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.

Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swelling of the right side of my face started within a few hours later. Called Drs. , He recommended taking Tylenol. (Second Day) Next day, felt short of breath, weak, applied ice packs to my face. Third day, felt weak. By the fourth day, swelling and itching subsided; but skin on my face felt gritty under the skin. Drove me to the doctor's office the third day. I was short of breath walking from the car to the door to the doctor's office. I was wearing my mask. I saw a PA; but, she didn't tell me much of anything. I don't think she knew what to say.

Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Severe sore arm at injection site.

injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lousy arm feels like its blown up but doesn't look like it is

Jan 26, 2021: 3:00 pm, mild fatigue 9:00 pm sound asleep (unusually early for me) Jan 27, 2021 1:30 am woke up feeling hot and perspiring (really unusual for me, but I did not think much about it at the time) 3:00 pm - mild headache ( unusual for me, but I did not take anything for it) 5:00 pm felt mildly unwell and felt mildly chilled 5:30 pm, took temperature - 99.5 - and did not want anything to eat - no nausea, just not hungry. 8:30 pm, took temperature - 100.2, ate some mild cheese and fruit (pear) and coca-cola to settle my stomach a little

Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I told her I wasn?t sure how long it was on Dec 19 I was raking leaves and I thought I should do this because I started having runny nose. I didn?t feel well that afternoon sneezing because I thought it was nothing. As the week went on I started sneezing and coughing and stopped up nose. I always end up with sinus infection when I get a cold Dec 28 I went to the doctor at doctors care and they did a covid test before the doctor would see I tested positive. I went home and rested, no energy, felt like I was hit by a train, couldn?t breathe, sneezed a lot and hardly coughed. January 1, I called ambulance and went to hospital, I was sick the first week of January. I didn?t know that you should wait 90 days to get the vaccine after you?ve had Covid. After I got the vaccination the adverse reaction, I woke up during the night with my arm hurting bad and throbbing and a very large red circle appeared on my arm 2? in diameter. The next 3 days I felt like I had covid all over again, the 4th day I woke up and felt a little better and got out of bed and started making progress each day. Now I?m not good, but I?m ok.

Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 or 3 inches from the injection site; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm on to 14Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), known allergies: animals. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), lorazepam (ATIVAN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN). The patient previously received a typhoid shot (MANUFACTURER UNKNOWN), for immunization and had very adverse reaction to third typhoid shot. The patient experienced sore arm, mild nausea, mild headache and low-grade fever and an odd red mark on left shoulder about 2 or 3 inches from the injection site on 14Jan2021 21:00. No treatment was received for the events. The outcome of the events was recovering.

Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monitoring my blood pressure which had gone up to 159 (usual is around 120), began uncontrollable shaking. After about 1 1/2 hours my blood pressure lowered to 136 and I was transported by wheel chair to car to return home.

16 hrs after the injection.. i had a shaking chill lasting about 30 min relieved somewhat by tylenol and motrin, followed by feeling hot and sweaty, the next day I was wiped out and rested ... the shortness of breath began somewhat later on weds pm and worsened on Thursday ... I had several breathing treatments thurs and friday which seemed to help somewhat.. On Saturday I am feeling better overall with less dyspnea . still feeling wiped out after several hrs of mild activity.

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.

red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection site, became itchy lasted 1 week.; elevated temperature; body weakness; severe headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3246), via an unspecified route of administration at site of left arm at 11:00 on 09Jan2021 at single dose for covid-19 immunization. Medical history included lung cancer, chronic obstructive pulmonary disease (COPD), atrial Fib, hypertension and COVID. The patient's concomitant medications were not reported. The patient experienced red swollen arm at injection site, became itchy lasted 1 week. elevated temperature, body weakness, severe headache for 3 days, all occurred at 05:00 on 10Jan2021. Facility type vaccine was Doctor's office/urgent care. No other vaccine received in four weeks. Other medications received in two weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No COVID tested post vaccination. No known allergies. The outcome of events was recovered in Jan2021.

Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the facility with her husband. The 2 of them drove 2 blocks away to a restaurant to eat. Midway through her meal, she reported that she started to feel "funny" like she was "drunk" or something, and felt nausea and hot/sweaty. Her husband got her in the vehicle and drove to the vaccination facility, When he arrived, she was obtunded and "out of it." No respiratory distress, No noted rash, but some clamminess/diaphoresis. She was initially examined by FNP and cursory limited neuro exam while patient was seated did not reveal any gross motor deficits. FNP called 911 and staff called for me. When I arrived, patient was groggy, but responsive. She was A&O x3 and in no distress. Pulse 54, strong and regular (normal rate for her per patient--on a Beta blocker). BP 120/74. O2 sat 97% on outdoor cold air. Patient was able to move all extremities equally and with equal strength. Lungs CTA, Heart regular no murmur, abdomen soft. Patient complained of continued malaise/grogginess and nausea, no vomiting. EMS arrived, checked glucose, which was "normal" (I didn't hear the result) and patient declined transport. I discussed ER evaluation vs. continued monitoring by me. Patient and husband requested monitoring. Patient stayed in the vehicle with her husband, I gave the husband my phone number to call if any worsening. I checked on her 5 minutes later, then 10 minutes after that. By that time, her adult daughter had arrived. We again discussed continue family monitoring vs. ER. The family wanted to take the patient home to monitor. Patient stated "If I could just go to bed, I think I will be fine." I called to check on the patient at 6p. She had rested well and was improved. She still felt a bit groggy, but otherwise was feeling better. I called to check on the patient 1/29 at noon. At that point, husband stated that she was "back to normal. Symptoms and signs appeared to be consistent with a vasovagal response. I suspected symptoms may have been prolonged by her Beta blocker

Patient experienced chest heaviness and warmth from her chest to her arm. Her blood pressure was 220/120s. We monitored her and her blood pressure decreased to 170s/110s over 30 minutes. EMS was called to evaluate her but she refused to go to the hospital.

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.

Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat, very high BP, Swelling and numbness on tongue and lips, pain and burning of feet, tingling all over, joint pain,

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.

Site uncomfortable for week plus one day. Then hard pain in shoulder and spreading across shoulder, up neck and down around collar bone. Went to Dr. and was told it was neuropathy and was prescibed Prednisone.

Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.

Sensation seeming to involve nerves or nervous system, radiating through back, shoulders, arms and hands. Started 24 hrs after first shot and decreased intensity and duration over next 3 wks till almost completely gone. Sensation began again less than 24 hrs. after second shot on 02/04/21 but much less severe than with first vaccination. Tingling is as close as I can describe the sensation but not altogether accurate.

C/O BILATERAL FACIAL NUMBNESS. NO SOB, TONGUE, LIP OR FACE SWELLING. 0940 BENEDRYL 25MG GIVEN ORALLY. PATIENT OBSERVED FOR APPROXIMATELY 45 MIN. NO PROGRESSION OF SYMPTOMS. PATIENT HOME WITH GRANDSON. INSTRUCTED TO CALL 911 FOR SOB OR FACIAL SWELLING. TO CALL MD IF FACIAL NUMBESS CONTINUES.

Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 15 seconds. HR 52 & irregular, BP 110/80

Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours

I had tremors for 48 hours after the shot, starting about 2 hours after shot also had a choking feeling. I took Benadryl before and after.

Two days after receiving the vaccine, I began to have the feeling that my insides (as in my "guts" or my intestines) were on fire. I didn't have diarrhea, but the feeling was very intense and I had to go to bed. I took Pepto Bismal, hoping it would alleviate the awful feeling. It wasn't like any other stomach or intestinal upset I've ever had. It literally felt as though my insides were "on fire", inflamed. The feeling persisted for 2 days and then went away. During that time, I just ate tea and toast and hoped that I wouldn't see any blood in my stool. It was very frightening.

When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your bone". When I got home and took the Band-Aid off there was a small red mark, which went away by the next morning. Then next day after that I started having extreme pain and numbness in my left arm. The pain is from my shoulder, to my fingertips, and under my arm. It is still hurting today. I have been taking Advil, putting pain cream on it. It is still hurting as of now.

Her arm is sore; This is a spontaneous report from a contactable consumer(patient) from a Pfizer sponsored program. A 76-year-old female patient received the first dose of BNT162B2 (lot number: EL8982), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history included asthma and allergy. Concomitant medications included unspecified medication for asthma and allergies. The patient received the first dose of the COVID-19 vaccine and her arm was sore after receiving it, she wanted to know if she can take Tylenol or use an ice pack. The outcome of the event was unknown.

BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.

Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM. 10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93. Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.

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.

extreme Chills followed by being very Hot and then chills again , headache , teeth hurt , eyes sensitive to light and eye balls aching and still are ,temperature 3rd day morning 100.2 never checked on 2nd day. Shot in the arm hurt 1 st day where a 1st doze shot did not hurt till next day, nausea, weakness all over and joints hurt. I took1/2 of 2 percocets 1half every 3 hours for 12 hours and that helped with headache and teeth..tylenol did not help headache and I never have headaches. I thought I was dying. I spoke to friends who have had 2nd dose and most experienced some but not all and many nothing after 2nd dose.

Woke from sound sleep at 4 am (approximately 14 hours after having the vaccine shot) -- chilled, and every part of body hurt. Went back to bed. 6 am still hurt everywhere, short of breath (oxygen concentration at 90 and sometimes below--thankfully I had oxygen as I sleep with it). Running a temperature of 100., disoriented, heart rate at 115+ and I hurt everywhere. 8 am called Dr. & left call-back. 1 pm tried Dr. again. Told person on telephone and he told Nurse Practitioner. They ordered nose spray because I mentioned I may have a sinus infection as my head hurt, my ears hurt. I continued Tylenol every 6 hours on Friday and Saturday (all day). I was able to get up and do a few things on Saturday. Felt better on Sunday but still weak feeling. Oxygen saturation back to 95-96 and heart rate under 100.

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.

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.

Injection was painful - arm numb and tingled to fingers. 10:45b/p 116/62 pulse68 respirations 16 Normal movement,color and temperature in fingers. Capillary refill <3 seconds. Client refused further medical treatment.

A feeling of extreme tiredness , & semi nauseous . High temperature 100.2 . ache all over . My arm ached but not too much but my body ached all over like you get with the flu which I've never had. I was like that for 2 days. I didn't want to eat or do anything. Then I tried to keep eating a little & drinking anything water, coffee,& tea hot & iced . On the 3rd day I felt better not well but better.

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.

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.

My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. Next day pain was in the right lung, severe, (could not take a breath). Next day the pain and discomfort traveled dow my right leg, extreme cramps, soreness, etc. The next day it was my left lung in severe pain. By Monday my breathing is very shallow and my cough is much worse, each cough produces its own package of phlem. Breathing is diffiicult I HAVE AN APPOINTMENT TO RECEIVE SECOND SHOT ON FEB. 24. I DO NOT THINK I SHOULD

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'.

Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache one day later, disorientation/foggy mind 2 days after, then cleared up, muscle pain was short-lived, moderate chills, feeling unwell with weakness, restless leg syndrome (managed since 2004 with medications) returned 10 days after second shot.

post injection, c/o pain and tingling bilateral arms, chest tightness, and tongue "feels strange", difficulty breathing

Within 1-2 days of second COVID vaccine, patient developed ataxic gait. After ~7-10days of symptoms, she saw her primary care, who referred the patient to the ER for stroke work-up. MRI of the brain with and without gadolinium contrast showed sub-CM lesions. Pan-CT scan showed no evidence of malignancy. LP for CSF analysis shows lymphocytic pleocytosis. Complete axonal MRI of the spine (cervical, thoracic and lumbar) shows T2 cord signal abnormalities concerning for demyelinating process. Overall, highly concerning for COVID mRNA vaccine induced acute disseminated encephalomyelitis (ADEM). Treatment initiated with glucocorticoids.

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 experienced pain headache or migraine after vaccination . Onsite EMS was called vitals BP 158/94 99% O2 room air HR 64. Patient Refused Evaluation/Care released against medical adive.

speech/word finding difficulty ( dysarthria ), Novocain like feeling left perioral area( perioral anesthesia ) , drooling of food occasionally

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.

Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again. She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.

Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still have some throat pain

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.

migraines; anxious; headache; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly, on 23Jan2021 at 11:30 (at the age of 76-years-old) as a single dose in the left arm for COVID 19 vaccination. Medical history included stress related to work and a preservatives allergy which give her headaches. Historical vaccinations included pneumonia vaccine (UNKNOWN MANUFACTURER but reported as "Pneumonia 13") on an unspecified date "four years ago" after which she developed a headache which she attributes to an allergy to unknown preservatives. She never received the second "Pneumonia 13" because of the reaction with the first one. She also reported that she has had this same reaction of headache attributed to allergy to unknown preservatives when eating fast foods and foods with sauces. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered at a County Convention Center. On 23Jan2021 at 11:45, fifteen minutes after she received the vaccination, the patient developed a headache which she has had ever since she got in on Saturday. She also stated that it feels like "a migraine on steroids." She did tell the person at the clinic where she received it. She stated that she is "hypoallergenic" and she had to sit for thirty minutes after receiving it. She was already anxious and about fifteen minutes in, she developed the headache and nothing has helped so far. She added that she has not had a headache in a long time and that is why she feels it is the shot. She reported that what she took for treatment did not work. These treatments included: Acetaminophen Extra Strength 500mg NDC 21130-111-90. Lot 9ME2806A, expiration 20Jul2021. Count size is 500 caplets, Motrin Ibuprofen tablets 200mg. Lot 6ME1058A, Expiration Sep2018. Count size 100 caplets which when taken was an expired product, SalonPas Roll On Lot 192498, Expiration Jan2022. Count size is 1 container with 3 fluid ounces or 88ml and Neck Wrap and Wrist Heat Wraps which is reported as "a generic equivalent of Thermacare" with Lot number 91211OC16, Expiration 10Dec2022. She did not take the heavy duty Motrin because it was out of date. She commented that all of these things had helped in the past. The clinical outcomes of the event headache, migraine and anxiety were reported as unknown.

Three days after the Covid-19 vaccine injection, left arm became reddened, warm to the touch, painfully tender, lumpy under the skin, over an irregular area approximately 4x5 inches. Doctor diagnosed infection as cellulitis, and prescribed doxycycline 100mg for 5 days. Because of the underlying primary immune deficiency, this will be a difficult adverse event to overcome. First noticed on February 25, 2021. Covid-19 vaccine was administered on Monday February 22nd 2021.

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

Experience symptom similar to restless leg for about half to one hour in evening. Feeling I had to move lower extremities. Didn't last long.

Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left cheek and brow. Right cheek hurts because of the swelling. Took 2 Benadryl at noon. Right cheek is burning. Today is Monday and it is still swollen but not as red. It hurts and got more Benadryl to take. Took 2 at 3pm today.

10:15- Pt initially c/o left arm numbness sensation, brought back to observation area 10:20- Pt c/o thick throat sensation - Emergency Response Team Called 10:22- Pt c/o increased throat sensation "swelling in back of my tongue and throat" with onset of difficulties breathing- Epinephrine Auto-Injector 0.3mg administered. 10: 26- Emergency Response team arrives 10:28- Pt transported to ER for evaluation

Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; 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, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.

Developed pain of 10/10 in arm the day after the vaccine which continues to today. MD office visit scheduled.

Aprox 10 minutes after receiving the vaccine client started c/o stinging and tingling in her hands and they were red, she felt flushed. No medications given. She felt better shortly afterwards. She did not let her PCP know of this information.

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.

Very cold, chills, many many trips to the bathroom, flu-like very upset stomach, 101 temp, throwing up ,

pustules across her back; In her throat she is getting hoarse; itching with the rash; rash that is all over her body; splotches on her belly on her right side, right below her waist /Two splotches on right hand side; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration at left upper arm on 26Jan2021 at 14:19 at SINGLE DOSE for COVID-19 immunisation. The patient had no previous immunizations. The patient had no prior vaccinations within 4 weeks and no additional vaccines administered on the same date. Medical history included allergic to penicillin, bladder infection, in the middle of her chest she had the pain cling through her back, and thyroid getting lazy and does not work. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine sodium (SYNTHROID) for thyroid getting lazy and does not work, vitamins, and sulfa drugs for bladder infection. It was reported that after getting the first dose of the vaccine the patient noticed she had pustules across her back on an unspecified date. The patient stated she "got this rash from the tips of fingers, even the palm of my hands and it starts right under the neck and goes across my breast, on my belly, on my back and both arms and is now halfway down my shin bone." On an unspecified date in Jan2021, she noticed this the afternoon of her vaccine around 7:00 when she saw two splotches on her stomach and it kept spreading. Sunday morning she went to Quick Care and yesterday went to her regular doctor. Her doctor gave her prednisone to take 10 mg 4 times a day, and hydroxyzine 10 mg for itching. In her throat she was getting hoarse on an unspecified date and was keeping a water bottle on her desk to keep hydrated. She stated she read on (website) that a rash can be a symptom of the vaccine. The caller asked, "if the pustules burst will this cause anyone to get Covid 19? Is this a possible side effect of the vaccine? How long will this last? Is it okay to get my second shot with this reaction? Is there anything I should be taking to make it go away?" It was further reported that patient received paperwork to call if there was any type of reaction. The patient mentioned she has a rash that was all over her body on 28Jan2021. It was on the top of her hands, in the palm of her hands, on her arms, back, under her breast, on her chest, on her stomach, on her bottom end, it was going down her legs and to her knees at this point. The patient initially stated she noticed the rash on Friday (29Jan2021), she later stated it was Thursday 28Jan2021 when the rash first started. She stated she first noticed splotches on her belly on her right side, right below her waist on an unspecified date in Jan2021. At first when looking at it she did not think too much about it. Later in the call she further clarified and stated it was possible she noticed these splotches the same day in the evening on the day she got the vaccine. She was not sure. If it was not the same day it was the next day. Friday (29Jan2021), she started to get as initially stated bumps, but later clarified rash under skin and it really proceeded from there. Additionally, it was reported that the rash continued to spread throughout her whole body. It was down to her shin now. Her whole upper body was horrible. She has some across her back. There are pustules on them like a pimple. It was like water in it ready to break. Sunday she went to a (clinic name) to get it looked at. She went Sunday 31Jan2021. She was given an intravenous (IV) and three needles were placed in it. She knows one was a steroid, she does not know what the other two were for, but she thinks one was probably for itching. The patient also confirmed she also experienced itching with the rash on 28Jan2021. It started the same day she noticed the rash. The patient stated it was like a full blown case now. The itching was with the rash on 28Jan2021. The itching and rash has continued to go down her body. It was on her buttocks now. It was hard to sit. It was in private up between her legs and stuff. Her body was almost 80 % full and covered with this stuff. She saw her regular doctor yesterday. The doctor at (clinic name) thought this reaction may have been an allergic reaction to a Sulfa drug she was taking for a bladder infection coincidentally at the same time, but she does not believe this was the case. Stated she had taken that sulfa drug before previously. She does not have the name of the drug to provide of the sulfa drug. She does not have it with her. No blood work was done. She was just looked at. They saw what was going on. The patient also mentioned she went on the internet to do research. She saw on Pfizer page three pictures that resembled what she had going on. It was also reported that the two splotches on right hand side started about 7'clock in the evening. At first did not think anything of it. Thought it was possibly a bug bite at first. Additionally, it was reported that patient went to see a doctor. She was already going to the doctor for a bone density scan and she showed the doctor what was going on at the same time. Her primary doctor thought this was due to the COVID 19 Vaccine. At end of call, patient questioned "if the pustules across upper back and behind neck, will that cause anyone to get COVID 19? Side effect?" The patient had no emergency visit. Therapeutic measures were taken as a result of itching with the rash, rash that is all over her body, and two splotches on right hand side. The patient had not yet recovered from rash that is all over her body while outcome of the events pustules, itching with the rash, in her throat she is getting hoarse, and "splotches on her belly on her right side, right below her waist /Two splotches on right hand side" was unknown.

only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself). A 76-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 76) single dose on 02Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced only sore arm and feeling tired both on an unspecified date. She has had to take a nap everyday since. The outcome was unknown. Information on the lot/batch number has been requested.

Became nauseous with headache within one hour of getting vaccine, developed irritable bowels third day after, and became extremely hot the morning of the fourth day after the vaccine and again on the seventh day after the vaccine. The nauseous, headaches, and irritable bowels subsided by fourth day after the vaccine. Did not receive any treatment.

At the time of the injection a small red area was identified. There was mild pain in my arm for a day or two. Six days later the red area has became about four times larger and spread around. Pain is still mild- the upper arm is sore and itchy.

Numbness in upper and lower jaw. This occurred about 15 min. after vaccination and lasted about 45 min.

I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and top of my back.

Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching behind eyes, especially right eye which lingered until about day 7, headache on right side for about last 4 of the 7 days, some discomfort in right armpit and tenderness of right breast nipple. No treatment except fluids and bed rest for first 3 days. By day 6 I felt myself again.

Heavy, aching legs from the knee down. Knees throb. Right shoulder intermittent aching. Walking affected in that the aching reduced distance I could comfortably cover. Dragging body after a walk beyond a quarter of a mile. worst symptoms in the evening and night. Sleep disturbed on many nights. tylenol helped but did not always allow for a good sleep.

arm is still aching/right arm continues to throb; This is a spontaneous report from a contactable consumer (patient herself). This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 19Jan2021 (at 16:00, at the age of 76-years-old) at a single dose on the right arm for COVID-19 immunization, administered at hospital. No other vaccine was received in four weeks. No relevant medical history was provided. Past drug history included allergy to sulfur. Relevant concomitant medications included losartan.The patient stated 'my arm is still aching/right arm continues to throb'. The patient had not recovered from the event.

nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the vaccine: polyethylene glycol; rectal bleeding which then became rectal hemorrhage; stomach cramps; bowel movements; diarrhea; This is a spontaneous report from a contactable consumer. A 76 years old female consumer reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 12Feb2021 at around 04:30PM single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. At midnight that same day on 12Feb2021, she started getting stomach cramps, bowel movements, diarrhea, rectal bleeding which then became rectal hemorrhage. She did not go to the hospital. She said the effects dissipated; however, she still felt nauseated today (26Feb2021). The patient was currently taking ondansetron (ZOFRAN). She has been feeling weak and not well. She had a colonoscopy planned soon. She's concerned about receiving the second dose. She mentioned as well that she believed she was allergic to an ingredient in the vaccine: "polyethylene glycol". Outcome of nausea was not recovered. Outcome of other events was unknown. Information about lot/batch number has been requested.

Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a spontaneous report from a Nurse (Patient). A 76-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, Expiry Date: unknown, NDC number: unknown), on right arm, via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunization. Covid vaccine was a Pfizer product. Covid vaccine manufacturer was unspecified. No lot number of Covid vaccine was not provided as complainant (patient) does not have the product with them at the time of call. Medical history included Heart attack five years ago, Open heart surgery four years ago, Pulmonary hypertension about 10 years ago, Diastolic dysfunction about 10 years ago. The patient's concomitant medications were not reported. Age at time of onset event was 76 years. Caller (patient) stated that on Monday 08Feb2021, she had her first dose of the Pfizer Covid vaccine and what happened was she waited 15 minutes and the girl came and she said she was fine which she was and she went and sat on the chair and in an hour and a half, she started to feel sick and had a slight headache, and nausea, about an hour and half later it went away. Stated the next morning she got up, sort of too weak to get out of bed, went to the bathroom and went bed and woke up about 5 hours later, felt alright, not so bad. Still did not feel very strong and she sat in her recliner and she was playing on her tablet and she didn't have an appetite, and then she got the chills and then after she got the chills she had to take everything off because she started to sweat. Did not have the strength to go get her thermometer, after she started to sweat she started to feel fine. Caller would like to know if she should get the second dose. NDC, Lot, and expiration date unknown, caller does not have her patient card. The patient experienced sweating, weakness, loss of appetite, chills on 09Feb2021; felt sick, headache, nausea on 08Feb2021. The outcome of the event sweating, weakness, chills was recovered on 09Feb2021; nausea, felt sick, headache was recovered on 08Feb2021; loss of appetite was not recovered (still ongoing). Information regarding lot/batch number has been requested.

Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in the form of hives and itching on lower extremities and slightly on lower side of upper arms. (No adverse reaction to first shot)

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

Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.

A cough began 3 days after the vaccine. On the 4th day I woke up with a fever, heavy cough and heavy head cold. I slept the whole day. The fever was gone by morning of the 5th day, but I felt like a piece of "rubber" the following 2 days. The cough has lingered until today (2 weeks after the first vaccine).

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.

Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.

Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, knees; chills; headache; Pain was severe enough as to interfere with sleep; This is a spontaneous report received from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration to left arm on 18Jan2021 13:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure and Allergy to tomatoes/walnuts. Concomitant medications included Lisinopril, Metropolol and Hydrochlorothiozide. On 26Jan2021 patient experienced with severe joint pain especially in feet, ankles, knees; chills, headache. Pain was severe enough as to interfere with sleep. Patient did not receive any treatment for the events. Seriousness was reported as non-serious. Outcome of events was not recovered.

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

EUA Pfizer -BioNTech vaccine 3 days after vaccine, patient complained about facial droop. She saw her PCP who diagnosed her with Bell's Palsy. She was prescribed acyclovir and prednisone. 4 days after the vaccine, she began to feel dry eyes, and difficulty swallowing. She was advised that symptoms will improve with time and steroids and to return to the ED if she experiences voice changed or cannot tolerate liquids.

2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date

SCRATCHY, GRAVELY THROAT; IRRITATION OF VOICEBOX; SOUNDS "FROGGY"; HARDER TO SPEAK AS DAY GOES ON, WORSE IN EVENING; HURTS TO TALK. HAS HAD SIMILAR SYMPTOMS IN PAST BUT BROUGHT ON BY STRONG SCENTS/SMELLS (HAS HYPERSENSITIVITY TO SMELLS) AND RESOLVES WHEN SHE IS ABLE TO GET FRESH AIR. THESE SYMPTOMS STARTED ABOUT 24 HOURS AFTER VACCINE AND HAVE STILL NOT RESOLVED AS OF TODAY PER PATIENT. HAS CALLED DR. 2 TIMES AND WAS SEEN ONCE IN HIS OFFICE. HAS TAKEN A ZPAK.

Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.

I think I am having a bad reaction to my covid shots. The first shot was 1/31; a week later on 2/7 I started having headaches that travel around my head: some are behind my eyes and my teeth ache; some more like migraines that go up the back of my head; some more on the top of my head or on the side. My sense of taste changed. My second shot was 2/27. The day after I slept all day. The headaches continued (I have had a headache of one kind or another since 2/7). I had a tooth that broke off last June and was removed on March 8. I thought the tooth was infected and part of the headache problems, but since then I have been having really bad fibro pain and for the week of 3/8- 12 I ran a fever, had chills and more headaches. I was on amoxicillin from 3/8 to 3/14, but the tooth was not that badly infected and is healing well. The headaches do not seem to relate to the tooth. I have had a headache every day since 2/7 of various intensity and in different areas of my head. I am extremely fatigued and need to nap some days. My fibromyalgia symptoms are worse than they ever have been and some nights keep me awake. I also muscle stiffness and spasms in my neck occasionally. This is not normal for me. I saw a ARNP on 3/16 and she tested me for neurologic symptoms. Here are her notes: NEUROLOGIC: negative findings: speech normal, mental status intact, cranial nerves 2-12 intact, gait, including heel, toe, and tandem walking normal, Romberg negative, muscle tone normal, muscle strength normal, rapid alternating movements normal, finger to nose normal, reflexes normal and symmetric I have a video appointment with my primary care provider 3/26 to discuss this further

chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved. Information on the lot/batch number has been requested.

Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injection. Feeling generally bad all over, aching muscles, much like the symptoms of the covid 19 but only lasted a day and a half. I had covid in December through the new year and it last 3 1/2 weeks.

The patient's daughter called to report her mother developed a swollen tongue the evening after her second covid vaccination. It was mild at first but progressed to the point that it was interfering with the patient's speech. Her breathing was not affected. The swelling did subside some when the patient took allergy medication. I recommended the patient be seen by a doctor, and her daughter agreed, but the patient was not keen on seeking medical care.

she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling. The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month. Pfizer : Lot: 12831/8/21 Lot 9261 1/25/21

COVID VACCINE BREAKTHROUGH CASE - COVID SYMPTOMS WITH POSITIVE COVID PCR TEST GREATER THAN 2 WEEKS FOLLOWING 2ND DOSE OF VACCINE; SYPTOMS INCLUDE DIARRHEA, ANOREXIA, WEAKNESS, VOMITING, COUGH, SHORTNESS OF BREATH

Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago), nausea, stomach pain, bilateral ankle swelling, drainage in back of throat, right ear is clogged), Pt was admitted to hospital for AMS last month, uncertain underlying cause. Over past few days shes gotten more weak, possibly more confused, more back pain, and lost voice, some congestion and ear congestion. Her son is managing medication. She has SOB and nausea too. No vomiting or diarrhea. Symptoms worsening. No sick exposures, 1st covid shot 2 days ago

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.

has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and via sponsored program . A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took steroid shots that cause blood sugars to sky rocket, but that was expected. The patient stated, "about the time I got the shot, started having pain at tip of radius- sore to touch. Very sore. No trauma there. It doesn't comes and goes. I'm aware of it" on 23Feb2021. The patient also said she has had increased blood sugars since the vaccine (readings of 197, 147, 154) on 23Feb2021. The patient further stated that she was looking at book and has had higher numbers of 197,147 and 154. Stated that she was usually 120 or below. Stated that she does not know if it had anything to do with it. Stated that the tip of her radius was terribly sore to the touch. Stated that it said that joint pain was a side effect on an unspecified date in 2021. Patient wanted to know if it was a side effect or just her own aches and pains. The outcome of all events was unknown. Information on the lot/batch number has been requested.

My right hand started hurting in the afternoon where it would hurt when I closed my hand; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number and expiration date were not reported) via an unspecified route of administration in the morning of 16Mar2021 (at the age of 76-years-old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In the afternoon of 16Mar2021, the patient's right hand started hurting where it would hurt when she closed her hand and it has not gone away. The patient asked how long for the pain to go away. The patient was referred to health care practitioner(HCP) provider for additional guidance. The outcome of this event was not recovered. Information on the lot/batch number has been requested.

nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in my left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9264; Expiration Date: unknown), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 09:00 as SINGLE DOSE for COVID-19 immunization. Medical history was unknown. There were no concomitant medications. The patient experienced slight soreness at injection site in my left arm (vaccination site pain) on 04Feb2021 with outcome of recovered, feel a little punk on 08Feb2021 with outcome of unknown, nausea, hot flashes, slight sore throat on 09Feb2021 with outcome of not recovered. The patient is scheduled for the second dose on 25Feb2021. No follow-up attempts are possible. No information is required.

Day 5 and still have symptoms. Leg spasms like charlie horses from my knees (both replacement knees) up through my thighs to my hips, pretty much 24/7. Chills, loss of apatite and some foods taste strange. have been unable to sleep through the night because of the pain.I do think that the antibiotic did not mix with the second shot even though the medical staff cleared me at the COVID clinic that I could have the shot.

Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission. She remained intubated for 12 days. Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure. Family made decision to transition to comfort measures only. She died shortly after extubation.

Pain in left side of Neck and Ear and both eyes ,Then on the second night the pain moved to the right side of Neck and ear and both eyes,The third day I noticed that the lip is shiffted to the right

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.

She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st vaccine. She then started feeling very cold, laid down and watched TV. She then had chills all night and did not sleep well due to that. When she got up on Tuesday the chills were gone but had a slight headache off and on throughout the day, her temp was 97.2. Throughout the day she would get warm spurts/hot flashes, as well as fatigue. She did sleep that night, and when she got up yesterday morning still had the hot flashes and it was 94.2, and took it twice due to it being so low. She was like that with fatigue and not able to sit up. She went to bed, took some Tylenol and rested. The heat feeling it started going away. Around dinner time she felt more like herself, the headache was gone and her temp was 97. She was doing pretty good, and the last thing she had was she felt on her cheeks and noticed a rash on her face, like a prickly heat type rash. Before she went to bed she put Neosporin on it, and when she got up this morning it was almost gone but still has a tiny few bumps. The arm itself did not hurt at all. Feels that it is a stressful situation as to where to get the vaccine and having to travel to get it as it's not available in locations closer to their homes. The people at the pharmacy were great, but had to travel and if it wasn't for her daughter she would probably not have her shot.

Presented to emergency department with chest pain, report symptoms a few days prior to presentation. Reported mild shortness of breath, chills, and hot flashes. Was found to be COVID-19 positive upon admission to hospital floor. Symptoms are believed to not be related to COVID-19 infection and was not treated for infection.

is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. She did have a stress test years ago and was "fine". She had a dental appointment planned that she had to cancel, she has moved it to May 4th.

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.

It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's from below where the shot was; Going around the arm and it's kind of like a burning itch; it is annoying; little redness on my arm; allergic to the preservatives in the vaccine; Going around the arm and it's kind of like a burning itch; it is annoying; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing cholesterol. Concomitant medication included rosuvastatin taken for cholesterol, start and stop date were not reported. Historical vaccine included FLU for patient had a Flu Shot but it only got little red, little redness on my arm and first dose of BNT162B2 (Lot number: EN6200, Expiration date: Jun2021) via an unspecified route of administration on 27Jan2021 for Covid-19 immunization. Patient stated, "patient got the Pfizer second shot on Wednesday (Clarified as 17Feb2021) patient arm didn't start to bother me or it was very sore (Further clarification was unknown if consumer's arm was sore or not, hence captured as event) but then on Friday patient noticed patient was getting a reaction and it started to turn red so patient had an allergic reaction to it, except that it keeps spreading on patient arm it's from below where the shot was, it didn't hit the elbow yet but it is going around the arm and it's kind of like a burning itch it's not something terrible it's not something patient cannot deal with but patient was concerned about it and patient wondering if there is something patient can take or do because it is annoying on 19Feb2021" Patient believe because patient had a Flu Shot (Captured as provided) but it only got little red. patient think patient was allergic to the preservatives in the vaccine (COVID-19 Vaccine) because a friends of my works in a doctor's office and she was with me and she said I am probably allergic to, what you call the preservatives in the vaccine." Patient stated, "No it's been a while, it's been, you know it was just a little redness on my arm on 19Feb2021." Patient received a treatment that put some Ice on its last night and then patient took a Benadryl, you know generic Benadryl from a Walmart. The patient underwent lab tests and procedures which included Cholesterol and Urine: unknown results on an unspecified date in 2021. The outcome of the events was unknown. Information on Batch/Lot number has been requested

Feeling cold, headache,cough, extreme tiredness Took ASEA cell stimulating molecules, 1 Tylenol, slept 10 hours and was fine

About three days after getting vaccine, I began having pain in my shoulders and neck. For three weeks I had sharp, nerve like pain on the top of my shoulder which kept me awake most of the night. I thought it would go away. The sharp pain went away after three weeks, but pain in shoulder and bilateral neck persists. I saw on 04/09/2021. She prescribed a muscle relaxant and physical therapy. The muscle relaxant didn?t help and I didn?t do the p.t. She offered to refer me to an orthopedist, which I declined.

Patient dreamt she was having a stroke around midnight (estimated) the night of her vaccine. Woke with LUE/LLE weakness and facial droop. Did not immediately report, but after persistent symptoms presented to ED 3/10 for evaluation. MRI showed early infarct right frontal lobe in setting of extensive chronic ischemic small vessel disease throughout the periventricular and subcortical white matter. MRA head/neck negative. EKG: NSR

03/17: Got 2nd dose of Pfizer vaccine 03/23: Pain started in chest and leg 03/24: Pain forced her to go to ER where it was discovered that she had a clot in her lungs and leg. Now on Xarelto

feeling cold throughout the day; sore area on her arm; This is a spontaneous report from a contactable nurse (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date was not reported) intramuscularly on 02Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 23Feb2021. It was stated that she had heard rumors by word of mouth and blogs that the second shot is a real doozer. Some of the things she had heard were really disturbing and was hearing that a lot of elderly people had died from the second shot. On an unspecified date, patient was having a sore area on her arm and feeling cold throughout the day after receiving the first injection, and state that both of those side effects passed throughout the day. Patient asked how many people had died after receiving the second vaccine and probably doesn't have right up to the minute information about how many people were dying from this vaccine. Patient reported that she had friends that took the second dose and they all had chills, body aches, headache and fevers. Patient also asked If she don't take the second shot, or take it months later from now, and a new variant strain comes out, will she more susceptible to the new variant strain by not taking the second shot and being covered totally and stated Dr. (Name)came out and said if she don't take the second dose, she will be more susceptible to the variant strain attacking her and she could die from it. Patient wanted to know instead of taking her second vaccine next week, can she delay it and take it months from now and asked will the vaccine be effective. Patient wondered why there was no expiration date on her vaccine record card. She made the comment might be because it was so new, that's why there wasn't one. The outcome of the events was unknown.

Arm was sore from vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunization. Patient was 76 years old at the time of vaccination. Patient medical his-tory and concomitant medications were not reported. On 05Feb2021 the patient experienced arm was sore from vaccine. Outcome of the event was unknown.

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.

Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. On 22Feb2021, the patient experienced rash, itching from the injection site, pain on right arm, swelling on the right arm. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of rash. The outcome of the event rash was recovering, and rest event outcome was 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.

Unable to speak, (stroke like symptoms), was taken to ER and was treated for a stroke but was later determined to not have had a stroke. Was unable to function for two days. After two iv ingested antibiotics she started to talk and walk. There was never a diagnosis given for the 3 days spent in ER.

Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.

Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left leg and to her ankle; had the worst pain through her side that ran down her left leg and to her ankle; nerves are all tangled up; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:50 (at 76-years-old) as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. It was not administered at a military facility. Medical history included hip replacement four years ago in 2017 (First right then 2 months later left) and knee replacement six years ago in 2015 (both 2 months apart). There were no concomitant medications. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), administered in Left Arm on 25Feb2021 (at 76-years-old) for COVID-19 immunisation and experienced bad headaches. The patient received the second dose of vaccine on 17Mar2021. On 29Mar2021, she was not hurting and went to brunch with friends. Afterwards (on the same date, 29Mar2021), she was sitting and got the worst pain through her side that ran down her left leg and to her ankle. She drove herself home but was in such misery. She went to the emergency room the next day, on 30Mar2021, wherein she had a CT (computerized tomography) scan that showed a blood clot in her lower abdominal area. She was taking pain medication every 6 hours, or she could hardly stand it. On 08Apr2021, she went back to the emergency room because she could hardly stand it. She was kept in observation status but was not admitted. She was scheduled to have another CT scan on 06May2021. She is not sure what they will do because the nerves are wrapped around it. She also mentioned that her doctor wants to do a biopsy. The pain was also running down to her ankle. She stated that she has had both of her hips replaced in the past. She added that her doctor will do an MRI (magnetic resonance imaging). He will put in a drain if it has not shrunk. The doctor can't do anything because the nerves are all tangled up (2021). As corrective treatment, the patient was taking pain medication for the blood clot and pain through her side that ran down her left leg and to her ankle. Outcome of nerves are all tangled up was unknown, while outcome of the other events was not recovered.

sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore muscles, especially lower back; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in in Arm left on 09Feb2021 14:30 (Batch was not reported /Lot number 2192050) (at the age of 76-years-old) as single dose for covid-19 immunisation. Medical history included breast cancer from an unspecified date in 2016, penicillin allergy and sulphate allergy. Concomitant medications included multi vitamin (unspecified), acetylsalicylic acid (ASPIRINE) and anastrozole. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date, administered in arm left (Batch/Lot number was not reported) for covid-19 immunisation. On 10Feb2021 14:00, the patient experienced some shakes and/or chills, sore muscles, especially lower back. No treatment was given for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the nausea started to the point where my husband had to take me to the ER . They gave me some pain medicine, nausea medicine and did a cat scan of my abdomen. Nothing was found and I was sent home. April 4th the pain got so severe and the dry heaving to the point where blood came out. Again I went into the ER this time by ambulance because I was so weak at that point where I couldn?t walk. Again they gave me pain medicine and nausea medicine along with prednisone. It took about a week to recuperate and now I have severe tinnitus.

Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a little; This is the spontaneous report received from a contactable consumer(patient). A 76-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history included usually constipated, her doctor put her on magnesium and docusate sodium (COLACE). Concomitant drugs included magnesium and docusate sodium, both for constipated. She experienced tiredness, arm hurts a little bit, chills, back hurts a little. The clinical course was reported as follows: the tiredness did not start until a couple days later and eventually went away. The arm hurting did not happen the first few days, it was not as bad the second day. She added that she could not complain about it. She did not have a fever, her temperature was 97.5. Her back hurts a little, but it hurts a lot anyways. She did not like to sit a lot. She liked to be active because it helps, but it was too gloomy to do anything on 12Apr2021. The seriousness of the events was unspecified. Outcome of tiredness was resolved. Outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Left side of face paralysis- eyebrow, eyelid and mouth, pain in left ear. Symptoms left after 2 weeks.

03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has a history of paroxysmal atrial fibrillation but has not had an event for many years. She had her second Covid vaccination yesterday and did have flulike symptoms including headache, myalgias, and shakiness through the last night. She wonders if this triggered her symptoms. No chest pain, dyspnea, or lightheadedness. 23: 18. Cardizem 17.5 mg IV. 03/10 still in ER 00: 17. The patient is discussed with hospitalist. would not recommend admitting the patient given her stability. The patient's atrial fibrillation responded very well to the IV Cardizem. Her atrial fibrillation is now in the 80s. She is asymptomatic. CHA2DS2-VASc score of 2. 00: 18. Cardizem 30 mg p.o. The patient is quite concerned about stroke. Her mother died of CVA. We will start anticoagulation today pending cardiology follow-up. Eliquis 5 mg po. Recommended follow up with cardiology 03/16 visit with cardiology Paroxysmal atrial fibrillation Established Recently symptomatic with RVR after Covid vaccination Rhythm controlled with flecainide 100 mg twice daily Rate controlled with diltiazem 120 mg daily ? CHA2DS2-VASc Risk Factors/Score: AGE(>=75), Female Gender and 3 points: "moderate-high" risk - Stroke risk as 3.2% per year and 4.6% risk of stroke/TIA/systemic embolism. o HAS-BLED Risk Factors/Score: Age > 65 years and 1 Points - "Low Risk" - 3.4% annual risk of major bleeding in one validation study and 1.02 bleeds per 100 patient-years in another validation study. Continue Eliquis 5 mg twice daily for embolic prophylaxis (creatinine 0.76 on 3/9/2021) 04/02 appt with PCP for ER follow up Patient is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. 04/20 ER visit: Patient is a 76 y.o. female who presents with palpitations that started this evening, sudden onset, has a history of paroxysmal atrial fibrillation, and is maintained on 100 g of flecainide twice daily and diltiazem daily. She also has short acting diltiazem 60 mg tablets to take for episodes of breakthrough arrhythmia. She took a 60 mg short acting diltiazem prior to arrival She endorses some chest pressure with this though not severe, denies any dyspnea diaphoresis or nausea Not anticoagulated 04/29 Follow up with PCP For years she has been well controlled on low dose methimazole. Recently she has had 2 bouts of a-fib, when trying eliquis prescription and again following her 2nd COVID-19 vaccine. Upon recheck her TSH remains suppressed and FT4 elevated. Increasing from 5 to 10 mg methimazole now. Left side of thyroid is palpably thickened with no nodules noted. Recommended Ultrasound. Explained that if nodules are seen, a follow up image may be indicated to assess nodule activity. Not in a-fib today. C/o general malaise, shakiness, chest tightness, & flushing. Graves since 2006 She is feeling out of sorts, shaky, flushing, chest tightness, recurring headache. She has to stop and rest when trying to do activities as she will feel weak. Not sleeping well. Systolic BP labile, from 105, to 155, to 135.

she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day. Pt tested positive for COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd dose: 1/31/21

Butterflies in the chest that went to quivering; quivering; A-Fib/Arterial fibrillation with rapid ventricular response; Arterial fibrillation with rapid ventricular response; cannot rule out anterior infarct and abnormal EKG; cannot rule out anterior infarct and abnormal EKG; trouble breathing; Her heart rate is screwed up; she feels so weak; irregular heart beat; 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 on 18Mar2021 (lot number: EP7534) as SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), irritable bowel syndrome described as a condition where you're in the bathroom a lot, fibromyalgia, little depression, heartburn, upset stomach, heart fluttering issues, congestion spray (nasal congestion), and had part of a lung taken out. Family medical history included heart issues (dad and uncle). Concomitant medications included salbutamol (VENTOLINE [SALBUTAMOL]) for asthma; venlafaxine hydrochloride (EFFEXOR) for little depression; pantoprazole for heartburn and upset stomach; fluticasone propionate (lot number: AA47468, expiration date: Aug2020) for congestion spray (nasal congestion); fluticasone propionate, salmeterol xinafoate (ADVAIR) for heart fluttering issues. The patient previously took SHINGRIX (also reported as shingles vaccine, for clarification) for immunization and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 25Feb2021 (age: 76 years) in the left shoulder for COVID-19 immunization. On 18Mar2021, right after taking the vaccine, patient started to experience quivering inside. Initially it felt like butterflies in the chest and then to quivering, it was then quivering the whole week. She knew she was going in for a test , an endoscopy, where they go down the throat. So she waited, the quivering did not go away for a whole week. It lasted until Friday before her endoscopy. When they found out, they sent her to ER at the hospital. They did not do the endoscopy. They said they might have to shock her heart or something. They wanted her to see the cardiologist right away. From the ER, she had 2 IVs, 1 in each arm. They were also taking blood every 4 hours (unknown results). The provided diagnosis was arterial fibrillation with rapid ventricular response and cannot rule out anterior infarct and abnormal EKG (Mar2021). The events cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, A-Fib/Arterial fibrillation with rapid ventricular response resulted in emergency room visit and physician office visit and let to hospitalization. The patient was hospitalized from 2021 to an unknown date (also reported for 2 days, for clarification). It also gave her A-Fib, trouble breathing and now her heart rate is screwed up (Mar2021). On an unspecified date in 2021, she feels so weak and has irregular heartbeat. Therapeutic measures were taken as a result of the events which included Eliquis, Atorvastatin, Diltiazem, and other unspecified medications. The outcome of cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, arterial fibrillation with rapid ventricular response, she feels so weak was not recovered; while the other events was unknown.

arm was hurting; This is a spontaneous report from a contactable consumer via Medical information team. A 76-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number and expiration date: Not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on an unknown date. The patient past medical history included Alzheimer's. Concomitant medications were not reported. The patient reported that on an unknown date, she woke up in morning and her arm was hurting, so she felt her arm and the band aid felt wet. She wants to know if this could be fluid from the vaccine that leaked out. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Mild sore arm; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number EL9266, Batch number- DDM#32), intramuscular, in left arm on 23Feb2021 (at the age of 76-years-old) at a single dose for COVID-19 immunization. Medical history included covid-19 in Nov2020 (reported as also had the virus) with no taste or smell for 4 months and was very tired for 2 weeks and Stage 3 kidney disease from Feb2019 and ongoing. There were no concomitant medications. The patient was vaccinated at Pharmacy/drug store. No other vaccine was given in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318, Batch number- DDM#32), intramuscular, in left shoulder on 02Feb2021 at 5:00 PM at a single dose for COVID-19 immunization after which the patent experienced mild sore arm and chills. The patient experienced mild sore arm and chills on an unspecified date. The events lasted for about 4 hours. The outcome of the events was recovered. Information about lot/ batch number has been requested. Follow-up (23Apr2021): New information received from the same contactable consumer (patient) included: Patient medical history and details, Product batch number and lot number, Outcome and duration of the events. Follow-up attempts are completed. No further information is expected.

