Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from other company (Pfizer) and from a patient concerned a 63 year old female. Initial information was processed along with the additional information received on 18-AUG-2022. The patient's height and weight were not reported. The patient's concurrent conditions included: asthma and drug allergy (Cholesterol Meds). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, dose 1, 1 total administered to the right arm on 09-MAR-2021 15:00 for covid-19 prophylaxis. Age at time of vaccination 61 years old. The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and were not reported, batch number: 017F21A and expiry: UNKNOWN) dose was not reported, administered to the right arm on 26-OCT-2021 10:00 for covid-19 prophylaxis. Age at time of vaccination 62 years old. The patient received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 3) (form of admin, route of admin, and were not reported, batch number: 037A22B and expiry: UNKNOWN) dose was not reported, administered to the left arm on 29-MAY-2022 11:30 for covid-19 prophylaxis. Age at time of vaccination 62 years old.  The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number and expiry were not reported) dose was not reported, administered from 26-JUL-2022 to 30-JUL-2022 for treatment of COVID-19. The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. No concomitant medications were reported. After starting treatment with Paxlovid on 26-JUL-2022, the patient's symptoms gone in a day and a half and she tested negative for covid on 30-JUL-2022, 31-JUL-2022 and 01-AUG-2022.  On 06-AUG-2022, the patient started getting symptoms (coded as confirmed covid-19 infection) (dose number in series 3) which led to confirmed clinical vaccination failure (dose number in series 1). On 07-AUG-2022, the patient tested positive. As of 10-AUG-2022, the patient was still testing positive for covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 9000024698.; Sender's Comments: V0:20220834440-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.