Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac failure, Fall
Clinical narrative: heart failure; Falling down for no reason; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (heart failure) and FALL (Falling down for no reason) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Anxiety (took something for anxiety) and Heavy smoker.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criteria death and medically significant) and FALL (Falling down for no reason) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Heart failure. It is unknown if an autopsy was performed. At the time of death, FALL (Falling down for no reason) outcome was unknown.            Concomitant products included unspecified anxiety medication.  The patient was falling down for no reason and ended up dying. She had no heart history, but it might be from other complications. The patient was on her way to the nursing home, so they might not have treated her. The patient took something for anxiety and was a heavy smoker. The reporter thought that the patient might have cut off her smoking and given unspecified medicine, and the patient died of heart failure.   Treatment information was not provided.  Company comment: This spontaneous case concerns an 86 year old female patient with relevant medical history of smoking, who experienced the unexpected serious events of Fall (medically significant) and Cardiac failure (medically significant, death), unknown days after receiving a dose with mRNA-1273.222 bivalent vaccine. It was reported that the patient was falling down for no reason and ended up dying. The reported cause of death was cardiac failure. No information on co morbidities, detailed clinical course, investigations, treatment of the events and autopsy details was available in the report. Elderly age of the patient and history of severe smoking could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an 86 year old female patient with relevant medical history of smoking, who experienced the unexpected serious events of Fall (medically significant) and Cardiac failure (medically significant, death), unknown days after receiving a dose with mRNA-1273.222 bivalent vaccine. It was reported that the patient was falling down for no reason and ended up dying. The reported cause of death was cardiac failure. No information on co morbidities, detailed clinical course, investigations, treatment of the events and autopsy details was available in the report. Elderly age of the patient and history of severe smoking could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: heart failure