Age: 50.0
Sex: M
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 patient via other company (Pfizer) concerned a 51 year old male. Initial information was processed with the additional information received on 21-DEC-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: childhood reaction to penicillin (Allergy). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: Unknown) dose was not reported, 01 total administered at left arm on 13-MAR-2021 11:00 for covid-19 prophylaxis. Age at time of vaccination 50 years old. No concomitant medications were reported.  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 at left arm on 23-NOV-2021 16:00 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 was also vaccinated with 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 04-AUG-2022 16:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3).  After symptoms on Day 0 (24-NOV-2022), the patient took a rapid test and a PCR test on Day 1 (25-NOV-2022). Both were positive. The patient was prescribed Paxlovid via telehealth on Day 1 (25-NOV-2022), took first dose on Day 1. Took all doses as described, took last one on Day 6 (30-NOV-2022) for COVID-19 Treatment. After 3 days of negative rapid tests, unmasked on Day 8 (02-DEC-2022). On Day 11 (05-DEC-2022 19:00), symptoms started to return. The patient had a positive rapid test on Day 12 (06-DEC-2022). Still positive today (Day 15 /09-DEC-2022). The patient had sinus, throat symptoms and some fatigue at the time of this report (Dose number in series 3). On an unspecified date, the patient experienced confirmed clinical vaccination failure (Dose number in series 1).  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 90000264122.; Sender's Comments: V0: 20221243817-. 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.