Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cardiomyopathy, Weight increased
Clinical narrative: CHF ( Congestive Heart Failure ); cardiac myopathy; This spontaneous case was reported by a health care professional and describes the occurrence of CARDIAC FAILURE CONGESTIVE (CHF ( Congestive Heart Failure )) and CARDIOMYOPATHY (cardiac myopathy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (CHF ( Congestive Heart Failure )) (seriousness criteria hospitalization, medically significant and life threatening) and CARDIOMYOPATHY (cardiac myopathy) (seriousness criteria hospitalization, medically significant, life threatening and intervention required). The patient was treated with CARVEDILOL for Adverse event, at a dose of 6.25 milligram; FUROSEMIDE (LASIX [FUROSEMIDE]) for Adverse event, at a dose of 40 milligram and ROSUVASTATIN CALCIUM (CRESTOR) for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC FAILURE CONGESTIVE (CHF ( Congestive Heart Failure )) and CARDIOMYOPATHY (cardiac myopathy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight increased: gained 19lbs (High) gained 19lbs and gained weight one month later (High) gained weight one month later. On 09-Aug-2021, Weight increased: lost 11 lbs (Low) lost 11 lbs.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that shortly after the first dose (around end of June), patient experienced swelling his legs, shortness of breath and gained 19 lb. weight. Lasix was prescribed as a treatment on 09Aug2021 and patient lost 11 lb. while he was on Lasix. One month later from his office visit, when patient finished taking his Lasix, patient gained weight again and ended up in a hospital where he was diagnosed with CHF (Congestive Heart Failure) and cardiac myopathy.  Company comment: This case concerns a 57-year-old male patient with no relevant medical history, who experienced the unexpected, serious and AESI events of Cardiac failure congestive and Cardiomyopathy. Time to onset from vaccination was not reported. The rechallenge was not applicable. The benefit-risk relationship of the vaccine is not affected by this report. Further information is expected.; Sender's Comments: This case concerns a 57-year-old male patient with no relevant medical history, who experienced the unexpected, serious and AESI events of Cardiac failure congestive and Cardiomyopathy. Time to onset from vaccination was not reported. The rechallenge was not applicable. The benefit-risk relationship of the vaccine is not affected by this report. Further information is expected.