Age: 54.0
Sex: F
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 other company (Pfizer) via a patient concerned a 55-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, 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: 026D21 A expiry: UNKNOWN) dose was not reported, administered 1 in total on 24-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 54 years old. On 23-SEP-2022, the patient experienced confirmed clinical vaccination failure following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Patient received non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 2) (batch number: 056M21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 24-OCT-2021 for covid-19 prophylaxis.  On 24-OCT-2021, the patient experienced revaccination with different covid-19 vaccine following vaccination with elasomeran (Dose number in series 2). Patient received non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 3) (batch number: 056MZ1 A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 13-MAY-2022 for covid-19 prophylaxis. No concomitant medications were reported.  On 23-SEP-2022, the patient experienced confirmed covid-19 infection. Laboratory data included: COVID-19 virus test Positive following vaccination with elasomeran (Dose number in series 3).  Patient received non-company drug included: paxlovid (batch number: Unknown expiry: Unknown, form of admin, route of admin, and were not reported) dose was not reported, administered from 23-SEP-2022 to 27-SEP-2022 for covid-19 treatment. On 28-SEP-2022, Laboratory data included: COVID-19 virus test Positive. On 01-OCT-2022, Laboratory data included: COVID-19 virus test Negative, patient started feeling better and then again started feeling sick. On 04-OCT-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable. The patient was recovering 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, and reference number requested. Sender's Comments: V0:20221027458-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.