legs became very weak. After the second shot on Feb 9 I was confined to a wheel chair, unable to walk. I currently am unable to walk.

severe dizziness on arising from bed; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1686; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration in the left arm on 31Jan2021 13:15 at a single dose for covid-19 immunization. Medical history included allergy to artificial crabmeat, NIDDM (non-insulin-dependent diabetes mellitus), HBP (high blood pressure), GERD (gastrooesophageal reflux disease) and BPH (benign prostatic hyperplasia). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but has other medications the patient received within 2 weeks of vaccination. On 04Feb2021, the patient experienced severe dizziness on arising from bed at 0800 hours. The dizziness subsided approximately 6 minutes later with no recurrence. The event did not require treatment. The event was considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 04Feb2021 0806 hours. No follow-up attempts are possible. No further information is expected.

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.

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

pt stated he had a head ache about 15 minutes after getting the vax but subsided quickly. When he woke up the next morning he had tightness in his chest that last a while and then went away. A couple of days later he had a dizzy spell which would come and go. This lasted about 3 days. He had another episode of tightness in his chest. On 3/7/2021 he developed a red rash on his chest that had a hive in the middle of it that was itchy. He started getting itchy spots on the top of his hands, fore arms, top of his ears, and the top of his head. At this time he only has slight rash on his chest and shoulders that are not itching.

Death Narrative: Patient received first COVID vaccine does on 3/13/21 at 07:53 without complications. Home telehealth nurse informed by family member on 3/18/21 the patient passed away on 3/13/21 at approximately 1300. Per medical record documentation, "Patient had been at facility getting COVID vaccine that morning at 0800, came home and was taking out his garbage when he started to stumble and fell to his knee, a neighbor saw and assisted patient up and was walking with him back to the apartment when "...he stopped breathing and feel over, dead." Per medical record review, patient had several co-morbidities including hypertension, hyperlipidemia, chronic hyponatremia, alcohol abuse, alcoholic fatty liver, chronic thrombocytopenia, and GERD.

I have experienced light dizziness the first day (3/24) Today (3/25) I am unsure on my feet and have not been able to keep anything on my stomach. At first, I attributed this to a weight management plan that I am on, but late recalled the symptom described in my covid response reporting texts. I Have yet to receive a Covid update text today, so I am submitting this report. I am scheduled to see my PCP tomorrow.

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.

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.

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.

weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-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 Right on 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more 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.

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.

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.

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

loss of balance; Headache; Fatigue; dizziness; nausea; pain in muscles all over body; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 18-FEB-2021 07:00 AM (at age of 77 years), as a single dose for COVID-19 immunisation. The Patient's medical history included Benign nerve-sheath tumor, not growing. Concomitant medications included Atorvastatin, Tamsulosin, Pepcid, Allegra. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 26-JAN-2021 07:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Atorvastatin, Tamsulosin, Pepcid, Allegra within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The Patient had experienced Headache, fatigue, loss of balance, dizziness, nausea, pain in muscles all over body on 18Feb2021 08:00 PM. Patient didn't receive any treatment for the event. Outcome of the event was reported as Recovered/Resolved with Sequel.

Vertigo. It is very serious in the morning when I get out of bed and eases somewhat during the day. I have attempted the Eppley maneuver at home and my Primary Care Provider did a similar maneuver in her office recently

When I put the daily pataday and/or travoprost drops in my eyes, starting the night of my first injection, I often have vertigo - not just diziness, but dramatic everything turning uncontrolably. The vertigo goes away in a few minutes, but is uncontrolled while it lasts, and happens within a second or so after putting in the drops.

From the day following the injection, I felt to be in a mental fog that has very slowly nearly abated. Uncommonly tired, no headache fever, chills, or neurodeficit otherwise. ( I am a retired physician). This lead to change in gait: slow, foot dragging, unstable. Near accident in driving auto. More than 4 time of urinary incontinence ie incontinence when bladder overfilled. Mental clarity lost. speech impaired by word searching. Obvious change in behavior to those around me.

77-year-old male with past medical history of stroke, hyperlipidemia, diastolic heart failure, diabetes mellitus, and hypertension presents ED for evaluation of sudden onset of dizziness. Reports his dizziness started today early in the morning while he was outside taken to trash. He later went to his house and sat down but his dizziness did not go away. His dizziness only resolved after arriving to the ED. Denies loss of consciousness. Did not fall. Has only eaten tangerines today

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.

Patient presents to the ED on 4/23 with complaints of dizziness described as presyncopal episodes happening twice that day. Felt lightheaded early in the day. Patient noticed his stool was dark black colored the last 2 days, no prior history of GI bleed. Patient is not on anticoagulation therapy currently, is taking fish oil and acetaminophen. INR is at 1.2 upon admission. Patient diagnosed with severe diverticulitis, patient was operated on to remove polyps, no source located for GI bleed. Patient was treated for anemia and discharged after 6 days.

Pain in some muscles in leg; Itching throughout body; Headaches; Chills; Dizzy at times; Pain in joints; This is a spontaneous report received from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) as a single dose via unspecified route of 1st dose on 26Feb2021 at 8 AM for COVID-19 immunization. The patient's medical history included prostate cancer low grade, penicillin allergy and sulpha allergy. He was allergic to Gadolinium when he had it for an MRI or Cat Scan. He broke out into a rash for a few days. Concurrent medical condition and concomitant medication were not reported. Patient did not test positive before vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient believe he had COVID in Mar2020 on and off until Aug2020 but did not had any trouble breathing or fever. On 27Feb2021 20:00, the patient experienced chills, dizzy at times, pain in joints, runs, headaches and so on. Actually his normal temperature dropped from 98.4 to 96.4. When he had BNT162B2, 8 days later (06Mar2021) he had pain in some muscles in his legs and then had major itching throughout his body for about 36 hours. He took strong doses of B12, B, C, D3, Zinc, olive leaf extract, baby aspirin, Dandelion root tea. Clinical outcome of all the events were reported as recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient received Pfizer Covid vaccine 2nd dose (LOT#: EW0171 EXP: 8/21) at 1453 on 4/20/21. Patient alerted PHN that he was done with his 15 minute observation. PHN asked patient if he felt fine. Patient stated he felt a little dizzy. PHN asked patient when it started and patient stated as soon as he got up. PHN asked patient to stay an extra 30 minutes for observation. Patient agreed to stay. Patient was given water. Patient finished water. After 5 minutes patient stated that he wanted to leave and no longer felt dizzy. PHN advised patient to stay the recommended 30 minute. Patient insisted that he no longer felt any symptoms and wanted to go. PHN stated that he was now agreeing to leave against medical advice. PHN educated patient on worsening signs and symptoms of covid vaccine and when to call EMS or go to ED/urgent care. Patient verbalized understanding. Patient left vaccination site at 1525 unassisted and with a steady gait.

Case developed extreme fatigue and disorientation resulting in a fall. Case was taken by ambulance to Hospital. Case suffered a stroke, admitted to hospital 06/02, then into ICU 06/07/2021.

Patient had bad headache within the hour, difficulty breathing soon after, became delirious, couldn't make sense, couldn't walk and had to call EMS.

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.

4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; 4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in Left arm on 26Jan2021 13:00 at the age of 77-years-old as 2nd dose, single dose for covid-19 immunisation. Medical history included CHF (Congestive heart failure) from an unknown date and unknown if ongoing, PE (pulmonary embolism) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included unspecified medication, Allioyrubikm; Dabigatran (DABIGATRAN) taken for an unspecified indication, metoprolol (METOPROLOL) taken for an unspecified indication, spironolactone (SPIRONOLACTONE) taken for an unspecified indication on unspecified date received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in Left arm on 05Jan2021 at 13:00 as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. Covid test post vaccination was no. On 29Jan2021 at 06:00, 4th day after dose 2 the patient experienced pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain. still have pain 10 days after dose 2. No treatment was received for adverse events. The outcome of event, mobility decreased was unknown and for other events was not recovered. Follow-up (07MAY2021): Follow-up attempts completed. No further information 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.

Hospitalization, Dizzy, lightheadness, nausea, and vomiting Body part and time not know for vaccine Covid Tested on 7/14/2021 tested positive Patient is currently in hospital

slight fever; chills; tiredness; achy all over; slightly dizzy; This is a spontaneous report from a contactable consumer, the patient. A 77-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: OW0150) via an unspecified route of administration in the left arm on 30Mar2021 at 10:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included enlarged prostate and cholesterol. Concomitant medications included atorvastatin calcium (ATORVASTIN), finasteride (MANUFACTURER UNKNOWN) and dexamethasone, tobramycin sulfate (TOBRAMYCIN/DEXAMET) . The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (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. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 07:00 the patient experienced slight fever, chills, tiredness, achy all over, and slightly dizzy. 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 any treatment for the events. The clinical outcomes of the event slight fever, chills, tiredness, achy all over, and slightly dizzy were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

Extreme pain in joints, reduced mobility, inability to move legs, arms, hands; increased white blood count. Was hospitalized four different occasions for 2-5 days each. Various tests and medicines were tried. Pretizone was used for 4 months.

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.

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.

Pfizer-BioNTech COVID- 19 Vaccine EUA:Patient with significant PMHx of alcoholism, AFIB, CHF, COPD, DM, GERD, MI, HTN, pacemaker placement stroke, and hyperlipidemia who presents to the ED with CC of dizziness. Pt states that two days prior he slipped and fell and hit his head, and was unable to ambulate after the fall. Pt denies any LOC, but states he is currently on Xarelto. Pt currently c/o back pain. Pt went for his first COVID-19 immunization 1/22/2021 when he became suddenly dizzy. Patient denies chest pain, shortness of breath, nausea, vomiting, diarrhea, abdominal pain, fever, chills, or any other acute complaints. Progress Note: "Dizziness, near-syncope: Onset following injection of COVID-19 vaccination.

He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks; dizzy; vertigo; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: not reported), via an unspecified route of administration on 12Jan2021 (around 11:00 or 11:30 AM) on left shoulder (arm left) for COVID-19 immunization. Vaccine was not administered at a military facility. There were no additional vaccines administered on same date of bnt162b2. He did not receive other vaccines 4 weeks prior to COVID-19 vaccination. Medical history and concomitant medications were none. The patient had his 1st dose on 12Jan2021. He was fine that day, but on the 13Jan2021, he woke up and was dizzy. He stated that he had no problem after having the shot, 15 minutes later, he had no problems; but, the next day he began having vertigo and dizziness. Vertigo and dizziness began 13Jan2021 at about 8:00 AM. This has continued the past 3 days. It is getting better, but he is wondering if that is a big problem. At the time of report, it's getting better but still have it. He asked if he should be concerned. It is quite a bit improved but it's still there. If he had to drive a car for an emergency, he thinks he could do it, but he wouldn't volunteer for that right now. He looked up all that stuff and it says that 20% of the people who take it have that. But when they list the side effects, they don't list dizziness until they list severe that is the only thing that has concerned him. He was scheduled for the 2nd dose on 09Feb2021, longer than the 3weeks. Outcome of the events was recovering.

Lightheadedness; Headache; tightness in his chest; 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: EK4176, via an unspecified route of administration in the left arm/ shoulder area on 15Jan2021 at 11:15 at single dose for COVID-19 immunization. Medical history included ongoing epilepsy, patient has epilepsy that has been controlled since 1977; and issues with his blood pressure. He has no allergies. Concomitant medications included phenobarbital and phenytoin (DILANTIN), both for epilepsy. He takes HTZ TRI something, it is a long word but is basically 2 diuretic. He is also being followed by a cardiologist. Patient has no prior vaccinations within 4 weeks. The patient got the COVID injection 2.5 hours ago on 15Jan2021 and after that he had a slight case of lightheadedness. He was instructed to drink water and walk if he was able, he did that and it helped. The patient relays that he was fasting that morning and thinks that had some degree of relatedness in the lightheaded feeling. He ate lunch and the light headedness resolved but now he has a slight headache. He was reading the paperwork and on the form under severe reactions, it mentions dizziness, weakness, and difficulty breathing. While he is breath ok, he has noticed a slight degree of tightness in his chest. He did not see this listed but wants to know if this is normal or if it would be related to the difficulty breathing. His main concern is if this is a severe reaction. He had lab work done prior to getting the vaccine, then none afterward. The events did not require visit to emergency room and physician office. The outcome of the event 'lightheadedness' was recovered while unknown for the other events.

Sore arm at site of injection; balance problems (from a couple hours after injection continuing and worsening somewhat morning after.

Myocardial infarction Narrative: PMH significant for aortic valve stenosis, mitral valve stenosis, CKD, CHF, DM, HTN, obesity, hypothyroidism and dyslipidemia. Per report from primary care - the patients wife reports that the patient went on Saturday (1/30/21 - about 1050) morning to receive his COVID vaccine. He returned home and told her about the experience and denied any side effects. He then proceeded to sit in his easy chair for a while and around 1:30, she asked him if he wanted any lunch. The patient's wife reports he "grumbled" at her, and then got up to go to the bathroom. She then heard a loud crash and found him lying on the floor of the bathroom, with his head knocking hole in the wall as he fell. She could not detect a pulse. She called 911 and began compressions. First responders to the scene likewise tried to revive him but were not successful in her efforts. Per primary care documentation - Uncertain if related to Pfizer vaccine; vaccine administered on 1/30/21 and approximately 3 hours later suffered fatal MI at home.

brainfuzz headache; Aches; woke up nauseous; wobbly Almost fell over twice. Had to steady self; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Jan2021 at 11:15 (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history included prostatitis, high blood pressure, and high cholesterol, all from unknown dates and unknown if ongoing. The patient previously had COVID-19 prior to the vaccination on an unknown date to an unknown date (not ongoing). The patient did not have any allergies to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jan2021 at 07:45, the patient experienced brainfuzz headache, aches, woke up nauseous, and wobbly (almost fell over twice and had to steady himself). The patient did not receive any treatment for the events. The clinical outcomes of brainfuzz headache, aches, nausea, and wobbly, were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Felt fine after the shot, shoveled some snow mid to late afternoon. Felt woozy around nine, check BP and recorded results below. 2nd shot scheduled for 2/22,. Apparently this could have been a rare reaction, any input re the second dose would be appreciated. Per website, " Among the 21,621 people in the trial who received BNT162b2, four related serious adverse events were reported: shoulder injury related to vaccine administration, right axillary lymph adenopathy, paroxysmal ventricular arrhythmia and right leg paresthesia."

Pt concerned about mild headache, chills, and fatigue after first dose of covid vaccine yesterday afternoon. Denies pain at injection site L. Deltoid. Denies NVD. States he feels a little dizzy when he stands. Denies chest pain or shortness of breathe.

Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.

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.

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.

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.

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.

3 days after the first Pfizer COVID vaccination, the patient had nausea, vomiting, dizziness, hearing loss and loss of equilibrium. These symptoms slowly resolved, but recurred 3 days after the second dose of the Pfizer COVID vaccine.

Dizziness; Hypoglycemia; Hypotension; Generalized rash; This is a spontaneous report from a non-contactable healthcare professional. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; dose 1) intramuscularly on 25Jan2021 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. On 25Jan2021 during the 15 minute waiting period after the vaccine, the patient experienced dizziness. He denied difficulty breathing and swallowing. A differential diagnosis of systemic reaction (hypoglycemia, hypotension, generalized rash) was provided. The patient was given unspecified treatment and follow-up response was good. The patient denied dizziness when standing up and walking to leave the medical evaluation bay and clinical outcome of dizziness was completely resolved prior to discharge. No follow-up attempts are possible. No further information is expected.

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

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.

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.

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.

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

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

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.

muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; muscle stiffness and soreness - legs,arms, shoulders, etc.- for the past 14days or so - since injection.; Movement, sleeping, bending, etc.,almost impossible; Movement, sleeping, bending, etc.,almost impossible; This is a spontaneous report from a contactable consumer reported for himself. A 78-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=em9801), via an unspecified route of administration at the age of 78 years old on 12Feb2021 at single dose on arm left for covid-19 immunisation. Medical history was none. No Allergies to medications, food, or other products. The patient received no 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 had not been tested for COVID-19. The patient received no other medications within 2 weeks of vaccination. The patient's concomitant medications were none. The patient experienced muscle stiffness and soreness - legs, arms, shoulders, etc.- for the past 14 days or so - since injection. Movement, sleeping, bending, etc., almost impossible. 4- 200mg-ibuprofen helps for about 4 hrs. The onset date for the adverse events was reported as 13Feb2021. The events outcome was not recovered. The seriousness of the events was reported as no.

After receiving vaccine, client stated he feels dizzy. Vital signs obtained. BP 160/81, HR 80, O2 sat 93%. Client states he feels better. Client discharged home by EMS.

patient began to have left sided chest pain which radiated to left arm. stated sharp pain but also belt like pressure. does not have history of similar chest pain. he also described dizziness and SOB, but additional questioning suggests this is his baseline. 12 lead showed a fib. patient denies history of similar. patient given ASA and transported to ED for additional work-up for his chest pain

Iwent for routine jog about 48 hours post injection. At end of run, I became light-headed and dizzy. I thought I was going to pass out. I laid flat on ground for some minutes and became less lightheaded. Sensation re-appeared, did drive home and laid down for about one hour. No recurrence. I had jogged day before the injection of 10 March and on 11 March without problems. I have not jogged since then.

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

Dizziness following vaccination, swelling of eyes, slight facial swelling around cheeks and eyes. without resp distress. BP 138/94, 76, 18, 98%, BS 135

Onset second morning after injection: headache, chills, nausea, loss of motor control in legs ( unable to stand or walk, unable to roll over to get out of bed), profuse sweating. About 1pm my wife assisted me to the bathroom toilet, where I passed out for approx 30 mins. These severe reactions finally started to recede about 6pm, although the sweating continued into Sunday. Mild nausea, and mild headache continued into today Tuesday.

Very bad muscle and joint pain in my hips, groins, and knees. My shoulders were much sorer than normal as well as I have had soreness in both shoulders which has been ongoing. My symptoms continue. My walking, sitting, and standing up, all are affected.

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.

my left shoulder feels like it has what I would relate the pain to as a rotator cuff pain/injury. They gave me the injection at the joint of my shoulder. I could not lift my arm. I have had to go to therapy which is helping.

The day after the injection I started felling disoriented and suffering from what I call a mind-body disconnect. Walking was unsteady and organizing thoughts was difficult. This was my primary symptom with the infection which lasted through 02/16/2021. The last three days were spent in the Covid-19 unit of a local hospital after which the symptoms disappeared. The day after the vaccination, the symptoms came back but only lasted for about 24 hours.

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.

Death Dehydration Community acquired pneumonia Closed head injury, initial encounter Fall at home, initial encounter Acute hypoxemic respiratory failure

Client went to Urgent Care on 4/16 complaining of excessive fatigue, excessive sleeping, unsteadiness and fatigues easily when mobile. He was having trouble getting up and down the stairs. States he had a runny nose and congestion and started taking Mucinex since approximately 4/6. He had some chills on 4/15. When he wakes up in the morning he still feels tired and could go back to sleep. After his initial assessment he was admitted to hospital for treatment and further evaluation.

Vaccination on March 15, 2021. Onset of severe vertigo one day following the vaccination, leading to a fall. Several other less severe vertigo attacks. Decreased balance persisting one month after vaccination

I have developed a very painful region in the left deltoid muscle and the right deltoid muscle is less severe. It prevents me from lifting my arm(s) higher than the elbow, and significant weakness in the both arms, especially the left. My kneecaps also have significant weakness and pains and makes standing difficult. this developed the day after the shot. I also have significant fatigue all the time since receiving the shots. The second shot (Right arm) was given March 5th.

