Received Feb 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
Covid; lack of effect; This spontaneous report received from a consumer concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's concurrent conditions included: non smoker. The patient was previously treated with janssen covid-19 vaccine for covid-19 prophylaxis. (dose series 1) 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 2, for covid-19 prophylaxis. 0.50 mL. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid and lack of effect. (dose series 2). It was reported that the Johnson and Johnson vaccines were of the poorest quality and they did not work. Patient had her second vaccine with Johnson and Johnson 2 years ago before Christmas or 3 years ago in November and in January, she died of COVID. And she was perfectly healthy. She had no problems. She didn't have any diabetes, cancer, or what have you. And she was a nonsmoker, and she died of it. The action taken with janssen covid-19 vaccine was not applicable. It was unknown if an autopsy was performed. Reported cause of death was covid. The patient died of covid on an unspecified date. The outcome of lack of effect was not reported. This report was associated with a product quality complaint: Product Complaint 90000353174. Investigation Results: 90000353174:Void:N:Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information.. This report was serious (death and other medically important condition).; Sender's Comments: V0: COVID-19: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: NATURE OF THE EVENT . Therefore, these events are considered not related. Drug ineffective: The event is a special reporting situation and owing to its own nature, it is not possible to attribute this occurrence to the suspect drug. Hence, the causality is considered as not related.; Reported Cause(s) of Death: Covid
Medical History/Concurrent Conditions: Non-smoker