Sex: M
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information processed with additional information received from reporter on 05-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (1 beer a week), and non smoker, and other pre-existing medical conditions included: Patient did not had any medical condition and was not on any medication other than the supplements of Aspirin, Vitamin C, Vitamin D3 and Zinc which he started after testing positive for COVID. Patient did not had any known allergies. There was no drug abuse or illicit drug usage. The patient previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 204A21A, expiry date: unknown) dose was not reported, 1 total, administered in left arm on 14-MAY-2021 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 additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose was not reported, 1 total administered in left arm on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2022, the patient experienced fever of 37.8 degree Celsius (dose number in series 2). On 01-MAY-2022, the fever was resolved and patient experienced mild symptoms of sore throat and runny nose (dose number in series 2). On the same day patient tested positive for covid via two self tests, one test was I-health brand and another was Abbott (suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 2). Patient stated that, he was not clinically diagnosed and had not taken any PCR (Polymerase Chain Reaction) tests, the patient was self medicating with Aspirin, Vitamin C, Vitamin D3, Zinc and consulted with his doctor over the phone for advice on medication to take after testing positive via the self tests and the doctor asked him to continue taking these supplements. Patient stated that his symptoms were mild because he had taken janssen COVID-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229509.; Sender's Comments: V0: 20220506411-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS