CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sports induced asthma, high blood pressure, high bad cholesterol, penicillin allergy, and fish, shellfish, pork, egg yolk allergy, and other pre-existing medical conditions included: Patient was non-pregnant at the time of vaccination. Patient was previously experienced drug allergy when treated with clindamycin. The patient was previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 and expiry date: unknown) dose was not reported, 1 total, dose number 1, administered on 06-APR-2021;11:00 on left arm for prophylactic vaccination. 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 received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: unknown) dose was not reported, 1 total, dose number 2, administered on 23-NOV-2021;11:00 on left arm for prophylactic vaccination. Age at time of vaccination 63 years old. Concomitant medications included clonazepam, linum usitatissimum seed oil, olmesartan medoxomil, rosuvastatin calcium, supple and salvia hispanica. The patient received non company co-suspect Paxlovid (form of admin and route of admin were not reported, batch number: unknown and expiry: unknown) dose not reported, administered from 17-MAY-2022 to 21-MAY-2022 for treatment of COVID-19. On an unspecified date in MAY-2022, the patient experienced confirmed clinical vaccination failure, and confirmed covid-19 infection (dose number in series 2). The patient was doing great had absolutely no symptoms starting day 3 of Paxlovid. On 20-MAY-2022, Took a test on day 4 (Friday) of dosage and seemed negative. On 25-MAY-2022, patient started again with symptoms of itchy nose, eyes and a little cough on Wednesday (25-MAY-2022) morning (dose number in series 2). On 26-MAY-2022, the patient underwent test again and very positive. Patient do not feel bad but it felt like a full blown hay fever attack with a little dry cough. Have taken Mucinex to control nose discharge and cough. Laboratory data (dates unspecified) included: Blood pressure high, and Cholesterol High bad cholesterol. 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 a product quality complaint.; Sender's Comments: V0: 20220610716-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.