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: 1469574
Sex: U
Age:
State: IN

Vax Date: 07/02/2021
Onset Date: 07/02/2021
Rec V Date: 07/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: he reported that on 02JUL2021 a patient was administered ROTATEQ that expired on 03JUN2021; no adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported. On 02-JUL-2021 the patient was vaccinated with an expired 2 ml dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis (lot number: 1684142 and expiration date: 03-JUN-2021) (vaccination scheme frequency were not reported). No adverse event was reported.

Other Meds:

Current Illness:

ID: 1469575
Sex: F
Age: 63
State: OR

Vax Date: 10/06/2014
Onset Date: 09/06/2014
Rec V Date: 07/14/2021
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: Inappropriate schedule of vaccine administered; Information as received from a lawyer and medical records and refers to a 63-year-old non-smoking female patient. Historical vaccinations inculded: tuberculine PPD, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (twice), influenza vaccine inact sag 3v(FLUVIRINE) and zoster vaccine live (ZOSTAVAX). On 06-OCT-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration were not reported) for prophylaxis. On 01-SEP-2016, the patient was vaccinated with a dose of pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) 0.5 milligram, in left deltoid, lot # M5t193, expiration date 02-MAY-2017 for prophylaxis. On 06-SEP-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration were not reported) for prophylaxis. On 06-SEP-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in 0.5 milligram right deltoid, lot # N011491, expiration date 04-NOV-2018 for prophylaxis. Concomitant therapies included influenza vaccine inact sag 3v(FLUVIRINE).; Sender's Comments: US-009507513-2101USA000011:

Other Meds: FLUVIRINE

Current Illness: Prophylaxis

ID: 1469576
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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 further information provided. No additional AE reported.; Caller stated the adult patient over 40 years old received the first dose of GARDASIL 9 in 2019. There was a gap between the first and second dose. Second and third doses were both administered sometime in 2021.; This spontaneous report has been received from an unspecified reporter (conflicting information as it was reported as physician and other) and refers to an adult patient of unknown gender reported as over 40-years-old. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies. On an unspecified date in 2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) for prophylaxis (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter). On an unknown date in 2021 (also reported as "sometime in 2021"), the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter). It was reported that there was a gap between the first and the second dose (inappropriate schedule of product administration). On an unspecified date in 2021 (also reported as "sometime in 2021"), the patient also received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter). No additional adverse event (AE) was reported.

Other Meds:

Current Illness:

ID: 1469577
Sex: U
Age:
State: IL

Vax Date: 06/06/2021
Onset Date: 06/19/2021
Rec V Date: 07/14/2021
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 symptoms reported by the caller; Inappropriate schedule of vaccine administration; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported. On 06-JUN-2021 the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route, lot # and expiration date not reported) for prophylaxis. On 19-JUN-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637641, expiration date 16-FEB-2022) 0.5 mL intramuscularly (IM) (frequency not reported) (inappropriate schedule of product administration). No symptoms or additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637641; expirationdate: 16-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: GARDASIL 9 SYRINGE (DEVICE)

Current Illness:

ID: 1469578
Sex: M
Age: 43
State: IL

Vax Date: 08/01/2019
Onset Date: 08/01/2019
Rec V Date: 07/14/2021
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: passed out; Dizziness; This spontaneous report was received from a 43-year-old male patient via other company Pfizer (2021855371). The patient's medical history and concomitant medications were not reported. It was reported that the patient was nervous about the vaccinations. On an unknown date in August 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient had dizziness and he passed out when he got the vaccinations. The patient thought that this happened because "he was nervous about it". The action taken with the suspect vaccines, the outcome of the events and the relatedness between the events and the suspect vaccines were not reported. Upon internal review, the event of passed out was determined to be medically significant.

Other Meds:

Current Illness: Nervousness; Prophylaxis

ID: 1469579
Sex: U
Age: 74
State: MD

Vax Date: 07/09/2021
Onset Date: 07/09/2021
Rec V Date: 07/14/2021
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: No other adverse event involved; Nurse calls and states an expired dose of PNEUMOVAX 23 PFS was inadvertently given to a patient; Information has been received from a registered nurse reporting on a 74-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 09-JUL-2021, the patient was vaccinated inadvertently with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot# S034299, expiry date 01-JUL-2021 (dose and route of administration were not reported). No other adverse event involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability

Other Meds: PNEUMOVAX23 SYRINGE (DEVICE)

Current Illness:

ID: 1469580
Sex: F
Age: 13
State: AL

Vax Date: 06/15/2021
Onset Date: 06/22/2021
Rec V Date: 07/14/2021
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: she has been having abdominal pain; This spontaneous report as received from a pharmacist refers to a non-pregnant 13-year-old female patient. There were no patient's concurrent conditions, medical history and concomitant therapies. The patient had her 2nd injection with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, lot number, expiration date were unknown) for prophylaxis (reported as "Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58, Genital warts (condyloma acuminata) caused by HPV types 6 and 11, And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52,and 58: Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS), Cervical intraepithelial neoplasia (CIN) grade 1, Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3") on 15-JUN-2021. Since 22-JUN-2021, she had been having abdominal pain. It had been off and on since then. She gave it about 1-2 level of pain out of 10, sometimes her pain was 6-7. She was still having abdominal pain yesterday and into this morning." No treatment was given for the event. There were no laboratory/studies performed. The patient did not seek for medical attention. At the time of reporting, the outcome of the event was considered to be not resolved. The causality was not provided.