Right knee pain; tenderness; swelling; Pain at injection site; 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; lot number: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.

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.

After vaccine on Wednesday three fingers on my right hand went numb and my mouth felt like I had a shot of Novocain, then my tongue had a little tingling. I texted my doctor and he said to go to the ER and they checked me out did EKG, blood work, CAT scan, covid test that was negative and I was admitted. I got an MRI and did other urine test, I was being checked every hour. I was given Plavix and other meds and was told that I had a stroke/TIA.

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.

Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site in which it was a soreness; Aching in arm; Achy; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 04Feb2021 at 10:30 as first dose,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. On 04Feb2021, the patient experienced after is that she felt a little achy and 04Feb2021 at 8:00 pm that evening her arm was aching, patient took an Ibuprofen and had no problem afterward, On 05Feb2021, the day after patient mentioned had pain under the arm, under the injection site in which it was a soreness which had no lump. She cannot discern whether it was a lymph node or muscle, but is leaning more into it being a muscle because patient could feel a pulling sensation when patient raises her arm at the shoulder. Patient was asking if these are common side effects and for how long do these usually last. On 06Feb2021 soreness under her arm, unsure if muscle or lymph nodes. The outcome of the events achy, pain under the arm, under the injection site in which it was a soreness were unknown, soreness under her arm was recovering and aching in arm was recovered on 04Feb2021. Follow-up attempts are completed. No further information is expected.

she is a little tired; slight headache; arm hurt; she felt lousy; fever/she was running at 99.5 low grade fever; didn't feel well; She had chills; didn't sleep well; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Deltoid Right on 26Jan2021 15:00 (at the age of 76-years-old) (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient was not Vaccine Administered at Facility. The patient had no medical history (including any illness at time of vaccination). The patient had no family medical history relevant to AE(s). There were no concomitant medications. Historical vaccination included flu vaccine for the indication of flu vaccination which gave a reaction of sore arm. On 26JAN2021 patient experienced fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, arm hurt and she felt lousy. The patient underwent lab tests and procedures which included body temperature: 99.5 on 26Jan2021 low grade fever; Her normal temperature is 96-97.0. On 27Jan2021, the patient had slight headache. On 28Jan2021, body temperature was 98.1 and she is a little tired, but her fever was 98.1. Therapeutic measures were taken as a result of fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, slight headache, she is a little tired, arm hurt, she felt lousy. The patient got the first dose yesterday and had some reaction. She got a fever, her arm hurt and she felt lousy. She also mentioned that she took Tylenol yesterday. She and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could effect the efficacy of the vaccine. She wants to know does it effect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not gotten through the day without the Tylenol. Today, she is a little tired but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really lucky. The patient had no prior vaccinations (within 4 weeks). No AE(s) require a visit to Emergency Room. The patient had no relevant tests. The patient is healthy. The seriousness of the events was reported as non-serious. Outcome of the events fever/she was running at 99.5 low grade fever, She had chills, didn't sleep well, slight headache was reported as recovered on 28Jan2021, didn't feel well, she felt lousy and arm hurt was reported as unknown, she is a little tired was reported as not recovered. No investigation assessment needed. Follow-up attempts are completed. No further information is expected.

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.

She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)'; When she vaccination provider put the needle in, it really hurt/soreness; Her arm ached; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that . A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included for her belly. Concomitant medications included fish oil (OMEGA XL) (Has been taking for years) ongoing and glycopyrrolate [glycopyrronium bromide] taken for her belly, (Once a day) ongoing. On 24Jan2021 the patient experienced Black and Blue mark on arm, when she vaccination provider put the needle in, it really hurt/soreness and her arm ached. On an unknown date the patient experienced she bled a little bit. The patient stated that She got the vaccine on as confirmed Sunday 24Jan2021 and later that day her arm ached. She has heard a lot of people had ache, arm ache after getting the vaccine, but no specific patient details provided.She looked at her arm and she had a black and blue mark as big as a tangerine. She is not too happy that happened. She has to get the second dose of the vaccine 14Feb2021. She is not sure if she wants to get the second one. If this occurred with the first one. She also hurt with getting the vaccine. She is not sure where the needle was placed when getting the vaccine, but it hurt, and she bled a little bit. The nurse had to place a Band-Aid on it. Her arm is still black and blue. She noticed the black and blue mark on the same date she got the vaccine. It was later that day in the evening. She does not know the exact time. The black and blue mark is on her right arm. She noticed her arm ache shortly after she got the shot. It was a few hours after getting the vaccine, but she does not know what time. She stated this seems to be a complaint of a lot of other people, but no other specific patient details provided. It is her right arm that aches. She stated she is wondering if she needs to be concerned about these events. Should she be concerned about what her arm looks like. She is still having soreness. Therapeutic measures were taken as a result of a 'black and blue mark on the arm. The outcome for the events black and blue mark on the arm (as big as a tangerine, and is still there) and her arm ached was recovering. The outcome for the event when she vaccination provider put the needle in, it really hurt/soreness was not recovered. The outcome for the event she bled a little bit was unknown. Follow-up attempts are completed. No further information is expected.

March 15th right upper thigh pain, sore to the touch. Around April 1st had to buy a cane to help with walking

not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/feeling so bad; weak/weakness; miserable; nausea/nauseous; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration (administered in arm Left) on 29Jan2021 at 11:30 AM (at the time of 76-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that her first dose of Pfizer vaccine on 29Jan2021. first dose of the vaccine by injection. Stated having side effects yesterday. Today patient has headache, chills, tired, just not feeling good, weak and miserable. Then all of the sudden yesterday she felt really bad. She was very tired with cold, chills, nausea and weakness. she received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 11:30 AM in the left arm. She was not sure of the time because she was feeling so bad and adds she has not gotten up out of the chair today. Then on 2Feb2021 in the afternoon, she started to felt really bad. Mentions that she thought she was nauseous because she was so nervous about getting the vaccine. Adds it wasn't really just like nausea but more like not wanting to eat. She stopped having chills last night. She was scheduled to get the second dose of the vaccine 19Feb2021. Patient mentioned she was shrinking due to natural aging. The outcome of chills was recovered on 02Feb2021 for tired/very tired and malaise (PT) was not recovered for weak/weakness and nausea (PT) was recovering while for other events was unknown. The reported events felt really bad, tired, nausea and weak were considered as related to suspect product. 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.

weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Nausea; sore arm; I don't like the way I'm feeling; This is a spontaneous report from a contactable consumer (the patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0773) via an unspecified route of administration in left upper arm on 04May2021 11:00 at age of 76-year-old at single dose for COVID-19 immunisation. Doctor wanted her to get it. Caller said that her doctor told her she wouldn't make it if she got COVID. Her heart couldn't pump very well and was very weak. Other medical history included a lot of allergies (They made her sit in a recliner for 30 minutes) and thyroid disorder. No further details provided by the caller regarding her thyroid condition. Caller did not think there were any other medical conditions that she had that would be relevant as she was pretty darn healthy. Family medical history relevant to AE: Not that she knows of. Daughter had the shot and was sick for 2 days. She had the Pfizer. No vaccine administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid from an unspecified start date for 20 years and ongoing. Got the shot 04May2021. Dry heaves on 04May2021: Didn't really throw up, but she had them all day. Still has them but not as bad. Nausea/ nauseated on 04May2021: It was actually kind of steady. Caller was able to eat and drink, not that she wanted to. She did not know what to do with herself. She was eating and drinking. She took TUMS [CALCIUM CARBONATE] and always had a cast iron stomach. Skin is so itchy on 04May2021: Skin started itching right away, that evening that she got the shot. She even used a back scratcher. It was all over and still felt the same. Treatment: Had taken diphenhydramine hydrochloride (BENADRYL) maybe once or twice and when she went to bed. She didn't take it steady. She did not take the TUMS steady either. Yesterday, she felt better, and currently felt worse again. Had a little more energy and was feeling good. Sore arm on 04May2021: Was sore right away, after the shot. It was still sore but it was better. It was not red or anything. Treatment: Took 1/4 of a paracetamol (TYLENOL), 325mg, so it was 12 or something. Weak on an unspecified date and did not feel well on an unspecified date. Her blood pressure was good and she has no fever. She also stated her stomach was upset 24/7. She didn't like the way she was feeling after the first dose (May2021). She just wish this would go away. She didn't feel good. 10 days was a long time to have a reaction. Tests: Recently had blood work and everything was normal. Even her thyroid stimulating hormone (TSH) which she got tested for every month is fine. It was off but currently was regular. The event did not require a visit to emergency room or physician office. Her next shot was on 25May2021 and was scared to get it. The patient asked what would happen if she did get the second dose. The outcome of events "skin so itchy", "nauseated/nausea" was not recovered, of events "dry heaves", "sore arm" was recovering, of "TSH is off" was recovered, of other events was unknown.

head ache; chills; fatigue; weakness; I had no appetite but drank water; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201; expiration date: unknown), via an unspecified route of administration, administered in left arm on 01Mar2021 11:15 (at the age of 76-year-old) as a single dose for covid-19 immunisation. The vaccine was administered at Public Health facility. The patient had no known allergies. Medical history included controlled high blood pressure. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 08Feb2021 11:15 (at the age of 76-year-old) at a 1st dose, single dose for covid-19 immunisation. Concomitant medications included lisinopril (LISINOPRIL); naproxen sodium (SYNFLEX DS); ascorbic acid, betacarotene, biotin, boron, calcium carbonate, calcium pantothenate, calcium phosphate, chromium picolinate, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, lycopene, magnesium oxide, manganese sulfate, nickel, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, sodium metavanadate, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (SENTRY SENIOR). On 01Mar2021 at 08:00 PM, the patient experienced headache, chills, fatigue and weakness. These symptoms lasted through the following day and the majority of the second day. The patient had no appetite but drank water. The morning of the third day the patient was back to normal, no more symptoms. No treatment received for adverse event. Patient did not had COVID prior vaccination and did not had COVID tested post vaccination. Patient did not had any other vaccine in four weeks. The outcome of the events were recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.

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.

Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiration date was not reported), via an unspecified route of administration on 03Mar2021 14:00 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 03Mar2021, the patient experienced outbreak, looked like hives, on her torso and stomach area, with sequelae after the first dose, chills after first and second vaccine, injection site sore after first and second vaccine, Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine (Patient visited office). she would like to know about percentages in age groups who have experienced any numbness and tingling, and if there are any correlation with developing blood clots of this, and also, she wanted to know if she needs further medical attention and to prevent a serious outcome. The outcome of the event was recovered for urticaria on 21Mar2021, the outcome of chills was unknown. Vaccination site pain, Hypoaesthesia Paraesthesia was not recovered. No follow-up attempts are needed. No further information is expected.

Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; She hasn't been able to eat; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (reporter's mother) at the age of 76 years old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously had first dose of BNT162B2 for covid-19 immunisation. patient had the Pfizer Covid vaccine about a month ago and about 10 days after her second vaccine, she is in hospital and she hasn't been able to eat since. She is probably going to die this week. They say that there is no blockage but she has all those nerve damage in her intestine and they are not working. reporter don't know if it is related to the vaccine or not but reporter wanted to ask if anybody else is having this problem. She has nerve and muscle damage in intestine and that is why she cannot eat. She has been fed with an IV for a month now. reporter stated it just happened 10 days after her second shot, she was fine before that. She had some other health problems and issues and other things as she is an old lady, she has had some other health things but reporter don't know if it is related or not but reporter wanted to call and see if one are getting other calls about this, about nerve damage or maybe information or what was going on. Outcome of the events was unknown. Information on lot number/batch number was requested.

I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R56.9 - Unspecified convulsions

and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head, after the second vaccine; Face spasms on the left side of face; after the second vaccine and it was worsened; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips after first and second dose; Left side of the body had tingling, numbness; This is a spontaneous report from female contactable consumer (Patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, lot number was not reported) via unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (at the age of 76-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6204) via unspecified route of administration in left arm on 03Mar2021 at 14:00 as single dose for COVID-19 immunization and on same day patient experienced outbreak, looked like hives, on her torso and stomach area, chills, injection site sore (which subsided after 18-days), arm was numb, tingley and painful from the shoulder to the fingertips. Medical History and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations within 4 weeks prior vaccinations. On 31Mar2021 (same day of 2nd dose of vaccination), patient experienced face spasms on the left side of face, after the second vaccine which was intermittent in the evening, headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head and left side of the body had tingling, numbness and pain down to the foot, ankle and calf areas, along with the events of first dose, which were worsened after second dose that included chills and injection site sore (which subsided 18-days after first dose), arm was numb, tingley and painful from the shoulder to the fingertips. Patient required to visit physician office, primary care doctor for her numbness, tingling and pain. Reporter stated she was very interested in percentages in age groups who have experienced any numbness and tingling and asked if there are any correlation with developing blood clots and would like the information to see if she needs further medical attention and to prevent a serious outcome and discuss it with her doctor and agrees to be transferred to Medical Information. The outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.

urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; feels strange and voice has changed; feels strange and voice has changed; suddenly had to have a bowel movement; This is a spontaneous report from a contactable consumer or other non-HCP. A 76-years-old female patient (at the age of: 76-years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Left Arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient Medical history was not reported. Concomitant medication included losartan potassium 50 mg once a day, ergocalciferol (VIT D) and calcium taken for an unspecified indication, start and stop date were not reported. No vaccination within four weeks prior to the first administration date of the suspect vaccine and No Family medical history relevant to ae and relevant tests. The patient experienced chills, hot flashes in my upper body, feels strange and voice has changed, and suddenly had to have a bowel movement on 02Mar2021, urge to have a bm and left side of head had a funny sensation on an unspecified date. she got the first dose of the Pfizer Covid vaccine this morning around 08:00 AM, then the person who gave her the shot asked her what medication she takes and she told them, they did not say anything to her about it. States she took her medication for blood pressure around 09:30 AM at her regular time to take the medication, wants to know if it is okay Takes Losartan Potassium 50mg one time a day, states she took it with Vitamin D and Calcium. And States her voice is changed, she feels strange, states around 10:20 wanted to take bowel movement suddenly, could be a regular thing, states she feels some sort of hot flash sensations not bad, here and there and then feel chills. The patient underwent lab tests and procedures which included weight fluctuates between 144 and 145 on unspecified date. The outcome of the events feels strange, and voice has changed was not resolved and other events was unknown. No follow-up attempts are possible. No further information is expected.

pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She already had numbness and tingling throughout her entire body (including lips and face) but became much more severe in April. In the last couple of weeks she has developed rashes on various parts of her body. Pt had appt w/ PCP. She had blood work that was negative and was referred to a Rheumatologist. On 6/3/21 she went to another doctor. She had more blood work. Pt is waiting on results. She also went to see another doctor. She had more blood work and waiting on these results. She has an appt Neurologist. She also had swelling with her gums for a couple of days. She has a very foggy feeling like she is spaced out. She feels like her vision has been impaired. She still feels bad most days saying the her symptoms come and go and she has felt this way since taking the vaccine. She has headache that come and go for the last couple of weeks.

I took the Pfizer vaccine in January and had a anaphylaxis reaction which I reported earlier. This is not about that but a week ago I began experiencing sharp pain in my thumbs when I tried to open a jar, pull up my pants, rub my hands together, flush the commode, etc. I have never had this kind of pain before. I looked on the internet to see what might help and noticed that the pain could possibly be a reaction to the Covid vaccine. Therefore, I am reporting it to you.

I have pain in my left arm since 2nd shot.; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Feb2021 10:45 (Batch/Lot Number: EL8982) at the age of 76-year-old, as single dose for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number : EK9231) on 11Feb2021. Medical history included from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced pain in left arm since 2nd shot (pain in extremity) (non-serious) on 01Feb2021 11:00 with outcome of not recovered. Therapeutic measures were taken as a result of the event pain in extremity. No follow-up attempts are possible. No further information is expected.

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.

A few days after I got the shot I started having night sweats, nausea. The night sweats went away until I got my second vaccine. Now I have them every night. They are not as bad. My doctor put me on medicine. I have fluid around my heart. Pericardial effusion is what I was diagnosed with. I also have small cell vasculitis. My red blood cell dropped.

redness of injection site; arm aches; itching around injection site; Swelling around injection site; This is a spontaneous report from a contactable consumer reporting for herself. A non-pregnant 76-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 10Mar2021 13:30, at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension, kidney disease, stroke survivor, breast cancer survivor and allergy to nichel and to shrimp, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 17Feb2021 13:30 , at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Concomitant medications included allopurinol, metoprolol, atorvastatin, lisinopril and rivaroxaban (XAREL), all taken for an unspecified indication, since an unspecified date. The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior to vaccination and was not tested positive for COVID-19 post vaccination. On 11Mar2021 08:00 the patient experienced redness of injection site, arm aches, itching around injection site and swelling around injection site. No treatment was received for the events. At the time of the report the events had not resolved yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

I started having bad headaches about two weeks after taking dose 1. Then after the second shot, the headache started getting better but I still feel exhausted and tired all the time. I have no energy and I sit down and fall asleep and someone has to wake me and that's not normal. I go to see a cardiologists on 7/06/2021.

has trouble moving her arm/ received vaccine in left arm but right arm was hurting; muscles in her right arm to her elbow was hurting; Swelling; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 05Feb2021 02:55 (Age at Vaccination: 76 years) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included PRESERVISION (reported as eyes) for AREDS 2, 1 twice daily from Feb2021 to ongoing started a week ago; hair skin and nails (reported as stye) as 2 gummies daily on an unknown date in 2020 (reported as 3 to 4 months ago). On 06Feb2021, the patient experienced swelling. On 07Feb2021, the patient has trouble moving her arm/ received vaccine in left arm, but right arm was hurting. The patient reported that when she woke up on Saturday her right arm was hurting. She received the vaccine in her left arm. The muscles in her right arm to her elbow was hurting. She also has swelling in her arm. She used Hemp Pain Cream. She is asking if she can take any type of pain killers. She is also having trouble moving her arm. She confirms that this started after receiving the vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to emergency room or physician office. There were no prior vaccines administered within 4 weeks. The patient still had pain even after using Hemp Vana Pain Cream. Patient received treatment as Hemp Vana Pain Cream (Lot number: 37455C, expiration date: Dec2021). The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.

First COVID-19 vaccine: arm was really, really painful; This is a spontaneous report from a contactable consumer. This 76-Year-old female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via Intramuscular route of administration on 14Jan2021 (at 76-years old) on left arm, as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant products included thyroid pills. No further details provided or obtained regarding this statement. On 14Jan2021 15 minutes after the first vaccine her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. On 15Jan2021 the patient recovered. It was mentioned that the caller declined to include a healthcare professional for this report. It was attempted to gather product information for the first and second vaccine, but caller stated that she could not read the writing. There was a product complaint: The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. Information on the lot/batch number has been requested. Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.

chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal. Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown. Follow-up attempts are completed. No further information is expected.

felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number, NDC number and expiry date was not provided), dose 2 via an unspecified route of administration on 03Feb2021 (at the age of 76-years-old), as dose 2, single for covid-19 immunization. Medical history included ongoing asthma diagnosed when she was a child. There were no concomitant medications. Family medical history relevant to ae was not provided. The patient had previously taken the first dose of the bnt162b2 (batch number: EL9263) on 13Jan2021 (at 13:30-16:00, as reported) for covid-19 immunization (Unknown dose shot in right shoulder once, as reported). Patient age at first and subsequent immunizations if dates of birth or immunizations not available was not provided. No other medication were administered within four weeks prior to the first administration date of the suspect vaccine. Prior vaccinations patient had no adverse event. The patient stated that she felt real weak in her legs. Clarified that it is for the Pfizer Coronavirus shot. Wanted to know what to do about it. It was reported that the patient feeling weak started 3 days ago and feeling week in her legs which started 2 days ago. The patient stated she is still doing what she has been doing. Vaccination facility type was nursing home. On an unspecified date, the patient experienced "felt real weak in her legs", not feeling well, on 07Feb2021 felt weak and at 20:00, stomach upset. The adverse events did not cause emergency room or physician office visit. Treatment was for taken with Pepto Bismol as a result of stomach upset. Outcome of the events were not recovered. Follow-up attempts completed. No further information expected.

couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; 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, Batch/lot number: E20792 (but she doesn't know for sure) and Expire Date: unknown) intramuscularly administered in left arm on 04Feb2021 10:15 (at the age 76-year-old) as dose 2, single for COVID-19 immunisation. Patient took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) intramuscularly administered in left arm on 14Jan2021 (at the age of 76 years), and stated that arm was really, really painful on 15Jan2021. Vaccination facility type was physician's office. The patient's medical history was not reported. She mentions she takes thyroid pills as concomitant medication. No further details provided or obtained regarding this statement. None of the additional vaccines administered on same date of the suspect. The patient did not receive any Prior vaccines within 4 weeks. With the second vaccine in feb2021, her arm hurts but it is not anything she cannot stand. However, she didn't sleep again all night last night. She was so tired but she could not sleep. She has taken other medications and she does have insomnia. She has tried melatonin for sleep and it worked just the opposite. It kept her up all night. Caller verifies she has no NDC, Lot number or expiry date for the melatonin, this was a while back. She mentions someone also told her to take Benadryl which typically makes one sleepy but she stayed up all night when she took it. She confirms she has no NDC/UPC, Lot, or expiry date to provide. She took that a while back. She was just wondering if the vaccine could cause patient not to sleep it was weird. The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. She just inquired if this could be a side effect of the vaccine and there been any reports of this. In Feb2021,She also had the chills which she read was normal. She mentions she does have sleep medication but she didn't know if it was safe to take after having a shot. Every once in a while she takes it. Caller mentions she did have a blood test done, not too long ago. Like cholesterol and everything and it was good. Caller verifies this was prior to receiving the vaccine. Caller was curious if this common or anybody else have trouble sleeping after receiving the vaccine. No emergency room visit and physician office visit was reported. Treatment was received for couldn't sleep, up all night. The outcome of events was unknown. No further details were provided or obtained. Follow-up attempts are completed. No further information is expected.

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.

Pt call hospital call center on 5/26/21 c/o Shortness of breath, rapid heartbeat and weakness started 2 days ago. Patient stated received covid vaccine 2nd dose 5/22/2021 which she received at outside pharmacy. Pt advised to go to ED but she declined. ED education were reiterated to patient.

Tingling in my tongue and lower lip; It is like if you put pepper on your tongue, I am feeling it from the tip of tongue to the sides of my tongue like from the tip you go towards you jawline; It is like burning and it started out as tingling; It feels like it is there and there is something wrong; This is a spontaneous report from a contactable nurse. This 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9265, expiration date was not reported), intramuscularly in right upper arm on 02Mar2021 (age at the time of vaccination was 76-years-old) as single dose for COVID-19 immunization. The patient took the shot at 11.30 yesterday morning, got the shot at around 11:10 AM, the patient was asked to wait for 15 minutes and the patient waited for 25 minutes. The patient's medical history included high blood pressure and it was controlled and taking high blood pressure medication, anxiety. The patient's concomitant medications included the patient take Synthroid and Levothyroxine because the patient had thyroid gland removed years ago (not clarified further) and Sertraline, which was Zoloft (not clarified if consumer was taking Zoloft or Sertraline, hence not captured in tab), 50 mg for anxiety. On an unknown date, the patient would reduce it to a burning, yesterday it was more pronounced, and it continued all night, so the patient didn't sleep flat. The patient was not sure if it will get to anaphylactic or anything, it was like put pepper on tongue, that was best description that the patient can give, it was like if put pepper on tongue, the patient felt it from the tip of tongue to the sides of my tongue like from the tip go towards the jawline and it was not under whole tongue, it was right around it and it was like burning and it started out as tingling and sometimes, it does like it did today morning (on the day of reporting), but it was not a severe tingling but it was felt like it was there and there was something wrong (not clarified appropriately further, hence ongoing not checked). The patient did not received any treatment and was just ready to go hospital if the patient had to just in case but there was nothing. The patient had no breathing problem and nothing at all. The outcome of the event was not resolved. The patient was hesitated to get the second dose. The patient just wanted to report the side effect that did not see in the list and all of the literature. No follow up attempts are possible. No further information is expected.

tremor; insomnia; intense itching; loose stools; 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, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

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.

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

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.

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.

anxiety attack on Feb 5 and again on Feb 17...did not seek medical attention...took a baby aspirin and a half a muscle relaxer. both dissapated on their own. Had another much more serious attack June 15 with heart rate at 126...visited ER...they did ECG but after waiting in receiption for over an hour my heart rate and bp were back down within normal range. Have also been having "flushes" through my system like warm water is being put into my system...lasts seconds..sometimes increased heart rate other times not. June10-11 major spike in blood pressure. with 3 day hospital vist as a result. Now on BP meds.

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.

Patient states that a few hours after getting second vaccination she experienced edema and nerve pain in her legs that traveled up past her ankle causing her to not be able to sleep. She does have some edema and neuropathy as part of her history but she states that this was much more severe than normal.

Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event. appointments for a CT scan. Has mild facial drooping on the side that is already affected by TIA / cerebral hemorrhage. The long-term or permanent outcome is unknown.

arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: unknown), via an unspecified route of administration on 02Jan2021 08:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient noticed her arm was sore a few hours after vaccination on 02Jan2021. Yesterday on 03Jan2021, her arm was sore. On 04Jan2021, when getting dressed she noticed her arm was slightly swollen and there's a rash around the injection site. Outcome of the events was unknown.

20 MINUTES AFTER RECEIVING VACCINE, SHE COMPLAINED THAT SHE FELT A HOT SENSATION THROUGH HER BODY RIGHT AFTER THE VACCINE THAT LEFT AS QUICK AS IT CAME. SHE COMPLAINED OF FEELING LIKE THERE WAS A "LUMP IN HER THROAT". SHE DENIED ANY SWELLING OR DIFFICULTY BREATHING, ONLY THAT IT FELT LIKE A LUMP IN HER THROAT. THIS SYMPTOM GOT BETTER IN BY THE TIME SHE LEFT THE HD AT NOON.

patient complained of "flushed feeling" within 7 min of receiving vaccine; 2 min later c/o "tongue feels funny". Benadryl given, symptoms resolve

A little bit of tiny soreness in my arm; It is about the same that I would get from a flu shot; This is a spontaneous report from a contactable nurse (patient) and another nurse. This nurse reported similar events for two patients. This report refers to the wife. A 77-year-old female patient received first dose of BNT162B2 (lot number: EL3246, expiry date: 30Apr2021), via an unspecified route of administration on 06Jan2021 at single dose in the right arm for "to prevent getting Covid/COVID-19 vaccination". There were no medical history and concomitant medications. The patient previously took a flu shot and had soreness in her arm. The patient stated, "I am fine. I am not having any symptoms at all. A little bit of tiny soreness in my arm, it is about the same that I would get from a flu shot but that's it I am not sick, I don't have any temperature". The outcome of the event was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021028796 same reporter/drug, different event

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.

sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (enough to go to bed), stayed in bed all afternoon, got up for dinner (couldn't eat normal amount) and went back to bed and slept all night. Woke up ok on January 21 but still have light fatigue.

Approx 1 hour after injection (arm ok) top of head near crown on left side felt pressure extreme soreness to touch and like nerves were tingling. Did not have any of this before injection. This went on for rest of evening , all next day. Next morning was back to normal. Never any severe pain just pressure and soreness. Got inj. At 3:35 on Tuesday 1-19 2021 started feeling apps 4:30 same day into night. All next day Wednesday 1-20-2021 into night. Next morning Thursday 01-21 it was gone. Could not stand to touch that area on top of head.

10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have a BM, arriving home had diarrhea then tremors of both hands, fast heart, and extreme tiredness

within 45 minutes my face turned bright red and felt very warm lasted for a day and a half otherwise felt fine

While waiting 15 min. following vaccine administration in clinic waiting room per clinic protocol, pt. began experiencing numbness and tingling in arm where vaccine was administered. Symptoms went down patient's arm into hand/fingers. Pt. declined need for medical attention at the hospital and reported she just wanted to return home. Encouraged pt. to call HCP with any further symptoms or worsening of numbness/tingling. Pt. left clinic. Follow-up phone call made to patient in afternoon at approx. 1520 (01/21/2021). Pt. reported that symptoms had resolved at time of follow-up phone call and denied further need for medical attention.

Entire left side of my bod y, from head to foot, became numb and tingly very suddenly. I called 911 to make certain I was not experiencing a stroke. EMT assured me I was not. This was Saturday night. It is now Monday morning, January 25, and the numbness has not gone away.

Noticed the next day after the vaccination my arm was sore, then itching with hives. Took Benadryl and put some cortisone on it to stop the itching.

Sore arm; This is a spontaneous report from a contactable consumer (patient's husband). This reporter reported similar events for two patients. This is 2nd of 2 reports. A 77-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 11Jan2021 12:00 PM at single dose for covid-19 immunisation. Patient's medical History and family medical history was none. No additional vaccines administered on same date of COVID vaccine. No other vaccines were received within 4 weeks prior to the first administration date of COVID vaccine. The patient's concomitant medications were none.The patient got the Pfizer Covid-19 vaccine yesterday and had sore arm on12Jan2021. The patient's soreness in arm didn't start until this morning, 24 hours later. It's not a real big problem for her and it's getting better and almost gone. The outcome of the event was recovering. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026388 same reporter/product/Event, different patient.

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.

Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shaking for 12 hours. Urine is now colorless instead of yellow-orange. I have had no treatment. Urine remains colorless, but other symptoms are almost resolved.

Approximately 25 minutes after receiving the vaccine, pt. started c/o headache. Upon assessment, pt. appeared to be weak and lethargic. BP: 130/74, HR: 42, RR: 16, O2 sats: 93-98%. No other symptoms noted at this time. Local EMS was called for assessment. Pt. and daughter decline taking patient to emergency room, but is going to make an appt. with PCP at this time.

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.

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...

Palpitation, shaking, weakness, sudden onset on 1/27/21 at 8:00am. Was seen in the ED and found to be in sinus tachycardia; resolved without intervention.

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.

arm soreness; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies- there's a whole list of things she couldn't take; carried an epi pen for years. Concomitant medication included cetirizine hydrochloride (ZYRTEC) to avoid allergies. The patient had the 1st dose yesterday and she's feeling good. She had no side effects except for a little bit of arm soreness on Jan2021. Her doctor told her to take Tylenol for arm soreness, but another woman told me not to take Tylenol, but the patient didn't need it anyway (unknown if treatment was received). Her doctor was giving her Zyrtec to avoid allergies because there's a whole list of things she couldn't take and have carried an epi pen for years. She took Zyrtec before having the vaccine and would take another before the second dose. Would this make the vaccine less effective? Her appointment was 16Jan2021 and she have already scheduled for 08Feb2021. Do they give you a timetable? What was the timing of the 2nd dose of vaccine? The outcome of the event was unknown. Information on the lot/batch number has been requested.

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

1/26/21 @ 5PM C/O TINGLING ALL OVER BODY AND RIGHT EYE". DENIES ANY TROUBLE BREATHING OR SWALLOWING, NO EDEMA OF LIPS. A/0 X3, SKIN PINK W/D, RESP REG WITH EASE. 1/26/21 @ 5:15PM CLIENT STATES SYMPTOMS ARE THE SAME AND "WILL TAKE BENADRYL WHEN SHE GETS HOMEIF NEEDED". 1/27/21 @ 9:25AM CLIENT STATES ALL SYMPTOMS HAVE RESOLVED.

ABOUT AN THIRTY MINUTES OR SO AFTER THE SHOT THE PALM OF MY HANDS AND BOTTOMS OF MY FEET STARTED HEATING UP AND TURNING RED. I TOOK A BENADRYL AND IT HELPED A LITTLE. SUNDAY THE SHOT SITE STARTED TURNING RED AND WAS SWOLLEN A LITTLE LARGER THAN A QUARTER.

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.

Short lived but I thought you should be advised. Heavy feeling in legs starting around 4.5 hours after shot, lasted for approximately 24 hours. Also arm felt sorer that on first show. Now feeling fine

Chills; low grade fever 99.4 orally; fatigue; weakness; This is a spontaneous report from a contactable Physician. A 77-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose (2nd dose) for covid-19 immunization. Medical history included high cholesterol and has no known allergies. The patient's concomitant medications were not reported. The patient had her first dose on left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685) at 12:00 on 22Dec2020 but had slight discomfort site injection and occasional soreness site injection over the subsequent 3 weeks. For vaccine dose 2, it was reported that after 30-36 hr, patient developed chills, low grade fever 99.4 orally, fatigue, weakness and took ibuprofen. She slept normal by 42 hrs and no further complications. The outcome of events recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in a school clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number has been requested.

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.

Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; 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 EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.

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

About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme muscle aches and headache. My fever lasted about 12 hours running between 100 and 102 (on tylenol) Headache continues. Muscle aches and fever subsided about 24 hours after onset.

Sore arm started in the middle of the night--still sore two days later. General achiness all over. General tiredness.

soreness in right arm; numbness in right hand; tingling in right foot; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EL9262), via an unspecified route of administration in the right upper arm on 20Jan2021 at single dose for covid-19 immunisation. The patient medical history included ongoing diabetes. Concomitant medications were not reported. The patient experienced soreness in right arm, numbness in right hand and tingling in right foot on 22Jan2021 with outcome of not recovered. She was schedule for the second dose on 10Feb2021.

sore arm, chills and exhaustion so bad came close to being nauseous. All in first 24 hrs. Was fine 24 hrs later

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.

Note:Tested positive to CV19 27th October 2020 Pharmacy. CV19 Symptoms: High fever and fatigue. No loss sense of taste and/or smell. No breathing problems. 5th February 2021 Pfizer 1st dose CV19 vaccine. Scary symptoms started in grocery store parking lot around 6PM (after vaccine at 8:35A) my legs felt like they were partially paralyzed and I would not be able to walk to the car. I struggled to walk. Got home and laid down. Thought it was side effects to vaccine and it would pass if I went to sleep. Woke up and felt totally paralyzed and it required a lot of effort to turn on my side to try to reach my phone. All my muscles and joints ached. I am never sick and not a complainer.

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.

By the time 24 hours passed, I felt fine. Around 1:00 the following day I began to feel generally sick. I felt tired, headachy, nauseous. I rested and felt worse and worse. I soon began chilling -- couldn't get warm. After a couple hours, I took my temp and it registered 101.1. I went to bed feeling quite unwell. When I awoke the next morning, I felt pretty good and felt fine all the next day.

muscle in the right arm started to hurt.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982) via an unspecified route of administration in right arm on 23Jan2021 09:00 at single dose for COVID-19. Medical history included rotator cuff surgery on her left arm on 28Dec2020 that was affected by a flu shot that she just got (sore left arm Flu vaccine, 26Oct2019-27Oct2019), chronic lymphocytic leukaemia (CLL) (had it 20-25 years ago stated that she watches her white blood cell count on it). Family medical history relevant to AE was none. No vaccine was received within four weeks. There were no concomitant medications. The patient experienced muscle in the right arm started to hurt on 24Jan2021 17:00. She put ice on it as treatment. Relevant tests were none. The event didn't require Emergency Room visit or Physician Office visit. The outcome of event was not recovered.

Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain, swelling, lymphadenopathy persist now Taking acetaminophen. At home for now. Also adv warm compresses/drinks for comfort. Adv to FU with HCF trouble breathing or if symptoms persist/worsen.

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.

My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; 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: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing thyroid disorder. Concomitant medication included hctz. The patient experienced that her blood pressure was a little elevated, high for her/elevated blood pressure on an unspecified date. On 25Jan2021, the patient experienced arm sore. The patient underwent lab tests and procedures which included blood pressure measurement: 160/88 on an unspecified date, blood pressure measurement: normal (reported as normally around 130, 135, 138, normally runs 140/35-38), heart rate: 85 on an unspecified date, laboratory test: unknown result on an unspecified date. Clinical outcome of arm sore was recovering, while for blood pressure increased was unknown.

chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, joint pain. Injection site pain. Muscle pain. Nausea--did throw up twice. General feeling unwell. The fatigue has gone on for two weeks now. Starting to get better.

Patient received 1st dose of Pfizer Covid19 vaccine today at the Health Department at approx 10:56 AM; pfizer lot number EN5318. Patient has history of feeling 'flushed' after paxil, sulfa, flexeril, codeine; no history of anaphylaxis. Patient alerted the guardsman at 11:09AM that she was experiencing swelling and burning on her face and lips. Nursing and medic staff responded and observed swelling over her right eye and cheek. The medic reported a significant increase in swelling from her pre-vaccinated appearance. BP 118/76. EMS already on site. Epi 0.5mg 0.5ml (Lot 339384) administered RD IM and Benadryl 50mg IM LD administered at 11:11 AM. EMS called for 2nd transport vehicle and arrived at 11:23AM and assumed care of patient. Patient transported to hospital. Called patient on 2/11/2021. Patient stated feeling better. Stayed at hospital and was observed for 4 hours. IV and oral Prednisone given. Still has some facial swelling. PCP recommends not getting second dose.

One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place. Later in the day, I felt fatigued, and aching, and my left arm started to get very tight and sore. The next day I felt the same, and my lymph nodes under both my arms began to swell and hurt and my rectum began to have severe pain. Still had diarrhea. By day 5 my left arm ,at the site of the injection ,started to swell, get very hot ,and a large, bright red welt appeared which almost reached my elbow and went across the width of my upper arm.. I called my doctor and went to see her on the next day because it had gotten worse. She thought it was a local reaction and recommended ice, tylenol and benedryl. Again, as with the first shot, I am not sure if this is an allergic reaction or not., but thought I would report it.

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.

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.

She had Pain: Headache or Migraine after the vaccine. Onsite EMS was requested.BP 142/86 HR 86 99% O2 on room air. They were able to find a specific cause and she refused additional workup

Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was not tolerated as well. Patient experienced 4 days of a low-grade fever, fatigue, facial flushing, injection site pain, and itching of the upper arm with little relief from OTC ibuprofen. Recommended OTC acetaminophen and a follow-up appointment with her PCP.

Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left side) and painful throbbing on right side of neck.

Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health. On 2/14 @ 2 hours after having lunch, patient was found unresponsive with Respirations 60, pulse 130, PO 84%, blood pressure 105/68. Patient with lots of white foam coming out of mouth. Temperature to 101.3. Patient DNR B and family deferred transfer, wanted comfort measures only. Nursing received order for MSIR. Patient continued with temps in 99-100 range with tylenol suppositories. Patient passed on 2/16.

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

Sore left arm from 2/16/2021 thru 02/18/2021. Extreme fatigue and tiredness from 02/17/2021 thru 02/18/2021

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.

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.

Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever. Slept most of day until late afternoon when I finally took 2 aspirin. Injection site tenderness.

Patient face was flush. Noticed by family after the 15 min observation. Pt had no DIB or other complaints. Pts BP was high and has a history of hypertension. Unknown if this was caused by the vaccine or the patients preexisting health conditions. Pt was transported to hospital by ambulance.

chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.

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

on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke the next day my arms and legs and neck and head ached, like I was coming down with a flu bug. Slight headache, Lymph nodes in neck painful and sore, legs and arms aching, flu like symptoms

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.

Severe Diarrhea, vomiting, nausea, Severe weakness, Chills. Put on Ondansetron, the BRAT diet, and Pedialyte. Vomiting lasted 2 days, Nausea lasted 5 days, Diarrhea lasted off and on for 14 days, weakness lessened by lasted for 12 days, chills lasted for 14 days

2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last until about 4 PM 2/19/21 2/19/21 2:00 AM - discomfort chest/heart- Thought maybe I should mention it to doc if continued. Lasted 20 min. max. 2/19/21 12:30 AM-lower abdominal discomfort, bowel movement did not relieve discomfort - intermittent for several days until 2/23/21. Did not interfere with activities. Since symptoms were mild, I "toughed" it out. No medication

the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning, in cardiac arrest at home. Temperature on arrival to ED was 91 degrees. found to have severe anoxic brain injury after 60+ minutes of CPR. may already be brain dead.

Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective a 77 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L hand numbness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, 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, rapid progression of symptoms and respiratory distress. PMH includes DM, HTN, asthma. Takes metformin and losartan around noon every day. She has not taken her bp medication yet today as she takes it with lunch. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1145 02/25/21 1201 BP: (!) 160/97 124/83 Pulse: 72 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. 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 cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Coordination: Coordination is intact. Gait: Gait abnormal (walks with walker, steady gait). Comments: +5/5 strength against resistance to both upper and lower extremities. Assessment/Plan Treatment included: water 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) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved. Pt monitored for 20 minutes. She feels well. Possible more likely anxiety related than a local reaction. Pt aware to monitor and follow up with pcp if needed. Pt here with husband whom walked out with her. She declined wheelchair. She feels well. APRN Electronically Signed 2/25/2021 11:59 AM

Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Arm is sore; Heart is pounding; I'm a little jittery. I am very nervous; I'm a little jittery. I am very nervous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the right arm on 27Jan2021 (10:00) at a single dose for COVID-19 immunization at the school/student health clinic. Medical history included diabetes diagnosed about 12 years ago; high blood pressure diagnosed about 30 or 40 years ago; and weight loss. Concomitant medication included insulin (INSULIN) for diabetes. The patient previously took influenza vaccine, sitagliptin phosphate (JANUVIA) and tramadol (ZALDIAR); and had rash on both medications. The patient had previously received a flu shot around the 6th or 7th of Dec2020. On 27Jan2021, at "about 4PM", the patient had felt jumpy on the injection site/right arm started jumping; it had "been jumping, jumpin jumpin jumpin, a muscle twitch". Also on 27Jan2021, at "about 4PM", the patient's arm was sore; heart was pounding; was a little jittery; and was very nervous. The outcome of the events, 'felt jumpy on the injection site/right arm started jumping', 'had "been jumping, jumpin jumpin jumpin, a muscle twitch"', 'arm was sore', 'heart was pounding', 'little jittery' and 'very nervous', was unknown.

Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happened a day later, but I don't know if it was the shrimp I had that day. I was flushed and I got welts, so I went to the urgent care. I was prescribed an Epi-pen by my allergist after following up with them. I feel comfortable getting the second dose." Pharmacist and vaccine clinic lead notified. 30 min after dose given, pt states, "My ears are feeling a little itchy." Vital signs @ 1002: BP 175/80 P 69 O2 97% Temp 98.3 F R 12. VS @ 1007: BP 165/79 P 64 O2 98% Temp 98.4 F R 14. 1015 Pt states, "I'm feeling better and my husband is at home to watch me. I think I was just nervous." Pt declines dizziness/lightheadedness upon standing and declines any itching after second set of VS. Educated pt on strict ER precautions. Pt verbalized understanding and was appreciative for visit.

