Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 55 year old female. 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 not reported, batch number: 1802072, expiry: unknown) dose was not reported, 1 total, administered on 11-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with 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: 1855194, expiry: unknown) dose was not reported, 1 total, administered on 02-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 54 years old. No concomitant medications were reported.  On 24-AUG-2022, the patient got a fever out of nowhere of 104 (dose number in series 2). On 25-AUG-2022 and 26-AUG-2022, it was staying high could not break it. On 26-AUG-2022 (at night), the doctor called her husband and told him to have her get a PCR (polymerase chain reaction) even though none of the symptoms were there and all at home tests (covid-19 test) were negative. On 27-AUG-2022 (Saturday, in the morning), even the one she took (home test) was negative, the patient woke up and felt like a whole new person and nothing happened. Hence on same day, she went to the pharmacy (consumer value store) to get her PCR test. Patient further stated that, she went shopping (masked), went out to dinner, and felt fine, all was well. On 29-AUG-2022 (Monday), patient got up to go to work. Her husband asked her to take another test. She turned off her street and her husband called her and said it was positive which led to confirmed covid-19 infection and thus had confirmed clinical vaccination failure (dose number in series 2). Patient stated, she was shocked since she felt fine, no symptoms, no fever, nothing. She was absolutely fine. Her work said not to come in for 5 days. So she went back home and to her shock the pharmacy and department of health called within 10 minutes of each other that she had a positive PCR test. On 30-AUG-2022 (Tuesday), she lost some taste but she was fine, working out, working from home, not feeling ill at all (dose number in series 2). A friend told her to eat as much spicy food as she could handle, she did. On 31-AUG-2022 (Wednesday), she could taste everything again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient 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 product quality complaint: 90000269194.; Sender's Comments: V0: 20230163685- confirmed clinical vaccination failure. 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.