Sex: U
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 a consumer via Pfizer concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with additional information on 30-NOV-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (tincture of benzoin). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered to right arm on 09-MAR-2021 13:00 for covid-19 prophylaxis. Concomitant medications included simvastatin for an unknown indication The patient additionally received non-company suspect covid-19 vaccine (Moderna, Spikevax) elasomeran (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 066F21A, expiry: UNKNOWN) dose was not reported, administered to right arm on 30-OCT-2021 16:00 for covid-19 prophylaxis, which was revaccination with different covid-19 vaccine (Dose number in series 2). It was unknown whether patient had any adverse event post covid-19 vaccine (Moderna, Spikevax) (Dose number in series 2). The patient additionally received non-company suspect covid-19 vaccine (Pfizer biontech covid-19 vaccine) tozinameran (Dose number in series 3) (form of admin, route of admin were not reported, batch number: FP7139 expiry: UNKNOWN) dose was not reported, administered to left arm on 08-AUG-2022 16:00 for covid-19 prophylaxis. On an unspecified date, the patient experienced covid-19 (confirmed covid-19 infection) (Dose number in series 3) and hence confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect Paxlovid (Nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, administered from 29-OCT-2022 to 02-NOV-2022 for covid-19 treatment. On 04-NOV-2022, 2 days after completion of Paxlovid, the patient tested negative for covid via Home Binax Now test. On 05-NOV-2022, Laboratory data included: COVID-19 virus test Negative. On 06-NOV-2022, Laboratory data included: COVID-19 virus test Negative. On 07-NOV-2022, Laboratory data included: COVID-19 virus test Negative. On 08-NOV-2022, at 07:00 the patient tested positive and symptoms returned, symptoms included headache, chills, congestion, tightness in chest and cough. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable and with paxlovid treatment discontinued. 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 product quality complaint: 90000261269.; Sender's Comments: V0: 20221163593-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.