Dizziness; 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), via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:10 (Lot number FR8733 or ER8733) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing High cholesterol, ongoing COPD, ongoing to help his blood circulation. Prior Vaccinations (within 4 weeks) was None. The patient received first dose of bnt162b2 (lot number: EN6199 or FN6199) on 05Mar2021 14:10 Intramuscular in left arm for COVID-19 Immunization. Concomitant medication(s) included atorvastatin taken for High cholesterol from an unspecified start date (for years) and ongoing; budesonide, formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease from an unspecified start date (for about a year, maybe more than that) and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken To help his Blood circulation from an unspecified start date (for at least 10 years) and ongoing. The patient experienced dizziness on 04Apr2021 after his second Pfizer COVID-19 vaccination shot and it has lasted approximately 7-8 days. The event did not require a visit to Emergency Room or Physician Office. The outcome was not recovered. No follow-up attempts are needed. No further information is expected.

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.

After receiving the injection, patient had not been feeling well. Low appetite, lightheaded, fatigued, difficulty breathing. They had been traveling and returned on 3/7. He was tested for covid and the test was positive. He presented to the ED on 3/25/21 and was subsequently admitted to the hospital for 4 days with pneumonia.

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.

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.

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.

Extremely dizzy, almost fell, after reaching up. This has never happened before; Extremely dizzy, almost fell, after reaching up. This has never happened before; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 28Jan2021 18:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included glucose tolerance impaired. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination.Patient did not have allergies to medications, food, or other products and no known allergies. The patient's concomitant medications were not reported. On 29Jan2021 08:45, the patient experienced Extremely dizzy, almost fell, after reaching up. This has never happened before. Treatment was not received for the adverse event. Outcome of the event was recovered on an unspecified date. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.

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.

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.

vertigo; This is a spontaneous report from a contactable Physician. A 78-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in arm left on 03Mar2021 as a 2nd dose, single for COVID-19 immunisation. The patient's medical history included HTN, dyslipidemia. Age at vaccination was 78 years. The patient's concomitant medications in two weeks included atorvastatin, hydrochlorothiazide, triamterene (TRIAMTERENE-HCTZ). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in arm left on 10Feb2021 as a 1st dose, single for COVID-19 immunisation. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 05Mar2021, the patient experienced vertigo. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included was meclizine. The outcome of the event was recovering. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.

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.

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.

1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days. June 17: Chest pain of # 9and jaw pain. No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.

had a temperature of 100.4; pain in his shoulders and neck/has joint pain across his neck; he has joint pain across his shoulders and neck and that he cannot turn his head/ pain in his shoulders and neck; he has joint pain across his shoulders and neck and that he cannot turn his head; This is a spontaneous report from a contactable consumer. This 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 05Feb2021 (at age 78-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On an unspecified date, Caller stated that he had his first Pfizer shot Friday 05Feb2021. Stated that he had a temperature of 100.4 that went back to normal. Stated that he had pain in shoulders and neck since he got the shot. Clarified that it was for Pfizer Covid 19 shot. Stated that it may be normal or if others felt this way. Clarified that he had joint pain across his shoulders and neck and that he couldn't't turn his head. Wanted to know if this was serious. Patient underwent lab test includes body temperature for which result 100.4 was reported. The outcome of event was resolved for body temperature increased, whereas unknown for all other events. Information on lot/ batch number has been requested.

Pfizer COVID vaccine EUA Pfizer Dose 1 2/13/21 (EN6201) Pfizer Dose 2 3/13/21 (EN6204) COVID Positive 5/24/21 5/24/21: 78-year-old man brought to the emergency department for further evaluation of worsening shortness of breath and cough. He was in his usual state of health until approximately 11 days ago when he started to have upper respiratory symptoms characterized by congestion, rhinorrhea, sneezing episodes. Symptoms gradually worsened until 5 days ago when he started to have for productive cough accompanied by shortness of breath. He denies accompanying fever, chills, nausea or vomiting. His sister who accompanied him has been checking on him daily and has noted worsening bouts of coughing as well as shortness of breath, unable to keep up with ADLs. Upon checking on him today she noted that his lips were blue, brought in to the emergency department by private passenger car and in trial urge his oxygen saturation was noted to be 64% on room air. He was immediately started on supplemental oxygen via OxyMask, nebulizer therapy. COVID-19 rapid antigen test was subsequently positive, CT pulmonary angiogram was done which is negative for PE but also did not demonstrate any evidence of pneumonia. He is fully vaccinated against COVID-19 since March, denies any known contacts being treated for or with symptoms suggestive of COVID-19 infection. While in the ED continued to deteriorate requiring increasing amounts of oxygen via OxyMask, desaturating to 82-85% on 15 L OxyMask. Has been started on NIPV and will be admitted to the ICU for further treatment and evaluation. Of note, he reports that he and 5+ of his family members were all fully vaccinated and all tested positive to COVID around the same time. 6/14/21: The patient presented to the hospital on May 24 with cough and shortness of breath, COVID-19 test positive, initially he was hypoxic requiring 6 L of oxygen then his oxygen demand increased until he require to be on BiPAP and high-flow nasal cannula, then on May 29th require endotracheal intubation the ICU and started on Remdesivir, Decadron, but he was not candidate for Acterna, on June 3rd the patient had a fall with dislodged endotracheal tube require immediate re-intubation and his CT show simple nondisplaced skull fracture and subgaleal small hematoma without intracranial hemorrhage. Patient extubated on June 6 to BiPAP then the oxygen requirement taper down. The patient post extubation kept having shortness of breath and cough, sputum culture grow Klebsiella pneumonia and he was on Zosyn which cover it and will complete the antibiotic on June 15th. The patient is hypercoagulable with elevated D-dimer 2 to COVID-19 infection and will continue Lovenox b.i.d. with his aspirin and Plavix for CAD with pantoprazole. Will continue his chronic steroid. The pulmonologist recommend to keep the patient in isolation due to prolonged virus shedding. On per oral Vanco for C diff prophylaxis due to history of recurrent C diff infection and he is currently on antibiotic. Echocardiogram showed normal EF without significant valvular disease. Patient had episodes of dysphagia and swallow studies show some aspiration and he placed on pureed diet/dysphagia level 1. Sign-out given to SELECT LTAC team, they will follow on management.

Pfizer-BioNTech COVID-19 Vaccine EUA: Within fifteen minutes of receiving vaccine patient experienced lightheadedness and dizziness. Remained awake alert and oriented and able to stand and ambulate. Initial vital signs were within normal rnage except blood pressure 152/67 mmHg. Patient denied chest pain, palpiatations, shortness of breath, difficulty breathing, nausea, vomiting, and pain. Patient stated they had not eaten yet that day and was immediately given juice, food, and water. One hour after vaccination patient stated symptoms were resolving. One hour and fifteen minutes after vaccination patient stated lightheadedness and dizziness returned and were slightly worse and developed a new symptom of "ear and head pressure". Repeat vital signs were within normal ranges except blood pressure was 139/92 mmHg. After discussion with healthcare provider decision made to transfer patient to urgent care/emergency department.

3rd day after shot had lots of phlegm in morning lasting about a week. Easy to cough up. Green/yellow. More than a teaspoon. No breathing problem but did feel fatigued. After coughing up in morning, no other phlegm all day. Then, for a week, I had trouble with balancing, like walking after too many drinks. That has essentially resolved itself. OK now. Really don't know if adverse reaction or possibly a 'bug'. Thought it best to let you know.

Dizziness, nausea, irregular HR. EKC revealed AF. Drank full glass of red wine at 2 AM on the day of the vaccine. Went to the ED

After duing light work on Saturday morning. I sat down for a few minutes and felt a little light headed. My stomach became quisy and I had to go into the bathroom, became nauseated and had to vomit. I had a quisy stomach most of the balance of the day. I experiecnced a restless night. However, by mid-morning Sunday I began to feel better and have had no additonal inegative effect. The only other unexplained item was that on Sunday I checked my blood presure and it was 154/ 85. This is very unusual, as due to the nifedipine I take for my DES, my average for years is around 125/80. Today, Tuesday, I checked it again and it still at 158/87. I have an appointment with my cardiologist in 2 weeks and will discuss this with him.

PT states active lymphoma, sees Doctor. Did not discuss vaccine with PCP. Received verbal permission from Pt to contact D=providers. TC to Doctor's office, spoke with nurse, who states, spoke with Doctor who gave permission to vaccinate. 14:22 - After vaccination patient stood and stated he felt dizzy. Mentioned has a history of anxiety with vaccination. Rested while seated. After 5 minutes, c/o nausea, denies SOB, urticaria, or other SX anaphylaxis. Escorted via WC to first aid area. 14:33 VS: BP- 162/78 P 56 O2 Sat 98%. Provided rest / H2O. 14:45 - States SX resolved. VS - BP 164/72P - 52, O2 Sat 97%. Escorted to driver @ 15:00.

Severe pain in right hip, right knee, and the muscles in between. 2 Aleve 220 mg, In the am and pm, walking very slowly. Symptoms improved after 36 hours. By 02/13/21 walk with slight limp, but much better.

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.

The same day that the person was vaccinated he started feeling dizzy and had difficulty breathing. He was hospitalized from February 5 to February 23. Patient died in the hospital on February 23, 2021

About 5 days after the Vaccine shot I noticed that my finger joints were stiff. I couldn't make as tight of a fist, especially my right hand. When I open my right hand my ring finger would hang up and not extend with the others. It would lock up half way open and then extend the rest of the way. The condition has not changed since. I had my second shot on 02/10/2021 at 2pm. I didn't see a doctor about it since it is not critical except for a little lose of dexterity.

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.

Male patient who to the hospital on 3/15/2021 due to 10 days of shortness of breath on exertion and right-sided chest pain. He went to his PCP for follow-up and had a CT PE study today which was positive for right upper lobe and right lower lobe pulmonary embolism. He notes that he received a 2nd 5 0 COVID-19 vaccination on March 6th and since then has not felt well, feeling short of breath and generally fatigued. He notes that he has not been very active since receiving the vaccine. CT PE study showed an increased RV to LV ratio 1.2. He had no elevation in his troponin or BNP. His echocardiogram showed an EF of 60% and there were no wall motion abnormalities and grade 1 diastolic dysfunction. Patient would prefer Eliquis at this time. He will need a 6 month course of Eliquis. Given the setting of recent COVID vaccination and recent decreased mobility as possible provoking factors, this will be treated as a provoked pulmonary embolus. Per hospital COVID vaccine protocol, patient presentation will be reported to pharmacy for FDA reporting.

Patient developed substernal chest pressure and lightheadedness prompting visit to the ER where he was found to have a STEMI and developed Vfib arrest and had cardioversion x 2. Patient was found to have an inferior wall MI. Mechanical thrombectomy was performed for a thrombotic occlusion of the mid-distal RCA and DES X 1 placed. Significant CAD was present in the proximal-mid LAD and proximal-mid left circumflex.

Patient received first covid vaccination today, at around 1140 Volunteer monitoring patients noted that individual scooted down in his chair. She asked if he was okay and stated he was feeling dizzy. Vaccination clinic staff responded. Patient was able to assist to floor. Feet were elevated. He was provided water and ice pack. Patient did not appear to lose responsiveness at any point. He was able to state he was at the hospital as well as his name, DOB and where he was from, but patient was slow with answers. Patient then stated he was starting to feel better. He denies SOB or chest pain. As staff continued to interact with him, he was slower to respond again. He shared he had nobody in attendance with him and no family in the area. A code medical was called. BP cuff arrived BP was 164/110. ER nurse began assessment. Patient was able to get to standing position with staff assistance. He was taken to ER via stretcher for evaluation.

severe allergic reaction; has a drop foot that felt rubbery; Dizziness; Dry mouth; This is a spontaneous report received from two contactable consumers (once is patient himself). A 79-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection and Lot Number: EN6208), via an unspecified route of administration in the left arm on 15MAR2021 15:15 (at the age of 79-years-old) at a single dose for COVID-19 immunization. Patient medical history included Diabetes ongoing, patient has had three heart attacks. The first was over 20 years ago. He is waiting to have a stress test prior to having an angioplasty and Heart condition ongoing. Concomitant medications were reported as none. Lab data includes patient had all kinds of testing at the emergency room, test results that he had at the emergency room were all negative. They checked his heart and did a CT scan on 15Mar2021. Patient received the first dose of the COVID-19 vaccine on 15Mar2021. He received the vaccine at 3:15 pm. Within a minute after getting the vaccine he was getting dizzy. He was monitored for 15 minutes. He thought the dizziness went along with it. On the way home the dizziness was really hard to explain. He has never gotten this dizzy. It took his whole head over. It wasn't a spinning dizziness. He is 79 years old and has a lot of physical problems. He has a drop foot on his good leg. When he got home his drop foot felt rubbery. It is not usually like this. He also had a dry mouth. The papers said this is under the severe allergic reaction. Patient's daughter called the doctor and was told to go to the emergency room. He had all kinds of testing at the emergency room. 3-4 hours later the dizziness dry mouth went away. His foot was back to normal. He is wondering about the second dose. He is asking if the second dose will be stronger than the first. Patient received first dose of vaccine on 15Mar2021 and experienced dizziness, he believes it was a severe allergic reaction. His symptoms subsided a few hours later. He has a history of diabetes and heart issues. Event has already been reported to Pfizer. Patient has a Nuclear cardiac stress test on 01Apr2021. His second dose is schedule for 06Ap2021. He would like to know is it safe to get second dose considering his side effects. Outcome of event (severe allergic reaction) was unknown and recovered on 15Mar2021. No follow-up attempts are possible and no further information was provided

he felt drowsiness.; it hurts to turn his head and he cannot drive safely; muscle pain went over to the other shoulder and basically spread out all over his upper body; he's been having muscle pains; This is a spontaneous report from a contactable patient. A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL8982 and Expiration date not reported), via intramuscular route of administration in the left arm on 28Jan2021 07:30 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not allergic to anything. It was reported that patient was generally in good health in 79. He knows there may be some adverse effects. Last Thursday (on 28Jan2021) he got his first dose of the Pfizer covid vaccine and he's been having muscle pains. The only thing that has happened to him was a lot of muscle pain, quite a bit. Through the day he started to feel the muscle pain and through the night he felt some stuff (referring to the muscle pain), very lightly enough to be a nuisance. States from the waste up he felt drowsiness. The first night he slept some but not much since he could not get in a position where he could sleep very much. The next morning the muscle pain was much more severe, more pronounced on his left-side, which is the side he had the shot, particularly in several areas like right underneath his armpit and between his arm and elbow. By the end of 2nd day, the pain had spread to the right hand and the day after that, it was concentrated on the left arm on the injection site. The next morning the muscle pain went over to the other shoulder and basically spread out all over his upper body. It has since worsened by then. He broke down last night and he took two Advil, and he got a really good night sleep. This morning he got up and the muscle pain gradually came back but not quite a s bad, states maybe the Advil was slowly wearing off. States it was a funny sensation, a lot of them. Patient feels it on the bottom of the side of his rib cage and neck. He was asking how long the muscle pain will go on. He hates to combine anything he will experience from the second dose with what he was currently experiencing. Patients understanding was that the second dose will worse. Patient ask can he take the 2nd dose on his opposite arm (right), he do not want to feel pain on the same side again. He has a card that states when he was supposed to get his second dose. States it hurts, it hurts to turn his head and he cannot drive safely. States his wife got her vaccine two days before him. He puts his glasses on to read the con-tact details from his hcp card. When querying outcome of drowsiness, he reports it occurred a few times off and on and it comes and goes, it does not stay around. Prior to vaccination patient did not take any other vaccines within 4 weeks. The patient experienced he's been having muscle pains, he felt drowsiness, it hurts to turn his head and he cannot drive safely, muscle pain went over to the other shoulder and basically spread out all over his upper body. The outcome of event was not recovered for myalgia, condition aggravated and unknown for somnolence, impaired driving ability. Follow-up activities have been completed and no further information is expected.

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.

About 2 weeks following 2nd vaccination I began to experience dizziness when first laying in bed, getting out of bed or chair. I have never had this before and am otherwise quite healthy. I have tried Epley maneuver for Vertigo. I still have the problem. Blood pressure was normal. I contacted my PCP after 2 weeks and he referred me to an ENT specialist. Internet sources say this happens to 18% of Covid vaccine recipients. So I question if the ENT Dr would be of any help, and can this go away soon on its own.

Received the vaacine on 2/3/2021 I felt fine that whole day. The following day as I was showering I got lightheaded and fell in the bathroom . I went to the ER and the sent me home because I had no injuries. My blood pressure was high . For a few days I got lightheaded off and on. Then on 2/24/2021 I went for the second dose again i felt fine the whole day. On 2/25/2021 as I was showering I got lightheaded and fainted. My family called the ambulance and I was hospitalized from 2/25/2021 to 2/27/2021. I had facial fractures, fractured septum (nose) and cut upper lip received 10 stitches and teesth and gums were numb and still are a little numb.

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.

This 79 year old white male received the Covid shot on 2/16/21 and went to the ED on 2/21/21 and was admitted on 2/21/21 after a fall with rib fractures and traumatic hematoma. He went to the ED again on 4/27/21 and was admitted with Abdonminal aortic aneurysm and died on 4/28/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

he fell in the bathroom and passed out; he fell in the bathroom and passed out; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient's son). This consumer reported similar event for two patients (father and mother). This is the first (father) of the two reports. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) via an unspecified route of administration, administered in the left arm on 26Mar2021 (batch/lot number: ER8727) at 79 years old as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing AFib (atrial fibrillation) diagnosed between 1 and 2 years ago. Patient also has a pacemaker from an unknown date. Patient was exposed to COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS) oral from an unspecified start date and ongoing at 5 mg twice a day taken for AFib (atrial fibrillation). On 07Apr2021, the patient was admitted to the hospital due to a fall; he fell in the bathroom and passed out. The patient is on Eliquis, so they were worried about bleeding. He tested positive for COVID on 07Apr2021, this was the same day he was admitted to the hospital. He was discharged on 10Apr2021 and was improving. It was reported that the reporter (patient's son) tested positive for COVID on 27Mar2021, so it was likely his parents were exposed or infected prior to their first dose of the vaccine. The reporter confirmed he has not been vaccinated. The patient was due to get the second shot today, but the reporter cancelled the appointment since his dad was still in quarantine. The reporter heard different things about when to get the second dose, everyone says to wait 90 days, they're getting mixed information, then he has heard 3 weeks is long enough to wait. The reporter wanted to know when his dad can get the second dose of the vaccine after having the COVID-19 infection. The patient is recovering from "he fell in the bathroom and passed out." Outcome of the event "tested positive for Covid" was unknown. This case involves a Product Complaint: Consumer reported that his father and mother tested positive for Covid infection on 07Apr2021 after receiving the first dose of the Pfizer COVID vaccine on 26Mar2021. It was not provided if a sample of the product was available to be returned, if requested and if packaging was sealed and intact.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021443810 same reporter, same drug, same event, different patient

Woke up in the middle of the night dizzy on the evening of 3/11/21,started vomiting blood, syncope, when woke up had altered mental state, when reoriented he was able to call EMS, taken to hospital where he was diagnosed with an abdominal clot size of a grapefruit

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,

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.

who sponsored the Vaccine site. Adverse event: Was starting to drive and was kind of lethargic and was slow reacting. My wife was asking questions but I was having slow responses. She said I had glazed stare and I was a little off balanced and the ambulance was called but the symptoms had subsided by the time the ambulance got there: Blood pressure - a little elevated; Blood Sugar was fine . At that time could follow finger across eyes (before when symptoms were still there, had not been able . Ambulance left and just said to keep an eye on him at home when I refused to go to hospital. We called the family doctor and she said to go to ER immediately. No return of symptoms since that episode.

