VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1353527
Sex: F
Age:
State: NY

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 05/27/2021
Hospital:

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Symptom List: Dysphagia, Epiglottitis

Symptoms: Arm was swollen and sore; Arm was swollen and sore; Felt under the weather/Did not feel well; Fever; Felt achy; Headache; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 19Apr2021 11:00 (Lot Number: ER8731) as 1st dose, single for covid-19 immunisation. Medical history included Chronic pain, covid-19 from Jan2021, Aneurysm on an artery to her spleen, Multiple back and hip surgeries, 8 Surgeries, Cholesterol, Osteoporosis, Nerve pain, pain, Multiple failed fusions. Concomitant medications included atorvastatin taken for cholesterol; colecalciferol (VITAMIN D) taken for osteoporosis; gabapentin taken for Nerve pain; marijuana taken for pain; calcium. The patient previous received the Trumemba meningococcal vaccine in 2017 for immunization and experienced Seizures; Meningococcal vaccine for immunization and experienced felt under the weather; Pneumococcal vaccine for immunization. She did not feel well after vaccine. She stated her temperature never got above 99 after the first dose. Arm was swollen and sore, felt under the weather, fever, felt achy, headache; they were occurred maybe 20 to 21 hours after vaccine (20Apr2021). Her arm was swollen and sore. She felt under theadds that this was for about 5 days, her temperature was 99 and that was as high as it got. She felt achy and her arm was sore. She had a headache. She added that this went into the second day and she started feeling worse. She had COVID in January, which is probably why she reacted to the first shot. She stated that is what she has heard. She started to feel better until she got the second shot. The causality as yes. She received a chest xray at the end of Feb2021 and she just saw pulmonologist and has to go back for a pulmonary function test. She confirmed this was from before the vaccine and to follow up after she has had Covid. The patient reported the events as serious as medically significant. The outcome of the events was recovering.; Sender's Comments: Based on the available information, a possible contribution of the drug to the events Arm was swollen and sore, Felt under the weather/Did not feel well, Fever, Felt achy and Headache 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.

Other Meds: ATORVASTATIN; VITAMIN D [COLECALCIFEROL]; GABAPENTIN; MARIJUANA; CALCIUM

Current Illness:

ID: 1353528
Sex: F
Age:
State: TN

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/27/2021
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Symptom List: Anxiety, Dyspnoea

Symptoms: Tingling in esophagus and chest.; warm/burning sensation in esophagus; warm/burning sensation in chest.; This is a spontaneous report from a contactable Other Health Professional (patient). This is the 1st of 2 reports for the second dose. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in right arm at age of 34-years, on 11May2021 14:00 (Lot Number: EW0173) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included systemic lupus. And the patient diagnosed with COVID-19 prior to vaccination. She had not tested for COVID-19 since the vaccination. The patient was not pregnant. There were concomitant medications but unspecified (the patient received other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine included the first dose of BNT162B2 that was administered in right arm at age of 34-years, on 22Apr2021 10:15 (Lot Number: ER8730) for covid-19 immunisation. The patient experienced tingling and warm/burning sensation in esophagus and chest on 11May2021. Treatment received included Benadryl for above events. Events outcome was unknown. No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the available information the events Paraesthesia, Oesophageal pain and Chest pain are most likely related to an intercurrent or underlying condition which is not related to the subject drug. 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.

Other Meds:

Current Illness:

ID: 1353529
Sex: F
Age:
State: MS

Vax Date: 04/28/2021
Onset Date: 04/29/2021
Rec V Date: 05/27/2021
Hospital:

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Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: shingles; couldn't sleep; limping; arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip; muscle spasms in her legs; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 28Apr2021 09:00 am (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included ongoing diabetes had for about 6-7 years, ongoing arthritis patient has had for years, started when she was little; family medical history included her dad had rheumatic fever and high blood pressure. Concomitant medication(s) included ongoing metformin taken for diabetes. Patient was borderline due being overweight, if she lost weight it would probably go away. 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. No additional Vaccines Administered on Same Date of the Pfizer Suspect other than the first dose. Prior Vaccinations (within 4 weeks) was none. Patient received first shot on 02Apr2021 8:40 am (Lot: EP7334) in left arm for covid-19 immunisation. It was noted that with the first shot, there was pain and it turned red at the injection site that last 6 days and then that went away. She took Tylenol and hot water in the shower to treat this event. Caller reported that the first dose just swelled her arm. Expiry and NDC are unknown for both shots. The patient experienced arthritis is acting up/ throbbing, aching, tightening, and painful; pain is in one leg in the thigh; leg was swollen and painful and spread up to her hip and muscle spasms in her legs on 29Apr2021, shingles, couldn't sleep and limping on an unspecified date. Caller stated that she had both doses of the vaccine. Agent called back to verify that the doses were the Pfizer covid 19 vaccine and the date of the second dose. Caller stated that her second dose of the Pfizer covid 19 vaccine was on 28Apr2021. Caller reported that after the second dose she was diagnosed with muscle spasms in her legs by one doctor and the ER doctor told her that her arthritis is acting up. Caller stated it felt like she got the second shot in her leg. Caller reported that the pain is in one leg in the thigh on the side that she got the shot on. Caller stated her doctor wants her to go to a neurologist thinking it could be shingles. Caller stated the doctor called a medication in for her for shingles. Caller stated she was using the heating pad and taking flexeril and neurontin. Caller stated she has not gotten any sleep. Caller stated she missed work yesterday and today. Caller stated she has pain in her legs and wanted to know how long that will last. Caller, reporting on the Pfizer COVID shot, and who explained that after getting the shot her leg started acting up the next morning. She explained that it has been throbbing, aching, tightening, and painful. She went to the emergency room and they told her they think is it is her arthritis; that the shot irritated and made it worse. She was given a shot, they thought maybe it startd with a T or like Tylenol, but it was something for pain. They wanted to give pain medication to take with her but she refused; told them she would just do Aleve and Tylenol. She still got no relief so she went to her medical doctor and they told her it was muscle spasms, the nurse said she could feel a knot. They treated it and that didn't help. Finally her doctor gave her Neurontin yesterday. She has been taking that since 12 noon yesterday through today and she will say it is getting better explaining that she hasn't able sleep but now can get cat naps. Caller reported she is a caretaker, like a medical assistant. She had been missing days from work because of this. The doctor was going to try and find her a specialist, a neurologist. When asked Primary / Prescribing Healthcare caller stated she saw in the emergency room and as a medical doctor because her normal primary care doctor retired. She didn't have contact details for either of these doctors. The shot was given by some people. It was clarified that this was after the second shot. The second shot was on 28Apr2021. She explained she was limping cause it hurts so bad, ever since she got the second shot. Neurontin was started yesterday and since starting it she is better, she was able to sleep some where she couldn't sleep before. Caller reports the product is in a pharmacy bottle with the NDC: 65862-0523-05. Name and NDC captured as provided by the caller. When asked about the products taken that didn't offer relief, everything prior to the Neurontin the caller only had the Flexeril bottle handy. She didn't have the name of the medication, the shot given in the emergency room and didn't want and pain medication from there because she didn't want to get hooked on pain pills. She also took Aleve and Tylenol. Gave her Flexeril, on 06May2021 it was filled. It is in a pharmacy bottle, no manufacturer, Lot or Expiry, NDC: 48547-0400. There are little number and hard to read but confirmed it is in pharmacy bottle. Treatment: she did have blood work but was told her cholesterol and everything was fine, everything was good. AE(s) required a visit to emergency room on 02May2021. And resulted in physician office, doctor on 10May2021. AE(s) following prior vaccinations was none. Caller received her second dose of the covid-19 vaccine and the next day woke up and her leg was swollen and painful and spread up to her hip. Caller went to the emergency room and was given medication which she states helps a little. Investigation included blood test with unknown result on unspecified date. The event outcome for all events was unknown.

Other Meds: METFORMIN

Current Illness: Arthritis (she has had for years, started when she was little); Diabetes (had for about 6-7 years)

ID: 1353530
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
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Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Very unusually heavy period; painful lymph nodes in armpit and under arm of right side where shot was administered; painful lymph nodes in armpit and under arm of right side where shot was administered; This is a spontaneous report from a non-contactable other hcp (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation. Pregnant at the time of vaccination was No. No known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was none. The patient's concomitant medications were not reported. After 1st shot, the patient experienced painful lymph nodes in armpit and under arm of right side where shot was administered. This pain started 5 days post vaccine and lasted 3 weeks! The patient also experienced very unusually heavy period as well. The adverse events resulted Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Advil, counseling. The outcome of events "painful lymph nodes in armpit and under arm of right side where shot was administered" was not recovered, the other event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353531
Sex: F
Age:
State: CA

Vax Date: 05/07/2021
Onset Date: 05/08/2021
Rec V Date: 05/27/2021
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Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: feeling tired/excessively tired; left arm was shaking a lot/left arm was shaky like a heartbeat; knocked her out; sleepy; her left arm was sore/still had some left arm pain; excessive, bad diarrhea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female consumer patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170) via an unspecified route of administration, in arm left, on 07May2021 15:00 (at the age of 48-year-old) as single dose for COVID-19 immunization. Medical history included ongoing migraine; patient had another allergic reaction but she wasn't sure what it was from. Her forehead got swollen and she had hives all over her body. It wasn't from medication. Her friend had traveled overseas and brought back Arabian candy and she ate a piece of the candy. Within 20 minutes of eating the candy her eyes started to get itchy and the hives started. Concomitant medication included migraine medicine when she needed but she did not get a migraine with the Covid 19 vaccines and patient declined to provide the name of the medication. The patient previously had allergy to cefalexin (KEFLEX), she got really bad diarrhea when she took cefalexin (happened about 3 or 4 years ago). The patient previous receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7534), in arm left, on 16Apr2021 14:00 (at the age of 48-year-old) as single dose for COVID-19 immunization, then it was the next day she noticed, on 17Apr2021, her tiredness and her arm soreness, the arm soreness only lasted about 2 days, and the tiredness only lasted for a day. Patient received her second vaccine on 07May2021. She felt ok the day she got the vaccine but the following day (08May2021), she was sleepy and her left arm was sore and she thought that was normal. Then Saturday night, 08May2021, she got really excessive, bad diarrhea. She thought maybe that's part of the vaccine maybe it wasn't. The diarrhea continued into Sunday morning, 09May2021 and she called the appointment center for her primary care doctor. Her arm was sore, she was still feeling tired and her left arm was shaking a lot. She asked the appointment center to notify her doctor. She was supposed to work Sunday night, 09May2021, and she needed a work note. She had been leaving messages at her doctor's office and no one was returning her calls. She was wanting to know if someone here at Pfizer could help her. She received the second Covid 19 vaccine on 07May2021 and the second Covid-19 vaccine hit her more and knocked her out the following day (08May2021). She was really excessively tired and her left arm was really sore. When she got up she was resting her arm and her left arm was shaky like a heartbeat. She still had some left arm pain but it's improved. Her left arm shaking lasted for about a day and a half. No AE require a visit to emergency room and physician office. No prior vaccinations (within 4 weeks). The outcome of the event "her left arm was sore/still had some left arm pain" was recovering, of other events was unknown.

Other Meds:

Current Illness: Migraine

ID: 1353532
Sex: F
Age:
State: NM

Vax Date: 04/08/2021
Onset Date:
Rec V Date: 05/27/2021
Hospital:

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Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: mild sepsis; It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely; swelling in her brain; thyroid felt swollen; gained 10 pounds overnight of fluid.; lymph nodes got huge; headache; Her tongue feels swollen; Pain in all her organs; Her arm was so sore/ sore left arm; so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks; gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too; affected her brain and speech/difficulty pronouncing words; Affected her brain and speech; allergic reaction; experienced a personality change; feeling puffy; felt like she had a tourniquet around her neck/Her organs felt swollen; cognitive issues; Throat swelling; pain in the part of her liver; couldn't remember where she put things; muscles did not work right; bladder infection; She was so cranky; Intense stomach ache; This is a spontaneous report received from a contactable consumer (patient reported for herself) from a Pfizer- sponsored program. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 08Apr2021 at the age of 64 years old (Lot Number: ER8732) as 2nd dose, single for covid-19 immunisation. Medical history included Cancer: Gerson Therapy; Autoimmune disorder; allergies ongoing; Parvovirus B19: exposed to Parvo B virus, it's called the 5th Disease, she had a rare reaction to it and it gave her Rheumatoid Arthritis ongoing, Fibromyalgia ongoing, Multiple Sclerosis ongoing and Behcet's like overnight; allergies to food (she got swelling, intense depression, suicidal tendencies, and a fight or flight response), drugs (Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet), air, dirt, trees, and bugs. It runs in her family; inflammation. Concomitant medications included ongoing fish oil (FISH OIL); ongoing curcuma longa (TURMERIC [CURCUMA LONGA]); several other supplements; ongoing Benadryl for allergies when need. The patient previously received the first dose of BNT162B2 on 19Mar2021 09:00 at the age of 64 years old (lot number: EN6207) in Left arm for Covid-19 immunization and experienced allergic reaction, throat itchy, numbness on her left side/ Legs were like spaghetti and she felt like the scarecrow in Wizard of Oz, lungs itchy and inflamed, coughing, barking asthma cough, Speech slurred, Oxygen level felt like it was in the 80s (80%), muscles not responding, Crooked walk, died 6 times and experienced an out of body experience. Vaccination Facility Type was Hospital. Vaccine was not Administered at any Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Caller wanted to know about the need for booster dose; Was it going to be like the first or second dose of the vaccine. Caller wanted to know the ingredient of the Pfizer covid vaccine. She said she took both of the doses and had a bad reactions from it. Caller stated she had a lot of issues with the first dose but not as bad as second dose. The second dose almost killed her and affected her brain and speech. She had the Pfizer Covid-19 vaccine, and experienced a bad reaction after both doses. Caller asking what was in the vaccine that could cause her bad reaction. She never had a reaction to any vaccine. She had allergies and autoimmune disorder. Her arm was so sore/ sore left arm the first time. It was difficult to get in and out of car for 3 weeks, but she recovered completely. She helps the handicap people, so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks, but she recovered completely. Caller added she needed to decipher what was written on the vaccination card. She wished they would write better. She used her glasses. Caller took no pharmaceuticals, just Benadryl for allergies when need. The Hospital where she received her vaccine was used and created by another facility, but not a an offsite facility. But for them to use also. Caller added she was cured of everything she had from the Therapy. After the second dose: She started same day as vaccine on 08Apr2021. She did her protocol that time, and as far as breathing and that, it was not like the first dose, but towards the evening she had an auto immune response that lasted for 3 weeks. She felt like she experienced mild sepsis and gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too. When this happened it started with feeling puffy that evening and lasted for 3 weeks. Caller added if she was exposed to a virus, or had an allergic reaction this happens. Caller added even her lymph nodes got huge and thyroid felt swollen, felt like she had a tourniquet around her neck. That lasted for 3 weeks. It was bad the 1st week. That caused a severe headache that started on the 3rd day and lasted 4 days. It was really bad on the 1st day and she wanted to go to the Emergency Room. She took Benadryl and Ibuprofen, and a Doctor told her she shouldn't take Ibuprofen because of Covid. She was allergic to Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet, Everything except Ibuprofen. Caller did not have the bottle to provide details. She usually put Ibuprofen in her Benadryl bottle for her inflammation. That was the only thing that she took. She took Turmeric and fish oil and several other supplements. Her headache peaked on the 4th day, and she took the Ibuprofen and was better the next day. Throat swelling started on the 5th day and lasted and was still causing her difficulty pronouncing words. Her tongue felt swollen. Her cognitive issues started the 4th day of her headache and was intense. It continued, but was much, much better. She did her normal protocol, and had gotten by, but it was not normal. Her organs felt swollen and the doctor did a test. It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely. The muscles did not work right and she got an bladder infection and received antibiotics, about 2 weeks after the injection, because her bladder wasn't working right. Urine test: infection. Intense stomach ache: started at the time her headache stated after 3 days along with the headache and ended with her doing the Therapy. They lasted for 4 weeks. Pain in all her organs: started the 3rd day after the second dose. The pain started, she felt swelling and it lasted for 3 weeks, actually, for 4 weeks, the pain in the part of her liver by her stomach. She experienced a personality change and she wouldn't have the vaccine again. She couldn't remember where she put things, started on the 7th day after her second dose and lasted until the Therapy made her feel better. Finally, after 4 weeks, she recovered completely and was pretty much back normal now. Caller added she was a happy person and was with her Cancer. People asked how she did it. But with this experience she literally wanted to hurt someone or kill herself, and no it was not normal. She was so cranky. She was sure it was the swelling in her brain. With her food allergies she got swelling, intense depression, suicidal tendencies, and a fight or flight response. She wanted to leave her life, it was scary. Caller added she did not feel like this now. For the Vaccine Indication: Caller added that people that need it most, didn't want it. Because of her autoimmune disorder, she was a long huller and she had died 6 times, so she was willing to try it and take it and deal with the side effects. She was hoping it would not cause any. Her boyfriend died at Christmas. After 24 hours he was dead. He had a mild sepsis from a virus. He has Autoimmune disease. If she got Covid, she didn't want to end up like him and see her arms and legs amputated. Caller asked if anyone else had reported symptoms she had experienced. Caller asked to clarify details of her symptoms of suicide and killing and hurting others. Caller denied she was experiencing this at time of cal

Other Meds: FISH OIL; TURMERIC [CURCUMA LONGA]; BENADRYL

Current Illness: Allergy; Fibromyalgia; Multiple sclerosis; Rheumatoid arthritis

ID: 1353533
Sex: F
Age:
State: UT

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 05/27/2021
Hospital:

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Symptom List: Pyrexia, White blood cell count decreased

Symptoms: 1-20 minute bouts where tics appear "seizure-like," repetitive; many persistent involuntary tics including coprolalia and violent motor tics; had one minor chronic tic before vaccination/many persistent involuntary tics including coprolalia and violent motor tics/Noticed increase in severity and frequency; many persistent involuntary tics including coprolalia and violent motor tics; Tics often include hitting oneself and banging head against things/violent; significant distress; persistent headache; chronic fatigue/sleepiness; lightheadedness; decrease in appetite; feeling of pressure in certain locations inside the head; intermittent earaches in both ears; persistent feeling of brain being "on fire," and "like a parasite has invaded the brain."; chronic fatigue/sleepiness; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as first single dose and on 16Apr2021 as second single dose (Batch/Lot number was not reported) for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included asthma, allergy to nuts, penicillin and ongoing chronic tic. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Concomitant medications included duloxetine; atomoxetine; hydroxyzine; loratadine. The patient previously took amoxicillin and experienced allergies. The patient experienced neurological symptoms included many persistent involuntary tics including coprolalia and violent motor tics. Smaller tics can be suppressed for minimal amounts of time before uncontrolled, violent/loud tics occur in rapid succession. Tics often include hitting oneself and banging head against things. The patient had one minor chronic tic before vaccination. Initial onset occurred nine days after vaccination from 04Apr2021. Noticed increase in severity and frequency approximately nine days after second dose of Pfizer vaccine. Symptoms cause significant distress. Additional symptoms included: persistent headache (from date of first vaccine to present); chronic fatigue/sleepiness; light-headedness; decrease in appetite; feeling of pressure in certain locations inside the head not related to the skull or skin; intermittent earaches in both ears; persistent feeling of brain being "on fire" and "like a parasite had invaded the brain, start date was 26Mar2021; and "1- 20 minute bouts where tics appear "seizure-like," repetitive, violent, and controlling". The patient underwent lab tests and procedures which included Spit test: negative (other) on 26Mar2021 and Apr2021, Covid test: negative on 26Mar2021 and on Apr2021. The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received; the patient was not recovered. Information on lot/batch number has been request.

