Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 66 year old male. Initial information was processed along with the additional information received on 09-JAN-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (unspecified drug). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on 08-MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 64 years old. Concomitant medications included atorvastatin and Zetiamid from 01-JAN-2022 to 12-DEC-2022 for an unspecified indication. The patient additionally received a non-company suspect vaccine included: elasomeran (Moderna) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 10-NOV-2021 for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with elasomeran (Dose number in series 2) The patient again received a non-company suspect vaccine included: elasomeran (Moderna) (Dose number in series 3) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered at left arm on 13-SEP-2022 at 09:30 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3).  On 13-DEC-2022, Laboratory data included: COVID-19 virus test Positive (confirmed clinical vaccination failure, Dose number in series 1). Treatment medication included, Paxlovid for COVID-19 treatment from 13-DEC-2022 to 18-DEC-2022. On 21-DEC-2022, Laboratory data included: COVID-19 virus test Negative, after being symptom free for 3 days.  On 23-DEC-2022 16:00, the patient was symptomatic with chest and nasal congestion (confirmed covid-19 infection / covid rebound, Dose number in series 3) and tested positive on 25-DEC-2022. On 26-DEC-2022, the symptoms were mild, slight sore throat and nasal congestion. Had chest congestion as well the previous 2 days (Dose number in series 3).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran 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). This report was associated with product quality complaint: 90000266165.; Sender's Comments: V0: 20230109886-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.