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.

Temperatures 105; chills; confusion; unsteady walking needing, great assist; Severe pain in back and neck; Severe pain in back and neck; Not eating, taking water OK; Incontinent of urine and stool; Incontinent of urine and stool; This is a spontaneous report from a contactable (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:00 (at the age of 79-years-old), as single dose for COVID-19 immunisation. Medical history included aortic heart valve replaced, mild COPD, edema in legs, irregular heartbeat. Patient had no known allergy. Patient not diagnosed with COVID-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included MELOXICAM, LASIX and HCTZ. On 04Mar2021 at 14:00 (same day after vaccination), patient experienced temperatures 105, chills, confusion, unsteady walking needing, great assist, severe pain in back and neck, not eating, taking water OK, Incontinent of urine and stool. Patient did not receive any treatment for the events. Since vaccination patient not tested for COVID-19. The patient underwent lab tests and procedures which included Body Temperature: 105 on 04Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

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.

Two weeks after the first Pfizer Covid-19 vaccine, the patient experienced vertigo-like symptoms with severe nausea, vomiting and diarrhea. He was admitted to the hospital where he stayed for a few days. After treating for vertigo, symptoms subsided. These symptoms have recurred several times since then. He was hospitalized again last week for several days. He also made another trip to the ER. Other times he was treated at home with prescribed medicine. He had symptoms of encephalitis. After multiple tests proved inconclusive, we now suspect this was an adverse event brought about by the first Covid-9 vaccine.

pronounced malaise including headache, slight nausea, muscle ache, shortness of breath, dizzines for three days followed by heart palpitations on day four. Palpitations continued for several weeks and then slowly cleared. BP, heart beat all normal. Palpitations were infrequent, then increased in frequency and the slowly diminished.

I had a full on body rash, started slowly the night I received the first dose. Spread from my back, to the rest of my body and lasted for two months. Two or three hours after the injection, I had issues walking on my left leg for about 6 or 8 hours.

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.

Wasn't felling heathy/Wasn't feeling well/not feeling good/Felling ill/Feeling sick; Using a bathroom number 2 four times a day, regular stool not soft; Back hurt; Slightly dizzy; I worry about how I am feeling until I know it is from the shot or not I am not going for another shot; Maybe nauseous; Feeling down; This is a spontaneous report received from a contactable consumer (patient) reported that: A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0123; Expiration date: unknown), via unspecified route of administration on 02May2021 (at the age of 79-year-old) as first dose, single dose COVID-19 immunisation. The patient medical history included atrial fibrillation and the concomitant medications included blood thinner for atrial fibrillation. The patient took pfizer shot 3 weeks ago. The patient experienced was not felling heathy, I wasn't felling a 100 percent; Was not feeling well/not feeling good, using a bathroom number 2 four times a day, regular stool not soft, back hurt, Feeling ill, Feeling sick, Slightly dizzy, worry about how he is feeling until he know it is from the shot or not, patient not going for another shot, May be nauseous, Feeling down on unspecified date in May2021. The patient stated that he got the shot 3 weeks ago and patient was due for second shot tomorrow but he have a concern, he do not think he is going for it, 2 days after he was not well about 8 days and then he felt better and then about 4 days ago he felt the same thing again, The patient stated that "he did not really care to report it but what he was calling to see his second shot is tomorrow and he is not going for it, but he would like get it may be when he feeling mentally after it, Could he take it couple of weeks later, if that ok?" the patient had a reaction to the flu shot (Unspecified Flu Shot) and he was feeling ill for about another 9 days it went away, but then it came back 4 days ago; didn't feel well/ not feeling good. The patient was scheduled for my second shot this morning I did not go because he is not feeling that great. The patient said he got the flu shot 3 weeks ago and 2 days after this shot, he did not feel well for about 7, 8, 9 days and then it went away, he felt okay and then about 4 days ago he got back the same feeling, not feeling good, slightly dizzy, maybe nauseous. Using the bathroom, number 2 frequently 4 times a day and he was scheduled for my 2nd shot this morning I did not go because he was not feeling that great. The patient stated that he took the vaccine three weeks ago and he was scheduled for his second shot this morning, he did not go because he is experiencing some side effects(Further not clarified hence captured as verbatim) and he was concerned to see this is related to the vaccine (confirmed as Pfizer COVID vaccine) or not?" He got this vaccine shot 3 weeks ago two days after he was not feeling well, he was feeling down for about 8 or 9 days and then it passed, the patient felt better then 4-5 days ago the same thing come back, this is 3 weeks now. The patient did not receive any treatment for the events, the outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

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.

tested positive for COVID-19; tested positive for COVID-19; dizziness; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9264), dose 1 intramuscular, administered in right arm on 30Jan2021 as single dose for COVID-19 immunisation. Medical history included COPD. The patient's concomitant medications were not reported. The patient was tested negative for COVID-19 several times before getting the first dose of the vaccine. On an unspecified date he tested positive and went to rehab centre in Feb2021, prior to received his second dose of the product. In Feb2021, patient had dizziness had been ongoing for might be about 2 to 3 weeks. The patient underwent lab tests and procedures which included COVID-19 test: positive in Feb2021. On an unspecified date, the patient was discharged from rehab centre. he outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

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

Extreme muscle pain over entire body; Headache; Skin pain; Chills; Sweat; Hard to keep my balance; This is a spontaneous report from a contactable consumer, patient. A 79-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on unknown date (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included blood pressure high. The patient had known allergy with sulfa drugs. The patient taken other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance on 15Mar2021 at 23:00. Therapeutic measures included treatment with high doses of Tylenol. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme muscle pain over entire body, headache, skin pain, chills, sweat, hard to keep his balance was recovered on an unknown date. Information about lot/ batch number cannot be obtained. No further information is expected.

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.

Within 2 days of second shot, Patient exhibited extreme fatigue. This continued for the next several weeks culminating with the inability to move which resulted in admission to Hospital the week of 2/22/21. After weeks to stabilize vital systems, a diagnosis of multiple myeloma was obtained. Patient continued to decline until multiple organ failure occurred within 30 days of admission. Death occurred on 3/25/21. It is not clear whether the vaccine potentially caused and/or exacerbated a previously undiagnosed condition (multiple myeloma). However, the proximity of an immune cell related cancer which resulted in rapid decline and death within 60 days of vaccination should be noted in case there are any other previously undiagnosed blood cancers being found in newly vaccinated individuals.

Neurological problems; Was imbalanced; Unable to walk; This is a spontaneous report from a contactable consumer (patient's daughter). A 79-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE), dose 2 at vaccination age of 79-year-old via an unspecified route of administration in the right arm on 20Mar2021 10:30 (Lot Number: EN6207) as dose 2, 0.3 ml single for covid-19 immunisation. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) on 27Feb2021 (LOT: EN6202) injection in the right arm at dose 1, 0.3 mL single at vaccination age of 79-year-old for COVID-19 Immunization. The patient medical history, family medical history and relevant Tests were none. The patient's concomitant medications were not reported. The patient did not receive other vaccination 4 weeks prior to the first administration date of the suspect vaccine. The reporter stated that she called with regards to the Pfizer vaccine that her father received two weeks within (Mar2021) having the second dose, he started to have neurological problems, he was imbalanced, and unable to walk. She added that he is in hospice and they don't think he's going to make it. She stated that she wanted to report just to let Pfizer know so maybe Pfizer can prepare someone else. The patient was first hospitalized from 28May2021 to 02Jun2021 and the patient came home on 02Jun2021 but went back to the hospital on 04Jun2021 to 05Jun2021 (second hospitalization). The third hospitalization was on Saturday (05Jun2021), he went to a rehabilitation center and was there until 14Jun2021. The reporter stated that they weren't allowed to see him for 10 days because of the COVID stuff and when they saw him on 14Jun2021, he had diminished drastically so he went back to the hospital. The daughter stated that he went right into the Palliative care unit. The adverse events resulted in emergency room and physician office visit. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

80YO male who htn, cva, epilepsy, ckd, cerebral avm s/p repair, cad s/p cab, cva (left sided hemiplegia) , hx of prostate cancer recent admission for pna on abx presents to ED on 1/11 with dizziness, hypoxia. CT with Bilateral PE "Large bilateral pulmonary artery emboli in the right and left main pulmonary artery extending into the right and left main pulmonary artery branches bilaterally. Findings are associated with right-sided heart strain." "Patchy alveolar airspace disease within the lungs highly suspicious for COVID pneumonia" Covid negative. Patients wife recovered from Covid-19 infection within last month. Patent thus far has tested negative. Doppler lower extremity revealed Acute occlusive vein thrombosis of the entire course of the gastrocnemius vein and soleal vein. Patient received covid vaccine on 1/4/21. Patient has several risk factors for clot - age, previous CVA, hx of prostate cancer. Also had positive covid exposure though tested negative

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."

Extreme muscle weakness, could not get out of bed unassisted, slight nausea. After 48 hours symptoms went away rapidly. Never had a reaction to a vaccine previously. Have had flu, shingles, pneumonia previously..

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.

Felt dizzy after the shot with resultant spike in blood pressure to 190/80. Blood pressure receded to 156/76 before7:00 pm to allow drive home. Please provide information with medications taken and results for safety.

trouble breathing; fatigue; muscle and body aches; muscle and body aches; trouble standing up; 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: EK 4176), via an unspecified route of administration on 18Jan2021 11:30 AM at single dose on left arm for COVID-19 immunization. Vaccine facility type is hospital, Medical history included dialysis patient, "dibeties" and High blood pressure. No known allergies and no COVID prior vaccination. No other vaccines in four weeks. Concomitant medications included unspecified medications (reported as "other medications in two weeks: yes"). The patient experienced trouble breathing, muscle and body aches, trouble standing up and fatigue which occurred within 1 hour after taking shot on 18Jan2021 12:15 PM. No treatment was given for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.

Patient scheduled, arrived and consented to receive the first dose of the Pfizer Covid vaccine on Thursday Feb 4,2021 around noon. Patient received his vaccine and was directed to an observation seating area, accompanied by his wife and completed at least 15 minutes of observation prior to being released home. When patient stood up from his chair to exit the clinic , he fell and hit his head on the floor which caused substantial bleeding. He was immediately attended to and transported to the Emergency Dept on the campus of this vaccination site for treatment.

Roughly 9 hrs after shot malaise. During next 30 hours loss of balance, incontinence, nausea, mild headache. By 40 hours symptoms had diminished and I could eat, although sparingly, again

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.

within 2 days of the vaccine he began to feel dizzy, this progressed. he was admitted to hospital 2/1 and was found to have lacunar infarct as well as chronic cholecystitis as well as hypereosinophilia with AEC 4500-11000. no rash or renal failure. he had transamintiis that resolved with treatment of cholecystitis (percutaneous cholecystectomy). eosinophilia work up not yet completed at the time of this report.

Patient became dizzy and hypotensive 70's systolic after receiving his 1st PFIZER COVID-19 MRNA VACCINATION. Patient was taken to the ER.

Reaction occurred on 2/7/21 (about 48 hours after first dose): Severe dizziness and blurred vision for 10 minutes. Patient has no prior history of dizziness, vertigo, or blurred vision.

fell and broke his hip; fell and broke his hip; tested positive for COVID-19; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot EL1283, expiry date 30Apr2021), intramuscular in right arm on 22Jan2021 10:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing Parkinson's disease diagnosed in Jan 2018 and the Neurologist said that the patient probably had it for 6-8 years; ongoing hypertension (its been years); had cardiac and thyroid disorder. The patient was on unspecified medication for his thyroid. The patient fell and broke his hip on 02Feb2021 08:30 and was hospitalized. It was reported that he will have a surgery. The patient underwent laboratory test Sars-cov-2 test: positive on 02Feb2021, weight: 170-175 lbs on unknown date. He also had an echocardiogram a couple of weeks ago (2021) because he was seeing a new heart doctor. The doctor did say that he had a mild leaky aorta and will continue just the medication he was on. He was scheduled to receive the second vaccine on 12Feb2021. The outcome of events was unknown. No further details were provided or obtained.

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.

Patient was found on bathroom floor by spouse @ approximately 02:30 am (2.5 days after receiving 2nd dose of Covid-19 vaccine). He had fallen and had an obvious head injury & demonstrated altered mentation from usual baseline. Family utilized 911 to transport him to local ED. He was febrile upon arrival to ED and admitted for severe sepsis with unknown etiology. He was found to have positive SIRS criteria and elevated LA. He was admitted to hospital and received IV antibiotics for 11 days (spent 7 days as an inpatient and completed remaining infusions in home environment)

1 day after taking vaccine, noted stiffness on left side of the body, beginning on left buttock down left leg to the left foot; leg was swollen and stiff

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.

extreme fatigue; feeling of faint; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) at the hospital, via an unspecified route of administration on 03Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included 10 nerves killed in back lumbar region on an unknown date (reported as '5/02'). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium (manufacturer unknown), gabapentin (manufacturer unknown) and tamsulosin hcl (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced extreme fatigue and feeling of faint on 05Feb2021 at 07:00. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. The events were reported as non-serious.

10/5 :Fri 2:00 PM Nausea,9:30 PM Fell down and could not get up without assistance, unable to walk or setup, Dizzy and confused, bad itchy rash on body including large red spots(stomach, back, legs, arms, head , neck) Sat 10/6 admitted at Hospital tests results dehydration. Continued problem with walking. Tues 10/9 visit with primary doctor. Pictures were taken of his body and entered in computer at Clinic. Walking issues getting better.

At 2 a.m.the following morning after the vaccine , my father got up to use the bathroom and realized his legs were so weak he could not stand from the bed. This happened again at 5 a.m.and 7 a.m. when he awakened to urinate. He called his doctor that morning who advised him to go to the ER to rule out a stroke. He was admitted overnight for observation. A CT scan of the head was negative for stroke. He had a follow up MRI head which was also negative for stroke. He will follow up with his neurologist.

About 72 hours after the 1st dose, I experienced a fullness in the left ear accompanied with a low frequency, low volume buzzing or humming . These symptoms persisted over the next week, but would switch from left to right ear or occasionally in both. At the end of the first week I experienced two episodes of mild vertigo lasting for about 3 or 4 hours on two separate days & then stopped. The fullness & humming persisted until about 14 days after vaccination & then cleared & have not returned. The symptoms seem to stop when I went to bed at night.

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.

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.

Severe muscular collapse and diagnosis of myasthenia gravis, requiring a feeding tub, after 2nd Pfizer injection for Covid-19. Hospitalized for one month. Patient had unknown condition. Vaccine made him a vegetable and he can't eat or walk or write. Please call me.

PATIENT STATED THAT APPROXIMATELY 26 HOURS AFTER HIS INJECTION HE WAS INCOHERENT, FELL, AND COULD NOT MOVE. ADVERSE EVENT LASTED 24 HOURS.

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.

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

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

About a day and an half after the injection patient had a sudden onset of extreme nausea, vertigo and vomiting. After 1.5 hours of vomiting, he was taken to the hospital by ambulance and was admitted for four days. CAT scan and MRI, ECG and bloodwork ruled out stroke, heart attack etc. The hospital administered anti nausea medications (meclizine sp?). The nausea resolved about 8 pm.

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.

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.

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

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.

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.

crying; feeling nausea; depression; feeling dizziness; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17May2021 09:00 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunization. Medical history included heart valve replacement from 12Mar2021, kidney infection, had a heart bypass and is diabetic. The patient has no concomitant medications. The patient got the Pfizer Covid Vaccine on 17May2021, and the next day (18May2021) he woke up with dizziness. The reporter asked how long the symptoms last after the Covid vaccine. He is sort of getting nausea when he tries to get up. He was also real depressed. It kind of started the next day after the vaccine (18May2021), but Wednesday she was concerned because the patient was crying a lot which is unusual for him. The nausea started today (25May2021). He hasn't been up and about. The dizziness is about the same. They called his primary caregiver who started him on some antidepressants. She picked up the information sheet that was given to them with the Covid vaccine and read there that dizziness was a side effect and a feeling of impending doom which is sort of how he was feeling. Now that's why she was wondering when the symptoms would be over. She doesn't really think he needs anything. He has never been depressed. She thinks now it is a side effect from the vaccine. She thinks the depression has improved. He is not crying anymore, but somebody is with him all the time. This was his first dose of the vaccine. He is supposed to go back on 07Jun2021 for his second. The outcome the event depression was recovering, event crying was recovered on an unspecified date and the other events was not recovered.

Vertigo type feelings; Woosey and a little nauseous; This is a spontaneous report received. A contactable consumer (patient) reported 80-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration, administered on left arm on 10Mar2021 10:00 (at the age of 80 years old) (Batch/Lot Number: not reported) as 1st dose, single dose, for COVID-19 immunisation. Patient's medical history included benign prostatic hyperplasia (BPH) on an unspecified date and penicillin allergy. Concomitant medications were not reported. The patient has not had COVID before vaccination nor tested after vaccination. On 12Mar2021 06:00, the patient experienced vertigo type feelings. The patient felt woosey and a little nauseous. The patient did not receive treatment for the reported events. The outcome of the reported events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

Within a few minutes of his 2nd dose, he said his throat felt tight like it was closing. I alerted staff. They checked his blood pressure. 155/50. Made us wait another 20 minutes and my dad said he felt better after drinking water. Once we got home he said he felt brain fog and a bit dizzy. He passed away on May 4th, 2021. 3 days after his 2nd dose of Pfizer. It was ruled a heart attack.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/31/2021). Patient was admitted to the hospital on 7/5/21 for cough, poor appetite and dizziness for at least 3 weeks and tested positive SARS-CoV-2. On admission patient was febrile to 100.3, O2 SAT 95% on RA but desaturated to 89-90% with ambulation. He did not receive any COVID specific therapies and was discharged in stable condition on 7/7/21.

dizziness; he couldn't stand up; he laid down the bed would float; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry: Apr2021), via an unspecified route of administration on 09Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included retired, he became allergic to penicillin when he was 17 year old and hasn't taken it since, lost his taste and smell, potassium is high sometimes - the doctor recommend he cut down on banana and potatoes, extra heart beat, stomach acid, and thyroid disorder. Ongoing concomitant medications included levothyroxine sodium - has been taking it for a year and a half to two years for thyroid, metoprolol succinate - has been on it about a year and half because an EKG showed he had an extra heart beat, and omeprazole capsule - been on it two or three years for stomach acid. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and experienced allergy. After having a Pfizer shot on Saturday, he had a reaction - dizziness. His wife also received the COVID vaccine but did not have any reaction. He sat in the office for 15 minutes like he was supposed to. He drove home and was fine. Two hours later he was so dizzy he couldn't stand up. He was holding onto things to walk through the house. That was two hours after he took the vaccine. After that he thought it would go away in a day. All day yesterday, which was the second day, he was still dizzy. If he laid down the bed would float. It was an awful experience. He received the vaccine at 11:45am on 09Jan2021. Two hours later is when it started. He had to hold onto the rail to get up there. If he gets up quick it is still there. He just had blood work and was due back in Apr for check up. He hasn't had taste and smell for four years or better. He lost his taste and smell and never got it back. He doesn't know what caused that. He hasn't been sick. Outcome of the event dizziness was recovering, for the other events was unknown.

