Age: 65.0
Sex: M
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 65 year old male. Initial information was processed along with additional information on 25-OCT-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (unspecified). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received three doses of spikevax (elasomeran) (Dose number in series 2) (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for covid-10 prophylaxis.  It was unknown whether the patient had any adverse events following vaccination with three doses of spikevax (elasomeran) (Dose number in series 2).  The patient also received spikevax (elasomeran) (Dose number in series 3) (form of admin and route of admin was not reported, batch number: AS71448, expiry: Unknown) dose was not reported, administered at left arm on 07-SEP-2022 15:30 for covid-19 prophylaxis and was associated with revaccination with different covid-19 vaccine. On 03-OCT-2022, the patient had covid-19 symptoms and had confirmed covid-19 infection (Dose number in series 3) which leads to confirmed clinical vaccination failure (Dose number in series 1).  The patient received non company suspect drug paxlovid (form of admin, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered from 05-OCT-2022 to 10-OCT-2022 for covid-19 treatment.  On 08-OCT-2022, the symptoms were resolved (Dose number in series 3).  On 11-OCT-2022, Laboratory data included: continued to had COVID-19 virus test Positive. On 13-OCT-2022, Laboratory data included: COVID-19 virus test Negative. On 15-OCT-2022, with no symptoms the patient again COVID-19 virus tested Positive. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug discontinued. The patient was 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: 90000256598; Sender's Comments: V0:20221046930-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure.The event(s) has an unknown/unclear 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.