Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, Palpitations, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; METALLIC TASTE; PALPITATIONS; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 67 year old female. Initial information was processed along with the additional information received on 17-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: paroxysmal atrial tachycardia. The patient was nurse by profession. The patient was not pregnant at the time of reporting. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 in total was administered on 11-MAY-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: 1822811 expiry: unknown) dose was not reported, 1 total, administered on 21-NOV-2021, to left arm for covid-19 prophylaxis. Age at the time of vaccination was 66 years old. Concomitant medications included famotidine, gabapentin, meloxicam, and metoprolol succinate. On an unspecified date, the patient experienced covid-19 infection (coded as confirmed covid-19 infection) (dose number in series 2). The patient was treated with Paxlovid for the treatment of covid-19 infection with the start date of 23-JUL-2022 and end date of 28-JUL-2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 23-JUL-2022, the patient experienced metallic taste in mouth, some diarrhea, palpitations, rebound symptoms and positive rapid covid test after 2 negative tests (confirmed clinical vaccination failure) (dose number in series 2). The patient also experienced respiratory symptoms for which for which treatment medications (dates unspecified) included: benzonatate, and amoxicillin trihydrate/clavulanate potassium. Laboratory data (dates unspecified) included: covid-19 rapid antigen test positive, and covid-19 virus test which was done twice resulted negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with paxlovid was drug discontinued. The patient had not recovered from metallic taste, palpitations, and 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: 90000246756.; Sender's Comments: V0-20220832455-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.