Wednesday morning he started to feel a lot of muscle soreness in the back of his neck and shoulders and could not put his head back to drink water. Wednesday evening put muscle rub on achy areas and took a couple of Aleve. Thursday morning was feeling better and Thursday evening a lot better. Friday just a slight tight feeling to remind him it is still there.

fatigue Narrative: Did not feel good, appeared to have symptoms prior to getting vaccine, but had declined ER evaluation prior to vaccine. Pt was light headed, VS stable. Pt reported to have fatigue with exertion. Was sent to MER at 1:30p, routine labs revealed elevation in SCR and admitted for AKI. Pt was determined during admission to be volume depleted exacerbated by diuretics and administered IV fluids. follow-up appointment scheduled for 01/31/2021.

Syncope. Patient presented to ED due to syncope in the shower. Patient received 2nd dose of Covid vaccination this afternoon. Patient also received dialysis today. EKG sinus rhythm with 1st degree AV block. BP WNL, BG 132. Admitted. It is possible that patient had mild hypovolemia following dialysis or vasovagal event, and less likely by Covid vaccine thus got discharged. Patient had a ground level fall on next day at ALF. No acute findings noted

My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; My knee joints and elbow joints feel very stiff and feel as if they were swollen but they're not/My joints do not look physically swollen up but they feel; I'm having trouble walking; got up every 15 minutes after that with frequent urination/ I got up 5 or 6 times and even could not get bathroom fasten up and couple of occasion is very unusual for me; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (lot number: EL3249), via an unspecified route of administration on 14Jan2021 at single dose in the arm for COVID-19 immunization. Medical history included atrial fibrillation, diabetes and a heart attack 30 years ago. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) for A-fib, empagliflozin (JARDIANCE) for Diabetes, metformin hydrochloride (METFORMIN ER) for Diabetes. It was reported that the patient had no after effects the day he had the shot. In the morning of 16Jan2021, he got some things going on but he was not sure if it is connected with Pfizer or not. Usually he wakes up and go to the bathroom once in middle of a night. Last night he got up 5 or 6 times because he had to go and couple of times, he did not even get to the bathroom on time so he really had to urinate. Stated this is very unusual for him. And when he woke up this morning, her joints do not look physically swollen up but they feel, stated "how do I describe it, they feel very (incomplete sentence)". His knee joints and elbow joints felt very stiff and felt as if they were swollen but they're not. Stated that he's having trouble walking. Stated that it may be totally unrelated. The patient stated, "The only thing I had was, every year they make me go to a lab and make sure I have no issues with Pradaxa because it is a blood thinner. I have that lab. Work done couple of weeks ago. I have not gotten the answers yet". Also stated that he had lab test because he has acid. The outcome of the events was unknown.

hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason. Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.

Minor headache began within 24 hours of injection; resolved within 48 hours of onset of symptoms Slight loss of balance

1/20 i was tired for about 2 hrs. 1/21 I had a little different bowel movements . about 8 days later. started to get a little wobbly getting out of chair. 3 days later i had to use a cane to get around. and then the next morning i was fine.

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.

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.

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"

Day after second vaccine woke to complete loss of hearing in left ear. Next day balance was off and still is-and hearing in left ear is still gone.

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.

4 days after receiving the second injection on Feb20, 2021, I experienced significant weakness in my legs which caused me to be unable to stand upright for any extended period of time and prevented me from taking care of my self. This condition has persisted since then and has not improved significantly.

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

My RA began to really act up. My whole body stiffened up-(legs, hands, hips, back). Lower back made it hart to bend over, Rt shoulder had a swelling and hurt at a pinch point in shoulder, my rt hip hurt when I walked more than 0.25 miles, my hands swelled and could not use hand well. Did not initially link to Covid shot, so called my Rheumatologist on the sixth day that the symptoms continued. Received prescription to reduce muscle tension and an anti inflamatory. However, a couple of days after talking to my doctor and before taking any of the prescribed meds, the symptoms went away and since that time, my RA is back to typical old symptoms and pain level.

Patient developed a syncopal episode one day following the vaccine. Without warning, he fell to the ground, losing control of bowel and bladder, although no seizure activity noted at the time. He transiently lost consciousness and then woke up confused and combative. Brought to emergency room and admitted with multiple rib fractures. Initial brain imaging was negative but 24 hours later, noted to have small hemorrhagic brain contusion in left frontal/temporal region and a small subdural hematoma. One day later, there was not noted to be any extension of the hemorrhage/hematoma.

Patient reported feeling lightheaded immediately following 2nd dose. Floating RN took serial blood pressures, documented below:1120 Rt arm 197/108, pulse 68; Left arm 214/99, pulse 74. 1130 Left arm- 217/92, pulse 64 1134 Rt arm 212/106; Left arm 222/105. Patient reported feeling "average" with resolution of lightheadedness. ED called and ED RN transported patient to the ED for further evaluation.

Patient received his 2nd dose of the Pfizer vaccine at on Monday, February 15. That evening, he experienced visual disturbances with slightly blurred vision. Not thinking anything of it at the time, the vision cleared, and he continued about their evening/week without telling anyone of his visual disturbances. On Sunday, February 21, he experienced additional visual disturbances including double vision and dizziness, and we had him visit a local ER for evaluation. He was discharged with a diagnosis of dehydration and vertigo. No scans were performed. The visual disturbances cleared up the following week and the only persistent symptom was a slight dizziness. An eye exam was performed on Friday, February 26 with no problems found. An MRI was performed on March 3, and he was diagnosed with the below conditions. Impression (3/3/2021) 1. Small acute to subacute infarcts in the left splenium of the corpus callosum and parasagittal left occipital lobe. 2. Trace subarachnoid hemorrhage in the parasagittal left parietal lobe. 3. Mild chronic microvascular ischemic disease. He was admitted to the hospital and remained there until Saturday, March 6. Follow-up scans and testing were performed with no underlying reason for the stroke being determined. Prior to the stroke, he had been a very active individual with osteoarthritis as is only health complaint. He was not on any prescription medication prior to the stroke. While in the hospital, the tests for high blood pressure, high cholesterol (LDL 92 MG/DL), sugar inadequacies (glucose 93 mg/dl, A1C 5.7%), etc. came back without major concerns. His follow-up CT scans also did not reveal the stroke shown on the MRI. No inquiry was made by any of his doctors or hospital staff as to his COVID vaccination status/dates to even consider the connection. Below are the results of the last CT scans: Impression (3/4/2021) 1. Age-related volume loss and white matter disease similar to prior exams. 2. Small infarct seen on MRI are not well seen on CT. 3. No acute intracranial abnormality demonstrated on the CT scan. Impression (3/5/2021) 1. No evidence of acute infarct or intracranial hemorrhage. No significant change. 2. Periventricular white matter disease is likely secondary to chronic small vessel ischemic changes.

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 80 and discharged on 2/17/21 with hospice after falling and suffering a subdural hematoma. Patient was likely reaching end of life from metastatic prostate cancer before fall.

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.

Fluid in right ear, wax build up in left ear; Fluid in right ear, wax build up in left ear; Ear infection; Dizzy; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration Date: Jun2021), via an unspecified route of administration, in left arm (shoulder) on 25Mar2021 at 15:30 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included dimenhydrinate (DRAMAMINE) (Lot number: P118702 and Expiration date: 01Feb2023) 50 mg pills/100 count taken for motion sickness, patient mentioned that it did not help. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient mentioned that he and his wife had the COVID virus and they had to wait 90 days for their first shot. On 27Mar2021 in morning, the patient experienced dizzy and went to the doctor. The doctor checked his ears. On 05Apr2021 in morning, the patient experienced fluid in right ear, wax build up in left ear and ear infection. The patient was given drops for a week. On 12Apr2021, he went back to the doctor and reports that everything looked good. The doctor flushed the wax out of his left ear, but noted that he has an ear infection. The patient visited physician office due to events. The patient is taking is Amoxicillin 875 mg tablet, take one tablet by mouth every 12 hours. The patient would like to know if he should still take the, second vaccine, as he has 7 more days left for his antibiotic. The patient asked the doctor if he should take his second vaccine, and the doctor didn't know. The patient thinks the dizziness was the fluid and wax buildup in his ears. He believed it will get better and does not think the vaccine caused the dizziness. He is still dizzy at times but not as dizzy as he was. The wax is gone and the ear infection is not as bad as it was. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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.

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

Patient Male, 81-year-old, 7/19/1939 Admitted 5/16/2021 Admitted with femur fx after a fall. COVID-19 PCR positive 5/16/2021 No indication that he is from a Nursing Home, etc.

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.

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.

Severe dizziness; This is a spontaneous report received from a contactable consumer, the patient. An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 81-years-old), as a single dose for COVID-19 immunisation. Patient did not have known allergy and did not have any other relevant medical hisotry. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration in the left arm on 23Feb2021 at 16:00, as a single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the vaccine. The patient did not receive any other medications within two weeks of vaccination. On 19Mar2021 at 02:00, the patient experienced severe dizziness on awakening. The patient did not receive any treatment for events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of severe dizziness was resolving at the time of reporting. Information about lot/batch number cannot be obtained. No further information is expected.

20 mts after vaccination when I was driving I suddenly starting feel an intense VIBRATION at the site of the injection(left up arm),then quickly extended to the whole limp and gained the right up limp after my lower extremities THEN my BRAIN and I was loosing vision.i told to my wife take the wheel and at that time EVERYTHING mean the intense vibrations including my sight came to normal.

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

Verbalize feeling Dizziness, was evaluated on site by EMS and released home at 10:42 am feeling better.

Verbalize feeling dizziness, was evaluated on site by EMTs and released home at 10:42 am feeling better.

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.

Patient's wife stated that patient had been feeling weak and dizzy prior to administration of vaccine. During observation patient's wife informed medic that patient was feeling dizzy. Patient was taken to medic area. Vital signs as follows 63/49, pulse 112 O2 97% BS 146.

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.

Patient had fall x 2 with or without sycnope (conflicting documentation) with humeral fracture after recieving the vaccine. Workup demonstrated PE and DVT (appears PE was not submassive/massive, unlikely it directly precipitated fall/ syncope)

Feeling very lethargic ("can barely walk"); Feeling very lethargic ("can barely walk"); Severe tiredness; This is a spontaneous report from a contactable consumer. An 82-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In the morning of an unspecified day in Jan2021, the patient was feeling very lethargic. The reporter (patient's wife) stated that they both received the vaccine at 2AM on Saturday and was asking if the event was common. It was also reported that the patient had severe tiredness all of a sudden after receiving the vaccine. The reporter stated that it had been about 55 hours since the shot and she wanted to know if this was a time frame to expect this; stated that it came on so sudden. Outcome of the events was unknown. Case was reported as non-serious. Information on the lot/batch number has been requested.

Patient got up at 4:30 am and nearly fell he was so dizzy. This dizziness had lasted from Thursday to Saturday and he has improved but not completely back to normal

Complete body ache, nauseous, sweating, fever.......I felt like someone beat me up with a baseball bat....couldn't even get out of bed it started about 12:30 AM and lasted about the rest of the following day...

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.

Patient felt dizzy after Pfizer COVID-19 vaccine and was moved to recover room with EMS. Blood pressure was elevated as below: 11:10 - BP 154/107, Pulse 90 11:25 - BP 148/94, Pulse 86 Patient was observed for 30 minutes. After 30 minutes, patient was released with his companion back to his house.

After client received vaccine client states he felt dizzy. Vitals obtained bp 120/78, pulse 100, O2 sat 97%. Client stated he feels better. Client discharged home.

During the patient's 15 min observation period, he began to complain of "lightheadedness" and palpitations. No other symptoms. He was moved to a treatment room. Blood pressure checked, EKG performed, observed for 30 min. Ate small snack. Complete resolution of symptoms.

right hip was very painful, it killed him/ right hip started to kill him/ couldn't walk without his hip giving way from the pain; hardly could walk on it/ couldn't walk without his hip giving way from the pain/didn't have any problem with walking around until he took the vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration (left arm), on 02Feb2021 09:00, at single dose, for covid-19 immunization. Ongoing medical history included cholesterol, GERD, heart, and prostate. Concomitant medication included carvedilol (COREG) from 2011 and ongoing for heart; lovastatin (MEVACOR) from 2011 and ongoing for cholesterol; alfuzosin hydrochloride (UROXATRAL) from 2011 and ongoing for prostate; omeprazole (OMEPRAZOL) from 2016 and ongoing for GERD; torsemide from 2001 and ongoing for water pill for his heart; and sacubitril valsartan sodium hydrate (ENTRESTO) from 2011 and ongoing for heart. The patient took the first dose of the Pfizer vaccine yesterday, 02Feb2021, at 9:00 and at 15:00 his right hip was very painful, it killed him; hardly could walk on it. His right hip started to kill him. He couldn't walk without his hip giving way from the pain. He didn't have any problem with walking around until he took the vaccine. He wanted to know if it was going to go away. The patient had not recovered from the adverse events at the time of the report. The adverse events did not require a visit to a physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was planning to receive the second dose on 23Feb2021 and mentioned that he was having a heart test later this week.

passed out; felt lightheaded; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, high cholesterol. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 25Jan2021, the patient felt lightheaded since vaccine. On 02Feb2021, the patient passed out. The patient has never passed out before. He went to the cardiologist on 04Feb2021 and had EKG and review of BP readings and HR readings etc., all checked out ok. Today was 08Feb2021 and still lightheaded. The cardiologist suggested we call you but cannot get through. We were extremely concerned about getting the 2nd vaccine because of reports of worse symptoms with that one. We cannot get through to you and do not know what to do. The 2nd vaccine was scheduled for 15Feb2021.The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. Treatment was received for the event passed out and ordered Exam-EKG-Holter Monitor. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

passed out; light headed; This is a spontaneous report from a contactable consumer (patient's daughter). An 82-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 25Jan2021 09:50 at single dose for covid-19 immunization. Medical history included visual problem. The patient's concomitant medications were not reported. The patient experienced passed out on 02Feb2021 and light headed in 2021. Clinical course: Consumer was calling regarding her dad who got the Pfizer COVID-19 vaccine. She said her dad had an event and she took him to his cardiologist who checked him out and suggest they call about it. She said that her dad passed out a week and a day after getting the vaccine and had been light headed. She said she was concerned that the second dose of the vaccine was supposed to be worse for effects, and she knew he was supposed to get it, but she wasn't sure that he should. She said her dad would say to call his daughter, because he had a visual problem, which he had since before the first dose of the COVID-19 vaccine. Caller said that NDC/EXP were not provided on the handwritten card. She said it said he got his first dose 25Jan2021. She said that the report she filed online asked what time he got the vaccine dose, and she put 09:45AM since it would not let her put 09:50AM, it was really at 09:50AM. Outcome of events were unknown.

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.

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)

Patient received first dose of Pfizer/BionTech vaccine ~2:40p Patient experiencing palpitations and dizziness. patient took 1 nitro tablet, 3 minutes later patient told staff he was having chest pain and and nausea. He stated nitro was helping but he knew this was gonna be a bad one and 911 was called . 2 minutes later(2:56p) took 1 nitro tablet. still having chest pain, dizziness nausea. took third nitro tablet at 3:01p. BP 125/101 and 86 BPM. 5 minutes later BP was 138/78 mmHg. A and O x 3. ambulance transported him to hospital for further evaluation

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.

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.

03/15/2021: Presented to the emergency department after losing his balance and falling down five stairs. The patient hit the back of his head, but didn't lose consciousness and currently takes a blood thinner. The patient was admitted with a pubic rami fracture and T12 fracture. The patient remains admitted and may undergo surgical repair.

patient experienced TMI approx 2 hours post vacc presneted with loss of balance and listed to right. diagnosed by MRI the next day.

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

Every day after the vaccine shot he had more difficulty moving around till he could no longer walk by the 17th of March

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.

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

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

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.

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.

Went to ER for headache. Got CAT scan. Scan showed nothing but ER doctor said to watch it because it might come back. Headache lasted gir two weeks thereafter and balance was affected.

No access to SIH documentation: 4/6/21 Occult blood positive - Cancer Center 4/27/21 Dx Melena, Medical Center, VCE, EDG/upper enteroscopy and colonoscopy discussed / ordered? - wife cancelled? 5/17 ER - Admission: falls, bruising abdomen, pelvic area, right back, buttock - Hospital 5/29/21 ER - Admission: The patient is a 82 y.o. male with a PMH notable for uro lift on 05/26/2021, BPH, CAD, diabetes, atrial fibrillation, hypertension, and CABG who presented on 5/29/2021 for evaluation of catheter problems. Patient presented to our emergency room with complaints of leaking around his catheter. Patient had a uro left done on Wednesday 05/26/2021. Wife and patient stated they went back yesterday due to the catheter was clogging up with clots and they replaced catheter. Patient stated he has been urinating clear but around the catheter and none has been going into his leg bag. Patient wife states that he has not taken his diuretic all day because he was worried about taking it since urine was not going into the Foley catheter bag. Upon arrival to the emergency room patient's temperature 98°, pulse 83, respirations 18, blood pressure 153/77 oxygen saturation 100%. Hemoglobin 8.8, glucose 285, BUN 24, sodium 134, INR 1.3, BNP 1460, urinalysis has culture pending. The emergency room called Dr and he requested that the patient be placed in observation here to assure that anemia is not worsening, CHF improves and patient is able to void on his own without retention. Patient received Lasix 40 mg IV push in the emergency room. Patient was admitted observation status for further treatment and evaluation systolic congestive heart failure, acute post hemorrhagic anemia, anticoagulant induced hematuria. Upon entering the patient's room this morning patient is resting in bed in no acute distress. Patient is alert and oriented x3. Patient states he is voiding without any difficulty from having Foley catheter removed. Patient states he came to the ER because he did not take his diuretics due to he was peeing around the catheter and then of his urine was going in Foley catheter bag. Patient denies any increase in shortness of breath, chest pain or any weight gain. Explained to patient that he is going to be here for the next day receiving IV diuretics to see if we can get swelling decreased on bilateral lower extremities and to continue monitoring his urine for blood and checking his hemoglobin. Rounds made with another Dr.

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.

Very lethargic for 3 days followed by headache, dizziness and shortness of breath. Has continued up to today but the symptoms have lessen each week. Most common is headache and dizziness. Went to emergency in May thinking I was having a heart attack but they could find nothing wrong.

I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

APPROXIMATELY 30 MINUTES AFTER VACCINATION, DEVELOPED DIZZINESS AND PRESSURE IN CHEST THAT LASTED UNTIL THE FOLLOWING MORNING.

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.

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.

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.

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.

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.

Had a fall and hit his head; Had a fall and hit his head; This is a spontaneous report from a contactable pharmacist. A 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Jan2021 (age at vaccination: 83 years old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the 1st vaccine dose "today" (23Jan2021) but he had a fall and hit his head. Patient was now requiring TDAP. The clinical outcome of the event fell and his head was unknown. The reporting pharmacist was seeking information on the use with other vaccines, particularly the benefit vs risk of co-administering in an emergency case. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/12/21 ON 02/20/21 REPORTED TO ED AFTER BECOMING LIGHT HEADED AND HAVING A SYNCOPAL EPISODE. REPORTED SOME SOA ON EXERTION THAT DEVELOPED EARLIER THAT DAY. ON 02/20/21 PT ADMITTED INPATIENT TO HSOPITAL WITH DIAGNOSIS OF SYNCOPE AND COLLAPSE, AOMMUNITY AQUIRED PNEUMONIA, ACUTE COLITIS, AND LEUKOCYTOSIS.

