Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54-year-old male (age at time of vaccination: 53 years). The patient's weight was 204 (unit unspecified), and height was 177.8 centimeters. The patient's concurrent conditions included: alcohol use (one drink in a week), non-smoker, hypertension, hypothyroidism, coronary artery disease, and cancer- lymphoma (since 1995). The patient had no known allergies. The patient had no history of drug abuse, no illness at the time of vaccination, no past history of similar event, no adverse event after any previous vaccination(s), no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause, no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1802072, and expiry: unknown) dose was not reported (single dose), 1 total, administered on 10-MAR-2021 at 12:00 to right deltoid (shoulder) for prophylactic vaccination. Concomitant medications included Aspirin (acetylsalicylic acid), Niacin (nicotinic acid), Nexium (esomeprazole magnesium), atorvastatin, lisinopril, metoprolol, and levothyroxine sodium for unknown indication.  On 06-NOV-2021 and 07-NOV-2021 (8 months post vaccination), the patient was exposed to the delta variant of the covid-19 virus after travelling and became infected. He was vaccinated and felt fine. The patient reported having a dry cough from the concomitant medication lisinopril. On 09-NOV-2021 (Tuesday), he took a test with the provided rapid test kits from J and J, which was negative for covid-19. He went to work on 10-NOV-2021 (Wednesday) and 11-NOV-2021 (Thursday), with no interactions with anyone and noticed a difference in the cough on Thursday (confirmed covid-19 infection). The patient's taste was also impacted. On 12-NOV-2021 (Friday) morning, he started getting congested, in the evening he lost his sense of smell when he noticed he didn't smell the candles in his room, and his congestion became more pronounced following which he re-tested with the provided rapid test kits from J and J which came out positive. On the same date (at night), he also had fatigue and very mild fever (99.2 Fahrenheit). On 12-NOV-2021, the patient underwent a coronavirus disease 19 polymerase chain reaction (COVID-19 PCR) test which was positive for covid-19 infection (confirmed clinical vaccination failure). At the time of reporting, the patient's congestion nearly resolved, slight cough and fatigue continued to improve and taste was reported as still intact. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering 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 case, from the same reporter is linked to 20211133630. This report was associated with product quality complaint: 90000202400.; Sender's Comments: V0 20211134630-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. 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.