Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
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 patient through other manufacturer (Pfizer) concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 05-APR-2021 to left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. The age at time of vaccination 59 years old. Concomitant medications included balsalazide sodium. The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 27-OCT-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following elasomeran (Moderna Covid-19 vaccine) (dose number in series 2). The patient received non-company suspect vaccine elasomeran (Moderna Covid-19 vaccine) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 18-APR-2022 to left arm for covid-19 prophylaxis. On 29-JUN-2022, the patient was treated with non-company suspect drug Paxlovid (form of admin, route of admin and batch number were not reported, expiry: unknown) dose and frequency were not reported for covid-19 treatment and last administered on 3-JUL-2022. On 04-JUL-2022, after non company suspect drug paxlovid treatment (for covid-19) laboratory data included: COVID-19 home antigen test Negative.  On 08-JUL-2022, the patient was rebounded with COVID-19 and tested positive for coronavirus disease-19 polymerase chain reaction (COVID-19 PCR) test which was coded confirmed covid-19 infection (dose number in series 3) and confirmed clinical vaccination failure (dose number in series 1). On 09-JUL-2022, the patient experienced runny nose (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and paxlovid was drug discontinued on 03-JUL-2022. The patient had not recovered 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: V0-20220732582 -COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.