Urinary tract infection; high blood pressure; Fall; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. An 83-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: 31Mau2021), via an unspecified route of administration on 02Feb2021 13:12 at SINGLE DOSE for Covid-19 immunisation. Medical history included heart surgery (Between 6-9 years before), Congestive heart failure, blood pressure (problems with blood pressure) and fall (history of falls). Concomitant medication included ongoing carvedilol for Congestive heart failure. The reporter stated that her husband has high blood pressure (occurred on an unspecified date) and was having problems falling. He fell the night of 03Feb2021. She called the paramedics to come help get him up. He was taken to the emergency room on the morning of 04Feb2021. He was found to have a urinary tract infection (on 04Feb2021) and was admitted. The patient was hospitalized for the event urinary tract infection on an unspecified date for 2 days. He is now in rehab and will have to learn to walk again. She is calling to ask what needs to be done about her husband getting the second dose. The patient underwent lab tests and procedures which included blood pressure: 150/90, CT scan, labs, urine test and X-rays: unknown, weight: 175-180 lbs on an unspecified date. Outcome of the event urinary tract infection was recovered with sequelae on 06Feb2021. Outcome of the event fall was recovered with sequelae on 03Feb2021 while outcome of the event blood pressure increased was recovering.

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

Patient reported to emergency room on 2/20 with increasing of shortness of breath, quantitated unable to walk from room to room in his house. Patient was admitted.

2 days after 1st Covid vaccination my right arm at the site of the injection, the muscle became very sore and any exertion such as shoveling snow or lifting is very hard.. The muscle is always sore, even laying on my right side when sleeping is uncomfortable and will wake me up from sleeping

general feeling of unwellness; chill; headache; loss of balance; This is a spontaneous report from a contactable consumer (reported for himself). An 83-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL9262, expiry date not reported), via an unspecified route of administration on 26Jan2021 10:30 at a single dose in the left arm 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 had no allergies to medications, food, or other products. Concomitant medications included quinapril at 5 mg, cyanocobalamin (B-12) at 2500 ug (2500 mcg), and atorvastatin at 40 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 08:00 pm, patient experienced a general feeling of unwellness, chill, headache, and loss of balance. 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. No treatment received for the adverse events. The events recovered on an unspecified date in 2021.

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

Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 83 -year-old male patient receieved bnt162b2 (BNT162B2) , intramuscular on 2Jan2021 09:30 toat SINGLE DOSE for an COVID-19 immunizattion. Medical history included lung disorder from an unknown date and unknown if ongoing had some lung issues in the past. She said that he was hospitalized in Jan2020 for something really odd , cough, pulmonary oedema , atypical pneumonia, mycobacterial infection; Couple of years ago and had to take some IV medications through a PICC line and that was about 2 years ago and it has cleared up. There were no concomitant medications. The patient experienced nausea and dizziness on 13Jan2021 04:00 The outcome of events was recovered.

Received second dose on a Thursday. No immediate reactions to first or second dose other than very slight soreness at site of injection. On Saturday morning, however, following second dose, experienced moderate dizziness upon rising--had to hold on to furniture to maintain balance. Dizziness gradually subsided and was completely gone after 20-25 minutes. Additional note: several years ago experienced one episode of extreme benign postural vertigo, but experience after second dose of vaccine was milder and shorter in duration.

You got the vaccine, and had no reactions to the vaccine, and it was close to 3 weeks later that he walked out of the house, went in the garage and all of a sudden his right ear was not working at all, that was 3/7/21. He still has no hearing from the ear. He has bad balance and afraid of falling down, dizziness when he tries to get up. He called his doctor and he prescribed Methyl Prednisolone, and for him to call back today which he is waiting on him to call him back.

Day 1 Pain Both Shoulders, Neck Only Day 2 Pain Hips, Spine Only Day 3 Pain Both Knees Only Day 4 Pain Both Ankles Only Remainder Time, Ankles Only Second Shot Reaction: Week 1 Very Little Reaction Week 2 Pain Right Ankle, Difficulty Walking, Low Energy Then pain Left Ankle, less Right Ankle Then Significant Pain Left Ankle, Calf Muscles Then Pain Both Ankle, Calf Muscles, Some Thigh Muscle Pain In Legs Would Wake Me up From sleeping One Advil 200 mg Pill Would Reduce pain in 15 minutes, Max 4 pills per day

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.

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.

PRIOR to receiving the 2nd covid-19 Pfizer vaccine had a bowel movement each day after each meal- 3x/day everyday. 03/17/21- The day after the vaccine, bowel movements stopped completely. Became bloated with severe abdominal pain, shortness of breath and difficulty walking due to pain. Tried OTC stool softeners, miralax, prune juice and no relief. Seen in ER on 03/20/21 for abdominal pain, bloating and constipation. CT scans did not provide answers. Seen by GI specialist and had colonoscopy and EGD on 03/29/21 which did not provide answers on sudden stop of bowel movement. Almost a month later still not having bowel movements regularly despite taking Linzess as prescribed, still have abdominal pain and bloating daily, difficulty eating due to bloating and pain, have lost 7 pounds in the past 3 weeks and now remaining in bed more throughout the day due to pain/bloating. Becoming depressed and irritable which was NEVER a problem prior to the 2nd Pfizer covid-19 vaccine.

Lightheadedness/almost fainted; Nauseous; Headache; fluish sick; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included artificial heart valve from Jun2018 and ongoing, transient ischemic attack (TIA), high cholesterol, blood pressure (abnormal), all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS) tablet taken for transient ischemic attack from Oct2019 and ongoing; rosuvastatin tablet taken for high cholesterol from an unspecified start date and ongoing; metoprolol caplet taken for blood pressure from Nov2020 and ongoing. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 22Jan2021 13:00 (Lot Number: EL9263) for COVID-19 immunization. Patient was reporting reaction to Pfizer COVID vaccine. Patient stated he read some articles to call and reported if you have a type of reaction or something after having the COVID vaccine. Patient had second COVID vaccine on 14Feb2021. Three or four days later (as reported), he began feeling lightheaded, nauseous and headaches beginning around 18Mar2021 or 19Mar2021. Patient reported he almost fainted a few times and it had gotten progressively worse. The patient reported having headaches not every day, but pretty much close to every day, 4 out of 5 days a week. Patient reported sometimes the headaches were bad and sometimes constant. Patient was hospitalized and had every test known to mankind. The patient reports actually being kind of fluish sick for 2 days after having vaccine, the normal feeling that every one says they have. He completely recovered; started night of the 14Feb2021, lasted next two days and then totally gone on 16Feb2021. Blood thinner stopped a couple of days before the shot per his doctor. Patient stated that every test he had was negative, nothing that would cause the symptoms. He had a Computerized axial tomogram (CAT) scan with dye; CAT scan without dye; carotid artery tested; echocardiogram; left the hospital said they didn't find anything to cause it. After talking to people and reading, he decided to call Pfizer. All results came back negative. Vaccination Facility Type was community center - other. Vaccine was not administered at Military Facility. No additional vaccine was administered on same date of Pfizer COVID vaccine. No additional vaccine was administered. Adverse events lightheadedness, nauseous, headache required a visit to Emergency Room. The patient was hospitalized for 2 days from 29March2021 to 31March2021 due to lightheadedness, nauseous, headache. The outcome of event fluish sick was recovered on 16Feb2021, of other events was not recovered. Follow-up attempts were completed. No further information was expected.

The patient presented to the emergency department after falling and hitting his head. Upon presentation to the ED, the patient tested positive for COVID-19 (on 04/10/21).

Approximately 1 hour after completion of an IVIG infusion (his 17th dose in the past 22 months) the patient experienced severe chills, altered mental status, temperature of 103.0 and was unable to stand or ambulate. His wife called 911 and the patient was admitted to the hospital.

Fell in the bathroom and wet himself and he could not get up; This is a spontaneous report from a contactable consumer (patient's wife, reported for her husband). An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) via an unspecified route of administration on 05Feb2021 (83-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient got up this morning on 06Feb2021 and fell in the bathroom and wet himself and he could not get up on 06Feb2021. The caller helped him get up and he was back in bed, he was sleeping but he took a nausea tablet (treatment). The caller did not know what she was supposed to do because she did not think something like this would happen to him. No treatment received for event. The outcome of event was unknown. Information on the lot/batch number has been requested.

Awoke with extreme dizziness. Over next few days, blacked out 3 times. Vomited 3 times. Remained in bed much of the time for a week. Constant tinnitus (still present). Current working diagnosis: Vestibular Neuritis and Labyrinthitis. Still have significant problem with balance (current date - 05/10/2021)

83 yo c/o dizziness and blurred vision 15 minutes after receiving his 2nd dose of the Pfizer vaccine. Patient stated to staff member that after he stood up he felt like passing out. Patient was escorted to the triage area where he was evaluated by on-site EMS and NP. Vital signs and EKG initiated . BP elevated. Patient states he has not taken morning BP meds which may be causing the elevation. Patient has a PMH of HTN. Allergic to Pollens and Perfumes. After about 15 minutes, BP decreases and patient states he's feeling better. Patient agreed to leave and have daughter drive him home.

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.

Fatigue; lightheaded; temperature around 99.3; This is a spontaneous report from a non-contactable consumer (patient himself). A 83-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9261; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 25Jan2021 14:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Patient had not any known allergies. Patient had not received any other vaccine in four weeks. Concomitant medications included levothyroxine, pregabalin, mirabegron (MYRBETRIQ), zinc and vitamin b nos (B-COMPLEX [VITAMIN B NOS]) taken for an unspecified indication. It was reported that on 29Jan2021 patient experienced fatigue, lightheaded and temperature around 99.3, required 2 days of bed rest. Symptoms began 4 days after receiving the first dose. Therapeutic measures were taken as a result of fatigue, lightheaded and temperature around 99.3 as patient had received paracetamol (TYLENOL) and Ibuprofen. The patient underwent lab tests and procedures which included body temperature: around 99.3 on 29Jan2021. Patient was not diagnosed with COVID-19 prior and since the vaccination. The outcome of all events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

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.

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!

Within 10 minutes of receiving the vaccine patient complained of dizziness and a slight headache. Had patient sit down and drink something preferably water. A few minutes later checked patient's blood pressure which was 160/98 mmHg, but patient was still complaining of feeling dizzy or like he was afraid he might fall if he stood up. After eating lunch and drinking more fluids roughly 30 minutes after vaccine was administered patient felt better and did not report any other or worsening symptoms. No medications were administered to patient to treat symptoms.

Woke up about 2:30 AM with uncontrollability with bowels and urinary. Black ink like stoll. Chills and Sweating, Joint and Bone pain. Dizziness on arising, unsteady in Walking. Lasted for 2 days before subsiding. Still remain weak on 2//4/2021. Second shot due on 2/16/2021 Same Faculty.

Severe attack of shivering, followed by increased pulse rate - 70 to 120, loss of stability, stiffness in joints, tiredness, loss of apatite. Treated with extended sleep. Stiffness lasted 20 hr and was treated with Ibuprofen

This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received first dose of bnt162b2 (COVID 19, Pfizer, Solution for injection, Lot number: EL9262), via an unspecified route of administration on Left arm on 29Jan2021 14:00 at single dose for covid-19 immunisation. Medical history included high blood pressure and the patient also had PE. No allergies to medications, food, or other products was reported. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included valsartan, metoprolol succinate (TOPROL), doxazosin mesilate (CARDURA), rivaroxaban (XARELTO); all received within 2 weeks of vaccination. The patient had neck pain and can't move head to either side without pain on 31Jan2021 14:00. No treatment was received for the adverse event. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

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.

Patient was observed post Covid-19 immunization for 15 minutes and during that 15 minutes at 0915a reported to RN that he was feeling dizzy/lightheaded at 0915a. Bp was 134/81, RR 18, p 75, t 96 oral and 02 sat 96 on RA. Patient states he is tired as well and has history of COPD, sometimes wearing mask can increase SOB. Patient given water and offered crackers, which declined. Removed coat and hat and continued to monitor with wife at side. T 0934 BP was 135/64, O2 sat 95 on RA, RR 20, t 96.5 continue to monitor for another 10 minutes. At 0934a, pt states still feeling lightheaded but slightly better. Had patient stand and stated he was dizzy, EMS at side and assessing at 0934. EMS continued to monitor patient and at 1000a, pt stated he was "much better" and EMS released. Walked short distance without any dizziness or lightheadness. Encouraged wife and patient to notify PCP of events and if symptoms return

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.

03/14/2021: Presented to the emergency department due to fall which occurred prior to arrival. Patient states he climbed up his attic, lost balance came down rolling the stairs and hit the back of his head. He did not lose consciousness, but is taking a blood thinner. The patient is currently still admitted with subarachnoid hemorrhage and pelvic hematoma.

3-17-21 1:35PM PT AMBULATING TO SECOND DOSE REGISTRATION AND ALMOST FELL. PT PLACED IN WHEELCHAIR. A/O, PINK, W/D, RESP WITH EASE. DENIES ANY DIZZINESS, PAIN OR SOB. TO EXIT PER WHEELCHAIR TO BE TAKEN HOME PER FACILITY EMPLOYEE. NO ACUTE DISTRESS NOTED. 3-19-21 8:45AM: 'FEELS FINE'.

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.

Light headness, Loss of appetite, overall listlessness, slight nausea, fever 101.6, dramatically excessive sweating,dark urine. Spent the next 24 hrs in bed.

Patient arrived to ED via EMS after wife called reporting the patient became acutely dizzy, diaphoretic, and short of breath during a bowel movement. Patient was found to have COVID-19 via rapid swab with basilar opacities and effusions noted on X-ray. The patient had an elevated lactate of 3.9 and was in AKI with a serum creatinine of 2.36 (baseline 1.5 on 3/26/21). The patient will be admitted to the hospital. The patient has received azithromycin and ceftriaxone in the ED, as well as a fluid bolus of 500 mL NS. Patient is not hypoxic.

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.

Progressive ascending paralysis consistent with Guillain-Barre Syndrome. At time of hospitalization, patient was unable to walk. Diagnosis confirmed by spinal tap. IV IG therapy administered for 5 days post diagnosis with significant alleviation of symptoms. As of the date of this filing patient is near completion of at-home PT and has regained the ability to walk using a cane, but recovery is ongoing.

He believes the trouble started in the wake of his CoViD-19 immunizations (Moderna #1was given on 2/12/2021 and #2 was given on 3/12). Both shots were given into the left arm. He reports some soreness at the injection site on the left arm after both shots, but this soreness has persisted with some stiffness and difficulty abducting the arm beyond 90 degrees. Two weeks after the first shot, his right shoulder started hurting also, worst distal to the glenohumeral fossa without radiation, also aggravated with abduction beyond 90 degrees. Some soft tissue swelling was noted around the hand. Simvastatin was discontinued with no improvement in symptoms. Labs showed a sed rate of 54 mm/hr and C-reactive protein of 46 mg/L. Blood cultures were drawn which were negative, suggesting no evidence of osteomyelitis flare. He was started on prednisone 15 mg PO daily on 4/5/2021 with rapid and dramatic improvement in symptoms. Presumptive diagnosis is polymyalgia rheumatica, but he had no previous history of same, and onset of symptoms was remarkably close to the immunizations.

went on Saturday afternoon to the Arena where the 2nd dose was given. On Sunday afternoon he was not feeling well, achy, and by evening slightly light headed. Monday morning he had worsened, and tried to stand, and collapses, the home health nurse called for an ambulance. By mid afternoon on Monday March 1st he was blue around the lips and skin, doctor worked to try and stabilize him throughout the evening, until his heart stopped at 1:30am on March 2nd.

4/16/21 Patient presented to ED w/complaint of "fogginess in the head." No dizziness or lightheadedness. Stroke alert was called and pt was placed in observation. Pt screened positive for SARS-CoV-2 in the ED Altered mental status Dizziness Stroke like symptoms CT head-no intracranial hemorrhage or acute findings. Atrophy with chronic microvascular disease CTA H& N-normal CT of the brain. No carotid or vertebral artery stenosis in the neck. EKG-normal sinus rhythm. No significant ST-T wave changes Check A1c, lipid panel Continue aspirin, Lipitor Hold antihypertensives until stroke ruled out with MRI Noted MRI of the brain Consult neurology,PT/OT/ST. Pt discharged to home after assessments COVID-19 positive Chest x-ray-no acute cardiopulmonary process Patient is not hypoxic No indication for remdesivir or dexamethasone at this time Start patient on zinc, vitamin D, vitamin C

Tired the day after shot, then a week or so later, began c/o mild nausea and mild headache .. comes and goes ... Off and on until this past week when he really hasnt felt like doing anything, legs feel week, short of breath more than usual and BP is sometimes LOW for him ...104 / 60 with lower pulse at 45 or 50 instead of his consistent 66. Also , has had intermittent dizzy, foggy head or wobbly legs.

It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; It occurred to him that maybe he had COVID when he got the vaccine and it was just developing; dizzy; irate; yelling; This is a spontaneous report from a contactable consumer, the patient. An 84-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) (at the age of 84-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started feeling bad and it may have nothing to do with a side effect of the vaccination. On an unspecified date, the patient felt pretty bad. He was coughing up phlegm. He was supposed to go back on 28Apr2021 but he was sick. It occurred to him that maybe he had COVID when he got the vaccine and it was just developing. He was pretty sick. He was coughing up a lot of grey mucous from his lungs. He felt terrible like he had a bad flu on an unspecified date. He might go to the hospital. He probably should have done that anyways. He was dizzy and terribly sick on an unspecified date. The patient was irate and yelling on an unspecified date. The outcome of events 'it occurred to him that maybe he had COVID when he got the vaccine and it was just developing', 'dizzy', 'irate' and 'yelling' was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Urinary tract infection; Has been ill; He has been falling a couple times; Had a fracture at the base of his spine; Has gout in one knee; Couldn't walk; In a lot of pain; his knee swelled up, was very hot,the doctor said it was inflamed; hurt his right knee; he has not been eating; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for an 84-year-old male patient (reporter's husband) who received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0158) on 10Apr2021 at right arm for COVID-19 immunization. Relevant medical history included ongoing high cholesterol diagnosed a long time ago when he was very heavy at one point he was quite heavier than he was. Now he was skin and bones, ongoing high blood pressure diagnosed 10 years ago or longer and ongoing diabetes diagnosed 10 years ago, ongoing pacemaker and ongoing irregular heart beat and falls. The patient previously had sore arms at site after receiving the flu shot for immunization. Ongoing concomitant drugs included Carvedilol for high blood pressure, atorvastatin calcium for high cholesterol, amiodarone (this is the medication that would cause an issue with the antibiotic if it was taken orally), acetylsalicylic acid (BABY ASPIRIN) to thin his blood, sitagliptin phosphate (JANUVIA) for diabetes, vitamin D3, cyanocobalamin (B12), ubidecarenone (CO Q10), sertraline (generic of an old drug called Zoloft) as something to calm him down. The patient was scheduled to get the second vaccine on 01May2021, however he was in the hospital and did not have his. They rescheduled the vaccine for this coming Saturday because he was still in the hospital. He was actually getting moved to a rehabilitation facility with intravenous antibiotics for a urinary tract infection and will not be able to get it. The patient was on an IV antibiotic which could not be administered orally do to the fact he has a pacemaker and irregular heart beat. The doctor told her that the oral medication would interrupt the spikes of the pace maker, his heart. The reporter was wondering if her husband can still have the COVID vaccine while taking the antibiotic. She asks will it interfere with that medication. Will he have to start all over again with number one of the vaccine because he missed the vaccine in the allotted time span. The last time the patient was weighed he was 155, but he has not been eating since he has been ill. He had so many problems since he has been ill, he has been falling a couple times. The reporter wanted to protect him from the terrible disease, but didn't want the injection into his body creating anymore problems than he already has. The doctor said that she thought the caller could take the patient out of the rehab facility for the day and get his vaccine and then bring him back. The facility said they would have to do research about that and get back to her. Caller states that her husband kept falling and had a fracture at the base of his spine, in addition to other problems, he has gout in one knee. She states that he would be standing up talking to her and the next thing she knew he was on the floor. She states that he has fell six times in a month. She states that she has become friends with the fire department because they came out so much. The falling occurred before he got the vaccine. She states he was fine when he went for the first vaccine and then the following week it started all over again, he couldn't walk. He had a physical therapist helping him strengthen his walking. She states that her husband says he fell and hurt his right knee while working with the physical therapist and the physical therapist said no, no, no, he didn't fall, he had a strap wrapped around him and the physical therapist caught him before he fell. Caller states that the physical therapist is 30 pounds lighter than her husband and doesn't know if he could of grabbed him before he hit the floor. She states that her husband was in a lot of pain and his knee swelled up, was very hot. She states that the doctor said it was inflamed. She states that she brought him back to hospital because they could not get him up and he could not walk. She couldn't pick him up, her son couldn't pick him up, her daughter couldn't pick him up and her son and daughter together finally got him up but he couldn't walk. She states that she called the emergency medical team. They said he has to go to the hospital and that was the last time he was at home. Has a walker and it takes a little while. She didn't know if he got the gout from that knee, but when they took out his fluid the following day you could of heard him screaming in the next county over. They were suppose to have the results but they didn't, they discharged him from the hospital. She states that he hasn't been able to come up with a breather of fresh air and feeling better. Caller states that he was now taking a gout medication at the hospital and that they told her that her husband had a second fracture to lower spine. The outcome of the events was unknown. Information on the lot/batch number has been requested

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.

Client received his Pfizer vaccines on 1/14/2021 and 2/4/2021. On 5/13/21, client had a Watchman device placed in his heart, spending one night in the hospital. From 5/13 through 5/27, client complained of a sore throat, fatigue and had a cough. These symptoms escalated and became much worse on 5/25, according to his wife. On 5/26, client fell at home, was taken by fire rescue to the hospital, admitted early AM on 5/27, and diagnosed w/ COVID-19 pneumonia (and possibly a fractured back).

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.

He started feeling woozy; Feels things in his workouts in his legs and feet, sometimes his back; He got a scratchy thing in his throat about 2 months ago; Exposed to Covid-19 after having vaccine; Caller states the second shot was really rough; This is a spontaneous report from a non-contactable consumer received from a Pfizer- sponsored program Pfizer RxPathways CEP 5570. A 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 17Feb2021 (at the age of 84-year-old) as a dose 2, single for COVID-19 immunisation. Medical history included cancer and had surgery, prostate surgery in Tombstone and caller stated he always has headaches. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 (at the age of 84-year-old) as a dose 1, single for COVID-19 immunisation. It was reported that, He gave transfer agent some dates of the 2nd, the 17th and the 21st and then stated it was the wrong one. Those were the dates the transfer agent was given. Transfer agent stated that, the caller never told her which vaccine it was. The caller was transferred to the call handler at that time he was asked to confirm information. The caller was asked whether he was calling about the Pfizer Covid-19 Vaccine when he referred to vaccine and he stated that, he has had both vaccines, he had them both way back. The caller stated that, the first was 27 21. Caller stated, it is the first month, call handler should not ask him that. The truth was, he cannot remember, was had been a while passed. Call handler asked for clarification of first month and caller does not provide. Call handler asked whether first month January and caller were stated that, it had to have been January or he does not know. The second was the 2nd, 17 27. The caller stated that was the second month, January and February. The call handler attempted clarification, but caller could not provide. He stated that, 27Jan2021 and 17Feb2021 he guesses means the second month and a first month, that was what was written on his card. No further clarification was provided. Dates remain unclear. The caller stated that, the second shot was really rough. It was a hard time before. The caller was asked for clarification and additional details were not provided. Caller stated that, he got the shot, he was skeptical about taking it but it was something he was taking. He was talking to a lot of different people and they were getting him to do what was important. The shots - the cold - nothing. He has never had to do that. He was really pretty to snuff other than at one point he got cancer and had surgery, prostate surgery, in Tombstone when he went through all that stuff. The caller did not provide additional details. Caller stated that, his problem was he saw his neighbor two weeks ago. He has not been talking to her a long time because she was over aggressive and pushy. He has tried to treat her kind but she was a drug addict and he was not interested in her or her lifestyle. He does her favors an cuts her grass. He was not interested in more than the process of doing this. Stated that, he had not talked to her in a long time and she stabbed him coming into the back of the house. She was stressed out and he thought she had a problem. He listened to this between him and her and at one point she got four or five feet from him and it was hot, like 90 something degrees. He was talking to her and he came back to her gate and then he started feeling woozy but maybe it was his head and heat. He could hardly get into the house. Since then, he was concerned about her because she said she had the virus and she worked at the hospital and she had the virus for 3 months and that was scary. The caller stated that, he always has headaches, he has always had them and that has nothing to do with this. The second shot gave him different types of things. Like, he had already had headaches so he could not say that was on the shot. Exposed to Covid-19 after having vaccine. Sometimes, he felt things in his workouts, in his legs and feet, sometimes his back. The caller did not clarified and stated that, he could not make a distinction between the workout and this particular thing. He workouts with 115 to 120 pounds every day and for a period of time it has happened over night. He has always done it, he started when 20 to 21 when it started. Stated that, he was not to the point he could not do what he had to do. He could walk and do all those things that has gotten better. He got a scratchy thing in his throat about 2 months ago. This occurred a long time after the vaccine. it was not so bad it was bothering him but he could still eat and do what he had to do. Still do normal things like his weights and stuff everyday. Something told him to get checked out and they told him to go back home because they could not believe he was so strong and he could hold 50 pounds. The caller was asked to clarify his question and events. Stated that, there was concern because he thought about what his neighbor said, that was 2 weeks ago he talked to her and he wanted to know what call handler thinks. The last two times he went to the hospital they said he did not have no Covid and sent him back home. Another day, they put him to another doctor. The caller stated that, he talked to call handler's office once before and she did not know the neighbor. He talked to and did checkups with Pfizer because he does not have knowledge and this was all new to him. The caller did not provide additional information. The caller stated that, not to stop and he was covered when he was talking to her. Caller clarified, he means that, he was wearing a mask and ever since he got the shot he was covered and the only time he was around people was the gas station or grocery store. He has no temperature and never did either. The caller was asked to clarify whether his question was regarding that, he had his Pfizer Covid-19 Vaccine and then was exposed to his neighbor who had Covid-19 for three months. The caller stated as yes, he wanted to know what call handler thinks because call handler works there and deals with people like him all day. The caller then stated that, he will tell call handler what - maybe he should call his doctor and if that was better he would call, where he has been there a long time and they can check him because of his athletic things and age. Stated that, he started calling them before Pfizer but it was lunch time. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Systemic: Blood Disorder (diagnosed by MD)-Mild, Systemic: PATIETN HAD HIGH BLOOD PRESSURE. PATIENT MISSED HIS LISINOPRIL DOSE. HE FELT ALITTLE DIZZY AFTER THE SHOT AND BLOOD PRESSURE WAS CHECKED AND IT WAS FOUND TO BE HIGH 180/90 PATIETN WAS MONITIERED

Had fallen early morning the day after the injection. At approx 12 noon, was eating lunch and became nauseous, diaphoretic, vomiting and ashen. Complained of chest pain. EMS activated and sent to ER for further evaluation. Cardiac work up completed and within normal limits. returned to facility. ER note: ?Very likely musculoskeletal in nature (maybe from recent Covid vaccination?

Passed out; massive diarrhea; fell and hit his face; fell and hit his face; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing (Caller says her father in law hasn't had seizure in years, it was diagnosed when he was a kid, 60-70 years ago). There were no concomitant medications. The reporter is calling on behalf of her father in law. She said he had his first dose of the COVID vaccine recently, she pulled this number off of the paperwork today. She says that she believes he had a side effect for it, and also he was rescheduled for his second dose. She says his second dose was supposed to be in 21 days but they rescheduled him for it at 18 days instead. She says he got the first dose on 11Jan, and they rescheduled his next for the 29th. She says she wanted to know if this was correct or ok. The reporter says that the following day he ended up having massive diarrhea, that it caused him while he was on the commode to pass out and he fell and hit his face, the best she can tell he was alone at the time. She says he did not go to the hospital for that, he got up and cleaned himself off and took a nap, and the nurse next door checked on him later on. The outcome of the events was unknown. Information on the lot/batch number has been requested.

REC'D CALL FROM PT'S DAUGHTER, HER FATHER WAS VACCINATED ON 1/22/21, WOKE UP 1/23/21 WAS SHORT OF BREATH AND DIZZY. PT PRESENTED TO ED OF LOCAL HOSPITAL AND WAS ADMITTED, PT PASSED ON 1/25/21. DAUGHTER STATES THAT FAMILY AND DOCTORS AGREE THAT THE VACCINE DID NOT CONTRIBUTE TOWARDS PT'S DEATH, BUT FELT IT NEEDED TO BE REPORTED. PT'S DAUGHTER CONTACTED THIS RN AT LOCAL HEALTH DEPARTMENT TO REPORT TO VAERS.

Trouble swallowing: 30 hours after shot, continuing though current time of 70 hours Nausea, vomiting, dizzy, fainting 65 hours after shot. 2 episodes Fever - 72 hours after shot

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

to not being able to get from his bed to the bathroom without help/to not being able to manage a phone call; From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Left arm on 05Jan2021 at 03:00 PM as a single dose, for COVID-19 immunization, lot number: unknown. Medical history was not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications in two weeks prior to the vaccination included amlodipine besylate, finasteride, hydrochlorothiazide. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 08Jan2021 at 08:00 AM (3 days after the vaccine) patient experienced a drastic decline. From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help. From still driving his own car, to not being able to manage a phone call. Events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient was treated for the events. Since the vaccination patient had not been tested for COVID-19. Outcome of the events was unknown. Information on the lot/batch number has been requested.

This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; This morning at 6 am his blood pressure was 156/74, with 65 beats. Then, at 7am, it was 167/76, with 65 beats. Then at 8:40 am, his blood pressure was 137/64, with 65 beats. So it is fluctuating; feel light headed and it's been coming on and off/feeling dizzy and light headed; This is a spontaneous report from a contactable consumer (patient). An 85-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EK4176, via an unspecified route of administration in his left upper arm, on 22Jan2021 at single dose for COVID-19 immunization. Medical history included surgery on aorta to put a stent in Nov2020. There were no concomitant medications. On 26Jan2021 at mid day the patient started to feel dizzy and light headed and this feeling has been coming on and off, so he decided to take his blood pressure. He didn't have his values from 26Jan2021. In the morning of 27Jan2021 at 6 am his blood pressure was 156/74, with 65 beats, then, at 7am, it was 167/76, with 65 beats and at 8:40 am, his blood pressure was 137/64, with 65 beats, so it was fluctuating. At the time of the report the events had not resolved yet.

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.

ound patient in sitting position in elevator s/p 2nd dose of vaccine. Patient awake, opening eyes, mumbling, incoherent speech, noted to be pale. As per patient's wife, "He felt dizzy and used walker to assist himself into a sitting position on elevator floor. He did not hit his head, I do not think he lost consciousness. He waited in the waiting room for more than 15 minutes and drank 2 cups of juice before we left." No obvious injuries noted. Palpated weak, thready pulse. Patient tachypneic w/ shallow respirations. Called for assistance. Vital signs: B/P 98/34, HR 121, RR 23, unappreciated O2 sat. Fingers cool to touch. FS = 139. Attempted to re-orient patient, given small sip of apple juice. 911 activated. Patient transported to ER with wife. Noted patient to be more alert, responsive with clearer speech upon arrival to ER. After monitored in the ER, the patient was cleared for discharge.

Feb 9, patient was light-headed, as if he was going to faint. He did not have appetite. Evening of Feb 9, started vomiting large amounts of blood. Ambulance took him to hospital. CT scans showed abnormally enlarged pancreas. Patient aspirated blood and was put on a ventilator for 48 hrs. Endoscopic ultrasound showed ulcers in stomach that appear to have been bleeding, which were clipped and shot with epinephrine. After being treated for ulcers, patient developed blood clots in leg and lungs. It is almost two weeks since initial emergency, and patient is still showing sings of internal bleeding (low blood pressure, low hemoglobin, blood in stool). Still no firm explanation for continued bleeding. Before adverse event on Feb 9, patient did not report other symptoms from shot, however, he did show unusual signs of large bruising on his arm. Patient is currently at Hospital. Blood thinners are being discontinued, but patient still has blood clots.

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

Pt fell within 24 hours after vaccine. was sent to hospital. pt was found to be hypoxic with multifocal opacities on CT scan

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.

While seated in post vaccine observation area, slumped in chair, losing consciousness.Lifted to stretcher and regained consciousnee. 911 called and responded transporting patient to hospital.

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.

Hallucinations (first time ever experienced), confusion, paranoia, loss of appetite loss of balance, dizziness, decline in ambulation ability. Dragging feet on ground, unable to use steps.

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.

for several hours my balance was much worse. By morning i was okay. Also, the next morning my right for arm was swollen and my skin had a reddish color. This has continued as of this moment

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

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.

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.

after 1st vaccine he noted slowed heart rate and irregular heart rate. Also developed dizziness/lightheadedness. These symptoms worsened after 2nd vaccine (received on 2/3/21.) PCP in community did Holter that confirmed heart block. He presented to clinic today.

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.

Shortness of breath, low blood oxygen which gotten increasingly worse the days following first vaccine. Went to ER two days after vaccine as symptoms continued to get worse and was placed on oxygen full time. Had a portable oxygen machine. Was also placed on hospice care March 18, 2021; 3 days after 1st vaccine. He had a stable bill of health on Feb 4,2021. Dizziness, fainting and falling down days after second vaccine on March 8 2021. Was in and out of urgent care, ER and assisted care as symptoms and health rapidly deteriorated. He died May 1, 2021

After the vaccine, the wife verbalized her husband felt lightheaded and dizzy. He was evaluated by Fire Rescue and released home at 2:32 pm.

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.

RN received a phone call from patient. Patient was found by home health physical therapy assistant to be extremely short of breath, dizzy, hypotensive and tachycardic at home following 1st dose of covid vaccine today. Blood pressure on initial check was 58/46 and 66/52 on recheck. Heart rate (on pulse oximeter) was initially at 130-142 but came down to 72, irregular. After resting and hydrating, patient denies shortness of breath, but is still dizzy. RN advised 911

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 FIRST DOSE OF PFIZER COVID VACCINE ON 02/03/21. REPORTED ER FALLING ON ICE WITH RIGHT HIP PAIN. ALSO HIT HEAD. IS ON BLOOD THINNER. IN ER O2 SAT DROPPED AND WAS PLACED ON 4L OXYGEN. ADMITTED INPATIENT AFTER BEING DIAGNOSED WITH HYPOXIA, CHF, AND PELVIC FRACTURE

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.

During the 15 minute respite the patient appeared to have a primary cardiac event and rolled forward off their chair onto the floor. Hitting their nose causing significant bleeding. 911 was immediately called Found to be pulseless, CPR was initiated within 30 seconds of event. Patient received 2 rounds of CPR, 1 AED shock, 1 mg Epi, Oral airway placed, High flow O2 with Bag Mask. ROSC returning in approximately 3+ minutes. Patient was able to talk appropriately after ROSC minus some coughing due to postnasal blood. Patient was transferred via EMS to local ED for cardiac workup. Code was run by Cardiac Surgeon, National Guard EMTs, Redmond Fire Paramedics

Pt reported feeling "dizzy" 5 min s/p vaccine. Initial vitals were: 153/117 HR52. at 15 minute post 191/68 HR 46. and 30 min post 181/68 HR 52. Pt ambulated with only standby assistance to to restroom to void times 2 during his 30 min stay. Pt stayed a total of 60 minutes total at which time he stated he felt much better and ambulated to his vehicle. While monitoring pt stated he was diabetic and didn't have breakfast but "felt better" after some juice and blueberry muffin cookies.

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.

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)

Patient was found sitting in his driveway around 4pm, dizzy with incontinent stool and vomiting. He was brought to ED where he was found to have skull fracture and SAH. Patient was admitted to the hospital . Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

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.

your head is bleeding; My wife heard my fall; This is a spontaneous report from a contactable consumer (patient). An 86-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 on 08Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 for COVID-19 immunization and experienced fall, felt dizzy and cut on his head. On Tuesday, 16Feb2021, the patient went to bathroom and the patient next remembered he was on his bed (3 yards away). Patient's wife heard his fall and came into the bedroom and she said that patient's head is bleeding. He had no recollection of episode. EMT arrived and patient was hospitalized on 16Feb2021. 5 staples were put in his head in hospital. On Tuesday and Wednesday (16Feb2021 and 17Feb2021), scan of his head was done, loop recorder inserted in his chest, ultrasound of carotids, echo cardiogram and pharmacologic stress test were also performed. On Wednesday 17Feb2021 17:30, the patient discharged from hospital. On 24Feb2021, chest incision was checked by technician and on 02Mar2021, staples were removed in hospital. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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.

he felt very dizzy; his lips felt very swollen; My lips and mouth felt numb and swollen; My lips and mouth felt numb and swollen; headache; his blood sugar was down to 50; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 86-year-old male patient started to receive second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot# EN9581) via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunisation. The patient's medical history includes diabetes. The patient's concomitant medications include carvedilol (COREG), rosuvastatin calcium (CRESTOR), repaglinide (PRANDIN), adenosine (TRICOR), metformin and amlodipine besilate (NORVASC). On an unknown date, the patient reported that blood sugar was 130 on that morning. He had his normal breakfast and went to get his shot within about an hour after getting a shot he was home and he was having my lunch. He was halfway through lunch he answered his doorbell and he got extremely dizzy. His lips and mouth felt numb and swollen. On 04Feb2021, his blood sugar was down to 50. There was no reason and no explanation for precipitated drop in blood sugar other than the fact that he had the Covid shot. Subsequently he spoke to cousin of his who is physician to heard of someone who had an adverse reaction like low blood sugar and was hospitalized. Nowhere in the side effects warning doesn't say anything about diabetic with low sugar and with low population over 65 it seems to me that would great number of people who have diabetes and low blood sugar problem. In case indeed of indication of adverse effect of covid. The patient advised that a warning should be on leaf. At least people have sugar tablets or some form of counteracting low blood sugar especially since these are 5-7 have driven to and he was just very thankful but he had to get the shot in (city). He was driving from (city) on 95 for 70 miles an hour. He would have got dizzy and headache and low blood sugar reaction while he was in transit. He was thankful that he got home in time for this not be a tragedy. It was reported that no other treatment was taken by the patient other than consuming large amount of orange peels. The outcome of the events was unknown.

dizziness; This is a spontaneous report from a contactable consumer. An 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL9261) via an unspecified route of administration in left arm on 09Feb2021 at 11:45 as single dose for COVID-19 immunization. Medical history included 1 kidney removed and known allergies to Penicillin, Cephalosporins and Hazelnuts. Concomitant medication(s) included losartan, amlodipine, atorvastatin calcium and aspirin. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. On 11Feb2021 at 10:00, patient started having dizziness 48 hours after vaccine. Patient did not receive the treatment for events. The outcome of the events was recovered on an unspecified date of Feb2021.