Shaking, chills, fever (101), headache, slight nausea, arm pain. Took Tylenol. Night sweat the following night. Event lasted 24 hours. Fine the following day, 2/27/21.

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

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.

Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covered up with more blankets. Upon wakening, felt felt totally exhausted and weak. I slept and took naps throughout the day. Some aches in the body and sore arm where injection was given. Continued to feel extremely weak and cold the next 24 hours. Felt better day after but still tired and weak. injectgion site reddened and sore. Injetion site still sensitive, rpink discoloration and lump under the skin

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.

Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension

Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to being put under anesthesia. Day 2 developed Redness and rash on chest and lower back. Day 3 developed a large cold sore on lower lip. Day 4 - 4 more cold sores on upper and lower lips. Day 5-6 fatigue. She was observed for an hour, offered water and juice following the vaccine and was released home.

Pain; Burning sensation; Hives; Injection site soreness; 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: el1284 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history included lymphoma from May2020, had chemotherapy for lymphoma from Jun2020 to 08Oct2020, shingles, knee replacement from 2008 and allergic to penicillin. The patient's concomitant medications were not reported. Patient stated she thinks she was having side effects from the Pfizer COVID-19 vaccine she got 19Jan2021, tomorrow 02Feb2020 was two weeks from when she got it. Patient didn't have any side effects to start with, just soreness to the injection site on Jan2021. She says last Wednesday, 27Jan2021, she noticed she had hives, not a rash, on her chest on the left side that are kind of on her breast, the top of her breast, which now spread under her arm up to her shoulder area and back. There was pain along with it, a burning sensation starting last night on 31Jan2021 in the inside area. Since she got her injection on her left side, she doesn't know if this could be a reaction to the injection or not. She had shingles several years ago, this was acting like that, and it looked like one of the side effects listed is lymphadenopathy, which she looked up information about that, but she doesn't know what it was, she doesn't know what else to blame it on. Patient hasn't seen her doctor yet for hives, and has not treated the hives. She got the OK from the nurse who said she didn't see a reason for her not to get the vaccine since she was coming off chemo several months prior. Patient was considered to be in remission right now, and she has an appointment next week with her oncologist for follow up. Outcome of the events was unknown.

Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itching. Rash to antecubital area of right arm starting on Sunday night.

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.

Got the vaccine, she went home around 3:30, and was very tired. She woke up after 6:00 PM. This morning she had swelling in her arms, real bumpy about 2 1/2" in diameter, looks like rocks, red/pink area 1 1/2". It is very painful throbbing area on her arms, getting worse. She has been taking Tylenol. She felt a little relief of the pain with the Tylenol. She rested all day yesterday. She left at 10:00 for her bridge club and that's where she noticed the reaction and has gotten home around 3:00 and not feeling well. They told her to call us as they did not have any side effects from the vaccine. She does have an appointment on 3/11/21 with her PCP.

DEVELOPED APPROXIMATE 3-4 INCH RED ITCHY RASH SURROUNDING INJECTION SITE 7 DAYS AFTER 1ST INJECTION. I APPLIED MEDICATED GOLD BOND ANTI-ITCH CREAM EACH DAY AND RASH LASTED 4 DAYS. DID NOT SEEK MEDICAL ATTENTION. RECEIVED 2ND VACCINE INJECTION 2/27/2021 WITH SORE ARM THE 2D DAY THAT QUIT THE NEXT DAY. SO FAR NO OTHER REACTIONS.

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

Two hours after injection severe pain in my right knee began and continues moderately today 3/3/2021. (injection given at 1452) The doctor suggested heat/cold, anti-inflammatory, brace and finally an x-ray which indicated nothing. Four days after the second injection I've experienced mild pain in my opposite thigh and fatigue. The second injection was given in the opposite arm (left). While chatting with others in recovery after second injection about knee pain, another woman said she was experiencing the same and thought it was her arthritis but it felt different.

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.

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 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 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.

It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; Felt like I was going to pass out; Felt unwell; 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 VACCINE, lot number: EN6201), via an unspecified route of administration (at the age of 77-years-old) on 15Feb2021 at a single dose for COVID-19 immunization. Medical history included Diabetes, asthma, High blood pressure, fibromyalgia, cane user, Neuropathy. Concomitant medication included pregabalin (LYRICA) and unspecified medications ("No, I am not because it's a very long list and I don't feel good, I am jerking and I just don't feel like doing that I am sorry."). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient stated, "My experience with the COVID-19, I had the injection on 15Feb, the second one and I went back and sat in my chair and I was okay. And then I got up to leave and I felt like I was going to pass out (15Feb2021). So, I sat down in the chair, my husband asked for the nurse and she came and she thought it was my diabetes which I also sort of felt that, but anyway I came home and I felt unwell (15Feb2021), that afternoon and then the next day, I would feel like that and then the next day I had improved but I started with this jerking and that has been going now since then but today it's more like (incomplete sentence). At first, it was like small and now they are getting big like a jerk. I called my family doctor yesterday and I talked with the nurse and she told me that I needed to be checked within 4 hours. So, I went to one of the in and out you know places, emergency places that you can go to and she took a lot of blood, and ones that came back were okay but the other results, she is not going to get until tomorrow, I have to go back. But have you have anybody else that has had this experience?" The date when adverse event started was reported as "Started out, it was like a little twitch on Wednesday night that would have been from Monday to Wednesday and then today it's just like a jerk, it's big. My whole body is just jerking. I did not feel well the afternoon I had it. But the next day, I thought I was better and that is when the twitch started." The patient was experiencing event worse than ever. It's like a bigger jerk now. No treatment was received for the events. Lab test: "They took 5 vials of blood yesterday when I went to that doctor, and I heard for some of it, but for the rest, I will have the results tomorrow and I just had my blood drawn on Thursday from my kidney doctor. So, I have blood drawn all the time." The outcome of the event "felt like I was going to pass out" and felt unwell was recovering, and "it was like a little twitch and then today it's like a jerk, it's big/whole body is just jerking" was not recovered.

tiny sore in her arm; 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: EN5318, expiry date unknown), via an unspecified route of administration on 23Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization. Medical history included back surgery on an unknow date and back pain from an unknown date. Concomitant medication included paracetamol (TYLENOL) for back pain from back surgery. The patient reported that her doctor prescribed Tylenol to ease the back pain after a back surgery that she had before. She is prescribed to take the Tylenol 4 times a day at 6 hour intervals. She stated that she read something about after taking the COVID vaccine to not take Tylenol. At the time of the report she is feeling good with no side effects but based on the report she read that after, she is not supposed to take anything, she wanted to ask will it affect the effectivity as she read in a literature that Tylenol will decrease the efficacy of the COVID vaccine. She was wondering if it is ok for her to continue to take Tylenol. The patient also reported that she only had a tiny sore in her arm on an unspecified date in 2021. She was scheduled for the second dose on 13Feb2021. The outcome of the event was unknown. The events were reported as non-serious.

Started having flu symptoms 3 hours after shot. By following morning had a temp of 105 and was not responsive. Rushed to Hospital by ambulance. Not responsive for 2 days. In hospital for 4 days. Hospital concluded she had a temp induced seizure. Worst response they had seen. Still rests and sleeps more than normal.

She can breathe better moving around but when she sits down, her breathing seems to be congested; Nose started stuffing up again; Her nose just swells; congestion in her chest; her arm was sore/ Little pain in her right leg; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) solution for injection, intramuscular on right arm on 01Feb2021 at 09:10 AM at single dose for COVID-19 immunization. Medical history included breathing problems and COVID-19 on 31Oct2020 in which she waited exactly 90 days to get the vaccine. The patient had a small touch of pneumonia on her lower lobe of her right lung, she was on a lot of antibiotics and a strong herbal solution. She was on one antibiotic for 5 days and another for 7 days. She was on the herbal stuff for 7 days. She took all that stuff and was drinking lemon juice and hot water and breathing in lemon scent and Vicks Salve all in her nose. She also was prescribed an asthma pump. She had all that stuff going into her system. She also was tested, and she has H. Pylori bacteria. She explained her whole family must have that, it's hereditary. That wasn't her issue. However, all that she put in her stomach and in her system caused her to have stomach issues. She told the doctor that antibiotics made her sick. She told the person administering the vaccine that antibiotics made her sick and she was told it didn't matter and that this wouldn't interfere with the COVID-19 vaccine. Her stomach was all messed from all that stuff. The patient also has anxiety. She has never been treated with anxiety. She has had anxiety since she was a very young women and she has never been treated for it. When probed for any product information she had available for the medications that messed her stomach up and made her sick she provided the following information: The first medication she took was azithromycin (Z-PAK, lot number: KG0706, expiration date: Nov2021, NDC number: 0781-8089-26) that was dispensed in a little box. Dose was 250 mg which she took daily doses for 5 days. One of the doctors gave her a levofloxacin 50 mg for 7 days. She was given the pump, salbutamol (ALBUTEROL SULFATE HFA INHALATION AEROSOL, lot number: 102B4, expiration data: 20Jan2022) 90mcg per actuation. She explained she only took this once. She was so scared from this stuff. It squirted down her mouth. Another doctor prescribed her omeprazole 40 mg capsule every day because she told him her stomach was messed up. The patient was prescribed amoxicillin 500 mg tablet, take one tablet, by mouth three times daily for 14 days and clarithromycin 500 mg tablet, take one tablet by mouth twice daily for 14 days. The new doctor also had her taking omeprazole (the doctor wrote another prescription for this). However, this time the dose was 20 mg and she was prescribed to take that twice daily for 14 days. She didn't finish this medication. She told the doctor that antibiotics made her sick and the doctor explained because of her bacteria, she ordered the antibiotics to make her feel better. The patient told the doctor if she could live like this, let her not take these medications until she gets her stomach better and she would eat healthy food and find natural antibiotics at the health food store. She mentioned using oregano. She took that once a day. When she knew she was getting ready to take the COVID-19 vaccine, she stopped taking that 2 weeks before taking the vaccine. She stopped taking cholesterol medicine at night 2 weeks ago, it was making her sick to her stomach. She stopped her potassium medicine. She didn't want any of the medicines interfering with the vaccine. The patient also took an herbal medicine that was called a Spiritual, Mental, Emotional, Elevation Science of Eternal Life. It's a detox mixture that was very strong. She took this for 7 days. She had lost weight because she was not eating. The patient has always been a junk food eater. She quit eating junk food and that probably also had something to do with her being sick. She cooks all her food. There was no additional vaccine administered on the same date with COVID-vaccine. The patient has no prior vaccinations within 4 weeks. She has never had a flu vaccine, pneumonia vaccine or shingles vaccine. This was her very first vaccine. Concomitant medication was reported as none. The patient didn't know if it was anything serious, but she tried to read all the information that was given to her. She was looking at the information and she saw "if you have any difficulty breathing". That was the only one that she was having. She could breathe better moving around but when she sits down, her breathing seems to be congested. She was calling to see if this was anything serious and if she needed to go the emergency room. Since her breathing has been acting funny, she has been trying to keep moving around. She was cleaning her bathroom and the Bleach Cleaner and other cleaner opened her nose. She was listening to a town hall meeting and when she sat down to listen to it, her nose started stuffing up again. She has just been trying to get up and move around. Since she has been talking on the phone, her breathing was a little better. Her nose just swells. She got up and was beginning to eat breakfast when all of a sudden, the difficulty breathing started happening. It was around 8:45 am this morning (02Feb2021). It has improved, but when she would sit down, it would tighten up and she would have congestion in her chest. Since she has been moving around talking, it has gotten better. Sitting down has something to do with the difficulty breathing. She has had breathing problems before. The patient received the COVID-19 vaccine yesterday, 01Feb2021. She sat for half an hour afterwards and then came home. She then slept all night and stated her arm was sore on Feb2021, but it was feeling better. She also had a little pain in her right leg on the side she received her vaccine on Feb2021, which was currently gone. She wasn't sure if the breathing problems were from the vaccine or something else. The patient did not go to the emergency room or visited his physician in response to the events. She mentioned that if this continues, she probably will go to urgent care. The outcome of the event dyspnea at rest and respiratory tract congestion was recovering, recovered on Feb2021 for pain in extremity, and unknown for all other events.

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

little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth area; As soon as I got the shot I felt a little strange; My arms hurting a little; I did not eat anything; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 25Jan2021 (at the age of 77-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid and mostly it's food allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) 125 ug, daily for low thyroid. The consumer stated, I took the vaccine on Monday (25Jan2021), three days ago and as soon as I got the shot I felt a little strange and I came prepared because I do have some reactions sometimes. Mostly it's food allergies but I guess was being prepared, so I took Benadryl with me and I took it out of the packet. When probed for the treatment, consumer stated, "I just took Benadryl as soon as I got the shot I felt a little strange and I was prepared and I took my Benadryl with me and we stayed there I guess about 45 minutes until I felt better it would have been 12:15 and I was fine." The consumer stated, "I have been trying for two days, that was in my arms hurting a little on an unspecified date in Jan2021 and then today (28Jan2021) around noon I was feeling a reaction again. I had the tightening in my neck and around my mouth area that's where I usually get the reactions from, but for two days I have been fine and I did not eat anything on an unspecified date in Jan2021 out of the way to give me a reaction to it. Now I took 2 Benadryl and it subsided but it's still tight around my neck and a little tight around my neck and throat, like a tightness. What am I supposed to do? After I took this shot on Monday today is Thursday and I am having the same reactions that I had when I took (incomplete sentence) (pending clarification). The outcome of the events as soon as I got the shot I felt a little strange was recovered on 25Jan2021, little tight around my neck and throat, like a tightness and tightening in my neck and around my mouth area was not recovered and other events was unknown.

Exactly 12 hours after second dose : Severe chills ,headache ,fever ,stabbing pains in both legs Shortness of breath Chills lasting 6hours Fever 12 hours Fatigue 2 days Weakness on going.

A few weeks after receiving the vaccination she felt confused, was going to drive. Ended up having a seizure she said and was taken to Hospital and then to another Hospital. Stated was there for 3 days.

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

March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -sore left calf March 6th- Sore left calf a little more so March 7th- Outside left calf hot to touch & back of calf red and sore. March 8th- Same as above, and I put doterra Deep Blue ointment on it, and it relieved the heat and pain Redness is gone March 9th -Left side of body joints ached. left calf aches/applied Deep blue ointment and a Pain relief ointment . Feels a lot better March 10th- Redness gone, but still feels sore March 11th- Left leg Calf feels a lot better, I put on the ointment again. Deep Blue, and Frank Woods Pain Relief ointment. March 12- Left calf a little sore. No heat . Now my left eye has a light grey spot in it. I can see around it. March 13-Eye's don't feel right. I still have the light gray floater in the left eye.

weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; expiration date 31May2021) via an unspecified route of administration on 05Feb2021 at 11:30 (at the age of 77-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included losartan, escitalopram, and atorvastatin from unknown dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL1284; left arm) on 15Jan2021 at 11:00. The patient previously received codeine on an unknown date for an unknown indication and experienced allergy. On 06Feb2021 at 13:00 the patient experienced a weak feeling and heartbeat climb up. The patient had a weak feeling, had to sit down and took her pulse with oximeter and her Apple watch. She watched her heartbeat climb up and up. She tried yoga breathing but could not slow it down. She was not sure how long this went on because it was very unnerving, but it reached as high as 105 before it started to go down. The beats went up, then down, finally started to keep going down. Once more there was a wave of the weakness through her before she stayed in the 73+ range. The patient was usually in the 60's. Since then the patient's heartbeats have been what is usual for her. During the episode the patient's husband found "rapid heartbeat" on the paper they received. The patient was concerned this happened a day after the vaccine, not within an hour. The events were reported as non-serious. The patient was not hospitalized and did not receive any treatment for the events. The outcomes of weak feeling and rapid heartbeat were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

Week 1 flu symptoms chills, fever ,fatigue, headache Week 2 chills, fever, fatigue Week 3 intermittent chills, fever, fatigue, night sweats week 3 continuing, some days no issue, next day all symptions

On the day after I had pain in my left side. On the following day, I went to the ER with severe sciatic. This recurred and on Feb. 24 I was admitted to the hospital with severe inflammation in my spine.

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.

severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/grip in arm/hand.

Lymph gland under left arm size of golf ball, smaller glands swollen underarm, (soft), neck swollen, left foot swollen, weakness, small blood clot in myopic of middle finger, small modules in upper thigh, sore on lower lip right side

3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the last 2 days. Diagnosed with pneumonia and hypoxia, confirmed by imaging. Covid test negative on admission.

Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in my head. Came home and covered up as chills started. After 12 hours the fever gradually subsided as did the pain in my neck and shoulder. Was left with headache that remained overnight but the pressure was not like the day before. Saturday I was just tired, I think from the fever, but by the evening I was back to normal.

One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.

Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose. Information about Batch/Lot number has been requested.

flushes - feeling hot on her chest as per patient; BP=180/104; HR=66, O2=96RA; lungs-clear. Hx-HTZ, increased cholesterol, hypothyroid.

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.

Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had complaints of tremor, weak voice and cough with deep inspiration. Appeared to be developing cellulitis to bilateral lower extremities- treated with oral antibiotic. Oxygen level was good in office, advised to monitor for worsening.

"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

Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Demetia increased to meditate to severe dementia in a matter of hours.

2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2021 DAY OF INJECTION #2 - MILD SORE UPPER LEFT ARM RADIATED TO LEFT SHOULDER BLADE, USED TOPICAL ARNICARE FOR THE SORENESS WHICH LASTED ABOUT 24 HOURS 3/21/2021 VERY SORE UPPER LEFT ARM, SUDDEN "CHARLIE HORSE" RADIATED FROM THE INJECTION SITE TO THE LEFT SHOULDER BLADE, LUMP/KNOT UNDER THE INJECTION SITE ABOUT THE SIZE OF A WALNUT, USED ARNICARE AND MASSAGE, NO RASH OR VISIBLE BRUISING, SORENESS LASTED SEVERAL DAYS

Red whelp developed at injection site approximately 24 hours ago, it was approximately a quarter in size and has progressed to redness down the arm. site is red and tender to the touch. The patient has applied an ice pack to the area.

10:25:10 minutes post receiving first dose of Pfizer vaccine pt reported having throat tightness and voice hoarseness "similar to when she has as asthma attack." HR 72, BP 180/60. Pt repeatedly apologizing stating "I'll be ok." 10:27:Ambulance service requested. 1030:Pt medicated w/ Benadryl 25 mg PO per standing order. 10:32 Ambulance arrived, report given to Paramedic. 1040: pt transferred to ambulance. 1045: Ambulance departs site.

facial flushing and redness, mild swelling. No shortness of breath or itching. Started within 1-2 minutes of receiving vaccine Treatment: Benadryl 50mg IM within 5 mins of reaction onset. Observed for 30 mins; feeling better; sent home; advised to call 911 if recurrent or new symptoms

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.

severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; 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 EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.

Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with blue tiny veins extending into left chest area.

Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up my arm . Some pain and lumps. Fast heart rate

I noticed my wife's face drooping about 9 PM Friday, 3/19/21. We went to Urgent Care on Saturday, 3/20/21. The doctor there, diagnosed her with Bell's Palsy. She was put on 60 mg 1X/day of prednisone, and 1g of Valtrex, 3X/day. The diagnosis was confirmed by our family doctor, on 3/25/21. She has completed the medication and the Bell's Palsy continues.

had diarrhea last night; had cramping most of the night; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry was not reported) via an unspecified route of administration in Arm Left on 02Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Feb2021, the patient experienced diarrhea last night and cramping most of the night. Additional Context included, caller states that she got the COVID vaccination. Caller states that she did not know what she was getting until after she got the injection and this paper they gave her. Caller states that her daughter had called and said that there was clinic, and the lady from the clinic called and scheduled an appointment for the caller. Caller had no other vaccines on the same day as the COVID vaccine. The outcome of the event was unknown. Follow-up nformation on the lot/batch number has been requested.

On March 1, I developed bed-shaking chills, fever to 101 and diarrhea lasting for several hours. Resolved without treatment.

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,

Severe muscle/nerve pain in neck, back, gluts, hamstrings while in bed from 3 am to 6 am. It has occured for four nights five days after the vaccine shot. Daytime okay. Taking Tylenol 625. Did not affect it. Need advice if this is a reaction or I should see a doctor.

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)

Diffuse body aches, muscle tenderness and neuropathic pain beginning 1 day following injection. No abnormal physical exam findings.

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.

headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was 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 COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering. Additional information has been requested.

sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative. The outcome of events was recovering. No follow up attempts are possible. No further information is expected.

I am 77. I had the Pfizer vaccine, March 9th, with a terrible reaction starting 2 days after. I couldn't use my brain to think, to read with comprehension, to remember things I wanted to remember and had difficulty finding my words. This lasted for 3 days when the fog began to lift. I also had some shortness of breath(SOB) and very low energy. The CDC has said that when giving the injection it is no longer necessary to aspirate (pull back on the syringe) which I was taught to do as a young nurse to ensure that you are not giving the injection into a vein (blood would appear in the syringe.) It is supposed to be given into the muscle which has plenty of veins so if you don't aspirate, how will you know if you are injecting into a vein? A week later, I ended up going to the local hospital ER because of the SOB and had Chest xray, EKG, brain Cat Scan and blood work which were all normal. I debated about getting the second shot but decided to get it as long as the injector gave the injection as I had been taught. Fortunately she was very experienced and agreed to inject me using the pullback method after I explained what I had gone through the 1st time. So for the second shot I had the sore arm but no other reaction. I think Dr is making a mistake about the pullback decision. Do we even know what happens if the vaccine is injected into a vein? I am not certain if my first shot was injected into a vein because the injector never pulled back to check. I have not heard of anyone else with my experience.

a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling good at all; Feels miserable/horrible and woozy; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included , thyroid disorder from an unknown date and unknown if ongoing Thyroid is low ,diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin at 500 mg taken for diabetes mellitus, start and stop date were not reported and levothyroxine sodium (SYNTHROID) at 100 mcg taken for thyroid disorder, start and stop date were not reported. The patient previously took Historical Vaccine BNT162B2 (she got her first shot on 19Jan2021 with no side effects; Batch/lot number: EN9581; Dosage text: Once by injection in the left arm )on 19Jan2021 for Covid-19 immunisation. The patient experienced a really bad headache, a very sore arm , fever with temperatures of 100.3 to 101f, she's not feeling good at all , feels miserable/horrible and woozy on 10Feb2021. she received the 1st dose of the vaccine last 19Jan2021 and had no side effects. She received the 2nd dose yesterday and woke up in the middle of the night due to a really bad headache and a very sore arm. She woke up today and still had the symptoms along with a fever with temperatures of 100.3 to 101 F. She's not feeling good at all and is asking if these are all common side effects of the vaccine and on what she should do. The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit on 10Feb2021 she took it again at 1:25 and it got up to 101. The action taken in response to the event for bnt162b2 was not applicable. The outcome for the events a really bad headache, fever with temperatures of 100.3 to 101F, and Feels miserable/horrible and woozy not resolved and for other events was unknown. Information on the lot/batch number has been requested.

Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills took Tylenol and napped for hrs for two days. 2 heavynosebleeds right nostril one wk later. 2nd shot on 2-21-2021, Hot, 4 nights of night sweats, Two more bloody noses right nostril. Tired

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.

Flushing of face and forearms, lasting a few minutes at a time. Occurring intermittently, up to 3-4 times per day

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

After vaccine it was almost a month later, the bed was shaking and she was having a seizure. I tried to get her back on target and called the ambulance. In the ER she started having a seizure again and I called the ER doctor. He said if that's what happened earlier and said its definitely a seizure.

she and they thought she was having a heart attack; she must have passed out because she didn't remember all the tests; she got a sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat; hard to breath, she got a sharp pain underneath her left rib cage; the muscle that goes around her heart, it was having like a charley horse; heart rate, She says 102, 103, it went up to 200 in the ambulance.; chest pain; Nausea; hard to breath, she got a sharp pain underneath her left rib cage; 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 EL3246), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation for a about 6 years , ongoing anemic for the last 20 years, glaucoma from 1998, had both eyes operated on and in 2016 she was operated on again, cataract had this 4 years ago in she says, in 1918, 1919, she clarifies 2018, Cardiac pacemaker insertion which pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe, blood pressure, arthritis throughout her body and had 30 operations, body doesn't absorb what she eats, anxiety, asthma, muscle spasms; she reported she has had a lot of surgeries, both of her ankles have had triple fusions, these were in 2005, 2010, 2014, 2018, both her ankles were fused, she had 5 surgeries on her feet; she has had both of her knees replaced because of arthritis, 2012 and 2015 she believes, had numerous other surgeries and she doesn't want to go through all of them, a right shoulder reverse rotator cuff repair, she had a rotator cuff put in, she doesn't have a rotator cuff, this happened in 2019, her left shoulder, because of an automobile accident, rotator cuff was so damaged that they couldn't repair it, she has minimum use of her left arm and has had operations on her left shoulder in 2005; had a pacemaker put in about 6 years ago, the next morning they kept her overnight, they came in, they took an Xray, she had to go back 2 days later because the lead had come of the heart, they had to go back in an reattach the lead to the heart; 2 years ago her pacemaker was going all over her chest, the doctor did not believe her and it landed under her armpit, it was the size of an orange, the doctor thought it was a lump, she went to the hospital, her pacemaker started falling apart, they took it out and put a new one in, it was about 4 years ago; a lump in her breast, she has been put under 30 times, they were all necessary, nothing for glamorizing; had surgeries in her left arm and some fingers than were numb. There was no prior vaccinations within 4 weeks, no events prior vaccinations and no family history. Ongoing concomitant medication included baclofen taken for muscle spasms for about 2 years, calcium for arthritis and her bones degenerate for 30 years, ergocalciferol (CALCIFEROL VIT D) taken for gets anemic real easy for 20 years, duloxetine taken for anxiety, taking this about 3 years ago; ferrous sulfate taken for anemic real easy for about 20 years; folic acid taken to rebuild cells taking this she thinks in 2015, furosemide taken for a diuretic to get rid of fluid for 2 years, metoprolol tartrate taken for atrial fibrillation, and blood pressure, taking this since she had her pacemaker put in; montelukast for asthma for 20 years; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis for 20 years, and warfarin taken for blood thinner/thin the blood out so she doesn't get blood clots; and adults vitamins for bone supplement and metabolism for 20 years as her body doesn't absorb what she eats. She says she takes a lot of medications and when she does blood bloodwork she was low so they make her take them. The patient previously took rivaroxaban (XARELTO). On 06Feb2021, the patient experienced she thought she was having a heart attack. The patient reported that she had to call an ambulance at 11:30 at night, she thought she had a massive heart attack. She had chest pain, nausea, it was hard to breath, she got a sharp pain underneath her left rib cage. She stated that when the ambulance got here they thought she was having a heart attack, they did nitroglycerin, when they got to the house, when in the ambulance on the way to the hospital they did another pill of nitroglycerin when they got to the hospital. The pain was a number 10. She stated she broke out in sweat, once they got her all hooked up they got to the hospital 6 miles away to the hospital. She was there for 2 full days, they did Xrays, dye in her, checked her hears, and did bloodwork. When she had chest pain, she reported they gave the morphine, it lasted about 6 hours; she still had problems breathing, they took her, she must have passed out because she didn't remember all the tests, she was in and out of it, the severe pain stopped after 6 hours, still had pain off and on, periodically. When she got pain in the ambulance then the nausea went away. After the hospital nitro and another shot for the pain, the nausea stopped. After the hospital after this they gave morphine and the pain subsided a little but didn't totally go away until 6 o'clock in the evening, she still had problems breathing because every time she breathed she got pain under her left rib cage. She says the sweat was at home, real bad, number 10, she broke out in a clammy sweat, on the 6th when she was having pain. She says that after the hospital, a couple days after that, she saw her cardiologists, he told her what happened, it was related to vaccine, it was the muscle that goes around her heart, it was having like a charley horse, he says it felt like you're having a heart attack, her tests said her heart was good. She talks about her blood pressure and heart rate, and says 102, 103, it went up to 200 in the ambulance. She says they thought it was a heart attack, her blood pressure was usually low blood pressure and all the symptoms she was having was because of her muscle having a charley horse that felt like it was coming from the heart, if they had contacted him, he said she would have just needed a massive amount of anti-inflammatory and it would have stopped the pain. The events required an emergency room visit. She wanted to know if anybody else has been hospitalized for massive heart attacks and says that's what she was having. The patient had her second shot on 22Feb2021. Outcome of event nausea was recovered on an unspecified date; and outcome of the rest of events was unknown.

Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool/there may be something in the vaccine that could help her Irritable Bowel Syndrome; Aching arm; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on the left arm on 28Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the Health Department. Medical history included ongoing irritable bowel syndrome for over 50 years; high level of hormones; was losing hair; and had rectal bleeding from Jan2021 to an unspecified date. Concomitant medication included ongoing spironolactone from Jan2021. On 01Mar2021, the patient did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool, and mentioned that there may be something in the vaccine that helped her irritable bowel syndrome; and had aching arm. On 02Mar2021, the patient was bleeding; had blood in her stools; and had volumes of regular stool, and went to the bathroom 20 times. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Mar2021.

Patient walked into clinic on 4/19/2021 to report adverse reaction that started on 2/27/2021. She stated that her arm had pain and was not relieved by cold compress, warm compress, and Aspercreme. Recommended that she follow-up with her primary care physician for possible injury at injection site.

Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Patient is a 77-year-old female with past medical history of bilateral breast cancer (post bilateral mastectomy), CHF, CAD, CKD stage II/III, HTN, obesity, obstructive sleep apnea (not on CPAP), and spinal stenosis presenting today. Patient presented via ambulance her daughter. Patient was unable to cooperate, HPI obtained from patient's daughter. Patient's daughter stated approximately 1 week ago patient started to be "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. She seemed the be "acting different". When asked, pt denied any pain over the last week. Her daughter denies any infectious process such as fever/chills or cough cough. Her daughter notes approximately 2 years ago patient has similar event, was seen in the ED, but nothing remarkable was found. Reviewed today, patient's daughter stated the patient had a "shaking "episode in had "on responses ". It was described as "shivering" and a blank stare during this unresponsive state. Episode lasted approximately 1 minute. The daughter denied any history of strokes or seizures. Pt usually lives with another daughter and so the daughter present was unable to verify if pt takes her prescribed medications daily. Her daughter denies knowing any Advance Directives or POA set up. Smoking, alcohol, and illicit drug use were denied. Pt was seen 9/2019 for a similar event with concern of stroke vs syncope vs TIA that resolved on its own. 3/25/21: 77-year-old F presented on admission that began approximately 6 days prior. HPI obtained from patient's daughter on admission. Patient's daughter stated approximately 1 week ago patient started to become "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. Patient's daughter stated the patient had a period of unresponsives and was shaking her left arm on the day of admission. It was described as "shivering" and a blank stare during this unresponsive state. Left sided weakness was noted. In the ED, vitals signs significant for 88% on room air. CXR showed bilateral infiltrates in lower lobes, CT of head was unremarkable, EKG normal sinus with sinus arrhythmia, CT of chest completed due to elevated D-Dimer showed no PE but showed ground-glass airspace disease and stable 14mm nodule at lower pole of right thyroid. Pt was admitted for Acute Encephalopathy with unknown etiology. COVID testing came back positive. Patient started on Routine COVID management protocol which included IV dexamethasone, remdesivir, vitamin D, vitamin C, zinc, with daily labs (d-dimer, CPK, CRP, CMP, LDH until stable/not upward trending). Patient to continue vitamin D, vitamin C, and zinc upon discharge to rehab. Patient had MRI obtained which showed scattered foci of acute infarcts right posterior parietal lobe/multiple foci of acute microhemorrhages likely hypertensive. Neurology consulted, stated infarct could be due to COVID so continued on lovenox and stopped aspirin. Recommended to keep blood pressures 110-140/80-90. Last documented note from neurology was 03/22/2021 - contacted multiple times but unable to reach afterwards. Discharging patient on xarelto for 30 days and recommending to follow-up outpatient to transition to aspirin and plavix. With this management on board, patient's symptoms improved significantly since admission. Patient discharged in stable condition to rehab.

Was feeling nervous and shaky prior to arrival at vaccine center, not much to eat today. Received Pfizer vaccine #2, few minutes later, shakiness increased, with observed mild physical shaking of arms. Patient brought to Med Obs #1, Assessed by PA and MD. VS initially at 1405- BP 174/80, HR 72, R 16, O2 sat 100, CTA, RRR, no focal neuro signs, mild B arm tremor, voluntary. Pt observed x40 minutes, shakiness resolved, VS 1415 HR 72, R 16, 156/81, O2 100%, pt released to son at 1445.

I felt very tired verbatim/ exhausted; low energy; felt lousey for about 6-8 hours; This is a spontaneous report received from a contactable consumer (reporting on herself). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EK9231and Expiration Date was not reported), via an unspecified route of administration in in Arm Left on 12Jan2021 12:00 as single dose for COVID-19 immunization. Medical history included, asthma, urticaria from an unknown date and unknown if ongoing , crohns disease all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunisation and experienced drug ineffective, covid-19 pneumonia, rash. The patient previously took cephalexine and experienced drug hypersensitivity. It was reported that when patient received her second injection, 2 was out of Quarantine for Covid. Also she asked her doctor If she Should even both to have this injection because apparently she had had Covid pneumonia, through by 02Jan2021. She was feeling a lot better , she was advised by her doc to go ahead & have it., which she did. No problem from Noon when she got shot to Noon Next day, but after lunch ,felt very tired, exhausted & low energy, was very wcepcited, lay on the cover, went to bed early & woke up next day feeling fine. Test: Blood test for HLA-B27 had lite @ 3x the testing Date: 15 years ago Also 25 yrs ago Result: Yes always 3x Comment: This is for Ankylosing spondylitis, Crohn's disease, Citifies, All of which she have had, the as ongoing.The outcome of the events was unknown.

allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; doesn't feel good; one heck of a temperature; By doing what she did, if that negated the COVID vaccine/ That's what she was afraid of; redness and swelling in her right arm; redness and swelling in her right arm; feeling hot all over the body; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 08Feb2021 at a single dose for covid-19 immunisation. The patient's medical history included weakened immune system because of the alcohol allergy (started while 19), and aches and pains. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (expiry date May2021) for COVID-19 immunisation at the age of 77 years old last 22Jan2021 administered on the upper righthand arm later clarified as upper right arm; and she was still going through that systemic reaction when she had her first COVID vaccine. The patient asked on regarding how effective the vaccine was related to receiving steroid therapy. Patient was advised by doctor to go to urgent care to have a covid test to see if she and husband were exposed to covid before the vaccines kicked in. Patient stated that on an unspecified date in 2021, she still didn't feel well and was running one heck of a temperature (increased). Patient reported she had a severe allergic reaction to the vaccine. She filled out the forms. Patient felt like she should be put in the hospital. She has a horrific allergy to alcohol. Each time she receives an injection it gets worse. She knew when she received the second dose that the third ingredient was alcohol. She thought about was worse, the virus or the reaction. Within a minute of taking the vaccine she had a reaction. She reported it at the site and was watched for a half hour. Her question was "because she took prednisone immediately after getting the vaccine does that negate the shot?" She was not asked the name of the steroid that she took. She was taking prednisone 20mg, 2 tablets as soon as she gets a shot then 2 daily Monday-Friday. It was still going through her system and it was reeking havoc on her. If she goes to the hospital they will give her Benadryl and monitor her. Patient stated that on 08Feb2021, she had an allergic response to isopropyl alcohol in second dose of COVID vaccine. Patient stated that she had both COVID shots and had adverse reactions and took some medicine for the adverse reaction and now the patient was concerned it might mess with the shot, it might not work for her as it should. She knew that this was going to be a long process and she knew her allergies were rare, but they were there. She is allergic to isopropyl alcohol, even if it is in shampoos or liquid soaps, she gets reactions. She had her first COVID vaccine and she had her own hospital cleanser that she has with her at all times and she used it which was not a problem. For her second COVID vaccine, the nurse was naming the 3 ingredients that were in the COVID vaccine and asked if she was allergic to any. She said this last shot had alcohol in it, she sat with her husband next to her, and thought which was worse: getting COVID, the cases in the city are high, or having a reaction to the alcohol. She chose the latter. When it went into her arm she immediately knew she was getting a reaction. She had steroids with her just in case this happened. Each time the reaction happens, it gets worse. She said she sat for half an hour and has been on steroids until last Friday. She was supposed to be on them for days. On Friday, she was wondering if taking the steroids negated the effectiveness of the COVID vaccine and that's why she called in. She knew that this was rare and it was not something that the company going to say that the company know how to fix it. Patient worked in the health unit of a university as a hiring and firing people person. So, she was around it, but she was not a doctor or a nurse. So, she guessed the answer was no. Last week she received her second COVID vaccine. She said, she has got to get rid of 5 pounds, but it's harder to do that when you're older. She experienced the reaction from the isopropyl alcohol within her second dose of the COVID vaccine last week, 08Feb2021. She said she was still going through it and will for a while. When asked for the outcome, she said she couldn't answer that honestly. She said she didn't feel good (2021). Period. She knew that when she goes through this it takes, each time, an extra 4 to 5 days to get over it. When she got up this morning, she didn't feel good. Her husband asked if she wanted to go sailing, and she said not in 30 degree weather, but for her to say no to sailing, her husband knew she didn't feel well. She couldn't say worse, but she can say she didn't know how long it was going to be, which was scaring her. By doing what she did, if that negated the COVID vaccine, then lets go from there. That's what she was afraid of. When she tells people she is allergic to alcohol, and when it happens, they look at her like "nobody is allergic to alcohol." She is 77 and has the aches and pains of a 77 year old, which she hates. But she doesn't think there are related medical conditions to what she experienced. This (allergy to alcohol) started when she was 19 and it has gotten progressively worse. So she tries to be careful. She says this was her, not dumb, but her decision that she made and now she is concerned. She said no to any tests done. She had the immediate reaction and she knew what to do. Patient further reported that she has allergy to alcohol and had an adverse reaction after the 2nd shot due to alcohol swab and on an unspecified date in 2021, she experienced redness and swelling in her right arm and feeling hot all over the body. Patient asked if her doctor will prescribe Benadryl to manage my allergy will it affect the effectiveness of the PFIZER-BIONTECH COVID-19 VACCINE. Therapeutic measures were taken as a result of the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The patient did not recover from the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The outcome of the other events reported was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : 2021167304 PFIZER INC

bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours; swelling at the entry of the injection; knot at the entry of the injection; just feeling unwell; Night sweats; lethargic; This is a spontaneous report from a contactable consumer(patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 02Feb2021 23:15 as SINGLE DOSE for covid-19 immunization. The patient's medical history included knee replacement, 3 times pneumonia, surgery for mitral valve repair ablation and atrial fibrillation, all from an unknown date and unknown if ongoing. On 25Jan2021 at 2:00 pm patient received first dose of Bnt162b2 (Lot no: EL3249) in left arm. On 11Feb2021 10:30 pm patient experienced bone very painful for 24 hours, extreme fatigue, weakness, muscle and bone very painful for 24 hours, swelling, knot at the entry of the injection, just feeling unwell, night sweats and lethargic. Outcome of the events was not recovered.

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.

Tingling in my left hand; severe throbbing pain in my left arm; This is a Spontaneous report from a Contactable other HCP (patient, self-reported). A 77-years-old female patient (patient was not pregnant) received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient's medical history included allergy to amoxicillin. The concomitant medication included vitamins. On 11Feb2021 at 12:00 AM, the patient experienced tingling in left hand for 3-days still present time, 2nd day after COVID Vaccine she had severe throbbing pain in left arm and took tylenol-MAPP 650 Mg every 8 hrs. Also Ibuprofen 400MG 4-hrs after taking tylenol. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not take any other vaccine in four weeks. Patient took tylenol-MAPP 650 mg every 8 hrs and Ibuprofen 400mg as corrective treatment. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was considered as not recovered. No follow up attempts are needed. Information on Lot/batch can not be requested. No further information is expected.

Client c/o sore LD. Minutes later c/o neck and shoulder pain. Nurse called EMT to do vitals on client. Client also explained that she was very nervous. Vitals taken BP 129/69, HR 66, Resp 19. Recheck BP 131/73. Client advised level of pain/discomfort down and released.

Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL7Z69 ; expiry was not reported) via an unspecified route of administration on 10Feb2021 as single dose for covid-19 immunisation (at the age of 77 years). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and sensitivity on right side of my face, nose, right nostril, and upper lip; and she took Lyrica (lot number: 19074111; Investigation Assessment: No) to see if this was a nerve issue and as therapeutic measures. She took a Lyrica this morning (12Feb2021) to see if this was a nerve issue and she took a Lyrica, Saturday as well. She was just checking to see if she had numbness and sensitivity on the right side of my face and the nose, the right nostril, and the upper lip of the mouth, was this a cause of the shot and is this the reason of Covid or not. The outcome of numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue was unknown. Information about Lot/Batch number has been requested.

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

Mild sensation in left chest area and along left side neck, along with mild shortness of breath starting about 3/20/21 Has since disappeared. On or about 3/25/21 a hard, painful rash appeared on buttocks and has since healed. A second larger painful rash appeared in a different area on or about 4/5/21 and lasted about 2 weeks. Along with rash is tenderness of skin in surrendering area of rash, there is pain under breast area which extends to back and persists.

could not walk or eat; could not walk or eat; sore arm; doctor took a test and the caller has antibodies and they are there but not very strong; anaphylactic reaction; excruciating pain in the body; felt like if her internal organ were shutting dow; was so weak her husband fed her and made sure she was drinking; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 08Mar2021 15:30 (3:30 PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hashimottos (reported as hoshimottos) Diagnosed 35 years ago, hypermobile Diagnosed 20 years ago, and disorder nomia Diagnosed 25 years ago; all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID); diazepam (VALIUM); and levothyroxine (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 on 15Feb2021 for covid-19 immunization first dose at the left arm and experienced immobile for a day, cannot walk, weakness and sore arm. The patient was to know if there is going to be a booster for the Pfizer covid vaccine. The patient stated she received the Pfizer covid vaccine both doses and she is calling to report the reaction she had with the first and second dose to help other patients, she said she was close to death after the second dose. In the middle of the night she was awaken due to excruciating pain in the body, like truck ran over her. The patient heard that someone had same reaction who was in the hospital, with similar symptoms to covid. She said she felt like if her internal organ were shutting down. She does not do well with the antibiotic, and does not go to the doctors. She could not walk or eat after the second dose. She said she has hashimoto dysautonomia hypermobility. she said she thinks she might have had anaphylactic reaction. The patient added that she has lived through it and her experience has been very unusual. The caller has underlying conditions that may have caused this event, she received the second dose on 08Mar2021, it was a horrible experience but since she is still alive she would want to report it. The caller does have strange reactions to chemicals and she typically goes to naturopaths and holistic doctors because of this. The caller also has multiple autoimmune disorders and feels like that may have played a part in this reaction. It was added that further added that she received her second dose 08Mar2021 at 3:30pm and had a little bit of a sore arm, she was thinking positive thoughts about all of this because she never gets vaccines. At 2:00am on 09Mar2021 the caller was awaken in excruciating pain, every surgery she has had or accident manifests in the greatest pain. The pain was excruciating the caller took over the counter pain medicine and diclofenac and it didn't help. The caller is unsure of what she took, she may be making this up. The caller felt like she was dying, she felt like her internal organs were shutting down, it happened all week. The caller was so weak her husband fed her and made sure she was drinking. The caller thinks she would die if she had to have a booster shot of this vaccine. The caller has never had anaphylactic shock, could this have been anaphylactic shock? All of the pain from a surgery all occurred at once and her entire body was wrecking, in horrible pain, that she does not think heroin could have taken care of. After the second vaccine she was literally so weak that she felt like all of her vital organs were shutting down and it lasted for 6 days, like she got hit by a truck, like had beat her up. The caller knows that there are new found reactions with (Company name) and they stopped thousands of doses because of it, she saw this in the news today. The patient wanted to make note that she has underlying autoimmune diseases, she is unsure if there is a correlation between this and her reaction. The caller was changing from her thyroid medicine and her thyroid went very high with the generic brand so she was swapped to Synthroid in the middle of this. The caller was on levothyroxine and it wasn't working, her thyroid was sky high (Unknown lot number and expiration date Feb2022). The caller was going through all of these changes as well when she received the vaccine. The caller's doctor took a test and the caller has antibodies and they are there but not very strong. The caller doesn't want to be spreading something because she is feeling healthy and fine today. The outcome of the events was unknown.

After my 2nd shot on 2/17/21, my L arm hurt as with my first shot on 1/27/21. Similarly I took Tylenol. [And, very grateful that arm soreness was the only after-effect after 2nd shot.] [No arm soreness past a few days with 1st shot.] HOWEVER:10 WEEKS! after my 2nd shot on 2/17/21, my arm is STILL SORE. Advice has been: try heat, try ice, try movement, try stretching, try Voltaren [Diclofenac]... info from any doctor I could ask, from nurse help-line, any nurse or anyone who might have an answer. I TRIED EVERYTHING THAT WAS SUGGESTED, and soreness is still there. CAN YOU HELP??

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.

Patient presented with acute onset neck pain radiating into her arms bilaterally on 4/25. On 4/27 she acutely became paralyzed in her lower extremities and lose sensation over her abdomen completely and decrease sensation in her legs bilaterally. MRI confirmed large spontaneous epidural hematoma in cervical and thoracic spine.

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.

stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is tired; shortness of breath; her eyes were blurry; her head felt like somebody put a spike in it on the right side; sore arm; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (Lot Number: EM9809) (at age of 77-year-old) as single dose for COVID-19 immunisation. Medical history included colitis ulcerative from Oct2020 (dropped weight, she dropped from 127 pounds to 109 pounds) , cardiac disorder, atrial fibrillation, and osteoporosis, all were ongoing. Concomitant medications included carvedilol taken for cardiac disorder, atrial fibrillation from an unspecified start date and ongoing; cyanocobalamin (VITAMIN B12) taken for cardiac disorder from 2018 (reported as has taking it close to 3 years) and ongoing; denosumab (PROLIA) taken for osteoporosis from an unspecified start date and ongoing; ubidecarenone (Q10) taken for cardiac disorder from unknown start date and ongoing; calcium, colecalciferol (CALCIUM + D3) taken for osteoporosis from 2020 (reported as a year ago) and ongoing; influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported, and vitamins NOS (MULTIVITAMIN) from an unspecified start date and ongoing, the patient started taking it when she was a senior in high school and stated because she is not the best eater in the world. There was no prior vaccinations (within 4 weeks). AE(s) following prior vaccinations: The patient stated arm is sore with flu shot and probably did when she was little when she got the loaded shot, the mumps one. She wouldn't remember that because she was little. The patient experienced stroke caused by a blood clot on 20Feb202114:30 with seriousness criteria hospitalization, sore arm on 07Feb2021, and right arm went completely numb, tired, shortness of breath, her eyes were blurry, her head felt like somebody put a spike in it on the right side on an unspecified date. The event stroke caused by a blood clot result in emergency room visit.The patient was hospitalized for stroke caused by a blood clot from 23Feb2021 to 24Feb2021. The patient reported that she received the first dose and she is thankful she got it on 06Feb2021 and the only side effect she had was a sore arm. Stated on 20Feb2021 she had a stroke caused by a blood clot obviously, she ended up in the hospital. She didn't think at the time, doesn't fault the physicians that took care of her. She didn't think it was related and her eldest son thought it was related. The patient stated they thought it was a mild stroke and after they did the C scan the neurosurgeon, while she was lying in the hospital bed, looked at her assistant and said he couldn't believe that she was talking and walking. The patient stated part of it was ignorance on her part, everyone thought it was the left side that numbs, but hers was the right side. Stated she didn't fall, she dropped something and went down to get it and her right arm went completely numb and she couldn't get back up and she tried to push with legs and couldn't get up. Stated all of a sudden her eyes were blurry and then she never gets headaches and her head felt like somebody put a spike in it on the right side, stated it is supposed to affect the left side. stated she has a heart problem. The patient stated she had a sore arm for about a week, lasted for a few days. stated she gets a sore arm with the flu shot. stated when she would roll over to lay on her left side and roll over on that arm it was enough to wake her up. stated it lasted about 5 days. She couldn't figure out why it was lasting so long. Stated the second thing that happened was that she went to her son's home that night for dinner, hadn't told him about it and while she was eating dinner she asked am if she leaning to the left and he said yes, she was and that her words were being slurred and only lasted for about 10 mins. Stated she didn't call and ignorance is unreal with this stuff. She went to urgent care the next day and they didn't call the ambulance. When she went to the doctor on 23 Feb2021 she was sent immediately to Hospital so she could go through the ER and that's when the neurosurgeon became involved. Stated right now her balance isn't quite right but she is driving and she was taking care of herself and they didn't send anyone home to help her. She was not having any problem talking. Stated she was not going to get into this and will beat it and get back to normal. She was tired a lot, which they said it's normal. Stated she was a real dynamite. Stated it is improving slowly, she was extremely tired and not taking her long walk like she was used to and has shortness of breath, she was not trying to over do it. Stated she always gets a sore arm with the flu shot. Stated her pain level is lower than most people. The patient stated the sore arm started late evening but the next day was really hurting and the main thing was rolling over. The patient stated she didn't take anything for her sore arm, she won't even take an aspirin because some of these Advil medications will mix with the heart medications. Stated in the hospital they were giving her medications she had through an IV in her arm but doesn't know what was going through that. Stated they put her on a blood thinner and they were testing the blood thinner through the IV. She was so miserable, she just wanted to go home and get a good nights sleep. Stated they took all kinds of test, checked her oxygen and had to have a certain number before she could go home. The patient received treatment for event stroke caused by a blood clot and not received treatment for sore arm . The outcome of events stroke caused by a blood clot was resolving, of event sore arm was resolved on 12Feb2021, of other events was unknown.

Burning back pain in the first lumbar dermatome distribution starting on 3/10. Drop attack on 3/17 leading to Hospital admission 3/17. Episodic acute confusional state leading to readmission to Hospital 3/24 A clinical diagnosis off absence seizure made prompting beginning Keppra with no further episodes of seizure The Neurologist as noted above

4/6/21: Woke up in pain on left side of face and cannot swallow 4/10/21: Went to fast med with a swollen lympth node on the left side of jaw. MD stated there was an infection and prescribed Augmentin for 14 days. 4/23/21: back to fast med. Still has no healed and was prescribed Doxycycline for `14 days 4/26/21: Patient developed a vaginal itch and raw legs * Stated had a headache during this whole duration

SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 months. Frightening. Swollen under left eye 3/9/2021 to 3/11/2021. Upper back of both legs painful 3/9/2021. Still have this today 5/5/2021, almost 2 months. Sore at injection site 3/8/2021. Fatigue 3/9/2021.

Right eye pain with tenderness and blistering around the eye. Nose numbness on the right side of nose and around. Top of head sensitive. She went to the ED, which diagnosed shingles and referred her to the eye doctor. Prescribed 10 days of Valcyclovir, erythromycin opthalmic ointment, and prednisolone opthalmic suspension. Symptoms lasted the month of April.

sore arm; chills; exhaustion so bad it almost bordered nausea; This is a spontaneous report from a contactable consumer or other non-HCP. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration in left arm on 04Feb2021 at 07:00 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 04Feb2021 at 22:00, the patient experienced sore arm, chills, and exhaustion so bad it almost bordered nausea. The patient did not receive any treatment for the adverse events. The outcome of events was recovered.

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.

felt like I got hit by an eletric shock in my heart going to my neck and left arm lasted 2 seconds; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration in left arm on 13Feb2021 at 11:00 (at age of 77-year-old) as 2ND DOSE SINGLE for COVID-19 immunization. The patient medical history includes AAA Aneurysm, Osteoarthritis, Costochondritis from unspecified date. The patient concomitant medications include losartan, carvedilol, ezetimibe, ascorbic acid vitamin D, Curcuma longa (TURMERIC) from unspecified date and unknown if still ongoing. Patient had allergic to penicillin and ciprofloxacin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), Lot number & Expiry date not reported) via unspecified route of administration in left arm on 23Jan2021 at 11:00 as single dose for COVID-19 immunization. On 14Feb2021 at 13:00 (one day after vaccination) Patient experienced she felt like got hit by an electric shock in my heart going to my neck and left arm lasted 2 seconds. No treatment was received by patient. The outcome of event was recovered. Information on the lot/batch number has been requested. No further information expected.

April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful; April 27th am pain on top of left side of head and face and over eye. Urgent care diagnosis shingles with eye complication; ER tested and then treated me for shingles. One week anti viral with f/u with ophtalmalogist and internist. Antiviral extended one more week and cortisone and triple for eye area. I am still doing the lotion treatment and have gone back to eye doc twice and tomorrow again. Tylenol 3 time a day. I have since come down with a cold but getting over that. It appears pfizer vacine has weakened my immune system for these other diseases.

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.

5:42 PM Note Telephone call with patient, she has been sick with intermittent fever, runny nose, back pain and leg pain for the past week. Does not seem to be getting any better but also not getting any worse. She has a procedure that is supposed to be done on 4/30. Patient states that she did have her 2 Covid vaccinations and the last vaccination was 5 weeks ago. She plans on canceling the procedure. Care Coordination Progress Note RN (Registered Nurse) COVID 19 Infusion Navigator Post Infusion Outreach #1 Infusion Date: 4/30/21 Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab

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.

headache; low energy; body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 at 11:00 am (age at vaccination was 77 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included atrial fibrillation and high blood pressure. The patient did not have any allergies. Concomitant medication patient received within 2 weeks of vaccination included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), atorvastatin and amlodipine besilate, olmesartan medoxomil (OLMESARTAN E AMLODIPINA EG). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EI9265, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 05Feb2021 at 11:00 am (age at vaccination was 77 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. On 27Feb2021 at 19:00 pm, the patient experienced headache, low energy and body aches. Today on 01Mar2021, 3 days after second dose patient was still experiencing headache, low energy, and body aches. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date. The patient received treatment with Tylenol Extra Strength. The outcome of events was not resolved. No follow-up attempts are needed. No further information is expected.

tiredness; nausea; whole body was twitching; 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, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, nausea and whole body was twitching. The outcome of the events was unknown. This Follow-up is being submitted to notify that lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed. No further information is expected.

Caller had noticed numbness around the life side of her body including the left hand and fingers; Tingly from her scalp to the bottom of her foot; Numbness around the life side of her body/The entire left side of her body, unilaterally, went numb; This is a spontaneous report from a contactable consumer. A 77-year-old female consumer received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on Arm left on 23Jan2021 (Batch/Lot number: EL3249), as 1ST DOSE, SINGLE for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported, she noticed numbness around the left side of her body including the left hand and fingers. The fingers are more numb than any other part of the body on 23Jan2021. She states My doctor thinks it's some kind of a vascular or neurological event. He doesn't recommend the second dose. I want to know if these side effects were associated with the vaccine. The entire left side of her body, unilaterally, went numb and tingly from her scalp to the bottom of her foot. It was first noticed in the hand. She called (Emergency number) as she feared a stroke. They said it was not a stroke. Her hand is still considerably dumb and she has lost some of its use. This occurred approximately 7 hours after getting the vaccine. It has improved. Everything is back to normal besides her left arm from where she got the injection leading down to her hand. Her hand is the worst. The outcome of the events for numbness in hand was unknown and for rest of event it was resolving. Follow-up attempts are completed. No further information is expected.

headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.

a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; 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, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021. 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.

tenderness in her left arm; mild pain in the arm; This is a spontaneous report from a contactable consumer or other non health care professional. A 77-years-old female patient received bnt162b2 (BNT162B2PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: Jun2021), dose 1 via an unspecified route of administration, in Arm Left on 23Feb2021 (at the age of 77-years-old) as 1 ST DOSE, SINGLE (0.3MCG/0.3m) for Covid-19 immunisation. The patient medical history included seasonal allergy. The patient concomitant medications were not reported. It was reported that, the patient received the 1st dose of the vaccine on 23Feb2021 and experienced nothing more than a little tenderness in her left arm where she gets the shot. She stopped taking her daily Claritin for her seasonal allergies to Tree pollen a day before getting the vaccine until now because she has read on an article and hear on the news that it was not recommended to take antihistamines during Covid19 vaccination. She is due for her 2nd shot on 16Mar2021. She had her first dose but having a minor allergy and tenderness on her arm. she stopped taking the generic Claritin, loratadine 10mg a 24hr antihistamine, takes for allergy to tree pollen that is picking up and affects her year-round, has never had a serious reaction to anything. The patient is asking when she can resume her Claritin and it was reported that if taking the Loratadine 10 mg tablet for her preexisting allergy which she last took on a day before she got her first dose of Covid-19 vaccine on 23Feb2021 can affect the efficacy of the vaccine. Patient also said that she felt mild pain in the arm after she got the first dose of the vaccine which according to her is nothing much serious. The outcome of the events was unknown. Follow-up(02Mar2021): New information received from a contactable consumer. Which includes: The event (she felt mild pain in the arm) was updated and clinical information added. No follow-up attempt is possible. 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.

weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown. Information about batch/lot number has been requested.

Benign Essential Blepharospasm; her eyes were red and irritated when she was in for her treatment; her eyes were red and irritated when she was in for her treatment; Her vision was blurry; white circle around the cornea; difficulty swallowing; exhausting; end of her fingers and toes are still hurting and feel frozen; end of her fingers and toes are still hurting and feel frozen; slow abnormal blink. Very slow blink; Neuropathy felt worse; Neuropathy felt worse; Her eyes were extremely sensitive to light./She couldn't open her eyes; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; Left arm hurting; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (Lot number: EN6201), via an unspecified route of administration, administered in arm left on 19Feb2021 09:30 (at the age of 77-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included multiple myeloma from 2017, fibromyalgia, Raynaud's phenomenon, neuropathy all was ongoing; Bone and blood transplant 3 years ago in 2018, pain, sleep disorder, herpes, cancer, dry eyes, and fungus from the pneumonia. Concomitant medications included ongoing gabapentin, started over 3 and a half years ago (unspecified date) for neuropathy; lorazepam for pain and to sleep; ongoing acyclovir for herpes; ongoing omeprazole (PRILOSEC); ongoing fexofenadine hydrochloride (ALLEGRA); ongoing glucosamine; ongoing cyanocobalamin (VIT B12); ongoing daratumumab taken for cancer treatment; ongoing vitamins; MSN (Did not confirm what MSN was), stuff for bones and for her fibromyalgia. The patient previously received the first dose of (BNT162B2, Lot Number: EL9264) administered in left arm on 29Jan2021 09:30 as single dose for COVID-19 immunization. The patient had a reaction to the second vaccine. The patient experienced left arm hurting on 19Feb2021. She did not feel first one at all. The second one hurt. Arm still hurts when gets up in the morning and reaches for something. She can still feel it. Two (2) days after the second vaccine on 21Feb2021, neuropathy felt worse; her eyes were extremely sensitive to light. She sat inside with shutters closed. She was very sensitive to light. She went outside to walk, wore sunglasses and large brimmed hat. At times she had to stop. She couldn't open her eyes. She felt more on her left side. She had to pull the brim down. She was also getting muscle spasms in right arm and under right breast and going across her stomach and in legs at times. It was more in her arm and stomach areas. She was getting in in legs also. Her eyes are still a little sensitive but not bad. Her doctors wanted her to go off her neuropathy medication. They also talked about replacing the Gabapentin with other medications, but it was explained they all have side effects. She had been taking 2 pills and went down to 1 pill. Neuropathy got worse. They did not think the Gabapentin was part of it. Confirmed with caller that neuropathy medication was Gabapentin. They did not think pill had anything to do with it. Caller stated that she had been on it for at least 4 years. She had been afraid to start on something else. She said everything had something. Caller reported that she has been back on 2 pills of Gabapentin for 3 weeks now. On unspecified date, the end of her fingers and toes are still hurting and feel frozen. At her next appointment, she wanted to know if can go on 3 pills and then cut back. She had it for 4 years, but it got worse. This was under control, the neuropathy, and now all of this threw it out of control. Caller stated that everything calmed down about 9 days later. She had problem with her eyes, she did not have to sit inside in the dark. The neuropathy was there but not quite as painful. After going down to 1 pill of Gabapentin, it got worse. In the past she had dry eyes. She went to 3 different doctors and had different eye drops. They mentioned that her blink was not normal. They put plugs in and for about year, her eyes didn't bother her. At her first appointment, she checked her eyes. She ordered permanent plugs for her eyes for her dry eyes. She had slow abnormal blink on 21Feb2021. Very slow blink. It was causing eyes to be dry. They had suspicion that it was Benign Essential Blepharospasm on unspecified date. She wanted her to stop taking the Gabapentin as side effect is loss of muscle. On unspecified date, her eyes were red and irritated when she was in for her treatment. She was having hard time in there. Her next appointment was 19Mar2021. Caller said her first appointment was 09Mar2021 and she put in plugs. Her vision was blurry. PRIVACY felt she definitely had Benign Essential Blepharospasm. She talked to other doctors and it was agreed this is what she had. The only cure for Benign Essential Blepharospasm is these little Botox injections in her eye. Caller stated on 23Mar2021 she went back. Her eyes were getting worse. She had abnormal blinking problems opening and closing her eyes. She injected Botox on top. Her vision was clear and her blink was back to normal. This only lasted for half an hour. At the visit she saw white circle around the cornea. Caller stated the cure didn't work. Next visit was 30Mar2021. Her eyes were getting worse and worse, mainly only the whites of her eyes were showing. She was having trouble keeping her eyes open. Caller said that a few years ago she got up 3 times in the middle of the night and it took a minute or two to get her eyes open. Her fear was that she couldn't get her eyes open. Caller stated that it was exhausting to keep her eyes open. She got medicine drops to keep her eyes open. 06Apr2021 the white circle around her cornea was getting smaller. It was still blurry. It was burning, but it was a pinch better. She had more control over the muscle. The drops were Apraclonidine ophthalmic drops. At this point her eyes were barely open. Mostly saw whites of eyes. Barely color. Caller stated that she started 2 pills of Gabapentin. On 19Apr2021 white around cornea gone. She had blurry days but also clear ones. They ordered MRI (Magnetic resonance imaging). Her blink was still abnormally slow. When she tried to read or watch TV, it strained her eyes. 02May2021 MRI was done. She saw PRIVACY 03May2021 for treatment and he already had MRI results. MRI normal. They talked about Gabapentin and said he did not believe it was that. Caller says she told him that she had gone back on it. She was getting more muscle control. She continued to use ointment that they had given to her. She told her not to drive. She used the ointment twice daily. It was Erythromycin 5mg. She put in in her eyes twice daily. On 07May2021 appointment PRIVACY said vision was 20/30. It was 20/50 when it was bad. The white circle in her eyes was slightly back. Seeing improvement. On 21May2021 was last appointment. PRIVACY checked her vision and it was 20/25. Caller said she was dancing around. She looked so much better. Her blink was more normal. PRIVACY confirmed that all of the problems were from the second dose. Caller stated that her friend knew a scientist that said that if it was from vaccine, it would take at least 3 months to get normal. It is getting more normal, her eyes. She is driving. Once in awhile it gets a little blurry but mostly pretty clear. It is nothing like before. She could only read one line and texting she knew where it was. She mainly sat around with her eyes closed resting them. Her biggest fear was they would close and not open. Treatment for the events slow abnormal blink, Benign Essential Blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea included Eye plugs, Apraclonidine ophthalmic drops, Botox on eyes, Erythromycin Ointment. She had transplant 3 years ago, bone and blood for Multiple Myeloma. Her doctors researched the chemotherapy she had for the transplant to see if it had anything to do with this. Caller than gave more information regarding the transplant. She had pneumonia. She was supposed to have transplant. There was a shadow on her lung. She had CT scan on unspecified date. She had to cancel her transplant. Something was in the lung. They did a biopsy on her lung (unspecified date). During the biopsy, they pulled her arm down hard. That is when the neuropathy started. She had fungus from the pneumonia. It took 3 months to heal the fungus. Cancer was back up higher than the first time. When it was down low enough, she had the transplant. Caller stated that day or two after blood test for Myasthenia Gravis, she had difficulty swallowing. She looked at internet. She thinks it was just nerves and trying to keep her eyes open. It was exhausting. She called a girl to come stay with her and it went away. When she looked at the internet, she got shook up. The events neuropathy felt worse, extremely sensitive to light, slow abnormal blink, benign essential blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea, muscle spasms in right arm and under right breast and going across her stomach and in legs at times resulted in physician office visit. The patient underwent laboratory test which included Blood test for Myasthenia Gravis in 30Mar2021 with negative result, MRI eyes on 02May2021 with normal result. The outcome of the events neuropathy felt worse, slow abnormal blink, Benign Essential Blepharospasm was not recovered; the events left arm hurting, eyes were extremely sensitive to light was recovering; the outcome of white circle around the cornea recovered on 19Apr2021; and the outcome of the remaining events was unknown.

Pain on left side with tingling, Shingles, Antiviral Valtrex, Nerve pain Gabapentin, and Zyrtec for treatment.

Last night all of the sudden the skin on my left leg started to fell like a had a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; she did not get a good night of sleep; exhausted; too I was very aware of my stomach, now feel the tommy again and burning is getting less; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) via unspecified route of administration on 25May2021 as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. The concomitant medication was not reported. Patient reported that in May2021 after the first dose of the vaccine patient was exhausted for 5 full days, her arm never hurt but she was very aware of her stomach and for 5 days she had to seat still and that finally past. On 10Jun2021 all of the sudden the skin on her left leg started to feel like a had a sunburn, it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn, she tried to put the Aspercreme on it thinking that her take care of this terrible feeling but that did not help it made it worse so she washed it off. This all started off around 9:30 pm last night she finally got in bed around 10 pm. Patient was trying to sleep with her leg outside of the covers because it felt like it needed to be cooled down, she had AC on and fan. "she did not get a good night of sleep because she kept feeling her leg and did not know what else to do for it. "This morning she was very tired of course from last night, very aware of her stomach again which happen along of getting the first shot for those 5 days and she was exhausted and then too she was very aware of her stomach, now feel the tommy again and burning was getting less, but she had no clue was this was something anybody has reported. Patient was highly sensitive to medications. Patient never get any type of immunizations prior to this since she was a child. in a week she will be 78 years old, she was due for her second shot on 15Jun2021.The outcome of the event exhaustion was recovered, stomach burning sensation was recovering and sunburn, burning sensation, tingling sensation, feeling abnormal, sleep disorder was unknown. Information on Lot/Batch number has been requested.

she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also very aware of her stomach; two twinges in her arm; she couldn't even stand clothes on her legs; skin on her left leg started to hurt so much that it reminded of her of having a neuralgia; She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh/stinging in certain parts of her leg; skin on her left leg feels burning; left leg felt like it needed cold and not heat; 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 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 25May2021 at 14:30 (at the age of 77-year-old) at a single dose for covid-19 immunisation at Clinic. Medical history included ongoing high blood pressure, high cholesterol and it runs in her family (She has tried all the different "statin" medications and she couldn't tolerate any of them. Her cardiologist told her there was an injection she could take for her cholesterol every two weeks and it was supposed to be like a "liquid plumber" for your veins. She is so sensitive to medications including all these "statin" medications, there is no way she can take the bi-weekly injection. It might have a much more profound negative affect on her. She was so leery of taking medications, even over the counter medications), gastrooesophageal reflux disease (GERD), 4 cardiac stent placements in 2015, blood pressure abnormal, allergies (unspecified), sinus are swollen, neuralgia, cataract surgery (a year and half ago), retina had swelled and sensitivity to heat. Concomitant medications included acetylsalicylic acid (ASPIRINE) chewable tablets at a dose of 81 mg daily for sinuses are swollen (her sinuses are not swollen at this time), loteprednol etabonate (LOTREL) for blood pressure abnormal. The Lotrel keeps her blood pressure around 120/70mmHg, famotidine (PEPCID) for gastrooesophageal reflux disease. The patient previously took tylenol and experienced allergy and giant hives. Aspirin give her hives but usually a hive here or there, not real big hives, ilevro for retina swelling and affected her skin on her face (She did have a problem while she was taking the steroid eye drops. They made her feel very unwell. She does not take Prednisone for the same reason. She had tried many different steroid eye drops and so many of them gave her a problem. She ended up taking Ilevro. She had no choice but to take it. The Ilevro affected the skin on her face. Her retinas had to stop swelling. Everything is fine now. She has no glaucoma or macular degeneration. This occurred a year and half ago when she had her cataract surgery). She had given the nurse who gave her the injection a list of all her allergies and sensitivities and the nurse reviewed the list and didn't see anything in the Covid 19 vaccine that would cause the caller harm based on her list of allergies and sensitivities. The caller took a deep breath and prayed while she received the Covid 19 vaccine. After the vaccine she waited at the facility and she was fine and then she left to go home. She ever had an adverse event with any other vaccines she reports she has not been vaccinated with anything since she was a child. She didn't even have the Polio vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration of the suspect vaccine. After getting the Covid 19 vaccine, on an unspecified date, the patient had 5 days of exhaustion where she felt like she couldn't get out of her chair and she was also very aware of her stomach. Her stomach wasn't upset but she was aware of it. That slowly passed and she started doing the things she needed to do. She needs to walk because of her heart stents. She had been fine after the Covid 19 vaccine until last night on 10Jun2021 at 21:30 the patient skin on her left leg started to hurt so much that it reminded of her of having a neuralgia. She provides an example of her sometimes feeling a draft and she can develop a neuralgia from the draft for a day or two. That's what her leg felt like initially. As the night wore on, around 22:00, she realized she couldn't even stand clothes on her legs. She wears nightgowns, not pajamas and she had to take her nightgown off her leg. The sensation in her leg started changing, she could feel that she not only had the skin hurting sensation but now she had stinging in certain parts of her leg. She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh. It was bizarre. She thought about it this morning, 11Jun2021, what it felt like. She remembered way back, long ago, and she was not a sun person, but it felt like how a sunburn would feel. The skin on her left leg feels burning. She used Aspercreme on her leg thinking it will help with the pain. She wiped all the Aspercreme off her leg. She could not cover her left leg. Her left leg felt like it needed cold and not heat. She does have a history of sensitivity to heat. She runs her air conditioner, and she had a ceiling fan above her bed. She had her left leg exposed and out of her bed covers to try and get the cold air on her hot leg. Finally, around 23:30, her leg still bothered her, but she was able to go to sleep. She twisted and turned at night but was finally able to put her bed cover back on her leg but lightly. The sensation was still there in her leg. She was so sensitive. On an unspecified date, the patient had two twinges in her arm and then her arm never hurt again. The events did not result in emergency room or Physician Office. She is due for her second Covid 19 vaccine on 15Jun2021. The outcome of the events she had 5 days of exhaustion where she felt like she couldn't get out of her chair, she was also very aware of her stomach, two twinges in her arm was unknown and the rest of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.

I'm experiencing muscle and joint pain on the right side arm and hands. On the left side inside muscle of the arm. Pain in right leg that is severe knee joint and the muscle behind the knee. Left leg pain in joint and muscle. Prescribed Ibuprofen 600mg that is not helping.

Started with left hand being useless, then shaking. Shaking moved up to elbow. She tried to take off her sweatshirt and her arm froze--this is the last thing she remembers. Husband called 911 and she went to the ER. She had had a seizure and they found 2 brain lesions. She had a CT scan and an MRI in the ER. There was memory loss in the beginning and slurring of words. She felt a weighty fatigue. Was put on Keppra for seizures. Had consults with neurology, a neurosurgeon, a neuro-oncologist--all unsure of what exactly these brain lesions were. Back left lower part of brain: a small lesion, which was basically ignored Right side, towards front, part of brain, on top of and/or intertwined with motor strip: not sure what this is, a stroke or tumor (the neurosurgeon and neurologist had differing opinions) 2/22--1st MRI--shows 2 spots between these 2 MRIs the bloodwork, CT scan, and ultrasound are done--results normal 3/23--2nd MRI--larger lesion is bigger. Was not thought to be a cancerous tumor 4/23--3rd MRI--Looks like larger lesion is improving. A scheduled brain biopsy is postponed 5/20--4th MRI--the small spot is almost gone and the larger spot is much smaller, about 1/8th the size of the February MRI. According to the neuro-oncologist, this was an atypical stroke.

getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; She was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects.; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: 31May2021)via an unspecified route of administration, administered in Left Arm on 28Jan2021 at 08:30 as First Dose, Single Dose COVID-19 immunization. The patient's medical history included shingles seven years ago, blood pressure abnormal, rheumatoid arthritis, hysterectomy at a young age and was put on Premarin. She was on a higher dose initially but is currently taking 0.3mg daily. When they have tried to take her off of Premarin she has a reaction. She is unsure if it is a reaction or mental. Product is filled in a pharmacy bottle. NDC, Lot and Expiry are not on the label. She has had shingles twice. Clarifies that her last episode was 10 years ago. She is due a Shingrix vaccine. Her physician says with her rheumatoid arthritis, taking Hydroxychloroquine and Covid he doesn't recommend that she get the Shingrix vaccine. No Patient's Medical History including any illness at time of vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN)Hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal from 2011 and ongoing; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis from Dec2019 and ongoing; estrogens conjugated (PREMARIN) taken for hysterectomy. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient mentioned that she had a sore arm after the first shot from 28Jan2021 to 01Feb2021 and she was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects, she was getting a rash on her back from 04Feb2021 and ongoing. This started as a little circle under her shoulder blade. Is this a reaction to the vaccine or could it be shingles. No relevant tests were performed. The patient did not visit any Emergency or Physician office for the AEs. The outcome for the events was sore arm was recovered/resolved and the Rash was not recovered/not resolved and Unknown for rest of the events. Follow-up attempts are completed. No further information is expected.

Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, it would you know kind of sickening but I ate,; I had unwell feeling, like you getting the flu; This is a spontaneous report received from a contactable consumer (patient). A 77-years-old (reported currently 77 and half, 78 in august so) female patient received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 (age at vaccination: 77 years) as single dose for covid-19 immunisation. Medical history was not reported. The patient's height is about 5 (feet) 3 (inches) and right now her weight this morning was 116.7 (pounds), closer to 117 (pounds) (not captured in tab). Concomitant medications included vitamins once a day (multiple vitamins), calcium plus D (calcium, colecalciferol) per day, ciclosporin (RESTASIS) for dry eyes (in eye twice a day). On 22Jan2021, the patient had first shot and started having a sore muscle and the body ache and everything; on the same night she had little bit chills too, but side effects were mostly at night and then about (incomplete sentence). And then during the day she was fine, and it was just during the evening when she would feel bad. And then about Thursday (dates unspecified) when she woke up and she had unwell feeling, like getting the flu. And then at times like if she smells food, kind of sickening, but ate, had a good appetite. Sometimes she would get up and would feel better. The symptoms had gradually gotten better and went to a grocery shopping in-between the time, but it was sick, but now she would not be sick again and she was almost back to normal today. She was wondering is this normal to have this kind of symptoms for 2 weeks. When questioned about stop date of events, she reported that she was not feeling really bad right now, she just feels, just a little bit weak today (05Feb2021), feel like everything's going away. When questioned about outcome of event: consumer stated, she thinks she was recovering. The patient did not take any treatment. She did call her doctor and didn't seem to be concerned. She didn't take any Tylenol or anything else. She did not have the seizure; she did not have injection site swelling or redness or so. She reported alright and was going to have her next one. The outcome of event asthenia was unknown and for other events it was resolving. Information on lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.

First dose: maybe a sore arm a little bit; a sinus issue and it led to mucus; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 4. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 23Mar2021 20:10 (76-years-old at the time of vaccination), as a SINGLE DOSE for covid-19 immunization. Patient vaccination because high risk of getting Covid, cannot wear mask due to breathing and lung issues. The patient's medical history included Breathing issues, Inoperable lung cancer, Diagnosed Nov2010. She took 2 different chemos for 3.5 years and had 6 weeks of strong radiation so that's whys she is at a risk of getting Covid, Lung issues (respiratory illness), Allergies like in spring and summer, compromised immune status, genetic / chromosomal abnormality, endocrine abnormalities (including diabetes), and obesity. The patient's concomitant medication included Xyzal every night for the allergies which does not always work and Amoxicillin 500mg 3 times daily for sinus issue. The patient previously took flu shot. On an unspecified date, the patient experienced first dose: maybe a sore arm a little bit and a sinus issue and it led to mucus. On An unspecified date Mar2021, the patient underwent lab tests and procedures which included blood test: unknown. On 12Apr2021, the patient was taking Amoxicillin, as Therapeutic measures as a result of a sinus issue and it led to mucus. The outcome of the events first dose: maybe a sore arm a little bit was recovered on an unspecified date and a sinus issue and it led to mucus was not recovered. No follow-up attempts are needed. No further information is expected

right arm is unbearably painful after injection/My arm is hurting so bad; didn't sleep all night because of the pain/I really can't sleep enough, I mean it's hurting; This is a spontaneous report from a contactable consumer. This 77-year-old female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date not reported) via unspecified route of administration in right arm on 03Feb2021 (at age of 77-years old) as single dose for Covid-19 Immunization. Patient medical history includes high blood pressure. Patient concomitant medications include Amlodipine (once a day) used for blood pressure from unknown date and ongoing, Hydrochlorothiazide, lisinopril (once a day) used for high blood pressure from unknown date and ongoing. Patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:EK9231, Expiry date not reported) via unspecified route of administration on 15Jan2021 as single dose for COVID-19 Immunization. On 03Feb2021, patient had shot at noon, she got the injection in her right arm, she developed the arm pain last night about 8 or 9 pm. She said it will feel better one minute, and then she will have a sharp pain going through her arm again. Patient experienced like her arm is hurting so bad; patient stated that I really cannot sleep all night because of the pain/I really cant sleep enough, I mean it is hurting. Patient right arm is unbearably painful after injection and stated that she did not let nothing get around the injection area and she rubbed her arm with alcohol.Caller verifies she talked with a man yesterday and reported this information and gave information on what was on her vaccine record card. Caller verifies she was not provided with any type of reference number.Upon follow up reporter stated that the reason she got it because she works at the hospital, what mandated, and she got it. Patient stated that, I am having a problem so I could get the paid today, okay but look can I rub my arm with some alcohol. Consumer was informed about Pfizer Medical information department.Treatment received for event by taking Tylenol. Patient underwent lab test and procedures include blood pressure measurement is high on unspecified date. The outcome of events was not recovered. Follow-up (04Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (mom) that: new information include vaccination at right arm and updated age 77years on onset of reaction, concomitant medications,Treatment received for event. Follow-up attempts are completed. No further information is expected.

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

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

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.

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.

Difficulty breathing/she could barely breathe; felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back; had pain in shoulder blade; felt like she is not getting enough oxygen/she was not getting enough oxygens to her brain; slept for 12 hours; she was angry and upset; she was angry and upset; her voice has changed; she has some wheezing but it is coming from in between her soft and hard palate; States after the vaccine was tired and lethargic; States after the vaccine was tired and lethargic; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number: EL9264, Expiration Date: 31May2021), via intramuscular, administered in Arm Left on 09Feb2021 (Age at vaccination 77 Years) as 1st dose, 0.3 ml single for covid-19 immunisation. The patient had past drug event to a reaction to the inhaler that was prescribed to her, had excruciating pain in feet, hands and knees never happened in her life. Inhaler was Albuterol sulfate, HFA, inhalation areol, 90mg per actuation, 18gm, inhale 2 puffs into lungs every 4 hours as needed for SOB, she did have Covid in Nov2020 prior to the vaccine, concomitant medications were not reported. The patient experienced she had been calling since the 16-17Feb2021, a week after she had the first vaccine shot on 09Feb2021 states about 2 hours after the first Pfizer Covid vaccine, she had difficulty breathing thought maybe it was a side effect from she had Physical Therapy earlier that day, but stated as the week went on the difficulty breathing, even walking down stairs, become more difficult, states the following Tuesday, she went to Physical therapy and everything went okay and when she came home and walked two houses down the road to her neighbours house to drop something off. she could barely breathe on 09Feb2021, felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back, had pain in shoulder blade, felt like she was not getting enough oxygen/she was not getting enough oxygens to her brain, slept for 12 hours and went to urgent care, (unspecified date in 2021) she was angry and upset she has some wheezing but it was coming from in between her soft and hard palate, her voice has changed sounds gravel-y, stated after the vaccine was tired and lethargic. She laid her head down on the table and went to sleep for 2 hours at the kitchen table, does not believe she had brain damage. She wanted to know she did not have good experience with first dose. Her second dose was due today and stated she will be late for her second dose, also wanted to know "YES or NO" about taking the second dose. States the urgent care doctor told her they have a theory that she already had antibodies in her body and then the influx of antibodies from the vaccine caused the reaction. The patient underwent lab tests and procedures which included sars-cov-2 test and she did have covid-19 on Nov2020 states she did have Covid in Nov2020. Patient received treatment of Stated she went to urgent care and they gave her a breathing treatment. The outcome of events was difficulty breathing/she could barely breathe was recovering, rest of the all events outcome was unknown. No follow up attempts are possible. No further information is expected.

very weak/wrung out in morning. Happened two more mornings over next two weeks. My heart normally beats irregularly due to mitral valve prolapse. But for about 3 weeks lying down particularly on my right side it was practically continual. Also my back started hurting. Also there was family stress. Also I was concerned when they weighed me at the doctor's office that I had lost 3 pounds. My weight had previously gone down from 130's to 129. But it went down to 126 at the office. Doctor did thyroid and liver blood tests. All was normal and stable. I have gotten the weight up to almost 128 since then.

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.

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.

Patient presented to the ED and was subsequently hospitalized on 3/11/2021 for acute cystitis with hematuria and acute kidney injury. Patient presented to the ED and was subsequently hospitalized on 4/19/2021 with generalized weakness and confusion. These visits are within 6 weeks of receiving COVID vaccination.

My mother has had her share of health problems predominantly relating to her Afib diagnosis,however after every dose she experienced side effects that have set her back in ways that were completely new,loss of memory Sluring her words, really bad head aches leading up to the first and second stroke.She was able to drive live on her own had sweet and kind,funny personality now that is all gone. She is a shell of who she was and our family just simply misses her,I truly just wish that we would have had been warned of the possible risks to patients like her prior to getting the vaccine.No matter how small the possibility of adverse reaction.We would have chosen to keep her longer.

Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route on left arm on 11Feb2021 at 14:00 (at age of 77-year-old at vaccination) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had medical history of hypertensive. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE); biotin; glucosamine; metoprolol succinate (TOPROL XL); fish oil for unknown indications within 2 weeks prior to the COVID vaccine. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient previously took scopolamine [hyoscine butylbromide] and demerol and experienced drug allergy. On 18Feb2021 at 12:15 PM, the patient experienced cramping and diarrhea starting a week after first shot and lasting 2 weeks after second shot. Doctor or other healthcare professional office/clinic visit for the events. The events were treated with Imodium and Bentyl. The outcome of the events of cramping and diarrhea was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of right lower rib cage and toward my back. A tightness feeling going also toward my back. Interfering with breathing because pain increase with deeper breath but did not feel short of breath. Area became tender to touch. Felt like muscle spasms in "bread basket" area. These cont'd off and on - affecting size of meals I would eat - too much increase the discomfort. Self exploring lead me too exercising and deep breathing to advice via website. Provided some relief and improved breathing ability. By May 2th things became more severe- 3 morning episodes of severe gripping pain, sweats, chills ,nausea, vomiting, weakness - Husband took me to Emerg May 4th. Bld in urine. Kidney scan - no stones; Bld work - normal. Agan in Emerg June 29th. No medical reason given for the severe pain. Sent home.

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.

A little sore arm; She then developed pneumonia and a urinary infection; She then developed pneumonia and a urinary infection; This is a spontaneous report from a contactable consumer or other non-health care professional. A 77-year-old female patient received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in arm on 03Jun2021 (at age of 77-year-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes Memory Loss, Breast Cancer, Allergic to Sulfa Medication, Flexeril, Allergic to Clams and Shellfish, Pneumonia, Urinary infection. Patient concomitant medications were not reported. Caller reporting on behalf of his wife who received her first Covid 19 vaccine on 03Jun2021 and she developed pneumonia and a urinary infection. She was prescribed amoxicillin for her infection. The caller wanted to know how the antibiotic will affect his wife. He reports her second Covid 19 vaccine is past due by 2 weeks. He reports his wife gets pneumonia every year and it is not from the Covid 19 vaccine. She received her first Covid 19 vaccine on 03Jun2021 and was due for the second Covid 19 vaccine on 24Jun2021. This is discrepant from the above information that his wife is past due by 2 weeks but is documented as provided by the caller. She will not be able to get the second Covid 19 vaccine until the first week in Jul2021. She waited because she was prescribed a Z-pack for her pneumonia started on 29Jun2021.She developed a urinary infection, she has a history of getting urinary infections too. The doctor also wanted a chest x-ray to make sure that her pneumonia was gone. The Amoxicillin will double check that his wife has no more pneumonia and will clear up her urinary infection. She was hospitalized in 2019 because of a urinary infection. The doctor prescribed Amoxicillin and she cannot wait any longer to get her second Covid 19 vaccine. She must get her second Covid 19 vaccine before time runs out. He reports none of this has to do with the Covid 19 vaccine. These are problems that his wife has had before.Upon follow up when probing for information regarding the sore arm he and his wife experienced he reports the sore arm was minor, it was just where the injection was in jun2021. His wife had breast cancer and can only get injections in one of her arms. It was a little soreness, nothing, barely noticeable. He and his wife did exactly what the pharmacist said, they took a lot of fluids, drank Gatorade for electrolytes. He reports his wife is sleeping right now because she was at the doctor's office this morning. He reports his wife's doctor is being thorough before his wife gets the second Covid 19 vaccine. He is supposed to call the pharmacy to schedule his wife's second Covid 19 vaccine on 03Jul2021. The pharmacist told him not to cancel his wife original appointment because it would remove her from the system. He's will call on 03Jul2021 and hopefully his wife will be able to get her second dose on 05Jul2021 or 06Jul2021. At that time, she'll almost be off the Amoxicillin. He is asking what the effectiveness rate is of receiving the Covid 19 vaccine while on an antibiotic.The pharmacist told him the effectiveness is diminished for people who have taken an antibiotic. He believes the first Covid 19 vaccine provides 70% effectiveness while the second Covid 19 vaccine provides 95% effectiveness. His sister-in-law has titanium plates in her back and must take an antibiotic for the rest of her life and she received the Covid 19 vaccine. Advised in response to caller to discuss with Health care professional about the final decision about receiving the second dose to discuss the risks and benefits of the administration of the vaccine and the HCP is most familiar with the health history of his wife. Pfizer is unable to make treatment recommendations for individual patients. Patient underwent lab test and procedures include Chest X-ray result was it showed nothing, no pneumonia; SARS-CoV-2 test was negative; Urine analysis result was unknown; all tests done on Jun2021. The outcome of event was unknown. Follow up (29Jun2021): This is a follow up spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a 77-year-old female patient (reporter's wife) that: New information include medical history, schedule of second dose, Lab test, event little sore arm, visit of physician office. No further information is provided or obtained.Information on lot/batch number has been requested.

RBC, Hemoglobin, and Hct continue to elevate; RBC, Hemoglobin, and Hct continue to elevate; RBC, Hemoglobin, and Hct continue to elevate; CBC w/manual differential shows RDW - CV 22.9 % and RDW - SD 75.6 FL; 3 days after 2nd dose pain both legs from knee to bottom of both feet. Continuing still, today is day 6.; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in arm left on 20Mar2021 at 08:30 (at the age of 77-years-old) as dose 2, single; and patient previously took BNT162B2 (Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in right arm on 25Feb2021 at 16:30 as dose 1, single for COVID-19 immunisation at other. Medical history included chronic obstructive pulmonary disease (COPD), Edema, Sleep Apnea, Irregular Heartbeat. And patient was allergic to ibuprofen and contrast dye. Concomitant medications included alendronate (FOSAMAX) 70 MG Oral Tablet Take 70 mg by mouth every 7 days. atorvastatin (LIPITOR) 20 MG Oral Table Take 1 tablet (20 mg total) by mouth at bedtime. calcium carbonate (TUMS) 500 MG Oral Chewable Tablet Chew 1 tablet three times daily. diltiazem (CARDIZEM) 60 MG Oral Tablet Take 1 tablet (60 mg total) by mouth twice daily. Fluticasone-Umeclidin-Vilant (TRELEGY ELLIPTA) 100-62.5-25 MCG/INH Inhalation Aerosol Powder, BREATH ACTIVATED Inhale 1 puff by mouth daily. furosemide (LASIX) 80 MG Oral Tablet Take 1 tablet (80 mg total) by mouth twice daily (8am/4pm) and Omeprazole 20 MG Oral Tablet Delayed Release Dispersible Take 20 mg by mouth daily. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks. On 23Mar2021, after second dose, the patient experienced pain in legs and feet. Treated for symptoms and bloodwork shows abnormal red blood cells. Labs repeated CBC with automated differential, CBC with manual differential shows RDW - CV 22.9 percentage and RDW - SD 75.6 FL. RBC, Hemoglobin, and Hct (Haematocrit) continue to elevate. The patient has been referred to hematology. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included blood test: abnormal red blood cells, computerised tomogram: unknown results, full blood count: RDW - CV 22.9 % and RDW -SD 75.6 FL (w/manual differential), haematocrit: elevated, haemoglobin: elevated, magnetic resonance imaging: unknown results (lower extremity), neurological examination: unknown results, red blood cell count: Elevated and ultrasound scan: unknown results. Therapeutic measures were taken as a result of events include medication for leg pain (bloodwork, ultrasound, CT, neurological nerve study, MRI and lower extremity). Since the vaccination, the patient had not been tested for COVID-19. It was reported there was no prolonged hospitalization. The outcome of the events was not resolved.

A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, difficulty with speech and language

Was exposed to a positive COVID person. On 4/4 PT reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 PT returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to Hospital.

Was exposed to a positive COVID person. On 4/4 pt. reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 pt. returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to hospital.

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.

Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 called. Had right arm pain and loss of consciousness. EMS got 180/104 BP and blood glucose was 122. Was transported to hospital. Returned to the facility the next day with no complications, was just fatigued.

After receiving the COVID0-19 vaccine, client verbalized facial tingling. Client was evaluated by onsite paramedics and released at 4:56 pm to go home

Client verbalize feeling hot and sweaty after taking the vaccination. Client was evaluated by onsite Fire Rescue and released to go home at 2:38 pm.

Patient stated she has had anaphylactic reaction to a flu vaccine a couple months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed premedication; however, patient stated that doesn't work. Patient was observed for 30 minutes. After that time, patient stated to the observer , RN her left arm "hurt all the way down" and "chest felts heavy". Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. , RN took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.

Patient stated she has had anaphylactic reaction to a flu vaccine a couple of months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed pre-medication; however, patient stated that doesn't work. Patient was observed for 30 minutes. After that time, patient stated to the observer RN her left arm hurt all the way down and chest felts heavy . Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. RN , took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.

At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021, they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the clinic.

Patient reports feeling flushed and lips/tongue tingling. Physical examination in the emergency department noted as normal. Patient given diphenhydramine 25 mg orally with resolution of symptoms.

Patient reports feeling flushed and lips/tongue tingling. Patient transported to the emergency department for evaluation. Physical exam noted as normal and no tongue or lip swelling. Patient administered 25 mg diphenhydramine orally and observed for 2 hours.

When I awoke this morning and was getting dressed, I noticed a soreness in the back of my left leg (on the right side of the left leg). I felt a lump, It was about 2-3 inches above the knee. It was what I would describe as a medium-sized lump. I called my doctor to leave a message about my symptoms. My doctor called a few minutes after 11 am and asked me to immediately come in so he could see the lump. He thought I might have a blood clot. This lump was not present late last night because when I put lotion on my legs after my shower, I felt no lump or soreness. I worked out this morning and by 11:00, it seemed to me the lump was not as big as it was when I was getting dressed earlier this morning.

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.

began to ache 2 pm of day of vacination, could not sleep. shooting pain ears, hands, head, much worse than 1st shot

Right facial numbness the day following first injection. Now 2 weeks late still have facial numbness

felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia. The patient previously took morphine and experienced drug hypersensitivity. There was unspecified concomitant medication. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021. All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening. The patient was hospitalized for the events for 4 days. After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment. The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion. The patient had a rapid nasal swab on 17Jan2021 which was negative. Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy. The outcome of the events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.

Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; 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; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.

Right side facial numbness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL1284, expiration date unknown), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and coronary artery disease. Concomitant medication included atorvastatin (LIPITOR), levothyroxine sodium (SYNTHROID), famotidine (PEPCID), and acetylsalicylic acid (BABY ASPIRIN). The reporter was reporting a side for "COVID-19 the Pfizer shot" which she received on 13Jan2021. On an unspecified date, she experienced facial numbness, right side facial numbness. She went to the emergency care on 15Jan2021, no treatment received. The outcome of the event was unknown.

Debilitating pain and swelling at vaccination site with a ring around the shot. Pain then transferred to other arm with body aches and low grade fever. Pain at shot site duration was 10 days with no relieving factors.

Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles and arches. Stomach pain, and feeling lethargic. I took Tylenol but i think that disturbed my stomach. Still having soreness in my legs and ankles and still don't have energy today.

On 1/9/21-Diaphoresis, O2 90%, respirations 22, increased weakness, wheezing bilaterally. Send to ER for evaluation and treatment. She was sent to ER, where she was admitted for 2 days, then expired there on 1/11/21

1/27/2021- Fatigue 1/28/2021 around 2 AM- Coughing, Difficulty breathing had to use breathing machine and inhaler, hoarse voice, fatigue. Ended up sleeping over 12 hours Went to lung doctor 1/29/2021- Still feeling same symptoms as 1/28/2021. Said had an adverse reaction to vaccine, prescribed to keep using inhaler and breathing treatments as needed, also prescribed AZITHROMYCIN 1/30/2021- Started to feel a little better, not as hoarse. 1/31/2021- Significantly Better than before. Still coughing 2/1/2021- About 70% better still coughing a little but improved

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.

Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; She didn't know what but it is itchy, it hurts or a combination of both; She didn't know what but it is itchy, it hurts or a combination of both; My arm hurts/her arm felt like a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) via an unspecified route of administration, on 06Jan2021 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included metoprolol and lisinopril, both for high blood pressure. Patient stated that she got the Pfizer vaccine on 06Jan2021. The regular reaction to it like her arm hurts and that was it, it lasted like for three days and it went away. Not yesterday, but the day before (15Jan2021), her arm felt like a little sore. Yesterday (16Jan2021), when she was in the showering, she noticed that the around the site of injection, it was like a red circle like a size of an inch that was (sentence incomplete). She felt like a little warm to her. She didn't know what but it was itchy, it hurt or a combination of both, it didn't bother her unless she touched it or rubbed against it but it was there. So, she just wanted to know whether that was a reaction to the injection or what that was, is that common or is that not common. Patient said she still felt it. As treatment, patient took a paracetamol (TYLENOL). She took one paracetamol this morning (17Jan2021) and one yesterday (16Jan2021). Outcome of arm hurts/arm felt like a little sore was recovered, outcome of other events was not recovered.

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.

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.

I felt fine the day of the vaccine but I woke up at 3:45 AM. I was so cold that I was shaking, I ached all over. When I got up my temperature was 102 and in stayed between 101.5 and just over 102 for about 30 hours. I also had cold like symptoms, a cough and diarrhea. It wasn't until 48 hours after the shot that my temperature was normal.

Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21

About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her face turned red and hands were shaking. Patient felt her heart skipping with irregular heart beats. The nurse measured the patient's blood pressure and it was 183/95 with a pulse of 104. The patient was observed for an hour.

view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning. view 2/5/2021 08:39 Orders - Administration Note Note Text: Resident passed. view 2/5/2021 08:33 Nurses Note Note Text: Body released to funeral home at this time. Personal effects sent with resident include: 1 pair of glasses, 1 yellow wedding band, 1silver spoon ring, 1 ring with black and clear stones. Resident has own teeth view 2/5/2021 08:32 Nurses Note Note Text: cause of death per CRNP failure to thrive. view 2/5/2021 07:44 Orders - Administration Note Note Text: Take and document temp & PO2 every 4 hours for MONITORING Resident passed. view 2/5/2021 06:49 Nurses Note Note Text: Son returned call and was updated of resident's passing this am view 2/5/2021 06:33 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Unknown Resident expired @ 0604 [linked] view 2/5/2021 06:06 Nurses Note Note Text: Res found without pulse or respirations. Pronounced at 0604. Updated. N/o's for RN to pronounce, release body to funeral home, dispose of medications per facility policy. Daughter updated. Funeral Home called to release body. view 2/5/2021 05:26 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Pulse ox 60% on O2 @ 5L/min via mask. Resps 44 per minute. view 2/5/2021 01:57 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/5/2021 00:52 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Residents resps are 40 per minute, pulse ox 76% on O2 @ 5L/min via mask. Resps are labored, shallow and rapid. view 2/5/2021 00:48 Nurses Note Note Text: Nonresponsive to verbal and tactile stimulation. Appears comfortable. view 2/4/2021 22:01 Nurses Note Note Text: Resident resting comfortably, breathing becoming increasingly shallow, wearing O2 via mask at 5L via mask, no dyspnea noted, feet are mottled, oral and peri care provided Q2H. No s/s of pain or discomfort. view 2/4/2021 21:40 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective [linked] view 2/4/2021 19:32 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger medicated for air hunger, RR 28 to 32/ min view 2/4/2021 19:22 Nurses Note Note Text: Daughter updated on N/O to increase Morphine Sulfate 20mg/mL 0.25mL to Q2H prn from Q6H prn. view 2/4/2021 18:06 Nurses Note Note Text: POA Daughter and daughter aware of residents current condition. view 2/4/2021 11:58 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/4/2021 11:13 Nurses Note Note Text: Pt. noted to be lethargic at this time. Does respond to verbal and tactile stimuli by opening her eyes but non verbal currently. Skin warm and dry. No mottling or apnea observed at this time. O2 sat 88% with O2 at 2 LPM via n/c. On increased to 3 LPM via mask as pt. noted to be mouth breathing. Respirations 28. F/U O2 sat 93%. HOB elevated. Pt. medicated with morphine by LPN. Daughter updated on pt.'s condition. Does not want pt. sent out to hospital and would like comfort measures to continue. Daughter also in agreement with delay in d/c d/t pt.'s condition.CRNP updated on pt.'s condition, delay in d/c and daughter's wishes. No n/o's at this time. view 2/4/2021 10:56 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB Resident showing s/s of discomfort. SOB at this time and high respirations. Repositioned, changed for incontinence care and mouth care provided. view 2/4/2021 10:34 Progress Note Note Text: Spoke with RN regarding change in condition. Updated Sr Living regarding change. Recommendation to cancel d/c/transfer for today, see how resident does through the weekend and re-evaluate on Monday. Daughter updated on cancellation of d/c today. view 2/4/2021 10:04 Nurses Note Note Text: Daughter aware that resident's O2 sat was 88% on room air on 3-11 shift and that oxygen was applied via nasal cannula. view 2/4/2021 10:03 Nurses Note Note Text: N/O: Discharge 2/4/21 with scripts to Sr. Living. Daughter aware. view 2/4/2021 09:53 Nurses Note Note Text: Pt. to be d/c'd to another facility this am as per MD order. Pt. alert and responsive. Skin assessment done as per facility policy. No pressure areas noted at this time. No s/sx of pain or discomfort observed at this time. V.S. 97.0 67 20 O2 sat 95% with O2 at 2 LPM via n/c. view 2/4/2021 07:45 Nurses Note Note Text: Resident seen by Dr. for discharge. Orders pending at this time. view 2/4/2021 07:36 Nurses Note Note Text: CRNP and Dr. updated on O2 sat 88% on RA with f/u of 93% with O2 on at 2 LPM as well as rest of VS, 3-11 shift 2/3/21. No n/o's at this time. view 2/3/2021 21:17 Nurses Note Note Text: Resident Sp02 88% on RA. Pulse 124. Respirations 40. PRN morphine given and O2 applied via NC at 2L/min. After recheck pulse ox up to 93%, pulse 100, and respirations 22. Resident appears comfortable at this time. view 2/3/2021 20:05 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective [linked] view 2/3/2021 19:48 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN given for SOB after elevation of HOB not effective. view 2/3/2021 11:51 Nurses Note Note Text: CRNP updated rapid COVID test done for d/c tomorrow was negative. No n/o's at this time. view 2/3/2021 11:44 Nurses Note Note Text: Daughter notified of rapid covid swab being negative. view 2/3/2021 09:50 Orders - Administration Note Note Text: Obtain Rapid Covid test on 2/3/2021 for discharge. Please give copy of results to Social Worker every day shift for covid testing for 1 Day Completed and negative. view 2/3/2021 08:45 Skilled Nursing Note Reason for skilled service: Therapy describe skilled service: Nursing, therapy assessment: V.S. 97.8 79 18 138/84 Orientation: Oriented to self only. Oxygen: O2 sat 94% on RA Edema: Trace edema noted BLE. Pedal pulses present. Pain: Denies pain or discomfort at this time. Nursing note: Pt. alert and responsive. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen soft. BS+ in all 4 quads. Continent/Incontinent of B&B. 1 assist with ambulation, transfers. 1 assist with ADL's. Working with therapy on gait training, therapeutic exercise, therapeutic activities & neuromuscular reeducation. view 2/2/2021 14:37 Progress Note Note Text: Per health professional at Sr Living, prepared to accept patient to their Memory Care Unit 2/4. Transportation arranged for 11 AM per family request. Daughter (POA) updated on d/c time on 2/4/21. Facility requesting rapid COVID test completed prior to d/c and results sent to them. All other information sent for continuity of care.

Headache; Chills; cognitive confusion, serious and unprecedented; extreme fatigue; weakness; nausea. These symptoms have continued to the present, 2/6/2021.

AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine

I began feeling weak around 3:15 and was worse by 4 PM. Then I began having shivers but no temp. I felt weak and pulse raced as soon as I got up and walked around. Some aches and pains and malaise but I slept all night. Next day still felt poorly but no chills. Got a cold spell towards evening bu lasted about 1 hr. Some slight congestions that was relieved with a good cough maybe twice a day for another couple of days. That is all.

About 10 minutes after receiving the covid vaccine, I developed a red flush on my face which was bright, hot and uncomfortable. The flush appeared nowhere else on my body so I concluded that the vaccine must have interacted with the tretinoin cream I use nightly. That is the only area of my skin on which i apply the cream. When I got home, I applied soothing skin cream but no relief. I then tried aloe, which grows in the area, and the flush/burning abated somewhat. The next day, my face was still flushed but less red. the skin surface was scaly. I am continuing to treat at home. No MDs involved.

Around 3:50pm patient had complaint of heart jumping. Heart rate was initially 104, after 30 minutes rest, coached deep breathing, heart rate 90 regular. Patient was persistently uncomfortable and tachycardic and requested EMS evaluation. Responding EMS checked EKG, glucose, BP (etc) and released. Patient seemed to have moderate reaction to vaccine.

Immediate tingling throughout my body when injection started. Stayed 25 min. in clinic following injection. Tingling remained but no breathing problems developed. Tingling lessened by next morning. Did have increased aches and pain sand more headaches on day 2. Contacted MD on Fec. 2 and she was aware of others having the full body tingling but said she thought it was OK to get 2nd dose Feb. 20.

lot not documented in EMR Call center call from adult son queryi8ng if symptoms were vaccine related.. Reported 78 yo mother awoke restless, agitated, could not describe what was wrong. She was Audibly moaning in the background, had difficulty responding to his instructions. Assessment revealed FSBG of 27. corrected with oral juice. Assessment after recovery did not identify any change in habits, had not missed meals, changed medications and is not on insulin; has no history of similar events.

A little weak at bedtime (Saturday) Next morning Strong toothache upper back left teeth, slight swelling/itching lower left side of mouth/chin area (Sunday) Pain all day (Monday) Feels like teeth are in a vice, swelling left side of roof of mouth

little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering the plausible temporal relationship. 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.

Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I literally slept all of the next day only getting up occasionally and most of the day after that. I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable. Sore neck and joint pain and a slight headache. I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm. That persisted for several days. I slept and took 1 800 mg Ibuprofen (on 1/27/2021). Am feeling better but still not feeling 100 %. That may be due to increased allergies due to time of year of etc a

Bilateral upper arms reddened, swollen and pain resident also presented with a temperature. No treatment rendered for the localized reaction however antipyretic medication given and resolution of temperature achieved. Primary care physician ordered allergy to the COVID-19 vaccine.

She had no side effects after the first vaccine and was tender on the first day, which went away; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 19Dec2020 10:30 at single dose for Covid-19 immunization. The patient's medical history included hypertension. The patient had an X-ray back in Sep2020 (unknown result). The patient's concomitant medications were not reported. On 19Dec2020, the patient had the first dose and stated that she had no side effects after first vaccine and was tender on the first day which went away. The outcome of the event was recovered on 20Dec2020. The event was treated with unspecified treatment. The reporter assesses the event as non-serious.

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

Significant facial flushing and burning sensation that developed just hours after administration. Possibly febrile during this episode. No reaction from first vaccine. Has had similar reaction to other medications and possibly a previous vaccine but patient is not certain. On day three saw provider with symptoms improved. No treatment needed. Monitoring.

Fever over 100 degrees, muscle aches and joint pains, general weakness and malaise, at approximately 20 hours after injection, until about 30 hours after.

Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral. Has history of Bell's palsy in the past. She started with right sided facial droop and was choking with swallowing.

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.

Vacinne given left arm 2/2/2021 3 days later Fri. 2/5 I left side of my face developed a sore face began to swell all way to my mouth.I've had cellulitis in the past. Began taking Kleflex saw my general medicine who advised me to contact your office

Received shot on Friday, February 12 around 1PM. Saturday, February 13:Approximately 30 hours after receiving shot, 8:00 pm, Saturday, Feb 13, developed stomach cramps. Over the next 4/5 hours, diarrhea, vomiting, cramps, chills. Felt very hot at times, but never ran a fever. Sunday, February 14, felt tired and weak, periodic cramps. No nausea or diarrhea. Monday, February 15, more energy, some cramps, By

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

I had right knee replacement surgery in 2018 and developed severe neuropathic pain in right leg . He pain subsided with time . After I got vaccine the pain came got . Now I have tingling , electrical like feeling , hot foot. I am applying ice. It tweaks me up at night.It is annoying

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.

This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 25Jan2021 at 13:00 (at 78 years) at single dose for COVID-19 immunization. The patient medical history included anxiety, headache, dry eye and low potassium, each from an unknown date and unknown if ongoing. The patient's concomitant medication included potassium oral at 10 meq daily for low potassium, cholecalciferol (D3) oral at 2000 iU once a day to help with bones, fish oil oral at 1200 mg once a day, alprazolam at 0.5 mg as needed (take one three times a day) for anxiety, clonazepam oral at 0.5 mg once a day for anxiety, nortriptyline HCl oral at 10 mg once a day, paracetamol (TYLENOL) at 500 mg as needed for headache, estradiol (SYSTEN) ophthalmic one drop as needed, all from an unknown date and ongoing. The patient experienced one or two hours after the vaccine (on 25Jan2021), she went to talk, she couldn't get her sentence straight. She knew what she wanted to say but she couldn't say it. Her first thought was that she was having a stroke and it really scared her. She became very tired and went to sleep, when she woke up, she was talking straight but she was still really tired. The next morning (on 26Jan2021) she had diarrhea three time and after that she felt better. The patient outcome of speech disorder and diarrhea was recovered on 26Jan2021 and the outcome of tiredness was recovering. The information on the batch number has been requested.

RECEIVED PFIZER COVID19 VACCINE ON 02/14/21 PRESENTED TO THE ED ON 02/19/21 WITH ABDOMINAL PAIN (CRAMP/ACHY PAIN) IN RIGHT LOWER QUADRANT X5 DAYS. DIAGNOSED WITH ACUTE ABDOMINAL PAIN IN THE RIGHT LOWER QUADRANT AND NON-INTRACTABLE VOMITING WITH NAUSEA. DISCHARGED FROM ED AND INSTRUCTED TO FOLLOW UP WITH PCP.

Malaise, weakness , headache, chills, severe abdominal pain, this continued through the night. Unable to sleep due to abdominal pain, considered calling ambulance. In morning, diarrhea, nausea, poor appetite. Now 2:30 pm. , pretty much recovered

Pfzer-BioNTech Covie19 Vaccine EUA. Joint and muscle pain in neck, shoulders, lower back, buttocks, legs.

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

Double vision; the way she talked she kind of had slurred speech; mouth was dry; she had Bell's Palsy/ Droop in her lip/mouth; her eye was still watering; puffiness around her eye; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (manufacture unknown, Lot Number: 9264), intramuscularly in left arm on 29Jan2021 14:55 at 0.3 ml, single for COVID-19 immunization. Medical history included non-hodgkin's lymphoma from Jul2019 and ongoing (The first time she was diagnosed was Jul2019. She then went into remission and then got the cancer back, she doesn't know when. She knows they started treating it as the cancer had returned in Aug 2020), watering eyes from an unknown date and unknown if ongoing (Her eye was watering before the injection. She knows her eye was watering before she received the vaccine), chemotherapy from an unknown date and unknown if ongoing (she is a cancer patient on chemotherapy), fever blister from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced she had bell's palsy and she does not know if she got this from the covid shot or not but she still has the droopy lip which apparently that can last a while. on 02Feb2021, droop in her lip/mouth on 02Feb2021, her eye was still watering on 02Feb2021, there was a little puffing around the eye/ puffiness around her eye on 02Feb2021, double vision on an unspecified date, the way she talked she kind of had slurred speech on an unspecified date. Caller was calling about the Pfizer COVID 19 vaccine. She said on Friday 29Jan2021 she had the first shot at about 12:30. Her eye started watering in the morning Thursday the day before and she maybe assumed she was getting a cold in her eye but it was really runny and she got the shot. She was a cancer patient on chemo and she went to the doctor because she was supposed to get her chemo. That Tuesday morning she had a droopy lip on the right side and her eye was still watering, there was a little puffing around the eye and the way she talked she kind of had slurred speech so she thought stroke but she was going to get her chemo in an hour or 2 so she when they checked her she told them what happened, she was seeing the PA that day so she left and came back 10 minutes later and said she had talked to the doctor, they were not going to give chemo today and told her she had Bell's Palsy and she does not know if she got this from the COVID shot or not but she still has the droopy lip which apparently that can last a while. This was her first shot so as a cancer patient on chemo should be getting the second shot 21Feb. She was concerned about taking that when she already has Bell's Palsy now, what else would it cause and then if she does not get it would she be 50 % protected. The doctor seemed to say she thought it was from the vaccine, but caller does not know because the eye watering began the day or 2 prior to getting the vaccine. Product details: She does not have the vaccine card right with her and she was using a walker to get up and down and so she was not able to provide NDC lot expiration right now. It would be available if needed at a later time. Indication: doctor said she should have it because she has no immune system. They don't know what to do they are just following what they told her and they were scared to death. The caller states she was a cancer patient on chemotherapy. She received her first Pfizer COVID-19 injection on Friday, 29Jan2021. Prior to the vaccine, her eye had been watering Thursday or Friday morning before she had shot, it was just her right eye. On Tuesday, 02Feb2021, she developed a droop in her mouth and puffiness around her eye and so forth. Caller clarified it was just on the right side and with her right eye. She also has double vision in her right eye. She got up in the morning on 02Feb2021, and her husband was in the other room and told her that she sounded funny. She explained to her husband her mouth was dry and she was kind of slurring her speech. Her husband came into the room she was in and said, "huh, your lip was drooping". Since it was in the morning and she had no other symptoms besides the talking funny and the puffiness around her eye, she didn't take it as a stroke. She figured she would just until she went to her chemotherapy appointment she had the same day, 02Feb2021. She went into her appointment and showed the person and gave her information on what happened. The person wanted an MRI of the brain to make sure she didn't have cancer there or cancer anywhere else up in that area and also that she didn't have a stroke. She confirms the MRI was fine, both were negative for any signs of this. She was told she developed bell's palsy. She has a drooping lip. The caller was concerned about her second shot. She wants to know should she getting the second vaccine, because the person at the (institution name) office (where she receives her chemotherapy) believes the bell's palsy came from the COVID-19 vaccine. She was supposed to have chemotherapy that day (02Feb2021), but they wouldn't give it to her then, but she did have it done yesterday. Caller explains she has no NDC, Lot number or expiration date for the chemotherapy she receives. She isn't given any stuff with any numbers and she gets numerous medications. Patient's Medical History (including any illness at time of vaccination): Her eye was watering before the injection. She knows her eye was watering before she received the vaccine because as she was sitting waiting to receive her injection, she remembers wiping her eye and thinking to herself, "I wish this eye would quit watering". Caller states she had a fever blister, but she was not quite sure about when this appeared. She doesn't know if she had developed the fever blister before or the next day after receiving the vaccine, she was not quite sure. The any events were not required a visit to Emergency Room. She went to the Oncology Office for her chemotherapy appointment. No Prior Vaccinations (within 4 weeks). Caller had the MRI (magnetic resonance imaging) on 02Feb2021 showed she didn't have a stroke and no cancer of the brain. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative on 02Feb2021 Negative for stroke and/or cancer. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

approx 6:00pm, front of left leg from knee to ankle went numb. No pain , strange like it fell asleep. After approx 24 hrs later started getting feeling back. Today, 2/23 back to normal.

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).

Waited 15 minutes after receiving the vaccine; went to car and when driving home about 30 minutes later my face and lips on the left side of my face went numb. The vaccine was placed in my left arm. The numbness lasted about 2 hours and then went away.

Awakened by severe leg cramps in both legs, upper and lower, front and back. Pain so intense it? brought tears to my eyes and I woke my husband with my moaning. It lasted about 15-20 minutes. I have never had muscle cramping like this before or since.

Next day after vaccination, I started getting sick. I wasn't holding anything down and this lasted 3 days and extremely sore arm

Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)

freezing to death; Chills; Fever; Headache; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I have mouth full of fever blisters; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 06Feb2021 (at the age of 78-years-old) at single dose for COVID-19 vaccination. Medical history included blood pressure and heart disorder. Concomitant medications included metoprolol succinate (TOPROL XL) for heart medicine and hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) for blood pressure. Historical vaccine included BNT162B2 for COVID-19 vaccination on an unknown date and had no problems with the first shot. On 06Feb2021, the patient experienced freezing to death; chills; fever; headache; was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; mouth full of fever blisters. Treatment for the events freezing to death, chills, headache, feeling bad, tired included acetaminophen (TYLENOL). The outcome of the events freezing to death, chills, headache, feeling bad, tired and mouth full of fever blisters was unknown. The outcome of the event fever was recovered in Feb2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the most affected finger (and the first that showed the arthritis) turned bright red. Now the whole joint is red and a few of the other nodes have turned red. Except for binding the first finger with the hope it would help (it didn't), I'm not treating them, since of course one can't do anything about osteoarthritis except ease the pain.

Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 02/21/21. Unable to prepare meals, wash dishes, do laundry or other daily chores. My son is typing this message for me. At this time I do not plan to get the second injection. Am sending this message to the CDC and Pfizer. Two 650MG Tylenol gives me little relief. I'm hopeful that someone might suggest something else.

A couple of days after receiving 2nd shot my arm was a little sore and then began to itch. Then I got a round red spot on my arm at the injection site. It continued to spread and get bigger

sore arm; This is a spontaneous report from a contactable consumer. This consumer reported same event for different patients. This is the second of two reports. A 78-year-old female patient received COVID vaccine (trade name unspecified), via an unspecified route of administration at left arm on 19Jan2021 17:45 at single dose for COVID-19 immunization. The patient medical history was no, no other products, no investigation assessment. Family medical history relevant to event was none. No prior vaccinations within 4 weeks. Vaccination facility type was clinic. Vaccine was not administered at military facility. The patient's concomitant medications were none. The patient experienced sore arm after getting the shot on 19Jan2021. No visit to emergency room or physician office. Her husband asked about this being related to the change of life but she didn't think so. The outcome of the event was recovered on Jan2021 (Duration of reaction was also reported as -18 days). Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021102026 same drug, same event and different patient

"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.

2/24 - Left arm very sore by 6:00 PM, took 500MG Tylenol. 2/25 - Arm still very sore, temp up 1 point above my normal, feeling very tired and achy, took 500 MG Tylenol at 12:30. Felt unwell all day. Took 650 MG Tylenol at 5:00PM and 11:00 PM. 2/26 - Arm is still moderately sore , but otherwise feeling better. 2/27 - Arm is still somewhat sore. With the 1st dose on 2/3, my arm was sore for 24 hours and I had no other symptoms.

Approx 4 hours after having the shot BOTH times; 1st time ache all over, bad headache; no appetite, very weak...stayed in bed for approx 30 hours 2nd dosage: approx 4 hours after shot; bad headache, no appetite, very weak lasted longer still in bed on following Sunday 2/28 (shot on 2/25) headache would come and go; was told to make sure someone stayed with me since I had had reaction with first shot and warned me thatif I had reaction to 1 would have for 2nd...No one to stay

lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 78-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 10:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated that she did not experience any problems until 27Jan2021 around noon, in which she started experiencing chills, cramps, and diarrhea all afternoon. She would like to know if these reactions have been reported and if they continue to persist, can she take something like Imodium. She didn't have any effect at all from it on Monday or Tuesday, and at noon on 27Jan2021, she had nausea and constant chills and diarrhea, she doesn't think this was a side effect, but wanted to check and see. She was not terribly ill, just uncomfortable, is this something she should be reporting? Stated she has a hearing problem, wished for DSU agent to speak slower. Nausea: was off and on all the time since noon today, it is better, the main thing is diarrhea, and the nausea is connected Constant chills: improving, it came and went all afternoon, she doesn't know if it has gone away, she thinks it is still here, but she is not constantly bothered, it has been periodically since noon today. Diarrhea: better since she has nothing left; nothing was getting worse, she was reporting it because she thought it may be a side effect. Outcome of the events constant chills and nausea was recovering, diarrhea was recovered on an unspecified date while unknown for the other events.

I have a temp of 100; feel tired; arm is really sore; achy; This is a spontaneous report from a contactable consumer, reporting for herself. A 78-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 78 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included restless legs, high blood pressure, and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 27Jan2021 at 08:00, the patient experienced temperature of 100, feels tired and achy plus the arm is really sore. The patient did not receive treatment for the events. The clinical outcome of temperature of 100, feels tired and achy plus the arm is really sore was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

felt fairly decent/feel bad; she "came down with covid"/test positive for COVID; she is kind of weak; her heart was racing; aching/aches; she ran a fever that got up to 101; cough; her arm got sore; allergies; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) on 15Jan2021 at single dose in left arm for COVID Prevention. Medical history included ongoing High Blood Pressure, she was diagnosed approximately 5 years prior to starting blood pressure medications in 1998. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) at 320mg/12.5mg, once daily, by mouth from 1998 and ongoing, amlodipine besylate at 5mg, once daily, by mouth at night from 1998, both for High blood pressure. The patient stated that she did not realize, but she must have been exposed to the COVID Virus, prior to getting her shot. She stated that on 15Jan2021, she went and got her Pfizer COVID shot, and that same day, by the time she got home, she was starting to feel bad and it went downhill from there. She mentioned that on the same day on 15Jan2021, she "came down with covid". She finally went in on 22Jan2021, and got tested, and she did test positive for COVID. The patient was tested Positive for COVID-19 on 22Jan2021. She did believe she was getting better. On 29Jan2021, she felt fairly decent, and today, she is kind of weak but she is assuming that will happen. She was scheduled to go back for her second dose on 08Feb2021, and she is wondering if there are recommendations about the second dose, for people who tested positive for COVID after having gotten the first dose. When queried for her PCP contact information, she stated that her head is not working really great and she feels stupid she did not have this information handy to provide. She states that the first week with her symptoms, she just figured she did have the virus. She had a cough but it never got down to where she had trouble breathing, and she just figured that her body had to go through, whatever it was going to go through, and as long as the patient felt like she was okay, there was not anything anyone could do, she just had to play it out. When she did finally go get tested, the doctor told her to get on Nyquil and Ibuprofen, so that is what the patient has been taking, and she feels like it has helped a lot. Before she saw the doctor, she was taking Acetaminophen, but the doctor told her to do the Nyquil and Ibuprofen, so that is what she has been doing. By the time she got home from getting her vaccine, her heart was racing. She took her blood pressure and it was okay at 125/73, and her heart rate was 72. She has high blood pressure and she takes two medications for that, so she took her night time blood pressure pill and the fast beating of her heart went away. The next day, she got to aching. She has had all different aches, and she ran a fever that got up to 101, and the rest of the time it was 100 or 99, but the fevers were not all day long, they would just come and go. Now she has had no fever in four or more days, and she is doing better. She does still have the cough, but she also has allergies so she does not know what is causing the cough. As far as the reaction to the vaccine, just her arm got sore. But she thinks she was exposed prior to getting the vaccine and just did not know it. she stated that the people took her temperature the day of the shot and she didn't have a temperature. She did not receive any other vaccines on the same day as the COVID vaccine. The outcome of fever was recovering, of cough and allergies was not recovered, of her heart was racing was recovered.

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.

Numbness and tingling in the left hand finger. Initial BP 172/63, pulse 71, 99% O2 sat. Patient went to the ED.

Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the next day. 102, finally lowered 48 hours later. Nausea; massive headache; complete body pain in muscles and joints, including jaws and eye sockets. exhaustion, fast hearbeat; no injection site swelling or pain. Reecovery within 72 hours, fatigue and nausea for another 12 hours more or less. I do feel it was worth it.

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.

Client verbalized numbness to left arm after receiving the vaccine. Client was assessed by Rescue Paramedics. According to client "I feel better." patient was released to go home at 9:45 am after symptom was resolved. Per Paramedic no further evaluation needed.

Right arm was sore for four days , and has had a headache since 3/5. Sometimes the headaches were sever and it has been mild in between.

Chills day Feb 6, Sick feeling & worse tremors Feb 7-Mar 1, Multiple Seizures Feb `13, & F22. Extreme sporadic stuttering started Feb 20 and continues till today Mar mad 2nd shot March 1st. Had multiple seizures Mar 13 preceded by stuttering. Had 3 extreme whole body seizures Mar 7, Today Mar 8.

At Midnight 24 hours later I felt a burning sensation in both legs. I did not have a fever. The burning sensation lasted 1 hour.

I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinated, I felt nauseated but I did NOT throw up. I have been sick ever since with one thing and another. For the first several days after being vaccinated, I had a sore arm, which I expected. I have also experienced extreme fatigue, chills, nausea, muscle and joint aches, a sore throat (briefly), an occasional headache, tenderness in my left armpit and along the left side of my rib cage, stomach pain and diarrhea and at times, a low-grade fever and sweating. My memory and ability to focus on my work have been affected. Yesterday (March 13), I felt OK all day and thought I was better at last, but after I ate dinner, I vomited and had diarrhea. I told my primary care physician about all of this in an email and she replied that my symptoms were "normal." I'm not so sure. I haven't read of anyone else feeling so sick for so long after the first dose of Pfizer.

Numbness in calves, pain in calf muscles, varying from slight to severe; slight numbness on occasion in arms and mouth area. This has not gone away. It is not debilitating. I had the same reaction to a flu shot several years ago. This lasted about 1 1/2 years, then slowly went away.

Patient called stating four days after shot, started to have pain in arm and was black and blue. Had been taking pain relievers and ice pack around the clock. Referred patient to PCP for follow - up and to continue until seen.

Pain in left leg - outside 2/7/21 went to clinic 2/8/21 Given an ultrasound Diagnosis: Blood Clot (Dvt) Given immediate shot in belly And prescription for Eliquis Followed up with Dr. (internist) 2/11/21

03/13/2021: Presented to the emergency department for fever, generalized weakness, nausea, and vomiting. The patient was admitted for GI evaluation who stated that the nausea, vomiting, and chronic diarrhea, could be from gastroparesis and diabetic diarrhea versus IBS. The patient was discharged the next day with outpatient follow up with her primary gastroenterologist.

muscle cramping in the right calf; This is a spontaneous report from a contactable consumer (Patient's husband). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL3246), on Left Arm via an unspecified route of administration on 30Jan2021 9:15 AM at single dose for covid-19 immunisation. The patient medical history was not reported. The patients concomitant medication included unspecified Vitamins since 50 year. It was reported that Patient experiencing muscle cramping in the right calf, began 30Jan2021 9:15am, cramping started that afternoon. 6 hours later or so. Patient questioned was this a normal side effect. Just feels different. The Fax sheet he received stating the indication was to administer the vaccine as 2 doses, 3 weeks apart. However, the card he received at vaccination center had both him and his wife scheduled 27Feb2021 which was 4 weeks. He also had to report a side effect for his wife. His wife got her vaccine on the left arm, but right leg calf muscle was constantly acting like a Charlie Horse, it's cramping, like the muscle was pulling in the right calf. His Wife's first dose was on 30Jan2021 at 9:15 AM, and in the afternoon on the same day was when right calf cramping started, since then it has been constant. The Right Calf Cramping was definitely the same. He did not know if it was worse or not but she was just complaining last night about it, it's continuing, it has caused her to wake up during the night. for both him and his wife the second dose may be schedule on 27Feb2021. He clarifies that he was not sure what his wife was told, but the young woman gave the same date on his card and said this was the earliest date that he can be scheduled. Outcome of the event was not recovered

left arm aching from the site of the injection; aching from back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger.; numbness down left arm/partially numb, she has feeling because it's aching; itchy torso from armpits to hips/itchy back and stomach; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201), intramuscular, administered in left arm on 23Feb2021, 14:00 as single dose for COVID-19 immunisation. Medical history included neuropathy in feet, cholesterol (abnormal), 2 vertebra in her back that are starting to fuse, shrinking as she's getting older, allergic to NSAIDS, she clarifies Advil, Tylenol and the medications reverses on her and gives her a headache, and she gets itchy; was in the hospital for surgery, for lady stuff and needs glasses. She doesn't have a heart problem she doesn't have any other medical issues. She's not diabetic the neuropathy was idiopathic. Concomitant medications included atorvastatin for cholesterol (abnormal), acetylsalicylic acid (BABY ASPIRIN), and duloxetine hydrochloride (CYMBALTA). The patient previously took morphine and was allergic, and hallucinating as she was told by the nurse, she said there were monkeys on the ceiling and her husband was trying to kill her and gets itchy with morphine. This is the same reaction she had when found out she had the reaction to NSAIDs, for example, she could take Advil or Tylenol for one night but it she took it two nights, that was when she woke up itching all over. She reports no rash, just itch. It just lasted that one night and it was gone. She could take some Advil and get that itchy feeling. On 01Mar2021, the patient experienced left arm aching from the site of the injection back down under the back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger; numbness down left arm/it was also partially numb, she has feeling because it's aching and she was describing it as an ache, not sharp just an ache. She can feel it, but its not all there. She knows all this stuff was new to all of us. She's following up and doesn't keep her up at night it's just not normal; and on 24Feb2021, her torso, the night after injection, from her armpits to her hips was itchy. She woke up and she went to the bathroom scratching her back and stomach. Her Covid 19 vaccine card was handwritten she sees 23Feb2021 and that's the date she got the shot. She's been isolating since Feb2020. She was only going out for necessity. She took a risk and had family at her home for Christmas. She hasn't been to church in almost a year, so she was taking this very seriously. Before they even started telling you to wear a mask she was listening to the news in December and January. She states, alright she's isolating, it's the safest thing she can do she's not ready to leave this world yet even knowing she's past her golden years. Her doctor put her on Atorvastatin it because of her age, she had blood drawn but she wasn't given any counts on an unspecified date. Her first thought was she had a chest problem but it's not a heart attack, the ache doesn't go any farther than what she told. It's not stopping her from being productive, from doing things. The events did not require a visit to the emergency room, physician office and was not hospitalized. The patient had no prior vaccinations within 4 weeks and no events following prior vaccinations. Outcome of event itchy torso from armpits to hips/itchy back and stomach was unknown; and outcome of the rest of events was not recovered.

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.

I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nausea and was very weak. After about 30 hours I felt okay again. However, a week and a half later, I noticed red bumps on the back of my neck. The next day, my neck and scalp had red, itchy blotches. Through the next five days, these spread down my body to my ankles until I was covered with the red, very itchy blotches. I did go to Urgent Care on the third day and I was given a 5-day prescription of Prednisone. It did not do much until the third day and then it relieved the itching somewhat for about 6 hours, but then it would start again. After the five days of Prednisone, I took Benedryl for three days until the itch and redness disappeared. I checked the facility web site on types of rashes and my rash fits the description (and the photo) of a drug-related rash, but I have not changed or added any drugs for several years other than the Covid vaccine (I did some research online and found two other people who have had the same problems I have had after the second Covid vaccine. Both of them had the typical reaction of chills, fever, aches and dizziness for about a day after the second shot and then 1-2 weeks later, broke out in a rash. Both reported having the rash start at the neck or head and then spreading down the body throughout one to two weeks before disappearing. There were photos on the facility site of drug-related rashes and they were exactly like what I had. Since the rash was almost certainly covid vaccine related, I am making this report, which my doctor recommended. I had no other changes in diet, medications, environment, etc. ? only the Pfizer vaccine was new to my body.

vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness, congestion, poor appetite, coughing. Previous headache and sweating had resolved by the time she presented. Discharged with isolation instructions. Returned to ED late on 1/22 with " right-sided chest pain described as sharp constant 6/10 nonradiating pain localized to the right side of upper chest, shortness of breath with exertion since this afternoon. She does endorse subjective fevers, with associated increased coughing which is productive in nature, shortness of breath." Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21.

Severe migraine headache and multiple joint pain until steroids Mar 21, now slight headach. Swollen face Mar 20, 21, 22. Fatigue and brain fog for 10 days. Went to emergency room twice. Mar 18 and 21.

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.

Resident found unresponsive found at 1545, CPR done, EMS responded and resident Pronounced Dead at 1615

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.

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.

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.

patient has drooping/paralysis on right side of the face presenting that it looks like temporary Bells Palsy

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.

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.

Moderate to severe bilateral wrist pain; Moderate to severe bilateral hand pain; This is a spontaneous report from a contactable 78-year-old female consumer reported for herself that: A 78-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198),dose 1 intramuscular, administered in Arm Left on 20Feb2021 13:00 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced moderate to severe bilateral wrist pain on 21Feb2021 15:00 and, moderate to severe bilateral hand pain on 21Feb2021 15:00 and Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 21Feb2021. Unable to prepare meals, wash dishes, do laundry or other daily chores. My son is typing this message for me. At this time I do not plan to get the second injection. Am sending this message to the CDC and Pfizer. Two 650MG Tylenol gives me little relief. I'm hopeful that someone might suggest something else. and outcome of the event was not recovered.

cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no urge to eat/Has no desire to eat or drink; lost 10 lbs; feel ill; General feeling of the flu; had a slight sore arm; nausea; severe pain, her hip and knee were killing her; was having major problems, a delayed immune response; Rash covering her entire body; acute pain and with deep breaths; low grade fever; cough/Cough was a dry, tight, non-productive cough; Weakness; Chronically dehydrated; the COVID Vaccine wasn't working; the COVID Vaccine wasn't working; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204) at the age of 78-years, via an unspecified route of administration on 04Mar2021 at single dose; first single dose of BNT162B2 (lot: EM9810) on 11Feb2021; both for COVID-19 immunisation. Medical history included osteoarthritis (having aches and pains) had for 20 years; large sliding hiatal hernia was diagnosed from an EGD six months before, didn't want surgery to fix it; heartburn (last five years); fatty liver, was not from drinking alcohol; generalized anxiety; was tuberculosis positive only because she was exposed years ago. Concomitant medications included pantoprazole started four to five years before at 40 mg twice a day for heartburn; escitalopram (tablet) been on for 15 years or longer at 10 mg 1 DF every day for generalized anxiety; clonazepam 0.5 mg nightly at bedtime for anxiety (been taking for last ten years or more, stops her from worrying about her kids and stuff like that). The patient experienced on 07Mar2021, low grade fever, weakness, chronically dehydrated and cough; on 15Mar2021, rash, acute pain and with deep breaths; on an unspecified date, no desire to eat or drink. Seriousness criteria of these events were reported as disabling. Patient reported that was having major problems, a delayed immune response. Told everybody if this keeps up she was not going to make it. It was wearing her down and she was not going to survive. Occurred after second COVID vaccine. She is active, goes to pool, and does different things. Had vaccine on Thursday and was ok until Sunday. Started Sunday with low grade fever. Kept being low grade and never got to 101, 102, or 103. She didn't take ibuprofen. Usually takes ibuprofen once a day for routine aches and pains. Having weakness. Had no desire to eat or drink. She waited a couple days, but then called her doctor. Doctor's office wouldn't give her an appointment. Stated this wasn't the routine and has been going on for 10 days. This was too much. Two days later, caller's daughter-in-law took her to a place like an ER. A bunch of tests were done. She asked for an IV because she was chronically dehydrated. Weakness was getting to her. After seeing the doctor in the mini surgical ER, she didn't feel any better. She felt the same. Same nausea, weakness, low grade fever, the whole thing. Decided to see her regular doctor. Stated it wasn't her chest. Wanted to be told what was going on. Her regular doctor didn't order any labs. She was given a steroid shot. Thought she was in deep doo-doo. Stated this was not a good sign and she was not going to make it. She woke up yesterday with a rash covering her entire body. She had no clue she had the rash. Never saw the rash. Rash didn't itch, but she still had it. After steroid shot from doctor, she felt a little bit stronger and thought maybe she was going to make it, but then started getting severe pain. Patient was used to having aches and pains that went along with old age and her osteoarthritis. This was severe pain as if she fell and hurt her ribs. It hurts to take deep breaths. Her hip and knee were killing her. It was acute pain, not normal pain. This morning stated she couldn't take it and was going to take ibuprofen, which was not the best for her. She didn't want to eat, but tried to have food in her stomach to take the ibuprofen. She cannot take good deep breaths because of the soreness in her ribs. Thought something in her body was having a delayed immune response and her gut told her it was not good. For low grade fever, did not take ibuprofen, 07Mar2021 was when she started feeling yucky, she wanted to see how she felt and her temperature never really got up, stuck it out, normal temperature for her was 97 or lower, her temperature once in a while would range from 98 to 100.3 or 100.8, she cannot take paracetamol (TYLENOL). For weakness, noticed right away, felt a little better after steroid, had not been out of her door except to the ER. For chronically dehydrated, clarified she had no desire to eat, usually drinks coffee and tea in the morning, but now had no desire, was making herself drink, felt something wasn't right beginning on 07Mar2021, everything went south and got worse, clarified it really wasn't nausea, but no desire to eat or drink, doctor today gave her ondansetron (4mg) which didn't help and made it worse, eating and drinking didn't make her sick, just didn't want it. She had labs done in the ER and was told her labs weren't really that off for her to be that dehydrated. Asked for an IV because she was not drinking what she normally drinks, didn't feel any better after the IV. Rash covering her whole body, but didn't itch. Acute pain and with deep breaths began evening of 15Mar2021, seemed the same today, she just took an ibuprofen a little while ago and was feeling better. Patient also mentioned that realized her body was trying to get monoclonal antibodies and resistance to build up her immunity so that if she ever got infected with COVID virus she could fight it, it was just not working, it was not doing its thing, she was having a delayed immune response, was very worried about that, going on 8-9 days and it was weakening her by the day, didn't think she could take this too much longer. Clarified the COVID Vaccine wasn't working and her body couldn't get its act together. Patient had a slight sore arm after the second dose, never reacted at the injection sight, it was strictly internal, which kind of scares her, something was not right, was having the rash, pain, and severe weakness. Was not expecting any kind of problem. Didn't think too much about the second COVID Vaccine. Stated people were like "oh that second shot." If she didn't get better soon she is not going to do well. Cough was a dry, tight, non-productive cough, lungs were checked yesterday and were clear, felt like all of a sudden she has an urge to cough and nothing comes up. For steroid shot, didn't know if it was dexamethasone (DECADRON) or not, made her feel a little stronger for the day, but then brought on severe aches and pains in her joints and ribs, did not have this until the steroid shot. Patient said that didn't take ibuprofen the first couple days because she didn't want to mess up the immune response starting in her body, asked doctor about immune globulin for her delayed immune response, but doctor shook his head, knew that people with autoimmune are ordered IGE or IGG to test the immune system, asked doctor about this, but he shook his head. Stated she didn't think a CBC with different was performed at the ER, confirmed she was only in the ER after the second dose and was not admitted to the hospital. As of 17Mar2021, she stated then two to three days after that she woke up with rash over her entire body that showed up overnight, that alarmed her even more of course, no itch or nothing, no clue it was there until she washed off and could see it, she had never had a rash before, her arm never got red, but she had a low grade fever, stated now didn't know if good or bad, cough, not productive, some urge to cough, no appetite, not eating or drinking, and increasing weakness, today she couldn't say anything was different about her rash maybe slightly faded but she didn't feel any better, she did get a steroid shot when she went to doctor yesterday and that made her feel less weak. As of 18Mar2021, patient stated that had no reactions for the 1st 2 days following her 2nd dose however she started to feel ill, low grade fever that never went above 100. General feeling of the flu; aches and pain, which she had before but more than usual. She had no urge to eat. Tried to see her doctor when it had been going on for 5 days but they were not concerned. By that Friday, she went to the hospital. They found nothing wrong in her lab tests but she asked them for I.V fluids since she hadn't eaten or drank anything. On Monday, she went back to her initial doctor because she had a rash all over her body, it did not itch and her injection site had no redness. She was given a steroid shot, today she might be feeling a bit better. She lost 10 lbs. She had to stay inside for the past 10 days, except for doctor visits, although she was usually an active person. She would like to know how long the side effects would last. Outcome of the events low grade fever/ wasn't working, weakness, rash and acute pain and with deep breaths, cannot take good deep breaths and soreness in her ribs was not recovered/not resolved while of remain was unknown. Relatedness per primary source reporter via global introspection of BNT162B2 to events low grade fever, weakness, chronically dehydrated, no desire to eat or drink, acute pain and with deep breaths and cough were related.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. 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.

