VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1345601
Sex: F
Age: 44
State: NV

Vax Date: 05/01/2021
Onset Date: 05/02/2021
Rec V Date: 05/25/2021
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: Penicillin Sulfa

Symptom List: Dysphagia, Epiglottitis

Symptoms: Within 24 hours of having my second dose of the COVID-19 vaccine, I became moderately depressed. Nothing had occurred in the days prior to trigger an episode nor had I suffered from a episode for a while. I have since encountered two other people who have had the same reaction and have encouraged them to retort it as well.

Other Meds: Citalopram 20mg

Current Illness: None

ID: 1345603
Sex: F
Age: 28
State: CA

Vax Date: 02/10/2021
Onset Date: 03/07/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Pericarditis occurred end of February and was seen by a doctor early March and was diagnosed. Still ongoing side effect and taking colchicine for the inflammation of the pericardium. Ongoing chest pain and pressure is present with pain radiating to the left side of my shoulder blade. There is also neck pain present. These symptoms are ongoing and still being treated for.

Other Meds:

Current Illness:

ID: 1345624
Sex: F
Age: 58
State: IN

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 05/25/2021
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: No additional adverse events reported; administration of improperly stored PNEUMOVAX 23; administration error; Inofrmation has been received from a registered nurse and an office administrator reporting on a 58-year-old female patient. The patient concurrent conditions included diabetes type II, hyperlipidemia, and fatty liver. The patient's allergies included cough with lisinopril (manufacturer unknown) (captured in MARRS# 2105USA004965), adverse reaction with merformin, and nausea with atorvastatin calcium (LIPITOR) and rosuvastatin calcium (CRESTOR). There was no information about the patient's concomitant medication or historical conditions. On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular, lot # T035379, expiration date 31-MAY-2022 for prophylaxis (first dose). That same date, the patient was vaccinated with an improperly stored dose of diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) intramuscular, lot # U6900AA, expiration date 18-NOV-2022 for an unknown indication (first dose). Both vaccines were administered in the right deltoid. The medication error occurred during the administration. No additional adverse events reported, and no prescription drug treatment was required. The vaccine after administered was placed into sharps. On an unknown date, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion of 34.5 Celsius degrees for 31 hours and 36 minutes. The refrigerator was out of the temperature range and the health professional/medical assistant did not acknowledge the temperature. The medical assistant gave the vaccines without any regard to the temperature. The patient was made aware of this afterwards. There was no previous temperature excursion. The call was not placed due to a digital data logger. After verifying that the remaining vaccines were not viable, they were removed from the fridge and shipped. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2105USA004965:

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness: Drug hypersensitivity; Hyperlipidaemia; Liver fatty; Type 2 diabetes mellitus

ID: 1345625
Sex: U
Age: 4
State: CA

Vax Date: 05/03/2021
Onset Date: 05/03/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: no additional information provided/no additional AE; improperly stored temperature excursion; This spontaneous report has been received from an office manager (also reported as administrator) referring to a 4-year-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported. On 03-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (formulation, strength, dose, and route were not reported; lot # T030760 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX). Lot number T030760 is a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA), expiration date reported as 05-MAR-2022, but upon internal validation established as 08-MAR-2022). The vaccine was improperly stored at 5.3 degree Celsius for 45 minutes (product storage error). The temperature excursion was detected by a data logger. There was no previous temperature excursion. No additional information or adverse event was provided. This is one of 2 reports received from the same reporter.; Sender's Comments: US-009507513-2105USA000596: US-009507513-2105USA000739:

Other Meds:

Current Illness:

ID: 1345626
Sex: U
Age:
State: MD

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 22-FEB-2021 , the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) dose 1 (units not provided) (strength, route, dose #, frequency, and anatomical location were unknown) with lot # T020109 and expiration date 26-JAN-2022 for prophylaxis.The patient was asyntomatic. The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9 degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes; on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes. There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:

Other Meds: VAQTA SYRINGE (DEVICE)

Current Illness:

ID: 1345627
Sex: U
Age:
State: MD

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 26-FEB-2021 , the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) dose 1 (units not provided) (strength, route, dose #, frequency, and anatomical location were unknown) with lot # T020109 and expiration date 26-JAN-2022 for prophylaxis.The patient was asyntomatic. The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9 degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes; on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes. There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:

Other Meds: VAQTA SYRINGE

Current Illness:

ID: 1345628
Sex: U
Age:
State: MD

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 05/25/2021
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: Pyrexia, White blood cell count decreased

Symptoms: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 12-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) dose 1 (units not provided)(strength, route, dose #, frequency, and anatomical location were unknown) with lot # T020109 and expiration date 26-JAN-2022 for prophylaxis.The patient was asyntomatic. The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9 degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes; on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes. There was no digital data logger involved, and no previous temperature excursion. The program did an audit, and they were unaware of the excursions. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2105USA003518: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:

Other Meds: VAQTA SYRINGE

Current Illness:

ID: 1345629
Sex: U
Age:
State: NJ

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: No symptoms were reported by any of the patients; Improperly stored vaccines administered; MMR II Lot: S039309 Exp: 4-DEC-2021, but upon internal validation established as 31-MAR-2018; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided. On 14-MAY-2021, the patient was vaccinated with one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S039309, which have been verified to be a valid lot number, expiration date reported as 04-DEC-2021, but upon internal validation established as 31-MAR-2018) as prophylaxis (product storage error and expired product administered). The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments: US-009507513-2105USA003873: US-009507513-2105USA003871: US-009507513-2105USA003872:

Other Meds:

Current Illness:

ID: 1345630
Sex: U
Age:
State: NJ

Vax Date: 05/14/2021
Onset Date: 05/14/2021
Rec V Date: 05/25/2021
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: No symptoms were reported by any of the patients; Improperly stored vaccines administered; MMR II Lot: S039309 Exp: 4-DEC-2021, but upon internal validation established as 31-MAR-2018; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided. On 14-MAY-2021, the patient was vaccinated with one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S039309, which have been verified to be a valid lot number, expiration date reported as 04-DEC-2021, but upon internal validation established as 31-MAR-2018) as prophylaxis (product storage error and expired product administered). The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments: US-009507513-2105USA003872: US-009507513-2105USA003873: US-009507513-2105USA003867:

Other Meds:

Current Illness:

ID: 1345632
Sex: U
Age:
State: NJ

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: No symptoms were reported by any of the patients; Improperly stored vaccines administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided. On 17-MAY-2021, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T005737, which have been verified to be a valid lot number, expiration date reported and upon internal validation established as 10-JUN-2022) as prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments: US-009507513-2105USA003867: US-009507513-2105USA003871: US-009507513-2105USA003872:

Other Meds:

Current Illness:

ID: 1345633
Sex: U
Age:
State: IN

Vax Date: 03/05/2015
Onset Date:
Rec V Date: 05/25/2021
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: congestive heart failure; vision problems; balance issues; shingles, herpes zoster; Information was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding the pt's current condition, historical condition, concomitant medication was not provided. On or about 05-MAR-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles, herpes zoster, congestive heart failure, vision problems, and balance issues. The outcome of the events was unknown. The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX). The pt claimed damages as results of injury to themselves, loss of consortium, loss of service and economic losses. Upon inernal review, congestive heart failure was considered as medically significant.

Other Meds:

Current Illness:

ID: 1345641
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: Got the first shingles shot but I was in bed for 2 days sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got the first shingles shot but was in bed for 2 days sick so the patient did not get the second one. The patient stated that his/her doctor said just getting the first one makes about 90 some percent sure of not getting it. The patient never even heard of getting shingle every year. No contact details provided for follow up.

Other Meds:

Current Illness:

ID: 1345644
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: I got the shingle shot,than a few years after that got the shingles/ Suspected vaccination failure; I got the shingle shot,than a few years after that got the shingles; Cannot describe the pain for 8 weeks; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient got the Shingles shot and few years after that got the shingles in/ on his or her head and could not describe the pain for 8 weeks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confiding shingles were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1345645
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I had both shots and have them/Suspected vaccination failure; I had both shots and have them.; Worse pain i ever had!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both the shots of Shingles and still had shingles. The patient stated that worst pain event had. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1345646
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: I got them a few months after I got the vaccine / worse case of shingles than the first case/ Suspected vaccination failure; I got them a few months after I got the vaccine / worse case of shingles than the first case; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. A few months after the patient got the vaccine, the patient experienced worse case of Shingles than the first case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1345647
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suspected Vaccination failure; Got the vaccine have had Shingles 3 times since; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and had Shingles 3 times since. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.

Other Meds:

Current Illness:

ID: 1345648
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suspected vaccination failure; shingles no bad I got them on the left side of my head; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles on the left side of head. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.

Other Meds:

Current Illness:

ID: 1345649
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: got the shot. Then got shingles/Suspected Vaccination failure; got the shot. Then got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient got the Shingle shot and then got shingles, still had a patch on forehead, a patch on boob and the patch on waist for three years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1345650
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: was vaccinated and still got Shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The patient was the reporter's niece. The age at vaccination was not reported. The patient received shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1345651
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: Was vaccinated and still got shingles twice/Suspected vaccination failure; Shingles twice; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and and still got shingles twice. The patient stated that no thanks to vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1345652
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: had both old and new shingles shots in past years. I recently got shingles/Suspected vaccination failure; shingles / my case was only about a 4 out of 10 compared to the worst cases; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (old shingles vaccine received on an unknown date in past years). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both old and new shingles shots in past years and recently got shingles. The patient stated that, so the word prevent was BS (unspecified) and however, his/her case was only about a 4 out of 10 compared to the worst cases. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1345653
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: Unevaluable event

Symptoms: Has been vaccinated / Shingles and it's broken out down his leg /Suspected vaccination failure; Shingles / broken out down his leg; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and and he was just told that he had Shingles and it was broken out down his leg and was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1345654
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: I got vaccinated and was hospitalized for a serious breakout, suspected vaccination failure; serious breakout all over my back; Horrific pain; still suffer nerve pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization), pain and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain and nerve pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, pain and nerve pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got vaccinated with the Shingles vaccine and was hospitalized for a serious breakout all over the back and horrific pain. The breakout was healed but the nerve pain persisted at the time of reporting. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation for shingles infection and time to event onset were unknown.

Other Meds:

Current Illness:

ID: 1345655
Sex: M
Age:
State: IL

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Kinrix pfs given on 4/2 Instead of infanrix; Kinrix pfs given on 4/2 Instead of infanrix; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 21-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 2nd April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported but could be 20 or 21 months old. The patient received Kinrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No side effects were reported. The reporter had asked for the date of birth of the patient and further additional information but had not got any updates. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1345658
Sex: F
Age: 61
State: CA

Vax Date: 04/01/2018
Onset Date: 01/01/2020
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Had a mild case of shingles a year and a half after her second shot / Diagnosed by her HCP/ Confirmed vaccination failure; Had a mild case of shingles a year and a half after her second shot / Diagnosed by her HCP; This case was reported by a consumer via call center representative and described the occurrence of confirmed vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In April 2018, the patient received the 1st dose of Shingrix. In September 2018, the patient received the 2nd dose of Shingrix. In January 2020, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: The patient stated that, she had a mild case of shingles a year and a half after her second shot. The reporter did not have the specific dates. The patient had phoned to praise the company about not using aborted fetus cells for vaccinations and upcoming Covid Shot. This case was considered as confirmed vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation were known at the time of reporting. The reporter did not consent to follow up.

Other Meds:

Current Illness:

ID: 1345660
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: administered the Menveo Diluent only / instead of the full reconstituted vaccine; administered the Menveo Diluent only / instead of the full reconstituted vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows : The age at vaccination was not reported. The reporter stated that, the patient was received only the Menveo diluent only instead of the full reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacy technician unable to provide full vaccine and patient details at the time of reporting. No further information was reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1345661
Sex: M
Age: 35
State: OH

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 05/25/2021
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: received a late second dose / first dose was administered on 03Mar2020 and the second dose on 31Mar2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 35-year-old male patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Engerix B (1st dose received on 3rd March 2020.). On 31st March 2021, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received the 2nd dose of Engerix B vaccine, more than recommended interval, which was lengthening of the vaccination schedule. No further information was reported. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1345663
Sex: M
Age:
State: MI

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 05/25/2021
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: 27 years old received a Havrix pediatric dose; 27 years old received a Havrix pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 27-year-old male patient who received HAV (Havrix pediatric) (batch number B23EA, expiry date 15th May 2022) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th May 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 20th May 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: A 27 years old patient received a Havrix pediatric dose which led to underdose and adult use of a child product. The reporter informed that, till the reporting, the patient was in the clinic and asked how to proceed in this scenario. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1345665
Sex: F
Age: 11
State: IA

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: an 11-year-old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date unknown) for prophylaxis. Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th May 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter was a clinic employee. The reporter stated that the 11 year old patient received kinrix which led to inappropriate age at vaccine administration. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1345668
Sex: M
Age: 68
State: TX

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 05/25/2021
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: first dose was on 2/7/2021 and his second dose was on 5/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received HAB (Twinrix) (batch number A955S, expiry date 22nd May 2022) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Twinrix (received 1st dose on 2nd February 2021, batch number A955S and expiration date 22nd May 2022). On 13th May 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th May 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown. The reporter considered the drug dose administration interval too long to be unrelated to Twinrix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follow: The patient received his 2nd dose late by 3 months which led to drug dose administration interval too long. The reporter was looking for guidance, as patient received both vaccines have same lot number and expiration date. The reporter consented to follow up by Fax.

Other Meds:

Current Illness:

ID: 1345670
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: has not received 6-month Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Twinrix (received 1st dose on 12th September 2019.) and Twinrix (received 2nd dose on 19th October 2019.). On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 3rd dose which led to incomplete course of vaccination. The reporter mentioned that, patient had not received the 6-month Twinrix dose. The reporter consented to follow up

Other Meds:

Current Illness:

ID: 1345671
Sex: F
Age: 64
State: IA

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 05/25/2021
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: Patient received a dose of Menveo instead of her second dose of Shingrix; Patient received a dose of Menveo / DOB: 24-MAR-1957; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 64-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA549A, expiry date 28th February 2022) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix on 4th January 2021). On 20th May 2021, the patient received Menveo. On 20th May 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional details were provided as follows: MA reported that the patient received a dose of Menveo instead of second dose of Shingrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1345673
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 04/11/2021
Rec V Date: 05/25/2021
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; CHEST PRESSURE/PAIN IN THE CENTER OF CHEST; SORE THROAT; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pneumonia. The patient received tylenol extra strength tablet (caplet, oral, batch number: SAA006 expiry: -OCT-2023) dose and frequency were not reported from 12-APR-2021 05:00 for headache, and fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 23-MAR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced chest pressure/pain in the center of chest. On 11-APR-2021, the subject experienced sore throat. On 11-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tylenol extra strength tablet was not reported. The patient had not recovered from headache, sore throat, and fever, and the outcome of shortness of breath and chest pressure/pain in the center of chest was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria), based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

Other Meds:

Current Illness:

ID: 1345674
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/25/2021
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:

Allergies:

