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 manufacturer 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: overweight, and allergy. 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: 1805029, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-MAR-2021 to right arm for covid-19 prophylaxis. Concomitant medications included ascorbic acid/calcium pantothenate/ergocalciferol/nicotinamide/pyridoxine hydrochloride/retinol/riboflavin/thiamine hydrochloride, bifidobacterium bifidum/bifidobacterium longum/lactobacillus gasseri, ergocalciferol, allergy pill and tirzepatide. The patient also received second dose with non-company suspect Pfizer Biontech Covid-19 Vaccine, (tozinameran), (Dose number in series 2), (batch number: 33130BA, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 14-DEC-2021 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 also received third dose with non-company suspect Pfizer Biontech Covid-19 Vaccine, (tozinameran), (Dose number in series 3), (batch number: FK9893, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 30-JUN-2022 to right arm for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (Dose number in series 3). On 17-AUG-2023, the patient tested positive for covid-19 and experienced confirmed covid-19 infection (Dose number in series 3) and confirmed clinical vaccination failure (Dose number in series 1). The patient was treated with paxlovid for 5 days from 19-AUG-2023 to 24-AUG-2023 for treatment of covid-19. 10 days after initial positive test patient tested negative for covid-19 on 27-AUG-2023. On 29-AUG-2023, 2 days after negative test patient experienced symptoms again, and 4 days after negative test, patient was tested positive for covid-19 on 31-AUG-2023. The patient reported to had cough, congestion, and fatigue which was almost worse than initial symptoms of covid-19. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Dose number in series 2), and tozinameran (Dose number in series 3) 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).; Sender's Comments: V0: 20230917219-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.