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VAERS Report 2157095

Case Report Section

Vaer Report Details

Age: NA

Gender: Unknown

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (JANSSEN))

Type: Coronavirus 2019 vaccine

Manufacturer: JANSSEN

Lot: unknown


Date report was received
2022-03-04
Date form completed
Date Vaccinated
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

suspected covid-19 infection; suspected clinical vaccination failure; this spontaneous report was received from literature. this report concerned multiple patients (526) of unspecified sex, age, race and ethnic origin. no past medical history or concurrent conditions were reported. the objective of this study was to describe clinical parameters comparison between vaccinated and non-vaccinated against covid-19 in patients hospitalized due to sars-cov-2-induced infection. the patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. the batch number was not reported. the company was unable to perform follow-up to request batch/lot numbers. no concomitant medications were reported. on an unspecified date, the patients experienced sars-cov-2-induced infection (suspected covid-19 infection), and were hospitalized (date unspecified) and resulted in lack of efficacy (suspected clinical vaccination failure). number of days hospitalized was unspecified. the results showed five hundred twenty-six patients were included in the clinical study, of which 297 were men, 9.7 percent were vaccinated patients (51), 90.3 percent were unvaccinated patients (475), 12.2% were intubated (64) vaccinated 11 percent (7), unvaccinated 89 percent (57). the vaccinated patients' median age was significantly increased compared to the unvaccinated patients' age. the mean value of time distance since the vaccination completion until hospitalization was 4.2 plus or minus 1.8 months. the mean value of hospitalization days was significantly increased in the vaccinated patients more than or equal to 60 years old compared to vaccinated patients more than or equal to 60 years old [9.0 (95% ci: 7.0 to 10.0) vs 5.0 (95% ci: 3.1 to 8.9), p=0.0001]. unvaccinated patients of age more than or equal to 60 years old presented significantly increased mortality risk compared to vaccinated patients more than or equal to 60 years old (hr: 2.71, 95% ci: 1.61 to 4.59, p<0.0001). the action taken with covid-19 vaccine ad26.cov2.s was not applicable. the outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. the authors emphasized that vaccination against covid-19 stands out as the optimal solution that can rapidly reduce mortality in this pandemic. this report was serious (hospitalization caused / prolonged, and life threatening). this case, from same literature article is linked to 20220258415, 20220258413, 20220257203, 20220258405 and 20220258762. this case was associated with product quality complaint. it was determined that manufacturer case numbers 20220258415, 20220258413 and 20220258405 were duplicates of this case master case 20220258394. all relevant information regarding these cases will be submitted under master case number 20220258394.; sender's comments: v0: 20220258394-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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. therefore, this event(s) is considered not related. 20220258394-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. 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). therefore, this event(s) is considered unassessable

Lab Data
na
List of symptoms
vaccination failure suspected covid-19
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
Yes
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na