Age: 65.0
Sex: M
Vaccine: 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 (himself is physician) via other manufacturer (Pfizer) concerned a 66 year old male. Initial information was processed along with the additional information on 04-AUG-2022. The patient's height, and weight were not reported.  The patient's concurrent conditions included: hyperlipidemia, non-alcoholic fatty liver disease (NAFLD), history of hairy cell leukemia, coronary artery disease (CAD), and an unspecified drug allergy. The patient was physician. The patient previously received three doses of Pfizer biontech covid-19 vaccine (tozinameran, dose number in series 1) (form of admin, and route of admin were not reported, batch number: EKS730 expiry: UNKNOWN) dose was not reported, administered on 29-DEC-2020 in left arm for covid-19 prophylaxis, (form of admin, and route of admin were not reported, batch number: EL3246 expiry: UNKNOWN) dose was not reported, administered on 20-JAN-2021 in left arm for covid-19 prophylaxis and (form of admin, and route of admin were not reported, batch number: EW0198 expiry: UNKNOWN) dose was not reported, administered on 01-AUG-2021 in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with three doses of Pfizer biontech covid-19 vaccine (tozinameran, dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-JAN-2022 in left arm for covid-19 prophylaxis. Age at time of vaccination 65 years old. Concomitant medications included rosuvastatin.  On an unspecified date in 2022, the patient had Covid infection (confirmed covid-19 infection) which led to confirmed clinical vaccination failure (dose number in series 2). The patient underwent COVID-19 rapid POC test which was positive. From 14-JUL-2022 to 18-JUL-2022, the patient received Paxlovid (nirmatrelvir and ritonavir) for treatment of covid-19 (completed 5 days of treatment). On 24-JUL-2022, patient again experienced covid-19 symptoms (rebound Covid infection). On 26-JUL-2022, patient tested positive with rapid test again. At the time of this report, the patient's symptoms persist but no evidence of severe disease. The action taken with covid-19 vaccine ad26.cov2.s 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: 90000245084.; Sender's Comments: V0: 20220805963- 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.