Age: 32.0
Sex: F
Vaccine: 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 32 year old female. Initial information was processed along with additional information on 23-DEC-2022.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient previously received two doses of pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 1) (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered first dose on 01-DEC-2020 and second dose on 01-JUL-2021 for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with pfizer biontech covid-19 vaccine (tozinameran) (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 01-MAY-2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine. The batch number was not reported and has been requested. Age at time of vaccination 32 years old. Concomitant medications included pseudoephedrine (from 04-DEC-2022 to 16-DEC-2022) and dayquil (from 03-dec-2022 to 10-dec-2022) for drug used for unknown indication. On 01-DEC-2022, Laboratory data included: COVID-19 virus test negative. On 02-DEC-2022, the patient had covid-19 infection and at 02-DEC-2022 to 12-DEC-2022 (DEC-2022), the patient had covid-19 virus test positive (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (Dose number in series 2). The patient took non company co-suspect drug paxlovid (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 05-DEC-2022 to 09-DEC-2022 for the treatment for covid-19. On 10-DEC-2022, the symptoms were resolved. On 14-DEC-2022, the patient cough and congestion was come back and COVID-19 virus test was negative. On 16-DEC-2022, Laboratory data included: COVID-19 virus test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with paxlovid was drug withdrawn. 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 case was associated with product quality complaint; Sender's Comments: V0: 20221251450-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.