Other Meds:

Current Illness:

ID: 1469581
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: Pain in fingers/flare ups with her Rheumatoid Arthritis; pneumonia; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer, license party for etanercept (ENBREL). This serious solicited report was reported to Amgen on 29/JUN/2021 by a consumer from a commercial program and involves a 50 year old female patient who experienced pneumonia [PT: pneumonia], pain in fingers/flare ups with her rheumatoid arthritis [PT: rheumatoid arthritis] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications was reported. The patient's co-suspect medications included Covid-19 Vaccine (covid-19 vaccine). The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient reported that she had to stop taking Enbrel for a while due to the Covid-19 vaccine and got pneumonia after the second vaccine dose. On an unknown date, the patient also reported pain in her fingers and flare ups with her rheumatoid arthritis due to not being able to take the Enbrel. No treatment information was received. The outcome of the events pneumonia, rheumatoid arthritis were reported as unknown. The causal relationship between the events pneumonia, rheumatoid arthritis and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. No further information has been requested. Amgen comments: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events with the Covid-19 Vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen's assessment: the event, Pneumonia, was assessed as related to etanercept. The event Rheumatoid arthritis flare up was assessed as unrelated to etanercept. No follow-up attempts are possible; information about batch number cannot be obtained. Follow-up (29Jun2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). CORRECTION DATED 29/JUN/2021: Version created to confirm that the patient's co-suspect medications included Covid-19 Vaccine (covid-19 vaccine). Amgen Comments: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events with the Covid-19 Vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen's assessment: the event, Pneumonia, was assessed as related to etanercept. The event Rheumatoid arthritis flare up was assessed as unrelated to etanercept. No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Event pain in fingers/flare ups with her rheumatoid arthritis is likely due to underlying condition and unrelated to etanercept and BNT162B2. A contributory role of etanercept and BNT162B2 to event pneumonia cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness: Rheumatoid arthritis (current medical condition.)

ID: 1469582
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: FLU; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received Flumist (influenza vaccine live reassort 3v), via nasal route, on an unknown date. No malfunction has been reported for FLUMIST. On an unknown date, the patient experienced flu (preferred term: Influenza). It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v). The outcome of the event was unknown. The event was considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: FLUMIST Common Device Name: Nasal Spray Product Role: Suspect

Other Meds:

Current Illness:

ID: 1469583
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: blood clot in the lungs; covid-19; This is a solicited report from a non-Pfizer sponsored program, received from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb(manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-065486), license party for apixaban. This 64-year-old male patient was involved in a patient support program. The patient (patient ID: redacted) received APIXABAN. The report describes a case of PULMONARY THROMBOSIS (blood clot in the lungs) and COVID-19. Co-suspect products included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced PULMONARY THROMBOSIS (seriousness criteria hospitalization and medically significant) and COVID-19 (seriousness criterion hospitalization). The patient was treated with Surgery for Pulmonary thrombosis. The action taken with APIXABAN(Unknown) was unknown. At the time of the report, PULMONARY THROMBOSIS and COVID-19 outcome was unknown. Patient reported he got the Covid-19 shot and then got Covid-19, and got a blood clot. Patient was then sent to emergency and had surgery to get the blood clot taken out of his lungs. For APIXABAN(Unknown), the reporter did not provide any causality assessments. The primary reporter was the consumer. The indication of apixaban therapy was unknown. Medical Evaluation Comment: This patient was hospitalized due to COVID 19 and Blood clot in lungs after receiving apixaban study therapy. Considering the anticoagulant nature of suspect therapy and the infective nature, mode of transmission and current pandemic situation due to COVID 19, a role of study therapy in the event COVID-19 is considered unlikely. Blood clot in lungs could be likely secondary to COVID-19 infection, hence not related to suspect therapy. Causality assessment about apixaban for events 'thrombosis pulmonary, COVID-19' was not related as per Company (Bristol-Myers Squibb) and was not provided as per reporter.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. Conversely, the company does not attribute the reported events to study drug apixaban. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1469584
Sex: F
Age:
State: TX

Vax Date: 12/31/2020
Onset Date: 05/14/2021
Rec V Date: 07/14/2021
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: Miscarriage at 8 weeks pregnant; Unevaluable event; This case was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) (seriousness criterion medically significant). 14-May-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) and UNEVALUABLE EVENT (Unevaluable event) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. On 05/14/2021 and 05/17/2021 unknown lab tests were done ,results not provided. No Concomitant medications were reported. No treatment information was provided. This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1469585
Sex: F
Age:
State: FL