Symptom List: Tremor

Symptoms: COMPUTERISED TOMOGRAM; ELECTROCARDIOGRAM; LABORATORY TEST; PULMONARY EMBOLISM; X-RAY; PAIN ON THE RIGHT-HAND SIDE UNDER MY RIBS; MYALGIA; ULTRASOUND SCAN; LUNG COLLAPSED; FLUID IN THE BOTTOM OF HER LUNG; This spontaneous report received from a patient via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 62-year-old female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, and penicillin allergy. The patient had no current illness. The patient had no heart problems, no pulmonary problem and diabetes. The patient experienced drug allergy when treated with paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included levomilnacipran hydrochloride for depression, and quetiapine fumarate for depression. On an unspecified date in APR/2021, little more than a week after single-dose coronavirus vaccine at hospital facility the patient felt general malaise and minor pain in her right side. The patient had shortness of breath, and she looked anxious and her heart rate was very fast. The vital signs were not stable. The physician suspected that patient had developed pulmonary embolism blood clots in her lungs. When combined with her vitals, the doctor knew it was an emergency. The patient also began to feel mildly ill. She was experienced general malaise, soreness on her right side, and while she was not struggling to breathe, it hurt when she took a deep breath, her right-hand side, like under her ribs, she felt some pain. It was not a bad pain, not enough to take anything for it but just noticed it. The symptoms seemed minor, and at the time. It was reported that by 21-APR-2021, she still was not feeling well and decided to make an appointment at the urgent care center. The patient visited emergency room or department/urgent care facility for treatment of the events. The patient soon learned she had developed blood clots (pulmonary embolism) in both lungs due to the vaccine, a doctor at the hospital told her. One of her lungs also had collapsed. She had developed blood clots in both lungs due to the vaccine, she was there for 10 hours (undergoing tests). The patient underwent a computerized tomography scan and an X-ray. They did everything and got the results of the CAT scan, with pulmonary embolism in both lungs. They immediately gave her some blood thinner and was as hospitalized (date unspecified). It was reported that she would spend five days in the hospital. According to the doctors this was from the vaccine. The patient was also experiencing the pain on the right-hand side and also started getting myalgia, muscle aches just in different parts of her body. The patient's legs also felt weird. So they rushed her down and gave a sonogram in her legs to check for deep vein thrombosis. The pain on her right side grew worse for a day or two, and she was treated with morphine. The doctors surmised the patient had fluid in the bottom of her lung, which her body eventually absorbed. The patient was still on a blood thinner and continued to recover. Laboratory data included: Heart rate (NR: not provided) very fast, and Sonogram (NR: not provided) Not provided. On an unspecified date in APR-2021, Laboratory data included: Computerised tomogram (NR: not provided) pulmonary embolisms in both lungs, Electrocardiogram (NR: not provided) Not provided, Laboratory test (NR: not provided) Not provided, Ultrasound scan (NR: not provided) Not provided, and X-ray (NR: not provided) Not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, had not recovered from computerised tomogram, electrocardiogram, laboratory test, ultrasound scan, and x-ray, and the outcome of myalgia, fluid in the bottom of her lung, lung collapsed and pain on the right-hand side under my ribs was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Additional information was received from company representative via social media on 18-MAY-2021. The following information was updated and incorporated into the case narrative: patient's city added, events added (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram).; Sender's Comments: V1: The follow up information in this version updates Patient's city, events (pain on the right-hand side under my ribs, myalgia, lung collapsed, fluid in the bottom of her lung), CT scan result updated, lab data updated (Heart rate and Sonogram). The follow up information received in this version does not alter the causality of the previously reported events 20210514298-COVID-19 VACCINE AD26.COV2.S-fluid in the bottom of her lung, pain on the right-hand side under my ribs: These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210514298- COVID-19 VACCINE AD26.COV2.S-myalgia. This event is labeled per RSI and is therefore considered potentially related. 20210514298-COVID-19 VACCINE AD26.COV2.S-Pulmonary embolism, computerized tomogram, electrocardiogram ,laboratory test, ultrasound scan, X-Ray: These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds: SEROQUEL; FETZIMA

Current Illness: Depression; Penicillin allergy

ID: 1345675
Sex: M
Age:
State: DC

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: SUSPECTED CLINICAL VACCINE FAILURE; ASYMPTOMATIC COVID-19; This spontaneous report received from a consumer via social media (press) via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient tested positive for covid-19 infection (suspected covid-19 infection and suspected clinical vaccine failure). The patient was not sick and had no symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210525619, 20210526031, 20210526205 and 20210526804. This report was associated with product quality complaint: 90000179542 and 90000179538. The suspected product quality complaint (90000179542) has been confirmed to be not voided. The investigation had been reviewed and the root cause and disposition determinations were documented properly. The investigation was approved and closed.; Sender's Comments: V0: 20210527411-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1345676
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/25/2021
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: CHEST PAINS; IRRITABLE BOWEL SYNDROME FLARE-UP; NAUSEA FLARE UP; FEVER; PAIN IN THE BACK OF THE HEAD; INFLAMED TISSUES IN THE NOSE; INFLAMED TISSUES IN THE EAR SINUSES; EAR PAIN; SINUS PRESSURE; FELT LIKE PASSING OUT; This spontaneous report received from a parent concerned a 24-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, irritable bowel syndrome, penicillin allergy, sulfas allergy, peanuts allergy, grapes allergy, and cephalosporin allergy, and other pre-existing medical conditions included no prior reactions to vaccination in the past, no vaccination in the month before Janssen covid-19 vaccination. The patient experienced drug allergy when treated with topiramate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Concomitant medications included fluticasone propionate for asthma, salbutamol for asthma, diphenhydramine hydrochloride for drug used for unknown indication, cyproheptadine for ibs, famotidine for ibs, lansoprazole for ibs, and ondansetron for ibs. On 2021, the subject experienced ear pain. On 2021, the subject experienced sinus pressure. On 2021, the subject experienced felt like passing out. On 2021, the subject experienced inflamed tissues in the nose. On 2021, the subject experienced inflamed tissues in the ear sinuses. On 2021, the subject experienced pain in the back of the head. Laboratory data included: Blood test (NR: not provided) No abnormalities, CAT scan (NR: not provided) no abnormalities, and Nasoendoscopy (NR: not provided) inflamed tissues in the nose/ear sinuses. On APR-2021, the subject experienced irritable bowel syndrome flare-up. On APR-2021, the subject experienced nausea flares up. On APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 11-MAY-2021, the subject experienced chest pains. Treatment medications (dates unspecified) included: ketorolac tromethamine, meclozine, hydrocortisone, azithromycin, prochlorperazine, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on APR-2021, had not recovered from pain in the back of the head, ear pain, sinus pressure, felt like passing out, chest pains, nausea flare up, and irritable bowel syndrome flare-up, and the outcome of inflamed tissues in the nose and inflamed tissues in the ear sinuses was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Other Meds: FLOVENT; ALBUTEROL [SALBUTAMOL]; CYPROHEPTADINE; PEPCID [FAMOTIDINE]; PREVACID; ZOFRAN [ONDANSETRON]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Allergic asthma; Allergic reaction to antibiotics; Fruit allergy; Irritable bowel syndrome; Peanut allergy; Penicillin allergy; Sulfonamide allergy

ID: 1345677
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/25/2021
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: BACK PAIN; PAIN IN BOTH LEGS; BODY PAIN; ANXIOUS; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and cigarette smoker. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced anxious. On 14-MAY-2021, the subject experienced body pain. On 15-MAY-2021, the subject experienced back pain. On 15-MAY-2021, the subject experienced pain in both legs. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body pain, pain in both legs, and back pain, and the outcome of anxious was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (1-2 times in a month); Cigarette smoker (1-2 Cigarettes per day)

ID: 1345678
Sex: F
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: PASSED OUT; SUNBURN FEELING IN VACCINE INJECTION ARM; SEVERE STOMACH ISSUES FOR A WEEK; UNSPECIFIED DISORDER OF JOINT OF SHOULDER REGION; FEELS LIKE NERVE DAMAGE; FEELING IRRITATED; FEELS LIKE THE HAIR ON ARMS HURT; ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING TOUCHES IT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, patient passed out. The patient had severe stomach issues. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something was touching it. It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. These events didn't last as long-maybe a couple of days and it was gone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, sunburn feeling in vaccine injection arm, severe stomach issues for a week, unspecified disorder of joint of shoulder region, feels like nerve damage, feeling irritated, feels like the hair on arms hurt, and arm from shoulder to pinky finger hurts if something touches it on 2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210525585.; Sender's Comments: V0;20210531194 -covid-19 vaccine ad26.cov2. s passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1345679
Sex: M
Age:
State: AL

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: PAINFUL LUMP IN THE RIGHT ARM; LETHARGIC; LOW GRADE FEVER; TIRED; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the patient experienced painful lump in the right arm. On 15-MAY-2021, the patient experienced lethargic. On 15-MAY-2021, the patient experienced low grade fever. On 15-MAY-2021, the patient experienced tired. Laboratory data included: Body temperature (NR: not provided) Low grade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever on MAY-2021, was recovering from lethargic, and tired, and had not recovered from painful lump in the right arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1345680
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 05/25/2021
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: METAL AFTER TASTE WITHIN AN HOUR; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced metal after taste within an hour after it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metal after taste within an hour after it. This report was non-serious.

Other Meds:

Current Illness:

ID: 1345682
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight was 225 pounds, and height was 67 inches. The patient's pre-existing medical conditions included patient does not consumed alcohol and non-smoke The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient underwent to laboratory test for antibody detection which was negative (confirmed immunological vaccine failure). The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210532314-COVID-19 VACCINE AD26.COV2.S-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1345683
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: POSITIVE COVID TEST AFTER VACCINE; SORE ARM; DRY THROAT; WARMTH WENT UP NECK; VERY THIRSTY; WATERY EYES; FEELING A LITTLE NASALLY; This spontaneous report received from a consumer concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feeling a little nasally. On APR-2021, the subject experienced watery eyes. On 09-APR-2021, the subject experienced sore arm. On 09-APR-2021, the subject experienced dry throat. On 09-APR-2021, the subject experienced warmth went up neck. On 09-APR-2021, the subject experienced very thirsty. On 18-APR-2021, the subject experienced positive covid test after vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 25-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from positive covid test after vaccine on 25-APR-2021, and the outcome of sore arm, feeling a little nasally, dry throat, warmth went up neck, very thirsty and watery eyes was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be pqv management approval - confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.

Other Meds:

Current Illness:

ID: 1345684
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CONSTIPATION; LETHARGY; COLD; SWEATING; MUSCLE WEAKNESS; CHILLS; MUSCLE ACHES/MYALGIA; FEVER; DARKLY COLOURED URINE; TREMOR; TINNITUS; LOSS OF APPETITE; STUFFINESS; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included knee pain, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and he consumed alcohol no more than 2-3 drinks at any one time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included celecoxib for knee pain, and minerals nos/vitamins nos. On 19-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 24-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE. On 30-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On MAY-2021, the subject experienced stuffiness. Laboratory data included: Body temperature (NR: not provided) 99.6-99.8 F. Treatment medications included: paracetamol. On 06-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) negative. On 09-MAY-2021, the subject experienced darkly coloured urine. On 09-MAY-2021, the subject experienced tremor. On 09-MAY-2021, the subject experienced tinnitus. On 09-MAY-2021, the subject experienced loss of appetite. On 09-MAY-2021, the subject experienced constipation. On 09-MAY-2021, the subject experienced lethargy. On 09-MAY-2021, the subject experienced cold. On 09-MAY-2021, the subject experienced sweating. On 09-MAY-2021, the subject experienced muscle weakness. On 09-MAY-2021, the subject experienced chills. On 09-MAY-2021, the subject experienced muscle aches/myalgia. On 09-MAY-2021, the subject experienced fever. On 12-MAY-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 13-MAY-2021, treatment medications included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from darkly coloured urine on 15-MAY-2021, tremor, tinnitus, loss of appetite, constipation, lethargy, cold, sweating, muscle weakness, chills, muscle aches/myalgia, and fever on 17-MAY-2021, and stuffiness on MAY-2021. This report was non-serious.

Other Meds: CELEBREX; CENTRUM [MINERALS NOS;VITAMINS NOS]

Current Illness: Alcohol use; Knee pain; Non-smoker

ID: 1345685
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: Unknown) dose was not reported, total 1 dose administered, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient underwent an antibody laboratory test for spike protein antibody test which returned negative (confirmed immunological vaccine failure) about a month after receiving the Janssen covid-19 vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000179849 The suspected product quality complaint has been confirmed to be Void: No based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210533168 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1345686
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
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: BODY ACHES; CHILLS; FEVER; WOKE UP THE NEXT MORNING WITH EXTREME HEADACHE; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced body aches. On 2021, the subject experienced chills. On 2021, the subject experienced fever. On 2021, the subject experienced woke up the next morning with extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, fever, and woke up the next morning with extreme headache on 2021. This report was non-serious. This case, from the same reporter is linked to 20210541124.

Other Meds:

Current Illness:

ID: 1345687
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 02/01/2021
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in 2021, the subject experienced suspected clinical vaccination failure, the patient reports to be tested positive for Covid-19 multiple time within 90 days after vaccination. On 01-FEB-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 16-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534882-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

ID: 1345688
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BLOOD CLOT; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient got blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210534929-covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1345690
Sex: F
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 05/25/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: BURNING IN MOUTH; SWOLLEN TONGUE; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning in mouth, and swollen tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning in mouth and swollen tongue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210534846.

Other Meds:

Current Illness:

ID: 1345691
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 05/08/2021
Rec V Date: 05/25/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: MAJOR HEART ATTACK, GOT PLACED WITH A STENT; This spontaneous report received from a patient concerned a 70-year-old male. The patient's weight, height, and medical history were not reported. Prior to the vaccination, patient was never on any medication. Patient had no pre-existing conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: not reported) dose was not reported, 1 total administered on 04-MAY-2021 at 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, four days after vaccination, the patient experienced major heart attack due to which he went in an ambulance (his spouse called 911) and was hospitalized on the same day. Patient was placed in ICU (intensive care unit) and got step down. On 10-MAY-2021, patient was discharged and he went home with a life vest. Patient was hospitalized for 3 days. No other side effects were reported. Patient got placed with a stent. Patient was discharged with Treatment medications (dates unspecified): lipitor 80 mg, losartan potassium 25 mg, plavix 75 mg, metoprolol succinate extended release 50mg, and baby aspirin 81 mg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from major heart attack on 17-MAY-2021. This report was serious (Hospitalization).; Sender's Comments: V0; 20210535227 -covid-19 vaccine ad26.cov2. s major heart attack. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1345692
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/25/2021
Hospital: Y

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: LOW PLATLET COUNT; BLACK AND BLUES; This spontaneous report received from a consumer concerned a 52 year old male. The patient's weight was 194 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included blood work clean in september 2020,no drug allergies. The patient did not had any illness at the time of vaccination, no similar event in the past. He never had any adverse event in past for vaccination. The patient did not had family history of any disease or allergy. The patient did not had medical history of blood clots, heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: Unknown dose was not reported, administered on 12-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included doxycycline for drug used for unknown indication. On APR-2021,he noticed black and blues appearing randomly all over his body for no reason whatsoever. They continued to worsen until he went to primacy doctor who did blood work on 29-APR-2021. On 1-MAY-2021 doctor called about blood work to said that he had dangerously low platelet count and to make sure he did not fall and hurt himself. He was instructed to go to the emergency room where they were waiting for him. He was admitted that day. He was treated with steroids for two days with no response, 2 day plasma treatment with minimal response. On May 7-MAY-2021 he was discharged from hospital and was told to continue Doxycycline 2 weeks treatment course. He later had more blood work and the levels have radically dropped again. He had an appointment with a Hematologist/Oncologist specialist on Friday 12-MAY-2021., Laboratory data included: Blood test (NR: not provided) low platelet count. Laboratory data (dates unspecified) included: Blood test (NR: not provided) levels dropped. Treatment medications (dates unspecified) included: plasma, Steroids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low platelet count, and black and blues. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210536558.; Sender's Comments: V0: 20210535373-covid-19 vaccine ad26.cov2.s-low platelet count. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: DOXYCYCLINE

Current Illness: Non-smoker

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm