Pfizer

Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing my balance on Sunday, January 3rd, could not do my regular jog my legs were so uncoordinated on Monday, January 4th, and I fell over on my side when I squatted to pick up my cat at the end of the jog, Difficult to climb my front steps. Tuesday , January 5th, similar leg weakness and lack of coordination, but milder. Less weakness on Wednesday, Jan 6th, when just walking. Thursday, January 7th, did a jog, almost normal, but my left ankle not as responsive as usual. Headache the whole time, and feeling like too much caffeine. I only have one black tea in am. Symptoms seemed most severe in AM. Headache eased up in evening of 1/7.

Felt lightheaded after covid vaccination given. Gave apple juice and she started feeling immediately better. She did state that she hadn't slept well the night before and that she hadn't eaten in a few hours. After monitoring for 15 minutes patient stated she was feeling totally normal. She was able to stand and walk without dizziness. She stated that she did not feel that she needed further treatment at this time.

Within minutes I felt dizzy and then my heart started beating rapidly. Nurse took my blood pressure, pulse, respirations. I was held at clinic for 30 minutes. Symptoms subsided gradually and were gone in 15 minutes.

Patient vaccinated at 1215. Reaction began at 1250. Pt was told she would be observed for 30 minutes due to previous history of a reaction to the typhoid vaccine. After 30 minute observation patient stated she was light headed, dizzy, warm, and nauseous. Nausea subsided at 1325. Stated she was still dizzy at 1335 and stated her throat started to feel scratchy and difficult to swallow. Rapid Response called and patient evaluated. Patient transported to ED for further evaluation.

Pt reports that she received her first dose of Pfizer Covid vaccine on 01/21/2021. She reports that on Saturday 01/23/2021, she was doing yoga and started to develop severe dizziness and the room "kept spinning." Pt reports that this morning she woke up out of a dead sleep and started to experience that severe dizziness, and states that she could not even "walk a straight line." She states that she has been very unsteady on her feet. She states that her whole body felt "shaky." All symptoms have resolved.

Shot about 11:30, Physical Therapy at 2:00 Substantial weakness in legs and core with difficulty getting out of car. Difficulty standing and walking, fell but caught by PT. Performed PT exercises ok. This report produced about 6:09.

1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a sound sleep with strange sensation of spinning. dlosed eyes tights and fell back asleep That morning upon waking at 6:00 AM and getting out of bed, I could not walk and I was extremely dizzy. I made myself get up and all i could do was stumble. Had to hold on to wall. could not put one foot in front of the other. My head felt very heavy like it wasnt attached right..... after Deep breathing and other calming techiques during the day, I was able to walk straight. Tues 1/26/2021 I contacted my Doctor and told him my story. 1/27/2021 I developed a rash across my nose and cheeks which is today.

Unsteady - 2 staff members accompanied resident to ambulate, resident was immediately lowered to sitting position in chair as resident experienced a change in LOC- approx. 5 sec. T- 99.3 O2 at 90% and pulse 44. Regained orientation X 2, began vomiting and diarrhea,. 911 transported to hospital, Family aware

I had no reactions with the first dose. The next morning on the 28th I woke up and couldn't get out of bed. I tried to get out bed and couldn't my husband had to come help me. I could barely walk because I hurt so bad. He helped me to the bathroom and then to my chair in the living room. It hurt so bad I couldn't stay long. My husband helped me back to bed, I stayed in bed all day besides when I needed to go to the bedroom. Today I am shaky, my stomach is bothering me, I can walk today but I real tired and shaky and have to come right back to my chair to sit down. I am better then I was yesterday. If I don't feel better by noon I will call my doctor.

36 hours after vaccine, on 01-30-21 went to bed at 9;00 PM. Could not sleep. Mind darting about and remembering past experiences. At 11;00 PM I started feeling cold with muscles twitching in legs. Got out of bed with difficulty walking and shaking and teeth chattering. Shaking became more intense. Put on more clothes and sat by fireplace. Took 2 Tyneol and ate banana. Continued to shake all over for 10 mins. Shaking so much could not hold phone. Subsided. Startrd again lasting for 10 mins. Subsided and finished at 11:30 PM. Stayed up until 1;00 PM. To bed and had difficulty sleeping. Feel alright today.

76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulosis, Osteopenia. Presenting to the ED after having Pre-syncope. She reported that today morning she felt nauseated with episode of vomiting, burping and abdominal discomfort after having her lunch meal, headed out to receive her vaccine, she felt well till 10 minutes after the vaccine where a nurse noticed she is pale and less responsive, BP was measured back then and was ~70 ?, the patient reported that she was sitting when that happened, she felt lightheaded, sweating, blurry vision, nauseated. But denies any chest pain, sob, palpitation, weakness or numbness. She was out of balance and feeling weak till she came to the ED where she felt better after IV fluids.

I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and still sick to the stomach. I had severe diarrhea and my bowels are still messed up- they are light yellow verging on white. I have been having migraines and am very weak and shaky. Pain at injection site is trivial. Pain through out my body is not. I am often dizzy.

I have been really nauseous and dizzy most of the day; I have been really nauseous and dizzy most of the day; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELT284), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included being diabetic, glaucoma. Concomitant medications were not reported. Patient stated that she had the vaccine on Tuesday (19Jan2021) she was reading over the 'notary' the side effects to be expected and that list one here it say, it could be an allergic reaction but it says that would happen after few hours after the injection but she got it on Tuesday, yesterday (20Jan2021) she was fine. On 21Jan2021, she had been really nauseous and dizzy most of the day, patient wondered whether that was something that she should expect you know would happen because the list here says dizziness and weakness is one of the side effects so is that just something that last for a while and then go away or she should be concerned about. 09Feb2021 is the date that would be for her second shot. Outcome of the events was unknown.

EMS was alerted to a person fallen in the parking lot- EMS found Pt face down unresponsive but breathing with a pulse- Pt was rolled to a supine position and became responsive Pt states she felt dizzy and fell- Pt was placed in wheelchair and taken to eval area- Vitals and Hx obtained. Pt within minutes is acting her normal self and requests to leave. Pt is CAOx3 now. Final evaluation shows Pt has recovered completely and is refusing anymore care or transport to the hospital. Pt was wheeled to her vehicle in a wheelchair.

Nausea with vomiting and dizziness; vomiting was constant when it began @ 2100. patient then came to er, received fluids dizziness and nausea decreased in ER

Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutching her chest and stated that she felt her heart racing. 911 called and pt transported to ED.

approx. 2-3 minutes after receiving the vaccine client started c/o feeling lightheadedness and she already had SOB which she normally has. She didn't bring her oxygen with her. She said the dizziness lasted a few minutes and she was monitored and then she said she felt better and was allowed to leave. She denies any other problems at this time.

Within 15-minutes of vaccination, the patient reported feeling lightheaded. EMS managed the patient's care on-site.

slight headache, nausea, not being able to move-sit up, walk, muscle pain, joint pain extreme for one day then a tapering off for about 3 days, Took Tylenol 500mg 2 every 6 hrs for a few days, ONDANSETRON 4mg 1every 8 hrs as needed for nausea

Patient reported to Observation area staff that she felt slightly dizzy. Vital Signs completed, within normal limits. 146/78 HR 76 O2 Sat 97%

Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she screamed out and fell out of her chair. EMS was called and patient was found to be in Vfib. ACLS was performed for approximately 42 minutes prior to arrival at ED. At that time the patient had been pulseless for 25 minutes. Patient received 450 mg of amiodarone, epinephrine x7, sodium bicarbonate x2, and 7 AED shocks. In the ED 3 more doses of epinephrine were given, one more dose of sodium bicarbonate, and 5 additional shocks. ROSC was not achieved and time of death was called at 1416.

Slight headache began about 6 hrs after shot. Extreme tiredness and light headedness hit the morning of the next day. Complete loss of energy...and I am a VERY energetic person. Tiredness and light headedness has continued from 2/4 thru 2/13 with no let up. 11 hrs of sleeping at night after being on couch all day. NO loss of appetite, taste, smell, fever, or aches. Headache lasted only a few days.

Got awake morning following vaccination feeling much like I did when I first became ill with COVID. Spent whole day in bed. No appetite. Felt a little better next day but knew I was about to pass out so laid down in hallway where my husband found me. Got better as day went on and feel fairly well today. Also had a mild case of night sweats last night. They were awful when I actually had COVID - for about 2 weeks.

I couldn't get out of bed for two days at least and I had high temperature between 103-104 and I had terrible chills, My hands were so cold that they were hurting me. I took some advil and that helped. By Sunday I was starting to feel to better, Monday I was still tired and a low grade fever.

Room was spinning; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 26Jan2021 (at 12:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included arthritis, blood pressure and allergies. Relevant concomitant medications included atorvastatin, furosemide and metoprolol. On 27Jan2021, the patient woke up in the morning the room was spinning and she was so dizzy she couldn't even get up. She remained dizzy for quite a while - she was not sure if she should receive the next dose. She also had nausea. The patient was not treated for the events. Pre and post vaccination COVID tests were not performed. The patient had recovered from the events on unknown date in 2021. Information about Lot/Batch number has been requested.

After the patient received her dose she was getting out of the chair she became dizzy. I sat her back on her chair and took her BP. Her BP was 73/46 we had the patient drink some water and took her BP again and it began to rise it read 113/76 we continued to watch her and took her BP again which it was 128/70. Her symptoms started to go away and she stated she felt better about 15 minutes after her dose and we took her BP again and it was 132/69 which then we moved her to our observation area and she no longer felt dizzy or was complaining of any symptoms. We continued to watch her for another 15 minutes and took her BP one last time and it read 138/82 in which she went home after.

One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applied ice and pain lessened...Then other events followed...My left wrist became swollen and red. then a day later the severe pain was in my left arm and I could barely lift it. I then had a swollen right foot. Podiatrist gave me a shot of cortisone but continued to have the pain and swelling...Shoulder pain returned. 2nd vaccine was 02/03/2021...Feb 10...both hands were stiff and I couldn?t open them...Then the shoulder pain in my right arm returned . This lasted 4 days...with the most severe pain.

Within 15-minutes of vaccination, the patient reported dizziness, lightheadedness, and nausea. EMS evaluated patient on-site and administered 4mg Ondansetron PO. Patient was hypertensive (156/84) in transport to Emergency Department. Patient remained hypertensive in ED. Discharged from ED with diagnoses of dizziness, nausea, resolved, secondary to vaccination.

Patient received second dose of Pfizer vaccine on 02/12. On 02/13 she experienced extreme vertigo. Hx of same but this is worse than her usual. She continues to experience this although it has improved over the days since. She reports nausea starting 02/15 or 02/16 and vomited one time yesterday 02/17. She is experiencing intermittent chills but no fever, highest temp was 97.6.

After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled before I received the vaccine). When I got to my doctor my blood pressure was elevated, it was about 180/88. My blood pressure is never that high. It did go down before I left to 140/84. When we were walking in the elevator after leaving the appointment my gait was unsteady. I felt very weak. I also light headed, and dizzy. It felt like the feeling of the sedation you have receive before having surgery. When we made it home I couldn't even see straight. This lasted about 2 hours. I feel much better today.

Complained of dizziness, watery eyes, runny nose, and weakness shortly after receiving her second dose of Pfizer. She \ requested to lie down and was escorted to a stretcher. She was provided oral loratidine with slight improvement of symptoms. Approximately 30 minutes after her inoculation her status had not worsened but she requested to be taken to the emergency department. Rapid Response team was notified and assisted her to the ED.

CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TALKING AND WAS JUST STARRING X 2 MIN, THEN BECAME RESPONSIVE AND TALKATIVE AGAIN. SHE WAS 'NOT QUITE HERSELF FOR ABOUT 3 DAYS'. MRI, MRA, CT OF BRAIN & U.S. OF CAROTIDS DONE. DX WITH RT TEMPORAL/PARIETAL CVA. NOW ON PLAVIX & ASA 81MG. HAS APPT WITH NEUROLOGIST 2-17-21. REMAINS 'NOT QUITE HERSELF AND OFF BALANCE'.

I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I began to feel a bit light headed. I went to bed around 11:30 and didn't sleep very well. On Wed. am after going to the bathroom, I felt woozy while washing my hands. When I thought I felt better, I made my way back to the bedroom and passed out. I fell on my right side, bruising the right side of my face, my right hip and my right thigh. I apparently had my left hand under me when I fell because I broke the knuckle under the pinkie of my left hand.

passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetic, stage 3 kidney disease, known allergies to penicillin. The patient's concomitant medications were not reported. It was reported that patient got the shot on Thursday morning (04Feb2021) and later that evening reported as at 10:00pm, the patient developed a nose bleed that would not stop. By 10:30pm she passed out/fell, site car management was called and she was sent to the ER where she stayed for evaluations for 2 days. The reporter does not think the Covid shot was connected to the event. No treatment was given to the patient. The patient had no covid prior to vaccination and was not tested for covid post vaccination. The patient was recovering from the events at the time of the report. Information about lot/batch number has been requested.

3-4 days after the vaccine, the patient developed severe stabbing pain in the hands and feet followed by worsening numbness in the hands and feet with weakness of the hands and trouble with her balance

Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated 175/91, HR 120-130. pOx 99% RA. talked patient through deep breathing, anxiety reducing exercises. Vitals started to come down (153/71, HR 96). Patient then complained that she was feeling unwell again, very dizzy, HR increased as well as BP again. 911 called to patient to go to ER for evaluation.

pt states that after she got the covid vax and within 10 minutes she started getting light headed so she sat down. After sitting about 10 minutes she felt better but felt like she was having a mild vertigo episode. After she got home , she ate and laid down where she was having another dizzy spell or vertigo episode and was also nauseated. She woke up next day, she got up but felt drained so went back to bed. Through out the night the next night she had chills, nausea, runny nose and bad vertigo episodes. She woke up w/ diarrhea and more vertigo. Pt had an appt w/ her physical therapist today 2/25/2021. They did a procedure to treat her vertigo. She is still having nauseated, having chills and vertigo episodes at this time. Pt states she is going to contact her PCP today.

Patient looses control of it's left side, falls on it's left side and hits their head. Take to the Hospital and is now connected to a mechanical ventilator.

Received shot at approximately noon and within a few hours, began not feeling well and by that night developed fever 102 with loss of appetite, chills, weakness, unable to stand - her legs developed spasms and jerking. The next day, temp continued to climb up to 102.6 with continued issues with spasms and jerking to lower extremities. Did not seek medical care but did take natural herbs and nutritional supplements to treat. Symptoms have lessened each day but were persistent for 10 days post vaccination. Has a hx of CLL diagnosed in 2008 and WBC runs persistently high.

Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking

Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes

Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.

Severe dizziness & nausea. Needed help standing & walking. B/P normal for her. Went to bed & slept for about 4 hrs. Just mild dizziness on waking. That resolved in a few hrs. No symptoms since then.

pt. felt lightheaded and dizzy. alert and verbally responsive v/s 97% RA 72 bpm, 18 cpm, 160/90 bp @10:30am 10:55am vital signs 97% RA, 69 bpm, 19 cpm, 150/90 BP pt. stable symptoms improved left at 11:00am

head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; light-headed and dizzy; Sweating; Chills; seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together; Not hearing correctly; not wanting to eat; She was beginning to feel dehydrated; shaking; equilibrium was off; sleeping for hours; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 29Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization. Medical history included pre-diabetic, thyroid (disorder), and cholesterol (abnormal). Concomitant medications included levothyroxine from unspecified date to 31Jan2021 as thyroid medication and rosuvastatin for cholesterol. The patient previously took first dose of bnt162b2 (lot number: PFREL1283, expiry date: 30Apr2021) on 08Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization and experienced Injection arm pain, a little more drowsy than normal, and more tired. On 29Jan2021, the patient experienced sleeping for hours. On 30Jan2021, the patient experienced when she woke up, she thought she was headed for the emergency room (ER) as she had pain in all of her joints. At first, it was only her fingers which lasted for five minutes or so where she couldn't move her fingers, she felt numb, she was very nauseous. she couldn't hold down food, she never threw up though, she felt unstable. If she drank water, she would immediately be going to the bathroom, she was beginning to feel dehydrated. She just couldn't hold it when she had to go to the bathroom. Then, the finger pain went to her joints in her elbows and knees. On 30Jan2021, she was also light-headed and dizzy, she was not wanting to eat, she tried to eat dry toast. She was nauseous in her stomach, but she didn't throw up. She experienced sweating and chills. On late Saturday evening of 30Jan2021, she also had an issue, a very mild case, of not hearing correctly but it was not a ringing in her ear, it was like her equilibrium was off. She ended up putting a little bit of liquid ear drops in her right ear, and that seemed to help it. Right now she feels like she has recovered from everything. When unstable, it didn't seem to last too long, she is in bed most of the time. By the time she got up to eat, she was fine. But then she lapsed into chills and shaking. The patient also experienced she seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together (30Jan2021). She can remember stuff now and it only lasted that day. On 31Jan2021, her head hurt. Therapeutic measure was taken as a result of the event a very mild case, of not hearing correctly. Outcome of events felt unstable, light-headed and dizzy, memory impairment was recovered on 30Jan2021. Outcome of the events arthralgia, felt numb, nauseous, head hurt, sweating, chills; not hearing correctly, not wanting to eat, dehydration, shaking and equilibrium was off was recovered on 31Jan2021. Outcome of event sleeping for hours was recovering.

Pfizer-BioNTech Covid 19 Vaccine EUA Started getting light headed and dizzy on early morning Sat. Have been having off and on since then. Have not been able to shower, drive for fear of having it happen again. I did have a B12 injection on 2/15/2021 after checking with my physician to see if would be a problem with getting vaccine.

MS symptoms escalated, everything hurt, major trouble walking, fever for about 24 hours, headache, ache all over.

On first shot, within 1 day I had all the symptons of Covid 19 (severe headache, sore throat, cough, loss of taste and smell, muscle pain, extreme fatigue). Within 2 hours after the second shot, I became foggy brained. I was not able to think properly or at times u was not sure where I was and what i was doing. I was also very unstable in walking.

Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head; could not stand from sitting position without pain). During night, could not turn over in bed without pain. This lasted for 3-4 days. Treated with Advil. Next symptoms were joint pains and stiffness and back pains, which also lasted about a week. Treated with Aleve and hot/cold compresses. Final symptoms are severe swelling and stiffness of hands and fingers, with cracked, peeling skin. I have had this for about a week now and it is not improving. Cannot grasp anything with either hand. Middle and index fingers on both hands useless.

feeling dizziness contacted the patient , patient states that she is not having any more dizziness , but some HA , took some tylenol .

Within 15-minutes of vaccination, the patient reported dizziness, nausea, and chest pain. EMS evaluated the patient on-site. Patient was found to have orthostatic hypotension, hypoglycemia, and was near-syncopal. EMS administered 400mL of normal saline and 15g oral glucose. EMS transported the patient to Emergency Department. In the ED, the patient was hypertensive (163/73). EKG demonstrated NSR, rate 67 bpm, no ST-T changes, no ectopy, normal PR & QRS intervals. CBC/CMP was unremarkable. Patient noted improvement and was discharged with a diagnosis of a probable vasovagal event.

She reports, "I have no balance." She had second COVID-19 vaccine on 2/12/2021 and afterwards had myalgias. Over the next few days she felt like her balance was off, particularly on 2/15/2021 when walking on the beach. On 2/18/2021 she went to urgent care and was diagnosed with lumbosacral radiculopathy. She doesn't agree with the diagnosis and states, "I feel like I've had a stoke." She has trouble controlling her right leg. Her right arm is okay and she's had not trouble speaking or had a facial droop. She is taking the prednisone which was prescribed. She started using a cane on 3/10/2021 due to dysequilibrium with veering towards the right. She felt more stable this morning but this afternoon is again needing to use the cane. She denies vertigo, nausea, vomiting.

Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my sleep. Husband finally woke me . When I got up to take a Motrin I was disorientated. Did not know where I was. . Next day experienced several sudden feelings a syncopye. Lasting a few seconds. Had to grab on to something due to a feeling that I was going to fall. It lasted just a quick second or two. Happened several times that day. Like what I would think a TIA would feel like. Arm was just slightly tender and stinging the first day,. In the night it was aching and hot up into my neck. The next morning it was fine again. Just tender and a little stiff. I attempted to report this on line at instructed on forms given me when I left the site. however the CODE that was to be sent to my phone never came. I then entered the wed site and attempted to report it there. . Finally I called my primary Dr and he has instructed me to report this to the person giving the second injection. I doubt they will know what to do seeing as they are volunteers with little experienc.e

Felt dizzy as we were leaving the facility where I received the shot. Extremely dizzy and light headed for 5 days after that. Called to report the dizzyiness and they sent me to Urgent Care

diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown.

Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on and was fine. Got up about 2AM to go to the bathroom; started back to bed; had a bad taste in mouth, so decided to brush my teeth. Started brushing and all of a sudden, felt faint; before I could get the toothbrush back, I fell and my husband rushed over. Said I was out completely; got me awake and back up and went to bed and slept. until 11am. At 3pm when taking a shower, noticed my left shoulder blade was real sore and looked and there were 3 red strips below should blade - no bleeding tho. top R. side of head kinda sore, so must have hit when falling. Went back to bed and slept good. Didn't need to go to the Dr. and am feeling good now. Just rested for a couple days. Had been feeling really good and don't take any prescriptions, so could only think it had to have something to do with the shot. Today is the 4th day and feel good.

Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea, feeling unwell, dizziness & weakness

Felt much like I did when I had COVID virus and after the first short. In bed for almost 2 days. No fever but just felt awful. Did not eat or do anything. Worst part was the intense pain at injection site in right arm. Pain was excruciating and it took 6 days for it to subside. Sleeping was especially problematic.

1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and "indigestion". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel. Died on 2/26. Family requested autopsy.

Intense pain in left knee. Red and swollen. Reports that she was screaming in pain and couldn't put any weight on it. taken by ambulance to ER. They completed a CT Scan and an ultrasound but found nothing. No med given helped with pain. She sent us an email on 3-23 and I called her. She is still experiencing pain (better) but has to use a walker to ambulate.

Patient daughter told clinic team her mother was not feeling well after receiving vaccine. Daughter also states patient was lightheaded and unbalanced prior to receiving vaccine. After receiving vaccine, patient became diaphoretic, light headed, BP 110/82. States her blood sugar was normal at breakfast, but could not remember #. Daughter states patient showing signs of confusion. Gave patient soda in case BS related. Decision was made to take patient to ED for further evaluation of DM vs. reaction to CoVID vaccine.

A few hours after injection, arm muscle started to hurt and it has never improved, I have used heat, muscle rubs, and pain relievers. It has been 6 weeks now with no improvement, Difficult to use that arm for many tasks

On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself. She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm. The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.

she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick; fall; bladder issue; sinuses; body aches; she was miserable; this was painful than the other shots she has taken; Chills; she was worn out/She was tired; nausea; Malaise/feeling sick; her "armpit" hurting; muscle and joint pain; muscle and joint pain; headache; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: EL3247, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, Chronic obstructive pulmonary disease (COPD), overactive bladder, osteoporosis, sinus headache, allergies also bother her, back issues, and broken femurs from 2019. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID vaccine on 10Feb2021 and is due for the second dose tomorrow. The patient stated that she has really heavy reaction from the first dose, she felt like she was dying, fall, bladder issue, had headache, nausea, sinuses, body aches, muscle and joint pain, she was miserable, her "armpit" hurting, this was painful than the other shots she has taken. The patient wanted to know if its ok to take her nebulizer and other pain medications she is taking generic for Norco. The patient clarified that she had headaches, feelings with her muscles and joint, nausea, and then there was the big symptoms that hit her, she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick. She herself didn't know what was wrong and so she couldn't go to the ER, she doesn't know what this is, it lasted 24 or more hours. The patient stated that it was the malaise, she's never had malaise before, it scared her. She is getting the second dose tomorrow and she is scared to death. The headache, muscle and joint pain and armpit hurting started 10Feb2021 while nausea and malaise/feeling sick started on 11Feb2021. The patient recovered from the event armpit hurting and malaise/feeling sick on an unspecified date. The outcome of the event headache, muscle and joint pain, was not recovered. The outcome of other events was unknown.

muscle pain; lot of pain; stiffness in muscles; difficult to walk; This is a spontaneous report from a contactable consumer (patient reported herself). A 76-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history included arthritis (history of arthritis/joint pain to begin). She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021. Concomitant medications were not reported. Call back made on 11Feb2021 at 11:51 AM and reached for discussion. She reported that "she thought she was having side effects from the second Pfizer-BioNTech Covid-19 shot". Patient stated she already reported it to Safety and was transferred to Medical Information. She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021 and second dose was on 04Feb2021. She was 76-year-old with a history of arthritis so she had joint pain to begin with but now she developed muscle pain, specifically after the second dose. She did not have it with the first dose. She currently had a lot of pain and stiffness in muscles, it was difficult to walk and she could not raise arms above shoulders without pain. It started about Sunday (07Feb2021), when this became more noticeable". She planned to discuss this further with her physician. No additional details. Outcome of the events was unknown. No PQC Present. Information on the lot/batch number has been requested.

transferred from shoulder to her neck; shoulder was in pain/ elbow and shoulder were in pain; injection area is a little sore; I cant sleep at night; She can't position her arm in a way that is not painful; deep muscle ache pain; she was miserable; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266, expiration date: Mar2021), via an unspecified route of administration in left arm on 23Feb2021 as single dose for COVID-19 immunization. Patient's medical history included stomach problem and bleeding problems in her stomach. There were no concomitant medications. The patient said that absolutely everything was okay until she went to get the shot, and was even okay the evening of the shot, then it went down hill from there. She said nothing she has that is related to the pain in her arm, or that she feels she should provide. She did not had any other recent vaccinations or started any new medications. The patient stated that the injection area was a little sore and the area became bigger and bigger by Wednesday (24Feb2021). She woke up on Thursday (25Feb2021) and her elbow and shoulder was in pain, described as a dull pain. The patient stated she has a stomach problem where she can't take medicine. She started treating her pain with aspirin cream with Lidocaine. She said that its kind of worked, it didn't take it away, but more manageable. Now it's been 6 days later (01Mar2021), it was reported a deep deep pain in the point she can't sleep at night. She can't position her arm in a way that is not painful. It was getting unbearable. It transferred from shoulder to her neck on Friday (26Feb2021). It got worse Thursday evening and has been the same since. Patient said, "I am not going to get the second shot if this pain does not go away or if I am going to experience this again." The patient was calling about a possible side effect and was wondering if anyone else had it and does it go away. She was suffering, she wanted to know if the pain she is in, that she is still experiencing will go away. She said that she had a deep muscle ache pain to the point she can't sleep at night. Patient stated that her pain began as soreness at injection site that started Wednesday and then it just got worse and worse and became deeper and deeper just between her shoulder and elbow, a deep constant achy pain. During the day when she is using her arm she can kind of forget the pain, but at night there was no comfortable position she can put her arm in without pain, so she has not been sleeping the last 3-4 nights, she can't sleep, she was miserable. She said she would rather get COVID than this, it was ridiculous. As she has bleeding problems in her stomach, she can't take anything to treat the pain, so she was trying to use lidocaine on her arm, which did at first give some relief but no longer works. She said that the only number listed on the bottle was next to "EXP date, LOT: 19C506, EXP: Mar2021 (as reported)." The outcome of the events was not recovered.

Faint; Fever; Dizzy; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 20Mar2021 12:00 (Lot Number: EP7534) as single dose for covid-19 immunization at age 76 years old. Not pregnant at the time of vaccination. The patient medical history was not reported. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included lisinopril; amlodipine besylate; and carvedilol; all taken for product used for unknown indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 26Feb2021 12:00 PM (lot no: EN6202) for COVID-19 immunization at age 76 years old. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced faint, fever, dizzy, and diarrhea. The events were reported as non-serious. No treatment received for the adverse events. The patient had not recovered from the events.

Two days after receiving second dose of fizer COVID-19 vaccine at a vaccine event patient admitted to hospital after fall and presumed seizure: diagnosed with brain glioma.

Total fatigue and lack of energy; pretty motionless, could take a shower & read but that was about it; sleeplessness; headache; recurring chills; allover muscle & joint pains, nausea, appetite loss -- lost 6 lbs. in 6 days; blurred vision, dizziness. On the 5th day was able to eat cheese sandwich; only chicken noodle soup & crackers & tea & toast prior to that. Finally on the 8th day began to feel normal.

09:11 - 76 y.o. female with h/o Graves disease brought in by EMS presenting with altered mental status after COVID vaccine. The pt reports that she received the first COVID vaccine several weeks ago and immediately afterwards she felt warm and had some difficulty focusing and walking. This resolved and she has since felt well. Today at 0800 she had her second dose of the COVID vaccine. About 15 minutes later she had an acute change in her mental status. She became disoriented and slow to answer questions. She also started having difficulty walking. She was also noted to be hypertensive with systolic BP in the 200s. She was subsequently sent here by the doctor at the vaccine clinic via EMS. Currently the pt is feeling somewhat improved and more back to her baseline. She notes that she still does not feel quite herself. Notes that her symptoms feel similar to her reaction after the first vaccine except much worse. Sates she takes Levothyroxine but no other medications. She last had her thyroid numbers checked in January and they were somewhat "off."

Patient is here today for her second Pfizer vaccination. She reports that after the first vaccine, she felt very cold and had a sore arm for about 4 days. States that she took a 3-4 hour nap after she got home and the chills improved/resolved. Reports that she received the vaccine at around 10:00 AM. Was in the waiting area and was having some blurring of vision that was "coming in and out" and dizziness. She was taken to the personal observation area to lie down at 10:36 AM. Vital signs monitored. Blood pressure elevated, even though symptoms of blurring vision resolved. At around 10:55 AM, patient sat up on edge of cot. Continues to reports symptoms have resolved. No return of symptoms with standing. Patient walked well without the need of assistance. Husband accompanied her out of facility. Advised that, should blurring of vision reoccur, she should be seen in ED. Advised to schedule a blood pressure recheck with her PCP before the weekend. Patient acknowledged understanding of above information.

Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She was unable to left her shoulder. She denied redness or swelling at the site. Used tylenol. Did not contact MD. States her shoulder hurt for approx. 3 weeks post vaccination. Was massaging her arm to help relieve pain and it eventually felt better. Also shared that her left thumb also was sore and reddened post vaccination but unsure if it was related. Does not recall an injury.

FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am going to faint. Chills low fever, Pain in joints and muscles severe headache.

03/29/21 - severe headaches started and continued 04/03/21 - balanced/dizziness/vertigo feeling started and continued 04/04/21 - admitted to ICU and diagnosed with Hemorrhagic Stroke

Started to feel dizzy; nauseous in evening received shot; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on the left arm 13Feb2021 at 2:15pm as a SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. Patient other vaccines within 2 weeks prior to the COVID vaccine included tamsulosin hydrochloride (FLOMAX), ondansetron (ZOFRAN), furosemide, oxycontin and oxycodone. The patient's medical history included bladder issues, celiac disease and allergy (reported as known allergies Yes 17 rxs). On 13Feb2021 at 11pm, the patient started to feel dizzy and nauseous in the evening received shot. The patient reported that the symptoms got progressively more pronounced. It was reported that patient did not receive any treatment for events. The outcome of the events was not resolved.

coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm; back started to hurt; tingling to the bottom of her feet; tired; severely sick; she couldn't walk or talk; she couldn't walk or talk; She shrunk; This is a spontaneous report from a contactable consumer (reported for herself). This 76-year-old female BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown), via intramuscular route on left arm as a single dose on 06Feb2021 12:15pm, for covid-19 immunization. Medical history included minimal (borderline high blood pressure (since 6 years prior to this report). Concomitant medication included Lisinopril 10 mg once a day orally. On 06Feb2021 About 4 hours later after she got the shot, the patient experienced some tingling to the bottom of her feet with and without walking and felt like needles, then it went away some but not totally, and her back started to hurt. On 10Feb2021, she was coughing and full of phlegm. On an unknown date, since getting the first dose of the covid vaccine she had been severely sick, she could not walk or talk, felt really tired, and she shrunk (weight about 130 pounds). The patient did not have any history of previous immunization with the Pfizer vaccine. She was not administered any additional vaccines on Same Date of the Pfizer Suspect. The events did not require emergency room/ Physician office visit. She did not receive any prior Vaccinations within 4 weeks. There were no relevant tests performed. The patient recovered from the event of tingling on 07Feb2021. The outcome of the event of was event of phlegm was recovering. The outcome of the events of coughing, severely sick, she could not walk or talk, felt really tired, and she shrunk was not reported. She had not recovered from the event of back started to hurt and it had worsened. Information about Batch/Lot number has been requested.

This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8730) via an unspecified route of administration on 24Mar2021 at 10:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing pollen allergy from an unspecified date and ongoing ribs sore from an unspecified date. The patient stated that the pollen was bothering her and that she had been taking Zyrtec in the morning and at night. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the event was reported as "her son also had a seizure after the polio vaccine when he was 7 years old". Concomitant medications were not reported. It was reported that the patient denied any medications or medical conditions relevant to symptoms. There were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations received within 4 weeks of the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN202) via an unspecified route of administration on 24Feb2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient previously received the polio vaccine on an unspecified date for immunization and experienced seizure and the patient previously received the flu shot on an unspecified date (6 years ago) for immunization and 8 hours after the vaccine was achy, sick, in bed for 9 days. Developed bronchitis and coughed so hard she cracked her ribs. Stated her ribs were still sore at times to this day. The patient stated that she would never get another flu shot and that her doctor agreed with her on that decision. On 25Mar2021 the patient experienced headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing. The patient stated that she got her second dose of the vaccine on 24Mar2021. She reported that after her first shot she was fine. She stated that she started having headaches and dizziness the day after her second vaccine and this had lasted for 14 days. It has gone on now for several weeks and was not getting any better. She felt her symptoms went in different degrees at different times of the day. She might go one day without a headache. Today her headache was more like a numbness all around her head. She stated that her headaches come and go, sometimes start when her eyes pop open in the morning or at 10 AM. If she was going to have a headache that day, it usually started by 10 AM and was a full-blown headache. Stated her head always fely fuzzy and woozy and sometimes she felt like her eyes were crossing. She stated that she never got headaches; not since her early 20s. Dizziness continued to come and go, but it affected her vision and she was scared to drive and have a wreck. She reported that the symptoms were driving her bonkers. She also reported that she had to hold onto walls when she walked. The dizziness did not go away even when she laid down. She was dizzy when sitting on the sofa. Her head also felt fuzzy and numb, the fuzziness was constant. She reported that she felt disabled and felt like she was turning 100 instead of 77. She cannot lay in bed all the time and wanted to know how long these symptoms would last. The patient denied any labs, testing or treatment relevant to symptoms. She had not been to the doctor or to the emergency room in relation to these symptoms. She stated that she thought about it at times. She stated that she would have to call an ambulance to take her since she was scared to drive. Yesterday she thought she was not doing so bad and drove to the store. She stated that while in the store, her dizziness had her to where she could hardly pay for her items. Stated that it kind of felt like she was drunk, but she was not drunk. The patient stated that her experience with the polio vaccine made her almost not get the COVID-19 vaccine for fear it would bring on a similar situation. The clinical outcomes of the events headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing were all not recovered/not resolved. No follow-up attempts are needed. No further information is expected.

Dizziness; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201), via an unspecified route of administration on Arm Left on 11Feb2021 as single dose for COVID-19 immunisation. The Patient's Medical history included asthma (since years ago) and lung cancer (but that is not a current condition, it was diagnosed Jan2017). The patient's concomitant medications were not reported. The patient historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982) and it was given on 21Jan2021 injected into her left arm for COVI-19 immunization at the age of 76-year-old. It was reported that, the consumer calling about the Pfizer COVID-19 vaccine who says she experienced dizziness for 11 days after her second shot in Feb2021. She says she saw the nurse practitioner one day at that office while she was having this problem. Caller says that on the 12th day her dizziness was gone, but she suffered 11 days with it. She says that she tried Antivert, different sized medication doses, it made her sleepy all day in addition to the vertigo and nauseousness, those were old pills in a pharmacy bottle without NDC/LOT/EXP on the label. She says she tried both 12.5mg dose and 25mg dose, one a day before sleep 24 hours apart. Caller says that the main reason she was calling is that she was concerned if there was a booster shot that might be required and she got it that this was gonna happen again if she has a booster shot in 6 months. Therapeutic measures were taken as a result of the event dizziness. The Outcome of the event was reported as unknown. No follow-up attempts are possible. No further information is expected.

She got her vaccine, started with a headache, severe and then it went to chills, then started with a low grade fever of 99.1. She was cold, shaking, then was tired, joint and muscles aching, and not wanting to move, just wanting to sleep. No appetite. She took a baby aspirin, the headache subsided but returned when the aspirin wore off. She was out of it from Saturday to Sunday morning. The headache was so severe and she took some Tylenol. During the night she sweated so much that everything was drenched. She had to get up and change her clothes again as she was wet from the chills, and urinating a lot possibly due to the water intake. She feels much better than she did yesterday and Saturday but still having headaches, and not wanting the 2nd vaccine. She did have COVID in July of 2020 and hospitalized 3 times during that time-frame. She does not want to experience the same reaction. She has an APT with her PCP coming up in May. She was also diagnosed with the regular flu in January and feels that she has the same symptoms if not worse than what she had experienced in the past. She did have dizziness a lot and had to use her walker to steady herself first.

Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, expiration date: 31May2021) via unknown route of administration in right upper arm on 21Jan2021 at 11:00, at a dose of 0.3mL as a single dose for Covid-19 immunization in Hospital and received new refill of Mycophenolate mofetil, which is an immunosuppressant at a dose of 250mg, 2 capsules by mouth two times daily for focal segmental glomerulosclerosis on the same day (21Jan2021). Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity), kidney problem and focal segmental glomerulosclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021, the patient experienced the dizziness, that started 10 days after the first dose of the vaccine and on the new refill of Mycophenolate mofetil and patient felt weird when she went for walk. On 01Feb2021, the patient was not feeling that great. Last Saturday (30Jan2021) and again today she felt some dizziness, felt weird, but did not think it can be blamed on the vaccine, or did that happen. She enquired whether that could also interact with the vaccine and had zero reactions until last Saturday. So, she wanted to check with Pfizer first and then with her kidney doctor. At that time, she was dizzy and could not shake it all that morning lone. Patient was on Mycophenolate mofetil for 2-3 years and it was a refill she just started on. With the timing right then with the dizziness wonders if related to the new batch she started that day. Unable to provide the NDC, Lot, or expiry for the Mycophenolate mofetil, but provided a discard date of 19Jan2022 from the white manufacture bottle and mentions (name) label over bottle. Mentioned that she does not take product as read on bottle it has been changed after discussion with the provider. Was using this prescription 2 in the morning and 1 at night and since she has been having the dizziness, she has switched to taking it 1 in the morning and 2 at night. Did read on the instructions that this can cause dizziness, but she had taken this stuff for over 3 years and was trying to figure out if it's a bad batch or not. On an unspecified date, the patient experienced headache and thinks she was shrunk and may have gained some weight. The outcome for the events dizziness, felt weird when went for walk, not feeling that great was not recovered and for headache, was shrunk and may have gained some weight was unknown. Information about lot/batch number has been requested.

she was gagging and coughing; started to spin; Her throat was so swollen and it felt like she was choking; Her uvula was so swollen that is why she felt like she was choking; choking; severe throwing up; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0158) via an unspecified route of administration in right shoulder (Deltoid Right) on 11Apr2021 in the afternoon around 14:00 or 14:30 (at 76-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. None history of all previous immunization with BNT162B2 considered as suspect. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for sinus disorder for years as needed. She took it the day before the COVID19 injection. She hasn't taken it since before getting COVID19 injection. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. She didn't have the ones on the paper. They didn't say she would have severe throwing up she almost had to call. She was choking on 12Apr2021. She was over it currently. She first threw up on Sunday evening and then was ok. On Sunday (11Apr2021 21:00) she only threw up once, but it was four intervals. Caller clarified an interval was where she would throw up then clean up and then throw up again. Then it was fine. On Monday (12Apr2021), in the evening around 9 PM she started to spin. She went to the bathroom and she was heaving and she couldn't say how many times she threw up. Her throat was so swollen and it felt like she was choking. Her throat was very raw. Her uvula was so swollen that is why she felt like she was choking. She was about to go the emergency room, but then looked it up. She did treatment that she saw online for 3 days. When she was gagging and coughing she looked up COVID19 Vaccine and it said that her throat would be swollen from severe throwing up. It made a lot of sense. She had all the symptoms listed online and it said it would get better in five days and if not seek treatment. It has gotten better. No visit for ER and Physician Office. Treatment received for all events. The outcomes of the events were resolving.

4/11/21 Extreme vertigo, nausea, severe vomiting. 4/13/21 Vertigo and nausea persisted, vomiting subsided. 4/15/21 Vertigo, nausea, difficulty swallowing. 4/16/21 Completely unable to swallow. Taken to ER. Upper esophageal sphincter spasm resulting in inability to swallow. 4/27/21 Laryngospasms began intermittently progressing to continuous on 4/28/21 severely compromising ability to breathe. Intubated and placed on ventilator.

Dizziness and sleepy. At 1314: BP 174/88, HR 50, O2 95%. Observed 15 minutes and pt drank water. At 1338: BP 155/77, HR 54, O2 96%. Pt stated feeling better and had steady stable gait. Advised to seek ED if sx worsen. Stable and released.

Dizziness and left side pain/discomfort around chest area (5/10). Pt received 2 L of O2 via NC and 325 mg of ASA. Vitals stable. Pt did not take BP med today, pt agreed to take her Benicar 20mg when escorted to her car (med in car).

Diziness, chest pain. Given Oxygen 2L via nasal cannula and ASA 325 mg PO. Patient saw cardiologist 2 months ago for valvular disease, not a candidate for surgery, does not have any NTG Rx, does not take her ASA or Benicar regularly (did not take them today). Symptoms resolved, patient stable & released from vaccination site.

Not focusing very well; Totally dizzy and unable to walk very well because of the dizziness; Totally dizzy and unable to walk very well because of the dizziness; Nauseous; This is a spontaneous report from a contactable consumer (patient) for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 13:30 as a single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus: Diabetic. Concomitant medications included metformin; acetylsalicylic acid (ASPIRIN); calcium carbonate, colecalciferol (VITAMIN D 2000), and Cholesterol Pill, Blood Pressure Pill (unspecified); all taken for an unspecified indication, from an unknown date and ongoing. The patient experienced totally dizzy and unable to walk very well because of the dizziness on 13Apr2021 with outcome of recovered on 14Apr2021, nauseous on 13Apr2021 with outcome of recovered on 14Apr2021, not focusing very well on 15Apr2021 with outcome of not recovered. Treatment included drinks a lot of fluids. The report is not related to a study or programme. She received the vaccine on Monday 12Apr2021 at 13:00. She drank a lot of fluids and ate and went to bed and slept a full 8 hours straight. When she woke up, she was totally dizzy and unable to walk very well because of the dizziness and she had a nauseous feeling, but never vomited. Stated that was on Tuesday and lasted most of the day, sort of subsiding towards evening. When she woke up, she was still dizzy. She was not focusing very well. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No AE require a visit to Emergency Room or Physician Office. There was AEs following prior vaccinations. No Prior Vaccinations (within 4 weeks). No vaccines were administered on same date of the Pfizer Suspect. No follow-up attempts are needed. No further information is expected.

left arm was inflamed and in pain and she was unable to lift it; woke up with pain in my left arm from my shoulder to my wrist; her left arm was inflamed; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), on unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. concomitant medication included Apixban (ELIQUIS) from an unknown date. The patient had taken vaccine in right arm, but she did not have any discomfort in that arm, whereas At 3:00am her left arm was inflamed and in pain and she was unable to lift it, she had to use her right arm to move her left arm. she had taken a blood thinner right before she got her vaccination. The outcome of events was unknown. 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. Information on the Batch/Lot number has been requested.

Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.

fell; broke her hip; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 03May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient's husband). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 18Mar2021 10:00 (Batch/Lot number: ER2613) at the age of 76-years-old female as single dose for covid-19 immunisation. Medical history included diabetes, pain and manic depression. Concomitant medication included metformin taken for diabetes from an unspecified start date and ongoing; paracetamol (TYLENOL) taken for pain from an unspecified start date and ongoing; valproate semisodium (DIVALPROEX ER) taken for manic depression from an unspecified start date and ongoing; furosemide taken for an unspecified indication from an unspecified start date and ongoing; nitrofurantoin (NITROFURANTOIN MONO) taken for an unspecified indication from an unspecified start date and ongoing; vitamin D taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine sodium (EUTHYROX) taken for an unspecified indication from an unspecified start date and ongoing; alendronate sodium (ALENDRONATE) taken for an unspecified indication from an unspecified start date and ongoing; lisinopril taken for an unspecified indication from an unspecified start date and ongoing; potassium chloride taken for an unspecified indication from an unspecified start date and ongoing; levothyroxine taken for an unspecified indication from an unspecified start date and ongoing. The patient fell and broke her hip 05Apr2021 and had to go to the hospital. He said now she is in a rehab center, so she couldn't get her second shot then, a few weeks later got she got her second shot. He said she had surgery for her broken hip and now she is in rehab. He said she left the hospital to go to rehab. She was in the hospital from 05Apr2021 to 10Apr2021. He said she was slowly improving. The outcome of the event fell was unknown, the outcome of the event 'broken hip' was recovering.

Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical history significant for hypertension, depression, hypothyroidism 2nd covid 19 vaccine on 3/26 who presented on 5/18 to the ER with complaints of lightheadedness and nausea that occurred over the weekend and was diagnosed with new onset rapid atrial fibrillation. She denied chest pain or shortness of breath but noticed intermittent bouts of palpitations. She went to see her PCP who referred her to the emergency room. EKG and telemetry in the emergency room were significant for new onset rapid atrial fib. She was given diltiazem and admitted to the hospitalist service. CT of the chest was negative for pulmonary emboli or focal consolidation. She had no electrolyte derangements she has no history of sleep apnea and no history of obesity. Her troponin and delta were unremarkable. She was subsequently admitted to the hospitalist service. She was treated with metoprolol and amiodarone along with Eliquis. She was seen by her cardiologist. Her recent echocardiogram was normal. Her TSH was actually elevated at 11.0 so her levothyroxine dose was increased to 175 mcg daily with a TSH in 6 weeks. At this time patient's rate is much better controlled but she remains in atrial fib. She will be following up with her cardiologist closely post discharge. She is also complaining of persistent R shoulder pain and weakness since her vaccine. Her shoulder x ray showed arthritic changes. She also c/o the worst headache of her life that lasted a week starting on May 4th. CT head was neg.

Patient complained of blurred vision & dizziness after leaving the observation room. BP 87/58, HR 94, R 18, T 98.6, O2 sat 97%. Patient was given water and crackers. Vitals were rechecked. BP 110/69, HR 93, R 18, O2 sat 95%. Patient stated she was feeling better and was discharged and escorted to family car driven by sister.

very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anything; mouth was very dry; achy body and lower back/felt aches and pains; achy body and lower back; went through was some kind of flu; it was hard to sleep at first; kids are watching over her, clean up stuff and doing laundry and all that; Arm hurt; discomfort; feet hurt; she could not walk; felt weak/she could not push herself up, her arm and legs would not push her up; more off balance/balance got worse; could not almost stand up; terrible stomach pains at went up and down her stomach; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Apr2021 (lot number: ER8731), as 1st dose, single dose, at age 76 years old, for COVID-19 immunisation, at a pharmacy/drug store. The patient medical history and concomitant medications were not reported. Historical vaccine included a flu shot for immunization and experienced hives after. In the evening of 29Apr2021, when the patient was about to go to bed, she experienced terrible stomach pains at went up and down her stomach. She almost called the ambulance. For the next 14 days (dates unspecified), she was very exhausted, was sleeping a lot/sleeping all the time causing the bottom of her neck area to ache, she was not able to eat anything for 2 days (I would just have 'brock' and cheese and crackers something easy), her mouth was very dry she had to keep hydrating, had an achy body and lower back, felt aches and pains, her feet hurt she could not walk, felt weak which made her more off balance/balance got worse (pending clarification) causing her to use a walker just to be careful. The patient stated that what she went through was some kind of flu which knocked her out, she was sleeping all the time and mentioned that it was hard to sleep at first. At one time (unknown date), as she woke up from her nap, she could not push herself up, her arm and legs would not push her up and had to be assisted by her grandson. The patient could not almost stand up. The patient reported that her kids are watching over her, clean up stuff and doing laundry and all that. The patient also experienced discomfort and her arm hurt on an unspecified date. On 13May2021, she had her first real small meal. She stated that she avoided taking medications until she gave in and took Tylenol for "bottom neck area to ache", "achy body and lower back/felt aches and pains", "feet hurt", "arm hurt", and discomfort. She stated, "I was very happy after getting the shot, I felt very good but after some days I felt like I was going to die here, should I call the ambulance, what going on with my stomach, and that's was shocking for me." The patient asked if what she experienced was normal and if she should get the second dose. The patient was recovering from the events (reported as "she was coming out of it"). Follow-up attempts are needed. Further information is expected.

At the time of vaccination, I had a headache and sore arm and felt tired for 24 hrs or so. My last check in report I would like to change my health status to serious vertigo experience beginning on May 1, 2021. In the middle of the night while in bed I felt like I was falling. The next day I had the need to fall to the left side all the way to the floor 2 times safety and felt very dizzy for the 2 days. I began my balance exercises. I continue to have frequent serious dizziness episodes since May 1. Can this recent on set of strong vertigo be a result of the vaccine? Until now all vertigo expressions were mild.

she experienced dizziness; dry cough; Headache; Sneezing; No taste; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 76-years-old, as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. Between the first shot (28Jan2021) and the second shot (on 18Feb2021), the patient experienced dizziness, dry cough, headache, sneezing, no taste, nausea, and was very tired/ extremely tired. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 thought to be a possible immune mediated side effect from her covid 19 vaccine .. since 5/9 she has been experiencing daily severe headaches, malaise, intermittent palpitations. Ct brain at that time neg for bleed but showed small/old b/l lacunar infarcts. cta was neg for pe/acute pathology. She was discharged out on amiodarone, metoprolol and eliquiss to follow up with cardiology.on follow up with him her amiodarone was dc'd and the plan was to see EP for possible cardioversion but She then was readmitted from 6/5 -6/8 with new pericardititis with new b/l pleural effusions, new chf and new cardiomyopathy. She c/o 2 days of sob, b/l shoulder pain, chest heaviness and pain, worsened while lying flat along with continued intermittent racing heart. cxr showed new Basilar predominant opacities in both lungs suggesting pulmonary edema and was admitted with new chf with bnp of 993. She was then noted to have an elevated wbc with left shift and a fever and her CRP was markedly elevated at 67. CT chest showing Nonspecific abnormalities including 1cm thick pericardial effusion, bilateral pleural effusions and mild right-sided ground-glass lung opacification. . She has had no recent infections, travel, cont meds, does not drink alcohol, smoke or use drugs or supplements covid 19 neg. She was started on colchicine 0.6mg bid and ibuprofen 600mg q8h on 6/6 and was discharged home to follow up again with cardiology. she has improvement in herwbc to normal, resolution of L shift, resolution of fever and only slight increased crp. She has also converted to sinus rhythm although still tachycardic around 110bpm. Her headache is gone and she is no longer vomiting. State echo done this am showing ef 55% and new hypokinesis of the basal inferior wall and a Small amount of pericardial effusion with out any doppler evidence of Tamponade She had an echo last month which was normal She was also started on antibiotics due to b/l effusions which were eventually stopped before discharge

Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Node Abnormal; Confused; foggy; This is a spontaneous report received from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) at the age of 76 years, as a single dose, for COVID-19 immunisation. Medical history included cerebrovascular accident (Mini Strokes), TIAs ( states she has had a few of them; the last one was years ago), Car Wreck with head pain on the side of the head. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 (Lot Number: EN6208). The patient did not receive any other vaccines within four weeks prior to the vaccination On 01Apr2021 the patient experienced legs wouldn't work; she couldn't walk, she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy. In April2021 she had lymph node abnormal. The patient was hospitalized from 01Apr2021 to 05Apr2021 (4 days). The patient had lab tests and procedures on unspecified date, which included computerized tomogram with Contrast: normal; electroencephalogram (EEG): abnormal; x-ray: abnormal lymph node. The verbatim chronological clinical course was reported as follows: the patient stated she received her second shot on 31Mar2021 and on 01Apr2021, she ended up in the ER and admitted to the hospital because her legs wouldn't work, she couldn't walk and she had slurred speech. The patient thinks the time of onset of the events was in the afternoon but stated it is foggy because she was a little confused at the time. Patient stated she also had a x-ray and it showed that her lymph node was abnormal. She also had really sharp pains inside her head. Patient stated that the event legs wouldn't work, couldn't walks, it was ongoing but she was doing Physical Therapy and she is starting to get back to her normal. In terms of the really sharp pain inside her Head, the patient stated that she was in a car wreck and had some head stuff and this really brought it out really sharp which she has never had before. The patient stated she thinks the vaccine just brought out her TIAs and she has had headaches in the side of her head but these were a lot sharper. The patient reported that she goes to her Neuro Doctor next week. The patient stated she went back to the doctor and he did a computerized tomogram (CT) with contrast. She stated that when she was in the hospital, her EEG was abnormal. She stated per the report of the x-ray guy, he said that the abnormal lymph node was caused from the shot, the Covid shot. She stated tomorrow she has an ultrasound or some kind of test to see if she needs to have a biopsy of the lymph node. The clinical outcome of she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy was recovered. The clinical outcome of experienced legs wouldn't work; she couldn't walk, was recovering. The outcome of the remaining event was unknown.

Do not take the second dose; I will not be able to be fully covered; Started shaking specially my hands; I started to feel very giddy; My tongue started to swell up badly; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 76-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. She had many vaccines in her lifetime. The Pox vaccine to live in abroad when she was young. Then vaccine to live abroad to work. Then another country and then in another country. She had so many but she never had any reaction to anything. On 22Mar2021, the patient had started shaking specially her hands and then within the first 15 minutes then it was okay and then she started to feel very giddy like she had several glasses of champagne and then her tongue started to swell up badly. The events were considered serious as medically significant events. Patient received Benadryl as treatment for the events. On an unknown date, patient stated that she definitely do not take the second dose. So, she will not be able to be fully covered. It was reported that patients doctor send her to an allergist to see if she should take the second dose. She told that she had even get a the green pass and who knows if she could take anymore vaccine that are created for the mutant strains of this virus. Further, this was a very severe reaction, and she was on the first one not even the second one and its not acceptable. Patient stated that there are people that did not have allergic reaction to anything before in their life. These things nothing, scorpion bite nothing and this was a huge surprise. They need to know this kind of things all this other stuff. It was reported that patient was not experiencing the problem or symptoms. At the time of report, patient was recovering from the events shaking specially my hands, started to feel very giddy and tongue started to swell up badly without hospitalization. The outcome of the event Do not take the second dose; I will not be able to be fully covered was unknown and for other events was recovering. Information about batch/ lot number has been requested.

Severe dizzy ness. It felt like if I was not deliberate in my steps I might fall. Balance was off. This lasted for 5 days off and on.; This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL92669), via an unspecified route of administration in the right arm on 09Mar2021 for COVID-19 immunisation. Medical history included rheumatoid arthritis, high blood pressure. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) were reported. The patients past drug history included Amoxycillin. 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 experienced severe dizziness on 09Mar2021. The therapeutic measures were taken for the dizziness, which included Meclizine. The adverse event resulted in emergency room visit. The clinical outcome of the severe dizziness was resolving. No follow-up attempts are needed. No further information is expected.

She has also has dizziness; She is pitching forward like vertigo; The dizziness got much worse this weekend; Memory issues; Confusion; Weakness in her legs; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Nausea; Not feeling right, very tired; Not feeling right, very tired; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 27Jan2021 16:30 (Batch/Lot number was not reported) (at the age of 76-year-old) as single for covid-19 immunisation. The patient medical history included digestive system, blood thinner, acid, high blood pressure, diverticulitis she went into the hospital in 12Nov2020 or 13Nov2020 for an emergency for diverticulitis and then while she was there, she was sleeping and when she woke up, she had atrial fibrillation. They did the electric shock to get her heart back without sedation and that had an effect on her. Mentions she had another episode of atrial fibrillation about three years before, but it went back on its own. She was also diagnosed with diabetes mellitus at this hospitalization on an unknown date in 2020. Concomitant medications included famotidine for acid at 40mg twice a day via oral, lisinopril at 5 mg via oral for twice a day taken for high blood pressure, metformin at 500 mg daily via oral taken for diabetes mellitus, metoprolol at 25 mg daily via oral taken for blood pressure measurement, lactobacillus acidophilus (PROBIOTIC ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]) daily (expiration date: Jul2022, Lot number: WHD204) for digestive system, rivaroxaban (XARELTO) since on an unknown date at 220 mg daily via oral taken for blood thinner. The vaccination facility was a medical centre. The vaccine was not administered at (name) facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect product. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient states she just wanted to report an experience after the vaccine. On 27Jan2021 (Wednesday) she went to the place for vaccination. It went very smoothly, and she didn't feel anything. The patient mentioned that she thought maybe it was her medicine and stopped taking her over the counter probiotic. The patient had problems, so she stopped this a couple of days before for the over-the-counter probiotic she stopped. On an unspecified date, in hindsight she thought some of the effects she was experiencing might be related to the vaccine. She was not sure if she was allergic to her usual medications or not. On 28Jan2021, the patient reports she had a lot of nausea; and not feeling right as in very tired. She didn't connect it to the vaccine. She thought maybe it was her medicine and stopped taking her over the counter probiotic. On 31Jan2021, she reported that weakness in her legs, pain in the back of her head, neck and above the ear and up to her skull. On 01Feb2021, she had worst memory issues and confusion. On an unknown date, she stated that she had had a lot of trouble with confusion doing her check book and questioning things that she did not do usually, and she also has dizziness and feeling like pitching forward like vertigo. On an unspecified date, the patient reported dizziness got much worse this weekend. She was supposed to get the next dose on 17Feb2021. The patient visited physician office. The outcome of the events the dizziness got much worse this weekend, she is pitching forward like vertigo was unknown. The outcome of the events pain in the back of her head, neck and above the ear and up to her skull was resolving whereas other events was not resolved. Follow-up attempts are completed. No further information is expected.

Pain in left knee making it difficult to walk upon getting out of bed.; Pain in left knee making it difficult to walk upon getting out of bed.; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810 and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:00 (at the age of 76-years-old) as DOSE 1, SINGLE for Covid-19 immunization. Not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included lecithin, hormone replacement, CA, D, levothyroxine. Patient had no allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any treatment and diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On an unspecified date the patient experienced pain in left knee making it difficult to walk upon getting out of bed. I had no previous problems with my knee. Patient did not received any treatment for the events. The most recent COVID-19 vaccine was administered at hospital. Non-serious report. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

This is a non-interventional study report from the marketing program received from a contactable consumer (patient) based on information received by Pfizer. A 76-year-old female patient received BNT162B2 (Pfizer BioNTech covid-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 12Apr2021 (at the age of 76-year-old) as dose 1, single for covid-19 immunisation. The co-suspect included upadacitinib (RINVOQ), oral from Oct2020 (Batch/Lot number was not reported) to an unspecified date, at 15 mg for moderate to severe rheumatoid arthritis. The patient's medical history included diabetes mellitus from 1960 to an unknown date, rheumatoid arthritis from 1987 to an unknown date, internal haemorrhage from 2018 to an unknown date, small intestinal resection from Dec2018 to an unknown date, abdominal hernia from 2019 to 02Jun2021, non-tobacco user from an unknown date and unknown if ongoing, knee arthroplasty from 15Feb2021 to an unknown date, difficulty in walking. It was unknown if she was enrolled in a COVID-19 vaccine trial. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for rheumatoid arthritis, start and stop date were not reported; gabapentin (NEURONTIN) taken for rheumatoid arthritis, start and stop date were not reported; prednisone taken for rheumatoid arthritis, start and stop date were not reported; flecainide taken for heart rate decreased, start and stop date were not reported; metoprolol taken for heart rate, start and stop date were not reported; warfarin sodium (JANTOVEN) taken for an unspecified indication, start and stop date were not reported; venlafaxine taken for pain, start and stop date were not reported. On an unknown date in Apr2021, patient experienced knee surgery. On 13May2021, patient had another procedure for her abdominal hernia. Patient mentioned that her hernia was located in five different places, there were two on her left lower abdominal area and three on the right lower area. She stayed in the hospital for six days until 20May2021 and was treated with unrecalled antibiotics and pain relievers. On 13May2021, the patient experienced could not open and close left hand and swelling of left hand. On an unknown date in 2021, patient stated that "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre", knee osteoarthritis. The reporter causality for the events knee surgery, knee osteoarthritis was not reported, blood sugar abnormal was possible, joint range of motion decreased, peripheral swelling, arthritic pains were not related. The manufacturer causality for all the events were no reasonable possibility. The patient underwent lab tests and procedures which included blood glucose abnormal: unknown mg/dl on an unknown date, blood glucose abnormal: unknown mg/dl on 09Jun2021, blood glucose abnormal: over 400 mg/dl on an unknown date in 2021, computerised tomogram: unknown on an unknown date, international normalised ratio: unknown on 09Jun2021, x-ray: unknown on an unknown date. The outcome of the events "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre" were not recovered. The outcome of the events, knee surgery, knee osteoarthritis, could not open and close left hand and swelling of left hand were recovering and the outcome of had another procedure for her abdominal hernia was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per the information provided in narrative, the events hernia repair, knee operation, Osteoarthritis is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association. The events hyperglycemia, joint range of motion decreased, peripheral swelling, and arthralgia is assessed as possibly unrelated to the suspect drug BNT162B2 since the reporter denies causality. Also, consider possible contributory effects from patient's medical history and/or concomitant medications. 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.

Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events. No follow-up attempts are possible. No further information is expected.

Room began to spin around while I was sitting in, I was so dizzy that I couldn't open my eyes; couldn't lift my head off the pillow/Extreme dizziness for 7 hours. Unable to function or open eyes.; My lips started tingling slightly and my tongue started tingling slightly; tired a little; This is a spontaneous report from a contactable consumer (patient). This is the clone master case and was report 1 of 2. A 76-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021, UPC, NDC number of Covid 19 vaccine: Unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 at 10:45 (vaccination at the age of 76 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included supraventricular tachycardia, slight hypertension and high blood pressure. Concomitant medications included atenolol and menthanenine; the patient received both medications within 2 weeks of vaccination and taken for an unspecified indication, start and stop date were not reported. The patient was allergies to medications, food, or other products includes clindamycin, ampicillin, erythromycin and novocain. Vaccination facility type was reported as hospital. The patient stated, patient received my first shot 06mar2021, Saturday and about 15 minutes after the shot, my lips started tingling slightly and my tongue started tingling slightly so they had me sit there extra 15 minutes that was okay, basically no big deal. The problem came in was, now I got the shot at 10 o'clock in the morning, at 7 o'clock in the evening, the room began to spin around while I was sitting in, at 7:45 PM, was so dizzy that I couldn't open my eyes because every time I open my eyes I felt like I was on a carousel it was just going round and round so my husband helped me to bed, helped during the night, this lasted till 4 o' clock in the morning. My concern is what will happen with the next shot. states she tried to open her eyes and could not open her eyes and it was like she was on a carosel and the room was spinning which lasted until 4:00am the following morning and is now completely resolved. The patient stated she was not too much concerned and heard from people that might have happened with them. The sensation on her tongue and lips after the 1st dose of the Pfizer COVID19 vaccine was very slight in sensation and it was completely resolved and did not last long at all and was resolved within a minute. Caller states she was tired a little bit but at her age that happens and she had a full day yesterday and is going to say that her arm did not bother her after the Pfizer COVID19 Vaccine and other people said that their arms bothered them but she did not have that; She has no other patient information to provide. Event dizziness resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient not had covid prior vaccination and the patient was covid tested post vaccination. Prior and since the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included blood test and covid-19; both were negative on 22Mar2021, and reported as In the last 2 weeks, the patient did go for a Covid test because patient supposed to go for surgery on Wednesday to have, had a problem with bladder, it's kind of dropped down on one side. Outcome of the event My lips started tingling slightly and my tongue started tingling slightly was recovered on 06Mar2021 and other was recovered on 07Mar2021 and event tired a little was unknown. Follow-up attempts are completed. No further information is expected.

Husband reported weakness in left arm the evening of vaccination. Patient's health has declined. She now needs assistance with moving from chair to bed. She can walk once she is on her feet, but cannot get to her feet by herself. Just very week.

Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; Second dose: almost passed out; Second dose: throat tightened; Second dose: jaw was tender; Second dose: lymph nodes under jaw were tender; Second dose: jaw was tender/Second dose: lymph nodes under jaw were tender; Second dose: tired; Second dose: nauseous; Second dose: diarrhea; Second dose: muscle pain; Second dose: joint pain; Second dose: chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (76-years-old at the time of vaccination), (Batch/Lot Number: EL9265, Expiry date May2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection dose 1 via an unspecified route of administration, administered in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as DOSE 1, SINGLE for covid-19 immunisation and experienced throat started tightening, Lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, couldn't do anything, all her joints were aflame, nauseous, pain in muscles, pain in joints, couldn't raise either of her arms, chills, low grade fever of 99.2 degrees Fahrenheit, Fatigue. Patient was dreading getting the second Covid 19 vaccine. One of the questions on the questionnaire she filled out prior to getting her second dose was if she had a severe reaction to any vaccine. She answered yes but no one at the facility asked her about it. She put that she may have had a severe reaction with the first Covid 19 vaccine but no one at the facility questioned it. She put question marks on the questionnaire on that question to indicate she didn't know if she had a severe reaction for sure or not. She did want to have protection against the Covid 19 virus, so she did get the second Covid 19 vaccine. After getting the second Covid 19 vaccine she experienced the same thing going home. Her throat tightened. Her jaw and lymph nodes under her jaw were tender. She was tired but didn't feel the leaden feeling she had with the first Covid 19 vaccine. She was nauseous and had diarrhea. She had muscle pain and joint pain and chills. These symptoms went on for 5 days. She thought she would be ok after the 5 days like she was after her first Covid 19 vaccine dose. On the sixth day she almost passed out in the grocery store. She had to sit on the floor of the grocery store and put her head between her knees. She was dizzy. She was still having the diarrhea, nausea, and chills. It was like having influenza symptoms. She went home that day and got into bed. Then gradually she got better. Maybe around the 9th day after the vaccine she was able to do some things around her house and on the 10th day she was better. Her lymph nodes under her jaw were still swollen. She doesn't know if what she experienced were normal side effects. She found the Pfizer reporting website obtuse. The website indicates there was a time limit to finish a report. She did not file online because she wasn't sure she'd be able to finish in the time limit. She was grateful for protection against the Covid 19 virus and would get the Covid 19 vaccines all over again, but she was not looking forward to getting a Covid 19 vaccine booster. She reported she was very healthy and active. When probed if she had seen her primary care doctor or gone to the emergency department, she reports the hospital was far away. She was living in a rural area in the mountains and did not trust the closest hospital to her. Her doctor friend who was an ophthalmologist told her that her antibodies were really kicking in and that's why she had the reaction to the Covid 19 vaccine like she did. When probing adverse events following any other vaccines, she reports she hasn't had a vaccine since childhood and doesn't remember having any adverse events from her childhood vaccinations. The last vaccine she had prior to the Covid 19 vaccine was the cold vaccine she received in 1992. She'd like to add she also had a rapid heartbeat with the dizziness on the day she almost passed out in the grocery store. That was the sixth day after the second Covid 19 vaccine on 05Feb2021. Her heartbeat was rapid for about a week after starting on 05Feb2021. The clinical outcome of the events lymph nodes under jaw still swollen was not recovered, remaining all events was unknown. No Follow up attempts are possible: No Further information is excepted.

Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day activities. 1. Covid Toes: One inflamed, swollen and discolored toe on each foot. Constant pain. Painful to touch. Spurts of searing, burning pain on back side of toe. 2. Exacerbated arthritic pain in both hands. Joints in fingers and thumb are swollen and extremely painful. Voteran for treatment. Referral to Rheumatologist

Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 days after receiving her first Covid 19 vaccine with flu like symptoms; Throat started tightening; Jaw was sensitive to the touch/tightening of her jaw; Lymph nodes under her jaw were sensitive to the touch; Jaw was sensitive to the touch/Lymph nodes under her jaw were sensitive to the touch; Feeling more and more tired; Entire body was leaden with lethargy; All her joints were aflame; Nauseous; Pain in muscles; Pain in joints; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Lot Number: EL3248; Expiration Date: Apr2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included cold vaccine and experienced sickness for a week (The COVID 19 vaccine is the first vaccine she's had since 1992. The last vaccine she received was called the cold vaccine. Clarified this vaccine was for the common cold). The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that She was calling about the COVID 19 vaccine. On 09Jan2021, the patient experienced, throat started tightening, jaw was sensitive to the touch, lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, all her joints were aflame, nauseous, pain in muscles, pain in joints, chills, low grade fever of 99.2 degrees Fahrenheit, she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms and on 10Jan2021, experienced couldn't raise either of her arms. She wanted to report her side effects because her side effects were dramatic. She wanted to contribute to the research being done on the COVID 19 vaccine. She reported with the first dose of the COVID 19 vaccine she waited the 15 minutes after receiving the dose and got in her car. She lived about 20 minutes from the vaccine facility. Her throat started tightening and her jaw and lymph nodes under her jaw were sensitive to the touch. She had errands to run but she felt herself feeling more and more tired. She needed to eat something, but she hadn't. She couldn't do anything. It was like her entire body was leaden with lethargy. She went home and took a nap for a couple hours. When she woke up from her nap all her joints were aflame. She felt nauseous. She got up to go to the bathroom and went back to bed. The next time she woke up she had pain in her muscles and joints. She has a friend who is a doctor and he told her to take some Acetaminophen. She took the Acetaminophen and went back to sleep and woke up the next day. When she woke the next day on 10Jan2021, she couldn't raise either of her arms. She couldn't raise the arm she got the vaccine in or the other arm. She couldn't reach up to get things out of her cabinets. She also had chills the first night after getting the first dose of the COVID 19 vaccine. She took Acetaminophen again and it eased her muscle and joint pain. She also had a low-grade fever of 99.2 degrees Fahrenheit. Her normal body temperature is low around 97.8 degrees Fahrenheit. She reported she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms. She didn't feel like she could get up and do her normal life for 5 days. On the last day, day 5, most of the other symptoms had gone away. She only had fatigue. The lymph nodes were very slow going getting better as well as the tightening of her jaw, that lasted a long time. She was grateful for protection against the COVID 19 virus and would get the COVID 19 vaccines all over again, but she is not looking forward to getting a COVID 19 vaccine booster. The patient underwent lab tests and procedures which included body temperature: 99.2 degrees Fahrenheit on 09Jan2021 Normal body temperature is low around 97.8 degrees Fahrenheit. Therapeutic measures were taken as a result of, all her joints were aflame, pain in muscles, pain in joints, low grade fever of 99.2 degrees Fahrenheit as Acetaminophen. The clinical outcome of the events Jaw was sensitive to the touch/tightening of her jaw, Lymph nodes under her jaw were sensitive to the touch was recovering, Fatigue not recovered, remaining all other events were recovered on 14Jan2021. No follow up attempts are possible. No further information is expected

headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new blisters on toes; finger pain; armpit pain; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs, lidocaine, penicillin and mouthwash. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) 325mg one pill per day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 08:00 the patient experienced headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog. The patient did not receive any treatment for the events. The clinical outcome of the events headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog was recovered with sequela on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Tingling sensation on their lips and tongues; head and room spinning; seizure; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205) via an unspecified route of administration, on 06Mar2021 (at the age of 76 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to many antibiotics wherein the patient got hives or intense vomiting, and an ongoing high blood pressure. Concomitant medication included an unknown high blood pressure medication. The healthcare professional also said for her to stop taking it because of that sensation she had on her lips and tongue. On 06Mar2021, immediately after the vaccination, it was reported that the patient experienced tongue and lips were tingling. The nurse had the patient stayed for 30 minutes longer until sensation disappeared. The patient was admitted to the hospital and did not receive any treatment for the event. 7 hours later, the patient experienced that her head and room was spinning so intensely she couldn't function or open her eyes. The patient's husband wanted to take her to the hospital, but due to COVID, the patient was afraid to go. The spinning lasted for 7 hours. The patient did go to a neurologist to be sure that she didn't have a tumor, the doctor said that she was fortunate that she didn't have a stroke. The patient had an MRI brain scan to be sure she didn't have any prior issues that may have caused that seizures. She never experienced the dizziness and intense length of time. The outcome of the event "tingling sensation on their lips and tongues" was recovered on 06May2021, vertigo was recovered on unspecified date in Mar2021, while for the remaining event was unknown.

Pfizer vaccine given at a pharmacy. within 15 minute, pt complained of lightheadedness, face swelling, hand swelling, throat swelling, difficulty breathing. Per patient all symptoms resolved within 15 minute wait period. no medications were given for symptoms.

Extreme dizziness, vertigo and disequilibrium causing a fall and lasting 60 minutes on 4/8/21. Vertigo and disequilibrium lasting 30 minutes on 4/9/21 Vertigo and disequilibrium lasting 30 minutes on 4/10/21

Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiation of supplemental oxygen continuous since 1-16-2021),acute hypotension, elevated heart rate, complaints of feeling unwell, increased confusion.

About 20 minutes after the injection I started to feel like I was going to vomit, got nauseated and dizzy.. I had left the site after the 15 minute wait, and since I read that Nausea was one of the side effects, I thought it would go away. I waited another 30 minutes in my car at a parking lot outside the hospital in case I really couldn't drive home. I did drive home , but have been feeling the same nausea every day and some dizziness and diarrhea for the past 11 days. I called my doctor and she said to take it easy, drink fluids, eat light and that I could get the second shot. I am not sure if this is just a reaction or a severe allergic reaction and I need advice and feedback on that issue.

Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand was very tingly and tight feeling and could not move very easily. A few minutes later her lip from the center left was also tingling, and then spread to entire left side of her body from head to feet, like her left side feel asleep that tingly feeling and numbness. Began to be worried, called 9-1-1 and the EMT reassured her that she was not having a stroke, and told her that they had heard of it before. Still today, Monday 1/25/21, particularly in her left hand which she is not able to use very much. Did take Ibuprofen but nothing else.

After first shot, I noticed stiffness and soreness in right knee but attributed it to a misstep in snow. It was annoying but not limiting; however, muscle soreness I attributed to a wrenched knee did not abate. At this point, I consulted my Primary Care Physican's office, and I also had an X-ray of my knee. It showed an aging kneecap, but I continued to report pain as muscular and on the side of my knee. An appt with local orthopedic center was suggested by PCP office and was scheduled. This was the day before my second shot. After my second shot, the pain and difficulty walking increased 100-fold. Orthopedist suggested PT for next 6 weeks, which I will do. Taking Tylenol and Ibuprofin, applying heat and cold, using some topical pain relievers; but for the most part, I am just not able to walk far, if at all. I run a business from my home, so I get around by "riding" my rolling office chair everywhere in my (fortunately) small home. If I can get to the car, I can drive without difficulty. I am a busy, active, independent person. Having experienced the polio epidemic in the '50's, I get all my vaccines; I am not anti-vaccines. I do feel the fact that my disability happened the same month as the vaccine is significant, and I wanted you to know my symptoms and situation.

Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the morning when I woke up, increased blood pressure at times and not as stable when walking. Very Tired. Took Benedryl on second day, one in morning and one at night. Seemed to calm symptoms. Soar Throat lasted two days and much better today (day 3). Left Arm also less soar today and stability when walking seems better...

After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were bearable and strong to disappear when i waek after the short I got Horrible chills, completely out of control, had to wear my night guard to stop teeth from getting chipped, lasted 3 or four hours. Could not warm up, had two down comforters on. The chills eventually stopped but the headaches Intensified, also I could. Or move my near and shoulders. Went to the ER, they did not believe it had anything to do with the shot, I was there for 12 hours, had head exrays, spinal taps to test for meningitis, they searched for anything else I might have...nothing else.. they would not say if I should have the second shot, called pfiser this morning, they could not tell me if I should have the second shot, that I should aske my doctor.......If Pfiser doctor does not know if it is safe how could my country doctor.

Within 15-minutes following vaccination, the patient reported lightheadedness. Medical staff managed patient's care on-site and they reported improvement before patient left the clinic.

Burning sensation of lips at 14 min post vaccine folliwed by mildly swollen upper lip. Then started feeling ill and lightheaded so reportedto site nurse/ems. Bp 190/100 which I have never experienced before. Bp on diovan 80 mg typically 110/60; without diovan is 140/80 -90. Given 2 benadryl and monitored and given 2 more. About 60-90 min bp 155/90 and I went home. Took more benadryl and bp 134/80 this morning and have not taken ot for 10 hrs but feel ok. No local rx.

Switching vision & lightheadness & felt flushed. vitals obtained; water & juice given. started feeling better, continued to observe & walked with pt & rechecked vitals

10:55 "I feel a little woozy" HR - irregular; dry; "feelin' a little nauseated" Neuro - intact; monitoring sats & b/p. 1103 - Nausea - gone! good V/S. Stayed with patient, V/S equalized and pt slowly got better.

she is having a problem with balance and dragging her right leg/balance was off; felt foggy; She has to walk very slowly; her arm started to feel funny. Patient stated it was not painful but felt numb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: 31May2021), via an unspecified route of administration (anatomical location: Arm left) on 18Jan2021 at 14:30 at 0.3 mg, SINGLE DOSE for COVID-19 immunisation. Patient's medical history included 'hyperthyroid' from an unknown date and unknown if ongoing. Patient has no prior vaccinations within 4 weeks. There were no additional vaccines administered on the same date of Pfizer suspect. Patient has no history of previous immunizations with the Pfizer vaccine considered as suspect as this was the first dose. Concomitant medications included levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]) for 'hyperthyroid'. The patient reported that she received her first dose of COVID vaccine yesterday (18Jan2021) afternoon at 2:30. Patient stated that at 09:00 pm last night (18Jan2021), her arm started to feel funny. Patient mentioned that it was not painful but felt numb. Patient stated that today (19Jan2021), when she woke up, she is having a problem with balance and dragging her right leg. Patient also mentioned that she also felt foggy. Patient would like to know if these are common side effects. Patient would also like to know how long the symptoms will last. Patient also stated that she has an appointment tomorrow with her HCP and she will be unable to drive in the current state she is in and will have someone else drive her to the appointment. It was also reported that patient was calling on the line calling about the Corona shot and clarified it to be the Pfizer COVID Vaccine. Patient initially stated she received her first dose around 2'oclock yesterday (18Jan2021). Patient mentioned that she is having a reaction that she does not see on the list. Patient received the injection in her left arm and her left arm feels funny which is to be expected, but her right leg is dragging. Patient also reported that her balance was off which it never was. Patient added that she also felt foggy. Patient was calling to see if this was a side effect and if it is, when will it go away. She started to notice her right leg dragging this morning around 7:30 am on 19Jan2021. She thought it would go away. Around this same time she noticed her balance was off. She has to walk very slowly. As she walks by she has to touch the wall and that is not like her at all. She is normally very active. Normally she walks for an hour as an active person. This feeling is not like her. She started to feel foggy this morning when she woke up. Patient clarified that time of vaccination was 2:30 pm. Vaccination facility type was reported as hospital. The events were assessed as non-serious. Outcome of the event 'her arm started to feel funny. Patient stated it was not painful but felt numb' was unknown, outcome of the remaining events was not recovered.

The shot was given in my left shoulder. Two days later the left shoulder blade became rather painful, making movement difficult. E.g. turning my head to the left was very uncomfortable. These symptoms lasted about two days -- by a week later they were gone I used a hot pad and tylenol to become more comfortable. Probably not a very significant issue, but it was uncomfortable, I wondered if I perhaps had "pulled a tendon" or something like that.

head started to spin when she put her head down on the pillow; dizzy /light headed, passed until she went to sit up and get out of bed/ Her head feels like it is swimming mostly when she gets in and out of bed. When she lays her head down and picks her head up; foggy headed/ floaty heady feeling/ she puts her head down, it is like woah this is strange; arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for 2 patients. This is the first of 2 reports. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiration date: 30Apr2021), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient is taking medication for ongoing blood pressure and ongoing thyroid. Ongoing concomitant medication included metoprolol succinate for blood pressure and levothyroxine sodium (SYNTHROID) for thyroid. She received the vaccine on Saturday 16Jan2021. It went very well. On 16Jan2021, she had a little bit of arm tenderness that lasted for 24-36 hours. Her arm was a little sore. The odd thing is that something took place when she got into bed on Sunday night 17Jan2021 which was 30 hours after the vaccine. Her head started to spin when she put her head down on the pillow. She was very dizzy. She was light headed/ foggy headed. That passed until she went to sit up and get out of bed. It happened again. It has been happening on and off for the last 3 days. She has checked her blood pressure because she is on a low dose blood pressure medicine. Her blood pressure was okay. Everything else seems to be normal. She gets that dizziness for a very short period of time. Her head is not a headache. It is so hard to explain. It is like a floaty heady feeling. She did have a little achiness in her arm. When she puts her head down, it is like woah this is strange. Her head feels like it is swimming. It is mostly when she gets in and out of bed. When she lays her head down and picks her head up. She provided that her height as 5'1" to 5'1.5". The event arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm recovered on 18Jan2021; outcome for all other events was not recovered.; Sender's Comments: Linked Report(s) same reporter/drug, similar event, different patient

Received injection at 0900, at 0910 began feeling sensation of itchy throat. By 0930, increased with raspy voice and urge to cough. Took at approx. 10am. By 1030 itchy throat mildly decreased but with dizziness and chills. O2 sat was 98%. By 1200 most symptoms resolved. At 1400 again with increased itchy throat so took 25mg of Benadryl. No other symptoms, O2 sat 96% and heart rate in the 80's.

Patient immediately felt dizzy, lightheaded, faint after received vaccine, also experienced nausea. Monitored for approx 1 hr until patient felt better/ "back to normal." Vitals signs remained stable and SaO2 WNL throughout observation period. Patient was transported in w/c from waiting area to observation bay and laid on gurney, bottle of water provided, snacks provided. Pt remained A&O throughout observation period. Husband present.

About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; then I felt dizzy; About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; diarrhea; This is a spontaneous report from a contactable consumer (patient) A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL324) on 14Jan2021 at 10:00 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included GERD, disc disease, meningioma, diverticulitis, panic attack and allergy to Macrodantin, Levaquin and Bactrim. Concomitant medications included metoprolol, atorvastatin, omeprazole and alprazolam. On 14Jan2021 about 20 minutes after the vaccine was administered patient felt a wave of nausea and felt like she was going to vomit, then she felt dizzy. Patient waited another 30 minutes before driving home hoping it would subside. Patient informed she have been nauseated, dizzy and had diarrhea on and off for 9 days. She didn't called her doctor yet or notified anyone at the site hoping it would pass, as she knew that nausea was one of the side effects. The patient was not treated for the events. At the time of the reporting the patient had not yet recovered from the event.

Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4th day. BP slightly elevated this morning 138/80.

Within 15-minutes of vaccination, the patient reported feeling short of breath and lightheaded. Patient stated this was a regular occurrence and that it happens multiple times a week. Patient also attributed it to her anxiety. Patient was hypertensive (180/88), A&Ox4 with GCS15. Patient sat down to catch her breath and stated improvement. Patient refused transport.

Patient complained of dizziness and said she was going to pass out. Observation nurse called site clinical lead over, at that time the patient was responding to verbal cues. Mask was taken down and she was guided to take slow deep breaths, continued to report feeling as though she was going to pass out. Site clinical lead then noted patient with fixed gaze to the size, clenching hands and rigid posture. Observation nurse called for EMS assistance. Patient breathing slowed, mouth open, eyes remain fixed to the size with rigid posture for 5-10 seconds. Patient did not respond to any verbal cues. Site clinical lead and observation nurse lowered patient to the floor, at which point patient became responsive. Responded correctly to reason for visit to site, location and how she was feeling. Denied history of seizures or stroke. Reported feeling anxious and needing to use the bathroom. Did not appear to lose bowel control at any point. Patient was very diaphoretic and pale, but alert overall. Cold compresses applied to forehead and back of neck while patient remained supine. EMS arrived and had patient sit up, at which point she again became very pale and reported feeling as through she was going to pass out. EMS transported to hospital for further evaluation.

arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; I feel in my arm, around that shot you know I had the injection, start itchy start feel itchy; my arm feel pink, it's swell up and it's scratch; my arm feel pink, it's swell up and it's scratch; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included bone disorder (reported as bad bone problem). Concomitant medication included denosumab (PROLIA) for bone disorder. The patient received her first injection on 09Jan2021 and had been experiencing arm pain which was mild to moderate but about a week later she developed itching in the same arm. It's become difficult to move her arm and had worsened since the injection. She wanted to know if this type of experience had been reported and if she should receive the second vaccination scheduled for the 30th. The patient stated that she had a hard time lift my arm in changing clothes and she can't her shoulder. After one week later about almost 1 week later she felt in her arm, around that shot she had the injection, started itchy started to feel itchy and she was afraid maybe infection, dead skin, maybe infection or something. She showed it to her friend, saying "Look my arm feel pink, it's swell up and it's scratch, it's itchy." Clinical outcome of event "difficulty to move her arm and had worsened since the injection" was not recovered while for the other events was unknown.

Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began around 7 or 8 am February 5 and continued all day and evening. I slept most of the day. Around 11:30 that night I woke up feeling quite a bit better. I slept all night. The next morning, Saturday, the aches had gone away and I was alot better. The cough, however, continued. The cough continued through Sunday. Monday the cough happened only a few times and I felt energetic and completely back to normal.

diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.

"I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinking clearly, history of reaction to high dose flu shot, HTN

dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.

Patient felt light headed x 1 hour. Drank H2O and laid down and resolved. Declined ED evaluation. All Vitals within normal limits. #21 D/cC home with instructions to return if new symptoms or old symptoms recur.

Patient felt light headed x 1 hour. drank H2O and laid down and resolved. Declined ED evaluation. All vitals within normal limits. #21. d/c home with instructions to return if new symptoms or old recurred.

RECEIVED BOTH DOSES OF PFIZER VACCINE. (01/23/21 & 02/13/21) AFTER 1 DAY (02/14/21) WENT TO ICC REPORTING SUDDEN HEARING LOSS IN RT EAR, LIGHT-HEADEDNESS, AND FEELING UNBALANCED. DIAGNOSED WITH HEARING LOSS OF RT EAR AND HYPERTENSION AND INSTRUCTED TO GO TO ER. WENT ER ON 02/14/21 AND WAS DIAGNOSED WITH ACUTE HEARING LOSS OF RT EAR.

Chills, vomiting, diarrhea, sweats, tremors, dizzy, headache, unsteady gait, fever 101. Symptoms lasted for 24 hours and then I was feeling bad and in bed for 3 days. I took Tylenol for symptoms. I called my doctor and was advised to take Tylenol.

02/05/21 6:00PM total exhausion, chills, headache, joint pain, felt like I had the flu. Also, my eyes seem to have new floaters, and I felt strange in my head. 10:00pm the symptoms continued, but when I got in bed I had terrible nauseau so bad that I couldn't sleep. The next morning my symptoms continued but did not worsen, and then I got so dizzy that I was stumbling. This all continued for three days. On 02/09/21 my symptoms subsided, and I felt normal again

Covid dose #2 (Lot EN6201) given at 1:19pm. Pt began feeling flushed, hot, and weak at approximately 1:30pm. She was able to walk into Triage under her own power. BP was 190s/90s upon arrival to traige. Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out. 400ml of orange juice given since patient stated that she had not eaten since 8am. Blood sugar taken 15 minutes after resulted at 116. Multiple blood pressures taken resulted in consistent 190s/90s. 911 called by provider at 2:07pm. Fire Department arrived on scene at 2:13pm. EMS arrived on scene at 2:16pm. Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department. EMS left the clinic at 2:30pm. Pt had all belonging with her and her family had been notified. She remained conscious and able to answer questions throughout the event.

Dizziness/lightheaded after getting vaccine. BP 181/111; repeat 174/82 (pulse 73). Given water and crackers. Patient has a history of anxiety and panic attacks.

fuzzy thinking; fatigue; pressure in head; dizzy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: L33U2) via an unspecified route of administration in Left arm on 20Jan2021 11:30 AM (at the age of 77-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history included high cholesterol, back scoliosis. Concomitant medications included cholesterol, vitamins, minerals. The patient was not pregnant. No known allergies. No other vaccine in four weeks. The patient experienced fatigue, pressure in head, fuzzy thinking, dizzy on 22Jan2021 06:00 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events. AE treatment included antibiotics. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Nasal Swab (normal and rapid) tested on 02Feb2021 showed negative result. The outcome of the events was not recovered.

Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine, Metachlopramide in ER. Persistent sxs of virtigo, decrease hearing, nausea resolving over several days treated with meclizine, ativan, phenergan, Virtigo improved but still persisting when moving quickly or looking up or down Left frontal discomfort and sinus congestion; hearing returned to near baseline after 10d Steroid 5d dose pack and Augmentin started 2/13 Still unsteady (untrustworthy gait), excess fatigue and fatigability, wt loss, head pain Has not had fever

Immediate blurred vision, numbness in extremities, loss of balance within 1 minute. Confusion of surroundings. Tingling in fingers and feet. Swollen tongue within an hour. No sense of time or place. these last about 30 hours.

77yo 69kg F received dose #2 COVID-19 vaccine. PMH significant only for basal cell carcinoma. Allrgy hisotry includes adhesive, ciprofloxacin, ibuprofen (swelling), meloxicam (swelling) . Approx 10 min after vaccination pt reported feeling flushed, hot, and weak at approximately 1:30pm. She was able to walk into Triage under her own power. BP was 190s/90s upon arrival to traige. Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out. 400ml of orange juice given since patient stated that she had not eaten since 8am. Blood sugar taken 15 minutes after resulted at 116. Multiple blood pressures taken resulted in consistent 190s/90s. 911 called by provider at 2:07pm. Fire Department arrived on scene at 2:13pm. EMS arrived on scene at 2:16pm. Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department. EMS left the clinic at 2:30pm. She remained conscious and able to answer questions throughout the event. BP in ED 162/89. Pt with no prior hx hypertension. Elevated BPS thought possibly due to "white coat hypertension". In ED pt received diazepam 2.5mg po x1. She returned to baseline and was able to be discharged a few hours later at 1742.

patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed for 10 more minutes. Patient started c/o numbness in face, shortness of breath and chest pain around 12:05pm. 02 was 99%. Consulted with Doctor and paramedics called. Patient was confused and had difficulty with balance while being transferred to ambulance. Transported to medical Center at 12:18pm

At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken to a room for observation, after about 30 minutes taken to Prompt Care Facility on premesis. Had slight nausea, shakiness, weakness, little dizzy, headache. Treatment: observation, asking questions, checking vital signs, checked Glucose: Normal. Stayed at Clinic approx. 1 Hour. Considered going to ER but continued to feel better as time passed and went home. BP was at 167/66 when leaving. Later same evening 10:30 p.m. at home: BP at 136/72/66, Next day 2/21/2021 BP at 128/70/63. 2/22/2021 BP 123/66/61. Continue to have headaches.

felt a little dizzy / If she moves too quick she is light headed; Her equilibrium is off; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9263, first dose) solution for injection intramuscular in the right arm on 26Jan2021 (at the age of 77-years-old) as a single dose for COVID-19 vaccination. There was no medical history. Concomitant medication included lisinopril for blood pressure. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient felt a little dizzy if she bends down / if she moves too quick she is lightheaded and her equilibrium was off on 27Jan2021. There was no emergency room or physician office. The outcome of the events dizziness and equilibrium loss was not recovered.

Tightening of neck, light headed- symptoms remained the same during monitoring. Did not get better of worse. Patient stated she took tylenol before vaccine and will take ibuprofen when she gets home. Water given.

Patient complained of SOB and dizziness. Patient was assessed by the Medical Assistant and Nurse Practioner. Patient was stable and provider instructed to notify PCP or seek ER help is systems persist or get worse.

Started with chills, fever. Next morning could hardly get out of bed. Very weak and throwing up black liquid. Could not take care of self for 2 and one-half days. Very weak for 4 days. I was sick with the 1st vaccine for a day one-half with chills and fever but nothing compared to the 2nd one. I will not taken another Pfizer vaccine ever.

patient felt extreme fatigue and weakness -- trouble in moving and getting to bed-- layed down for 30 min and improved after 30 minutes

Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of control/ She got the shakes so bad she shook for like 5 hours; Neck froze completely; She can't move her head up and down normal/ couldn't move her head; Pain in her neck; pulled muscles; Muscles were so sore; Fatigue/Extreme tiredness; Weakness; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL0140), via an unspecified route of administration at the right arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient had anaphylactic shock in the past to a sulfur antibiotic. There were no concomitant medications. She stated she did not have an extreme reaction for the first 3-4 days, it was fine and went away. She had fatigue, joint pain, all the regular things and they were easing up. She had an appointment on the 20Jan2021 and thought things were going okay. On day 7, 20Jan2021, that night, she had an extreme reaction of blinding headache, the shakes, her whole body was shaking out of control for hours, her neck froze completely, and she can't move her head up and down normal (this is still occurring). The patient has had joint paint on 14Jan2021; extreme tiredness, weakness and muscle pain on 15Jan2021; chills, pain in her neck and muscles were so sore from 20Jan2021. She figured that was side effects, and she was handling, and then exactly a week after, she got the shakes so bad she shook for like 5 hours, she had to put nightguard in her mouth to stop from cracking, and severe headaches and her neck completely locked up, she couldn't move her head, and she still can't. She had extreme headache, and she went to the ER on 26Jan2021, since she was in really bad shape, they wouldn't believe her that it was a COVID reaction, she was there for 12 hours, they did every test, she had spinal taps, she had a head X-ray, everything, as they said she had meningitis, but then ruled that out, they wouldn't believe she was having a reaction to the COVID shot, she can't move her head, her joints and that are ok otherwise, but she can't move her head, she has pain in her neck, and she is taking Excedrin for that. She stated her doctor told her to go ahead and take the second dose of the vaccine and just take Tylenol after. She stated Tylenol has no effect whatsoever. If she takes Excedrin the headache will go away and Tylenol won't budge it. She stated she is taking Excedrin regardless of what the doctor says. When asked for age of onset, states she was on Valium and she was not thinking straight, and asked her husband her age. She was not sure why it was given, now provides name as Diazepam 5mg. Muscle pain is fine now, it went away. She went to the doctor on 20Jan2021, as she had a regular appointment for bloodwork to be done, and said she felt pretty good, she had some reaction but was fine, and that night is when she got shakes and shivers so bad, she had 3 quilts on and couldn't warm up, her body was out of control, she couldn't stop, now states for 3-4 hours. Severe headaches started the night of the 20Jan2021. Her neck pain started right after the shakes, so maybe she pulled muscles when she had the shakes, the muscles were so sore, and she couldn't move her head, like down or to the side, she couldn't move it, which is why she went to the hospital, to the ER. She was there for 12 hours. She started taking Excedrin, states she ignored what the doctor told her. She knows her body and she can take Tylenol and Ibuprofen like it is candy, and it does nothing, one Excedrin puts everything away, she swears by Excedrin. The outcome of the event shaking recovered on an unspecified date; Joint pain and Muscle pain recovered on 19Jan2021; Blinding headache/ severe headache, Fatigue/Extreme tiredness was recovering, chills/ shivers, couldn't warm up, Neck froze completely, pulled muscles, fatigue was unknown; she can't move her head up and down normal/ couldn't move her head, Pain in her neck, Muscles were so sore, Weakness was not recovered.

walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very lightheaded; sore throat/ throat is sore; loss of taste/ She has no taste; swollen and puffy mouth/ mouth swollen/puffy; experiencing dry mouth to the point that she cannot talk/ Dry mouth; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), on the left arm, intramuscularly, on 23Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history included mild case of asthma from an unknown date. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient reported that she received her first vaccine a week ago this past Saturday. She didn't feel anything different until 2 days later on 25Jan2021. She became extremely tired and vomited twice, became very lightheaded, has no taste, throat is sore, mouth seems like it is swelling when she wakes up in the morning, her mouth is puffy. Her mouth is getting so dry she can hardly talk. On a unspecified date, the patient reported that she walks with a cane in her own house, she normally doesn't. But since she has had the shot, she has had to use the cane in her own house, she has shrunk. The reporter did not require a visit to a physician's office or emergency room. She mentions she is scheduled for her second vaccine. The patient was vaccinated on an active aging building. The outcome of the events extremely tired and vomited was recovered, for the events very lightheaded, throat is sore, mouth seems like it is swelling/mouth is puffy, mouth is getting so dry she can hardly talk was not recovered, while for the events has no taste, walks with a cane, and has shrunk was unknown.

Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital course 2/24 ? 2/26/21 2/24 Chief complaint: Chest Pain. Per EMS - CP and SOB started 1220. Mid CP radiating to left arm. semi-relief with nitro x 2. Reports N. Denies V and no other symptoms. Hx cardiac stents, MI. HPI: Patient is a 77-year-old female who presents to the ER for evaluation of chest pain. Patient states that her chest pain started this afternoon around 1230 when she was cooking lunch. She says it lasted for about 10 minutes and was a intense substernal chest pressure sensation with radiation down her left arm. She had associated shortness of breath and diaphoresis and also endorsed nausea without vomiting. Patient also states she is had some occasional dizziness which she described as a room spinning sensation is made worse when she is in positions and standing or moves her head. She has a history of 2 heart attacks and 2 stents placed which were done. She has no local cardiology follow-up and she lives at an apartment and follows with pace. EMS gave her 4 aspirin prior to arrival she takes no blood thinners but she does take Plavix. Patient has a history of COPD and also endorses some wheezing, she says they took her nebulizer away from her for fear of spreading coronavirus and she is oxygen dependent at nighttime. COVID positive 2/24/21 (this assay amplifies and detects The target rna using real-time pcr. Testing performed on cepheid genexpert) Patient states she tested negative for COVID 19 last week at her PCP and got her 2nd COVID 19 vaccine on 2/11/2021. She reports having dinner with a friend 3 weeks ago who just passed away from COVID 19. EKG shows normal sinus rhythm with incomplete right bundle branch block and no obvious ST segment elevations or acute ischemic intervals Troponin negative Patient admitted to the COVID unit. Home (baseline) O2 requirement 2.5L at night 2/25: 3L O2 nasal cannula continuously, reduced to 2L within 12 hours No fever COPD with acute exacerbation: Diffusely wheezing bilaterally and in tripod position on exam. Start IV Solu-Medrol COVID-19 viral infection: Start IV Remdesivir as she is now requiring supplemental oxygen. IV steroids as above. Chest pain, history of CAD with previous stenting --Denies any chest pain on exam. EKG negative for ischemic changes. Troponin negative x1. Continue to trend troponin x2 more occurrences. --Continue Aspirin, Plavix, statin, Imdur. Anxiety disorder: Continue Prozac. Add Xanax 0.25 mg 3 times daily as needed. 2/26: medically ready for discharge to SNF COVID unit. Augmentin 875/125 x 7 days dexamethasone 6mg daily x 8 days

DAY 1-mild headache during the day became migraine at night. Experienced chills, sweat, dizziness, fatigue, and sore arm (like tetanus). DAY 2-Migraine all day, chills, sweat, dizziness, fatigue, and sore arm. DAY 3- Migraine downgraded to functional migraine (I could open my eyes), sweat, dizziness, sore arm, fatigue, chills gone. DAY 4-headache, painful to move arm. DAY 5-Arm still painful to use.

became totally nauseous; light headed; very chilled; extremely tired; very cold; Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep); This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number en5318, Expiry date not reported) via an unspecified route of administration to left arm on 26Jan2021 08:15 at single dose for covid-19 immunization. Medical history included UTI (urinary tract infection), rosacea, severe breathing problems, no sense of taste or smell, severe bronchitis, pneumonia, productive cough (productive cough that lasted for 2 months) and known allergies: some eye drops; some pain killers (nausea). The patient became totally nauseous, light headed, very chilled, extremely tired, very cold, fell asleep under warm down quilt until 2:00pm (total 13 hours sleep) all on 31Jan2021. The events were reported as non-serious. Reporter states she Woke up 8:00 am and dressed. Felt fine until 9:00. Had some milk tea and 2 morning pills and became totally nauseous and light headed. Went back to bed immediately. Became very chilled, and extremely tired. Checked temperature at 97.5 and was very cold. Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep). Felt better, but ate little and wore a coat inside. After a light dinner, nausea mostly gone, but still tired. Reporter added that she almost certainly had a serious case of Covid in early February, 2020. Nobody knew the symptoms, so both urgent care and the ER sent her home with minimal treatment. She had severe breathing problems, no sense of taste or smell, severe bronchitis with some pneumonia (X-ray), and a productive cough that lasted for 2 months. The patient underwent lab tests and procedures which included body temperature: 97.5 (Unit unspecified) on 31Jan2021 and x-ray: some pneumonia on an unspecified date. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.

dizzy; broke out into a sweat; feeling a little nauseous; chills; breast cancer stage 1/taking anastrozole; breast cancer stage 1/taking anastrozole; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ELV5318, expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included stage 3 kidney disease, breast cancer stage 1 and blood pressure abnormal (reported as 'blood pressure') all from an unknown date and all ongoing. Concomitant medication included anastrozole (manufacturer unknown) for breast cancer, levothyroxine (manufacturer unknown) for kidney disease and amlodipine (manufacturer unknown) for blood pressure. The patient has breast cancer stage 1 and was taking anastrozole. The patient got the vaccine on 30Jan2021 and did not have any side effects 22 hours later, on the day of the report, 31Jan2021. The patient was grocery shopping and became very dizzy and thought she has to keep this together. The patient then just broke out into a sweat and managed to get herself home. She was feeling a little nauseous and she got the chills and then it (unspecified) was pretty much over in about 2-3 hours. The patient was scheduled for the second dose on 20Feb2021. The patient did not receive any treatment for the events. The outcome of the events was unknown.

they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.

Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.

Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generalized weakness, symptoms happened the day before yesterday, resolved, she noticed when she is trying to do any activities she gets heart fluttering. Epigastric pain noted in ED. Troponin Elevated, heparin IV started for possible NSTEMI. Patient is currently admitted.

Patient fell (did not sit down completely for vaccine), and lightly hit forehead. On Pradaxa. No visible head trauma. BP 160/100 (pulse 56), O2 sat 97%. Final BP 132/62.

Progress Notes (Nurse Practitioner) ? ? Infusion Center Cosigned by: MD at 3/4/2021 8:28 AM Expand AllCollapse All COVID VACCINE CLINIC 3/2/2021 Subjective Patient is a 77 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience chest tightness and lightheadedness. She denied rash, glossal tightness or increased work of breathing This provider was notified of patient reaction and I was then assessed in the emergency bay area. PMH HTN, obesity and NIDDM. Cardiac cath 2 years ago: normal per report. Pt has NIDDM, ate eggs/baco this AM with AM FBS: 150 mg/mL. Pt has re-applied her long sleeve sweater and heavy coat as she began her observation period. She was alert, mild pallor with normal VS on arrival. Blood sugar: 80 mg/dL. Oxygen applied. BP138/62, HR76. Sat 100 % Granola bar/water provided with complete resolution of symptoms Monitored patient for severe reaction symptoms, including but not limited to any need for additional diagnostics. Recommendation for 30" observation period at Dose #2 of 2 . APRN-C Previous Reactions: none Objective Vitals There were no vitals filed for this visit. Blood Sugar 82 collected at 0953 Arrives in wheelchair, awake, alert HEENT: No glossal issues, no stridor LS CTA S1S2 Skin pale. No rash Anxious Assessment/Plan Treatment included: oxygen, blood glucose, VS monitoring, snack Follow up response to treatment: complete resolution of symptoms Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: hypoglycemic event APRN Electronically Signed 3/2/2021 9:52 AM

has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not clear; flipped out; her blood pressure went up while she was in the Emergency room; panicked; Lightheadedness; Weakness; felt a little tired at that time; atrial fibrillation/started racing/Heartbeats irregular; anxiety; couldn't breathe/shortness of breath/hard time breathing; it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated; her heart rate was flying; scared; she said it was not a migraine headache like she is used to, but more of a mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EM9801), via an unspecified route of administration on the left arm, first dose on 04Feb2021 (Administered between 9:30-10:00AM) at single dose for COVID-19 immunisation. Medical history included chronic migraines all her life. She said her migraines have let up as she has gotten older. She also had an irregular heart rate before, saying her irregular heart rate started in her adult life. She said she considered herself more of a "carrier" for an irregular heart rate because her irregular heart rate doesn't happen enough for her to think about it. She said she doesn't have an irregular heart rate now. She said her father had a pacemaker & her 2 brothers had heart problems; her oldest brother passed away from his heart problems & her other brother has blood pressure issues. Patient also had mild asthma as an adult. She said she worked at (name) in a dusty environment, and lived near a landfill, where a lot of her neighbors have gotten sick. She said she needs an inhaler for her asthma. She said when she needs the inhaler, she takes 3-4 puffs at a time. She said she doesn't use the inhaler every day and also mentioned that her grandfather had died of a bad asthma attack. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on the same date of vaccine. No prior vaccinations within 4 weeks. There were no concomitant medications. On 13Feb2021, the patient experienced an atrial fibrillation in which she started racing and couldn't breathe. She mentioned that she recently attended a funeral but attributed the symptoms as side effects of the vaccine. She was taken to the Emergency room where she was given cortisone and resolved her symptoms. Patient also further reported she had side effects with the Pfizer COVID-19 Vaccine. She clarified she had her first COVID-19 Vaccine dose on 04Feb2021. She said her side effects happened less than 14 days after getting the COVID-19 Vaccine. Patient thought her side effects from the COVID-19 Vaccine may have been anxiety within. She said her nephew had died of COVID-19, and when she was at his funeral at the graveside, she flipped out while she was at her nephew's funeral, she was not doing good. She said she has a history of chronic migraines, and mild asthma. She said she had to lean against a gravestone because she couldn't breath. She said it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated. She said her heart rate was flying, and she had an irregular heart beat. She said she left her nephew's graveside and went to an urgent care. She said the doctor at the urgent care had done an EKG result abnormal, and told her she needed to go to the Emergency Room right away. She said the doctor had called the paramedics to transport her from the urgent care to the Emergency Room at (Institute name). She said she did not have any pain, but had a hard time breathing. She said she may have been scared because her grandfather had died of a bad asthma attack. She said she has chronic migraines, but what she had at the time was a mild headache, and not a migraine. She said she has not smell or taste a lot of the time. She clarified she has had no smell or taste for a while, saying she would not be able to tell if she got the COVID-19 Virus because of her loss of taste and smell. She said she was tested the Friday before her nephew's funeral and was negative for the COVID-19 Virus. She said she has had a total of four COVID-19 Virus tests before, and all her COVID-19 Virus tests have been negative. She clarified she did not have a COVID-19 Virus test while she was at the ER on Saturday, 13Feb2021. With her nephew's death, getting her COVID-19 Vaccine had left her mind. She said it didn't dawn on her until she settled down, and she thought her high heart rate and irregular heart beat were side effects of the COVID-19 Vaccine. She said she read the paperwork that was given to her at the time she got the COVID-19 Vaccine. She said the side effects listed for the COVID-19 Vaccine is what she had, a very fast heart beat, and it was very hard for her to breath. She said the Emergency Room doctor didn't think to ask her about the COVID-19 Vaccine. She said she panicked when she got to the hospital. She said she didn't even know that someone had drew blood from her. She said someone put a label on her, and told her the label was to show blood was drawn from her. She said when she looked down at the label, she saw an IV access was put in her arm. Additional treatment reported when she was in the Emergency Room, she was given an injection (clarified as IVPB on 13Feb2021) of Diltiazem 120mg at 12:13:50 PM, she said she was given another Diltiazem 5mg injection at the same time. She clarified she was diagnosed in the Emergency Room with Atrial Fibrillation. Patient stated that her blood pressure went up while she was in the Emergency room. She said she was kept in the Emergency Room so she could be monitored up until that evening. She said after the Diltiazem injections were given, her heart rate went down. She said the Emergency Room doctor gave her a prescription for Diltiazem 120mg white capsules, and told her to take the Diltiazem 120mg every day. She said the emergency room doctor told her she could go home, and that she needed to follow-up with her regular doctor. Reported she no longer has the shortness of breath, lightheadedness, or weakness. She said had felt a little tired at that time, as well. Patient also reported that on 22Feb2021 was her first day outside of her house since last Sunday (14Feb2021) and reported she has a slight headache, and her sight is not clear. She said she now feels she has "name" back, clarifying she has recovered completely. She has a follow up with her doctor on 24Feb2021. She is scheduled to take her 2nd dose on 04Mar2021 and is asking if she should take anything before the shot. Vaccination Facility Type was a pharmacy/drug store. Vaccine was not administered at Facility. The outcome of the events was recovered on an unspecified date.

Beginning 2-4(injection date) dull headache on top of head 2-6 vertigo began(room spinning), followed by sinking feeling in head, followed by spasms in center of head felt like seizures. 2-19 hospitalized for CT Scan of Head 2-23 EEG in Doctor Office

Was monitored for 30 mins and felt lightheaded and weak at the exit table. I was put in wheelchair, moved to a cot, and Paramedics were called. I was weak, couldn't stand without help and I felt drugged. I was taken to ER for monitoring and testing for reasons why this occurred. Continued to feel passed out for 2 hours. Tests for heart attack, diabetes and anemia were negative Diagnoses was Vasovagal attack - sent home after 8 hours monitoring

dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (herself) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9269) via an unspecified route of administration in left arm on 11Feb2021 14:00 at single dose for Covid-19 immunization. Medical history included Cholesterol, high blood pressure and history of ovarian and breast cancer. Concomitant medications included Pregabalin, rosuvastatin calcium (CRESTOR), fluoxetine hydrochloride (PROZAC) and amolodipine. Patient is good health had a bad reaction to the 1st COVID dose vaccine. Ended up in hospital emergency room on Friday 18Feb2021 with extreme dizziness and nausea and heart palpitations. Fatigue which had been going on since Friday 12Feb2021 14:30. Having had these reactions patient need to know from Pfizer is it safe for me to have second dose which is scheduled 04Mar2021. Seriousness was reported as non-serious. Patient did not receive treatment for events. No follow-up attempts are possible. No further information was provided.

she felt a little dizzy/a little dizziness; headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 04Feb2021 (at the age of 77-year-old) at a single dose for COVID-19 immunisation. Medical history included cancer, heart problems and ongoing COVID. The patient's concomitant medications were not reported. The patient reported that she has had a light case of COVID and took the COVID vaccine this morning. She said that after receiving the vaccine, she is experiencing, not major, a little dizziness/dizzy and headache on an unknown date in Feb2021. She is not really worried about it. She did not want to take anything before she called and verified if it was ok; but she called to ask if she can take TYLENOL after having gotten the vaccine. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 10:00, at single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing food allergy (to cantaloupe). Patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin b complex (B COMPLEX) and calcium carbonate, colecalciferol (CALCIUM + D3). Patient did not receive other vaccine in four weeks. The patient experienced seizure (medically significant) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, chills (non-serious) on 27Feb2021 with outcome of recovered in 2021. No therapeutic measures were administered as a result of the events. Clinical course: the patient reported that she had been having chills for several hours. During the night while sleeping, she believe she had a seizure. She was awakened with her body quivering from head to toe. She had no pain. She was aware of what was happening. She could not move nor speak. The event did not last very long and, when the quivering ceased, she no longer had chills. Patient did not test for COVID-19 post vaccination. The information on the lot/batch number has been requested.

1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Scared and my heart races.

Fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 10:00 (lot number: EN6201) at the age of 77 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced allergies. The patient previously received first dose of bnt162b2 on 04Feb2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9264, administration time: 09:45 AM, vaccine location: left arm). Next morning after vaccination (occurred on 24Feb2021 08:00), the patient felt lightheaded while bending over to empty dishwasher. The patient sat down on chair; and the patient's husband found the patient on floor, as she had fainted. The patient had no recall of fainting. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The patient did not receive other vaccines four weeks prior to COVID vaccine. The patient recovered from the events on unspecified date.

Woke up to go to bathroom about 3:50 am and couldn't get out of bed. I was completely off balance. I tried to walk and couldn't. Sat down again but had to do so I hung on to the bed, walls, and doors to steady myself to get to bathroom. Had a little diarrhea. Managed to take 2 Tylenol and drank lots of water. I held on to everything again and got back to bed but sat up instead of laying down. I still had diarrhea so I held on to every thing again and took one Anti-Diarrhea pill. Went back to bed sitting up and tried to sleep. Got up around 8 am and felt better but still a little woozy.

Within 5 minutes I became very light headed and weak. Also very hot and shaky. They had to put me into another room that was much cooler and put me into a recliner with feet up, ice behind my neck and on my forehead. I was pushing water so it was not dehydration, and I had eaten my normal healty breakfast also so not low blood sugar. This was my second shot and I had the same reaction with the first shot. It took about an hour before I could stand and walk again, but was still a bit shaky and faintly light headed for about another hour.

"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care

She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the hospital for her high BP/admitted to Hospital with 200/103 Bl; she has constant spiking of her blood pressure (BP) and lack of sleep; Racing Pulse; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; This is a spontaneous report from a contactable consumer. A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9262), via an unspecified route of administration in left arm on 25Jan2021 (vaccination age 77 years) at single dose for COVID-19 immunization. Medical history included: cholesterol, spinal fusion L4/5, stenosis, allergies to medications, food, or other products: kefex, Zithromax, levofloxacin, oxycontin, methylprednisolone, Lisinopril, ezetimibe, Amlodipine. She reported she has constant spiking of her blood pressure (BP) and lack of sleep for 37 days (average 1-3 hours daily), since the vaccination. She described the following: She has experienced "dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function". When she "lays down", her "heart is racing so fast and [her] BP gets so high that it won't let [her] sleep". She feels like her "body is going crazy". She "cannot get more than 2-3 hours of sleep other than 1-2 exceptions". Also, her "BP wakes her from a dead sleep". When she wakes up, she usually "takes a rice [pad] and applies hot and cold to her neck, and she sometimes takes some Tylenol". "Every time [she] wakes up, her BP [readings] are around 152/101 and 160/97. She has been in and out of the hospital for her high BP. After the hospital, she called (Number) because her BP "was off the chart". Her cardiologist ruled out heart issues. She did an "echo, a stress test and EKG". On 01Feb2021 she was admitted to hospital with 200/103 blood pressure. Ruled out cardiovascular & placed on Amlodipine. Now 37 Days later with many visits to doctors, blood pressure remains high. Cardiologist ran stress test & echo with no heart issues. Placed on many Blood Pressure Medications that also created side-affects (urination, flushing, dizziness, extreme headaches); Amlodipine 5 mg, Metoprolol 25 mg, Alprazolam 0.25 mg as needed, Propranol 20 mg. Today, picking up yet another (Hydralazine?) as last-ditch effort. BP daily spikes remain high (160/99 and 175/100). Racing Pulse & BP wakes me out of a dead sleep within 1-2 hours. So weak & constant neck pain that feels like someone is placing pressure around my neck. The blood pressure medication received are the following: Amlodipine from 1Feb2021 until 9Feb2021. She explained it work well to manage her BP but she "could not urinate and had red flashes in [her] face"; therefore, it was stopped by her cardiologist. She was off the BP medication from 9Feb2021 until 17Feb2021. Metoprolol from 18Feb2021 until 25Feb2021, but it didn't work. She explained it was stopped by her doctor because of side effects. Propranolol in combination with Alprazolam as needed for anxiety. She explained she "took 3" of the tablets for anxiety. Hydralazine 25mg which she started yesterday, after seeing her cardiologist. She explained she only got 3 hours of sleep last night. She woke up around 1:30am/2am" her heartrate was at "93" and she put heat and cold on her neck to settle the pain. She specified the headache and pain were so bad it lasted for 1.5 hours, and her BP was 150/93 at 3 am .She added she had a "red and flushed face" and therefore took a "Benadryl at 4am". She explained her BP was down to "125/78", after taking the Benadryl, but got up to "147/90" at 7 am when she attempted to call Pfizer. She explained she has "done [her] due diligence: she consulted HCP, did all the test, she attempted to go for walks and do activities she can tolerate, but her symptoms persist. She added she use to golf and cannot anymore. She explained her symptoms are persisting until this day and her body won't handle it further. She mentioned she knows she is COVID-19 free because when helping take care of her quadriplegic son in the summer, she tested negative. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : PFIZER INC-2021277006 same patient, different vaccine dose/AE.

She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m.

Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with headache & anxiety, improved & discharged to home

The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able to control with Tylenol for the most part. However, over the next 4 weeks, my mom gradually lost the ability to control her bladder function, and her ability to transition between sitting, standing and lying down w/o help. She also exhibited even more difficulty with walking than she did before (shuffling). My mother experienced pain all throughout her body, and the pain became as bad as an 8-9 in a range of 1-10. She struggled to raise her arms, reach her arms out, or grasp objects. She lacked energy, she would sleep for 10 hours every night, and she had difficulty concentrating and remembering what she was reading,

numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; Dizzy; little taste in mouth; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 77-years-old) as single dose for protection. There were no medical history and concomitant medications reported. The patient experienced Dizzy, little taste in mouth, numbness at injection area, swelling came back 1 week later, 4 inches and round in shape on 21Jan2021 and itchy in Jan2021. It was reported that the patient got her vaccination on 21Jan2021. When she got it, she felt a little dizzy, and a little taste in her mouth that disappeared. She did experience numbness at the injection area and swelling that disappeared after two days. Then, after one week, the swelling came back. She still has it. It is 4 inches, and round in shape on 28Jan2021. She wants to know if this is life threatening. Her next vaccine is on 12Feb2021. Her height has went down. She got it at the Hospital. She doesn't have a prescribing doctor. She experienced the dizziness and taste in her mouth occurred while in the recovery room, it lasted a couple of hours. The arm numbness and swelling started a few hours later and lasted two days. Right now it is itchy, but she tries not to scratch her arm. The initial injection wasn't itchy when she had the numbness and swelling. It was just numb and swollen the first time. This time, it is itchy and swollen. She got the vaccine because she wants to be safe, for protection. The patient underwent lab tests and procedures which included body height: her height has went down in Jan2021. The outcome of events, dizzy, little taste in mouth on 21Jan2021 and numbness at injection area on 23Jan2021. The outcome of swelling came back 1 week later, 4 inches and round in shape was resolving and was not recovered for event itchy. No follow-up attempts are possible. No further information is expected.

I started feeling weird in my head, terrible ringing in my ears like 10x's worse than normal, spaced out that I can hardly function, dizziness, misplacing things, disoriented, left eye twitching, vision is more blurry than normal. (patient stated she didn't know if she can live like this because it makes her want to take her life)

She got the vaccine, did not have any reaction or that she was even given a vaccine. Then around 7:00 PM her arm started to get a little sore but kept moving it and massaging it. She then could not move anything by 10:00 PM, and had gone straight to bed as she felt so bad. She was dizzy, light headed, and these symptoms continued all night and all day Thursday. She dozed to sleep off and on all day Thursday and was in so much pain, didn't have to move to have pain. She is still having some pain today, but feeling much better. She still is a little bit dizzy. Feels as if she laid down she could sleep for a long time. She has pain in her back area, her arms, her hips. She did not take anything for her reaction as was told not to take aspirin and does not use other medications. She feels exhausted and if she moves her arm too much and also her legs then they start to hurt. Getting in and out of bed is easier today, but she could not get them over the bed to get in or out on Wednesday. Her neck also hurt to turn. She had similar symptoms to when she had the COVID virus in November/December. She had been hospitalized for it twice, was informed that she had a stroke after she had passed out.

Reports dizziness immediately following vaccine inject. She reports same symptom with first vaccine, and was transported to Rush ER. VS 130/78, 68, O2 sat 99 %

Severe ongoing vertigo. Treated with meclizine 12.5 mg as needed, augmentin 500 mg every 12 hours for ten days, and prednisone 20 mg once daily for five days.

Pt self-reported heart palpitations and dizziness 1 day post-vaccine. Resolved on its own with no treatment.

1325 Pt sitting in chair in OBS. Pt appeared slightly vague and hands shaking. Pt did grasp bottle of water when given. Pt unable to open water bottle and increase hand trembling noted. Pt began leaning forward. Pt did not respond when asked name or if she needed help opening water bottle. Pt became unresponsive and slouched forward with left UE contracted and gerbilled words unable to identify. EMS activated. Pt eased to floor without complications with EMS asst. Pt aroused after appx 10-15 sec with verbal cuing. Pt alert and oriented, unable to remember all details, diaphoretic. Pt asst to med eval room via WC. Within 2 minutes of obtaining pt demo and info, pt displayed another episode as previous: unresponsive, left UE contractured and diaphoretic. EMS assessed eyes/pupils-fixed and non-reactive. Pt arouse again with vague and confusion. Pt denies hx of SZ or TIA. No loss of bowel or bladder. Reports dizzy and confused. IV started to left posterior wrist by EMS and EKG complete-SR. TC to pt daughter information given. Pt to be transferred to medical center. Pt A&O. Pt transferred to stretcher with asst. and HOB elevated. Pt with personal belongings and reassured to return in 3 weeks for 2nd dose of vaccine.

1/20 vaccination About 2 weeks later, I started getting up in the mornings with my hands hurting. I was doing water aerobics and stopped. I called the doctor and explained having pain in my hands. I have been using different ointments for the pain. *blood work scheduled with f/up with PCM 4/30 Hot flash experienced 2-3 days after vaccination.

Chills, sweats, fever for 2 days Excruciating headache for 3 days Nausea, severe for 3 days Nausea, moderate to light for 4 more days Weakness 5 days Dizzy, foggy condition for 5 days These symptoms were simultaneous for close to a week Not inclined to get booster in 12 months

4:51pm Patient c/o dizziness. Patient fasting for religious reasons. Patient refused water. Vitals: B/P 138/87 P 93 RR16 O2 97%.

Developed massive Pulmonary Blood Clots in both lungs. First symptom was shortness of breath and feeling I would faint. Went to Hospital Emergency room and was admitted immediately spent 2 1/2 days in ICU for treatment to dissolve blood clots (TPA) Was discharged on third day as oxygen level, heart beat, breathing and blood pressure appeared normal. Took second COVID19 (Pfizer-BioNTec) shot on Monday, March 29, 2021 at 1:00 p.m. (Lot ER8732) No adverse reaction to second shot except some muscle paid in left leg (calf).

Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown. No follow-up attempts are possible; No further information is expected.

affected her balance and walking/out of balance; affected her balance and walking; TIA; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 25Mar2021 10:00 (batch/lot number EP6955 and expiry date not reported) at 77 years of age as single dose for covid-19 immunization in a clinic facility and not in military facility. Medical history included Stroke from 2014 and another in Dec2018; the patient had MRI to confirm, ongoing blood thinner (therapy). Concomitant medications included rivaroxaban (XARELTO) taken for blood thinner from Jan2019 and ongoing. The patient previously took first dose of bnt162b2 on 04Mar2021 at 77 year of age for covid-19 immunization and experienced arm soreness, Eliquis for 2.5 years after the first stroke for blood thinner and couldn't deal with Eliquis very well and made her feel like she was dying. The patient had no prior vaccinations (within 4 weeks). On 30Mar2021, the patient experienced TIA (transient ischaemic attack). The patient informed that at first she had nothing then five days after the second dose (30Mar2021), she had a TIA. The TIA that she experienced was so sudden and so alarming. It affected her balance and walking (unspecified date). The patient informed that when she was walking to pick up a stick she felt out of balance. The patient was walking like she was a drunken sailor and was staggering. It was the oddest thing. The patient has not talked to her doctor. The TIA was quick then it was gone. It was scary. The patient did not seek treatment (no treatment received). The outcome of the event TIA was recovered on 30Mar2021, while unknown for the rest of the events. The patient considered that the TIA may have had nothing to do with the shot, it happened 5 days later.

immobile for a day; cannot walk; sore arm; weakness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 77-years old) (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included Hashimoto's disease from an unknown date and unknown if ongoing, Diagnosed 35 years ago, hypermobility syndrome from an unknown date and unknown if ongoing, Diagnosed 20 years ago, "anomia" (unspecified) from an unknown date and unknown if ongoing, Diagnosed 25 years ago, and thyroid high from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for thyroid disorder, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; and diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient experienced immobile for a day on an unspecified date, cannot walk from kitchen to the other room on an unspecified date, she is so weak which lasted one day and was bearable on 15Feb2021, and sore arm on an unspecified date. The patient underwent lab tests and procedures which included investigation: has antibodies, they are there but not very strong on an unknown date. The clinical outcome of the events immobile, gait disturbance and pain in extremity was unknown; asthenia was recovered on an unknown date Feb2021 (lasted one day). 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-2021409340 Same patient, different dose and event

Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was or what day it was, my husband had to hold me to help stop the shaking.....NOT CHILLS, could not walk, diarrhea. This happened also on March 31st, my FIRST injection.....My heart was beating out of my chest.... very scary. Please don't tell me this is NORMAL!!! I've lost at least 5 lbs. I am petrified to get the booster, if there is one, I WILL NOT GET IT... ANY SUGGESTIONS.

sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling unwell; Weakness; light headed/weak when standing up; polymyalgia; sick; This is a spontaneous report from a contactable nurse (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9284; Expiration Date: 31May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 (Verbatim: Giant Cell Vasculitis, Reported she started taking Prednisone about a year ago for Giant Cell Vasculitis. She said she started at Prednisone 60mg a day, and now is down to Prednisone 10mg a day), Congestive Heart Failure, COPD, Hypertension, Pulmonary Hypertension. There were no concomitant medications.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry Date: 30Apr2021) on 21Jan2021 via Intramuscular, anatomical location was arm left, prednisone for Giant Cell Vasculitis (she started taking Prednisone (60mg a day)about a year ago for Giant Cell Vasculitis and was down to Prednisone 10mg a day.her side effects are not that bad. She said she just expected to feel better.), flu vaccine (She gets temperature 101 and sick from the flu vaccine, so she doesn't get the flu vaccine anymore and it had been quite a few years since she took the flu vaccine.), pneumonia vaccine (got a pneumonia vaccine about a year or so ago).On 12Feb2021, patient had been on the couch and watching television. She was fine laying down, but when she got up, she was lightheaded and didn't feel well and had weakness when she got up. Patient had a sore throat with swollen glands in her neck, her throat felt swollen and like it was closing up and glands started hurting on 15feb2021. She was sick when got up, but when lay down she was fine. she had polymyalgia was doing better before the vaccination. She was wondering if it was normal for the COVID-19 Vaccine side effects to last that long or were the COVID-19 Vaccine side effects expected to last that long. Wanted to know if because she was taking Prednisone, her COVID-19 Vaccine side effects were lasting longer. Patient stated she always thought she was 5'5", but the last time she was measured at the doctor she was told she was 5'. No further details provided. her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine. She took 1 Tylenol on 11Feb2021 and again on 15Feb2021 (Lot Number: 06V1489, Expiration Date: May2022). She said she took 2 Equate Brand Tylenol 500mg tablets because her throat felt swollen, and the throat swelling went away on 16Feb2021. Patient had severe pulmonary hypertension until she had a cardiac catheterization. She said she was told from the cardiac catheterization that she had the potential for pulmonary hypertension but did not have severe pulmonary hypertension. She said prior to the cardiac catheterization she had years of cardia echos performed, and the cardiac echos were not correct. The outcome of the event throat felt swollen was recovered on 16Feb2021, for feeling unwell, lightheadedness, weakness it was not recovered and sore throat, swollen glands it was recovering.

sx: headache the day after vaccination and local pain in the opposite shoulder (right shoulder) from where she was vaccinated (left arm). headache resolved with apap dosing. but rt shoulder pain/tightness has persisted on and off for the last 9days. pt said she is not using apap on regular basis. and also admitted to doing light gardening during this time.

Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very weak; Dizzy; Spinning around like in a tunnel/ Vertigo; Had like 4 attacks a day and I did not hold down laying in bed and looking up ceiling and ceiling starts spinning; Frightening; little warm in the arm; Resting heart rate but the oxygen was running low it was like 84-80; I don't feel good;; Hit me like a rocket; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer Sponsored program. A 77-year-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. edical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included metoprolol succinate at 50 mg, once a day for hypertension, alprazolam (XANAX) at 2.5 DF, twice a day for anxiety, albuterol at Every 3 to 4 hours as needed for chronic obstructive pulmonary disease, budesonide at 5 mL, twice a day for chronic obstructive pulmonary disease, arformoterol tartrate (BROVANA) at twice a day morning and night for chronic obstructive pulmonary disease, tiotropium bromide (SPIRIVA) Inhaled through the mouth, once a day as a bronchodilator, aspirin, omeprazole (PROTONIX) at 40 mg, once a day for Acid reflux, diltiazem at 300 mg, once a day for hypertension and unspecified vitamins. Patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 26Jan2021 and experienced warm arm. It was reported that, the patient had a very bad experience with the shot. On Tuesday in this rehabilitation, they were giving out the shot, this was her second shot in this place. The first shot she had no reaction, just a little warm arm. On an unspecified date in Feb2021, the second hit her like a rocket, the day after the shot or the day over the shot just a little warm in the arm nothing really, the next day woke up extremely fatigued did not even want to eat breakfast did not have the energy just wanted to sleep and she said what was going on with her and then she got up very fatigued. Then the physical therapist came in to give physical and they "supposed to" (not clarified) her. It showed a good blood pressure everything was good resting heart rate, but the oxygen was running low it was like 84-80 and she knew she was because she could feel it while she was walking and patient told them she does not feel good, she felt very weak and thought it must be from the shot. So that went on then and go on to this same thing very dizzy on the next day of second shot on 17Feb2021, spinning. That day spinning around in like a tunnel. She had like 4 attacks a day and she did not hold down that she was laying in her bed and she was looking up in the ceiling and this ceiling starts spinning with the whole room. That was 4th of those on Thursday, Wednesday she was just tired, Friday she had less of them but the same thing spinning around, never fell down but again it was not while she was standing up. The physical therapist said to her sit up do not lay down in the bed. Now she was taking pulmonology medication through a nebulizer. Patient also taking bronchodilator and she take a prednisone pill 20 mg, albuterol and she take other medication. Patient did the Covid test when he had blood work up. They do a blood work up every 2 weeks here. But everything was good. The outcome for events was reported as unknown. Information about lot/batch number has been requested.

After receiving COVID dose 2, patient was found sitting on the floor in the pharmacy waiting area. She seemed to be mildly short of breath and patient seemed to be slightly dizzy. Patient was assisted to a nearby chair and seemed to be recovering. She and her caregiver remained there as I returned to the pharmacy and they were within my line of sight. A few minutes later they were gone and it was assumed they left the building. They were in a different part of the store and the patient sat on the floor again. Her caregiver called 911 and she was transported to a local medical facility.

headache; Exhausted; Chills; Joint Pain; achy pain; Flu; Eye floaters; Feeling Strange; Nauseaus; Dizzy; This is a spontaneous report was received from a contactable consumer or other non hcp. A 77-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 05Feb2021 14:00 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history included digestion problems, ongoing coeliac disease and allergy to gluten. Concomitant medications included vitamin b complex (vitamin b), zinc (zinc), vitamin c [ascorbic acid] (vitamin c [ascorbic acid]), colecalciferol (vitamin d [colecalciferol]), bifidobacterium lactis (Probiotic [bifidobacterium lactis]). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 05Feb2021 at 18:00, the patient was exhausted and experienced chills, headache, joint pain started in left ankle, later she had achy pains all over and felt lousy like she had the flu. The patient had new floaters in her eyes and a strange feeling in her head and was also extremely nauseous and dizzy. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered on an unspecified date in 2021. Follow up attempts are completed. No further information is expected.

feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up; really ill; memory is a little off right now; felt like I am going to faint; ringing in the ears; dizzy/light headed; a really really sore arm for two days after the vaccine; allergic reaction; This is a spontaneous report from a contactable consumer, the patient. This 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included allergies and sinus headaches which she takes (Excedrin) off and on for years in the past, and high blood pressure. Concomitant medications included atenolol (manufacturer unknown) taken for hypertension, start and stop date were not reported. Past drug history included the patient received a flu shot (unspecified Flu shot) with a mega reaction she was sick for weeks which was at least probably 15-20 years ago So, she never got a flu shot after that and she has never had the flu. On 29Apr2021, the patient had a really really sore arm for two days after the vaccine, dizzy/light headed, felt like I am going to faint, and ringing in the ears. On an unspecified date in 2021, she experienced allergic reaction. On 01May2021, she was really ill, and her blood pressure went up over 220 and pulse rate went way up. On 02May2021, she experienced headaches. On 06May2021, she was feeling a little weird and nauseous. On an unspecified date in May2021, her memory is a little off right now. The clinical course was as follows: the patient reported, "I had a really really sore arm for two days after the vaccine, it's okay now, I couldn't really move it. I feel I may be having a severe allergic reaction to the Pfizer vaccine (Pfizer Covid-19 Vaccine) got on Thursday (29Apr2021) of this past week. I am very light headed, dizzy and felt like I am going to faint, has ringing in the ears, and all that has been going on about a week, since last Thursday (29Apr2021). Then I was really ill last night (01May2021). It started last night when we went to bed around 11 O'clock. I have never had anything like this in my life. My blood pressure was through the roof. With a blood pressure cuff and a stethoscope, her blood pressure went up over 220 which was so high that had never happened before, so I took an extra pill (atenolol 25 mg tablet) last night (01May2021) which helped a little bit but not enough, and I really thought that I was going to pass out and be really sick. Because I thought that it was either having a stroke or a heart attack, my husband had to call ambulance to take me to the hospital last night. The systolic and diastolic and pulse rate went way up. They did chest x-ray, blood work, and urinalysis, and everything came back fine and they could not find anything. They just felt that I was just having a major reaction to the shot so they sent me home. I just got home this morning (02May2021) from having to go to the emergency room. But as soon as we got home, I started with a humongous headache and so I had Excedrin/Tylenol for headaches because I used to get sinus headaches. So, I took that, and it helped a little bit, my headache got a little better. Anyhow, I am much better right now and I am sleeping. But tomorrow it will be the same." Later the patient also reported, "Today (06May2021) I am feeling a little weird with ringing of ears and is light headed sometimes. Because of the light headedness, I feels a little nauseous. But I am a still very nauseous. I feel like I am going to faint again and my blood pressure I think has gone back up. I am trying to keep calm and trying to figure out what is going on. But I am really afraid if I am having a reaction to the vaccine unfortunately. I am dizzy and I do not want to start getting worst again. I guess I will feel better if you tell me that this happens sometimes and what can I do to decrease somehow?" She also stated that she did contact her doctor about this event but she didn't get very far. Her memory is a little off right now because she really has not felt well. She stated that her biggest thing is her blood pressure. She also stated, "The only thing that I am really concerned now is about getting the second shot because I already had the reactions by the first shot. Am I going to face the same thing or even the worse with the second shot?" Treatments were received for her blood pressure went up over 220 and headaches. The clinical outcomes of the event "a really really sore arm for two days after the vaccine" resolved on 01May2021, the event nauseous was not resolved, while the events, allergic reaction, really ill, felt like I am going to faint, pulse rate went way up, ringing in the ears, dizzy/light headed, Headaches, feeling a little weird and memory is a little off right now were unknown.

became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.

Nausea; fatigue; sore arm; vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 77-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unknown route of administration on 09Mar2021 at 03:00 PM (at the age of 77-years) for COVID-19 immunisation. On 09Mar2021 at unknown time, the patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: not provided) via an unknown route of administration for COVID-19 immunisation. Medical history includes osteoarthritis. The patient was allergic to darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient experienced nausea, severe fatigue, vertigo and sore arm on 09Mar2021 at 03:00 PM, which were intense for 24 hours then intermittent for 6 days. No therapeutic measures were taken as a result of these events. On an unknown date, the patient was recovered from the events nausea, severe fatigue, vertigo and sore arm. Information about lot/batch number cannot be obtained. No further information is expected.

brain fog, dizziness, strange sensation in sinuses difficulty in concentrating, difficulty focusing eyes when reading, eye events such as "flaters" flashing at outer sdges of eyes, exhaustion and needing more sleep than usual

Vaccine on Wednesday 4/28/21. Started to have mild headache, nausea, generalized malaise and chills on Thursday 4/29/21. Seemed to then improve but then became lightheaded and dizzy. Came to emergency room 5/2/21 at 1000. BP stable at 136/69, O2 sat 99% on room air. No significant findings on blood work (CMP, CBC, Troponin, BNP, TSH all within normal limits). Chest Xray was normal. EKG showed atrial fibrillation with rapid ventricular rate in the 150s. She was given IV diltiazem and her heart rate was controlled. She was admitted to the hospital for observation and conversion from IV to PO diltiazem. She declined oral anticoagulation. She was discharged home on 5/3/21 and instructed to follow up with her PCP and was to see cardiology.

getting lightheaded; Excessive hypertension/ 180/88 to 94; This is spontaneous report from a contactable nurse reported for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 21Mar2021 (Batch/Lot Number: ER8727) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included hypertension, paroxysmal atrial tachycardia, stroke when she was 40, had COVID in Mar2020 (Her cardiologist believes she had COVID too but never did a test) and broke her ankle. Concomitant medication included warfarin sodium (COUMADIN) because she had a stroke and broke her ankle and got a clot from her ankle to her groin; ongoing diltiazem hydrochloride (DILTIAZEM HYDROCHLORIDE) taken for paroxysmal atrial tachycardia and hypertension; Chlorthalidone taken for polyuria and hypertension; verapamil hydrochloride (VERAPAMIL) taken for paroxysmal atrial tachycardia for years. Patient received first dose of bnt162b2 on 28Feb2021 in left upper arm. Patient was a retired nurse and stated about a month after the second dose of the vaccine she started getting lightheaded, she went to Urgent Care because her daughter who is a nurse insisted. Her blood pressure at Urgent Care was really, really high, she was having excessive hypertension. Before the vaccine she was on a blood pressure medication for several years and had no issues. She went to see her cardiologist and they moved her from one medication to 3 medications (then add Losartan, Diltiazem) to get this controlled. In the morning she was lightheaded and her blood pressure is high before her morning medication. Diltiazem is 24 hours. She gets up at 3AM and once she takes the medication it seems to be ok. Her blood pressure is reasonable now. It is not like it was initially when elevated. Initially it was 180/88 to 94 when she first went to see the cardiologist after second COVID19 Vaccine. Currently her blood pressure in the morning is usually 154/ 77. That was when she first takes it when she gets up. Later in the morning it is running 110/77. The event outcome was unknown. She was feeling that it had to do with the second injection. Patient considered it was medically significant for high blood pressure and lightheaded, and considered both events related to COVID19 Vaccine.; Sender's Comments: Based on the known drug profile, there is a reasonable possibility of casual relationship between the drug BNT162b2 and the events Dizziness and Hypertension. 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.

Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleepy; palpitations; My chest has been beating like a 107 and it is normally like in the 70/Fast heart beat; lymph nodes in the neck that made her hard to move her head; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; she was sneezing; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiry Date; UPC and NDC number: Unknown), via an unspecified route of administration on 26Feb2021 01:00 PM in the right arm at 1ST DOSE, SINGLE for COVID-19 immunisation. Patient's age at vaccination was 77 Years. Medical history reported as, the patient first states that she was medication free, but then clarifies that she does takes a vitamin D that is prescribed by her doctor. She had a lot of allergies when she was very young, she was tested for allergies. Two years ago she didn't think she was sick but her calcium was high, she had 2 parathyroid glands removed and she was stronger than she was before. She takes no pills for it, she has nothing wrong with her, outside of the cancer she had when she was 55 years old. Caller reported that the injection did not hurt for either herself or her husband, and it was wonderful. The patient states that she had no fever or chills from the vaccine, but both the caller and her husband were tired after receiving the vaccine, but caller thought it was from stress. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included an unknown vaccine and patient states as, that back a long time, when she was a youngster, when she was given whatever vaccination is needed to go to school, her arm swelled past her elbow, and she was sick for a few days. Caller does not remember which injection it was, it was whatever injection she had to have to go to school, she was 5 years old. Caller doesn't recall the name of the injection. No prior vaccinations (within 4 weeks). The patient states that she does not take the flu shot or anything like that, ever. Vaccination facility was reported as outside the distribution center in the parking lot. On an unspecified date in Feb2021, the patient experienced My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose, lymph nodes in the neck that made her hard to move her head, I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help and she was sneezing; On 26Feb2021, experienced my chest has been beating like a 107 and it is normally like in the 70/Fast heartbeat, sleepy, palpitations; On 01Mar2021, experienced leg cramps; On 03Mar2021, experienced lymph nodes in the neck that made her hard to move her head; On 04Mar2021, experienced Jaw pain up into eye. The report received as, the patient was pleased where she had the injection it didn't have swelling or get red and she does have a history of allergies and her doctor said it was ok to get the shot. The doctor told her, that if she had any eye tearing, nasal drip, or other things like that, to take a Benadryl. Caller waited 12 hours, because her eyes did start to tear, and she was sneezing and so she took a non-drowsy Benadryl, but she waited 12 hours to take the Benadryl, because she didn't want it to interfere. The patient experienced fast heartbeat started in the evening on the same day. Patient also had fast heartbeat yesterday. She reports she had a fast heartbeat; it was in the low 90s, she knows that's not fast for some people, but it was fast for her, and it would come and go like palpitations. Patient does have a machine, her heartbeat was in the 90s, and her chest has been beating like a 107 and it was normally like in the 70s. Caller was in the kitchen when she felt it, so she sat down. The patient reports that she has not experienced the palpitations today. The patient states that she was doing something in the kitchen, she's very active. She normally gets up in the morning and does the breast stroke for 1.5 hours, and patient states that she only got up to the pool once this week, and she didn't stay at the pool long because of the leg cramps. The patient reports she did have a fast heartbeat yesterday. The patient reports that she also started to have a lot of cramps in her legs, which she has never had before in her life. The patient states that 2 days ago, the lymph nodes in her neck must have been swollen, and it hurt so bad last night, she didn't know what to do, she took regular over the counter Tylenol and it did help. The patient states that it's not bothering her today. it's right down the sides of her neck. She looked on the internet for lymph nodes in neck, she knew she had lymph nodes in her neck and it was really, really tight. It was both sides of her neck. It's not as bad today because she couldn't stand it anymore last night so she could take Tylenol. She was to a point sitting in a chair, how could she stretch her neck because it hurt so bad. But this morning she can move it pretty good. She told her husband if it continued that she would go to hospital. She was concerned with if she should get the second shot or not. She was wondering did the first Covid shot cause this. She did take Tylenol this morning, she also reports jaw pain and up into her eyes, that started yesterday, and it has been relieved. She's concerned if she got this with the first shot, could she get it with the second which was scheduled on 19Mar2021, and she was a little doubtful about getting that second shot. The patient states that she was very seriously thinking of not getting the second shot, because she had an awful lot of discomfort with this first shot. The patient states that it wasn't that she was tired, she was just sleepy, she was sleepy on the day she got the vaccine, and then on Saturday, 27Feb2021 she had 3 naps, then on Sunday, 28Feb2021 she had 2-3 naps. Then on Monday, 01Mar2021 she was back to normal. The only things caller was concerned about was if she should get the second shot. She read about not getting the second shot if you had a fast heartbeat. She would call her doctor, but all the doctors are telling people to get the shot. The only reason she got it was because of her husband and his underlying conditions. No specify Antipyretic used around the dates of Vaccination. No relevant tests. The patient underwent lab tests and procedures which included Heartbeat: 107, 90s on 26Feb2021. Outcome of the event lymph nodes in the neck that made her hard to move her head was recovering; events palpitations, jaw pain up into eye recovered on an unknown date; event leg cramps recovered on 03Mar2021 and outcome for remaining events was unknown. No follow-up attempts are possible. No further information was expected.

dizziness 48 h after injection; This is a spontaneous report from a contactable other hcp (herself). A 77-year-old non pregnant female patient received (patient was not pregnant at the time of vaccination) BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9265, Expiration Date was not reported), via an unspecified route of administration on 30Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included hypertension, cholesterol elevation. The patient previously took aleve and experienced allergy (drug hypersensitivity). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021, 48 hours after injection, the patient experienced, dizziness. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. No treatment was received for the adverse event. The adverse event resulted Doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.

Hyperoxia; could not move her body or a finger or anything; Her arm was starting tingling; Tiredness for a few days after second shot; she was frozen; Blood oxygen level was at 163; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 77 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were unknown) via an unspecified route of administration, administered in left arm on an unknown date at 10:45 AM (3 weeks after 1st dose) as 2nd single dose for COVID-19 immunisation. The patient received glycopyrrolate (batch/Lot Number and expiry date were unknown) via unspecified route of administration on an unknown date at a dose of 2 mg tablets daily (once daily in the morning) orally for peptic ulcer. The patient stated that she guesses glycopyrrolate would be expired when the 30 days are up. The patient did not have glycopyrrolate during reporting. The patient had just called the office and ordered a new refill when the freezing thing started. The patient was blind, so she could not read the label and batch number. The patient medical history included blindness called retinitis pigmentosa, diagnosed at 43 years old, she did not take anything for retinitis pigmentosa and it was genetic, ongoing and low thyroid (for several years). Family Medical History was mentioned as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were unknown) via an unspecified route of administration in left arm in Jan/Feb2021 at 10:45 AM. The patient's concomitant medications included unspecified thyroid medications (for several years) and unspecified sleeping pill daily. On 25May2021 at 08:45, the patient went for her physical exam, the patient's blood oxygen was up to 163. The patient added high blood oxygen levels could affect the heart. The patient never had blood oxygen over 98. The consumer clarified she meant low oxygen and not low blood pressure. The patient had the writing on the tape recorder. Recorder spelled the term as Hyperoxia. The patient stated that a week and a half ago, she was sitting in a chair after both of her vaccines but that she started those pills again and felt tired. Tiredness was first noticed after second shot that evening and it lasted for some days. She was taking a nap while watching tv and that lasted couple of days. She would be tired and then have to take a nap, but did not feel bad. The patient sat in the recliner and went to sleep and when she woke up, she was frozen and could not move her body or a finger or anything. She went in around 1400 and had no idea how long she was asleep but her mind was working. The patient stated she told herself to concentrate and to move but could not. She had no idea how long she was in that state but kept concentrating on trying to move a finger and was able to get a finger to move. Her arm was starting tingling like when it falls asleep and she was just cautious when she finally got up to walk. The patient did not visit emergency room/physician office. The patient told that she did not feel this bad before the vaccines and that was why she thought it was the medication (glycopyrrolate) that caused it. The patient started back taking the medication a few weeks after and did not know what it was for and that was why she thought it was this medication. The patient underwent lab tests and procedures which included high oxygen level 163 on 25May2021 and blood pressure was 133/64 on an unknown date. The outcome of the event blood oxygen was up to 163 was not recovered, Hyperoxia, could not move her body or a finger or anything, Her arm was starting tingling, she was frozen was unknown, Tiredness for a few days after second shot was resolved. Information on Lot/Batch number has been requested.

Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient had faint feeling, chills, temperature normal, blood pressure 164/90 pulse 60. Chief complaint was unusual taste and numbness of lips. Symptoms improved over 30-45 min period

hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has been sleeping a lot for about 3 days; Foot pain; foot redness; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9261)via an unspecified route of administration, administered in Left Arm on 02Feb2021 at 12:00 (at the age of 77-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included parkinson's disease, transient ischaemic attack, hypersensitivity, sinus disorder, Cardiac disorder, vaginal infection, pain, incontinence, antidepressant therapy, hallucination, unspecified vitamin D deficiency. No relevant tests done. The concomitant medications included ongoing estradiol (ESTRACE VAGINAL) taken for vaginal infection from 2019, ongoing colecalciferol (VITAMIN D 3) taken for vitamin d deficiency, ongoing pimavanserin tartrate (NUPLAZID) taken for hallucination from 05Feb2021,ongoing venlafaxine (VENLAFAXINE) taken for antidepressant therapy, ongoing carbidopa, levodopa (RYTARY) taken for parkinson's disease, ongoing mirabegron (MYRBETRIQ) taken for incontinence, ongoing atorvastatin calcium (ATORVASTATIN CALCIUM) taken for cardiac disorder, ongoing aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for transient ischaemic attack ,ongoing clopidogrel bisulfate (CLOPIDOGREL BISULFATE) taken for transient ischaemic attack, ongoing paracetamol (ACETAMINOPHEN) taken for pain, ongoing loratadine (LORATADINE) taken for hypersensitivity, sinus disorder, ongoing ascorbic acid, biotin, calcium, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, potassium iodide, pyridoxine hydrochloride, retinol acetate, zinc sulfate (CENTRUM MULTIGUMMIES WOMEN), amantadine hydrochloride (AMANTADINE HYDROCHLORIDE) taken for parkinson's disease. Since receiving the vaccine she had been sleeping a lot for about 3 days (on 03Feb2021). Caller stated she knew that was supposed to be a side effect. Adds her mother was a Parkinson's patient and usually able to walk using a walker. She was having a hard time walking (03Feb2021) and had to use the wheelchair. Clarifies her mother started sleeping quite a bit about three days after the vaccine on Friday 03Feb2021. Mentions previous to this on Wednesday after the vaccine, her mother was complaining of foot pain (on 03Feb2021) towards the side midway on the foot in the arch and on the top where you tie your shoe. It was almost like she dropped something on it but she did not. It was slightly swollen on the top and red and warm (on 03Feb2021). Friday when her mother started sleeping so much, they had resort to the wheelchair. She took her to see the nurse practitioner on Friday for the foot, who sent her to the ER for an X-ray on Saturday so they went out again on Saturday to get the foot x-ray done. The foot was not broken. They did treat her mother's foot with Cephalexin. Her foot was fully recovered now. Her mother's tiredness (on 05Feb2021) was persisting and she was having a hard time just getting up from the bed and to go across the room even though the foot was fine. Today they have a message into her neurologist. Adds today was the first day her mother started talking about needing or wanting to go to the hospital for her tiredness and not being able to walk (06Feb2021) Her mother was scheduled for the next dose 23Feb2021.The patient underwent lab tests and procedures which included x-ray limb: the foot was not broken on. Therapeutic measures were taken as a result of foot pain, foot redness, foot swollen, foot hot to touch.The outcome for the events foot pain, foot redness, foot swollen, foot hot to touch was recovered/resolved on 08Feb2021 and not recovered/not resolved for rest of the events. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected

Dizziness, my arm hurt. Saw the ENT on Thursday, 03/04/2021, for my dizziness. The doctor said there was nothing wrong with my inner ear. I have had a persistent headache, subtle headache after the vaccine.

