Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a patient of an unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 26-AUG-2022.  The patient's height and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis (took immunosuppressant, Orencia, but have not had infusion since 6/28.) and allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, dose 1, 1 total administered on 15-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown) dose was not reported, dose 2, administered on 27-SEP-2021 for covid-19 prophylaxis. The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of administration, route of administration, batch number were not reported, expiry: unknown) dose was not reported, dose 3, administered on 26-MAR-2022 for covid-19 prophylaxis. The patient also additionally received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 4) (form of administration, route of administration, batch number were not reported, expiry: unknown) dose was not reported, dose 4, administered on 30-JUL-2022, 10:00 for covid-19 prophylaxis. On 01-AUG-2022, the patient experienced symptoms and tested positive for covid (coded as confirmed clinical vaccination failure (dose number in series 1) and confirmed covid-19 infection (dose number in series 4)). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 02-AUG-2022 to 07-AUG-2022 for treatment of COVID-19.  The patient felt fine and had no symptoms since 06-AUG-2022 which was fourth day from starting of Paxlovid or sixth day after testing positive for covid. The patient tested negative for Covid on 11-AUG-2022 (4 days after stopping paxlovid, 11th day after testing positive for Covid). But on 15-AUG-2022, the patient started to have a congested chest/throat feeling but tested negative still. Symptoms worsened to add congested/runny nose, lots of post nasal drip, bad cough when laying down and raw throat/back of mouth. On 18-AUG-2022, the patient clearly tested positive again for covid (11 days after stopping paxlovid). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose number in series 2), elasomeran (dose number in series 3), elasomeran (dose number in series 4) was not applicable and with Paxlovid was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000248235.; Sender's Comments: V0: 20220856447-covid-19 vaccine ad26.cov2.s-confirmed 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.