Other Meds: DULOXETINE; ATOMOXETINE; HYDROXYZINE; LORTADINE

Current Illness: Tic

ID: 1353534
Sex: F
Age:
State: OK

Vax Date: 04/19/2021
Onset Date: 05/08/2021
Rec V Date: 05/27/2021
Hospital:

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Symptom List: Pharyngeal swelling

Symptoms: Throat was super tight; Tongue swelled; It felt weird. Her oxygen was fine in the ER, but it felt almost heavy like there was something heavy on her.; Super exhausted; She took a nap and when she woke up her neck was stiff.; Dizzy; Lips swelled; she experienced some kind of allergic reaction; Throat was kind of itchy; When she had the lip swelling, it was like little blisters on her lips mainly on her top lip; Her lips are a little sore still in that spot with the blister, and it is a tiny bit swollen; is like a dry patch of skin, but kind of like a blister; This is a spontaneous report received from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE 2), dose 1 via an unspecified route of administration, administered in right arm on 19Apr2021 (Lot Number: EW0162) at the age of 31 years, as a single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism, allergic reaction to bee sting. Concomitant medications taken within two weeks of vaccination included levothyroxine/liothyronine (NP THYROID) taken for hypothyroidism. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took levothyroxine for hypothyroidism. On 08May2021 the patient experienced lips swelled, throat was kind of itchy. When she had the lip swelling, it was like little blisters on her lips mainly on her top lip, is like a dry patch of skin, but kind of like a blister. Her lips are a little sore still in that spot with the blister, and it is a tiny bit swollen. On 09May2021 the patients throat was super tight, her tongue swelled, it felt weird. Her oxygen was fine in the emergency room (ER), but it felt almost heavy like there was something heavy on her. Patient was super exhausted, she took a nap and when she woke up her neck was stiff, she was also dizzy. The patient visited the emergency room due to the events. The patient received treatment for the events. The clinical course was reported as follows: After her first dose, about 19 days later she experienced some kind of allergic reaction. Her lips swelled, her throat was super tight, and her tongue swelled. She ended up in the ER, and they put her on steroids. She was supposed to get her second shot "today", but now she will get it in 2 weeks. She needed to know if this was a common reaction. The reaction happened on Saturday 08May2021 the day before Mother's Day. She took Benadryl a couple of times on 09May2021. Around noon 09May2021 she went to the ER. She has no NDC, lot, or expiration date available for the Benadryl, it is at her house and she is currently at work. It was Waldryl, the store version the of Benadryl. When she had the lip swelling, it was like little blisters on her lips mainly on her top lip. The next day her bottom lip was swollen. Her tongue got big and her throat was super tight. It felt weird. Her oxygen was fine in the ER, but it felt almost heavy like there was something heavy on her. That's why she decided to go to the ER. She was already on Waldryl for a day and a half, and her lip had swelled out more and her tongue had swelled. She called urgent care, and they didn't have an appointment until 16:00 that day. They told her to go to the ER. She had taken more Waldryl before she went to the ER so her tongue was not as swollen but her lips were pretty swollen. She has a little bit of swelling on the left, kind of like a dried blister on her top lip. It is like a dry patch of skin, but kind of like a blister. It is weird. As far as her lips there is not near as much swelling now. They gave her a shot of steroids in the ER and then put her on steroids. It is Prednisone, 20mg for 3 days. NDC: #. She does not see an expiration date or a lot number on the bottle. Her throat was kind of itchy but it wasn't tight on Saturday. She tried to go to an event on Sunday and left and came home by 11:30. She thinks the Waldryl was getting to her. She was super exhausted and dizzy. She took a nap and when she woke up her neck was stiff. Her itchy throat has gone away. It was probably yesterday when she didn't notice it anymore. She hasn't noticed it yesterday or today. She doesn't know what steroid shot they gave her or if it was Prednisone or not. They just said it was a steroid shot. She doesn't feel any throat discomfort or anything anymore. She has no more discomfort in her throat or her neck. Her lips are a little sore still in that spot with the blister, and it is a tiny bit swollen. It is her left upper lift. She has braces so when her lip swelled it could have irritated her lip. The tightness in her throat went away Sunday night or Monday morning. She doesn't really remember when it went away. She remembers not really noticing it yesterday. When she woke up from her nap her tongue was swollen and her throat was tight. She went to the ER. The swelling in her tongue and her throat went down. She doesn't remember when it went away. She hasn't been feeling good and has been out of it. She takes her last steroid tomorrow, and they wanted her to wait 2 weeks after that to get the second shot. She has to call and schedule because they only schedule a week out. She has to call back in a week or so and schedule it. The heavy feeling is gone. Everything went away at about the same time. She doesn't know when it went away. She has not noticed it yesterday or today. The steroid may have helped. She is still exhausted and kind of out of it. It could be from the steroid she is sure. She is not used to medications like that. Feeling out of it and the exhaustion still feel the same since they started. She is still dizzy. It is a little better, it is not as bad. She doesn't really know when her stiff neck went away. She has been out of it. She doesn't remember when it stopped or anything. She hasn't noticed it today. Investigations: They didn't do any bloodwork or x-rays or anything. They just gave her a steroid shot. She thought she was having a reaction to a candle. She had a candle that she burned several times in her house and never had a reaction to, but she assumed it was a reaction to that. It was the only thing around that was different, she blew out the candle. She thought it was a reaction to the candle and they weren't positive, so they gave her the steroid. The clinical outcome of throat was kind of itchy, throat was super tight, and neck was stiff, was recovered. The clinical outcome of the events was lips swelled, and dizzy was recovering. The clinical outcome of when she had the lip swelling, it was like little blisters on her lips mainly on her top lip, and super exhausted, was not revered. The clinical outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: NP THYROID

Current Illness: Hypothyroidism

ID: 1353535
Sex: F
Age:
State: MD

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 05/27/2021
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Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Vaginal bleeding in a menopausal woman with blood clots.; Vaginal bleeding in a menopausal woman with blood clots.; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; Also slept for 13 hours the day following the shot and had a continual headache with nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06May2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 56-year-old. Lot number EW0183. Medical history included menopausal woman. Concomitant medications were none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Apr2021 at 10:30, Lot number EW0164, dose number: 1, in left arm. On 06May2021, the patient also slept for 13 hours the day following the shot and had a continual headache with nausea. On 10May2021, the patient experienced vaginal bleeding in a menopausal woman with blood clots. It was very concerning; the patient was going to Ob/Gyn soon. The patient underwent ultrasound and biopsy. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Follow up needed, further information has been requested

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Current Illness:

ID: 1353536
Sex: M
Age:
State: AR

Vax Date: 05/07/2021
Onset Date: 05/01/2021
Rec V Date: 05/27/2021
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Symptom List: Diarrhoea, Nasal congestion

Symptoms: 90% of his body has a rash on it; breaking out in rash; it's over like 45% of his body, his toes and his legs; that's very itchy; rash all over his body; Hives covering over 50% of my body that randomly come and go; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) and a contactable consumer (patient) reported that a 37-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07May2021 (Batch/Lot Number: EW0168) as single dose for covid-19 immunization. Medical history included adult-onset diabetes developed just a few years ago that was controlled with a pill. He was not a insulin diabetic patient and unknown renal disorder Concomitant medication included metformin taken for diabetes; lisinopril taken for diabetes as to protect kidneys. He had his first vaccine on Friday evening of this last week and by Monday he was in the ER, 90% of his body has a rash on it, and it looked out as he poured some hot water on him, it's over like 45% of his body, his toes and his legs. He went to an urgent care, walk-in and that's very itchy and so they sent him over to look in hospital and they put him on steroids and Benadryl and anti-itchy cream (Treatment), he was missing work because he had got this rash all over his body. The event was also reported as hives covering over 50% of body that randomly come and go. Events were started from May2021. The patient underwent lab tests and procedures which included blood sugar monitor continuously which was tested on machine. The outcome of the events was unknown.

Other Meds: METFORMIN; LISINOPRIL

Current Illness:

ID: 1353537
Sex: F
Age:
State: IN

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 05/27/2021
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Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: First dose: just some pain; First dose: fatigue; This is a spontaneous report from a contactable nurse (the patient herself). A 39-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6199, Exp 30Jun2021) intramuscular in left arm on 04Mar2021 12:50 (at the age of 39-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes flu shot in Feb2021 (exact date unspecified). Other relevant medical history was not reported. Concomitant medications included vitamins (unspecified) taken for years. The patient experienced some fatigue from 04Mar2021 and just some pain on an unspecified date. It was further specified that she experienced fatigue the same day/night she got the first vaccine. She was just really, really exhausted and mentioned she just had some pain. She confirmed she recovered completely from the fatigue and pain. No seriousness was reported for the events. The events resolved on an unspecified date and both were considered related to the vaccine. No follow-up attempts are needed. No further information is expected.

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ID: 1353538
Sex: F
Age:
State: DC

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/27/2021
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Symptom List: Rash, Urticaria

Symptoms: felt like Bell's palsy like a paralysis in my face; Swelling in face; This is a spontaneous report from a contactable consumer (the patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168) via an unspecified route of administration, administered in Arm Right on 11May2021 10:00 at age of 63-year-old at single dose for COVID-19 immunisation. Medical history included Bell's palsy (reported as "I had in my life I had Bell's palsy"). No other medical history. There were no concomitant medications. On 11May2021, the patient had like some swelling in her face and she was still having it. She had in her life she had Bell's palsy and that was what it felt like, it felt like paralysis in her face (also reported as "felt like bell's palsy like a paralysis in my face") and she wondered if she had to go to the emergency room. No treatment received for the events. No investigation assessment. The outcome of event "swelling in face" was not recovered, the outcome of event "felt like bell's palsy like a paralysis in my face" was unknown.

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Current Illness:

ID: 1353539
Sex: F
Age:
State: TX

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 05/27/2021
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Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: severe brain fog; intense cramping; she got red really fast and almost a strange itching inside her body; felt she had Covid; Mild diarrhea; body aches; fever; Headaches; This is a spontaneous report received via medical information from a contactable consumer (patient). A 61-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (Batch/Lot Number: ER8737) at the age of 61-year-old, as single dose for covid-19 immunisation. Medical history included ongoing thyroid disorder has had for years, ongoing hypertension started about 8 years ago, ongoing immune system disorder ( Her spleen has been removed, and she is immune compromised). The patient was immune compromised and has no spleen and she had Covid and has Covid long haulers. The patient's concomitant medications were not reported. The patient received the second dose of Covid vaccine received on 20Apr2021, at 09:00, right arm injection. After the 1st dose of Covid vaccine she felt she had Covid. Mild Covid again, for about 4 days. She experienced fever, body aches, and some mild diarrhea the same day of vaccination. The patient did not confirm if she just felt like she had Covid again or tested positive for COVID-19 after first dose. She had diarrhea until she received the second dose of the vaccine then got ulcers in her mouth, body swelling, and had headaches with both doses. The patient stated that fever started after the 1st shot, within 4 hours, It was fast. She was sitting with a friend and she got red really fast and almost a strange itching inside her body. She told her friend she needed to lie down. Her friend told her she didn't look good. It happened so quick. It started on 30Mar2021 and she recovered completely. Body aches started on 30Mar2021 but not until the evening and lasted until it ended with the fever. She recovered completely. She was a long hauler and this was a whole different ball of wax. Patientdidn't feel it when she had Covid. Mild diarrhea started in the middle of the night on 30Mar2021 and she doesn't think it ever ended. It spun around, It was now constant diarrhea and continues from the first dose. It waswater and with intense cramping and is constant. She is on the BRAT diet. It won't hold so she is living on Gatorade and white rice. Headache started with the first dose. The headache came in after the first dose and was very mild. It left just like the symptoms did. The headache started when the fever started and it started quickly and it hasn't left. Patient also complained severe brain fog. The patient experienced felt she had covid (suspected covid-19) on 30Mar2021 with outcome of unknown, mild diarrhea on 30Mar2021 with outcome of unknown , body aches on 30Mar2021 with outcome of recovered , fever (non-serious) on 30Mar2021 with outcome of unknown , headaches on an unspecified date with outcome of unknown, severe brain fog (feeling abnormal) on an unspecified date with outcome of not recovered , pruritus on 30Mar2021 with outcome of recovered , intense cramping on an unspecified date with outcome of unknown.

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Current Illness: Blood pressure high (started about 8 years ago); Immune system disorder (Her spleen has been removed, and she is immune compromised. No further details provided by caller.); Thyroid disorder (has had for years)

ID: 1353540
Sex: U
Age:
State: MN

Vax Date: 04/12/2021
Onset Date: 05/03/2021
Rec V Date: 05/27/2021
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Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: can't even sleep at night.; couldn't diagnose that the part was either dermatitis or shingles; couldn't diagnose that the part was either dermatitis or shingles; This is a spontaneous report from a contactable consumer (patient). A 48-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, via an unspecified route of administration, administrated in arm right on 12Apr2021 (Batch/Lot Number: EW0150) at the age of 48-years-old as single dose for covid-19 immunisation. Medical history included Hypothyroid. Concomitant medications included liothyronine sodium (CYTOMEL) taken for Hypothyroid from 2017 to an unspecified stop date; levothyroxine sodium (SYNTHROID) taken for Hypothyroid from 2017 to an unspecified stop date; venlafaxine hydrochloride (EFFEXOR) taken for Hypothyroid from 2017 to an unspecified stop date. The patient previously received the first dose of BNT162B2 ('EW/N 6207', is it E, don't know is it EN or EW) on 20Mar2021 at the age of 48-years-old for covid-19 immunization. Patient had the Covid vaccine on an April 12 and it went three week now and patient just recently started having a reaction and patient went to see my doctor yesterday and they couldn't diagnose that the part was either dermatitis or shingles. The patient had second dose of vaccine on April 12. Last Monday (03May2021), patient started having itchiness on only the right side of upper portion of face. Patient had shot in right arm, patient lymph nodes were enlarged. That's the one thing then second thing was last Monday, patient started this, this itchiness started and right side of nose and over to cheek up to a kind of outside corner of eye and next the itchiness was gone away for that well patient guess eye was still there for cheek portion is done. Now it's from that outside corner of forehead and on scalp and it was so itchy, it's like chickenpox patient mean like patient had to take two Benadryl every four hours to keep itching it's kind of that pain but patient do have some red spots on head but again they couldn't diagnose as shingles, they couldn't diagnose it really yesterday. The only thing patient had done making patient aware, patient could potentially have recurrence of shingles and patient did have that two years ago. Patient was loosing mind, it's so itchy. patient mean patient could even sleep at night. Patient had to put cold tampons on head and it just on right side, it is never move to left side only to right side which was so weird. The patient was just having a really bad reaction, first it was itchiness was on, it went from like the center of patient's forehead nose all the way over to right side. Patient had shot on the right side and it was on nose and cheeks to begin with, just itchy not a rash and now it's moved to forehead and in to patient's scalp and on patient scalp there are little red dots. Patient went on to primary doctor and they can't diagnose it because it didn't look like shingles, the patient was about out of my mind itchy, so bad. The patient was having to take 2 Benadryl's every 4 hours to kind of keep it at bay or a cold compress. Other treatment for the events included Valacyclovir and prednisolone. Valacyclovir 1mg, three times a day for 7 days. Prednisolone 20mg, 3 tablets for first 3 days then 2 tablets for three days, one tablet for three days, half tablet for three days and I am on my second day of that. Tablet, orally. The patient underwent lab tests and procedures which included computerised tomogram (CT) scan: negative on an unknown date, magnetic resonance imaging (MRI): negative on an unknown date. The outcome of the events was unknown.

Other Meds: CYTOMEL; SYNTHROID; EFFEXOR

Current Illness:

ID: 1353541
Sex: M
Age:
State: NM

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
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Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: couple pains in the left chest area behind the breast; his stomach was feeling sick and his body was hurting; His whole torso hurt and his stomach; The pain now is not like where it hit him with the back. He has back pain every day but more than he used to. the back pain was just the one day.; his arm was a little sore; He was lethargic and had no energy; He was lethargic and had no energy/weakness; diarrhea; Responding strangely to people/but is still there and is so weird; dizzy; getting really irritable; Slept all day for several days; Arm started hurting where he got the shot; been sick pretty much everyday; not feeling good in his stomach; he passed out for 2 days; breathing hard; wouldn't feel good; a fast heartbeat; chills; nausea; headache; he gets really short and impatient; forget a little something still, but just once in a while; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:30 (Lot Number: WR8783) as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included ongoing sciatica, back problems, stomach was sensitive, lower back pain, bone spurs down his spine. He was a medical marijuana patient, he had Shigella when he was a baby. He was 2 or 3 and almost died but came out of it; His mom had cancer from smoking, he got the worse flu sick of his life. His stomach was sensitive all of the time. If he was too happy or too nervous get upset. He can eat spicy food, not super hot, but he can eat anything and it doesn't go crazy. He has a little bit of a sensitive stomach sometimes. He can't take a multivitamin or supplements because he would get sick to his stomach, this was before the vaccine. He was getting that same sick feeling now that he would get if he was taking a multivitamin. He had his blood drawn a week before he had the vaccine to check his kidneys with the pills he is on. It was perfect and normal, and he has had nothing since then. In his 20s he had the flu vaccine, and he had never had the flu in his life. That year he got the worse flu sick of his life. He never got the flu vaccine or other vaccines after that. That was probably between 1987 to 1990. His folks passed away. He had been in the hospital when he was little.Concomitant medications included acetaminophen taken for back pain, sciatica from an unspecified start date and ongoing; nabumetone taken for sciatica, back pain from an unspecified start date and ongoing. The patient experienced he passed out for 2 days (medically significant) on Apr2021 with outcome of unknown, been sick pretty much everyday (non-serious) on 07Apr2021 22:00 with outcome of not recovered, not feeling good in his stomach (non-serious) on 07Apr2021 with outcome of not recovered, slept all day for several days (non-serious) on 08Apr2021 with outcome of unknown, responding strangely to people/but is still there and is so weird (non-serious) on 12Apr2021 with outcome of not recovered, his stomach was feeling sick and his body was hurting (non-serious) on 15Apr2021 with outcome of not recovered, his whole torso hurt and his stomach (non-serious) on 15Apr2021 with outcome of unknown, diarrhea (non-serious) on 12Apr2021 with outcome of not recovered, getting really irritable (non-serious) on 09Apr2021 with outcome of not recovered, he had no energy (non-serious) on 12Apr2021 with outcome of recovering, he was lethargic/weakness (asthenia) (non-serious) on 12Apr2021 with outcome of not recovered, dizzy (non-serious) on 10Apr2021 with outcome of not recovered, couple pains in the left chest area behind the breast (non-serious) on 17Apr2021 with outcome of not recovered, breathing hard (non-serious) on Apr2021 with outcome of not recovered, wouldn't feel good (non-serious) on Apr2021 with outcome of not recovered, arm started hurting where he got the shot (non-serious) on 08Apr2021 with outcome of not recovered, headache (non-serious) on Apr2021 with outcome of unknown, his arm was a little sore (non-serious) on 13Apr2021 with outcome of unknown, a fast heartbeat (non-serious) on Apr2021 with outcome of unknown, chills (non-serious) on Apr2021 with outcome of unknown. Patient got sick around 10:00 at night. He was supposed to get his second dose but he was so sick and they said lets give it a week. Then he talked to his doctor and he said to wait 2-3 weeks to make sure he is back to normal. So he is scheduled for the second dose next week at 6 weeks. He asked if it was okay that the shot was given in the sunlight. He stated that he saw that it was in an ice chest but the person had to walk it over to him 20 feet and deal with his sleeve for a second or two so it was in the sun. He said all that walking it was 100% in the sun and he has read that it should not be in the sun. He asked if this could have caused bacteria and caused his symptoms. He stated his doctor was only concerned about giving him antibiotics for bacteria if it was in the sun and if that was a problem. He just read from CDC, once mixed the vaccine can be left at room temp for 6 hours and mixed vaccine does not need to be protected from light. So it sounds like his first shot was good. He had gotten the shot at about 1430 in the afternoon. He was like he is going to get the shot and everything will be great. He didn't think there would be an effect. Then strangely enough at about 2200 he was about to eat dinner and he got to not feeling good in his stomach. It had been close to 8 hours. The next day he slept all day, got up and had coffee, and Saturday he was in the chair in the living room. He is never in the chair during the day because he works. He slept all day and all night and the next day. He was responding strangely to people, and he was in and out of it. He had the shot on Wednesday and then his stomach was feeling sick and his body was hurting. He has back pain anyway and bone spurs on his spine. He was telling his wife whatever pain he is normally in was enhanced. His whole torso hurt and his stomach. The following Monday he had diarrhea. Then he started getting really irritable and didn't want to talk and was impatient. He was lethargic and had no energy. That was the second week. By the end of the second week he had a couple pains in the left chest area behind the breast. He thought it was a heart attack, then thought it was just pain not a heart attack. Every time he wouldn't feel good he would start breathing hard. Once in a while he gets pain through his chest area. His stomach would start and he would breath hard every time he didn't feel good. The third week he was supposed to get the second shot. He called the department of health for New Mexico. The nurse called back and said not to do the shot that week but to wait a week. He rescheduled for a week later. By the third week he was still not feeling good and called the doctor. He asked about the pain in his chest 3 times and he said it seemed to be okay. His arm started hurting where he got the shot in the second week. He still had no energy and he told the doctor this. Patient started taking 2 extra Tylenol during the day for pain. Lately he has been good until one little thing and then all of a sudden his stomach is hurting and he is holding his stomach. He was good today, all he did was eat a cookie and he didn't get sick. He was worse for a little while in the first or second week, he was really bad. It came and went over the next 2 weeks and now it is coming and going less frequently. He slept through 2 or 3 days. Thursday, Friday, and then Saturday he was in and out. He woke up to take the garbage out on Friday then saw he already took it out and forgot it was out there. And it was Saturday. He was kind of out of it. When he would respond strangely he would respond with a question he just asked and someone answered. It is like brain fog or like he is on something. It started after the weekend, more on 12Apr2021. Once in a while he will forget a little something still, but just once in a while. He would walk and hold his rib cage with both arm

Other Meds: ACETAMINOPHEN; NABUMETONE

Current Illness: Sciatica

ID: 1353542
Sex: F
Age:
State: FL

Vax Date: 04/27/2021
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Rec V Date: 05/27/2021
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Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: lot of pain in the vaccinated arm/ 2 of her fingers feel pain; 2 of her fingers feel pain, and numb; pain is all the way in the back and it's getting worse; This is a spontaneous report from a contactable consumer reporting for her wife. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient's concomitant medications were not reported. The patient experienced lot of pain in the vaccinated arm/ 2 of her fingers feel pain, 2 of her fingers feel numb, pain is all the way in the back and it's getting worse all on an unspecified date with outcome of unknown. She has been taking some medication ibuprofen 800mg 3 times a day but that's not helping The reporter is wondering if the patient should be taken to the ER or wait 3 days to see the doctor This has been going on for 2 weeks already. The reporter doesn't know if this is the side effect from the vaccine. If they put it in the wrong position or in the nerve. She's not getting better and she's getting worse and it's past 7 days. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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ID: 1353543
Sex: F
Age:
State: HI

Vax Date: 02/27/2021
Onset Date: 02/28/2021
Rec V Date: 05/27/2021
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Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Pain; Headache; Severe Myalgia to legs nest day after 2nd dose then to shoulders, arms; This is a spontaneous report from a contactable physician. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) via intramuscular on 27Feb2021 (at the age of 37-year-old) as single dose for COVID-19 immunisation. Medical history included right blepharospasm, history of angioedema, vulvodynia, and endometriosis. Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM9810) intramuscularly on 06Feb2021 (at the age of 37-year-old) as single dose for COVID-19 immunisation. The patient experienced pain and headache on an unspecified date, experienced severe myalgia to legs nest day after 2nd dose then to shoulders, arms on 28Feb2021. None prior vaccinations within 4 weeks. Seriousness criteria for event pain was reported as disability. The outcome of the events was unknown. Reporter considered the suspect product had a causal effect to the adverse event. No follow-up attempts are needed. No further information is expected.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) to reported events is possible based on temporal association and known profile of the product.

Other Meds:

Current Illness:

ID: 1353544
Sex: F
Age:
State: CA

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: sore arm only; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 26Feb2021 at age of 68-year-old (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included the patient had Bell's Palsy about 10 years ago. The patient's concomitant medications were not reported. The patient experienced sore arm only on 26Feb2021 with outcome of unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353545
Sex: M
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: his chin, the left upper and lower jaw wet numb as well as his left ear, which was the same side as his injection; he almost passed out; felt a lump on the bone of the upper jaw on the inside; upset; This is a spontaneous report from a contactable consumer (parent). A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date in 2021 as first dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took procaine hydrochloride (NOVOCAIN) and experienced numb. Patient previously had a flu shot last fall (28Sep2020) which was influenza, inactivated split 4V (QUADRIVALENT INFLUENZA VACCINE; Lot number PLOOZZ9091 or PLOOZZ7091. Manufacturer), and experienced face went numb. Patient received the vaccine yesterday (date unspecified in 2021) at 6pm. He waited for 30 minutes at the vaccination site and then left. An hour to an hour and a half later his chin, the left upper and lower jaw wet numb as well as his left ear, which was the same side as his injection. His hearing was okay. He said it was like getting Novocain. He went back to the ER and was told since the vaccine people were already gone they couldn't help him unless he wanted to be checked into the ER or he could go home. He hung out in the waiting room for 3 hours incase something else went wrong and then went home. This morning he felt a lump on the bone of the upper jaw on the inside, way above the cheek and he was still numb. Patient told that he almost passed out- because he freaked himself out, not from the vaccine. She said he had a similar experience with a flu shot last fall - face went numb on the same side for four hours Quadrivalent Influenza vaccine on 28Sep2020. Reporter wanted to know what ingredients could be causing this reaction. Reporter asked if there was something in this like sulfur/nickel, mercury, sulfer, sulfates, sulfites, nickel, thimerosal that could cause this reaction. She wanted to know if the company had anyone else that has had these symptoms. It was reported that when patient got the flu shot he also had the numbness in his jaw, with the flu shot it lasted for about 4-5 hours but now he has had the same experience this time with the COVID 19 vaccine but it was worse and now he also fekt a lump in his upper jaw on the inside. They were trying to figure out what is in the vaccines that could make his jaw go numb. He reported through the thing, she told him to scan the paper, he scanned it and he put in his symptoms yesterday so he should be starting to get text messages about it. The lump was in the inside of his jaw, it did not hurt but there was a lump on the bone and he was upset (2021), he almost passed out and he was going to go to the doctor and he just wanted to find out if he was the only one getting these symptoms and what he needed to be aware so he does not go and do it again next flu season like he can go with different brand or something because his jaw was going numb. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1353546
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: experienced small amount of pain at the injection site of left shoulder/his coworker experienced similar side effects with the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history was and concomitant medications were not reported. On an unspecified date, the patient experienced small amount of pain at the injection site of left shoulder/his coworker experienced similar side effects with the Pfizer COVID-19 vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353547
Sex: M
Age:
State: WA

Vax Date: 04/15/2021
Onset Date: 04/17/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: feeling kind of sick on it two days later on Saturday on 17Apr2021/I have got the COVID/he had left was like a little pneumonia; This is a spontaneous report from a contactable consumer (patient). A 43 years old male patient received Covid-19 Vaccine (unspecified trade name) dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: GD7533) as single dose for covid-19 immunization. Medical history included blood testosterone low. Concomitant medication included testosterone cipionate taken for testosterone low regularly for a year 500 ml a week. The patient didn't have any adverse effect or anything like but he can add a peculiar situation where he got first vaccination and then after he didn't know when he actually got COVID. The patient got first vaccine on Thursday and started feeling kind of sick on it two days later on Saturday on 17Apr2021 and then the patient got tested on Sunday on 18Apr2021 and it actually turned out that the patient had got the COVID. The pharmacist said well don't get second one if still have symptoms. The patient had not got the second vaccination. The second shot was scheduled for last week on 06May2021 when the patient cancelled it and he still had symptoms. He felt pretty fine, he thought all he had left was like a little pneumonia. He took for pneumonia antibiotic Benzonatate 100 mg. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds: TESTOSTERONE CIPIONATE

Current Illness:

ID: 1353548
Sex: M
Age:
State: ID

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: had swelling off and on in different limbs but not in this arm; after he had the Pfizer Covid vaccine, left arm had gotten bigger/arm that he got it in was swollen, almost the entire arm; had swelling off and on in different limbs but not in this arm; after he had the Pfizer Covid vaccine, left arm had gotten bigger/arm that he got it in was swollen, almost the entire arm; This is a spontaneous report from a contactable physician (patient himself). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were not reported) as the 1st dose, single for COVID-19 immunization. Relevant medical history included an accident a year prior reporting in 2020 and had swelling off and on in different limbs, but not in this arm from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated that he received two doses of the Pfizer vaccine, the last one was one week prior reporting. He stated that the arm that he got it in was swollen, almost the entire arm and wanted to know if he needed to get it checked out. The patient further stated that he had an accident a year prior reporting and had swelling off and on in different limbs, but not in this arm; he stated that after he had the Pfizer Covid vaccine, the left arm had gotten bigger on an unspecified date. The outcome of the event was unknown. Information on the batch/lot number has been requested.; Sender's Comments: The contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were not reported) to reported events is possible based on temporal association and known profile of the product.

Other Meds:

Current Illness:

ID: 1353549
Sex: M
Age:
State: WA

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
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Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: voice had been messed up; hardly walk; Mild fever; Body aches; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; Muscle pain and joint pain in his hips, shoulders, knees, and back of neck; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EP7533), via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6204) on 09Mar2021 (at the age of 48-years-old) in the left arm for COVID-19 immunization and had no events following the first dose. The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 30Mar2021, the patient experienced body aches, muscle pain and joint pain in his hips, shoulders, knees, and back of neck. On Apr2021, the patient experienced a mild fever and could hardly walk. On an unspecified date, the patient's voice had been messed up. The course of events was follows: On 30Mar2021 at around 20:00-21:00, the patient had full body aches (further described as muscle pain and joint pain in his hips, shoulders, knees, and back of neck ) and then it got a little better for a couple of days. The patient woke up on 31Mar2021 and it was really bad. He tried to work through it. However, he finally went to the doctor and then the Emergency Room (ER) for the first time. He was put on meloxicam 15mg for 4 days and it didn't do anything, although it was reported he didn't take them all. On Apr2021, the first week after the second vaccine (also reported as a few days later, even up to 5 days), the patient had a mild fever, for one or two days it got up to 100.3 degrees F. The patient had not had respiratory problems or breathing problems. When the meloxicam didn't work, the patient went back to the ER. He received a steroid shot while there. He received 5 days of 60mg daily of prednisone. The patient felt fine when he was taking it, but when it wore off, he crashed real hard and was right back to where he could hardly move. After the prednisone wore off, he went back to the ER for the third time, on approximately 23Apr2021, because he could hardly walk. He was told to take ibuprofen and paracetamol (TYLENOL) until he could get into see his primary care. That was probably for about a week. The patient saw his new primary care and was so bad he had to use a wheelchair. The patient had regular blood panels completed with unknown results. The provider put him on the second round of prednisone, but he was told he couldn't keep taking it because it could really screw him up. He was prescribed prednisone 10 mg tablets to take 6 tablets for 3 days (for a total of 60mg), then 4 tablets for 3days, then 2 tablets for 3 days, then 1 tablet for 3 days and stop. He felt good at the beginning, but as the dosage went down, the medication wore off, his pain came back real bad. He was hurting really bad because he was tapering off the steroid, prednisone. He went in "last Friday" and they put him on duloxetine (CYMBALTA) 30mg by mouth once a day. He was also taking over-the-counter naproxen sodium (ALEVE) 220 mg about every 8 hours for pain. The patient was checked for "rheumatoid stuff" with unknown results. The patient was put on duloxetine because he was normally a very active person, but this had been debilitating, some days he cannot even get off the couch because of the pain and not being able to walk. He just started a new job and now he's not been able to work. For example, "today", the patient can hardly lift his arms above his head because his shoulders hurt so bad. The patient reported that the muscle and joint pain persisted, but some days the pain got real bad. "Yesterday" he couldn't even get up hardly to go use the restroom, he had to use a cane. This morning, he has been able to get up better today. The pain is just always there since this all happened. He can't move very good, it hurt so bad. The patient also added that his voice had been messed up since all of this. The patient underwent the following lab tests on 27Mar2021 COVID-19 rapid test: negative, on 09Apr2021 COVID-19 test: negative, on 10Apr2021 COVID-19 rapid test: negative. The clinical outcome of mild fever, voice had been messed up and hardly walk was unknown, of body aches and muscle pain and joint pain in his hips, shoulders, knees, and back of neck was not resolved. No follow-up attempts are needed; no further information expected.

Other Meds:

Current Illness:

ID: 1353550
Sex: M
Age:
State: PA

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: someone was on the floor; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller is a consumer calling in regards to the Pfizer Covid-19 vaccine. Caller was self-reporting on adverse events when he reported that another person, the patient, had some kind of reaction while he was at the vaccination facility for his first dose of the Covid-19 vaccine. Caller reported that while he was waiting for the Covid-19 vaccine at the vaccination facility on 09Apr2021. Caller reported that while he was waiting, he noticed that someone was on the floor and all the sudden, facility staff members put a rolling screen around the patient. Caller reported that he could tell the patient was male. Caller reported that the event occurred between 2 PM and 3 PM on 09Apr2021. Caller reported that he didn't think that the patient was a senior citizen. Caller reported that he thinks the patient was someone younger. Caller reported that he did not know what happened to the patient. The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1353551
Sex: M
Age:
State: TX

Vax Date: 04/30/2021
Onset Date: 05/02/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 30Apr2021 at 13:00 (Lot Number: EP6955) (at the age of 67-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 09Apr2021 at 13:00 (Lot Number: ER8737) (at the age of 67-year-old) as single dose for COVID-19 immunisation. The patient experienced swollen red and burning tongue on 02May2021 with outcome of recovered on 08May2021. The events required emergency room visit (not the emergency room in the hospital, but one of those after care places) and physician office visit, both on 06May2021. Therapeutic measures were taken as a result of the events and included some mouthwash stuff and take a vitamin. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353552
Sex: M
Age:
State: AL

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: dizzy and felt like was going to faint; headache; extreme fatigue; not being able to sleep; red rash; tongue and right arm became numb; stomach ache; joint aches; swelling in right ankle; sweating; dry mouth; watery eyes; nightmares; lethargic; spacey; Extreme hunger; tongue and right arm became numb; welps on my arms and stomach; This is a spontaneous report from a contactable consumer (patient). An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Apr2021 11:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included an unspecified "dauphin". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021, 11:15, 15 minutes after shot, patient became dizzy and felt like I was going to faint, headache, extreme fatigue for a few days, followed by a couple of days of having a lot of energy and not being able to sleep, red rash on neck, lower face and welps on his arms and stomach, tongue and right arm became numb. After massage of vaccine site symptoms were stomach ache for a day, joint aches, swelling in right ankle,,sweating, dry mouth, watery eyes , nightmares, lethargic and spacey , feeling, Extreme hunger. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1353553
Sex: F
Age:
State: IA

Vax Date: 03/24/2021
Onset Date: 04/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: positive COVID-19 test with symptom; positive COVID-19 test with symptom; This is a spontaneous report from a contactable consumer (patient's daughter) reported that a 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8736) via an unspecified route of administration, administered in Arm Right on 24Mar2021 at age of 95-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, Alzheimer's disease, depression and blood clot. Concomitant medications included amlodipine taken for high blood pressure from an unspecified date; apixaban (ELIQUIS) taken as blood thinner from an unspecified date; donepezil hcl taken for Alzheimer's disease from an unspecified date; memantine taken for Alzheimer's disease from an unspecified date; escitalopram oxalate (LEXAPRO) taken for depression from an unspecified date; folic acid taken for an unspecified indication from an unspecified date. The reporter was actually calling how to schedule for the second dose since her mother tested positive second week after getting the first dose (Apr2021) and currently she still didn't have the second dose of shot. It also reported about 2 weeks after she got the first vaccine, she got COVID. She just had a fever for couple of days that was it, the reporter asked when she got the second vaccine. No treatment received for the event. No lab work other than COVID that was positive in Apr2021. The outcome of the events was unknown.

Other Meds: AMLODIPINE; ELIQUIS; DONEPEZIL HCL; MEMANTINE; LEXAPRO; FOLIC ACID

Current Illness:

ID: 1353554
Sex: F
Age:
State: IN

Vax Date: 05/10/2021
Onset Date: 05/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: problem with her throat; Ears were ringing; turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her; felt an intense heat in her chest and throat; This is a spontaneous report from a contactable registered nurse (the patient's mother). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 10May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: reflux, "weird allergy" that had popped up before and caused Steven Johnson Syndrome (further clarification unknown). Concomitant medication included an unspecified reflux medicine. The patient daughter received the first dose of the Pfizer BioNtech COVID-19 vaccine yesterday (10May2021), and she had a problem with her throat (May2021). She took diphenhydramine hydrochloride (BENADRYL), and it was resolved after an hour (treatment). The patient's mother also specified that the patient felt an intense heat in her chest and throat, and her ears were ringing (both May2021). The patient turned red on her neck and her chest, it was not like hives, but it was as if someone had slapped her (May2021). At the vaccination site, they were able to put an ice bag on her neck and on her chest, and it resolved afterward, after an hour, so ice was applied for an hour as well. The symptoms resolved at the time over there (at the center where the vaccine was given), and they gave her BENADRYL. The patient's weight was maybe in the 150 range. The outcome of the events was resolved in May2021. Information on Lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) 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.

Other Meds:

Current Illness:

ID: 1353555
Sex: F
Age:
State: IL

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 05/27/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

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

Other Meds:

Current Illness:

ID: 1353556
Sex: F
Age:
State: CA

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: dizziness and felt woozy almost all days; When I lay down I do get the spins and stuff; Nauseous; This is a spontaneous report from a contactable consumer (patient). This 21-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 21-year-old) as single dose for COVID-19 immunization. The patient denied having any medical condition and confirmed not taking any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 17Mar2021 (at the age of 21-year-old) as single dose for COVID-19 immunization. On 14Apr2021, the patient experienced dizziness and felt woozy almost all days, "when I lay down I do get the spins and stuff" and nauseous. The clinical course of the events was as follows: The patient reported, "I have been having dizziness and mild nausea since my second vaccine and I have got my vaccine on the 13Apr2021 and I have started on 14Apr2021 the day after the vaccine and it's been like a whole month already that I have been feeling like that dizzy and nauseous when I wake up in the morning and when I lay down I do get the spins and stuff, and then during the day as I work and stuff, I have to look up the stuff I get woozy. I have been taking Dramamine 25 mg tablet." The patient also mentioned that she cannot set an appointment at her doctor's office since they don't have appointments for 2 months. She is just calling to get a recommendation on which medication she can take and what she can do. The clinical outcome of the events, dizziness and felt woozy almost all days, "when I lay down I do get the spins and stuff" and nauseous was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353557
Sex: F
Age:
State: NY

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Exhaustion; Red itchy arm; Red itchy arm; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-Sponsored Patient Support Program. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN6201), via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included allergies (had a reaction to a lot of things in life), headaches since she was about 12 years old, supraventricular tachycardia, cardiac loop which died, normally had abnormally low blood pressure her whole life (normally 98 would be high and 58-60 as the bottom number would be normal). Concomitant medications were not reported. On 12Mar2021, the patient experienced red itchy arm. After the vaccination, she was told to sit in the sitting area because she had an unspecified underlying condition and had a reaction to a lot of things in life, just allergies basically. The patient's arm was red. Within a couple minutes and all of a sudden, she had streaks down it and it started getting very itchy. The red, itchy arm lasted about half an hour. On 13Mar2021, the patient experienced heavy duty exhaustion for a week - she thought she was just tired from stress. The clinical outcome of "red itchy arm" was resolved on 12Mar2021, of exhaustion was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539682 same patient, different dose number and event

Other Meds:

Current Illness:

ID: 1353558
Sex: F
Age:
State: WV

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: severe allergic reaction; Second dose: throat is sore; Second dose: lips feel like someone is pricking them with a pin; Second dose: her lips look windburned; Second dose: face is starting to itch, her neck is itching really bad; Second dose: doesn't feel the greatest; Second dose: looks like she's starting to get a rash on her neck; Second dose: her head hurts; Second dose: head is itching so bad; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171, expiration date: not reported), via an unspecified route of administration, administered on arm left on Tuesday 11May2021 13:30 at single dose for covid-19 immunisation/to prevent the Covid 19 virus. Medical history included migraine from an unknown date and unknown if ongoing, multiple sclerosis (diagnosed in Oct2020, her doctor said she probably has had multiple sclerosis for 20 years, but no one would do an MRI to verify the diagnosis) from Oct2020 and ongoing. No additional vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). The concomitant medications included glatiramer acetate (COPAXONE) injection (Lot number: 107311, NDC: 68546-317-30), the first medication which she took for ongoing multiple sclerosis made her throat close up. It has been several months, maybe 3 months since she took Copaxone. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164, expiration date: not reported), via an unspecified route of administration, administered on arm right on 20Apr 2021 at single dose for covid-19 immunisation. The patient previously took flu vaccine (NDC/lot/Expiry: unknown) years ago and was told never to take the flu vaccine again. She doesn't remember what kind of reaction she had. She reports she's been through so much she doesn't know anything anymore. On 11May2021, about 3 hours after receiving the second Covid 19 vaccine, the patient experienced face is starting to itch and her neck is itching really bad. Her throat is sore and her lips feel like someone is pricking them with a pin. She doesn't know what to think. She doesn't feel the greatest. It looks like she's starting to get a rash on her neck. Her lips aren't swollen but her lips look windburned. Her head hurts. She has migraines but she's not sure what her head hurting is from. Her head is itching so bad. The events has not resulted in emergency or physician visit. There was no relevant lab tests reported. The outcome of the events was not recovered. Upon follow up on 14May2021, She experienced a ongoing severe allergic reaction which included a swollen tongue and lips, tingling of tongue and lips, facial redness, and itching. She took Benadryl the day of the reaction and was prescribed prednisone starting 12May2021. If she doesn't take her medications on time her lips tingle and her face turns red. She notes that the swelling has improved her but lips are tingling and itchy. It was reported as there was product complaint(PQC). Follow up (14May2021): Upon follow up, new information included: treatment details for events, Therapy and lot details of first dose and second dose, ongoing details of event reactions. No follow-up attempts are needed. No further information is expected.

Other Meds: COPAXONE

Current Illness: Multiple sclerosis (diagnosed in Oct2020, Her doctor said she probably has had multiple sclerosis for 20 years)

ID: 1353559
Sex: U
Age:
State: GA

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: my doctor immediately said you know we want to rule out a blood clot so blood was drawn to the lab; Right ankle was swollen; There is some problem down with the leg not as bad I say but having the same pain I feel a sensation in my feet when I stand; This is a spontaneous report from a contactable consumer (patient). An 81-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 81 years of age), via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE for COVID-19 immunisation; amlodipine besilate (manufacturer unknown), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 10 mg, 1x/day for blood pressure management and valsartan via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 80 mg, 1x/day at bed time (anywhere between 9 and 10:15 PM) as blood pressure medication. Medical history included glaucoma and hypertension (Blood pressure) from an unknown date and unknown if ongoing; additional medical condition reported as felt at times like he/she want to itch ('felt itching but never scratch myself or anything like that'). Concomitant medication included bimatoprost (LUMIGAN) taken for glaucoma, start and stop date were not reported. Historical vaccine included BNT162B2 dose 1 on 01Mar2021 (at 81 years of age) for COVID-19 immunisation. The patient took the two treatments of the Pfizer vaccine. The patient had a problem from the second vaccination administered on 22Mar2021 with the LOT# EN6206. The patient took the last treatment on 22Mar2021 at the health department, which was the one that had created problems for him/her. The patient mentioned that there was no problem at all with the first treatment. The patient stated that first of all, he/she was on the blood pressure medications and one of the medications was valsartan 80 mg and the other one was amlodipine 10 mg, once a day; the patient take valsartan at bed time (anywhere between 9 and 10:15 [something like] that PM). The patient was taking amlodipine 10 mg for blood pressure, and then from reading what he/she got from the pharmacist on the valsartan, it was supposed to work by relaxing blood vessel so the blood can flow more easily lowering high blood pressure to help prevent stroke, heart attack and kidney problems; so the patient had been taking those two. It was reported that after the patient took the second Pfizer vaccine on 22Mar2021, in the evening he/she noticed that his/her right ankle was swollen not in the morning but in the evening say by anywhere from 6 to 7 PM to 8:00 PM, it was swollen occasionally and then it looked like there was some problem down with the leg not as bad he/she said but having the same pain he/she felt a sensation in the feet when he/she stands. So the patient saw his/her doctor, had an appointment with him on 20Apr2021 and at the time of the appointment which was at 2:45 in the afternoon, there was no swelling; the patient did tell him that he/she had this reaction and it started the same day he/she got the treatment but it was in the evening that she/he noticed it, not in the morning, not the afternoon but the evening, late evening. The patient did not take any treatment for these adverse events which the doctor immediately said that they want to rule out a blood clot, so blood was drawn to the lab. The patient saw the doctor on the 20th about a week later and called his office and was told report had not come in and the patient had not heard from his office since that time. The patient was making assumption right or wrong that had there been a blood clot, the office would have called him/her okay. But the doctor said that he wanted to rule that out then he said they might have need to lower the dosage of amlodipine, those were the things he remembered him saying so. But the patient's concern was not it was because the ankle does swell and then when he/she went to bed and lie down of course it stopped it did not swell, when he/she got up in the morning it was normal ankle so but the patient did not know what was going on and did not know if this was the reaction that no one else had; he/she was not sure what to do about it at this point. The patient wondered if the symptoms were direct result of his/her mixed medications that he/she had taken with the Pfizer vaccine and commented that he/she certainly had no problem with the first. The patient added concern whether there was a causal relation between the medication he/she was taking and that second vaccine, he/she does not know what. The patient's main concern was to get his/her ankle un-swollen which what happened since the last dose, no problem with the first dose but the last dose that was where it was. The patient did not know what the diagnosis that was causing the problem as he/she said the doctor had taken the had blood drawn to send to the lab to rule out the blood clot. The patient underwent lab tests and procedures which included blood test: unknown results on an unspecified date. The action taken in response to the events for amlodipine besilate and valsartan was unknown. The outcome of the events was unknown. Pfizer is a marketing authorization holder of Amlodipine Besilate in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Amlodipine Besilate has submitted the same report to the regulatory authorities. No follow-up attempts are needed. No further information is expected.

Other Meds: LUMIGAN

Current Illness:

ID: 1353560
Sex: F
Age:
State: OH

Vax Date: 05/10/2021
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Acid reflux reaction; like something is coming out it is like something is blocking her throat; Acid reflux reaction; like something is coming out it is like something is blocking her throat; This is a spontaneous report from a contactable consumer (reporter's wife) from a Pfizer sponsored program. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 10May2021 (Lot Number: ER8735) (at the age of 30-year-old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. The patient experienced "acid reflux reaction; like something is coming out it is like something is blocking her throat" on an unspecified date with outcome of unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353561
Sex: M
Age:
State: NC

Vax Date: 04/08/2021
Onset Date: 05/02/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Hives; This is a spontaneous report from a contactable consumer. A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation (age at vaccination 53 years). Medical history included , lower limb fracture on an unknown date. Tetanus vaccine taken because of broken leg. The patient's concomitant medications were not reported. The patient experienced hives on 02May2021 with outcome of not recovered. The reported event was considered an Important Medical Event. The event was treated with diphenhydramine (BENADRYL) tablet and cream. Course of the event. The patient reported he got the first Covid shot on 08Apr2021 and everything was fine until about a week ago. He started breaking out in hives and going through Benadryl. States nothing in his life has changed, no change in detergent or what he eats, the only thing different was him getting the shot. Is due for the other one and is concerned if he should get the other one with him having the hives. Will this go away or will he get more hives with the second one. Has been taking Benadryl tablets and the hives go away but within 6 hours they come back and he has been using a Benadryl anti-itch cream so that he is not over doing the tablets. Has been through at least 7-8 tubes of cream in the last week or so. The patient also clarified he is actually using a generic Benadryl, its called generic healthcare allergy relief tablets. Has been taking 2 tablets every 8 hours for the last 7-9 days and when the hives come back he uses the Benadryl cream, it has diphenhydramine as active ingredient the same as Benadryl. As soon as the pills wear off he uses the cream. Information on the Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 1353562
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: kidney infection; fever as high as 103 F; This is a spontaneous report based on the information received by Pfizer (Reference ID: NVSC2021US100597). A contactable consumer (patient) reported that a 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported she experienced fever as high as 103 F and was admitted to the hospital on 30Apr2021. Patient stated she was discharged on 03May2021. Patient noted that while admitted to the hospital she was found to have a kidney infection, and also stated that she received the COVID-19 vaccine 1 week prior to start of fever. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1353563
Sex: U
Age:
State: FL

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 05/27/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: my heart rate went to 168 BPM; chest pains; numbness is face and arms; numbness is face and arms; shortness of breath; elevated blood pressure; Numbness and tingling in my arms and legs; Numbness and tingling in my arms and legs; At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!; This is a spontaneous report from a contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported " I received my first Pfizer shot on06May2021. Immediately after the shot I began feeling symptoms, my heart rate went to 168 beats per minute (BPM), I had chest pains, numbness is face and arms, shortness of breath, elevated blood pressure. I was taken via Fire Rescue to the hospital where I was later admitted. Now that I am out of the hospital I am experiences a new set of symptoms. Numbness and tingling in my arms and legs. At night my limbs keep falling asleep and waking me up. I am very concerned by these symptoms!". The outcome of events was unknown.

