Sex: M
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: DEATH; CLOT BLOOD; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose not reported, dose number in series was 1, 01 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was full of blood clots (clot blood) and got corona virus disease (COVID)-19 (suspected covid-19 infection) which resulted in suspected clinical vaccination failure. On an unspecified date, the patient died a very painful and unnecessary death from an unknown cause (dose number in series was 1). It was not reported whether autopsy was performed or not. The reporter reported that, "My brother had Johnson and Johnson vaccine and got Covid and was full of blood clots. He ended up dying a very painful and unnecessary death. I blame them". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date and the outcome of suspected covid-19 infection, clot blood and suspected clinical vaccination failure was not reported. This report was serious (Death and Other Medically Important Condition). This report was associated with product quality complaint.: 90000211571. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 20-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2:This version updates: The case validity assessment was updated to valid from the previously incorrect assessment of non-valid. The prior causality assessment remains unaltered with this added information. 20220123845-COVID-19 VACCINE AD26.COV2.S-Death, clot blood. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220123845-COVID-19 VACCINE AD26.COV2.S-suspected 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH