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 (REBOUND); REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: surgery on 07-NOV-2022 and other pre-existing medical conditions included: The patient was on other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (first dose) (suspension for injection, route of admin not reported, batch number: 1808978 expiry: unknown) dose was not reported, 1 total, administered on 28-MAR-2021 at left arm for covid-19 prophylaxis. Concomitant medications included ibuprofen and paracetamol. On an unspecified date in NOV-2022, 19 months after vaccination, the patient experienced covid-19 infection (rebound) which led to confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect vaccine (Spikevax) elasomeran (Dose number in series 2) (second dose) (form of admin, route of admin were not reported, batch number: 039F21A and expiry: unknown) dose was not reported, administered on 09-NOV-2021 at left arm for covid-19 prophylaxis and (third dose) (form of admin, route of admin were not reported, batch number: 056M21A and expiry: unknown) administered on 17-JUN-2022 at left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with two doses of non-company suspect vaccine (Spikevax) elasomeran (Dose number in series 2). The patient received non-company suspect vaccine (Spikevax) elasomeran (Dose number in series 3) (fourth dose) (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered on 08-SEP-2022 at left arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On NOV-2022, the patient experienced confirmed clinical vaccination failure and confirmed covid-19 infection (rebound). The patient was treated with Paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 09-NOV-2022 to 14-NOV-2022 for treatment of covid-19. On 15-NOV-2022, the patient had a covid test (SARS-CoV-2 test) Negative. On 01-DEC-2022, Patient had rebound positive covid test (SARS-CoV-2 test) after a complete cycle of Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and paxlovid was drug discontinued on 14-NOV-2022. The patient had not recovered from confirmed covid-19 infection (rebound) and the outcome of 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 product quality complaint: 90000262587.; Sender's Comments: V0-20221217139-Confirmed Clinical vaccination failure. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.