Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericardial effusion, Pyrexia, Troponin, Ventricular extrasystoles
Clinical narrative: myocarditis/pain felt deep, into his lungs; irregular heart rhythm continues /Heart palpitations; Fluid around heart muscle; Sporadic PVCs; Ventricular Tachycardia; felt sick; Pain and achiness all over; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (irregular heart rhythm continues /Heart palpitations ), PERICARDIAL EFFUSION (Fluid around heart muscle), VENTRICULAR EXTRASYSTOLES (Sporadic PVCs), VENTRICULAR TACHYCARDIA (Ventricular Tachycardia) and MYOCARDITIS (myocarditis/pain felt deep, into his lungs) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SB21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced MALAISE (felt sick), MYALGIA (Pain and achiness all over) and PYREXIA (Fever). On 04-May-2021, the patient experienced PERICARDIAL EFFUSION (Fluid around heart muscle) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced ARRHYTHMIA (irregular heart rhythm continues /Heart palpitations ) (seriousness criteria hospitalization and medically significant) and VENTRICULAR EXTRASYSTOLES (Sporadic PVCs) (seriousness criterion hospitalization). On 07-Oct-2021, the patient experienced VENTRICULAR TACHYCARDIA (Ventricular Tachycardia) (seriousness criterion medically significant). On an unknown date, the patient experienced MYOCARDITIS (myocarditis/pain felt deep, into his lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-May-2021 to 05-May-2021 due to PERICARDIAL EFFUSION and VENTRICULAR EXTRASYSTOLES. On 01-May-2021, MALAISE (felt sick) had resolved. On 02-May-2021, MYALGIA (Pain and achiness all over) and PYREXIA (Fever) had resolved. At the time of the report, ARRHYTHMIA (irregular heart rhythm continues /Heart palpitations ), PERICARDIAL EFFUSION (Fluid around heart muscle), VENTRICULAR EXTRASYSTOLES (Sporadic PVCs) and VENTRICULAR TACHYCARDIA (Ventricular Tachycardia) had not resolved and MYOCARDITIS (myocarditis/pain felt deep, into his lungs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Magnetic resonance imaging: abnormal (abnormal) showed fluid around his heart muscle.. In May 2021, Troponin: abnormal (abnormal) elevated at 93,later at it's peak it reached 550-560. On 28-Sep-2021, Cardiac monitoring: abnormal (abnormal) heart palpitation. On an unknown date, Cardiac monitoring: abnormal (abnormal) worn a 7 day heart monitor  and it showed sporadic "PVCs"..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    initially his troponin level was elevated at 93 (units unknown) and later at it was peak it reached 550-560 (units unknown).  He remained in the hospital for two nights and received supportive care with intravenous fluids and monitoring.  He was released on 05-MAY-2021.  He has been prescribed a beta blocker to control his heart rate.  Relationship with the vaccine dose: after 2nd dose. Cardiologist stated it was likely due to the 2nd dose of the vaccine.Treatment:  Supportive care with IV and constant monitoring. Was instructed for following 3 months do not lift heavy weights, no contact sports or anything intense for the body.  Recently started a beta blocker to control heart rate. Clinical outcome: Released from the hospital but was still being monitored and has experienced PVCs and ventricular tachycardia. company comment: This case concerns a 22-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious AESI events of Arrhythmia, Ventricular tachycardia and Ventricular extrasystoles, the expected serious AESI events of Myocarditis and the unexpected serious event of Pericardial effusion. The events pericardial effusion and myocarditis occurred approximately 3 to 4 days after the second dose of mRNA-1273 vaccine and patient required hospitalization. It is reported that troponin level was elevated. Ventricular tachycardia was detected 6 months after the second dose. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 22-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious AESI events of Arrhythmia, Ventricular tachycardia and Ventricular extrasystoles, the expected serious AESI events of Myocarditis and the unexpected serious event of Pericardial effusion. The events pericardial effusion and myocarditis occurred approximately 3 to 4 days after the second dose of mRNA-1273 vaccine and patient required hospitalization. It is reported that troponin level was elevated. Ventricular tachycardia was detected 6 months after the second dose. The rechallenge was not applicable since the events happened after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.