Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden cardiac death, Ventricular extrasystoles, Ventricular fibrillation, Ventricular tachycardia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (acute myocarditis), SUDDEN CARDIAC DEATH (sudden cardiac death), VENTRICULAR TACHYCARDIA (ventricular tachycardia (VT)), VENTRICULAR FIBRILLATION (Ventricular fibrillation (VF, V-fib)), VENTRICULAR EXTRASYSTOLES (PVCs at a rate of 10-15 per minute) and STERNAL FRACTURE (fractured sternum and crushed xiphoid) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 021C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced VENTRICULAR TACHYCARDIA (ventricular tachycardia (VT)) (seriousness criteria hospitalization, medically significant and life threatening) and VENTRICULAR FIBRILLATION (Ventricular fibrillation (VF, V-fib)) (seriousness criteria hospitalization, medically significant and life threatening). On an unknown date, the patient experienced MYOCARDITIS (acute myocarditis) (seriousness criteria hospitalization, medically significant and life threatening), SUDDEN CARDIAC DEATH (sudden cardiac death) (seriousness criteria hospitalization, medically significant and life threatening) and VENTRICULAR EXTRASYSTOLES (PVCs at a rate of 10-15 per minute) (seriousness criterion hospitalization). an unknown date, the patient experienced STERNAL FRACTURE (fractured sternum and crushed xiphoid) (seriousness criteria hospitalization and medically significant). The patient was treated with CARVEDILOL for Adverse event, at an unspecified dose and frequency; AMIODARONE for Adverse event, at an unspecified dose and frequency; PREDNISONE in June 2021 for Adverse event, at an unspecified dose and frequency; CLONIDINE in July 2021 for Adverse event, at an unspecified dose and frequency; Manual therapy (ECMO) for Sudden cardiac death; Surgery (Cardioversion/Subcutaneous implanted cardioverter device (SCID)/Ventricular ablation) for Ventricular tachycardia and Surgery (Cardioversion/Subcutaneous implanted cardioverter device (SCID)/Ventricular ablation) for Ventricular fibrillation. At the time of the report, MYOCARDITIS (acute myocarditis), SUDDEN CARDIAC DEATH (sudden cardiac death), VENTRICULAR TACHYCARDIA (ventricular tachycardia (VT)), VENTRICULAR FIBRILLATION (Ventricular fibrillation (VF, V-fib)) and VENTRICULAR EXTRASYSTOLES (PVCs at a rate of 10-15 per minute) outcome was unknown and STERNAL FRACTURE (fractured sternum and crushed xiphoid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Blood test: negative (Negative) negative. On 07-Jun-2021, Laboratory test: negative (Negative) Negative. On 07-Jun-2021, SARS-CoV-2 test: negative (Negative) never had COVID-19 tested multiple times while hospitalized. No concomitant medications were reported. Company Comment: This is a Spontaneous case reported by a patient, concerning a 32-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization, life-threatening and medically significant) AESI of Myocarditis, the unexpected and serious (due to hospitalization, life-threatening and medically significant) AESIs of Ventricular tachycardia, Ventricular fibrillation and Sudden cardiac death, and the unexpected and serious (due to hospitalization and medically significant) events of Ventricular extrasystoles (AESI) and Sternal fracture. 3 days after administration of the second dose of mRNA-1273 vaccine, the patient collapsed at work. He received cardiopulmonary resuscitation (CPR), and medics cardioverted him at the scene. He was taken to hospital, where he was diagnosed with ventricular tachycardia (VT) and was in and out of Ventricular fibrillation (VF). After various tests (such as blood tests) with negative results, patient was placed on extracorporeal membrane oxygenation (ECMO) for 3 days. He crashed 13 more times, being implanted a subcutaneous cardioverter device (SCID), being discharged from hospital after 10 days. Patient started treatment with prednisone, anti-inflammatory, immunosuppressants, clonidine, carvedilol and Entresto. He also had to recover from a fractured sternum and crushed xiphoid. Approximately 3 months after mRNA-1273 vaccine, he had to be hospitalized 2 more times due to VT and VF. Finally, he received a ventricular ablation and switched anti-arrhythmic medication to amiodarone. He has had periods where he has lapsed back into VF. Doctors have stated his symptoms were due to acute myocarditis resulting in sudden cardiac death. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a Spontaneous case reported by a patient, concerning a 32-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to hospitalization, life-threatening and medically significant) AESI of Myocarditis, the unexpected and serious (due to hospitalization, life-threatening and medically significant) AESIs of Ventricular tachycardia, Ventricular fibrillation and Sudden cardiac death, and the unexpected and serious (due to hospitalization and medically significant) events of Ventricular extrasystoles (AESI) and Sternal fracture. 3 days after administration of the second dose of mRNA-1273 vaccine, the patient collapsed at work. He received cardiopulmonary resuscitation (CPR), and medics cardioverted him at the scene. He was taken to hospital, where he was diagnosed with ventricular tachycardia (VT) and was in and out of Ventricular fibrillation (VF). After various tests (such as blood tests) with negative results, patient was placed on extracorporeal membrane oxygenation (ECMO) for 3 days. He crashed 13 more times, being implanted a subcutaneous cardioverter device (SCID), being discharged from hospital after 10 days. Patient started treatment with prednisone, anti-inflammatory, immunosuppressants, clonidine, carvedilol and Entresto. He also had to recover from a fractured sternum and crushed xiphoid. Approximately 3 months after mRNA-1273 vaccine, he had to be hospitalized 2 more times due to VT and VF. Finally, he received a ventricular ablation and switched anti-arrhythmic medication to amiodarone. He has had periods where he has lapsed back into VF. Doctors have stated his symptoms were due to acute myocarditis resulting in sudden cardiac death. The benefit-risk relationship of mRNA-1273 is not affected by this report.