Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
blood clots in both legs and passed away on Sept 18, 2024; following a fall on April 12, 2024/passed away on Sept 18, 2024; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots in both legs and passed away on Sept 18, 2024) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Apr-2024, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FALL (following a fall on April 12, 2024/passed away on Sept 18, 2024). On an unknown date, the patient experienced THROMBOSIS (blood clots in both legs and passed away on Sept 18, 2024) (seriousness criteria death and medically significant). The patient died on 18-Sep-2024. The reported cause of death was blood clots in both legs. An autopsy was not performed. At the time of death, FALL (following a fall on April 12, 2024/passed away on Sept 18, 2024) outcome was unknown. No concomitant medications were reported. No autopsy was done, but nursing home staff suggested a possible link to the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided.; Reporter's Comments: Company comment: Event fall was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Blood clots in both legs