Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Organ failure; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789655 (MODERNA). A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (ongoing), notes: Current Condition: Diabetes mellitus. There were no concomitant medications. The following information was reported: ORGAN FAILURE (death), outcome "fatal". The patient date of death was 08Feb2022. Reported cause of death: "All organs shut down/Due to the vaccination, whole body went down [Organ failure]". It was not reported if an autopsy was performed. Clinical course: On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and dose of COVID-19 vaccine NRVV Ad26 (withheld) (Janssen COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORGAN FAILURE (All organs shut down/Due to the vaccination, whole body went down) (seriousness criterion death). The patient died on 08Feb2022. The reported cause of death was all organs shut down/due to the vaccination, whole body went down. It was unknown if an autopsy was performed. No concomitant medications were reported. It was reported that, the patient was diabetic. got vaccinated and all organs shut down, and died, on 08Feb2022. Due to the vaccination, whole body went down. No treatment information was provided. Reporter Comment: Patient's condition of diabetes mellitus and co-suspect products Tozinameran and Janssen COVID-19 vaccines remail as confounding factors. The benefit-risk relationship of the product was not affected by this report. Batch/lot number is not provided, and it cannot be obtained.; Reporter's Comments: Patient's condition of diabetes mellitus and co-suspect products Tozinameran and Janssen COVID-19 vaccines remail as confounding factors. The benefit-risk relationship of the product was not affected by this report.; Reported Cause(s) of Death: All organs shut down/Due to the vaccination, whole body went down [Organ failure]
Diabetes mellitus (Current Condition: Diabetes mellitus)