Other Meds:

Current Illness:

ID: 1353564
Sex: M
Age:
State:

Vax Date: 05/07/2021
Onset Date: 05/10/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07May2021 (Batch/Lot number was not reported) as 1single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever (non-serious) on 10May2021 with outcome of unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353565
Sex: M
Age:
State:

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Headache; Nausea; Malaise; Chills; Fever; Fatigue; Myalgia; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 10Apr2021 (at the age of 23-year-old) (Lot Number: 204A21A) as single dose (unknown if first or second dose) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced myalgia on 10Apr2021 with outcome of not recovered, headache on 11Apr2021 with outcome of not recovered, nausea on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 15 hours), malaise on 11Apr2021 with outcome of recovering, chills on 11Apr2021 with outcome of recovered on 11Apr2021 (duration 2 hours), fever on 11Apr2021 with outcome of recovering and fatigue on 11Apr2021 with outcome of not recovered. The events were considered as non-serious. The patient underwent lab tests and procedures which included body temperature: fever, temperature not measured on an unspecified date. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1353566
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: experienced the event of atrial; This is a solicited report from a specialty pharmacy based on information received by Pfizer. A contactable other HCP reported that a 63-year-old female patient 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 single dose for COVID-19 immunisation; treprostinil sodium (IH TYVASO, delivered by Tyvaso Inhalation Device (TD-300/A)) oral from 06Mar2015 (Lot Number: 2101911; Expiration Date: 31Oct2021) and ongoing at 60-120 ug (10-20 breaths) 4x/day for pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension. Concomitant medication included warfarin. The patient got second coronavirus disease (COVID) shot and then went into atrial fibrillation about seven day later, so they were unsure if that had anything to do with vaccine or not. But, she would be going to get an ablation done on 17May2021. She had no issues with her breathing, no chest pain or other side effects. She had a history of atrial fibrillation a while ago. The action taken in response to the event for treprostinil sodium was unknown. The outcome of event was unknown. The reporter did not provide causality for the event of atrial fibrillation. Senders Comment: The company has assessed the serious adverse event of atrial fibrillation as not related to IH treprostinil and TD-300/A device. The event was likely due to complications of secondary pulmonary arterial hypertension. Underlying medical condition which led to secondary pulmonary arterial hypertension also likely contributed. 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. No further information expected.; Sender's Comments: The association between the event atrial fibrillation with BNT162b2 can not be completely excluded based on the temporal relationship. The pre-existing pulmonary arterial hypertension may have been contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: WARFARIN

Current Illness: Secondary pulmonary arterial hypertension (began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device)

ID: 1353567
Sex: F
Age:
State: CA

Vax Date: 04/03/2021
Onset Date: 04/04/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: It's like eczema in skin/patches like an eczema; Itchy; little blots of red; Allergic reaction; Pain Whole Left arm; Headaches; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Deltoid Left on 03Apr2021 12:00 (Lot Number: EN6198) as 1st dose, single, and via an unspecified route of administration, administered in Deltoid Left on 24Apr2021 12:00 (Lot Number: ER8737) as 2nd dose, single for COVID-19 immunization. Medical history included Crohn's disease and immunodeficiency from an unknown date. The patient is not on other medication and doesn't take anything. On 04Apr2021, the next day after vaccination of the first dose, the patient had pain whole left arm and headaches and took Tylenol. On 05Apr2021, patient experienced it's like eczema in skin/patches like an eczema, little blots of red, that is really itchy, and allergic reaction. The patient took an antihistamine. On 25Apr2021, after the second dose, the patient again had pain whole left arm and headaches and on an unspecified date after the second dose had the same patches like an eczema not clearing still itching. Patient was still taking antihistamine. No emergency room and physician's office visit was done. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1353568
Sex: F
Age:
State: WA

Vax Date: 05/07/2021
Onset Date: 05/01/2021
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: My whole stomach is covered in hives; Rash; This is a spontaneous report from a contactable pharmacist (patient). A 52-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: unknown, expiry date: unknown) via an unspecified route of administration on 07May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included propranolol taken for an unspecified indication, start and stop date were not reported. On May2021, the patient had rash and her whole stomach was covered in hives. The patient stated that she had never had hives in her whole life. Pharmacist stated that, I don't think I should get the second shot if I am covered in hives. So I will call them tomorrow and let them know about the hive, then the rash and see if I should not get the second shot then. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds: PROPRANOLOL

Current Illness:

ID: 1353569
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: ringing in their ears; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), 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. The patient got the Pfizer covid 19 vaccine and three days later got ringing in their ears and it went away. The patient recovered from the event on unspecified date. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353570
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Could not see out of it for a little; Head was pounding; Eyes were clouding up again in right eye; She also had temperature of 103; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization and had no reaction. Patient received Covid shot and first injection she had no reaction but with second one her head was pounding, eyes were clouding up again in right eye and could not see out of it for a little. She also had temperature of 103 F. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1353571
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: allergic reaction; This is a spontaneous report from a non-contactable consumer received from Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced allergic reaction to the vaccine on an unspecified date with outcome of unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1353572
Sex: F
Age:
State: WA

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 05/27/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: The caller received the first dose of the Pfizer Covid vaccine on 20Apr2021. The second dose was on 11May2021, but on her vaccination card sticker says Jansen; Her blood pressure is low, not qualified low, but it runs like 96/69; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Deltoid Left on 20Apr2021 (Batch/Lot Number: EW0153; Expiration Date: Jul2021, 42-years age at the time of vaccination) as single dose for covid-19 immunisation. Medical history included endometriosis from 1997 to ongoing. Patient has endometriosis and is suspected to have it right now. Has had it her whole life and had 4 surgeries, the first in 1997. The patient's concomitant medications were not reported. The patient experienced the caller received the first dose of the Pfizer covid vaccine on 20Apr2021. the second dose was on 11May2021, but on her vaccination card sticker says Jansen and her blood pressure is low, not qualified low, but it runs like 96/69 on 2021. Patient had labs yesterday and everything was normal and Her blood pressure is low, not qualified low, but it runs like 96/69 in 2021. Reporter also stated that She just noticed today that she was given the Johnson & Johnson for the second dose. She called the pharmacy who told her they have no way of knowing if they messed up the sticker. She would like the second shot but now has the first shot of Johnson & Johnson. She has had zero symptoms. She did not have any symptoms with the first dose. Everyone she knows that had Pfizer had no symptoms. The sticker has Jansen 0.5ml listed in this spot.The outcome of events was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness: Endometriosis

ID: 1353573
Sex: F
Age:
State: WA

Vax Date: 05/03/2021
Onset Date: 05/01/2021
Rec V Date: 05/27/2021
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Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; Severe pain in upper neck, left shoulder, left arm; pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm; Left wrist ache; was not sleeping; severe muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 10:00 (Batch/Lot Number: EN6208) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included nerve injury from an unknown date and unknown if ongoing, intervertebral disc operation from 2019 to an unknown date, nuchal rigidity (Can't turn neck to the left past a certain point) from an unknown date and was ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2m (Lot number: EN6198) on 12Apr2021 (at the age of 61-year-old) for covid-19 immunisation; the past drug includes naproxen which worked well. The patient developed pain to left shoulder and left arm where the shot was given a week later/ Severe muscle pain on injection arm, on an unknown date in May2021, severe pain in upper neck, left shoulder, left arm on 07May2021, experienced left wrist ache, was not sleeping on an unknown date in May2021. It was reported that patient used ice packs on it and taking Naproxen around the clock, but nothing touches it. Starts to feel like she was getting better, but really was not. The patient had no cold or flu symptoms. It was reported that patient visited chiropractor on 01May2021 for this crick in her neck. States she did not have COVID arm and did not have redness or swelling on the injection arm. It was also reported that patient had severe muscle pain on an unknown date in May2021. The patient has been taking Naproxen (Kroger brand, Formulation: 220mg caplets, NDC: 30142-617-90, Lot: 9ER0418, Exp: Dec2020) at a dose of three caplets in the morning. A couple of nights did two caplets 12-14 hours later; Lidocaine Patches (NDC: 0603188010; Lot: 74098; Exp: Jun2017; Formulation: 5%, 700mg patches) at a dose of patch on last night where the main part of the pain was at, which was the injection site, put one patch on the left arm and one patch on the upper part of the left shoulder near her back, left patches on overnight, about six hours. The outcome of the events pain to left shoulder and left arm where the shot was given/Severe muscle pain on injection arm, Severe pain in upper neck, left shoulder, left arm was not resolved, left wrist ache was resolved on May2021 and was not sleeping, severe muscle pain was unknown. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness: Neck rigid (Can't turn neck to the left past a certain point)

ID: 1353574
Sex: M
Age:
State: PA

Vax Date: 05/11/2021
Onset Date: 05/13/2021
Rec V Date: 05/27/2021
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Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: pain in calves worse on left side then right; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0176), via an unspecified route of administration in left arm on 11May2021 13:30 (at the age of 34-year-old) at first, single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. Prior to vaccination, the patient did not have other vaccinations within four weeks prior, did not have other vaccinations on the same date. On 13May2021, the patient reported that he started with pain in calves worse on left side then right. It felt like they were sore, like he was working out. But he had just been sitting at his desk and doing nothing. Outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1353575
Sex: F
Age:
State: IL

Vax Date: 04/21/2021
Onset Date: 04/22/2021
Rec V Date: 05/27/2021
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Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Bleeding starts 1 day after dose given; large blood in urine output at night; increased lethargy; WBC and Hgb drop; WBC and Hgb drop; This is a spontaneous report from a contactable consumer (the patient). The consumer reported similar events for herself with two doses. This is the second of two reports. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included PNH anemia since 2006 and known allergies: Latex, sulfamethoxazole trimethoprim (BACTRIM). The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications (received within 2 weeks of vaccination) included iron, cyanocobalamin (VITAMIN B12) and one a day women vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8732) via an unspecified route of administration in left arm on 26Mar2021 10:15 AM at age of 53-year-old for COVID-19 immunisation. Minor side effects after first dose but did have some spotting blood in urine at night. Told MD and was told to proceed with dose 2. After second dose on 22Apr2021 23:00, large blood in urine output at night and increased lethargy. Bleeding starts 1 day after dose given. Lasted less than 1 week but white blood cell (WBC) and haemoglobin (Hgb) decreased/drop (22Apr2021). The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529122 same patient/drug, similar AE, different dose of vaccine

Other Meds: IRON; VITAMIN B12 [CYANOCOBALAMIN]

Current Illness:

ID: 1353576
Sex: F
Age:
State: ID

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/27/2021
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Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering. Information about lot/batch number has been requested.

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Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am