Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
died suddenly; started complaining of pain in her legs and she was having all kinds of problems walking with the pain.; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN DEATH (died suddenly) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (Patient used to get flu shots every year.). Past adverse reactions to the above products included No adverse effect with INFLUENZA VACCINE. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (started complaining of pain in her legs and she was having all kinds of problems walking with the pain.). The patient died in November 2021. The reported cause of death was died suddenly. It is unknown if an autopsy was performed. At the time of death, PAIN IN EXTREMITY (started complaining of pain in her legs and she was having all kinds of problems walking with the pain.) had not resolved. Concomitant medication was not provided. It was reported that the patient had been in very good health at the beginning of 2021. The reporter indicated that the patient routinely received annual influenza vaccinations and felt pressure to be vaccinated. The reporter mentioned that they had advised the patient that vaccination was not necessary; however, the patient chose to proceed with vaccination. The reporter stated that after the patient's death later in 2021, they reviewed the patient's wallet and discovered documentation indicating receipt of the Moderna COVID-19 vaccine, with two doses administered in February and March 2021. According to the reporter, shortly after receiving the second vaccine dose, the patient began complaining of pain in her legs and experienced difficulty walking due to pain. The reporter stated that the patient was still able to walk but she was fighting the pain and reported that she did not know the cause of the pain. The reporter indicated that the patient's mobility was somewhat limited, and she was unable to walk as she normally would, but she continued fighting it. The reporter stated that they did not initially consider the symptoms to be significant. The reporter further reported that the patient died suddenly in Nov-2021. The reporter expressed the belief that the COVID-19 vaccine caused the patient's symptoms and death, stating that the patient had been healthy and that her life had been cut short as a result of vaccination. The reporter emphasized their conviction that the vaccine was responsible for the patient's death. The reporter stated that the patient was never hospitalized prior to her death and there was no medical diagnosis was made. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: Company Comment: The event sudden death was assessed as not related due to long latency from vaccination. Patient´s age could be confounder factor for fatal outcome. The benefit-risk relationship of the product is not affected by this report.; Reported Cause(s) of Death: died suddenly