Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
Died; This spontaneous report received from a health care professional concerned an 82 year old female patient. The patient's height and weight were not reported. Age at time of vaccination 9 old. The patient's concurrent conditions included: carpal tunnel, pain on toes, diabetes, heart condition, and pain on chest. Initial information was processed with additional information received on 11-Feb-2025. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Dose number in series 2. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced died. (Dose number in series 2). It was reported that the patient got 2 Covid shots and she died after a month of getting the shots. The action taken with janssen covid-19 vaccine was not applicable. It was unknown if an autopsy was performed. Reported cause of death was unknown cause of death. The patient died of died on an unspecified date. This report was associated with a product quality complaint: Product Complaint 90000353966. Investigation Results: 90000353966 - (Void:Y). This record reports patient death with no allegation of a product quality issue. This report of patient death was not referred by Safety partners for investigation. No quality investigation is required at this time. Approval to void due to no PQC identified. This report was serious (death).; Sender's Comments: V0-Death. 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
Carpal tunnel syndrome; Chest wall pain; Diabetes; Heart disorder; Pain in toe