Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
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 (nurse) via another pharmaceutical company (Pfizer) concerned a 58 year old female. Initial information was processed along with the additional information received on 02-AUG-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: Hashimoto, rheumatoid arthritis, and drug allergy (unspecified). The patient was not pregnant at the time of vaccination. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 05-MAY-2021 at 12:00 to left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 57 years old. The patient received dose 2 with non-company suspect Pfizer Biontech covid-19 vaccine (tozinameran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 11-APR-2022 at 14:00 to right arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with non-company suspect Pfizer Biontech covid-19 vaccine (tozinameran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 10-JUN-2022 at 14:00 to left arm for covid-19 prophylaxis. Concomitant medications included levothyroxine sodium. On an unspecified date in 2022, the patient experienced confirmed clinical vaccination failure (Dose number in series 1), and confirmed covid-19 infection (Dose number in series 3). The patient received non company co-suspect drug Paxlovid (form of admin and route of administration were not reported, batch number: GA8849, expiry: unknown) dose was not reported, administered from 05-JUL-2022 to 09-JUL-2022 for treatment of COVID-19. Post receiving Paxlovid, the patient was tested negative for covid-19. Later the patient had received non-company suspect drug abatacept (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported on 19-JUL-2022 for an unspecified indication. On 20-JUL-2022, at 16:00, patient started to became sick again and tested positive for covid-19. The patient reported that her symptoms were worse than the first time. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Dose number in series 2), tozinameran (Dose number in series 3), abatacept was not applicable and with Paxlovid was drug discontinued. 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 product quality complaint: 90000244680.; Sender's Comments: V0:20220803967-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.