Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: obesity, and drug allergy (Amoxicillin). The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 09:30 to left arm for prophylactic vaccination. Age at time of vaccination 50 years old. No concomitant medications were reported.  The patient additional received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (batch number: 012F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 23-OCT-2021 15:00 to left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Moderna covid-19 vaccine.  The patient additional received non-company suspect vaccine Pfizer biontech covid-19 vaccine (elasomeran) (Dose number in series 3) (batch number: FK9894 expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 30-MAR-2022 16:45 to left arm for prophylactic vaccination. On 17-JUN-2022, the patient was tested covid-19 positive and received Paxlovid within hours of my positive test Day O of 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 same day the patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number: GC0470 expiry: UNKNOWN) dose was not reported, last administered on 22-JUN-2022 for treatment of COVID-19.The patient took full dosage as prescribed 3 pills, 2 times a day for 5 days. The symptoms were sore throat, stuffy head, digestive issues and fatigue disappeared by day 6 (22-JUN-2022) and tested negative on day 9 (25-JUN-2022). The patient reported symptoms (sore throat, stuffy head, and fatigue) returned on Day 10 (26-JUN-2022) and tested positive again on Day11 (27-JUN-2022) (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and with Paxlovid was drug discontinued and with tozinameran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product Quality Complaint 90000241599.; Sender's Comments: V0-20220716421-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure . The event(s) has an compatible/suggesstive 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.