02/04/ 2021 the day of the vaccination, within the hour, so dizzy and weak I couldn't sit in the chair. I felt I had to lie down. I couldn't keep myself upright. The doctor thought it was inner ear disturbance and sent me to an ENT. ENT did not find anything abnormal. I had to get my potassium on the 3rd of March. I saw the ENT on the 4th of March. The vertigo persisted for a while, and every now and then I feel weakness and I need to sit down.

Did not receive 2nd dose of vaccine, lisp tongue, couldn't pronounce any words, dizzy, itchy rash/hives on torso, very wobbly could not stand, prescribed an EpiPen.

Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not listed) COVID Positive 5/25/21 at PCP office (but negative upon repeat testing 5/25/21) 5/25/21: The patient is a 78-year-old female presents emergency department today after testing positive for COVID-19 at her PCP office, they recommended she present to ED to rule out pulmonary embolism. Patient has a past medical history significant for ESRD on HD Monday Wednesday Friday, hypertension, diabetes mellitus type 2, anemia of CKD, and osteoarthritis. Of note, the patient had her COVID-19 Pfizer vaccination series completed in February of this year. On arrival to the ED, the patient's temperature is 98.4° F, heart rate 68, respiratory rate 26, saturating 90% on room air with blood pressure 163/63. The patient did desaturate to 87% on room air when ambulating in the room. The patient's laboratory studies were significant for HGB 11.3, ESR 44, CRP 1.7, BUN 17, CR 4.80, UA: Proteinuria, trace hematuria, small leukoesterase, many bacteria, 11-30 pyuria, 1-3 RBCs and moderate squamous epithelial cells sent for culture. Blood cultures x2 obtained. Chest x-ray shows no acute cardiopulmonary findings. V/Q scan showed normal exam. EKG showed normal sinus rhythm. The patient was seen emergency department laying in bed. She reports worsening shortness of breath over the weekend and COVID like symptoms for the past week. She reports some dyspnea on exertion. She states she has been weak, fatigued, had some chills, and was seen by her PCP, who tested her for COVID-19 and she tested positive. This COVID-19 test is not and are records. The patient has had some desaturations less than 90% when she falls asleep. She wishes to be a full code. 6/1/21: She is admitted to the hospital, as mentioned above 0 repeat COVID test is negative. V/Q scan is reported as normal. She is started on dexamethasone 6 mg IV daily, along with IV antibiotics ceftriaxone Zithromax and Acapella. Pulse ox is monitored, oxygen is weaned off patient has been stable on room air and has been afebrile. Nephrology consult is requested, patient had hemodialysis as per Nephrology recommendations on Monday, Wednesday and Friday. Her blood pressures were uncontrolled, her home medications Coreg dose was increased to 37.5 mg p.o. b.i.d. and Procardia XL increased to 60 mg p.o. daily and blood pressures have been stable now. Patient did complain of weakness to ambulate, had physical therapy and occupational therapy evaluation. She is being discharged home today in stable condition for skilled nursing. She is off steroids now. Discharge plan is discussed with the patient.

I first lost my nail. It was unusual because there was no trauma to the nail. I was reaching for something across my bed, and I started experiencing radiating pain across my chest as well as pressure. I stayed very still and then it spread through my left arm and up into my shoulder, neck ear and jaw. I remained still and tried breathing the best I could. This lasted a minute or two and then it released and was over. About a month later, I was diagnosed with RSV which ran down into my lungs and soon my blood pressure was going up because my heart was working so hard to breathe. It was over 200/175 which is abnormal for me. I had to end up calling an ambulance because I was having trouble breathing. I was prescribed blood pressure medication, steroids, antibiotics, prednisone and oxygen. I was not allowed to get out of bed, I couldn't walk. They told me it would take baby steps.

RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WENT UP ABOUT 40 POINTS AND I WENT TO DR AND HE RAISED MY BLOOD PRESSURE DOSE. THEN BOTH MY KNEE JOINTS SWELLED FOR A WEEK. THE SWELLING LEFT MY KNEES AND WENT DOWN TO MY ANKLE BONES. IT HAS BEENOVER A MONTH AND I CAN BARELY WALK.

she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her heart started racing; Just didn't feel good; Tired; Felt queasy; Dizziness; blood sugar was low; Sore Left Arm; This is the spontaneous report from a contactable consumer. This 77-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201 and expiry date: 31-May-2021) via an unspecified route of administration on 24-Feb-2021 at 08:15 in left arm (77-year-old), as dose 2, single for COVID-19 immunization. Medical history included of the patient included a dental surgery. When she got up in the morning her face was real puffy and she thought she looked like the Pillsbury dough boy. Both cheeks were swollen. This surgery was to remove a tooth. She stated that she took her premedication before her oral surgeon appointment. She previously had a kidney replacement and a shoulder replacement. She always takes pain meds before she does any dental work. She had blood pressure measurement, depression, knee arthroplasty, shoulder arthroplasty, thyroid atrophy, renal failure, coronary arterial stent insertion, hypothyroidism and steroid therapy. Concomitant medications of the patient included sertraline taken for antidepressant therapy, levothyroxine taken for hypothyroidism, potassium citrate taken for renal failure, atorvastatin taken for coronary arterial stent insertion, hydrochlorothiazide taken for blood pressure measurement, prednisone taken for steroid therapy from 27Jan2021 to an unspecified stop date; amoxicillin taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265 and expiry date 31May2021) via an unspecified route of administration on 02Feb2021 in left arm (77-year-old), as dose 1, single for COVID-19 immunization and had no problems. It was mentioned that additional vaccines administered on same date of the pfizer suspect were reported as none. On 25Feb2021 the patient experienced sore left arm. On 28Feb2021 the patient did not feel good, tiredness, felt queasy, dizziness and blood sugar was low. So she had some orange juice and went about her day to grocery shop, so she laid down to take a nap and then felt okay. On 01Mar2021 she could not breathe very good and her heart started racing. Caller reported that she did not get clammy and that was why she did not feel it was hypoglycemia. She has not had that for years as she watched and made sure she does not eat too many carbs. She was tired and took a 3 hours nap. Caller states the whole time she just did not feel herself, but she just went on and pushed things aside as she had a life to live. She did not relate it to the vaccine at first. She got out her information paper and she had all of the symptoms that were on the paper besides the rash. The patient did not require emergency room and physician office visit. On an unknown date in 2021 breathing difficult, Heart racing, Feeling unwell, Tired, Felt queasy, Dizziness, blood sugar was low recovered. On 27Feb2021 sore left arm recovered. Caller would like to know if it is typical to experience side effects four days after receiving a dose of the Pfizer vaccine. Caller stated that she was home when she experienced the side effects and felt like a wet noodle and just wanted to lay down and did not seek medical attention. Caller did not clarify what the other number was that she had called and was directed to Pfizer DSU, but stated she had not made any reports previously. Caller does not have an email for her doctor at this time. She said she has not called him. She felt sick yesterday. Her cousin wanted her to go to the hospital but she said she can not do it as she could not breath good and just wanted to lie down. She was so weak. Caller mentioned that she was a little chubby, but she exercises and moves around a lot. Caller stated that she was not feeling good but went on because she has a life to live and go on with things. Caller stated she was taking Prednisone when she received her second Covid vaccination and she wondered if that had anything to do with her reaction. The patient took Excedrin Migraine for headache took Saturday, caller was unaware of dose she took. She stated that it was just over the counter. The Excedrin Migraine expiration date 21Dec and Lot SP2W, but she stated that she usually just takes Tylenol. Caller Mentioned taking normal vitamins daily and I Caps, she stated she feels like she does well for her age, and then restated that she does Damn well for her age. Caller states her family has heart disease issues during Vaccine supplemental form but continued to stated that she does not feel that was relevant to this report. Follow-up attempts were completed. No further information was expected.

7/20/21 1st Covid vaccination (pfizer) appt was at 10:30 actually received injection approx 11:15 am. around 6 hrs later, left arm/injection site began to ache. THEN, approx 8:00 pm, (approx 9 hrs after injection) I experienced slight shortness of breath (sob) plus some fatigue, headache, dizziness. Was able to go to sleep--after a while. Next morning, 7/21/21 sob more noticeable. Didn't do my regular 3-4 mile walk. By afternoon (7/21/21) great fatigue, greater headache, dizziness and shortness of breath stronger. In middle of day I went to bed and slept 4 hrs. --to nap like this...very rare except when I had Covid, late 2019/early 2020. Following evening, 7/22/21, approx. 8:00 PM, because that day had been free of sob, I took dog for walk...only reached l/8 mile, or less, because sob returned, in a stronger manner. I had to rest before able to walk back home. By 9:15 pm, same evening (7/22/21), sob worsened--although only sitting at computer. Husband found my 2019 rx of "albuterol sulfate" inhaler...( 90 mcg per puff, take 2 puffs back to back) something I've NEVER used before. This was prescribed because in 2019 because of extreme sob, now considered to be symptom of Covid. The inhalant helped. July 27, 2021, I had to use inhalent again--sob.

July 28 2021 woke up with slight cough , sore throat, also had some knee pain July 29 woke up 4;30 am With Excruciating knee pain and swollen knee , could not walk . My husband and son In law had to help me get up Also had sore throat and laryngitis Not sure if the above is related to my second shot 7/22/21 or not

CDizzy. Weak after an hour, increasing so could barely stand by 8 pm. severe abdoominal pain, chills, throat swelling during night, feeling as id needles pricking entire body for an hour or so around 2 or 3 am. Better next day exvept tired and weak. Ok since then.

Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All Date: 1/25/2021 Subjective 78 y.o. male who was seen today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience dizziness. He denied difficulty breathing and difficulty swallowing. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to hypotension and rapid progression of symptoms. Patient ate a bowl of oatmeal this morning prior to receiving his vaccine. He has only drank a small amount of diet coke today, no water. He became dizzy when standing up and some while walking. He notes the dizziness resolved on his walk to the medical evaluation bay. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing and headaches Previous Reactions: Denies Objective Vitals Vitals: 01/25/21 1150 BP: 133/86 Pulse: 84 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Patients symptoms of dizziness completely resolved prior to discharge. He denied dizziness when standing up and walking to leave the medical evaluation bay. Electronically Signed 1/25/2021 12:02 PM

initially next day had redness and swelling at site >3 inches around site, still red when speaking today, but dizziness onset 1/28/2021 in the morning. Drinking plenty of fluids

This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.

In one minute dizziness and couldn't clear throat little swollen. They checked heart beat and blood pressure and injection site and kept me extra waiting time

Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, nauseated, and lightheaded. She reported her blood pressure was low 80/60 and her heart rate about 100. She rested and her pressure came up. Then she reported a couple hours later she felt that way again while walking around house. She sat down and felt better. Then around 6p symptoms came back and she also had a headache and a little shortness of breath. She then decided to go to the ER.

Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Brain fog; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Sjogren's, asthma, low Igg, A-Fib, osteoporosis. The patient has known allergies: Methylparaben, Rocephin, lidocaine, oats. Concomitant medications included metoprolol, hydroxychloroquine sulfate (PLAQUENIL), apixaban (ELIQUIS), propafenone. On 16Jan2021 14:30, the patient experienced Headache, dizziness, lightheaded, gait and speech Disturbance, tired, brain fog. The outcome of the events was unknown. The patient did not receive treatment for the events. Information on the lot/batch number has been requested.

Patient states she was feeling dizzy and was advised to stay for observation. Patient states that she was feeling better and decided leave ,but upon leaving, she felt dizzy again and started having left sided numbness and tingling in her hand and leg. patient vitals were taken 165/71 P84 02 99%. Patient states having history of stroke and HTN and blood pressures medications. Patient was transferred to the ED for observation and evaluation via w/c.

Injection time 1302. Symptoms: Lightheaded and flushed. Per pt's daughter, felt symptoms around 1325. Pt. has history of diabetes and also currently taking antibiotics for UTI. BP 110/78. Symptoms improved 1335. Observed pt. until 1355. Pt. is feeling better and in stable condition at the time she left.

Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid infection in Sept 2020. Meds admin - NaCl 0.9% I.V. bolus. 500 ml. Tyl. + Hydrocodone 650/25 - Labs - UA. lactic acid, SARS antigen, BMP, CBC, CXR - revealed pneumonia - F/U with family practice on Monday. In addition to above - numbness from waist down to toes, loss of bowel + bladder. T-102.F. Unable to walk - this lasted for 17 hrs.

she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.

3rd day became very dizzy, dry heaves. Dizziness continues for 2 weeks now, gradually improving in intensity and frequency.

Patient complained of difficulty swallowing, tingling feeling in her tongue. She initatally took 50 mg of benedryl, and after 15 more minutes, she continued to have the same symptoms, and in addition was breathing more labored, was having a harder time swallowing, and complaining of feeling dizzy and a headache. She then received an Epi Pen, was placed on oxygen, used her Xopenex inhaler, and EMS was called. She was then transferred to the ED for continued monitoring.

double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days. Patient states she got her first COVID vaccine on 2/5/21 and had a slight headache but no other symptoms. Today, she was sitting the car when she started to have double vision. She reports dizziness/lightheadedness that is moderate. Patient states the double vision isn't everything but random things and at random times today. Denies dehydration, fever, or injection site abnormalities. No headache today. Reports that last week at her PCP's office her BP was slightly elevated and she thinks her BP may be elevated right now but does not have a cuff with her to check. Went to the Emergency Department on 2.6.21 - admitted overnight until the 7th. DETAILS OF HOSPITAL STAY: DX: Diplopia [H53.2] Blurred vision, bilateral [H53.8] HOSPITAL COURSE: 1. Double vision post COVID vaccine. Unclear etiology or if related to vaccine reaction. Resolved. CVA ruled out. Could be migraine associated. Advised patient to talk to PCP about migraine prophylaxis and see ophthalmology as outpatient. 2. HTN 3. HLD Advised patient not to drive till cleared by ophthalmology Inpatient workup included myasthenia gravis panel which is still pending The patient is a 78-year-old right-handed woman who received her first Pfizer COVID vaccination February 5. This morning she developed double vision. Images were horizontal she does not know if they were binocular or monocular. She saw couple with 1 child and it appeared that they had 2 children. She looked at her son and saw 2 heads on 1 body. She saw 2 traffic lights. Each time she saw diplopia, it lasted for maybe 1 minute, and after blinking it went away. The double vision was not associated with headache, facial numbness or weakness, numbness or weakness in her extremities, speech change or imbalance. She recovered from each episode. She has had torn retina twice in each eye. Those were each associated with flashes of light in floaters. She did not have a fever today. She has never had double vision before. Review of systems: She admits to a history of headaches. She said she had catamenial headaches and sinus headaches.

Symptoms: c/o chest pain, lightheadedness, vitals WNL. Intervention: rest, reassurance - symptoms resolved.

Severe Muscle ache over entire body. 1st day bedridden. 3rd day improving. 1st evening trying to sleep I had very vivid, realistic dreams.

At about 2:00 a.m. on Feb. 6th I was awakened by nausea and vertigo that lasted until about 10:00 that morning. Sat. afternoon I was feeling much better.

Flashes of lights in my eyes, burning pain in my legs, my ankles were on fire. Totally fatigued, could hardly walk and had to walk with a cane and hold onto wall. Just plain pain all over, I felt nauseated but never threw up. I took anti-nausea pills and pain pills.

Felt faint and lightheaded thirteen minutes after receiving shot. Hypotension down to Systolic Blood pressure of 72. Became unresponsive; EpiPen used. Patient improved. Taken by paramedics to emergency department

Few minutes post vaccination, after moving to observation area via wheelchair, the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1. Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed, V- Fib was rhythm, Shock # 1 given, CPR resumed. Shocked again. Fire truck and additional EMT arrived on site and took over care. Epinephrine was given 3 times via intra-osseous route, Amiodarone given intra-osseous route. Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag, no airway obstruction or peri-oral edema noted. Code called at 12:40 PM.

After vaccine a feeling of something going thru my body. Got very hot and dizzy. Sat in chair and nurse took my blood pressure which spiked to 208. I was shaking and my heart was pounding. I was rushed to the emergency room. Put on IV, Heart monitor, lung x-ray and blood test. Blood pressure was still at 188 at 2:00 PM. Asked to leave at 3:00 PM, I still did not feel good but I needed to get home, because my husband was home my himself and very upset. I am his caretaker. My pressure dropped to 158 at 10:00PM I had bad headaches for 4 days and I still get them once in a while. I do not have high blood pressure, my blood pressure is usually between 120 - 130.

Vertigo, nauseous, sweaty Symptoms lasted 3 to 4 hours. Not like orthostatic hypotension when bp is low. Did not stop when sitting. Did not vomit but felt very sick. Hope it doesn't happen again.

Pt felt flushed, had a HA and was dizzy. Was taken to first aid and medic reported pt BP 200/99 several times. Pt transported to ER for high BP and dizziness

10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her left hand, and palpitations. At 15 minutes after vaccination, her blood pressure was found to be 200/84 LA and HR90 . O2 sat 98% on RA. T 98.2 F. Pt remained alert and in no distress, but continued to feel dizzy and unwell. Her repeat blood pressure was 184/84. EMS was notified and patient was transported to the emergency room.

Exp. Date 6/30/2021. Unable to lift my left arm higher than my shoulder, swelling of upper left arm, tiredness.

On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar "episodes" with low BG. EMS checked BG (POC = 144).

At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell. She wondered if she should call Fire Dept (but wasn?t making total sense). Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out. **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).

1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed

Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.

Patient c/o "lightheadedness" approximately 15-20 minutes after receiving second dose of Covid vaccination.

"Pfizer-BioNTech COVID-19 Vaccine EUA" My left arm/shoulder had pain shortly after the vaccination. Tha pain has been there since day one (1). I have not been able to raise my arm above my shoulder level without pain. It has been difficult to perform a number of daily activities.

Neurology consult 2/13/21: This is a 78-year-old female we were consulted by Dr. for possible guillian barre s/p COVID vaccine. The patient tells me that she was in her normal state of health, and she received her 1st dose of the COVID-19 vaccineseen 7 days ago. Subsequent to that, the next day she developed chills, fatigue that continued for approximately 2 days. She states that 3 days ago, she woke up and was unable to lift her legs or get herself out of bed on her own. She felt weak in her proximal lower extremities and her trunk. She denied any bandlike sensations or paresthesias. She cannot tell me that she developed any distal lower extremity weakness initially but felt that it was the acute onset. She needed some help her out of bed when she was upright, she was able to use her walker to slowly get to the factor. She may have had some urinary incontinence, she does complain of diarrhea now. Denies any tingling sensation, no bulbar symptoms. This is a 78-year-old female who we were asked to evaluate for possible Guillain-Barre syndrome. She had acute onset of lower much greater than upper extremity weakness without any definite ascending features, of relevance, is that she received the COVID-19 vaccine 3 days prior to the onset of her symptoms. She did exhibit flu-like symptoms prior to this. Given that she does not have any specific area of intrathecal enhancement to suggest Guillain-Barre or other areas of radiculitis, I think it is reasonable to proceed with lumbar puncture to look for any other source. --Given the findings on the MRI cervical and lumbar spine including enhancement of the bilateral sacral S1 region, I would like Neurosurgery to further evaluate. -- would likely benefit from CT chest abdomen pelvis to rule out any underlying occult malignancy particularly if workup remains unremarkable. -- continue supportive care, monitor for shortness of breath, new vital capacities Patient remains admitted to the hospital with continued weakness at the time of this report

1218 Complaint of feeling lightheaded. States she had a similar reaction to first vaccine. BP 99/58, R 15, O2 98%, P 93. 1230 BP 102/70, R 16, O2 98%, P 96. Patient states she feels slightly better but still a bit lightheaded. Declined offer for EMS. Alert and oriented x 4. Slow and steady ambulation. Denies any other symptoms.

Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming down with cold; Sinus swelling; Quickly fatigued still here a week later; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the right arm on 23Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included environmental allergies (many), gastrooesophageal reflux disease, atrial tachycardia, blood pressure abnormal, cholecystectomy, hysterectomy, retinopexy, cellulitis, sepsis and pneumonia from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included diltiazem, dexlansoprazole (DEXILANT), flecainide, hctz , and triamterene. The patient previously received and experienced allergies from ciprofloxacin hydrochloride (CIPRO), cefalexin (KEFLEX), tetracycline, sulfamethoxazole, trimethoprim (BACTRIM), glycopyrronium bromide (ROBINUL), doxycycline (DORYX), loratadine (CLARITIN), tetracycline hydrochloride (SUMYCIN), lisinopril and clindamycin hydrochloride (CLEOCIN). On the day of shot, on 23Jan2021 10:15 had a brief feeling of coming down with cold. Next day on 24Jan2021, the patient experienced briefly queasy, 3rd day fine, 4th day very dizzy (room spinning falling) and dry heaves. The patient also experienced dizziness, sinus swelling, and fatigued still here a week later. She took weekly immunotherapy shots for her multiple allergies. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Jan2021. Therapeutic measure was taken for all the events. Clinical outcome of the events was not recovered. Information about lot/batch number has been requested.

Weak and fatigue. Not wanting to eat or drink. Unable to walk without holding onto items. Sleepy, but unable to sleep. Nine days after 2nd shot still having the same symptoms.

2 days after getting 2nd dose of vaccine I became dizzy and queasy and my breathing changed. I spoke with pulmonologist on 3/1/21 and he advised me to start a 5 day regimen of 40 mg. prednisone. I am on day 3 and breathing has been better, not back to normal.

Pt received vaccine at 1414. 1430 pt started getting dizzy, b/p 142/70, p-81, 02 98%ra, r-18. 1441reports a little dizzy and now feels very tired would like to lie down and sleep. 1446 dizziness resolved cont to be tired. 1456 b/p 158/78, p-75, r-18, 02 sat 98% ra reports tired but no other issues. Instructed to follow up with MD as needed. Pt released with husband

Guillian Barre reaction (difficulty walking, difficultyusing hands- small motor skills; difficulty speaking; began on 2/7/21 and continued to worsen until hospitalization on 2/24/21 and 5 plasmapheresis treatments. While hospitalized patient has developed double vision.

3/1 tired and diarrhea 3/2 I was ok. 3/3 I had chills all day and I was dizzy. I was also nauseous in the mornings. 3/4 I had no nausea and no diarrhea but I had no appetite and food made me gag. still had chills and extremely dizzy. felt the same until 3/7 the chills went away. 3/8 I was and am still dizzy and I had soft stools and no appetite.

Extreme fatigue, lightheaded and dizziness, extreme joint pain, vision blurryness and sore eyes, starting Wednesday March 3rd and continuing through today Monday, March 8th. Also beginning Friday, March 5th woke up with right arm swollen just below the elbow. Not sure if any of this is related to the Covid shot or having other problems. Just noticed that my vaccine card shows Lot #EN6202 but the letter sent says Lot #EL9263, for the 2nd dose.

Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well, I feel dizzy and I had a rash." Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time. She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies). Patient did complain of nausea and dehydration. Discharged on 3/9/21.

LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The following information was gathered from discussion with RPH at Hospital. The patient received second dose of Pfizer COVID vaccine on 2/26/2021. The patient then had nausea, vomiting, and poor oral intake. On 2/27/2021, the patient went to the bathroom and while on the toilet, had a vasovagal event which led to her hitting the side of the face while falling. Patient was then taken to the hospital for evaluation. The patient does have a pacemaker but the cause of the event was determined to likely be due to dehydration. Lab work was performed and pertinent lab values include: potassium of 3.1, SCr of 0.8, and BUN of 13. The patient received potassium supplementation and IV hydration in the hospital. Patient was discharged on 2/28/2021. Of note, the patient does have a pacemaker and a follow-up appointment with cardiology to evaluate the pacemaker was scheduled upon discharge.

Slightly Nauseous; Slightly dizzy; Thinks it activated her reflux; clogged up; This is a spontaneous report receive from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EL9626) via an unspecified route of administration on the left arm on 28Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included ongoing Reflux. Concomitant medication included esomeprazole sodium (NEXIUM). Patient previously took BNT162B2 on 07Jan2021. On 28Jan2021 20:00 the patient experienced slightly nauseous, slightly dizzy, thinks it activated her reflux and clogged up. Seriousness was reported as non-serious. Outcome of events was recovering. No follow-up attempts are possible. No further information was provided.

Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.

On 02/22/2021 received Pfizer 2nd shot of Covid 19 Vaccine. Next morning, 02/23/2021 around 6am could not lift my head off pillow, the room and everything was spinning around. I called my husband and he tried to get me to sit up but i could not. He took my blood pressure and it was in the high 165+ so he called our neighbor who is a registered nurse, she took the blood pressure and now 179+ and kept going up and at 190+ she called 911 and they took me to the ER at the hospital, they took the blood pressure and it was 212. At the hospital it reached 237 but the dizziness was going away. I came home around 3:14pm. Follow up visit with my doctor on 2/26 and 3/15 by phone call going over testresults. Some of the tests given on 03/02 Electrocardiographics & Vascular lab. Then on 03/15 more test MRI and MRIA. Than on the last Dr. office visit on 03/15 all tests were clean. Before the last visit we did a lot of checking around with people we know (doctors and nurses) about what was going on and mentioned about the Covid-19 vaccine shot given the day before and they mentioned that people were getting dizziness and some vertigo also one we talked with was a nurse, who missed two days of work because she as dizzy the day after the vaccine. So I mentioned this to the Doctor who said he has heard the same thing. He said that this could have caused what happened to me

I just started coughing and they told me to go to the emergency room so I did you know; arm got real sore; Fever; feel nauseous; Dizziness; got progressively worse; I could hardly do over I was just so sick with the dizziness; Dizziness; got progressively worse; I could hardly do over I was just so sick with the dizziness; I have been so off-center; This is a spontaneous report received from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 10mar2021 (formulation: Solution for injection, lot number: EIV6202) via an unspecified route of administration at single dose for covid 19 immunisation. The patient medical history included ongoing tubular dysfunction, migraine and patient had the vestibular Dysfunction from 40 years, ongoing migraine headache. The patient historical vaccine included BNT162B2 (formulation: Solution for injection, lot number: EL9267), (first dose) via an unspecified route of administration on 17feb2021 at single dose for covid 19 immunisation and took Flu shot for immunization. The patient had regular flu shot a few years ago it was mentioned that doctor told get a Benadryl an hour before my shot which I did and she was in the hospital for 5 hours on a Breathing machine. Concomitant medications included rizatriptan benzoate (MAXALT) at 10 mg, as needed for migraine. Consumer stated, "I had Tubular Dysfunction been diagnosed many years ago and I live with dizzy every day In Mar2021. I have tried everything to get rid of it and nothing is working. This is going on for Probably 40 years may be more anyway (Intent: History). I had my second vaccine on 10Mar2021 and on the first day, my doctor told me since I had the reaction to the regular Flu shot a few years ago my doctor told me get a Benadryl an hour before my shot which I did and the first day everything was wonderful. I was so happy you know no reaction, I didn't have any. The first time I got the flu shot I was in the hospital for 5 hours on a Breathing machine, it was beautiful. I thought I was free and then the next day my arm got real sore and I expected that and I expected to have a fever I expected to feel nauseous and all but the dizziness set in and just got progressively worse and it will be a week tomorrow since the vaccine still I was dizzy In Mar2021. I have been so off-center In Mar2021. Sunday I could hardly do over I was just so sick with the dizziness and yesterday the same thing and this morning I thought I will get over maybe today will be a good day and it's the same. I called my neurologist and he said that any pre-existing condition can be exaggerated by the vaccine while the system is building up his anti-bodies so I expected but is this going to go away, this thing, is this going to go away and reported just so beside myself, I just can't live like this anymore everyday you know this is beyond dizzy." tried taking, I do have a prescription for it starts with M wait a minute it hasn't helped but I tried it , if it doesn't help for the first time I won't take it again but I have a prescription for Meclizine 25 mg Tablets. Consumer stated, "I spoke to somebody earlier and told me to call this number and tell you that what's going with me. Tomorrow will be one week, since I had my second Covid shot and the first day, I got it everything was fine. The second day I was feeling a little off and I thought okay will they told me that I would feel little, may be not sick-sick but not feeling good and then the second day after that Friday. I got it on Wednesday and by Friday, I have a pre-existing condition and it is called Vestibular Dysfunction. Consumer stated, "I had the Vestibular Dysfunction from 40 years. So, I live with dizzy all the time. But by Friday, it is just unbelievable dizzy, Saturday was worse, Sunday was even worse, yesterday was little bit better. Today, I am still shaking and dizzy and Tomorrow will be one week since I have the shot and I read that stuff happened in the first week and I was wondering, have you had the other people with the same problem, Consumer further added, "It is not an inconvenience, this is horrible way to live. I feel dizzy all the time, this is horrible. Was I told that I should talk to you about, can the shot exacerbate a bad situation like this, they told me to call you, now I getting no help at all can anybody tell me." Consumer stated, "Nothing I have no recollection of any of that no, I just started coughing and they told me to go to the emergency room so I did you know In Mar2021. The patient has received treatment with Meclizine 25 mg tablets. The outcome of the events was reported as unknown.

extreme vertigo, vomiting, diarrhea - lasted about an hour. This was repeated the following night, about 3:00 am. Since then I have had several more vertigo incidents with vomiting and diarrhea, and I have some dizziness and nausea on a regular basis

Pt received vaccine and waited 30 minutes post-vaccination due to list of allergies/intolerances to medications/vaccines. After leaving vaccine clinic, Pt developed weakness and dizziness and returned to COVID Vaccination Clinic to report symptoms. Vitals signs taken: 238/101 HR 87BPM, O2 97%; Emergency Responders called to transport Pt to ER for evaluation; BP 217/100 on recheck.

she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would drive someone crazy; her eyes felt like they were burning out of the sockets; she was tired the next morning; she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet; she was nauseated; temperature of 103; she broke out in a terrible sweat; she was weak as water; light headedness; high blood pressure; This is a spontaneous report from a contactable consumer via Medical information centre. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 27Jan2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications was not reported. On 27Jan2021 20:00 the patient experienced light headedness, she broke out in a terrible sweat, she was weak as water. On 27Jan2021 the patient experienced high blood pressure. On 28Jan2021 her eyes felt like they were burning out of the sockets, she was tired the next morning, she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet, she was nauseated, temperature of 103 (pyrexia). On 05Feb2021 she woke up dizzy and it was like everything was moving or shaking just a little bit, and it would drive someone crazy. The event high blood pressure was considered as serious (Medical significant). It was reported that she had the Pfizer COVID shot 2 weeks ago today. She had severe reaction to the shot, she didn't have it immediately she got the shot on 27Jan2021 and at 2 pm and at about 8 pm she was sweeping the floor and she broke out in a terrible sweat and after that she was weak as water and then started feeling lightheaded and her blood pressure was going up, she put cold rags on her head. She did not take temperature but she did take her blood pressure and it was like 198/something, she said she noted at 8:30 she took it again and it was 180/98 she started drinking water she thought she might be dehydrated and finally by 9:45 she got it down 148/58, she slept that night felt pretty good but she was tired the next morning, about 4 o'clock that afternoon the second day she felt wonderful she went to sleep at about 10 o'clock, but when the clock was striking midnight it woke her up and she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet she was lightheaded her eyes felt like they were burning out of the sockets, she was nauseated when she stood up so she took Tums and that took care of the nausea. She came in and took her blood pressure and that is when it was 194/90 the second time, she has a Rely On arm band and it said 205/98 and then she took it again and it said 235/117. She called the medic and he told her he thought she had a false reading but her temperature was 103 and before he left her blood pressure come down 180/70. Her heart rate was 86 the medic got ready to go her temperature came down to 102.2. On 05Feb2021 which was last Friday she woke up dizzy and light headed and but it was like everything was moving or shaking just a little bit, and it would drive someone crazy .On Saturday she took 3 Motrin that morning and Amlodipine 5 mg and 20 gm Omeprazole and she also takes 1 24 HR Allegra with Fexafenadine and her temperature was normal that day, all day it has been normal. On Sunday at lunch time she got light headed and was floating again and she checked her blood pressure and it was 183/77.She stated that her doctor recommended to get the second dose if she have no more side effects She plan on getting the second dose next Wednesday. Therapeutic measures were taken as a result of high blood pressure, she was nauseated and temperature of 103. The outcome of the events was unknown.

The injection was given high up on my arm and was very painful. About an hour after receiving the shot my arm felt weak and my hand and fingers felt numb. I could not raise my arm. This lasted into the next day, when my shoulder began to hurt. The feeling returned to my hand but I started getting drawing pains in my arm, and increasing pain in my arm when raising it.

03/23/2021: Patient presented and was admitted through ED for right lower extremity pain after a recent fall. CT of the pelvis which showed to have Comminuted subtrochanteric proximal right femoral shaft fracture with angulation. She had difficulty walking, and difficulty with activities of daily living skills. Patient had PMH of arthritis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

Migraine 10 hours? Headache and foggy head on and off for four weeks? Muscle pain and weakness upper arms, thighs to pelvis, sometimes buttox Most difficulties with muscles are during the night and upon arising in a.m. At least four days I was unable to function. Tylenol helped for short periods.

blood pressure sky high; blood pressure sky high; couldn't walk; almost having a stroke; little dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, blood pressure high, asthma. There were no concomitant medications. No other products. They have not had any other recent vaccinations or started any new medications. Caller said she had her first dose of the Pfizer COVID-19 vaccine shot 25Feb2021, then two weeks later her blood pressure was sky high and she couldn't walk and she went to the emergency room and they said that she was almost having a stroke. She said she was admitted 11Mar2021 and stayed until this past Sunday which was 14Mar2021. She hadn't seen her primary care provider (PCP) yet she only saw the doctor at the hospital. She was supposed to go back on 18Mar to get her second shot, so she wanted to know if it was gonna be safe. Caller said that she has recovered, and when she came home, she was a little dizzy, but they gave her a medication for vertigo and right now she was ok. Outcome of the events was recovered in Mar2021.

Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a spontaneous report from a contactable other HCP. This 78-year-old female other HCP (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN6201) via an unspecified route of administration from 08Feb2021 at 1:00 pm to 08Feb2021 at 1:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type vaccine was doctor's office/urgent care. The patient was 78 years old and not pregnant at the time of vaccination. Patient's medical history included hypothyroid, hypertension, elevated cholesterol, possible heart condition, obesity, known allergies: shellfish, MSG (dates unspecified). Concomitant medications included Losartan, hydrochlorothiazide, triamterene (Dyazide), Levothyroxine, Pravastatin via an unspecified route of administration from unspecified date to an unspecified date at unknown dose and frequency for an unknown indication. If other vaccine in four weeks: No. Patient experienced trembling, muscle weakness, palpitations. light-headed, dizziness, slight headache on 08Feb2021 at 01:15 pm. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment AE: no, If covid prior vaccination: no, If covid tested post vaccination: no. The outcome of events was recovered on an unknown date.

her immune system since has not been the same and has been very deprived; her immune system since has not been the same and has been very deprived; wasn't feeling right; Dizzy; weak and very disoriented; weak and very disoriented; did not feel good; terrible headache and laid down right away; things started spinning/head spinning; Nauseous; Flu like symptoms; Flushed; very cold; chills; very cold; chills; Pain in arm; rapid heart beat; anxious; like something was going to happen; bathroom a couple times and felt week with the flu like symptoms, they were very bad; did eat something later yesterday, but food was flat tasting; didn't taste right; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization in the clinic. Medical history included neoplasm malignant, chemotherapy, radiotherapy, immune system disorder (her immune system since has not been the same and has been very deprived) from an unknown date and unknown if ongoing. Concomitant medications included bee venom for arthropod sting. The patient experienced wasn't feeling right , dizzy, weak and very disoriented, did not feel good, terrible headache and laid down right away, things started spinning/head spinning, nauseous, flu like symptoms, flushed, very cold, chills, pain in arm, rapid heart beat, anxious, like something was going to happen, bathroom a couple times and felt week with the flu like symptoms, they were very bad, did eat something later yesterday, but food was flat tasting, didn't taste right on 28Jan2021 and her immune system since has not been the same and has been very deprived on an unspecified date. the first Covid shot yesterday at 10:00. They had her to sit for 15 minutes to make sure she was okay to walk. About 7-8 minutes she noticed she wasn't feeling right, dizzy, weak and very disoriented. She got up and didn't want to create a scene and started walking through the clinic and stopped to ask the receptionist to call her husband in the car. There was so many people so she just kept walking and luckily was able to get to car and told her husband she did not feel good. By then she had a terrible headache and when she got home she laid down right away. Then things started spinning and she was very nauseous and is aware that these things can happen with the vaccine. Had flu like symptoms like she never had before, but this was worse. She did not have a fever, but was flushed and very cold, chills. Her arm was not hurting until about 9pm and during the night she had a rapid heart beat, but not really. Was very anxious like something was going to happen and she tried to calm herself by taking deep breaths but does not know if that worked. Finally, after 3 hours she was able to go to sleep and did go to the bathroom a couple times and felt week with the flu like symptoms, they were very bad. When she got up today she was 60-65% better. She did eat something later yesterday and had thought the nausea was because she hadn't eaten all day long. The food was flat tasting and she know she has that whenever she has the flu where nothing tastes right. She clarifies she has that anyway since 16 years ago she had cancer and a strong dose of chemotherapy and radiation and her immune system since has not been the same and has been very deprived. Whenever she gets sick she gets deathly sick and has to be watched or she may have to get hospitalized due to weakened immune system. States some people say that the second dose is worse, is that true or is it the same feeling. If she feels like that with the second dose she may not get it. No further details provided. Mentions as the day goes on she comes around more. Has to get her glasses to see card given. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The outcome of event her immune system since has not been the same and has been very deprived was unknown and other events were not recovered. No follow-up attempts are possible. No further information is expected.

Patient complained of dizziness and presented with substernal chest pain and mild shortness of breath within 15-20 minutes after receiving COVID-19 vaccine. History of hypertension and non-compliance with antihypertensive medications. Relative reports patient also with possible history of stroke with no anticoagulation. Patient hypertensive initially with Systolic in 180s and diastolic in the 80s, upon onset of symptoms. Chest pain minimized within 10 minutes after blood pressure came down to the systolic level in the 170s. Ground ambulance called to transport to Emergency Department, but patient declined ambulance transport and was taken to ED by car with son-in -law.

Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat 206/86. HR decreased from 106 to 90; regular rhythm and rate. O2sat 99 RA. Lungs CTA. Denies chest pressure, tightness, sob. Also reported throat discomfort; benadryl 25 mg po x1 given. Sent to ER.

Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many joints, tremendous fatigue, inability to concentrate, dizziness. Swelling, pain, redness left arm shoulder to elbow.Took Tylenol, spent most of the day in bed. Not hungry. By Tues I felt much better, but fatigued (still needed 2 naps), little appetite. Wed continued recovery, but weak, arm continued red, swollen, painful to the touch. Today, Sunday and a week after injection, I feel normal.

gained weight since COVID,she was 136 pounds and she just weighed herself and weighs 142 pounds; she could not step down on her left leg; Charley horse; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), dose 2 intramuscular route of administration, administered in Arm Right on 02Feb2021 17:00 as SINGLE DOSE for covid-19 immunization. Medical history included breast cancer (additional Information for Other Conditions: 19 radiations and they took out three lymph nodes on the left, she was diagnosed 3 years ago), blood pressure, 19 radiations, shingles shot. Reports she had the shingles shot a few months ago, vein disorder from Sep2020 to an unknown date. Patient was not sure if vein injections might be indicative of something and clarifies that she had vein issues in her legs had vein injections to dispose of the larger veins. She has had the vein injection a number of times throughout the years. The last time she had it done again was in Sep2020. Concomitant medications included losartan; taken for blood pressure abnormal; amlodipine besilate taken for blood pressure abnormal; tamoxifen taken for breast cancer. It was reported that, she has been taking losartan for years for blood pressure and amlodipine besylate about a year ago. The patient previously administered first dose BNT162B2 on 12Jan2021 11:30 (Lot number:EL3246), intramuscular injection in right arm for covid-19 immunization On 03Feb2021, patient experienced charley horse, gained weight since covid, she was 136 pounds and she just weighed herself and weighs 142 pounds, she could not step down on her left leg. Clinical course of events includes, patient was curious, she had her second shot at 5pm on Tuesday. Yesterday morning when she woke up at 6:30 or 7 in the morning, she could not step down on her left leg. For the last day and a half, she has had what had a bad charley horse behind her knee on the upper part of the calf. She was asking if the vaccine has any indications of a blood clot. Reports she was sitting in a car for 5 hours waiting to get the vaccine. She plays golf, stays busy, she does a lot, she was not someone that is very stagnant normally. When she went to get out of bed, she could not put her foot down, she was limping. She cannot step down without being in pain. She was trying to walk now. Therapeutic measures were taken as a result of charley horse, she could not step down on her left leg. She read walking was good and drinking water, drinking tea, she did a warm compress four times this morning. The outcome for the charley horse, she could not step down on her left leg was recovering and outcome for gained weight since covid, she was 136 pounds and she just weighed herself and weighs 142 pounds and was unknown.

Pt @ 1745 began to feel dizzy, nauseous, and lightheaded, cold. Water and snack given BP 153/71, HR 62. @ 1802 symptoms resolved, pt able to return home.

She got the vaccine, had no reactions. She told them that she was going to have a procedure and they told her that it would be okay for her to have the vaccine. Then she had the procedure on 3/25/21 and then 2 days later she lost the use of her legs. She has fatigue, no energy whatsoever, it took 3 days for her to be able to get up and walk, and slept on the floor as she could not use her legs to get into the bed. She did call her doctor about 5 days later and he thought that it could have been a combination of the vaccine and anesthesia from the procedure. She continues to have the fatigue and no energy whatsoever.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: 24 hours after vaccination patient experienced paralysis and was rushed to ER where ER physician said reaction was most probably due to the vaccine. patient recovered within 2 weeks. MD said patient can get 2nd dose but patient has refused second appointment for vaccination,

Extremely sick with vertigo, nausea, headache, runny nose, mild fever. Sicker than I've ever been in my life. Couldn't even stand up.

2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Treatment: Tylenol Caplets (temporary relief) 3/3/2021 - Left Upper Arm Tricep Muscle noticeably Swollen and Hard when touched- No pain. Treatment: Cold compresses (little relief) 3/8/2021 - Left Arm Periodic Tingling up and down under skin, in addition to Swollen Tricep Muscle Treatment: Cold compresses & Tylenol Caplets (temporary relief) 3/25/2021 - Urgent Care for Swollen Upper Arm & Tingling discomfort Advice: Continue Cold Compresses, Monitor and follow up with Primary Care Provider 3/29/2021 - Continued Left Arm Tingling and increasing Pain at Left Upper Back & Shoulder, weakening Left Arm Strength, usage challenge, sleep discomfort, Tricep Muscle less swoIlen, Treatment: Cold Compresses and Tylenol (temporary relief) 4/12/2021 - (Pending) earliest available appointment with my Primary Care Provider

3/17: dizzyness attributed to hunger, ate, went to bed. 3/18: unsteadiness walking, difficulty eating and speaking. Did not call 911/alert family. 3/19: symptoms continued. Daughter observed symptoms, including facial droop, and transported to local hospital ED. 3/20: discharged without seeing neurologist. CT scan and other tests failed to show stroke. However, MRI not performed. 3/22: outpatient visit to neurologist who, based on symptoms, concluded stroke had occured on left side of brain due to COVID 19 vaccine. 3/24: MRI performed and shows stroke. 3/30: MD orders additional tests. 4/1: admitted to Rehab. Hospital for 9 days.

Arm started hurting the next day. Hard to lift arm above shoulder. Did not get better. After a month I called the dr. and was told to take 2 naproxen twice a day to relive swelling. T his helped, but when I stopped the pain came back. Does not hurt just sitting, only when I try to lift something. Think injection was given in a muscle. Hurts when I left arm above shoulder.

After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.

On 2/18/21, 10 days after receiving the vaccine, I donated blood as usual. About 30 minutes later I was light headed, had abdominal cramping pain, bowel emptying and possibly fainted. I was transported by EMTs to the ER and was later diagnosed with inflamitory bowel by a CT scan. I took antibiotics and was feeling fine. My gastroenterologist performed a colonoscopy on 3/24/21 and the findings were that I was healed and tissue samples were normal. 3/25/21 I had an annual physical and was told I was in good health. Later that afternoon I began feeling light headed upon standing. In the night I called my health insurance hotline because my blood oxygen meter was beeping continuously. The Dr. on call told me to go by ambulance to the ER. When sitting or lying down, I felt fine and all the tests at the ER for my heart and my vital signs were good. A few hours later, they did a hest Xray and then a CT scan of my lungs which showed a saddle embulism. I had also thought I had bruised my knee if and when I fainted on 2/18 and 1o hours later a blood lot was found by ultrasound of my left knee. I was given blood thinners in the ER and then in ICU where I spent the next night. I am now taking Eleris. I was also given pantoprozole for GERD coughing the next day. I continue to have periods of abdominal ramping/pain, light headedness in waves and pressure in my head. I have disontinued the stomach medication with some feeling better with the lightheadedness.

Pt developed HA, dizziness, and nausea about 10 minutes after vaccine. Denies chest pain, palpitations, SOB, but does endorse "indigestion"." Hx HTN, took all BP meds this AM. BP in clinic 203/84 and 186/81. Pt taken to ER.

Blood clots in Lungs; No longer able to do activities of daily living; Almost fell to floor from sitting position; short of breath; total body exhaustion/fatigue; sleepy throughout the day; unstable, weak; debilitating symptoms bedridden/unstable, weak; debilitating symptoms bedridden; passed out completely while sitting; Unable to complete daily 1 mile walk at park/Unable to take stairs; Lightheaded/dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included patient had COVID-19 Dec2021 and recovered completely in 2 weeks. Symptoms: fever, sleepy. Went back to daily walk after 2 weeks. No loss of smell, no loss of taste, no mental changes- was very happy with my complete recovery. Took vaccine 26Mar2021 at recommendation of doctor to be safe from variants. Regret deeply, still hospitalized as of this writing. Concomitant medications included ramipril; rosuvastatin calcium 40mg; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur and experienced allergies. The patient experienced unable to complete daily 1 mile walk at park/unable to take stairs on 27Mar2021, lightheaded/dizzy on 27Mar2021, passed out completely while sitting on 28Mar2021, unstable, weak on 30Mar2021, short of breath on 31Mar2021, total body exhaustion/fatigue on 31Mar2021, sleepy throughout the day on 31Mar2021, almost fell to floor from sitting position on 09Apr2021, debilitating symptoms bedridden/unstable, weak on 26Mar2021, debilitating symptoms bedridden on 26Mar2021, no longer able to do activities of daily living on 13Apr2021, blood clots in lungs on 14Apr2021, all with outcome of not recovered. Reported adverse event: 27Mar2021 - Unable to complete daily 1 mile walk at park. Lightheaded, dizzy 28Mar2021 Dizzy, passed out completely while sitting. Revived and taken to hospital by ambulance 28Mar2021 Admitted to (hospital name withheld) 30Mar2021 Discharge from hospital - unstable, weak 31Mar- 08Apr2021 - short of breath easily. Unable to take stairs. Discontinued daily walk, weak, total body exhaustion, sleepy throughout the day 09Apr2021 - Almost fell to floor from sitting position. Patient's daughter lowered patient gently to the floor. Revived shortly 13Apr2021 Saw primary doctor Dr (name withheld). Shared her debilitating symptoms bedridden since Covid-19 vaccine on 26Mar. BP taken from lying down, sitting and standing was markedly different and explained caused passing out and lightheaded. No longer able to do activities of daily living 14Apr2021 - Exhaustion and fatigue, her daughter to her back to the hospital 14Apr2021 - Passed out in Emergency Room @ (hospital name withheld). Admitted. Blood clots in LUNGS. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for unable to complete daily 1 mile walk at park/unable to take stairs, lightheaded/dizzy, passed out completely while sitting, all from 28Mar2021 to 30Mar2021. The patient underwent lab tests which included blood pressure measurement: markedly different on unknown date. Patient was not pregnant. No other vaccine in four weeks.Patient had covid prior vaccination. No covid tested post vaccination. The treatment received for events included Heparin administered, still hospitalized as of now. Information about Lot/ Batch number has been requested.

nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life. No follow-up attempts are needed. No further information is expected.

Low grade fever, headache, fatigue, balance issues, some dizziness. Started 2/28/21. Continuing as of 4/26/21

Adverse events: unstable, too dizzy to walk, through-up, double vision. Treatment: wait for the symptoms to pass.. The symptoms have lessened but are still with me.

she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:45 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, atrial fibrillation from Aug2020 and ongoing , cystitis. Concomitant medications included sulfamethoxazole, trimethoprim taken for cystitis from 27Mar2021 to 02Apr2021; apixaban (ELIQUIS) taken for atrial fibrillation from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for Blood pressure from an unspecified start date and ongoing. The patient received first dose of bnt162b2 for COVID-19 immunization on 15Mar2021 lot number: EN6202, Expiry date: 30Jun2021. The patient received the second dose of the Covid vaccine around 8:45 a.m. and states that she "felt fabulous." On 06Apr2021 she felt fabulous. She said that she had a doctors appointment at 1200 06Apr2021 and her blood pressure was good. She said that she was also taking an antibiotic prior to that week. She asked the doctors about taking vaccines after taking the antibiotic since the medication said that you should avoid vaccines while taking the antibiotic, and they all said that it was fine. She came home about 1330 06Apr2021 and she passed out while making her lunch. She hurt her ankle from it and she is not a happy camper. She said that all her vitals were good and her blood was good. That was all taken 2 hours before she passed out. The weird thing was she never felt better that day after she passed out. She said that she had no reaction after the first shot. Prior to this she felt good and there was no warning, she just felt dizzy so fast and passed out. Caller said that her ankle is getting better and she hurt her toe too, but it is getting better. She treated the ankle with ice. She said that it could have been worse. She said that she did not understand this and had no side effects previously. The event passed out was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test: good on an unspecified date her blood was good. Therapeutic measures were taken as a result of she hurt her ankle from it (arthralgia). The outcome of the event passed out was recovered with sequel on 06Apr2021, unknown for the other events.

hips were hurting; having hard time getting up and down; This is a spontaneous report from a contactable consumer (Patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EN6201, expiration date: unknown, via an unspecified route of administration in Arm Right on 22Feb2021 11:00 as single dose for covid-19 immunisation. The patient medical history included atrial fibrillation from Jan2020 and ongoing and breast cancer about 8-9 years ago in the left breast. The patient concomitant medication included apixaban 5mg twice a day by mouth taken for atrial fibrillation, diltiazem hydrochloride 180mg once a day by mouth, lisinopril 20mg twice a day by mouth taken for blood pressure measurement and was ongoing, hydralazine 25mg twice a day by mouth taken for blood pressure measurement and all were ongoing. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EL3247, expiration date: unknown, via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation and had soreness in her arm for a couple of days. The patient clarified that she had the first dose on 01Feb2021. She said that her arm was sore for like a day and a half, but she had no other reactions with the first vaccine. On 23Feb2021, after second dose, the patient stated that her hips started hurting around 3 and then they hurt all night and have hurt ever since. She is having a hard time getting up and down. She said that around 14:00-15:00 her hips started hurting and got progressively worse. She said that she kept a hot water bottle on it. She said that it is hard to get up and down, especially off of the toilet. She took a Tylenol at 0900 23Feb2021. She said that she has had no problem with her hip prior to this. Her pain in her hips has improved since she took a Tylenol. She said that she does have a sensitivity to medication. She said that she had no reaction except for soreness from the first shot. Her arm is a little sore now, but it is her hip that is bothering her now. She said that she does not have any artificial hips or anything. She said that she has all of her body parts. Outcome of the event hips were hurting was recovering and having hard time getting up and down was not recovered.

I had an unsettling waking event happen to me yesterday morning, so I didn?t feel like I could gather myself to be at an appointment after the event. I was very disoriented upon waking. I could not gather my thoughts and memories. Things like: I knew I was in a city , but didn?t know where the city was in the world; and other things like that. It was as though I had stepped out of my life and didn?t remember enough to step back in. It only lasted maybe 5 min, but was completly disconcerting & disarming. I?ve never had a similar event. And it came after another disarming 10 min bout of dizziness / sense of off-balancedness and a very slight nausea the night before. It too, was arresting because I had had no alcohol to drink for months. I felt continually better during the early morning and didn?t think about it much during the rest of the day.

hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination. Information on the lot/batch number has been requested.

Elevated troponin Essential Hypertension Abmulatory dysfunction Generalized weakness COVID-19 infection Hypomagnesemia

Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.

after vaccination, patient began to feel lightheaded and dizzy, experienced syncope. after waiting for about 15 minutes she began to complain about chest pain. We decided to call 911 as she was extremely agitated and tremors

tiny bit of dizziness, felt like everything was going dark; This is a spontaneous report from a contactable Consumer. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL0140; Expiration Date: 31Mar2021) via intramuscular route administered in left deltoid on 14Jan2021 12:41 as single dose (0.3mL) for COVID-19 immunization. Medical history included atrial fibrillation and blood pressure high. She was on medication for this condition. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks. The patient experienced tiny bit of dizziness, felt like everything was going dark on 14Jan2021. Caller stated that she received the second COVID-19 vaccine. She was scheduled to receive her second vaccine and she doesn't know whether or not to do it. Caller explains she had the shot, and her facility had her wait 15 minutes. She didn't think much about it. She went to the bathroom to kill some time. It was about 1 minute until it was time to leave, and she was getting her husband gathered up so by the time they got to the door, she could probably leave. Very quickly she had this tiny bit of dizziness and it felt like everything was going dark. She states this episode was very quick and didn't last long at all. After that, she was totally fine. She doesn't know whether to have her second vaccine or not. No relevant tests done. The outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.

tongue tingling, light headed, Benadryl given BP 142/78, P 85, R 12, Pulse Ox 100% Was able to drive to sisters house after recovery

intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, just didn't feel good/just hasn't felt right; bursitis in her hands./both of her arms that felt like bursitis; feeling weak, her legs, she could barely stand she had to go to bed; feeling weak, her legs, she could barely stand she had to go to bed; problems with her stomach, intestinal things, intestinal problems; problems with her stomach, intestinal things, intestinal problems further described as lower intestinal; joint pain/shoulders, knees and wrists hurt; Muscle pain; Tenderness; fever; weak; tired; Left arm hurt, injection site pain/tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 78-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 13:37 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunization. The facility in which the vaccine was given was . Medical history included ongoing arthritis (If she does much your arms will ache/Doesn't take anything for her arthritis, her fingers and joints), hypersensitivity from an unknown date and unknown if ongoing allergy to milk , urticaria from an unknown date and unknown if ongoing (When she gets stressed she gets hives if she does not take her liquid Benadryl she will swell up) , covid-19 from Nov2020 to an unknown date Sick for 3 weeks/intestinal flu, diarrhea, couldn't eat anything/ test oxygen level; knuckles are so big it was registering like 76. Patient's doctor recommended the vaccine since she had Covid virus in Nov2020. Concomitant medication(s) included takes cholesterol and thyroid medication (details not provided); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing; calcium (CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took influenza vaccine and experienced influenza, Previously took Aspirin and experienced angioedema. The patient experienced left arm hurt, injection site pain/tenderness at the injection site on 05Apr2021, fever, weak on 06Apr2021, weak, tired on 06Apr2021; joint pain/shoulders, knees and wrists hurt, muscle pain, tenderness on 08Apr2021, problems with her stomach, intestinal things, intestinal problems on 12Apr2021, intestinal problems after she eats, and feels like intestinal flu, balance is off, feeling unwell, just didn't feel good/just hasn't felt right,bursitis in her hands./both of her arms that felt like bursitis, feeling weak, her legs, she could barely stand she had to go to bed on an unspecified date. The adverse events did not require a visit to the Emergency Room or Physician's Office. The patient underwent lab tests and procedures which included body temperature: '100.57 ' fahrenheit on 06Apr2021. Clinical course was reported as follows the patient received the first Pfizer-BioNTech Covid-19 Vaccine on 05Apr2021. On the same day 05Apr2021 her left arm hurt, injection site pain. On 06Apr2021 in the afternoon she had a fever of 100.57 Fahrenheit. She was also very weak and had to lay down because she was tired. She had site pain, joint pain, and muscle pain. With the joint pain her wrists hurt, it was her shoulders, knees and wrists hurt. The tenderness at the site didn't go away until Sunday. She reported her problems with her stomach, intestinal things, intestinal problems, further described as lower intestinal. She started feeling weak, her legs, she could barely stand she had to go to bed. She was tired, started to get joint pain and feeling unwell, just didn't feel good. She felt that just to stand she would fall down, so she had to lie down. Her balance is off, and she felt weak for about 2-3 days, weak is not completely gone but noticed her balance is off a little bit which is ongoing. She just hasn't felt right since she's had the shot. With the muscle pain it felt like she had bursitis in her hands. She had tenderness at the injection site as well as in both of her arms that felt like bursitis, which went away on 12Apr2021 or 13Apr2021. She has intestinal problems after she eats, and feels like intestinal flu. Someone saw her and said she looks tired. On 7Apr2021, she had a visit from the the insurance company doctor and he recommended her not to take the second shot, and that's why she called Pfizer. The second dose of Pfizer-BioNTech Covid-19 Vaccine is due on 26Apr2021 but she's not sure she wants to because she is still recovering from the first one. The clinical outcome of the events Joint Pain, Muscle pain recovered on 12Apr2021, Vaccination site pin Recovered 10Apr2021, Fever recovered 06Apr2021, Weak, tired, balance is off, feeling unwell, just didn't feel good, intestinal problems after she eats, and feels like intestinal flu was unknown, Tenderness was recovered Apr2021, problems with her stomach, intestinal things, intestinal problems was not recovered

muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; weakness; I can hardly walk right now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unspecified route of administration on an unspecified date (4 weeks and 2 days after the first dose) (at the age of 78-year) as single dose for COVID-19 immunization. The patient medical history included lumber stenosis. The patient concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On an unspecified date, patient felt awful with muscle and joint aches, teeth and bones hurt, chills, weakness. She stated that she could hardly walk right now and could not get over to her primary care physician. The patient informed that she received a steroid injection of some kind on her back for lumbar stenosis 2 weeks and 2 days after the first dose of the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

VS 141/83 mmHg, 98 bpm, 95% RA Around 15 mins after receiving vaccine, pt stood up and felt dizzy/near syncopal, no hives, itching, swelling, SOB, HA, CP or numbness Heart rhythm, swelling, SOB, HA, CP or numbness Heart rhythm regular, no murmurs, lungs clear to auscultation. No cyanosis. Resting tumor history Pt says history of breaking out in hives after getting a shot of "something" Despite rest, giving water and putting pt in Trendelenburg position still felt unstable gait/station with standing

Per patient report / description: "The day after the shot I had a lot of arthritic type pain all over my body for two days then continuing pain until now 5/14/21. I cannot walk more than a block, cannot stand for more than 5-10 minutes, Lingering pain all the time." Called PCP with this report: " adverse reaction to my Pfizer 2nd shot. The next day after the shot it seemed like the vaccine searched out every part of my body that might/might not have arthritis and moving was very difficult for two days. Thereafter I have had a great difficulty getting up in the morning, some days better than others. I have seen (chiropractor) often, but results have not cleared up the discomfort. I cannot walk more than a block without discomfort, cannot sit unless my feet are up for great amounts of time then expect to be able to move. Is there something that you could prescribe that would give me comfort and be able to walk without pain. I am not interested in anything that would be considered an opioid, would rather go without. Currently I am taking Excedrin. Someone told me that Advil would be better for arthritis, but I had a bad headache on day two of taking that." Told to scheduled appointment with PCP for evaluation.

Severe pain in both legs from the back of my knees down to my ankles. Lasted about 3 days. The second day I could barely walk at all. Same happened after second injection but pain was not quite as severe. Pain lasted about 4 days.

2 1/2 hours after receiving 2nd shot, I developed total stiffness in back could barely stand up straight and had a stabbing, electric nerve pain down the L leg that was causing me to walk with a cane and take pain pills. I am still with pain, can walk only short distances and feel fatigue and L leg shakes . My gait is unsteady.

WOKE UP NEXT DAY WITH ACHING IN MY LEFT HIP AREA, CONTINUED TO GET WORSE THAT DAY AND NEXT DAY TO THE POINT I WAS HAVING TROUBLE MOVING AND BREATHING BECAUSE OF THE PAIN. EARLY MORNING THURSDAY HAD MY HUSBAND TAKE ME TO ER AS THE PAIN HAD MOVED UP MY BACK ON THE LEFT SIDE. ER TOOK X-RAY AND SAW NOTHING, GAVE ME PAIN MEDICATION, PRESCRIBED PREDNISONE AND THE PAIN STARTED TO SUBSIDE. TOOK PREDNISONE FOR A WEEK AND THE PAIN DISAPPEARED.

About 45 minutes after 2nd shot I had very odd feeling of lightheaded and dizzy. Also felt like a tight band around chest and difficulty in a deep breath. This lasted about 20 minutes. Since then a lot of joint pain and fatigue

The patient called in around 1:00 pm on 5/25/21 to report symptoms after vaccine. She said that she had pain in the right side of neck and in the back of the head and felt dizzy after the 15 minute wait when she stood up to leave after receiving her vaccine. She said that she felt tired later and slept well all nigh. At 6 am she said that she had cramps in calves, legs, and arms. At 9:30 am she woke up and felt tired and had a strange sensation in the back of the neck and numbness in the mouth and jaw. She said she is feeling a little better now.

back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; so dizzy I could not stand up; no appetite; brain fog; I shuffle very short distances and very slowly trying to avoid a fall.; toes and bottoms of feet were also totally numb; This is a spontaneous report from a contactable other health professional (patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration, in the right arm, on 15Mar2021 08:45 (lot number: EN 6207), at the age of 78, at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at the hospital. Patient medical history was not reported. Concomitant medications included losartan, hydrochlorothiazid and fexofenadine hydrochloride (ALLEGRA) for unspecified indications. The patient previously received first dose of bnt162b2 via unspecified route of administration, in the right arm, on 23Feb2021 14:30 (02:30 pm) (lot number: EN 5318) for COVID-19 immunization. On 15Mar2021 11:15, exactly 2 and a half hours after receiving the second dose of vaccine, patient tried to stand up but experienced back was so stiff; it was extremely difficult to stand. When patient was in a standing position, an electric bolt of pain shot in her left groin and down the right of her left thigh and into her left knee on down inside the left calf, left ankle and left toe; all on 15Mar2021 11:15. The pain has been constant and the most horrible pain she have ever suffered, as reported. It was reported that patient have never had this type of episode before in her life, which causes her to believe it has been a side effect of the 2nd dose of the vaccine. The pain continues to this day, at the time of reporting. Patient also experienced being so dizzy, she could not stand up; no appetite and brain fog on 15Mar2021 11:15. Before the shot, patient reported she can walk 50 blocks daily for the past 10 years. After 15Mar2021 (on unspecified date in Mar2021) she shuffles very short distances and very slowly trying to avoid a fall. Her toes and bottoms of feet were also totally numb when she wakes up each morning, since unspecified date in Mar2021. Treatment was received for the events (unspecified medications) on 28Apr2021 and physical therapy. Patient went off the medications the doctors gave her on 28Apr2021, choosing to tolerate the pain. The pain to this day, somewhat diminished. The events resulted to a Doctor or other healthcare professional office/clinic visit. Events were assessed as serious, disability. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events, musculoskeletal pain, dyssastia, groin pain, pain in extremity, arthralgia, postural dizziness, hypoesthesia, feeling abnormal cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.

headache; feels lightheaded and as if her head is floating around; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration on 26Feb2021 2nd dose, single for COVID-19 immunization. The patient took historical BNT162B2 on 05Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. On 27Feb2021, the patient experienced woke up this morning with a headache, feels lightheaded and as if her head is floating around. Therapeutic measure was taken with Tylenol and her headache went away. She now feels lightheaded and as if her head is floating around and she was not dizzy and her balance was not off. The patient would like to know if her lightheadedness was associated with the vaccine. The clinical outcome of the events headache was recovered and event feels lightheaded and as if her head is floating around was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

kind of unsteady on her feet; dizziness; her head was feeling peculiar; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:20 (Batch/Lot Number: EL5318) (at the age of 78-years-old) as a single dose for covid-19 immunisation. The patient medical history included blood pressure issue from an unknown date and ongoing. Concomitant medication(s) included atenolol (ATENOLOL) 25mg take once daily by mouth and benazepril (BENAZEPRIL) 20mg take once daily by mouth taken for blood pressure for years (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she got the vaccine on saturday (30Jan2021 09:20) and she didn't have any side effects except dizziness. Mention she didn't see that as one on the list. Adds she was dizzy when she wakes up and feels dizzy right now if she moves her head just right. Patient was asking is are we aware of this side effect. Patient further stated that after vaccination she was sitting in the car waiting for 15 minutes she was laughing with her family and she noticed her head was feeling peculiar. Adds that may have been the start of it (dizziness). Adds the peculiar feeling was kind of right in the center of her forehead. States she thought maybe she was dehydrated and slammed water all day long yesterday and as she was going to bed she felt dizziness. Today she noticed she was still dizzy and kind of unsteady on her feet. Patient was scheduled for the second dose of the vaccine on 20Feb2021. At the time of this report head was feeling peculiar (feeling abnormal) and dizziness were not recovered and the event kind of unsteady (Unsteadiness) on her feet was unknown. Follow-up attempts are completed. No further information is expected.

She got her vaccine, had no reaction. The next morning/afternoon she had a headache/head pressure, light headedness. As the days went on she had impaired equilibrium issues, which she is still having therapy for. She called her doctor after about 4 weeks of experiencing these symptoms every day, and he suspected that since she was dizzy and had equilibrium issues that it could be an inner ear problem, and referred her to an ENT. She went to the ER with pressure in her chest and headache. She had an EKG, stress test, doppler on the carotid arteries, and chest x-ray. All of these tests were negative for any findings. She then saw the ENT and he ruled out Meniere's disease, any inner ear problem, ordered a brain MRI. This showed mild constriction of the small blood vessels consistent with her age and that was all. She continued to have the problems, and her PCP recommended balance therapy and sent her to therapy for that. This therapy is helping her, and she continues to still go for the therapy. Any of the doctors that she saw felt that it was an over-reaction of her immune system to the vaccine.

Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient was able to grocery shop after and felt fine. She started to feel bad later in the day and went to bed around 8PM. Patient says she could not sleep, dozed on and off and had chills and sweats. When she woke up at 5:30AM, she said her legs felt like they had been crushed, she was in extreme pain and her legs felt paralyzed and she could not move them an inch. She had to use her arms to move her legs. She states it took her an hour to get to a chair. She sat in the chair for 45 minutes and was then able to gradually prop herself up to a dresser and eventually made it to her bathroom. Her condition gradually improved over time and she was able to walk much better on 5/29, Today she reports no leg pain, but reduced energy levels.

First dose: Redness in her eyes; First dose: Couldn't focus; First dose: Pressure behind left eye; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3248), via an unspecified route of administration, administered in left arm on 30Jan2021 at 14:30 (at the age of 78-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included ongoing glaucoma (had it for 7 years), ongoing hypothyroid (started 7 years ago). It took her 5 years to find the right doctor and the right medication. It took a while to balance it off. She has been okay the last 2 years with the right medication; asthma from 1969(controls her allergies, so it did not turn into asthma), ongoing high blood pressure (had it all her life), allergy to glycerin and ongoing vertigo (started way before she had the vaccine). Concomitant medications included ongoing irbesartan (AVAPRO) for high blood pressure (She just went back to it about a year ago because it was doing really good then her blood pressure spiked up) and ongoing levothyroxine sodium (TIROSINT SOL) for hypothyroidism for 3 years. The patient previously took flu shot and then had the flu and got pneumonia. On an unknown date, couple of days after the first dose the patient experienced redness in her eyes, about a week or 2 after the vaccination the patient couldn't focus. On 06Feb2021, the patient had pressure behind left eye and vertigo (vertigo). There were no relevant tests done. She was being treated for vertigo, but the vertigo was basically gone though she was seeing a physical therapist. The vertigo started way before she had the vaccine. The patient visited physician's office for the adverse events. The Patient did not go to the emergency room. The patient should have gone to the hospital, but she was afraid to be around people with Covid. She did not get vaccines at all because she fears having a reaction. The last vaccine she had in 2006 made her so sick she got pneumonia. It was for the flu, and she got the flu. The patient did not have any vaccination within four weeks prior to the first administration date of the suspect vaccine. The patient thought it was important for her to take the vaccine which it took her awhile to talk herself into it because of her previous experience with adverse reactions. She took levothyroxine sodium solution because the patient was allergic to so many things. The first one they gave her was a gel capsule and it caused an itching reaction. The patient is allergic to glycerine and could not take capsules that have a glycerine encasement. The first one they gave her was a gel capsule and it caused an itching reaction. She was allergic to the preservative in eye drops. She did not know if the Covid vaccine had any preservative, she did not think it did. She looked it up and did not see anything she was allergic to. The patient had a long list of allergies. Her family all has high blood pressure and allergies. The outcome of the event vertigo was recovered on an unknown date, for redness in her eyes was not recovering while unknown for rest of the event. Additional details unable to be obtained.

Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9810 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 04Feb2021 14:35 as 1st dose single dose for COVID-19 immunisation. The patient medical history included anxiety from Unspecified to Unspecified date. The patient concomitant medication included alprazolam (XANAX) taken for anxiety from Unspecified to Unspecified date. The patient received no other vaccines in the past 4 weeks period. On 05Feb2021, morning, she noticed she is feeling unwell and had a fast heart beat. After eating it got a little better. It says on the paperwork normal side effects to expect like feeling unwell and fast heartbeat which has calm down for her, but she was wondering how long this was expected to last and have the side effect. She was not feeling good this morning. She doesn't want this to last a long time. The patient reported that after the vaccine she felt nothing, no pain, no pain even at the arm. The patient reported that, she was not completely sure how she was feeling because she was sitting now, she felt nauseous and unbalanced, she was feeling unwell. As she was sitting down, she thinks it was better, but she still feels unbalanced when walking. The patient took half a Xanax when her heartbeat was fast, that was usually the trick that slows it. It was reported that, she takes Xanax for anxiety and maybe that was it was. She took the Xanax because she had to wait on the phone for so long to speak to someone. The second dose was schedule date on 02Mar2021. The patient had so many medications, but had not taken them before this started, she took them later. The patient received list of what she could expect, on the list what she had was a common reaction, but the Fast heart rate was in the call section, but it was not that bad for her to call 911 as she knows a fast heartbeat can happen with her anxiety. She usually gets the flu vaccine and pneumonia vaccine, she does not remember when she had it last, she usually gets them when it comes out or when pharmacy announces it and asks her. The patient noticed that people who usually get the COVID virus die of Pneumonia, so she thought she would get the pneumonia vaccine. The patient had some exam 2 weeks ago, and yesterday the Physician left a message about the results and did state on the phone that she has nothing to worry about. The outcome of Feeling unwell was not resolved and fast heart beat was resolving. Follow-up attempts are completed. No further information is expected.

12 hours after vaccine patient developed bilateral lower extremity "paralysis". She felt feverish and achy at night, didn't sleep well, and at 6am decided to get up and couldn't move her legs. She remembers using her hands to move her legs over. She tried to stand but slid down off the bed. It took about an hour until she could put weight on them. Felt normal by the next day. Exam and labs 1 week later normal. Back to baseline active self. Denies LOC, no upper extremity sx, no edema. Didn't try to wiggle her toes. Was advised not to get the booster dose.

I woke up the next morning with a very soar arm, a fever, chills and so achy. The next day, the fever and chills were gone, but I felt worse. Very weak, my legs felt as though they couldn't hold me up. I was so exhausted. I am still having issues. I thought I was feeling better, I thought, but I am still experiencing the issue with the weak legs, being so tired. I also feel light headed lately. I did see my family doctor 2x and spoke with him on the phone a couple times. He did blood work, all came back good.

severe rash/worsened considerably; severe itching; dizziness; swollen tongue; tight throat; even bothering my eyes; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, neuropathy, heart disease, starts and stop date was not reported for all and patient was allergic with sulfa. The patient's concomitant medication(s) included prednisone; gabapentine and unspecified blood pressure medicine, all are taken within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 78-year-old at the time of vaccination), via an unspecified route of administration in left arm on 25Jan2021 at 03:00 pm as a single dose for COVID-19 immunisation. Patient previously took simvastatin and had allergies. On 24Feb2021 at 12:00, the patient experienced severe rash and worsened considerably, severe itching, dizziness, swollen tongue, tight throat, even bothering my eyes. Patient received treatment with benadryl then Zyrtec for all events. Patient not received other vaccine in four weeks of vaccination. Patient visited doctor office/clinic visit for the events. Patient had not covid prior vaccination and not tested covid post vaccination. The final outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck and shoulder pain

Dizziness; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 03Feb2021 (at the age of 78-year-old) as a single dose for out of an abundance of caution/COVID-19 immunisation. The patient's medical history included muscle relaxer. Concomitant medication included methocarbamol (Strength: 500 mg) at 250 mg, as needed for muscle relaxer. The methocarbamol medicine was 500 mg, and she takes half which was 250 mg as needed, she took 250 mg the night of 03Feb2021. She has been using this medication for a couple of years now. Reporter was calling because she received the first dose of the vaccine about 22 hours ago and she was concerned about a side effect and she wanted to ask if this was a normal side, that side effect was dizziness, it just started about an hour ago on 04Feb2021. No investigation assessment. The outcome of the event was not resolved. 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.

This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.

feels lightheaded; fever; chills; headache; stomach upset; could not eat; diarrhea; aches all over; weak; This is spontaneous report from contactable consumer. This consumer (patient) reported that a 78-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot Number: EW0170), (at the age of 78-years-old) via an unspecified route of administration on 28Apr2021 at 15:00 (Wednesday afternoon) on right arm as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after received shot she had been sick ever since. She has been taking two Tylenol every six hours. On 28Apr2021, the patient feels lightheaded when she gets up, fever and chills at night, headache, stomach upset, could not eat up until today and stated that she ate jello, diarrhea, stated that she did not known if she can drive or not that she was weak, aches all over and that the other day when she had the headache that Tylenol would not take it away. Stated that she was okay when she got it and it took 4 hours to get sick. Stated that she could not even drive. Stated that she had Covid on 28Jan2021 and waited 90 days to get the shot. The patient treated herself by using cold packs. The outcome of adverse events feels lightheaded, stomach upset, diarrhea, weak and aches all over was not recovered. On 29Apr2021, fever, chills were recovered. On 30Apr2021, headache was recovered. The outcome of adverse event could not eat was unknown. No follow-up attempts are needed. No further information is expected.

Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine. Denies any fever, rash, cough, cold symptoms s/p vaccine. She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".

dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown. No follow-up attempts are possible. No further information is expected.

Two days following the vaccination, patient (my mom) began to have hallucinations of seeing family members in her home that weren't there, and it was exasperated throughout the week. The first noticeable hallucination was on a Sunday (6/20) and she was sent to the hospital that Thursday evening (6/24). As of today (7/1) she is still in the hospital and experiencing hallucinations. Mom/Patient was recently diagnosed with alzheimers and although there has been confusion over the last few months, the onset and intensity of delusions did not start until the 20th. Patient was initially put on antibiotics thinking hallucinations were caused by a UTI but stopped less than 48 hours later as she did not show bacteria in her urine. Additionally, mom was able to walk with assistance (a cane) prior to hospitalization and now is having trouble with very short distances.

