Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion, Carditis, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Cardiac pacemaker insertion; Her heart was found to be inflamed; A burning pain began in her chest/ constant pain; shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of CARDITIS (Her heart was found to be inflamed) and CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced CHEST PAIN (A burning pain began in her chest/ constant pain) and DYSPNOEA (shortness of breath). In November 2021, the patient experienced CARDITIS (Her heart was found to be inflamed) (seriousness criterion medically significant) and CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) (seriousness criteria hospitalization and medically significant). The patient was treated with COLCHICINE (MITIGARE) for Adverse event, at an unspecified dose and frequency and Surgery (Pacemaker surgery) for Carditis. At the time of the report, CARDITIS (Her heart was found to be inflamed), CHEST PAIN (A burning pain began in her chest/ constant pain) and DYSPNOEA (shortness of breath) had not resolved and CARDIAC PACEMAKER INSERTION (Cardiac pacemaker insertion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Electrocardiogram: abnormal (abnormal) diagnosed with inflammation in her heart.         No concomitant medications were reported. Patient had undergone extensive testing, labs, ECG, cardiac test, cardiac enzymes and was diagnosed with inflammation in her heart. Patient reported that she is attempting to become pregnant but is not pregnant as of yet. No history of COVID-19 infection.  Company comment This case concerns a 39-year-old female patient with no details on relevant medical history, who experienced the unexpected serious event of Carditis and Cardiac pacemaker insertion after mRNA- 1273 Moderna vaccine. The events occurred approximately 6 months and 28 days after the second dose of mRNA- 1273 vaccine. Very limited information was provided. Clinical manifestations included chest pain and dyspnoea. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a 39-year-old female patient with no details on relevant medical history, who experienced the unexpected serious event of Carditis and Cardiac pacemaker insertion after mRNA- 1273 Moderna vaccine. The events occurred approximately 6 months and 28 days after the second dose of mRNA- 1273 vaccine. Very limited information was provided. Clinical manifestations included chest pain and dyspnoea. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report