Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: 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 concerned a 66 year old female. Initial information was processed along with additional information on 21-DEC-2022. The patient's weight was 198 kilograms, and height was not reported. The patient's past medical history included: tons of surgeries (Complicated history with tons of surgeries but non has to do with this), and concurrent conditions included: non smoker, alcoholic (3 or 4 times a year), drug allergy (Vancomycin, element in that vancomycin that is present in Moderna and Pfizer, PEG, Iodine), and common variable immunodeficiency, and other pre-existing medical conditions included: The patient did not had drug abuse or illicit drug usage. Patient was immunocompromised severely. The patient previously received covid-19 vaccine ad26. cov2. S (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805025, expiry: Unknown) dose was not reported, 1 total, administered at left arm on 29-MAR-2021 for covid-19 prophylaxis.  It was unknown whether the patient experienced any adverse events following vaccination with 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: 1822811 expiry: UNKNOWN) dose was not reported, 1 total, administered at left arm on 26-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 65 years old. No concomitant medications were reported. On 27-DEC-2021, the patient had covid-19 (Dose number in series 2). On 14-DEC-2022, the patient had second covid-19 infection (Dose number in series 2) which was diagnosed in emergency room for both the times in DEC-2021 and DEC-2022 (covid-19 virus test) (confirmed covid-19 infection) which lead to confirmed clinical vaccination failure. The patient also stated that fortunately it was omicron type in both times.  In DEC-2021, the patient first visited the emergency room (ER) and got monoclonal antibodies. In DEC-2022, second visit of emergency room, the patient received paxlovid for 5 days and a high dose of prednisone 50 mg injection and they sent the patient to home with 5 days supply of 50 mg prednisone orally because of patient's immunodeficiency disease. The patient did not stay overnight in the hospital in both the times.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint. The suspected product quality complaint has been confirmed to be (voided (did not meet criteria) (this case indicates that both COVID infections occurred at a timing interval of more than 14 days post the booster dose. Therefore, the reported symptomatic COVID infection will be processed against the booster dose only. Complaint captures the report for the booster. Approval to void this report due to no for primary vaccination based on the evaluation/investigation performed.; Sender's Comments: V0: 20221245588-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: MEDICAL HISTORY, SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration. 20221245588-confirmed covid-19 infection . The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.