Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Myocarditis, SARS-CoV-2 test, Swelling, Ventricular tachycardia
Clinical narrative: experienced myocarditis; caused atrial fibrillation/Atrial tachycardia; Ventricular Tachycardia; swelling; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (experienced myocarditis), ATRIAL FIBRILLATION (caused atrial fibrillation/Atrial tachycardia) and VENTRICULAR TACHYCARDIA (Ventricular Tachycardia) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 20-Oct-2020. Concurrent medical conditions included Hypothyroidism and High cholesterol (Recent change in status such as improvement or worsening:. Normal).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (experienced myocarditis) (seriousness criterion medically significant), ATRIAL FIBRILLATION (caused atrial fibrillation/Atrial tachycardia) (seriousness criterion medically significant), VENTRICULAR TACHYCARDIA (Ventricular Tachycardia) (seriousness criterion medically significant) and SWELLING (swelling). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and METOPROLOL SUCCINATE at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (experienced myocarditis) and SWELLING (swelling) outcome was unknown and ATRIAL FIBRILLATION (caused atrial fibrillation/Atrial tachycardia) and VENTRICULAR TACHYCARDIA (Ventricular Tachycardia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant product was provided.   Patient reported myocarditis she experienced caused the atrial fibrillation. She also reported she experienced swelling and "everything" causing her to have surgery.  Company Comment: This is a Spontaneous case concerning a 74-year-old female patient, with no relevant medical history, who experienced the expected, serious (medically significant) and AESI of Myocarditis, and the unexpected, serious (medically significant) and AESI of Atrial fibrillation and Ventricular tachycardia. The events started within 3-4 days after the second dose of mRNA-1273 vaccine. Patient received treatment with Apixaban and Metoprolol succinate, and got elective surgery where an implant was implanted to prevent clots. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Live Significant FU: Event added.; Sender's Comments: This is a Spontaneous case concerning a 74-year-old female patient, with no relevant medical history, who experienced the expected, serious (medically significant) and AESI of Myocarditis, and the unexpected, serious (medically significant) and AESI of Atrial fibrillation and Ventricular tachycardia. The events started within 3-4 days after the second dose of mRNA-1273 vaccine. Patient received treatment with Apixaban and Metoprolol succinate, and got elective surgery where an implant was implanted to prevent clots. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.