Sex: F
Vaccine: COVID19
Symptoms: Coronary artery disease, Dyspnoea, Echocardiogram, Fibrin D dimer, Glycosylated haemoglobin
Clinical narrative: b/l pulmonary edema; new onset heart failure; Idiopathic non ischaemic cardiomyopathy; Non obstructive coronary artery disease; Medistinal lymphadenopathy; shortness of breath; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of PULMONARY OEDEMA (b/l pulmonary edema), CARDIAC FAILURE (new onset heart failure), CARDIOMYOPATHY (Idiopathic non ischaemic cardiomyopathy), DYSPNOEA (shortness of breath), CORONARY ARTERY DISEASE (Non obstructive coronary artery disease) and LYMPHADENOPATHY MEDIASTINAL (Medistinal lymphadenopathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Crohn's disease and Obesity.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (b/l pulmonary edema) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE (new onset heart failure) (seriousness criteria hospitalization and medically significant), CARDIOMYOPATHY (Idiopathic non ischaemic cardiomyopathy) (seriousness criteria hospitalization and medically significant), CORONARY ARTERY DISEASE (Non obstructive coronary artery disease) (seriousness criterion hospitalization) and LYMPHADENOPATHY MEDIASTINAL (Medistinal lymphadenopathy) (seriousness criterion hospitalization). The patient was hospitalized on 11-Apr-2021 due to DYSPNOEA. At the time of the report, PULMONARY OEDEMA (b/l pulmonary edema), CARDIAC FAILURE (new onset heart failure), CARDIOMYOPATHY (Idiopathic non ischaemic cardiomyopathy), DYSPNOEA (shortness of breath), CORONARY ARTERY DISEASE (Non obstructive coronary artery disease) and LYMPHADENOPATHY MEDIASTINAL (Medistinal lymphadenopathy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Angiogram: abnormal (abnormal) minimal non obstructive CAD.. In April 2021, Chest X-ray: abnormal (abnormal) bilateral pulmonary edema.. In April 2021, Computerised tomogram thorax: abnormal (abnormal) mild cardiomegaly/ bilateral pleural effusions/ pulmonary edema. Also showed non specific mediastinal adenopathy.. In April 2021, Echocardiogram: abnormal (abnormal) Severe global hypokinesia and ejection fraction of 15%.. In April 2021, Fibrin D dimer: 655 (Inconclusive) 655. In April 2021, Glycosylated haemoglobin: 6.3 (Inconclusive) 6.3.         Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although it is likely that underlying pathology existed with respect the cardiomyopathy, heart failure and associated symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although it is likely that underlying pathology existed with respect the cardiomyopathy, heart failure and associated symptoms.