Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) and concerned a 51 year old male. Initial information was processed along with additional information received on 26-DEC-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Drug name not reported), restless leg, and asthma and other pre-existing medical conditions included: The patient was taking any other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received first dose covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) 1 total, dose was not reported, administered on 27-MAR-2021 into left arm for covid-19 prophylaxis. Age at time of vaccination 49 years old. Concomitant medications included ropinirole. The patient received second dose of non-company suspect vaccine included: elasomeran (moderna covid-19 vaccine) (dose number in series 2) (form of admin, route of admin and were not reported, batch number: 026D21A expiry: UNKNOWN) dose was not reported, administered on 04-OCT-2021 into left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with elasomeran. The patient received third dose of non-company suspect vaccine included: elasomeran (dose number in series 2) (moderna covid-19 vaccine) (form of admin, route of admin and were not reported, batch number: 003F21A expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 into left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with elasomeran (dose number in series 2). The patient received fourth dose of non-company suspect vaccine included: elasomeran (dose number in series 2) (moderna covid-19 vaccine) (form of admin, route of admin and were not reported, batch number: 083J21A expiry: UNKNOWN) and dose was not reported, administered on 25-APR-2022 into left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with elasomeran (dose number in series 2). The patient received fifth dose of non-company suspect vaccine included: elasomeran (dose number in series 3) (moderna covid-19 vaccine) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 15-SEP-2022 at 12:00 into left arm for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 3). On an unspecified date in DEC-2022, the patient experienced covid-19 and had symptoms along with extreme fatigue which led to confirmed covid-19 infection (dose number in series 3) and confirmed clinical vaccine failure (dose number in series 1). On 04-DEC-2022, the patient had treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported until 09-DEC-2022 as treatment for covid-19. On 10-DEC-2022, the patient was tested negative. On 11-DEC-2022, the patient was tested positive and on 12-DEC-2022 tested positive more strongly. Patient's mild symptoms also had reappeared (mild chest congestion). At the time of report, the patient had not experienced a resurgence of the extreme fatigue which was felt during the first week of COVID-19. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine 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: 90000264627.; Sender's Comments: V0: 20221251654- confirmed clinical vaccine 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.