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Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 53-year-old female. The patient''s height, and weight were not reported. The patient''s current conditions included penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: unknown) dose was 0.5 ml, 1 total administered on 06-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the patient experienced confirmed clinical vaccination failure and confirmed COVID-19 infection. Laboratory data included: Rapid test and antibody testing for COVID-19 (NR: not provided) was positive for antibodies, and COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed clinical vaccination failure and confirmed COVID-19 infection. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179016. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified. Additional live follow up information was received from Product Quality Vigilance on 11-MAY-2021.; Sender''s Comments: V0: 20210518529-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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