Received Oct 3, 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 | — | — |
All her organs shut down/Due to the vaccination, her whole body went down; This spontaneous case was reported by a consumer and describes the occurrence of ORGAN FAILURE (All her organs shut down/Due to the vaccination, her whole body went down) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and COVID-19 vaccine NRVV Ad26 (JNJ 78436735) (Janssen COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Diabetes. 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 (JNJ 78436735) (Janssen COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORGAN FAILURE (All her organs shut down/Due to the vaccination, her whole body went down) (seriousness criterion death). The patient died on 08-Feb-2022. The reported cause of death was all her organs shut down/due to the vaccination, her whole body went down. It is unknown if an autopsy was performed. No concomitant medications were reported. It was reported that, the patient was diabetic. She got vaccinated and all her organs shut down, and she died, on 08-Feb-2022. Due to the vaccination, her whole body went down. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-310582 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2025: Live non-significant follow-up received included reporter phone number and reference numbers were added. On 26-Sep-2025: Live non-significant follow-up received included reference numbers were added.; Reporter's Comments: Patient´s condition of diabetes mellitus and co-suspect products Tozinameran and Janssen COVID-19 vaccines, remain as confounding factors. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-310582:Reporter case (Master case); Reported Cause(s) of Death: All her organs shut down/Due to the vaccination, her whole body went down
Diabetes