Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Positron emission tomogram, Ventricular tachycardia
Clinical narrative: Monomorphic ventricular tachycardia; During EP study, patient was in VT with a different morphology than the prior arrhythmia; Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of VENTRICULAR TACHYCARDIA (Monomorphic ventricular tachycardia), VENTRICULAR TACHYCARDIA (During EP study, patient was in VT with a different morphology than the prior arrhythmia) and MYOCARDITIS (Myocarditis) in a 62-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VENTRICULAR TACHYCARDIA (Monomorphic ventricular tachycardia) (seriousness criterion medically significant), VENTRICULAR TACHYCARDIA (During EP study, patient was in VT with a different morphology than the prior arrhythmia) (seriousness criterion medically significant) and MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). The patient was treated with AMIODARONE (intravenous) for Monomorphic ventricular tachycardia, at a dose of 300 milligram and SOTALOL at an unspecified dose and frequency. At the time of the report, VENTRICULAR TACHYCARDIA (Monomorphic ventricular tachycardia) had resolved, VENTRICULAR TACHYCARDIA (During EP study, patient was in VT with a different morphology than the prior arrhythmia) outcome was unknown and MYOCARDITIS (Myocarditis) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac electrophysiologic study: Showed  ventricular tachycardia (VT) with a different morphology (RBBB, superior axis, positive precordial concordance, cycle length 290-300 ms) than the prior arrhythmia. On an unknown date, Catheterisation cardiac: Normal. On an unknown date, Echocardiogram: Normal. On an unknown date, Electrocardiogram: Showed monomorphic ventricular tachycardia. On an unknown date, Magnetic resonance imaging heart: Showed curvilinear near transmural delayed enhancement of the basal to mid inferior and inferolateral wall without T2 signal suggestive of scar tissue. On an unknown date, Positron emission tomogram: negative for sarcoid and showed scar tissues as in MRI.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered VENTRICULAR TACHYCARDIA (Monomorphic ventricular tachycardia), VENTRICULAR TACHYCARDIA (During EP study, patient was in VT with a different morphology than the prior arrhythmia) and MYOCARDITIS (Myocarditis) to be related.    Concomitant medications were not reported.  The patient presented with dyspnea and a syncopal event. Patient had prior syncopal events with ventricular tachycardia (VT) refractory to antiarrhythmics that started 2 weeks post Moderna second dose for over a month. Patient monomorphic VT ceased with Amiodarone.  During the electro physiology (EP) study, patient was in VT with a different morphology (RBBB, superior axis, positive precordial concordance, cycle length 290-300 ms) than the prior arrhythmia. Patient underwent endocardial ablation of mid to basal LV septum with termination of VT. Activation mapping was coherent with focal endocardial exit in the mid inferoseptum and voltage map found patch abnormal myocardium throughout the septum. Dual chamber implantable cardioverter-defibrillator (ICD) was inserted. The MRI, PET scan and clinical history were consistent with COVID-19 vaccine related myocarditis causing scar tissue and VT which prompted ablation and implantation of an ICD.  Author stated although the benefits of the COVID-19 vaccine are evident, fatal events like VT should be considered.  Company comment: This is a literature non-study case concerning a 65-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant), expected AESI of Myocarditis and the serious (due to medically significant), unexpected AESIs of Ventricular tachycardia (VT), 2 episodes. The event of Myocarditis occurred after the mRNA-1273 vaccine (further clarification is needed if this was after the first or second dose); the first episode of the event Ventricular tachycardia occurred 2 weeks after the second dose of mRNA-1273 vaccine, and the second episode of Ventricular tachycardia occurred on an unknon date, after the second dose of mRNA-1273 vaccine. The patient had prior syncopal events with ventricular tachycardia refractory to antiarrhythmics that started 2 weeks post Moderna second dose for over a month. The EKG showed monomorphic VT which ceased with 300mg IV Amiodarone. TTE and cardiac cath were normal. A cardiac MRI findings were suggestive of scar tissues as a sequelae of myocarditis leading to VT possibly induced by COVID-19 vaccine. During Electro physiology study, he was in VT with a different morphology than the prior arrhythmia. He underwent endocardial ablation of mid to basal LV septum with termination of VT. The PET scan was negative for sarcoid and showed scar tissues as in MRI. Dual chamber ICD was inserted and he was started on sotalol. The outcome of the event myocarditis was reported as resolved with sequelae; the outcome of the first episode of Ventricular tachycardia was reported as resolved, and the outcome of the second episode of the event Ventricular tachycardia was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Live follow-up received by safety on 16-Mar-2023 has an email with full text article and contains significant information. Reporter information, literature information and lab data were updated.; Sender's Comments: Company comment:  This is a literature non-study case concerning a 65-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant), expected AESI of Myocarditis and the serious (due to medically significant), unexpected AESIs of Ventricular tachycardia (VT), 2 episodes. The event of Myocarditis occurred after the mRNA-1273 vaccine (further clarification is needed if this was after the first or second dose); the first episode of the event Ventricular tachycardia occurred 2 weeks after the second dose of mRNA-1273 vaccine, and the second episode of Ventricular tachycardia occurred on an unknon date, after the  second dose of mRNA-1273 vaccine. The patient had prior syncopal events with ventricular tachycardia refractory to antiarrhythmics that started 2 weeks post Moderna second dose for over a month. The EKG showed monomorphic VT which ceased with 300mg IV Amiodarone. TTE and cardiac cath were normal. A cardiac MRI findings were suggestive of scar tissues as a sequelae of myocarditis leading to VT possibly induced by COVID-19 vaccine. During Electro physiology study, he was in VT with a different morphology than the prior arrhythmia. He underwent endocardial ablation of mid to basal LV septum with termination of VT. The PET scan was negative for sarcoid and showed scar tissues as in MRI. Dual chamber ICD was inserted and he was started on sotalol. The outcome of the event myocarditis was reported as resolved with sequelae; the outcome of the first episode of Ventricular tachycardia was reported as resolved, and the outcome of the second episode of the event Ventricular tachycardia was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.