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.

had a subdural hematoma to his head; stated that he was on floor; This is a spontaneous report from a contactable consumer (patient's son). An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9269), via an unspecified route of administration, administered through his left arm on 09Feb2021 13:00 (also reported as 09Apr2021) at the age of 86-years-old as single dose for COVID-19 immunization at a hospital. There were no additional vaccines administered on the same date of BNT162B2. The patient had no medical history and no family medical history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249) through the arm on 19Jan2021 at the age of 86-years-old for COVID-19 immunization and did not experience adverse events. The patient's son reported that the patient got the second vaccine on 09Feb2021. He reported that the patient was healthy. On Friday night (12Feb2021 at 24:00, as reported) at midnight, his mom heard a thump and stated that he was on the floor. The reporter stated that he had a subdural hematoma to his head on 12Feb2021 at 24:00, as reported (also reported as 12Apr2021). The reporter stated that the patient thinks that since he had the vaccine and no other health issues that they needed to call and make Pfizer aware. The patient was hospitalized due to a subdural hematoma to his head from 13Feb2021 to 12Mar2021. The patient had to have craniotomy on 21Feb2021 at 13:00. The events required a visit to emergency room. It was reported that there were relevant tests and no investigation assessment. The outcome of the event "stated that he was on floor" was recovered on 12Feb2021. The outcome of the event subdural hematoma to his head was recovering.

noticed cut on my head, stopped bleeding with gentle pressure; noticed cut on my head, stopped bleeding with gentle pressure; Fell in my bedroom; felt dizzy for a few seconds; 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, formulation: Solution for injection, Batch/Lot number: EL3302) via Intramuscular in deltoid muscle on 18Jan2021 at 10 AM as single dose for COVID-19 immunisation in nursing home/senior living facility. Patient's medical history included high cholesterol, acid reflux, both ongoing. Concomitant medications included ongoing simvastatin oral for high cholesterol (for years), oral generic acid reducer for acid reflux (for years). On Wednesday 20Jan2021 at 11 AM he fell in bedroom in narrow area between bed, bookcase, and file cabinet. Did not lose consciousness but felt dizzy for a few seconds. Got up quickly; noticed cut on his head; stopped bleeding with gentle pressure. The patient underwent lab test which included Covid 19 test on 07Jul2020: Negative. Initiation of new medication / other treatment / procedure was not required for event. The outcome of event cut on his head was unknown, for other events was recovered in 2021. Follow-up attempts are completed. No further information is expected.

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 1/20/21 and went to the ED on 1/23/21 and was admitted on 1/23/21 and again went to the ED and admitted on 4/4/21 and again to the ED on 4/26/21 with the diagnoses listed below and died on 5/4/21. D50.0 - Blood loss anemia I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC) S09.90XA - Closed head injury, initial encounter W19.XXXA - Fall, initial encounter S01.01XA - Laceration of scalp, initial encounter S06.5X9A - Subdural hematoma (CMS/HCC) S06.5X9A - Traumatic subdural hematoma (CMS/HCC) Z74.09, Z78.9 - Impaired mobility and ADLs

86 y/o male with past medical history of Vertigo, Open Heart Surgery, HTN, DM and Brain Aneurysm, who presents with mild dizziness post vaccination. Patient states that this is his 1st dose in a two-dose series. Patient denies headache, nausea, sore throat, difficulty breathing of shortness of breath or rash. NP and Paramedics at patients? side. Patient initial vitals 160/90 BP, 99%RA, 78 HR, 12 Resp. Glucose was unable to be obtained due to malfunction. EKG NSR. Patient was closely monitored and placed in Trendelenburg. Patient provided water. Patient states that he took all his meds this am. Patient monitored for 30 mins with resolution of symptoms. Patient vitals upon discharge 156/98 BP, 99% RA, 64 HR and 12 Resp. Patient wheeled to car via wheelchair with staff.

Developed dizziness. Had several episodes a week or so after the shot getting progressively worse. On April 10, 2021 three bad episodes - last one resulted in fainting and splitting head open. EMT's came took me to the hospital and on April 12th I had a pacemaker installed. Breathing problems improved after pacemaker.

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 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.

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.

Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized for 2 weeks. Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus. Micro vascular ischemic changes. Critical test result of acute stroke.

Reported due to being transferred to hospital within 3 days of vaccination. Patient sustained a fall and likely this is not related to COVID vaccine as he had no post vaccination symptoms and has a history of falls. He returned after being evaluated and hospitalized for 6 days Dx included urinary tract infection and acute kidney injury. We were instructed to report any hospitalizations within 3 days of vaccine.

- vomiting multiple times 2-3 hours after the vaccine - severe headache 2-3 hours after the vaccine- given tylenol - severe dizziness 2-3 hours after the vaccine - fainting 2-3 hours after the vaccine - extremely tired

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.

fainted; nauseated; vomited 4 times; dizzy; bad headache; extremely tired; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 87-year-old) on 21Jan2021 at 12:00 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL) and melatonin (minimal usage). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 21Jan2021 at 02:45 PM (also reported as 2 1/2 hours after vaccine) patient became nauseated, he vomited four times, was dizzy, fainted, had bad headache and was extremely tired. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events with nausea medications and ibuprofen (ADVIL). Since the vaccination patient had not been tested for COVID-19. Patient recovered with lasting effects from the events.

fall; bruised rib; bruised hip; This is a spontaneous report from a contactable consumer (reporting for his father). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: 30Apr2021), via an unspecified route of administration into the left arm on 12Jan2021 at a single dose for COVID-19 immunisation (COVID prevention). The patient's medical history included Alzheimer's disease and stroke. There were no concomitant medications. The reporter was calling regarding his father who was an 87-year-old combat veteran. The reporter stated that the patient received the first dose of the Pfizer COVID Vaccine on 12Jan2021. The patient was scheduled for his second dose on 02Feb2021, but they had to cancel that appointment because the patient was in the hospital from a fall he had on 29Jan2021 where he bruised his hip and bruised his rib. The patient was hospitalized from 30Jan2021 and was released from the hospital on 05Feb2021. The reporter stated that the clinic said they are not able to make any more appointments right now. The reporter was wondering if there were consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient is now on a waiting list to get the second dose and he would like to know how far past the recommended 21 days can he go and still have the vaccine be effective. The patient received no other vaccines on the same day as the COVID vaccine. The patient has had an MRI before where it was indicated that there were some spots from a past stroke. The reporter stated that no paralysis has been identified. The outcome of the events was unknown.

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.

Pt presented to the ED after a syncopal episode at home. Pt was on the toilet having a bowel movement when he developed sudden-onset nausea, light-headedness, and dizziness. He felt that he was going to pass out and his daughter came into the room and helped him. He did not lose consciousness or hit his head. Symptoms resolved "several minutes later." Pt complains of new-onset heartburn. Pt states that the symptoms he felt during the episode were similar to the sensation he felt during a heart attack he had several years ago.

Complaints of left sided tongue swelling, scratchy/sore throat, dizziness with onset appx 30mins post vaccine administration.

On 3/5/2021 patients left elbow showed extreme swelling, while the injection was done on the right arm. On 3/14 patients 2 knees down to the ankles showed extreme swelling. By 3/18, patients neck was stiff, and sore created an inability to move and nighttime sleeplessness due to pain/discomfort. By 3/22 patient experienced swelling in the buttocks. Patient visited ER on 3/16/21, Internist on 3/17/21 and internist again on 3/23/21. On 3/23/21 internist referred patient to rheumatologist.

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.

FALLS, CHEST PAIN, HEMORRAHAGIC CONTUSION, COVID, PNEUMONIA, HYPOXIC RESPIRATORY FAILURE Narrative: 2/22/2021 Patient presented to hospital with multiple complaints. He was reporting falls, chest pain, his wife was diagnosed with Covid. While he was there, he was found to have hemorrhagic contusion in the right frontoparietal region with minimal surrounding edema, Covid, pneumonia, elevated troponin. He was accepted in transfer by trauma surgeon Dr. and arrives with no complaints. 2/26/2021 Patient died after code blue was called Death Diagnosis: s/p fall with head trauma Focal area right intracranial hemorrhage per initial CT - serial CT head showing stability Acute hypoxic respiratory failure secondary to COVID-19 viral illness COVID-19 viral illness Acute chest pain, improved Elevated troponin, suspected type 2 NSTEMI Elevated D-dimer - V/Q scan with intermittent probability PE Acute kidney injury on CKD, improving unlikely that vaccine contributed to patient's death.

Patient received his first dose of Pfizer COVID vaccine on 3/29/21. On 4/9/21, patient developed confusion, dysarthria, shakiness, and falls at home. Patient was brought to the ER by his family on 4/11/21 and was admitted to the hospital. Patient was found to be COVID positive in the ER and had low O2 saturation (83% on room air). Supplemental oxygen and COVID treatment were started and patient was admitted to the ICU on 4/11. Patient was later transferred to a medical floor on the evening of 4/12.

Dizziness; body chills; body aches (arm); headache; tired; sleepy; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in left arm on 22Mar2021 12:30 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included high blood pressure, prostate cancer, COVID-19. Concomitant medications included amlodipine besylate, tamsulosin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced dizziness, body chills, body aches (arm), headache, sleepy, tired on 22Mar2021 23:00 with outcome of recovering. No treatment was received. Patient would like to know if the second dose of the vaccine will give me the same reaction. Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, has the patient been tested for COVID-19 was no. Information on the lot/batch number has been requested.

Light headed; This is a spontaneous report from a contactable consumer (patient). A 87-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration, administered in arm left on 24Jan2021 13:30 as single dose for covid-19 immunisation (at the age of 87 years). Medical history included macular degeneration, neuropathy and no known allergies. Concomitant medications included metformin, gabapentin and statins. There was no covid prior vaccination and no covid prior vaccination and no other vaccine in four weeks. On 25Jan2021 14:00, the patient experienced light headed. The outcome of event was recovered on an unspecified date in 2021. Information of Lot/Batch number has been requested.

This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 22Feb2021, 02:00 PM, at 87-year-old. No medical history and concomitant medications were not reported. No other vaccine in four weeks and no other medications in two weeks. On 22Mar2021, 03:30 PM, the patient had lost consciousness 10 hours, could not walk, fever 101, extreme dizziness, vomiting, had to crawl when vomiting. No treatment. Outcome of the event was resolved on unknown date. Information about lot/batch number has been requested.

fatigue; head cold; head ache; light headedness; This is a spontaneous report from a contactable physician. An 87-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing diabetes Type2, ongoing chronic obstructive pulmonary disease (COPD), ongoing neuropathy peripheral, ongoing heart attack, ongoing blood pressure control, ongoing hyperlipidemia. Concomitant medications included all ongoing metformin; metoprolol; pravastatin; gabapentin; asa; vitamins nos (MULTIVITAMINUM). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Jan2021 for COVID-19 Immunization. There is no prior vaccination. He did report that after the second dose (believe the second shot was 14Feb2021) and he had some head cold, fatigue, but no fever and had a dull headache and felt a light headedness he started at that time that this started 3 days after receiving vaccine (17Feb2021 or 18Feb2021). He took Tylenol which helped his symptoms. The patient stated that the light headedness he experienced did not keep him from doing his ADLS. The outcome of event lightheaded was resolved with in 2 days, the outcome of the other events was unknown. No follow up attempts are possible; Information about lot/batch number cannot be obtained.

Contact w and exposure to oth viral communicable diseases (Primary Dx); Infection due to 2019-nCoV ED to Hosp-Admission Discharged 3/23/2021 - 3/29/2021 (6 days) INPATIENT DISCHARGE SUMMARY Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Hospital Course Patient is a 87 y.o. male with a past medical history of coronary artery disease, chronic systolic heart failure, hypertension, hyperlipidemia, type 2 diabetes mellitus who was admitted to Hospital with COVID-19 pneumonia. Hospital Course: COVID-19 pneumonia. The patient was treated with convalescent plasma and IV remdesivir and completed the course. He was treated initially with IV Decadron which has been transitioned to oral tablets for discharge to complete a 10-day course. Chronic systolic heart failure. Coronary artery disease. Orthostatic hypotension in the setting of chronic hypertension. The patient does have chronic systolic heart failure with an EF around 20% and is followed closely at the heart failure clinic. He is chronically prescribed Lasix at 80 mg twice daily, however he did have some episodes of orthostatic hypotension during his hospitalization and has been unable to tolerate other guideline directed medical therapy due to his hypotension. He is euvolemic at this time. I have decreased his Lasix dosing to 40 mg twice daily to restart tomorrow morning. His last dose of the 80 mg of Lasix was yesterday morning. I do feel that in the setting of COVID-19 pneumonia and decreased oral intake that he is more at risk for continued hypotension and dehydration aggressive diuresis. He will remain on aspirin, Plavix, and simvastatin. Type 2 diabetes mellitus. His last hemoglobin A1c showed good control at 6.3 on 3/3/2021. His glipizide was held while inpatient. He was on long-acting Lantus insulin 10 units with stable blood sugars in the hospital. He was also on correctional lispro insulin. His glipizide will be resumed upon discharge.

dehydration; dizziness; weakness; This is a spontaneous report from a contactable consumer. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Mar2021 (Lot Number: EN6208) at age of 87-year-old as 2nd dose, single for COVID-19 immunization. Medical history included ongoing cognitive impairment. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 19Feb2021 (Lot Number: EN6201) at age of 87-year-old for COVID-19 immunization. He provided the first Covid 19 vaccine was given on 19Feb2021. Second Covid 19 vaccine given on 20Mar2021. The third Covid 19 vaccine was given on 07May2021. The patient has some cognitive impairment. The patient was recently admitted to hospital for dehydration. That was a week or so ago. He was admitted for dehydration that caused some dizziness and weakness. This hospitalization occurred after the second Covid 19 vaccine and prior to the third Covid 19 vaccine. The patient was better now, he was receiving some physical therapy. The patient had a Covid 19 virus test that was negative. He also had some medical tests that were all negative. He had some blood work, urinalysis, CT scans to rule out anything else. The doctor determined the patient was dehydrated. The events require a visit to emergency room and no physician office. There was no prior vaccinations (within 4 weeks) received and no events following prior vaccinations. The patient underwent lab tests and procedures which included blood work, CT scans, urinalysis: unknown results; Covid 19 virus test: negative; medical tests: all negative. Therapeutic measures were taken as a result of all events. The outcome of the events was recovering.

Clouded mental state, very "foggy". Trouble communicating verbally. Muscle weakness, trouble moving and standing. Very tired. Got better after a long night's sleep, mobility retuned as did mental capabilities.

pyrexia; Was unable to stand; This is a spontaneous report from a contactable consumer (Patient). A 87-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733), via intramuscularly in arm left on 29Mar2021 at 08:00 AM age at time of vaccination as 87 years-old, as a dose 2, single for COVID-19 immunisation. The patient's medical history included ongoing type 2 diabetic, ongoing hbp, ongoing congestive heart failure and COVID-19, on an unspecified date in 2020, not going, the patient was hospitalized for 10 days and recovered. His treatment did not necessitate ventilation. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via intramuscular in arm left (left upper arm) on 05Mar2021 at morning as a dose 1, single for COVID-19 immunisation and within 12 h experienced low grade fever, was unable to stand and ambulance transported to emergency room. Released within 7 hr and underwent lab tests (Sepsis Lactate with reflex, XR Chest 1 Vw, differential auto, ECG 12-lead, cbc w/ auto differential, EGFR, comprehensive metabolic panel, resulted as unknown results), on 06Mar2021. The patient's concomitant medications included brimonidine tartrate (ALPHAGAN P), 0.1% drops, 2x/day (1 drop into both eyes 2 times a day, morning and evening) intraocular on 01Apr2021, ascorbic acid 250 mg tablet (commonly known as Vitamin C), 1x/day (morning), oral on 02Apr2021, acetylsalicylic acid (ASPIRIN (E.C.), 81 mg, 1x/day (morning), oral on 02Apr2021, atorvastatin (commonly known as Lipitor), 40 mg, 1x/day (nightly, bedtime), oral on 01Apr2021, carvedilol (commonly known as Coreg), 3.125 mg, 2x/day (with meals, morning and evening), oral on 01Apr2021, cetirizine (commonly known as Zyrtec), 10 mg, 2x/day (dinner and bedtime, morning and bedtime), oral on 01Apr2021, cholecalciferol vitamin D3 2000 units, 1x/day (morning), oral on 02Apr2021, copper gluconate, 2 mg, 4x/day (morning), oral on 02Apr2021, Cyanocobalamin (commonly known as Vitamin B12), 1000 ug/ml, cyclic, intramuscular once a month on an unspecified date, fexofenadine (commonly known as Allegra), 180 mg, 1x/day (morning), oral on 02Apr2021, fish oil, 1 capsule, 2x/day (morning and evening), oral on 01Apr2021, furosemide, 20 mg, 1x/day (morning), for leg swelling, oral on 02Apr2021, Gabapentin (commonly known as Neurontin), 300 mg, 1x/day (nightly, bedtime), oral on 01Apr2021, glipizide (GLIPIZIDE XL), 2.5 mg, 2x/day (morning and evening), oral on 01Apr2021, ketoconazole, 2 % as needed, topical on an unspecified date, latanoprost (commonly known as Xalatan), 0.005 % 1 drop (nightly, bedtime), intraocular on 01Apr2021, metformin 500 mg, 2x/day (morning and evening) with meals, oral on 01Apr2021, polyethylene glycol 3350, 17 g, as needed upto 30 doses, oral on an unspecified date for constipation, sacubitril;valsartan (commonly known as Entresto), 0.5 mg, 2x/day (morning and evening), oral on 01Apr2021, triamcinolone (commonly known as Kenalog), 0.1 %, 2x/day, topical on an unspecified date for irritation or rash, mirabegron (MYRBETRIQ), 50 mg, daily, oral on 02Apr2021, multivitamin capsule, 1 capsule/day (morning), oral on 02Apr2021. BD Luer- Lok Syringe, blood glucose diagnostic strip, blood glucose meter, lancets misc, used to check blood sugar daily morning. Prior vaccinations within 4 weeks was reported as none. It was reported that, the patient experienced on two occasions a reaction of Covid-19 vaccination. The patient was diagnosed with Covid-19 on an unspecified date in 2020. He was hospitalized for 10 days and recovered. His treatment did not necessitate ventilation. The patient dosed with second dose in left upper arm on 29Mar2021, within 12 hr, the patient was running a low-grade fever (+101) and was unable to stand and ambulance transported to emergency room. Admitted to hospital giving rise to a 3 day stay. Test was completed and patient was given the medication. The patient was hospitalized from 30Mar2021 to 02Apr2021. Treatment was not received for the events. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included fever, resulted as 101+ and on 30Mar2021, POCT GLUCOSE DEVICE, XR Chest 1 Vw, DIFFERENTIAL AUTO, CBC W/ AUTO DIFFERENTIAL, EGFR, resulted as unknown results, INFLUENZA A/B, RSV, COVID-19 PCR, resulted as negative, Troponin T, resulted as high-sensitivity 4 & 6-hour, urinalysis, resulted as unknown results, microscopic. The outcome of the events was recovered on 02Apr2021. Follow-up attempts are completed. No further information is expected.

