Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media through a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, many months after vaccination, the patient experienced a bad cold for a week and a half and got covid (suspected covid-19 infection) which indicated suspected clinical vaccination failure. The patient had no other after effects and had barely felt the shots. (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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. No concomitant medications were reported. No adverse events were reported following covid-19 vaccine ad26.cov2.s (Dose number in series: 2). The reported stated "My wife and I took the JNJ shots. We have had two of them now. No after effects, barely felt the shots. We both got covid but it was after many months and basically we had a bad cold for a week and a half." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint: 90000217255. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220230357.  Additional information received from Complaint Vigilance department on 22-FEB-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result. Upon review following information was updated Case processed as valid(Received from J&J social media corporate account) identifiable patient from invalid.; Sender's Comments: V1: This follow up version was created to update following information: Product quality complaint investigation result. This added information does not alter the causality of previous reported event. 20220230288-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. Follow-up received regarding Clinical Details. 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. Therefore, this event is considered not related.