Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
MYOCARDITIS; This spontaneous report received from a consumer concerned a female patient of unspecified age via social media. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose and frequency not reported, administered on Mar-2021, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 21-Dec-2021, the patient experienced myocarditis. (dose series 1) The reporter did some research and found that myocarditis was a side-effect of Pfizer vaccine. the reporter informed if myocarditis is listed, then the reporter will be going to the lawyer. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable. Reported cause of death was myocarditis. The patient died of myocarditis on 21-Dec-2021. The reporter considered the causality between janssen covid-19 vaccine and myocarditis as related. Company causality between janssen covid-19 vaccine and myocarditis as possible. This report was serious (death).; Sender's Comments: V0; Myocarditis; The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: myocarditis