Upon leaving the site my husband had great difficulty walking. Upon arrival home he seemed unusually confused and over the course of the next 15 hrs had bouts of incontinence. He was up 6 times during the night (usually only 1-2x) and unable to get himself out of bed without assistance. Walking continued to be very unsteady. I thought perhaps he had a mini-stroke. I relayed this to his PCP but he didn't think it was vaccine related

Had vaccine on 1/18. No reported fevers or change in functional status/fatigue. Patient appeared in usual state of health. Is ambulatory with rollator. No prior h/o DVT. Was found in bathroom after presumed fall on 1/27. When attempted to lift patient become hypotensive (40-60 systolic). hypoxic (PO would not read). Was placed on 10 L oxygen without PO reading. Sent to ED-required 15 L nonrebreather to get PO into 90s. Was diagnosed with large bilateral PEs. Found to have dvt RLE. Patient was hospitalized 4 days. His covid test was negative. He returned to facility without oxygen, on Eliquis.

on feb o4,2021 in the morning, i had severe pain in my left arm under the shot, it remins, i cannot lift my arm. i took tylonol, motrin and it did nothing. today i stared taking tramadol, it is the most severe pain i have ever expererence .the pain is off the chart, worst than knee replacement and open heart surgery. my question, was this a batch

Extreme confusion High blood pressure was suddenly very high He wandered out of his apartment in the middle of the night. Ambulance picked him up. He was fine before the vaccine.

Pfizer-BIONTECH COVID 19 VACINE EUA 1. MUSCLE PAIN MAKES IT DIFFICULT TO MOVE AROUND 2. JOINT PAIN IN KNEES AND HIPS causes slip and fall issues

He was very very weak, and very off balance. He fell down and couldn?t get up he was so weak. Mixed up all day.

Mass confusion , lack of appetite, unsteadiness, extreme fatigue and malaise. This started exactly 1 week after his shot and has improved some but still lingers up to this date. We don't know if there was permanent damage.

2 weeks after vaccine, noted increased essential tremor; "cotton head" trouble wit balance. This lasted about 2 weeks. However, essential tremor continues

Extreme confusion, words were unintelligible Dry heaves Could barely walk Doing odd things...trying to drink out of tissue box Sucking on blanket table & walker Could not understand directions Slept then awake every 20 min No fever

Patient was a 88 yo M who presented to hospital on 2/19/2021 with acute onset unsteadiness and trouble swallowing. The patient noted that these symptoms began on day of admission and receiving his vaccine 7 days ago in which he noticed he had increased malaise and increasing DOE/SOB. Patient was noted to be hypoxic with SpO2 in 80s increasing to 90s on 2L NC and in atrial fibrillation on admission. Patient tested positive for COVID-19 on admission and was placed on dexamethasone 6 mg daily for 4 days, ceftriaxone 2g qd for 4 days, and doxycycline bid 100mg for 4 days. Patient improved over the 6 day stay until he was stable on room air at rest and upon ambulation at which time he was discharged home on 2/25/2021.

The weeks following vaccination, the patient felt lethargic, dizzy, unstable on his feet. Mental cognitive ability was unchanged, and he seemed to still be sharp. Up until the day of death, the patient was still active, able to drive, speak, make jokes, eat, and do everything normally. The morning of death, he had a bad fall, but couldn't recall what happened. It's assumed that a low blood pressure event, syncope, partial aneurysm, something of that nature causing temporary loss of consciousness occurred. We attended a funeral that afternoon, ate lunch, and dropped him off at his home. Sometime during that evening, he fell and died. The cause is unknown and still "undetermined" on the death certificate. (Heart attack or brain aneurysm is what I'm guessing)

My father was given his second dose of the Pfizer vaccine on Feb. 13, 2021. He went downhill the following week. He fell 9 times and was very confused. He was taken to the hospital on Feb. 20 and admitted that day. He spent a week there. His condition continued to deteriorate. He was totally bedridden for a week. His mental status deteriorated. By Feb. 22, he was unable to talk, he drooled, and had to be fed. He made slow improvement later in the week. We were never given any reason for his condition. There was no infection, no stroke, etc. He was discharged and sent to rehab on Feb. 27. He remained there until April 8. He is currently doing fairly well. He uses a walker and gait belt in the house and is receiving home therapy. He is not as independent as he was before. His short term memory seems to be more impaired than it was previously.

On Sunday afternoon, March 14, I received the first dose of the Pfizer vaccination. On the morning of March 16 I had a sudden hit of fatigued and my left leg started going numb while doing some menial work in the yard, The numbness cleared when I went inside and laid down but some form of the fatigue persisted for several days. Then, on March 28, two weeks after the vaccine, I woke up to a leg severely swollen from toe to hip. I waited two days to see if it went down but it only got worse, swelling to double the size by volume. I went to the doctor and they sent me to the hospital for ultrasound, suspecting a blood clot. No blood clot was evident but there were multi swollen limp nodes in the upper leg area. The problem worsened and two days later I was sent in for a CTscan which now showed multi blood clots near the swollen limp nodes. I was barely able to walk as major pain persisted with no signs of decline. I am now on blood thinner. It has been 2 months since the vacination and my leg is still swollen the same amount (2X by volume).

Drooping of face, double vision and loss of balance representing stroke like symptoms. Symptoms began 4 days after receiving the Pfizer vaccine on the same side as vaccine was administered.

loss of equilibrium; dizziness; This is a spontaneous report from a contactable Consumer. A 88-year-old male consumer (patient) received Current Age: 88 Current Age unit: Years Gender: male COVID vaccine details: Product: COVID 19 brand: Pfizer-Biontech COVID-19 vaccine Lot number: EN6200 Administration date: 18Feb2021 Vaccine location: Left arm Dose number: 2 COVID vaccine details: Product: COVID 19 brand: Pfizer-Biontech COVID-19 vaccine Lot number: EN 5318 Administration date: 26Jan2021 Vaccine location: Left arm Dose number: 1 other medications in two weeks: Latanoprost & Dorzolamide-Timolol eye drops On Day 8, 26Feb2021, following second COVID vaccination, I experienced dizziness and loss of equilibrium upon getting out of bed and, later, arising from desk chair. Dizziness continues this AM, Day 10, upon arising from bed though appears less pronounced if I prop myself up first on my elbow. Adverse event start date: 26Feb2021 Adverse event start time: 05:00 AM If patient recovered: Recovering If treatment AE: No If COVID prior vaccination: No If COVID tested post vaccination: No No follow-up attempts are possible. No further information is expected

extremely lightheaded; like he was about to fall down; This is a spontaneous report from a contactable physician. This physician reported similar events for 2 patients. This is the 1st of 2 reports. An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL0140), intramuscular on the right arm on 30Dec2020 10:10 at single dose for vaccination. Medical history included covid-19 on Jul2020 and had it fairly severe and almost died and he mentions he was overweight. There were no concomitant medications. The patient previously took flu shot (INFLUENZA VACCINE), a couple of months ago. He mentions he was in the military so he had a lots of shots in his life but he has never had a reaction like this. The patient stated that on 30Dec2020 10:30, "he became extremely lightheaded, like he was about to fall down. He sat down and is currently sitting down. This lightheadedness started about 20 minutes after the injection. When probed for the outcome, the caller explains it might be improving a little. The lightheadedness is not still not gone, but it has not worsened. When probed for seriousness criteria, the caller explains he is just resting and sitting. He would say its not serious but it could be medically significant. He states he isn't sure if this is something that happens to just people who have had COVID before. He states none of his friends or relatives have this type of reaction. He lives in a retirement home and everybody is getting the injection. This is the second day of injections. He doesn't know if anybody had a reaction to the COVID-19 vaccine here". The outcome of the events were recovering.; 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 lightheadedness and pre-syncope due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.,Linked Report(s) : US-PFIZER INC-2020520862 same reporter/drug, similar event, different patient.

Veteran was found by family slumped over and unresponsive at the breakfast table on 1/13/21, had expired

Patient stated that he was feeling faint, and his body went limp and he became unresponsive. It lasted approximately 15-20 minutes.

brief ache in arm went away overnight, left side from thigh to knee muscles/ joint pain, hard to get up

At 0908, RRT was called at the post-vaccination monitoring area for an 89 y/o male that was experiencing dizziness after administration of the Pfizer vaccine at 0900. Client?s car was off, 4 RRT nurses responded to the scene with the E-kit, stethoscope, and pulse oximeter. Head-to-toe assessment done, all WNL. Reports a Sulfa allergy and denies taking any medications today. Initial vitals ? HR: 79, RR: 18, BP: 137/70, denies pain. Client reports that he fell once last week and once this week. With the second fall this week, client reports he hit his head but he states it wasn?t a big deal. He is AA0x4, in no acute distress. During RRT, client was on the phone with his doctor?s office and doctor?s office reported that his PSA level was elevated and he was positive for E.Coli in the urine. 911 called by Site Manager, Deryl Bactad, at 0923. Fire Engine #94 arrived at 0942 and report was given to them. Their initial vitals were: HR: 79, BP: 146/106, O2: 98% on RA. Client denies pain and remains AAOx4. He stated he was fine to drive home. Client refused transport to the hospital at 0957. Last BP before paramedics left: 146/95. Client remains AA0x4, no acute distress noted. Client advised to wait in monitoring area for an additional 15 minutes. Client verbalized understanding. Upon leaving, client was AA0x4, in no acute distress, reported feeling fine to drive. Client advised that if symptoms worsen or if he is SOB, to contact his PCP and/or call 911 and/or get to the nearest hospital. Client verbalized understanding of all information given. All questions answered, all concerns met. Client left at 1015 via car, by himself.

patient complained of dizziness and vitals were taken and bp was 179/47, spo2 99% on room air with numbness and tingling in left arm. retake of blood pressure was 194/47 and pt was transported to urgent care via wheel chair.

Resident developed increased confusion on 01/30/2021 that may have been related to vaccine or to residents other medical conditions including dementia, anxiety, shortness of breath, history of lung cancer, and COPD. Sustained a fall with fracture and was transferred to Hospital. Surgical intervention performed to repair hip. Resident returned to Skilled Nursing facility. Did not recover after surgery and family chose palliative measures. Resident died/ expired on 02/09/2021.

Upon leaving observation room after 15 minute wait period lost feeling from knee down on both legs. Unable to ambulate safely. Patient initially refused to go to ER, so RN observered patient outside for 30 minutes, where same symptoms persisted. RN insisted patient go to ER. Patient escorted to ER while in wheelchair. Accompanied by daughter.

Weakness (Mar 5 evening), not able to stand / walk (March 6) ending up in slurring of voice /lethargic , high BP (morning Mar.7). Called 911 and moved to ER @ Hospital. CT Scan did not show stroke, EEG showed slowness in brain activity, MRI showed minor stroke left side of brain. Low salt (124) at the time of admittance. Released from Hospital on Mar 10.

Client c/o headache and dizziness after receiving vaccine. Client seen by EMT and assessed, vitals taken: BP 109/69, P 60, O2 sat 95. 15 mins. after assessment, client verbalized that he was feeling better with no dizziness or headache. Client was cleared to go by EMT.

The way he is acting is more like he had a stroke; eyes glazed over; disoriented; felt funny; very weak; can barely stand and barely walk without human assistance and his walker; can barely stand and barely walk without human assistance and his walker; This is a spontaneous report from a contactable consumer. An 89-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 12:15 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included vascular dementia; hypertension; hypothyroidism; malignant melanoma of back (resected/in remission); bladder cancer (surgery in Nov2018/in remission); prediabetic; chronic kidney disease stage 3 due to hypertension; and sleep related hypoxia. No known allergies. Concomitant medications included donepezil taken for an unspecified indication, start and stop date were not reported; memantine taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; lovastatin taken for an unspecified indication, start and stop date were not reported; fluoxetine taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] taken for an unspecified indication, start and stop date were not reported; and unspecified multivitamin tablet. The patient previously received 1st dose of bnt162b2 (Pfizer-BioNTech COVID 19) on 26Feb2021 07:45 PM in the left arm for Covid-19 immunization. The patient has not received other vaccine in four weeks. The first day after the shot, there were not any adverse reactions. The next morning at approximately 11:00 am, the reporter found patient laying on the floor next to his bed, eyes glazed over, disoriented, and he said "he felt funny". The reporter got him sitting up leaning on the side of the bed and called. The EMT's came and checked his vitals. Within half an hour from finding the patient laying on the floor, he seemed almost back to normal. However, since he is 89 years old, the patient was transported by ambulance. Blood was drawn, a urine sample was taken, a chest Xray, and a CT scan of his head and his spine were the labs that were run. All the labs came back normal. However, once patient got home after being in the ER for 5 hours, he is very weak, can barely stand and barely walk without human assistance and his walker. The way he is acting is more like he had a stroke. Onset of the events reported as 20Mar2021 11:15 AM. The events resulted in emergency room/department or urgent care. Outcome of the events was not recovered. The patient used walker due to can barely stand and barely walk; for other events, there was no treatment given. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination.

slightly dizzy; pain in arm slightly; His head was still just a little foggy; Unrestful night; This is a spontaneous report from a contactable consumer (patient). A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 1 intramuscular, administered in arm right (Injected into right shoulder in the muscle) on 10Feb2021 09:50 to 10Feb2021 09:50 (at the age of 89-years-old) as single dose for prevention (COVID-19 immunisation). Medical history included ongoing AFib (Diagnosed 7-10 years ago), sulfa allergy, ongoing to keep bowels soft and pliable, down from 210 lbs (he found out his wife had breast cancer, he lost the weight, prior receiving vaccine), bad ankles (uses a cane and walker and noticed he was having). Concomitant medications included warfarin at 5 mg daily (Started taking 7-10 years) for AFib; diltiazem hydrochloride at 180 mg daily (Started taking 2 years ago) for AFib and omeprazole at 20 mg daily (Taking for 7-10 years) to keep bowels soft and pliable and unspecified medication. They reported that he called Pfizer yesterday about the same question; however, today he would like to know if he can get a letter stating that it was permissible to get the vaccine 4 days short of the 21 days. Caller reports that he received first dose yesterday, and felt slightly dizzy afterwards and today he had pain in arm slightly Feb2021. Caller reports he had a sulfa allergy. Caller was scheduled for second dose on 27Feb2021. He received the first shot this morning. It went along nicely. He had two questions. He went back in to reschedule next appointment and the only thing they had available at (College name) was this month on 26Feb2021 or 27Feb2021, so he picked out the 25Feb2021, which he later stated was 26Feb2021. He had the shot this morning and it was only 15 days and he understands it was not supposed to be given until 21 days and wanted to know if that was true. His second question was after he had injection and he told them he was only allergic to Sulfa, they told him not to worry about it that there were so little problems with that. Before he got it, he had a sleepless night. He said he was old and he was worried about all kinds of things. He started talking to the guy the drove him over. He noticed he was a little dizzy and he probably could drive but should not. They dropped him off at his place and he was only one block away. When he got home, he drank some water and ate lunch and still feels a little bit out of it. He had a feeling if he got a good nights sleep, he would be fine. But, he wondered if it was related to the Sulfa allergy. He was down from 210 lbs. It just happened when he found out his wife had breast cancer that he lost the weight, which was prior to receiving the vaccine. She just passed away 6 weeks ago and had bone and breast cancer. He was bending and his back was starting to arch. He used to be 5' 11.5". That was before the vaccine. This has been happening for years. He has bad ankles and uses a cane and walker and noticed he was having more trouble right after he got the vaccine. Now, he was not having any more problems than usual. His head was still just a little foggy on 2021. When getting up, he stated he did not fall. He had a very unrestful night on 2021 and it could be related to that. He heard second dose should be 21 days and not 15 days. He provided on his vaccine card. They were having an influx of cases in his area and his wife and he had planned to get the vaccine as soon as they offered it. He said the reason he takes Omeprazole was his insides, all through his hose system, every once in a while he had some problems, and it started to bleed, so this was something to keep it soft and pliable. He was allergic to Sulfa. He does not have the name of medication, manufacturer, lot or expiration. The outcome of event slightly dizzy was recovering and other events was unknown.

States that his symptoms are like he had a stroke; his health declined after the shot; not eating; he is not able to walk by himself; Can't stand up on his own; Mind is not working correctly/The patient was not himself/his mind goes in and out; Speech is Difficult/he was not responding to her and his speech was bad; not feeling very well/not feeling good; Tired and Sleepy; Tired and Sleepy; Noticed patient was warm but didn't take temperature; The patient didn't receive the second shot because he has been in the hospital.; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 14:15 (Lot Number: EN6198) at the age of 89 years, as single dose for covid-19 immunisation. Medical history included pituitary gland tumour from 2018 and ongoing (it is not growing according to tests), ongoing asthma which he had for years, and ongoing low blood pressure. His blood pressure goes up and down. He has had it for a long time but started this medication 2 years ago because it was too low. Clarified that it was not taken within 2 weeks of receiving the vaccine because his blood pressure had been too high. There were no concomitant medications. The patient previously took fludrocortisone 0.1 mg once a day. The consumer (patient's wife) stated that she called on behalf of her husband. The patient was still in the hospital. The patient received the vaccine on 04Mar2021 and by 11Mar2021, the patient was in the hospital. They have not been able to find out what was wrong with him. The patient's symptoms were like he had a stroke. The patient was 89 years old, so she took him to get the shot and his health declined after the shot and he is still under the care of the (Hospital name) in (City) (State). The reporter clarified that his symptoms were that he was feeling tired and sleepy on 08Mar2021. The patient said he was not feeling good on 08Mar2021. On 11Mar2021, he was not responding to her and his speech was bad, and now he is not able to walk by himself and can't stand up on his own. This started after he received the shot. The patient didn't receive the second shot because he has been in the hospital. He was doing fine before and now he has these issues. The patient's wife (reporter) noticed the patient was a little warm but didn't take his temperature on 08Mar2021. The reporter stated that last Thursday (11Mar2021) they called the doctor and the doctor suggested taking him to the ER at the hospital. On 11Mar2021, the patient was not himself and not eating and she doesn't know what is going on with him, but he is under care at the hospital. Reporter stated the patient is doing therapy in the hospital and they are helping him to walk but he is having difficulty. She stated they keep asking if she knows what is going on, but she has no results or medical records. Reporter stated the patient's mind is not working correctly and speech was difficult for him. She clarified that he wasn't making sense sometimes and she was not able to understand him. States the patient speaks two languages but he started speaking a third language to her. She stated that his mind goes in and out. Treatment: rest and at the hospital they are doing therapy for his legs. States she will get on update on his progress on Friday. States she can't see him because of Covid restrictions. The patient did not receive any vaccines 4 weeks prior to COVID vaccine. Outcome of the events was unknown.

he felt tired the day of but continued doing his daily activities, on april 6 morning a friend couldn't reach him by phone and went to his home and found him on the floor, the hospital said he had a brain bleed, acute hypoxia, the bleed was on the left side of his brain, the doctor stated it was a cerebral bleeding that cause him to fall.

Incredibly weak; unsteady on feet; 6cm mass on neck; rash on legs; now food all tastes metallic; This is a spontaneous report received from a contactable consumer, the patient. An 89-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route in the right arm on 11Feb2021 at 09:00 as a single dose (at the age of 89-years-old) for COVID-19 immunisation. Medical history included benign prostate hypertrophy. The patient had no known allergies. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 after vaccination. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) and prostate pill (MANUFACTURER UNKNOWN) for unknown indication and from an unknown date. On 19Feb2021 at 14:00, the patient experienced incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic. It was reported that the patient was perfectly healthy prior to vaccine and had a great appetite prior. The events resulted in emergency room visit twice and the patient was treated for these events. On an unknown date, the patient underwent lab tests as treatment for events which included blood work, EKG, chest X-ray, urinalysis, CT scan all with normal results. All the testing done in emergency room had been normal except for mass on neck, it was scheduled to have biopsy of neck on 23Mar2021. The doctors suggested that it was all from the vaccine. The clinical outcome of the events incredibly weak, was unsteady on feet, had a 6cm mass on neck, rash on legs and food tasted metallic was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.