She got her vaccine, and started feeling real dizzy and stumbling around and cold not do anything, and has had no energy and was in a wheelchair for a little while. She went to her PCP and he told her that she had an infection from the Covid shot, and gave her some antibiotics and some prednisone. This did not help. She was able to walk with her rolling walker before but since then she has had this problem. Her hands hurt, burn, turn red. She drops things steadily. When she gets up in the morning she is not able to do much as she drops things. She still has the same symptoms, and still having no energy and not herself. Her son has now moved in with her to help her as she is not able to take care of herself anymore.

Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ache; Thyroid nodule; Lung nodule; sciatica; Nauseous; Light-headed; Feelings of weakness; Difficulty in walking; This is a solicited report from a marketing program received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular on 29Mar2021 (Batch/Lot Number: ER8733) at age of 78 years old as single dose for covid-19 immunisation; upadacitinib (RINVOQ), oral from Dec2019 (Batch/Lot number was not reported) and ongoing, at 15 mg, once per day for moderate to severe rheumatoid arthritis. Medical history included non-smoker: secondary tobacco exposure, abstains from alcohol, high blood pressure, glaucoma, rheumatoid arthritis, muscle cramps in legs, cholesterol, acid reflux, and dry eyes. The patient had a relevant medical history of osteoporosis, hiatal hernia, DURICEF allergy manifested by pseudomembranous colitis. The patient had secondary tobacco exposure. She had history of usage of Remicade for unknown indication. Concomitant medications included amlodipine taken for hypertension; vitamin D3 taken for supplementation therapy; ciclosporin (RESTASIS) taken for dry eye and glaucoma; latanoprost taken for eye disorder; folic acid taken for rheumatoid arthritis; methotrexate taken for rheumatoid arthritis; magnesium taken for muscle spasms; fish oil taken for blood cholesterol; omeprazole taken for gastrooesophageal reflux disease; all start and stop date were not reported. Solicited report by a consumer of a female with events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, vomiting, back ache, pain worsened, spot on the lung and kidney stones and non-serious lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung and nauseous with RINVOQ (upadacitinib). On unknown dates, the patient experienced kidney cancer that possibly moved onto liver and nodule on thyroid and right lung. On 29Mar2021, the patient experienced lightheaded, felt weak, could hardly walk and nauseous. On 29Mar2021, the lightheaded, felt weak, could hardly walk and nauseous resolved. In May2021, the patient experienced back ache. On 29May2021, the patient experienced vomiting and pain worsened. On 02Jun2021, the patient experienced kidney stones. On 03Jun2021, the patient experienced colon cancer metastasize to the liver and spot on the lung. On 03Jun2021, the vomiting resolved. On 17Jun2021, the kidney stones resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 27May2021, she was sent to the emergency room because of back ache and was given prednisone. In Jun2021, she had a terrible back ache. She thought she had sciatica. In Jun2021, she went to the doctor, physician pressed on her back and she went through the roof. She was vomiting and had pain in her back and her daughter took her to the emergency room and did x-ray and cat scans and she had kidney stones and she was having an ultra sound. Went back to the emergency room from 02Jun2021 until 04Jun2021 because of vomiting and pain. She also had kidney cancer that had possibly moved onto her liver. She had an endoscopy done. The biopsy and other tests to decide what was going to happen. There was a nodule on her thyroid and her right lung. She felt ok and had a little backache at times, but she was taking. She already had the COVID-19 vaccines first dose but was advised not to had the second dose because of the adverse events she experienced after the first dose. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 29Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. The patient was treated with PREDNISONE. Relevant laboratory and other diagnostic tests included: 17Jun2021 abdominal ultrasound: No more kidney stones; Unknown date biopsy: Unknown; Jun2021 CAT scans: Kidney stones; 03Jun2021 chest X-RAY: Spot on the lung; 04Jun2021 colonoscopy: Colon cancer; 03Jun2021 computed tomography scan: Colon cancer metastasize to the liver; 04Jun2021 endoscopy: Hiatal hernia; Jun2021 endoscopy: Unknown; Unknown date lab tests: Unknown; Unknown date ultrasound: Unknown; Jun2021 X-RAY: Kidney stones. The action taken in response to the events for suspect product upadacitinib was dose not changed. The outcome of events colon cancer metastatic, kidney cancer, and lung disorder was not recovered, events vomiting was recovered on 03Jun2021, kidney stones was recovered on 17Jun2021, light-headed, feelings of weakness, difficulty in walking, and nauseous was recovered on 29Mar2021, events back ache, and pain worsened was recovering, of other events was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of colon cancer metastasize to the liver, vomiting, back ache, pain worsened, spot on the lung, kidney stones, lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung unknown onset, nodule on thyroid and right lung unknown onset and nauseous was not provided. The reporter's causality for the event(s) of kidney cancer that possibly moved onto liver with RINVOQ(UPADACITINIB) was no reasonable possibility. (Withheld) opinion is that the events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, spot on the lung, nodule on thyroid and right lung unknown onset and nodule on thyroid and right lung unknown onset are not assessable. (Withheld) opinion is that there is no reasonable possibility that the events of vomiting, back ache, pain worsened, kidney stones, lightheaded, felt weak, could hardly walk and nauseous are related to RINVOQ(UPADACITINIB). The reporter's assessment of the causal relationship of the events with the suspect vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering the close temporal association, a causative role of BNT162B2 vaccine for the reported Light-headed, Feelings of weakness, Difficulty in walking, and Nauseous cannot be excluded. All other events are considered unrelated to BNT162B2 vaccine.

Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started hurting; Condition aggravated/flare/a flare with hands and achiness; Bilateral cataracts; Depression; Vomiting; Back pain; Foot pain/fingers hurt; Shoulder pain; Localised erythema; her joints continued to be swollen at times; Diabetes; Heart disorder; Osteoarthritis; Joint range of motion decreased; Lower extremity mass; finger would not bend was straight as a board; Burning finger; one finger was bruised looking; swollen finger on left hand/hand swelling; This is a solicited report from a non-Pfizer sponsored marketing program (MARKETING PROGRAM NAME NOT AVAILABLE) received by Pfizer from AbbVie Inc. A contactable consumer (patient) reported that a 78-year-old female patient received tozinameran (PFIZER BIONTECH COVID-19 VACCINE), dose 2 intramuscular in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to Feb2021 at citrate free 40 mg, 1 in 1 week for moderate to severe rheumatoid arthritis and moderate to severe adult crohn's disease. Medical history included moderate to severe rheumatoid arthritis, moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient previously received first dose of tozinameran intramuscular in 2021 for covid-19 immunisation. The patient previously took adalimumab from 05Dec2019 and experienced lack of drug effect; On 16Apr2020, the patient experienced body aches. On 01May2020, the body aches resolved; fatigue from 2019, Urinary tract infection from 2020 to 2020, recovered; recurrent urinary tract infection from 2020. She had another urinary tract infection and she was placed on another unknown antibiotic therapy. On 14Apr2020, the patient was taking ciprofloxacin shot for urinary tract infection however it made her sick and had vomiting, depression and pain and therapy stopped. The patient experienced events of condition aggravated, flare, cataracts on both eyes (bilateral cataracts), nausea and flu like symptoms and non-serious heart condition (heart disorder), osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, joint range of motion decreased, lump on left knee (lower extremity mass), one finger was bruised looking/burning (burning finger) and swollen finger on left hand from 02Mar2021, hand swelling, depression, diabetes, vomiting, after taking covid vaccines, a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, redness in the hand (localised erythema) and swelling in hand with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was considered suspect. She was hospitalized due to extreme flares, body aches, flu like symptoms and nausea. She went to the eye specialist and was diagnosed with cataracts. she was told by her primary physician that she had a heart condition. she reported that her joints continued to be swollen at times and painful. She had shoulder, back pain, foot pain and also had osteoarthritis that affected her knees and hands. She took humira weekly and thought humira helped with pain. She also had diabetes. She stopped humira after taking covid 19 vaccines. She had swelling and redness in her hands and lump on her left knee. Her fingers were swollen, hurt and look bruised. she could not bend two fingers on left hand and thumb. she feels that all of her symptoms started after the second Pfizer covid 19 injections. She developed body aches and a flare with hands, achiness and restarted taking her humira. In 2021, she had cataract surgery on both eyes and had the outcome for the cataract surgery on both eyes was reported as recovered. when sitting long times, everything started hurting. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with kenalog, prednisone and amoxcillin. The patient underwent lab tests included body temperature: normal value. The action taken in response to the events for adalimumab was unknown. The outcome of events flare, cataracts, nausea, flu like symptoms, was recovered; everything started hurting, back pain, swelling of fingers was not recovered; other events was unknown. The report was considered involved or prolonged inpatient hospitalization and other medically important condition. Causality for humira (adalimumab): the reporter's causality for the event(s) of flare, body aches, nausea, flu like symptoms, depression, vomiting, lack of effect and urinary tract infection with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of cataracts on both eyes, heart condition, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, diabetes, another urinary tract infection, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of flare, cataracts on both eyes, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02 mar 2021, depression, diabetes, vomiting, lack of effect, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand are related to humira(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the events of body aches, nausea, flu like symptoms, urinary tract infection and another urinary tract infection are related to humira(adalimumab). Abbvie's opinion is that the event of heart condition is not assessable. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Reported events nausea, flu like symptoms, and vomiting are assessed as related to the suspect drug based on drug safety profile and temporal association. Other events are probably associated to patients underlying condition and are not related to BNT162B2. Case to be re-assessed upon receipt of new information.

Has terrible fatigue; The blood work showed swelling and the doctor is monitoring that; The caller states people can verify seeing the caller walk with a cane; Dizziness; Body aches from the left side of body that move through neck and to the head; Has been having migraine headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient's concomitant medication included prednisone (PREDNISONE: Started out taking 10mg, after told Doctor it was bothering the caller, reduced to 7.5mg and now the caller was on 5mg once a day.) on 13Apr2021, furadantin taken in 1985 (PRE Covid vaccine) where she was hospitalized and in a coma for 3 days. On 01Mar2021, the patient had migraine headaches. On 03Mar2021, the patient experience Body aches from the left side of body that move through neck and to the head, had terrible fatigue was reported as worsened and dizziness. The migraine headache started three hours after receiving the second dose Pfizer Covid Vaccine. The migraine that day lasted for 10 hours and finally got the headache to go away. The headaches have been on and off. Body aches from the left side of the body that move through the neck and to the head. The body aches had the reporter in the bed. The caller had two good days and then four bad days. The doctor had the reporter on Prednisone for rheumatoid arthritis. Body aches from the left side of body that move through neck and to the head: The patient was lying down because this was one of the days the patient cannot move around. Everything was aching on the caller's body. The patient was trying to get up. She had never had arthritis. The doctor was treating her for arthritis. The patient had never heard of onset arthritis three days after receiving a vaccine, second dose Pfizer Covid Vaccine. The patient states she called the number on the paper that was provided from the vaccination facility and mentioned everything. The reporter states it was just like a recorded thing. In the meantime, the reporter thought every morning when the caller woke up, thought it would all be gone, and the caller would be fine. The reporter was a normally healthy woman with no underlying side effects, no underlying conditions rather. When asked if it was Pfizer the patient called and reported the events to, the reporter replied she did not keep the paper, but it said to call Pfizer at this number, no person answered, and it was leaving a message. Had been having migraine headaches: The reporter had migraine headache on the left rear quadrant of the head. The headache was like something piercing the head all by itself. The reporter states a migraine headache lasted 10 hours and began three hours after receiving the second dose Pfizer Covid Vaccine. body aches: two days later, had terrible fatigue and it was difficult for the patient to get off the couch and the terrible fatigue had been on and off. The caller had one good day and one bad day. Had been having migraine headaches: The terrible fatigue began as soon as the caller was up with migraine for 10 hours. The migraine continued with a moderate headache which persists still today, 02Jun2021. The reporter may go a day or two without the headache, but it keeps coming back. The patient underwent lab tests and procedures which included blood test: showed swelling and other than that was normal. The outcome of events swelling, and gait disturbance was unknown, and the outcome of remaining events was not recovered. No follow-up attempts are possible. No further information is expected.

went right back to sleep after her call and didn't wake up till next morning,; dull headache; head was swimming; blood pressure went to 220/blood pressure was really high; black spots across my face; swimmy headed; legs didn't feel like they would hold her up/felt like my legs weren't going to hold me up; weak; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731), via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (at the age of 78-years-old) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She had her shot and just had a bad reaction to her very first shot. She came home, states sometimes she may doze off for 15 minutes or so but she fell asleep until at 16:00 she was woken up by a call from a friend. On 15Apr2021, she felt very fatigued and weak on Friday; later adds she was tired the day of shot as well. She laid around all day sleeping on Friday. On 17Apr2021 Saturday her legs didn't feel like they would hold her up and so she laid around again all day. On 18Apr2021 Sunday she knows had gotten up to go to bathroom a couple of times in the night; but then in the morning she was going to get up and felt faint; later adds she felt dizzy; states her head was swimming and she saw black spots and it scared her to death. Adds she thought she should go and sit up in the living room. But even after she sat down, sitting straight up, she kept seeing black spots. A friend took her to the emergency room (ER) for the dizziness and seeing spots. At the ER they found her blood pressure was really high; she thinks it was 220 over something, she forgot the bottom figure. They put an IV in to give her medication; did an electrocardiogram; a chest xray; blood work; a urinalysis and all of those tests everything was fine. The ER staff helped her to bathroom and her head was still swimming but they said that was because her blood pressure was still high. Adds her blood pressure went down on it's own and she had no medication for the blood pressure. They told her you are remarkable at your age to not to be on medication. She saw her doctor yesterday. Reports at the doctor's office her blood pressure was about 128/63. The doctor told her it was kind a low and that she basically runs low. She was not dizzy anymore on Sunday after her blood pressure went down. Adds she got a dull headache yesterday but she thinks it might of been a caffeine headache because she has had a caffeine headache in the past when she had to stop caffeine for a test or something. She has to take the second dose on 06May2021, and her doctor told her to take it; but she is scared to death. She asking for a recommendation as to whether she should get the second dose. The adverse event resulted the patient to visit emergency room and was not admitted and also visited to physician office. Outcome of the event hypertension was resolved on 18Apr2021, while for events- black spots across my face, dull headache, swimmy headed, feeling abnormal, head was swimming was resolved on 19Apr2021 and that for fatigue, weak was not recovered and sleep disorder was unknown. No follow-up attempts are possible. No further information was expected.

TIA, right side of body weakened to point of not being able to stand, left side of face numb, emergency hospital 24 hours for monitoring and tests.

shoulder blades started hurting/then the pain went down to both hips and her back too; collar bones they started hurting like hell; then the pain went down to both hips and her back too; pain all over the body; could not move there left arm or neck; Physician instructed patient not to get second dose of Pfizer Covid Vaccine so patient did not get second dose as scheduled for 18Jun2021; pretty bad headache/headaches; severe chills and temperature; severe chills and temperature/chills; move her left arm where she had gotten the shot and couldn't move it/ arm was paralyzed; This is a spontaneous report received from a contactable consumer (patient). This is report 1 of 5. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 28May2021 at 17:30 as single for covid-19 immunization (at the age of 78years). The patient medical history included First serious fall from May2021 to an unknown date-Shattered left hip that was May2019; shattered left hand and wrist; When shattered left hip they had to fix the shattered hip then they put a metal rod from the hip to the kneecap inside the femur bone. Second serious fall from 27Nov2019 to 27Nov2019, fell again in her home and that time she shattered the left knee, hip fracture- Broke right hip 4 or 5 times, shoulder arthroplasty- On the right arm. She broke that right before get to the shoulder, the upper arm and the shoulder and everything was all mangled, stevens-johnson syndrome from on an unspecified date in 1954 and ongoing-very severe autoimmune disease she got at age of 12, in roughly 1954. It is also called Erythema bullosum-that's what it starts out as-then becomes Stevens-Johnson Disease, then Stevens-Johnson syndrome. Affects mucus membranes in body and appears to be rejecting the eyes-this is relative to her blindness. When contracted had 108 degree fever, implantable defibrillator insertion from on an unspecified date in 2015 and ongoing- installed back about 6 years. She was taking some kind of, the numbers are way down now, she does not think there's a problem but they were thinking she was prediabetic which was probably attributed to her diet. The day before they did the blood test she had ice cream for lunch and for dinner. Then she had the blood test taken the next morning which could have set the numbers off the chart; since then the numbers have gone down. glucose tolerance impaired. They were thinking she was prediabetic and blind from an unknown date and unknown if ongoing, wheelchair user from an unknown date and unknown if ongoing. She only has 1 eye now-left eye; has been legally blind since age 24 years; now left eye is just about gone. She was the 5th person in the world to have Stevens-Johnson syndrome with blindness that could still see and lived. First 3 people with Stevens-Johnson syndrome died-4th lived but was blind. Concomitant medication's included sertraline hydrochloride (ZOLOFT), diazepam (VALIUM), hydrocodone bitartrate, paracetamol (VICODIN), cholesterol (CHOLESTEROL) taken for an unspecified indication and Unknown product: Some kind of stomach pill, does not know, it is the size of caraway seed in rye bread. Regarding concomitant medications caller reported she has no idea. She is taking products that the drug store puts a bubble pack for her. She was taking high blood pressure but her blood pressure was never high, it always ran on the low side; but they started giving her that when she had a pacemaker and defibrillator 2-in-1 installed back about 6 years ago. Otherwise unknown. Cholesterol meds but those numbers are all under control. She has been having trouble; so she thinks this is the last months she is getting her meds after that she thinks she is stopping everything. There's 5 or 6 meds in the morning and 2 at night, one is cholesterol from #. She cannot provide further information for her concomitant products as she is blind-Lots/NDCs/Expiries: Not provided, She cannot provide further information for her concomitant products as she is blind. With the old flu vaccines with the live viruses she was always coming down with the flu after getting the injections. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient did not visit emergency room or physician office. Adverse reaction was very bad: Started out with pretty bad headache around noontime, 12:00 on 29May2021 with the most severe part of event starting probably about 22:00. From there it went to severe chills and temperature. Then she went to move her left arm where she had gotten the shot and couldn't move it; she tried to move her fingers and make a fist but couldn't do it; the arm was paralyzed. Then her shoulder blades started hurting like hell, like incredible. If she had a gun she would have put it to her head. Then where the neck connects to the body, collar bones she guessed; in between like if she had an adam's apple it would be on both sides of those bones that are right beside the neck, they started hurting like hell. The paralyzed arm the pain coming from that was incredible; then the pain went down to both hips and her back too; but back wasn't as severe as the bones. All of Saturday, 29May2021 into Sunday, 30May2021 she was unable to get out of bed. This whole thing just intensified, she had nobody there; she lives in senior housing, they are confined to their quarters, to their apartments, the whole thing. She did not have access to anyone, had problems with her phone with no dial tone, nothing. Finally on Sunday, 30May2021 early evening she was able to, she would say, slither out of bed on her back and drop her feet over the edge of the mattress so those are kind of like on the floor. Her wheelchair is next to her; she has to get her upper body upright to be in seated position to be able to get into the wheelchair which was damn near impossible to do. She never knew that kind of pain existed. She was then able to get into the bathroom and use that. She had nothing to drink because obviously if you drink have to urinate and use the bathroom there was no way she was going to go through that again. She thought at that time she might as well go and unlock the door so if an ambulance does come they can haul her to the hospital or they could retrieve her body. She was totally convinced she was going to die on Sunday night into Monday morning, 30May2021-31May2021. She was up until 04:30 on Monday morning, 31May2021 because she was so scared if she fell asleep she would pass away in her sleep. The pain she could not describe how bad that was. That was Monday morning, 31May2021, all of this interim information she is discussing here; basically she was a total mess until it started backing off on Wednesday, 02Jun2021. She was told by the commission for the blind, that they were able to set up the appointment with # because she was due for in-home inoculation with J&J but when they had trouble with that it was pulled and the appointments were cancelled. The commission for the blind took it upon themselves to set up appointment for her Pfizer Covid Vaccine which was given at # on 8 #. #-that was where her Pfizer Covid Vaccine was administered. She did not call anyone or go to the doctor, emergency room or hospital; she has life alert but thought it was in God's hands so if he takes her he takes her. She did not call her daughter. She did call her doctor the early part of last week; he wants her to have a blood test to check for antibodies to see how much of the vaccine is in her or how much she is covered. Once he sees those numbers he says maybe she should get the J&J Covid Vaccine, but if she already got the Pfizer Covid Vaccine and with the J&J trouble with that too, that does not even make sense. She asked for information about that. She was due for a physical about a week ago but her daughter was unable to take her to her physical appointment because she had to take granddaughter to hospital because granddaughter has a hole in her heart and they had to do some testing on her. The patient underwent lab test which included body temperature of 108 degree on 29May2021. The outcome of events were unknown. Information about lot/Batch has been requested.

I had no issues with 1st dose. After taking the 2nd dose, I played golf afterwards. By the end of the round, I was having pain in my left foot. The pain got worse to where I couldn't walk on it. The pain went up my leg to my knees. The next day, I went to the Ortho Indi facility. They did an x-ray on me that indicated that there was no structural damage to cause pain. The doctor recommended me to put on a boot that go up to my knees and to ice it. I did that from Wednesday through Sunday. The pain went away. Every now and then I would get a sharp pain in my left foot, but then it goes away.

Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out of bed or chairs, able to dress herself, use the toilet and shower and communicate verbally (although voice was not very loud. She received the second Pfizer/BioNTech COVID-19 vaccine 2:30 PM on March 18, 2021; on March 21, 2021 she had gotten up at 4:00 AM and was walking through the kitchen when she found herself on her back on the floor and was unable to get up. She required help in getting up and has not been able to walk on her own ever since. She requires help in getting in and out of bed, in and out of chairs, cannot use toilet and shower on her own, is unable to dress herself and her voice has become a whis

and really horrible radiating pain down both of her legs, front and back.; She also said there was numbness in her leg; swelling in her sacrum; headache; nausea; She said she had severe joint pain; severe muscle weakness, and pain; she did not have any appetite; and had troubles staying awake.; HCP said that she also had neurological problems; had a fever of 102 for 5 days; diarrhea; dizzy; severe muscle weakness, and pain/ weakness in legs; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; This is a spontaneous report from a contactable other HCP (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Borderline multiple myeloma (Borderline Multiple myeloma for 10-15 years), ongoing Monoclonal gammopathy, covid-19 from Mar2020, Severe allergies, ongoing having a lot of immunology problems going on/ immunocompromised, sarcoidosis from 1970, Russian flu, 5 episodes of anaphylaxis, had 9-10 episodes of total body hives, has been resuscitated twice, B cell blood malignancy, allergic to over 30 drugs and lingering COVID symptoms: dry cough, muscle and joint pain, headache, dizziness, and diarrhea. The patient's concomitant medications were not reported. Patient previous received hepatitis vaccines and TB for immunization and experienced did not respond/ nonresponsive, received Swine Flu for immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173, expiry: 31Aug2021), on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation and experienced high fever, joint pain, some weakness in her legs/severe muscle weakness, headache, nausea, she was very ill / She said she was pretty sick for 10 days, diarrhea and muscle pain. The patient experienced dizzy, and severe muscle weakness, and pain/ weakness in legs, both on 10Jun2021 with serious criteria of disability, diarrhea, and had a fever of 102 for 5 days on 10Jun2021. Her immunologist cleared her for the vaccine because she has an unsettling allergy history. He did an immunology review of her allergies and prior vaccination problems before determining if she could get the COVID vaccine. He wrote her a letter that said she had to get the vaccine in a room with an IV ready and the defibrillator ready as well. Her immunologist thought it was prudent she try the first dose. She did have COVID already in 2020. She ended up in the emergency room from the vaccine. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. The second dose reaction was different. The day she got the second dose 09Jul2021, she got home okay without problem and went to bed. When she got up in the morning she had trouble getting out of bed. She had difficulty walking. She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking (10Jun2021). She also said there was numbness in her leg, swelling in her "sacrum," and really horrible radiating pain down both of her legs, front and back. She was fine the day she received the shot, but had great difficulty getting out of bed the next day. She said she still could not drive because she was still dizzy and nauseated. She added that she had headache, nausea, and diarrhea. She said she had on and off diarrhea for 6 or 7 days, and couldn't keep anything down without having it. She said she had severe joint pain, severe muscle weakness, and pain, and had a fever of 102 for 5 days (from 10Jun2021 to 15Jun2021). On the 5th day of her having fever, she said she was struggling to put one foot in front of the other in terms of walking. She said she was also starting to feel as if she was paralyzed. She was having troubles trying to walk normally since there was weakness in her legs. She also said she did not have any appetite. She spent a lot of time in bed, sleeping, and had troubles staying awake. She said she had a bad headache. She said she called 911, and went to the hospital. She stayed there for 2 days. She said it was very unpleasant. She also had neurological problems as well such as extreme difficulty in walking, standing up, and profound leg weakness. However, she said that her neurologist assured her that it would go away within 4 to 5 weeks. She said it has already been 5 weeks since her 2nd dose, but she was still not feeling well. She was improving, but not well. She said she was physically not much better. She was having severe bilateral leg and sacral pain. Her sacrum was hot and swollen so she called the ambulance. She went to the ER because she had difficulty walking. She went to the ER. After five days of the second dose she still had a fever and trouble walking. The ER did multiple scans including a CAT scan of her abdomen and pelvis, an x-ray of her pelvis, and MRI of her upper and lower spine. She also had blood cultures and multiple lab work done. They were trying to rule out Guillain-Barre. She was in the ER for 2 days. She was very sick. The second day she was in the ER they told her she could go home. She thought it was because they were busy. No one explained to her the results of her tests or what was going on. Once her fever was done they didn't have to deal with her anymore. They sent her home when she was still sick with leg pain, trouble walking, and still had diarrhea. She was still nauseated, and was just eating jello. It is week 5 and she is really physically not much better. She can't drive because she was still dizzy and nauseated. She has leg pain, trouble sleeping, and muscle weakness in her legs. She is not recovered from the second dose. She thought she was going to die from it. It took a lot to call 911 especially as a nurse, but the numbness and pain in her legs was really severe. She had such weakness that she had trouble standing up and navigating through her apartment without falling down. She had made slight improvement. She mentioned that she had the flu back in 1988, so she felt very ill, and was in the hospital for 2 weeks. She was a long haul COVID patient who is enrolled in a long haul COVID program. She has been sick for a year and a half now since having COVID. She got COVID in Mar2020, and did not recover well. that is one of the reasons why they delayed her vaccination. She had to do prednisone during that time, and had to wait 6 weeks after completing the Prednisone to get the vaccine. Her baseline was a subnormal temperature of 96.1 because of her immunology issue. So 102 is really high for her. She had lingering COVID symptoms, and was a long haul patient. She had a cyclic problem with dry cough, muscle and joint pain, headache, dizziness, and diarrhea. She would have it bad for 7 days, and then recover a couple of days, and then it repeats itself. She couldn't drive because she was too dizzy and weak to drive. It was not safe to drive. She didn't have enough strength in legs to stop the car. She was seen by a neurologist several days after her emergency room visit. He examined her, and asked her reaction to the Pfizer vaccine. He said he had other patients with similar outcomes. She was immunocompromised . She has had borderline Multiple myeloma for 10-15 years. She has Monoclonal gammopathy, MGUS, she had it for a while. There are periods of time where her protein is elevated making her borderline for myeloma. She has had a couple rounds of prednisone to suppress the protein. She has a positive ANC. She has a multitude of issues. She was diagnosed with sarcoidosis in 1970 bust is in remission. She is tested regularly for sarcoidosis. She thinks she might be having a gallbladder attack now. In the past, she has been a non responder to vaccines. She got out of healthcare for that reason. She did not respond to hepatitis vaccines. She doesn't have NDC/lot/expiration for those vaccines. The infectious disease doctor at the time told her she shouldn't be a nurse for that reason because it put her at risk for hepatitis. She was also nonresponsive to TB. She doesn't have NDC/lot/expiration to any of the ones she has been non responsive to. Last time she was vaccinated she had Swine Flu. She was having a lot of immunology problems going on. The doctor recommended her not get a flu vaccine. It was later discovered that she was a non responder to hepatitis and TB. She has had no flu vaccine since swine flu in the 70s. In 1988 she had the flu, and was in hospital for two weeks and almost died from that. One of the doctors she worked with died from flu. He was a surgeon. He died so she thought she was going to. She barely squeezed by. She was allergic to over 30 drugs'. No information on those drugs provided. She has had 5 episodes of anaphylaxis. She had been resuscitated twice. She has had 9-10 episodes of total body hives. The COVID vaccine knocked her down to 0. She has had to cancel her last 5 weeks of life. She was homebound. She couldn't get out of bed and get dressed. When she had COVID in Mar2020, she had an antibody tested 3 months later and 6 months later that both showed no antibodies. She has a B cell blood malignancy, and the b cells pump up the immune system. So she wasn't surprised she didn't have antibodies. Events caused emergency room visit and physician office visit. The outcomes of events dizzy, severe muscle weakness, and pain/ weakness in legs, She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking, nausea, diarrhea, had a fever of 102 for 5 days were recovering while other events were unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events "dizziness and muscular pain" and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; fatigue; had so many naps; cutting the zinc in half because it made her terribly sick; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 at age of 78-year-old (Batch/Lot Number: EL3249) at single dose for COVID-19 immunisation; zinc (manufacturer: Nature Bounty), via an unspecified route of administration from an unspecified date (Batch/Lot Number: 529254-01; Expiration Date: Nov2024), at 50 mg daily for immunity. Medical history included COVID-19 in Sep2020 and her primary symptoms were different than the typical symptoms, she had the fog, lightheadedness, and dizziness, she healed up pretty good, but she would occasionally have a bout with it. Concomitant medication included colecalciferol (D3, Brand: Nature Bounty, lot number: 506697-01, expiry: Sep2023) taken for immunity. Additional vaccines administered on same date of the Pfizer Suspect were none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior vaccinations within 4 weeks were none. Back in probably 1958 she had a reaction to the Polio vaccine for immunization. She didn't remember the symptoms and they said to stay away from it. She had shingles vaccine for immunization and had no problem. The patient did not have lot number or expiry for the Polio Vaccine. She didn't have lot and expiry for the Shingles vaccine. She got the Shingles vaccine in 2019 because she had a friend that had shingles and it wouldn't go away. Her friend had not gotten the shingles vaccine. The patient's friend recommended that patient get the shingles vaccine. She had the opportunity to get the first vaccine on 11Feb2021 and she asked her doctor if she should do it with her having continued symptoms. The doctor said yes and for her to take Zinc and D3. So that is what she did. Every day since she got the vaccine she had fog, lightheadedness, and dizziness in Feb2021 worse than when she had COVID. She was fine the first 24 to 30 hours. When she woke up the next day in Feb2021 she was dizzy again. Then it has gone off and on. She can't even go grocery shopping without holding onto the cart an begin fearful. When she sat she was fine. She imagined she had fatigue. She had never had so many naps. The patient clarified that she lay down because of dizziness. The patient asked how does that relate to her getting the second one. That was the first one and they said the second one is worse. She is a caregiver and it can't get worse. They said the first shot is 85% effective is that enough and asked if that last for very long. She used to be 5 foot 2 inches. She saw her doctor on 25Feb2021 and doctor thought she should still have the vaccine. she was still leery. The 26Feb2021 is a better day, but she had felt real promise before. She took supplements. She thought she read that you shouldn't take anything for immunity. The patient asked if the zinc and D3 is considered for immunity because that is what the doctor told her to take it for. She had to cut the zinc in half because it made her terribly sick in 2021. It was 50mg, but since she was cutting it in half she is taking 25mg per day. She did not have any test or bloodwork since the vaccine. She wished the doctor would have done something when she messaged doctor on 25Feb2021 on app. She would feel better if someone else said she should get it. The events did not required a visit to emergency room. The action taken in response to the events for zinc was dose reduced. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.

Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minutes after receiving vaccination. Upon ambulating to depart facility, patient returned to area complaining of dizziness and fast heart beat. Patient was immediately seated and vital signs were obtained. 0954- BP 150/82, pulse 80, Oxygen saturation 95%, and temp 97.8. Patient drank 8 ounces water. Patient reported feeling better after 10 minutes. Repeat vital signs at 1007 BP 127/74, pulse 80, oxygen saturation 95%. Patient with no further complaints of dizziness or fast heart beat. Patient did not verbalize any other complaints. Patient denied escalation to emergency department. Condition was resolved prior to leaving facility. Patient left facility ambulatory without any difficultly, and was accompanied by family member. Patient instructed to call 911 and report to nearest emergency room for any further issues or complaints. Patient verbalized understanding of instructions in her own words.

dizziness; weakness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient non-pregnant received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13246), via an unspecified route of administration on 06Jan2021 13:00 at single dose in right arm for covid-19 immunization. Medical history included arthritis. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. The patient experienced dizziness, weakness, nausea, diarrhea on 07Jan2021. The patient was not received any treatment. The outcome of the events was not recovered.

Verbalize at 1:02 pm feeling light headache, blurred vision like vertigo. He was evaluated by Fire Rescue and released home feeling better at 1:05 pm.

Started getting headache within minutes of shot. Bad body aches for about 12 hours. Everything ached and couldn't get comfortable to sit, stand, lay down. Stomach cramps that doubled me over lasted for a few hours. Last 4 hours could barely walk. Husband had to help walk me to the bathroom. Chills and shaking and could not warm up after the 1st hour through the rest of the night! Everything started going away about 1:00 in the afternoon and felt better at 2:00.

After covid vaccine, unable to move arm for 8 days, slowly subsided. Likely SIRVA. Patient requesting I report this for her.

right arm unusable for 48 hours following injection, high blood pressure (200)4th day, TMJ 4th and 5th days, joint pain in both shoulders 3rd day

Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted Severe nausea/throwing up Fever No appetite

Shortly after vaccination, patient developed dizziness and tingling sensation along jawline. Patient mildly hypertensive. Approximately 15 minutes later, dizziness developed but tingling sensation also experienced in bilateral feet. Evaluated in ER and ultimately sent home without further complication.

1300 - After vaccine administration pt c/o dizziness/lightheadedness. Skin was pale & diaphoretic. Assisted to supine position on floor. Feet elevated. BP 190/80, Pulse 96, RR 28 Axox3. 1305 pt remained on floor confusion noted, Axox1, repetative questions BP 189/80, states "Why am I here?" 1310 Pt. remained in supine position, continues to ask repetitive questions even after re-orienting to person/place/time. Husband states "I think she's just nervous." 1320 Pt. continues to show signs of confusion, states "What happened, who are you? Why did I get a covid vaccine? who gave it tome?" 1320 911 called 1345 Pt. transported to Hospital via Medic

very dizzy felt like I was going to faint, could not shake it, was at work went home. went to bed and slept 10 hours outcome= was fine when I woke up

Seated playing cards. Sudden onset extreme dizziness, short seizure, blacked out X 1-2 seconds Other player called 911. One fire truck followed shortly by one ambulance both with two very cute EMTs. All vital signs normal. Very similar to dehydration attacks but worse and that always followed rising and walking. This attack worse and was not set off ambulating. Worried about a worse effect after second vaccine.

Client reported warm feeling to face and neck, lightheadedness 3 minutes after receiving the vaccine Care initiated by facility. Vital signs within normal range. Client declined further treatment.

Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.

Dizziness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration (right arm shoulder-pending clarification) on 17Jan2021 at singe dose for Covid-19 immunization. The patient's medical history included high blood pressure. There were no concomitant medications. It was reported that the patient got the shot on Sunday (17Jan2021) along with her husband. All of the sudden she was getting dizzy, otherwise they had no problem. She even made a second appointment. The dizziness started today (19Jan2021), a couple hours ago. It concerned the patient. She thought maybe because she didn't eat breakfast, but she ate and that hasn't helped. She would like to know if dizziness is a side effect because she really doesn't want to go to the hospital. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061667 same reporter/drug/event and different patients.

Pt received COVID 19 vaccine at 1400. While in 30 minute observations area patient had c/o chest pressure, SOB, lightheadedness, Patient appears in NAD, skin PWD, patient is restless. Patient requesting b/p to be checked. Patient taken to first area where EMS on duty assessed patient. B/P 190/8-0 HR 90, RR 18, SaO2 96% on RA, CBG 144. Patient sitting in wheelchair and did state that she had a history of HTN and did not take prescribed medications, Lisinopril, Norvasc, today. Pt also take venlafaxine for anxiety. Pt observed by EMS, given snack, and water. Patient reports improvement of symptoms. VSS: b/p 156/70, HR 88, RR 18. Patient cleared by EMS and discharged home at approximately 1445.

Lightheaded 20 minutes after the vaccine, no other symptoms. BP 144/70, pulse 68, O2 sat 100%. Patient offered water/juice, refused. Stable to go home.

Difficulty in walking / could not walk; her feet feel like they are numb; Dementia; This is a spontaneous report from a contactable consumer (patient). This 79 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) in left arm, on 18Jan2021 at 12:00 PM or 01:00 PM, for COVID-19 immunisation. Medical history included pacemaker (she just had it checked on 18Jan2021 at the cardiologist and they said it was good for five more years), heart issue, dementia (before getting the vaccine). Concomitant medications were none. On an unspecified date in Jan2021 the patient experienced dementia (she had a bit of dementia right now, which she also had before getting the vaccine) and her feet felt like they were numb, like neuropathy (maybe she had that, it had never been checked). Since 19Jan2021 the patient could not walk, had difficulty in walking. She was using a cane as she did not want to fall, she weighed 200 lbs and her partner would never be able to get her up if she fell. She was able to walk with the cane. The patient said that there had been no other treatment for her difficulty in walking and it seemed to get better. The initial caller (patient's partner) said she had the shot too on 18Jan2021 and did not have those symptoms, she was not the one who was sick, she did not know what else was going on in her partner's body, they did not think the shot caused it. The patient said she was supposed to be on a sleep apnea machine but she could not get in to the doctor to get the machine checked, it needed a test to be rechecked but they could not get in to do it because of everything that is going on. The patient was scheduled to get the second dose on 08Feb2021 at 10:00AM. Difficulty in walking was improving. The other events outcome was unknown.

Felt fine the day of event, during the night she felt like she had a heavy head, but when she woke up around 8:00 and she realized that something was very wrong, she could not sit up due to nausea and the room spinning. She texted her daughter who is a nurse and got there about 1:00 PM, she was still in bed. When she tried to sit her up she felt like she was going to throw up. She put her legs over to the side of the bed, and she felt like somebody was pushing her with her daughter over a cliff, in a tornado and on a Ferris wheel. She started vomiting and having diarrhea. She had heard about an epley maneuver and after a time she sat her up again and still had the previous feeling of going off a mountain in a tornado. She did the epley maneuver and tilter her head to the left and was still very dizzy but not as bad. She then tilted her head to the right and it was not as bad. Things started to settle down and eventually she was able to get up, still nauseated but 90% better. She was able to go to the restroom with her daughter's help. She stayed in the bed all that day and finally in the evening was abler to keep food down. She limited her distance to the bed to the bathroom. Her doctor was notified and called in some nausea and vertigo medicine (meclizine), which he did and only took 2 doses of that. The next morning she went up and down the stairs to make sure she was able to. She was very, very cautious but each day has been better. On 2/2/21 she called and got an APT with ENT but will not see him in a couple of weeks. They are going to send a therapist tomorrow to evaluate her for the vertigo. She is scheduled for the 2nd vaccine on 2/11/21. Saw her internist today and he evaluated her and did 2 blood tests and sent the referral for the therapist to come tomorrow.

urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient

Severe vertigo; pressure in the ears; eye nystagmus drastically worsened; Strong intense pressure in the head (not a headache); Fatigue

Pifizer BioNTech COVID-19 vaccine administered at 9:19am. At 0930 patient reports feeling lightheaded. Vital signs taken x3 -WNL. Patient given water. After 20 minutes client reports feeling dizzy, but wants to leave. AMA paper signed, left at 0956. Vital signs: 0938 BP 168/68, HR 62 RES 20 02 SAT 97% 0943 BP 158/73, HR 68, RES 20, 02 SAT 96% 0948 BP 152/73, HR 69, RES 20 02 SAT 97%

This vaccine clinic was held at the Center in on 1/23/21 and hosted by the Hospital.. Vaccine administered at 1340 by LPN. Patient with immediate c/o of feeling light headed, hot all over, flushed. Patient stated she felt better but at 1357 c/o of itching all over body and tongue swelling. Epinephrine pen administered at 1358 by LPN. Emergency services contacted. Patient transported to ER at approximately 1410.

79 yo female with past medical history only significant for endovascular coiling of cerebral aneurysms over 30 years ago presenting with fevers, fatigue, weakness, noise sensitivity, myalgias,and tremors. She exercises regularly and has become so weak that she cannot climb stairs. Neurological exam revealed hyperreflexia, subtle proximal muscle weakness, the presence of a startle reflex and rooting reflex, clonus, and a positive Babinski. Infectious work up has been negative, autoimmune evaluation is underway. Inpatient neurology consultation has been obtained, she was given a trial of diazepam for stiff person syndrome and started on daily IVIG on 2/3/2021 for a 5 day course. She continues to have an elevated CRP, a mild transaminitis, and mild thrombocytopenia. The ESR dropped from 44 to 20 with hydration. She has had no cognitive changes. No headache, visual changes, jaw pain. We are unable to obtain MRI given the presence of these coils which are not MRI compatible. Encephalitis immune antibodies are pending, myositis panel, MOG antibodies ADEM are pending, GAD65 antibody pending.

I recieved the shot on 2/5/2021 on 2/8/2021 I was off balance all day. I would run into walls and doors. As I went down the steps of my home I couldn't stop at the bottom. I ran into the door and it stopped me. I was this way all day. When I got up the next morning on 2/9/2021 I was o'k until around 9:00 then my tongue got sore and my mouth got all coated. My whole mouth was coated. Around 10:00 my tongue swelled. This lasted all day. The next morning I was fine.

Dizziness and nausea began overnight on Feb 4-5, continuing throughout the day on Feb 5. Went to ER for treatment the evening of Feb. 5. IV fluids administered to treat mild dehydration. Symptoms eased temporarily, then increased on Feb 6. As of today (Feb 10), symptoms have steadily improved, but not yet fully recovered.

Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded. EMS managed patient's care on-site. Patient was hypertensive (178/96), SPO2 96%, and HR 90bpm. EKG was unremarkable. FSBG was 137 mg/dl. During EMS evaluation, patient stated they were feeling better and refused transport to hospital.

Swollen knee right, Difficulty up and down stairs especially up. Initial trouble standing.. Lifting leg to out in pants. Tx: ice, elevate, rest. Water exercise, Tylenol at night.

91.2kg 79 yo nonsmoking/nonEtOH drinking M with PMH significant for Parkinson's disease, postural hypotension, recent hip surgery and eye problems was at the vaccine clinic for his 2nd Covid-19 vaccine with the product. Allergy history includes tree nut and MSG allergy (hives, swelling, pruritus) and Sinemet, midazolam and fentanyl causing nausea or vomiting. After IM injection of the vaccine (lot # EM9810) into his left arm, the patient felt lightheaded. Patient was diaphoretic and pale. BP was 64/49 with HR 66 and O2 sats 92% on room air which is near baseline. Patient was moved to a recliner chair with feet elevated and given something to drink and monitored

After receiving vaccine client states she feels lightheaded. Vital signs obtained. BP 130/73, pulse 75, O2 sat 98%. Client states she is feeling better. Client discharged home. Client advised to call if symptoms return or worsen.

Severe dizziness and nausea since Saturday 2/13/2021 . Called doctor who prescribed medication. Nausea has abated, but dizziness is still an issue. This is the fourth day.

4 seizure type episodes (including shaking, eyes rolling back for about 15-30 seconds long) after being moved out of bed - lasted 4 days Fever up to 102.5 - lasted 5 days Could not stand - 8 days Body aches - 8 days Could not walk - 9 days Weakness - on going since vaccine Shaking - on going since vaccine

may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine; Batch/lot number: EL9262), via an unspecified route of administration injection to right upper arm on 22Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing she was a fainter (She was a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine administered to her by nurse while she was in her car seat. She just asked the nurse to let her lay down in the car seat when injection was administered so that if she fainted she would not fall far; she was still getting the wash cloth on her head preparing when the Nurse had already finished administering the injection.); ongoing depressed sometimes (she was depressed sometimes, was stressed. She was the primary caregiver for her 96 year old mother. She had seen something about stress and COVID and shots and everything); ongoing Very tired (She was almost 80 years old so she was very tired often. She was the primary caregiver for her 96 year old mother. By the time she comes home at night around 21:30 she was just wiped.); Obesity (She was really overweight but she did not like the term obesity.); thyroid disorder; hypertension; Cataract and glaucoma in left eye; family history of ongoing facial paralysis (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes). Concomitant medication included Levothyroxine at 100mcg taken once daily in the morning early before she eats with Start date unknown, but at least 10-15 years ago for Thyroid. Enalapril at 10mg taken once daily (Caller initially reported product name as Vasotec, but clarified it is not Vasotec, it is drop for eye cataract and glaucoma) for High blood pressure. Brimonidine with Strength unknown, 1 drop in both eyes twice daily, started maybe 1 year ago. Specified cataract and glaucoma in left eye; but drop was administered to both eyes; and left eye was eye affected by Bell's palsy for Cataract and glaucoma in left eye. The patient previously took codeine and experienced allergy with onset maybe about 50 years ago, she was not sure; occurred during dental procedure; had bad headaches but no lasting effects so they assumed allergy to codeine; she did not know if still has allergy but says she does if asked. The patient experienced bell's palsy/developed facial drooping/her eye was drooping on 29Jan2021 with outcome of recovering, may have had a mini stroke on an unspecified date with outcome of unknown , fell on 27Jan2021 with outcome of unknown (reported date of end of reaction was 27Jan2021), she could not blink that eye on 29Jan2021 with outcome of not recovered. Five days later she fell and developed facial drooping. HCP suggested she may have had a mini stroke causing facial drooping and the fall. She went to the ER on 29Jan2021 and the ER believed it was Bell's Palsy. She was still experiencing facial symptoms but they are improving. This consumer was administered her first dose if Pfizer COVID-19 Vaccine 22Jan2021. She reported having fell 27Jan2021. She was diagnosed with Bell's palsy in 29Jan2021 after having been seen in the emergency room. She is supposed to have the second dose/booster of Pfizer COVID-19 Vaccine on 12Feb2021. She called to ask if she should or should not still get the second dose as scheduled; and if Bell's palsy could be a reaction to the Pfizer COVID-19 Vaccine. The emergency room staff did not know how she got Bell's palsy, but knew she had the Pfizer COIVD-19 Vaccine and were kind of assuming the Bell's palsy was a reaction to the vaccine. She dis not have Bell's palsy bad. The emergency room staff thought at first she had a stroke before diagnosing her with Bell's palsy. On Wednesday, 27Jan2021 she had a friend named (Name withheld) who came over for tea. Patient has an oriental rug, and around 15:00 patient fell face first on oriental rug. She was just fine after the fall initially. She wonders if her having fell has anything to do with the Bell's palsy. She thinks it was the night of 27Jan2021 or 28Jan2021 when she asked her son if her face looked funny, did she look ok, because her face felt a little funny. She was looking in the mirror and her smile was looking crooked, and her eye looked like it was drooping. When she got up Friday, 29Jan2021 she could see her eye was drooping, and she could not blink that eye. She called her Ophthalmologist who saw her the afternoon of 29Jan2021 around 13:30-13:55. The Ophthalmologist said yeah something is going on with that eye. Her friend called his friend who is a Pediatric Neurologist that advised her to go to the emergency room. She was seen in the emergency room of (Hospital name withheld) around 17:00 on 29Jan2021. She was not admitted to the hospital at that time; but was evaluated and treated. She Bell's palsy outcome: she is doing so much better. She still has a hard time blinking her left eye, she still cannot blink her bad eye: left eye, without also closing her good eye: right eye. She is not drooling, she can drink without drooling. Her smile is still just a little crooked. She was given 2 prescriptions in the emergency room which were Prednisone and Valtrex. On 29Jan2021 in the emergency room they did tests including testing her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure. There were no notable or abnormal results of any of those tests. They wanted her to go see her doctor last week but she did not have a chance to do so. She has an appointment with her primary doctor on Monday coming up. She has not yet seen her primary doctor about this. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. The event Bell's palsy require a visit to Emergency Room, no to Physician Office. The patient was not hospitalized. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests which included her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure, all with no notable or abnormal results of any of those tests on 29Jan2021.

began to hallucinate; Dizzy; bed nightmare; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Expiration Date: May2021), via an unspecified route of administration on 31Jan2021 at 79-years-old at a single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing, shrunk a little from an unknown date and unknown if ongoing ("about 5'9 and I was always 5'10 but I think I shrunk a little"). Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure high from an unspecified date to an unspecified date ("I have blood pressure, high blood pressure. I am taking a blood thinner. I was taking the other one, but they told me to look the other one (BYSTOLIC). It (BYSTOLIC) is a new drug I would say."). The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date and experienced adverse event ("no problem, nothing happened, there were minor things here and there"). On an unspecified date in Feb2021, the patient began to hallucinate (medically significant), dizzy (non-serious), and bed nightmare (non-serious). The patient did not receive treatment due to the events; "No, I just ignored it." The clinical course was reported as follows: The patient stated, "I took the virus vaccination shot (clarified as COVID 19 vaccine). The first one, there was no problem, nothing happened, there were minor things here and there. The second one I took was just this past Sunday. Something weird happened not right away, not the first day but probably it was second day, second or the third day, I am pretty sure I am not sure exactly, I think. I was not keeping track of all of that." The patient began to hallucinate; and when she got out of her bed, she suddenly had a feeling that she should look back. The patient stated that she looked back and there was her deceased sister (who died 37 years ago; according to the patient) and her daughter who was still alive; both were looking at her. The patient further reported the following: "They remained in my bed beside me. Okay, I ignored it and thought it was kind of funny because I know that my daughter is in (place name) and my sister is deceased. So, I am having a bed nightmare or something, so I ignored it. Then next thing it happened for a few days and then the dog that we just had euthanized, my daughter (name) had cancer and it was euthanized and what happened is, I was sitting on my sofa and I have seen the dog come out of my bedroom going to the bathroom but only the back of her and she disappeared. Then I spent the night at my other daughter's house and somewhere in the middle of the night I was awake in my something and I woke up and I looked over into my sistert's dining room and there was my brother standing there looking at me and there was two of his children sitting at the table also. I thought this is getting a little weird." The patient reported that nothing like this happened before. The patient wanted to understand the event because she "never had been dizzy from my drug, taking the drug (unspecified medication) that made me dizzy but that not the same thing what is going on here." The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.

sinus infection; cannot see out of her right eye; sick; terrible terrible splitting headache on her right temple; can't sleep; pressure behind her right eye; head is all fuzzy; mind isn't good; throat hurts; jaw hurts; little off balance; she walks she falls into things; she walks she falls into things; can't see things hardly in her right eye; pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included atenolol for blood thinner. The patient previously took first dose of bnt162b2 for Covid-19 immunization and experienced no adverse event. The patient stated that she received the second dose of the vaccine on 04Feb2021 and has been sick ever since. She has a terrible terrible splitting headache on her right temple and can't sleep and was having so much pressure behind her right eye. She stated she can't even lay her head on a pillow. She stated she had no reaction to the first shot but this time her head is all fuzzy, her mind wasn't good and when she sets things down she can't remember where they are. The second shot was really giving her a fit. Her throat hurts, jaw hurts, head hurts, and feels like she is running a temperature. She is a little off balance, when she walks she falls into things because she can't see things hardly in her right eye. She stated she can't put up with the pain any longer, it is terrible behind her temple and eye. She thought it was a sinus infection but now she thinks it was from the shot. She stated she almost had a wreck today because she cannot see out of her right eye because of the shot. She hit a telephone thing and almost wrecked 3 or 4 times. She tried to get tested for Covid but she didn't have an appointment and she cannot go to work until she finds out about the virus. She was going to get tested tomorrow but was going to have to call the rescue squad because she can't drive and she was not putting her son through this if she has the virus. The patient asked if she was allergic to the second shot or if these were normal symptoms. She asked what she should do. She stated she takes Atenolol, a blood thinner, and thyroid medicine. She stated she was taking Tylenol but it doesn't help any and nothing seems to help. All the events occurred on Feb2021. Outcome of all the events was unknown. Information on the lot/batch number has been requested.

When making way to the bathroom, patient got dizzy and fell head first onto hardwood floor injuring her face and her knees. This bruised her entire face except a portion of her left cheek. She had already been having muscle and joint pain in her arms and shoulders and had been light headed since her 2nd vaccination. Patient did not make appointment.

Four days after first Covid shot woke up with extreme dizziness/vertigo at 3:30 am. Called Hospital ambulance because I was alone. Went into ER where they did a CAT scan and an MRI. Showed nothing unusual, so they sent me home after 5+ hours with Meclizine.

Patient complained of feeling dizzy 10 minutes after receiving vaccine. Elevated blood pressure. Was seen in the Emergency Department related to her ongoing elevated blood pressure, headache, and dizziness.

At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a reaction including itchiness all over my body, redness all over my body, abdominal discomfort, diarrhea, vocal changes, lightheadedness, felt hot (but didn't have a temperature, 97.4 degrees Fahrenheit), joint pain. Took Benadryl, and symptoms resolved after about an hour.

Patient had shot Tue. eve.2/9. Woke up Sat AM with sever lower back pain to where she could not stand up without help. Specifically complains of pain in her tail bone, especially when she sits. Went to ER on Sun. AM (2/15) . (diag. Lumbosacral Strain). Saw GP (2/17) ordered PT. Started PT 2/19. 2/23 pain in tailbone gets worse, went to Urgent care, had X-ray of tail bone (OK). Diagnosed with UTI on 3/1, put on Levofixacin 500mg. Received 2nd vaccine 3/3, RT on 3/5 patient walking better. patient on 3/6 complaining of pain getting worse

Three days after second vaccine, I started to get sore in left shoulder, two hours later the pain had moved up my neck. By nighttime I could barely move my head to the left and pain was severe. i was very chilled and could hardly stop shivering until I took a heating pad and dressed warmly and went to bed. Sunday, still have a lot of pain and taking aspirin for the pain. Also will use SalonPas for the painful areas to see if that helps. Still cannot move my head to the left without pain.

Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/8/2021 3:04 PM COVID VACCINE CLINIC 3/8/2021 Patient Date: 3/8/2021 MRN: Subjective Pt is a 79 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis Date ? Allergic rhinitis, cause unspecified ? Allergy ? Asymptomatic postmenopausal status (age-related) (natural) ? Atrial fibrillation (HCC) PAF ? Breast cancer (HCC) ? Calculus of kidney ? Depressive disorder, not elsewhere classified seasonal ? Egg allergy ;No flu vaccine due to egg allergy ? Measles without mention of complication ? Mixed hyperlipidemia ? Obstructive sleep apnea (adult) (pediatric) ? Osteoarthrosis, unspecified whether generalized or localized, unspecified site ? Other complications of anesthesia, initial encounter hard to wake up ? Outcome of delivery, single liveborn ? Rubella without mention of complication ? Tinnitus ? Unspecified essential hypertension ? Unspecified hypothyroidism ? Varicella without mention of complication ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, dizziness and headaches Negative for vision changes: + lightheaded: Previous Reactions: vaccines d/t hx of egg allergy. Objective Vitals Vitals: 03/08/21 1313 BP: 126/64 Pulse: 61 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious (slightly, improved after removal of mask for a few minutes. Pt placed mask back on. Feels better). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: see physical exam Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Anxiety Pt observed in bay area for 15 minutes. Improved and is doing well. Pt assisted out via wheelchair by husband. Pt declined help out. She felt well in standing position in the medical bay prior to discharge. Pt declined water and snacks. F/up with pcp as needed. APRN Electronically Signed 3/8/2021 1:33 PM

1120 Rec'd vaccine; while checked on, no complaints At 1140, let nurse know with further questioning, upon sitting after vaccine, slight nausea and lightheadedness, headachedenied issues with shortness of breath, no swelling of lips, no apparent hives/itching, slightly improved. Notes walked quite a far way from parking lot; would now like wheelchair ride back . BP 120/70 ; HR 52-58 notes on metoprolol; p ox 96%. Monitored another 10-15 minutes, took sips water; felt ready to go. Knows to seek medical attention if further symptoms. Encourage to follow up with MD re: tiredness, low pulse; notes it is normal for her in 50s/60s.

Patient presented to the ED 3/11/2021 after rolling out of bed and landing on her right knee. Patient reported pain of the right knee but denies any other symptoms.

Dizziness; feels unsteady at times; nearly passed out/totally passed out; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN6198), via an unspecified route of administration, administered in Arm Left on 27Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. There were no concomitant medications. It was reported that the patient received first COVID shot Saturday. She confirms the Pfizer COVID 19 Vaccine. She says 24 hours after she had the shot she nearly passed out, she got really dizzy and someone asked, are you okay, and she said no and they caught her before she totally passed out and she sat down. She is still having waves of dizziness and she feels unsteady at times, not every second but she is a little scared to drive a car. She just thought someone should know that. It was reported that dizziness began the next day on 28Feb2021 around 3pm. She closes her eyes and says she doesn't want to look at that. It is ongoing but it is not so bad after she gets up. It seems to have lessened after about 3 pm yesterday it is bothersome. She confirms it is ongoing but improved a little since it began. The outcome of the event dizziness was recovering, while unknown for the other events was unknown.

Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat - all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.

03/14, face flushed. 03/15, felt as if I was hit by the flu: chilled, aching, sore throat, feeling exhausted. 03/16 no sore throat but "dizzy," off-balance all day in addition to other symptoms. 03/17, not feeling chilled but still feeling slightly "dizzy" (off-balance) all day with mild aching and still feeling tired. 03/18, virtually all symptoms disappeared.

Started experiencing Vertigo, I am still having symptoms. Been to the doctor 3 times. Seeing ENT this week

I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed out for couple of minutes; Chills; Weak; Dizzy; Nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 79-year-old, on 06Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation. After taking the second dose on 06Mar2021, the patient waited for half an hour and there was no problem. The patient came home no problem. In the middle of the night, the patient woke up with chills, the patient know that is one of the side effects, she was okay and not worried about it. The patient took her temperature that was normal but then couple of hours later, she went to the bathroom and the next thing she knew was that she woke up on the bathroom floor, the patient passed out for couple of minutes. Then she went to bed and was very weak and dizzy and nausea. The patient didn't want to call right away or did not wanted to go to the emergency room. The patient called her friend because she got very nervous and she said come back to her house. The patient took a Benadryl (treatment) and came back home and slept few hours. The patient woke up this morning, felt pretty good and took Benadryl (treatment) and then came here of her friend house and took Benadryl (treatment) again few minutes ago and four hours later. The patient had several things like these like she was dizzy and had nausea. The patient felt okay now and she doesn't want to go to emergency room and she seems to be fine now. The patient was dizzy, nausea and passed out. The patient had a chills and experience sore arm. Outcome of the events was recovered in Mar2021. Information on the lot/batch number has been requested.

On 3/11 pt reported severe n/v to pharmacy - called back 3/12 to state sx resolved. On 3/22 pt called back stating sx started again 3/13 and lasted thru the week. Pt currently in emergency room post fall on 3/21 and getting fluids for severe dehydration

Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart attack or a stroke or something; Fell on her right side; Cerebrovascular accident; Diarrhea; Nose running; Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt; like having charley horse where her calf muscles were so tight it hurther calf muscles were so tight it hurt; her calf muscles were so tight it hurt; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included family history of glaucoma from 2019 (Her mother has Glaucoma); memory ain't that good (she puts everything on her calendar because her memory ain't that good); ongoing irregular heart beat since 2006 (periodically when she goes to the doctor they have her walk the treadmill and stuff like that); ongoing diabetes since 2011; and was allergic to Penicillin (as a kid she was bitten by a dog, she must have been about 12 years old, went to hospital they gave her a shot of penicillin, her head blew up, she looked like a monster, she went back they gave her Streptomycin). Concomitant medication(s) included brimonidine taken for glaucoma from 21Feb2021 to 01Mar2021; latanoprost taken for glaucoma; apixaban (ELIQUIS) taken for arrhythmia, and dyspnoea from 2019 and ongoing; and metoprolol taken for arrhythmia. The patient was administered with her first dose of COVID-19 vaccine on 18Feb2021. It went beautiful, she did not have any aftereffects or anything initially. On 01Mar2021, while in her own apartment she stood up to go to the bathroom and could not put her right leg down; she thought she was having a heart attack or a stroke or something and she fell on her right side. She went to the hospital where she was hospitalized overnight for observation and testing. MRI performed during that hospitalization had result of Cerebrovascular Accident-CVA. She also reported onset of diarrhea and nose running around 01Mar2021. When she went to the hospital on 01Mar2021 she was laying down, and when the doctor moved the blanket to test her legs her calves were so sore, like having charley horse where her calf muscles were so tight it hurt. The events were reported to have required a visit to the emergency room. They did not find anything else during hospitalization with testing. The only thing she can think of related to these events was the COVID-19 vaccine. She called to ask if she should or should not get the second dose of the COVID-19 vaccine as scheduled for 11Mar2021 relative to these events. She was scheduled for second dose on 11Mar2021, but she is scared because of events that occurred 01Mar2021. The outcome of the events diarrhea, "Nose running", "Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt", "her calf muscles were so tight it hurt" was recovering, and for other events was unknown.

First and second day (1/21/2021 and 1/22/2021) after receiving vaccine: sore arm, slight fatigue. Fourth day (1/25/2021), extreme vertigo, nausea, vomiting, weakness, unable to stand. Husband called primary care physician who said I should go to ER immediately. Blood pressure elevated. Fluids administered. Chest X-ray, CT head. Morning of 1/26/2021,MRI brain w/o contrast. Later same day: MRA head, MRA head IAC w/ and w/o contrast. MRI IAC, MRV w/o contrast. Ultrasound carotid duplex bilateral. Diagnosed with Right Vestibular Schwannoma, benign, measures approximately 1.5 x 0.9 x 1 cm. Remained hospitalized until 1/27/2021 about 7:00pm. Follow-up with physician. primary care physician; (Otologist and Neurotologist,) and (Clinical Audiologist) at. Follow-up treatments will include consultations with above physicians, additional MRIs and CTs, and possible targeted radiation or surgery.

Initial rash on forehead after first injection. After second dose several weeks later she immediately (next day) had hip pain and difficulty walking. It continued to worsen every day. On the 9th day after the second dose she started vomiting. Currently she has joint and muscle stiffness, extreme weakness and fatigue. She can hardly lift up her toilet seat. Her PCP started her on oral prednisone and she is now on 10mg qod.

Tightness in chest; dizziness; chills; headache; warm red injection site; warm red injection site; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old non-pregnant female patent received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm at the age of 79-years (non-pregnant at the time of vaccination), on 17Feb2021 at 01:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number: EL8982), via an unspecified route of administration in left arm at the age of 79-years on 27Jan2021 at 01:30 AM at a single dose for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced tightness in chest, dizziness, chills, headache and warm red injection site on 17Feb2021. The seriousness of the events was reported as no. The patient did not receive any treatment for the events. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Syncope. about twelve hour later she developed some chills and fever and dizziness which was not unexpected. Overnight into Saturday morning 3/27/2021 however she fell a few times and believes that she did pass out. She injured her face in the fall but no other injury and the injuries or not severe. By our appointment on 3/29/2021 She is feeling a little bit fatigued at this point but otherwise back to her normal self.

Headache; very sore joints; so weak had trouble walking; so weak had trouble walking; went to bed night of vaccine didn't get up till Sat morning; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown), dose 2 via an unspecified route of administration, administered in right arm, on 25Feb2021 at 12:15pm (at the age of 79 years old) as single dose, for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Public Health Clinic/Veterans Administration. Medical history included allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was receiving other medications within 2 weeks of vaccination however they were not provided. The patient received dose 1 of BNT162b2 (Lot number EL-9262) in right arm. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 25Feb2021 at 18:00 (6:00pm), the patient experienced headache, very sore joints, so weak had trouble walking and "went to bed night of vaccine didn't get up till sat morning". Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the events headache, very sore joints, so weak had trouble walking and "went to bed night of vaccine didn't get up till sat morning" was recovering. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.

Temp of 101.3, chills, discomfort in left arm so couldn't not raise it ....in evening Next morning temp was 99.7 (usual am temp is 97.7) and felt much better.

patient had dizziness about 5 minutes after the vaccination, patient felt like she needed oxygen and so we decided to contact ems once she stated she was having feelings of passing out. patient was seen by ems an ekg was run, blood pressure was 200/100 and the ems advised her that this may be a panic attack related to getting the vaccine that the increase in blood pressure was not a hypertensive emergency. patient then chose to stay and wait for her daughter to come pick her up. her blood sugar was also taken and it was 99 within normal range.

Starting the day after receiving the vaccine, I was so exhausted that I could barely get out of bed. This was accompanied by trembling, especially in the upper body. This exhaustion and trembling has continued, with some remissions, through today, seven days later.

my arm is a little bit sore; shivering; I was so cold; I ached all over; I am getting the flu; I could not walk, it was like I was drunk; pulse rate was like 116; O2 stat was like 98 percent; headache; diarrhea; short of breath when I walk up to the stairs; blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's; This is a spontaneous report from a contactable Nurse (Patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included High cholesterol. Concomitant medication(s) included rosuvastatin (40, not clarified further); aspirin [acetylsalicylic acid] (ASPIRIN) (81, not clarified further); zinc (50, not clarified further); alendronate sodium (Generic Fosamax) and Multivitamin. Historical Vaccine included First dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation and experienced sore arm (The sore arm went away, it descended in about 12 hours and gracely went away), got really tired and itching (It started itching, okay no problem). The patient experienced my arm is a little bit sore on an unspecified date, shivering on an unspecified date, I was so cold on an unspecified date, I ached all over on an unspecified date, I am getting the flu on an unspecified date, I could not walk, it was like I was drunk on an unspecified date, pulse rate was like 116 on an unspecified date, O2 stat was like 98 percent on an unspecified date, headache on an unspecified date, diarrhea on an unspecified date, short of breath when I walk up to the stairs on an unspecified date, blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's on an unspecified date; all (non-serious). Reporter (Nurse) stated "I had my first Pfizer vaccine on Friday, I think 22Jan2021 and the only thing I have was the sore arm and got really tired okay and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching, okay no problem. I had my second vaccine this past Friday at about 8 O'clock between 8:15 in the morning. As the day went on I felt my arm is a little bit sore, no problem. Okay I went to bed and about 3 O'clock in the morning, I woke up and I was shivering, I was so cold and I ached all over and I said okay I am getting the flu, went back to sleep, by the time I got up in the morning about 6 o'clock the aching was gone but I could not walk, it was like I was drunk. I have a little dog and she was barking to go out and it was like 0 here so I sat there for a minute and I left her out and she started barking, to bring her back and I could not walk, I kept walking into the walls and my house was just this dark, I thought it's so dark in my house so I got my little dog back in, sat down and again and I thought what, maybe I will take my blood pressure, so I did and it was 66 over 48 so I though okay, so I started drinking, I thought I got to eat, I got to drink, so I get that, my pressure came up to 80 over 62 or something, my pulse rate was like 116, my O2 stat was like 98 percent so that was not a problem. So, I ate and drink, as the day went on the pressure came up to like about 103, gradually last night by the time I went to bed, the only thing I had was a little bit of headache, I did not thought enough to take anything for, when I went to bed, my pressure was like 120, the systolic was 120 and diastolic was like 70 something, this morning when I got up my pressure was in the 90's. I was not taking any blood pressure medication, I mean I have but doctor took me off long time ago, I did not I mean I have no aches, I have no pains, I have nothing just a little bit of headache, not even enough to bother me, every now and then I think about it, I also, I mean I thought I have got to the bathroom, I had diarrhea terribly, something, I did not know if any of this is from the vaccine. I have not called my primary, I thought I called him tomorrow I mean I am fine, I am little short of breath when I walk up to the stairs but that is nothing unusual." Causality: Reporter stated "I don't know, I am thinking it does I never had anything like this before but you know I don't know, I don' know, I am just reporting it, I am 79 so I don't know how much this is, I don't know." When probed from where reporter got the vaccine, Reporter stated "I got it the first one at (Institute name)." LOT# of COVID-19 Vaccine administered on 22Jan2021: Reporter stated "You know it's not on my little card, just the LOT# of second one is on here. The first vaccine was 22Jan2021, the second one was 12Feb2021." Reporter provided the LOT# as EM9809 for second shot of COVID-19 Vaccine administered on 12Feb2021 and did not have LOT# of the first vaccine administered on 22Jan2021. Date of side effects: Reporter stated "I think when I started having difficulty was the morning of 13Feb2021." (Not clarified further). Still experiencing side effects: Reporter stated, "No, finally last, I felt yesterday I felt like I kind of had the flu, I have got to get the flu, but it was not enough to stop me, I kept going, I went to work, I did all my stuff, this morning I got up I felt fine." (Not clarified further). Treatment: Reporter stated: No, did not take anything, no. Other medications: Reporter stated "the generic 10 mg." (Not clarified further). Reporter stated "No I was just going to report this, like I said I don't know if this is a problem or not. I have never had anything like this before, I thought this is something you needed to know." Reason of delay: Daily spike of incoming calls due to COVID-19 Vaccine. The outcome of all events was unknown except for event I ached all over, outcome was recovered on an unspecified date.

suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tiredness she could hardly walk; muscle aching; Joint pain; felt very sick and couldn't really function; could hardly walk; stayed in bed all day; This is a spontaneous report from a contactable (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:00 (Batch/Lot Number: GL9269) as single dose, dose 1st via an unspecified route of administration, administered in Arm Right on 21Jan2021 (Batch/Lot Number: el8982) as single dose for covid-19 immunization. Medical history included apnoea from 2019 to (Verbatim: Apnoea, Diagnosed 2 years ago) , hypertension ( Verbatim: Blood pressure high, diagnosed 15-20 years ago). The patient's concomitant medications were not reported. Family Medical History Relevant to adverse event was none. On 10Mar2021 the patient woke up to a big reaction. The patient had exploding diarrhea, extreme tiredness she could hardly walk, muscle aching, joint pain, felt very sick and couldn't really function, she stayed in bed all day, got better in the late afternoon. It was as if the patient had covid, then it disappeared. The outcome of the events was recovered.

couldn't walk straight; use a cane; Guillain-Barre syndrome; left knee and left hip were so painful; equilibrium was totally off; tired; pink blotches and a red rash on her legs; pink blotches and a red rash on her legs; didn't feel good; her legs started burning; her eyes were bloodshot with dark circles; This is a spontaneous report received from a contactable female consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. The patient did not have any relevant medical history. Concomitant medications includes: Plavix (CLOPIDOGREL BISULFATE) 75mg, once a day, Oral, Losartan 100mg, 1/day, Oral for blood pressure high, toprol XL (METOPROLOL SUCCINATE) 50mg, 1/day, Oral for Blood pressure high, ezetimibe (ZETIA) 10mg, once a day for , Oral for High cholesterol. Vitamin C (ASCORBIC ACID) 1000mg, 1/day, Oral. Omega 3 1000mg, 1/day, Oral, taking for 2 years. Vitamin D 1000IU, 1/day, Oral, taking for 6 months. Multivitamin dose unknown, 1/day, Oral. Aspirin (ACETYLSALICYLIC ACID) 81mg, 1/day, Oral. All the Concomitant medications started dates was unspecified. It was reported that Consumer states she got the first dose 11Feb2021 of the Pfizer COVID 19 vaccine at 0945AM in the right arm. Adds she had no reaction the first day. Then about three days later (14Feb2021), she noticed pink blotches and a red rash on her legs; and she didn't feel good. About five days later she called the doctor who did a blood test. No results known. The doctor put her on Prednisone and she took three doses and on Feb2021 her legs started burning so she stopped. Adds she doesn't think it had anything to dowith the Prednisone; it was the vaccine. Reports she started to have balance and coordination problems, on 25Feb2021 her left knee and left hip were so painful that she had to use a cane and could not walk straight and her equilibrium was totally off so that she was she was walking into the wall. Mentions that on 17Feb2021 she was tired, on Feb2021 other eyes were bloodshot with dark circles. Mentions she did lots of research on her phone and decided that all of her symptoms seem to relate to GBS, Guillain-Barre syndrome. Clarifies she does not know if she has GBS. She has been to the doctor again and they are telling her not to get the second dose of the shot. Mentions that pretty much everything cleared up by 1Mar2021. Additional information includes plavix was used for head and neck blockage, taking for 10 years, Losartan patient took off the water pill portion HTZ part of months ago, toprol XL taking for 13 years. Zetia taking for 8 years. Vitamin C patient taking for her immune system, taking for 3 years. Omega 3 taking for 2 years. Vitamin D was taking for 6 months. Multivitamin. Aspirin patient taking for taking for keep blood flowing since 14 years. Outcome of the events didn't feel good, couldn't walk straight and use a cane and Guillain-Barre syndrome was unknown. Outcome of the events left knee and left hip were so painful, equilibrium was totally off and recovered on 01Mar2021. Outcome of the event her legs started burning was recovered on Feb2021. Outcome of the events her eyes were bloodshot with dark circles on 04Mar2021. Additional Information has been requested/ Additional information on lot/batch number has been requested.

Extreme weakness and fatigue. Could not walk, could not stand, could not lift head. Had to lift her to a portable toilet. Slow to respond. Lasted for about 3 days and then started to improve each day. Took about about 5 days to be back to pre-covid vaccination state.

she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered. Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.

immediate headache; extreme tiredness; dizziness; nausea; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry were not provided), via an unspecified route of administration, in right arm, on 06Feb2021 at 01:00 AM, as a single dose for COVID-19 immunization. Patient did not receive other vaccines within 4 weeks prior to COVID vaccination. Patient's medical history included known allergy. Patient received unspecified medications within 2 weeks of vaccination. It was reported that on 06Feb2021 at 01:00 AM, the patient experienced immediate headache followed by extreme tiredness, and dizziness. Patient also had nausea after 3 days which lasted several days. Patient did not have COVID-19 prior vaccination and since the vaccination, the patient was not tested for COVID-19. No treatment was given to the patient for the events. Outcome of the events was recovered on an unknown date in Feb2021. Information on the lot/batch number has been requested.

left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; little bit of soreness on my left arm where the injection went; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunization. Medical history included blood cholesterol, glucose tolerance impaired, pre-diabetic with HbA1C 6.1. Patient was allergic to Penicillin (swell), Metformin (swell), Sulfa (breathing trouble) and Allegra (headache). Concomitant medication(s) included rosuvastatin, calcium, vitamin D3, vitamin B complex. On 09Feb2021 (Monday, same day of vaccination, patient experienced little bit of soreness on my left arm where the injection went, on 10Feb2021 (Wednesday) left leg went to sleep and when stood up i fell on my left foot; maybe i have just sprained my ankle and there was extreme, swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing (Throbbing pain). The patient was treated with Ibuprofen 200 mg (Intent: Advil) and Aspirin but it was not doing anything to the patient. Patient states that she was usually very healthy and dont have problem with blood pressure. She was prediabetic and just taking care with diet and exercise. Patient was worried if this affect heart in anyway. There was a heart disease on her mother's side of the family, everybody on her side of the family died of a heart attack and patient younger brother has a stent put in and seen other people who have heart problems, and they have the swollen legs and feet and just wondering if that's the same thing that's happening to her. The second dose of vaccine was scheduled for 03Mar2021. The outcome of the events was unknown.

