Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
stage 4 lung cancer; internal bleeding; head to toe Blood clots; death; This spontaneous report received from a consumer concerned a female patient of unspecified age. received via JnJ managed 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, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. Company was unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced death. On an unspecified date, the patient experienced stage 4 lung cancer and was hospitalized on an unspecified date. On an unspecified date, the patient experienced internal bleeding and was hospitalized on an unspecified date. On an unspecified date, the patient experienced head to toe blood clots and was hospitalized on an unspecified date. (dose series 1) The patient had internal bleeding. One month in the hospital with no answers and then they said she developed head to toe blood clots and stage 4 lung cancer. 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 stage 4 lung cancer, internal bleeding and head to toe blood clots was not reported. This report was serious (death and caused/prolonged hospitalization).; Sender's Comments: V0; Death, Lung neoplasm malignant, Internal haemorrhage and Thrombosis; The event has an unknown/unclear 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: unknown cause of death