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

Date Died:

ID: 1646859
Sex: F
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: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: heart attack; cytokine storm; inflammation; This is a spontaneous report from a contactable consumer reporting for a friend. A 61-years-old female patient received bnt162b2 (BNT162B2) at the age of 61-years-old, 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 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization at the age of 61 years. After the second dose, the patient had inflammation, a cytokine storm, a heart attack and then died on an unspecified date. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attack; cytokine storm; inflammation

Other Meds:

Current Illness:

ID: 1646860
Sex: F
Age:
State: IL

Vax Date: 07/16/2021
Onset Date: 07/01/2021
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: 202106; Test Name: antibodies; Test Result: 100 %; Comments: just after receiving the first dose Pfizer Covid Vaccine.; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/80; Comments: prior to receiving the first dose; Test Date: 202106; Test Name: Blood pressure; Result Unstructured Data: Test Result:146/80; Test Date: 202106; Test Name: EKG; Result Unstructured Data: Test Result:Unknown results; Test Date: 202106; Test Name: enzymes; Result Unstructured Data: Test Result:Unknown results; Test Name: tested for red measles; Result Unstructured Data: Test Result:no antibodies

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: vertigo; topples over all the time; This is a spontaneous report from a contactable consumer(patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0187), via an unspecified route of administration, administered in the right arm on 16Jul2021 (at the age of 58 years old; as reported) as dose 2, single for COVID-19 immunization. Medical history included tachycardia from an unknown date (for probably 20 years) and unknown if ongoing. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0178, expiry date: 21Aug2021), via an unspecified route of administration, administered in the right arm (near rotator cuff) on 08Jun2021 (at the age of 58 years old; as reported) as dose 1, single for COVID-19 immunization and experienced vertigo, blood pressure went up so high, terrible brain fog, nausea, anxiety so bad and tunnel vision; measles vaccination for immunization (this was so long ago, the caller's child is now 25 years old); and small pox vaccination for immunization (in the 4th grade). The patient experienced vertigo and topples over all the time on an unspecified date in Jul2021. It was reported that the patient received both doses Pfizer Covid vaccine and has been left with vertigo. The vertigo was horrible, and she toppled over all the time. She has accrued so many medical bills. She had to have her brain looked at. It was also reported that the patient visited the emergency room and was discharged from the emergency room each time. She has never had Covid. But her father died of Covid and her husband had Covid. The patient underwent lab tests and procedures which included antibodies: 100 % (just after receiving the first dose Pfizer Covid vaccine) in Jun2021, blood pressure: 110/80 (prior to receiving the first dose) in 2021, blood pressure: 146/80 in Jun2021, EKG: unknown results in Jun2021, enzymes: unknown results in Jun2021, tested for red measles: no antibodies on an unspecified date. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Date Died:

ID: 1646861
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: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: killed my roommate; This is a spontaneous report from a Pfizer- sponsored program. A Non-contactable consumer reported for a patient (reporters friend) that a patient of unspecified age and gender received bnt162b2 (BNT162B2, the Pfizer COVID Vaccination), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that "you killed my roommate, My friends death is worth nothing to you" on an unspecified date. The patient died on an unspecified date. The outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed my roommate

Other Meds:

Current Illness:

ID: 1646862
Sex: U
Age:
State: TN

Vax Date: 05/14/2021
Onset Date: 08/08/2021
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: 20210808; Test Name: COVID; Test Result: Positive

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: tested positive for covid-19 Fever, congestion and chest; tested positive for covid-19 Fever, congestion and chest; This is a spontaneous report from a contactable consumer (patient) reported that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: ER8729) as dose 1, single and dose 2 via an unspecified route of administration on 14May2021 (Batch/Lot Number: EW0171) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient is tested positive for covid-19 Fever, congestion and chest on 08Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Aug2021. The seriousness criteria was medically significant for the event covid-19. The event outcome was Unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646863
Sex: F
Age:
State: TX

Vax Date: 08/09/2021
Onset Date: 08/09/2021
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: 20210809; Test Name: Pulse; Result Unstructured Data: Test Result:Good

Allergies:

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

Symptoms: Passed out for about a minute or less; Seizure; fell; Shaking; This is a spontaneous report from a contactable pharmacist. A 30-year-old female patient received BNT162B2, intramuscular, administered in left arm on 09Aug2021 14:57 (Batch/Lot Number: FC3181; Expiration Date: Oct2021; NDC number: 59267-1000-01) at the age of 30 years old as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included rheumatoid arthritis and had a history of passing out. Family medical history relevant to adverse event was unknown. There were no concomitant medications. The patient previously took whooping cough vaccine in 2010. There were no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). On 09Aug2021, about 5 minutes after she was got the shot, the patient passed out for about a minute or less. She was in the waiting room. They had to call an ambulance. Upon the minute, the caller was awake, responding, had a good pulse. She was breathing, talking after passing out. The reporter explained that as far as what she witnessed, it was not serious. She was okay. When asked if event required a visit to - answered, "Emergency Room?" The patient was taken by ambulance, but she was not sure where it went. She is not sure if it was to the ER, but they took the patient out. The patient did mention she had not eaten all day. The caller didn't move the patient from where she passed out and fell. While she was on the ground, the patient mentioned she had a history of passing out. However, on the form she filled out, the patient responded 'no' to the question of "have you had any reaction to any previous vaccination including fainting or dizziness." A witness said she also thought the patient had a seizure because the patient was shaking. It's all subjective though. Outcome of events passed out was recovered on 09Aug2021, while other events was unknown. The reporter assessed the report as not serious and considered the relatedness of COVID-19 vaccine with passed out for about a minute or less as unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events seizures, passed out and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646864
Sex: F
Age:
State: IL

Vax Date: 03/26/2021
Onset Date: 08/05/2021
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: Test Date: 20210808; Test Name: SARS-CoV-2 by PCR; Test Result: Positive ; Comments: (at 10:00 AM), Swab (result came back last night at 4:25)

Allergies:

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

Symptoms: Tested on Sunday and it came back positive; Tested on Sunday and it came back positive; feeling terrible/feeling bad; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, Expiration date: 30Jun2021), via an unspecified route of administration on administered in right arm 05Mar2021 (at the age of 61-years-old) as a dose 1, single; and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER2613, Expiration date: 31Jul2021), via an unspecified route of administration administered in right arm on 26Mar2021 (at the age of 61-year-old) as a dose 2, single; both for COVID-19 immunisation (Indication presented as reported: it was mainly so she wouldn't get it at the time. She's got grandkids, she would've been the first one to say she wouldn't have got it). Adverse events (AE) following prior vaccinations were reported as none. The family medical history relevant to AE(s) was reported as none. The patient's medical history (including any illness at time of vaccination) was reported as none. The patient's concomitant medications were none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) were reported as none. It was reported that, she got the COVID vaccine, Pfizer, back in Mar2021 and they got tested on 08Aug2021 (Sunday) and it came back positive. Stated that, the first vaccine that she had the first part was fine the second one was horrible, and she usually gets a text or email where they send her a note. It was a weekly update on how she was feeling. She had gotten one a month ago and everything was fine and then this hit. She got tested on 08Aug2021 (yesterday) and had been feeling bad/feeling terrible since 05Aug2021 (last Thursday). It started on 05Aug2021 (Thursday), in the morning, she just felt a cold coming on and thought it was a summer cold. She didn't get out. Between congestion it was worse. Stated that, she called to see whether she could get that infusion because she understands there was an infusion to shorten it. The antibody infusion was for people with underlying health conditions such as diabetes and she didn't have that. She has had a chest cough on 05Aug2021, body aches and headaches on an unspecified date in Aug2021. Stated that, she called in to her family doctor and when she said she wasn't eligible for the infusion her other daughter in law said to ask for a ZPACK or antibiotics. They are supposed to get back to her. Stated that, was there going to be a booster or once she gets covid was she still eligible to get it. The events did not result in emergency room and physician office. The reporter seriousness for the events was unspecified. On 08Aug2021, the patient underwent lab tests and procedures which included SARS-CoV-2 by PCR, resulted as positive (at 10:00 AM), Swab (result came back last night at 4:25). On 10Aug2021, the reporter stated that, his wife had the COVID shots, and she tested positive for COVID 19. The outcome of the events for feeling terrible/feeling bad was not recovered while for the Covid-19 was unknown. Conclusion (for the lot EN6206): The complaint for Lack of Effect with the product for the COVID-19 Vaccine was investigated. The investigation included review of manufacturing records, analytical results at the time of lot release, retained reference samples, deviations and complaint lot history trends. The final scope was limited to include the reported finished goods lot EN6206, fill lot EN5339, the bulk formulated drug product lot EN5327. No returned complaint sample was received. All deviation investigations performed during the manufacturing process of the lot were reviewed. The conclusion of all investigations confirmed there was no quality issue which would affect the quality of the lot. No root cause or CAPA were identified as the complaint was not confirmed. Conclusion (for the lot ER2613): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER2613 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER2613, fill lot EP8678 and the formulated drug product lot EP8565. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.

Other Meds:

Current Illness:

ID: 1646865
Sex: M
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: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

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

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: COVID; COVID; This is a spontaneous report received from a contactable Nurse. A 57-years-old male patient received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included covid: positive on an unspecified date. On an unspecified date, the patient experienced covid. Patient was hospitalized in ICU with COVID after receiving Pfizer COVID vaccine. The clinical outcome of events 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 and a plausible temporal relationship, a possible causal relationship between the events DI and Covid 19 and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1646866
Sex: F
Age:
State: FL

Vax Date: 07/22/2021
Onset Date: 07/30/2021
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: Test Date: 20210730; Test Name: Covid test; Test Result: Positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that patient received the first dose of vaccine last 22Jul2021 and tested positive for Covid last 30Jul2021. Patient asked when her schedule was to receive the second dose. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646867
Sex: U
Age:
State:

Vax Date: 07/31/2021
Onset Date: 07/31/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Pain on the left side of the hip; it is preventing her from walking; she said felt heavy; This is a spontaneous report from a contactable pharmacist. A 12-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 31Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jul2021 the patient experienced pain on the left side of the hip, it is preventing her from walking, she said felt heavy lot number and expiration date of the suspected medication were not provided limited information was available from the reporter. The outcome of the events arthralgia, gait disturbance, limb discomfort was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646868
Sex: M
Age:
State: FL

Vax Date: 03/25/2021
Onset Date: 03/01/2021
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: leg had a deep infection in it; I broke out in the really bad all over my body rash. I mean it was on my legs, my chest my, stomach my face and all over me; This is a spontaneous report from a contactable consumer (patient). A 64-year-old (also the age at time of vaccination) male patient received bnt162b2 (BNT162B2), via an unspecified route of administration administered in Arm Left on 25Mar2021 (Batch/Lot Number: ER8732) as DOSE 1, SINGLE for COVID-19 immunization. The patient had blood pressure abnormal (reported as blood pressure) and he took medication to keep it under control. Concomitant medications included amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL) taken for an unspecified indication and therapy dates and unspecified medication for blood pressure. Three to four days after he received the first dose (Mar2021), he broke out that was really bad all over his body rash. It was on his legs, chest, stomach, face and all over him. He did not got his second vaccination as nobody can really tell him what caused this. He was afraid as he was not sure what's crazy thing will go again on him. It was also reported that he had to go to the hospital for a night and it was noted that he had a deep infection in his leg. He was on antibiotics and was discharged instantly. He was also on different kind of creams as he went to the dermatologist. Outcome of deep infection in his leg while recovering from the remaining event. Follow-up attempts are completed. No further information is expected.

Other Meds: AMLODIPINE BENAZEPRIL

Current Illness:

ID: 1646869
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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: severe allergic reaction post-vaccination; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included cancer and cancer surgery. The patient's concomitant medications were not reported. The patient experienced severe allergic reaction post-vaccination on an unspecified date. The event was reported as serious, medically significant and resulted in emergency room visit. Outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646870
Sex: M
Age:
State: TN

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: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Alopecia Areta; This is a spontaneous report from a contactable consumer reporting for a male patient (son). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "alopecia areta". The reporter stated that after COVID Vaccine the son developed Alopecia Areta. Just want to hear from Pfizer all about that. The reporter was also asking whether the vaccine trigger auto immune response. 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: 1646871
Sex: F
Age:
State: GA

Vax Date: 08/08/2021
Onset Date: 08/09/2021
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: arm was sore on Sunday; swollen lymph nodes on the left arm; This is a spontaneous report from a contactable consumer and from a sponsored program Support. This 45-year-old female Consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Jul2021 (at the age of 45-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 09Aug2021 after the second dose of vaccination, the patient experienced swollen lymph nodes on the left arm and on an unspecified date arm was sore on Sunday. It was reported that after got second dose of vaccine, patient was experienced swollen lymph nodes on the left arm (side of injection) that began yesterday and became worse last night. Patient also reported that her arm was sore on Sunday. Her question was, was that normal because she needs to know if she needs to go to urgent care. After information provided, patient stated that she will watch and if it did get better, she will reach out to her Healthcare Professional. Patient asked if she can took Tylenol for her symptoms. Patient provided PMI number and HOO. While talking to the agent and providing the caller's demographics, the call got disconnected. Created AE form. The outcome of events were unknown. Unknown if reporter was a Healthcare Professional (HCP). Unknown if reporter's contact information available to you or a sub-contracted party. The reporter was not the prescribing Healthcare professional Medical Information: Yes, Customer and/or medical inquiry forwarded or referred to Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646872
Sex: M
Age:
State: MI

Vax Date: 02/04/2021
Onset Date: 08/01/2021
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: Test Date: 20210805; Test Name: PCR; Test Result: Positive ; Comments: covid test type post vaccination = Nasal Swab

Allergies:

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

Symptoms: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable other health care professional. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose (lot number EL3248) on Jan2021 05:45, 2nd dose (lot number EL3248, as reported) on 04Feb2021 06:00, both at 61-year-old intramuscular in left arm for Covid-19 immunization. Medical history was not provided. There was no other medications in two weeks. There was no other vaccine in four weeks. It was unknown if patient had covid prior vaccination. There was no known allergies. Patient experienced symptoms of covid starting on 01Aug2021, and was tested positive for covid PCR Nasal swab on 05Aug2021. Treatment was unknown. Outcome of the event was not resolved.; Sender's Comments: The possibility of Covid19, 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.

Other Meds:

Current Illness:

ID: 1646873
Sex: F
Age:
State: FL

Vax Date: 08/06/2021
Onset Date: 08/07/2021
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: very congested; hard for me to breathe; cant taste food was reported as worsened.; Tightness in chest; heavy cough was reported as worsened.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 06Aug2021 11:00 (at the age of 37-year-old) (Batch/Lot Number: EW0164) as dose 1, single for covid-19 immunisation. The patient had no medical history and no concomitant medications. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on the same date as the bnt162b2. On an unspecified date, the patient was very congested and hard for her to breathe. On 07Aug2021, the patient experienced heavy cough. On 09Aug2021, the patient had tightness in her chest. On 10Aug2021, the patient had can't taste her food was reported as worsened. The patient reported that she could taste her food yesterday but not today. The events did not required a visit to emergency room and physician office. Patient was referred to a healthcare provider (HCP) for medical evaluation. The patient asked if she were to be tested again for Covid, would the vaccine cause her to have a false positive. Prior vaccinations (within 4 weeks) was none and no events following prior vaccinations. Outcome of events heavy cough was reported as worsened, cant taste food was reported as worsened was not recovered; tightness in chest was recovering; and outcome of the rest of events was unknown.

Other Meds:

Current Illness:

ID: 1646874
Sex: F
Age:
State: FL

Vax Date: 04/02/2021
Onset Date: 04/03/2021
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: 20210403; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Date: 20210403; Test Name: Heart rate; Result Unstructured Data: Test Result:High; Test Date: 2021; Test Name: HR event monitor; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high; tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 02Apr2021 as dose 2, single (at the age of 62-years-old) for covid-19 immunisation. Medical history included high blood pressure (under control with medicine before), supraventricular tachycardia (under control with medicine before) and allergies to almonds (all from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955 and Expiration date was not reported), via an unspecified route of administration, administered in right arm on 05Mar2021 at 13:30 hours as dose 1, single (at the age of 62-years-old) for covid-19 immunisation and patient blood pressure (BP) had been quite high and hard to control. Patient had now added Lisinopril and actually tried an anxiety pill because of the stress of the high BP. Patient was also wearing an event monitor now. Concomitant medication(s) within 2 weeks of vaccination included metoprolol tartrate taken for high blood pressure and supraventricular tachycardia, start and stop date were not reported and multivitamin for unknown indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 03Apr2021, the day after the second shot, patient tried to exercise, and her heart rate (HR) and blood pressure (BP) were extremely high, and patient could not get her heart rate (HR) back to normal after her workout. Events were assessed as non-serious by the reporter. The outcome of both the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: METOPROLOL TARTRATE

Current Illness:

ID: 1646875
Sex: M
Age:
State:

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

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: fell; This is a spontaneous report. from a non-contactable consumer (reporter's uncle) A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient shortly thereafter fell on an unspecified date with outcome of unknown and was hospitalized. Caller would like to knowhow long he can go between shots or if he needs to start the series again. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1646876
Sex: M
Age:
State:

Vax Date:
Onset Date:
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:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Full body hives 24 hours later; This is a spontaneous report from a contactable other healthcare professional (nurse). A 12-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3180, Expiration date, NDC and UPC number was 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 unspecified date, 24 hours later/the next day, patient experienced full body hives. Patient do not know if he should get the second dose. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646877
Sex: M
Age:
State:

Vax Date: 07/26/2021
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: I have got a aneurysm on the valve of my heart and I have got diabetes; I have got a aneurysm on the valve of my heart and I have got diabetes; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 26Jul2021 (Batch/Lot Number: FG7484) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that "I have got a aneurysm on the valve of my heart and I have got diabetes. I took the first dose and now I am kind of little skeptic about taking the second. The patient added that he is thinking if he can take the second dose of the vaccine and he is currently on a medication for the diabetes. The patient may not take the second dose. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1646878
Sex: F
Age:
State: IN

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Received her initial COVID vaccine and she ended up developing COVID after that; Received her initial COVID vaccine and she ended up developing COVID after that; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: EW0191; Expiration Date: 01Sep2021) as DOSE 1, SINGLE (at the age of 63 years) for covid-19 immunisation. The patient medical history included hypertension. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported. The patient received her initial COVID vaccine and she ended up developing COVID after that (medically significant) on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957591 similar report from same reporter, second dose

Other Meds: AMLODIPINE BESILATE

Current Illness:

ID: 1646879
Sex: M
Age:
State: TX

Vax Date: 07/19/2021
Onset Date: 07/21/2021
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:

Allergies:

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

Symptoms: A little fever; This is a spontaneous report from a contactable consumer (patient). A 23-years-old male patient received second dose of bnt162b2 (Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration in left arm on 19Jul2021 13:45 (at age of 23-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration in left arm on 28Jun2021 11:00 as dose 1, single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. On 21Jul2021 at 11:30, the patient experienced a little fever. Therapeutic measures were taken as a result of a little fever (pyrexia). The outcome of event was recovered. Information on batch number has been requested.

Other Meds:

Current Illness:

ID: 1646880
Sex: M
Age:
State: CO

Vax Date: 03/17/2021
Onset Date: 08/06/2021
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: 20210806; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab

Allergies:

Symptom List: Unevaluable event

Symptoms: Breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted at laboratory. Patient displayed mild symptoms including loss of smel; Breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6205), via intramuscular route of administration in the right arm, on 25Feb2021 (age at the time of vaccination was 38-year-old), as dose 1, single and dose 2 received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6207), via intramuscular route of administration in the right arm, on 17Mar2021, as dose 2, single for COVID-19 Immunization. Medical history was not reported. Concomitant medications included emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and alprazolam (XANAX). 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 and Since the vaccination, the patient had tested for COVID-19 and the result was positive. The patient was breakthrough COVID infection. Identified by positive PCR covid-19 detection test conducted at laboratory. Patient displayed mild symptoms including loss of smell and sinus pressure. On 06Aug2021, the patient underwent lab tests which included positive PCR covid-19 detection test (also reported as: Nasal swab test) conducted at laboratory and the result was obtained as positive. The patient received unspecified treatment by consulting with doctor via phone. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: TRUVADA; Xanax

Current Illness:

ID: 1646881
Sex: U
Age:
State:

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

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: They administered the second dose at that point of second. I got very ill. I ended up in emergency room; They seemed to think in the emergency room that I was administered the double dose; They administered the first dose. It was pharmacy and then I was told that dose was empty, that syringe was empty; They administered the first dose. It was pharmacy and then I was told that dose was empty, that syringe was empty; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0191), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was not reported. It was reported that patient received first dose of vaccine on Wednesday, 04Aug2021. Patient stated they administered the first dose, It was pharmacy and then patient was told that dose was empty, that syringe was empty, and they administered the second dose at that point of second. patient got very ill and ended up in emergency room and not sure, they seemed to think in the emergency room that patient was administered the double dose. Patient need to know that if patient going to require the actual second dose. Patient was hospitalized due to got very ill and ended up in emergency room. Outcome of the events was Unknown.

Other Meds:

Current Illness:

ID: 1646882
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
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: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown result; Test Date: 202108; Test Name: antibody test; Result Unstructured Data: Test Result:antibodies were extremely low; Comments: she is at risk now of getting the COVID19 infection

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: rash all over her body when she woke up (that burned her); Costochondritis; rash all over her body when she woke up (that burned her); eye was swelling up as well; developed severe anxiety; allergic reaction; condition had affected her patient's work and that it greatly impacts her; This is a spontaneous report from a contactable consumer (parent). A 32-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm on 2021 around 15:00 or 15:30, at the age of 32-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Two or three days after receiving the first dose of the vaccine, the patient woke up with rashes all over body (that burned her). The reporter can't tell the agent how many doctors the patient has ended up having to go to. It is very bad. The patient had rashes that looked like someone took sandpaper and rubbed it all over the patient's body. The patient also had chest pain. The patient was brought to the hospital and the hospital stated the patient was having an allergic reaction to the first dose Pfizer Covid Vaccine. The patient's eye was swelling up as well. The next day, the patient went to a specialist, the number one top allergist. The allergist did all kinds of blood work and don't know what is wrong except that this is a reaction after the patient received the first dose Pfizer Covid Vaccine. Reporter added that as a result, her patient have to go to the hospital, she was tested and given blood work to rule out everything and was administered with an antihistamine. Overall, the patient has to visit an allergy doctor and found out that she has no allergies except they don't know what happen ("she got a reaction to the shot"). The patient was having such bad chest pains, so bad the patient went to a Cardiologist. The patient was a perfectly healthy girl. After going to the cardiologist, the cardiologist believed the patient's heart was fine and stated the patient should now go to a Rheumatologist. The patient goes to the Rheumatologist and they take constant blood, doing blood work. The reporter's patient also saw an orthopedic surgeon from the chest pain. All of the doctors determined, whatever is going on with the patient is caused by the first dose Pfizer Covid Vaccine. No one will take responsibility, nobody cares. The patient ended up back at the Cardiologist, patient's heart was pounding out of her chest from nerves. No one can claim what is happening. She also added that some of those doctors, she has to see twice (overall 10 visits to doctors). After thorough medical examination, her patient's physicians were in a final consensus that her patient "developed as a result" of the shot a chronic condition called Costochondritis ("an inflammation of the bones between the breast and the sternum"). Thus, her physicians advised her not to proceed in taking the 2nd dose of the vaccine following the reaction she had. The patient also went for antibody test, doctor's office left message stating the antibodies were extremely low; she is at risk now of getting the COVID19 infection. The doctors did not want the patient to get the second dose Pfizer Covid Vaccine because of how the patient reacted to the first dose Pfizer Covid Vaccine. The patient went to get blood work. Reporter also emphasized that this condition had affected her patient's work and that it greatly impacts her since she is self-supporting and that she had developed severe anxiety. The events were assessed as serious, medically significant. The events involved emergency room visit and physician office visit. The reporter states it took weeks for the patient's rashes to go away with medication. The reporter states the patient recovered with lasting effects because now the reporter gets rashes on and off and takes steroids and antihistamines. The reporter does not know the names of the steroids and antihistamine the patient was taking. The reporter believes maybe the steroid was a Medrol pack where you take one and the next day you take two. The outcome of the event rash and allergic reaction was recovered with sequelae in 2021; the event eye swelling was recovered in 2021; while the other events was unknown. Treatment was received for the rash, allergic reaction, burning sensation and eye swelling. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646883
Sex: F
Age:
State: NC

Vax Date: 02/02/2021
Onset Date: 07/26/2021
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: Test Date: 20210729; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Had COVID positive result.; Had COVID positive result.; Cough; Fatigue; Sore throat; Headache; Loss of smell; Muscle body aches; Inability to stay awake; congestion; runny nose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient/Pfizer employee). A 35-years-old non-pregnant female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 02Feb2021 (at the age of 35-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history included known allergies maybe Penicillin. The patient had no other medical history. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. The patient had no COVID prior vaccination. On 26Jul2021, the patient experienced cough, fatigue, sore throat, headache, loss of smell, muscle body aches, inability to stay awake, congestion or runny nose. The patient was COVID tested post vaccination on 29Jul2021, nasal swab taken, and the polymerase chain reaction (PCR) test done which showed COVID positive result. As a result of events the patient visited to doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646885
Sex: F
Age:
State: MI

Vax Date:
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: Test Date: 20210804; Test Name: Covid; Test Result: Positive

Allergies:

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

Symptoms: Tested Positive for Covid. Fully vaccinated; Tested Positive for Covid. Fully vaccinated; This is a spontaneous report from a contactable consumer (Pfizer employee) via COVID-19 Vaccine Adverse Event Self-Reporting portal. An adult female patient 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 1, single, and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single, for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no Covid prior vaccination. On 04Aug2021, the patient tested positive for Covid (post vaccination). The patient was fully vaccinated. Treatment for the adverse event (AE) was unknown. The patient was recovering from the event. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646886
Sex: F
Age:
State: LA

Vax Date: 08/07/2021
Onset Date: 08/07/2021
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: Nausea, Pain in extremity, Pyrexia

Symptoms: "golf ball" size swollen gland under her arm; swollen arm; headache; fatigue; injection site pain and swelling; injection site pain and swelling; 1st dose 14May2021 & 2nd dose received 07Aug2021; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 07Aug2021 17:00 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included had a child with COVID on top of her for 2 days and she didn't catch it on an unspecified date. The patient's concomitant medications were not reported. No prior vaccinations within 4 weeks other than bnt162b2. No relevant tests. The patient previously received the first dose of bnt162b2 on 14May2021 at 50 years old in the Arm Left for COVID-19 immunization. On 09Aug2021, the patient experienced a "golf ball" size swollen gland under her arm and was asking if this something that is normal or that she should be concerned about. The patient also experienced other "typical" reactions which include swollen arm, headache, fatigue, injection site pain and swelling on 08Aug2021. The events were treated with Advil and the patient will be consulting with her physician on the phone. The patient received the 1st dose 14May2021 and 2nd dose on 07Aug2021. The outcome of the event "golf ball" size swollen gland was not recovered, for the events headache and fatigue were recovered on an unspecified date in Aug2021 while for the other events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646887
Sex: F
Age:
State: NY

Vax Date: 03/06/2021
Onset Date: 03/06/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Swelling of all joints, very painful; Swelling of all joints, very painful; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Mar2021 17:00 (Batch/Lot Number: EN6201) as dose 1, single; on 06Mar2021 (Batch/Lot Number: EN6208) as dose 2, single for covid-19 immunisation; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Mar2021 17:00 at 60-years-old (Batch/Lot Number: EN6201) as dose 1, single; via an unspecified route of administration, administered in Arm Left on 06Mar2021 (Batch/Lot Number: EN6208) as dose 2, single for COVID-19 immunization. Medical history included ankylosing spondylitis (AS) and osteoarthritis. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA); tramadol. The patient previously took statins and experienced drug allergy. The patient experienced swelling of all joints, very painful (disability) on 29Mar2021 with outcome of not recovered. The patient was given Injections in knees, back and 3xs pretizone. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Events reported as serious due to disability.

Other Meds: CYMBALTA; TRAMADOL

Current Illness:

ID: 1646888
Sex: F
Age:
State: NJ

Vax Date: 04/17/2021
Onset Date: 08/02/2021
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: 20210728; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210802; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: tested positive on Aug 2.; tested positive on Aug 2.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727) via an unspecified route of administration on 27Mar2021 as dose 1 single and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration on 17Apr2021 as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. 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. Patient presented with sore throat, headache and coughing on 31Jul2021 and tested positive on 02Aug2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Hospitalization prolonged was no. Traveling companion was tested positive 30Jul2021. Since the vaccination, the patient had been tested for COVID-19 (sars-cov-2 test) via Nasal Swab which revealed negative on 28Jul2021 and positive 02Aug2021. The outcome of the event was recovered on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646889
Sex: U
Age:
State: CA

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:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: My face has rash then my arm; My ears swelled and coming to bother; my right ear can't hear anything and today my other ear start to swell; My ears swelled and coming to bother; my right ear can't hear anything and today my other ear start to swell; My right face was numb; I had arm sore; This is a spontaneous report from a contactable consumer (patient). A 35-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Aug2021 (Batch/Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin allergy (allergy to Penicillin) and allergic to ants and cockroach; all from an unknown date and unknown if ongoing. There was no prior vaccination (within 4 weeks). The patient's concomitant medications were not reported. It was reported that "On 04Aug2021, I just had the Pfizer Covid Vaccine first dose and then the first day I had arm sore and on 06Aug2021 my ear start to swell and coming to bother, my right face was numb and on 07Aug2021 I went to the Emergency Room and while my right ear can't hear anything and now today my other ear start to swell." The patient also stated, "I got vaccine, before I told them about my allergy to Penicillin and allergic to ants and cockroach, still they gave me the shot (vaccine). I don't know why my right ear can't hear anything and my right face is numb." For the treatment the patient stated "No, I didn't." It was added, "I don't know what should I do for my ear, I was going in Emergency Room to see ENT Doctor, I don't know if they can fix my problem or not. My face has rash then my arm, my right ear is swelled and now my left ear start to swell." And, "Can you get me call back or something like that how to resolve my problem of my ears swelling." The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1646890
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/28/2021
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: Test Date: 20210728; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab; results received on 30Jul201; Test Date: 20210730; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Injection site pain

Symptoms: Upon landing took rapid test at airport on Jul 30 and tested postiive ; Upon landing took rapid test at airport on Jul 30 and tested postiive ; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single and on an unspecified date (Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient been tested for COVID-19 since the vaccination. The patient took polymerase chain reaction (PCR) test nasal swab on 28Jul2021 prior to boarding flight and received the result as positive upon landing on 30Jul2021. Upon landing took rapid test (nasal swab) at airport on 30Jul2021 and tested positive was quarantined. The patient was not hospitalized and did not receive any treatment. The outcome of the events was recovered on an unspecified date in 2021. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646891
Sex: M
Age:
State: SC

Vax Date: 08/10/2021
Onset Date: 08/10/2021
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:

Allergies:

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

Symptoms: shortness of breath; chest pain and tightening; chest pain and tightening; This is a spontaneous report from a contactable nurse (patient's spouse). A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in deltoid left on 10Aug2021 09:00 (Batch/Lot Number: FC3180) (at age 52-year-old) as dose 1, single for covid-19 immunisation. Medical history included high cholesterol from Jun2021 to an unknown date and gastrooesophageal reflux disease from Jun2021 to an unknown date. Concomitant medication(s) included omeprazole (PRILOSEC); pravastatin sodium; paracetamol (TYLENOL); ibuprofen and multivitamins. There were no other vaccines administered on the same date. The patient had his 1st dose of the vaccine the morning of 10Aug2021 and within a minute, he experienced shortness of breath, chest pain and tightening but went away after 3 minutes. Reporter was asking if patient need to get the 2nd dose of the vaccine. Events did not require a visit to the emergency room nor physician's office. Outcome of the events was recovering. The reporter considered the events medically significant.; Sender's Comments: A contributory role of BNT162B2 to events shortness of breath, chest pain and tightening cannot be excluded based on temporal association and available information. 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: PRILOSEC [OMEPRAZOLE]; PRAVASTATIN SODIUM; TYLENOL; IBUPROFEN

Current Illness:

ID: 1646892
Sex: F
Age:
State: NH

Vax Date: 07/22/2021
Onset Date: 07/22/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: shortness of breath, constricted breathing, tightness, couldn't get enough air in, and was thought to be an asthmatic reaction; shortness of breath, constricted breathing, tightness, couldn't get enough air in, and was thought to be an asthmatic reaction; shortness of breath, constricted breathing, tightness, couldn't get enough air in, and was thought to be an asthmatic reaction; This is a spontaneous report from a contactable consumer (patient's sister). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on 22Jul2021 17:11 (at the age of 46-years-old) at dose 1, single for COVID-19 immunization. Medical history included asthma, ongoing severe nut allergy, and allergies. Concomitant medication included montelukast sodium (SINGULAIR) for asthma and allergies. The patient previously took epinephrine (Epi-Pen) for allergies. The patient has no prior vaccinations (within 4 weeks). On 22Jul2021 21:11, 4 hours after the vaccination, the patient had reactions to the vaccine which included shortness of breath, constricted breathing, tightness, couldn't get enough air in, and was thought to be an asthmatic reaction. The night the reactions happened, it was reported that the patient messaged everyone saying that she loved them because she was unsure if she was going to wake up. The patient messaged her doctor and the doctor told her that they did not have any recommendations for her and that she needed to speak with an allergist. The patient was put in contact with an allergist and the patient was told that the allergist couldn't help and that she needed to speak with her primary care doctor. The patient felt that no one can help her and that she was left to make this decision on her own. The patient has been told that maybe she should take an antihistamine prior to her second dose and have an Epi-Pen with her just n case. The patient's sister stated that it was a scary thing and compared the patient's experience to her being allergic to peanuts and sticking her head in a jar of peanuts but will be okay since if a reaction occurred, Epi-Pen will be used. The patient was trying to determine if she should receive the second dose of the vaccine or not due to the reactions she experienced after the first dose. The patient would like to have the second dose because she was high risk due to her and her husband's job and that they are caring for their 95-year-old grandmother and wanted to keep her safe. The patient's sister was asking if the patient can take antihistamines or Tylenol before or after the dose. They thought of taking prednisone before the dose but the doctor explained that this would be a bad idea, so they are not going to take it. The reporter took a long time to convince the patient to get the shot. The patient was concerned about getting the second shot due to the terrible reactions happened after the first dose vaccination. It took a couple of days before the patient felt okay and before the patient's breathing became better. The patient was afraid the night the reactions occurred because she thought that she would not wake up in the next morning, it was that bad. But the next morning, the patient felt better. She had this feeling at least until she went to bed and through the night. For the next few days, she took it easy; she would just sit and read and do no exercising. After that she was not afraid anymore. The patient took two Benadryl, 3 puffs of the Albuterol inhaler, and two applications of Vapor Rub under her nose as treatments for the events. The events did not result to emergency room visit, however, the events required physician office visit. The patient went to the doctor, but she was not admitted to the hospital. The patient was thinking of driving directly to her doctor's office and sitting in the parking lot there after her second dose. The patient lives in a rural area and it takes 30 minutes just to get an ambulance there. The patient was still unsure if she would get the second dose or not. Outcome of the events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: SINGULAIR

Current Illness: Peanut allergy

ID: 1646893
Sex: F
Age:
State: VA

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Facial numbness; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in arm left on 23Jul2021 at 18:45 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing hyperthyroidism (over 20 years). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for hyperthyroidism from an unspecified start date and ongoing. The patient experienced facial numbness on 23Jul2021 (reported as 20-30 mins after). The clinical course was as follows: The patient experienced the facial numbness with no other symptoms 20-30 mins after she received the dose. Stated numbness lasted 4 hours; she took 2 diphenhydramine (BENADRYL) and facial numbness (including across cheekbone and nose) started improving an hour after she took BENADRYL dose. The patient explained she is scheduled for her second shot on Friday, 13Aug2021. After the first dose, she experienced numbness in her face. She wanted to know if this is a normal side effect, she hasn't seen it listed anywhere. The first shot was given on 23Jul2021 at around 6:45pm in the left upper arm. The facial numbness was noticed about a half hour later, after getting the shot. She took a couple Benadryl and about 4 hours later after waking from a nap, it improved. By the next morning it was gone. She hasn't received a lot of vaccines, just childhood vaccine and one as an adult that she doesn't remember what it was, but she had no reaction. She doesn't normally get vaccines. Therapeutic measures were taken as a result of facial numbness. The outcome of the event was recovered on 24Jul2021. No follow-up attempts are needed. No further information is expected.

Other Meds: SYNTHROID

Current Illness: Hyperthyroidism (had hyperthyroidism over 20 years.)

ID: 1646894
Sex: F
Age:
State:

Vax Date: 07/27/2021
Onset Date:
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:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: shocks in different parts of her body; arm soreness; ankle swelling; muscle soreness; tiredness; headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jul2021 as Dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shocks in different parts of her body, arm soreness, ankle swelling, muscle soreness, tiredness, and headache on 27Jul2021.The outcome of the events was unknown. The patient had query that whether the medical team can provide her with information on receiving the second dose if she continues to experience ongoing symptoms. The call centre team replied the patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as Pfizer cannot answer about the patient receiving the 2nd dose after experience of adverse events. The patient had not received any treatment for the events. Outcome of the events was unknown. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1646895
Sex: F
Age:
State: OR

Vax Date: 08/09/2021
Onset Date: 08/09/2021
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:

Allergies:

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

Symptoms: 25 minutes after the shot was administered I felt nauseas; almost passed out; was covered in sweat and became short of breath; was covered in sweat and became short of breath; my jaw hurt; back of my throat hurt; head hurt; cotton mouth; lips turned blue; I immediately had arm pain; foggy head; forgetful; This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient (Age at time of vaccination 27-years) received first dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Aug2021 at 11:45 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced lips turned blue on 09Aug2021 at 12:10, I immediately had arm pain on 09Aug2021 at 11:45 and 25 minutes after the shot was administered I felt nauseas, almost passed out, was covered in sweat and became short of breath, my jaw hurt, back of my throat hurt, head hurt and cotton mouth all on 09Aug2021 at 12:10 and foggy head and forgetful on 09Aug2021. Patient reported, I immediately had arm pain and then 25 minutes after the shot was administered I felt nauseas and almost passed out, was covered in sweat and became short of breath, lips turned blue, then my jaw hurt and the back of my throat hurt and my head hurt. Then it faded and I had cotton mouth. The rest of the day I was nauseated, foggy head and forgetful, with really intense arm pain. The event Lips turned blue was reported as serious-medically significant. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646896
Sex: F
Age:
State: MN

Vax Date: 01/13/2021
Onset Date: 01/13/2021
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: hair loss; extreme dizziness; tingling and swollen lips; tingling and swollen lips; decreased left ear hearing; joint pain/extreme joint pain; brain fog; fatigue; This is a spontaneous report from a non-contactable healthcare professional (patient). A non-pregnant 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 13Jan2021 (Lot Number: ek4176, unknown expiration; at the age of 46 years old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included colecalciferol (VITAMIN D); biotin; and unspecified multivitamin. The patient previously took Percocet, amoxicillin, and doxycycline, and has known allergies to it. On 13Jan2021, few hours after the vaccination, the patient experienced extreme dizziness, tingling and swollen lips, decreased left ear hearing, joint pain, brain fog, and fatigue. Now (on 10Aug2021), the patient experienced hair loss and extreme joint pain, and dizziness on and off 8 months later. No COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient had not yet recovered from the events. No follow-up attempts are possible; information about batch number was already obtained.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events dizziness, paraesthesia oral, lip swelling, hypoacusis, Arthralgia, feeling abnormal, fatigue and alopecia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: VITAMIN D [COLECALCIFEROL]; BIOTIN

Current Illness:

ID: 1646897
Sex: M
Age:
State: MO

Vax Date:
Onset Date: 08/09/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210809; Test Name: Covid-19; Test Result: Positive

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: positive for COVID; positive for covid; This is a spontaneous report from a contactable other healthcare professional. An adult male patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot numbers were not reported), via unspecified routes of administration on unspecified dates as single doses for COVID-19 immunization. Medical history included leukemia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient who was fully vaccinated got exposed to his wife who was not vaccinated, and he came up positive for COVID which resulted in hospitalization. The patient underwent lab tests and procedures which included COVID-19 test: positive on 09Aug2021. The events resulted in emergency room/department or urgent care visit. It was unknown if treatment was received for the events. 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 information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported positive for COVID based on the known safety profile.

Other Meds:

Current Illness:

ID: 1646898
Sex: F
Age:
State: MO

Vax Date: 03/04/2021
Onset Date: 08/05/2021
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: 20210805; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: Patient loss her sense of taste and tested positive for COVID; Patient loss her sense of taste and tested positive for COVID; This is a spontaneous report from a contactable other hcp. A 30-Years-old female patient (pregnant: unknown) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EN5318), via intramuscular route of administration, administered in Arm Left on 04Mar2021 as (at the age of 29-Years-old) unknown dose number, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as workplace clinic. The patient medical history and concomitant medications were not reported. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications received within 2 weeks of vaccination. Prior to vaccination, the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, the patient been tested for COVID-19. The patient loss her sense of taste and tested positive for COVID on 05Aug2021. No hospitalization was prolonged. The adverse event was resulted in doctor or other healthcare professional office/clinic visit. Prior The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Aug2021. No treatment was received for the reported events. The outcome of the event was reported as not recovered. Product Quality Complaint: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2.

Other Meds:

Current Illness:

ID: 1646899
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date:
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: It felt like a heart attack type of thing; Pins and needles through his chest, arm pits, and arms; Electric shock waves...feelings / felt like he was poisoned; acidic reflux feelings; really weak; felt nauseous; he did not go back to receive his second shot; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that he received the first shot of the vaccine on April and he did not go back to receive his second shot due to a serious reaction that was a lot worse than others. He also mentioned needles, electric shock waves, and acidic reflux feelings. He reported that he felt like he had electric shock waves, he felt really weak and nauseous, felt like he was being poisoned. He said that it lasted for weeks and months and sometimes he still feels it. He said that he also had the pins and needles through his chest, arm pits, and arms. He said that it felt like a heart attack type of thing although he has never had a heart attack. There was no way he was the only person that had bad side effects He said that he has never had a problem with any other vaccines that he has taken in the past, but he did have a problem with this vaccine. He said that he feels better, but said that he does not know the long term implications of the vaccine. He also asked if he was the only person to ever report a serious adverse reaction with the vaccine. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1646900
Sex: M
Age:
State: CO

Vax Date: 07/28/2021
Onset Date: 07/29/2021
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 Name: CT scan with dye contrast; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210729; Test Name: covid test (nasal swab); Test Result: Negative

Allergies:

Symptom List: Pain in extremity

Symptoms: severe diverticulitis attack; bloody stool; diarrhea; fever; nausea; severe vertigo; difficulty breathing; profuse sweating; intense abdominal pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 28Jul2021 08:15 (batch/lot number EW0187 and expiry date unknown) at 43 years of age as dose 1, single for covid-19 immunization in an urgent care center. Medical history included asthma, hyperlipidemia, hypertension, chronic pain, GERD, diverticulitis. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included lisinopril, omeprazole, ibuprofen, ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that within 24 hours of vaccine being administered (approximately midnight on 29Jul2021), he had severe diverticulitis attack to include bloody stool and diarrhea, experienced fever, nausea, severe vertigo, difficulty breathing, profuse sweating, and intense abdominal pain. The patient informed that he required ER visit via paramedics. He had CT scan with dye contrast administered and was then admitted to the hospital for four days on high IV antibiotic regimen plus IV narcotic pain meds. The patient informed that the adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported serious as caused hospitalization (hospitalization not prolonged). The patient underwent lab tests and procedures which included covid test (nasal swab): negative on 29Jul2021. The outcome of the events was recovering.

Other Meds: LISINOPRIL; OMEPRAZOLE; IBUPROFEN; MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR

Current Illness:

ID: 1646901
Sex: F
Age:
State: MO

Vax Date: 02/17/2021
Onset Date: 07/30/2021
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: Test Date: 20210730; Test Name: Nasal Swab; Test Result: Positive.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable other Healthcare Professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 17Feb2021 (at the age of 53-year-old), as dose 2, single in left arm, and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 27Jan2021 (at the age of 53-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported as unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown if the patient had COVID prior vaccination and the patient was tested COVID post vaccination. On 30Jul2021, 5 months and 13 days after second dose of vaccine, the patient was tested positive for COVID and became ill. The patient visited to Doctor or other healthcare professional office/clinic in response to event. It was reported as unknown if the patient received any treatment for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test nasal swab, positive, on 30Jul2021. The clinical outcome of the events was reported as resolving. Based on the available information ,a possible contributory role of suspect product BNT162B2 to the development of the event covid 19 cannot be excluded.

Other Meds:

Current Illness:

ID: 1646902
Sex: M
Age:
State: MO

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

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

Lab Data: Test Date: 20210716; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: Colleague was exposed to his sister and ended up testing positive for COVID will symptoms.; Colleague was exposed to his sister and ended up testing positive for COVID will symptoms.; Accidental overdose; dose 1 administered on 28Jan2021 and dose 2 administered on 28Jan2021; This is a spontaneous report from a contactable other HCP. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), intramuscular in left arm on 28Jan2021 (at the age of 35-years-old) as dose 1 single and dose 2 via an unspecified route of administration in left arm on 28Jan2021 (Batch/Lot Number: EN5318) (at the age of 35-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the colleague was exposed to his sister and ended up testing positive for COVID symptoms on 16Jul2021. The patient did not require hospitalization for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab taken for the test which showed positive on 16Jul2021. The outcome of event the colleague was exposed to his sister and ended up testing positive for COVID symptoms was recovered on an unspecified date in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)

Other Meds:

Current Illness:

ID: 1646903
Sex: M
Age:
State:

Vax Date: 06/01/2021
Onset Date:
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:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 21-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 (Batch/Lot number and Expiry date was not reported) (at the age of 21-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on an unspecified date for covid-19 immunization. On an unspecified date, the patient experienced myocarditis. The patient was subsequently admitted to the hospital with a diagnosis of Myocarditis. The clinical outcome of the event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1646904
Sex: F
Age:
State:

Vax Date: 03/19/2021
Onset Date:
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:

Allergies:

Symptom List: Vomiting

Symptoms: aches and pain; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient). This case is generated for the 2nd dose of reporter self. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 19Mar2021 (Lot number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included urinary tract infection and exposure to COVID-19 (my daughter-in-law, my son, and one of his sons all got COVID). Concomitant medication(s) included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for urinary tract infection, start and stop date were not reported. The patient previously received the first dose of bnt162b2 in Feb2021 for COVID-19 immunization and experienced sore arm. On an unspecified date, the patient experienced aches and pain, muscle pain and dizziness. The patient reported that on Saturday night, she went out with her son, who just had 1 shot of his vaccine (he did not tell which one he got) and his wife and their 2 children. The patient's daughter-in-law came down this COVID-19 the previous day. The patient don't have to do anything. She live alone. She don't see anyone. Her daughter-in-law, her son, and one of his sons all got COVID. She further reported that she was taking Cipro for a urinary tract infection so she did not know if they were symptoms of the antibiotic or of COVID illness. After the first shot, she had a sore arm. After the 2nd shot maybe for 3 days, she had aches and pain. A day an half of muscle pain and very bad dizziness. She wanted some guidance or what to do since she was exposed to someone with COVID over the weekend. The 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: CIPRO [CIPROFLOXACIN]

Current Illness:

ID: 1646905
Sex: M
Age:
State: NY

Vax Date: 08/09/2021
Onset Date: 08/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210810; Test Name: pain level; Result Unstructured Data: Test Result:10; Test Date: 20210810; Test Name: pain level; Result Unstructured Data: Test Result:2

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: abdominal pain/pain level was 10 and now it was down to a 2 on a scale of 1 to 10; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 09Aug2021 17:00 (batch/lot number EW0196 and expiry date 30Sep2021) at 42 years of age as dose 1, single for covid-19 immunization in a hospital facility. The patient has no medical history including any illness at time of vaccination. Concomitant medications were not reported. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect, has no additional vaccines administered on same date of the Pfizer suspect. The patient informed that his first dose of the Pfizer Covid-19 vaccine was on 09Aug2021 and today (10Aug2021), he was experiencing severe abdominal pain that has lasted for 3 hours, it was ongoing and improving. The patient informed that the pain started around 9:00 am, it got better and it improved around 12 pm. The patient's pain level was 10 and now it was down to a 2 on a scale of 1 to 10. The patient informed that he went to the hospital, thought it was the best thing to do. The patient went to the emergency room at 9:30. The patient had to wait so so long, the pain went down and by the time he was ready to be seen his pain level had gone down and he left. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1646906
Sex: M
Age:
State:

Vax Date:
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: RA

Lab Data: Test Date: 202108; Test Name: COVID; Result Unstructured Data: Test Result: Positive.

Allergies:

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

Symptoms: This is a spontaneous report from a non-contactable consumer (patient). An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was not tested positive for covid-19. On an unspecified date in Aug2021 the patient underwent lab tests and procedures which included covid test which resulted positive. It was reported that on an unspecified date in Aug2021 the patient was symptomatic and tested positive for covid-19. It was further reported that the patient was not hospitalized. The patient received the treatment for the events was unknown. The patient was resolving from the event covid-19. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1646907
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
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: 202108; Test Name: covid test; Test Result: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Tested positive for COVID and was symptomatic. I was able to confirm the person was NOT hospitalized.; Tested positive for COVID and was symptomatic. I was able to confirm the person was NOT hospitalized.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). An elderly nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. On an unknown date in Aug2021, the patient was tested positive for covid and was symptomatic. It was confirmed that the patient was not hospitalized due to the event. On an unknown date in Aug2021, the patient had lab test to Sars-cov-2 infection and results were positive with symptomatic symptoms. It was unknown if the patient was treated for the event. The outcome of the event was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1646908
Sex: M
Age:
State: NY

Vax Date: 07/14/2021
Onset Date: 07/19/2021
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: RA

Lab Data: Test Name: CAT SCAN; Result Unstructured Data: Test Result:couple of abnormalities; Test Name: MRI; Result Unstructured Data: Test Result:couple of abnormalities

Allergies:

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

Symptoms: collapsed and hit his head and was unconscious; he collapsed and hit his head and was unconscious; numbness and pain in his head; numbness and pain in his head; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Jul2021 13:30 (Batch/Lot Number: 187) (at age 69-years-old) as dose 1, single for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. Family history included heart attack (father died from this). Concomitant medication included acetylsalicylic acid, caffeine (BAYER BACK & BODY PAIN) for back pain. On 19Jul2021, patient collapsed and hit his head and was unconscious. He continued to experience numbness and pain in his head. His head, half of his head, his forehead and the top of his head is still numb since the fall. 8 days later he checked himself into the hospital with possible stroke or heart attack and recently got out of the hospital. He had no permanent damage as far as walking or talking but it knocked him down. He doesn't remember anything before the fall; he doesn't remember falling or being unconscious; he just remembers waking up on the floor. He didn't go to the hospital for about eight days, but it didn't get better so his children convinced him to go to the hospital. He was admitted on 30Jul2021 and discharged 02Aug2021. Events resulted in emergency room. He has indoor outdoor carpet with concrete and he hit his head on the concrete. He was getting on 03Aug2021, just a little feeling in his right forehead. He does not blame anyone and doesn't know if this is even related to the shot. He wanted Pfizer to know about his experience. He was scheduled for the 2nd dose of the Pfizer Covid-19 Vaccine on 04Aug2021 and he did not get it for fear that his body would reject it. Patient had all kinds of tests, MRI and a CAT SCAN. When ask for results he states there was a couple of abnormalities but they sent him home anyway. He thinks he should be under care, being monitored, and they should not have sent him home. Outcome of the event hit his head was not recovered, for event numbness in head was recovering and for the remaining events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: BAYER BACK & BODY PAIN

Current Illness:

ID: 1646909
Sex: F
Age:
State: LA

Vax Date: 07/21/2021
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:

Allergies:

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

Symptoms: Bitten by wasps; Itchiness; Local reaction / local irritation; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported she was bitten by wasps on Saturday afternoon, 07Aug2021, and she was taking Benadryl 25mg three times a day for the wasps bite as well as for itchiness and local reaction/local irritation on an unknown date in Aug2021. The events were reported as non-serious. The patient was scheduled to have her second dose on 11Aug2021 and would like to know if she can continue with the vaccination as scheduled. 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:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am