Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | IM |
Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024; Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) and CARDIAC DISORDER (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Concurrent medical conditions included Kidney tumor (She was fighting a cancerous kidney tumor that was stable for four years through immunotherapy.). On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 18-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC DISORDER (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced CARDIAC DYSFUNCTION (Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024) (seriousness criteria death, hospitalization and medically significant). The patient was treated with Surgery (After a year, they kept a pacemaker in her heart, which had severe consequences.) for Cardiac disorder. The patient died on 22-Jan-2024. The reported cause of death was blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the moderna covid-19 vaccine/she passed away on january 22, 2024 and blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the moderna covid-19 vaccine/she passed away on january 22, 2024. It is unknown if an autopsy was performed. Concomitant medication was not provided. It was reported that she started having side effects the following day after vaccination. Two weeks later, she ended up in the hospital for over a week, with a blood clot in her heart that took several months to dilute, but the damage to her heart was already done ad she was fighting for her life. After a year, they put a pacemaker in her heart, which had severe consequences as she was fighting a cancerous kidney tumor that was stable for four years through immunotherapy. Still, her medication was stopped due to the heart complications caused by the Moderna COVID-19 vaccine. Meanwhile, her hospital cardiologist had advised her not to take another vaccine because her life could be in jeopardy, and she never took another immunization. It was reported as in the last six months of patient's life; the reporter was her caregiver. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported.; Reporter's Comments: Concurrent medical condition Kidney tumor is a contributor for the events. As Cardiac dysfunction is likely a consequence of the cardiac disorder event, it was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Blood clot in her heart/damage to her heart/her heart function dropped to 15%/heart complications caused by the Moderna COVID-19 vaccine/she passed away on January 22, 2024; Blood clot in her heart/damage to her heart/her heart function dropped to 15
Kidney tumor (She was fighting a cancerous kidney tumor that was stable for four years through immunotherapy.)