Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic stenosis, Cardiac failure congestive, Myocardial ischaemia, Pulmonary oedema
Clinical narrative: pulmonary edema; AEScongestive cardiac failure; aortic stenosis; ischaemic heart disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY OEDEMA (pulmonary edema), CARDIAC FAILURE CONGESTIVE (AEScongestive cardiac failure), AORTIC STENOSIS (aortic stenosis) and MYOCARDIAL ISCHAEMIA (ischaemic heart disease) in a 95-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included B-cell lymphoma NOS (had cancer several years previously but had been successfully treated with chemotherapy) and Chemotherapy. Previously administered products included for Product used for unknown indication: Pfizer Covid vaccine (multiple times without problems). Past adverse reactions to the above products included No adverse event with Pfizer Covid vaccine. Concurrent medical conditions included Frailty (Frailty of old age).    In 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PULMONARY OEDEMA (pulmonary edema) (seriousness criteria death, hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (AEScongestive cardiac failure) (seriousness criteria death, hospitalization and medically significant), AORTIC STENOSIS (aortic stenosis) (seriousness criteria death, hospitalization and medically significant) and MYOCARDIAL ISCHAEMIA (ischaemic heart disease) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized on sometime in May 2024 due to AORTIC STENOSIS, CARDIAC FAILURE CONGESTIVE, MYOCARDIAL ISCHAEMIA and PULMONARY OEDEMA. The patient died on 23-May-2024. The reported cause of death was Congestive cardiac failure, Aortic stenosis, Ischaemic heart disease, frailty of old age and large b cell lymphoma. It is unknown if an autopsy was performed.            No concomitant medication was reported. Patient's date of birth was reported as 1928.  Patient was frail 95-year-old who started feeling unwell, notably shortness of breath, the day after receiving a Moderna Covid shot (late April/early May). She deteriorated and was taken into hospital about a week or 2 later (early May) where she was diagnosed with pulmonary edema and were treating her for that before she passed away on 23-May. She was frail and had multiple health problems. The death certificate lists the cause of death as: 1) Congestive cardiac failure/aortic stenosis and ischaemic heart disease, and 2) Frailty of old age and large B cell lymphoma.  As per reporter, although patient was physically frail, she was mentally fine, and strongly felt that deterioration/shortness of breath was attributable to the vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.     Company Comment: This is a spontaneous case concerning a 95 year-old, female patient with a history of B-cell lymphoma, frailty and multiple health problems, who experienced the serious (due to medically significant and hospitalization), Fatal,  unexpected, events of pulmonary oedema (AESI), cardiac failure congestive (AESI), aortic stenosis and myocardial ischaemia (AESI), which occurred approximately 1-2 weeks after a dose of SPIKEVAX 2023-2024 vaccine, received as a booster dose of COVID-19 vaccination schedule. Patient received previous vaccinations with Pfizer Covid vaccine. It was reported that patient started feeling unwell, with shortness of breath, the day after receiving a Moderna Covid vaccine. She deteriorated and was taken into hospital about a week or 2 later: pulmonary edema was diagnosed. She died while being treated for that condition on May 23. The death certificate listed as causes of death: 1) Congestive cardiac failure/aortic stenosis and ischaemic heart disease, and 2) Frailty of old age and large B cell lymphoma (she had cancer several years previously but had been successfully treated with chemotherapy). The mentioned medical history and elderly age remains as confounders. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.; Reported Cause(s) of Death: Congestive cardiac failure; aortic stenosis; ischaemic heart disease; Frailty of old age; large B cell lymphoma