Sex: U
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 patient of unspecified age, sex, race and ethnic origin. Initial information was processed along with additional information received from complaint vigilance department on 03-APR-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, high triglycerides, blood pressure, and sulfa 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: 1808978 expiry: UNKNOWN) dose was not reported,1 total administered at left arm on 29-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received two doses of non-company co-suspect vaccine Moderna (elasomeran), (dose number in series 2) (form of admin, route of admin was not reported, batch number: 071F21A  for (first dose) and batch number: 048L21A for (second dose) expiry: UNKNOWN) dose was not reported, administered first dose on 01-NOV-2021 and second dose on 12-APR-2022, and dose was not reported, administered at left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following Moderna (elasomeran),(Dose number in series 2). The patient also received non-company co-suspect vaccine Moderna (elasomeran) (dose number in series 3) (form of admin, route of admin was not reported, batch number: AS7146B expiry: UNKNOWN) dose was not reported, administered at left arm on 20-SEP-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3). No concomitant medications were reported.  The patient received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 28-FEB-2023 to 05-MAR-2023 for covid-19 treatment.  On 14-MAR-2023 (Day 15), Laboratory data included: COVID-19 virus test Negative and also patient had not symptoms. The patient went outside/ public between 15-MAR-2023 to 22-MAR-2023. The patient noticed coughing, sneezing, runny nose, congested at night for 3 to 4 days which was getting worsened on 22-MAR-2023. On an unspecified date in MAR-2023, the patient had home covid-19 test which resulted in positive (confirmed covid-19 infection) (dose number in series 3) which leds to 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; and action taken with nirmatrelvir/ritonavir was not reported. 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 a product quality complaint 90000277524.; Sender's Comments: V0: 20230378112-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.