Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | Unknown | — |
death; BLOOD CLOTS in brain; third surgery; This spontaneous report received from a consumer concerned an 18 year old female patient. 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: Unknown) dose, frequency and therapy dates not reported, 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 an unspecified date, the patient experienced death, blood clots in brain, and third surgery. (dose series 1) It was reported that the patient had to have 2 surgeries for her blood clot in her brain and on the third surgery the patient died. The patient died around august or september-2021. It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable. Reported cause of death was unknown cause of death. The patient died on an unspecified date. The outcome of blood clots in brain and third surgery was not reported. This report was serious (death and other medically important condition).; Sender's Comments: V0: Death and surgery. -. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration. Cerebral thrombosis: 000-. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: unknown cause of death