Age: 41.0
Sex: F
Vaccine: 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 patient via other company (Pfizer) concerned a 42 year old female. Initial information was processed along with additional information on 31-JAN-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and drug allergy (Unspecified). The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-MAR-2021 on left arm for covid-19 prophylaxis. Age at the time of vaccination was 41 years old. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, bupropion hydrochloride, cetirizine hydrochloride, and montelukast sodium for unspecified indication.  The patient additionally received non-company suspect vaccine (Moderna Spikevax) elasomeran (Dose number in series 2) (second dose) (form of admin, route of admin were not reported, batch number: 026D21A expiry: UNKNOWN) dose was not reported, administered on 24-OCT-2021 on right arm for covid-19 prophylaxis, which was revaccination with different covid-19 vaccine (Dose number in series 2) and patient received third dose (form of admin, route of admin were not reported, batch number: 012H22A expiry: UNKNOWN) administered on 27-OCT-2022 on left arm for covid-19 prophylaxis. On 09-JAN-2023, the patient had confirmed covid-19 infection (Dose number in series 2) and tested positive, which let to confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect Paxlovid (form of admin, route of admin were not reported, batch number: GF3201 expiry: UNKNOWN) dose was not reported, administered from 09-JAN-2023 to 13-JAN-2023 for covid-19 treatment. On 13-JAN-2023, 14-JAN-2023 and 15-JAN-2023, patient tested negative and had no symptoms. On 18-JAN-2023, the patient was sick again and tested positive (rebound covid). On 21-JAN-2023, patient went to urgent care and was given (Prednisone) Methylprednisolone (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable, action taken with paxlovid was drug discontinued. 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: 90000269245.; Sender's Comments: V0-20230162246- 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.