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.

the pain is going up higher and higher.; I feel flush; Flu like symptoms; Arm pain; This is a spontaneous report from a contactable consume. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249) via an unspecified route of administration in Arm left on 21Jan2021 11:00 (Age at time of Vaccination: 78-years-old) as single dose for covid-19 immunisation.Medical history included ongoing blood pressure abnormal, arthritis, gastrooesophageal reflux disease. She also takes a medication for reflux, but does not know the name of it. The patient's concomitant medications were not reported. On 23Jan2021 the patient experienced flu like symptoms, arm pain. On an unknown date the patient stated the pain is going up higher and higher and I feel flush. She got the vaccine last thursday, on 21Jan2021. She stated she was fine the day after, but then the next day she started to get flu like symptoms. She is also having arm pain and the pain is going up higher and higher. The pain is going up behind her head, it is hurting there too. She wants to know why she has not stopped hurting. She stated she kept taking Ibuprofen thinking that was a good thing to do. However, she would only take half of it.Therapeutic measures were taken as a result of flu like symptoms, arm pain , the pain is going up higher and higher. It was reported that she is scheduled for the second dose on 11Feb2021. No prior vaccinations was given to patient within 4 weeks. The outcome of the event flu like symptoms and arm pain was not recovered and outcome of other events was unknown.

Back pain; leg pain; general rib pain; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Jan2021 as single dose for COVID-19 immunization in an public health department. The patient's medical history was not reported. The patient has no concomitant medications. No other vaccine was given within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced back pain, leg pain and general rib pain for the last 3 days on 24Jan2021 12:00. No treatment was received. The events were considered non-serious since it did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. The outcome of the event was not recovered.

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.

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.

felt paralyzed and nauseous; felt paralyzed and nauseous; fever; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via antibodies test on an unspecified date with positive result. On an unspecified date, a day after receiving the vaccine, the patient developed a fever and said that she felt paralyzed and nauseous. The patient needed to go to the hospital in order to recover and tested positive for antibodies. The outcome of events, fever, felt paralyzed and nauseous was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021 - Periodic Tingling up and down beneath skin of Left Arm,in addition to Swollen Muscle Applied Cold Compresses and Tylenol Caplets with relief of tingling sensations 3/16/2021 - Covid Pfizer Vaccine #2 (Right Arm) - only temporary small bruise spot at injection site 3/25/2021 - Urgent Care for Swollen Upper Left Arm and unchanged Tingling discomfort (Advised to continue Cold Compresses and follow up with Primary Care Provider) 3/29/2021 - Left Arm increasing pain up to Shoulder and Neck - weakened arm strength, use challenge, and sleep discomfort 4/12/2021 Earliest Upcoming Appointment with my Primary Care Provider

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.

pt states that she has sore left arm. Pt has metal screws and plates in her left ankle and later that night after getting the vax she got severe shooting pain in left ankle. This pain lasted about 15 or 20 minutes. Today 4/7/2021 about 11 AM she started feeling like she has an exposed nerve in her mouth. She said the pain traveled through her mouth, to her ear, then to her head. She says it is now numb and tingling. She has a rod in her femur to her hip and so far has not had any pain in that location. Pt says called her PCP and she was instructed to take Tylenol or go to the ER if her pain persist.

fever up to 101 degrees; weakness; Body aches; headache; exhaustion; Chills for 3 hours; This is a spontaneous report received from a contactable (reporting on herself). A 78-years-old Non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6201 and Expiry date not reported), via an unspecified route of administration in Arm Left on 11Feb2021 16:45 as single dose for COVID-19 immunization. Medical history included penicillin allergy. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283 in Arm Right on 22Jan2021 17:15 for COVID-19 immunization. Concomitant medication(s) included Liothyronine/Levothyroxine T3/T4, and usual vitamin. 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 12Feb2021 at 13:00 symptoms started (at 20 hours after the injection) Chills for 3 hours, fever up to 101 degrees, weakness, body aches, headaches, exhaustion. Patient did not received any treatment for adverse event. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering.

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,

Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), intramuscular, administered in Arm Left on 17Feb2021 12:08 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included stiff neck. There were no concomitant medications. The caller explains the arm soreness developed on 17Feb2021 after she got home from receiving the vaccine. She couldn't sleep on her left side, which she is used to doing that. She hasn't slept on her left side still. Right now, where the needle went is a little sore, but her arm is okay. Her neck just hurts. The caller states her neck started to get sore probably last night while she was sleeping. She had a little bit of sore neck yesterday (18Feb2021) and last night. But, she woke up this morning and it was worse. She could move her neck and everything up until this morning. The outcome of the events sore arm was reported as recovering. The outcome of the event Sore neck was reported as not recovered. The outcome of the event Sore neck was reported as worsened was reported as unknown.

3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolved the next day woke up with severe right arm pain, hurts to lift it sleeps on side and this also hurts it no weakness but hurts to raise it up no prior injuries no trauma pain in lateral shoulder, minimal neck pain, no pain distal to elbow no numbness or tingling on warfarin so has been afraid to take anything for this pain 5/10 at rest and much worse with movement

Pt states that 3 days after her Pfizer covid vaccine, she developed swelling and pain of left hand. Doctors notes state she was diagnosed with gout with a Uric acid of 8. The doctor states the covid vaccine could trigger gout and that she is taking HCTZ which can predispose. This was the pt's first episode of gout. She was treated with a medrol pak. Doctor's notes state that pt improved 1 day after taking steroids. she has not had any recurrence of gout.

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

it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; blood pressure went up to 198/203; still has tiredness; difficulty swallowing like her throat is still tight; difficulty swallowing like her throat is still tight; short of breath; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), first dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 11:00, single dose for covid-19 immunisation. Medical history included silent heart attack, ongoing Barrett's oesophagus from 2008, fall she had over two months (2021), eye surgery on an unknown date. She does not get any shots and can't have shots even for the flu shot because she had problems with two flu shots she had; states she had a problem with each one of the flu shots and does not know the names of the flu shots and has no lot numbers to provide for them; states she had the flu shots in the early 1990's and worked in healthcare and had to have them and they told her back then if she wanted to work she had to have the flu shots and then she got sick with both of the flu shots and they said they guessed they would not force her to have the flu shots. The patient's concomitant medications were not reported. Patient had the first dose administered and then about 14 hours after (12Mar2021) that she had no problems until it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours. She does not know what to do about getting the 2nd dose of the vaccine and was at her cardiologist's this week and he said he is not familiar with the Pfizer vaccine causing chest pain; caller states she has a history of silent heart attacks. She still has tiredness and difficulty swallowing like her throat is still tight and they told her to mention if she does go for the second dose of the vaccine to mention that she had this situation.The chest pain and arm pain began 12Mar2021 and the arm pain is in her right arm where the vaccine was administered and the arm pain and chest pain have resolved; states the arm pain and chest pain stopped and she thinks that lasted about an hour and a half and she called a family member to take her to the hospital; states about 2:30am that same day she was admitted the morning of 12Mar2021 and was discharged on 13Mar2021. They ran every test known to the patient and for a while her blood pressure went up to 198/203 in the emergency room (12Mar2021) and she is not on any medication; caller states she does have Crestor but has not started on it and has not taken it yet. The tiredness and difficulty swallowing like her throat is still tight began the same time she was having the chest pain and she is not having any chest pain or anything like that right now but the tiredness and difficulty swallowing like her throat is still tight is still ongoing; states she did go get cardiac clearance to make sure which was this past week and she does not feel well and like for her the tiredness is bugging her. The tiredness and difficulty swallowing are better but she knows they are there and she tries to swallow something and is like boy her throat is still tight. They did an ultrasound in her left leg because she was limping from a fall she had over two months ago but still has a sore ankle from that and they sent her down for the ultrasound and a CT looking for blood clots in her lungs because she was short of breath (12Mar2021); caller states she thinks they were running everything they could to rule out things; states everything was negative for the CT and ultrasound and she believes the CT and ultrasound were done on 12Mar2021. She has no idea when she was diagnosed with silent heart attacks but they kept asking her about this when she went in for eye surgery and asked her when she had a heart attack and she said she had never had one and they said yes she had and she never knew. She just set up a HCP appointment after the reported events with a gastroenterologist because she has Barrett's and because of the esophagus she did not know if it flared up by the Pfizer vaccine and that caused the pain because the two pains of the heart and esophagus mimic each other with pain going up into the jaw so they were ruling out which one it was; states she went out as an atypical chest pain and called the cardiologist and went in and went over her records from the hospital with the cardiologist. She does not know what caused what in terms of the pain. The outcome of the event blood pressure increased was unknown, chest pain and pain in arm was recovered, other events was recovering.

passed out for a very short period of time; was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; her body felt warm but then she was freezing; her body felt warm but then she was freezing; was sick and was different and very weak; muscles were sore; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), via an unspecified route of administration, administered in the left arm on 17Mar2021 12:10 (Batch/Lot Number: EN6207; Expiration Date: 31May2021) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of the Pfizer BioNTech COVID19 vaccine on 23Feb2021 (lot number: EN6198 with expiry date 31May2021) for Covid-19 immunization. The patient experienced passed out for a very short period of time and awakened by total body shaking and it was not just shivers but was uncontrollable shaking on 18Mar2021; her body felt warm but then she was freezing, she was sick and was different and very weak, and muscles were sore in Mar2021. It was further reported that the patient got the 2nd dose of the Pfizer BioNTech vaccine that day on 17Mar2021 and about 12:45am or 1:30am the next morning she was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; the shaking has resolved completely but she is not sure when it resolved but she was shaking for a good while because she can remember being so uncomfortable with her body moving so much which went on for maybe 20 minutes or so when her husband woke up.Patient's husband then woke up and got Ibuprofen and gave it to her and that stopped the shaking which surprised her and she did not know the Ibuprofen would work to stop the shaking that well and the Ibuprofen did work in stopping the shaking. The Ibuprofen stopped the shaking and she can remember to touch her body felt warm but then she was freezing and she does not know what this means but this was not ongoing and resolved when her husband gave her the ibuprofen and she stopped shaking right away which always amazed her that the Ibuprofen worked. She stated fortunately the Ibuprofen stopped her from shaking and she was able to sleep until early morning when she woke up and knew she was sick and was different and very weak; states the weakness was not ongoing and the approximate time the weakness resolved was unknown but she was down the rest of the day and after that she passed out for a very short period of time and held her head up and stood up and thought wow something was going on and asked where was this coming from and it was not nausea but she was just weak. She has not passed out for a huge amount of time but fortunately she had some towels laying close by and was able to use a towel; states after that she stopped for the rest of the day and only got up to go to the potty and was just so weak and heard that from many people that they just slept afterwards.Caller states her muscles were sore and she realized that was just normal and after the 2nd dose of the vaccine she knew her muscles would probably be sore and this was resolved. She came downstairs and was sitting on a chair and then stood and no longer sat in the chair and her husband knew things were not right with her and her eyes looked funny and she passed out and that never happened to her before and she was passed out for a few moments. Other than the Ibuprofen she did not have treatment and did not go to the emergency room or the HCP office. Patient only took one Ibuprofen and she has a very small body and her husband sometimes takes 2-3 Ibuprofen and she thinks wow that is so many but she herself does not have any medication and she just took one Ibuprofen and it worked; She took the Ibuprofen on 18Mar2021 in the early morning. Fortunately she was in good health. Outcome of the event passed out for a very short period of time, was awakened by total body shaking and it was not just shivers but was uncontrollable shaking and muscles were sore was recovered in Mar2021, and unknown outcome for the remaining events.

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.

Critical Limb Ischemia Symptoms: Progressive BL lower extremity and back pain starting on 3/20/2021. She presented to the ED twice and DVT ultrasound and lumbar spine CT showed no acute findings. Symptoms progressed to the point of severe pain on 4/1/2021 with toe numbness and paralysis. CTA of BL lower extremities was performed showing bilateral arterial thrombus. She underwent bilateral common femoral artery thromboembolectomy with vascular surgery. Of note, patient was on eliquis 5 mg BID given history of PE in 2018. She was compliant with this medication.

Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged home from ED with apixaban.

Pneumonia after getting the COVID Vaccine; Pneumonia was related to MRSA; Very weak; mild fever; This is spontaneous report received from a contactable consumer (patient's husband). A 78-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 78-years-old, administered in arm on 25Feb2021 15:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included diabetes mellitus from 2011 (Verbatim: Diabetic; Diagnosed 10 years ago), rheumatoid arthritis from 1995 (Verbatim: Rheumatoid arthritis; Diagnosed in 1995), cardiac failure congestive from Oct2020 (Verbatim: Congestive Heart Failure), adrenal insufficiency from 1990 (Verbatim: Adrenal insufficiency; Diagnosed in probably 1990), atrial fibrillation from 2017 (Verbatim: Atrial fibrillation; Diagnosed 4 years ago). Concomitant medication included unspecified medications ("she takes lots of medications. Too long of list she probably takes 15 different medications, reporter chose not to provide them). No-other vaccines were given at the same time. She gets the flu vaccine every year, shingles vaccines, pneumonia vaccines every year but, has no idea where they were manufactured. Confirmed she did not get the listed vaccines at the same time she got the COVID Vaccine. The patient's husband and the patient (his wife) both received their 1st COVID shot on the 25Feb2021 and was scheduled for 3 weeks later. He got his COVID on the 18Mar2021. The patient got Pneumonia and was admitted to the hospital but he does not know the exact time the Pneumonia started. It developed over a period of several day started with a mild fever (in Mar2021) and after the 2nd or 3rd day her fever spiked and that's when she was admitted to the hospital. He reports his wife went into the hospital with Pneumonia on 18Mar2021, the day she was supposed to get the 2nd shot. It was also reported that Pneumonia was related to MRSA. She laid up in the hospital for 2 weeks, the weakness ("very weak") may have happened in the hospital or a few days before, date was confirmed to be on 15Mar2021. The event "pneumonia" was totally unrelated to COVID and now she is in a nursing home, she went in on 26Mar2021. She probably won't be able to have the 2nd shot for a couple of weeks. She was in there for a couple of weeks and still quarantined. He wanted to know will the fact that she is not getting the 2nd shot at the 3-week interval reduce the efficacy of the vaccine since she is getting the 2nd dose late. Does it make a difference with the effectiveness of the vaccine if she's going take the 2nd dose 3-4 weeks or even a month and a half rather than the usual 21 days interval? No treatment before going to the hospital other than calling the doctor and the doctor saying take her to the hospital (not reported if patient received treatment during hospital stay). No treatment done over the weekend, while she was in the nursing home. The adverse event pneumonia required a visit to Emergency Room. The patient was hospitalized from 18Mar2021 to 26Mar2021. Investigations included had a lot of blood work done, a CT scan, an X-ray on unspecified dates. He does not have any of the results but, the physicians have them. The outcome of the event mild fever was unknown, for very weak was not recovered while for the rest of the events was recovered on 26Mar2021.

78 Y/O FEMALE C/O NUMBNESS/TINGLING TO LEFT HAND. NO OTHER COMPLAIINTS PT MONITORED BY EMS UNTIL 10:45 A.M, PT STATED SYMPTOMS STARTED TO SUBSIDE. PT THEN CLEARED ADVISED IF SYMPTOMS RETURN TO SEEK MEDICAL ATTENTION PER EMS.

Bell's Palsy/facial paralysis; Bell's Palsy/facial paralysis; This is a spontaneous report received from a consumer (patient's husband). A 78-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 78 years, administered in right bicep on 16Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Patient's medical history includes bells palsy from 1997, lower right lobe of her lung removed in 2016, and removed for carcinoid tumor on an unspecified date. Patient did not have prior vaccinations in 4 weeks. Concomitant medications were none. There were no other vaccines administered on the same date as the suspect. Patient previously too quite a few medications but she hasn't been taking for years or that would affect it. It was reported that patient and the reporter received first dose on 16Mar2021 at 09:00 AM in the right bicep as recommended by the pulmonologist and oncologist. It was reported that on 29Mar2021, also reported as "13 days later from vaccination", facial paralysis started around noon. At the time of report, patient was experiencing Bell's Palsy from 29Mar2021 and asking for recommendation for second dose. Patient was also officially diagnosed with Bell's Palsy when she went to the ER on 31Mar2021. Patient has seen the doctor and been to the ER and the doctor refused to comment saying he had no opinion, they had asked him if she should do the second dose and he said he had no opinion. Reporter relayed that on the website there is no specific notable balance in the numerical groups to suggest a causal relationship to the vaccine. Reporter was asking if the second dose was prohibited, stating patient was scheduled for 06Apr2021 which is 21 days after her first dose. Patient's husband spoke from the FDA's briefing document that "Bell's palsy was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination," and mentioned that there have been 4 reports of Bell's Palsy during the study and 1 of those was after the first dose and 3 were after the second dose. They wanted to know if it is allowed should she get it or could it be rescheduled to a later date. For tests, no testing was done they just did a visual exam on an unspecified date. Vaccine was not administered at Facility. The outcome was unknown. Information about lot/batch number is requested.

swollen lymph node in my left arm pit that was red and tender to the touch. Swelling and tenderness disappeared in approximately 25 days. Dr viewed it on April 13th & confirmed it was a swollen lymph node

Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertensive crisis BP 223/113 needing Emergency department admission. Following this ED visit the the BP had been uncontrolled with ongoing headaches and right sided neck pain radiating to the right eye/head through March and in April have improved. During this time had #2 Pfizer vaccine 2/12/21 and had experienced arm pain and headache as well as a spike in her BPs as well as right sided neck pain radiating to her right eye

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.

nerve pain in face; Tooth pain; severe nerve pain left ankle/nerve pain in mouth/pain in her legs/pain in the calf; Numbness. It affects my face and head. Anything that goes to your brain.; feels numbness/feels it in her eye too; Deep pain.; trigeminal neuralgia; severe damage in both legs; tingling; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021, at the age of 78-year-old, (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included ongoing Allergies. The patient had allergies to ciprofloxacin (CIPRO), clindamycin, amoxicillin, penicillin, sulfamethoxazole; trimethoprim (BACTRIM), cefalexin monohydrate (KEFLEX), clarithromycin (MACROBID), levofloxacin (LEVAQUIN), valsartan (DIOVAN) (blood pressure med). Some of them allergic and can never take. Some have minor effects like itching or rashes, allergic reaction to dairy, the enzyme, not the lactose. The patient had bloodwork 2 weeks before the vaccine (in Mar2021) to see if there were any antibodies. Stated that she not only had the short test and the long test but that she went for the blood test that showed no antibodies and was told she could take the shot. Stated that she has taken blood pressure medicine every day since she was 29. No prior vaccinations within 4 weeks. No AEs following prior vaccinations, no family medical history, no relevant tests. Stated that she had an accident that promoted a lot of her nerve damage. No history of all previously immunizations, no additional vaccines administered on same date. The patient had plates and screws. Rod attaches to her hip. Metal Clips in shoulders. Severe spinal stenosis. Rotator cuff operation. Arthritis and a scar in her arm. Concomitant medications included levothyroxine sodium (SYNTHROID) been taking more than 15 years for thyroid, start and stop date were not reported; ongoing hydrochlorothiazide taken for an unspecified indication, start was not reported and stated that this is a water pill that she takes as part of her program; ongoing amlodipine besilate (NORVASC) taken for an unspecified indication, has been taking since age 29; ongoing budesonide (NASOCORT) taken for allergies, Stated that she did take on the day she received the vaccine. Have a lot of pollen down here; ongoing hydrocortisone taken for an unspecified indication, start was not reported, Only takes half of that, takes 2.5mg. Doctor thinks it doesn't do anything, that it's like taking 3 Advil and Has been taking on and off only at night did not take it Monday night. ongoing Coreg -Has been taking since age 29. Ongoing desloratadine (CLARINEX) for allergies, ongoing Vitamin D nos and states she takes either 1000 or 2000 in liquid form for unspecified indication; ongoing Magnesium (Powdered drink mix) for unspecified indication and ongoing ascorbic acid (VITAMIN C) for an unspecified indication. The patient experienced severe nerve pain left ankle on 06Apr2021 (it happened later that night, after 2 or 3 in the morning, so it was 06Apr2021), nerve pain in mouth and face on 07Apr2021, Had plates and screws, so knows the difference between hurting and nerve pain. She experiences pain constantly every day. This was severe nerve pain. Stated that just the ankle was severe. Stated that when she woke up, she already felt pain in her legs. States that she also had pain in the calf but didn't pay much attention because the pain was mostly in her ankle. States that it was where the metal was and went on for about 15 or 20 minutes. States that it has subsided. None treatment received. The patient experienced tooth pain and states that this started today (07Apr2021) around 10:30 or 11:00 this morning. States that all of a sudden felt an exposed nerve in the tooth, like the worst toothache you've ever had. States that it was pretty devastating and nerve pain really hurts a lot. States that she knows you don't have to have exposed nerve to know. States that it started on her face on the left side, the way neuralgia starts and goes to the eye, all on the left side, same side as the shot. States that it was weird to her. The patient was told by her doctor to take Tylenol but she did not take it because it really doesn't work. States that she can't feel everywhere. States that she would like to know what is going on and she still feels numbness (in Apr2021). States that her face is not numb but feels numb-ish, and can't even explain it. States that she feels it in her eye too. States that it feels better now then when she first noticed it. States that she will take something eventually if it keeps up. Caller states that when getting the shot, she told the man that she already had a scar in the right arm from a full rotator cuff. States that she is leery of the shot. The patient had numbness. It affects my face and head. Anything that goes to your brain on an unspecified date. She wanted to know if any metal in their body metal ankle screws in place 47 years. Rod attaches to her hip. Metal Clips in shoulders. Trigeminal neuralgia. Nerve that goes to face. Severe spinal stenosis. Vaccine in left arm. Rotator cuff operation. Talked to HCP. He is going to leave it up. She just don't want to experience a bad reaction. Deep pain. Eye and Face. Left arm. Did not affect the rod. Affected all the nerves on the left side. Supposed to get the shot the 26th. Now this to her face. It makes she think do she want that shot to her brain. That's what makes she wonder. HCP told to take Tylenol 500mg or go to ER. She chose not to go to ER. Asking if this adverse event has been reported and if she should receive second dose. States that she had the vaccine on Monday 05Apr2021, on that night. States that are several things wrong with her and she questioned everyone about taking it. States that she did report today (07Apr2021) about her recent experience. Is not sure whether she wants to take the second shot. States that she has severe damage in both legs. States that she has trigeminal neuralgia. States that she has middle ankle screws and plates that she has had for 47 years on her left side. She have arthritis. On the right side, from the femur to the hip, she has a rod attached there. Has severe spinal stenosis and has long lasting problems. States that this is why she was worried about taking the shot. States that all of her doctors said to really take it because she is 78 years old, so she took it. States that Monday night (05Apr2021), she got the shot in the left side of her body. States that the person giving her the shot noticed a scar in her arm in the muscle area. States that she had one of many operations on that shoulder, including the rotator cuff. States that he asked her if there was any metal in there and she stated that there probably is metal in there, or clips, does not know for sure if metal. States that he went ahead and gave the shot. States that on Monday at about 2 or 3, she woke up with severe nerve pain in that ankle area. States that she has had other things long enough to know that the nerves were affected. States that it subsided after 15 minutes or so. Today (07Apr2021), got up and felt like an exposed nerve in her mouth, then from her face to her brain. States that she put heat on it, states that she knows things to do and knows that it is not exposed nerve. States that right now it is acting up a little and feels like exposed nerve and a little tingling and numb (in Apr2021). Caller states that she figured they didn't find anything about people who have metal in their body. States that she does not take meds for nerve damage because she chooses not to. States that they are rough medications. States she is kind of leery about taking the second shot. The events did not require emergency room and physician's office. The outcome of the event severe nerve pain was recovered on 06Apr2021; the outcome of the event nerve pain in face was recovering; of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

little bit of a sore arm; 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: EL9266) via an unspecified route of administration, administered in left arm on 16Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing osteoporosis and Degenerative vertebrae and covid. Concomitant medication included calcium lactate and ubidecarenone (COQ-10). The patient experienced little bit of a sore arm on an unspecified date. Patient had Covid and she had no effect and showed no effect at all. The patient underwent lab tests and procedures which included covid-19 positive. The outcome of the event was unknown.

Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a hangover; Muscle pain/all over her body; chills; low temperature/was just a couple digits off; Joint pain/all over her body; during these days that she felt so awful she couldn't work her way through it; had a bad spell; felt bad; restless legs; felt unwell; tossing and turning, trouble sleeping; tossing and turning, trouble sleeping/did not sleep except for a couple of times; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199 and expiration date: Jun2021, via an unspecified route of administration, administered in right arm on 15Mar2021 as single dose for Covid-19 immunisation. Medical history included arthritis, diabetes, hypertension, rotator cuff repair, cancer (mom and dad both have passed from it. two uncles and grandparents have had cancer. cancer is pretty relevant in the family), alcoholism (mom and dad both have passed from it). Concomitant medication(s) included metformin taken for diabetes mellitus, metoprolol tartrate taken for hypertension, losartan potassium and lovastatin, ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). The patient stated that she was fine until a few days ago, 4 or 5 days ago she started to feel tired, headache on one side of her head, muscle pain and chills, low temperature, joint pain and just felt unwell. By the weekend the patient stated that she was down on the couch and her son was worried about her and suggested that she go to the hospital, which she refused. The patient described the headache as 'just there', states not terrible, not like a hangover. Since waking up today, she has not had a headache. She also added that she had trouble sleeping on Saturday night (03Apr2021). She stated she did not sleep except for a couple of times and she was just tossing and turning and took ibuprofen and it didn't help. The patient stated that the muscle pain and joint pain was all over her body. She had rotator cuff surgery on her right-side years ago and during this time she was carrying groceries on her own and her left shoulder started throbbing like the rotator cuff pain that she had in the past and she recognized it right away. She stated that she is not real sure if the muscle pain in her shoulder is a result of the vaccine or not. She has full of arthritis and was not sure if the pain is caused by the vaccine or not, but with her regular arthritis, if she has been sitting and gets up and walks around she is able to work her way through it, but during these days that she felt so awful she couldn't work her way through it. The patient stated that she feels like she has been suffering from sundowners but states she feels it's not related to COVID vaccine. She writes herself notes and forgets what notes mean. The patient was on hold so long with the first one. The patient had her first vaccination on March 15th and she am supposed to go back Wednesday April 7th for the second one. She had a bad spell for about 4 days last week. Today, she feel fine and have no temperature. She didn't have a temperature when she felt bad. The patient was having chills, restless legs, couldn't sleep. Now, the patient was feeling better. The patient recovered from the event headache unilateral, muscle pain, chills, body temperature decreased, generalized joint pain and feeling unwell on 05Apr2021, for events difficulty sleeping and restless was recovered on 04Apr2021. The outcome of other events was unknown.

Tingling in arm, slight hypertension. EMS called and evaluated patient. Pt. refused transport, sx resolved

Client received the COVID vaccine (Pfizer dose 2, lot #EW0179, expiration date 4/28/2021) at 1330. At 1345, the client reported right sided numbness and bilateral jaw tightness; RN, PHN; RN responded. Vital signs were as follows: blood pressure 140/75, heart rate 83, respiratory rate 14, O2 97%. The client stated that she has no allergies, takes lipitor, eliquis, and "colon medication," and she has a medical history of COPD, asthma, cardiac arrhythmia, and high cholesterol. At 1350, 50 mg of Benadryl PO was given and water was given. The client's color was within normal limits, she was neurologically intact (alert and oriented) and in no visible distress. The client denies shortness of breath and her lungs were clear to auscultation bilaterally. At 1355, the client's vital signs were: 96% O2, heart rate 89, temp 98.5, At 1401, the client stated that the numbness had decreased. Her blood pressure was 130/66, O2 99%, heart rate 92, respiratory rate 16. The client stated she did eat and drink today. At 1410, the client's blood pressure was 135/72, O2 96%, and heart rate 75. The client stated her symptoms had resolved at this time. Education provided regarding v-safe, emergency management, and AMR activation. At 1420, the client's vital signs were as follows: blood pressure 122/65, heart rate 72, and O2 96%. The client left at this time, ambulating to her car with a steady gait.

Approximately 5 minutes after vaccine patient had a suspected stroke. Patient was in observation area and reported right side weakness, facial droop and slurred speech. Patient was attended to by EMS service and transported to a local hospital.

tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; 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, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events. Information on the lot/batch number has been requested.

left arm was sore; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810 and expiration date was not reported), intramuscular on arm left on 06Feb2021 at 11:00 as single dose for Preventative (COVID-19 immunization) in hospital. The patient medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not administer additional vaccines on same date of suspect vaccine. No relevant tests were reported. It was reported that she got first shot of COVID vaccine on 06Feb2021 (Saturday). She was fine, she just had a sore in left arm Saturday night (06Feb2021). She was due to get the first shot on Tuesday 02Feb2021 but due to the snowstorm she had to get the shot on Saturday instead. The appointment for her second shot was scheduled for 23Feb2021, stated this was four days before the 21-day guidance and she inquired if this was ok. She stated that it was just like getting a flu shot, she occasionally got a sore arm for a couple of hours. She had been getting one for 24 years. She did not have the name or lot number for the flu shot she had received. She declined for any treatment of the event. She did not visit emergency room or physician office. The outcome of the event left arm was sore was resolved on 06Feb2021.

Very sore arm by pm. Today 4/28/21 I am running temp 99 and now 100 via ear. Achy, chills, tired. I had a colonoscopy done Monday 4/26/21 and did fine. Just want to stay in bed. Not yet feel need to call doc or be seen at ER.

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

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.

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

Loss of voice; Asthma; her voice became extremely hoarse; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 09:15 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. Family history included sore arm. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6198) on 23Feb2021 in the right arm for COVID-19 immunization. About 3-4 days after (as reported), her voice became extremely hoarse, in which she lost a voice for 3 weeks. She mentioned that she was diagnosed with Asthma on 23Mar2021 and was started with a Breo Ellipta inhaler. The Breo had a listed side effect of hoarseness of voice in which she started a week after receiving the vaccine, to which her hoarseness became worse. She mentioned that according to the paperwork she received from Pfizer, hoarseness of the voice was also listed as a side effect. She consulted with her Pulmonologist who determined that the inhaler was working pretty well and would like to continue her on it and wanted to see if the hoarseness is still there by May. As of calling, she already has some of her voice back, but the hoarseness was still continuing, which gets worse in the afternoon or evening. She would like to know if this has been reported and for how long it will last. She had the injection/vaccine and hoarseness started about a week before she started on the Breo Ellipta inhaler (NDC: 01730859-10 Lot: UL4F Expiration: 10/2022 Dose: 100mcg/25mcg). She stated they both can cause the same thing with hoarseness. She clarified that when she lost her voice, it was just above a whisper. It had gotten progressively worse since it started a week prior. It lasted almost 3 weeks. Now she has started to get her voice back, but still has the hoarseness and this was as good as her voice gets, it gets worse in the afternoon and by 2:00 P.M. it was back down to no voice. She went down to see the pulmonary specialist and prescribed her 2 different inhalers. The specialist said it was an unusual hoarseness, but he couldn't tell what one it was from. The patient clarified she experienced the hoarseness first from the Pfizer Covid Vaccine after the second vaccine, and then a week later she started on the Breo Ellipta, and the hoarseness got worse. The doctor wants to wait until 19May2021 and see if she still has the hoarseness and then he might switch, but it was working so well, he didn't want to switch her yet. The patient was prescribed Breo Ellipta and Albuterol but she hasn't used the Albuterol. The patient reported that she considers the event as medically significant because hoarseness can cause cancer and she doesn't want it to get worse. No other vaccines administered on the same date of the BNT162B2 and no prior vaccination. The event hoarseness started on 18Mar2021 and loss of voice on 23Mar2021. The events did not require a visit to the emergency room. The outcome of the event hoarseness was not recovered, Loss of voice recovered on 13Apr2021 and asthma was unknown. The events hoarseness and loss of voice was reported as serious-medically significant. Follow attempts are possible. Further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Hoarse voice and Loss of voice cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulder where she got the shot; her shoulder aches; shoulder aches and the feeling goes into the arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 78-years, at single dose in left arm on 03Mar2021 10:00 (Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes that diagnosed about 3 years ago, this year makes 4 years, and she took medications for it. And she was a little overweight, supposed to drop some but gained some back that because of diabetes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 78-years, at single dose in left arm on 02Feb2021 13:00 for covid-19 immunisation and she had no problem with that one. Another Historical Vaccine included flu shots, it just lasted a day or two, maybe that's it, never had problems before. The patient's concomitant medications were not reported. The patient reported side effects from the Pfizer COVID vaccine. Her arm was still bothering her. There was a lump down from where the injection site was and that she kept rubbing it but it won't go away and that she still had pain. She was told she should go to the doctor, but she thought she would call to see what was best to do. She had not a fever, just the lump on the arm, 4 inches down from the shoulder where she got the shot. The patient stated that both Pfizer COVID vaccines were in her left arm, she should have gotten it in the other arm. The patient stated she heard about blood clots and thought she'd better check it out. The patient stated that she had the lump and her shoulder aches; not the shoulder the upper arm. The lump was on the inside and she kept rubbing it but it didn't go away. The patient had the second Pfizer COVID vaccine in the morning around 10:00 AM on 3Mar2021. The pain started the same day on 03Mar2021, then stated that night after midnight and that she thought it would go away. The lump in the arm started a couple of days after the Pfizer COVID vaccine, she thought it was a couple of days but maybe sooner, she didn't pay too much attention. The patient stated the lump felt like it was the size of a nickel, she was pushing to try to feel it and that maybe the lump was a little larger than a nickel. Her shoulder aches and the feeling went into the arm and it started the same week she had the shot but that she didn't pay any attention so is not sure exactly when it started. It was best to check it out with her doctor. The outcome for event pain and vaccination site lump was not recovered, while for remains event was unknown. Information on the lot/batch number has been requested.

nurse was putting it in the wrong spot because it hurt so bad; pain in left arm; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9809; Expiration Date: 30Jun2021), via an unspecified route of administration on Left arm on 07Feb2021 14:10 as 0.3 mL, single for COVID-19 immunisation. Medical history included rotator cuff surgery from 2013; Back problems, had brain surgery when she was 39 and she still has ongoing disability from that. Patient stated that born with the disability in her right hand and a cyst, they just didn't find the cyst until she was 39 and that's when she had the surgery. Family history was reported as none. The patient's concomitant medication was unspecified allergy shots, once a week and ongoing. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283, Expiry date: 30Apr2021) on 17Jan2021 for COVID-19 immunisation. It was reported that, the patient has gotten both shots and she didn't have any problems with the medication, but she had a problem with the 2nd shot, so she was calling for advice. States that she got her 2nd shot on Sunday, and the nurse either stuck it into a nerve or into the muscle because she felt like her arm was going to fall off before the nurse even pushed in the medicine; states that she wanted to scream. Now she was still having pain in that arm, but it's not exactly where the shot was, it's running down her arm and it's not constant, it comes and goes. States that she did have rotator cuff surgery in 2013, and that's kind of what the pain feels like now. This is in her left arm, which was the only arm that she can really use, because she had brain surgery when she was 39 and she still has a disability from that. Clarifies that she was born with the disability with her right hand and a cyst, they just didn't find the cyst until she was 39 and that's when she had the surgery. States that it scares her because she only has the use of one arm already. She had no problem with the medication in the vaccine either time. States that the second time she got the vaccine, she knew that the nurse was putting it in the wrong spot because it hurt so bad, like so bad that she wanted to slap her. States that the pain is nowhere near like it was on Monday, but she didn't know who to call. She gives herself allergy shots, so she knows how to give herself injections. States that the vaccine was perfect, she had no side effects from that. The first shot, she didn't even know that she had gotten a shot. States that yesterday her arm didn't feel as bad as it does today. It's more aggravating. Again, states that the pain was like what she had after her rotator cuff surgery. States that she hasn't felt that pain since her surgery, then on Sunday when she got the shot the pain has kind of started back up. States that it has definitely improved. On Monday and Tuesday, she would feel a little twinge of pain about every 3-4 hours, but today it's every 10-15 minutes. The patient not visited emergency room and not visited physician office. The outcome of the event pain in left arm was recovering and was unknown for another event.

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.

Non-ST elevation (NSTEMI) myocardial infarction Facial weakness NSTEMI (non-ST elevated myocardial infarction) CHEST PAIN CEREBROVASCULAR ACCIDENT

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

harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills; Shaking; This is a spontaneous report from a contactable consumer (patient reported for herself). A 78-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982) administered in left arm via an unspecified route of administration on 27Feb2021 at 10:00AM as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, known allergies to sulfa and Tetanus shots. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration on 06Feb2021 at 10:00 am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Other historical vaccine in 4 weeks included Prolia on 21Jan2021 in doctor office. On 28Feb2021 at 12:30 am, the patient was harder to breathe, smell of food made me sick later that day, blood pressure went down, cold chills and shaking. The patient reported as Shaking was so hard as she could not hold glass of water or get the pills out of the bottle because they flew all over the place. This lasted for 2 hours. Then smell of food made the patient sick later that day and then with the cold chills. It took heating pad and other heating products to stop from shaking. patient blood pressure went down to 98/60 and harder to breathe for just a short time. Treatment received for the event shaking and no treatment received for other events. The outcome of the events was recovering. No follow up attempts were possible. No further information was expected.

A severe irritation, burning and itching all over legs and arms. It was like a sun poisioning or severe sunburn. Dermatologist treated me with a steroid shot and betamethasone cream. Followed up with dermatologist a week later and it had improved but was not fully healed.

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.

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.

1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to come and go still having pain in arm where injection was

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.

Flu like symptoms; Weakness; Headache; Tiredness; just sleeping /. She slept it off for a couple of days./felt very sleepy; she could feel her heart racing; had a heavy feeling on her head; This is a spontaneous report from a contactable consumer (patient) or other non hcp. 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 26Jan2021 10:00 (at the age of 78-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included asthma and chronic obstructive pulmonary disease from an unspecified date, diagnosed many years ago. Broken collarbone and Broken wrist on 28Dec2020. It was reported that she had three broken bones in her wrist, she can't lay in bed anyway, so she sleeps on the sofa, getting constipated on an unspecified date, The patient was allergic to Benadryl. It was also reported that she doesn't sleep too well, due to the sitting up in the chair business. concomitant medications were not reported. On 26Jan2021, 2-3 hours after, she felt very sleepy, had a heavy feeling on her head that was almost flu-ish but had no fever nor chills, and she felt that her heart was racing Influenza like illness, weakness, headache, and tiredness. She slept it off for a couple of days. She was enquired if she can still take the 2nd dose of the vaccine given these side effects. It was reported that she had her first dose of the shot on the 26th of Jan and thinks she had a reaction, though it was not enough to go to her doctor or anything, she was too weak. She said she didn't have chills, was not nauseous, had no fever, she feels like she had the flu, and. She said that she gets up and eats then goes back to sleep or does whatever else she had to do. she can't lay in bed anyway so she sleeps on the sofa. she did get up the next day and all the time had a headache. She says she doesn't take the flu shot because her older brother had a terrible reaction to that, none of her siblings take that shot, but she knows what it feels like to have a bad cold with your head heavy, that kind of feeling, she imagines that is what the flu feels like. The patient received treatment with Tylenol for headache. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): 110/70 mmHg on an unspecified date, blood test: unknown on an unspecified date, Pulse (heart rate): pulse was ok on an unspecified date. Caller said that she was so surprised when she went to her doctor's appointment that her heart was racing, and she thought her blood pressure would be sky high, but the bottom number was 70 something, which is low for her, and the top number was 110, so it was perfect, which she doesn't usually have. She said that her pulse was ok and everything else was ok, and she had blood work taken that day but they didn't get those results back yet, so she doesn't know what they are. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

I had the vaccine and three hours I was on a walk and I had to turn around half a mile and come back home and I had extreme fatigued for a whole month and my husband would have to wake me up three times a day to feed me, I have severe head aches, my kidney level functioning drop to above 50, then the second month I would sleep 3 3 hour nap for the day, I could not get my stamina back. I went about 2 days later to the doctor. She did some blood tests, I have had 4 of them, and all of them have been fine. Now is month 4 and I am slowly recovering, my heart doctor gave me Colchicine and I have been on that for 5 days. I have to get up 7 times in the night to go to the bathroom for diarrhea. In the 29th of June I will have an ECHO cardiogram.

Her arm of course was aching, Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient reported A 78-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in upper left arm on 01Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced her arm was aching. The patient reported that she received the first dose of the Pfizer vaccine on 01Feb2021, but patient was questioning how many don't have any issues and no symptoms. Reporter stated, she thinks it was normal. It's not going to be effective, she was expecting something, That's kind a good. The patient had a sore arm on the first day, and it subsided, it went away. it's a tiny sore. The patient was a little concerned because she did not have a reaction, that tend to worry. she was not experienced any symptoms except for her arm of course was aching, it was gone away now, is it still effective if there are no symptoms. The patient clarified her arm aching is very slight now. The outcome of the event was resolving. Information about Lot and Batch has been requested. Follow-up: 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

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.

Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021. Follow-up attempts completed. No further information expected.

her tongue felt burned; her mouth was burning; her throat was burning; acid reflux; everything was still burning; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 78-years-old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included macular degeneration. The patient's concomitant medications were not reported. Historical vaccine included tetanus vaccine on an unspecified date for immunisation. She got her first dose of the Pfizer Covid 19 vaccine on 25Feb2021 and thought she was having a reaction. She called her doctor and he said go get some Benadryl to make sure your throat doesn't get swollen. She went out and bought Benadryl and she took the Benadryl every six hours. Her doctor said don't get the second dose of the Covid 19 vaccine because these side effects she had are a warning and the second dose might not be helpful for her. The patient reported that she stayed at the facility that gave her the Covid 19 vaccine for 20 minutes and her husband was waiting for her. When she was driving away from the facility her tongue felt burned and then her mouth was burning and then her throat was burning on an unspecified date. She does have acid reflux but this wasn't like any acid reflux she's ever had. She got home and she drank some cool water but everything was still burning. By then it was almost supper time so she took 20 mg of Pepcid. Her mouth burned throughout her meal. She called her doctor again and he asked her if her mouth was swollen and she told him she didn't know. She took more Benadryl. One of her daughter's told her that the Covid 19 virus was so bad that she should get her second dose of the Covid 19 vaccine no matter how bad her reaction was. Her doctor told her not to get the second Covid 19 vaccine. She assumed it was a done deal. She wasn't going to get the second dose. She was supposed to get her second dose on 17Mar2021. She had gone to the doctor a couple times and each time he told her, do not get the second Covid 19 vaccine. He showed her the Pfizer Covid 19 vaccine print out with side effects. When her mouth started burning after she got the first Covid 19 vaccine her husband did ask her if she wanted to turn around and go back to the facility where she got the vaccine but she told him no. Now she's missed her second Covid 19 vaccine on 17Mar2021 because she thought that what her doctor told her was the final word. She was afraid to get the second Covid 19 vaccine and she wants to listen to her doctor because he knows what's best. During this Covid 19 virus time she was also diagnosed with Macular Degeneration. That's keeping her from driving and she's lost even more of her independence. She's heard if she gets the Covid 19 virus it can attack her eyes. Every time she hears the words fully vaccinated it makes her want to cry. She's worried that people won't want to be near her because she's not fully vaccinated. Her husband had both of his Covid 19 vaccines and he had no side effects. Her husband gets every vaccine on the market and never has any side effects. As far as she's concerned she feels like a pariah because no one will want to be around her because she's not fully vaccinated. Therapeutic measures were taken as a result of all events. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (02Jun2021): No follow-up attempts are completed; information about lot/batch number cannot be obtained.

Blood pressure high; her doctor could see that she had some pneumonia showing; Coughing; soreness in her arm; slept all day long; started running a 99.9 temperature; could not catch her breath, her breathing was down in the danger zone at 220; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old elderly female patient received bnt162b2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 11Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient experienced, the patient could not catch her breath, her breathing was down in the danger zone at 220 reported dyspnoea and hospitalization on an unspecified date, had high blood pressure, her doctor could see that she had some pneumonia showing, coughing, soreness in her arm, slept all day long. Additional Context: Consumer states that her doctor wanted her to call and report this, because she has asthma and allergies that are chronic. Consumer states that she took her first Pfizer injection in April. She saw her allergy specialist on the 1st, and she tested the Consumer before she took the vaccine. She states that her breathing was at 113% breathing capacity (good) and the allergy specialist wanted her to go ahead and get the injection, which the Consumer did. Consumer clarifies that she received the first Pfizer COVID vaccine on 11Apr2021 and that she did really good with that one. Consumer then received the second COVID vaccine on 13May2021. She came home and slept almost all night long and thought she was okay. The Consumer explains she was not feeling real good before she went to receive her second dose. It was kind of like she was having some coughing and stuff, but she thought it was not bad and that she could still go ahead and get it. She went ahead on 13May2021 and had the second dose. Consumer states that on the first day, she slept all day long- the whole entire day, she didn't even wake up. On the second day, the Consumer states that she had soreness in her arm. Then, she noticed she was getting really sick and started running a 99.9 temperature. It was getting worse day by day, and she kept coughing and getting worse. Then, on 18May2021, her husband took her to the emergency room and they just automatically treated her for asthma and allergy and sent her home. This was on Tuesday night. On Thursday night, she got so bad that her breathing was down in the danger zone at 220. She couldn't breathe. Her husband rushed her back to the ER and this time, they kept the Consumer and hospitalized her for a week. Her blood pressure was high. She clarifies normally her breathing on her peak flow meter, she can always do from 350-400. Well on Thursday night, her peak flow was all the way down to 220 and she could not catch her breath. Consumer states that she was admitted to the hospital and they had her on oxygen and blood pressure medication. She states that they did a bronch on her and still did not really come to a conclusion of what was happening. She was told it looked like it could be an infection in her lungs. Consumer states that she is having to see three doctors this week because of this since she got out of the hospital. She saw her medical doctor, Dr., yesterday who was very concerned because she had a recent patient that was about the same age as the Consumer- he was 75 years old. This patient had done the same thing, only he ended up taking pneumonia and dying with it. The doctor told the Consumer in her x-ray, her doctor could see that she had some pneumonia showing. The Consumer asked her doctor while she was in the hospital about the pneumonia and they refused to listen to anything the Consumer said, so Dr. told her that the Consumer needed to report this because she is still so sick. Consumer clarifies that she was hospitalized for a week and that she just got out on Saturday, 29May2021. While reporting the event details, the Consumer stated that she had and emergency call coming through and that she had to take it. Consumer had to end the call, stating she had to go and requested this call handler call her back. The patient was hospitalized due to events. The patient underwent lab tests and procedures which included blood pressure measurement, body temperature: 99.9, peak expiratory flow rate: 220 Units: x-ray: had pneumonia showing. The outcome of the events was unknown.

erythematous, mildly itchy confluent macular rash near injection site; erythematous, mildly itchy confluent macular rash near injection site; erythematous, mildly itchy confluent macular rash near injection site; After second dose, had initial mildly sore arm for two days.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6202), via an unspecified route of administration, in left arm on 01Mar2021 11:30 (at the age of 78-year-old) as second dose single, for COVID-19 immunization. Medical history included osteoporosis, bladder cancer, status post radical cystectomy with ileal conduit diversion in Nov2020. The patient had no known allergies. Concomitant medication(s) included alendronate sodium (ALENDRONATE SODIUM) and others. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EM9810), via an unspecified route of administration, in left arm on 08Feb2021 at 11:15 AM (at the age of 78-year-old) as first dose single, for COVID-19 immunization and only had mildly sore arm. The vaccine was administered at Doctor's office/urgent care. No other vaccine was administered in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 03Mar2021 after second dose, had initial mildly sore arm for two days. Two days later on 05Mar2021 noted erythematous, mildly itchy confluent macular rash near injection site. Has persisted to present, but appears to be fading. No other side effects noted. No treatment was given for the events. The events had not resolved. No follow-up attempts are possible. No further information is expected.

Tingling in arms and legs; red, swollen ear lobe; rosacea; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN620U), dose 1 via an unspecified route of administration, in left arm on 04Mar2021 11:30 (at the age of 78-year-old) as 1st dose, single dose for covid-19 immunisation. Facility type reported hospital. Medical history included breast cancer. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies reported to dairy, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), monascus purpureus (RED YEAST RICE), probiotics, vitamin D [vitamin D nos]. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04Mar2021 at 15:00, the patient experienced tingling in arms and legs, red, swollen ear lobe and rosacea. The patient received treatment of benadryl for events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

She felt 'weird'.; she noticed a cooling effect at the bottom of her ribcage; This is a spontaneous report received from a contactable female consumer (Patient) and a contactable consumer (husband). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Mar2021 15:50 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism from an unspecified start date and ongoing and multivitamins. The patient experienced she felt 'weird'. (feeling abnormal) (non-serious) on an unspecified date with outcome of unknown, she noticed a cooling effect at the bottom of her ribcage (feeling cold) (non-serious) on 09Mar2021 with outcome of not recovered. Follow-up attempts completed. No further information expected.

Left arm was sore when received the vaccine which she expected. Then it started traveling and now it is completely up to the shoulder area and she is in extreme pain. Her doctor told her to call local DOH to report adverse effects.

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.

This is a spontaneous report from a contactable consumer reported (herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration in left arm 28Apr2021 16:15 (at age of 78-years-old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes ongoing blood pressure, ongoing (Gastroesophageal reflux disease) GERD reflux, ongoing back pain. Patient had allergies to things like hay fever, pollen, dust, mold. Historical vaccine include Shingles shot on unspecified date and experienced flu. If she had the booster, she would not have shingles. Patient past drug includes Zantac for about 6-8 months ago. Other conditions include scoliosis, has had back operations. She has lost a lot of height due to scoliosis. Patient concomitant medications include irbesartan used for prevention of high blood pressure from unspecified date and ongoing, metformin hydrochloride (METFORMIN ALPHARMA) (1000 mg, 1x/day frequency) used for preventative for Diabetes, she does not have Diabetes from unknown date and ongoing, Famotidine (20mg) taken for GERD reflux from 6 to 8 months from unspecified date, Vitamins taken from unspecified date and unknown till ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Apr2021, Patient experienced shingles, pain in her back, rash on lower back which are ongoing and does not feel great, itching or burning in her back was worse. She is unsure if it started the day before or the day of the vaccine. Patient received treatment for events by Mederol/ Methylprednisolone 4 mg for pain as prescribed by the doctor only taken for 1 day/ 6 pills. Also took an Advil the day before and the night of the shot. Patient didn't visit any emergency room but just called her physician. she had a rash on back which doctor confirmed was shingles. The patient had a side effect after the first dose of the vaccine. She asked should I get the second dose. The patient wanted to know if it is accurate that she can delay the 2nd dose up to 6 weeks. She is supposed to get her second dose of Pfizer Covid Vaccine this coming Wednesday, 19May2021, but she still has shingles and does not feel great. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. In response to caller, they suggested to consult healthcare provider they know your health situation and has access to information that can better help inform this decision. Second Pfizer Covid Vaccine shot, she said it is scary, and the doctor said it was scary for her not to take it, all. The Outcome of events was recovering. Follow up attempts are needed. Further information has been requested.

Swelling, pain and weakness in right arm. The symptoms were diagnosed as lymphedema. Treatment consisted of 2 weeks of antibiotics and steroids and, eventually PT with a specialist in lymphedema swelling. This side of the patient has many of her lymph nodes removed in conjunction with a surgical removal of a right breast cancer lump removal some 25 years ago. No lymphedema symptoms had ever incurred in the patient prior to the covid vaccination. PT is ongoing but little improvement after 2 weeks of treatment.

Sore arm after first dose; This is a spontaneous report from a contactable other hcp (patient, retired registered nurse). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9264, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 13:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history included diabetes mellitus, hypertension. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. It was reported that, on 4Feb2021 patient had her first vaccine and had no symptoms of a reaction. She had a sore arm after first dose for a couple days from 4Feb2021 to 6 Feb 2021. Patient took Pfizer Covid-19 vaccine to prevent the disease. Relatedness for event sore arm after first dose was related. The patient underwent lab tests and procedures which included ultrasound scan: numerous blood clots below the knee on 04Apr2021. Seriousness for sore arm after first dose was reported as not serious. The outcome of the event was recovered. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499940 same patient/drug, diff dose/event

Pain in the shoulder; Hurt when I take a deep breath (lasted for days), pain radiated around my breast in the front.; Hurt when I take a deep breath (lasted for days), pain radiated around my breast in the front.; The "pain in the hip and there was also pain in the big toe- 'in the very core of toes' and next 2 toes/foot pain; And arms hurting/arm was really sore; She was sleepy tired; She was sleepy tired; Had tingling on the lips; A sore on my tongue; Felt like I got stabbed in the butt/hip and butt was hurting; Hip joint was hurting; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was reported as FW0179 or EW0179, Expiry Date and NDC number are unknown), via an unspecified route of administration, administered in Left deltoid on 27May2021 at the age of 78-years-old as 1st dose, single dose for covid-19 immunisation. Medical history included asthma, osteoarthritis, hypertension from an unspecified date. It was reported that patient has food allergies, drug allergies, and environmental allergies. The patient had tingling on the lips and stated that she had experienced this before when she gets exposed to chemicals with a very strong aroma that her body didn't like. Concomitant medications included losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLORZIDE), simvastatin (SIMVASTATIN), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for unspecified indication, on unspecified date. The Caller reported having possible side effects after the first dose. She said that she has a lot of allergies and was asked to stay for 30 minutes and nothing happened. She went home (10 minutes from site), and she had tingling on the lips, right away on 27May2021. She stated that she had experienced this before when she gets exposed to chemicals with a very strong aroma that her body did not like. she knows that is an allergic reaction. She also reported a sore on her tongue (not sure if from vaccine), felt like I got stabbed in the butt, hip joint was hurting on 27May2021, and arms hurting. The next day on 28May2021, she stated that her arm was really sore and that she was sleepy tired. Her arm hurt and she had pain all day and was sleepy. The caller knows that being sleepy and the pain in the arm is normal. On the third day, 29May2021, she said that the pain in the hip and there was also pain in her big toe- 'in the very core of toes' and the two toes next to it. The next day on 30May2021, she didn't feel the toe pains but still felt sleepy and tired. That Wednesday, 02Jun2021, she had pain in her shoulder when she took in a deep breath. This went on so the caller went to the doctor and had an x-ray on Thursday. She was prompted to consult because of "pain in the shoulder" she said it hurt when she takes a deep breath (lasted for days), pain radiated around my breast in the front. Her shoulder wasn't hurting that bad, but it was still there until Friday. The pain was in her shoulder blade and it went to the front near her breast. She went to the chiropractor on friday, and he said he thought it was from the vaccine. Upon checking up with Doctor with an x-ray, Doctor confirmed that he couldn't see anything; nothing to indicate pericarditis. In addition to this, she mentioned that the nurse practitioner also experienced the toe pains (Age and Gender not provided). On the next day on 03Jun2021, she set an appointment with her chiropractor, and confirmed these side effects were from the vaccine. It was reported that age at time of onset of reaction/event was 78. Does the caller wait to a take the vaccine. Does the caller not even take the second dose. Her hip hurting was like a jab. Her foot pain woke her up in the middle of the night. She received her first dose on 27May2021. She was scheduled for her second dose on 16Jun2021. She was worried and has her reservations about getting the second dose because she had a reaction. She asked if it would make a difference to wait for getting the second shot; "is it better if I wait between vaccine one and two" She has heard that people get adverse events after the second dose. The patient underwent lab tests and procedures which included chest x-ray: normal on the same week that she received the shot on an unspecified date in 2021, the nurse practitioner said the chest x-ray was unremarkable and x-ray: normal on an unspecified date in 2021. Reporter seriousness for events was unspecified. The outcome of the event had tingling on the lips was recovered on an unspecified date in 2021 and for Felt like I got stabbed in the butt/hip and butt was hurting, Hip joint was hurting, arms hurting/arm was really sore was not recovered while for other events was unknown.

Flu like symptoms; Headache; Aches and pains; Sore arm; lower lip broke out with cold sores; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186, Expiration date and NDC number are unknown, time the vaccination was given: Noon), via an unspecified route of administration, administered in Left arm on 03Jun2021 at the age of 78-years-old as 2nd dose, single dose for covid-19 immunisation. The patient s medical history including any illness at time of vaccination were osteopenia, osteoarthritis and fibromyalgia, diagnosed over 20 years ago in 2001. The patient s concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0186, Expiration date and NDC number are unknown), via an unspecified route of administration, administered in Left arm on 13May2021 at the age of 78-years-old for covid-19 immunisation. Prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. 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) were none. Additional vaccines administered on same date of the pfizer suspect were none. It was reported that event happened after the second dose of the vaccine. About a week after receiving the second dose, her lower lip broke out with cold sores on an unspecified date in Jun2021 and she has been fighting this more than a week now. She tried Zovirax (NDC and lot unknown, expiration date 31Mar2021) which usually helps with this but it did not this time. It has been years since this has happened. Yes, this has happened to some other people. It has been two weeks now. The Zovirax tamped it down a little but did not get rid of it like it normally does. She thinks her immune system is working and her immune system is causing the issue. It was reported that she had the normal flu like symptoms and headache on 04Jun2021 and it went away in under three days, she thought it was normal. The caller also had a sore arm on 03Jun2021 and aches and pains on 04Jun2021. By the fourth day the caller was fine. The caller wanted to make Pfizer aware that someone else had the herpes complex problem. The adverse events did not require a visit to Emergency Room or Physician Office. It was reported that age at time of onset of reaction/event was 78. Time of onset of adverse events was unknown. There was no investigation assessment. It was reported that she is tired of lock down and she does not want to wear a mask the rest of your life. She googled to see if anyone else had this come up and it seems to be a minor amount of people that have experienced it. She didnt expect for this to happen to her. The reporter assessed events as non-serious. The reporter assessed events relatedness to Pfizer covid vaccine as Related. The outcome of event, lower lip broke out with cold sores was not recovered while for other events was recovered on an unspecified date in Jun2021. Additional information is requested.

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

spasms; her arms "tightens up" during the night; having trouble sleeping/she barely sleeps 3-4 hours per night; muscle in her arm tightens up so tight it wakes her; both arms hurt from her elbows to shoulders and it is terrible at night.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: ER8737, expiration date: 31Jul2021) via an unspecified route of administration administered in Arm Left on 03Apr2021 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included ongoing breast cancer diagnosed 2.5 years ago and still being followed for it, ongoing irritable bowel syndrome diagnosed 5-6 years ago and had muscle aches in her legs from cholesterol medicines in the past. Concomitant medications included acetylsalicylic acid (ASPRIN, strength: 81 mg) at 81 mg once daily, bumetanide (strength: 1 mg) at 1 mg tables, 2 tablets on Monday, Wednesday and Friday and one tablet the rest of the week, glucosamine, methylsulfonylmethane (GLUCOSAMINE & MSM) one in the morning and one at night, 2x/day), letrozole (strength: 2.5 mg) at 2.5 mg once daily, levothyroxine (strength: 25 mg) at 25 mg, alternate day, lisinopril (strength: 5 mg) at 5 mg one at night, loratadine (CLARITINE), lorazepam, omeprazole (strength: 20 mg) at 20 mg, alternate day, probiotics once daily, calcium (strength: 600 mg) at 600 mg twice daily, vitamin c (ASCORBIC ACID, strength: 500 mg) at 500 mg once daily, vitamin d3 (strength: 500 mg) at 500 mg once daily, simethicone (strength: 125 mg) at 125 mg once daily. It was reported that within 2 days after vaccination, on 05Apr2021, the patient right arm started hurting from elbow to shoulder along with left arm then started hurting also but doesn't recall at what point it started. Patient thought that pain was due to the vaccine since in her left arm was also in pain. Further patient described pain as excruciating at night, in the evenings or when lays down, and tolerable during the day. On an unspecified date, the patient specified about the spasms and arms that tightens up during the night, which keep her up. On an unspecified date, the patient added she barely sleeps 3-4 hours per night, despite the muscle relaxant she takes. Patient further explained she cannot lift her arms as high in the morning and provided the following example: she couldn't open her venetian blind or put her coat without help. She specified the pain eases up during the day and can't move her arms as it hurts, the pain on a scale of 1-10 was a 15. Reporter assessed the event as non-serious. On unspecified date the patient underwent lab tests and procedures which included left arm x-ray and left arm x-ray found to be negative. The outcome of the events both arms hurt from her elbows to shoulders and it is terrible at night was not recovered while the outcome of the rest of events was unknown. Follow up attempts needed. Further information is expected.

only side effect from the first one was a sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER COVID VACCINE, Solution for injection) via an unspecified route of administration to her left arm on 13Jan2021 10:45 (age at vaccination: 78-year-old) (Lot number: EL8982, NDC number: Unknown, No Expiration) as single dose for prevention. Vaccination facility type: Clinic. The patient's medical history was reported as none. Concomitant medications were not reported. Family medical history reported as none. The patient previously took flu shots and experienced sore arm at site (annual flu shots). The patient had the first one three weeks prior and the only side effect from the first one was a sore arm. It was sore for about 30 hours. That was on the left arm. She received it on 13Jan2021. It was the Pfizer COVID vaccine with Lot EL8982, No expiration. Time of day was 10:45. No relevant test reported. Outcome of the event recovered on an unspecified date in Jan2021. PSCC Communication: Attempted to warm transfer caller to Pfizer Medical Information, however, due to extended hold time, caller opted to be transferred to hold place in the queue. Provided caller with websites of www.cvdvaccine.com and www.pfizermedinfo.com, along with phone of 800-438-1985, option 3, with hours of 8a-8p, Monday-Sunday. Follow-up attempts are completed. No further information is expected.

Beginning approximately two days after my first vaccine shot, I have experienced joint pain and stiffness. It is most prevalent in my left shoulder and the middle finger of my right hand. I have not had pain in these places before. I have also had pain and stiffness in my knees and lower back, and I have had problems in these places before. The pain is not debilitating and is relieved with Advil and Tylenol. I expected it to just resolve itself, but it has not. I have communicated this to my health care provider, Dr. , by telemedicine.

chills; shaking; not feeling well; This is a spontaneous report received from a contactable Consumer (patient's husband). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date was not reported), via an unspecified route of administration, in right arm, on 06Feb2021, Saturday (at the age of 78 years), as a single dose for covid-19 immunization. The patient medical history included A Fib and mitral valve replacement (caller states that his wife has had two mitral valve replacements, as she out-lived the first one). Concomitant medications included Jantoven (warfarin sodium) for a fib and mitral valve replacement. The patient had taken Covid vaccine for Covid prevention. On 07Feb2021, the next day, the patient had experienced not feeling well, chills, and shaking. Caller states that he wrapped his wife in a bunch of blankets and finally after about three hours, it subsided. Caller states that this morning, his wife got up and went to the bathroom and before she could get back to bed, she started to shake again. Caller is wondering if this is a normal side effect of the product. Caller confirmed that his wife had no other vaccines on the same day as the COVID vaccine. The outcome of the event chills was recovered on an unspecified date in 2021. The outcome of the event shaking was not recovered. The outcome of the event not feeling well was unknown. Follow-up attempts are completed. No further information is expected.

I had itchiness and swelling around my eye. I thought it was a bug bite but it kept getting worse. Eventually, I had a rash around my eyes, my forehead, my hair. I went to the urgent care where they prescribed me an antiviral. The antiviral seems to be slowing things down. I am also now experiencing a crawling sensation throughout my body. It feels as if a bug crawling on me. This is something new that I have never experienced before.

One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered mental status. At admission exhibited SIRS (fever, tachycardia), ultimately no infection was identified on work up.

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.

neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Right arm on 29Jan2021 (at the age of 78-year-old) as single dose for covid-19 immunisation. Medical history were none. There were no concomitant medications. The patient experienced chills on 03Feb2021 slightly loose stools on 03Feb2021, gas on an unspecified date, fatigued on 03Feb2021, slightly right sore arm on 29Jan2021, slight body aches on 03Feb2021. Therapeutic measures were taken with a couple of Tylenol and Pepto Bismol as a result of event chills, loose stools, gas, fatigued, slightly right sore arm, slight body aches. The outcome of event gas was unknown and for event slightly right sore arm was recovered on 30Jan2021 and slight body aches was recovered on 07Feb2021 and for rest all event outcome was recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. 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".

polymyalgia rheumatica; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; This is a spontaneous report from a contactable consumer (reported for herself). A 78-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8737/Batch was not reported), dose 1 via an unspecified route of administration, administered in arm left 03Apr2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation and experienced muscle pain in upper right arm on 05Apr2021. The reporter stated that patient received the vaccine in left arm on 03apr2021. On 05apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse and contacted her physician. Physician ran multiple blood work, ruled out possibilities and gave me a diagnosis of PMR (polymyalgia rheumatica). Started prednisone 30 msg on 24May21 in decreasing doses. Pain was relieved and she still on the medication. The reporter stated that patient have never experienced such intense pain in her life. Physician attributed her pain to the vaccine. The event polymyalgia rheumatica assessed as serious. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. The reporter stated the events result Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of patient for the events with prednisone 30 msg started on 24May2021. The outcome of the events pain in extremity, condition aggravated was resolving and polymyalgia rheumatica was unknown. Information about lot/batch number has been requested.

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.

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.

Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207), via an unspecified route administration in the left arm on 19Mar2021 at 12:45 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to mites, grass pollen, cats and latex (skin contact). Concomitant medications included multiple vitamins (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and bifidobacterium infantis; lactobacillus acidophilus (PROBIOTICS); all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6205), via an unspecified route administration in the left arm on 26Feb2021 at 00:15 (at the age of 78-years-old), as a single dose for COVID-19 immunisation and received doxycycline hyclate (MANUFACTURER UNKNOWN) and potassium dichromate (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. On 19March2021 at 14:00, the patient experienced headache, chills, muscle ache, joint ache, left arm pain, feeling sick and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, chills, muscle ache, joint ache, painful left arm, feeling sick, fever was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45 (at the age of 78-years-old), as single dose for COVID 19 immunisation. Medical history included acid reflux, coronary artery, pre-diabetic and bee venom allergy. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN), levothyroxine (LEVOTHYROXIN), telmisartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cefuroxime (FURO); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 25Feb2021 at 09:30 (at the age of 78-years-old) as single dose for COVID 19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), levofloxacin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, the patient experienced fever, headache, overall fatigue and swollen sore arm that lasted for 4 days. On 23Mar2021, fifth day onwards, the patient experienced rash and patient still had it on 24Mar2021 (sixth day). The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, overall fatigue, swollen arm and pain in arm were recovered on 22Mar2021 and rash was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

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.

Pt. states after receiving 2nd Phizer 04/01/2021 started experiencing pins and needles in the feet advancing to the arms and head 06/01/2021. ER visit 06/292/2021 resulted in recommendation for a Neurologist visit. Appt. set for 07/20/2021

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.

Massive seizure, with no history of seizures, occurred within minutes of injection. Given Ativan at Center then moved by ambulance to Hospital emergency room while unconscious. Was sedated, intubated, and put on ventilator. Full range of tests performed, such as cat scan, MRI, EEG. Home in a week, back to normal (taking anti-seizure med) by second week. Hospital said seizure was due to alcohol withdrawal, which is ridiculous. Furlong did not stop drinking before the seizure. He was told to stop drinking afterward, which he did with no problems whatsoever. Then went to PCP, neurologist, and cardiologist. Multiple tests, but still no cause for seizure found.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe

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.

same pain feeling in bladder and pelvis; Sore arm; had pain that was just in the knee replacements, where knee replacements; Pain; pain in her pelvis; Standing up feels weird; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in the left arm on 28-JAN-2021 16:00 as 1stdose, single for covid-19 immunisation. The patient received second dose BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in the left arm on 05-MAR-2021 16:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history included ongoing cardiac disorder heart condition , ongoing hypertension high blood pressure , cardiac operation from 25Jan2020 to 25Jan2020 heart surgery , knee arthroplasty from Jan2014 to an unknown date double knee replacement surgery made out of unknown titanium and plastic , office visit from an unknown date and unknown if ongoing foot doctor appointment , biopsy uterus from an unknown date and unknown if ongoing scheduled for a biopsy on her uterus , breast cancer from Sep2020 to an unknown date breast cancer , arthritis from an unknown date and unknown if ongoing arthritis , immunisation from an unknown date and unknown if ongoing very active , genetic counselling from an unknown date and unknown if ongoing genetic testing relative for breast cancer, heart surgery for other conditions was 2 heart stents placed, double knee replacement surgery was the prosthetics are each 9 inches made out of unknown titanium and plastic. Caller interchangeably referred to surgical date as Jan2014 and about 5 years ago. She was fine without any assistance for about 4 years never needed to use canes or walkers only at 1st when had replacements-did for that immediate after surgery-was down 4 months with replacements. Foot doctor appointment was she will tackle soon. Scheduled for a biopsy on her uterus was she is concentrating on that once she gets past that they picked that up in annual pelvic exam about a month ago; if that doesn't have any lasting need for any further treatment she will tackle this knee pain, breast cancer was 1st stage taken care of no further mammograms not on any medication for it; operated on Sep2020 until now another part of her needs to be looked at no reason it won't be nothing just questionable if something might be brewing; just going to do a biopsy of uterus because of ultrasound need to be looked at again. Arthritis was definitely what caused the knee surgeries. Very active gone on to have a full life radio program curates the art in her town. Does her own grocery shopping. Lives alone since husband died. Patient tested her for genetics relative to breast cancer she is not passing anything on to her daughter of the female breast genes don't think it goes any further. Patient does not take a lot in the past she had very serious lyme disease; no real relapse in that last 10 years; before that she spent 10 years in treatment for lyme disease so she could go back to that. 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. Concomitant medication(s) included celecoxib (CELEBREX) taken for pain, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for thyroid disorder from 2001 to an unspecified stop date. The patient experienced pain in her pelvis on 31Jan2021, same pain feeling in bladder and pelvis on an unspecified date, sore arm on an unspecified date, had pain that was just in the knee replacements, where knee replacements on unspecified date, pain on 31Jan2021, standing up feels weird on 28Jan2021.This is report 1 of 8. The patient who reported pain standing up feels weird and sore arm after first dose of Pfizer Covid-19 Vaccine. Pain on the 3rd day after the first dose of Pfizer Covid-19 Vaccine she woke with pain in her pelvis and thought she had a urinary tract-captured as provided as only urinary tract- which she doesn't usually have. Then on the 4th day after first dose of Pfizer Covid-19 Vaccine she had the same pain feeling in bladder and pelvis. She was seeing a cancer doctor that day for a 6-month check-up who ran a urine sample, and it was negative. She knew it was negative because that symptom was pretty intense on 3rd and 4th day but then it was gone. The pain took her all the way back to when she had the knee replacement surgeries; she was on Morphine then which she can't do that now; they wouldn't give it to her. She had using Advil and some Celebrex which she was not supposed to use those because of her heart condition which was under control. Advil and Celebrex taken for the pain have done nothing for the pain they are doing nothing they don't touch the pain. Her family doctor suggested she try marijuana. her cancer doctor was trying to get her medical marijuana; but nothing's happened in 6-8 weeks. Pain was making her crazy, did buy the marijuana it comes like candy like little gummy bears to try to alleviate the pain that way but did not get the medical marijuana. The oncologist talked to his secretary and she was told they would contact her in 6 weeks. 6 weeks went by and they haven't contacted her. The Oncologist texted her she told him she hasn't gotten the medical marijuana card yet and you have to pay for the card. So her daughter in Massachusetts can buy marijuana that's legal there-so the patient tried little bit of a gummy bear which did nothing for the pain; so she tried a little more of a gummy bear which still did nothing for the pain; then another day she tried a whole gummy bear which still did nothing for the pain in her knees but she felt kind of fogged up in the head, after 6 days after the first dose of Pfizer Covid-19 Vaccine she woke up with both knees that she had a knee replacement in in 2014; and she had basically gotten over most of it; the 6th day after the shot she woke up and had pain that was just in the knee replacements where knee replacements both were. It was excruciating pain it woke her up and she has been pretty bad ever since. That was the most extreme day of pain was 6 days after the first dose of Pfizer Covid-19 Vaccine. It was pretty bad and then it woke her up 10May2021 also. For the pain Advil doesn't touch it she has taken 600mg of Advil every day which she was not allowed to take because she had 2 stents in her heart during heart surgery performed in 2020. They don't really want you to take Advil or anything after that. She's pretty much suffering and was probably going to end up in pain management. She got the second dose of Pfizer Covid-19 Vaccine and that second dose didn't make any difference did not worsen or affect events. She has to use a walker now; she had really gotten pretty much through that major surgery 5 years ago the double knee replacement surgery which she verified as being in 2014. She never got really great, but she could walk without a cane or any assistance. 09May2021 she when went to the cemetery to spread her deceased husband's ashes and had to use 2 canes so the pain definitely came from the Pfizer Covid-19 Vaccine. The patient reporting adverse events with Pfizer Covid-19 Vaccine. Mentioned she has been using Advil and some Celebrex taken for pain which have done nothing for the pain they are doing nothing they don't touch the pain. Advil expiry: Jul2023 Lot: WJ22828 UPC/NDC was Unknown on top over the code they use when they do inventory or all. Patient has friends with hip replacements and knee replacements, and no one was saying anything about pain with their replacements. She was thinking the Pfizer Covid-19 Vaccine was just attacking the foreign particles in her body which are the knee replacements. Celebrex: Lot/NDC/Expiry: Unknown dispensed in pharmacy vial. The outcome of the event pain in her pelvis was recovering, same pain feeling in bladder and pelvis, sore arm, had pain that was just in the knee replacements, where knee replacements was unknown, pain was recovering, standing up feels weird was recovered on unspecified date. No follow-up attempts are needed. No further information is expected

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.

pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.

Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.

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.

Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70 Two hours later another seizure at the home, with emesis, Sent to hospital at 2pm. Focal Status elepticus. Seizure activity along with continuous persistent activity with emesis throughout the 12 hour time in the ED. Seizure during the CT scan.

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.

muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itching, frequent urination

She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nauseous; This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received first dose of bnt162b2 (also reported as Pfizer Covid vaccine, lot number: EK4176), intramuscular into left arm on 05Jan2021 16:00 at single dose indicated as presentation because she is a nurse/Covid-19 immunization. Medical history included Type 2 Diabetes, about 2 years ago in 2019 in which she takes metformin 1,000mg twice daily. Concomitant medication included metformin on unspecified date at 1,000mg twice daily for Type 2 Diabetes. There was no history of all previous immunization with the Pfizer vaccine nor there were additional vaccines administered on same date of the Pfizer Covid vaccine. The patient received the Pfizer COVID vaccine last Tuesday and since 06Jan2021 at 06:00, she has been sick as a dog. She is running a fever, has chills, can't eat and has no appetite because she is nauseous; all on 06Jan2021 at 06:00. This is the third day of it. She would like to know what she can she do. She said that it all started Wednesday morning when she got up. It just gets worse every day. It looks like it would get better by now, but it hasn't. She never runs a temperature, but she has now (unspecified date). She is still freezing to death on unspecified date. She usually has a good appetite. Even the thought of food makes her sick. She further reported that she has had nothing but chills, fever, and nausea and states it will not go away. She is treating it with ibuprofen. She confirms she already talked to a nurse in this department to report this and she was transferred to see what she could do and states they never answered. This is her first dose and she does not know if she should get the second dose. The patient can't calm down since she has been sick since last Wednesday. She stated that she needed some help because she is so sick. She was suggested to call again calling Pfizer medical information department. She stated that she had called back three times, but there is no such number. The events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous were considered serious (Other medically important condition). The outcome of the events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous was not recovered, and the outcome of the remaining event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completed based on known safety profile and a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Swollen right index finger and joint. Quite painful - most pain is subsided but swelling is still there on joint.

Within 5 minutes of receiving the vaccine, my heart started racing, my blood pressure shot up to 190 over ? (Usually my BP is low normal), my face was very flushed.

patient presented to her primary care for evaluation of leg pain. Noted on US that patient had a DVT in Left distal superficial femoral and popliteal veins. patient was hospitalized for treatment as patient had recent diagnosis of GI bleed and would need close monitoring of blood thinning medications. Of note- patient is 1/3 hospitalized with cardiac/blood issues currently in this facility who received a vaccine from this pharmacy in the last month and all three patients have the same COVID vaccine lot number. Physician elected to have a VAERS put in on all patients to ensure investigation was properly handled.

Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my teeth clatter and also dry heave for some hours until I took the medicine under the tongue and it got better. I still have shaking in my hands and feet as well.

At night headaches started and lasted all night and they were all over my head, just like I was wearing a helmet. I also had 2 days of beinf lethargic and sleepy. Still feel tired. I recovered from everything except the trembling and the fatigue.

Numbness and tingling sensation on right side of the body (leg, arm, back) Flushing in the face Higher than normal blood pressure Sensations started earlier in the day on Saturday. On Sunday at 1pm, she went to the hospital and the symptoms stayed until 6pm. She was sent home from the hospital with diagnoses of parasthesia and numbness. Sensations started again earlier today, Wednesday the 27th. Called the doctor and said there isn't much they can do because they don't know much about the vaccine.

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.

Patient presented to hospital 1 day following vaccination with slurred speech, left sided weakness, and left gaze preference concerning for acute neurologic injury.

slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-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 the left arm, on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included major reaction to eating conch, and tested positive for COVID on 22Nov2020 There were no concomitant medications. Patient read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 from diagnoses. When she had COVID she had major headache, chills, and diarrhea. After the vaccine she had had the same thing, terrible chills, bad headache and diarrhea on Jan2021. The side effects say that this was normal but she wants to know should she have waited the 90 days before getting the vaccine. Patient still had the headache and chills but she took an Imodium and the diarrhea was better. Patient had also fatigue in Jan2021,and slept all day yesterday (13Jan2021). She has had a very sore arm and at 2am she woke up trembling with chills on Jan2021. Outcome of the event chills and headache was not recovered, for diarrhea was recovering and for the remaining events was unknown. Patient had a major reaction to eating conch and wanted to make sure there was no shellfish involve in the vaccine. Information on the batch/lot number has been requested.

Vaccine at 11:;50 am. 9:30 pm severe pain in left leg with cramps. then right leg but not as severe. pain all night, no sleep. Next day, severe pain back, upper left started about 4:30pm. then pain all over, muscular. lasted al night. Better next morning but still muscular pain.

Ran 100 and 99 for 2 days, and had chills, also a little weak.... started at 3pm on the 28 and continued thru the 29th. Finally normal temp. on the 30th.

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.

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.

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.

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.

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.

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.

diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat; painful esophagus; This is a spontaneous report from a contactable consumer (patient). A 79-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 15Jan2021 05:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient receive the vaccine Covid vaccine and had no problems. The next day on 16Jan2021, she had aches and pains but found them not unusual. 24 hours later that she had reflux on 17Jan2021. She had reflux all day on 17Jan20210 and took Gaviscon all day. Patient had very serious reflux Monday (18Jan2021) morning and took Prilosec. She also had a sore abdomen/ abdominal pain and took four Gaviscon that evening. She had diarrhea and stated that the same thing happened Tuesday (19Jan2021) but she was little better in the afternoon. She had no Gaviscon then. On Wednesday (20Jan2021), she very bad reflux all day, sore abdomen and diarrhea. Patient took Prilosec in the morning one hour before eating and took Gaviscon all night. Her voice was grabbly and she has sore a throat, painful esophagus and abdomen on Jan2021. She felt better the morning of 21Jan20221 and had Prilosec. She still has diarrhea and loose stool, and felt better after going to the bathroom. Her healthcare provider and the nurse stated to keep taking Prilosec. Patient wanted to know if this may be a side effect though not very prominent that is out there but not very common. Outcome of the event of diarrhea was not recovered while for the remaining events was unknown. Information on the lot/batch number has been requested.

Left arm got a little sore; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), via an unspecified route of administration on left arm on 19Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, had had all her life. There were no concomitant medications. The patient experienced left arm got a little sore on 20Jan2021. She went for her second dose by 10Feb2021. The patient did not receive any treatment from event. The outcome of event was recovered on 20Jan2021.

injection site pain, subsiding as of 3 days later; upper arm tenderness, continuing ; entire arm noticeably swollen down into hand, still present.

Pt began experiencing feeling "short of breath" pt is double masked. Pt removed mask and did a couple deep breaths and felt slight improvement but s/s returned. Offered and pt accepted cold water, alleviating feeling short of breath. 5 pm pt began feeling more short of breath and was breathless w/speech. Nurse alert called and PO benadryl 25 mg in 10 ml PO given lot c13e exp 3/21. Vitals taken 145/745 56 HR and 95 O2. Pt taken to advanced urgent care by staff via wheelchair 507 pm

Sore arm 3 days. Fever and exhaustion 2nd day extremely cold. Felt similar to when I had Covid but worse. 3rd day still tired but other symptoms gone.

Arm got a tad sore; makes her tired; Nausea; Chills; Hot flash; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program Pfizer First Connect. A 79-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. Medical history included gastroparesis. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), mirtazapine, calcium, colecalciferol (VITAMIN D). It was reported that the patient got the vaccine on the 13Jan2021. Wednesday and Thursday night, she was fine. On Friday (15Jan2021), she started getting nausea and chills. Then Saturday she was ok again. Then Sunday the nausea came back. She had had nausea since then. It comes in waves. When it is kind of mild, she doesn't feel so bad. This morning it has been bad. It makes her tired when the nausea gets like this. It may subside during the day. When she firsts get nausea, she gets hot flash. The patient's arm got a tad sore, but only a little. The outcome of the event chills was recovered on an unspecified date, nausea was not recovered while unknown for the other event.

heavy sweat; night of shot arm hurt so bad I could not sleep, arm still sore; night of shot arm hurt so bad I could not sleep; achy; chills; 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 VACCINE, lot number: EJ1686), via an unspecified route of administration on 19Jan2021 10:30 AM at single dose for COVID-19 immunisation. Vaccine location was Left arm. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Patient was allergies to penicillin, keflex lisinopril and Spiriva Respimat. Other medical history included asthma and heart electrical problem. Concomitant medications the patient received within 2 weeks of vaccination included many for asthma and heart etc. Patient administered the most recent COVID-19 vaccine at Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced shot arm hurt so bad and she could not sleep became achy and chills in the night of 19Jan2021, slept deeply Wed (20Jan2021) and Thursday (21Jan2021) nights. The patient experienced heavy sweat in the night of 21Jan2021 (Thursday) bedclothes very wet in morning Friday (22Jan2021) feel better but arm still sore. Patient was not received treatment for the adverse events. The outcome of events reported as recovering. All events reported as non-serious: adverse event resulted in none of seriousness criteria.

About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriented (now believe was sudden drop in blood pressure), followed by mouth feeling odd, tongue felt too big, difficult to swallow, followed by sensation of intense heat. This all lasted about 5-10 minutes. Resolved on its own. Felt a little shaken but OK afterwards.

I had no issues with the first dose. When they gave the 2nd dose, I felt strange feeling in my arm. I felt fine after that until the night. About 8PM I got a bad headache, I was so cold all over and I could not get warm, My blood pressure was 153/93. Body aches all over. My skin be sensitive it felt like it hurt to touch my skin. I couldn't sleep last night and was up and down all night. Today I still got a headache. I have been taking Tylenol which didn't help and tried Excedrin. I feel very tired today but I was awake a lot last night. I still have the chills as well.

Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became hot like a hot flash again; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at Left arm on 21Jan2021 15:45 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included high blood pressure, arthritis, known allergies: sulfa drugs, dust, mold. Concomitant medication included atenolol, atorvastatin, lactobacillus nos (CULTURELLE), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+). No other vaccine in four weeks. The patient's body became hot up to her head then red haze seen in room on first day 21Jan2021 07:00 PM. Body became hot like a hot flash again, no color haze on the second day (22Jan2021). Loose stools and stomach ache on third day (23Jan2021). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered in Jan2021.

At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O2 Sats 89% on RA, PR 88, Temp 97.3, RR was hardly counted because of body movement. Blood sugar was 172 mg/dL. Hooked on O2 at 4L per NC. Informed MD and ordered to send to ER. Family - were updated. Ambulance was called. Family clarified resident's status is DNR. Report was given to ER nurse. Updated ER that INR today is 5.5 and MD ordered to HOLD Coumadin till 02-11-21.

45 minutes after injection the left side of my face became numb to half of my tongue BP was higher than normal 177/97! Numbness lasted about 45 minutes! BP was back to normal the next morning! 2/9/2021

Chills and fever. It was only 99.8 and then later in the day it did go to 100.3 and nausea. Weakness.

Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; This is a spontaneous report from a contactable 79-year-old female consumer (patient). A 79-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration in left arm on 28Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included embolism in 2012 and cardiac pacemaker insertion in 2019. Concomitant medication included warfarin (unknown manufacturer), levothyroxine sodium (THYROXIN) and lisinopril (unknown manufacturer). The patient previously took lidocaine and ciprofloxacin and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 for covid-19 immunisation and experienced four small raspberry type "burn" left arm and small taste in mouth. The patient experienced burning sensation on skin on feet on back on 28Jan2021 with outcome of recovering. The patient was not treated for the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112990 Same reporter/patient/drug, different events

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild

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

Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.

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.

I received my vaccine on Sunday, work up Monday with sore arm which I expected. Monday night around 9pm I had a fever 101.3, my normal pain lever increased bad, and my balance of worse than normal, to walk 20 yards I had to stop at least 5 times because my back was hurting so bad. The next day, I woke up with normal fever but there was redness on the injection site a little larger than a silver dollar, around 8 my fever went up to 100. The next night, Wednesday night my fever was at 99.6, the next day my temp was normal and continued to be the rest of the time. The redness on my arm started fading and has continued to fade but I can still see where it is.

The night of the vaccination, I experienced icy cold hands and feet throughout the night. I had to get up twice to put additional blankets on the bed, even though the house was heated as usual. I also experienced frequent muscle spasms and cramps in both legs throughout the night. The following day, Feb 18, 2021 and today, Feb 19, 2021 I have been very low on energy, simply sat all day. Experienced lower than usual blood pressure (98/84 w/ 127 heart rate, 89/71 w/ 77 heart rate. Currently feeling normal at 4:25 pm.

Involuntary shudders I had no control over that lasted 4-5 minutes that left me gasping for my breath. Left arm is quite red and very warm. I was down all day Wednesday & most of Thursday. It so happened that I had a scheduled appointment with my cardiologist on Thursday and checked ok

Severe chills with abrupt onset 21.5 hours post second dose, accompanied by fever of 102.3 F by oral digital thermometer. She was shaking uncontrollably while dressed, wrapped in a blanket, and sitting in warm room within two feet of fire in fireplace and using hand warmers. Symptoms lasted approximately 75 minutes.

to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P

After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had flu for 5 days. Had rash on left arm ob 6 day, still tired but better. 7 day ok.

Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days after receiving the vaccine and my palms were suddenly blue and I could see every vein in my hands and fingers. they were cold and color returned after submerging them in warm water.

grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Patient was given the vaccine and waited the recommended time (15 minutes) after the administration of the vaccine and did not report any reaction at that time. Approximately six hours after the injection, she suddenly noticed she was having trouble breathing, could not catch her breath, and a call was made to 911. She was transported via ambulance to the hospital, where she remained for a week.

has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021.

Pt developed a flushed feeling, numbness in hands and palpitations(heart racing) several minutes after injection. Symptoms slowly subsided after 20-30 minutes of observation. HR: 100, SBP: 150, SP02: 99. EMS services/hospital evaluation was offered and pt declined. She elected to go home with her husband as the driver with a plan to self monitor at home.

Began running low grade fever next morning, by evening the temp was 100 . I had no energy an began to fall asleep in the early evening.. Woke up in a sweat. Felt exhausted all the next day but temperature left. Should be almost normal by tomorrow. I hope.

Started with aching arm followed by shaking chills, fever, body aches, headache, nausea, and lasted about 24 hours.

2/26 - severe flu symptoms (achy, no energy), drastic increase in memory related issues (has mild cognitive impairment) 2/28 - vomiting and diarrhea

chills for 2 days, then itchy for several days, then urine burning, then nerve jumping in arms, then clammy all separate in afternoons 2nd shot was 2 weeks ago

79 yr old caller had first vaccine yesterday at 1425 (pfizer) late in the afternoon she had chills and pain in arm, mouth was sour. she hasnt been taking her potassium on large amount of diuretics for kidney and heart. she is on 2.5 mg eloquis. today she stayed in bed this am her temp was 100. an hour ago it was 101.3 adv apap for fever if ok with your medical situation, sx are normal for vaccine. ok to go for dr next week if f/u is needed. these sx are not contagious.

pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the injection site and arm/pain at injection site all the way to her elbow; felt like someone stuck a knife in her muscle; 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 VACCINE, solution for injection) lot number A3249 and expiry date unknown, via unspecified route of administration at the left arm on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included other medications. The patient had the first dose of the Pfizer vaccine on 21Jan2021 and the following day (22Jan2021), she experienced pain in the injection site and arm. The patient informed that it felt like someone stuck a knife in her muscle. The patient informed that the pain was improving and not sure if she wanted to get the second dose. The patient informed that she had a dental procedure done and was taking pain medication to help with that but it didn't help with her pain in her arm from the shot. The patient has been having pain at injection site all the way to her elbow. The patient informed that the first day they it was like she had a shot. The patient informed that it felt like a knife was being stuck in her muscle the second day (22Jan2021). The patient informed that today it felt like pressure. The patient informed that at night time that she sleeps perfect and when she gets up in the morning that it was bad pain. The patient informed that she was leery about getting her second shot. The patient informed that she had two teeth pulled on Friday (unspecified date) after she got the vaccine. The patient informed that they redid her partial for those teeth. The patient informed that they had prescribed 800 mg of ibuprofen for her teeth. The patient stated that she thought it would help the pain in her arm but it did not. The patient was told to keep taking it but she stopped. The patient informed that she has to take antibiotics for her teeth until they were all gone. Therapeutic measures was received by the patient due to the events. The outcome of the events was recovering.

I experienced throat congestion:a feeling of thickness and swelling.; I experienced throat congestion:a feeling of thickness and swelling.; higher temp; arm ache; This is a spontaneous report from a contactable consumer for herself. A 79-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 30Jan2021 14:30 (Lot number: EL9264) via an unspecified route of administration in the right arm at single dose for COVID-19 Immunization. The patient's medical history included cholesterol but not high. The patient had no known allergies to medications, food, or other products. The patients concomitant medication included rosuvastatin at 5mg, aspirin (acetylsalicylic acid) at 81mg. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The dose was received at 2:25pm. The dose was received on adverse event start date: 30Jan2021 at 2:25pm. patient waited the 15 minutes waiting period & went home. 95 minutes after (30Jan2021 16:00 PM) the injection she experienced throat congestion: a feeling of thickness and swelling. The symptoms lasted 35 minutes. Other reactions were normal: higher temp & arm ache. There was no treatment received for the adverse events. The outcome of the events was recovered on 30Jan2021 16:35. No follow-up attempts are possible. No further information is expected.

Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21.

headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issues

pt stated that she had a sore arm and trouble sleeping. Pt contacted her PCP about not being able to sleep so she was given a RX for Trazodone 50mg but pt is concerned about taking it due to the side affects.

tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during the night Saturday to Sunday stuffy nose, dry cough, fatigue, chills (no fever), nausea, sore arm - Sunday and Monday on third day the only thing remaining are chills sought no treatment

Shot was on 2/15. No adverse until about 9 pm on 2/19 when started having. Neuropathy in feet, legs and mouth started to burn. This burning and tingling has happened every night since. Was hoping would clear up on its own. Had some neuropathy before but nothing like this. Went to Dr on 3/1. This was first appointment. I could get. He did number of tests should hear from them soon. At the present time of typing this I have some tingling and burning and numbness. But is extremely bad at night

Patient presented with bilateral ptosis and weakness in the jaw while chewing that progressively gets worse as the day goes on. Patient was prescribed pyridostigmine bromide 60 mg with improvement of symptoms. Patient is following up with neurology.

Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue". The patient also reported that she had a herpes simplex virus that was dormant unless she get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.

She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EN6201), intramuscular at upper left arm on 17Feb2021 10:15 at a single dose for COVID-19 immunization. Medical history included ongoing Rheumatoid arthritis (arthritis in right shoulder and arm gets inflamed and sore; rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore) diagnosed in late 2019, ongoing Autoimmune deficiency disease diagnosed in late 2019 and lower left eyelid which was inverted. There were no concomitant medications. No prior vaccinations (within 4 weeks). The patient previously took Shingrix vaccine (Shingles vaccine) at left arm last year-2020 and she felt soreness and achiness in right shoulder and arm. The patient received the first dose of the Pfizer COVID-19 vaccine yesterday on 17Feb2021 at her left arm. A few hours later her right shoulder and right arm felt sore and achy. On 18Feb2021, the patient's right arm and shoulder were aching. The patient mentioned that this has also happened last year when she had a Shingrix vaccine. She was also injected in her left arm but her right arm got sore and achy. She felt soreness and achiness in right shoulder and arm. She wanted to know if this is a normal reaction from the vaccine. The patient stated that it was weird. On unspecified date, when she lifts her arm up high it hurts, she stated that she does have an inflamed shoulder. She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine. During the night it was very bad. She does have rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore. She was wondering if there is a relationship with the COVID 19 vaccine because she felt like she got the COVID 19 vaccine in the right arm, she asked if she's reacting to the medication. No treatment was administered for right shoulder. Routine lab work done on 02Feb2021 but it has nothing to do with this. The events did not require a visit to Emergency Room or Physician Office. The patient is also scheduled to have Botox in her lower eyelid for her left eye to release the nerve muscle. She asked if it is ok since she just had the Pfizer COVID-19 vaccine. She is scheduled to get botox injection next week for lower left eyelid which is inverted, it was bothering her. They have to release the muscle by getting an injection of botox. She was receiving conflicting information from her PCP, who says wait a month and her ophthalmologist who says its ok to get the COVID 19 vaccine. She thought she heard something about not mixing botox with the vaccine. The outcome of the event "She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm" was unknown; and other events was recovering.

pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.

short of breath taken to ED. At home- Had aphasia after 1st dose for about 5 minutes. PCP said to get 2nd dose

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.

pt stated that several days later she started having trouble with her left leg, hip and foot. Pt went to her PCP after she got these symptoms and they did xrays on her leg which showed no breakage. He prescribed her anti-inflammatory and pain pills. She has been applying ice to affected areas. She has been referred to an orthopedic doctor but is waiting for them to contact her. She has also been to a message therapist and a Chiropractor with no help for the pain. Pt states that the pain is not getting any better.

arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt achy in her arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that when she got the first dose of the vaccine in Jan2021, she felt that the needle went in, she felt a little discomfort with the needle, had some blood on the band-aid, she felt achy in her arm afterwards in Jan2021; and her arm swelled up/had arm swelling on unspecified date. She did not feel anything with the second dose and there was no swelling like the first time. She asked the nurse if it went in for the second dose and the nurse said it did. The patient mentioned that there was nothing that showed like anything went in her arm when she received the second dose. She heard that the second one should feel something going on more than first time. She did not know if she could get another vaccination or what she needed to do. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when shots given for dental work begin to wear off. Tingling pain from hairline to mid throat, from behind ear to right side of nose. areas of numbness, , noticeable swelling of lymph node under right chin. Painful to swallow, painful to open mouth, pain in jaw like having a really bad tooth ache. this is nine days. I had a titanium tooth implant in the last six months. Painful to chew food - eat soups, ice creams, soft food like bananas.

Rash on face/It was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there; It's really red, a red face; Red flushed face; This is a spontaneous report from a contactable nurse (Patient). A 79-year-old female patient received BNT162B2 (BNT162B2; Lot number EK4176, expiry date not reported) via an unspecified route of administration to left arm on 24Jan2021 at 14:00 single dose for covid-19 immunization. Medical history included wheelchair user (She is in a Wheel chair), amputee (she is an amputee, Right leg above the knee, known as "AKA."), leg amputation from an unknown date. There were no concomitant medications. The patient experienced rash on face/it was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there on 25Jan2021. Reporter also added it's really red, a red face on an unspecified date and red flushed face on 24Jan2021. The patient underwent lab tests and procedures which included cardiac stress test: unknown results on 22Jan2021 and Nasal Swab: negative on Nov2020 (She got tested about 8 weeks ago and it was negative/test was done end of Nov2020). Therapeutic measures were taken as a result of rash on face/it was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there, it's really red, a red face and red flushed face. Reporter stated her rash on the face started on Sunday, it's really red, a red face, it is a blotchy rash on chin, which then moved up to the cheek, and as of yesterday it is now starting on the forehead. Her first dose was on 24Jan2021 at 2pm. She clarifies that it actually started with a red flushed face mainly her cheek on Sunday 24Jan2021, then on Monday she noticed that she thought her chin was breaking out, it was more definite Monday and then faded. By Tuesday it was on her cheeks. It was more definite on Wednesday, it was like a bumpy rash, like little pimples but no heads on them. When queried Weight caller adds that she is an amputee, Right leg above the knee, known as "AKA." Her rash is getting better it goes up the face but its erupting on the forehead and starting there. Caller clarifies it is about the just in different locations on the face. She put cortisone on it. On Friday 22Jan2021, she actually did go for a cardiac stress test, in which they gave her something, radioactive, some medication, since she can't do the stress test running on the treadmill. She has had No Positive Covid test. She got tested about 8 weeks ago and it was negative, it was done via a Nasal Swab, she recalls she got tested prior to a procedure, and so the test was done end of Nov2020. She is in a Wheel chair. The outcome of the event Rash on face/It was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there was not recovered. Outcome of all the other events was unknown.

On my right leg down close to the ankle I have a swelling that is showing bruising and a lump that is painful. I am not sure if it is a clot or not. I have not been to Urgent care . I informed people giving me vaccine I was on blood thinners. Nobody seem to show concern about that. I have already received 2nd shot, which I got very sick after, but symptoms seem to happen to others. My concern is the lump on my leg if it is a clot and concern if I will get more now that I took the 2nd vaccine.

Headache and sore arm; Headache and sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: unknown), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunization. The patient's medical history included Hypertension, Osteopenia and Prediabetes. Concomitant medication was not reported. Patient has not tested positive for COVID-19 since having the vaccine (03Feb2021). On 04Feb2021, the patient experienced Headache and sore arm, for which Tylenol was given as treatment. The outcome of the event Headache and sore arm was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

No immediate common listed side effects. Periodic tingling, deadness in arm. Phoned the Clinic where vaccine was administered. Was told that there was a possibility that a nerve was hit. Have scheduled an appointment with my primary physician.

sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in addition to previous symptoms. In the emergency department on March 11th with complete right facial droop consistent with Bell's palsy; this has persisted as of today, also with evidence of right serous otitis media

nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc. The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.

nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to perform daily activities, took bonine and tylenol

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.

Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: El3247), via an unspecified route of administration, administered in Gluteus Medius Right on 31Jan2021 as single dose for an unspecified indication. Medical history included AFib, sleep apnoea, high cholesterol and drug allergy to Sulfa. Concomitant medications included apixaban (ELIQUIS), diltiazem (trade name not reported), atorvastatin (trade name not reported), paracetamol (TYLENOL) and melatonin (trade name not reported). The patient previously took atropine and experienced drug hypersensitivity. The patient experienced burning pain in left buttocks area, researched and thought it was a sciatica issue. Could not lay down, bend over or put weight on that leg. Used alternately ice and heat. No fever. Pain lasted over 48 hours on 31Jan2021 16:00. The outcome of the event was recovering.

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.

blood sugar raised up; being unbelievably freezing cold; This is a spontaneous report from a contactable consumer (patient self). A 79-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 09Feb2021 10:30 (Lot number was reported as ELO1265 or EL01265, the patient was not sure if the third digit was letter or number; unknown why this Lot was 7 digits when first dose Lot was 6 digits) at the age of 79 years old, at single dose for covid-19 immunisation. Medical history included diabetes from 2018 and ongoing, family Medical History includes: All diabetics stage I and stage II, ongoing scoliosis, 60 degrees of scoliosis diagnosed when she was age 75 years; assumed it was congenital, ongoing asthma when she was around 40 years of age, ongoing thyroid disorder when she was around 45 years of age, diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, back pain, celiac disease. Concomitant medications included insulin lispro (HUMALOG) taken for diabetes from 2019 and ongoing; sitagliptin (JANUVIA) taken for diabetes from 2019 and ongoing, because of celiac disease-she cannot take others; she wondered if getting vaccine may have knocked this out of her system and it is having to build back up, prednisone taken for back pain from 27Jan2021 to 01Feb2021, She knew prednisone can increase blood sugar levels. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration, administered in arm right on 19Jan2021 14:00 at the age of 79 years old, at single dose for covid-19 immunisation, and previously took second shingles vaccine for immunization and described as a bruiser, she was really sick, the vaccination date of second shingles vaccine was reported as maybe 1.5 years before 12Feb2021. There is no other vaccination within four weeks prior to the first administration date of the suspect vaccine BNT162B2. No other vaccines were administered on same date with the BNT162B2. The patient experienced very high blood sugar levels and being unbelievably freezing cold on 10Feb2021 after she was administered the second dose. She called to ask if anyone else has reported very high blood sugar levels after getting the vaccine. Her normal blood sugar level in the mornings was about 122; normal blood sugar level in the evenings was about 180. She had not gone to physician's office, emergency room or been hospitalized for this event at this time. As long as she stayed under 300 and she was ok she knew. Blood sugar level was 164 on 10Feb2021 morning, exact time unknown, blood sugar level was 247 on 10Feb2021 evening, exact time unknown, blood sugar level was 182 on 11Feb2021 morning, exact time unknown, blood sugar level was 296 on 11Feb2021 evening, exact time unknown, blood sugar level was 172 on 12Feb2021 morning, exact time unknown. The patient had to use insulin lispro more than normal in response to very high blood sugar levels. Increased doses provided as took 13 units this morning: 12Feb2021; 14 units evening of 11Feb2021: Started with 10 units, but when got blood sugar level of 296 she took 4 more units. The patient experienced unbelievably freezing cold on 10Feb2021 about 13:00 or 13:30. She woke up around 13:00 or 13:30 and was unbelievably freezing cold. She was freezing. She wrapped up in a bathrobe, 2 blankets and her husband; took a couple of Tylenol and Benadryl and this event subsided. She recovered completely from event within about 1 hour of onset on 10Feb2021. Event described as the craziest thing. The events did not result in emergency room visit or physician office visit or hospitalized. The outcome of the event high blood sugar levels was unknown, outcome of the event unbelievably freezing cold was recovered on 10Feb2021. Information about lot/batch number has been requested.

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.

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.

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.

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.

Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - urine totally colorless though I was not drinkiing anything, yellow tint gradually reappeared over next 3 days), no fever, memory and concentration much worse than usual, could not even think well, joint pain ,prolonged excessive sleepiness (nearly has resolved after 2 weeks)

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.

Very sore arm. Achey joints muscles, extreme fatigue, stiff neck, "fuzzy" thinking. Most gone after one day. Arm still a little sore.

not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), Pfizer Covid vaccine manufacturer; unspecified, NDC number, expiry date; unknown, intramuscularly from 26Jan2021 at 12:45 pm to 26Jan2021 at 12:45 pm at single dose on left arm, towards the shoulder up high for prevent Covid. Vaccination facility type; hospital, Vaccine was not administered at military facility. Patient was 79 years old, weight; 77.11 kg, height; 155 cm at the time of vaccination. Patient medical history, relevant tests and concomitant medications were reported as none. Past drug event included soreness with flu shot (drug name unspecified). Patient did not have name, lot, ndc, or expiration date for the flu shot. 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, additional Vaccines Administered on Same Date of the Pfizer Suspect and prior Vaccinations (within 4 weeks) were reported as none. Patient experienced not feeling well, weak, freezing/chills, aches and pains and nauseated from 26Jan2021 at 12: 45 pm to ongoing. Patient got her Pfizer Covid vaccine on on 26Jan2021 at 12:45 pm, Tuesday afternoon. She has not been feeling well since then. She was freezing, she had the chills, aches and pains, she is really kind of nauseated. Nausea is the most irritating thing right now and it seems like chills have gone away. She asked how long does this last and is there anything she should be done. Advised to contact hcp, HCP: no email. All her symptoms started Tuesday night. She has had to stay covered up all the time. She feels kind of weak, and she has been laying around covered up, states that could make her sore since she is not up and doing anything. She is not throwing up, she is queasy, she does not want to eat anything like she is afraid. Patient declined any treatment given. The reported adverse event did not require a visit to emergency room or physician office. The outcome of events was recovering for chills and not recovered (From 26Jan2021 to ongoing) for other events . Investigation assessment; no.

Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black and blue bruise; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; there is a little nodule; 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: EN6198) via an unspecified route of administration, at the age of 79-year-old, on 18Feb2021, as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included losartan. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: not reported) on an unspecified date, as SINGLE DOSE for covid-19 immunisation and did not have any reaction. On an unspecified date in 2021, like the last week or so, the patient had some pain in legs. The left leg is all bruised and the patient did not hit it, the patient did not remember hitting it but it is all swollen and black and blue and it is like the patient had tingling going from the ankle bone up to kind of half way in to calves. The right leg it is like the ball, the top of it is all kind of shiny and swollen and it is very painful. The patient did not have that before. The patient clarified almost all over the side of legs where the bone is and like to the toes and above the ankle, it is like there is a little nodule that is little sore and same thing is on the right leg. But on right leg, the patient can barely put any weight on it. The left leg tingles and its tender, like the patient have tingling above the ankle up to like half way in to the leg. The patient would like to know if it is possible to have blood clots from the vaccine, it actually looks like a little nodule. The patient underwent MRI on an unspecified date with unknown result. The patient did not receive treatment in response to the events. Outcome of the events was unknown.

Arm hurt; Chills; Fever; Aches; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine) via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:00 (Lot Number: EN6201) at single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Hospital for Covid: Apr2019 - 05May2020), pneumonia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine, lot number: EJ1686) via an unspecified route of administration, on 19Jan202110:00 AM at single dose for covid-19 immunization and Past drug reaction included night of shot arm hurt so bad I could not sleep, arm still sore, achy, chills, heavy sweat from 19Jan2021 with no Admission to hospital due to event , no treatment received and outcome of recovered. The patient experienced arm hurt on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown, fever on an unspecified date with outcome of unknown, aches on an unspecified date with outcome of unknown. Vaccination facility type was senior Independent Living. No vaccine administered at Military facility. There is no other product(s) that were taken together with those indicated above. The clinical course was reported as follows: Second shot on 09Feb2021 was a lot worse. Arm hurt but not as bad as first shot. Chills, fever, aches a lot worse. 36 hours very bad.

Patient began having symptoms of pain in upper R leg on 3/16/21. Presented to ER on 3/20/21 and was discharged on lovenox. Presented back on 3/21/21 after venous duplex - now being treated with Eliquis.

mild "sore arm"; This is a spontaneous report from a contactable consumer. This consumer reported for a 79-year-old female patient that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included hypothyroidism and hypertension from an unknown date and unknown if ongoing. Patient reported a mild sore arm starting one day after receiving the Pfizer Covid vaccination (morning of 04Feb2021). The event is ongoing at the time of reporting. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was reported as not recovered. Information about lot/batch number has been requested.

severe pain, swelling of Right DIP joint right index finger, thumb and wrist. Acute onset. No fever. Responded to 400 mg oral ibuprofen.

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.

Skin bright red from neck down to below buttocks back and front; Down both arms; Very lethargic the entire day; This is a spontaneous report from a contactable consumer or other health care professional (patient herself) of 79-years-old female non pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, Expiration number: not reported) via an unspecified route of administration on 04Feb2021 14:45 (at the age of 79-years) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not known to allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, patient experienced skin bright red from neck down to below buttocks back and front, down both arms and patient felt very lethargic entire the day. No therapeutic measures were taken for the events occurred. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

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.

Developed shakes a few days after shot. Broke out with Shingles on 28/29 of March. Started medicine (IC VALACYCLOV-IR 1 Gram every 12 hours for 10 days) on 4/3/2021 from Doctor. Rash starting to clear up on 4/5/21. Still burning slightly on 4/7/21.

right hand started to feel like it was going to sleep; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer it has been in remission for 3 years , milk allergy, ongoing high blood Pressure, ongoing cholesterol, ongoing Diabetic. The patient historical vaccine included flu shot for immunization. Concomitant medication included lovastatin at 40 mg, twice a day taken for cholesterol, Ongoing metformin at 500 mg, twice a day taken for diabetic,amlodipine besylate;benazepril at once a day (10-40mg once a day) for high blood pressure from an unspecified start date and ongoing, vitamin d (Lot number: 507530-01 and expiration date: Oct2023) at 800 iU (takes two 400IU); ascorbic acid (VITAMIN C Lot number: 526680-01 and expiration date Sep2024) taken 1000 mg (takes two 500mg to make 1000mg) for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12-VITAMIN Lot number: 505721-03 and expiration date: MAR-2023) taken 500 mg, daily for an unspecified indication, and multivitamin. He noticed one hour after receiving the first dose of the vaccine his right hand started falling asleep. It occur only in the arm where he got the vaccine. It got better and five minutes later it happened again. Caller wants to if this side effect is associated with the vaccine. The outcome of the event was unknown

03-26-2021 patient developed LLE pain, progressively worsened. Admitted to hospital on 03/29 and discharged 04/01. Pt diagnosed with superficial femoral artery occlusion and popliteal artery thrombosis. Left femoral artery stent placed 03/31/2021.

left arm soreness; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2 Pfizer-BioNTech COVID-19 Vaccine; Solution for injection), via an unspecified route of administration on 11Feb2021 as single dose for covid-19 immunization. Medical history included bronchitis and illness from Dec2019 to an unknown date. Concomitant medications were not reported. The patient experienced left arm soreness, lack of energy on an unspecified date. The reporter said that she become very ill in dec2019 while on vacation in (place name), went to walk-in clinic twice. no pneumonia though coughing, horrible wheezing, told me it was probably bronchitis. given numerous drugs, still doctoring when and returned home. more drugs. no energy for 2-3 months. had been told lots of sickness in (place name) when she was there. heart and lungs checked and ok. often wondered if she had covid. woman across aside from me on plane coughed all the way to (place name). 3 days later she was sick. The outcome of the events was unknown.

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.

Pfizer Covid 19 vaccine: hives/broke out in hives/received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm; she still has "lizard skin"; has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient previously had flu vaccine and had a flu and shingles vaccine and had shingles for 3 weeks after she took the shingles vaccine. The patient received her first vaccine on 30Jan2021. On 31Jan2021, the patient ended up in ER with hives from the vaccine. She was told that she would be given Prednisone for hives but not to take it until Monday at noon. Stated that they wanted her to wait 48 hours after vaccine before she started it because it would cut it in half. She started Prednisone 40mg on Monday and did get a few more hives on Tuesday and Wednesday. She had the shot in her right arm, and all this happened on the left side of her back. She had a patch of hive of 5x6 to 8x8 on her back and on the back of her arm by her elbow and forearm. She put apple cider vinegar on her arms, and she did not itch anymore. Someone told her that this could be shingles. She stated that she got flu vaccine and got sick with flu and she took the shingles vaccine and got shingles. She could not stand in shower with the shingles but that she can with this, so she knows that it is not the shingles. The patient did not want to take the second shot on 20Feb2021 and wanted to know what Pfizer thinks. She does like to travel and hopes to soon so she wanted to know if not taking the shot could get a stipulation if they required two shots to travel. She has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming, but she knows that it is there which came on in the past week (2021). She was on Prednisone 40 mg for 5 days and she still had hives (though they are diminishing). The patient stated that she still has "lizard skin". She received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm where she had shingles. Her ER doctor told her not to take the second dose and her primary care physician told her to wait and think about it. She is wondering if she should receive the second dose. The outcome of the event hives was not recovered while the other events was unknown. Information on the Batch/Lot number has been requested.

She has been noticing tingling involving all her extremities, initially intermittently and now progressing to constant numbness/tingling, after the second shot of COVID 19 vaccine . Symptoms started may be a few days after the 2nd COVID 19 vaccine.

Sore arm; tired; itching; This is a spontaneous report from a contactable Nurse(Patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1st via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. Medical history included High cholesterol (Verbatim: High cholesterol). Concomitant medications included rosuvastatin, acetylsalicylic acid (ASPIRIN (E.C.)), zinc, alendronate sodium (FOSAMAX), Multivitamins. Patient had first Pfizer vaccine and the only thing had sore arm and got really tired and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching. Patient think she started having difficulty was the morning of 13Feb2021. Patient was not experiencing side effect anymore. Patient did not took any treatment. The outcome of the event was recovered.

Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. Also radiating down arm and up into chest and back

Patient with a history of LLE revascularization on 2/1/2021 with fem-bkpop 6mm PTFE bypass for limb salvage in the setting of rest pain and great toe gangrene. She was discharged on Xarelto. Patient was admitted to the hospital on 4/13/2021. Patient reported she noticed return of the rest pain to the left lower extremity starting on 4/12/2021. Patient was found to have acute on chronic limb ischemia of the LLE and was found to have an occluded left femoropopliteal bypass graft. She was taken to the OR on 4/14/2021 and underwent a thrombectomy and removal of distal portion of the graft, which appeared to be infected. Cultures from the left femoral thrombus was positive for gram-negative rods. Blood cultures from 4/13/2021 were positive for Pseudomonas aeruginosa. Postoperatively, her left lower extremity continue to be numb, cool, and she was unable to dorsiflex the foot. Patient ultimately underwent a left lower extremity below the knee amputation on 4/16/2021. Patient remains hospitalized at this time.

Severe back and leg pain lasting at least 6 weeks; still continuing, but now about 60% better than it was. Must use a walker due to pain Saw neurologist's Nurse Practioner and am receiving Physical Therapy 2x weekly. Scheduled to see doctor at pain clinic about injection in low back.

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.

Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself). This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown. No further information was provided.

Patient was fully vaccinated. Presented to ED on 4/24/2021 with fever of 101.8, chills, weakness, malaise/fatigue. Pt tested and COVID-19 PCR positive. Patient remains hospitalized

1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.

excruciating cramps in stomach; numbness in hands; numbness in arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Right arm on 06Feb2021 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2000 and ongoing Verbatim: Diabetes. Concomitant medications included metformin taken for diabetes mellitus from 2000 and ongoing insulin glargine (LANTUS) taken for diabetes mellitus from 2011 and ongoing. On Feb2021 the patient experienced numbness in hands, numbness in arms and on 24Feb2021 when she was in the kitchen she had excruciating cramps in her stomach. The patient would receive the second dose this Saturday. The clinical outcome of the events was not recovered except excruciating cramps in stomach was recovered on 24Feb2021.

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.

sore arm; more of a tingle/tingling arm; like a nerve, maybe she hit a nerve; injection site pain; injection site swelling; injection site redness; This is a spontaneous report from a contactable consumer (husband). A 79-year-old female patient (unknown pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 in the arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. On unspecified date, patient still had a sore arm, she just wanted to shake it, more of a tingle, like a nerve, maybe she hit a nerve. Patient saw her PCP doctor last week (Apr2021) and she was told that it sometimes happened. Patient experienced tingling arm 1 month after 2nd injection. She also experienced injection site pain, injection site swelling or redness on unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

exhausted/tiredness; She says she feels a little fuzzy, like she is not thinking clearly; Discomfort; mild malaise; Trembling; 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 VACCINE; Solution for injection; Lot Number: EN6202; Expiry Date: 30Jun2021), administered in left arm on 03Mar2021 (at the age of 79-years) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced discomfort, mild malaise, trembling, on an unspecified date she says she feels a little fuzzy, like she was not thinking clearly and she says she was not able to do anything due to exhaustion. she has been having three days of discomfort and mild malaise for a week. The patient says she was not able to do anything due to exhaustion, so she thought Pfizer would want to know. She says that she could not type due to trembling to complete a report online. Patient second dose was on 26Mar2021, and they did not ask for her vaccine card, so she does not have and was not able to provide NDC/LOT/EXP from the second dose. She says that the NDC was not provided on her vaccine card for the first dose. The patient mentions a COVID test, but says that this was just a paper, she had forgot that she had a card, the test was to do a job. Patient says it was the second dose that she had a reaction after. She says she got both doses in her left arm. She says her reaction was discomfort and mild malaise beginning Saturday. Patient said that it has not got better or worse, she was having intermittent trembling periods where she would feel ok but then start shaking and be exhausted again, so it has been about the same since Saturday. Patient said that she will be ok for a couple hours, and then it will all start again, and she will shake all over. Patient felt a little fuzzy, like she was not thinking clearly, and so tired and trembling. The patient said that her prolonged reaction was not enough to go to the hospital, but she was not feeling so good, and thinks maybe people should be warned. The patient did not receive any treatment for adverse event. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Experiencing progressive weakness and numbness in arms and hands. Legs feel heavy. Hands become stiff and freeze in position, occasionally cramping. I've described the arm and leg sensations as "dead arm" and Heavy legs. Also have a feeling in them that I can't describe. I started paying attention to this in early March. Now it is frequent…several times a day lasting for 15 to 20 minutes.

past medical history significant for coronary artery disease s/p PCI, chronic hypoxic respiratory failure on 2L, hypertension, multinodular goiter who presents to ED on 4/25/2021 with symptoms of progressive shortness of breath, dysphagia and neck pain. Labs showed elevated BNP of 3000 and a hemoglobin of 8.5. Patient was incidentally positive for COVID-19 pneumonia

On the 3 rd day after pt received her first shot. She started getting symptoms of Bells Palsy on the Right side of her face. Eye and mouth drooping. On 4/25/2021 she still has some drooping and her Right hand eye is blurry.

Her arm was sore; hangover; sneezing; nose was stuffy; 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: EL9265), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications were not reported. On 30Jan2021, patient nose was stuffy and she was sneezing. On 03Feb2021, patient experienced hangover. She has recovered completely she says the next morning she woke up and felt rejuvenated. She said the stuffiness and sneezing happened before the hangover feeling it was probably Saturday after the vaccine that she had the stuffy nose and sneezing, she says 30Jan2021 sounds right. She says she has recovered completely since then everything is going good. Patient asked who she was talking to she got the number off the paper she got after the Pfizer COVID 19 vaccine. She wanted to people applaud her people for being so orderly and efficient it only took, she only had to wait half an hour all together it was about 45 minutes but the efficiency was great that they gave them at the Hospital. She said she wanted to tell Pfizer how much she appreciated and just check to see how long after the vaccine could she have any kind of reaction. She said she was asking because she thinks she may have had a reaction but she does not know so she wanted to try to see if it was one. She said this happened a week later didn't have any thing when she got the vaccine except her arm was sore but that was it. Then, she is 80 years old and she doesn't drink but she felt like a she had a hangover and her nose was stuffy and she sneezing. Patient declined to provide email address. She hardly ever uses it. It was reported that decline to provide because she was fine. She feels like a million bucks. She had to get her glasses to read the vaccine record card. She does not see and expiration date or NDC number just the date she got it. It was reported that she did not want to get the dangerous flu at her age that would be a horrible death. She was only on high blood pressure medication. The outcome of the event her arm was sore was unknown and outcome of the other events was recovered. No further information provided.

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.

vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

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

Hypertension; Tachycardia; Extreme flushing to face and neck; glowing red; took her pulse and it was 145; Persistent head to toe macular erythematous Rash; Dull Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered on the left arm on 21Apr2021 13:12 (Batch/Lot number was not reported; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included fibromyalgia (diagnosed more than 20 years ago), bladder cancer (diagnosed 13 years ago the first time, 8 reoccurrences and has been cancer free for 2 years, cancer free for 2 years), multi drug allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, and obesity. Concomitant medications included lisinopril, levothyroxine, and oxazepam. No vaccines received within 2 weeks. In 12 minutes after the injection on 21Apr2021, while she was still sitting in the parking lot, patient developed tachycardia on and extreme flushing to face and neck on 13:20. They were as red as being in the sun. She was aware of tachycardia first. Then she looked in the mirror and was glowing red. Patient was observing in parking lot and took her pulse and it was 145. Persistent head to toe macular erythematous rash occurred next. They took her to the ER about 20 minutes after the injection. In the ER, she was given 25mg of Benadryl IV and 125 mg of Solumedrol IV. When both of those wore off the next day, the generalized rash came back on Thursday (22Apr2021). The rash was persistent but not as flushed looking as before. When they got her into ER, the first blood pressure reading was 198/117, which was within 20 minutes of injection. Hypertension was experienced on 13:30. Her blood pressure usually was fairly low and was back to normal now. She had one reading of 124/76 to 170/something. Her normal range is anywhere between 150-170/70-80's. She is on Lisinopril. The other morning when it was 124/76, was just a fluke. That was an unusually good reading. They did a regular panel of lab work when she went to the ER. They did not tell her that anything was abnormal. She asked them to run an A1C, but they told her they could not. They did a chest film, EKG, placed IV to give medications, but no fluids given. Her doctor said not to get second dose of the vaccine. She had it at the hospital and they had reports of other people with a rash. The patient considered the events tachycardia, extreme flushing, macular erythematous rash and hypertension were medically significant while for headache was non-serious.; Sender's Comments: The reported events were possibly causally related to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved

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.

she has a lot of fatigue did not take temp but is colder than usual and wearing sweater which she says she normally doesn't, and if she takes a deep breath it is tight and hurts her chest and does have an occasional cough Contact with and (suspected) exposure to covid-19

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.

headache; fatigue; pain at the site; pain at the site, swelling; chills; lethargic; temperature and it was holding steady at 99 degrees; her arm had gotten red and became very hot; her arm had gotten red and became very hot; This is a spontaneous report from a contactable Nurse (Patient herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), on 28Jan2021 at 09:15 (Batch/Lot Number: EL1283) (at the age of 79-year-old) as first dose intramuscular administered in arm right unknown dose, single for covid-19 immunisation. Medical history included ongoing Gastric anomalies, ongoing Allergies, breast cancer (also took cancer medication for 5 years but hasn't had that in 2 years), she had 2 implants (ongoing), but she hasn't had any radiation or chemotherapy in the last 2 years. She has arthritis down her spine and a couple other things wrong with her. She states it magnified those conditions and it stayed that way for a while. Her historical vaccine reported Flu in Sep2020. Ongoing concomitant medication included patient states she does have allergies and she does take daily medication for it. She also has a nasal medication, Montelukast and she was also on an oral tablet every day also takes dexlansoprazole (DEXILANT) which was a very powerful antacid for her gastric anomalies. She wasn't supposed to take it but for only 3 months but she has continued to take it for 5-10 years, more like 10 years and no one has stopped her. She states "Patient had a headache, fatigue, pain at the site, swelling but no lymphadenopathy after receiving her first dose. She had cancer in the past but clear now. Patient mentioned she got the first dose on 28Jan2021 and scheduled for her second dose 23Feb2021. Caller wants to know the side effects expected with the second dose. Patient received the first COVID-19 vaccine on 28Jan2021 at 9:15am. Around 2am or 3am the following morning (29Jan2021), her arm had gotten red and became very hot. It became really quite swollen. She couldn't move without it hurting. She took Tylenol without any advice from a doctor, she just took it herself. The Tylenol relieved some of the pain, but not all of it. Patient verifies the Tylenol is not handy when probed for NDC/UPC, Lot number or expiration date. She also started to experience chills but she never took her temperature. So at this point all of this was within 2 days after two 24 hour periods. Patient states on the 3rd day, everything seemed to lighten up and started to back off a bit. She took her temperature on the 3rd day and it was holding steady at 99 degrees. She didn't feel that any of this was earth shattering. She was taking more Tylenol and it relieved some symptoms. The Tylenol did help. By the fourth day, she was almost normal. She was so lethargic. She became extremely lazy and was laying around the TV. She states its all COVID's fault. She continued to have the magnification of her pre-existing conditions. Patient mentions her weight may be a little more than provided. She has been eating ice cream. Patient confirms at this point, she has recovered to her normal self, eating ice cream watching TV and playing with the puppies. The caller confirms the symptoms started letting up and she has recovered. Patient states she had some ablations on her back and muscle spasms. Her muscle spasms are pretty mellow and she hasn't had any treatments in a year and a half. Outcome of the event pain at the site was recovering and all other events was unknown. Events, redness in arm, arm became very hot and swollen, Chills and Lethargic was reported as related. Follow-up attempts are completed. No further information is expected.

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.

no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100.6 degrees; Headache; her joints swelled; her hands were swollen and tight; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), an unspecified route of administration, administered in Arm Right on 25Feb2021 at 10:30 (Batch/Lot Number: EL9267) as 1st dose, single for covid-19 immunization.Concomitant medication(s) included warfarin sodium (COUMADIN), she takes a 5mg tablet, by mouth, once daily on tuesday, thursday and saturday's. The rest of the days she takes a half of a 5mg tablet confirmed as a 2.5mg dose, by mouth once daily. Indication: She had 2 strokes about 12 years ago, so it keeps her blood regulated, not too thick or too thin, usually it's right on. When probed for any product information, the caller made the comment let her get in some light so she can see better. She confirms the bottle is dispensed in a pinky peach pharmacy vial. She sees an Rx number, Use by date: 26Jan2022 and losartan potassium (COZAAR) taken for blood pressure measurement was the generic for Cozaar, Losartan potassium. She takes a 25mg, tablet, by mouth, once daily for her blood pressure. She verifies this medication is also dispensed in a pharmacy bottle. She mentioned she takes both medications, Coumadin and the Losartan potassium, at night time because it's easier for her to remember. The patient stated she takes a blood pressure medication and a coumadin tablet, She clarifies she has been on these medications for a long time, more than the 2 week time period leading up to receiving the COVID-19 vaccine. She went to bed early on Friday night, 26Feb2021, because she had issues all day long and she forgot to take these medications. She only takes 2 pills at night but she forgot all about them because she had all that stuff going on during the day. o prior vaccinations within 4 weeks. Medical history included cerebrovascular accident (She had 2 strokes about 12 years ago). O 25Feb2021, the patient experienced headache and on 26Feb2021, the patient had asthenia, nausea , pyrexia (temperature was 100.6 degrees), joint swelling and peripheral swelling. It was reported that patient had a really crazy experience, She received her first dose on 25Feb2021 at around 10:30 am afterwards, she had just a regular headache and then the next morning, she tried to get out of bed and had no strength at all in her legs and her arms. She got up out of bed, and her legs would not hold her up so she collapsed on the floor. She mentions her husband is hard of hearing and she was calling for his name to help her. She could not even scoot on the floor, her muscles just did not work at all. The caller states her husband came in and got her up. She went to the bathroom and then for the rest of the day, she stayed in the recliner. Really, the next day, she got back her strength in her shoulders. She clarifies on Saturday, 27Feb2021, she started to get back her strength. She also read in the newspaper to not get a mammogram and a COVID-19 vaccine on the day and she did because they didn't know. She confirms her mammogram was scheduled on 25Feb2021 at 2pm, which was after when she received the COVID-19 vaccine, so her mammogram might not be right. The outcome of events recovered on 27Feb2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

sleepy and wanting to sleep all day; Chills; fever; weak; no appetite; fatigue; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267), via an unspecified route of administration, administered in right arm on 22Feb2021 12:00 (at the age of 79-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, acid reflux and shell fish allergy. The patient's concomitant medications were not reported. On 24Feb2021 at 12:00 chills, fever, no appetite, weak, fatigue, sleepy and wanting to sleep all day. The patient did not receive any treatment for the events. The patient did not have COVID prior vaccination. She was not COVID tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; the tip of the tongue tingling and sore.; the tip of the tongue tingling and sore.; 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 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 27Jan2021 (age at vaccination 79-year-old) as 1st dose, single for covid-19 immunisation. Medical history included allergy related with sinusitis from an unknown date and its ongoing. Concomitant medication included prednisone (PREDNISONE) taken for sinusitis, start and stop date were not reported. The patient reported that she was administered with the first dose of the Pfizer's COVID-19 vaccine on 27Jan2021 (Wednesday) and a few hours after the administration of the vaccine she started feeling the half of her face swollen, thick and numb and the tip of the tongue tingling and sore. The patient reported that she took Prednisone that she had in her house and was previously indicated for the management of an allergy related with sinusitis. The patient reported that she has taken 3 doses of Prednisone, one each 24 hours. Patient asked for information about if her symptoms could be related with the administration of the Pfizer's COVID-19 vaccine. The outcome of the events was reported as unknown. Information on the Batch/Lot number has been requested Follow-up attempts are completed. No further information is expected.

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.

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

This is a spontaneous report from a contactable consumer. A 79-years-old female patient received BNT162B2 (COVID-19 Vaccine, Solution for injection, Lot number: EM9809), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date, 10:00 (at the time of 79-years-old) as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The vaccination facility type was hospital. The patient previously took prolia for her bones and osteoporosis and historical vaccine as bnt162b2 (Lot Number: FF1283) on 25Jan2021 administered via unspecified route, in arm left as first dose for covid-19 immunisation. The patient had first COVID-19 shot this past Monday. Gets the next one in three weeks. The patient was told information by someone and wants to see if that information was correct. The patient would get Prolia shot on a Monday and that Wednesday would get the second COVID-19 Vaccine. The patient gets Prolia every six months for her bones and osteoporosis. The patient had sore upper arm- put ice on - gone melt day. The outcome of event was unknown. No follow-up attempts are possible. No further information is 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.

I had pain on the left side of my head above the ear; I was freezing; had terrible chills; completely exhausted; My stomach hurt; couldn't eat; lost 2 1/2 lbs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6198, Expiration Date: not reported) via an unspecified route of administration in left arm on 05Mar2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunization at pharmacy or Drug Store. Medical history included an unspecified allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included atenolol at a dose of 50 mg twice daily, received in two weeks. 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 received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number PAA156051, Expiration Date: not reported), via an unspecified route of administration, in right arm on 10Feb2021 at a single dose for COVID-19 immunization and experienced very tired for over a day. On 05Mar2021 after the second shot at 18:30 (reported as within 6 hrs), the patient experienced pain on the left side of her head above the ear and was freezing, had terrible chills for 2-3 hrs and had to be covered with several blankets. Patient did warm up, but completely exhausted into Sunday AM (as per report), her stomach was hurt, couldn't eat and patient lost 2 1/2 lbs. Patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. 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.

rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW1051), dose 1 via an unspecified route of administration, administered in Arm on 15May2021 17:30 (at the age of 79years) as 1st dose, single for Covid-19 immunization. Medical history included allergic to lemons, vinegar and white wine, severe reaction to some eye drops 4-5 years ago, vomiting, and diarrhea, rectal bleeding, stomach hurt, and felt like her head was going to explode. The patient's concomitant medications were not reported. The patient reported that she was allergic to lemons, vinegar and white wine and can't take any pills because they make her stomach hurt, she now only takes natural medicines. She had a margarita the week before the vaccine that had some lemon juice in it, and she had rectal bleeding for a few days. She also had a severe reaction to some eye drops 4-5 years ago, she does not know the name of the medication, just that it was a generic. Half an hour after putting it in one eye she said it felt like her head was going to explode and thought she was going to die. The ambulance was called but refused to go in and had her friend take her in. She also experienced vomiting and diarrhea. On 16May2021, the day after the shot (Covid vaccine) she had some rectal bleeding similar to a light period but only for one day. She also had the shot in the left arm but had a sensation/pain in her right arm that went away quickly. The patient was unsure if that happened because she also had 2 margaritas and they made it with lemons which she is allergic to so it might have been that. The patient asked if the vaccine have any vinegar or wine in it. The patient also asked if she could get the second dose of the vaccine if she's had a severe reaction to some eye drops 4-5 years ago. She doesn't remember name of medication but had severe side effects including her head felt like her head was going to explode, vomiting, and diarrhea. The outcome of event rectal bleeding was recovered on 17May2021, while the outcome of event sensation/pain in her right arm was recovered on an unspecified date.