Age: 30.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 32 year old male. Initial information was processed along with the additional information received on 08-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis, and other pre-existing medical conditions included: Patient was not having any drug allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered 1 in total to the left arm on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 30 years old. On an unspecified date, the patient experienced confirmed clinical vaccination failure following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Concomitant medications included ustekinumab (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 14-OCT-2021 for an unspecified indication.  The patient received first dose of non-company suspect vaccine included: tozinameran (pfizer vaccine) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered to the left arm on 09-AUG-2021 for prophylactic vaccination. Age at time of vaccination 31 years old. It was unknown whether patient had any adverse events following first dose of tozinameran (Dose number in series 2).  Patient received second dose of non-company suspect vaccine included: tozinameran (Dose number in series 3) (pfizer vaccine) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered to the right arm on 09-FEB-2022 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced and confirmed covid-19 infection following vaccination with second dose of tozinameran (Dose number in series 3) and was treated with non company suspect Paxlovid (form of admin, route of admin, and batch number were not reported) dose was not reported, administered from 18-JUN2022 to 22-JUN-2022 for the treatment of covid-19. On 22-JUN-2022, Laboratory data included: COVID-19 virus test Negative. On 27-JUN-2022 Covid-19 returned after 5 days of completion of Paxlovid treatment (Dose number in series 3). On 27-JUN-2022, Laboratory data included: COVID-19 virus test Positive.  The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and tozinameran was not applicable The patient had not recovered 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 report was associated with product quality complaint: 90000241602; Sender's Comments: V0: 20220715398-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.