Age: 57.0
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 who is a health care professional via other manufacturer (Pfizer) concerned a 58 year old female. Initial information was processed with the additional information received on 05-OCT-2022. The patient's height, and weight were not reported.  The patient's concurrent conditions included: urticarial vasculitis, vitiligo, hashimoto thyroid, sulfa allergy, and dapsone allergy. Patient was not pregnant at the time of vaccination. The patient was health care professional.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered 1 in total to the right arm on 25-MAY-2021 09:00 for covid-19 prophylaxis.  Age at time of vaccination 57 years old.  The patient received additional dose of non-company suspect vaccine included: tozinameran (Dose number in series 2) (form of admin and route of admin were not reported, batch number: FE 3592 expiry: UNKNOWN) dose was not reported, administered to the right arm on 23-DEC-2021 10:00 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2).  Concomitant medications included alprazolam, ergocalciferol, and levothyroxine.  On an unspecified date in 2022, the patient experienced COVID-19 infection (Dose number in series 2).  To treat the COVID-19, the patient received non-company suspect drug: Paxlovid (nirmatrelvir and ritonavir) (form of admin and route of admin were not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, administered from 15-SEP-2022 to 20-SEP-2022 (5 days). The patient completed 5 days course and was compliant with instructions. The patient tested negative on day of completing medication (20-SEP-2022) and continued to test negative every day until 27-SEP-2022.  The patient became symptomatic on 26-SEP-2022 05:30 with congestion and sore throat but had negative test.  The symptoms remained on 27-SEP-2022 morning and retested as positive (confirmed covid-19 infection (Dose number in series 2) and confirmed clinical vaccination failure (Dose number in series 1)). On 20-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 21-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 22-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 23-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 24-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 25-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 26-SEP-2022, Laboratory data included: COVID-19 virus test Negative. On 27-SEP-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and action taken with Paxlovid was not reported. 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: 90000254271.; Sender's Comments: V0: 20221005843-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.