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 patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: obesity. The patient received 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, start therapy date were not reported, 1 total administered 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 (elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Moderna (elasomeran) (Dose number in series 2). The patient received non-company suspect vaccine Pfizer Biontech (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 07-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included Zoloft (sertraline hydrochloride) for drug used for unknown indication.  On unspecified date in AUG-2023, the patient experienced covid-19 infection (confirmed covid-19 infection) (Dose number in series 3) which led to confirmed clinical vaccination failure (Dose number in series 1).  Patient was treated with paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 30-AUG-2023 to 04-SEP-2023 for treatment of covid-19.  Patient tested positive for covid again after 3 negative tests over 5 days. Last dose of Paxlovid was on 04-SEP-2023. The patient had negative rapid antigen tests on 04-SEP-2023, 06-SEP-2023, and 08-SEP-2023. On 10-SEP-2023, patient had a bad cough, so took a rapid antigen test again. It was positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, 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 a product quality complaint: 90000296996.; Sender's Comments: V0: 20230927820-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.