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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN||1805025 / UNK||- / -|
Administered by: Other Purchased by: ??
Symptoms: Vaccination failure, COVID-19, SARS-CoV-2 test
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Preexisting Conditions: Comments: No known drug allergies
Diagnostic Lab Data: Test Date: 20210502; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: POSITIVE
CDC 'Split Type': USJNJFOC20210506427
Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient tested positive for Covid-19 (coded as confirmed covid-19 infection and confirmed clinical vaccination failure). Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000178477.; Sender''s Comments: V0: 20210506427-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
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