Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via other company (Pfizer Inc.) concerned a patient of unspecified age, sex, race, ethnicity. The patient's weight, height, and medical history were not reported. The patient received first dose with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2022 for covid-19 prophylaxis. No concomitant medications were reported.  The patient additionally received 2 doses with Non-company suspect vaccine Moderna covid-19 vaccine, (elasomeran), (Dose number in series 2), (batch number: 035C21A, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 27-AUG-2022, and (batch number: AS7163B, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 22-SEP-2022 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient also received Non-company suspect vaccine Moderna covid-19 vaccine, (elasomeran), (Dose number in series 3), (batch number: 041C21A, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 08-OCT-2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3).   On an unspecified date, the patient experienced confirmed covid-19 infection (Dose number in series 3) and had confirmed clinical vaccination failure (Dose number in series 1).  The patient started taking treatment with Non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 04-JUL-2023 to 08-JUL-2023 for treatment of covid-19.  The patient experienced Rebound covid-19. No additional symptoms yet but tested positive after testing negative 48 hours prior. Laboratory data (dates unspecified) included: COVID-19 virus test Positive, COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20230733563- confirmed clinical vaccination failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.