Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure, Echocardiogram, Ejection fraction, Heart disease congenital
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID-19 and was hospitalized for a week.), HEART DISEASE CONGENITAL (Congenital Heart failure and Difficulty Breathing) and CARDIAC FAILURE (Congenital heart failure with 20% ejection factor) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Contracted COVID-19 and was hospitalized for a week) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEART DISEASE CONGENITAL (Congenital Heart failure and Difficulty Breathing) (seriousness criterion medically significant) and CARDIAC FAILURE (Congenital heart failure with 20% ejection factor) (seriousness criterion medically significant). At the time of the report, COVID-19 (Contracted COVID-19 and was hospitalized for a week), HEART DISEASE CONGENITAL (Congenital Heart failure and Difficulty Breathing) and CARDIAC FAILURE (Congenital heart failure with 20% ejection factor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: congenital heart failure with a 20% ejection facto (abnormal) Congenital Heart Failure with a 20% Ejection factor. On an unknown date, Ejection fraction: 20% (Low) 20%. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported by the reporter. Treatment information was not provided. It was reported that several cardiac assessments were carried out. Company comment: This is a spontaneous case concerning a 52-year-old, female patient with no reported medical history and with vaccine history of receiving 2 doses of unknown dose number of mRNA-1273 vaccine as previous doses, who experienced the unexpected serious (hospitalization) AESI event of Covid-19 and the unexpected serious (medically significant) event of "congenital heart failure". The events occurred approximately 5-6 months after the most recent dose of mRNA-1273 vaccine administration. The events was described as, 5-6 months after the most recent dose of mRNA-1273 vaccine the patient contracted Covid-19 and was hospitalized for a week. Patient was discharged home and returned that same week with difficulty breathing. Patient underwent heart ultrasound and several unspecified cardiac assessments and was diagnose with "congenital heart failure" with "20% ejection factor". The event Covid-19 remain confounder for the occurrence of difficulty breathing and for the event "congenital heart failure" with "20% ejection factor". The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 52-year-old, female patient with no reported medical history and with vaccine history of receiving 2 doses of unknown dose number of mRNA-1273 vaccine as previous doses, who experienced the unexpected serious (hospitalization) AESI event of Covid-19 and the unexpected serious (medically significant) event of "congenital heart failure". The events occurred approximately 5-6 months after the most recent dose of mRNA-1273 vaccine administration. The events was described as, 5-6 months after the most recent dose of mRNA-1273 vaccine the patient contracted Covid-19 and was hospitalized for a week. Patient was discharged home and returned that same week with difficulty breathing. Patient underwent heart ultrasound and several unspecified cardiac assessments and was diagnose with "congenital heart failure" with "20% ejection factor". The event Covid-19 remain confounder for the occurrence of difficulty breathing and for the event "congenital heart failure" with "20% ejection factor". The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.