Sex: U
Vaccine: 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 consumer by a Other company concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: UNKNOWN) dose, therapy start dates were not reported, 1 in total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, 1 in total administered on 07-MAR-2022 for covid-19 prophylaxis. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient reported that, the initial symptoms began on 08-MAY-2023 mid day, test was performed which showed negative covid-19 home test. On 09-MAY-2023, 06:00 the symptoms increased (sore throat, cough, hoarseness, malaise), with the positive covid-19 home test (dose number in series 2). The patient was treated with Non-company suspect drugs included: nirmatrelvir/ritonavir (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 09-MAY-2023 at 08:00 to 13-MAY-2023 for treatment of covid-19. The patient took as instructed for 5 days. No concomitant medications were reported.  On 13-MAY-2023, covid-19 home test was performed which gave negative result. Symptoms had resolved. On 18-MAY-2023 20:00, the patient experienced burning sensation in the nose and slight cough returned. On 19-MAY-2023, full return of covid-19 symptoms (frequent cough, hoarseness, malaise, burning sensation in the nose, sore throat) and covid-19 home test was performed which gave positive result (confirmed covid-19 infection) which led to confirmed clinical vaccination failure (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering 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, and reference number requested.; Sender's Comments: V0: 20230563383-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.