I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of back; She felt achy; fatigued; back discomfort; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; Her breast felt like it weighed 60 pounds and ached.; had the worse headache; Her shoulder blade was tender; neck pain; achy feeling was ongoing with her muscles; achy feeling was ongoing with her legs; legs felt rubbery; short winded; sweaty; she felt clammy and hot.; she felt clammy and hot.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration in left shoulder on 11Feb2021 at age of 79-year-old at single dose for COVID-19 immunization; methylprednisolone (MEDROL, Tablet), orally from 20Feb2021 to 26Feb2021, at 4 mg, by mouth, frequency was different based on the day, from 27Feb2021 to an unspecified date, at unspecified dose for swelling, the back. Medical history included thyroid and pericarditis fluid. Family history included brother had heart disease. There was no prior vaccinations within 4 weeks. Concomitant medication included levothyroxine sodium (SYNTHROID) ongoing for thyroid for 20 years. Historical vaccine included first dose of bnt162b2 in left shoulder on 21Jan2021 (Batch/lot number: EN6201) for COVID-19 immunization with no side effects. The patient had her 2nd Pfizer vaccine dose on 11Feb2021 and received a "medrol pack" on 20Feb2021 for "shoulder, back and neck pain. She have felt lousy for 4 weeks. She went to the hospital with palpitations and it probably was from the 2nd pack of methylprednisolone, she was prescribed after the 1st pack did not really help her pain. She haven't been sick or had a cold for 25 years and the 2nd dose through her for a loop. She stated her daughter called her and she said that her doctor told her that her vaccine may not be effective and she may not be protected because she took methylprednisolone. The patient received the second vaccine on 11Feb2021 and she had a lot of shoulder, under arm, and left breast swelling. The patient mentioned she went to her doctor because after calling the COVID hotline they said they had cases where some of the vaccine had seeped into the lymph nodes. She was told to have her lymph nodes. No patient demographic details provided regarding those other patients who had the vaccine seep into lymph nodes. She went on to explain she went to the doctor, but the doctor said there were no problems with the lymph nodes. On 13Feb2021, she felt achy and fatigued, back discomfort. The lightheadedness occurred on 18Feb2021. The doctor gave her a high dose of the methylprednisolone 4mg pack for a week. 16 days later on 27Feb2021 it had not touched the discomfort in back, fatigue and lightheadedness and gave her another pack of methylprednisolone. She also had heart palpitation, was sweaty and went to the Emergency Room. The patient mentioned she took a low dose of levothyroxine sodium (SYNTHROID). She asked the doctor about the methylprednisolone being taken after the shot. The patient heard it diminished the effect of the shot, that she may not have as much protection. She had called the COVID hotline to address this issue and they said people who were on chronic steroid therapy had no problem as far as they know. The patient asked if she was protected because she had the methylprednisolone pack the first one within 9 days after shot and a second pack 16 days later. She took a low dose of generic levothyroxine sodium every day. She commented she was concerned with the drug interaction and wanted to make sure still protected. She was informed by individual who answered COVID hotline she felt like she was still protected because others have been on chronic steroid therapy. Shoulder swelling started a couple day after the second shot, explained it was there or about around 13Feb2021. Her shoulder blade was puffy and tender. The swelling went into the arm and breast. Her breast felt like it weighed 60 pounds and ached. That took a while to go away. The patient explained initially it was also there or about around 13Feb2021 when she noticed she was so fatigue and had the worse headache (Feb2021), she never got nauseous. Her shoulder was still swollen a week ago as of 09Apr2021. She went to a chiropractor for an adjustment and the chiropractor said shoulder was still a little swollen. She had terrible back pain in center of back on 18Feb2021. It was so much that she was afraid something else was going on. The patient stated the swelling it was ongoing up until a few days ago as of 09Apr2021. She still had puffiness around that area when went to chiropractor. For the back discomfort she went to chiropractor for adjustment. She was unsure when that discomfort went away. The achy feeling was ongoing with her muscles and legs until last week as of 09Apr2021 when she started to feel better. Her legs felt rubbery. Her muscles felt achy. She felt better as of 09Apr2021. It had gotten better within the last week as of 09Apr2021. The fatigue was ongoing until last week as of 09Apr2021. The patient felt so bad for month and had no idea what was going on. Her lightheadedness went away last week as of 09Apr2021. She commented she did not want to blame all of this on the shot because she did not know what methylprednisolone did to her. The patient confirmed she had back discomfort. She still had some back discomfort. She started to fell short winded a week before the heart palpitations appeared really bad on 21Mar2021. She did not feel short winded anymore, but she was unsure when that stopped. With her heart palpitation she felt clammy and hot. Therefore, she wen to the ER. The heart palpitations gradually got better, and probably stopped totally last week as of 09Apr2021. She mentioned she had a headache for a good month after the second shot. It started either the 13Feb2021 or 14Feb2021. She stated all her symptoms were getting much better since last week as of 09Apr2021. There was no other treatment beside the methylprednisolone for her symptoms. Therapy start and stop date of methylprednisolone captured as confirmed by reporter in formal field, unable to clarify further. The patient confirmed all had been discarded and no lot/exp/NDC to provide. When she was in Emergency room, they did two EKG, drew blood work for the heart, chest x-ray back and front, and verified vital signs which were all good. She went home that same night on 21Mar2021. She went back to doctor on 05Apr2021 and did another chest x-ray and another echocardiogram and everything was fine. The event heart palpitation required a visit to emergency room, the patient was not sure if from the vaccine or methylprednisolone. The patient's heart rate got to 120, her normal was 80. The relevant Tests on 21Mar2021 they did Chest x-ray back and front, a couple EKG and blood work. The patient went back about a week ago as of 09Apr2021 because she was still not feeling great. They did an EKG, ordered echocardiogram and chest x-ray which were done on 05Apr2021. Test results came back on 08Apr2021. She had pericarditis fluid in the past and that's what they were checking for with the echocardiogram. The lab tests and procedures for investigation on 21Mar2021 included: chest X-ray: negative, EKG: negative, blood work: negative, negative. The action taken in response to the events for the methylprednisolone was unknown. The outcome of achy, back discomfort, back pain was resolving, the outcome of short winded was resolved in 2021, outcome of headache was resolved in Apr2021, the outcome of other events was unknown. Information on the batch number has been requested.

Since the second dose of the Pfizer vaccine, up to and including today, I have had daily periods of fogginess. I feel as though I am wrapped in cotton and am seeing things from a distance. These events generally go away in anywhere from 15 minutes to half an hour. Sometimes the recur in the same day, sometimes not. When I am in the fogged state, when I take a step, I find I have no control of, or contact with my lower limbs and I stumble. This has been going on for over a month. And the feeling of exhaustion felt after dose #1 and dose #2 has continued intermittently.

lightheaded; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration at left arm on 25Feb2021 (79-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes. Concomitant medications were not reported. With the first COVID-19 vaccine the patient was lightheaded (from 25Feb2021) for 2 days then she was great. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

she has been dizzy; She also has tremendous problems with depth perception/She can't tell how far away cars are from her; This is a spontaneous report from a contactable consumer (patient). This is the first report for the 2nd dose. A 79-year-old female patient received 2nd dose of BNT162B2 (Covid 19 vaccine) on 19Mar2021 at single dose on left arm for covid-19 immunization. Medical history was ongoing Type 2 Diabetes. Concomitant drug was not reported. Historical Vaccine was the first Covid 19 vaccine on 25Feb2021 she was lightheaded for 2 days then she was great. She reported online that ever since getting her second vaccine she has been dizzy. She just got done with a neurology evaluation and the neurologist said he's never heard of this before. She can't drive, it's difficult to walk, it's awful. The neurologist is sending her for an MRI. She's never been sick or had a reaction to anything. With the second Covid 19 vaccine she was dizzy, everyone told her to take it easy, but the dizziness never went away. She's been on her couch since 21Mar2021. She also has tremendous problems with depth perception. She reports she is a psychologist. She reports she'll have routine blood work done in about a week and a half. She has routine blood work drawn every 3 months. She's doing good considering. She has not scheduled her MRI yet. When probing for additional information regarding vision problems, she reports depth perception. She can't tell how far away cars are from her. She didn't even want to get the Covid 19 vaccine. Her doctor's told her she should get the vaccine. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; sore left arm; This is a spontaneous report from a contactable consumer (patient's husband). A 79-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 79-years-old, via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP6955) as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. No Additional vaccines administered on same date. No Prior vaccinations within 4 weeks. Repoeter stating that he and his wife had shot number one, 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm on 27Mar2021. Sore left arm, same arm as shot. Arm was sore for the day. Treatment was none. Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe. Was prescribed pain medicine for a week but did not take because it makes her feel funny. Is one of those powerful medications, can't remember the name. No AEs require a visit to Emergency Room or Physician's office. Event outcome of sore arm was recovered on 27Mar2021, of broken right arm was recovering, of the remaining was unknown. No follow-up attempts are needed. No further information is expected.

Swelling of my tongue and throat. The second and third days I was unable to stand or walk without assistance and was extremely tired and also had memory lapses.

patient felt lightheaded and nauseous suddenly on the morning after the 2nd covid vaccine. she tried to lower herself to the floor, but blacked out and hit her head, requiring staples. she is still experiencing extreme fatigue, which is unusual for her. she is highly functional at baseline.

painful muscle; joint aching; temperature of 99.4; injection site pain; dizziness; general feeling of malaise; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 18Feb2021 at 10:15 (at the age of 79 years old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergic to penicillin. Concomitant medications included Levothyroxine .075MG, Losartan 25MG and Eye vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine on first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) in left arm on unspecified date for covid-19 immunisation. On 19Feb2021 at 12:30 the patient experienced 15 hours after the second dose COVID 19 vaccine I had painful muscle and joint aching, temperature of 99.4, injection site pain, dizziness and general feeling of malaise. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 99.4 on 12Feb2021. The outcome of the events was recovering.

Lightheaded and dizzy; Nauseous; Dehydrated; Lightheaded and dizzy; Atrial fibrillation with rapid ventricular response; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at the age of 79 years old, (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 Batch/Lot number was E or F, N6205;) as a single dose, for covid-19 immunisation. Medical history included diabetes from 2009, coronary artery disease from Jan2020, and atrial fibrillation and Shingrix Vaccine/NDC, Lot Number, Expiration Date not known by caller.Vaccination Date: Jul2018. Concomitant medications were not reported. On 17Apr2021, the patient reported not feeling well. 18Apr2021 she woke up in the morning and was lightheaded and dizzy. She was also nauseous.States she called an ambulance. She was found to be in Atrial Fibrillation. she also found out when she got to the Emergency Room that she was dehydrated. States she does not know if that ties in with the vaccine or not. She states someone told her she should be drinking a lot of water since she had the vaccines; asks if this is true. She was admitted to the hospital on Sunday 18Apr2021 and was released yesterday afternoon 20Apr2021.On 19Apr2021, she was lightheaded and dizzy, nauseous. She also experienced atrial fibrillation with rapid ventricular response and was dehydrated. The patient was admitted to the hospital on 18Apr2021 and released on 20Apr2021. The outcome of the events of not feeling well, lightheaded and dizzy, nauseous were recovered on 20Apr2021, the remaining events was unknown. .

Lethargy second and third day, but then felt fine afterwards; Dizziness during evening of vaccination and next day; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN6201 and expiration date was not reported), via an unspecified route of administration, administered in arm left on 18Feb2021 at 09:30 (at the age of 79-year-old) as single dose for COVID-19 immunization. The patient other medical history and concomitant medications were not reported. The patient previously took quinolones and had allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not COVID tested post vaccination. On 18Feb2021 at 20:15, the patient experienced dizziness during evening of vaccination and next day and lethargy on second and third day, but then felt fine afterwards. The patient did not receive treatment for the events. The outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

SEE LIST FOR LIGHT HEADED , FACE FLUSHED 5/6 DAY OF 5/9 AWOKE 00:45 WITH SHORTNESS OF BREATH, FACE PRICKLY feeling , CHILLS, oxigen sat 99/% lung clear,

Patient has been complaining of left hand paresthesias since receiving her COVID-19 vaccination. She received her first dose in her left upper extremity on 3/12/2021. Paresthesias began 4/8/2021. She had her second vaccination on 4/11/2021 in her right arm and reports one episode of right paresthesia on 5/5/2021. Describes paresthesias as numbness and tingling and have been constant since onset in left hand. She at times will even have a sensation of bugs crawling across her body.

Lightheaded/feeling dizzy; BP 168/68, BP 158/73, BP 152/73; O2 SAT 97%, O2 SAT 96%, O2 SAT 97%; HR 62, HR 68, HR 69; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 79-year-old non-pregnant female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number: el3302, Expiration date: unknown), via an intramuscular route of administration in left arm on 04Feb2021 at 09:19 at a single dose for covid-19 immunization in clinic (at the age of 79-years). The patient had rash to PCN (penicillin). The patient's medical history included HTN (hypertension) and concomitant medication included lisinopril for an unspecified indication on an unspecified date. The patient did not have any other illness at the time of vaccination and up to one month prior. Patient's vital signs were taken three times. On 04Feb2021 at 09:36, the patient experienced feeling lightheaded, BP (blood pressure) 168/68, BP 158/73, BP 152/73, oxygen saturation 97%, O2 SAT 96%, O2 SAT 97% and HR (heart rate) 62, HR 68, HR 69. Patient given water. After 20 minutes the patient stated feeling dizzy but wanted to leave. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

muscle pain; joint pain; tiredness; feeling unwell; a little bit of dizziness; losing strength in her hands; fingers are swollen up; achiness and pain are more pronounced than usually; This is a spontaneous report from a contactable other hcp. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported), dose 2 via an unspecified route of administration on 14Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, losing strength in her hands, fingers are swollen up, achiness and pain are more pronounced than usually. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 18Mar2021 and the second dose on 14Apr2021, about 2 and a half weeks ago or 3 she started experieinced side-effects, she had this side-effects in the past also and they include: muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, she's also losing strength in her hands because her fingers are swollen up. She states that this time the achiness and pain are more pronounced than usually. She would like to know if this could possibly be side-effects from the vaccine. She would like to know what are the recommendations. She would like to know how far after vaccination the side-effects were reported (onset). She would like to know how long this side-effects can last. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

her arm was sore near the injection site; then the soreness spread to her shoulder; she can barely move her arm and shoulder; She added she is in "excruciating pain";; it is "terrible" and "debilitating".; her arm pain; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. Patient medical history included spinal stenosis from an unknown date and unknown if ongoing. Patient concomitant medications were not reported. Patient persistently asked what to do to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She explained her doctor said he cannot help and has not seen this before. She then threatened to call her lawyer if a doctor or scientist from the company could not assist her. It was stated that patient received the second dose of the Pfizer-BioNTech COVID-19 vaccine on 26Feb2021. She explained a few days after, her arm was sore near the injection site, then the soreness spread to her shoulder and she can barely move her arm and shoulder. She added she was in excruciating pain; it is terrible and debilitating. She took pain medicine for the arthritis in back and described it as spinal stenosis. She mentioned this medication was barely doing something to help with her arm pain. She then specified she also consulted her doctor who prescribed gabapentin and methyl prednisone tablets, which aren't relieving her arm pain. She expressed her concerns on the persistence and intensity of her pain. She asked if her symptoms were reported as side effects to the vaccine. Patient expressed her disappointment on the lack of information provided to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She said she was excited to get this vaccine among the other brand, and now that she is injured from it, she feels like Pfizer should be by her side and thus claims to have help from Pfizer. Outcome of the event her arm pain and her arm were sore near the injection site was not recovered. Outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Caller is unable to receive her monthly osteoporosis injections; dizziness; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an intramuscular route, administered in Arm Right on 28Jan2021 07:50 as UNKNOWN, SINGLE for covid-19 immunisation. Patients medical history included hypertension, sleep disorder, blood cholesterol abnormal, acid base balance abnormal, osteoporosis, hypersensitivity, seasonal allergy, allergy to animal dogs, allergy to animal cats, dust allergy, vertigo, inner ear disorder, compromised immune status, obesity, endocrine abnormalities (including diabetes), genetic / chromosomal abnormalities, respiratory illness and diagnosed allergies. Concomitant medications included melatonin taken for sleep disorder and amlodipine 5mg once daily, taking for 3 years taken for hypertension. Patient did not receive other vaccine in four weeks of vaccination. Patient did not have adverse event prior to vaccination. Patient stated that, she was unable to receive her monthly osteoporosis injections. she just had her first Pfizer vaccine today. She supposed to get a shot called Evenity, in each arm monthly for osteoporosis. How long do I need to wait after receiving the Pfizer vaccine she was suppose to have it last week and the Nurse said I should wait. She did have a reaction that was not too bad. She was dizzy about 20 minutes after getting it. They took her blood pressure and heart rate and they were a little high. They rechecked it twice and it went down a little bit. It is still a little elevated. They were more concerned it was too low, but it was not. That is not her main reason for the call though. She would like to know how long does she need to wait before she can get her Evenity injection. There was no prescriber. It was an initiative for her age group. (Hospital name) is the place that send her an invitation by email and they were sending to people over age 75. They did not give her a card yet, just 3 pages about the vaccines. Her next appointment is 3 weeks from today. She had to go to bed earlier. She only has taken it 3 times. She did not even sleep well with it. She is on blood pressure medication, cholesterol and acid blockers but was on all prior to taking. She took Melatonin the night prior, but said she has only taken it 3 times over the last 2 months. She still did not sleep that well. She did not have a lot or expiration to provide. She usually takes the blood pressure medication before she goes to bed. She did not take it last night and she took it this morning, which is not her usual habit. It is Amlodipine 5mg and is in a pharmacy vial with no lot or expiration. When she had Shingles vaccine a couple of years ago, she had a rash after the first one on her arm. After the second one, it was worse on her arm and face and she had a headache. It was the new Shingles vaccine and she does not remember the name or manufacturer. She did not have a lot or expiration for either dose. It was given probably on the left arm. medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She does have a lot of allergies. Most of them are environmental such as seasonal allergies, dog and cat air, dust and mold. She does have a history of Vertigo caused by an inner ear problem. In the last 7 years, she has had 3 occasions of vertigo. On an unspecified date, the patient experienced caller is unable to receive her monthly osteoporosis injections and on 28Jan2021 08:10 (20 minutes of the vaccination), dizziness. Outcome of the event caller is unable to receive her monthly osteoporosis injections was unknown and for dizziness was recovering. Information on lot/batch number has been requested. Follow-up (19Apr2021): 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.

ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis without hematuria +1 more Clinical impression Sore Throat ? Fever ? Back Pain Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Sore Throat ? Fever ? Back Pain 80-year-old female with multiple complaints. Patient states she had her second Covid vaccine yesterday. Since then she is complaining of having generalized weakness, headache, body aches, back pain, cough, nausea, generalized weakness and dizziness. No abdominal pain. She has nausea but no vomiting or diarrhea. No dysuria. Denies any chest pain.

10 minutes after the shot was given, her daughter yelled out to us that patient had slumped over momentarily in the chair of the waiting area. We went out to assist her, she was sitting upright with assistance from her daughter when we got out there. As we asked her questions, she was staring blankly at us and not responding to our questions, we called 911. She did not answer us for as least a couple minutes, although there was a pulse and she was breathing. She was sweating profusely. Daughter said she was warm and dizzy right after, also that she has a history of fainting and fear of blood.

tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient). A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep. Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.

a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information expected.

She got her vaccine, she had no symptoms. The following day had very little soreness and nothing else. Went to bed, woke up soaking wet, diarrhea, vomiting, dizzy. She did not have skin feeling funny like with regular flu, but mostly all intestinal. She changed her clothes and then was shivering and could not get warm, and had hard shaking chills. She slept very little and has had it continuous since the vaccine. She has been falling a sleep a lot, day, night and was previously very active and now falls asleep at a drop of a hat. Over the past week and a half has had the cold chills less, but has awakened moist. She is having the diarrhea and GI issues less, but feels nauseous at times during the day. She is still waking up between 11:00 and 2:00 waking up, but falls sleep a lot, does not have a regular schedule as she did before. It is not debilitating as much but still tired a lot.

3/11 woke up with severe chills, joint pain and headache 3/25 experienced numbness down my entire left side, had a severe headache and difficulty walking

nauseous; couldn't sit up; spinning; This is a spontaneous report from a contactable consumer. A 79-year-old female consumer (Patient) reported that she started to receive BNT162B2 (BNT162B2, formulation: Solution for injection, vaccinated at the age of 79-year-old) via unknown route of administration from 21Jan2021 16:00 to 21Jan2021 16:00 at single dose daily for covid-19 immunization. Patient's medical history was reported that, I have allergy to penicillin and sulfur but this was 50 years. Felt like my throat and ears were closing. Concomitant medications were not reported. It was reported that caller she received the first dose of the Pfizer vaccination on 21Jan2021 at around 4 in the afternoon. She had a bad reaction. She drove 1 hour and 45 minutes away and she was fine that night. Caller stated, "The next morning, I was nauseous. I couldn't sit up. I had to call my daughter to help me sit up. When I tried to sit up. it was like it was I had to push (myself and my daughter) up a mountain in a tornado. I couldn't control my body even if you tried. It was a very severe reaction if not vertigo. It was awful. spinning widely, nauseous. I called the doctor and he prescribed some vertigo medication/nausea medication. We tried an Epley maneuver for vertigo. spinning uncontrollably. which ear it was in. did the epley maneuver itself. I couldn't bend down. The last week or so I've been cautious but ok, tried to seen ENT and I have a therapist to help me do that Epley maneuver again. I don't want to set off anything. I don't know if you had any reports of any like that? I'm due to get my next shot 11Feb2021 and I have to drive 2 hours again and will have to drive home again. I'm most concerned and my doctor feels I need to get the second dose too. I reported to VAERS. The outcome of events was "unknown". Information on lot/ Batch number has been requested. 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.

I started feeling tired later on that afternoon and in the middle of the night I started having chills and fever. The very next day I was so weak I couldn't get out of bed and was having a hard time breathing. I called 911 and was taken to the hospital which resulted in being admitted.

CONTINUING PALPITATIONS, SHORTNESS OF BREATH, FATIGUE, AND DIZZINESS.. . JUST ABOUT THE SAME TIME, i HAD A NEW HEART DEVICE IMPLANT. A-FIB SUSEQUENTLY DIAGNOSED. MY CARDIOLOGIST DOES NOT THINK THERE IS A CONNECTION. I WANT TO BRING THIS TO YOUR ATTENTION BECAUSE THERE MAY BE A CHANCE THAT OLDER PERSONS ALREADY PRESENTING WITH CARDIOMYOPATHY MIGHT BE SUSCEPTIBLE TO THESE SYMPTOMS WHILE NOT HAVING THE SAME LEVEL OF INFLAMATION AS IS BEING NOTICED IN YOUNG ADULTS. INDIVIDUALS AT MY AGE TEND TO HAVE SO MANY COMORBIDITIES UNTIL THEY MAY BE UNLIKELY TO NOTICE NEW SYMPTOMS.

2d dose: Covid19(Pfizer-BioNTech), Lot EL1283given by injection, Left Arm, Feb 3, 2021, 3 PM. Pt walking stamina declined over the next week. Prior to second dose, she could walk about 1.25 miles; afterward her stamina declined to a few blocks distance. On Friday, Feb 12, Pt collapsed after bath. Saturday, Feb 13, 2021, Pt did not get up. Began episodically screaming in pain. Ambulance to Hospital. Admitted and given emergency pericardial window to address pericardial effusion. Pt was discharged Feb 19, 2021, diagnosed with 1:Cardiac tamponade; 2:Hypotension; 3:Sepsis; 4:Acute kidney injury. Slowly Pt recovered some ability to walk but as of June 11, 2021 her distance has not exceeded 0.25 mile.

Two weeks after first shot was dizzy,. One night after second vaccine dizzyness and emesis lasted for one day

6 migraines after the first vaccine/Increased migraines; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: GR8736 or GR8136), via an unspecified route of administration, administered in Arm Left on 04May2021 (at the age of 79-years-old), as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included chronic migraine which she had them for years and then 5 years ago they came back with vengeance, herpes zoster from 01Feb2021 had shingles on her head and shingles pain. The patient's migraines got worse when she lost her husband 3 years ago, she thought it a stress migraine. The patient previously took amoxicillin and experienced drug hypersensitivity and botox for the past year for migraines. The patient was having around 8-10 migraines a month prior to starting Botox. The patient was late to get her dose of Botox because of covid and would have to go into the fourth month before she could get it instead of the usual 3 months. The Botox didn't seem to cover the patient with the vaccine. The patient was due 12Jul2021 for the next dose of Botox, but she had these migraines before then. The Botox had been working very well for the patient prior to the vaccines. The patient didn't know why the last dose of Botox didn't cover her like it usually does. The Botox dose was 125 units. They start on the lower dose and up it and see how you're doing, the highest was 150. Concomitant medications included gabapentin taken for herpes zoster from an unspecified start date to 28May2021; ibuprofen taken for shingles pain from 12May2021 to 28May2021. On 04May2021 (10 minutes after vaccine), the patient experienced dizziness and waiter for 30 minutes and then it went away. On 05May2021, the patient experienced first migraine after vaccine, had migraine yesterday and had migraine brain. The patient had 6 migraines after the first vaccine and 8 migraines after the second dose. The outcome of the event migraines was not recovered and for event dizziness was recovered on an unspecified date. Information on lot/batch number has been requested.

It started with a "tingling" feeling starting at the top of my head and going down to my feet. For a period of time, I was unable to move - my legs week; could not stand. I could not move my fingers and hands. I felt like I was "out of my body" It was very frightening.. After about an hour, all my feeling came back to my body; I was able to walk (not very confidently yet)). I was weak for several hours.

felt sick/sick as a dog; feeling nauseous; threw up like crazy; funny feeling around her head/Feeling really funny; face usually gets red when her blood pressure is high and it she is not red at this time; vertigo; blood pressure/ up to 210/110 mmHg; not walking well; funny feeling around her head/Feeling really funny; felt chills/Chills; Felt yucky; her balance was not quite right; felt the really funny feeling going up her throat; Her heart rate has been wanting to be a little higher than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021(at the age of 79-years-old) (Batch/Lot Number: EL1283) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Family medical history relevant to AE(s) was none and she is getting close to obesity if she keeps eating like this. The patient previously took first dose of bnt162b2 on 11Jan2021, (Lot Number: EK9231, Expiry Date: Unknown, this is not on the CDC vaccine record card) via Injection administered in Arm Left for covid-19 immunisation and experienced Left arm was real sore after first dose injection. The historical vaccine included shingles vaccine. The patient experienced blood pressure/ up to 210/110 mmHg on 20Feb2021 felt chills/chills on 31Jan2021, felt yucky on 31Jan2021, not walking well on 20Feb2021 , felt sick/sick as a dog on 20Feb2021, feeling nauseous on 20Feb2021, threw up like crazy on 20Feb2021, funny feeling around her head/feeling really funny on 20Feb2021, face usually gets red when her blood pressure is high and it she is not red at this time on 20Feb2021, vertigo on 20Feb2021, felt the really funny feeling going up her throat on an unspecified date in 2021, her heart rate has been wanting to be a little higher than usual on an unspecified date in 2021 and her balance was not quite right on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood pressure measurement: 220/110 mmHg (normal value: 120/80) on 20Feb2021, computerised tomogram: doctor mentioned 3 little places on 20Feb2021, electrocardiogram: unknown results on 20Feb2021, heart rate: little higher than usual on an unspecified date in 2021, laboratory test: unknown results on 20Feb2021. Patient received both dose of the Pfizer covid vaccine on 11Jan2021 and 30Jan2021. On the next day after the 2nd dose, she felt chills. On 20Feb2021, she started not walking well, thought she would fall. All of a sudden, she felt sick and threw up like crazy while she was visiting her daughter for the day. The firefighters came to take her blood pressure and it was up to 210/110 mmHg. They advised her to go to the ER. After several hours, she was given blood pressure and nausea pills. They mentioned vertigo. She says it got okay. However, 2 weeks ago, she started to have a funny feeling around her head. Not dizzy but her face usually gets red when her blood pressure high and she was not red at that time. It was again reported that the day after she was administered the second dose of Pfizer-BioNTech COVID-19 Vaccine she had chills and felt yucky that day. She also reported feeling really funny since 20Feb2021. She was asked for further information on events related to Pfizer-BioNTech COVID-19 Vaccine. She was at her daughter and noticed her balance was not quite right. She started feeling really funny so just lay down there for a little bit. When she did get up after about 15 minutes she started feeling nauseous. She got to the bathroom really fast and threw up like crazy. She did not have her blood pressure cuff with her so her daughter called the fire department and took her down there real fast. At the fire station they took her blood pressure which was 210/110 mmHg, so they suggested she head to the emergency room so she did. She was under observation in the emergency room, but not admitted to the hospital. The doctor mentioned vertigo somewhere along the way before she left the emergency room. She just kind of brushed the vertigo off until she was reading about that the Pfizer-BioNTech COVID-19 Vaccine can cause vertigo. She guesses vertigo was what caused these events because she had been sick as a dog. When they got her on the bed and rolled her back she felt like she was going 90 miles per hour and by the time they got her back on the bed she was throwing up again-but this time and the initial onset of throwing up was the only times she threw up. They gave her something after probably 5-6 hours, blood pressure medicine and nausea medicine and she got ok and left there. Her heart rate has been wanting to be a little higher than usual. About 2 weeks ago she was just sitting on the couch and noticed especially when she would turn her head she still feels really funny; not dizzy, dizzy; she was walking ok; but the really funny feeling keeps hitting her continuously. During call when she sat back down she felt the really funny feeling going up her throat. It was just the weirdest thing, she wishes she had a word to really explain what the really funny feeling was but she does not. She has not checked her blood pressure for a while because she has been holding for a while for this department, so her blood pressure could be up a little bit, but she stated event was worse right now than it has been. Regarding testing/investigations while in the emergency room they did a CT head scan, lab tests, and an EKG. CT head scan results, the doctor mentioned 3 little places but when she talked to her doctor he said that was really just nothing to worry about with age; he said they will check it in 6 months and make sure areas are not growing. Caller has no further information to provide regarding lab tests or EKG results, they did not mention anything. Therapeutic measures were taken as a result of blood pressure/ up to 210/110 mmHg and feeling nauseous. The outcome of the events, felt chills/Chills , Felt yucky, her balance was not quite right, felt sick/sick as a dog, threw up like crazy, face usually gets red when her blood pressure is high and it she is not red at this time, felt the really funny feeling going up her throat, Her heart rate has been wanting to be a little higher than usual was reported as unknown, not walking well, feeling nauseous and vertigo was reported as recovering, funny feeling around her head/Feeling really funny and blood pressure/ up to 210/110 mmHg was reported as not resolved. No follow-up attempts are possible. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration in arm left on 06Mar2021at 11:00 (at the age of 79-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, sinus issues. Family Medical History included that her daughter has had reaction to medications, she had flu vaccine and she ended up in the emergency department, she had trouble breathing. Concomitant medications included atenolol started a long time ago taken for high blood pressure. Patient previously used clindamycin as in her age she occasionally breaks. Patient previously received flu vaccine in 2009 for immunization and had a reaction. She had the Flu vaccine for many years and the one she had trouble with was a vaccine without preservatives. On 06Mar2021, seven hours after receiving first dose of vaccination, in the evening patient noticed that her mouth started to burn, accidentally pinched her arm and the pain was more than expected and it left a bruise. On 12Mar2021, patient experienced sinus issues. On 20Mar2021, patient experienced that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. On 22Mar2021, patient experienced burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area, which caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. On an unspecified date in 2021, patient experienced hypersensitivity reaction. Patient stated that when she was changing her outfit she accidentally pinched her arm and the pain was more than expected and it left a bruise. About 7 hours after, she noticed that her mouth started to burn. She mentioned that she also had pineapple that day and was not sure if it was caused by the vaccine. On the 09Mar2021, she consulted a nurse practitioner who said that the burning may have been caused by the Pineapple. On 10Mar2021, she consulted her allergologist and got tested for a pineapple allergy. The results came in on 15Mar2021 and they came back negative for the allergy, but her allergologist mentioned that pineapple can still irritate the mouth. On 18Mar2021, she consulted with her Primary in which she was given magic mouthwash that made it worse. She was made to continue her benadryl and aspirin spray. On 20Mar2021, that Saturday night, as she was walking, she felt that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. It lasted for about 20-30 minutes before subsiding. Last Monday, 22Mar2021 she really started to notice the burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area. She described it as not constant but comes and goes. On 25Mar2021, she consulted with her primary again in which she was recommended not to get the 2nd dose of the vaccine and her side effects lean to a more neurologic cause. The doctor mentioned that the vaccine was still too new. These side effects has caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. She said that has not been fun. it has been horrible, and she would choose dying over this burning sensation in the mouth. Patient visited physician Office, 3 times and allergist did it virtually. Reportedly, after eating dinner she was eating pineapple from a can. She had the can and tried it. She had not had pineapple in a long time. While sitting in her recliner, she experienced her mouth burning. She added that began about an hour and a half after eating the pineapple and it has lasted for approximately 2 weeks. It was not constant all the time. She did not know at the time if the burning in the mouth was related to the pineapple. Caller added they thought it was the pineapple causing this. Last Sunday, the caller indicated that it was leaving and going away. Caller saw her new primary medical doctor on 09Mar2021. The Nurse Practitioner said it was probably the pineapple, She started her on Benadryl. Manufacturer was unknown to caller. Caller took 2 tablets on 09Mar2021 and stopped taking it on 10Mar2021. She restarted taking the Benadryl on about 14Mar2021. Caller stated she was primarily calling and asking because on Monday, 22Mar2021 she started having burning in her face and had burning in her arm. Caller reported the burning in her arm was not from the vaccine and she thought it was caused by her blood pressure cuff. Caller took her own blood pressure. Burning was better today, she still had burning in her arm. She took Zyrtec as instructed by her physician twice a day. She took a half tablet on 10Mar2021 through 13Mar2021. She was taking half a tablet in the morning and a half tablet at bedtime. Caller added that the Zyrtec made her feel unsteady and it made her sleepy. She did not tolerate it. Dose was 10mg. She has recovered completely from unsteady and being sleepy with Zyrtec. Caller took Tylenol because she was having sinus issues. She did not have the manufacturer, she took it on 12 and 20, two times. Its 325mg, by mouth, the regular strength. Caller saw an allergist on 10Mar2021 who tested her for pineapple allergy. The Allergist called on 15Mar2021 and reported she was not allergic to pineapple. Allergy was also tested for egg white, milk, wheat, corn, peanut, soybean, potato, yeast, and tomato. All resulted as negative. Benadryl: took 2 times in 09Mar2021. Caller restarted Benadryl and took it on 14Mar2021-17Mar2021. These days she only took it in the evening. She took 25 mg at night. Then she took Flonase, twice, on the 17th and 18th. Its over the counter. Lot number: TE8G, caller doesnt have box to provide UPC, stated there was another number of 0140592, expiry Mar2021. Dose was 27.5mcg per spray, spray into each nostril. When providing strength, states writing was so small for her to see. Gets a magnifying glass to confirm strength, states it's with her age. The doctor also suggested for the caller to try Afrin spray on 18Mar2021. Caller started it on 20Mar2021 and used it only once. She didnt like it. Caller said at her age she occasionally breaks out and uses Clindamycin for that. Dermatologist has her using Clindamycin 1 per cent pledgets. Applied twice to face once daily, She stopped 20Mar2021. Given Magic Mouthwash, which was in a pharmacy bottle, she took it once on 18Mar2021, but stopped. It was 5-10ml swish and spit. It made things worse and did not improve it. The doctor forgot to give her a measuring cup, and caller thought she told her a teaspoon. Caller added she tried using a warm cloth on her sinus area and her skin felt like a sunburn. The cloth left a red area around her cheek. Then this Sunday, after using the pledgets, went for a walk, next day noticed her face was really burned, not just face, her neck, arms, but she was not exposed, but had a burning pain, and she still continued to have it. She asked the dermatologist if this could be caused from the Clindamycin. The dermatologist told her no. She took a walk on Saturday and did not know if she was dehydrated. She felt like there were weights on her feet as she walked. It lasted 30 minutes. The burning in mouth started 7 hours after the first dose and it had improved. Therapeutic measures taken in response to the events included Benadryl, Zyrtec, Tylenol, Flonase, Afrin spray, clindamycin, magic mouthwash. Outcome of the events "mouth started to burn/burning in mouth" and "sinus issues" were ongoing-not recovered and for all other events were unknown at the time of report. Information on Lot/Batch number has been requested.

Patient stated that she started to feel dizzy and ever since she had the shot her blood pressure has risen. Before receiving the vaccine she had her blood pressure under control.

Well like I said, I woke up and my arm after the shot was sore. The joint was bothering me, and I thought that it was a side effect of the shot and after about a week I had a little bit of movement but still pain. So later in May I finally called the orthopedic doctor. I got an MRI and he said it was a significant tear to the rotator cuff. I did not do anything so I do not know what or how it happened. I just figured it was the COVID vaccine, although the doctor thought it was highly unlikely. I had surgery to repair it on May the 20th 2021, at local hospital. I came home that night after the surgery. The doctor gave me tramadol for the pain as well. I will have another MRI next week, in mid-July 2021.

she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.

shot was given around 11am and around 1-2 she began to get chills and body aches worse than covid, exhausted, several weeks later she began to having issues with walking, she will get pains in her knees and legs, its hard to walk she begins to walk like a penguin, she is now using a cane.

first dose, dizzy; first dose, dizzy like all the energy went out of her foot; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6205), dose 1 via an unspecified route of administration, administered in Upper Arm Left on 26Apr2021 11:00 (at the age of 79-years-old) as dose 1, single for covid-19 immunization. The patient medical history included she was allergic to Penicillin. After taking that for about 50 years she had an allergy to the Penicillin vaccine, and she came home and she got hives on her chest and neck and up on her face. She confirms it was Penicillin vaccine. That has been about 20 some years ago. The patient had no other medical history. The patient had no family history. The patient's concomitant medication(s) included cyanocobalamin (VIT B12) taken for immune system disorder from Mar2021, ergocalciferol (VIT D) taken for an unspecified indication from Mar2021 and zinc taken for cataract, macular degeneration. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. The patient took the first one 26May2021 and within an hour she got dizzy and like all the energy went out her foot and then she was over it, within 30 minutes she was fine and was like she never knew she took it after that. She is a mother and a grandmother, and a great grandmother and she debated about this because she was not too sure about it but she watched and listened every day at noon they talked about it and she does not think she would have survived if she got COVID. She confirms she got it for prevention of COVID. The adverse event not required visit to physician office and Emergency Room. She was thinking about going to doctor to see him, but she kept thinking she would start feeling better. She tries to walk every day. No relevant test done. She takes vitamins to keep herself healthy, she takes B12 and then she takes Vitamin D and Zinc. Zinc: She had problems with her eyes to start with. She confirms that's why she started the Zinc; she says she has cataracts and macular degeneration. She confirms she had those prior to using the Zine. She was going to have cataract surgery 04Aug2021. She just got this herself the doctor did not tell her to, she has enough trouble with her eyes. She takes it for her eyes, she has problems with her eyes. Vitamin B12: She was taking that way before the shot. She had a bone scan, and it showed her bones were deteriorating from get older so that is why she started taking it. Vitamin D: She says the bottle says 125 mg (5000 mcg). She says she started mar 2021 that was when she had her wellness check. No further information provided. The outcome of the events was recovered on 26Apr2021. Follow up is excepted. Additional information has been requested.

tested positive for Sars-COV-2; tested positive for Sars-COV-2; Felt terrible and hardly out of bed; Felt terrible and hardly out of bed; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 29Jan2021 08:00 (Batch/Lot number was not reported) as dose 2, single, via an unspecified route of administration, administered in arm on 08Jan2021 08:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Age at vaccination was 79-year-old. The patient medical history was none. Family medical history relevant to the events was none. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTEREEN/HYDROCHLOORTHIAZIDE) taken for blood pressure measurement; vitamin B12; ascorbic acid (VITAMIN C); colecalciferol (VITAMIN D 3); biotin. Prior Vaccinations (within 4 weeks) included: She got a flu shot, but she did not know the date of when she received it last. She did not remember whenever she got her shingles shot. It was two shots, that she got from Pharmacy. She thought she got the second shingles shot in Mar2021. She thought she got the first shingles shot six months before that (2020). Lot number and expiration date were unknown for both doses of the shingles shot. The patient experienced that she tested positive for Sars-COV-2 on 11Jul2021. She stated her symptoms consist of respiratory, a bad cold, chills. She felt terrible and hardly out of bed. She did not have fever. Coughing, cold. She walked three miles a day. The patient underwent lab tests and procedures which included Rapid covid test: negative on 11Jul2021, Send off covid test: positive on 11Jul2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied drinking alcohol, knew she was not able to speak correctly and visibly frustrated . With great difficulty she was able to communicate that she had a headache and was slightly dizzy. Failed FAST and does have a history of CVAs. EMS called and patient was taken to ER where they admitted her for observation post Stroke. Per the hosp nurse, patient received tPA treatment and will be moved to step-down unit when a bed is available.

Pfizer-BioTech COVID-19 Vaccine EUA Witihin 5 minutes, burning chest pain. Within less than 20 minutes BP measured at 203/185 and 15 minutes later 191/187. (normal for me is 128/65). Heart rate 130 (normal is 92) Lightheadedness. EMTs on site did EKG and subsequent BP checks. Recommended Emergency Room care, which I did. Aspirin given, blood work done (at 3 different times). 2 Additional EKGs done with no abnormalities noted.. BP and heart rate went down in approximately 2 hours, to 138/85 and 105, but not to normal status. Have been normalized since.

Patient observed slumping over in chair. When assessed she stated she felt lightheaded and was diaphoretic. Blood pressure obtained at 1400, BP 63/34, HR 84. EMS contacted and dispatched. Patient experienced syncope. 1405 EPI administered per protocol. 1414 vital signs as follows: BP, 168/135; HR 60.

Dizziness, lightheadedness, sweating, diaphoretic. Patient is diabetic, had high BP, dizziness, loss of hearing, tunnel vision, emotional/crying. Patient was given juice, observation done, vital signs monitored, glucose checked, pulse ox checked. Patient improved after interventions. Patient verbalized feeling better and was discharged to home/self care with husband @ 1:15PM.

Within 15-minutes of vaccination, the patient reported dizziness and a heartburn sensation in her chest. EMS noted orthostatic hypotension in the field, systolic was in the 130s when sitting with a rapid drop to the 70s upon standing. Patient was transported to emergency department. In the ED, the patient reported having a dry mouth and having not eaten breakfast. Patient was administered IV fluids and noted improvement. Labs were unremarkable. Diagnosed with orthostatic hypotension secondary to dehydration, vasovagal episode, and GERD.

Amyloidosis; felt a sweep over her stomach up her body and up to her head; Eyes swollen; hands hurt; sharp pings up and down legs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 16Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetic and previously took the flu shot one time and started having right arm pain across her chest over to the left side right after getting it. So she don't take it anymore and takes a bunch of herbs. The patient's concomitant medications were not reported. The patient reported that she has a disease, amyloidosis on an unspecified date, where there is a build up of protein in the body. She didn't know that there is protein in the shot and doesn't know the affects it has with her condition. She found out the day after getting the first Pfizer C-19 (clarified as COVID-19) shot that there was protein in it. The patient wanted to know the affects it has with her condition and if it will affect her getting the second dose and if it covers the new virus and booster shot. The patient got the vaccine on 16Jan2021 and found out about the protein in it the next day when it came across her phone. The patient received it at a school, where they vaccinated 1,169 residents. They text her to inform her she could get the vaccine. They also have the health department there. No other vaccines given that day or 4 weeks prior. On an unspecified date in Jan2021, the patient took 1 Tylenol about 15:00 that afternoon and seated herself in the chair about 17:45, then she felt a sweep over her stomach up her body and up to her head. She stood up and walked around to see if she was going to faint and she did not faint. She walked through the house and nothing else happened. The patient mentioned that her eyes have been swollen and her hands hurt, that's where the protein build up comes in the body. Has pings up and down her legs, they are sharp pings that lasted through on to Tuesday. She took 1 Advil to help and as of yesterday (as reported) no pings. Her hands still hurt, because this condition forms chains in the body and the chains are around the hands like carpel tunnel. The protein normally should leave the body and with this condition it doesn't and it leaves chains. When she was diagnosed with it they took a spot off the ankle to test it, the Dermatologist did and sent it off. No further details provided. Wants to know the affects of her getting the second shot. No further details provided. The outcome of the events amyloidosis and hands hurt was not recovered, the events felt a sweep over her stomach up her body and up to her head and sharp pings up and down legs was recovering, and the event eyes swollen was unknown.

had the vaccination Jan 28. On Jan 31 woke up at 7am with a wobbly walk and dizziness (neurologist subsequently said not dizzy).

I was like and off balance; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; Little bit light headed /The way I was laying down I got more dizzy; This is a spontaneous report from a contactable consumer (patient) An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 20Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included blood pressure problems and Blood sugar abnormal (a little bit of blood sugar). Concomitant medications included metoprolol tartrate for blood pressure management. On 22Jan2021 the patient experienced 'little bit light headed /the way I was laying down I got more dizzy' and 'was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish'. On an unspecified date the patient also complained 'I was like and off balance'. At the time of the reporting event outcome was unknown. Information on Lot/Batch number has been requested

Became dizzy when she bent over to tie her shoe. Came to lie down for dizziness to pass. Reported a headache and being hungry. Juice and trail mix given. Later went to the restroom and vomited a small amount per client. Rested further, reported her headache improved and wanted to go home. Was informed we would like for her to get a ride home. She did not want to and declined to stay for further observation. b/p 138/76 pulse 72. Informed to seek medical help for further problems.

0934 am: per pt. daughter, pt reports SOB and dizziness. Pt. is slow to answer questions, EMT arrival 0939 am VS: BS 115, BP 154/73, REsp 19, HR 96, O2 98%. Rev BP: 124/73, HR 70, O2 95%

The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.

chest pain, diaphoresis, incontinence, N/V, dizziness; symptoms are no longer occuring after be treated and released from hospital 2/3/21

Patient felt dizzy, no other sx. BP was 142/75 P79 O2sat96. Had her sit for 10 more minutes and gave her apple juice. She felt better afterwards and felt safe to leave with her daughter.

itching of the skin in the neck area. Lightheaded. Ambulated with staff to the medical area. Given water and Benadryl 50 mg po. Rested lying down for 15 minutes, felt much better and declined to receive further medical care. Husband with her and driving her home.

After client received her vaccine, client stated she feels dizzy. Vital signs BP 170/72, HR-65, O2 sat 97.8, temp. 96.8. Client stated she feels better. Client discharged home by EMS.

Vaccine administered on 2/11/21. Presented to emergency department on 2/18/21 following an episode of syncope and collapse at home. Patient reports becoming dizzy and diaphoretic at home and passed out in bathroom. Presented with left-side rib pain and headache attributed to hitting door and ground during fall. Was checked for COVID19 prior to transferring to observation unit and was found to be positive. Patient was discharged home in stable condition from observation on 2/19/21.

pt states that she had a left arm and mild body aches for a couple of days after getting the covid vax. Three or four days later she started getting dizzy and nauseated. She says she feels hungry even after she eats. Pt states the dizziness comes and goes and is normally in the morning. She doesn't feel right and feels unsafe when she walks like she may fall. Pt contacted her PCP on 2/23/2021 and they just told her to see if the symptoms went away and the FU if they did not.

Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago. Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do. She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021 Information about batch/lot number has been requested.

Feet felt stiff and bone in right leg felt strange; Feeling dizzy and faint like; tired; Sinuses started to drain; itching on the right shoulder (where she had the vaccine); Itching on right side of arm near elbow, middle part of stomach and neck; pain in the shoulder; This is a spontaneous report from a contactable consumer, the patient. AN 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201, Expiry date: 30Jun2021) intramuscularly in the right arm on 11Feb2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included highly sensitive and highly allergic to everything from food to medicine; had been through near death with allergies; allergic to penicillin, iodine and shellfish; high blood pressure, eye disorder (unspecified), allergies with her sinuses. Concomitant medications were not reported, but the patient took unspecified high blood pressure and eye medication. The patient previously took dextropropoxyphene hydrochloride (DARVON), ether and castor oil and experienced allergies; sulfamethoxazole and trimethoprim (BACTRIM) for severe acute sinusitis on Jan2021 (about a month ago). On 11Feb2021 at 13:20, the patient start feeling dizzy and faint like, and felt a little tired. She came home and went to bed and on 11Feb2021, had itching on the right shoulder (where she had the vaccine) and on the right side of the arm near the elbow, the middle part of the stomach and the neck (itching came and went) and later, her sinuses started to drain. On 12Feb2021, the patient's feet felt stiff and the bone in the right leg felt strange. On an unspecified date in Feb2021, the patient had pain in the shoulder. The patient queried if she can take aspirin for the pain in the shoulder and diphenhydramine (BENADRYL) if the itching comes back. The clinical outcome of pain in the shoulder was unknown, of "itching on right side of arm near elbow, middle part of stomach and neck", "feeling dizzy and faint like", tired, sinuses started to drain, "feet felt stiff and bone in right leg felt strange" and "itching on the right shoulder (where she had the vaccine)" was resolving.

red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.

Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.

Had shot on Thursday 2/25/21. Friday didn't feel well-laid around all day. Saturday was so dizzy I had to hold on to walls and furniture to walk around house. Sunday was still dizzy and nauseous so I ate a sandwich and 3 or 4 tums. All came up and I continued to vomit throughout the day. Could not even keep water down. Monday I had someone bring Ginger Ale. Nausea gone, but still very dizzy. Never had a temperature but continue to be dizzy. I am a very active 80. Clean my own house and Mow my yard. I play bridge 2 or 3 times a week and walk my 2 Yorkie Dogs several times a week and never have been dizzy before.

Tingling in ankles, lightheadedness, "heat" in the back of the throat. Pt was observed for an hour and felt better. Dr. stated she can leave, no additional care needed besides observation. BP 131/44, O2 98, Pulse 71. Pt reports similar reaction to 1st dose.

She did not feel good; Eyes were blurry/ she felt pressure in them; Bad head cold; she couldn't bend over; Aches all over; Back pain; Eyes were blurry/ she felt pressure in them; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1687), via an unspecified route of administration on the left arm, at the age of 80 years, on 29Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included cataract, arthritis and seasonal allergy from an unknown date and unknown if ongoing. There were no concomitant medications.The patient stated that a couple of times she did not feel good and got very sore and could not bend over to pick things up and her eyes blurred up. After she got the shot, she gradually noticed aches all over and back pain. It was stated it hurt really bad in her back on the right side on the bone and she used the heating pad on it. Then the next day she was stiffer than ever and she couldn't bend over. She added her eyes were blurry, they felt like she had a cold in them, and she felt pressure in them. She added she always has this problem with her eyes but it got a little worse after the shot. All of that has gotten better now. It was stated they are telling her the second dose was worse and she was unsure about getting the second dose. Also mentioned they were saying you can wait a little longer and she was unsure if maybe she should wait. She wanted to ask about getting the second dose. She added she was scheduled to receive the second dose of the vaccine on 19Feb2021. The patient said it was right sided back pain. She said she applied heading pad and took ibuprofen. She also experienced "eye pressure" and "blurry eyes", "how you feel when you have a bad head cold". She said, "I have allergies-seasonal, so this isn't new to me". Therapeutic measures were taken as a result of back pain (back pain). The outcome of the events did not feel good, eyes were blurry/ she felt pressure in them and bad head cold was unknown while other events were recovered on 31Jan2021.

hand felt like it was sleeping especially her finger tips it felt like neuropathy; Joint pain; Exhaustion; same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9266 and expiry date 31May2021, via unspecified route of administration on 15Feb2021 at single dose for Covid-19 immunization. Medical history included, broke her elbow from 04Dec2020 and surgery from 12Dec2019 and second surgery was from 15Jul2020; the patient thought that the second surgery on her arm was in 2020 and she actually broke her arm in 2019. She thinks it was actually Dec2019 when she broke her arm and the second surgery was on 15Jul2020; ongoing with the arm the pain and movement in that arm (movement disorder) and arm; weakened (same arm that she broke). There were no concomitant medications. The patient was taking the same medications she always takes, and she waited until after the dose to take them. Historical vaccine included first dose of BNT162B2 lot number EL02162, expiry date 31May2021 for Covid-19 immunization. The patient was calling about the vaccine, the second Pfizer COVID 19 vaccine. She experienced some side effects, there was joint pain on 15Feb202 later that nigh and the most obvious thing was exhaustion that began later the same day as well; but one thing was unusual, the strange side effect that has happened on 16Feb2021 was that her hand felt like it was sleeping especially her finger tips it felt like neuropathy but it was much better now, it was the same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before. The patient stated that the main thing was the neuropathy thing, it felt like she was sitting on her hand and that persisted, but it was 90 percent better and she thinks it will go away. The neuropathy feeling was ongoing but much less, it was improved it happens only if she squeezes her hand so it was much less and she hoped it just dissipates. The patient's main concern was the neuropathy and it has improved a great deal. The patient mentioned with the arm the pain and movement in that arm has worsened since the injection (Feb2021). The worsened pain and movement has persisted about the same since she noticed it. The patient informed that was the joint she guessed, because she broke the elbow. The outcome of the events hand felt like it was sleeping especially her finger tips it felt like neuropathy, joint pain, exhaustion was recovering, same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before was unknown, while not recovered for the rest of the events.

Patient presented with back pain for 2 weeks, with fall prior to arrival. Patient had evidence of discitis and UTI on admission. ID felt that the seeding of the discitis was related to cholangitis from recent cholecystectomy. Treated with IV antibiotics with plan for 6 weeks duration and discharged to SNF. Patient had significant pain treated with Percocet and Dilaudid with dramatic but incomplete esolution of pain. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

Pt. in observation was feeling dizzy and hot flash. Paramedics assessed pt. once symptoms subsided and vitals were cleared pt. was released to leave. (tent 11).

On 2/17/2021 (2nd dose)about 4 p.m. started feeling nauseous and dizzy-injection arm became very sore. The next 2 days t he same as late afternoon on the day of injection. 2/20/2021 woke up feeling fine. 2/21, 2/22 back to feeling nauseous and dizzy with the injection arm hurting a lot. 2/22, 2,24, 2/25 were fairly good days. But 2/26 woke up at 3:30 a.m. feeling very, very nauseous and then vomiting violently and again at 6:30a.m. and 8:30a.m. (along with a bad case of diarrhea. Was nauseous for the next 3 days and could not move my left arm above my elbow.

Pt denied any complaints upon arrival to vaccine site at 1205. After vaccine, pt states to observation team that she has been dizzy for a few days and is now feeling dizzy at 1225. ALS assesment at the vaccine site revealed HTN and pt remained dizzy. ALS transport was arranged at 1227 and transported pt to Emergency dept. Medics from vaccine site completed EPCR reporting system. PFIZER Covid 19 EUA

On the 5th day after receiving the vaccine I became dizzy. The next morning I became very dizzy and went to the hospital. They admitted me to Emergency because my blood pressure was extremely high-they said later it was about 187/ ?. While I was there the blood pressure went up over 200 to 214/81. I was dizzy and nausious and shaking because I became very cold even though the nurse covered me with 3 blankets. After I left the hospital it took until after I got a prescription for meclizine filled and took one at 7PM before I was able to get the blood pressure down to a normal range - 130/64. Today I am still taking meclizine as prescribed and am still slightly dizzy. I do not know if this was related to the vaccine or not.

pt CC of light headed took pt's vitals to find pt HTN. BSL was 111. Pt refused transport to ED. Advised pt of rights and risks of refusal. Pt signed refusal. Advised pt to seek help if symptoms worsen EOR.

She got out of bed at 2AM to go to bathroom and doesn't remember a thing. She fell face down on tile floor.

7"30 p.m. on day of vaccination (2-26-21) my arm where I got the shot (left) began to hurt. Today is March 13th the arm still hurts not just at the injection site but the pain throbs throughout the arm and it is hard to carry/pick up items. It's not life threatening but I don't understand why it is still hurting Also I wonder if when I get my second vaccine next Friday, March 19, 2021, if I should get it in my right arm.

choking experience; throat tickled; dizziness; bowel movements all afternoon which is a common allergic reaction; bowel movements all afternoon which is a common allergic reaction; Her heart started to pound/a rapid heartbeat; her ears started to ring (a pounding in her ears); had pressure in her jaw, chest, head, ears, and allover; high adrenal stimulance; excreted 1 cup of urine more than what she usually does; high pressure; dehydrated; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 01Mar2021 13:30 (at 80 years old) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome, allergic to gluten, lecithin, and other barky parts of plants, high pressure, she did not hear very well, left breast surgery, skin cancer. She had a small skin cancer taken off each of her legs, one removed in Jan2020 and one removed in Feb2020. They are all healed up and they are fine, it was not the bad kind. There were no concomitant medications. The patient experienced choking experience in which her throat tickled, and dizziness, dehydrated, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, excreted 1 cup of urine more than what she usually does, couldn't sleep due to high adrenal stimulance, bowel movements all afternoon which is a common allergic reaction all on 01Mar2021 with outcome of unknown. Clinical course was reported as follows. She mentioned that she was fine for 20-30 minutes to an hour after she got home. That afternoon, she noticed that her bowel movement was regular, constant, and repeating which was not normal and would typically indicate SIBO (Small intestine bowel overflow) in which the colon empties everything. She mentioned that this was indicative of her gluten allergy. She reported having had bowel movements all afternoon which is a common allergic reaction she has to plants like lectin and gluten especially due to the irritable bowel system-her whole bowel system will empty and she will have to replace 2 days worth of food. With this event starting 01Mar2021 her bowels just kept emptying and emptying. During dinner while she was eating and watching tv, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, and a choking episode in which her throat tickled, and dizziness that she couldn't get up. She took hot water for the tickling sensation and took one aspirin for the other symptoms, but she still did not feel very well. She went to bed at 9pm but couldn't sleep due to high adrenal stimulance, she only slept like 2-3 hours long which she can get from Novocaine with her teeth. She got up 3 times and excreted a cup of urine per time. In the morning, she woke up and excreted 1 cup of urine more than what she usually does. She got herself weighed and had a weight of 109lbs versus the normal 122lbs which indicated that she was really dehydrated so she took her fluids and ate breakfast. Other than this, she mentioned that she got up today and felt fine and feels that in 2 days she will be fine. She felt pretty good and she was going to run but did not dare burn any more calories or fluids so she is sitting still and taking it easy. Regarding outcome of event she reported the pounding pressure like high blood pressure are better, fine# she had a normal breakfast# she can get around and do whatever she needs around the house except she needs now to spend the day recouping from the dehydration so she needs pay attention to what she eats and drinks. She mentions that she runs 3-4 miles a day and tries to be active for her age. She is asking if she can take the 2nd dose in 3 weeks. She is unsure if this is an allergic reaction or something psychological. The outcome of the event was reported as recovering.

Patient has chronic autoimmune conditions of ITP and Evans syndrome. Her platelets and other blood counts are monitored monthly by a Hematologist. Her platelets run low usually between 81-100. On her CBC taken 2/18/21, her platelets were 51. On 3/2 they were 47 and on 3/8 they were 34. The first part of March a change in gate was noted in patient, sh fell on 3/8/21 and hit her head. On 3/8 a CT scan detected bilateral subdural hematoma. Certain internal bleeding was believed to be caused by the fall, other bleeding appeared to be present prior to the fall.

While sitting, patient felt a severe pain on L side of head about 8.5 hours after injection. Then the L foot started throbbing and pt wasn't able to move L foot. Pain traveled from L foot up to the L thigh. Next R entire leg started out with a grabbing, throbbing spastic unbearable pain that lasted for about 30 minutes. Predominant pain was on the R thigh and continued to seize up and caused incredible pain, every bit of a 10 on the pain chart. Pt took salt and 1000 mg acetaminophen. Pt states that if she hadn't been sitting she would've gone down and not been able to walk or move

The following reaction signs/symptoms were observed: abdominal pain, nausea and other dizziness with vomiting Emergency response notified: EMS (911) EpiPen administered by RN as per standing order?: No Required VAERS reporting completed?: No Report given to EMS (911) EMT evaluated her Found her to be stable enough to wait at parking lot until symptoms resolved. She stayed in lot with daughter on phone until 115 when she reports her symptoms resolved and was able to drive home RN took vitals

After vaccination patient claimed she feels dizzy so we told her to sit for monitoring . After 15 min she still felt dizzy so we measure her blood pressure which was really elevated ( 190/110 , 185/100 ) . We asked if she has history of hypertension which she denied . She claims she was feeling fine and that vaccine caused this reaction . She denied being on any medication . We offered to call 911 to take her to hospital but she asked her sister to pick her up and take her to ER.

reported Blood Pressure jumping/blood pressure shot up; nausea; headache; icky feeling; patient experienced light headedness, dizzy and icky feeling; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 80-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6204, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Mar2021 13:30 as single dose for covid-19 immunisation. Medical history included hypertension, caller says she has had hypertension prior to getting vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 as single dose for covid-19 immunisation. There was no family history relevant to adverse events. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 13Mar2021, patient experienced light headedness, dizzy and icky feeling, on 15Mar2021, experienced blood pressure jumping/blood pressure shot up and on an unspecified date patient experienced nausea and headache. Caller says she has had hypertension prior to getting vaccine. Caller got her 2nd dose, "last Wednesday on 10Mar2021". Caller says she had no issues until Saturday/Sunday. Caller experienced: nausea, light headedness, icky feeling, headache. Caller says she has never had a "continuous headache before". Caller had a pre-existing appointment with doctor that Monday after. During appointment, caller had systolic blood pressure reading of 205. Caller says the doctor "gave me a little orangeish coloured pill, she was monitored after that in office." Caller says she was told to go to emergency room from doctor office. Caller had EKG and blood work done at emergency room and sent home to continue to monitor blood pressure and follow up with her doctor. Caller is asking, "has anyone else reported Blood Pressure jumping". Caller also says, "I know people have headache and nausea, how long does that usual last" Caller asking how long her headache might last. Dizzy/Lightheaded/Icky feeling: She said that she still has a kind of a funny headache. She said that she is never really sick and can't even remember having a cold. Caller said that her blood pressure is currently in the 140's and 150's systolic. She said that it has been high for a number of years, but it has never been as high as 205 that she can recall. Caller said that her blood pressure dropped while she was at the hospital and she was discharged from the emergency room. The caller was not admitted to the hospital. Caller does not remember the diastolic number from her blood pressure. The patient underwent lab tests and procedures on 13Mar2021, which included blood pressure measurement: systolic was 205. The outcome of the events light headedness, dizzy, icky feeling and blood pressure jumping/blood pressure shot up were recovering and nausea, headache were unknown.

Off balance; Slight nausea; Slight headache; Not feeling well; This is as spontaneous report received from a contactable consumer (patient herself) of 80-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: Not reported) via unspecified route of administration on 12Feb2021 at 09:15 AM as a single dose for COVID-19 immunization. Patient's medical history was not reported. Concomitant medications included losartan, Norvasc (amlodipine besilate), ezetimibe. The patient did not receive other vaccines in four weeks. Prior to vaccination patient did not have COVID-19 and was not tested post vaccination. On 13Feb2021 at 04:30 AM, the patient experienced off balance, slight nausea, slight headache and not feeling well. NO treatment was received for events occured. Outcome of events was recovering. Information on the lot/batch number has been requested.

Severe cramps and diarrhea 2 days after 2nd shot. Sweaty, lightheaded and achy with shaking chills, but no fever.

was observed post Covid-19 immunization for approximately 1 hr and 45min. Patient complained of being hungry stated she had not eaten all day around. was given water and crackers, said she was feeling better but during further assessment she said she felt dizzy and light headed. Blood pressure right arm 160/103 hr 75. No complaints of chest pain or shortness of breath. She was talkative through out episode. Next BP was 184/91 HR 75. needed to go to the ladies room ambulated to rest room with nurse in attendance. No notable issue with gait. The patient stated that she was feeling better but the blood pressures where elevated. Decided to ask EMT to do a manuel BP in the right arm BP 160/82. Even though was verbal, her responses where vague. One minute she felt fine then she was dizzy. was encouraged to call someone, but she felt she might be able to make it. There was a concern with her driving her self home. EMT performed a cognitive test she stated the wrong year and did not know who the president was when asked in two separate assessments. They also performed a neuro assessment which was uneventful. EMT tried to contact sons but were unable too and patient could not find her phone where we could call a neighbor. EMT suggested that she should go to the ED to be evaluated to be on the safe side and she agreed.

high blood pressure , dizziness , blurred vision , nausea saw doctor , was in hospital 4/15-contacted the patient , patient has been feeing much better for some time , no issues now

Blood in left leg. Hospitalized for 3 days. Now on Eliquist. Couldn't walk on left leg. Had to pull the cord and maintenance called the ambulance. Still having pain in left leg even after a cortisone shot still not better and they don't know why. Next appoint is on Thursday. There is another appoint at the pain clinic for her back pain tomorrow

very ill and had to be taken to hospital; terrible pains all over; dehydrated; headache; feeling like something was choking her in mouth; coughing real hard; it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like; joint pain; patient was like fainting; panicked; allergic reaction/face swollen up; and lymph node was swelling up; white lumps on lip; some white patches on face/couple of patches around mouth; white lips; Short of breath; sore around mouth; face swollen up; pneumonia; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200; Expiration Date: 06May2021) as single dose for covid-19 immunisation. Medical history included insomnia from an unknown date and unknown if ongoing. Patient weight was 155 now. Patient was overweight because this eating and eating. Feeling inactive, not going out so patient gained a lot of weight. Patient took blood pressure medication and for heart some basically and patient didn't sleep well, so patient took Alprazolam to relax to sleep, but patient was an insomniac but that was basically problem. The patient's concomitant medication included isosorbide. Patient had the first Pfizer shot and wasn't even sore or anything, patient was so happy but that about 4 or 5 hours later about maybe 5 o'Clock, patient had allergic reaction and started to feel a sensation in lip and when she looked in the mirror, what was all that on lip and one side on lip it had turned white and it had lump was extended along lip line, lymph node was swelling up and patient had white lumps on lip which still had but it was going down and some white patches on face. Nothing happened on the 24Feb2021. Patient thought it was the 25Feb2021 that was when all trouble started. Patient felt like nightmare because she started feeling like something was choking her in mouth and next minute patient started coughing, coughing real hard and that was terrible cough then after this strange voice and patient realized it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like. Patient start to get out of bed and then waken to kitchen, patient had terrible headache, joint pain, pain all over from head to foot and patient was certainly dehydrated. She had no water in at all, she was like don't know something come over and felt like she was sort of leaving the world, patient was like fainting, and panicked. Patient had terrible pains all over and felt like patient was dying, patient was going to die. Patient said she need an ambulance, patient was very ill and had to be taken to hospital. They came within a few minutes, they started questioning about what was happening and they put patient to the emergency room and well they test patient for Covid as well naturally. It was negative, they did it 2 times and it was negative. When they took patient to one of the room in fact patient was frightened because they didn't told patient it was negative. Patient said she got the virus, they said not but patient had to take the oxygen as it's surge to scan on lungs. They said patient had allergic reaction to the vaccine. Patient was supposed to have it but at the same time there was the variant, doctor said patient was 70% covered, didn't have it but patient want to just check the status was with a person like her was allergic. Patient had shots in face and patient did tell them that she had all sorts of things on face. Now patient still had the white lips and couple of patches around mouth and naturally patient was worried like what to do. The patient didn't take the second shot because she was too nervous. Patient went hospitalization on the 25Feb2021 very early, and was relieved on 27Feb2021 (not sure). Reason of Hospitalization: On the University hospital. They put down to the Pfizer injection but that was older happens to patient, they infused patient with antibiotic they gave pills. Patient said she won't be able breath with them and that was what they did, they 'reflect' her, they said patient had pneumonia which she did not have (Further clarification was unknown). Early the next morning they put patient down 2' o'clock in the morning. Patient wanted to go home, they said patient can't as she had very bad infection in lungs which was completely untrue. The next morning (the same morning early), patient was okay because the pains and everything was gone but she believe the medication they put patient on that caused to short of breath and patient said please don't give her the medication and they did. They only give generic medicine in the hospital and patient took brand name. On 26Feb2021 patient actually called the doctor for all results and she told nothing, patient didn't get the result. Anyway they took patient off one medication, they didn't give it to her and this medication you can not get off of it and through that patient had a headache the whole of the day and the whole day on the 26Feb2021 patient was suffering with very bad headache and kept asking for the medication they said they would give to the patient. Finally the doctor gave only to the aspirin and paracetamol (TYLENOL) that both the same and in the end patient husband have to go and get the pill because they still hadn't given it to patient all day long. Patient said to doctor because she was breathing hard and she said the doctor did this to her by giving these pills that don't agree with her. She told she can not take this medication, anyway the doctor said to patient husband go home and get her medication, and he said so now you are medicating yourself. By the next day patient was ready, she was breathing normally and was ready to go home but late afternoon they said patient should go home but she still had those white patches but they were not as prominent as what they were. Patient whole lip turn white, whatever they did, whatever they gave, patient had sore around mouth and face swollen up. Patient didn't know whether she was allergic to the medicine or what but her face, it looked like she had, patient was fine anyway couldn't get an appointment with GP to the Wednesday (unspecified week) but it free appointment on the Tuesday and patient went in and showed him what it looked like. He said it should return to normal within 2 weeks and it but still face like normally excepted lips. Outcome of events pain, short of breath was recovered in 2021, and outcome of other events was unknown. Date of second shot was 17Mar2021, it was reported patient had got the both shot of covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404239 similar report from same reporter

body aches everywhere; severe headache; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; Nausea; by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating; bloating; could still void but it was pressure tying to go/severe pain and abdominal pain was causing pain to void; couldn't eat or anything; intestinal cramping/severe gut, lower abdominal, intestinal pain; This is a spontaneous report from a contactable consumer via An 80-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in arm on 04Apr2021 15:00 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Ehlers-Danlos syndrome (states she was diagnosed about 40 years ago), Allergies, lung collapses (due to Ehlers-Danlos syndrome), preemie, no fusion in her eyes (States she sees out of one eye most of the time), does not retain sodium and potassium (related to Ehlers-Danlos syndrome), egg allergy. The patient previous received pneumonia and shingles vaccine for immunization and was fine, the first dose of the bnt162b2 via an unspecified route of administration in arm on unspecified date as single dose for covid-19 immunisation and fine. Concomitant medication included potassium as does not retain potassium; spironolactone; a list of medications. Her mom got her 2nd dose on Sunday and is in the process of needing to report that. She ended up with severe gut, lower abdominal, intestinal pain and bloating along with other normal things. States she saw her doctor yesterday and he believes it could be caused by the Propylene Glycol in the vaccine. Her mother received her shot at 3pm on 4Apr2021 and does not know which arm. Her symptoms started around 8:30 with body aches everywhere, a severe headache, her bones and joints were hurting so bad she couldn't barely walk much, she made it to the bathroom and that was it, and nausea. Caller states by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating. States her mom could still void but it was pressure tying to go and caused severe pain and abdominal pain was causing pain to void. Caller provides that her mom continues the same until Tuesday morning and then the intestinal cramping and bloating is still continuing now and it's more primarily her lower left area as of Wednesday. She has a big history of Ehlers-Danlos syndrome and her doctor that she met with yesterday feels this is probably from the propylene glycol component that caused the flare up, as she usually doesn't have this and he is hoping it will calm down in about a week. Her mom also couldn't eat or anything until Tuesday. She was down all of Sunday night and Monday for about 36 hours. Stated the voiding is somewhat better but not much better and the rest of the symptoms are consolidated and persisting. Reporter stated her mom can't go without her medications. Her mom did a virtual doctor visit and will follow up later this week. Her mother got the second dose of the vaccine and had severe intestinal pain, headache, joint pain, nausea, abdominal pain. The outcome of the event Dysuria was recovering, Unable to eat was recovered on 06Apr2021, other events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

2 weeks after received 1st COVID vaccine patient began having fatigue and dizziness; also having issues with elevated blood pressure; patient states she will not get the 2nd dose of the vaccine

First shot reactions: I woke up I was in so much pain over my whole body. I was sobbing. I was told I could take ibuprofen, so I did , it helped relieve some of the body aches. But the headache on the left side continued for 4 days. I stayed in bed for 4 days. The second shot, I got a horrible headache within the fifteen minutes, I told the staff I had a horrible headache but they said to go home anyway. This was March 10th. I went home and was in bed for 2 days. Since then I have a sick headache on left side, and blurred vision, the fatigue is terrible and I am dizzy, I don?t feel like I have my balance. I?ve been to 4 specialists since then with numerous tests, but no one has an answer.

soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered. No follow-up attempts are needed. No further information is expected.

I had an allergic reaction to the Pfizer Covid vaccine; I fell; Passed Out Without Warning and Hit her Face on the Tile Floor; Busted Mouth; Stitches in Mouth; Right Knee Very Sore /Left Shoulder Very Sore and Can't Use It; Black Left Eye; states it was black, blue, purple, green and yellow; Tiredness; Left Hand Pinky Sore; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 14:00 at age of 80-year-old (Batch/lot Number: EN6205) at single dose for COVID-19 immunization. The vaccine was not administered at Military Facility. Medical history included she has hearing aides but it is hard to hear or understand sometimes. There were no concomitant medications. Prior Vaccinations (within 4 weeks) was the first dose of Pfizer COVID Vaccine (Batch/lot number: EL9267) on 18Feb2021 at age of 80-year-old administered in right arm and no adverse events following prior vaccinations. The patient reported she had an allergic reaction to the Pfizer COVID vaccine, she fell on 11Mar2021, not fainted. On 11Mar2021, the patient passed out without warning and hit her face on the tile floor, experienced busted mouth/stitches in mouth, right knee and left shoulder were very sore, black left eye/it was black, blue, purple, green and yellow, tiredness, left hand pinky sore. The patient was calling about the Pfizer COVID Second Shot; verified Pfizer COVID Vaccine. Her second shot was on 11Mar2021 and on the same day she passed out without any warning whatsoever, and she hit the tile floor and ended up in the hospital for five days. She passed out and didn't remember falling or feeling anything before falling. The patient also has a primary physician, but she had been seeing the plastic surgeon for this. The patient asked what does she do if she needs to get a booster. It scared her to death if she would have to take another shot. The patient asked (name) to hand her a pair of glasses to read the plastic surgeons name. She stated the printing is so small on there. She was supposed to see the doctor on 19Apr2021, but she didn't feel good enough to go see the doctor. For busted Mouth, they put in 3 layers of stitches. The stiches have been giving her a fit because sometimes they come undone and hang down. She had to go back into him and get them cut out twice, and she had another one from last night (18Apr2021). It is very sore. States the stiches inside the lip have not resolved and it was still hard. One part of her lip is soft and one part is hard. It was all hard in the beginning. The stitches on the inside are supposed to dissolve. For right Knee it was very sore and she can't hardly use it. For left shoulder it is very sore and she can't hardly use it. It made it awkward to get in and out of bed when she can't use her left arm or her right knee. Her left shoulder was really bothering her and she may have to go have some more work done. It has been popping and went in and out of the joint. That would be back with her primary doctor. Sore pinky on left hand had recovered it didn't stay that long. Black left eye, it was black and blue purple green and yellow. It cleared up in the last couple of days. She was lucky she didn't break the bone around her eye. Treatment included stitches, hospitalization, given antibiotics and blood clotting shots so she didn't get blood clots, she had 3 of those in her belly. She wasn't allowed to get out of the bed when she was in the hospital. She had a terrible experience in the hospital. For the event onset time, it was at 20:00, they drove home from (place name), which is an hour and something, and they stopped at (place name), came home and set outside and she said she had to go lay down because she was tired. She woke up an hour and half to 2 hours later, got out of bed, sat on side, stood up and got herself together and walked to bottom of bed and went out flat. The events required a visit to emergency room and physician office. For emergency room visit, it was reported on 11Mar2021 at (hospital name); the patient should've called redacted number but didn't, they drove in. The patient was hospitalized from 11Mar2021 to 16Mar2021 at (hospital name). The outcome of passed out, tiredness were resolved on 11Mar2021, outcome of 'black left eye/it was black, blue, purple, green and yellow' was resolved on 17Apr2021, outcome of left hand pinky sore was resolved in 2021, the outcome of fell, allergic reaction to the Pfizer COVID vaccine were unknow, outcome of busted mouth, right knee/left shoulder very sore were not resolved.

feeling very, very dizzy/dizziness; diarrhea; This is a spontaneous report received from a contactable consumer. A 80-year-old female consumer (patient) received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection), (Batch/lot number: EL3249) on 20Jan2021 at single dose for COVID-19 immunisation. The medical history of the patient included genito arthritis and asthma. The concomitant medication was not provided. On 20-JAN-2021 patient was feeling very, very dizzy and diarrhea. Patient was concerned about diarrhea as she got a shot 20Jan2021 and on 27Jan2021 she was still experiencing diarrhea. The patient took the vaccine on last Wednesday and had side effects or dizziness and 2 days later I started with diarrhea which is going on now. Patient did not received any treatment. Patient had some blood work done. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Sever muscular pain and disability in arms and left upper thigh. Ability to walk diminished. Lasted 4 days and disappeared suddenly after 4 days.

The morning after Mom's first dose of the Pfizer shot, Dad woke up and found Mom lying on the floor next to the bed. Mom said, "I can't move my arm." Dad called paramedics who checked her. They said her vital signs were normal and left. On 2/9/21 in the morning my da awoke to see that Mom had large amounts of bubbly saliva pouring from her mouth onto her pillow. Dad called paramedics, who said this was a diabetic reaction. Mom had NEVER had anything happen like this before. Mom was very sleepy, could not be aroused, and made only gurgling noises. She was admitted to the hospital for care and therapy. She pulled her own IV out. Mom had to be restrained in the hospital and sedated, due to confusion and worsening dementia. By 2/18 when we spoke by phone mom's speech was abnormally slow and very repetitive. "I'm very tired today" was spoken many times. In morning time mom was able to follow basic conversation. Not so later in the day. Mom came home from rehab on 2/26/21. She was able to walk steadily and independently at home after her therapy. After a week or so, Mom began hitting the in-home caregiver. Dad's presence would calm her. In a short time Mom seemed not to know dad anymore, and would hit him and the caregiver when they helped her. She also pulled all covers off the bed and pulled clothes out of the closet, throwing them all over the room during the night. Mom was usually walking around the house during each night. On 4/16/21 Mom and dad were napping sitting up on the couch in the morning. Mom fell forward and hit her head on the hearth. Dad and caregiver gave first aid and called paramedics, who took her to the ER. Mom came home on 4/17/21. On 4/18/21 Mom pulled her catheter out in the early morning. In the afternoon Mom's appearance was concerning, so Dad called paramedics. They said that Mom's BP had dropped very low and took her to the ER. Mom was combative the next day in the hospital. Dr. adjusted her medications periodically to ensure that mom's care would be manageable when she would eventually be sent home. Minimal therapy was done due to dementia. By 5/3/21 doctor said that Mom is bed bound and needing total care. Her blood sugar spiked high despite special diet. Staff waiting for insulin order from doctor. 5/4/21 Doctor called Dad to say that Mom had died during the night.

Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21). She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot. She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril. Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68. She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range. On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am: 132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss. She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.

Stroke Sudden fall around 1:15 PM on May 6, 2021. Laceration on head and eyebrow as result of fall. Lightheaded after fall. Loss of feeling on left side. Dystonia of left hand. Arrived at ER around 2:30 PM. MRI Diagnosis: Cerebrovascular accident due to embolism of right middle cerebral artery (HCC) Transferred to Another hospital around 5:00 PM. Treated with blood thinners. ICU for about 24 hours Numerous CT scans and MRI, ECG Normal function of left side restored. Slight loss of sensation remains on left side. Discharged from hospital and returned home. 5/9/21

Swelling and peeling of lips, peeling and soreness inside mouth, Diarrhea, upset stomach ache, dizziness

Kind of vertigo; All of sudden she felt unbalanced; Like her head was heavy; she was holding onto things when she walked; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 15:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included visually handicapped and could not read her vaccine card; vertigo before, a year ago. There were no concomitant medications. The patient had her first COVID 19 vaccination, on 28Jan2021, about 3PM and she will get the booster on 22Feb2021, but it seemed like she had kind of vertigo on 29Jan2021, this just happened in the last hour, all of sudden she felt unbalanced, like her head was heavy, and she was holding onto things when she walked, She did call her primary doctor, he didn't think it had to do with the vaccine, so she thought to call and ask, she was fine, and then all of a sudden she started to get this kind of vertigo, he asked if her head was spinning, but it's not, it felt heavy and she has had vertigo before, a year ago, but she doesn't know. Her doctor told her to rest, so she was laying down, and when she lifted her head she could feel, it was not spinning, she knew she was not feeling balanced. When asked to clarify her question, states she wasn't sure this happening had anything to do with the vaccination, she called her primary care doctor and he thought it wasn't, had nothing to do with it, so she thought since she called, she would wait and talk to Pfizer in case, that other people have experienced the same thing. States she was hoping this agent could tell her it would go away in a little while, but her primary care doctor said it has nothing to do with it, but it may have to do with it, it was somewhat of a coincidence that was happened, and she was fine for 24 hours, all of a sudden she started to feel this whatever. States she did not need anything else at this time. Outcome of the event vertigo was not recovered and all other events was unknown. Follow-up attempts are completed. No further information is expected.

When she woke she felt like she did when she had Covid/felt like she had Covid; Chills; headache; temperature of 99.6-100.1F/Fever; I still felt a little tired; my arm was killing me; felt weird; felt weird like she was unsteady on her feet; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient (Weight: 53.52 kg, Height: 157 cm) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:30 as 1ST DOSE, SINGLE for covid-19 immunisation. She is unable to clearly identify the Lot due to illegible handwriting on the vaccine card. She thinks it is EN6200 or EN06200. Vaccination Facility Type: Clinic sponsored by (Name). Vaccine not administered at Military Facility. Medical history included covid-19 from 2020. She was also told that she might not need to get the second dose because of having antibodies. When she had Covid it was mild. She did not have the traditional symptoms. It affected her gastrointestinal system more. It was weird. Prior Vaccinations (within 4 weeks) was None. There were no concomitant medications. On 26Feb2021, after she got the vaccine, her arm was killing her. It was awful. She took Tylenol for it. Around 3-4pm she was feeling a little bit weird/"felt a little funny" like she was unsteady on her feet. She was not dizzy. She woke up the next day, 27Feb2021, felt "rotten", "almost like I felt when I had covid/ felt like she had Covid. Same symptoms, milder form": slight headache for 3 hours, chills lasted a couple of hours, temperature of 99.6-100.1F for 3 hours. She was awful in the morning and better as the day went on. It remined her of when she had Covid. After symptoms went away, she still felt a little tired. Didn't feel as good as she did before the day she took the vaccine. Caller said the vaccination Nurse told her that she might have more reaction because she may still have antibodies. Caller asking did she need to get 2nd dose? Should she expect reactions from the second dose? She still plans on taking it. The outcome of arm was killing her was recovering. Her arm is better but if she lays on her arm she can still feel it. The outcome of felt a little tired was unknown. The patient was recovered from other events on 27Feb2021. Information on the lot/batch number has been requested.

I was very tired and my arm was a little bit sore and I ran a 99 temperature that just made me miserable. I sat around and didn't do anything because I didn't have any energy. It lasted 3 days until 02/29/2021. I did not see my Doctor for this.

her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness; nausea; This is a spontaneous report from a contactable nurse. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9265) via an unspecified route of administration, left arm on 02Feb2021 at a single dose (at the age of 80 years-old) for COVID-19 immunization. The patient's medical history included vertigo, arthritis, anemic, muscle spasms, high cholesterol quadruple vessel bypass graft and patient concomitant medications included as atorvastatin, cyclobenzaprine. On 03Feb2021 during the night patient experienced dizziness, light headedness, nausea, heart rate abnormal, activities of daily living impaired. Patient's normally her heart beats heavy but that was normal to the patient. The patient had already been diagnosed with vertigo prior vaccination. Patient paperwork stated that it was not recommended to receive the second dose, but patient wanted to know if what patient experienced qualified for her not to take it. The patient known second dose was higher than the first dose. There were unknown investigations done. The labs from last time patient went for them, they were concerned patient LDL was very low and the cholesterol was off, this was about a month ago. The outcome of the events dizziness, light headedness and nausea was recovered. The outcome of the remaining events outcome was unknown. No follow-up attempts are needed. No further information is expected.

started of with just muscle pain in left arm, as time went on, both arms,shoulders, legs, are all quite painful. they get worse when not moving,move arms hard to stand up, or

Woke up with excruciating pain in right hip; Could barely walk; Was tired the next morning on the 12th; severe chills of her life with her entire body shaking; Hard to get warm and sleep; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 9266, Expiration date: Unknown), via an unknown route in the left arm on 11Feb2021 at 15:00 as a single dose for covid-19 immunization. Medical history included known allergies: sulfur as a preservative and in any form and her blood does clot, but more slowly. Concomitant medications included Atenolol, 25 mg 2 times a day. Historical vaccine included first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 8982), via an unspecified route in the left arm on 20Jan2021 at 16:00 as a single dose for covid-19 immunization. Patient did not receive any other vaccine in four weeks. On 11Feb2021 night and 12Feb2021 at 15:00, patient experienced most severe chills of her life with her entire body shaking, hard to get warm and sleep. She was tired the next morning (12Feb2021). She took a nap in the afternoon and woke up with excruciating pain in right hip and would barely walk (12Feb2021 at 15:00). Her severe pain continued. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received unknown treatment for the events. The patient underwent lab test and procedure which included sonogram on 18Feb2021. The clinical outcome of the severe chills with her entire body shaking, hard to get warm and sleep, tired was recovered, patient received a sonogram on 18Feb2021 and the next day the pain (excruciating pain in right hip) suddenly disappeared (19Feb2021) and outcome of event barely walk was also recovered (19Feb2021). No follow-up attempts needed. No further information expected.

It was an extremely painful shot. It was a screaming painful shot. Once I made it home my pinky finger was numb and I couldn't move my arm above my head. It was hard lifting my hands and arms.

Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021. No follow up attempts are possible. No further information is expected.

loss of balance; Staggering; This is a spontaneous report from Pfizer-sponsored program. This is a report from contactable consumer or other non health professional (patient). A 80-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Right on 31Mar2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased from 2009, ongoing macular degeneration, ongoing osteoporosis and high cholesterol. Concomitant medication(s) included ongoing calcium (CALCIUM) taken for osteoporosis and has been taking longer than 2016. Stated she takes calcium 1500 mg daily and the calcium was 600 mg and she takes 2.5 tablets; ongoing levothyroxine (LEVOTHYROXINE) taken at dose of 50 mg once a day for an unspecified indication from an unspecified start date; ongoing lovastatin (LOVASTATIN) taken at dose of 40 mg at bedtime for blood cholesterol increase from 2011; ongoing vitamin d3 (VITAMIN D3, Batch/Lot Number: EP6955) 500 units daily, for an unspecified indication from 2016; ongoing Areds 2 Eye Vitamin at dose of 2 every day, she has been taking 8 years. Stated she was told she has macular degeneration then told she does not. Stated she was prescribed this in error and had just continued to take it. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number : EN62(or 7)05) via an unspecified route of administration, administered in Arm left on 10Mar2021 at 09:00 or 10:00 as 1st dose, single dose for covid-19 immunisation. Family Medical History Relevant medical history to AE none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. On an unspecified date the patient experienced loss of balance. She was unsure of exact date that it began. Stated she wasn't sure at first and was staggering and has to hold onto rails when she goes up steps. Stated it's all day. Stated she hadn't reported it because she thought it would clear up. she stated it had improved, but was still continuing. Caller added she was a very active person so she just didn't associate it with anything other than her age, when it first started she just felt like it was her age, then she calculated that it started soon after the shot, and confirms it was after the second shot. The outcome for the event Loss of balance was recovering and Staggering was unknown.

Discomfort in site for several weeks then finally left. Since then trouble with arm right arm lifting, exercising doing household chores. I am right handed.

today feeling headaches; fatigue; dizziness; 2nd lethargic; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; dose number=1/administration date=11Jan2021/other vaccine same date product= Pfizer, other vaccine same date vaccine date=29Jan2021,other vaccine same date dose number=2; sleepy on the first day; This is a spontaneous report from a contactable consumer (patient). A 80-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 29Jan2021 (at the age of 80-year-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history included tobacco(Smoker). Concomitant medications were not reported. The patient previously took buspar. Other medication in two weeks included Buspar. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 11Jan2021 13:00. No other vaccine was received in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. On 29Jan2021 the patient experienced sleepy on the first day, 2nd lethargic, 3rd ok and 4th day, today feeling headaches fatigue and dizziness. No treatment received for AE. The outcome of the events sleepy, lethargic, headaches, fatigue, dizziness was reported as not recovered and unknown for other events. Information on batch/lot number was requested. Follow-up (26May2021): 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

dizziness; nausea; headache; This is a spontaneous report from a contactable female Nurse (patient). A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN5318) via an unspecified route of administration on 06Feb2021 11:45 as dose 1, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure had this for years, ongoing high cholesterol, ongoing allergies had for at least 20 years, perennial allergy from an unknown date and unknown if ongoing she has perineal allergies. also, she has an allergy to penicillins and erythromycin with penicillin being an anaphylaxis reaction. Caller has no NDC, Lot, or Expiry for any of the products which caused these reactions, this was a long time ago, cancer from an unknown date and unknown if ongoing, swine flu from an unknown date and unknown if ongoing AE(s) following prior vaccinations: In the 1970's with the swine flu, she was given the vaccine and right after she felt like she was going to pass out. EMS gave her oxygen, and she was fine. No NDC, Lot, manufacturer, or expiry. Concomitant medications included lisinopril (LISINOPRIL) 40 mg taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. No prior Vaccinations within 4 weeks. On 06Feb2021, less than 48 hours ago the patient experienced after she had the first shot, she has had a headache and mild nausea for 2 days. On 08Feb2021, this morning she has been very dizzy and so she was wondering if this was normal; she didn't see it on the side effect list, but I am not having weakness or anything really bad and asked if this dizziness could be from the COVID-19 vaccine. When she eats, she feels sick to her stomach, in regard to the nausea. She gets a flu shot every year and has never had a problem. The clinical outcome of the events was not resolved. Follow-up attempts completed. No further information expected.

Immediately I had "funny bone" pain in the opposite arm (right) of the injection. That comes and goes at night but less as time goes on. Left arm still hurts at the injection site. Main Problems: Headaches and extreme dizziness. I thought the dizziness was a UTI problem. I took 14 pills twice to get rid of the "UTI" effect as per my GP. The dizziness and headaches started after the vaccine and is getting worse and worse. The room is spinning when I get up at night or lay down to sleep and many times during the day. My husband cannot drive anymore and this problem is scary. I wish I did not get the vaccine. I believe I had Covid after holidays of 2019 and into Jan. of 2020. Serious coughing and could not breath. We we

Headache; Right arm funny bone nerve pain that would go all the way up and down arm; nerve pain; UTI; she is still dizzy and having bad effects for the UTI; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/NDC number: Unknown; Expiry date: Unknown) via an unspecified route of administration in left arm on an unknown date in 2021 14:00 (at 80-year-old) on left arm as single dose for COVID-19 immunization. The patient's medical history thyroid issues was over 30 years ago, penicillin allergy (since 1964) that gave her hives so bad. loaded with hives and was a pimply mess, ongoing doxycycline allergy that gave her severe diarrhea, sulfonamide allergy, iodine allergy, fever and could not breathe/extreme difficulty breathing. The past drug event included tetracycline, arithromycin, Levaquin, ceftin, Zithromax that caused drug allergy (ongoing). Concomitant medications included levothyroxine (Other products: Yes) taken for thyroid disorder (had it for 30 years or more and had been taking for the same then). The patient previously took doxycycline and experienced diarrhoea, tetracycline and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, levaquin and experienced drug hypersensitivity. It was mentioned that no investigation assessment was done. She came home on an airplane on 03Jan2019, the year COVID started. When she got back, she told her doctor she thought she had gotten Covid, so they tested her, but she was negative. She thought she had it and volunteered for antibodies. She did not get over it until mid Jan2019. They told her she was over it for too long though if she had it. It was mentioned that history of all previous immunization with the Pfizer vaccine, prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration were reported as none. Received call from consumer regarding the Pfizer COVID vaccine. She has ongoing symptoms that started after she received the vaccine. She only got the first dose. On an unknown date in 2021, she started having headaches that she never knows when they are going to come on and they are continual. She did not have them before she got the vaccine. She did not remember the start date and said it was right away after the first dose that she received about a month and a half ago. It started right away. She was not getting the second one because the headaches would not go away. They become more continuous and more often. She was hesitant to get the vaccine because she was allergic to just about all antibiotics. She does not have names, lot or expirations for any. She later provided that Penicillin gave her hives so bad. She was loaded with hives and was a pimply mess. She also said that Doxycycline gave her severe diarrhea. She then found her list and also provided allergies to the following: Tetracycline, Arithromycin, Sulfa, Levaquin, Ceftin, Zithromax, and no contrast Iodine. She does not remember the exact reaction. It is either severe hives or severe diarrhea. She does not have the lot or expiration for any of them. No further details provided. She had another issues immediately after the shot. She had funny bone pain in the right arm but she got the shot in the left arm. This pain was described as a nerve pain that would go all the way up and down her right arm. It would come at night after the shot but then it went away. She does not have it right now. Right now she was trying to get rid of a UTI. It was recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she was still dizzy and had bad effects for the UTI. She took the medication and had to refill it. Medication was Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It was in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. She finished them and has none left. Her friends were upset because she would not get second shot and certainly not a third because of these headaches. She felt she may take a chance at getting something worse than these headaches. She does not feel she should get them or anymore. The patient did not require emergency room and physician office visit. She had been to her doctor since and she mentioned the headaches, and all they say was to take Advil. Outcome of the events headache, urinary tract infection and dizzy was not recovered, whereas other events were recovered on an unspecified date in 2021. Description of Product Complaint: Description of complaint: Right now she is trying to get rid of a UTI. It is recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she is still dizzy and having bad effects for the UTI. She took the medication and had to refill it. Medication is Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It is in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. It was mentioned that product strength and count size dispensed: 100mg, 14 count. Information on lot/batch number had been requested.

Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown. Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .

This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 80-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 80-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation and had pain in her arm. The patient reported that she had first shot on 25Feb2021 and followed the procedure 21 days later and received second shot on 18Mar2021 after the first shot. When probed for second shot vaccination timings, consumer stated, "her second shot was on "319" (Further not clarified). On 19Mar2021, she woke up and her teeth were killing her like she slept she was fine but in the morning she had terrible toothache and she was taking care of her teeth, she had Flu like symptoms her eyes puffed up, swelled and runny nose, she went to a Dermatologist Doctor and she gave her some medicine to take swelling down, she had severe leg cramps and could hardly barely walk. She was trying to find out if she could have blood clot, she could have everything, she went to funeral and she had to leave early, she left and fly back Home, it disturbed her, it could be from Pfizer shot. She was 80 years old and she was not be able to, she should be hardly be able to function. Consumer stated, she was in pain and on pain medication, she was in terrible pain because her legs and back hurting so much. Her eyes swelled up badly. When probed for any laboratory test, consumer stated, she had pain today, she walks 3 miles a day, today she probably walked a mile and it was painful. She went Dermatologist for her eyes. Consumer stated, she went to a Dermatologist to see why her face is swallowed up. She would like to be followed up, what she was to do with her pain, she was like crippled, she was in pain all the time, she would like to know Pfizer to tell her what medication she needs to take. She did not know, the Doctor knows what to give. She needs them to recommend what they are giving to other people those are having these severe reactions. Consumer stated, she had two Pfizer shots (both doses) and she had a severe adverse effect. Now it was difficult she had severe pain in her legs. she walks 3 miles a day. she had her eyes swell as well, she went to a Dermatologist. She walks to her Doctor after the severe pain from the Pfizer shot, he gave her some pain treatment Tramadol and "Ibuprofen" (not clarified) besides the fact that it will help. She started to walk, she sneeze a lot, swelled up like her eyes swelled up and she had sticky stuff that was for 9 days, no apparent reason then she went to the Dermatologist. She had severe swelling then she had her teeth ache, for eye condition and skin she went to Dermatologist and he gave her "Hydrocortisone" (name not clarified) several days for two weeks and her teeth have no pain in her teeth. She woke up this morning and felt cry it was painful and she don't know what to do about this adverse effect. she wanted to ask to Pfizer people to get medicine. The caller has had severe adverse effects after receiving the Pfizer Covid 19 Vaccine. The caller could barely use her legs, the legs were in severe pain. The caller was a person that walked and exercised, walked 3 miles a day. The caller could barely get around, and up and down in the morning is hell. The caller was so weak and the legs hurt so bad. The other effect was the caller's eyes swelled up and ran sticky oozy stuff. The caller went to the dermatologist and was given cortisone and after 14-15 days that cleared up, it was white. The caller went to her doctor about the pain in her legs. The caller was taking Tramadol and Ibuprofen and they were not a lot of help. The doctor said it will run its course. The caller asked how long it will be and the doctor said the good news is it will go away and that is about all the doctor would say. In the mean time, the caller was in severe pain and is asking what can be taken for the legs. The caller states she had been in severe pain since February. The caller states if she is not going to get any help why this was not put on the news report. All it is go get another shot. No reports on how it may have these adverse effects. Another thing is the caller goes to bed at night fine and wakes up in the morning with jaws and teeth killing the caller. The caller had excellent dental work. The caller's eyes still run, continually run. The caller states she specially asked what the caller can get for some relief from the pain or is the patient to call the rest of her life. The caller states she could walk. The caller said Pfizer doesn't report a thing, no side effects, everybody is shut up on tv. The caller thinks the side effects, percentages and dangers for the elderly like the caller and the young, young children should be told. The caller states she did talk to her doctor and he gave the caller tramadol (50mg, Expiration date: 12Jul2022) and Ibuprofen (Expiration date: 21Jun2022). Outcome of the event toothache was recovered in 2021; eye discharge was not recovered; other events was unknown. Information about the Lot/batch number has been requested.

Dizzy; Nauseous; Unable to breath; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot unknown, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure increased. Concomitant medication included sertraline (UNKNOWN MANUFACTURER) for high blood pressure. On an unspecified date the patient experienced dizzy, nauseous and was unable to breath. The patient still had those symptoms and was wondering if it was normal and how much longer will these symptoms be. The outcome of the events was not resolved. Information about lot/batch number has been requested.

Friday afternoon ... headache and right thigh muscle discomfort . Saturday ... headache and more thigh muscle discomfort. By night, muscle ache was continual and continued throughout the night. Very difficult to walk. Sunday ... called Telehealth around noon, They triaged me into Dr.'s office. By Sunday afternoon, less discomfort, but still a headache. During this discomfort time, I would take 2 Tylenol (500 mg), which relieved it. Before I settled down for the night, I took 1 Tylenol and when I woke up at 3:00 a.m., the ache was not there (the Tylenol would have worn off by then). Monday a.m. ... could walk much better. The headache and the constant muscle ache are gone. Nurse called; I am to keep watch, and if there are any changes for the worse, I will go into the Dr.'s office.

12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away

Patient felt faint, hot, weak, had to sit down upon trying to leave the facility after observation period. Vital signs stable, blood glucose measured = 89 Orthostatics conducted, negative for orthostatic hypotension Patient given crackers, water. Evaluated by nurse practitioner, advised to take deep breathes, patient felt better and left facility with daughter

weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, Expiry Date: Apr2021), via an unspecified route of administration at right arm on 08Jan2021 13:00 at single dose for covid-19 immunization. Vaccine was not administered at military facility. Vaccination facility type was health department. The patient got the flu shot every year and never had a problem. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021, the patient experienced severe dizziness/head was dizzy, feeling weak, nausea, neck was sore. The events did not require a visit to emergency room or physician office. She was very dizzy and laid back down. Today (14Jan2021) was better but she felt weak and wanted to figure out what was going on. She took it to make sure she felt better but the only thing she's had was discomfort. No treatment, not contacted the doctor. The outcome of events weakness/feeling weak, dizziness/head was dizzy was recovering. The outcome of events nausea, neck pain was not recovered. The outcome of event discomfort was unknown.

Resident was fine Day of the vaccine. The pharmacist stayed after for 30 minutes to check the well-being of the residence. Three days later resident was feeling weak wasn?t able to stand so we had to get a chair for her to sit in which was unusual. We did rapid testing and it was the only positive in the facility.

fast heartbeat, dizziness and it took about 45 minutes to feel better. Had a bad taste in her mouth received Gatorade. On Saturday I felt nausea and just not feeling good and terrible taste in her mouth. Denies any shortness of breath during this entire time. Needed to eat to make her stomach to feel better, chills. injection site sore. Sunday felt better and Monday was almost normal and Tuesday no complaints.

Watery drainage from her right eye; Nose feels full; congestion; Phlegm; Fever blister on her tongue (sore blister on the right side of her tongue); sores on her tongue; Feels a little weird; Dizzy or dizziness like vertigo (funny feeling like vertigo); Headache; Slept hard - she never sleeps that much; Drinking a lot of water; Fever; feverish; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, Expiration Date: 30Apr2021), via an unspecified route of administration, on 11Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history included colitis and diverticulitis (chronic; diagnosed years ago); and allergies. The patient's concomitant medications included chlordiazepoxide/ clidinium bromide (LIBRAX) for colitis, omeprazole (PROTONIX), levocabastine hydrochloride (ZYRTEC) for allergies, and cyanocobalamin (VITAMIN B12) for colitis. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899, Expiration Date: 31Mar2021) on 21Dec2020 for COVID-19 immunization and experienced a little sore on site; and varicella zoster vaccine (SHINGLES VACCINE) for immunization and it hurt and she got blisters at the injection side. The patient just got her second shot on Monday (11Jan2021) at 9 in morning. After a couple of hours (11 AM), the patient feels a little weird, dizzy or dizziness like vertigo (funny feeling like vertigo), and headache. That night, the patient took ibuprofen (MOTRIN) and paracetamol (TLENOL) and she just slept hard - she never sleeps that much, she is drinking a lot of water. The patient also had a fever that night and received treatment for this. On Tuesday (12Jan2021), the patient was okay but, in the evening, she started feeling feverish and has a fever blister on her tongue (sore blister on the right side of her tongue). The patient never had a fever blister before. Last night (13Jan2021), the patient was a little feverish, still has the sores on her tongue and she was having watery drainage from her right eye and her nose feels full; congestion and phlegm. The patient wanted to know if she should go to work tomorrow but was encouraged to reach out to a health care professional for medical advice. The patient asked health employee and they told her to call the company. Got the vaccine from work at a center. The patient recovered from "Dizzy or dizziness like vertigo (funny feeling like vertigo)" in Jan2021. The outcome of "Feels a little weird", "Headache", "Slept hard - she never sleeps that much", and "Drinking a lot of water" was unknown. The patient had not recovered from the remaining events.

Received Dose 1 of Pfizer COVID vaccine. Per vaccine administrator: Patient stated she felt lightheaded She did not appear pale or diaphoretic I continued to engage her I conversation and she was conversing normally No intervention. I observed her for 10 minutes while seated with me at vaccination station. She stood up without assistance and I observed her walk and she appeared steady and stated she felt normal.

pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm; To the point where she felt like she "was going to pass out"; kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy; felt dizzy; She has not been sleeping good; having a funny feeling; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscularly on 15Jan2021 16:15 at single dose in left arm for COVID-19 immunization. Medical history provided as none. There were no concomitant medications. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no vaccines received within 4 weeks Prior Vaccinations. The reporter stated she received the first dose of the COVID-19 vaccine on 15Jan2021 (Friday) and felt fine. She added it then made her kind of weak on next Saturday morning on 16Jan2021, to the point where she felt like she was going to pass out on 16Jan2021, but it went away after laying down. She stated she felt pain on her left shoulder where they gave her the shot on 20Jan2021 but is fine today (21Jan2021). Lastly, she mentioned having no energy. She asked if her symptoms were reported sided effects of the vaccine. She has been having a funny feeling in Jan2021 and does not know if it is from the vaccine. She clarifies that she does not seem to have the energy on 16Jan2021. When she got home she was ok, the next day after she got the shot, she thought she was going to pass out and felt dizzy for about an hour on 16Jan2021. She has not been sleeping good for the last few days since Jan2021 and states that may be why she does not have the energy. For event does not seem to have energy, reports it comes and goes, states it just droopy and it may be she had pain where they she had the injection in her arm on 20Jan2021. She is asking if this is normal. The patient declined any Treatment. The reported adverse events did not require a visit to Emergency Room and Physician Office. The reported stated it wasn't that bad. The outcome of event Dizzy was recovered on 16Jan2021. The outcome of the event "was going to pass out" was recovered in Jan2021. The outcome of event "pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm" was recovered on 21Jan2021. The outcome of event 'kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy' was not recovered. The outcome of the other events was unknown.

Patient was flushed and sweating, seemed to be a little dizzy. Vitals were all okay and within normal limits (BP, glucose, O2 Sat, HR). I administered a Benadryl 50mg IM injection to the patient, and the hospital staff later gave her a dose of Zofran as she felt nauseous. Since then the patient seems to be reacting well to treatment.

Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.

"While in the waiting area after receiving her vaccination Pt. developed chest pain with changes in skin color. She denied any shortness of breath. BP 179/71 P 66 R16 SaO2 96% 911 was called Pt. was transported to hospital." Per RN. Paramedic documented. "Post vaccination pt started to become very light-headed and had near syncopal episode, also c/o chest discomfort over L anterior chest, denied any shortness of breath, Pt was evaluated 911 called, Pt was transported to hospital for evaluation w/VFD and AMR."

my right foot swelled up and turned bright red. It was incredibly painful. I couldn't walk. It lasted 2 days and then receded. I took 5 Tylenol for the pain in 48 hours.

her equilibrium was off; She said feels cold all the time now; bone and muscle in her body hurt; hands and body were jerking; she ached all over; she felt tired; rigors; shaking; muscle and joint aches/her muscles hurt; muscle and joint aches/her joints hurt; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration at left upper arm on 21Jan2021 08:00 at single dose for covid-19 immunization. Medical history included lymphoma from 2018. The patient's concomitant medications were not reported. There were no additional vaccines administered on same date of the Pfizer. The patient previously took rituxan for lymphoma (Reported she had been in remission for a little over a year. She said she had received only 4 Rituxan infusions for the lymphoma before she went into remission). 12 hours post injection: she "experienced significant rigors and shaking, muscle and joint aches, her equilibrium was off at some point, she was tired, had generalized pain, and chills". She also confirmed feeling better. She stated she heard the the second dose of the vaccine caused more reaction than the first dose and would like to validate the information. She explained the first instance she experienced rigors was after a lymphoma treatment. She believed the rigors lasted "12 hours" but was not certain because she "fell asleep and got warmed". The patient felt great all day on 21Jan2021 after receiving her first COVID-19 Vaccine dose. She said almost exactly 12 hours later, she started to have rigors. She was shaking so hard that her hands and body were jerking. Her muscles and joints were hurting, her equilibrium was off, she ached all over, she had pain, felt tired, and she had chills. The rigors started first. She said she felt really cold at the same time, so she went to bed and covered up, trying to get warmed. She fell asleep for awhile, and then woke up and went to the bathroom. When she went to get out of bed to go to the bathroom, she stood up, and every bone and muscle in her body hurt. She said she was aching all over, and her equilibrium was off. She didn't feel like getting up, and finally went to sleep to get the rigors to stop. She felt cold all the time now, but the rest of her symptoms had improved. She said it seemed like the muscle in her right leg was still pretty sore. She said she recovered from the rigors completely. She had rigors once before when she had an infusion. She clarified the infusion was Rituxan. She said she had a reaction to her first treatment of Rituxan. She said she had rigors when the Rituxan infusion was first started. She was given a couple things (but she didn't know what those things were), and she stopped shaking. She said the infusion staff waited a few minutes and tried to restart the Rituxan infusion, but she would have rigors again. She said the infusion staff tried slowing down the Rituxan infusion rate, as well. She said the Rituxan infusion normally takes 2 hours, but after 8 hours, she had only got about 20% of the Rituxan infusion, before the Rituxan infusion was stopped. She stated she had 3 subsequent Rituxan infusions at later dates, and did not have any problems with those infusions. Her first dose of the COVID-19 Vaccine was administered high up in the muscle of her left arm, close to the shoulder joint. She said the COVID- 19 Vaccine injection didn't hurt, and her left arm never got sore. She said on 30Dec2020 she had lab work done for her oncologist. She went about every other month for blood work to make sure she was still in remission. She saw her oncologist on 06Jan2021, and her oncologist said her blood work looked pretty good and was better. She asked her oncologist about the COVID-19 Vaccine, and her oncologist said she definitely wanted her to get the COVID-19 Vaccine. Her next appointment with her oncologist was in Mar2021. She said she had been seeing her oncologist every month, but her oncologist this time, wanted to try seeing her after 2 months. The events did not require a visit to emergency room or physician office. The outcome of events rigors, shaking was recovered in Jan2021. The outcome of events muscle and joint aches/her muscles hurt, equilibrium was off, aching all over, tired, bone and muscle in her body hurt, hands and body were jerking was recovering. The outcome of event feels cold was not recovered.

cough, slightly dizziness, gave 50 mg Benadryl po, took vital signs every 5 mins patient recovered and walked out with friend to her car

About 2 days after the injection, my heart started beating very hard. It was not a rapid beat but noticeably hard. Saturday and Sunday I stayed prone which seemed to feel better. On Monday, it seemed better and I had an EKG at my cardiologist?s office which came back fine. No trouble since then. Now I?ve just had my second shot.

Patient had Pfizer vaccine. Approximately 20 minutes after vaccine, patient unable to stand upright. Patient said she felt dizzy. After sitting and having 8oz of water, patient complained of dizziness. Dr. called and came to assess patient. Dr. assessed patient and referred patient to ED for further evaluation unrelated to vaccine. Patient transported to ED via wheelchair and assessed by triage. Patient will remain in ED for further evaluation.

Approximately 75 minutes after vaccine had significant shortness of breath, extreme fatigue (difficulty walking to the bathroom). Over the next week and a half, blood pressure and heart rate swung widely (outside of normal range). Heart rate periodically dropped down into 30-40 range. Experienced whiteouts.

Very dizzy/ Light headed; I felt very washed out and thought I was tired/ exhausted; Lethargic; She still has a little weakness; Almost like a flare up of Hashimoto; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; she was feeling bad; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; joint pain, knees, feet, even my hands; joint pain, knees, feet, even my hands; It felt like some kind of nerve ending issue; She was also very off balance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration at left arm on 23Jan2021at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease; scalp issue; abrasions on her head like eczema; and weight loss. She was diagnosed a couple of years ago with Hashimoto. A thyroid disorder. She is not on a thyroid medication. They have just been watching it to see. She took the shot. For background, the last couple of months the patient has had abrasions on her head like eczema. She has been going to the Dermatologist for the last year. They have been trying to figure out what is going on. Concomitant medications included Phentermine for weight loss. The patient took the shot on a Saturday 23Jan2021. She did fine Sunday, but by Sunday evening on 24Jan2021, she was feeling bad. On 24Jan2021, the patient experienced injection site really red, hard and warm but didn't hurt; head broken out so bad; and joint pain. On 25Jan2021, the patient felt very dizzy/ light headed, fatigue and lethargic. As the evening went on for two to three days later from the vaccination, she experienced side effects. She got up in the middle of the night that night, and her head was broken out so bad that she couldn't comb her hair. There were least 100-150 small little bumps on her head. They almost feel like they have oil under them. They were sore and very irritated. Her scalp was blood red with inflammation. This has went on the course of 8-9 days. She also had joint pain really bad. Almost like a flare up of Hashimoto. She hasn't been having issues with it. It was like her skin was on fire. Even regular water in the shower feels like it was burning. It felt like some kind of nerve ending issue. She was also very off balance, and light headed. She never ran a fever. She was so exhausted that she couldn't get out of bed for the last 8 days. She is scheduled for the second shot. She is scheduled for the second dose 16Feb2021. Her doctor told her to go ahead and get the other shot, but she would like more information. She did not have a prescribing doctor. She got the vaccine at a a local hospital where she goes for testing. She could never get through to get ahold of the hospital so she tried to go through another facility. She finally got an appointment through the hospital. She was wondering if it is okay to get the second shot. She has had a scalp problem, but nobody knows what it is. They have tried to treat it with a steroid. She has seen several who don't have a clue what is could be. Whatever she has, the vaccine aggravated it 10 times worse. The joint pain was almost 100 % better since yesterday. It was mostly in her feet and knees. She was very dizzy and light headed. She wasn't falling all over the place or anything. That has improved over the last day or two. The first night, she got up to go to the bathroom, and she lost her balance but caught self. she was very careful from then on. She has fatigue as well. She still has a little weakness since the 25Jan2021. She never lost her appetite, but she felt very lethargic since the 25Jan2021. She has recovered from most of these issues, except for her head. She is in very good health except for her thyroid issue. That she has been diagnosed with for a couple of years, and the stuff in her hair. They don't know what has caused that. Every test has been negative. She thought at one point it could be the medication she was on. She was taking Phentermine to lose weight. She was wondering if it would have any recourse, but her doctor said no. She quit taking it the day before the shot just in case. She hadn't taken it again until today. The dose is 37.5mg. The way she felt at first, she felt like she had COVID. The patient stated, "I had some reaction to the (first) Pfizer covid 19 shot I took on 23Jan2021 wanted to ask if I would be able to take the 2nd shot. I took the shot fine, got home. The injection site was red, hard, kind of warm. My arm was never sore but the day after into Sunday I felt very washed out and thought I was tired. I have a thyroid issue, I've been having a scalp problem and this sometimes come with my thyroid issue. Little bumps in my scalp, they were kind of under control because of the Clobetasol propriate foam that I put in my hair and ever since then my skin is on fire. But the main thing I was exhausted, joint pain, knees, feet, even my hands. I laid around and for 5-6 days and today is the first real good day. I still have the bumps but I'm seeing a different dermatologist. I have an over active immune system Hashimoto's disease and something can set up a flare." The outcome of the events almost like a flare up of hashimoto and a scalp problem, but nobody knows what it is/ whatever she has, the vaccine aggravated it 10 times worse was not recovered; events she was feeling bad, joint pain, knees, feet, even my hands, very dizzy/ light headed, i felt very washed out and thought i was tired/ exhausted, lethargic and she still has a little weakness was recovering; events the injection site was red, hard, kind of warm was recovered in Jan2021; and outcome of the other events was unknown.

10 minutes following vaccination, patient complained of dizziness and feeling warm. Vitals showed elevated blood pressure 193/78, normal pulse, oxygenation, and temperature. She noted mild improvement in symptoms after 30 minutes, but patient was still unsteady to ambulate independently. BP remained elevated 189/73, 191/86. She denied headaches, SOB, chest tightness, difficulty breathing, GI symptoms, rash. Patient noted history of intermittent elevated BP with systolic measurement in 250s, but no diagnosis of hypertension or hypertensive medications. She reported feeling well this morning and having normal breakfast prior to appt. Ambulance transport was called due to hypertension and persistent dizziness. Patient refused transport upon arrival and was taken by personal driver.

Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative. Information on the lot/batch number has been requested.

Started upon rising from sleep on morning after vaccine. Very dizzy, needed help to bathroom, began dry heaving, did not feel sick to my stomach. Dry heaved 3 different times, then vomited 2 times. Still Dizzy. My roommate called ambulance and I had just finished vomiting as they arrived. My blood pressure was 227/70. They monitored me for a while until my blood pressure was at 160/72. I opted not to be taken to the hospital at that time. I ate a slice of toast, which stayed down, them took my morning medications. They also stayed down. I had liquids all day and some crackers. Was dizzy all day. Blood pressure before retiring was 150/74. Slept well last night and am still a little dizzy yet today, but appetite has returned. Blood pressure is now 135/74. which is about my normal.

Patient became flush and light headed after her 2nd shot of Pfizer. Patients BP was 140/78 and continued to rise to 170/80, pulse dropped from 78 to 62, patient developed facial redness and after 90 minutes of observation she became to feel a lump in her throat. No difficulty breathing or respiratory issues.

COVID 19 Pfizer - 2nd dose, 2/16/2021 Lot number - EL9261 - About 48 hours later, I got this pain breastbone. I couldn't turn over to the left or right when down because of the pain. It was not shortness of breath. It was pretty bad. This pain lasted about 3 weeks. Soreness is my arm appeared the day of vaccination but that went away within 2 days. I also kept sneezing non stop, and my nose was runny this also started about 48 hours after vaccination. It is better but not completely gone yet. The sneezing is not constant, as of today but still there.

muscle and joint pain; wanting to faint/dizziness; blurry eyes; sweating; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side/she was having pain on her wrist/joint pain; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; swelling in her hand and was hardly able to bend her fingers; swelling in her hand and was hardly able to bend her fingers; wrist was swollen; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), via an unspecified route of administration on 06Feb2021 15:00 at single dose at left arm for covid-19 immunisation. Medical history included wrist had arthritis (pain). There were no concomitant medications. Patient height was a little less than 5. She used to be over 5 but she shrunk. Her weight used to be at 226 lbs, it came up to 230. This year (2021) it went up because, its her, she ate too much and she did not obey the rules. Patient received Pfizer vaccine on 06Feb2021 afternoon at 300 pm in her left arm and that night developed itchiness, numbness and tingling in her fingers on the right side. Last night (07Feb2021) she unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side. she also reported swelling in her hand and was hardly able to bend her fingers. She tried to bend her fingers and she can but her wrist was swollen, it was less right now but she still had the pain. She applied muscle relaxant (unclear if topical) and took paracetamol (TYLENOL) and massaged her hand with warm water and then for the second time she used the muscle relaxation. She hadn't taken paracetamol yet she was waiting 4 hours but the pain was still there, it was a little bit less. Not sure if it her arthritis or side effects from vaccine but believes it was from the vaccine. Stated she used to have the same problem with her wrist arthritis (pain). Also reported that she experienced additional side effects on 08Feb2021 which lasted about 5 minutes then went away: blurry eyes; wanting to faint; dizziness, sweating (whole body started to be like sweaty). Asking for information on muscle and joint pain after the vaccine and recommendations on what to do. So far she didn't know what it was, and if it was a side effect of the arthritis, because once in a while that happens but when it happened it went away right away but this time her wrist pain was there still there. Patient sat down and now she was stretching her leg, she sat down on the chair and its gone she had no more problems. Patient said her right hand, she was very slow writing. She said at least she can write her hand was going back to a routine but she was in a lot of pain. Outcome of event wanting to faint/dizziness, blurry eyes, sweating was recovered on 08Feb2021, and outcome of other events was unknown.

Became lightheaded within 5 minutes after receiving the vaccine. Initially thought it was because she had to stand and walk for over an hour before receiving the vaccine and had not had much to drink or eat. Dizziness/ lightheadedness continued off and on for 10 hours. She also experienced a rapid heart rate (90-100 bpm, which is high for her) and elevated BP (140/80, also high for her) that started about an 2 hours after receiving vaccine. The increased heart rate and elevated BP occurred intermittently over the next 10 hours and she also felt occas. palpitations. After the 10 hour period she felt fine

RECEIVED FIRST DOSE OF PFIZER COVID VACCINE ON 02/21/21. WENT TO ICC ON 02/28/21 WITH COMPLAINT OF FEELING LIGHT HEADED AND HAD AN ELEVATED BLOOD PRESSURE. INSTRUCTED TO GO TO ER. WENT TO THE ER ON 02/28/21 AND BE EVALUATED CURRENTLY.

SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA STOMACH ACH AND SLEPT HOURS AND HOURS AND WEAK.

weight was 236-238 and bounces back and forth; Started getting real dizzy that comes and goes/ if she moves too fast that the dizziness comes and goes; Right arm is sore and not tender; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249 expiration date: May2021, via an unspecified route of administration on 26Jan2021 at a single dose in the right arm for COVID-19 immunization. Medical history included heart problem from Nov2019 and ongoing and angina pectoris. Concomitant medication included a lot of pills for her heart problem. She was on blood thinners, sugar pills, and uric acid because of the diuretics. The patient stated that she got her shot yesterday (26Jan2021) a little after 1. Later this morning (27Jan2021), that she started getting real dizzy that comes and goes. She was reading the list and dizziness was one of more serious side effects. She wanted to know what to do about it, it was one of things. She has another shot coming up on 16Jan (as reported). The patient further mentioned that her right arm was sore and not tender on 27Jan2021. If she moves too fast that the dizziness comes and goes. Her weight was 236-238 and bounces back and forth because she was on diuretics. The outcome of the events dizziness was not recovered, right arm was sore was recovering while for weight was 236-238 and bounces back and forth was unknown.

patient developed unexplained diplopia and vertigo; extensive diagnostic workup including mris and LP. Felt to have aseptic meningitis with vestibular neuronitis

Patient felt short of breath, lump in throat w/ difficulty swallowing, head ache & dizziness. Vitals 220/120, tachycardia, 98% on RA Treated w/ Benadryl 50, Pepcid 40 prednisone 60

She went to the living room and fell and couldn't get up; She went to the living room and fell and couldn't get up; tiredness; She has a sore throat and fever blisters on her mouth; lost almost 18 pounds in the last week with all this stuff; severe headache; muscle pain in the back of her neck and back; She has a sore throat and fever blisters on her mouth; violent chills; sick with diarrhea; Dry heaves; This is a spontaneous report from a contactable Consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported) via an unspecified route of administration to left arm on 25Jan2021 at single dose for covid-19 immunization. Medical history included Crohn's disease and Type II Diabetes. The patient experienced sick with diarrhea on Jan2021, dry heaves on Jan2021, she went to the living room and fell and couldn't get up on 27Jan2021, tiredness on Jan2021, she has a sore throat and fever blisters on her mouth on Jan2021, lost almost 18 pounds in the last week with all this stuff on Jan2021, severe headache on Jan2021, muscle pain in the back of her neck and back on Jan2021, violent chills on Jan2021. The patient underwent lab tests and procedures which included weight: lost almost 18 lbs on an unspecified date (lost almost 18 pounds in the last week with all this stuff). She received the first dose of the vaccine a week ago on Monday. For two days she was absolutely normal and fine. The night of the second day she had fallen asleep on the couch and when she woke up it was midnight. She knew immediately she was going to be sick with diarrhea. She had dry heaves. She never vomited. The dry heaves were longer than she has had in her life. The diarrhea kept going and going. She went to the living room and fell and couldn't get up. She is 80 years old (as reported). She has never had that happen before. She slept on the floor until six in the morning. When she woke up she managed to get up. She had so many of these side effects. She has tiredness, severe headache, muscle pain in the back of her neck and back, violent chills. She has never had chills so violent before. She has a sore throat and fever blisters on her mouth. There must be 9 or 10 of them. It is a never ending list. She has lost almost 18 pounds in the last week with all this stuff. The symptoms have not stopped. Outcome of the events was not recovered

Got intense pain in upper thigh, right leg, so bad I could barely walk. Had to told onto walls. Went on all night. Next morning I also had bad, but not AS bad, pain in upper left thigh, closer to groin. It went away completely by 2pm on 3/5. Had made with apptmt with my PCP for getting bloodwork and xrays. When pain was mysteriously gone, I canceled. But pain was incredibly intense on 3/3 and into morning.

Right upper arm intense pain . 45 minutes later I laid down in bed and it was like explosions in my upper body, torso and arms. Intense pow-pow, - pow pow pow on and on for an hour Intense in my left arm but continued constantly for about an hour. When it subsided I got intense chills radiating up and down my legs,. That stopped and I had regular chills throughout my body. Started to have a headache. Went to sleep after some time, and when I awoke the next morning, I had such fatigue, I could hardly get out of bed. I spent the next two days sleeping most of the day. I did not eat because I just wanted to sleep.

Trouble breathing. Taken to ER. Diagnosis Congestive Heart Failure. No Previous such diagnosis. Admitted for 6 days with Metropolo benign only new prescription. After 2nd shot on February 2 had follow up visits but started experiencing light headless. On February suddenly went limp with loss of pulse and breathing. Taken to Hospital ER, admitted without neurological responses. Died on February 22.

Pt states she received vaccine around 10am. States "it ached going in and then was ok until noon". Reports she took Ibuprofen with no effect. States left arm "ached" and rated pain 8/10 at that point. Reports she took a 45 minute nap and after waking, could not lift her arm. Reports "by supper she could not grip, arm felt weak". Reports took APAP at supper and before bed with no effect. Reports she could "not cover herself up in bed nor dress herself before bed". States she woke up in the middle of the night to use the restroom and could not pull up her pants herself. Was then not able to go back to sleep due to the pain. Reports she then took an Excedrin (around 3am) and by noon she could move her arm "about

Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Admitted to ER on 3/15/21 released on 3/16/21. Experienced extreme vertigo, vomiting, and diarrhea. Still a little weak today (3-18-21).

dizziness / vomiting both occurring now paramedics called. Conference call operator / patient's daughter. Pt rcvd Covid vaccine 2nd dose yesterday. patient having protracted vomiting/dizziness. pt does get medication for dizziness regularly and has history of stress induced vomit. pt not feeling well. Daughter able to provide some of the information regarding vaccine but very nervous and d/c as soon as EMS arrived. Agency had recommended to have EMS evaluated and transport as needed. Adv pt should f/u w/PCP ASAP. Adv to call back if any questions. Adv daughter that she may get call back from PIC/Covid Hotline.

ADR occurred in covid vaccination clinic 3/25/21. PT presented to ER for evaluation on 3/25/21 after receiving their 2nd dose of Pfizer covid vaccine received on 3/25/21. PT stated they developed mild lightheadedness and ?felt like their lungs were shutting down?. Patient felt short of breath briefly that started to resolve by the time they presented to ER but still felt short of breath. ER documentation stated on reassessment after labs, imaging and EKG, symptoms completely resolved. PT was discharged same day with instruction to return if any symptoms return. Pfizer Dose 1 LOT# EL9264, dose 2 LOT# EN6204.

Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.

Couldn't control leg muscles for 2 days, knee aching on right side, couldn't stand or walk for two days.

light headedness; queasiness; I was functional but I wasn't myself; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via Intramuscular on 29Jan2021 at single dose in arm left for covid-19 immunization. The patient relevant medical history included I have environmental allergies pollen (took an antihistamine), mild asthma and paroxysmal atrial fibrillation. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for environmental allergies. Past drug included Allegra (before I took the shot and I also gave an Allegra to my husband before he took his shot, and he was fine). On an unknown date, the patient experienced a mild reaction which was light headedness, queasiness and it lasted several hours. She was functional but she wasn't herself. After about several hours the patient began to feel somewhat better. The patient didn't take any treatment for the events. The outcome of the events was recovering.

passed out; dizzy spell; fell down; have gotten shorter/ shrunk; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes, thyroid disorder, and bleeding. The patient stated "I am bleeder. My father had hemophilia and I have the female version which I never remember what it's called but I bleed easily but I didn't bleed at all for when I had the shot, it was fine." Concomitant medication included levothyroxine sodium (SYNTHROID). Patient stated, "Yes, I took my medication that morning. I take thyroid medication, blood pressure medication. I don't remember what I take for blood pressure." The patient reported "Well I am calling I felt just fine right now. I had my first shot by Pfizer on the 24th and I felt great and they watched me and I left and I was driving home and I had a dizzy spell while I was driving. I don't know if I passed out or not, I might have but if I did, it wasn't for very long, they were digging up the road I couldn't stop, couldn't park so I made it home okay and I was fine the rest of the day but then the next day, I had a lot of dizzy spells but I was at home so I didn't worry, I just sat down and I was okay and then the 3rd day I got up for breakfast and I bumped into everything, I dropped everything and then I started to get out of chair and the chair fell down and I fell down and that was just a mess. So, I went to bed and I felt at least if I fall, I fall on bed and that was the day I was dizzy but then it went away and I have been fine ever since. That began on 24th, the 24th was the first day and I did call my doctor and I have been trying to call here and I never think it through but finally today, sat to watch, hang on to the phone and what I am concerned about is getting my second vaccine. Is there anything I should watch for or tell anybody or, because my doctor said you shouldn't get dizzy but I did?" The patient confirmed the vaccine as Pfizer's Covid 19 vaccine. About the lot number, the patient stated, "It looks like EN, I am not sure if it's E and N 6203." The patient further reported, "No, I just went home and the first day I was over with it by the time I got home and I didn't had anymore. The next day I just sat down and rested, I knew it will go away and it did and then 3rd day I went to bed and just thought I would fall and hurt myself and that's everything I did. Well I used to be 5 foot 2 and a quarter but I think I have gotten shorter, I don't know what I really am but little bit shorter than that now and my weight is 100 and lets see, I am going to say 170, I don't think that's exactly right but it's pretty close to that I think, I didn't really weighed myself lately. 5 foot 2 and a quarter that's what I was when I did last but now I shrunk and less than that but I don't remember what I am." The outcome of the events was unknown.

inflammation/inflammation on her right side of waist and in the back down in to pelvis, ovary and groin area; pain in her arm; muscle pain; pain; Her arm bothered her: she could not lift her arm; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Left Arm on 29Jan2021 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation (Indication: Felt that getting COVID at her age would be worse than getting a possible reaction to the vaccine). Patient had an allergic reaction to the swine flu vaccine in 1979-1980. Patient had muscular problems that resulted from the Swine Flu shot. She had weakened muscle. Most of the time she was okay, but she was more prone to getting back pain and stuff, not pain on her side and on the front side like she has now. Patient wanted to know if the swine flu shot and the covid 19 vaccine had similar ingredients. The Swine Flu shot was back in 1979 or 1980. This is the only type of flu vaccination she has ever had. She did not take more after that. She does not have a lot number to provide. She does know though, that a lot of people at that time came down with (Name) from that vaccine. With this vaccine, nobody seems to be getting strong side effects from it. No Other Products. Patient History reported as No. No Investigation Assessment. The patient medical history and concomitant medications were not reported. The patient experienced pain in her arm statin she could not raise her arm for a day. Her arm bothered her: she could not lift her arm on 30Jan2021and recovered on 31Jan2021. The patient experienced a day later pain and inflammation on her right side of waist and in the back down in to pelvis, ovary and groin area muscle with not recovered (reported as worsened). Caller stated that it was quite painful describing the pain as muscle pain and inflammation. Caller stated that this pain had not gone away. Caller stated she was due for her second dose and wanted to know if she should get the second dose based on her side effects to the first dose. The patient was having to take anti-inflammatory medications for the pain associated with her side effects to the covid 19 vaccine. Patient thought she had a reaction to the Pfizer COVID Vaccine. The day after she had the usual side effect of her arm bothering her. Then she started to experience pain and inflammation around her right side from the waist area down to the front of her pelvis to her groin muscle. It seems like pain and inflammation. It has not gone away. If patient stays home and did nothing she felt a little better. If she took an anti inflammatory she also felt a little better. If she was going out and doing something it flares up. That was why she felt it was muscular, it felt inflamed. Caller stated that it overall had gotten worse in the last few days. She was doing more things than the first couple of days. Treatment: The anti inflammatory was Diclofenac 25mg. She had also been taking Tylenol at night. She said that it does not make the pain completely go away, but it helps keep the pain tolerable. Did not have either of these medications on hand to provide the lot numbers. The outcome of event Her arm bothered her: she could not lift her arm was recovered on 31Jan2021, of other events was not recovered.

Patient received her first dose of covid vaccine on 3/17 who comes to the hospital on 3/31 for increased fatigue and decreased appetite which began 3d after vaccine. In ER she tested + for covid and CXR was unremarkable, pt was discharged home. Patient returns to ER for increasing shortness of breath causing her to increase her home 02 to 3L and then ultimately 4L prior to EMS arriving. She notes she is dizzy and fatigued. She denies chest pain, n/v, but did have 1 episode of diarrhea PTA. This morning patient requiring 5L NC 02 and ID asked to evaluate for recommendations. Remdesivir withheld as symptom onsent > 2 weeks ago. Tocilizumab 8 mg/kg and dexamethasone 6 mg daily initiated.

Pain in arm; She was slightly dizzy; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 11Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 81-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL8982), via an unspecified route of administration in the left arm on 10Feb2021 18:30 (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included (caller mentions she dyslexia but this was prior to the COVID vaccine). Concomitant medication included apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date (taking for 6-7 years) at unknown dose and frequency for an unknown indication. On an unspecified date the patient experienced pain in extremity and dizziness. Caller, reporting that she took the COVID shot and was told that if she is on a blood thinner she shouldn't have gotten the vaccine, is that true. She asks if we make Eliquis. The only small issue she had after the vaccine was some pain in her arm. She worked the pharmacy at one time. She got the shot on 10Feb2021 at 6:30pm. Treatment: Hot compress to the area. Caller remarks that just now when she stood up, she noticed she was slightly dizzy. Could that be caused by the vaccine. Therapeutic measures were taken as a result of pain in arm (pain in extremity). The clinical outcomes of the pain in extremity and dizziness were unknown. No follow-up attempts are possible.

break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; pain in her arm; blood clot in right leg; couldn't walk; veins are swollen; right knee got swollen; ear ache; felt like burning/ sore in her mouth like she was burned; sore in her mouth like she was burned; nausea; headache; slight fever; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 09Mar2021 (Lot Number: EL9266) at single dose for covid-19 immunization. Medical history included arthritis, respiratory issues, allergies, Eczema of the nipples and breast, arthroscopic surgeries, she lost her voice. Caller stated she exercised everyday, she did yoga. Caller reported the last 2 years she hadn't been able to climb the mountain on the stairs. Caller states she didn't catch a cold, she was fine, she was very active. She was good except arthritic conditions, she has had arthroscopic surgeries, that was a side effect of that. Caller reporting she was a first responder and had some respiratory issues. Caller stated she had some allergies, if with dust or smoke, her throat constricts, it was just small, like her throat. She cannot be around that. She got once in a while, when she got in a rush. Caller stated before the vaccine, she had eczema in her nipples, on her breast. Caller stated she never got sick, besides the rash she got once in a while. Caller states but she was very healthy otherwise, no medication, no smoking, no drinking. Caller stated she was from 9/11, this was what happened with her voice once in a while, she lost her voice. Caller stated she had had some respiratory issues and allergies and so on. Caller stated she was here for 56 years and her mother died of old age so she was not sure. There were no concomitant medications. The patient previously took advil. Caller stated she used to take Advil when she went to the gym and had problems but she hasn't taken Advil for a while. She didn't take meds. Caller stated she didn't drink or smoke because what it did was it gave you a release. Caller stated she was not taking none, she was pushing through and hoping it will heal itself. The patient experienced blood clot in right leg on 26Mar2021, break in rash on an unspecified date, headache on 09Mar2021, slight fever on 09Mar2021, veins are swollen on 12Mar2021, right knee got swollen on 12Mar2021, sore throat on an unspecified date, ear ache on 10Mar2021, nausea on 09Mar2021, rash in mouth and throat on an unspecified date, felt like burning/ sore in her mouth like she was burned on 10Mar2021, sore in her mouth like she was burned on 10Mar2021, dizzy on an unspecified date, weak on an unspecified date, felt like sleeping all the time on an unspecified date, couldn't walk on 12Mar2021, pain in her arm on an unspecified date. Was a first responder, sometimes break in rash once in a while. Got Pfizer 1st vaccine 09Mar, was scared to have difficulty breathing however had headache, slight fever, right knee and veins were swollen, sore throat, ear ache, nausea, rash in mouth and throat also felt like burning also was dizzy and weak and felt like sleeping all the time. Caller stated she was told by her doctor to take the shot on 09Mar2021. Caller stated she had headache, slight fever, then her head was ok the fever was gone but the headache persisted as of today. Caller stated she still had headache and ear ache and her knee got swollen, her right knee. Caller stated for a few days she couldn't walk. Caller reported she has arthritic conditions in knees, she exercises everyday and no problem, but she couldn't walk for a few days. Caller states now she is able to walk on something, but the veins in the knee were still there and she didn't know. Caller stated she was due for second next on Tuesday and she was wondering what to do. Caller stated she was honestly worried about this reaction after the first shot. Caller stated she was told the 2nd had a worse reaction, so she was really weary and worried. Caller stated she only slept 5 hours at night, but now she wanted to sleep all the time. Caller stated she had such a headache and earache. Caller stated it made her nauseous, like in a sea or something. She stated she didn't know how to explain. She didn't vomit like when you were nauseous, it wasn't that feeling. Caller stated it was just lingering like when you were in the ocean. Caller reported headache has gotten better. It has gotten worse and then gotten better. Caller stated the earache was so painful and was still there. Caller reported she got it during the day and when she lied down, but the severity had subsided. Caller stated she didn't measure fever. She wanted to say after that, her mouth was sore after fever from the heat or from the vaccination. Caller stated her mouth was still today, still sensitive. Caller reported it was like her throat and her mouth was so sore like a burn. Caller reported her headache was mostly on the left side, but went to the right side too. Caller reported she could feel it in her eye, it hurt and her ear hurt. Caller reported her sore throat, the upper part, was still sensitive. Caller stated she couldn't swallow, but it was clear, her mouth was clear, only the upper top she would say. Caller stated it's 99% gone, its healing. Nauseous, like in a sea, its not like she has it all day long- nauseous- maybe once a day, nothing severely like what she had for a few things. The patient had a pain in her arm and she had that symptom one night and the following day she had nothing. Her arm was cooperative. Since she had been diagnosed with a blood clot. She saw her doctor on Friday and was recommended that she took some medications. She continued to have headache which she reported, though not as bad. She also reported that she had a sore mouth and earache. She was still fighting symptoms and didn't know what to do with the blood clot. She was scared to take the blood thinner Eliquis and that she will have side effects that it will do her harm she felt Eliquis will do her harm if she received the second dose of the vaccine or takes Eliquis. She was supposed to 20mg daily which she felt will kill her given her body was not healed from receiving the first dose of the Covid-19 vaccine. There was no prior vaccinations within 4 weeks. She was prescribed Eliquis Film-coated tablet (Lot Number: ABN4449S, Expiry date: Feb2023) 20mg daily for blood clot but had not started because she felt it will kill her was scared to take the second dose of the vaccine. The patient underwent lab tests and procedures which included Sonogram: blood clot in right on 26Mar2021. Therapeutic measures were taken as a result of blood clot in right leg. There was Physician Office Visit for all events. The outcome of the event blood clot in right leg, veins are swollen, right knee got swollen, couldn't walk was not recovered, of event slight fever was recovered on 10Mar2021, pain in her arm was recovered, of event ear ache, nausea, felt like burning/ sore in her mouth like she was burned, sore in her mouth like she was burned was recovering, of other events was unknown.

Ongoing dizziness, lightheaded ness, shortness of breath. Visit to urgent care showed no remarkable results from blood tests and CT scan of head

Pt relays that 4 hours after she received the vaccine, she developed acute bilateral weakness in the legs and had to crawl up the stairs. "legs were not working"

This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.

Presented with fall and worsening shortness of breath, clinical impression that hypoxia secondary to HFpEF rather than COVID infection. Patchy infiltrates on Chest CT- Rx with dexamethasone.

weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no energy; chills; could not walk across the room; This is a spontaneous report received from a contactable consumer (patient). An 81-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder upper arm from 13Mar2021 02:00 to 13Mar2021 02:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No family history. No additional vaccines administered on same date. No Prior Vaccinations within 4 weeks. Patient received 1st dose of the Pfizer COVID vaccine on 13Mar2021 and experienced side effects on 31Mar2021. She mentioned that she could not walk across the room (2021) due to shortness of breath that began 31Mar2021 and was ongoing and about the same, her temperature was not high, down by 1 which would then be the onset of her chills (2021) which would come and go, just like a roller coaster, she felt terrible, had achiness, could not decide what to eat, and would feel better for 2-3 hours but felt bad right away. She mentioned that she felt just terrible and that all she wanted to do was die. Patient had whole body aching that was off and on since 31Mar2021 and not it finally diminished starting yesterday; she had weakness in her arms and legs that began not right away but on 04Apr2021 and was better; her energy level was just no energy and it started on 31Mar2021 and ran through 05Apr2021 and thank goodness the energy finally came back and she is finished now with that and feeling better since yesterday; she felt better but that only lasts 2-3 hours and she felt bad again and the chills start in again. She mentioned that she took acetaminophen and ibuprofen for the achiness, whenever needed. Patient stated she had no treatment, no visit to the HCP or emergency room and just took acetaminophen and ibuprofen and did not know when the took them but it was just in that timeframe. This morning, she had Gatorade to regain electrolytes and felt energized. As of calling, she was finally been feeling better and ally symptoms have decreased. AEs did not require a visit to ER or MD office. Outcome of shortness of breath was not recovered, outcome of achiness and weakness in arms and legs was recovering; outcome of other events was unknown. No investigation assessment. No follow-up attempts are needed. No further information expected.

Clinical Summary Patient is a 81 y.o. female with a history of HTN, IDDM2 w/ neuropathy, HLD, COVID-19 infection (11/5/20) and hypothyroidism who presented to hospital Observation 4/21/2021 from AL s/p fall with right knee/hip pain. Admit Hgb 12.0, COVID-19 +. CT right knee showed large hematoma in the prepatellar region measuring up to 16.4 cm. Evaluated by ortho, recommended supportive measures. 1. Traumatic Hematoma of Right Knee: s/p fall as detailed below. Patient endorsed immediate pain to her right hip/knee, described as sharp/aching with muscle spasms. Denied numbness/tingling. Admit CT pelvis non-acute, CT right knee as above. Held ASA. Pain control, ice, elevation. CBC remained stable. Ortho followed, recommend continued monitoring of skin integrity and local wound care. 2. Left Forehead Hematoma: s/p fall. Admit Hgb stable. CTH on admit with noted hematoma, otherwise unremarkable. Encouraged ice, pain control. 3. Mechanical Fall: Patient tripped and fell in the hallway at her AL facility while participating in fire drill. Denied LOC, did strike head on a nearby shelf. Initially reported dizziness that has since resolved, continued gentle IVF. 4. COVID-19 Infection: asymptomatic. Patient initially tested + for COVID-19 11/5/20, and received her 2nd vaccination 2/10/21. Denied dyspnea, chest pain, fevers/chills, cough. Discussed with infection prevention, will require additional 10-day isolation (last day 4/30/21). Isolation precautions, supportive care.

shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result in 2021, echocardiogram: unknown result in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021 and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.

6 days following vaccine patient had blurred vision and collapsed; refused transport to hospital from EMS; 10 days after vaccine, patient suffered what was deemed to be a TIA but actually found to be an ischemic stroke. Was speaking and was to be released to at home rehab; 1.5 days later suffered what appeared to be a stroke but brain MRI showed no change. She now has C3 nerve involvement not related to the stroke and, speech and movement issues. Cause undetermined.

ears went dead with no sound to be heard, went to walk felt like could not control body, was swaying all over the place, and really sick. sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours. Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital. Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.

Patient's daughter reported that about 2 weeks after second vaccine her mother became very ill. She was having trouble talking, walking, and moving. She stated that she had been taken to the hospital and it was possibly a stroke. We have since spoken with the patient on multiple occasions on the phone and she has not mentioned problems concerning her vaccine.

Patient complained of lightheadedness. Pt reports she only had coffee this morning, provided patient with water and snack bar. BP 84/67, HR 91, RR 18, O2 sat 100%. Pt reports history of hypertension but medications halted by MD due to low blood pressure. Pt taken to Emergency Room. Patient eloped from ER.

I received the vaccine at 3:15, due to my allergies I stayed for 45 minutes. I walked to car and felt dizzy driving home. I was seeing lighting bolts in visual field. I felt fatigued and foggy. I had chills, fever, a pain from the top of my legs to my feet . I had no reaction on the arm that I received the vaccine, I had pain in the opposite arm. I had pain from my neck to my waist in the back of me, no pain in chest area. Each day following I had headaches that went into optic migraines. Continues from the shot up to present. I have been taking Tylenol each and every day. I don't normally take over the counter medication. I have had less stamina since the injection. I am doing 50% of my daily routine due to fatigue

Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she started experiencing after receiving 2nd dose of Covid vaccine. Found to have a positive troponin, hyponatremia. Stress test revealed reversible myocardial ischemia of the inferior and lateral walls of left ventricle with a large defect size but mild defect severity. Patient underwent PCI with DES placement and was placed on triple therapy with aspirin, clopidogrel and eliquis. Patient presented to ED again on 5/23/21 outcome: patient is brought to ED after a fall and loss of unconsciousness, hit her head with large laceration at back of head, 2 episodes of vomiting, leading to terminal events: brainstem compression and rapid deterioration and CS of 2T preclude meaningful survival

Heavy right foot 4/13 in afternoon. Then Thursday at 2:30am got up to go to the bathroom and had a difficult time walking and returned to bed afterward and had tingling sensation in right arm. Next morning still felt odd and at 8:00am went to primary and he sent her to the ER room. They ran many test and then discovered she had a stroke. There was damage also to the heart. She had lost all mobility in her right side but has since regained it. Transferred to hopital for 3 days. Many test ran. Never previous heart damage or issue with Blood pressure. Supplement list cont. - Immune Defense, B, Apha GPC, Theanine

Equilibrium affected; I could not hear; I woke up with pressure in both of my ears; Deaf in my right ear; arm soreness; This is a spontaneous report received from a contactable Nurse (patient). An 81-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 21Apr2021 at 09:00 as 1st DOSE, SINGLE for covid-19 immunization. Medical history included atrial tachycardia (From: 2015 To: Unspecified), macular degeneration diagnosed about 3-5 years ago, low thyroid hormone seems like she's had forever, high cholesterol just beyond normal has had for years, latex allergy since the 1980's, banana, avocado, and kiwi allergy (states all are interrelated because they are cousins to the rubber tree plant and also healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is Metamucil), Psyllium allergy (states she had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight. thankfully was at work). Reported having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. States it was a mild case. NDC, lot, expiry unknown. She stated every flu shot she received, she has gotten the flu and only takes periodically. States she retired in 2017 and had to take in 2016 and 2015, she would have lost her job if she didn't take. It had been 5-10 years before that, and another 5-10 years before that. States she stays away from the flu shot. Concomitant medications included metoprolol ER from Jan 2016 for atrial tachycardia, SYNTHROID started about 15 years ago for low thyroid hormone, Simvastatin ongoing, started about a year ago for cholesterol slightly elevated, OCUVITE PreserVision(Ongoing) taking about 3 years for macular degeneration age related has not changed or gotten worse in 3 years, baby aspirin started Jan 2016 (Ongoing) as cardiologist thought it would be a good idea, Vitamin D3: taking for 3 years (ongoing) for bone health, calcium with magnesium been taking a long time. 5-10 years to prevent osteoporosis (ongoing), glucosamine chondroitin taking since late 1990s. about 20 years for joint health (ongoing), multivitamin taking since 1995 or 1996. about 25 years for general health, vitamin C about 3 years ago started with the Ocuvite (eye doctor though it was a good idea to take together. On April 28th2021 patient could not hear. She was deaf in right ear and the day before on April 27 it was like she woke up with pressure in both ears. It sounded like hell like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and still deaf in right ear." She confirmed pressure is gone, but still deaf and under medical treatment with otolaryngology. She was kind of tossing whether to get the vaccine or not. First went to family doctor to see, didn't think she had an ear infection because no pain and was hoping maybe she would have wax in her ear, but ears were clean and no wax. So they sent her to an ear specialist and they did hearing test and she has pretty severe hearing loss in that ear. So she was still being treated. First the doctor put her on valacyclovir and methylprednisone for about 7 days and then that didn't seem to do anything and now she's getting dexamethasone injections into her middle ear. States she is due for one about lunch time. Pressure in both ears: patient reported has subsided, but then confirms it is a lasting effect comes and goes a little bit. Left ear is pretty much clear but right ear still has pressure and cannot hear and has not subsided. On an unknown date her equilibrium affected and stated has gotten slightly better, minuscule. Patient added she's pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. Patient was treated with Valacyclovir: 1 gram tablet every 6 or 8 hours, states can't remember. Started 05MAY2021 for 7 days. Caller confirmed it did not help and she threw bottle away. Methylprednisone: 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Confirmed she threw package away. Stated cortisone decreases irritation and inflammation. And Valacyclovir is an antiviral. Started dexamethasone injections last Thursday, 20 May 2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help she will have an MRI. Airborne: started taking about one week ago after first dexamethasone injection through tympanic membrane into middle ear. Relevant Tests: Hearing Test (Date: 05MAY2021)Result: pretty severe hearing loss in right ear, Test: Ear exam (Date: 03MAY2021; 05MAY2021) Result: Normal. Outcome for pain in extremity was recovered, for ear discomfort and deafness it was resolving, for hypoacusis and. equilibrium affected it was unknown. Reporter seriousness for pressure in both ears and equilibrium affected: Medically significant, Deafness right ear: Disabling, Arm soreness: non-serious Reporter causality: deafness in right ear: Causality: strong suspicion it's related to the vaccine, maybe not necessarily the vaccine itself, but her immune system reaction to the vaccine. Causality for pressure in both ear, arm soreness and equilibrium: related; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events such as deafness,balance disorder and ear discomfort cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

My teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw: Medically significant; Inflamed gums; Abscessed teeth on her lower jaw; some kind of side reaction; My gums and the roof of my mouth (Incomplete sentence)/my gums were so raw, I couldn't brush my teeth; My mouth became all inflamed; I have a very hard time hearing you; Equilibrium affected; But I am still deaf in my right ear; This is a spontaneous report from a contactable Nurse (patient). An 81-year-old female nurse received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0169; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left on 12May2021 20:00 (at the age of 81-year-old) at a 2nd dose, single for COVID-19 immunization. Medical history included macular degeneration (diagnosed about 3-5 years ago), low thyroid hormone (seems like she's had forever), high cholesterol just beyond normal (has had for years), banana, avocado, and kiwi allergy (stated all are interrelated because they are cousins to the rubber tree plant. Also, healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is metamucil); psyllium allergy (patient had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight), flu (every flu shot she received, she has gotten the flu and only takes periodically. She had to take in 2016 and 2015. It had been 5-10 years before that, and another 5-10 years before that), latex allergy (since the 1980's), shingles (having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. Stated it was a mild case. Patient gets the shingles vaccine and gets the shingles, gets the flu vaccine and gets the flu), atrial tachycardia from 2015 to an unknown date, anaphylactic reaction to a metapower bar from 2015 to an unknown date (about 7 minutes after eating the bar, she went into a severe reaction). Concomitant medications included levothyroxine tablet at a dose of 50 ug, 1x/day, vitamin B complex and akurit (not clarified hence not captured in tab). The patient previously took first dose of BNT162B2 (Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), administered in arm left on 21Apr2021 09:00 for COVID-19 immunization and experienced deaf in my right ear, I woke up with pressure in both of my ears, I could not hear and arm soreness. The patient drug history included synthroid from an unknown date to ongoing (started about 15 years ago) for low thyroid hormone, simvastatin from an unknown date to ongoing (started about a year ago) for cholesterol is slightly elevated, ocuvite preservision from an unknown date to ongoing (taking about 3 years. Macular degeneration has not changed or gotten worse in 3 years) for macular degeneration age related, vitamin D3 (taking for 3 years) for bone health from an unspecified date to ongoing, calcium with magnesium (it has calcium citrate. Been taking a long time. 5-10 years) to prevent osteoporosis, glucosamine chondroitin (taking since late 1990s. About 20 years) for joint health from an unspecified date to ongoing, vitamin C (about 3 years ago. started with the Ocuvite. Eye doctor though it was a good idea to take together), multivitamin (taking since 1995 or 1996. about 25 years) for general health; metoprolol ER for atrial tachycardia from Jan2016 to an unspecified date, baby aspirin from Jan2016 to ongoing (81 mg daily, cardiologist thought it would be a good idea). The patient reported, she received first Pfizer vaccine on 21Apr2021 and equilibrium affected and on 28Apr2021 she could not hear in her right ear and the day before on 27Apr2021 it was like she woke up with pressure in both of her ears. It sounded like heck like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and she was still deaf in her right ear. She got second vaccine on 12May2021 and on 16May2021 and 17May2021 her gums and the roof of my mouth became all inflamed and her teeth were so sore she felt like she had an abscessed tooth. My gums were so raw, couldn't brush my teeth. So she gargle with some peroxide and some saline and then her teeth were sore like you have an abscess teeth on lower jaw. And then that went away within two days. Pressure in both ears has subsided, but then confirms it is a lasting effect comes and goes a little bit from 27Apr2021 to ongoing. First the doctor put her on valacyclovir and methylprednisone 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Started 05May2021 for 7 days. And then last week he started me on the dexamethasone injections through tympanic membrane into her middle ear last Thursday, 20May2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help, she will have an MRI. States cortisone decreases irritation and inflammation. Adds she is pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events I am still deaf in my right ear, I have a very hard time hearing you was not recovered; equilibrium affected, some kind of side reaction was unknown; my teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw, inflamed gums, abscessed teeth on her lower jaw, my gums and the roof of my mouth (incomplete sentence)/my gums were so raw, I couldn't brush my teeth, my mouth became all inflamed was recovered on an unspecified date in 2021. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, unilateral deafness, non infective gingivitis, tooth abcess, toothache, balance disorder cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate

Two days after patient's first vaccine@ about 4 pm, I could tell that something was wrong with her. Every day she and I play cards, but this day she was really struggling. She couldn't figure out where any of the cards went, and was missing every play. I tool her up to lay down. At about 6pm, her eyes looked really glassy and she was unable to speak clearly. Her words were very slurred, and her sentences did not make any sense. I called 911, and they came and took her to the ER. The doctors said that she had a small stroke. She was put on a low dosage of blood pressure medicine, and was hospitalized for 6 days to monitor her. During that time many tests were run on her. 2nd Vaccine- 2-24-21 Two hours after returning from getting the second vaccine, the patient went upstairs to go to the bathroom and she passed out onto the bathroom floor. Again, when talking to her, her words were slurred. She was very weak. I called 911 again. Initially they were not going to take her, but when she went to get up she fell back down. She was too weak to walk, so they took her to the ER again. She was released to go home that evening. Sher saw her primary doctor and was referred by her oncologist to see a hematologist. She endured a three month waiting period until she could be tested for APLS. She will go this Friday to find out the reslts of that test. Additionally, she saw her vascular neurologist, Dr. He looked at her scans and said it was NOT a stroke. He said that her body basically had a surge as a result of trying to fight off the vaccine. He said that the CAT scan that was done at the time she went to the ER the first time did NOT indicate signs of a new stroke, but that what they were seeing on the scans was from her past stroke. Dr. said that he saw no indication that she had another stroke and that her body was just reacting to the vaccine. He said that all of the symptoms that she had were all things that could happen because of the surge.

half cm tumor in her fallopian tube/1.5cm tumor in the fallopian tubes; Paraneoplastic cerebellar degeneration; meningitis; Severe headache; eyes would move back and forth involuntarily; severe vertigo; This is a spontaneous report from contactable consumer (sister) from Medical Information Team. An 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at the age of 81-year-old in Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included bladder cancer. The patient's concomitant medications were not reported. Caller states ''My sister and I both received the Pfizer COVID-19 vaccine. My sister developed Paraneoplastic cerebellar degeneration two weeks after receiving the Pfizer vaccine. They did find a half cm tumor in her fallopian tube. Her doctors have reported the side effect but at that time she was not fully diagnosed. They thought at that time it was meningitis .'' Caller wants to know if Meningitis or Paraneoplastic cerebellar degeneration has been associated with the Pfizer COVID-19 vaccine. Response: Spoke from the attached document. These two disorders have not been listed as side effects associated with the vaccine. However we may not have the list of all the possible side effects associated with the vaccine. Caller was reporting side effects for her sister related to the Covid 19 vaccine. Her sister had received the Pfizer Covid 19 vaccine and 2 weeks later developed a disorder called Paraneoplastic cerebellar degeneration. They had found a tumor in the fallopian tube that was a tiny half centimeter tumor. Said that the doctors had reported the side effects but at the time it was not yet diagnosed as paraneoplastic cerebellar degeneration. At the time, they thought she had meningitis. The event happened about 2 weeks after the vaccine, so about 11Feb2021, was about 2 weeks before or 2 and a half weeks before 11Feb2021 that she got the vaccine. She was in the hospital 10 and a half weeks (about for 74 days). She contacted Pfizer, she believes in Mar2021. Since Feb2021 she had been in 3 different hospitals. They did send her some paperwork but she has not completed it yet. At that point in Mar2021 her diagnosis was meningitis. As it later turns out, it turned to a new diagnosis of the Paraneoplastic cerebellar degeneration. Her sister lives in PRIVACY, she does not even know where she went for the vaccine. She hasn't filed the written report yet. She was not diagnosed with the Paraneoplastic cerebellar degeneration until the very end, 10 days before she died. She died on 24Apr2021. Cause of death: They had removed her ovaries and fallopian tubes had the suspicion that this might have been the diagnosis without ever seeing the tumor. She had multiple CT scans (2021) and never saw the tumor until they removed the fallopian tubes. They found a 1.5cm tumor in the fallopian tubes which is what the cause of death was. She was calling to see if this has happened to anyone else. They say the tumor was the cause because it would have been so odd that it came on so suddenly, 2 weeks after the vaccine. The caller is terrified to get the vaccine, since she had bladder cancer. She had asked if anyone had reported this because that was the diagnosis at the time. They did not do an autopsy, probably because that was up to her brother in law and can understand why an autopsy was not done. They also say when her sister was having all of these bizarre symptoms, it was an auto immune reaction. She was perfectly fine and had come home from a bird watch. She had severe headache, eyes would move back and forth involuntarily in 2021. That never went away. She had severe vertigo in 2021, and it all happened in one day, it didn't go away. They did an immunoglobulin infusion treatment, she had very good treatment. They put her on steroids. The immunoglobulin treatment was for five days and nothing touched those symptoms. They had moved her from one hospital to a rehab facility in PRIVACY. The rehab doctor reported all of these symptoms to Pfizer. At that time, they were still calling it meningitis. He said that the elephant in the room was the vaccine. Felt the vaccine is not totally what caused it but accelerated what ever was going on with her, these bizarre disorders. Maybe this would have happened without the vaccine. They will never know. She wishes that someone can tell her whether or not she should get the vaccine. She asked her doctor who said he was not going to tell her to not get the vaccine. She was calling to see if this has happened to anyone else. They say the tumor was the cause because it would have been so odd that it came on so suddenly, 2 weeks after the vaccine. She had asked if anyone had reported this because that was the diagnosis at the time. The patient was hospitalized for events for 74 days. Therapeutic measures were taken as a result of events. The patient died on 24Apr2021. An autopsy was not performed. The outcome of event half cm tumor in her fallopian tube/1.5cm tumor in the fallopian tubes was fatal. The outcome of events Paraneoplastic cerebellar degeneration and meningitis was unknown. The outcome of other events was not recovered. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: half cm tumor in her fallopian tube/1.5cm tumor in the fallopian tubes

Intense pain in upper thigh, both legs; sometimes unable to walk/ could barely walk/ could hardly walk; muscle weakness; Cannot sleep at night; Had pain pretty much all day, This was intense pain and it kind of changed a little bit during the day; muscle pain in arms; 'BUN' test was outside of the parameters; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot Number: EN6205) (at the age of 81 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included low back pain, overactive bladder urgency, allergies: dye in CT scan, type 2 diabetes mellitus, flu, been achy, hip replaced about 2 years ago in 2019. Concomitant medications included metformin taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; glimepiride (GLIMIPRIME) taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. Patient previously took modafinil (PROVIGIL). Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot Number: EL9264) (at the age of 81 years) as single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was reported that patient experienced intense pain in upper thigh, both legs, sometimes unable to walk, general muscle weakness, began 48 hrs post-2nd vaccine (also reported as occurring on 10Mar2021 22:00). Became less in 24 hrs, became intense again in another 24 hrs, and has continued ever since. Patient cannot sleep at night. Patient clarified she had it ever since 48 hours after second dose on 01Mar2021 and it's very unpleasant and does not know what to do about it and wanted to report it. These did not happen immediately and after second vaccine, patient did not have any problem till 48 hours, 10 o'clock, she had it on Monday at 12:00 and at 10 o'clock in the evening on Wednesday, she started to get intense pain on right side, she could barely walk and she have never had pain there before and she tried to walk and she was 81, she goes to the bathroom frequently with bladder issues and that was hard and it went on all night. In the morning, she had it not only in right leg but upper side like above the knees but in the front not in the back of the leg and then the next day, when she woke up and then, she had it in the upper side in left leg and closer to the groin and more like around and didn't know what to do and she wasn't going to go to an emergency ward as she was 81 and she doesn't go around that easily. Patient called her doctor, and patient had pain pretty much all day and he said how was it now and told him that it was slightly better. He said more than likely it will go away but he kept saying these are the kind of side effects that they were reporting though flu like achiness was nothing like what she had, she have had the flu (history) and been achy (history) but this wasn't like that. This was intense pain and it kind of changed a little bit during the day but it was still there. Her doctor said, if it doesn't go away by tomorrow morning which was Friday, then make an appointment and come in to see her, she will do blood work or whatever. So, she got an appointment for 2:30, by noon, it was just gone totally gone like if it never had been there. She cancelled the appointment then yesterday she got it back again and she could hardly walk but it wasn't as intense, it was really painful and hard for her to walk and it was around both legs and she doesn't know what to make of that, she went to rheumatologist because she thought she might be having muscle pain in arms from something else, he did some blood work (unknown results), he couldn't make anything out of it and he said he will look at the blood work and he gave her kind of a steroid cream to rub on arm (treatment) which she thought she had a problem but months ago (consumer was not sure). Now she couldn't sleep last night, it was so uncomfortable, and she had to go to the bathroom several times and again it really hurts to walk. So, that was what happened to her and she would not call that achiness of the flu at all. Regarding treatment, patient took Tylenol, do take other medications but nothing unusual and take the same that she always have and by the way the intense pain was only in one leg for twelve to twenty hours and then all of a sudden it began in the left leg as well and slightly with different pace but still on. The one in the right leg was most intense, she could barely stand. For laboratory test, the 'BUN' test was outside of the parameters and after getting several tests he did, she wanted to see if she had some sort of rheumatoid thing and they are all in her record. This was not one of the typically adverse reactions that people reported at least according to what she read and according to aspects of it. The outcome of events pain, muscle pain in arms, and BUN abnormal was unknown while for other events was not recovered. No follow-up attempts are needed. No further information is expected.

Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ear infection; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EN6208, Expiration date: Jun2021), via an unspecified route on an 10Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9266, Expiration date: 31May2021) via an unspecified route on an 17Feb2021, both as a single dose for covid-19 immunization. Medical history included thyroid and blood pressure. Concomitant medication included lisinopril taking for about 4-5 years and levothyroxine taking may be for 15 years for thyroid. On an unknown date after receiving the first dose, patient experienced stomach upset, nausea, sinuses, tiredness, muscle pain and dizziness. She feels so unwell that she went to the emergency room after the first Pfizer Covid vaccine administered on 17Feb2021 for feeling so unwell. They could not find anything wrong, hence not admitted her. She had improved some but was not really good when she went for the second dose on 10Mar2021. Therapeutic measures taken as a result of the events included antibiotics after the first dose for sinuses and possible ear infection and treated with amoxicillin Clav 875/125mg tablet, dosage two times a day for 21 days, came in an orange colour. The clinical outcome of the events was still experiencing the same side effects after the second dose. No follow-up attempts are needed. No further information is expected.

I FELL TWICE AFTER 1ST VACCINE DOSE HAD HEADACHES AND I WENT TO THE DOCTOR WHO SENT ME FOR A CAT SCAN WHICH DIAGNOSED A CONCUSSION.

Shortness of breath; dizziness; numb tongue; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199), dose 1 via an unspecified route of administration in Right arm on 05Mar2021 at 01:00PM (at the age of 81 years) as single dose for COVID-19 immunization. The patient's medical history included known allergies to the Opioids. Concomitant medications taken within two weeks included, Gabapentin 300 mg, paracetamol (TYLENOL 500), Acetylsalicylic Acid (ASPIRIN) 81mg, all were received for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the suspect vaccine. She did not have Covid prior vaccination. On 05Mar2021 at 01:15 PM patient experienced, Shortness of breath, dizziness and numb tongue. Patient received treatment for the events. She had not been tested for covid post vaccination. Outcome of all the events were recovered. No follow-up attempts are possible. No further information is expected.

2-11-21 Blood pressure was elevated at 150/87. Appointment made at Dr. office. Seen on 2-12-21 Instructed to monitor Blood pressure and call if remains elevated. On 2-13-21 at 7:55am I woke up with a bad headache, dizziness, and slurred speech. EMS called, Blood pressure dangerously high. I was taken to Medical Center with a Thrombolytic Stroke. I had a CT, 2 MRIs, and clot retrieval preformed. Thankfully I can still function pretty normally. The only adverse effects are slight brain damage.

Severe muscle pains in both arms, could not lift arms to put clothes on, couldn't use arms worse at night. felt like cutting into arms with scissors or knife did not sleep, callsed drs that week, they all said it would go away. Lasted about 8 days. Never felt pains like this. A couple of weeks later arthritis dr gave me a steriod shot which helped. but still have troubles lifting arms and moving fast up to this day

Homebound patient vaccinated with 2nd dose Pfizer at around 10:30 am after the first 15 minutes of observation, around 10:45 patient looked dizzy as she was getting ready to get up from the sitting position to escort us out. At this time, the patient indicated that this happened with the last dose. I noticed her dizziness and pale advised the patient to lie down legs propped up and gave her some water to drink. Attempted to take blood pressure with her own blood pressure cuff but the batteries died out. Continued to monitor for another 15 minutes, while patient continued to lie down and sipping water. After an additional 15 minutes passed I remembered we had a blood pressure cuff in the emergency kit , blood pressure reading was 138/56 and pulse was 76. Pt stated she felt better and wanted to escort us to the door. I advised against getting up and discussed the event with her son in law. Advised to monitor mother in law, call 911 if symptoms worsen. I also asked the son in law to escort us to the door so that the patient did not feel the need to get up out of the bed. Placed a call to person of contact on homebound list, Daughter currently out of town. Advise daughter of the event and to follow-up with her mother to see if she is okay, call 911 if symptoms worsen, and to follow up with PCP regarding event and any other concerns.

My heart rate and blood pressure went up for two days.; My heart rate and blood pressure went up for two days./her blood pressure was 160/82; felt lightheaded; This is a spontaneous report from a contactable consumer or other non-health care professional and other health care professional. A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 19Mar2021 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took olmesartan for blood pressure, indapamide, atorvastatin for blood cholesterol, potassium chloride for blood pressure. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she was trying to decide if she should keep her appointment for the second dose of the Pfizer-BioNTech COVID-19 vaccine. The patient received the first dose on 19Mar2021, was scheduled to receive the second dose on 13Apr2021, and reported to have had some possible side effects. She felt okay within 15 minutes after the first dose. When patient was on her way home (25-28 minutes after) the patient felt lightheaded. Upon checking, her blood pressure was 160/82 and heart rate was 72 bpm (beats per minute) and this continued to go down the rest of the day. The patient asked if this are normal side effects. The patient's husband has allergies and asthma had both Pfizer vaccines no side effects. The patient took the first vaccine and 25 minutes after heart rate and blood pressure went up for almost two days. The adverse events were not resulted in a visit to emergency room and physician office. The patient underwent lab tests and procedures which included blood pressure measurement: 160/82 on 19Mar2021 (Elevated), blood pressure: 121/74 on 19Mar2021 (came back down), blood pressure: 115/69 on 19Mar2021 (back down), heart rate: 72 bpm (beat per minute) on 19Mar2021, heart rate: 75 bpm (beat per minute) on 19Mar2021, heart rate: 96 bpm (beat per minute) on 19Mar2021 (Elevated). The outcome of "felt lightheaded" was reported as resolved on 19Mar2021; blood pressure increased, and heart rate increased was resolved on 20Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Blood clots, strokes, death I believe that there were subtle unrecognized signs starting in March - off balance, slurred speech, confusion- thought to be diabetes related. I would have her check her sugar and it would be fine, but I dismissed it as a good thing that her sugar was ok. It didn?t cross my mind until the major strokes that it could be related to the vaccine. She had major strokes in May as a result of blood clots in heart and head. I strongly believe that her death is related to the vaccine. She was well, and had her diabetes under control, and three months after getting the vaccine, she was dead.

The clicking of the bone is a situation; Left brother's house about 2100, doesn't even remember driving away; The caller states or passed out or what the heck ever is going on with the caller's brain; The second dose Pfizer Covid 19 Vaccine was given in the right arm and had the bad side effect of excruciating pain 3.5 hours later and the pain was for some reason was in left arm.; In the evening, after done driving around doing shopping on that Saturday, 15MAY2021, did not know she fell asleep on the couch with the radio on; Had wobbly ankles, knees and hips; Had blurry eyes; Tiredness; After receiving the second dose Pfizer Covid 19 Vaccine, was what thought was a blood clot coming from the nasal area; It was extreme pain. It has not done anything but stayed in the muscle occasionally; This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported for herself. An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 15May2021 (at the age of 81-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 24Apr2021 at 12:15 or 12:30 (at the age of 81-year-old) as DOSE 1, SINGLE. The patient medical history includes Pneumonia cryptococcal (Dormant Lung disease cryptococcus), Osteopenia, Pancreatic disorder, Crohn's disease and Colectomy (2002), Cancer, Diabetes mellitus and Polyp, aphasia and seizures (1996). Dormant Lung disease cryptcoccus, this comes from pigeons, bats and birds poo flying in the air. With allergies the caller breathed it in on some far at the time in year 2000. Checked every year since year 2000. Gastroenterologist after many undisclosed solution for drastic weight loss since year 2018, now several tests have determined the caller's pancreas and stomach are not cooperating with each other. The caller has many issues with what the Gastroenterologist are doing with the caller, she feels like a Guinea pig. Concomitant medications include PANCREATIN (CREON) for Pancreatic disorder, AMITRIPTYLINE for Cerebral disorder and CYANOCOBALAMIN (B12-VITAMIIN). The patient was taking concomitant products creon because stomach and pancreas not cooperating with each other. In relation back up to brain thing drug for that is Amitriptyline. Began taking probably 12 years ago, 10 years ago at least. B12 was taking for memory, began taking probably 4 years ago courtesy of all the testing the general physician had done. The caller states she was lacking in so much and will be on this for the rest of life. Amitriptyline was supposed to take 10mg pill twice a day but don't take twice a day. Caller is getting antsy about putting too many chemicals in the body. When the caller is crying again will take more amitriptyline. So far just upset about current Pfizer situation. Only member to have Crohn's disease and intestines removed. Gall bladder, caller has not gotten. Cancer, diabetes and polyps in family history. On 15May2021, after the vaccination, the patient experienced bad side effects of excruciating pain 3.5 hours later and the pain was for some reason was in left arm. This arm pain lasted off and on for two days. It was extreme pain. It has not done anything but stayed in the muscle occasionally, and the shoulder joint was picking occasionally, on the left and the caller still had the clicking. The pain was a normal like grade of 2 to 3 type pain at the time of this report. Whenever the caller twinges the pain happens on its own. Patient also experienced wobbly ankles, knees and hips. The caller's walking was terrible, caller states this is just persisting but at a lower level. The caller is concerned because she is a fracture risk person because of osteopenia. Patient experienced blurry eyes and tiredness. The caller usually gets blurry eyes when the caller is not hydrated enough because of loss of weight and the ileostomy bag itself is free flowing so the caller's retention is not good to begin with. The caller clarifies the infectious disease doctor when the caller was reviewed in April, prior to receiving the Pfizer Covid Vaccines, knew the caller was under weight and severely effected because the caller wears an ileostomy bag due to Chron's disease and intestines being removed twice. The caller's absorption is not normal to begin with. When the doctor's office authorized the caller to get the Pfizer Covid 19 Vaccine in the first place it was within a 20 minute response time and nobody evidently checked the caller's chart prior to approving the caller to get this serious serious of Pfizer Covid Vaccines. Which is why the caller is so annoyed. The patient fell asleep on the couch with the radio on. The caller woke up to her surprise not knowing that she had even gone to sleep for a God knows unknown period. The caller continued to listen to all her favorite shows on the Saturday night radio and it happened again, the caller doesn't know the time it was the caller fell asleep again, patient also states that she passed out or what the heck ever is going on with the caller's brain. Patient also experienced tiredness, she states she delivered the grocers and unloaded the groceries and was really wiped out. She also experienced impaired driving ability that on the way back from her brothers house she doesn't even remember driving away at about 21:00. She states God knows how many minutes later in the caller's driveway sitting at the steering wheel of the caller's car. The caller has no recollection of what transpired in the 12 miles from the brother's house to the caller's house. Patient also experienced blood clot coming from the nasal area on 15May2021. It was a tiny blood clot, not normal, red from end to end. A hair, two or three like hair from the head coming out of the left nostril when the caller blew her nose. Tiny, red tipped white, no pain, no drip, nothing except naturally what came out when the caller blew her nose, hardly. caller states this went away and didn't last at all. on 16May2021, the next day with pain in the arm was off and on. On 17May2021 patient called the doctor's office and listed all of her side effects and passed the message to whatever nurse on duty and the nurse consults the doctor. The caller had been told to do the report to Pfizer for anything wrong. Also, the caller went to the Urgent Care, they told the caller she could not get her B12 shot for memory. The caller states her memory is not too good at the present time. The event blood clot from nose assessed as serious. The patient underwent lab test includes loss of wight 97 lbs at the time of vaccine. The outcome of the event thrombosis was recovered on 15May2021. The outcome of the events loss of consciousness, Somnolence, Joint stiffness, Blurry vision, Fatigue, impaired driving ability and Bone disorder was unknown and The outcome of the event pain in arm and myalgia was recovering.

Post Covid-19 vaccine (1st dose) to L Deltoid at 12:15. 12:30 Patient with c/o "dizzy, heart racing" Patient transferred to wheel chair by staff, team lead and BP taken to LUA 191/78 73 and O2 sat 00% ra. Patient given sips of water and BP retaken at 12:33 154/75 62 Patient stated that she normally has high BP however, she has taken her morning metoprolol. 12:38 Patient stated she started to feel better and requested back to be raised, BP 152/85 70. At 12:40 patient informs staff that she is feeling better and wanting to stand and ready to go. Team lead notice patient unstable gait and patient verbalized being dizzy and jittery. Patient return to clinic sitting back down in wheel chair. Patient called to daughter to inform her of her condition and meet at clinic. Team lead attempted without success to encourage patient to be evaluated in ER with transport by EMS. Patient agreed to be evaluated in ED and daughter to transport. BP upon discharge from clinic was 166/89 60 with c/o head ache.

pain from top to bottom of her body; couldn't lift right leg; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0217, expiration date unknown) via an unspecified route of administration in the arm left on 30Jun2021 at 12:00 PM at age of 81-year-old for COVID-19 immunisation. Patient was not pregnant at time of vaccination and events onset. Medical history included blood pressure high (Hbp) and diabetes. Patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EW0186, expiration date unknown) in the left arm on 08Jun2021 at 12:00 PM at age of 81-year-old for COVID-19 Immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as monthly prescriptions. Patient reported pain from top to bottom of her body to the point she was having trouble concentrating on anything but her pain. Patient couldn't lift right leg and Tylenol and ibuprofen were not making it go away. Adverse events start date was 01Jul2021. Adverse events start time was 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. Outcome of the events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 by Nasal Swab on 08Jul2021 which was negative.

I have felt horrible; Every bone in my body ached except my eyebrows and eyelashes; I am so weak I have no energy; I can hardly walk; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history included autoimmune disease and "bad back", both from an unknown date and ongoing. The patient's concomitant medication included prednisone for autoimmune disease and tramadol 75 mg daily for back pain. On an unspecified date, the patient reported that: "I felt horrible, every bone in my body ached except my eyebrows and eyelashes, I am just wiped out when does this go away, I am so weak I have no energy, I can hardly walk". The patient underwent lab tests and procedures which included blood test: unknown result, on an unspecified date. The patient outcome of the events was unknown. The information on the batch number has been requested.

On day one I had some dizziness a couple of hours after my injection. That lasted for 2-3 hours. On the 2nd day just had some tiredness. Since then I have been fine.

torticollis---can't turn head to the left at all. Since driving home after observation--nothing during observation

This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11 a.m. she was in her usual state of health prior to that time. About two and half hours afterwards she became nauseated. She had several bouts of emesis and then had a fall. She was found to be hypotensive and bradycardic. The ambulance crew actually gave her atropine at the same because she had a pulse in the 30s, improved her quickly and she presented to the ER. She is to remain very orthostatic, received several liters of IV fluid as now symptomatically better. She remains a little nauseated. She denies any headache, diarrhea, fatigue, or myalgias. She does not feel quite right. She is still dizzy with sitting up.

pt stated the night after the covid vax she had chills, headache, nausea, fever, weakness. Pt stated in bed next day since she was unsteady on her feet and had 101 fever. Pt called PCP to let them know and will FU with regular scheduled appt.

Resident received the 2nd dose of Covid-19 Vaccine on 01/29/2020, reported feeling Nausea on 01/30/2021 and had 2 falls, second fall resident became lost consciousness while ambulating and abruptly feel to the ground . Paramedics were called and transported her to ER evaluation.

Jan 31, About 1pm , diarrhea . 7pm-9pm shaking chills. Diarrhea at 7pm. Temp., 94.7 at 8pm / 97.0 at 9:30pm / 100.7 at 10pm. Normal by 9:30am Feb 1. Very weak about 10pm. Needed help to get out of bed and help walking. Condition improved overnight. Tired for lack of sleep first half of day. Feeling normal by 6pm Feb 1.

Patient presents to the ED with left leg myopathy leading to pain and subjective weakness making it difficult to ambulate

felt dizzy and sick; felt dizzy and sick; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the first dose of bnt162b2 (Lot Number: EL9261), via an unspecified route of administration in left arm on 21Jan2021 14:30 at single dose for covid-19 immunization. Medical history included Thyroid issues, whole body hurts, car accident in 2006 (lost her arm and husband, she only has part of her right arm), A-Fib, cardioversion (about a little over a month ago), heart disorder. Concomitant medication included apixaban (ELIQUIS) for heart, thyroid medication. The patient previously received the Shingle shots for immunization and experienced tired the next day. The patient experienced increased heart rate, felt dizzy and sick on 21Jan2021. She got the shot on 21Jan2021. She was ok at first but then about 4pm when got home she felt dizzy and sick. She took her heart rate and it was 156. She had A-Fib but just had a cardioversion about a little over a month ago so this really scared her. She felt really sick and didn't want to go into the hospital. She was ok overnight other than her heart was beating too fast. She took her heartrate this morning (22Jan2021) and it was back to 67-70. Today she is just taking it easy. The events did not require a visit to Emergency Room/Physician Office. The second dose is due on 13Feb2021. She is leery of getting it but is going to talk her heart doctor about it and will also see her primary care doctor on Monday. She had a Thyroid issues, things like that. Basically her whole body hurts, this is something that was going on prior to the shot. The only issue with the shot is the increase in her heart rate. There was no treatment, she had nothing to take for this, she doesn't think Tylenol would have helped but she doesn't know. The patient's mom had cancer. The outcome of the events was recovered on 22Jan2021.

Itching, heart racing, high blood pressure (162/86/111) at 11pm. on 1/29/21, day of the event. On 1/31/21 - vertigo during the day, chills. On 2/1/21 at 4:30am heart racing, high blood pressure (168/84/74), vertigo. At 8:52 am blood pressure was 142/70/74. Called Dr. to see if I could be allergic to the shot. She thought my reactions to the shot were probably a normal immune response to the vaccine.

12 hours post vaccination - couldn't lift feet off floor, had to shuffle her feet to walk, headache, brain fog, memory difficulties, body ache, sinus drainage, extreme tiredness, tenderness at injection site, increased shortness over breath 24 hours post vaccine- mild headache, tiredness, joint pain, lethargy, no pain at injection sight, able to walk fine, mild shortness of breath,

Started feeling achy around 11:00 PM. Took Tylenol. Was achy all day Wednesday and took Tylenol every 4-6 hours. Woke up Thursday morning and couldn't get out of bed. I was dizzy and nauseous. I got up 3 times to use the bathroom and couldn't even swallow water until 9:30 PM. I had 1/2 cup soup and water that evening. Thursday I was only slightly dizzy but was able to eat and drink. I didn't feel well enough to leave my house until Sunday. Today is a week since the second dose and I'm almost back to normal, but still tired. FYI, I did have COVID last March. I was quite sick but not hospitalized. I received phone calls every other day from the DOH during the almost 3 weeks I was in isolation at home. I gave plasma 3 times after recovering.

About 10minutes after vaccine patient felt light headed. Vital signs were within normal limits (BP: 130/60, Pulse: 80, Respirations: 12, Pulse ox: 96%), and patient started to feel better. Offered a snack but patient declined. Patient was reassessed after 10 minutes and patient was back to baseline and ready to go home.

Client stated that she was experiencing sudden headache, jittery, and slightly lightheaded. She voiced that the feeling of getting lightheadedness was not unusual but the sudden headache was. Pt was seen and assessed by EMT. VS as followed BP 150/89, HR 76, O2 97. Pt cleared by EMT to go home.

Cannot walk; Dizzy; Feeling off balance; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in left arm, on 19Jan2021 (Tuesday), at a single dose, for COVID-19 immunization; and pregabalin (Unknown manufacturer), via an unspecified route of administration, on 22Jan2021, at 75 mg, twice daily, for an unspecified indication. The patient had no medical history and concomitant medications. The patient took her first dose of the BNT162B2 vaccine last Tuesday, 19Jan2021 (a week before the reporting). The patient felt fine as of Wednesday and Thursday (20Jan2021 and 21Jan2021) but started to feel dizzy and off balance on Friday (22Jan2021). The patient did start taking the generic medication, pregabalin on Friday (22Jan2021), took one pill that morning, then got extremely dizzy, has not taken any more since, still just feeling off balance. The patient was prescribed pregabalin twice a day but only took 1 pill, it is a new prescription. Medication (pregabalin) was started on the same day as the event but prior to onset of event. The patient had been dizzy ever since, it really feels more like she is just off balance. The patient can function, just an off-balance feeling. The patient read on the information sheet for BNT162B2 that dizziness could occur in the first 15 minutes. The patient was asking and wondering if this is a delayed reaction to the vaccine. This is why she thinks it could be a delayed reaction to the vaccine because she only took one pregabalin pill and it should be out of her system by now. The patient was just going back to the effect today (25Jan2021), the patient was not dizzy (as reported but also reported as not recovered), but she cannot walk, and she was little off balance. The patient was just wondering if that could be a side effect and if there was anything to be worried of. The action taken in response to the events for BNT162B2 was not applicable; and for pregabalin was temporarily withdrawn on 22Jan2021. The patient had not recovered from the events. Pfizer is a marketing authorization holder of pregabalin in the country of incidence. This may be a duplicate report if another marketing authorization holder of pregabalin has submitted the same report to the regulatory authorities.

PATIENT VACCINATED AT 10:10AM, WAITED FOR 15 MINUTES. FELL AT 10:42 AM WHILE ENGAGED IN RECREATIONAL ACTIVITY. NO ANAPHYLAXIS. NO FAINTING. AMBULANCE CALLED AND PATIENT TRANSPORTED TO HOSPITAL.

Fri 2/5/21 , 6 am teeth chattering, weak, nausea, tiredness, slight headache, light headed, extreme diarrhea (may be due to antibiotic) very slight soreness as injection cite. This lasted for 48+ hours. Did not feel myself for 72 hours.

I had my 2nd Pfizer vaccine , Lot:EL9264 at 10:30 on Feb. 13, 2021 at MC. I was beginning to get slight pain in my back by late afternoon the same day. By bedtime, it was much worse. I woke up around 2:am to go to the bathroom. I couldn't even stand up. My husband was able to help me and get me back to bed. I had excruciating pain with every step. I couldn't bend, turn, etc. I spend all of the next 2 days in bed. Yesterday, on the 3rd day, I was able to sit in a chair for a short time. Today I am better and can get along without assistance.

Patient received first dose of vaccine. Experienced light headedness, feeling stuffy, and trouble breathing. Patient was transported to emergency room for evaluation. Patient was observed but did not require treatment or intervention.

Client proceeded to an upstairs restroom post-vaccination, rather than to observation area. Upon exiting rest room, client experienced weakness, mild light-headedness with elevated BP of 203/98. She was evaluated by paramedics on site who recommended further evaluation. Client declined stating she felt better and would take her medication when she arrived home. RN encouraged her to call her physician when she got home. A friend drove her home . A follow-up call was made at 1:46 p.m. by reporting RN. Client stated she took medication, was resting and BP was 168/70, and she was planning to call her doctor. She felt the episode was due to the exertion of going directly upstairs to the rest room, rather than sitting down in observation area.

About 3 hours after shot I got diarrhea and it was bad. Pain in arm, dizziness and loss taste and i have not gotten back yet, joint pain, tiredness, fever. I have been so thirsty i have been drinking a ton of water. i had all the symptoms of covid . I had covid in November and symptoms were worse .

Immediately after receiving the vaccine, client started c/o severe pain in her arm and lightheadenness and shallow breathing. vital signs monitored. no meds administered. Son at her side. This information was obtained from her son. He says she has bad arthritis and the shot hurt her and she almost passed out. She has had no other problems since and didn't have any with the first dose.

gets 102 degree fever; Could not speak much next two days; Within one hour or so after: found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.

Systemic: Weakness-Severe, Additional Details: patient was unresponsive and staring blankly later that evening after receiving the first dose of vaccine, she was not able to verbalize symptoms, however, she experienced weakness in legs requiring assistance to walk per her caregiver

10:05 am Pt received vaccine and was seated in observation area. Pt alert, interacting with staff and other pts. 10:15am Pt appears asleep, rouses with touch and when spoken to. Observation area nurse notified, provided pt with bottle of water and helped her take a drink. Nurse then notified pharmacist who came to pt's side. Pt given 25 mg benadryl caplet. Able to swallow it, needed assistance for holding water bottle. Pt breathing regular, pulse regular and easily palpable. 10:25 Pt increasingly lethargic. Nurse and pharmacist with pt. Lips and tongue slowly swelling, responsiveness decreasing. Pharmacist called 911. 10:30am Pt's daughter administered epipen 30mg, L outer thigh. Swelling of lips and tongue quickly resolving. Pt lethargy increasing. Increasingly slow to open eyes and respond to questions. Pulse and breathing continue regular. EMS arrived on scene approx 10:35-10:40. BP 80/60, NSR, pulses palpable, pupils reactive, able to answer questions but slow to respond and weak voice. Pt transferred to Medical Center. In ER pt given IV solumedrol, IV fluids, CXR, EKG. Awake and oriented, arms shaking, weak, requires assistance to stand, intermittently drowsy. Admitted for observation. 3/3/21 pt preparing for discharge, BP extremely high. Pt given metoprolol, BP increased, tachycardia increased, pt very drowsy. Continued to monitor, given Lisinopril, bp decreasing. Pt feeling much stronger, alert, interacting with staff and daughter. Discharged home.

Patient reports at 1302 with mild dizziness after receiving her 2nd dose vaccination. Pt is taken to treatment are to be further assessed. Initial Vitals: 1304 BP: 126/72 HR: 66 Sat: 95% RR:18 Pt was given water to drink and approximately 10 min later pt reports feelin "much better and no longer dizzy" Vitals were repeated at this time and are as follows: 1314: BP: 128/78 HR:61 Sat: 95% RR :17 Pt was given instructions if symptoms reoccur to consult PCP or call EMS. Pt verbalized understanding and was escorted to the car with husband without further incident by RN

Severe headache, very low blood pressure and blood sugar , dizziness , fatigue that cause fall. Body aches , low grade fever abs coughing and none stop running nose abs very dry throat

Vaccine recd 1/20 and 9 days after I got really sick and still having breathing trouble and short of breath, now using breathing treatments, I'm having a hard time walking, weakness all over, headaches, and I feel so out of it.

elevated blood pressure; a sensation of tingling on the right side of her chest and her right arm; burning sensation in my chest and right arm; felling dizzy/light-headed and "crummy"; This is a spontaneous report received from a contactable consumer (patient herself) via a Pfizer sponsored program Pfizer First Connect, and via Medical Information Team. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number was not reported), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included cancer and blood pressure issues (she had been treated prior to vaccination). The patient's concomitant medications were not reported. It was reported that, the patient received her first dose of Pfizer-Biontech Covid19 vaccine on 27Jan2021. She has since been feeling dizzy, light-headed and "crummy" in Jan2021. She reports going to the ER (emergency room) yesterday morning (08Feb2021) reporting an elevated blood pressure, with dizziness and a sensation of tingling on the right side of her chest and her right arm (the same arm that was vaccinated). Her MD says that she should not take the second dose, but her daughter-in-law who is a nurse says that it is her (the patient's) decision. On 27Jan2021, patient had been having issues with her blood pressure- sent to the ER yesterday morning- blood tests twice already. BP elevated and dizzy because she had a burning sensation in her chest and right arm in 2021. The patient supposed to get second dose on Wednesday doctor says not to take it, since she was experiencing adverse event, and her HCP sited the deaths in as a reason for her not to receive the second dose. The outcome of the events was reported as unknown. Information on the lot/ batch number has been requested.

1158 - Vaccine administered 1348 - Witnessed fall in front of OCC patient entrance on MLK. Patient had been waiting for Ride Connection scheduled at 1400 since vaccine observation complete. Stepped off curb to look for ride in pick-up area then tripped trying to step back onto sidewalk. Landed on bilateral knees and then down to right right hip. Witnessed in full by Safety Lead. Partially witnessed by Observation Lead and RN Lead. Assessed by these staff with MD Lead present. Okay to stand. Transferred to wheelchair. Okay to go home. 1412 - Observation Lead stayed with patient until ride arrived and patient left.

A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extremely light headed; nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at single dose for Covid-19 immunisation. Medical history included hydrocephalus condition-corrected with surgery also wear hearing aides, and seasonal allergies on occasion. The patient was not pregnant. The patient had no known allergies. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR). The patient received first dose of bnt162b2 on 03Feb2021 for Covid-19 immunisation and experienced lightheaded and lost hearing in left ear. A few days after she received her 2nd vaccine dose, she lost hearing in her right ear and have become extremely lightheaded and somewhat nausea in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.

lost the hearing in her left ear; became light headed; This is a spontaneous report from a contactable consumer (patient herself). An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 03Feb2021 at 15:45 as a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hydrocephalus condition, which was corrected with surgery and for which the patient was also wearing hearing aides; all from an unknown date and unknown if ongoing. The patient had no known allergies; however, she had seasonal allergies on occasion from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR); both taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. Right after the patient received her first vaccine dose (while at the clinic) on 03Feb2021 at 15:45, she became light headed. The next day, on 04Feb2021, she lost the hearing in her left ear. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The patient was not recovered from the events.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: pt was very anxious -Severe, Systemic: Shakiness-Severe, Additional Details: after pt received her shot she shopped in the store and then sat down and was very anxious, dizzy, and was shaking uncontrollably

dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.

Got her vaccine, came home drove herself, had no problem whatsoever, felt perfectly fine during the day. She then went out, got lunch, brought it home, nothing about the day was out of the ordinary other than the vaccination. She often stays up too late and watches TV in her recliner and falls asleep. She guesses she didn't put things away properly, and the next thing that she remembers was going into the bathroom to get ready for bed, extremely cold evening. She then remembers when she went to hang up fuzzy robe up in the bathroom on a hanger on the doorway, and when she reached up just at that moment she felt herself falling/passing out. She does not remember the moments before or after the event. She fell over her bathtub that was in the doorway, and remembers the pain of hitting the tub. The next thing she remembers is like she was in a dream, and remembers thinking that she had to call her son as she knew she was in trouble. She does not remember dialing his # at that point, but her memory tells her that she told him that she needed him. She was told that was her 2nd call and she does not remember that. She remembers thinking at some point that she was coming in and out of consciousness, and remembers her son didn't come. She called 9-1-1 and remembers talking to somebody and telling them that she could not get up. She answered that she had her door unlocked and remembers that, and apparently told them that she could not stand up. She remembers crawling, possibly to the front door to unlock it. She also remembers telling the 9-1-1 person to tell the sirens off when they get to the neighborhood. They came and took her to the hospital, but doesn't remember that but then suddenly felt like she was freezing, and asking for a blanket, and asked if somebody opened a door. She does not remember the ride to the hospital, going out of her house, just being so cold she was hurting. She doesn't remember anything whatsoever of being in the ER, running tests. They apparently did 2 CAT scans and 2 MRI's, with and without contrast on both. The ER report said that when they got her that she was having extreme chills, and in a stroke-like condition, she could not see and she could not move her body. No tests indicated that she had a stroke. She doesn't think any of them knew that she had the vaccine, they only knew she was a heart patient, and looking for the stroke by doing typical stroke tests. She apparently had called her son first and told him that she was going crazy, and he called his sister, and then she called him again and said that she needed help, and didn't understand what she was talking about. She had no temperature she was told when they took her to the hospital. At some point she then started to spike her fever, which went up to 103. The next clear memory she has is that she woke up on Sunday in the hospital in a pool of sweat after her fever had broken. She also has a memory that she woke up and somebody was touching her in her privates, and there was somebody trying to catheterize her. At first she didn't understand why and then had a vague memory of trying to get a bedpan under her, and decided to catheterize her. She then back to sleep and woke up on Sunday and was completely waking up then and saw her son sitting there. All memories other than this was vague and in and out. After she was awake on Monday they came and did an EEG of her brain, it was normal. She then was given speech therapy on Sunday afternoon, had 10 questions, and answered 9 of them, but on one of them she told them that she could not do that, and did it the next day again and was able to complete that test. When she fell and hit the bathtub she did hurt her arm from her elbow to halfway toward her wrist. Then they discharged her home with someone with her 24 hours a day and could not drive or use the stairs until she had been seen by her family doctor in a week or two to make that she was safe. She had home health care coming in and PT had been coming as well. She had home health still as of yesterday 3/25/21, and PT discharged her as of yesterday. She has been by herself, and is OK to use the stairs and driving again. She has one more home health nurse visit for them to sign off and say that she is now OK. She did get her 2nd vaccine, and she had minor issues, a weird feeling in her head for 12 hours, but nothing bad enough to take something for it. It was a little uncomfortable and out of the norm for about a day, and at one point the next afternoon was making a sandwich and had something that went through her body and felt like she was going to pass out and got into her recliner. She laid down for about 15-20 minutes, it passed and she has been fine. She had somebody stay with her for 24 hours and has done well since. She is convinced that this reaction did come from the vaccine, and that the first vaccine can cause adverse reactions, and that she does live alone and never occurred to her that she needed somebody to stay with her, and now she is afraid to be alone.

Fell; This is a spontaneous report based on the information received by Pfizer (Mfr Report# UNT-2021-002835). A non-contactable female consumer reported an 82 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Co-suspect medication included treprostinil sodium (REMODULIN, Lot# 937303, Exp. Date: 31May2022) 10 mg/ml Subcutaneous at 0.070 ug/kg for secondary pulmonary arterial hypertension since 09Sep2010. Relevant medical history included secondary pulmonary arterial hypertension (ongoing). Concomitant medications included apixaban (ELIQUIS) and tadalafil (ADCIRCA). On 18Jan2021, 10 years 4 months 10 days after initiating SQ Remodulin, the patient fell after receiving the COVID vaccine and was hospitalized. Action taken with SQ Remodulin was not reported for the event of fall. At the time of reporting, the event of fall was considered as resolved on 18Jan2021. The patient was discharged from the hospital on 22Jan2021. The reporter did not provide causality for the event of fall. Case Comment/Senders Comment: The company has assessed the event of fall as not related to SQ treprostinil considering that the patient has been on drug for more than 10 years. Fall was likely an accidental event in this elderly patient or could be caused by a syncopal episode associated with the underlying PAH or could also be associated with the administration of COVID vaccine. Additional information has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

She has not been feeling right; she does not feel normal/ Fuzzy head; she feels very sick; She feels like her symptoms from her thyroid have like over taken her body; She feel like everything is aching, everything hurt; everything burns; It's hard for her to have her balance; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration at the age of 82 years, on 07Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for covid-19 immunization. The reporter stated, "I am a daughter for patient who got the Pfizer shot". On an unspecified date, the reporter further stated, "I am calling in regards to my mother, she is 82 years old and she got her second vaccine on the 7th, on the Sunday and ever since then, she has not been feeling right, she has a condition where she has too many antibodies for her thyroid, but the first shot she got she felt fine after. This time she feels like her symptoms from her thyroid have like over taken her body and she feels very sick, she does not feel normal, she feel like everything is aching, everything burns, everything hurt, her head is fuzzy, it's hard for her to have her balance, it's only after she got the second shot she started feeling like that, the next day Monday, so we don't know what to do because we don't know how long will this last, she feels like she is dying, which is lot for my mom to say because she can take some pain, so I want to know the way this functions." The outcome of the events was unknown.

After the vaccine, after I sat down, I started to feel shaky and felt light headed. My blood pressure was elevated and wasn't going away it lasted for a while. I went to UC to be seen.

overwhelming feeling of dizziness/she felt the sudden urge to faint and then became so dizzy that she had to lie down on the couch; very weak; very tired; she has slept a lot; she felt the sudden urge to faint; unable to visually focus, if she closed her eyes and she opened one eye it would be blurry and the people on TV were sliding off the screen and everything was sliding away; pain behind her left eye into her head; she tried to get up to go to the bathroom the room was spinning; an inner ear problem or problems with the "crystals in her ear"; When she got up, she couldn't put her two feet on the floor out of bed without leaning towards the left; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 01Mar2021 11:00 as SINGLE DOSE for covid-19 immunisation, at 82 years old. Medical history included history of a stroke from an unknown date (previous history of a stroke 19 months ago). There were no concomitant medications. The patient previously received BNT162B2(Lot# EW5318) on 07Feb2021, at 82 years old for COVID-19 immunization and experienced no adverse event (no reaction). Other historical vaccine included Flu shot (influenza vaccine) on an unspecified date and experienced almost killed her. The patient reported no reaction and no problems (no pain, no nausea, no anything) from the second dose until the evening of 08Mar2021 when she was in her kitchen cooking and chopping vegetables, she felt the sudden urge to faint and then became so dizzy that she had to lie down on the couch. She had an overwhelming feeling of dizziness. A feeling like she wanted to faint, and she never faints. Her daughter got her to the sofa. She couldn't get off the couch. The room spun unbelievably. Everything spun. She went to bed and when she woke up, she felt worse. She states that the dizziness was worse, she was unable to visually focus, if she closed her eyes and she opened one eye it would be blurry and the people on TV were sliding off the screen and everything was sliding away, and she had pain behind her left eye into her head. When she tried to get up to go to the bathroom the room was spinning. It lasted through the next day (09Mar2021). When she got up, she couldn't put her two feet on the floor out of bed without leaning towards the left. She didn't fall. It was so bad she had to grab onto things to walk. During that day they brought her downstairs and she stayed on the sofa and it just got worse. Her daughter had her call her primary care doctor and he said that if her neurologist had heard any of what had happened, then go to the emergency room, to which is where she was 19 months ago with her stroke. She spent the 11Mar2021 and 12Mar2021 in hospital (due to dizziness). They couldn't find anything. She had not had a new stroke. She had every test known to man. They did a full neurological work up including an MRI, CT Scan, carotid artery studies and checked everything and could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke. The told her that she could potentially have an inner ear problem or problems with the "crystals in her ear" which could be causing her dizziness, however, they could not positively identify the cause of her problem. They found evidence of her previous stoke. When they were sending her home, it says on her discharge paperwork, they were going to put her in a vestibular clinic. It has to do with crystals in her ear. She was still dizzy and still walking with a walker which she hasn't had to use in 19 months since her stroke. And she has slept a lot, the night she was discharged on 12Mar2021 and the following day. On 14Mar2021 she woke up a little bit. But on 15Mar2021, she is very tired and very weak and still very dizzy. The dizziness is not the room revolving kind. She is taking an anti dizzy pill. She has to see her doctor tomorrow morning, her neurologist at hospital. The dizziness is still persisting but not as bad and she can jump up and walk and do things with the walker. Regarding tests done at the hospital, she came out with shining colors apparently. All tests came through fine. There was no evidence of stroke, her blood pressure, triglycerides, fluids or liquids, everything tested perfect. When querying if she had gone to her physician's office, she reported she had a morning call with her doctor on a phone appointment and he sent her straight to the hospital. She is still dizzy and walking with a walker which she has not had to use in 19 months. She states that doing a lot of hand-eye coordination exercises at home. She has the television on to check her vision which seems to be returning to normal. She stated, "I just don't know where to go from here." She stated that she has a follow up appointment the following day with her neurologist. She wanted to know if this side effect has been reported and how long she can expect to feel this way. The patient underwent lab tests and procedures on Mar2021 which included blood pressure, triglyceride, fluids or liquids: tested perfect; and CAT scan, EKG had unknown results. On 11Mar2021, CT Scan: unknown results (could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke/they could not positively identify the cause of her problem); MRI: unknown results (could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke/they could not positively identify the cause of her problem). Therapeutic measures were taken as a result of overwhelming feeling of dizziness and unable to visually focus. Outcome of the event dizziness was not recovered; outcome of the event unable to visually focus (visual disturbance) was recovered on an unspecified date in Mar2021; while room was spinning (spinning sensation) was recovered on 09Mar2021, while unknown for the other events.

Within 2 hours, hallucinations, fainting and falling down first two days. Total 4 times. Muscle weakness in legs, mild confusion then and continues.

Numbness in right hip/leg that continues as of April 13, 2021 Walking & Kneeling hard , afraid of falling.

Large hemorrhagic stroke with severe headache & throwing up. Not sure when it actually happened but found her on bathroom floor when I woke up. Transported to local hospital & transported to Neuro icu at major hospital. Now in nursing home with rehab. Unable to assist yet with much therapy. Impaired vision, can't feed herself or sit unattended. Very groggy & sleepy. Never lost consciousness.

This all happened after the second shot I felt nothing except a sore arm after the first shot. I immediately felt dizzy and nauseous. Nausea continued for days--intermittently for 3 weeks. Severe headache, muscle and joint pains, fatigue. Very very cold the fist night. slight fever. In the morning my nightgown was soaking wet. Headache persisted for a few days. Eventually loss of tast but that returned. The only thing that persists is intermittent fatigue and nausea.

Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less responsive and slump in her chair. Speech not clear, could not keep eyes open. Appeared pale and clammy. Lightly retching but did not vomit. With 2 assist were able to get patient to wheechair and then to gurney nearby. BP immediately taken - it was ~ 165/80. Pulse = 70. Pulse ox = 94%. Her color remained somewhat pale. Pt able to talk more clear and state she is a diabetic and requests glucose check. We called a "first responder". Glucose machine arrived and her glucose was noted to be 287. She notes it has been "very up and down lately" and recently made changes in her insulin/med regimen. She states she did eat breakfast and took both her long and short acting insulin. She did eat a cracker and then after ~ 20 minutes wanted to sit up. She sat up and appeared improved but not 100%. Her BP sitting up was ~ 125/70. Pulse remained 70. She then stood up to get into wheelchair but once in wheelchair began to become less responsive again and appeared more pale. She was then put back on gurney with assist of 3 and taken to ER. Per ER note, she did have some vomiting and dizziness. Her BP was initially 222/99. BP improved to 1178/84. She was given meclizine and rested. She felt improved and able to ambulate, and was dc'd from ER.

vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous report from a contactable other Non- HCP. A 82-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 06Feb2021 (at the age of 82-Year-old) for COVID-19 immunization. Medical history included diabetes, high blood pressure, overweight. The patient was not pregnant. Concomitant medication included ezetimibe 10 mg once daily; metformin 1000 mg twice daily; acetylsalicylic acid (ASPIRIN) 81 mg once daily; chromium picolinate, cinnamomum verum bark, colecalciferol (CINSULIN ADVANCED STRENGTH) (medications in two weeks). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1283) in left arm on 16Jan2021 for COVID-19 immunization. On 06Feb2021, patient experienced muscle pain, fatigue, stomach cramps and diarrhea, mucus from sinus, vertigo. No treatment was received for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

it hurt; Vertigo; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered on left arm on 17Feb2021 09:30 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included quadruple bypass on Oct2020 with symptom of difficulty breathing. Patient was sent to heart system downtown and they cold not do an angiogram and stated she was filing a complaint against her original doctor because he sent her out to have a heart attack or stroke. The family doctor took an x-ray and said it was fine. The hospital kept her a week to get her restarted and doctors were worried of the artery involved, and was also worried if she would have a heart attack. Patient did not have pain, even now, except where surgery pain in legs was and her legs have scars. Other medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Patient lost height; she was 5 foot 2 inches and was probably 5 foot 0 inches now but it has not been documented. Weight was about 102lbs. Concomitant medication included acetylsalicylic acid, clopidogrel bisulfate (PLAVIX) in which patient got black and blue marks along the way. Patient previously took flu shot in Oct2020. Three days later after vaccination, on 20Feb2021 patient developed vertigo and still had it. The doctors have been doing tests but haven't got the final report. Patient reported she had even had the make you dizzy test done. She has had vertigo before but it usually only lasts 3 or 4 days max. On 26Feb2021, patient went to urgent care to see a doctor and confirmed that patient had vertigo and that was all the doctor could do. Since then, patient has seen her regular doctor, heart doctor, had audio tests, MRI radiology and seen and ENT. Patient stated that this was very disturbing. She can't drive go to store to even get toothpaste and she was used to being independent and doing this. Initially she thought the vertigo was not related to the Pfizer Covid vaccine but since has heard from people in the groups that she was in that vertigo was a problem other people have had. Patient was pretty active, just had quadruple bypass and she has been walking and everything. This going on has limited her. The vertigo has changed but she still can walk around generally. If patient turned her head or looks up she gets dizzy. She can't do yoga exercises because she has to look up and she is sensitive to that. Laying down, head on pillow or headrest was bad. She has a leaning aspect and that leaning right or left feels like a balance problem. Treatment included Epley maneuvers which hasn't worked. Patient stopped taking Meclizine per doctor's order and has been taking gingko biloba. She was taking some medication that could make her dizzy, but it has not, and she was on them on for a while. They have a dizzy effect. However, patient did not think it was from the other medications. She thought it was triggered from the shot. Patient reported no immediate reaction Pfizer Covid vaccine except it hurt on an unspecified date. Outcome of the event of vertigo was not recovered while for the remaining event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021392500 same reporter/drug/event, different pt

about a week after taking 1st dose of covid vax her left knee became stiff and painful with swelling. She has been applying ice and taking Tylenol which seems to help but has had these symptoms going on 3 weeks. She recently had her 2nd dose on 4/21/21 with no reactions but continues to have swelling and pain in her left knee.

was fine until Thursday evening 4/22/2021. Started feeling body aches and restless. Friday morniing 4/23/2021. She woke up and went to the bathroom. Go out and fell and went into cardiac arrest. #12: GAD, Fibromyalgia, migraine, ventral hernia, hypothyroid, hypercholesterolemia, neuropathy, Hx of Covid-19

Pt presented to the emergency room 4/19/21 in the evening c/o the sudden onset of severe dizziness, light-headedness, nausea and diaphoresis. She received her second covid 19 vaccination at 10am earlier that day. pt was brought in via ambulance. she had a past history of vertigo but felt this incident was very different than her past episodes. she denied any problems with the first vaccine dose. she was admitted with a near syncopal episode and observed overnight in the hospital on telemetry. she was discharged home the following day feeling better with improvement in the dizziness. orthostatic blood pressures were negative.

could hardly walk; arm was very sore; stomach was upset; Slight Headache; Diarrhea; Slight fever; Muscle ache; felt bad; Sore throat; bled after her injection; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727), via an unspecified route of administration in the left arm on 25Mar2021 between 15:30-16:00 (at the age of 82-years-old) as a single dose for COVID-19 immunization; apixaban (ELIQUIS) via an unspecified route of administration at 5 mg twice a day from an unspecified date in 2018 and ongoing as a blood thinner/for the heart. Medical history included diabetes (started a couple of years before 2018), arthritis, lupus since 2020 (started just 6 months ago), high cholesterol, heart disease, all ongoing; as well as aortic valve replacement and pacemaker in 2016; she had all 3 types of arthritis: osteo, rheumatoid, and the one with the rashes, she has had aches and pains for a long time; arthritis pain; heart surgery in 2016; COVID-19 in the last part of Jul2020 to the first 2-3 weeks in Aug2020 (and then tested negative on 19Aug2020) with the following symptoms: bad headache, muscle aches, diarrhea, loss of smell and taste, "just about everything" for almost 4 weeks, autoimmune disease, diuretic and muscle relaxant therapy. Ongoing concomitant medications included glimepiride for diabetes from 2014, potassium tablet as a diuretic from 2016, furosemide as a diuretic from 2016, metoprolol for the heart from 2016, atorvastatin for cholesterol, hydrocodone for pain, tizanidine as a muscle relaxant, cinnamomum verum (CINNAMON) capsule, ascorbic acid (VITAMIN C), fish oil, ubidecarenone (COQ-10), vitamin D3, paracetamol (TYLENOL ARTHRITIS PAIN) tablet for arthritis pain, and an unspecified multivitamin. There were no additional vaccines administered on the same date or 4 weeks prior to BNT162B2. On25Mar2021, the patient bled after her injection, the blood started running down her arm when they pulled the needle out. The patient experienced sore throat on 25Mar2021 at 22:00, which was not excruciating, and the patient did not take anything for it. After waking the next morning, the sore throat was gone. The patient took paracetamol daily in the morning, and she wasn't sure if that was why her sore throat went away or not. She stated that when she had COVID disease the paracetamol didn't help her sore throat or headache at that time. The patient then started to have muscle ache on 26Mar2021 and a slight fever, never over 98 degrees, and she felt bad. The patient's normal temperature was around 97 degrees. The patient experienced a slight headache on 27Mar2021, diarrhea for 1 day and stomach upset on 27Mar2021 and then diarrhea again on 31Mar2021 for 1 day. The patient didn't take anything for the diarrhea, it was not that severe. The muscle aches continued in the upper part of legs, thighs, upper arms to her elbows. The patient had never had a hurting like that in her muscles and on an unspecified date, the patient could hardly walk since it was hurting so bad. On an unspecified date, the patient's arm was very sore. The events did not require an emergency room or physician office visit. The patient did call her doctor because she was hurting so bad who informed her that he had heard of other people who had the disease were having a reaction to the first vaccine. The action taken in response to the events for apixaban was dose not changed. The clinical outcome of sore throat was resolved on 26Mar2021 (duration 1 day), muscle ache was resolved on 03Apr2021 (duration 8 days), slight headache was resolved on 04Apr2021 (duration 8 days), diarrhea occurring on 27Mar2021 was resolved on 28Mar2021 and diarrhea occurring on 31Mar2021 was resolved on 01Apr2021, slight fever was resolved on 26Mar2021 (duration 1 day), stomach was upset was resolved on an unspecified date, and of could hardly walk, arm was very sore, bled after her injection, felt bad was unknown. No follow-up attempts are possible. No further information is expected.

Second shot, cold light temp, diarrhea, injection site pain, arthritic knee hurt badly- felt fuzzy and lightheaded for everyday since shot. Added 5/7 some days super duper tired Pfizer 03/13/ 2021 left arm. No medicine, has arthritis,

Patient is an 82 y/o female with PMHx of HTN, HLD, COPD, CAD s/p CABG, AFlutter post CABG who presented to the ED c/o generalized malaise, nausea, diaphoresis, dizziness, and a HA after her first Pfizer COVID vaccine on 4/22/21.She presented in Aflutter with RVR. She converted to sinus rhythm s/p IV Diltiazaem. She was evaluated by Cardiology and cleared for discharge on Multaq, diltiazem, carvedilol, ASA, and Eliquis. Echo showed LVEF 65%. Mild MR. Moderate TR. Her symptoms resolved on the day of discharge. She is to follow up with Cardiology.

Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Diarrhea; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in right arm on 09Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included ongoing Parkinson's disease started 5 years ago or more. The patient's concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot# EL9267) on 12Mar2021 and second dose 09Apr2021, which was technically more than 21 days, it was 4 weeks. The patient was very sick and experiencing diarrhea on 12Apr2021, diarrhea was better last night on 14Apr2021 and she was feeling pretty good when she went to bed and then it is back with a vengeance this morning. The patient took 2 Imodium and then she had another episode of diarrhea so she took another one. The patient experienced lightheaded and felt like she may faint, cold sweats, then freezing on 15Apr2021. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received first dose of bnt162b2 (COVID-19 VACCINE, solution for injection, Lot Number: ER8737; Expiration Date: Jul2021, NDC number: Unknown), via an unspecified route of administration on 07Apr2021 (at the age of 82-year-old) at single dose for COVID-19 immunisation. Medical history included had headaches most of her life, she knew it was her cervical spine because of bone spurs, arthritis, and bulging disc; she has also had change in vision, she was coming down the road from seeing her cardiologist and was looking down the road, out of right eye the road continued straight, but out of her left eye it looked like the road was turning off to the left, it was actually going straight, her eye doctor had told her that her eyes were no longer compatible, she was having five prisms put in her glasses, the neurologist was concerned, the eye thing started four or five months ago; she had shrunk to 4 foot 10 inches or 4 foot 11 inches, she used to be 5 foot 2 inches and shrunk because she had osteoporosis. The patient's concomitant medications were not reported. Patient reported that she had diarrhea one day in Apr2021. She started coughing some yesterday (14Apr2021). Then she was coughing more a little later. That was not what she would normally do. 14Apr2021, she was moving her winter clothes out to her summer clothes. She worked for three to four hours. Then she got so sore and was hurting all over. She felt the same this morning (15Apr2021). She was wondering if muscle aches could be a part of it. She was really hurting last night (14Apr2021) all over. She woke up this morning and felt sore. She was better now. It was from the waist up to the rib cage and all the way around. It was general, all over. She felt so badly last night (14Apr2021) and didn't feel great this morning. Another reason she was calling was because she saw her neurologist three days before and he scheduled her for an MRI of her head and brain. She had the appointment for the MRI on the 21Apr2021. She had been told that particular test was a magnet test and not radiation. She wanted to make sure there was nothing in the vaccine. They were not sure what the vaccine was going to do. They were not sure what was dealing with. Diarrhea started a couple of days before in Apr2021 when she was out of town, just for one day. It had stopped, she had recovered completely from the diarrhea. Coughing started on 14Apr2021. It was kind of a deeper cough. She had a little coughing 15Apr2021, but mainly body aches that started late 14Apr2021. She hobbled around and went to bed and got up to go to the bathroom and was having a hard time walking because she was so sore on 14Apr2021. The soreness was all over the body. She was having the MRI on her brain and head because she had been having headaches in Apr2021. She has had headaches most of her life. She had seen him (neurologist) several years before. She knew it was her cervical spine because of bone spurs, arthritis, and bulging disc. The doctor said that was the reason for a headache, but this was a different headache. It extended from behind her eye on the left side to the back of her head. It came on suddenly and she would have it for two to three days. Then that side of the head when she was turning in the left direction was sore and hurts. The headaches that felt different had been on and off for the past several months. She would have them for 3 days running and then maybe get a reprieve. She didn't want to take the second vaccine and had that on top of each other with the MRI. She wondered if she could take the second vaccine a little later. She was not comfortable getting it around the same time of the MRI. The outcome of the event diarrhea was recovered in Apr2021, sore was recovering, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Left knee started to swell and reports that it is painful; Left knee started to swell and reports that it is painful; It is is stiff; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date (at the age 82-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient states that about a week and a half to two weeks after, her left knee started to swell and reports that it is painful. She states that it is not an "excruciating" pain but does report that it is really bothering her and that it is stiff. She is concerned that this may be an autoimmune response to the vaccine. She also mentions that she received her second dose of the vaccine the day before yesterday. The patient states that when she took Tylenol and placed ice on it, the swelling seemed to go down a little bit and does not know if she should continue with icing it and resting it, or if she should see her doctor. Outcome of the event was not reported. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Two days after vaccine I started with pain in my jaw joint down my neck into both arms that lasted 2 minutes, then it came back in a couple hours and now it's still coming and going. It's more in my right arm and I cannot lift my arm when it's happening and it leaves me weak, trembling and in a cold sweat and sometimes I'm real hot. In February I went to the hospital and 4 doctors looked at me, I stayed there one day overnight . I kind of think that I was given the whole vial of the vaccine and want to know how long will it take for it to wear off, I watched them draw up the vaccine and they gave me everything in the vial. I think I got the whole vial.

Was very weak, dizzy, poor memory. I felt very extreme health reaction for over 7 days. It was my error not acknowledging allergic to Sulfa.

can barely think; stated that she is a mess; can barely walk; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 82 years) for covid-19 immunization. The patient's medical history included allergic to sulfa and brain damage (she was hit by a drunk 30 years ago). The patient's concomitant medications were not reported. The patient experienced can barely think, stated that she is a mess, can barely walk on an unspecified date. It was further stated that she had a shot a week ago. Stated she made an error. When they acknowledged if she was allergic to drugs or medication she did not acknowledge that she was allergic to sulfa. Stated that she had brain damage because she was hit by a drunk 30 years ago. Stated there was sulfa in the medication and the brain damage was hitting her hard. Stated that she's a mess. Wanted suggestions as to what to do since she was in this state. She has it set up for the second shot and wanted to know if she should have a second shot with the same ingredients for Pfizer Cod 19 virus vaccine. Stated that she went online to see if it had sulfa in it. Stated that she had an initial reaction to sulfa before an it was extreme. Stated she should have looked it up beforehand. It has been a whole week and she can barely walk. Stated that she can barely think. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Frontal headache, heavy, lightheaded & dizziness. No chest pain or difficulty breathing. BP 140/45; HR 63; RR 16. Denies weakness/numbness, AOx4. Similar Hx with first dose. Given OJ & crackers. Able to ambulate with cane without difficulty. Pt states ok to drive, released from vaccination site, advised to f/u with PCP

Dizzy, head pressure, increased sleepiness, headache, nausea, congestion, ringing in ears, chest pain

Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; This is a spontaneous report received from a contactable consumer (patient). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EL9269) at the age of 82-years-old as single dose for covid-19 immunization. Medical history included heart attack when she was 25 years old. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for covid-19 immunization. Patient had called about a reaction to the second vaccine on 18Feb2021 and she was still having side effects. Wanted to know if this was a time released drug and how long can she expect the side effects to last. Stated that she has pain in her jaws down to her arm and she cannot even lift it. Stated that it was really bad in her right arm. Wanted to know when she got a pain really bad was there anything that she can do to lessen it and when can she expect it to end. Was wondering if she was given more than the recommended dose. Wanted to know how many doses were in a vial. Wanted to know what would be the side effects if she were given more than the recommended dose or when it will end. Stated that she was in the hospital overnight and they did tests. Was told that she was having a reaction to the vaccine that they thought would not last long but has continued to last. Stated that the hospital did a temporary report. Stated that she had a report completed with Pfizer today. The outcome of the events was not recovered.

I had 100.2 temperature; Fever/ temperature in evening; Fatigue; Headache; Nauseous; Light-headed; Chills; This is a spontaneous report from a contactable consumer (Patient). An 82-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 82-years-old) as a first dose, single dose for covid-19 immunisation. The medical history included intolerant of iodine, shellfish, slight high blood pressure and known allergies: Comparing. The concomitant medication included 2 mult, levothyroxine sodium, losartan, HCTZ and pravastatin. The patient previously took morphine, demerol, darvocet, oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergy for all of them. The patient not received other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient reported, she had the first shot of the vaccine on 4th which was Thursday of March 10.30, 10:45 in the morning or 10:45. She had 100.2 temperature and seem to get temperature at night, chills, fatigue, nauseous and headache, lightheaded. It's getting better, took an Advil yesterday one and day before one, helps the fever, the temperature. Her second shot is scheduled for the 25th of March. Just want to know what to do. The patient not received treatment for the other events. The patient did not have COVID tested post vaccination. The outcome of the events chills, light-headed was unknown and the outcome of the events fever, fatigue, headache, and nausea was recovering. No follow-up attempts are needed. No further information is expected.

bothers her is that her problem remembering words is getting worse./: Knees hurt was reported as worsened.; it started from the top of her neck and her balance was off, she felt "fuzzy-headed"; She has been experiencing periods of tiredness where she does not want to do anything; increased forgetfulness in addition to her intermittent light headedness; increased forgetfulness in addition to her intermittent light headedness; Was cold; diarrhea; her knees hurt her; chills; mild fever; her arm was hurting; Arm was just a teensy bit sore at the injection site; Felt a little like balance was off; So tired I don't want to do anything; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199, Expiration date: Jun2021), via an unspecified route on 13Mar2021 (age at the time 82-year-old) as 2nd dose, single dose in the left arm for covid-19 immunization. The patient medical history included osteoarthritis, fibromyalgia (reported that she was diagnosed with fibromyalgia close to 20 years ago, between 15-20 years ago). The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route on 20Feb2021 at 10:00 (age at the time 82-year-old) as 1st dose, single dose in the left arm for covid-19 immunization. On 13Mar2021, the patient experienced armed was hurting, armed was just a teensy bit sore at the injection site, and the next day, on 14Mar2021 she had diarrhea and her knees hurt her and had chills and mild fever, was cold and felt a little liked balance was off. Patient reported that the next day, 15Mar2021, she was fine, on 16Mar2021 it started from the top of her neck and her balance was off, she felt fuzzy-headed, fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she doesn't wanted to do anything. Patient experienced periods of tiredness where she did not want to do anything was reported as worsened and reporting increased forgetfulness in addition to her intermittent light headedness. Patient reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. She reported that she was a senior, and most seniors had a problem where they couldn't remember a word then blinked and could've thought of it. She reported that the thing that bothers her was that her problem remembering words was getting worse and the problem remembering words had gotten worse from her baseline after she received the covid-19 vaccine, but it had stayed the same since originally worsening from baseline. Patient reported that the difficulty remembering words worsened around the same time that her fuzzy or lightheaded feeling began, and temperature was 99. 7. Patient explained that her armed did tended to hurt a little and that she received her shot in the affected armed and she was not sure if the diarrhea lasted the second day or not, but it resolved completely. she had a teeny problem with her knees and the covid-19 vaccine really nailed it. She reported that since she received the second dosed of the covid-19 vaccine, her knees had been terrible. She reported that what's really bothering her now was her knees. She reported that her knees were hurting so bad that she could've hardly walked. It was reported that patient visited to physician office. The outcome of the events diarrhea was resolved on Mar2021, armed was hurting was resolved on 14Mar2021, chills, mild fever, cold was resolved on 15Mar2021, felt a little liked balance was off was resolving, her knees hurt, so tired I did not want to be done anything was not recovered and other events was unknown. Information on lot/batch number was available. Additional information had been requested.

At time of vaccination my arm hurt badly. 24 hours after the vaccine I had fever and chills. On the 3rd day I woke up with sharp pain down my left arm, pain in my back and neck. On the 5th day I got lightheaded and dizzy. My blood pressure reached to 186/110 with a horrible headache. Went to the doctor and had a CT scan and stress test done. After 5 weeks my body is back to normal.

This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered in the right arm on 17Feb2021 06:30 (at the age of 82-years-old), as first dose, single dose for COVID-19 immunisation. Medical history included lipoma. Concomitant medications included hydrochlorothiazide (HTZ); levothyroxine, both taken for an unspecified indication, start and stop dates were not reported. The patient previously took ciprofloxacin (CIPRO), denusomab (PROLIA), and risedronate and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the first shot, the patient experienced vertigo and dizziness on an unspecified date in Feb2021 06:00. Patient reported events lasted 3 weeks. It was unknown if patient received treatment as a result of events. Patient did not seek consult to physician or urgent care. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 (at the age of 82-year-old) as 1st single dose for COVID-19 immunisation. Patient medical history included high blood pressure (HI BP), osteoporosis, blood cholesterol increased, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications taken in two weeks of COVID-19 vaccination included pravastatin (PRAVASTATIN), hydralazine (HYDRALAZINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on Day 2, 30Jan2021 at 05:00, the patient had pain in left arm, could not lift coffee cup, lower back pain was off and on. Event gone on Day 4, but 'now' patient was nauseous and lightheaded and back pain was back but higher up. Patient received no treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was reported as resolving and outcome of the event pain left arm was resolved on 01Feb2021. Follow-up attempts are completed. No further information is expected.

within 24 hours after second dose of vaccine my mother complained of chest pains and shortness of breath. She saw her Primary Care Dr on 5/10/2021 after experiencing dizziness, fatigue, confusion. She had lost a considerable amount of weight during this time and I was concerned and accompanied her to the doctor visit. Dr prescribed cyanocobalamin B-12 as she had been defficient in her latest blood analysis on 3/15/2021. She also added Donepezil 5mg tablet daily and trazodone 50 mg nightly to help with sleep. She gave referral to get Neuroligical evaluation. My mother had a driving episode on 4/30/2021 where she was taken to Medical Center and some Scans were taken of her brain that were apparently normal they contacted me to pick her up around 2:30 AM 5/01/2021. The number on her release folder to obtain medical Records. My mother was residing with me my home until her appointment for evaluation . She passed away on 6/02/2021 in my home.. Dr was contacted to sign off on her Death Certificate . I have not received Death Certificate as of today but I believe the cause she was putting was Natural Causes due to age.

lightheadedness; very very tired for a day or two; Memory was worsened than that it was before; This is a spontaneous report from a contactable female consumer. This consumer(patient) reported for herself that: An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199), via unspecified route of administration in left arm on 20Feb2021 (at the age of 82-years) as single dose for covid-19 immunization. The patient medical history included osteoarthritis and fibromyalgia. Concomitant medications were not reported. On 21Feb2021, the day after the first dose of covid-19 vaccination, the patient experienced lightheadedness for a day and then it was gone. She stated that she felt "very very tired for a day or two" on an unspecified date in 2021 and then was alright for a while. On an unspecified date in 2021, after the first dose, her memory was worsened than it was before. She stated that she had met two people, who had the same thing. She stated that she had initial symptoms one day and after that she had other things. The patient confirmed the vaccine was Pfizer Covid-19 vaccine. She wanted to know early that how long these symptoms would last and if more symptoms would appear. The outcome of the event lightheadedness was recovered on 22Feb2021. The outcome of the event tired was recovered on an unspecified date in 2021. The outcome of the event memory impairment was unknown. Reporter seriousness for Memory was worsened than that it was before: Unspecified Additional information has been requested.

Severe headaches, pain in body, night sweats, weakness in legs, tiredness, lumps throughout body, ringing in ears, unbalanced when walking

Admitted to hospital testing positive for COVID after being fully vaccinated. Patient admitted 05/29/21 with a GI bleed, patient asymptomatic for COVID s/s but was tested following hospital admission policies and had a positive PCR test on 05/29/2021. Patient reports her husband was positive for COVID a few weeks prior. Patient treated for GI bleed and d/c'd home on 05/30/2021. She returned to the hospital same day within a few hours reporting dizziness, syncopal episode, and slurred speech per medic. Admitted again with a-fib with RVR. No fever or cough, did report some shortness of breath at home. Discharged on 06/04/21, then readmitted for a-fib with RVR again, discharged home with homecare on 06/14/21.

She just feels terrible; Trouble walking; Splitting headache; Shortness of breath; Cough; She can't do her daily activities/she feels out of sorts; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer (patient) reported. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, solution for injection; Batch/Lot number: EN5318), via intramuscular, administered in Right arm on 07Feb2021 at 14:00 (at the age of 82-year-old) as 1st dose, single for covid-19 immunisation. The patient Medical history included cough from 19Jan2021 to an unknown date, dyspnoea from 19Jan2021 to an unknown date, malaise from 19Jan2021 to an unknown date. On the 19Jan2021, she was not feeling well and went to a medical facility and had blood work, a chest x-ray, and a Covid-19 swab done. They said that she probably had Covid, but they weren't sure. She was sent to another facility and had a antigen test. Her swab came back from the swab test a few days later and came back positive. On the 20Jan2021 they did a throat swab and it came back negative that she did not have Covid-19. She went back to the first facility about 10 days later and they did another throat swab and she tested negative. The concomitant medications were not reported. No History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No Prior Vaccinations (within 4 weeks). The patient was not ill at the time of vaccination. On 08Feb2021, the patient experienced splitting headache, felt terrible, Trouble walking. The reporter stated that the Covid-19 Vaccine and reported that she had the vaccine on 07Feb2021 and on 08Feb2021, she was feeling so horrible that she went to her physician. She said that she had a splitting headache and does not know if it is associated with the vaccine. It is Thursday, and she still has a headache, shortness of breath, and she just feels terrible. The patient reported that she also had cough. She said that she can't do her daily activities and she feels out of sorts. She feels like she does not want to do anything and the headache hurts. She does not know if it is a migraine or what, but it hurts. She reported that she has been having trouble walking. She stated that this started this past week since she had the vaccine, since 08Feb2021 and stated that it is persisting. The headache is driving her crazy. The adverse events resulted to visit physician office. They prescribed her a Z-pack of Azithromycin and an albuterol Inhaler. The outcome of the events Splitting headache, She just feels terrible, Trouble walking were not resolved and other events were unknown. Follow-up: Follow-up attempts completed. No further information expected.

The day after the second shot i had a low grade temperature of 99.3, Severe muscle aches, and very tired. I began to have huge amounts of blood mucus, spitting it up and choking on it. Was given a sinus infection amoxicillin antibiotic and musilix and nasal sprays. 2 weeks The heavy blood mucus traveled into my eustachian tubes, imparing my hearing and making me off balance...3 weeks. Experienced sever headahce for a week and went to ER for Ct scan . No stroke or anyerism . Then the heavy bloody mucus went into my bronchi and lungs causing shortness of breath and weakness...given a pneumonia antiibiotic . I am currently on a prescription for Prednisone ( on the refill) and improving slightly but still weak and tired and shortness of breath. Still having shortness of breath (6/26/21_ and very tired. Cannot perform all my daily functions like taking a walk . I am able to prepare meals. adverse reaction still exits 2/25/21 - 6/26/21

My left hip was very sore and it got worse; My left hip was very sore and it got worse; The pain was so bad I couldn't move and I also had a lot of pain in my right shoulder; The pain was so bad I couldn't move and I also had a lot of pain in my right shoulder; I think it exacerbated, it kicks in my immune system; Pfizer shot affected my immune system and started this but this is my guess; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 26Feb2021 as 2nd dose, single for COVID-19 immunization (age at the time of vaccination was 82-year-old). The patient's medical history included blood pressure and arthritis. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken at 12.5 mg for blood pressure. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization vaccination. On an unspecified date in 2021, the patient stated after the second shot I got some side effects and a few days after it began, and it was my left hip was very sore and it got worse. The patient made an appointment with the orthopaedist but before she could get to see him, she had to go to the Hospital in the ambulance because the pain was so bad she could not move and she also had a lot of pain in my right shoulder which went on a couple of weeks, just beginning to light up a little bit that day. So, she thought it was a side effect because I thought it was exacerbated, it kicked in my immune system so that was what I was thinking it was and I just reported it. The patient stated regarding outcome as yes but it has alleviated quite a bit I mean it was very bad , quite a lot actually today anyways it's pretty good and I have been on Prednisone (treatment), I am in the middle of taking that. I started taking it (Prednisone) 10 days ago. I have another week to go on it's a reduce dose you know you take 2 a day to 5 days, when you take you take two twice a day for five days then you take one twice a day for five days and you take one a day for five days." When probed if consumer is taking any medication other than Prednisone, consumer stated, "Not for the pain, I mean I do have other medications beside Prednisone. I am taking Hydrochlorothiazide (Clarified as concomitant medication) and nothing else. "Regarding start date of event the patient stated, "I can only give you an approximation it was about maybe four or five days later approximately. I started felling sore on my hip and then it gone worse. From 02Mar would be a good guess. She was guessing that the Pfizer shot affected her immune system and started but this is my guess, I am not a doctor. Treatment medication included Prednisone for all the events expect I thought it exacerbated, it kicked in my immune system. Outcome of all the events was reported as recovering and unknown for the event I thought it exacerbated, it kicked in my immune system. No follow up attempts are possible. No further information is expected.

had previous shortness of breath but got much worse after vaccination, heaviness in chest, extreme fatigue and weakness, wheezing in chest, fuzzy eyesight, can't focus eyes, feels as if eyes are going cross-eyed, muscle weakness, trouble walking, previously had headaches but more frequent and worse since vaccination

After 2nd vaccination - patient was having trouble breathing whenever she worked out in the yard doing minor task such as raking leaves/gumballs. She had 3 or more episodes of feeling light-headed and stopping activity and walking into living room and sitting. Was able to catch breath and didn't want to go to hospital in any of these cases. However on March 8 at 3pm, she felt light-headed but on her way back to her living room, her breathing was disrupted. Her breaths were cut short and she was not receiving much air into her lungs. The breaths were shorter and shorter until she wasn't receiving hardly any air into her lungs. Her face turned blue. She passed out. She had CPR administered about 30 seconds after passing out. Ambulance arrived about 1 minute after passing out. EMT crew worked on her for 18 minutes and was ready to contact coroner when they got a heartbeat. She was taken to hospital on March 8. She was transferred to another hospital later than night. She was sent home for hospice (still unconscious) on March 16 or 17. She passed morning of March 19. Death certificate states cause of death was lack of oxygen to the brain, but no determination was made to what caused her breathing problems, which caused the lack of oxygen to her brain. EMT crew said her symptoms were very similar to blood clot in lungs. Hospital ruled out a blood clot. They also downloaded data from the pacemaker and ruled out A-Fib as the cause. Pacemaker data had indicated a mild event around 3pm on March 8 and sent a shock to her heart but nothing unusual. I believe the hospital also ruled out another cause or two, but never did determine the cause.

On phone follow-up after vaccine patient noted that she fainted and vomited ~1.5 days after vaccine. Event occurred in the public. EMS was called but patient declined transport to ER facility. Patient said she felt fine after event and no further issues after episode. Patient has had no further follow-up with another health care provider for event.

New onset altered mental status after fall. Per son, she was found in bed, unresponsive at around 12:15 AM on 1/10 by her husband. Brought to the emergency room and admitted, Began treatment for UTI w/ CTX. Discharged 1/11/21 with f/u appointments

At approximately 11:09 am, patient began complaining of dizziness, headache, blurry vision and nausea. Patient states that she had a headache on arrival and took her bp meds this morning. Patient released by EMS to home with friend on site.

Patient within 10 minutes experienced nausea, lightheadedness, and dizziness. Patient went to ED. received hydration and ondansetron 4 mg. Discharged from ED.

Patient has a long standing history of CHF and AFib, however, patient had a syncopal episode on 01/25/2021 in the morning. Per her hospital admission note, she stated that she felt fine, stood up, became dizzy and was able to lower herself to her chair then went unresponsive for a few minutes, but did regain consciousness. When she arrived to the emergency department, she was in atrial fibrillation with RVR with rate in the 140-150s. While the AFib is long standing, the RVR is new and potentially unexplainable. This was resolved with cardizem drip ending at 2220 on 01/25/2021. Alternatively, this patient is being put into VAERS as there are 2 other patients hospitalized with cardiac issues and received vaccine from the same pharmacy with the same lot number.

12:10 PM - Patient honked horn and RN responded. Pt lightheaded, short of breath. "Chest felt heavy." 12:16 PM - 911 called, vitals (BP 140/76, Pule 50, RR 20, Ox 93%) 12:19 - EMS on scene. Pt still short of breath but talking, vitals remained stable. Pt c/o headache. Pulse ox 94-95% 12:30 - Pt transferred to hospital for cautionary monitoring

On day of vaccine I went to lie down(3:15 pm.) and the room started spinning. I sat up and turned to the other side, and again the room started spinning. I got out of bed and phoned my Doctor. She said to hydrate. I took 1/2 bonine and drank all evening. At 10:15, going to bed, again the room started spinning. I felt unsteady all evening.

stroke-like symptom; Left arm droop; no feeling on left side; loss of mobility in left arm; droop on left side of face; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: Ek4176) via an unspecified route of administration on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history included blood pressure needs controlling and allergies: penicillin. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included nebivolol hydrochloride (BYSTOLIC), terazosin, famotidine, olmesartan (reported as olmsartan), amlodipine, and atorvastatin calcium (ATORVASTIN). Facility where the most recent COVID-19 vaccine was administered at nursing home/senior living facility. The patient was not pregnant at the time of vaccination. On Tuesday 19Jan2021 at 5 am, patient had stroke-like symptom: left arm droop, no feeling on left side, loss of mobility in left arm, droop on left side of face. The event resulted in emergency room/department or urgent care, and hospitalization. The event was reported as serious with seriousness criteria of caused/prolonged hospitalization. It was unknown if treatment received for event. The outcome of event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.

Tired; Dizzy; unstable; shoulder/injection site pain; shoulder/injection site pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Jan2021 (at the age of 83-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder/injection site pain and arm pain in Jan2021 and tired, dizzy, and unstable on 16Jan2021. The clinical course was reported as follows: The patient initially experienced shoulder/injection site pain and arm pain. On the next day after vaccination, she felt tired, dizzy and unstable. The day after was much better and on the fourth day after vaccination, she was back to normal. The clinical outcome of shoulder/injection site pain, arm pain, tired, dizzy, and unstable was recovered on 18Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

dizziness; fell on to her bed; feels extremely tired; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration in the left arm on 18Jan2021 15:00 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. Everything went fine, she felt good, nothing at all happened; then, in the morning about 8 AM or 9 AM of 20Jan2021, when she got up, she was very dizzy and she fell on to her bed and her little dog jumped on top of her, her dog was scared. She did not know if this normal thing after the vaccine. She is going to go to her regular arthritis doctor on 08Feb2021. She sees an arthritis doctor but she doesn't think that would have any bearing on this. She didn't to call them but she was thinking about calling them and telling them about how it felt. The dizziness had majorly resolved but she just feels extremely tired on Jan2021 and she is really okay but she wanted to make sure that they knew what was going on. She is just watching TV and seeing the new president come in and taking it easy today. She felt wonderful the day after she got the dose and she is not very easy person to have problems with her health, she is like a horse so this is surprising to her. She is fine now, just tired which is not anything unusual she just wanted to call to make sure they knew. She is never dizzy, she does not have any problems with her health. The administration of the vaccine does not hurt her at all, just like nothing ever happened. Outcome of the dizziness was recovered on Jan2021 while of the remaining events was unknown.

Started getting dizzy and stayed dizzy through night and still dizzy on Feb. 6, also had a slight pain in liver (right hand side)

12 days after first vaccination: Dizziness; high blood pressure; nearly passed out; right arm numbness; inability to grip or pick up items with fingers; feeling of "lopsidedness"; unsteady on feet, requiring assistance to walk. Primary care physician recommended ER visit where possible stroke was diagnosed. Hospital MRI confirmed: " Left acute arterial ischemic stroke, MCA (Middle cerebral artery)" . Spent 2 days in hospital with high blood pressure, dizziness. Residual right finger numbness upon release.

Reported feeling light headed while sitting in observation area. Was taken to emergency 1 and observed by nurse and EMT. No distress, interacting with staff. Reports feeling better.

Itchy Left Foot, Congestion, Swelling and Itchy Arm 8 days after shot. I had itching and congestion during the week after the shot, but nothing like the reaction I had on the 14th of February. Also was dizzy and felt like I was going to pass out.

Leaving pt after 20 min monitoring and felt dizziness as exiting site. Client reports taking meds this morning + not eating. O2 95%, BP 100/70, after eating a slice of pizza + sniker bar she reports feeling better. Hydrated with water. Monitor additional 30 min and scorted to her car. Recently hospitalized due to asthma 2 weeks ago.

First day following vaccine, very tired. some blurred vision the next few days. on fourth day following vaccination, blurred vision, unstable walking felt like having Vertigo. Today the 16th, all adverse symptoms are gone

RECEIVED BOTH DOSES OF PFIZER COVID19 VACCINES ON 01/30/21 & 02/20/21. ON 02/21/21 WENT TO urgent care COMPLAINING OF DIZZINESS BEGINNING THIS AM EKG THERE SHOWED SINUS WITH 1ST AV BLOCK. ON 02/21/21 WENT TO ER COMPLAINING OF DIZZINESS. DIAGNOSED WITH VERTIGO AND ABNORMAL CTA OF NECK. DISCHARGED AND INSTRUCTED TO FOLLOW UP WITH PCP IN 2 DAYS.

She thought she was going to pass out; felt like she was going to faint; chin felt funny; face was red; face was burning; This is a spontaneous report from a contactable consumer(patient). An 83-year-old female patient received first dose of BNT162B2(Covid-19 vaccine, lot number EL8982), via an unspecified route of administration on 27Jan2021 10:00 at single dose, left arm for protection from virus, vitamin D(lot number 15070802 with expiration date Jun2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at 2000 iU, daily, (25 mcg/1000 IU, takes 2 by mouth daily) for bones, vitamin b complex (B COMPLEX, lot number 14704704 with expiration date Apr2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at unknown dose, daily, (2 by mouth daily) for energy, digoxin(Non- Pfizer product), orally from Jun2019 and ongoing at 0.125 mg, daily to slow the heartbeat, rosuvastatin(Non- Pfizer product), orally from 2019 and ongoing at 20 mg, daily to lower cholesterol. Medical history included high blood pressure, blood thinner, low thyroid. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) from 2019 and ongoing for high blood pressure, rivaroxaban (XARELTO) from Nov2020 and ongoing as blood thinner, levothyroxine from an unknown date and from Nov2020 and ongoing for low thyroid(had been taking for 25 years or more). History of all previous immunization with the Pfizer vaccine considered as suspect reported as None. Prior Vaccinations (within 4 weeks) reported as None. The patient experienced felt like she was going to faint on 30Jan2021 with outcome of recovered on 30Jan2021, chin felt funny on 30Jan2021 with outcome of recovered 30Jan2021, face was red on 30Jan2021 with outcome of unknown, face was burning on 30Jan2021 with outcome of recovered on 30Jan2021. Caller was asking if she should get the second shot. She went to her doctor and was told it was ok if she got the second shot. The doctor said it was too far between the shot and the reactions for it to be the shot. She received the vaccine on 27Jan2021. On Saturday morning she took Vitamin D, B complex, Digoxin and Rosuvastatin. Twenty minutes later her chin felt funny. Her face was red and burning. She felt like she was going to faint. She got some ice and washed her face. She took 2 baby aspirin. She asked her doctor if she was allergic to the vaccine. Her doctor said the time between getting the vaccine and the events were too far between. She thought she was going to pass out. She felt better after washing her face with ice. She was her face for 30-45 minutes with ice water. She took apixaban (ELIQUIS) before and her chin felt funny. She added that her blood pressure went up and she had trembles. She felt dizzy. Clarified that she felt that way prior to taking the vaccine. At first she didn't think to take her blood pressure. When she took it the reading was 165/79. At 3:00 pm the reading was 162/79. At 6:00 pm the reading was down to 150/79. The trembles started two hours after she took her medications. When providing product details she stated she took two Vitamin D. The label indicated to take one. When asking for indication caller asked what does Vitamin D do? She was able to answer herself. Product is filled in a pharmacy bottle and does not include NDC, Lot or expiry. Prior to taking rivaroxaban (XARELTO), she was taking apixaban (ELIQUIS) 5 mg twice daily. Lot: ABL8694A, Expiry: Dec2022, It came from another country. She was sure she was allergic to it because she had a rash. That was when she was switched to rivaroxaban. She was taking levothyroxine 100 mcg until she turned 82. In Jan2021, the dose was changed to 112 mcg daily. Her last thyroid level was high on the test with a result of 7.46. The dose was changed to 112 mcg daily. Initially caller gave consent to contact her physician. She changed her mind stating she didn't want her doctor to think she was going over her head. She was worried and frightened at the time because something happened to her. She can't remember if her face was swollen. She drank some ice cold water and took two baby aspirins. She knew she needed to flush her system. She just wanted to make she was safe in getting the shot. Her doctor told her to take diphenhydramine hydrochloride (BENADRYL) if she ever felt that way. She felt fine after getting the shot and the few days after getting it. She wanted to get the shot. Events resulted in physician office visit. The action taken in response to the events for vitamin D, vitamin b complex, digoxin, rosuvastatin was dose not changed. The outcome of event "She thought she was going to pass out" was unknown.

she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on his right arm, via an unspecified route of administration on 22Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included blood pressure high and surgery. There were no concomitant medications. Historical vaccine included a flu shot for flu immunization and experienced arm is sore and pain. The patient reported she got the COVID shot last Friday at 3pm. That night she woke up at 2am and everything was spinning. She is better now but not completely. If she lies down and gets up or turns her head a certain way, she gets dizzy. She had a swollen arm and sore arm after the shot. No treatment was received for the events. The outcome of the events swollen arm and sore arm was unknown while recovering for the other events.

Patient resides in an assisted living facility and received the second COVID-19 vaccination. She experienced fatigue in the morning following vaccination. She fell on 2/22/21. Ambulance was called and she was transported to the hospital. Initial symptoms included fever of 101 F, disorientation, left face droop, unresponsive to commands and loss of memory.

On 02/18/2021 pt got up and said she felt like a "mac truck had run her over". Every part of her body hurt. She had chills and a fever. she was unable to eat. This lasted until Sunday, 02/21/2021. She started to feel better on Sunday and Monday. Then on Tuesday, 02/23/2021 when she woke up she was unable to walk, she did not have feeling in her hands and was in extreme pain. She was taken to her PCP. She stayed with her daughter until 02/25/2021 when she finally started to feel better. Her Cardiologist was also called and informed.

Pt. was lightheaded at observation lane. paramedics assessed pt. once pt. was stable paramedics released her to leave.

Weak mussels, particularly legs. Fell down, even using a walker. X-ray of possible broken collarbone showed only a bruise. This was done at hospital emergency room. Also very tired and slept most of day. Was getting up for supper when fall occurred.

fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.

Pounding in head; Heart pounding; Elevated BP; bouncing off the walls, and going from side-to-side when she tried to walk; oxygen saturation level kept dropping; shaking; cold; Weakness; Tiredness; Throat tightness; Dry mouth; This is a spontaneous report initial from a contactable nurse and follow up from a Pfizer-sponsored program. This Nurse (patient) reported for self that the 83-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 17Feb2021 09:30AM on right arm at single dose for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Reported she was diagnosed with Rheumatoid Arthritis about 10 years ago, fibromyalgia from an unknown date and unknown if ongoing and stated when the doctor couldn't figure out what was causing her pain, the doctor said she had Fibromyalgia, carotid endarterectomy from 2014, pain in extremity from an unknown date and unknown if ongoing She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. Family Medical History Relevant to AE(s) was not provided. Concomitant medication included cortisone (CORTISONE) for Pain in leg from 10Feb2021 and stated her doctor gave her a Cortisone shot in her right knee to help with her right leg pain. Reported she received a Cortisone shot in her right knee on Wednesday, 10Feb2021. She said the doctor gave her the Cortisone shot in her right knee to see if it would help her right leg pain. She said she has a problem with Cortisone, clarifying the Cortisone keeps her awake. She said the doctor wanted her to have another Cortisone shot in 3 months, and she is not going to take the Cortisone shot because she doesn't like how the Cortisone makes her feel. The patient experienced pounding in head (hospitalization, medically significant), heart pounding (hospitalization, medically significant), elevated bp (hospitalization, medically significant), bouncing off the walls, and going from side-to-side when she tried to walk (hospitalization, medically significant), dry mouth (medically significant) all on 17Feb2021 with outcome of recovering, throat tightness (medically significant) on 18Feb2021 with outcome of recovering, weakness (medically significant) on 19Feb2021 with outcome of not recovered, tiredness (medically significant) on 19Feb2021 with outcome of not recovered, oxygen saturation level kept dropping on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of unknown , cold on an unspecified date with outcome of unknown. He experienced terrible pain in the leg after the 1st dose and took a marijuana cookie and she was rushed to the ER because she was shaking and cold. The patient was hospitalized for events pounding in head, heart pounding, elevated bp and bouncing off the walls, and going from side-to-side when she tried to walk from 17Feb2021 to 18Feb2021. The nurse states that "I told her up until a Month ago, she was taking care of a huge house and husband that is blind. I've been having the pain in my legs for over a month, doppler was done, and I had an injection in my knee with cortisone, I won't do that again, it keeps me awake at night. There is no diagnosis yet on the pain, have an orthopedic appointment coming up. Caller states, I got the first Pfizer vaccine shot on Wednesday at 9:30 am in right arm. Never so much have felt it. or have not felt anything else since. My friend talked me into eating a marijuana cookie about 5pm that day, and at 6 or 6:30pm, I started feeling terrible, my head was feeling terrible, my heart was pounding, I could hardly walk, my mouth was dry as a bone. we called paramedics, we found out on Friday before the shot that I have a right bundle block. Woke up 4:30 in the morning the Friday before with chest pain. EKG found right bundle block, my blood pressure was 245/105, that night in the ER, they got my blood pressure down and sent me home. Wednesday, I had the covid shot in right arm, at 9:30am, that day about 4:30 - 5:00 had the cookie thing, about 6pm, had to call the paramedics, they kept me in the hospital overnight. because my oxygen saturation kept dropping, down in the 86% or 89%, I don't know. Gave me breathing treatments, CT scan for blood clots in lungs was done, Doppler for blood clots in legs, and a HgbA1C. They did an echo of my chest. I don't know all of the results yet. Even yesterday, in the hospital I felt better, but feel week and tired, while walking the hall in the hospital my Blood pressure went up a little bit. I told the nurse, my head feels like this when my blood pressure is up. They sent me home last night. Today, I am feeling okay. My mouth is still a little dry, got a little better yesterday. My legs are still killing me, I have an appointment with my Cardiologist and Rheumatologist, I have Rheumatoid Arthritis. My question is , the doctor didn't know if it was from the cookie or from the vaccine. I am wondering if I should get the second vaccine." She stated she never had a sore arm after getting the COVID-19 Vaccine. She said she did something stupid after she received the COVID-19 Vaccine. She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. She said her friend talked her into having a cookie that had marijuana in it. She said her leg pain was so severe at the time, she took the cookie with marijuana in it around 4:30PM-5:30PM on 17Feb2021. She said at 7:00PM she was bouncing off the wall (clarified as unsteady, and going from side-to-side when she tried to walk), her head was pounding, her heart was pounding, she was dizzy and shaky. She said she went to the hospital emergency room. She said the hospital kept her overnight because her oxygen saturation level kept dropping. She said she got home from the hospital last night (18Feb2021), clarifying she was discharged from the hospital at 6:00PM. She said she noticed her mouth was very dry when she went to the hospital on 17Feb2021, and her mouth continued to stay very dry all night. Caller asked if she should get the second COVID-19 Vaccine shot after experiencing what she did after receiving the first COVID-19 Vaccine. Reported her leg pain became severe about a month ago, clarifying she has had leg pain for a long time. Reported her blood pressure was up while she was at the hospital, clarifying she had one blood pressure reading of 145/82 that she recalls. She said her blood pressure is pretty normal, and she takes blood pressure medications. She said she believes her heart rate was up too, but was unsure what her heart rate was. Reported a couple days before receiving her first Pfizer COVID-19 Vaccine, she went to her doctor on 12Feb2021 because she was having severe chest pain. She said her doctor did an EKG and told her she had a right bundle branch block. She said her doctor sent her to the hospital Emergency Room. She said while she was in the Emergency Room she had an extremely high blood pressure of 245/105. She said she came home from the Emergency Room on 12Feb2021, and had a couple spells, but was OK. She said she was OK when she went to get her first COVID-19 Vaccine shot on Wednesday, 17Feb2021. Reported she had difficulty reading her COVID-19 Vaccine Immunization Card. She said the Pfizer COVID-19 Vaccine Lot Number looked like EN6200, and there was no NDC Number, or Expiration Date listed on the card. Reported she had blood work done at the hospital. No further details provided. Treatment included she was given Albuterol breathing treatments while in the hospital, along with some other things that she can't remember. Reported she believes her symptoms were medically significant because she was nervous from recently being to the Emergency Room for her severe chest pain a few days before. Reported she did not think her symptoms were from the COVID-19 Vaccine. She said she thought the cookie with marijuana in it caused her symptoms because the symptoms happened about 1-1/2 to 2 hours after she had the cookie with marijuana in it. Reported she feels very weak and tired. Reported yesterday (18Feb2021) while she was in the hospital, her head felt like it was going to explode when the hospital staff tried walking her around. She said she asked the hospital staff to check her blood pressure because her head will feel like that when her blood pressure is up. She said when the hospital staff checked her blood pressure, her blood pressure was elevated. Reported the pain in her legs is driving her crazy, so she called for an appointment with an orthopedist today. Reported she is feeling better, but is still experiencing a tightness in her throat. She clarified she felt the throat tightness on Wednesday, 17Feb2021. She said she has no problem swallowing or eating, but her throat feels tight. Vaccination Facility Type was Hospital. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. AE(s) required a visit to: Emergency Room (admitted to hospital), no Physician Office. Prior Vaccinations (within 4 weeks) was none.; Sender's Comments: The 83-year-old female patient had medical history included rheumatoid arthritis, fibromyalgia and carotid endarterectomy, and was on multiple concomitant drugs. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events, cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

complained of feeling light headed 20 minutes after vaccination. BP- 210/86, p-67 Repeat BP- 10:16- 197/86, Monitored in Triage area, repeat BP 10:30- 220/86, p-67, and manual BP- 224/85. Evaluated by Dr and patient instructed to take Lisinopril 20 mg tab now, and to call her primary MD for appointment in morning.

Mild lightheadedness after injection, observed 15" + 15"more. Ok then, drove home. Usual sore arm x 2 days, mild nausea, malaise, a little dizziness/light headed off and on x day 2-4. Ok till day 6, woke up with itching and red injection site. Continued increasing itching and redness next two days-- this is day 8 following injection. Still red, itchy, tender area on skin around injection site -- size approximately 2 cm across and 4cm long. Itching feels deeper than skin level, soreness around shoulder joint. No noticeable swelling of lymph nodes. Looked online and appears same as "Covid vaccine arm" reports I read, occurring with both Moderna and Pfizer at times.

During the night of receiving the injection when getting up to use the bathroom, felt very dizzy and almost fell over. In the morning she felt better but very tired. Dizziness continued at nights mostly but some during the day. Also has had extreme fatigue days 6-8. Also on day 4 had elevation in blood pressure, will have it checked again later this week on day 12.

Progress Notes Expand AllCollapse All 3/12/2021 Patient: DOB: 4/18/1937 Date: 3/12/2021 MRN: Subjective Patient is a 83 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness, sensation of sob. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, increased swelling, rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis Date ? Adnexal mass ? Atrial flutter (HCC) ? AV nodal ablation on 6/19/14 6/20/2014 ? Biventricular pacemaker (Medtronic) implanted on 6/19/14 6/20/2014 ? Chronic venous insufficiency ? Glaucoma ? History of mitral valve replacement 10/10/2006 29 mm Mosaic Porcine Bioprosthesis ? Hypertension ? Hypothyroidism ? Long term (current) use of anticoagulants COUMADIN - HAD TOO MUCH LOVENOX 2011 & HAD BLEED ? Nonischemic cardiomyopathy (HCC) ? Osteoarthritis ? PAF (paroxysmal atrial fibrillation) (HCC) ? PVC's (premature ventricular contractions) ? Systolic congestive heart failure with reduced left ventricular function, NYHA class 2 (HCC) ? Varicose vein Hx of covid, hospitalized for 5 days in December 2020. ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath (sensation, briefly) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, dizziness and headaches + lightheaded: Previous Reactions: none Objective Vitals Vitals: 03/12/21 0925 03/12/21 0935 03/12/21 0943 BP: (!) 146/75 (!) 157/69 136/78 Pulse: 97 68 68 SpO2: 97% 99% 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No facial asymmetry. Sensory: Sensation is intact. Motor: Motor function is intact. Coordination: Coordination is intact. Gait: Gait normal. Comments: + 5/5 strength to upper and lower extremities. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Lightheaded. Resolved with snacks and water. Pt to monitor bp at home. Follow up with pcp. Pt wheeled out to her daughter's car by RN. Pt and pt's daughter voiced appreciation of care today.

Soreness in joints and pain in arm from shoulder to elbow. Soreness is going into upper portion of back and neck on right side. Very hard to lift arm.

Fever; Dizzy; didn't feel right; little chills; Blood pressure was kind of low; This is a spontaneous report from a contactable consumer (the patient). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 04Feb2021 around 14:30 or 14:45 (at the age of 83-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient previously received the first dose of the COVID-19 vaccine on an unspecified date, 3 weeks before, for COVID-19 immunization. On 05Feb2021, the patient experienced fever, dizzy, didn't feel right. On an unspecified date in Feb2021, the patient experienced little chills and blood pressure was kind of low. The clinical course was as follows: The patient got her second COVID shot last Thursday 04Feb2021. She felt fine. Then, on Friday evening (05Feb2021), she started feeling bad. She had a fever and was dizzy, little chills and her blood pressure was kind of low. She had been trying to drink not today (as reported). Today was Monday (08Feb2021), and she still had a low fever. She still didn't feel right. She hasn't felt right since Friday and was improving a little. Her fever wasn't that bad now, but at night it was a little over 100. The clinical outcome of fever, dizzy, didn't feel right was recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.

6 hr. after shot, felt unwell, went to bed, awoke after 12 hours with chills, fever, nausea, arm so sore I could not move it without excruciating pain. Began forcing fluids as symptoms persisted. Slept almost all of the following two days and nights. Now 3 days have passed, much better now but no appetite, still forcing water and juice. Worse than any flu I have ever had! This was my 2nd shot. After my first shot I had slight fatigue and a sore arm only.

Client had Nausea and dizziness for 3-4 days: then on the 3rd or 4th day client blacked out. Client informed by her Physician that she had a concussion. On 3-16-2021 on a follow-up call it was reported by her son that she is now fine.

she felt a little dizzy/slight dizziness/dizzy; had a problem walking; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 83-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech covid-19 vaccine, Formulation: Solution for injection, Lot Number: Unknown, NDC number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient's medical history included surgery on her hips and radiation on her head. Concomitant medications were not reported. It was reported that, "caller felt dizzy for about 30 minutes after the Covid vaccine she received on 28Jan2021. A few days later, she was still dizzy at her home. Also reported a history of a surgery on her hip which made her feel unbalanced". There was no PQC present. She would like to know whether she should get the second dose of the Covid vaccine; whether dizziness is a serious reaction; would she have any benefit after just one dose of the Covid vaccine; would like to know my recommendation on whether to proceed with the Covid vaccination series. Individuals who had received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series. The caller wanted to find out what she needs to do. She had her first dose of Pfizer vaccine on the 28Jan2021. After she had given first dose, she stayed for half an hour, but her daughter said she needed to stay longer but when she was about to walk away, she felt a little dizzy. When she got home, she never mentioned this slight dizziness to the Pharmacist who administered the vaccine. She did not know it was important. After a few days, she read the pamphlets and saw dizziness is not a good thing. Several days after the injection, from time to time she would feel dizzy that she needs to hold on to something so that she will not fall. She was 82 years old and she had surgery on her hips and radiation on her head. She would like to know that what she needed to do about her situation. States that on 28Jan2021 she received a vaccine the Pfizer Covid vaccine, the first one, after sitting at the pharmacy for about 30 minutes she went to her car and was dizzy as she was walking, has a walking cane that she walks with because she is not young and has problem with her hips, did drive herself home, did not know there is a problem with being dizzy after the vaccine, after a few days she because dizzy and had a problem walking in the house, had to hold on to things, decided to call to find out what is the next thing that she should do, when she finally read the flyer it said that if someone is dizzy this is a serious thing. Caller wants to know what she should do, caller was encouraged to reach out to her health care provider for medical advice. Caller already filed a report. Did not have a reference number. Asked if the information she already provided could be looked up. Woman was reading a disposition about Pfizer and got disconnected. Caller asked should she take the second vaccine. Caller stated she used to be 5 foot 5 inches, stated she was shrinking. Declined to provide email address. Declined to provide HCP information. There was no product complaint to report and medical information requested. Outcome of the event dizzy was not recovered (reported as persisting) whereas had a problem walking was unknown. Information about Batch/Lot number has been requested.

Pt c/o feeling dizzy 15 min after administration. Pt was wearing a double lined cloth mask and says she feels that the dizziness resulted from wearing the mask so long. Pt felt fine and amb out of tent to remove mask and "get some fresh air." Pt then amb to car with spouse.

Mom started complaining she was itching all over her body appx 2 days after 2nd injection. We saw red bumps and gave her topical benadryl, but irritation still persisted. We called her primary Dr and she recommended we give her oral benadryl. Yesterday we were out to lunch and the way home mom fainted in the car so we called an ambulance. They kept her over night for observation.

83yo F w/ PMH significant for HTN, chronic thrombocythemia, and glaucoma followed by Heme-Onc without treatment who presented to ED 03/15/21 via EMS complaining of generalized weakness. She had felt well and had been in her usual state of health, and was able to cook and enjoy a turkey dinner with 5 individuals on 03/07/21, but on 03/08/21 she began to develop progressive generalized weakness up to the point where she remained in bed for several days. She could not support herself when attempting to rise from bed. She noted poor PO intake with nausea, no vomiting. Loose stools for several days, no noted stool blood. Did endorse waves of lightheadedness and had fallen backwards three times in the prior week, reportedly due to poor balance when standing. She was unable to elaborate regarding the falls but admitted to hitting her head at least once, unable to say if she lost consciousness or if she felt presyncopal symptoms before falling. She had initially presented on 03/12/21 to ED for evaluation, workup negative, labs and imaging normal. CT brain found no acute process. She was sent home with arrangements for home PT. She returned to ED 03/15/21 when symptoms had not improved. In the ED she was found to be afebrile, significantly hypertensive, mildly tachycardic, + orthostatic vital signs. Labs significant for heme occult positive stool, proBNP 397, WBC 10.1, H/H 13.4/39.9, PLT 493, UA neg for infection. COVID neg. CXR found slightly increased interstitial markings. MRI brain found no acute intracranial abnormality. She was evaluated by PT and found to be unsafe to DC home as she could not ambulate without leaning backward and to the right and needed 1-2 assist. She was admitted to HM service for further management. She has remained consistently afebrile. She continues to experience significant gait instability, cognitive slowing, and difficulty with finger-to-nose testing with noted dysmetria, no focal weakness.

Within 15-minutes of vaccination, the patient reported lightheadedness, nausea, and dry mouth. EMS evaluated the patient on-site. The patient stated they were currently taking Augmentin for a UTI. Patient was hypertensive (162/82) with a FSBG of 84 mg/dl. EKG demonstrated NSR, rate 99bpm, no ST elevation. EMS administered 250mL IV saline en-route to Emergency Department. In the ED, the patient reported lightheadedness, nausea, dry mouth, left arm injection site pain, and feeling like her throat was closing. Patient remained slightly hypertensive (144/81). Physician administered 1L IV saline bolus and 10mg IV Decadron. The patient was discharged with diagnoses of Dizziness and Vaccination reaction.

Patient felt dizzy, VS taken, water given. Patient reported she didn't take her medication this morning. BP 149/83, HR 60, 100% room air.

This was my second shot. With the first I had sore arm for 2 days and joint point at left hip. A few days prior to second shot i developed irritation on 2 days of left foot. Following second shot, I had sore arm for a day and a half, joint pain at left hip that extended all the way down my leg which caused difficulty walking. That pain lasted for 2 full days. The toe irritation developed into painful blisters and extended to 3 toes on my left foot. I am currently using Hydro cortisone cream on them.

Vertigo symptoms occurred 4/6/2021 less than 24 hours after vaccine was given. They persisted for 3 days along with balance issues. on 4/9/2021 at 6:50 am stroke type symptoms occurred with slurred speech and paralysis on Let side arm and leg. Several stroke episodes, and blood pressure spiking occurred over a 3 hour period. Low grade fever presented on 4/11/2021. After much testing she was diagnosed with a series of TIA attacks found to be and averse effect from The COVID vaccine.

pt did not wait for 15 minutes in the observation area. She went to buy groceries and when in cashier line she felt faint. she sat down, paramedics were called. The paramedics said she was alright and she left on her own. On follow up she says she has dizzy spells sometimes due to an irregular heartbeat. She said she was all better by the evening.

This is a spontaneous report from a Contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), dose 1 via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. There was none medical history. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Her leg was swollen and there was edema and there was a lump on the side and it was pink or getting red and she was on medicine (Clarification Unknown) for 7 days, twice a day and the leg is still (incomplete sentence), the edema has gone down some. The leg was still pink and it is tender to touch and if she stand on her leg for too long or walking around too much it hurts. She got pain. She was also sleeping whereby she was watching television and all of sudden she was sound sleep and she wake up over an hour or two after that and then she awake for a while but she have no trouble sleeping at night again. She had chest pain and it's not angina because that she did have (Further clarification was unknown if consumer had angina in past hence not captured on tab) but it's a sharp pain and it does not want her taking Nitroglycerin because it went away and it last for maybe (incomplete sentence) it just like a stabbed wound. She was dizzy. That's still, it's not like what it was but it is getting less but she was still dizzy. She cannot walk a straight line. She lived in an apartment house and she had to walk down the hall to go down the stair but she sometime had to stop because she was dizzy. she kind of lean against the wall for few seconds and then she continued on. Concern was not the word for it. It made her very nervous and the circulation was very poor in both feet now and one leg, the right leg that has the pink and still the tenderness in that leg. The foot turns very dark pink and the big toe that she had turned dark purple. She wrote everything down and she will say this at the time after the injection she did not have any problem until about four days later but she did have problem with doing my cross- word puzzles and doing her puzzles. She could not do any of her puzzles, nothing was computing in her brain (Clarification unknown) but that's coming back slowly, so is that to be expected. Start date of event: Consumer stated "It was 4 days after the 5th, about 09Feb2021. She went there and saw a doctor an MD of course and she went there on 12th so it was a week later. She went because the pain was terrible. The outcome of events Leg is still pink and it is tender to touch; If I stand on my leg for too long or walking around too much it hurts, I got pain; Dizzy; is not recovered, all of sudden she was sound sleep; Cannot walk a straight line; Nervous; Circulation is very poor in both feet now; Foot turns very dark pink and the big toe that I have turned dark purple; Nothing was computing in my brain; pain was terrible was unknown, outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.

Patient had a vasovagal episode. She stayed sitting in chair, but her head was flexed forward and wasn't taking obvious breaths. After lifting her head, she took some deep breaths and opened her eyes. She had similar episodes with fainting. EMS was called.

lactic acid was high; dementia had suddenly progressed; spot where her lung was starting to collapse; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; stopped talking; Cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen); it burned when she peed; blood in her urine; wanted to sleep/getting worse with sleeping; was shutting down; she was dehydrated because her urine was dark; urine was dark; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; arm was sore; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration, administered in the left arm, on 24Feb2021, as single dose, for COVID-19 immunisation. Medical history included mild asthma, dementia (moments like putting things in the wrong place and being forgetful) and was confused. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) received at age 83 years, on 03Feb2021, for COVID-19 immunisation. On 24Feb2021, after the second vaccinations, the patient's arm was sore. On 06Mar2021, the patient began just feeling bad, was having like a terrible time, having a hard time, was really not feeling good; was more confused; lethargic; had trouble getting her up, was having to do everything for her, feed her, bathe her; couldn't walk and lost her appetite. On 09Mar2021, the patient was shutting down. On the same day at 18:30, the patient had gone in the bathroom and said it burned when she peed. So, the patient was taken to urgent care so it would not get out of hand. At the urgent care, they said she has a UTI, there was blood in her urine so they gave her Cipro but they cultured her urine and it grew no bacteria but there was still blood in her urine and she was getting worse with sleeping and she didn't even get up to eat. The patient was also dehydrated and her urine was dark. The events dehydrated, urine was dark, it burned when she peed, blood in her urine required emergency visit on 16Mar2021. The reporter thought the patient was going to die. On 16Mar2021, in the ER, they did blood work (unknown result), chest xray which showed she had a spot where her lung was starting to collapse (they said it was a tiny place, from not getting up and moving around, they said it would correct itself) and the patient's potassium, Vitamin D and Vitamin B12 were low. They did a CT scan of the head and chest to look for stroke or seizure and there was nothing. They blamed it on her dementia that had suddenly progressed. The patient was hospitalized from 16Mar2021 to 18Mar2021. On 12Mar2021, the patient experienced cellulitis in her arm. The reporter clarified that the cellulitis was further down her arm, around her wrist hand area. Her wrist was huge, hot, red, and her hand was swollen. On 24Mar2021, the patient followed up with the family doctor because the hospital wanted her to follow up with a GYN because they didn't feel it was urinary at all. When the reporter took the patient in to see the doctor, she couldn't walk in, she had to roll her in a wheelchair, she had stopped talking again. On 26Mar2021, the doctor sent the patient to the emergency room (unspecified reason) and they kept her. They said her said lactic acid was high. She was admitted on 26Mar2021 and discharged on 29Mar2021. On 29Mar2021, the patient's potassium was 3.3 and her lactic acid level was back to 2. The patient was recovering from lactic acid was high; potassium, Vitamin D and Vitamin B12 were low; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; was shutting down; stopped talking. The patient recovered from cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen) in Mar2021; and arm was sore on 29Mar2021. The outcome of events spot where her lung was starting to collapse, dementia had suddenly progressed; she was dehydrated because her urine was dark; it burned when she peed; blood in her urine; and wanted to sleep/getting worse with sleeping was unknown.

7 day post shot 2: sore feet - could not stand up 9 days post shot 2: vomiting, lethargy, severe chest pains, lymphopenia, low magnesium, low glucose, mildly elevated troponin

She had buzzing in her ear or tinnitus; lost her balance; The dizziness started on the morning of 14Feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient; This is a spontaneous report from a contactable consumer. This consumer reported for an 83-ear-old female patient that received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's thyroiditis and She says she has had this since the 1970's, she was diagnosed in the 1970's but she had it long before that, they finally figured out what it was, ongoing tremor and she says she has had this for about 10 years, her brother has it, her sister has it, her mom has it, it is called familiar tremors. Concomitant medication(s) included ongoing levothyroxine sodium (LEVOTHYROXINE SODIUM) at 125 mcg once a day for Hashimoto's thyroiditis She says this is Synthroid, she has been taking it for years, She was diagnosed with Hashimoto's thyroiditis in 1970, but she's had it all her life; ongoing metoprolol tartrate (METOPROLOL TARTRATE) at 25 mg, once a day for tremor and She says its a heart medication but she takes for tremors, she has been taking it for a long time; ongoing nitroglycerin (NITROGLYCERIN) precautionary because she was having chest pain from 22Nov2019 and she says she has never had to use it, ongoing cobamamide (VITAMIN B12 [COBAMAMIDE]) and she says she has been taking this for a long time, it has green tea, coQ10, B vitamins in it for energy and ongoing Vitamin D3 and she says she has been taking this for a long time for energy. The patient previously took first dose of bnt162b2 for covid-19 immunisation. The patient experienced the dizziness started on the morning of 14feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient on 14Feb2021 with outcome of not recovered , lost her balance on 15Feb2021 with outcome of unknown, she had buzzing in her ear or tinnitus on an unspecified date with outcome of unknown. The clinical course was reported as follows: Dizziness - is this normal and how long will it last? Upon further discussion, patient stated that she got her second dose of the Pfizer Covid 19 vaccine on 13Feb2021. The dizziness started on the morning of 14Feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient. The other day, she lost her balance when going down the steps and almost fell. Her doctor suggested the Epley maneuver which she has been using for the past 2 weeks and it is not helping at all. She had buzzing in her ear or tinnitus (onset not reported). Her doctor has referred her to an ENT specialist for further evaluation. Discussed per Pfizer-BioNTech COVID-19 Vaccine EUA PI (LAB-1457-7.0, Revised: 06 April 2021) Adverse Reactions section (nothing found on dizziness, vertigo, tinnitus) and per attached CONS documents and VR re: 'dizziness and weakness' as part of possible allergic reaction, noting no specific information on duration as it may vary by individual. Referred to HCP for further discussion/guidance, based on medical history. Investigation Assessment: No Additional Context: The caller is calling about the COVID vaccine, Pfizer. She says she had her last vaccine on 13FEB2021 and got dizzy and it's not going away. She says she has seen her doctor, he suggested using the Epley maneuver but it its not helping any. She said that she is ondering if the Pfizer Vaccine is causing the dizziness? She is wondering if this is something she should be worried about it. Contact Details: She says she was a medical transcriptionist for many many years and a medical secretary. She does not have an email address. HCP: Caller does not have a full address or email to provide. Products: She reads EN6201, Pfizer EN6201. She says her first dose was on 23JAN2021 and reads EL8982 for that one. No expiry date for the first dose. History: She says it is hard for her to get around, she is so dizzy. She says she has nitroglycerin because she had chest pain back in 2019. She says her doctor is sending her to an ear specialist. VACCINE SUPPLEMENTAL FORM Pfizer Suspect Vaccine and Vaccination Details Time the Vaccination Was Given: 10:15 in the morning Anatomical Location of Administration of Pfizer vaccine considered as suspect: left arm Vaccination Facility Type hospital. No Vaccine Administered at Military Facility. No additional Vaccines Administered on Same Date of the Pfizer Suspect. AE(s) require a visit to no Emergency Room but Physician Office. Saw her primary doctor, she called and told him about it, her appointment was for this past Friday but he had her come in that day. She does not remember which day. She says she put up with the dizziness, it got worse. Prior Vaccinations (within 4 weeks): No. She says she needs to get a lot of vaccines, she is behind in a lot of this, she just hasn't done it yet. AE(s) following prior vaccinations: No She says she has had reaction to 3 medications. Sulfa, she says the reaction was low blood pressure. Celebrex, she says the reaction was severe chest pain, she thought she was having a heart attack, she went to the ER they thought she was having a heart attack. Codeine, she says the reaction was an extremely low blood pressure, all her vitals dropped really low, dangerously low. She says there was another one she can't remember, her reaction was she broke out in real bright red hives. Family Medical History Relevant to AE(s) She says her mother had cancer and died of cancer and her husband died of cancer. She is wondering if this is something she should be worried about it, if this is a normal side effect and is it going to last much longer because it is terrible. No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.

dizzy/dizziness; hot flashes; This is spontaneous report from a contactable other healthcare professional (the patient). An 83-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 22Mar2021 (Lot Number: ER6955), dose 2 on 14Apr2021 (Lot Number: ER8735) (Time the Vaccination Was Given as "1000", it did not specify if it refers to the first/second dose), both via an unspecified route of administration in the right upper arm at age of 83-year-old at single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Medical history included vertigo that happened 6-7 years ago and she was hospitalized for this. No family medical history relevant to AE. The patient's concomitant medications were not reported. The patient experienced the dizziness and hot flashes after the first dose of the vaccine (2021), the caller did not know dates of the dizziness and hot flashes she experienced after the first dose of the vaccine. The symptoms then weren't as bad as the ones she was having currently after the second dose of the vaccine. The caller stated that she had been dizzy, it was almost like vertigo that she had once before, she had been dizzy since Friday 16Apr2021 and was very dizzy on Saturday 17Apr2021 (after the second dose). She had also been having hot flashes. She has Meclizine and had taken those a couple of times. The patient had the same symptoms after the first dose of her vaccine but they were not as severe. Caller stated she did not know if her symptoms were caused by the vaccine. She thought they might be since they started after the vaccine but is not certain. No Emergency Room or Physician Office visit. The outcome of the events was recovering. The events were not serious. No follow-up attempts are needed. No further information is expected.

ED to Hosp-Admission Discharged 3/6/2021 - 3/7/2021 (29 hours) Hospital Last attending ? Treatment team COVID-19 virus infection Principal problem Hospital Course HPI: Patient is an 83 y.o. female in the emergency room with a headache that is been persistent for about a week. She is also having some increasing fatigue and weakness. Evaluation emergency room revealed she is positive for COVID-19. Chest x-ray showed no evidence of pneumonia. The patient did have her first COVID-19 vaccine approximately 3 weeks ago. She was due for her second dose of the vaccine this coming Monday. She denies any severe fevers at home. No shortness of breath, no chest pain. She was brought in for observation and started on dexamethasone. Hospital Course: Remained under observation and did not require any supplemental oxygen. He tolerated her diet and did not feel weak or fatigued. She denied any chest discomfort. I recommended that she postpone getting her second Covid vaccine until she is entirely cleared of her Covid infection. Should follow-up with her primary care office to assess breathing and when she is cleared for her second vaccination. Patient also have her family physician or gynecologist reevaluate her pessary which may have been dislodged slightly when she fell in recent weeks. She had noticed some blood tinge urine but generally no dysuria or major hematuria since that time. She left in satisfactory condition on the evening of 3/7/2021 with these instructions. She may use acetaminophen for the headaches which have disappeared over the course of this day.

Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp of 99.3; sweats then a temp of 99.3; I had to crawl in order to move from place to place; This is a spontaneous reporter from a contactable consumer (patient). This 83-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in right arm via unknown route of administration on 17Feb2021 at 10:30 am as single dose for COVID-19 immunization. The patient was pregnant at the time of vaccination. Medical history of patient was reported as osteoarthritis, rheumatoid arthritis, penicillin allergy, allergies from components of Epinephrine Solution and AVALOX. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin B1 nos, vitamin B12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER), ascorbic acid, retinol, tocopherol (OCCUVITE), cholecalciferol (D3) and aspirin. No covid prior vaccination. No covid tested post vaccination. No vaccine in four weeks. On 18Feb2021 at 07:30 AM, 20 hours after the injection the patient experienced severely dizzy and weak unable to stand. She had to crawl in order to move from place to place. This lasted about 15-20 minutes. She vomited and developed severe chills and sweats then a temperature of 99.3. No treatment was given. The outcome of events was recovered in 2021. No follow-up attempts are possible. No further information is expected.

I woke up dizzy; I still don't feel good; probably little weak; This is a spontaneous report was received from a contactable consumer or other non hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 19Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient was taking unspecified concomitant medications. She was fine for the first few days on the 5th day, i.e., on 24Jan2021, she woke up dizzy and she still do not feel very good and still do not feel good. Well patient just don't feel good, nothing can pinpoint it and probably little weak, she did not know and have not been doing much, she don't feel good. Patient do take medications, going to have to go get the list and took Tylenol couple of times as treatment. Patient reported that they scheduled the second one and it is 4 weeks rather than the 3 weeks. The patient was not recovered from "I still don't feel good" and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.

Chills; Tired; Light headed; General not feeling well; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 23Jan2021 at 09:50 (Batch/Lot Number: EL9263) as 1st dose, single for covid-19 immunization. Patient's medical history included, light-headed, hormone therapy, goiter, blood pressure and water pill (water retention), all were ongoing. It was mentioned that she was lightheaded before the vaccination and light-headedness was still ongoing. Patient's family history was reported as none. The vaccine was not administered in military facility. Concomitant medication(s) included amlodipine (AMLODIPINE) (ongoing since several years) at 5mg (one and one-half) daily orally for blood pressure, lisinopril (LISINOPRIL) (ongoing since several years) at 20mg take once daily orally for blood pressure, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) (ongoing since 8 months or a year) at 25mg (one and one-half) daily orally as water pill, levothyroxine (LEVOTHYROXINE) (ongoing since few years) at 25mcg (one-half) once daily orally for goitre, estrogens conjugated (PREMARIN) (ongoing since long time) at 0.03 mg five times a week orally for hormone therapy and also Vitamins since an unspecified date. The patient previously took clindamycin and experienced allergic reaction to an antibiotic. It was some years ago that a doctor gave her clindamycin and she had a reaction. Had no product or information to provide NDC, lot or expiration date for the clindamycin she took. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021, the patient experienced Light headed and not feeling well and on 25Jan2021, the patient experienced chills and tired. It was reported that patient had a vaccine shot on 23Jan2021 and she had chills and a general not feeling well and she was tired. The patient noticed about 24 hours later, she felt the chills really bad on 25Jan2021 monday morning. She had chills all day monday (25Jan2021) and Tuesday(26Jan2021). She also started to feel tired on Monday also mentioned she told the pharmacist and he suggested she got up too quickly. She was scheduled to take the second dose of the vaccine 13Feb2021.The outcome of the event chills was recovered on 28Jan2021 and outcome for the event tired was recovering, outcome for all other events was unknown. Follow-up attempts are completed. No further information is expected.

patient developed muscle and joint stiffness 5 days after vaccine administration that persisted, she was diagnosed with PMR on 3/24/21 when her symptoms were not resolving

gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees); sleeplessness; anxiety; inability to sit still; dehydration; loss of appetite; frequent urination; sensitivity to noise; This is a spontaneous report from a contactable consumer. A 83-years-old non pregnant female pa-tient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN9263, Expiration date: Unknown), dose 1 via an unspecified route of administration, in right arm on 05Feb2021 at 14:30 (at the age of 83-years-old) as single dose for COVID-19 immun-isation and the patient received second dose of BNT162B2 (Solution for injection, Lot Number: EL6203, Expiration date: Unknown), via an unspecified route of administration, in right arm on 25Feb2021 at 11:15 AM (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient medical history included arthritis and spinal stenosis. The Patient received concomitant medications in two weeks which included phytosterols nos and chondroitin sulfate sodium, glucosa-mine hydrochloride, multi-vitamins. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had no known allergies. The patient had experienced gas, balance problems, dizziness, sensitivity to being enclosed inside warm rooms (above 66 degrees), sleeplessness, anxiety, inability to sit still, dehydration, loss of appetite, frequent urination and sensitivity to noise on 06Feb2021 at 19:00. There has not been any pain at the injection site or anywhere else on her body. No treatment received for events. The patient went to physician or other healthcare professional of-fice/clinic visit, Emergency room/department or urgent care due to events. The patient underwent lab tests and procedures which included nasal swab test on 05Feb2021 and 25Feb2021 result was nega-tive. The outcome of all events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Received 2nd shot 4/16/21 SARS-COV-2 (COVID-19/PFIZER) mRNA BNT162B2 (PF) IM (LNP-S) EUA, beginning of May patient started to become OCD with her purse and wallet, on 5/12 she put ravioli that was to be boiled into the microwave and started a fire. After she did so, she realized it was wrong and said "how stupid" "why did I do that". I proceeded to make dinner for her and her meals for the next day, I advised her that I was going to take her to the hospital on Friday 5/14 for a Mental Health check as she began to decline. She returned home from but had her stay with me didn't trust her to stay alone. I followed up with her CP, Neurologist and Cardiologist, during her visits she struggled with words but was aware something was wrong as she stated "i just want the old me back". From 5/15 thru 6/1 her mental health only worsened, she had no cognitive functions (phone, tv, computer) unable to eat on her own and shower. We placed her in a Memory Care Facility on 6/2, she fell the next day and was hospitalized with a broken hip, she is now in rehab. The current reports are she is not eating well, put on a puree diet since she is having swallowing issues, cannot talk and attention span is minimal, The PET Scan determined Alzheimer's with Picks Disease. She showed absolutely no signs of decline prior to the 2nd vaccine.

lightheadedness; shortness of breath (sensation of sob); This is a Spontaneous report from a non-contactable other Healthcare Professional reporting for a patient. An 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on an unspecified date (At the age of 83-years-old ) as First dose, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 15 minutes after vaccination, the patient experienced lightheadedness and shortness of breath (sensation of sob). She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling Patient had differential diagnosis of Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). Water and snacks treatment received. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; This is a spontaneous report from contactable consumer 83-year-old female (patient) reported for herself. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in arm left on an unspecified date as 2nd dose, single for COVID-19 immunization (at the age of 83-year-old). Medical history included ongoing gout, ongoing High blood pressure and ongoing pain. Concomitant medications included allopurinol taken for gout, aspirin (ACETYLSALICYLIC ACID), losartan taken for high blood pressure, felodipine for high blood pressure, diclofenac sodium taken for pain. The patient administered BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), first dose via an unspecified route of administration, administered in arm left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On an unspecified date, the patient experienced Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine. The patient stated she wanted to go to the Urgent Care, but it was crowded. She feels stressed out, because she was waiting for her daughter to take her to the hospital. She cannot figure out why she hurts so bad. The patient stated she was a lady who can get around and take care of herself and stated several examples of how she was independent, and she exercises. The patient stated her daughter was going to take her to the hospital, because she feels there was something serious going on that day. Outcome of the events were reported as unknown. Information about lot/batch number is requested.

Numbness, starting at feet going upward to entire leg. Weakness in muscle affected by polio (legs). Unexplained physical and mental fatique, wants to sleep all the time. Trouble walking up and down stairs or around curves. Chronic joint and muscle pain. Restless legs. Trouble with swallowing. Cold intolorance. Sleep disorders. Low endurance. Memory and concentration problems.

I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago. I was paralyzed from the waist down, hospitalized, and had a very slow recovery. This paralysis caused clawed toes that were straightened surgically and affected my balance and walking (I use two hiking poles as aids for walking and balance.) Little was known at that time. I received the first Pfizer Covid shot on April 18, 2021. Two days after I had the Covid shot, the nerves in my left leg, below the knee, were sore when pressed and the affected muscles felt numb. This has persisted and at times different nerves in my lower leg are affected. Currently the muscles going down the back of my lower leg and around the ankle are affected. Three nights after the Covid shot, I had severe left kidney pains, became violently sick and the following morning went to my health facility emergency care department. I had no previous kidney problems or signs of a UTI. I had a CT scan of the kidney and was treated for a kidney infection and UTI with antibiotics. I have been to a kidney specialist and urologist with tests continuing. My breathing was erratic for a few days and I felt nauseous for 2 weeks. I have not had the second covid shot.

9 pm chills 4am found myself about to hit the floor was not aware of fall until I was about a foot from hitting floor Tried to get back in bed but felt like I had no knees or lower legs laid on floor for unknown time Unsure How I got back in bed but I was and need to throw up. With no use of legs throw up on floor 9 am tried to go to toilet but again fell as still had no use of legs. So did so on the floor.. removed wet pants Slept from 9:30 am until 5 pm. Friend came over and helped me get up. Had 70% of leg use back. Ate a cracker and drank water and went back to bed at 7 pm and slept til 9 am Now it is 2 days after shot and finally have leg control but sweaty All this time for the 3 days had body aches and head ach. Took 5 days before I was back to normal

Pain in chest; Lightheadedness; Chills; Fever; Splitting headache; Fatigue; Nauseated; Eyes were watering; Pain in lymph nodes in neck when touched; Loss of appetite; Felt like heart was going to go through her head; Heart was racing; Felt like her throat was closing up a little bit; This is a spontaneous report from a contactable consumer (Patient). A 83-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 (age at vaccination: 83-yesr-old) as single dose for covid-19 immunization. (Vaccination facility: Clinic). Medical history included bursitis, arthritis, High blood pressure, High cholesterol all from an unknown date and unknown if ongoing, body aches many years at least from 10 years ago. Concomitant medication included ubidecarenone (COQ-10) taken for myalgia (started shortly after she started taking the cholesterol medication and she found out she was having body aches many years at least 10 years ago), acetylsalicylic acid (ASPIRIN CHILDREN) taken for cardiac disorder (started since long time ago probably 15 years or better), LISINOPRIL taken for blood pressure measurement (stated since many years), SIMVASTATIN taken for blood cholesterol increased (from same time as the lisinopril, at least 10 many years). Vaccine not Administered at Facility. It was reported that patient stated she and her husband received their second dose of the Covid shot clarified to be the Pfizer Covid 19 vaccine. She stated that she got almost every symptom on the list. Later that both she and her husband experienced fatigue. reported that she broke her hip a few years ago and that her husband told her that she did better after breaking hip than after receiving the Covid 19 vaccine. She reported that she does not usually experience any side effects after vaccinations stating that she normally sails right through the flu shot. She stated she just retired from a full time job in the first part of February, and if she had still been working she wouldnt have been able to go to work. Patient reported that within 12 hours of receiving the Covid-19 vaccine she was woke up in middle of night around 2 AM with her heart was racing she felt like she was going to have a heart attack, and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. She stated it could have been her heart or her blood pressure that she felt like she was speeding. She also reported that she was running a fever had chills pain and a splitting headache. She stated that within 48 hours the worst had passed. headache improved after the first night but that for a few days after she would get a shot up the back of her neck into her head. She reported that it was quickly resolve on its own. fatigue was worse after the second dose and they are both still experiencing fatigue. She was stated that she feels that the fatigue has improved but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. She is still having some lightheadedness if she stands up too quickly, she has to take a moment to balance herself before she proceeds, this was began after receiving the Covid 19 vaccine. She stated she was Felt like her throat was closing up a little bit, she did not feel that it was emergent or life threatening that she thought it was related to her swollen lymph nodes. she noticed pain around her breasts when she put her bra on mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. She was unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05 Mar 2021. She reported that the pain gradually diminished. She stated that it didnt bother her, she was noticed it when getting dressed. She stated she was just slightly nauseated but that she didnt throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later around 06Mar2021 or 07Mar2021. Reported that the watering eyes have cleared up. She stated that it resolved quickly maybe a day or two after they began on 04 or 05Mar2021. She also reported had Pain in lymph nodes of neck she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry but her stomach just didnt feel like it had the room for food. She reported that the loss of appetite resolved a few days later around 06 or 07Mar2021. Received treatment with Tylenol she stated during the 48 hours after symptoms began she stayed in bed and slept. She reported that she was get up to get a drink or take Tylenol just a couple a day and was drank water. She reported that she drank lots of fluids. She stated that she was get up would take something and then go right back to sleep. Tylenol helped a little bit Tylenol doesn't do a whole lot but it's better than nothing. Adverse event not resulted in Physician Office visit or ER visit. The outcome for the event Fatigue and Lightheadedness was resolving, for events Loss of appetite, Eyes were watering, Nauseated outcome was resolved on Mar2021, for events Felt like heart was going to go through her head, Heart was racing outcome was reported as resolved on 03Mar2021 and for events Fever, Chills, Splitting headache, Felt like her throat was closing up a little bit outcome was resolved on 05Mar2021, and for remaining events outcome was resolved on unspecified date. Follow-up attempts are completed. No further information expected.

bilateral lower extremity weakness following 2nd dose leading to a fall. Hospitalized same day and found to have right bundle branch block on EKG.

Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her second vaccine; because has vertigo besides this; she can't swallow; Wheezing; got very sick; pains all over; headache; neck pain; arm pain; bone pain; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: GWO196), via an unspecified route of administration in Arm Left on 24Jun2021 at 04:00 (83-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included bl high cholesterol; reported that her body makes cholesterol, it is not what she eats. It is 350 sometimes, 300 is high. Asthma, swollen, blood pressure, allergy with some soaps, adhesives they have to put one with cloth that does not have the same qualities as adhesive or otherwise she gets a rash, history of stents for heart attack, couple of arteries clogged but not showing any signs of causing problems, cancer. The patient had allergy with some medicines like clindamycin, Percocet, Percodan, penicillins. Concomitant medications included amlodipine (AMLODIPINE, dose: 5 mg, 1x/day) taken for blood pressure; atorvastatin (ATORVASTATIN, dose: 40 mg (she has been taking for years)) taken for blood cholesterol; furosemide (LASIX [FUROSEMIDE, dose: 20 mg (for three years. Not every day)]) taken for when her legs get swollen; salbutamol sulfate (VENTOLIN ACCUHALER) taken for asthma. It was reported that amlodipine was taken 3 or 5 years she has been on, but does not remember off hand, atorvastatin was taken maybe 8 years, it runs in her family everybody has it. She has been taking all her medications 50 years but not her cholesterol medication, for Lasix she is running like a chicken with her head cut off because everything that has happened to her. She takes 20, her daughter takes 40 mg not every day, for Ventolin when foggy outside she gets wheezy and when she is outside walking, she does one spray once and that is it. Years ago, she had bad asthma but not in the last 5 years except with weather. The patient previously took flu vaccine vii every year and experienced her arm hurt a little bit, coughing, chest hurt, did not have breathing thing, she got the flu, fainted. Reported that she was getting the flu vaccine every year, she takes it, and was okay the first time but her arm hurt a little bit and it never hurt. Two years ago, she took it and 2 weeks later felt sick like coughing and her chest hurt and she did not have breathing thing. Coughing and chest hurting led to her going to the emergency because she also fainted, so she called # and they took her to the hospital. She did tests and it was not her heart. They tested her for the flu and she said oh I already got my flu shot and they said well good thing you did. Caller confirms she got the flu after getting the flu shot. Reported that after experiencing labored breathing, chest pain, she called a cardiologist and went to the doctors and was admitted to the hospital for cardiac testing, and complains of labored breathing and fatigue. She wants this documented and has a history of stents in the past but hospital workup was negative. She had a heart attack 3 years ago and has stents in her heart. What happened when she called, she had cancer 5 years ago, when she called the oncologist and told him he said call cardiologist and she told her that she had the vaccine. She was taken by ambulance to the hospital and they did a bunch of tests and electrocardiogram and xrays and put her on monitor. After a few hours, they sent her to the cardiac floor where they gave her an injection, more blood tests, more of everything. The next day, nuclear testing of the heard and all of that stuff and sent her home and said it was not her heart and it was fine. She still had a couple of arteries clogged but not showing any signs of causing problems so they do not have to put a stent in. Caller confirms this was prior to receiving the vaccine because she has arteries clogged but only one with a stent and she still does not need a stent. No history of previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccinations within 4 weeks. Reported that after vaccination they left her there for the 15 minutes and she had no reaction and came home and said my God, I should have done this a long time ago, because her arm was perfect and did not hurt and she had no symptoms till 2 o'clock in the morning. Reported that she is not planning to get her second vaccine. The second one she hears has worse and more side effects. She does not know what is going to happen if she only has one. She is supposed to have one 15Jul2021 in a couple days and right now she cannot take it if she is feeling this way because it is impossible and how should she do it if she is sick. Reported that Dr was afraid she was having a heart attack because she felt think someone was squeezing her chest and her breathing wasn't normal, so the hospital did all kinds of cardiac evaluation and they admitted her to the cardiac floor and continued to have all kinds of cardiac testing done, turns out her heart was okay, even though she has a stent in her heart and has 2 arteries that are clogged but they do not need to be fixed because there are not clogged to the point where it would cause her any problems, All the test showed that she did not have a heart attack. She has a lot of fatigue, if she walks from the bedroom to the kitchen, she really tires and feels like her breathing is labored, it's awful, and pains in the neck, even though before used to have a little pain in the neck, because has vertigo besides this but now has to be putting Ice packs constantly on the neck, waits and hour and then again and takes Motrin for the pain. Also the muscles, the doctor says the muscle in the chest, not in her heart and when she touches it hurts. Also having episodes where she can't swallow like she used to and had Asthma but kinda went away and now has started the past 2 days having Asthma, always has a pump with her because when it is foggy out she gets a little wheezing since yesterday, when she wakes up in the morning she hears the wheezing so will take a puff from the inhaler, so she would like this to be registered because she is 84 year old lady and has some issues that she never had other than when she had a heart attack, to which she had to change her medication. On 26Jun2021, the patient experienced labored breathing, chest pressure, fatigue, chest felt very tight, on an unspecified date, the patient experienced she is not planning to get her second vaccine, because has vertigo besides this, on 07Jul2021, the patient experienced wheezing, on 24Jun2021, the patient experienced got very sick, pains all over, headache, neck pain, arm pain, bone pain. It was reported that some term highlighted by the reporter as Labored breathing, chest pressure, fatigue. It was reported that it was not chest pain but it was pressure like somebody was squeezing her heart or had a rock on it and it weighed 100 pounds. It has gotten worse now that she is having wheezing in the morning. She had to use an inhaler for asthma yesterday. It has not gotten worse but it is the same. AE(s) require a visit to emergency Room and physician Office and hospitalized for one day. The patient was hospitalized for labored breathing, chest pressure and fatigue and chest felt very tight from 30Jun2021 to 01Jul2021. The patient underwent lab tests and procedures which included blood test resulted as unknown results, height resulted as 149.86 cm which she think shrunk and got fat, she used to be 4'11", electrocardiogram resulted as unknown results, nuclear testing of the heard resulted as it was fine, weight resulted as 100 lbs on 26Jun2021 which rock on it and it weighed 100 pounds, x-ray resulted as unknown results. Reported that all tests were negative but they put her in for her heart and no other reason to keep her because she did not need any kind of procedure done. Once they found it, she went home. Patient received treatment for events (labored breathing, chest pressure, fatigue, chest felt very tight, wheezing, pains all over, neck pain. The outcome of events Labored breathing, chest pressure, fatigue, chest felt very tight, Wheezing was not recovered, the outcome of events she is not planning to get her second vaccine, got very sick, pains all over, headache, neck pain, arm pain, bone pain, because has vertigo besides this and she can't swallow was unknown.

Pain in chest; Bursitis; High blood pressure; High cholesterol; stomach felt a little queasy or upset; Lightheadedness; Loss of appetite; Felt like her throat was closing up a little bit; Eyes were watering; Pain in lymph nodes in neck when touched; NAUSEATED; Fatigue; Felt like heart was going to go through her head; Heart was racing; fever; Chills; Splitting headache; This is a spontaneous report from a contactable consumer or other non-health care professional. An 83-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EM98089, Expiration date: Unknown), dose 2 via an unspecified route of administration in Arm Left on 02Mar2021 at 13:00 as dose 2, single for covid-19 immunisation. The patient medical history included bursitis, arthritis Verbatim: Arthritis, hypertension, ongoing blood cholesterol increased. The patient also received first dose on bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 09Feb2021 as dose 1, singe for covid-19 immunisation. The patient concomitant medications included ubidecarenone (coq-10) taken for myalgia, start and stop date were not reported; acetylsalicylic acid (aspirin children) taken for an unspecified indication, start and stop date were not reported; lisinopril (lisinopril) taken for blood pressure measurement, start and stop date were not reported; simvastatin (simvastatin) taken for blood cholesterol increased, The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Caller reported that within 12 hours of receiving the Covid-19 vaccine, she woke up in middle of night around 2 AM with her heart racing, she felt like she was going to have a heart attack and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. Caller reported that it could have been her heart or her blood pressure, that she felt like she was speeding. Caller reported that she was running a fever, had chills, pain, and a splitting headache. She stated that within 48 hours the worst had passed. Caller stated that the headache improved after the first night, but that for a few days after she would get a shot up the back of her neck into her head. She reported that it would quickly resolve on its own and also that both she and her husband experienced fatigue after receiving the first dose of the Covid-19 vaccine, but that the fatigue was worse after the second dose and they are both still experiencing fatigue. Caller stated that she feels that the fatigue has improved, but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. she was still having some light-headedness if she stands up too quickly. She reported that she has to take a moment to balance herself before she proceeds. She stated that this began after receiving the Covid-19 vaccine. Felt like her throat was closing up a little bit: Caller reported that she did not feel that it was emergent or life threatening, that she thought it was related to her swollen lymph nodes. Caller reported that she noticed pain around her breasts when she put her bra on, mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. Caller stated she is unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05Mar2021. She reported that the pain gradually diminished. She stated that it didn't bother her, that she just happened to notice it when getting dressed. she was just slightly nauseated but that she didn't throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later, around 06Mar2021 or 07Mar2021, went along with throat feeling like it was closing up. Caller reported that the watering eyes have cleared up. She stated that it resolved quickly, maybe a day or two after they began on 04 or 05Mar2021. she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Caller reported that the loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry, but her stomach just didn't feel like it had the room for food. She reported that the loss of appetite resolved a few days later, around 06 or 07Mar2021. Caller reported that during the 48 hours after symptoms began, she stayed in bed and slept. She reported that she would get up to get a drink or take Tylenol, just a couple a day, and would drink water. She reported that she drank lots of fluids. She stated that she would get up, would take something, and then go right back to sleep. Tylenol helped a little bit, Tylenol did not do a whole lot, but it's better than nothing. Tylenol: UPC/lot/expiry not provided. Caller stated that she was not supposed to take ibuprofen, saying the reason was something to do with blood pressure or something. She reported that if the AEs she experienced had gotten severe, she would have called her doctor and had them check it out or at least asked advice. She stated that because symptoms began resolving after 48 hours, she thought it was ok. She reported that she is going to the doctor in May for a routine check-up, and they will inform her if anything has changed. The outcome of events was fatigue was resolving and outcome of other events Felt like heart was going to go through her head, fever, Chills, Splitting headache, Felt like her throat was closing up a little bit was resolved on 05Mar2021, Heart was racing on 03-MAR-2021. Outcome of events Loss of appetite, Lightheadedness, Eyes were watering, Pain in lymph nodes in neck when touched, High cholesterol, stomach felt a little queasy or upset on an unspecified date. Outcome of Bursitis, High blood pressure was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Patient felt faint/lightheaded. Blood pressure decreased to 96/60. It quickly rebounded and she returned to baseline within 15 minutes.

Client verbalized feeling lightheaded. Client was evaluated by Fire Rescue and released to go home at 12:47 pm accompanied by spouse.

Dizziness - hx of high blood pressure. States she gets white coat syntrome. Checked blood pressure 190/90; P 82. Had a snack and juice and observed. Discharged at 9:47 B/P 188/80 P 74. Dizziness resolved.

About 5 hrs after had terrible stomach gas pains for several hours. Had terrible chills and became very woozy. Still chilled and woozy at 12 hrs after shot

dizziness (intermittent); This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 16:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 08Jan2021 at 07:00, the patient experienced dizziness (reported as intermittent for 5 days). Patient was given an unspecified treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering. Information on the lot/batch number has been requested.

Patient had gotten off of the elevator 30 minutes after vaccination and fallen down. She bumped her head and had a bloody nose

Within 10 minutes of injection, patient was seen slouching in chair and lips turning purple/blue. Syncopal episode witnessed. Patient regained consciousness quickly but was very confused. BP was monitored and patient was taken via wheelchair to ED for additional monitoring. No additional concerns noted by ED physician and patient was discharged.