Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Off label use, Troponin, Ventricular tachycardia
Clinical narrative: Myocarditis; multiple episodes of nonsustained ventricular tachycardia; offlabel use; This literature-study case was reported in a literature article and describes the occurrence of VENTRICULAR TACHYCARDIA (multiple episodes of nonsustained ventricular tachycardia) and MYOCARDITIS (Myocarditis) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VENTRICULAR TACHYCARDIA (multiple episodes of nonsustained ventricular tachycardia) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant) and OFF LABEL USE (offlabel use). At the time of the report, VENTRICULAR TACHYCARDIA (multiple episodes of nonsustained ventricular tachycardia) and MYOCARDITIS (Myocarditis) outcome was unknown and OFF LABEL USE (offlabel use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Troponin: increase (High) increase.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VENTRICULAR TACHYCARDIA (multiple episodes of nonsustained ventricular tachycardia) and MYOCARDITIS (Myocarditis) to be possibly related. No further causality assessment was provided for OFF LABEL USE (offlabel use).    Concomitant product and treatment medication use was not provided by the reporter.  In this retrospective multicenter study across 16 hospitals, patients <21 years of age with a diagnosis of C-VAM (coronavirus disease 2019 vaccinationassociated myocarditis) were included and compared with a cohort with multisystem inflammatory syndrome in children. Younger children with C-VAM were compared with older adolescents.  Included Sixty-nine patients with a diagnosis of acute myocarditis after COVID-19 vaccination who had presented between Mar-2021 and Jun- 2021. Fifty-nine patients (94%) had received the Pfizer-BioNTech vaccine, and 4 (6%) had received the Moderna vaccine. All except for one patient presented after the second dose.  This case concerns a 16-year-old, male patient with no relevant medical history reported, who experienced the expected serious AESI event of myocarditis the unexpected serious AESI event of ventricular tachycardia. The events occurred approximately at an unknown date after a dose of Spikevax. The rechallenge was unknown since no information about the other doses was available. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-364806.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received by safety on 28-Oct-2021 included an Email with Administration received from Team and does not contain any new information.; Sender's Comments: This case concerns a 16-year-old, male patient with no relevant medical history reported, who experienced the expected serious AESI event of myocarditis the unexpected serious AESI event of ventricular tachycardia. The events occurred approximately at an unknown date after a dose of Spikevax. The rechallenge was unknown since no information about the other doses was available. The benefit-risk relationship of Spikevax is not affected by this report.