Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; METALLIC TASTE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 64 year old male of unspecified race and ethnicity.  Initial information was processed along with the additional information received on 05-AUG-2022. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Patient received additional non-company suspect vaccine tozinameran (Pfizer vaccine) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with tozinameran (Dose number in series 2).  Patient received additional non-company suspect vaccine tozinameran (Pfizer vaccine) (Dose number in series 3) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on APR-2022 for covid-19 prophylaxis. No concomitant medications were reported.  On 22-JUL-2022 Friday, the patient started with a cough that continued on to Saturday 23-JUL-2022, coded as confirmed covid-19 infection (Dose number in series 3). On 24-JUL-2022, the patient tested positive for covid-19, coded as confirmed clinical vaccination failure (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive. The patient received non-company suspect drug Paxlovid (form of admin, route of admin not reported, batch number: Unknown and expiry: 31-MAR-2023) 150mg nirmaltrevir and 100 mg of ritonavir, administered on 24-JUL-2022 for treatment of covid-19. On 24-JUL-2022 Sunday the patient felt confused with the package of paxlovid and experienced metallic taste (Dose number in series 3). Patient stated it's like a piece of metal in mouth, a terrible taste. It was reported that patient still had metallic taste at the time of reporting. On 24-JUL-2022 Sunday, patient took one pill only, but not sure what pill. On 25-JUL-2022 Monday, patient read the blister pack and it said to take 2 pills in the morning and 2 pills in the evening, at the same time. On 26-JUL-2022 Tuesday patient took two tablets in morning and evening and ever since had been taking it that way. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and tozinameran was not applicable and action taken with paxlovid was not reported. The patient had not recovered from metallic taste, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000245287.; Sender's Comments: V0:20220807861-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.