Age: 68.0
Sex: M
Vaccine: COVID19, 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 manufacturer (Pfizer) concerned a 69 year old male of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 31-JAN-2023. The patient's height, and weight were not reported. 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, 1 total administered on 05-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 68 years old.  The patient additionally received non-company suspect vaccine included: elasomeran (Moderna) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 050CZ1A, expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of elasomeran (Moderna) (Dose number in series 2). The patient additionally received non-company suspect vaccine included: elasomeran (Moderna) (Dose number in series 3) (form of admin, route of admin, and were not reported, batch number: 0481Z1A, expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2022 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with third dose of elasomeran (Moderna) (Dose number in series 3). The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer) (Dose number in series 4) (form of admin was not reported, intramuscular, batch number: GH9702, expiry: UNKNOWN) dose was not reported, administered at right arm on 09-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 4). Concomitant medications included amoxicillin for dental implant. On 14-DEC-2022, the patient experienced mild symptoms of covid-19 infection (Dose number in series 4) which led to confirmed clinical vaccination failure (Dose number in series 1). On 15-DEC-2022, Laboratory data included: COVID-19 antigen test Positive (Mild symptoms). The patient was treated with Paxlovid (form of admin, route of admin were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered on 15-DEC-2022. On 19-DEC-2022, Laboratory data included: COVID-19 antigen test Positive (Mild symptoms). On 21-DEC-2022, Laboratory data included: COVID-19 antigen test Positive (No symptoms). On 22-DEC-2022, Laboratory data included: COVID-19 antigen test Negative (No symptoms). On 24-DEC-2022, patient experienced rebound covid (Dose number in series 4), Laboratory data included: COVID-19 antigen test Positive (Very mild symptoms). On 26-DEC-2022, Laboratory data included: COVID-19 antigen test Positive. On 28-DEC-2022, Laboratory data included: COVID-19 antigen test Positive. On 30-DEC-2022, Laboratory data included: COVID-19 antigen test Positive. On 01-JAN-2023, Laboratory data included: COVID-19 antigen test Negative. On 02-JAN-2023, Laboratory data included: COVID-19 antigen test Negative. On 03-JAN-2023, Laboratory data included: COVID-19 antigen test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, elasomeran, and tozinameran was not applicable and with paxlovid was unknown. The outcome of the confirmed clinical vaccination failure, confirmed covid-19 infection 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: 90000269254.; Sender's Comments: V0-20230161603-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.