VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1730479
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Bell's palsy; This is a Literature report. This reporter reported 3 reports, this is the 3 of 3 reports. This case was split from master case 202101198829 for a patient taking Bnt162b2 and experienced Bell's palsy.This information was from FDA briefing document. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Bell's palsy. It was reported in the Food and Drug Administration briefings suggest risk of Bell's palsy is greatest within 1 month of a second vaccine dose. Of the Pfizer briefing notes "from dose 1 through 1 month after dose 2, there were three reports of Bell's palsy in the vaccine group and none in the placebo group". The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101207187 Same article, different patients with same drug;US-PFIZER INC-202101207186 Same article, different patients with same drug

Other Meds:

Current Illness:

ID: 1730480
Sex: M
Age:
State: CT

Vax Date: 03/05/2021
Onset Date: 09/11/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210913; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: positive test result for Covid 19; positive test result for Covid 19; This is a spontaneous report from a contactable consumer. A 71-year-old male patient (father) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), dose 2 via intramuscular route in right arm on 05Mar2021 at 09:00 as single dose for COVID-19 immunisation. The patient's medical history included hypertension from an unknown date. There were no concomitant medications reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported) dose 1 via intramuscular route in right arm on 15Feb2021 at 10:00 as single dose for COVID-19 immunisation. On 11Sep2021 at 07:00, approximately 190 days after the second dose, the patient had positive test result for COVID-19, first dose was received on 15Feb2021/ second dose was received on 05Mar2021, flu like symptoms, slight fever, feelings of light headedness, cough and runny nose. The adverse events resulted in physician's office visit. The patient underwent sars-cov-2 test (nasal swab) which was positive on 13Sep2021. The patient was not tested positive for covid-19 prior to vaccination. The outcome of all the events was not recovered. The lot number for the vaccine was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1730481
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: My husband got the first shot but he broke out in, Like blisters, All over his body.; : This is a spontaneous report from a contactable consumer or other non hcp (patient's wife) for a male patient (husband). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The reporter reported her husband got the first shot but he broke out in, like blisters, all over his body on an unspecified date. She asked was that happened to anyone else. The outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730482
Sex: M
Age:
State: MO

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: since the second dose the neuropathy is "three times worse"; since the second dose the neuropathy is "three times worse"; missed work because his feet and legs bother him; like standing on pins and needles; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0186 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm on 01Aug2021 at 16:00 hours (Age at vaccination was 55 years) as dose 2, single for covid-19 immunization. Medical history included ongoing neuropathy peripheral. The patient did not have any other adverse event within 4 weeks of vaccination and also prior to vaccination. The patient did not take any additional vaccine. There were no concomitant medications. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EY0584 and expiration date was not reported), via an unspecified route of administration, administered in Right Arm, on 8Jul2021 (Age at vaccination was 55 years) as dose 1, single for COVID-19 immunization. In Aug2021 patient reported that he had a previous diagnosis of peripheral neuropathy in his feet and legs, related to his work in a battery factory, and since the second dose the neuropathy is three times worse like standing on pins and needles. The patient was missed work because his feet and legs bother him, like standing on pins and needles that diabetics usually get, but he was not diabetic. The patient did not perform any relevant tests. Patient was treated with Gabapentin 800mg 3 times a day, which was almost the max dose. Patient states he went to the doctor a week and a half ago and discussed it with him and he said to stick with what he was doing and if it doesn't get better to come back. Patient states it doesn't seem to be letting up, but some days are worse than others. The outcome of all the events was not recovered. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Peripheral neuropathy (Verbatim: Peripheral neuropathy)

ID: 1730483
Sex: F
Age:
State: CA

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: First dose: Severe flushing; First dose: Tingling in upper lip and tongue; First dose: Pain at the injection site of her right upper arm; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: ER8729,Expiry date was unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 05Apr2021 15:30 as DOSE 1,SINGLE for covid-19 immunisation (At the age of vaccination-36 yrs). Medical history included immune system disorder (previously had compromised immune system but not for about 2 years now), drug hypersensitivity (penicillin), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity and lot of drug allergies from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took heptitis A vaccine on an unknown date other than several years ago and experienced got hives. 05Apr2021 at 15:30 She reported at 15:30, immediately after injection she experienced pain at the injection site of her right upper arm. She thought it was just a muscle reaction; it was not swollen or hard. The Nurse examined her about 10 minutes later and asked her to stay longer so patient stayed another 30 minutes. Within that 30 minutes she had onset of severe flushing-clarified time of onset about 20 minutes after injection administered so around 15:50. She was administered 25mg of Benadryl oral. Also around 15:50 the flushing progressed to a little tingling in upper lip and tongue. She was sent to the emergency room and administered another 25mg of Benadryl and 20mg Pepcid oral. She was not admitted to the hospital, she was monitored and kept under observation in the hospital emergency room for a couple of hours and then released. She recovered completely from all of these events within about 24 hours of onset. Therapeutic measures were taken as a result of first dose: pain at the injection site of her right upper arm, severe flushing, tingling in upper lip and tongue. On 14Sep2021 she was pre-medicated with 25mg of Benadryl and 20mg of Pepcid. She was administered second dose of Pfizer Covid-19 Vaccine on 14Sep2021 at 10:23. She started to flush slightly around 10:40. She was administered 25mg of Benadryl and that resolved the event of started to flush slightly. She had no further incidents, was able to tolerate the second dose. She recovered completely from this event within about 24 hours also. They did not send her to the emergency room this time, they felt that the reaction was well controlled with the antihistamines. The patient visited emergency room and physician office. On 06Apr2021 the clinical outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1730484
Sex: M
Age:
State: PA

Vax Date: 04/23/2021
Onset Date: 04/01/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: sore arm; Fatigue; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored Program COVAX Support. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0162) via an unspecified route of administration, administered in Arm Left on 23Apr2021 13:00 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included barrett's oesophagus from an unknown date and unknown if ongoing. Concomitant medication(s) included lansoprazole (PREVACID) taken for barrett's oesophagus from an unspecified start date and ongoing. Patient historical vaccine included FLU vaccine via unspecified route of administration on 2019 for immunisation (the Pfizer vaccine is the only thing he has had since he had the flu vaccine in 2019). The patient experienced sore arm, fatigue on Apr2021. Reported as, he had none of the side effects after the vaccinations other than maybe a sore arm; and more like fatigue. Adds he doesn't really want to emphasize the fatigue as he is a truck driver, he was tired all the time, and he just kind of felt a little extra tired. He completely recovered from these effects. Outcome of all the event was resolved on 2021.

Other Meds: PREVACID

Current Illness:

ID: 1730485
Sex: F
Age:
State: PA

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210913; Test Name: she had blood work done; Test Result: Negative ; Comments: was negative, clot was ruled out; Test Date: 20210913; Test Name: d dimer test; Result Unstructured Data: Test Result:resulted -39, negative; Comments: was negative, clot was ruled out; Test Date: 20210913; Test Name: physical exam; Test Result: Negative ; Comments: The tests came back negative the same day; Test Date: 20210128; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: has not been able to sleep and she started crying last night; has not been able to sleep and she started crying last night; Caller received the first dose Pfizer Covid Vaccine on 30Jan2021/received the second dose on 10Sep2021; developed a focal neuropathy behind left knee; throbbing, stabbing pain under her left knee; This is a spontaneous report from a contactable pharmacist (patient herself) from a Pfizer sponsored program Covax US support. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 10Sep2021 14:00 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. Medical history included diagnosed with Covid-19 on 26Dec2020 and her symptom included an ear ache. On 04Jan2021 her husband was diagnosed with COVID-19 as well. There were no concomitant medications. Caller was not taking anything when received Pfizer Covid Vaccines. The patient had not received any additional vaccines on same date of the Pfizer Suspect considered as suspect. The patient did not receive any prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) received via an unspecified route of administration, administered in Arm Right on 30Jan2021 at 8:00 AM (at the age of 39 years old) for COVID-19 immunization and had lymph node swelling in right lower quadrant. The patient received the second dose of the Pfizer Covid-19 vaccine on 10Sep2021 and 12 hours later she started having complaints of a throbbing, stabbing pain under her left knee and spoke with her HCP who told her to take ASA 81mg PO (per oral). On Monday 13Sep2021, she went to her HCP where she had blood work done, d-dimer was negative, clot was ruled out, and there was no need for a doppler per HCP. HCP states that she was able to exercise and was fine during the day but when she lays down there was a constant throbbing in the middle back of her left knee area. HCP also stated that she had not been able to sleep and she started crying last night 14Sep2021 because of her complaints. HCP states that her HCP prescribed her Tegretol but she refused the medication but did start Gabapentin which makes her have complaints of constipation and drowsiness. It was reported that within 12 hours of receiving second dose, developed a focal neuropathy behind left knee: Caller states this was disabling and the caller could not sleep. Caller has never experienced anything like this. Caller had to seek out medical attention to rule out any cause, a d dimer test was done and resulted -39. Caller took 81mg Aspirin. Caller received the second dose on 10Sep2021. Caller was told not to get second dose, expected around July. Caller's son was in hospital and caller went on a vacation. Caller received second dose Pfizer Covid Vaccine on 10Sep2021. Caller clarifies the focal neuropathy behind left knee was like bells palsy. Caller started Aspirin 81mg immediately on Saturday, 11Sep2021 and on Monday 13Sep2021 caller had a physical exam and blood taken to get a d dimer test to see if caller needed more attention such as an ultra sound or doppler. The tests came back negative the same day, 13Sep2021. Caller is currently prescribed Gabapentin for this particular pain. The patient was calling for information on how to treat the adverse event. Caller is asking if there is any literature or if Pfizer can say the percentage of patients who have experienced a similar even to the patient. HCP enquired if there is information regarding complaints of focal neuropathy localized in one area after the administration of the Pfizer Covid-19 vaccine. HCP is asking how many cases have been reported of localized focal neuropathy after the administration of the Pfizer Covid-19 vaccine. The reporter assessed the event focal neuropathy behind left knee as disabling. Outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event "Neuropathy" due to temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1730486
Sex: F
Age:
State: NC

Vax Date: 08/13/2021
Onset Date: 08/16/2021
Rec V Date: 09/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210817; Test Name: echocardiogram; Result Unstructured Data: Test Result:Test revealed asymmetric septal hypertrophy; Comments: and thickening of heart muscle wall; Test Date: 20210816; Test Name: EKG; Result Unstructured Data: Test Result:A-Fib with RVR

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Test revealed asymmetric septal hypertrophy; thickening of heart muscle wall; palpations; chest heaviness; shortness of breath; A-Fib with RVR; This is a spontaneous report from a contactable nurse (patient). A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 58-years, on 13Aug2021 08:00 (Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Asthma, GERD, Seasonal Allergies, Basal Cell skin cancer. Concomitant medications included montelukast; cetirizine; omeprazole and budesonide, formoterol fumarate (SYMBICORT); all taken for an unspecified indication. There was no other vaccine received in four weeks. The patient previously took NSAIDS and doxycycline and experienced allergies. The patient experienced test revealed asymmetric septal hypertrophy and thickening of heart muscle wall on 17Aug2021; and experienced palpations, chest heaviness, shortness of breath and A-Fib with RVR all on 16Aug2021 13:00. Above adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization and Life threatening illness (immediate risk of death from the event). The patient was hospitalized for above events from 16Aug2021 to 17Aug2021 for one day. Therapeutic measures were taken included EKG, bloodwork, echocardiogram and medications as reported. There was no Covid prior vaccination or Covid tested post vaccination. The events outcome was recovered. The clinical course was reported as follows: 16Aug2021 went to ED for palpations, chest heaviness, shortness of breath. EKG revealed A-Fib with RVR. No previous history. After 5 hours in ED, converted to normal sinus rhythm with Cardizem IV drip. Cardizem drip stopped and placed on by mouth. Heparin drip started. Spent night in hospital and had echocardiogram next morning (17Aug2021). Test revealed asymmetric septal hypertrophy, thickening of heart muscle wall. Discharged on diltiazem and apixaban. PCP said was due to vaccine and after a few months with no events, will be able to discontinue medications. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cardiac septal hypertrophy, hypertrophic cardiomyopathy, palpitations, chest discomfort, atrial fibrillation and dyspnea cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: MONTELUKAST; CETIRIZINE; OMEPRAZOLE; SYMBICORT

Current Illness:

ID: 1730487
Sex: F
Age:
State: SC

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 2021; Test Name: TB test; Result Unstructured Data: Test Result:Unknown; Comments: had TB test done for work.

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: left leg from the thigh down to her foot was numb and tingling, on and off after first dose/left leg from thigh down to foot was numb or tingling after second dose; left leg from the thigh down to her foot was numb and tingling, on and off after first dose/left leg from thigh down to foot was numb or tingling after second dose; arm where she got the shot was sore after first dose/after her second dose; her left arm is sore; This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: FW0173, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 24Aug2021 at 15:45 hours as dose 1, single (at the age of 37-years-old) and received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: 30135BA, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 15Sep2021 at 09:15 hours as dose 2, single (at the age of 37-years-old) both for COVID-19 immunisation (at Clinic). Patient had no medical history (including any illness at time of vaccination) and had no relevant family medical history. Patient had no prior vaccinations (within 4 weeks). Patient had no additional vaccines administered on same date of the Pfizer suspect. Patient did not receive any other products/concomitant medications. Patient stated that she was healthy with no health issues and takes no medication. On 24Aug2021, patient stated that the arm where she got the shot was sore. On 25Aug2021, after the first dose, the second day, patient experienced that her left leg from the thigh down to her foot was numb and tingling, on and off. Patient stated that first time arm was sore for two days. On 15Sep2021, patient got her second dose and her left arm was sore; and her left leg from thigh down to foot was numb or tingling and it was doing the same thing, it was back the same way, it feels funny. Patient stated that she did not feel that feeling until when she goes to bed at night, she laid down it starts to feel numb and tingling, last night (15Sep2021) up to today (16Sep2021) and now she was at work in the day, and it had the same feeling and stated that arm was still sore from the second dose. Patient stated that her left leg from the thigh down to her foot was numb and tingling, never totally stopped since then it was persisting, and patient still experience this until now. No relevant tests were performed. Patient just called the doctor this morning (16Sep2021) and they gave her the number to call Pfizer, but if her symptoms do not go away, she was going to call back to be seen. Patient had no emergency room and physician office visit for the events. On an unspecified date 2021, patient had tuberculosis (TB) test done for work and results were unknown. The outcome of all the events was not recovered.

Other Meds:

Current Illness:

ID: 1730488
Sex: F
Age:
State: NC

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Swelling is still there under her arm; Arm was sore; Extra dose administered; Off-label; This is a spontaneous report from a contactable consumer (Patient). A 65-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, Batch/Lot Number: 30130BA), Solution for injection, via an unspecified route of administration, administered in Arm Right on 14Sep2021 between 10:30 and 11 am (age at vaccination 64-year-old) as single dose for covid-19 immunisation. Medical history included Blood pressure high and may be little obesity. Concomitant medication included lisinopril taken for hypertension 30 mg once a day, carvedilol taken for hypertension 25 mg once a day and amlodipine taken for hypertension 5 mg a day. Patient did not receive any other vaccine within four weeks of receiving Pfizer vaccine. No additional vaccines were administered on same date of the Pfizer suspect. Patient received her first dose of the Pfizer COVID vaccine was on 07Mar2021 (batch lot number: EN6206) administered in her right arm and received her second dose of the Pfizer COVID vaccine was administered on 30Mar2021, (batch lot number EP7533) administered into her right arm for covid-19 immunisation. On 14Sep2021, patient received extra dose which was off label. On 15Sep2021, her arm was sore and had swelling and was puffy under her armpit. As per the report, patient received her booster dose of the Pfizer BioNTech Covid 19 vaccine on 14Sep2021. Yesterday her arm was sore and had swelling and was puffy under her armpit. It was staying about the same but the swelling was still there under her arm today. No relevant test was performed. Patient did not visit to emergency room or physician office due to adverse events. At the time of this report, the outcome of swelling was still there under her arm was not recovered and other events was unknown.

Other Meds: LISINOPRIL; CARVEDILOL; AMLODIPINE

Current Illness:

ID: 1730489
Sex: M
Age:
State: AL

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210903; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: endocarditis; This is a spontaneous report from a Contactable Other HCP. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 23Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient received the first dose of bnt162b2 on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced endocarditis on 23Aug2021 with outcome of unknown. Patient was hospitalized for 20 days. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient had Nasal Swab on 03Sep2021 with negative result. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of endocarditis 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: 1730490
Sex: M
Age:
State:

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: flu symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported that: A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 as single dose for COVID-19 immunisation and experienced sore arm. On an unspecified date in 2021, the patient experienced flu symptoms for 36 hours after receiving the Pfizer-BioNTech COVID-19 vaccine. The clinical outcome of the event was reported as recovered on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1730491
Sex: F
Age:
State: CA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Sore Arm; This is a spontaneous report from a contactable consumer (patient's husband). A 65-years-old female patient (reporter's wife) received first dose of BNT162B2 (COMIRNATY VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot Number: EN5318) as dose 1, single and received second dose of BNT162B2 (COMIRNATY VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EN6203) as dose 2, single for covid-19 immunization (at the age of 65-years-old). Medical history included ongoing rheumatoid arthritis (diagnosed about 26 years ago). Concomitant medication(s) included adalimumab (HUMIRA) taken for rheumatoid arthritis from 2004 and ongoing. Reporter called on behalf of his wife and stated that after receiving the first dose of vaccine on 04Feb2021 the patient experienced sore arm and stated that she experienced the same after receiving second dose of vaccine as well which received on 26Feb2021. The patient had no reactions to the vaccine except soreness in the arm that started the same day and was gone by the next day. The patient did not receive any treatment for the event. The outcome of the events was recovered initially on 05Feb2021 and later on 27Feb2021. No follow-up attempts are needed. No further information is expected.

Other Meds: HUMIRA

Current Illness: Rheumatoid arthritis (Diagnosed about 26 years ago)

ID: 1730492
Sex: F
Age:
State: CO

Vax Date: 06/19/2021
Onset Date: 06/21/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: pulmonary embolism; pulmonary infarction; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Jun2021 12:00 (Lot Number: ER8724) at the age of 38-year-old as DOSE 2, SINGLE, for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Arm Left on 29May2021 11:00 (Lot Number: ER8729) at the age of 37-year-old as DOSE 1, SINGLE for covid-19 immunisation. The patient developed a pulmonary embolism, pulmonary infarction both on 21Jun2021 with outcome of recovering. Therapeutic measures were taken as a result of both events with anticoagulation and blood thinner medication. Events reported as serious with life threatening. Events caused doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient is not pregnant. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1730493
Sex: F
Age:
State: MA

Vax Date: 04/08/2021
Onset Date: 09/13/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210913; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: lack of efficacy- fully vaccinated with CV19 + via PCR on 15Sep2021.; lack of efficacy- fully vaccinated with CV19 + via PCR on 15Sep2021.; This is a spontaneous report from a contactable other healthcare professional. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular route, administered in arm left on 08Apr2021 (Lot Number ER8729 and expiry date was not reported, at the age of 31-year-old) as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular route, administered in arm left on 29Apr2021 (Lot Number ER8736 and expiry date was not reported, at the age of 32-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. On 13Sep2021, the patient underwent COVID test post vaccination, PCR (Nasal Swab) which was positive. It was unknown if patient received treatment for AE. It was reported lack of efficacy- fully vaccinated with CV19 + via PCR event reported on 15Sep2021. Device Date was 16Sep2021. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relationship the causal role between the events Vaccination failure and SARS-CoV-2 test positive cannot be fully excluded. However the possibility of Covid being an intercurrent condition cannot be ruled out.

Other Meds:

Current Illness:

ID: 1730494
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: He was sick for 3 weeks after the 2nd dose; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced could not move his fingers for 2 weeks after the first dose. She got both of the Pfizer COVID 19 vaccines. She will not get the booster dose. Caller stated that looking at how many had reactions and how many people died, Pfizer did not do so well. He was sick for 3 weeks after the 2nd dose. Caller stated a report that had information about the vaccines stating Pfizer and Moderna, showed that Pfizer had the highest number of reactions, lowest number of reported cases and highest numbers of deaths. Caller stated this was a "PRIVACY" report. Caller stated there were 7000 deaths and it was not over yet. Caller stated her husband will not get the vaccine because he thinks it was poetic garbage and bull. The outcome of sickness was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730495
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

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

Symptoms: sick; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A 20-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and was fine. On an unspecified date, after their second dose, patient felt as sick as they did when they had Covid (prior to vaccination). The outcome of the event was recovered on an unspecified date. Patient asked if there had been any data collected on how long the antibodies hang around in a person body and asked if they can mix the Moderna and the Pfizer doses, patient stated that she had heard of people that mix the series if one or the other was not available. Patient also asked that if Pfizer can explain why they were that sick, and if they get the booster dose, will they get as sick again. The outcome of the event was recovered on an unspecified date. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101229081 same reporter/drug/AE, different patients

Other Meds:

Current Illness:

ID: 1730496
Sex: M
Age:
State: IN

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: he had an outbreak of shingles around his right cheek and scalp area/Shingles rash; new bumps on the right cheek; it's been like a burning rash in the face with bumps, pus, welts, and stuff/got a rash on the right cheek; it's been like a burning rash in the face with bumps, pus, welts, and stuff; it seems like his immune system is laid low and has been compromised; This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, mRNA, formulation: Solution for injection, Batch/Lot Number: EM9810; Expiration Date: 30Jun2021, patient was 72-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 12Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included stent placement, he has 4 heart stents and so this would show he is a heart patient, blood pressure, Cholesterol medication, shingles. Concomitant medication(s) included metoprolol (METOPROLOL) taken for blood pressure, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for blood cholesterol, start and stop date were not reported; ezetimibe (EZETIMIBE) taken for blood cholesterol, start and stop date were not reported; losartan potassium (LOSARTAN POTASSIUM). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: E19262, stated Lot Could be an EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in Arm Left on 22Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. It was reported that 2-3 days post vaccination he had an outbreak of shingles around his right cheek and scalp area. The ER doctor and GP said it was shingles. He has read that the shot has been tested or shown to cause shingles. The outbreak was different this time as the medication he takes to treat shingles is not currently working. Caller states he looked on Pfizer website shingles has been related to the COVID-19 vaccine. He just wants to know if it's directly or correlated related to Pfizer COVID-19 vaccine. He also mentioned herpes virus can be aggravated with Pfizer COVID-19 vaccine that's why an outbreak is bound to happened. Caller states that this stuff wont go away, he has had it since the first of Mar2021. He First started this product on 26May2021. Caller adds that prior to the Valtrex generic he was on Acyclovir for years and then was put on the Valtrex generic. Caller clarifies that the Valtrex generic is actually called Valacyclovir. He confirms he was first on Acyclovir, then Valacyclovir, and now Famciclovir. He remembers that they told him he would have to take the Valacyclovir one time a day He confirms it was 500mg tablet and he was taking 2 of them once a day and that's why he wanted to go on it. He was taking Famciclovir 250mg but that do not work, and as soon as he ran out his face starts breaking out. His Initial Loading Dose was 250mg 2 tablets by mouth every 8 hours. After that his Maintenance dose was 250mg 2 tablets a day, NDC 6042936030, Lot GS036595 Expiry Date Dec2022. He was having fresh break outs; he's never had it like that before. He clarified that he had shingles in the past and for the last 10 years but usually it will go away when he's taken a maintenance dose, but this is different it wont go away. It's usually always curable and has never presented itself on the face like this in the past. Caller is looking in his phone trying to find earliest time that he had taken pictures because he has not been plagued with this before like this. Caller states that he had pictures available if needed. He was a patient at the veterans administration. He was taking another type of cyclovir medication prior in which he does not recall the whole name right now. The previous one worked great for a while and then it stopped working. The Previous cyclovir medication which stopped working, he was taking it prior to famciclovir and then he was switched to famciclovir. He states that he is having a mental block at the moment, but he recalls its the generic of Valtrex. Shortly after the Pfizer shot, he has read on websites that this will kick up chicken pox virus. Prior vaccination his immune system was gold. It is getting better, but after he ran out pills in 24 to 32 hours and had none, he would get it from a facility, he had them call it in the pharmacy, got it and paid for it, went and got it, and started with the initial prescribed dosage and thought he was cured, it did dry up but this morning it is right back again, not as bad as it has been in the past but it is 40% not as bad since he is on medication and taking it as prescribed. One time he went to a Dermatologist, and they gave an antibiotic for it, he has still got it, he still has it on hand. Acyclovir: 800mg and was taking 2 twice a day. On an unspecified date in Feb2021, the patient experienced he had an outbreak of shingles around his right cheek and scalp area/shingles rash, new bumps on the right cheek, it's been like a burning rash in the face with bumps, pus, welts, and stuff/got a rash on the right cheek, on an unspecified date in 2021, the patient experienced it seems like his immune system is laid low and has been compromised. Therapeutic measures were taken as a result of he had an outbreak of shingles around his right cheek and scalp area/shingles rash, new bumps on the right cheek, it's been like a burning rash in the face with bumps, pus, welts, and stuff/got a rash on the right cheek, it's been like a burning rash in the face with bumps, pus, welts, and stuff with Famciclovir and Valtrex, Valacyclovir. The outcomes of events (it seems like his immune system is laid low and has been compromised) were unknown, and the outcomes of events (he had an outbreak of shingles around his right cheek and scalp area/Shingles rash) was recovering, and the outcomes of events (new bumps on the right cheek, it's been like a burning rash in the face with bumps, pus, welts, and stuff/got a rash on the right cheek) was Not recovered.

Other Meds: METOPROLOL; ROSUVASTATIN; EZETIMIBE; LOSARTAN POTASSIUM

Current Illness:

ID: 1730497
Sex: F
Age:
State: CA

Vax Date: 08/27/2021
Onset Date: 08/27/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Tongue getting a tiny bit swollen; Her voice became a little raspy; A little difficulty breathing and had to take a deep breath; A little while later her teeth began to chatter which she had not experienced since she was a child; Very lightheaded/Dizziness; Some mild anxiety; It felt like an allergic reaction and it could have been more severe, but it was very mild; This is a spontaneous report from two contactable physician (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/ lot number: FC3183, Expiry Date of BioNTech Covid 19 vaccine was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 27Aug2021 19:00 (at the age of 65 years) as dose 1, single for covid-19 immunization. Medical history included Bladder infections, that was a long time ago about 20 years ago and she had the wheals all over her body she looked like a lizard, her teeth was began to chatter which she had not experienced since she was a child. The patient previously took Nitrofurantoin, an antibiotic for bladder infections and skin wheals. The patient concomitant medications was not reported. On 27Aug2021 the patient experienced tongue getting a tiny bit swollen, her voice became a little raspy, a little difficulty breathing and had to take a deep breath, a little while later her teeth began to chatter which she had not experienced since she was a child, very lightheaded/dizziness, some mild anxiety, it felt like an allergic reaction and it could have been more severe, but it was very mild. Foe AE there was no need to visit emergency room. Therapeutic measures were taken as a result of the events. Outcome of the events was recovering.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between all the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1730498
Sex: M
Age:
State: CA

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

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

Symptoms: Heart pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 57-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: FF2587) via an unspecified route of administration in left arm on 17Sep2021 11:30 as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy/drug store. Patient medical history included known allergies to Penicillun. The concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not received any other medications within 2 weeks of vaccination. On 18Sep2021 02:00, the patient experienced heart pain, sudden semi sharp pain in his heart that lasted for about 5 seconds and returned sometimes in a minute or two. The reported seriousness of the case was non-serious. Patient did not receive any treatment for the adverse events. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1730499
Sex: F
Age:
State: CA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210325; Test Name: heart rate; Result Unstructured Data: Test Result:40 bpm to 150

Allergies:

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

Symptoms: heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (no pregnant) received the first dose of bnt162b2 on 24Mar2021 at 08:45AM (lot number: ER 2613) (at the age of 58-years-old) via unknown route of administration in Right arm at single dose for COVID-19 immunization; the second dose of bnt162b2 on 14Apr2021 at 08:45AM (Lot Number: ER 8735) via unknown route of administration in Right arm at single dose for COVID-19 immunization. Medical history included COPD, Emphysema, Asthma, allergy to egg. The patient received some medications within 2 weeks of vaccination. Patient previously took Eurithimycin and experienced stomache. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. Patient experienced heart palpitations on 24Mar2021 at 10:30 AM. This event resulted in Life threatening illness (immediate risk of death from the event). Patient did not receive any treatment. This event did not result in death, hospitalization, disability or Congenital anomaly. Starting with the 1st Covid shot patient experienced heart palpitations. The second shot after one hour of vaccine patient also experienced heart palpitations but much more serious. Her heart rate was jumping from 40 bpm to 150 on 25Mar2021 and higher back and fourth for over 45 minutes. She was on the interstate on her way home. She thought she was going to die. Since then she now experienced heart palpitations which she had never had before and now some other side effects she had never had either. She still occasionally had heart palpitations. She was going to report this to her physician. The outcome of the event was Recovered with Sequel in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1730500
Sex: F
Age:
State: NM

Vax Date: 08/30/2021
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 202108; Test Name: lab test; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Unevaluable event

Symptoms: she had the condition that she have was kind of neuropathy, it was not kind of severe neuropathy, and she noticed that it has got more intense since she got the shot; she had the condition that she have was kind of neuropathy, it was not kind of severe neuropathy, and she noticed that it has got more intense since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3183, Expiry Date: Unknown), via an unspecified route of administration, administered on 30Aug2021 (at the age of 70-years-old) as dose 1, single for covid-19 immunization. Medical history included hypertension, probably pre diabetes, she was supposed to meet her doctor in a little bit because she had mild stroke in 2021, about 2-3 months back and she had ongoing neuropathy but she don't think it's diabetic neuropathy, it was different, started from my neck down to my toes on one side and knee down to my toes on the other side (not clarified further). Concomitant medications included metoprolol, clopidogrel bisulfate (PLAVIX), irbesartan, ascorbic acid (VITAMIN C). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Consumer stated that she got the first COVID shot on 30Aug2021 and she was due for the second shot on Monday on the 20Sep2021. Since she got first shot, she had the condition that she have was kind of neuropathy, it was not kind of severe neuropathy, and she noticed that it has got more intense since she got the shot in 2021 and she was wondering if she should go and get the shot done on day. The patient just wanted to know if should she take the second shot. She probably got one lab test in Aug2021 with results unknown. The outcome of the events was not recovered.

Other Meds: METOPROLOL; PLAVIX; IRBESARTAN; VITAMIN C [ASCORBIC ACID]

Current Illness: Neuropathy

ID: 1730501
Sex: F
Age:
State: NY

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 2021; Test Name: Antibody test; Result Unstructured Data: Test Result:Unknown results; Comments: Her antibodies went from 1287 to now 1171; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: She did not get a reaction other than a sore arm with the first one; This is a spontaneous report from a Pfizer Sponsored Program Support. A contactable 70-year-old female consumer (patient) reported for herself that: A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 19Jan2021 (at the age of 70-year-old), as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date in 2021, the patient experienced did not get a reaction other than a sore arm with the first dose. Patient has antibodies found in body and asked if patient can take third dose even though still has the antibodies. Patient reported that will see doctor on 01Oct2021 and wanted to see second blood test to see if patient still high in antibodies. Patient's antibodies went from 1287 to now 1171 and known people with Covid who have less antibodies and warn that still if patient can catch the virus. patient has seen other people who have had reactions after the 3rd dose and did not have any information to provide on any of those people. Patient did not want to get sick, and patient reported that did not get a reaction other than a sore arm with the first dose of vaccination. Patient already spoken with someone earlier and received a questionnaire in the mail and never returned it. Patient did not want to provide a complete report at this time and did not have a reference number for previous report and said it was a few months ago and forgot it. Patient received Pfizer COVID Vaccine was 19Jan2021 and did not have the lot or expiration for the first dose and it not written on the card. The second dose was given 09Feb2021 with Lot EM9810 expiration is unknown. Patient reported that on 09Oct2021, it will be 8 months in, and it was just approved to have booster 6 months in and received the vaccines. On unspecified date in 2021 the patient underwent lab tests and procedures which included antibody test: unknown results and antibodies went from 1287 to now 1171, on 2021 blood test: unknown results. The clinical outcome of event was unknown. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1730502
Sex: M
Age:
State: TX

Vax Date: 09/15/2021
Onset Date: 09/18/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210919; Test Name: Fever; Result Unstructured Data: Test Result: UNKNOWN RESULTS.

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Fever; Throwing up; Real Bad toothache; real sick; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: FD8448), dose 2 via an unspecified route of administration, administered in left arm (unable to confirm if given in the muscle) on 15Sep2021 at 10:30 (at the age of 21-years-old) as DOSE 2, SINGLE for COVID-19 immunization. GABAPENTIN, via an unspecified route of administration from 18Sep2021 (Batch/Lot number was not reported) to an unspecified date, at 800 mg, 1x/day (One tablet by mouth once) for an unspecified indication. IBUPROFEN via an unspecified route of administration from 18Sep2021 (Batch/Lot Number: Unknown) to an unspecified date, at 1x/day (Unknown dose. Took 3 tablets by mouth once) for an unspecified indication. NORCO via an unspecified route of administration from 18Sep2021 (Batch/Lot Number: Unknown) to an unspecified date, at 7.5 mg, 1x/day for prophylaxis. Medical history included schizophrenia, was diagnosed 4 months ago, from an unknown date and unknown if ongoing. Family medical history relevant to adverse events allergies. Historical vaccine included first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: EW0185) as dose 1, single administered in left arm (Unable to confirm if he was given in the muscle) on 19Aug2021 (at the age of 21-years-old) for COVID-19 immunization. Patient experienced Indication for use in the case, Tooth pain. Concomitant medication was not re-ported. Other products and investigation assessment reported as no. History of all previous immunization with the Pfizer vaccine considered as suspect or patient age at first and subsequent immunizations if dates of birth or immunizations were not available. Prior Vaccinations, within 4 weeks, and list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. Adverse events following prior vaccinations was none. Patient medical history was reported as none. Provide other relevant medical history including but not limited to these conditions diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes), and obesity. Vaccination facility type at Pharmacy. On 18Sep2021 at 22:00, the patient experienced throwing up and real bad toothache on an unspecified time, fever on 19Sep2021 at 08:30 and real sick on 2021. Patient took the second dose on 15Feb2021. Patient had a bad toothache and took 3 Ibuprofen, a Norco, and Gabapentin. Now, patient was real sick and throwing up and has a light fever. Patient wanted to know if the Pfizer COVID Vaccine tripped that off to happen. Patient did not think about having the vaccine last week before patient gave those things and was wondering if patient was not supposed to give him anything. Patient had an appointment to see primary care provider on 21Sep2021. It was mentioned that yesterday, patient got a real bad toothache and patient forgot that took the shot. Patient later stated has had the toothache on that same tooth for about 2 years. Patient took 3 Ibuprofen, 1 Norco, and a Gabapentin, 800 mg tablets. Patient took one tablet by mouth. Patient did not have the manufacturer, Lot or expiration for any of those medications. It was worrying because had a fever and was throwing up. Patient took Ibuprofen but did not know patient took 3 of them. Patient got those from some lady. Patient got the Gabapentin and Norco from and took it last night. Patient was 21, but acts like a 7 year old and did not know what patient was taking. Patient just wanted to get teeth to stop hurting. Patient started throwing up last night and it worried. Adverse events did not require a visit to emergency room/Physician office. The patient underwent lab tests and procedures which included pyrexia unknown results on 19Sep2021. The outcome of the event pyrexia and illness were unknown while other events were not recovered.

Other Meds: GABAPENTIN; IBUPROFEN; NORCO

Current Illness: Allergy

ID: 1730503
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: flu-like symptoms; fatigue; This is a spontaneous report from a contactable consumer reported for a male patient that: A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced flu-like symptoms and fatigue on an unspecified date with outcome of unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730504
Sex: M
Age:
State: FL

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210903; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210903; Test Name: Covid-19 Antibody test; Result Unstructured Data: Test Result:negative

Allergies:

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

Symptoms: COVID-19 antibody test negative; complained he felt like he had the flu; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a 50-year-old male patient (reporter's husband). A 50 year old male patient had received second dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 13Apr202 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient previously took BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 23Mar2021as single dose for COVID-19 immunization. On 13Apr2021, the patient had experienced felt like he had the flu, but then in a couple of hours it was gone. On 03Sept2021, the patient underwent lab test and procedures which included blood test with unknown result and SARS-CoV-2 antibody test with negative result. The reporter also reported that Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. According to the U.S. Centres for Disease Control and Prevention (CDC), if your body develops an immune response to vaccination, which was the goal, you may test positive on some antibody tests. Some antibody tests would only detect antibodies from infection, not from vaccination with the virus that causes COVID-19. The CDC states that antibody testing was not recommended to determine if a person is immune to SARS-CoV-2 (the virus that causes COVID-19) following COVID-19 vaccination because the usefulness of these tests in vaccinated people has not been established. In addition, antibody tests currently authorized under an EUA are not authorized to determine immune responses in vaccinated people. The outcome of the events were recovered. Investigations: Caller says that for the dates of the antibody tests, her husband and her did not go the same days. The reporter said her husband went and got tested after hers was negative and his were the same tests that she had: SARS CoV 2, IgG NUCLEOCAP, IgM SPIKE, QL as the top one, then indented on the next line it says SARS CoV 2 AB (IgG), NUCLEOCAPSID, QL then SARS CoV 2 AB IGG for specific test with negative next to that, then another title that says negative as well. Caller says that their tests both said negative as well for each result, and her doctor said this morning if one of the two results for the test said positive it would be good, they just did not want both results on the test to say negative. Date for her husband's negative COVID-19 antibody test either not provided or not captured by call handler. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730505
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Covid 19; Test Result: Positive

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on Thursday (05Aug2021), the reporter learned that the person who had sat closest to him and had the Pfizer Covid Vaccine had tested positive for Covid 19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730506
Sex: F
Age:
State: MA

Vax Date: 09/18/2021
Onset Date: 09/19/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210919; Test Name: Body temperature; Result Unstructured Data: Test Result:101.6; Comments: at 14:00

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Severe headache; Fever of 101.6; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the parent. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 301308A) via an unspecified route of administration in the left arm on 18Sep2021 at 14:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and the known allergies were reported as "not that we knew". Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. It was reported that the patient was small for her age and the patient was mandated to get the shot by the school a week before the school started. The patient was healthy. On 19Sep2021 at 14:00, (also reported as 24 hours after vaccination), the patient experienced severe headache, fever of 101.6 (unspecified units), and also had symptoms related to the fever which were chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken for the events of fever 101.6 (unspecified units), chills, and fatigue (reported as managed fever). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, fever of 101.6 (unspecified units), chills, and fatigue was recovering at the time of this report.

Other Meds:

Current Illness:

ID: 1730507
Sex: F
Age:
State: CA

Vax Date: 09/18/2021
Onset Date: 09/01/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210919; Test Name: Heart rate; Result Unstructured Data: Test Result:Elevated

Allergies:

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

Symptoms: Enlarged lymph nodes on left side of neck, clavicle and underarm; Red skin; Feeling very fatigue; Chills; Not feeling well at all; Cannot sleep; Heart rate is elevated; Feel dizzy at times; Headache; Nausea; Haven't been able to eat at all; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 18Sep2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and known allergies to mussels and various face and body creams. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Sep2021 at 16:00, about 4 hours after the vaccination, the patient experienced headache and nausea. The patient still had both the events even 40 hours later. Since an unspecified date in Sep2021, the patient had not been able to eat at all. It was reported that since the night of 19Sep2021 (last night), the patient started to notice many enlarged lymph nodes on the left side of her neck, clavicle and underarm which was in the size of a walnut with red skin on top of them. The patient was feeling very fatigued, was having chills and was not feeling well at all and could not sleep. Also, on the same day, her heart rate was elevated and she felt dizzy at times. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, haven't been able to eat at all, enlarged lymph nodes on the left side of the neck, clavicle and underarm, red skin, feeling very fatigue, chills, not feeling well at all, cannot sleep, heart rate is elevated and feel dizzy at times was not resolved at the time of the report.

Other Meds:

Current Illness:

ID: 1730508
Sex: M
Age:
State: MD

Vax Date: 04/14/2021
Onset Date: 04/17/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210916; Test Name: Nasal swab; Test Result: Negative

Allergies:

Symptom List: Nausea

Symptoms: Lost my sense of smell; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 14Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (controlled). The patient had known allergies to SSKI (Potassium iodide). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 16Mar2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, at 00:00 the patient experienced lost sense of smell. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent nasal swab SAR-COV-2 TEST and the result was negative. The clinical outcome of the event lost sense of smell was resolving at the time of this report.

Other Meds:

Current Illness:

ID: 1730509
Sex: M
Age:
State:

Vax Date: 05/15/2021
Onset Date: 05/01/2021
Rec V Date: 09/24/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: CATs; Result Unstructured Data: Test Result:Unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown

Allergies:

Symptom List: Injection site pain

Symptoms: seizures and went to the hospital; He is debilitated; This is a spontaneous report from a contactable consumer(parent). A 40-year-old male patient started to receive her second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on 15May2021 as DOSE 2, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Historical vaccine included received his first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Not reported) on an unknown date via an unspecified route of administration, as DOSE 1, SINGLE for COVID-19 immunization. On an unknown date the caller stated that her son had severe side effects and can get no help. He's in the hospital now. After the second dose that he had seizures and went to the hospital and released and problems every since. He's had problems since May. He is debilitated. On an unknown date patient took MRIs and CATs in the hospital and the results were unknown. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1730510
Sex: F
Age:
State: CA

Vax Date: 09/11/2021
Onset Date: 09/01/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Very irritable; Severe shooting back pain/ lower back and upper back pain; Neck pain; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 11Sep2021 at 17:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included no thyroid due to thyroid cancer, sulfa (sulfonamide) allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The concomitant medications included lorazepam (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from an unknown date, for unknown indications and unknown if ongoing . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Sep2021, the patient experienced severe shooting back pain with in one hour and for the next 3 days, with lower and upper back pain and on an unknown date in Sep2021 experienced neck pain which would not subside. Also, on 17Sep2021 at 18:30, the patient was very irritable. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shooting back pain, lower and upper back pain and neck pain and very irritable were not resolved at the time of this report.

Other Meds: LORAZEPAM; LIOTHYRONINE; LEVOTHYROXINE

Current Illness:

ID: 1730511
Sex: F
Age:
State: VA

Vax Date: 09/06/2021
Onset Date: 09/10/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Oral lesions; Blisters; Altered taste; Mouth burning; Raw mouth; Sore throat; Swollen tongue; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration on 06Sep2021 at 08:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Sep2021, the patient experienced oral lesions, blisters, altered taste, mouth burning, raw mouth, sore throat and swollen tongue. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events oral lesions, blisters, altered taste, mouth burning, raw mouth, sore throat and swollen tongue was not resolved at the time of the report.

Other Meds:

Current Illness:

ID: 1730512
Sex: F
Age:
State:

Vax Date: 09/18/2021
Onset Date: 09/21/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Small raised bumps on lip; Swelling and itchiness on lip; Itchiness on lip; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in right arm on 18Sep2021 at 10:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in right arm on 26Aug2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 07:00, the patient experienced small raised bumps on lip, followed by swelling and itchiness on lip. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events small raised bumps on lip, swelling and itchiness on lip was not resolved at the time of report.

Other Meds:

Current Illness:

ID: 1730513
Sex: F
Age:
State: CA

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Swollen throat; Numbness in "my" lips and tongue and gums; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183), via an unspecified route of administration in the left arm on 20Sep2021 at 17:30 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included sleep apnea and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO) and bupropion hydrochloride (WELLBUTRIN); both for unknown indication from unknown date and unknown if ongoing. On 20Sep2021 at 17:45, the patient experienced swollen throat, numbness in lips, tongue and gums, headache and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen throat, numbness in lips and tongue and gums, headache and nausea was not resolved at the time of this report.

Other Meds: LEXAPRO; WELLBUTRIN

Current Illness:

ID: 1730514
Sex: F
Age:
State: IL

Vax Date: 09/20/2021
Onset Date: 09/21/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: Weak knees; Fatigue; Pins and needles feeling throughout entire body; Vomiting; Dizzy; Headache; Extreme pain in right arm; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Sep2021 at 10:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression, inflammation of the shoulder, ridiculopathy (radiculopathy) in her arms. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Aug2021 at 17:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 21Sep2021 at 00:15, the patient experienced weak knees, fatigue, pins and needles feeling throughout her entire body, vomiting 14 hours after vaccine for 7 hours, dizzy, headache and extreme pain in her right arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weak knees, fatigue, pins and needles feeling throughout her entire body, dizzy, headache and extreme pain in right arm were not resolved, while that of the event vomiting was resolved on 21Sep2021 at 07:15, after the duration of 7hours. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730515
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: No menstrual cycle since she received the vaccine; This is a spontaneous report from a non-contactable consumer. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in 2021, the patient had no menstrual cycle since she received the vaccine and it had been 2.5 months. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event no menstrual cycle since she received the vaccine was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730516
Sex: F
Age:
State: NY

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Pain in right underarm; Period cycle changed; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the right arm on 17Sep2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 26Aug2021 at 18:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 18Sep2021 at 01:00, after the second dose, the patient experienced pain in right underarm and her period cycle had changed as well. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain in right underarm and period cycle changed were recovering at the time of this report.

Other Meds:

Current Illness:

ID: 1730517
Sex: M
Age:
State: CT

Vax Date: 03/25/2021
Onset Date: 09/19/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: diagnosed Shingles; This is a spontaneous report from a contactable pharmacist reported. A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via intramuscular, administered in arm right on 25Mar2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. No medical history and concomitant medications were reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via intramuscular, administered in arm right on 02Mar2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. On 19Sep2021, the patient was diagnosed shingles and treated with valganciclovir. The adverse event result in Doctor or other healthcare professional office/clinic visit. No Serious criteria was provided. Outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1730518
Sex: F
Age:
State:

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: tachycardia; heart palpitations; diarrhea; ocular migraine to right eye; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was experienced tachycardia, heart palpitations, and diarrhea for 8 days. Also complaining of a ocular migraine to right eye that was till present at the time of reporting. The patient was asking should she take the next dose, since she had the severe allergic reaction to the first dose in 2021. Outcome of the events tachycardia, heart palpitations, and diarrhea was recovered in 2021; for event ocular migraine to right eye was not recovered and other event of severe allergic reaction was unknown. The U.S. Centres for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for use of Pfizer-BioNTech COVID-19 Vaccine during the EUA. These interim clinical considerations from ACIP note the following: If the second dose is given later than 6 weeks (42 days), the vaccination series does not need to be repeated. There are only limited information available on how well the vaccine protects against COVID-19 if given after this amount of time. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1730519
Sex: F
Age:
State: WI

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: body aches, achy; severe headache; chills; This is a spontaneous report from a contactable other healthcare professional (medical technologist, patient) from a Pfizer Sponsored Program. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced quite a few body aches, achy, severe headache and chills on an unspecified date in 2021. The outcome of the events was unknown. The patient was querying if she can take her migraine medication (Rizatriptan 10mg). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730520
Sex: F
Age:
State: MA

Vax Date: 02/14/2021
Onset Date: 02/15/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Diarrhea; sore arm; Nausea; really tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EM9809, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 14Feb2021 at 14:00 (at the age of 55 years old) as dose 1, single for COVID-19 immunisation. Medical history included unspecified allergies and asthma - both diagnosed as a kid from an unknown date. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included flu shot given on an unspecified date in Oct2020 (at the age of 55 years old) for immunization. On 15Feb2021, the patient experienced sore arm, nausea and had been really tired. Then on 16Feb2021, the patient had diarrhea and was nausea but no fever. The events did not require visit to an emergency room nor to Physician Office Visit. The patient was asking if she should expect the same side effects during the second dose and if it will be worse and was also asking if these maybe related to her allergies. Furthermore, the patient heard that the symptoms after the second dose could be worse and wanted to know what she can expect, if that is true. The patient recovered from diarrhea on 16Feb2021 and was recovering all other events. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1730521
Sex: F
Age:
State: SC

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: body aches; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches after the first dose on an unspecified date. Event was reported as non-serious. It was reported that the patient isn't getting the "real deal", she does not even have redness, she does not feel sick at all. She wanted to know if it is ok and if she could take the second dose on 03Mar2021 as scheduled. The patient wanted to know if she is protected by the vaccine or not and was querying when she will be tested negative after the vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730522
Sex: M
Age:
State: MA

Vax Date: 02/14/2021
Onset Date: 02/15/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: congestion in his throat; pain in the jaw that radiated from his jawbone up to the ear; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EL9266, Expiration Date not reported) via an unspecified route of administration, administered in the right arm on 14Feb2021 08:00 (at the age of 76-years-old), as dose 1, single for COVID-19 immunisation. Medical history included stroke from 2017 and ongoing. Concomitant medications included warfarin taken for stroke from 2017 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other vaccines was administered with COVID-19 vaccine. The patient experienced pain in the jaw that radiated from his jawbone up to the ear on 15Feb2021 and congestion in his throat on 17Feb2021. Patient reported he had a lot of congestion in his throat that doesn't go up or down. He did not have any other problems and nor was he not feeling well. At night things were worse for him.. He reported that he was scheduled to get the second dose 07Mar2021. Patient took paracetamol (TYLENOL) every 8 hours as a result of pain in the jaw. Event did not result to either physician office or emergency room visit. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: WARFARIN

Current Illness: Stroke

ID: 1730523
Sex: F
Age:
State: NY

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: crazy cramps in her legs and they hurt. It comes and goes more in the left leg than the right leg; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Lot Number: EL9267, Expiration Date not reported) via an unspecified route of administration, administered in the left arm on 10Feb2021, between 10:30 to 11:30 (at the age of 72-years-old), as dose 1, single for COVID-19 immunisation. Medical history included HIV (reported as It is undetectable. She was diagnosed in 1995 or 1996). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other vaccines was administered with COVID-19 vaccine. The patient experienced crazy cramps in her legs and they hurt. it comes and goes more in the left leg than the right leg on 11Feb2021. It was reported that it was in the muscle and in the back of the thighs. Patient was inquiring on how to stop this. Her next dose was scheduled on 03Mar2021. Event did not result to either physician office or emergency room visit. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1730524
Sex: F
Age:
State: MD

Vax Date: 01/29/2021
Onset Date: 02/17/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: hurt her back when she reached down to pick up something / back was hurting; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the right arm) on 29Jan2021 (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing arthritis in her back (diagnosed about 5 years ago). The patient's concomitant medications were not reported. The patient has no other vaccines on the same day of COVID vaccine. The patient hurt her back when she reached down to pick up something / back was hurting on 17Feb2021. The patient further reported that she has a question concerning if a medication will impact her next COVID vaccine dose. She had the first dose on 29Jan2021 and was scheduled for her second dose tomorrow. The patient stated that she hurt her back yesterday and the orthopedic doctor prescribed her a Methylpredisone Pack. She stated that she has not started it yet, because she saw that it was contraindicated with vaccines, so she was just wondering if that was accurate and if she should wait to start it until after taking her 2nd dose. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness: Back arthritis (diagnosed about 5 years ago)

ID: 1730525
Sex: F
Age:
State:

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: altered taste-metallic taste; hungry; tired; This is a spontaneous report from a contactable consumer (patient) received via Information Team. An 83 (unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 22Jan2021 08:00 (Batch/Lot number: not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history included immunocompromised. Concomitant medications were not reported. On 22Jan2021, that evening, the patient experienced altered taste-metallic taste which went away the next morning. The patient was also very hungry and tired after the dose on unspecified dates in 2021. The patient recovered from altered taste-metallic taste on 23Jan2021 while the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730526
Sex: F
Age:
State: TX

Vax Date: 02/19/2021
Onset Date: 02/20/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Chills; migraine; dizziness; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: El9267), intramuscularly, administered in right arm on 19Feb2021 at 15:30 (age at vaccination was 45-year-old) as dose number unknown, single for COVID-19 immunization. The patient's medical history included ulcerative colitis. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as workplace clinic. On 20Feb2021, the patient experienced chills, migraine, dizziness, and body aches. No therapeutic measures were taken as a result of the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1730527
Sex: F
Age:
State: CA

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Twitching of tongue; intermittent right hand numbness; nasal discomfort; Headache; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 20Feb2021 10:00 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced known allergies. The patient was not pregnant at time of vaccination. The patient did not have COVID-19 prior to the vaccination. No COVID-19 tested post vaccination. The patient was not received other vaccine in four weeks and other medications in two weeks. The patient experienced twitching of tongue, intermittent right hand numbness, nasal discomfort and headache on 20Feb2021 20:00. No treatment was received for the adverse events. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1730528
Sex: F
Age:
State: VA

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 09/24/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210207; Test Name: blood work; Result Unstructured Data: Test Result:unknown results

Allergies:

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

Symptoms: wobbly and hardly able to walk; terrible; Dizzy; she fell asleep on sofa / would not wake up; sore arm; no recollection of the phone call; tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in right arm on 05Feb2021 at 12:00 (age at vaccination was 56-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included leg and back spasms, Ehlers-Danlos syndrome (diagnosed prior to vaccine), pain (takes oxycodone, and acetaminophen and codeine; both on and off since the 1980s); allergic to stuff and to a skin product that goes on her feet, and secondary infection. Concomitant medications included caffeine, codeine phosphate, paracetamol (ACETAMINOPHEN WITH CODEINE, reported as 300 mg / 30 mg tablet) from an unspecified date for pain, ongoing clobetasol from 04Feb2021 for allergic reaction to a skin product, ongoing diazepam (VALIUM) from Jan2021 for leg spasms and pain management for Ehlers-Danlos syndrome, ongoing doxycycline from an unspecified date for secondary infection, oxycodone 10 mg tablet from an unspecified date for pain and paracetamol (TYLENOL) from an unspecified date for pain management for Ehlers-Danlos syndrome. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient experienced sore arm, no recollection of the phone call, and tired all on 05Feb2021; dizzy and she fell asleep on sofa on 06Feb2021; would not wake up, wobbly and hardly able to walk, and terrible all on 07Feb2021. The patient further reported that she was in the COVID-19 clinical trial. The patient had the vaccine on 05Feb2021 at 12:00 and had a sore arm. She stated that on the evening her friend called, and she has no recollection of the phone call because she was so tired. On 06Feb2021 (next morning, Saturday) when she woke up, she was really dizzy, knocked a lamp over and cut her hand opening a box, went to ER and got it glued. She fell asleep on sofa on night and her mother called her 8 times on morning of 07Feb2021 (Sunday) and she would not wake up. The patient's mother came into her house and aroused her. She was wobbly and hardly able to walk. She triaged herself with primary care who told her to go to the emergency room and it took 3 people to get her to there. She was in the emergency room all day (Sunday), patient was very tired, just terrible, and couldn't make phone calls or hold drinks. The patient was not admitted. She went to primary care doctor and asked to test her for everything. She did blood work and exact values were not provided. It was reported that her immune system is off the charts and she was afraid of taking the second dose of the vaccine. The patient underwent lab tests and procedures which included blood test (blood work) with unknown results on 07Feb2021. The outcome of the event sore arm was recovered on 07Feb2021, tired was recovering; dizzy, wobbly and hardly able to walk was recovered all on 08Feb2021 and while the outcome for all the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: ACETAMINOPHEN WITH CODEINE; CLOBETASOL; VALIUM; DOXYCYCLINE; OXYCODONE; TYLENOL

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am