Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Off label use
Clinical narrative: BREAKTHROUGH INFECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via social media via company representative concerned a patient of an unspecified age, sex, race and ethnic origin. Initial information was processed along with additional information received on 28-NOV-2022 and 30-NOV-2022. The patient's weight, height, and medical history were not reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis. 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 second dose (first booster) of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2). The patient received third dose (second booster) covid-19 vaccine ad26.cov2.s (dose number in series 3) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis which was associated with off label dosing frequency (dose number in series 3). The patient received fourth dose (third booster) of covid-19 vaccine ad26.cov2.s (dose number in series 4) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The product was associated with off label use (off label dosing frequency) (dose number in series 4). No concomitant medications were reported. On an unspecified date, the patient had breakthrough infection (dose number in series 4) exactly 11 days before family reunion last July. The reporter stated as, "I got the J&J at the first opportunity, which made it so I could feel at ease attending my mother's funeral. I have had 3 boosters, and I did have a breakthrough infection exactly 11 days before our family reunion last July. I am so grateful for medical advances." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infection and off label dosing frequency was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000261034. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as the patient had breakthrough covid infection after vaccination and there is no timeline for date of vaccination to contracting covid and no positive confirmatory test reported) based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20221201945 (Dose series 3).