Vax Date: 06/04/2021
Onset Date: 06/14/2021
Rec V Date: 07/14/2021
Hospital: Y

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: Myocarditis; Chest pain; Pain in jaw; Neck pain; Dizziness; Hyperhidrosis; Impaired work ability; Malaise; This case was received. (Reference number: 1423608) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by a health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054czia) for COVID-19 vaccination. The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Hypothyroidism, Hypercholesterolemia and Arthritis. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), OMEPRAZOLE, MICONAZOLE and ROSUVASTATIN for an unknown indication. On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), PAIN IN JAW (Pain in jaw) (seriousness criteria hospitalization and life threatening), NECK PAIN (Neck pain) (seriousness criteria hospitalization and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization and life threatening), HYPERHIDROSIS (Hyperhidrosis) (seriousness criteria hospitalization and life threatening), IMPAIRED WORK ABILITY (Impaired work ability) (seriousness criteria hospitalization and life threatening) and MALAISE (Malaise) (seriousness criteria hospitalization and life threatening). At the time of the report, MYOCARDITIS (Myocarditis), CHEST PAIN (Chest pain), PAIN IN JAW (Pain in jaw), NECK PAIN (Neck pain), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), IMPAIRED WORK ABILITY (Impaired work ability) and MALAISE (Malaise) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Catheterisation cardiac: abnormal (abnormal) abnormal. On 14-Jun-2021, Electrocardiogram: abnormal (abnormal) abnormal at Urgent Care and abnormal (abnormal) abnormal in Emergency Room. On 16-Jun-2021, Echocardiogram: confirmed myocarditis (abnormal) Confirmed myocarditis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medications were listed as armor thyroid. No treatment was reported for these events. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CYMBALTA; OMEPRAZOLE; MICONAZOLE; ROSUVASTATIN

Current Illness:

ID: 1469586
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: First dose of Shingrix vac in November 2020 / Do I need to start over; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on an unknown date in November 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not applicable for this report. The patient had not received the second dose for more than 8 months, which led to incomplete course of vaccination. The reporter enquired if he/ she had to start over and get two more doses.

Other Meds:

Current Illness:

ID: 1469587
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: passed my / booster timeframe; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not applicable for this report. The patient just realized that he/she had passed Shingrix booster timeframe, which led to incomplete course of vaccination. The reporter asked what he/she could do. The follow-up would not possible as no contact details were available.

Other Meds:

Current Illness:

ID: 1469588
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: osteomyelitis/ immune stimulation post-Shingrix /may have helped to reveal this underlying infection.; lower back pain prior to Shingrix/ Post one dose / extreme pain at the lower back; This case was reported by a physician via sales rep and described the occurrence of osteomyelitis in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included low back pain (ongoing prior to Shingrix vaccination). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced osteomyelitis (serious criteria GSK medically significant) and back pain aggravated. On an unknown date, the outcome of the osteomyelitis and back pain aggravated were unknown. It was unknown if the reporter considered the osteomyelitis and back pain aggravated to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient's ESR (Red blood cell sedimentation rate) was a little elevated but no telling tales of an infection. Post one dose of Shingrix, patient developed extreme pain at the lower back that eventually revealed osteomyelitis. The patient and MD thought the immune stimulation post Shingrix vaccination might had helped to reveal this underlying infection. The consent to follow-up was granted.

Other Meds:

Current Illness: Low back pain (ongoing prior to Shingrix vaccination)

ID: 1469589
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: because of covid, was not able to get the second one within the time frame; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown. Additional details provided were as follows: Till the time of reporting, patient did not received 2nd dose of Shingrix, due to covid. The patient enquired and asked about his/her friend that what to do if he/she had shingles.

Other Meds:

Current Illness:

ID: 1469590
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: My arm hurt for a week after each vaccination shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR149439). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient reported that after every Shingle shot, his/her arm hurts for a week. The patient stated that he/she could not imagine how painful shingles were. The follow-up would not possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR149439:Same reporter.

Other Meds:

Current Illness:

ID: 1469591
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: sore arm/ I also had it (worse I might add); This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR149435). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The patient received shingrix vaccine and experienced sore arm, which was worst case. The patient was alive and did not had covid 19.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR149435:Same reporter

Other Meds:

Current Illness:

ID: 1469592
Sex: M
Age: 16
State: WA

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/14/2021
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: instead of using the liquid conjugate component/ they used a diluent instead / had been improperly reconstituted with non-GSK approved diluent; Menveo, second dose to patient / administered only one vial of Menveo vaccine to a 16 year old male patient, mentioned it vaccine number 2 in the series; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA415A, expiry date 20th September 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The preparing of the vaccine ended up being in error as instead of using the liquid conjugate component of the vaccine to mix both vials, they used a diluent instead, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Centers for Disease Control and Prevention (CDC) recommended meningococcal vaccination for all preteens and teens - all 11 to 12 years old should receive a single dose of a MenACWY vaccine. Since protection decreases over time, CDC recommends a booster at age 16 years and as this patient was 16 years old, and therefore receiving the second dose (booster) in the series as recommended by the CDC in this case as reported by the customer. The reporter did not consent to follow-up. Follow up information received via nurse on 8th July 2021: The age at vaccination was updated as 16 years. On 7th July 2021, Menveo injection had been improperly reconstituted with non-GSK approved diluent. The nurse reported that a diluent from MMR vaccine was used and so the patient only received the lyophilized portion of Menveo and only one vial of Menveo vaccine was given. The batch number and expiry date were updated. The VAERS details was updated. The reporter consented to follow up. No further information was available.

Other Meds:

Current Illness:

ID: 1469593
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: got / first dose of Shingrix on 11/27/20 but could not get the 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 27th November 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The patient reported this case for herself/himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wanted to know if he/she should get the 2nd dose only or get the first dose again. The reporter consent to follow up. This case has been linked with case US2021AMR150814, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR150814:same repoter (husband?s case)

Other Meds:

Current Illness:

ID: 1469594
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: My husband /got / first dose of Shingrix on 11/27/20 but could not get the 2nd dose; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on 27th November 2020). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The patient was the reporter's hudband. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if the patient should get the 2nd dose only or get the first dose again. The follow up would not be possible as no contact details were available. This case has been linked with case US2021AMR150813, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR150813:same repoter (reporter?s case)

Other Meds:

Current Illness:

ID: 1469595
Sex: F
Age:
State: VA

Vax Date: 05/29/2021
Onset Date: 05/29/2021
Rec V Date: 07/14/2021
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: pain from the left shoulder blade spread to the left rib cage; diagnosed with shingles; rash on left shin; the same location as the rash, subcutaneous nodes on the left shin; acute pain in her left shoulder blade; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for shingles, gabapentin for pain, prednisone for product used for unknown indication and ibuprofen for shoulder blade pain. The patient's past medical history included shingles (first case of Shingles in 1980's (when she was in her 20's)) and shingles (second case of Shingles 2019). Previously administered products included Zostavax (received in 2013). Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE). On 29th May 2021 09:00, the patient received the 1st dose of Shingrix (intramuscular). In June 2021, the patient started Valacyclovir 1 g 3 times daily (3 g daily). On 18th June 2021, the patient started gabapentin at an unknown dose and frequency. On 8th June 2021, the patient started prednisone at an unknown dose and frequency. On 4th June 2021, the patient started ibuprofen 400 mg 3 times daily (1200 mg daily). On 29th May 2021, 8 hrs after receiving Shingrix and not applicable after starting Valacyclovir, the patient experienced fever and chills. On 3rd June 2021, the patient experienced shoulder blade pain. On 7th June 2021, the patient experienced shingles, rash and subcutaneous nodule. On 8th June 2021, the patient experienced cough. On 15th June 2021, the patient experienced rib pain. On 18th June 2021, the patient experienced ankle swelling and pain. The action taken with Valacyclovir was unknown. Gabapentin was discontinued. The action taken with prednisone was unknown. Ibuprofen was discontinued on 6th June 2021. On 30th May 2021, the outcome of the fever and chills were recovered/resolved. On 13th June 2021, the outcome of the cough was recovered/resolved. On 22nd June 2021, the outcome of the ankle swelling was recovered/resolved. On an unknown date, the outcome of the shingles, subcutaneous nodule, rib pain and pain were not recovered/not resolved and the outcome of the shoulder blade pain and rash were recovered/resolved. It was unknown if the reporter considered the shingles, fever, chills, rash, subcutaneous nodule, cough, rib pain, ankle swelling and pain to be related to Shingrix. The reporter considered the shoulder blade pain to be unrelated to Shingrix. It was unknown if the reporter considered the ankle swelling and pain to be related to Valacyclovir. Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received Covid 19 vaccine 3 months before the date of reporting. The patient received Shingrix in the left arm. On 3rd Jun 2021, 5 days after receiving Shingrix, the patient developed acute pain in her left shoulder blade. The patient did not associate this pain with the Shingrix vaccine. On 4th, 5th and 6th June 2021, the patient took OTC Ibuprofen (400mg three times a day) and on 7th June 2021, the patient developed a rash on her left shin and in the same location as the rash, subcutaneous nodes on the left shin and stopped the Ibuprofen. On June 8th, the patient went to the healthcare professional (HCP) who prescribed a 6 days Prednisone Taper (no dosage noted). The patient developed a slight cough while on prednisone that resolved on 13th June 2021 when the Prednisone taper ended. On 15th June 2021, the pain from the left shoulder blade spread to the left rib cage and the patient went back to HCP who diagnosed her with Shingles. The HCP started her on Valcyclovir 1 gram three times a day for 7 days. The HCP started her on Gabapentin for shingles pain on 18th June 2021. On 22nd June 2021, the patient stopped the Gabapentin due to swelling in her ankles. The patient was currently not on any medication for the shingles pain. The HCP offered a 12-day Prednisone taper on June 22nd, but the patient declined the medication. The reporter does not wish to share her address or date of birth. The reporter gave permission to contact via phone only. The reporter does not give permission to contact HCP. It was unknown if the reporter considered the shingles, rash, subcutaneous nodule, cough, rib pain, ankle swelling and shingles pain to be related to Ibuprofen. It was unknown if the reporter considered the shingles, cough, rib pain, ankle swelling and shingles pain to be related to Prednisone taper. It was unknown if the reporter considered the ankle swelling to be related to Gabapentin. Upon a medical review performed following changes were made on 13th July 2021: The COVID 19 vaccine was updated as medical history instead of concomitant drug. Cough and ankle swelling were deleted as event because they occurred after treatment with non-GSK products. Event pain was deleted.

Other Meds: Valacyclovir; GABAPENTIN; PREDNISONE; IBUPROFEN

Current Illness:

ID: 1469596
Sex: M
Age: 18
State: LA

Vax Date: 06/11/2021
Onset Date: 06/11/2021
Rec V Date: 07/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: given a dose /nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th June 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 11th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug. No symptoms reported. The reporter consented to follow up. This case was 1st of 6 reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021142818:Same reporter US-GLAXOSMITHKLINE-US2021142817:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter US-GLAXOSMITHKLINE-US2021142813:Same reporter

Other Meds:

Current Illness:

ID: 1469597
Sex: F
Age:
State: MI

Vax Date: 06/24/2021
Onset Date: 06/24/2021
Rec V Date: 07/14/2021
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: administered an expired /BEXSERO (exp date: 05/31/2021) on the 24th June, 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st May 2021) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 24th June 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 24th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 reported. The patient was administered an expired dose of Bexsero, which led to expired vaccine used. No further details were provided at the time of call. The reporter did not have the lot number of the vaccine, date of birth or age of the patient. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1469598
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: might have administered/lyophilized vial without the adjuvant/not sure about it yet and did not mention any other diluent; might have administered/lyophilized vial without the adjuvant/not sure about it yet and did not mention any other diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 pharmacist reported on a voicemail that they might have administered Shingrix lyophilized vial without the adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered, they were not sure about it yet and did not mention any other diluent either. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1469599
Sex: F
Age:
State: OH

Vax Date: 06/05/2021
Onset Date: 06/05/2021
Rec V Date: 07/14/2021
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: First dose / on 05May2021 / second dose / on 05Jun2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number EZ4TD, expiry date 4th November 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 5th June 2021, the patient received the 2nd dose of Shingrix. On 5th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were provided as follows: The age at vaccination was not reported. On 5th May 2021, the patient received 1st dose of Shingrix. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1469600
Sex: F
Age: 67
State: VA

Vax Date: 07/02/2021
Onset Date: 07/01/2021
Rec V Date: 07/14/2021
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: not given in the deltoid muscle but just below; Redness; Pain; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis. On 2nd July 2021, the patient received Shingrix (intramuscular). On 2nd July 2021, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema, pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the erythema and pain to be related to Shingrix. Additional details were reported as follows: This case was reported by pharmacy intern. The reporter stated that, Shingrix vaccine was not given in the deltoid muscle but just below, which led to vaccine administered at inappropriate site. The patient developed redness and pain after a dose of Shingrix. The reporter consented to follow up. No additional information was provided.

Other Meds:

Current Illness:

ID: 1469601
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: 1st dose / January / 2021 / went / 6 of July 2021 to get the second dose / not administered at time of report; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (received first dose on 18 january 2021). On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient went to the facility on 6th July 2021 to get the second dose. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The health care professional did not provide lot number neither expiration date of the first dose of Engerix B. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1469602
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: fever of 103 which lasted a short time; first Shingrix vaccine about 2 years ago/she never received the second dose of Shingrix; did not feel well and this lasted for 2 weeks; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of Shingrix. On an unknown date, several days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the fever and feeling bad were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the fever and feeling bad to be related to Shingrix and Shingrix. Additional details were reported as follows: The patient received first dose of shingrix 2 years ago of reporting date. The patient experienced fever of 103 degrees and was recovered in short time. Also after couple of days patient did not feel well which was recovered within 2 weeks. Till now patient did not receive second dose of shingrix,which led to incomplete course of vaccination. Did not consent to follow-up.

Other Meds:

Current Illness:

ID: 1469603
Sex: F
Age:
State: PA

Vax Date: 07/06/2021
Onset Date: 07/06/2021
Rec V Date: 07/14/2021
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: 34 year old / patient / was inadvertently given a pediatric dose instead of an adult dose; 34 year old / patient / was inadvertently given a pediatric dose instead of an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number 77B59, expiry date 22nd September 2021) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 6th July 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 6th July 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced adult use of a child product and accidental underdose. On an unknown date, the outcome of the adult use of a child product and accidental underdose 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. The patient was inadvertently given a pediatric dose instead of an adult dose. Pharmacist believed this was the patient's first dose in the series, which led to adult use of child product and accidental underdose. The reporter consent to follow up via email. Pharmacist granted permission for safety to follow up via email.

Other Meds:

Current Illness:

ID: 1469604
Sex: F
Age:
State: FL

Vax Date: 07/09/2021
Onset Date: 07/09/2021
Rec V Date: 07/14/2021
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: Shingrix / was given / by error to a 12-year old female patient; 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 12-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 16th November 2022) for prophylaxis. On 9th July 2021, the patient received the 1st dose of Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were reported as follows: This case was reported by a clinic coordinator and a nurse. The Shingrix vaccine was given by error to a 12-year old female patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1469605
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 07/14/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: Unknown) dose was not reported,1 total administered on 09-MAR-2021 to the left arm for prophylactic vaccination. The patient received infliximab, recombinant (solution for infusion, route of admin not reported, batch number: Unknown) dose and frequency were not reported from 02-MAR-2021, dose and frequency were not reported from 31-MAR-2021, dose and frequency were not reported from 28-APR-2021, dose and frequency were not reported from 26-MAY-2021, and dose and frequency were not reported from 23-JUN-2021 for an unspecified indication. No concomitant medications were reported. The patient was complaining about three negative spike protein antibody tests that she has received since receiving JNJ COVID-19 vaccine on 09-MAR-2021. On 31-MAR-2021 the first negative antibody test was performed and after four weeks later on 28-APR-2021 second negative antibody test done and the last negative antibody was done on 23-JUN-2021(confirmed immunological vaccine failure).Remicade doses were given on 02-MAR-2021 which was a week before obtaining the JNJ vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of infliximab, and recombinant was not changed. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality number 90000184875. Additional information was received from product quality vigilance on 02-JUL-2021. The following information was updated and incorporated into the case narrative: PQC number added, narrative updated. Upon review following information was amended: The event onset date added.; Sender's Comments: V1 - This version is created to amend and update additional information received from product quality vigilance on 02-JUL-2021: PQC number added ; event onset date added. This does not change causality of previously reported events. 20210667208-covid-19 vaccine ad26.cov2.s-Confirmed immunological 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 20210667208-Remicade-Confirmed immunological 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: Diabetes

ID: 1469606
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/30/2021
Rec V Date: 07/14/2021
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: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 30-JUN-2021, the subject experienced chills. On 30-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1469607
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 07/03/2021
Rec V Date: 07/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: BRONCHITIS AND DIFFICULTY BREATHING; SHARP BURNING PAIN IN CHEST; DIZZINESS; HOT FLASHES; NERVE PAIN IN LEGS; CHILLS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included hospitalized, and electrocardiogram, and concurrent conditions included prinzmetal variant angina, myocardial bridge, non-obstructive coronary disease, vasospasm, alcohol user, smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 and expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 12:00 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, amlodipine, atorvastatin, clonidine, glyceryl trinitrate, and metoprolol tartrate. On 03-JUL-2021, the subject experienced bronchitis and difficulty breathing. On 03-JUL-2021, the subject experienced sharp burning pain in chest. On 03-JUL-2021, the subject experienced dizziness. On 03-JUL-2021, the subject experienced hot flashes. On 03-JUL-2021, the subject experienced nerve pain in legs. On 03-JUL-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve pain in legs on 03-JUL-2021, was recovering from chills, and hot flashes, and had not recovered from bronchitis and difficulty breathing, sharp burning pain in chest, and dizziness. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.

Other Meds: ATORVASTATIN; AMLODIPINE; METOPROLOL TARTRATE; CLONIDINE; NTG; ASA

Current Illness: Alcohol use (May be 2-3 drink at dinner, a couples of times per month.); Coronary artery disease; Marijuana abuse; Myocardial bridging; Smoker (About 1 pack per day. Trying to cut back.); Variant angina; Vasospasm

ID: 1469608
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 07/03/2021
Rec V Date: 07/14/2021
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: DIZZINESS OR LIGHT HEADEDNESS; PAIN LOWER BACK; WEAKNESS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced dizziness or light headedness. On 03-JUL-2021, the subject experienced pain lower back. On 03-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness or light headedness, weakness, and pain lower back. This report was non-serious.

Other Meds:

Current Illness:

ID: 1469609
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 06/26/2021
Rec V Date: 07/14/2021
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: STIFFNESS IN BACK OF NECK OR STIFFNESS OF SHOULDER; PAIN IN NECK; WOKE ME UP; SHOULDERS PAIN; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetic, non smoker, non alcohol user, and arthritis, and other pre-existing medical conditions included the patient had no known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204N21A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis, metformin for diabetic, and lisinopril for high blood pressure. On 26-JUN-2021, the subject experienced stiffness in back of neck or stiffness of shoulder. On 26-JUN-2021, the subject experienced pain in neck. On 26-JUN-2021, the subject experienced woke me up. On 26-JUN-2021, the subject experienced shoulders pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in back of neck or stiffness of shoulder, pain in neck, woke me up, and shoulders pain on 26-JUN-2021. This report was non-serious.

Other Meds: METFORMIN; LISINOPRIL; TYLENOL

Current Illness: Abstains from alcohol; Arthritis (Tylenol is used for arthritis for pain as needed.); Blood pressure high (Lisinopril 40 mg daily for high blood pressure.); Diabetic (Metformin 500 mg twice daily for diabetes.); Non-smoker

ID: 1469610
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/14/2021
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: NUMBNESS IN FEET AND HAND; TINGLING IN NERVES; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced numbness in feet and hand. On APR-2021, the subject experienced tingling in nerves. On APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, numbness in feet and hand, and tingling in nerves. This report was non-serious. This report was associated with product quality complaint: 90000185026. The suspected product quality complaint has been confirmed to be confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210710749 and 20210711353.

Other Meds:

Current Illness:

ID: 1469611
Sex: U
Age:
State: MN

Vax Date:
Onset Date: 07/03/2021
Rec V Date: 07/14/2021
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: PRODUCT STORAGE ERROR; PUNCTURED VACCINE DOSE ADMINISTERED TO PATIENT AFTER 6 HOUR HOLD PERIOD IN REFRIGERATOR; This spontaneous report received from a pharmacist concerned a 34 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUL-2021, the subject experienced product storage error. On 03-JUL-2021, the subject experienced punctured vaccine dose administered to subject after 6 hour hold period in refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and punctured vaccine dose administered to patient after 6 hour hold period in refrigerator was not reported. This report was non-serious.

Other Meds:

Current Illness:

Date Died: 06/14/2021

ID: 1469612
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 07/14/2021
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: DIED AFTER RECEIVING YOUR VACCINE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) 1 total 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 14-APR-2021, the patient died after receiving vaccine and cause of death was unknown. It was unspecified if autopsy performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210710773-covid-19 vaccine ad26.cov2.s - DIED AFTER RECEIVING YOUR VACCINE. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1469613
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 07/04/2021
Rec V Date: 07/14/2021
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: EXTREME BODY ACHE; JOINT PAIN; CHILLS; BAD FEVER; EXTREME HEADACHE; TIRED; This spontaneous report received from a consumer concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1821286 and expiry: UNKNOWN) dose was not reported, administered on 04-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the subject experienced extreme headache. On 04-JUL-2021, the subject experienced tired. On 05-JUL-2021, the subject experienced extreme body ache. On 05-JUL-2021, the subject experienced joint pain. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced bad fever. Laboratory data included: Body temperature (NR: not provided) 101 F. 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 bad fever, extreme body ache, joint pain, chills, extreme headache, and tired. This report was non-serious.

Other Meds:

Current Illness:

ID: 1469614
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 07/14/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: NAUSEOUS; PULMONARY EMBOLISM; FELT LIKE TRYING TO GET SICK; FELT LIKE COMING DOWN WITH A COLD; This spontaneous report received from a patient concerned a 41 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and the patient did not have any history of previous clots and no medical condition reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination, the patient felt like she was trying to get sick, and felt like she was coming down with a cold but did not really get sick. On 30-MAY-2021, the patient was working and ended up getting admitted in the hospital on 17-JUN-2021 night at 7 PM. On an unspecified date in JUN-2021, laboratory data included: chest X-ray (NR: not provided) multiple clots in both the lungs, and scan with contrast (NR: not provided) multiple clots in both the lungs and was diagnosed with pulmonary embolism. The physician were not sure if it was because of the vaccine. The patient was hospitalized until 28-JUN-2021 or 29-JUN-2021. The duration of hospitalization was 12 days. On an unspecified date, the patient felt like there was something sitting on her chest, was nauseous so she thought she had food poisoning. The patient had been a little short of breath, thought it was because she just started working out but it was not much noticeable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of felt like coming down with a cold, nauseous and felt like trying to get sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210713153-COVID-19 VACCINE AD26.COV2.S-Pulmonary Embolism. 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). 20210713153-COVID-19 VACCINE AD26.COV2.S-Nauseous. This event(s) is labeled and is therefore considered potentially related.

Other Meds:

Current Illness: Blood pressure high

ID: 1469615
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 07/05/2021
Rec V Date: 07/14/2021
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: SHORTNESS OF BREATH; CHEST PRESSURE; STOMACH PAIN; BACK PAIN; NECK PAIN; NUMBNESS IN CALVES; TINGLING IN FEET/SKIN FEELS STRANGE; SORE THROAT; BUBBLED EARS/RINGING IN EARS; PALE HANDS AND LEGS; RESTING HEART RATE WAS 99-110; SHOULDER PAIN; RIGHT LEG PAIN; HEAVINESS IN LEGS; CHILLS; PAIN AT INJECTION SITE (DURING ADMINISTRATION OF VACCINE); FEVER; HEADACHE; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight was 153 pounds, and height was 65 inches. The patient's concurrent conditions included positive for lupus anticoagulant factor (anti-phospholipid factor), non smoker, non-alcohol user, latex allergy, rubber allergy, allergic to silicone, and resting heart rate runs high. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 05-JUL-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, Laboratory data included: Heart rate (NR: not provided) 99-110, and Oxygen saturation (NR: not provided) 96-99%. On 05-JUL-2021, the subject experienced shortness of breath. On 05-JUL-2021, the subject experienced chest pressure. On 05-JUL-2021, the subject experienced stomach pain. On 05-JUL-2021, the subject experienced back pain. On 05-JUL-2021, the subject experienced neck pain. On 05-JUL-2021, the subject experienced numbness in calves. On 05-JUL-2021, the subject experienced tingling in feet/skin feels strange. On 05-JUL-2021, the subject experienced sore throat. On 05-JUL-2021, the subject experienced bubbled ears/ringing in ears. On 05-JUL-2021, the subject experienced pale hands and legs. On 05-JUL-2021, the subject experienced resting heart rate was 99-110. On 05-JUL-2021, the subject experienced shoulder pain. On 05-JUL-2021, the subject experienced right leg pain. On 05-JUL-2021, the subject experienced heaviness in legs. On 05-JUL-2021, the subject experienced chills. On 05-JUL-2021, the subject experienced pain at injection site (during administration of vaccine). On 05-JUL-2021, the subject experienced fever. On 05-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 102.3 F. On 06-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 F, Heart rate (NR: not provided) 117, and Oxygen saturation (NR: not provided) 97 %. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) high, and Lupus anticoagulant (NR: not provided) positive, slightly high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pale hands and legs, had not recovered from neck pain, and the outcome of fever, pain at injection site (during administration of vaccine), headache, sore throat, chills, heaviness in legs, tingling in feet/skin feels strange, shortness of breath, bubbled ears/ringing in ears, stomach pain, back pain, numbness in calves, chest pressure, right leg pain, shoulder pain and resting heart rate was 99-110 was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergy to chemicals; Antiphospholipid syndrome; Heart rate high; Latex allergy; Non-smoker; Rubber sensitivity

ID: 1469616
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient by a Business partner (Pfizer Inc., US-JNJFOC-20210714002) on 02-JUL-2021 was received on 12-JUL-2021 and concerned multiple patients. No past medical history or concurrent conditions were 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sars-cov-2 test positive. Laboratory data (dates unspecified) 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 sars-cov-2 test positive was not reported. This report was non-serious.; Sender's Comments: V1 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1469617
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/14/2021
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: NOT BEING ABLE TO BREATH; RIGHT LEG AND FOOT VERY SWOLLEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease. 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 05-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced not being able to breath. On JUL-2021, the subject experienced right leg and foot very swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not being able to breath, and right leg and foot very swollen. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious.

Other Meds:

Current Illness: Chronic obstructive pulmonary disease

ID: 1469618
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/26/2021
Rec V Date: 07/14/2021
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: APNOEA; PULSE DROPPED TO 48; OXYGEN DROPPED TO 89; SWOLLEN NASAL PASSAGES; PAIN AT THE BOTTOM OF LEFT FOOT AND THEN MOVED TO RIGHT FOOT; SHARP STOMACH PAIN FELT LIKE CRAMPING; LEFT ARM NUMBNESS AND TINGLING; MUSCLE SPASM IN RIGHT ARM AND LEFT ARM; MILD FEVER; DIZZINESS/LIGHTHEADEDNESS; BURNING SENSATION RADIATING THROUGH THE LEFT CHEST/LEFT ARM BURNING SENSATION; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the patient experienced dizziness within 5 to 8 minutes along with a burning sensation radiating through the left chest. The burning subsided to a medium burning sensation within 15 minutes and continued for several hours. On 27-JUN-2021, the patient started to get muscle spasms which lasted all day and night in left arm and experienced mild fever. On 28 -JUN-2021 the patient had no symptoms. On 29-JUN-2021, the patient had muscle spasms on the right arm that lasted several hours and sharp stomach pain that felt like severe cramping. Later in the afternoon, the patient felt lightheadedness and experienced left arm numbness and tingling with a burning sensation which lasted approximately for four hours. On 30-JUN-2021, the patient had muscle spasms on right arm for about 20 minutes. On 01-JUL-2021, the patient experienced pain at the bottom of left foot which then had moved to right foot. On 02-JUL-2021, the patient had to wake up in the middle of the night unable to breathe like sleep apnea with reduced airflow and swollen nasal passages. The pulse rate of patient was dropped to 48 and oxygen saturation dropped to 89. On 03-JUL-2021, the patient again woke up in the middle of the night with apnea and not being able to breathe but the pulse rate and oxygen saturation appeared normal. On 02-JUL-2021, Laboratory data included: Oxygen saturation (NR: not provided) dropped to 89, and Pulse rate (NR: not provided) dropped to 48. On 03-JUL-2021, Laboratory data included: Oxygen saturation (NR: not provided) Normal, and Pulse rate (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation radiating through the left chest/left arm burning sensation, and left arm numbness and tingling on 29-JUN-2021, pulse dropped to 48, oxygen dropped to 89, and pain at the bottom of left foot and then moved to right foot on 03-JUL-2021, and swollen nasal passages on 02-JUL-2021, and the outcome of dizziness/lightheadedness, muscle spasm in right arm and left arm, sharp stomach pain felt like cramping, sleep apnea and mild fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210716048-covid-19 vaccine ad26.cov2.s-apnea, pulse dropped to 48. 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:

Current Illness:

ID: 1469619
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 06/27/2021
Rec V Date: 07/14/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: STROKE/NUMBNESS OF LEFT SIDE OF BODY/INABILITY TO WALK; This spontaneous report received from a patient concerned a 44 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 27-JUN-2021, the patient woke up with numbness in left side of the body. The patient visited emergency room and diagnosed with stroke, and was hospitalized in intensive care unit (ICU) (date unspecified). The patient also experienced inability to walk after the stroke and visited physician's office and currently in rehabilitation. The number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke/numbness of left side of body/inability to walk. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210716287-Covid-19 vaccine ad26.cov2.s-Stroke. 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:

Current Illness:

ID: 1469620
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 06/25/2021
Rec V Date: 07/14/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 49 year old White and Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent condition included hyperlipidemia and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: not reported) dose was not reported, 1 total, administered on 16-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the patient had done an antibody test which resulted as negative and hence, it was confirmed as immunological vaccine failure. The patient reported that he was going to do a spike protein test to confirm his immunity. 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). This report was associated with product quality complaint: 90000185426.; Sender's Comments: V0:20210717374- 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: Hyperlipidemia (Treated by specialist.)

ID: 1469621
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/14/2021
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: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: not reported) 0.5 ml, at a frequency of 1 total, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, at the end of Jun or start of Jul, patient got fully developed Covid-19 with all the symptoms including cough and diarrhea. Covid-19 infection were clinically confirmed by the PCR test and Nasal test. Both test results were positive. On an unspecified date, patient was positive for Covid-19 (coded as Confirmed covid-19 infection). Exact date of tests were not reported. It is reported that, test were performed within the last week and half (at the end of Jun or start of Jul). Patient went to the urgent care and was in the quarantine. On an unspecified date, the patient experienced confirmed clinical vaccination failure. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Positive, and 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 confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185403. The suspected product quality complaint has been confirmed to be Void: N based on the PQC evaluation/investigation performed.; Sender's Comments: V0:- 20210722298- covid-19 vaccine ad26.cov2.s-confirmed 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: 1469622
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 07/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; SHOULDER PAIN IN THE LEFT ARM; GENERAL ILL FEELING; HEADACHES; FATIGUE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease called polymyalgia rheumatica (PMR) and patient had no spleen. 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, 1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included prednisone. On 06-APR-2021 (about 24 hours after vaccination), the patient experienced shoulder pain in the left arm, headaches, fatigue, and general ill feeling and the headache lasted about 4 days. On APR-2021 (approximately nine days following vaccination), Laboratory data included: C-reactive protein (CRP) (NR: not provided) inflammatory factors were quite high and Erythrocyte sedimentation rate (NR: not provided) inflammatory factors were quite high. Two weeks or more after vaccination antibody test (protein IgG and IgM) (NR: not provided) Negative. In JUN-2021, a follow-up antibody test (spike protein IgG and IgM) was done 2 months after the vaccine, which was negative for antibodies. The patient had confirmed immunological vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain in the left arm, general ill feeling, and fatigue, and headaches on 10-APR-2021, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185571; Sender's Comments: V0. 20210718749-covid-19 vaccine ad26.cov2.s-Confirmed immunological 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: PREDNISONE

Current Illness: Polymyalgia rheumatica

ID: 1469623
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 07/03/2021
Rec V Date: 07/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 49 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUL-2021, the subject experienced confirmed covid 19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the subject experienced confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid 19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was non-serious. This report was associated with product quality complaint Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm