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: 1646457
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210802; Test Name: Covid test/Nasal swab; Test Result: Positive.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: This is a spontaneous report from a contactable consumer or other non-health care professional. A 77-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 (Age time of vaccination; 77 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On an unspecified date in Jul2021, the patient experienced fatigue, diarrhoea, nasal congestion, and labored cough. The patient underwent lab tests and procedures which included Covid test/nasal swab: positive on 02Aug2021. The patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1646458
Sex: M
Age:
State: AL

Vax Date: 02/22/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
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: 202103; Test Name: Colonoscopy; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:no evidence of stroke activity

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: in Apr2021 he was diagnosed with Colon Cancer; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. This consumer reported different events for different vaccine doses for the same patient. This is one of the two reports. A 67-year-old male patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 22Feb2021 (at the age of 67-years-old) (Batch/Lot Number: EL9264) single, for COVID-19 immunization. Medical history included pancreatitis from 2020, heart attack from an unknown date and unknown if ongoing (2 heart attacks about a decade ago), high blood pressure (he is on a medication for this and it is under control), high cholesterol (he is on a medication for this and all his levels are healthy), stroke from Dec2017, and COPD (for which the patient takes no medications for). Last year he was sent for a test to determine if he had pancreatic cancer, it was to a specialist in (withheld), the name of the procedure is unknown but they go down into the small intestine with a contrast into the pancreas and as a result of that he got pancreatitis, he lost 50lbs in 6 months getting over that. Prior to the pancreatitis, he has had 2 heart attacks back about a decade ago. He had a triple bypass about 6 years ago 2014 or 2015 the outcome was no problems at all, the only time a cardiologist comes was when he has to be cleared for some other procedure. They have him on Plavix daily dose for a blood thinner. In 2017, he suffered a series of strokes in the back of the brain, that's where the damage was, located in the artery that comes up from brain and forms a Y, there was a blockage in there, an inch of the blood vessel collapsed, there was leakage there and found 3 different spots where there was injury. He had an MRI this year and there was no evidence of stroke activity. The stroke was in Dec2017 and he was not cleared to return to work. Concomitant medication included clopidogrel bisulfate (PLAVIX) taken as a blood thinner, start and stop date were not reported; and other unspecified medications. The patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) on 01Feb2021 (Lot number: EL3247); the patient had zero reactions to this shot. Earlier this year in Apr2021, the patient was diagnosed with colon cancer. In Apr2021 this year, they did a colon resection and removed 12 inches. Also in Apr2021, they referred him to an oncologist because of his examination, he had a colonoscopy. The surgeon said because this was spotted early, there was no reason for follow up treatment or chemo. The colonoscopy was done in Mar2021 and the doctor was his surgeon. He had actually been doing the colonoscopy's on him for a long time, and the spot that turned into cancer was something he, the doctor, had already been monitoring and was nothing new. It was reported that the spot was noticed way before him receiving his COVID vaccines in Feb2021. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202100999866 same report/patient, different vaccine dose/event

Other Meds: PLAVIX

Current Illness:

ID: 1646459
Sex: U
Age:
State: IA

Vax Date: 04/01/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
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: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:fever; Comments: Ran a fever and miserable for three days; Test Date: 20210729; Test Name: Covid 19; Result Unstructured Data: Test Result:diagnosed with Covid 19

Allergies:

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

Symptoms: Diagnosed with Covid 19; Diagnosed with Covid 19; Ran a fever and miserable for three days; Infections; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Apr2021 as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Apr2021 as dose 1, single both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the Pfizer two shots in April of 2021. On 29Jul2021, the patient experienced diagnosed with Covid 19. Ran a fever and miserable for three days in 2021. Patient thought breakthrough infections was higher than being reported in 2021. Should be tracked. The patient underwent lab tests and procedures which included body temperature: fever in 2021 and sars-cov-2 test: diagnosed with covid 19 on 29Jul2021. 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: 1646460
Sex: M
Age:
State: CO

Vax Date: 06/04/2021
Onset Date: 06/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210802; Test Name: Abbott Binax NOW; Test Result: Positive; Comments: Nasal swab

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This is a spontaneous report from a contactable consumer (patient's mother). A male baby of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0187) via trans mammary route on 04Jun2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0217) on 25Jun2021 as single dose for COVID-19 immunization. Patient had no medical history or known allergies. Patient concomitantly received prenatal multivitamins via trans mammary route within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. On 04Jun2021, patient received first dose of vaccine via trans mammary route (Vaccine exposure via breast milk) and later received second dose on 25Jun2021. On 02Aug2021, patient underwent lab test of Abbott BinaxNOW (Nasal Swab) and was tested positive, diagnosed with COVID-19. As per reporter (patient's mother), since her child got COVID-19, so the antibodies transferred through her breastmilk wasn't enough to protect him. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100998441 Mother case

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1646461
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; Brain fog,usually when you kind of feel retarded,like you had concussion or stroke or high altitude sickness,like less oxygen in brain,you just felt kind of gazed/confused or you felt extremely tired; vertigo; This is a spontaneous report from a contactable nurse (psychiatric nurse at a mental institute; reporting for the second family member, who also had the same symptoms, as reported). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient, who was described as another family member of the reporting nurse and had the reporting nurse's DNA, further described as another sibling, experienced "brain fog, usually when you kind of feel retarded, like you had a concussion or stroke or high altitude sickness, like less oxygen in the brain, you just felt kind of gazed or confused or you felt extremely tired." The reporting nurse didn't know if there was a bad batch, but they got like a horrible batches of Pfizer; had no clue and did not know if it got mixed with something else. The reporting nurse also mentioned that they (all) had tiredness; they went to sleep for 8 hours, woke up for 2 or 3 hours, and got some coffee, then were really tired, then had to lay in bed and deal with vertigo on an unspecified date. The 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: There is a reasonable possibility that the event fatigue was related to BNT162b2 based on known drug safety profile. The association between the events feeling abnormal and confusion can not be fully 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: 1646462
Sex: F
Age:
State: PA

Vax Date: 05/28/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
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: Shingles; pain in eye; This is a spontaneous report from a contactable consumer. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28May2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included appendectomy in 2011, chickenpox as a child, and also have sulfonamide (sulfa) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took chlorhexidine (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included levonorgestrel (MANUFACTURER UNKNOWN) for birth control on unknown date, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021, within 28 days of second dose of vaccine, the patient was diagnosed with Shingles within 28days of second dose of vaccine. This was first experience with shingles. Previously, the patient had chickenpox as a child. The patient was in good general health. Diagnosed with shingles within 2 days of symptoms and took prescription Valtrex. The patient visited to emergency room at eye hospital due to pain in eye. Therapeutic measures were taken as a result of adverse event shingles and included treatment with prescription drug Valtrex. Since the vaccination, the patient had not been tested for COVID-19. The events singles resulted in doctor or other healthcare professional office/clinic visit. The event pain in eye resulted in emergency room/department visit or urgent care. The clinical outcome of the event pain in eye and shingles was recovering at the time of this report. The batch numbers for BNT162b2 were not provided and will be requested during follow up.

Other Meds: LEVONORGESTREL

Current Illness:

ID: 1646463
Sex: F
Age:
State: IL

Vax Date: 05/14/2021
Onset Date: 06/04/2021
Rec V Date: 08/28/2021
Hospital: Y

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: 20210711; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Cerebellum stroke, flocculus modular area; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 14May2021 09:00 (Batch/Lot Number: EW0172) (at age 53-year-old) as dose 2, single for covid-19 immunisation. The first dose was received on 23Apr2021 13:00 on the left arm. There were no medical history. Concomitant medication included CBD for sleep and occasional calcium supplement. The patient experienced cerebellum stroke, flocculus modular area on 04Jun2021 05:30. The patient was hospitalized for cerebellum stroke, flocculus modular area (cerebellar infarction) for 3 days. Event resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Jul2021. Medication, testing/monitoring, physical therapy was given as treatment. Outcome of the event was recovered with sequel. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested on 11Jul2021 (nasal swab: negative).

Other Meds: CALCIUM

Current Illness:

ID: 1646464
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

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

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Tested positive for Covid and he had the Pfizer vaccine; Tested positive for Covid and he had the Pfizer vaccine; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection, lot number: unknown; expiration date: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history was not provided. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA). On an unspecified date patient tested positive for covid and patient has not had any issues other than loss of smell. Patient had the Pfizer vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. 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: ALLEGRA

Current Illness:

ID: 1646465
Sex: F
Age:
State: NJ

Vax Date: 02/09/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
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: 20210803; Test Name: temperature; Result Unstructured Data: Test Result:100.3; Test Date: 20210804; Test Name: temperature; Result Unstructured Data: Test Result:100.3; Test Date: 20210804; Test Name: rapid Covid testing/QuickView at home OTC Covid-19 test; Test Result: Negative

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: tiredness; voice is scratchy; Chills; low grade temperature; slight cough; could feel lymph nodes swollen; stuffy nose off and on; felt like her body was fighting something, something was off; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 37-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 09Feb2021 as DOSE 2, SINGLE for to protect her and family from Covid19 and elderly compromised family, children too young for vaccine. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL3247, patient was 37-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Left on 21Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. It was reported that patient got the Pfizer BioNTech Covid vaccine at mid-morning/late afternoon and then both her children (2 out of 3) both tested positive for Covid and she came down with symptoms. She did an over-the-counter rapid test, and it was negative, and it was suggested for her to retest in 24-36 hours. Patient weighs between 165-170 pounds. Reported that the oldest child was showing symptoms went to the withheld and took a test on Thursday evening, 29July2021 and got the positive results back on Monday, 02Aug2021. The middle child's symptoms started a couple of days after the oldest on Friday, 30July2021 and because of the weekend they went to submit a test Monday, 02Aug2021 and got those results back late last night which was also positive. She ensured the control line showed and worked properly. It suggested for her to retest in 24-36 hours. No History of previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines Administered on Same Date of the Pfizer Suspect. On 03Aug2021, the patient experienced voice is scratchy, chills, low grade temperature, slight cough, could feel lymph nodes swollen, stuffy nose off and on, felt like her body was fighting something, something was off, on 04Aug2021, the patient experienced tiredness. The patient underwent lab tests and procedures which included temperature resulted as 100.3 on 03Aug2021, temperature resulted as 100.3 and rapid Covid testing/QuickView at home OTC Covid-19 test resulted as negative on 04Aug2021. Patient received treatment for low grade temperature with Advil. Reported that after taking advil at night before bed for the temperature/slight fever and it seemed to help and next day she woke up and she didn't feel like she had a fever at all but had other events. No AE(s) require to visit emergency Room and physician office. The outcome of event (low grade temperature) was recovered on an unspecified date in 2021 and outcomes of all other events were not recovered. Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646466
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: I rush to the hospital with abdominal pain; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient was a bariatric patient and had gastric sleeve done. Concomitant medication was not reported. On an unspecified date, the patient rushed to the hospital with abdominal pain. The event caused hospitalization. The patient said that he just wanted to know was there any connection between the COVID-19 vaccine in bariatric patient that get bariatric sleeve. he outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646467
Sex: M
Age:
State: MA

Vax Date: 08/02/2021
Onset Date: 08/02/2021
Rec V Date: 08/28/2021
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: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Not feeling right; No idea where I was; Struggling to stay on the chair; blacked out; had a wave of heat hit my body/heat rushed back into my body; sweat/ skin was dripping; Head felt like it was being squeezed; Eyes rolled into the back of my head; my whole body was convulsing; I was ice cold; my body jerked; This is a spontaneous report from a contactable consumer via COVAES. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 02Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that within 2 minutes the patient started not feeling right; he woke up with his head against the shelf and had no idea where he was. The person who gave the shot was nowhere to be found and his wife and son were talking a few feet away. The patient's wife quickly noted he was struggling to stay on the chair and ran over to help. The patient told her he was not okay and then blacked out. Within about a minute the patient had a wave of heat hit his body; it felt like he was in an oven. The patient sweat right through his shirt and his skin was dripping in sweat; his head felt like it was being squeezed and he blacked out again. The patient's wife told him that his eyes rolled into the back of his head, his whole body was convulsing, and he was ice cold. After 1 minute of convulsing, he woke up again; a few minutes passed until the heat rushed back into his body. He lost consciousness for another minute while his body jerked, and his eyes were in the back of his head. He woke up to the paramedics helping him onto the stretcher. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was received. The events required an emergency room visit. The clinical outcomes of the events were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646468
Sex: U
Age:
State: LA

Vax Date: 08/02/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
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: Kind of achy all over; Feel achy; Feel of weak; Weak; This is a spontaneous report from a contactable consumer (patient). A 77-year-old (also the age at the time of vaccination) patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in arm Left on 02Aug2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. There were no medical history concomitant medications. On 03Aug2021, the patient felt weak and like kind of achy all over. No treatment was provided but the nurse who gave the patient the shot instructed that if the patient had any pain or anything, just to take Tylenol. Outcome of the events were unknown. Information regarding the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1646469
Sex: F
Age:
State: CA

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
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: This is a spontaneous report from a contactable consumer (patient) received via COVID-19 VaccineReporting System. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 03Aug2021 10:00 (Lot Number: EW0170; at the age of 55-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, allergy to sesame seeds and penicillin. The patient's concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 03Aug2021 17:00, The patient experienced rash, itching at the injection site, and across the chest and up towards the neck, nausea, and swollen lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as the result of the events which included Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1646470
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/05/2021
Rec V Date: 08/28/2021
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: This is a spontaneous report from a non-contactable consumer. This 44-year-old female consumer (patient) reported for herself that: A patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection and Batch/Lot Number: EW0187), dose 1 via an unspecified route of administration, administered in Arm Right on Jun2021 at 02:00 PM as DOSE 1, SINGLE for Covid-19 Immunisation. Medical history included Thyroidectomy, Food Sensitivities, Allergies to cashew, Allergies to peanuts, Allergies to gluten, Allergies to wheat, Penicillin allergy, Hair dye sensitivity from unknown date and unknown if ongoing. Concomitant medication(s) included SYNTHROID 100 Mg taken for an unspecified indication, start and stop date were not reported. Patient did not suffer from COVID prior vaccination and patient did not COVID tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Anaphylaxis on 05Jun2021, within 2 minutes my arm began to burn, Hot flash, and My neck began to tighten by 3 minutes on 05Jun2021. Benadryl was received as treatment for all the events. There was no other vaccine in four weeks. On unspecified date in 2021, the events were resolved with sequelae. No follow-up attempts are possible. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1646471
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date: 03/25/2021
Rec V Date: 08/28/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Nausea; This is a spontaneous report from a non-contactable consumer (patient). This 61-year-old male patient received dose 1 of BNT162B2 on 24Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included secondary progressive multiple sclerosis, nerve pain, anxiety, hypertension, itchy, skin red, sore, immune system compromised, broke fingers, flare ups, and painful. Concomitant medications included ocrelizumab (OCREVUS), hydrochlorothiazide, amlodipine, metoprolol, alprazolam (XANAX), naltrexone, baclofen, methylprednisolone (SOLUMEDROL), diphenhydramine (BENADRYL), and paracetamol (TYLENOL) from unknown dates for unknown indications. On 25Mar2021 the patient experienced nausea. The outcome of nausea was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : LRN4301673 Genentech

Other Meds: OCREVUS; HYDROCHLOROTHIAZIDE; AMLODIPINE; XANAX; NALTREXONE; BACLOFEN; SOLUMEDROL; BENADRYL; TYLENOL

Current Illness:

ID: 1646472
Sex: M
Age:
State: TN

Vax Date: 03/13/2021
Onset Date: 08/02/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: Test Result:Clean; Test Date: 202108; Test Name: Bloodwork; Result Unstructured Data: Test Result:Clean; Test Date: 2021; Test Name: Fever; Result Unstructured Data: Test Result:101 degrees; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Clean; Test Date: 202108; Test Name: CAT scan; Result Unstructured Data: Test Result:Clean; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:Clean; Test Date: 20210803; Test Name: Covid test; Test Result: Positive ; Comments: All tests were "clean" except for the COVID test, which yielded a positive result (03Aug2021, 10AM); Test Date: 202108; Test Name: Urinalysis; Result Unstructured Data: Test Result:Clean

Allergies:

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

Symptoms: COVID test, which yielded a positive result (03Aug2021 10AM); COVID test, which yielded a positive result (03Aug2021 10AM); Fainted; Unresponsive for 20 minutes; Hit his head while falling; Hit his head/ received 7 staples in head; This is a spontaneous report from a contactable consumer.A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 13Mar2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization.Medical history included heart bypass (5 years ago), prostate removed (2-3 years ago), lower lumbar surgery (10 years ago) and cholesterol.Concomitant medications within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) QD, blood thinner QD taken for an unspecified indication and cholesterol medication QD taken for cholesterol. There was no known allergies.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, had the patient been tested for COVID-19 was mentioned as no.It was reported that the patient attended a conference from 26Jul2021 to 30Jul2021 and returned home on 30Jul2021 where he presented with fever and dizziness. Fever self-reported at 101 degrees, symptoms persisted through 02Aug2021. On the morning of 02Aug2021, while preparing coffee at home he fainted and hit his head while falling resulting in being unresponsive for 20 minutes. Ambulance called and withheld taken to hospital. Woke up on his own after 20 min. Received 7 staples in head and hospital performed EKG, BP, chest X-ray, CAT scan, bloodwork and urinalysis. All tests were clean except for the COVID test, which yielded a positive result (03Aug2021, 10AM). Sample sent to CDC for variant confirmation. The patient was placed on fluids, antibiotics, steroids and was quarantined at the hospital. Also stated between 6 and 9 other conference attendees tested positive for COVID. As of 04Aug2021 (10AM), withheld reports fever has broken, no longer dizzy, feels better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for 3 days. The patient received treatment with regard to events. On 02Aug2021, patient recovered from loss of consciousness whereas patient was recovering from events syncope, fall, head injury and covid-19. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: BABY ASPIRIN

Current Illness:

ID: 1646473
Sex: M
Age:
State:

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 08/28/2021
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: dry eyes; dry mouth; Mucous with a little blood; arm swelled up associated it with vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 43 units not provided) received first dose of bnt162b2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced dry eyes, dry mouth, mucous with a little blood and arm swelled up so associated it with vaccine. Patient asked what happened if he did not take the second dose. He doesn't think he wanted to take the second dose. The outcome of the 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: 1646474
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210727; Test Name: COVID test Nasal Swab; Test Result: Positive.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Tested positive for COVID-19 with symptoms; Tested positive for COVID-19 with symptoms; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as dose number unknown, single (Age at vaccination was 75 Years) for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient underwent Nasal Swab test on 27Jul2021 which result was positive. Symptoms include diarrhea, nasal congestion, labored cough and fatigue. AE results in Emergency room/department or urgent care. The patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1646475
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: she is immunocompromised; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was inquiring as to if she would be an appropriate candidate for a clinical trial we have. The patient has gotten both doses of the Pfizer vaccine. The patient stated that she was immunocompromised, and her doctor has written a letter that she was a candidate for a 3rd dose. 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: 1646476
Sex: F
Age:
State: NY

Vax Date: 06/11/2021
Onset Date: 06/19/2021
Rec V Date: 08/28/2021
Hospital: Y

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: appendicitis and was rushed to the hospital where she had to undergo emergency surgery; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: ewo186), via an unspecified route of administration on 11Jun2021 (at the age of 23-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated exactly one week after receiving her first dose of the vaccine on 19Jun2021, she had appendicitis and was rushed to the hospital where she had to undergo emergency surgery. The event resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient considered the event as serious as it was life-threatening, caused/prolonged hospitalization (hospitalized for 2 days) and Disabling/Incapacitating. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of appendicitis was surgery. The event outcome was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646477
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 07/16/2021
Rec V Date: 08/28/2021
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: 20210715; Test Name: Nasal Swab; Test Result: Positive; Test Date: 20210719; Test Name: Nasal Swab; Test Result: Positive; Test Date: 20210723; Test Name: Nasal Swab; Test Result: Negative.

Allergies:

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

Symptoms: This is a spontaneous report from a non-contactable consumer. A 29-year-old non-pregnant female patient received second dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on an unknown date in Apr2021 (Batch/Lot number was not reported, age at vaccination: 28-year-old) as dose 2, single and dose 1 via an unspecified route of administration, administered in Arm Left on an unknown date in Mar2021 (Batch/Lot number was not reported, age at vaccination: 28-year-old) as dose 1, single for covid-19 immunisation administered in clinic. The patient was not pregnant at the time of vaccination. No medical history was reported. The patient had no known allergies. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination and has been tested for covid-19 since the vaccination. On 16Jul2021, the patient contracted covid-19 and tested positive for at least 10 days. No treatment was received for the event. The patient underwent lab tests and procedures which included nasal swab test on 15Jul2021 and result was positive, on 19Jul2021 and result was positive, on 23Jul2021 and result was negative. The outcome of event contracted covid-19 and tested positive for at least 10 days (covid-19) was recovered on an unknown date in Jul2021. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646478
Sex: F
Age:
State: TX

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/28/2021
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: 20210316; Test Name: Lab Work; Result Unstructured Data: Test Result:Okay; Test Date: 20210316; Test Name: Covid test; Test Result: Negative ; Comments: had Covid tests that were negative twice.

Allergies:

Symptom List: Unevaluable event

Symptoms: dizziness was so severe; So sick; Nausea; Sore Arm; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, Low Immune System, Pretty Bad Eczema, all ongoing. Concomitant medication included methylprednisolone acetate and other unspecified medicines. The patient had a historical vaccine of Tyhoid vaccine from 2006 to 2006 for Immunization and it hurt way worse. Patient just had a sore arm that day (10Mar2021). On 11Mar2021 04:00, 16 hours after taking it, she got up and was dizzy and nauseated. She went to the ER on day 6 and she saw 2 doctors that following week. They were figuring out what was going on, she was so sick and the dizziness was so severe. She was told at that time not to get the second vaccine by her doctor and the ER doctor said even with her side effects, she needs to get the vaccine. Her primary care physician after said he is not sure if she should get it or not because of the reaction she had to the first vaccine and she had never had Covid or antibodies. She had just fully recovered by the 3 weeks when she was supposed to get her second one, so she was planning to get the second dose at 6 weeks. She didn't because one doctor said no and one said yes. Her reaction is unlike any of her patients. She wants to be fully vaccinated, she is scared to death.She does have severe asthma, and she has been admitted to the ICU before with it. She is not around Covid, she works from home. Treatment: At the ER, they gave her fluids and drew lab work, but it was all okay. They gave her antibiotics to cover the bases. They also gave her Meclizine and it didn't help. They also gave her nausea medication in the ER that Tuesday 16Mar2021. She was treated in the ER and released. She also had Covid tests that were negative twice. She had a steroid injection 9 days before the Covid Vaccine. Caller states it is a Trigger Point Injection, she believes it was Methylprednisolone, a small dose into her muscle. For 16 days she was sick. She was able to work from home some, but she missed several days of work because it was too bad to work. She is trying to figure out now with new variant and her son going to withheld where no one will be wearing masks. No one has that severe of dizziness that she knows of. Blood Work, was all okay. The outcome of the events was recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: There is a reasonable possibility that the events nausea and pain in extremity were related to BNT162b2 based on known drug safety profile. Based on the close temporal relationship, the association between the events dizziness and illness can not be fully 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: METHYLPREDNISOLONE [METHYLPREDNISOLONE ACETATE]

Current Illness: Asthma (Verbatim: Asthma); Eczema (Verbatim: Pretty Bad Eczema); Immune system disorder (Verbatim: Low Immune System)

ID: 1646479
Sex: M
Age:
State: FL

Vax Date: 07/31/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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:

Allergies:

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

Symptoms: Numbness in hands, fingers and arms (Both); Tingling sensation in fingers and hands; Twinging in hands and body.; This is a spontaneous report from a contactable consumer, the patient. An unspecified aged elderly male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 31Jul2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had history of known allergies to sulfur (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included statin from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Aug2021 at 00:00, the patient experienced numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body. Since the vaccination, the patient had not been tested for COVID-19. 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 events. The clinical outcome of events numbness in hands, fingers and arms (both) and tingling sensation in fingers and hands, twinging in hands and body were not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1646480
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
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: 20210730; Test Name: tested positive for COVID-19 via PCR testing; Test Result: Positive.

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This is a spontaneous report from a contactable other hcp (nurse). A 4-decade-old (at late 30s) male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 2021 (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's wife reported she tested positive for COVID-19 after receiving both doses of the Moderna COVID-19 vaccine. She reports she was indirectly exposed to a patient who had not been vaccinated on Friday and swabbed the same day. The PCR test results came back positive for COVID-19 yesterday, 01Aug2021. Patient who was also fully vaccinated with the Pfizer vaccine, was directly exposed to an unvaccinated patient and also tested positive for COVID-19 via PCR testing (medically significant). The reporting HCP states she tested positive after exposure, but was completely asymptomatic, while the patient experienced a dry cough and a little headache for one day, the patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Jul2021. Declined to provide any identifiers other than initials, age, and gender. No additional information obtained. Safety team follow-up consent provided for reporter. The clinical outcome of event headache and dry cough was recovered on 31Jul2021 and for all other events outcome was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1646481
Sex: F
Age:
State: WI

Vax Date: 08/03/2021
Onset Date: 08/04/2021
Rec V Date: 08/28/2021
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: Rash/Hives all over torso; Rash/Hives all over torso; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA1484) via an unspecified route of administration in the left arm on 03Aug2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and allergies to latex, adhesive and multiple foods. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. 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 COVID vaccine. The patient did not receive any concomitant medications within two weeks of the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Aug2021 at 13:30, the patient experienced rash/hives all over torso. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events rash/hives all over torso was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646482
Sex: F
Age:
State: TX

Vax Date: 08/04/2021
Onset Date: 08/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: intense itching in left ear; throat and scalp began itching; throat and scalp began itching; cough; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 04Aug2021 09:15 (Batch/Lot number was not reported) as single dose (at the age of 59-years-old) for COVID-19 immunization. Medical history included multiple sclerosis (MS), asthma and known allergies: slight to shellfish, dust mites, roaches, feathers, box elder. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); levothyroxine sodium (SYNTHROID); spironolactone (SPIROLACTONE); and montelukast sodium (SINGULAIR); all taken for an unspecified indication, start and stop date were not reported. The patient also took an unspecified vitamin concomitantly. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Aug2021 09:30 (also reported as after 20 minutes), the patient experienced intense itching in left ear, throat and scalp began itching, and cough. The events were further described as: an intense itching in left ear began, itching intensified and throat and scalp began itching. The patient took liquid BENADRYL but itching in throat continued as well as an urge to cough. The patient took another dose of liquid BENADRYL and two puffs of albuterol inhaler. Itching continued until 10:45. The patient received treatments of 2 ZYRTEC, liquid BENADRYL and albuterol inhaler. 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 recovering from the events. The events were considered non-serious by the reporter. Information on the lot/batch number has been requested.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; SPIROLACTONE; SINGULAIR

Current Illness:

ID: 1646483
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: I just got COVID after getting my first shot; Test Result: Positive.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: I just got COVID after getting my first shot; I just got COVID after getting my first shot; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. This report received from program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced just got covid after getting first shot. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on an unspecified date. The clinical outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1646484
Sex: F
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Asthma; Ended up getting Covid-19; Ended up getting Covid-19; Sick; very weak; This is a spontaneous report from a contactable Nurse. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. It was reported that patient had been very careful even after being vaccinated. She had been mask-wearing even after second vaccine but on an unknown date in 2021, she was ended up getting Covid-19 and it's been a month and she was still sick. She was hospitalized because she has asthma, she was still very weak which was horrifying because she was an active woman. In 2021, the patient underwent COVID-19 test which resulted positive. Outcome of the events sick and very weak was not resolved and whereas other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: The possibility of COVID-19, Drug Ineffective, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out. As there is limited information in the case provided, the causal association between the event "asthma" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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: Asthma

ID: 1646485
Sex: F
Age:
State: TN

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 08/28/2021
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: 202107; Test Name: Allergy test; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: shortness of breath whenever I exercise/can't breathe very well; tightness in my chest; pain in chest whenever I exercise; This is a spontaneous report received from a contactable consumer (patient). A 26-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:00 (at the age of 26-years-old) (Batch/Lot Number: EP7533; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient had not received prior vaccination. The patient heard this, if she needs to report an adverse side effect. She states if she looking to report a side effect, can she do on website or you,she got shortness of breath and pain in chest whenever she exercises. It's Pfizer Covid 19 Vaccine. She wanted to report any time she exercises, she gets tightness in her chest and she can't breathe very well, and it started today when she got her first dose and that's in April and it still hasn't gone away on 09April2021. The patient had not tried anything as treatment in response to events. The patient underwent lab tests and procedures which included allergy test: unknown on unspecified date in Jul2021. The clinical outcome of all events was not recovered.

Other Meds: VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1646486
Sex: F
Age:
State: MA

Vax Date: 04/17/2021
Onset Date: 07/25/2021
Rec V Date: 08/28/2021
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: 20210803; Test Name: PCR; Test Result: Positive; Comments: Nasal Swab, Tested positive for Covid-19, results received 04Aug21.

Allergies:

Symptom List: Nausea

Symptoms: This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular, administered in arm right on 17Apr2021 at 11:15 (age at vaccination 18-years-old, non-pregnant) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE and dose 1 intramuscular, administered in arm left on 29Mar2021 at 10:45 (Batch/Lot Number: EP6955) as DOSE 1, SINGLE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. There were no concomitant medications. Facility where the recent COVID-19 vaccine was administered was clinic. 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. On 25Jul2021, patient experienced COVID-19. It was reported patient tested positive for Covid-19, results received 04Aug21. Patient did not receive any treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR/ nasal swab on 03Aug2021 which was positive (results received on 04Aug21). The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646487
Sex: F
Age:
State: KY

Vax Date: 07/12/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Choking; Tired/worn out all a week; sluggish; coughing; in a fog/starts laughing and it feels like something went down the wrong pipe; throat feels strange/feels like its closing but she knows its not; hoarse; can't think; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Jul2021 (Lot Number: EW0181; Expiration Date: 30Aug2021) as dose 1, single for COVID-19 immunization. Medical history included heart murmur which was diagnosed at birth on 07Apr1962 and laryngitis from an unknown date. The patient also had unspecified reactions to medicines. There were no concomitant medications. The patient had nothing with the first dose, she was just tired and sluggish and worn out all week in Jul2021. The patient had to go see the throat doctor. The doctor ordered the tube to go down her throat because she has been choking since she had the first dose but its not as bad. The patient choked on chicken noodle soup. The patient stated that she starts coughing really bad and starts laughing and it feels like something went down the wrong pipe in Jul2021. The patient's throat feels strange. It feels like its closing but she knows its not. The patient added that by 17:00 (unknown date in 2021) she will be totally hoarse. The patient was in a fog and can't think on an unknown date in Jul2021. The outcome of the event choking was not recovered. The outcome of the events tired/worn out all a week and sluggish was recovering while the outcome of the other events was unknown.

Other Meds:

Current Illness:

ID: 1646488
Sex: F
Age:
State: KY

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 08/28/2021
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: just tired/worn out all week; sluggish; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (reporter's mother) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 12Jul2021 (Lot Number: EW0181; Expiration Date: 30Aug2021) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included pacemaker on an unknown date, fall on 13Feb2021 and a concussion in her head on an unknown date. There were no concomitant medications. The patient was just tired and sluggish and worn out all week which started the day of the first dose of the vaccine, 12Jul2021 and lasted a week or so. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1646489
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date, it was reported that patient experienced: Pfizer covid vaccine effectiveness is lowered by 36 fold. Outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1646490
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: developed an autoimmune condition; probably has sjogren's syndrome; few symptoms of rheumatoid arthritis; couldn't walk; morning stiffness; joint pain; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient developed an autoimmune condition, probably has Sjogren's syndrome, had a few symptoms of rheumatoid arthritis, couldn't walk with the morning stiffness and joint pain after the vaccine. The outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events 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.,Linked Report(s) : US-PFIZER INC-202100998397 same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1646491
Sex: F
Age:
State: MS

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210804; Test Name: Blood pressure; Result Unstructured Data: Test Result:188/122

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: blood pressure was high; at 188/122; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work.; her left hand, the fingers were swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (left shoulder) on 30Jul2021 (about 12:15 or 12:30) (Lot Number: FA7485) as DOSE 2, SINGLE for covid-19 immunization. Medical history and family history included high blood pressure. Concomitant medication included losartan taken for high blood pressure from May2021 and from Jun2021. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jul2021 (lot number EW0198) for covid-19 immunization. The patient was calling regarding the Pfizer Covid vaccine. She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work. In her left hand, the fingers were swollen. She could not lay on her left arm. It was the fingers on the left side and it was on Monday and Tuesday. Today (04Aug2021), one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny. It kind of throbs but was kind of the same. The patient did not receive treatment for these events, she just took her blood pressure medicine. The events did not require visit to emergency room but she was going to go today (04Aug2021), this morning when she got up to take her blood pressure pill, her blood pressure was high. It was basically 188/122. Her hand was still swollen. The patient was advised to contact her primary care provider for any medical advice. Outcome of the event "blood pressure was high; at 188/122" was unknown, while not recovered for other events. Follow-up attempts are completed. No further information is expected.

Other Meds: LOSARTAN

Current Illness:

ID: 1646492
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Test Name: Covid; Result Unstructured Data: Test Result: Covid.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer reporting for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry Date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced had covid break through after taking pfizer covid vaccine. Reporter stated, had Covid break through after taking Pfizer Covid vaccine. Reporter did not have the information on Patient details. The patient underwent lab tests and procedures which included (Covid) sars-cov-2 test. Had covid on an unspecified date. Reporter seriousness for Had Covid break through after taking Pfizer Covid vaccine was unspecified. The outcome of events suspected covid-19 was unknown. The lot number for the vaccine, [Vaccine, BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646493
Sex: M
Age:
State: TX

Vax Date: 08/02/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: Just in case I die because of the vaccine; I feel real bad, I feel like everything around me is moving; Light-headed; I feel like, I am gonna fall down whenever I am walking or whenever I am sitting down; I got a burning sensation in my chest, I feel like its burning; It just uncomfortable that it burns; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Aug2021 in left arm at single dose, dose unknown for COVID-19 immunisation at the age of 36-year-old. Lot number was FA7485. There was no medical history. The concomitant medications were unknown. In Aug2021, the patient reported just in case the she die because of the vaccine, she experienced she felt real bad, she felt like everything around me was moving, Light-headed, she felt like she was going to fall down whenever she was walking or whenever she was sitting down, she got a burning sensation in her chest, she felt like it was burning; it was just uncomfortable that burned. The patient was treated with ADVIL. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646494
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: metastatic breast cancer; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 2, SINGLE and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A potential AE has been reported to the Pfizer Clinical Trials Contact Center. The caller (patient) stated that she has received both doses of the Pfizer vaccine. Caller has metastatic breast cancer and she is getting ready to start stage 4 of her treatment. She will be taking an immunosuppressant drug. No other additional information was provided. Outcome of the event was unknown. No follow-up attempts are possible; information about the batch/lor number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1646495
Sex: F
Age:
State: MN

Vax Date: 02/12/2021
Onset Date: 02/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Holter monitor; Result Unstructured Data: Test Result:results not reported; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:120; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:150; Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:130

Allergies:

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

Symptoms: My heart rate will jump up to the 120s just standing and doing normal none strenuous activities; my heart rate will go up beyond 150s/ rarely go over 130; feel light headed and dizzy; Major brain fog; heart palpitations; chronic fatigue/ exhausted; orthostatic intolerance; POTs; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. A 26-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201, Expiration date: unknown) intramuscular, administered in left arm on 12Feb2021 at 09:00 am (age at vaccination was 26 years) as dose 2, single for COVID-19 immunization. The patient's medical history included fatigue (probably had chronic fatigue, but undiagnosed). The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231, Expiration date: unknown) intramuscular, administered in left arm on 21Jan2021 at 09:00 am (age at vaccination was 26 years) as dose 1, single for COVID-19 immunization and experienced fatigued. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Feb2021 at 08:00, the patient's heart rate would jump up to the 120s just standing and doing normal nonstrenuous activities, her heart rate would go up beyond 150s/ rarely go over 130, felt lightheaded and dizzy, major brain fog, heart palpitations, chronic fatigue/exhausted, orthostatic intolerance and POTs (Postural orthostatic tachycardia syndrome). About 2 weeks after receiving her 2nd dose, she began to feel lightheaded and dizzy. Major brain fog and heart palpitations. Recently in the last couple months she has been diagnosed with chronic fatigue. She had probably had that since being a teenager and it had come and gone. But after receiving her vaccines she had become fatigued again but had developed these new symptoms as stated above. Her heart rate would jump up to the 120s just standing and doing normal nonstrenuous activities (like doing laundry) her heart rate would go up beyond 150s. She had a Holter monitor to evaluate what was going on, she also had her smart watch monitoring her heart rate during the day. Her doctor diagnosed her with chronic fatigue along with orthostatic intolerance or POTs. She thought she was getting a little better with her new meds, but some days she reverted back to waking up exhausted and her heart rate was still not under 100 bpm, but she rarely went over 130 now and didn't have palpitations or felt dizzy or lightheaded. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included heart rate: 120, heart rate: 150, heart rate: 130, holter monitor: results not reported on an unspecified date in 2021. Therapeutic measures were taken as a result of the events. The events were reported as non-serious. The outcome of the events feel light headed and dizzy and heart palpitations was resolved on an unspecified date of 2021. The outcome of all the other events was not resolved. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and increase in heart rate cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646496
Sex: F
Age:
State: MO

Vax Date: 08/04/2021
Onset Date: 08/04/2021
Rec V Date: 08/28/2021
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: Very thirsty no matter how much I drink; I'm on fire; Feels like spine is being ripped outof patient's body; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the right arm on 04Aug2021 at 11:45 (at the age of 42-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. The patient previously took brexpiprazole (REXULTI) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 04Aug2021 at 01:30, the patient felt like her spine was being ripped out of the body. She was on fire, very thirsty no matter how much she drunk. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of events felt like her spine was being ripped out of the body, patient was on fire, very thirsty was recovered with sequelae on an unknown in Aug2021.

Other Meds:

Current Illness:

ID: 1646497
Sex: U
Age:
State:

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 202102; Test Name: Covid; Test Result: Positive

Allergies:

Symptom List: Pain in extremity

Symptoms: Received Pfizer Covid shots already. I had Covid in Feb2021; Received Pfizer Covid shots already. I had Covid in Feb2021; pneumonia; Went home on oxygen for 3 months; Feel terrible every day/ so miserable; have to take naps everyday; No energy; Not get back to normal every day things; This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as a single dose, dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, the patient experienced pneumonia and stated that received Pfizer COVID shots already and had COVID in Feb2021. Hospitalized for a week. On an unknown date, the patient went home on oxygen for 3 months and experienced feel terrible every day/ so miserable, have to take naps everyday, no energy, not get back to normal every day things. On an unspecified date in Feb2021, the patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive. The outcome of 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: 1646498
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: can't handle antibiotics or seafood/allergic to them; can't handle antibiotics or seafood/allergic to them; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored Program COVAX Support (report's cousin). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced can't handle antibiotics or seafood/allergic to them. The outcome of the events were unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1646499
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Covid; Result Unstructured Data: Test Result: Covid; Comments: Covid after receiving first Pfizer vaccine.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional received from a Pfizer colleague. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient got Covid after receiving first Pfizer vaccine shot and experienced symptoms of sinus, headache, sore throat, and muscle ache on an unspecified date. Seemed like bad sinus infection. The events took place after use of product. On an unspecified date, the patient underwent lab tests and procedures which included Covid (SARS-CoV-2 test), resulted as got Covid after receiving first Pfizer vaccine shot. The outcome of the 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: 1646500
Sex: M
Age:
State: PA

Vax Date: 03/17/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210727; Test Name: PCR/Nasal Swab; Test Result: Positive; Comments: Nasal Swab; Test Date: 20210803; Test Name: PCR/Nasal Swab; Test Result: Negative; Comments: Nasal Swab.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6203), via an unspecified route of administration, administered on arm left on 17Mar2021 (age at vaccination was 46-year-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), via an unspecified route of administration, administered in arm left on 24Feb2021 as dose 1, single for covid-19 immunization at clinic. Medical history was reported as none. The patient concomitant medications were reported as none. Device Date was 05Aug2021.The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications the patient received within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. The patient stated tested positive for covid on 28Jul2021 and sick on an unknown date 2021. The patient was tested for COVID on the 27Jul2021 and received result. On an unknown date 2021 (following day) the patient was sick so was not able to log in and report. Since the vaccination, the patient was tested for COVID-19. The patient lab tests included polymerase chain reaction PCR (nasal swab) was positive on 27Jul2021 and negative on 03Aug2021. No treatment medications were received for the event tested positive for covid. The outcome of the event COVID-19 was resolving and the outcome for the event sick was unknown. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1646501
Sex: F
Age:
State: CT

Vax Date: 02/25/2021
Onset Date: 07/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210721; Test Name: Positive PCR COVID test; Test Result: Positive; Test Date: 20210803; Test Name: SARS-CoV-2; Test Result: Positive; Comments: Nasal Swab COVID test.

Allergies:

Symptom List: Vomiting

Symptoms: This is a spontaneous report from a contactable consumer (Patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 60-years-old) as a dose 1, single and again received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 60-years-old) as a dose 2, single for COVID-19 immunisation at clinic. No medical history and concomitant medications were reported. The patient has no known allergies. The patient received unspecified medications within two weeks prior to vaccination. The patient did not receive any other vaccine in four weeks prior to vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination. On 21Jul2021, the patient experienced Positive PCR COVID test. The patient underwent lab tests which included SARS-COV-2 test: Positive PCR COVID test on 21Jul2021, and SARS-COV-2 test: Positive Nasal Swab on 03Aug2021. The patient did not receive any treatment for adverse event. The outcome of event Positive PCR COVID test was recovering.

Other Meds:

Current Illness:

ID: 1646502
Sex: M
Age:
State: MD

Vax Date: 04/01/2021
Onset Date: 06/07/2021
Rec V Date: 08/28/2021
Hospital: Y

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: Patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli; Patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on 01Apr2021 (at the age of 59-Years-old) as dose 2, single for COVID-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on Mar2021 (at the age of 59-Years-old) as dose 1, single for COVID-19 immunisation with no reaction were reported. Prior vaccination was reported as none. The patient was not tested for COVID after vaccination. There were no known allergies. The patient experienced patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli on 07Jun2021. The patient was hospitalized for patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli for 2 days. Patient received treatment for the reported event included Eliquis. The outcome of the events reported as recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Thrombosis and Pulmonary embolism 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:

Current Illness:

ID: 1646503
Sex: F
Age:
State: MO

Vax Date: 03/23/2021
Onset Date: 07/17/2021
Rec V Date: 08/28/2021
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: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (the patient). This adult non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an intramuscular route of administration on 02Mar2021 (Lot Number: UNKNOWN) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an intramuscular route of administration on 23Mar2021 (Lot Number: UNKNOWN), both as single dose for COVID-19 immunization. Medical history included hypercholesterolemia, arthritis and premature ventricular contractions. The patient has no known allergies. The patient did receive other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. After the second vaccination received on 23Mar2021, the patient tested positive for COVID-19 on 17Jul2021 which resulted in a visit to the doctor or other healthcare professional office/clinic. No treatment was received for the adverse event(s). The clinical outcome of the event(s) "tested positive for COVID-19" was reported as resolved on an unspecified date in 2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1646504
Sex: F
Age:
State:

Vax Date: 03/25/2021
Onset Date: 04/23/2021
Rec V Date: 08/28/2021
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: Test Date: 20210423; Test Name: COVID-19; Test Result: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: she tested positive for COVID19; she tested positive for COVID19; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, around four weeks after administration of covid-19 vaccine, around 23Apr2021 she was tested positive for covid19. Patient said that it has been 5 months and she has not received her 2nd dose. Patient thought she was protected after the first dose but tested positive for covid19. Treatment details for the event was not reported. The outcome of the event was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646505
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Covid-19; Test Result: Positive ; Comments: Caller continues to say that the vaccine is giving him Covid-19.

Allergies:

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

Symptoms: Caller continues to say that the vaccine is giving him Covid-19; Caller continues to say that the vaccine is giving him Covid-19; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an un-specified date, the patient continued to say that the vaccine was giving him covid-19. The case was assessed as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of events was unknown. No follow-up attempts were possible; information about lot/batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1646506
Sex: F
Age:
State: VA

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: 20210120; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: Horrible headache pain; chest feels heavy; very tired; Rash under left arm and Rash on right armpit; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 01Aug2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included neck pain. The patient had no known allergies to medications, food or other products. Concomitant medications included lorazepam (ATIVAN), naproxen (MANUFACTURER UNKNOWN) and hydrocodone bitartrate, paracetamol (VICODIN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. On 01Aug2021 at 12:30, 30 minutes after vaccination, the patient experienced rash under left arm which was of size 5x3 inches, chest felt heavy and the patient was very tired. On 02Aug2021, next morning after the vaccination, the patient experienced horrible headache with pain rate of 10 which lasted for 2 days and rash on right arm pit that was same as the left arm. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event horrible headache pain was resolved on 04Aug2021, events rash under left arm, rash on right armpit, chest felt heavy and very tired were not resolved at the time of report.

Other Meds: ATIVAN; NAPROXEN; VICODIN

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am