Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Hypertrophic cardiomyopathy, Left ventricular hypertrophy, Magnetic resonance imaging
Clinical narrative: Left ventricle wall is twice bigger; Hypertrophic cardiomyopathy; Diagnosed with covid; Extreme shortness of breath, slowly got worse, but got much worse after Covid diagnosis; This spontaneous case was reported by a patient and describes the occurrence of HYPERTROPHIC CARDIOMYOPATHY (Hypertrophic cardiomyopathy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M2H9, 013F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Diagnosed with covid) and DYSPNOEA (Extreme shortness of breath, slowly got worse, but got much worse after Covid diagnosis). On 23-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERTROPHIC CARDIOMYOPATHY (Hypertrophic cardiomyopathy) (seriousness criterion medically significant). On 22-Sep-2022, the patient experienced LEFT VENTRICULAR HYPERTROPHY (Left ventricle wall is twice bigger). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, HYPERTROPHIC CARDIOMYOPATHY (Hypertrophic cardiomyopathy), COVID-19 (Diagnosed with covid), LEFT VENTRICULAR HYPERTROPHY (Left ventricle wall is twice bigger) and DYSPNOEA (Extreme shortness of breath, slowly got worse, but got much worse after Covid diagnosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2022, Magnetic resonance imaging heart: Hypertrophic cardiomyopathy. On 22-Sep-2022, Magnetic resonance imaging: Left ventricle wall is twice bigger.         Patient received first booster on 13-Nov-2021and second booster on 13-Apr-2022.  For 18 months, patient had shortness of breath, extreme shortness of breath, slowly got worse, symptoms started after 2nd shot, but got much worse after Covid diagnosis. Company comment: This spontaneous case concerns a 77-years-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant ) AESI  event of Hypertrophic cardiomyopathy that occurred 10 days after the fourth dose of mRNA-1273 vaccination. Patient also experienced non-serious events of COVID-19 and left ventricular hypertrophy. Previous doses of mRNA1273 vaccine were administered appropriately in accordance with schedule. Magnetic resonance imaging heart showed Hypertrophic cardiomyopathy and month later revealed Left ventricle wall was twice bigger. No information regarding clinical course, concomitant medication and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as serious based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2022-675672 (E2B Linked Report). This case was linked to MOD-2022-675637 (Patient Link).; Sender's Comments: This spontaneous case concerns a 77-years-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant ) AESI  event of Hypertrophic cardiomyopathy that occurred 10 days after the fourth dose of mRNA-1273 vaccination. Patient also experienced non-serious events of COVID-19 and left ventricular hypertrophy. Previous doses of mRNA1273 vaccine were administered appropriately in accordance with schedule. Magnetic resonance imaging heart showed Hypertrophic cardiomyopathy and month later revealed Left ventricle wall was twice bigger. No information regarding clinical course, concomitant medication and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as serious based on medical judgement. US-MODERNATX, INC.-MOD-2022-675672:Same reporter