Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Heart rate, Pain in extremity
Clinical narrative: Arrhythmia/ irregular heart beat; AFib; Arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia/ irregular heart beat) and ATRIAL FIBRILLATION (AFib) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21D and 003B21D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart pounding in October 2019, Pain in October 2019, Dizziness in October 2019, Feeling hot in October 2019 and Sweaty in October 2019. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure high.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced ARRHYTHMIA (Arrhythmia/ irregular heart beat) (seriousness criteria hospitalization and medically significant) and ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is hurting). The patient was hospitalized from 10-May-2021 to 11-May-2021 due to ARRHYTHMIA and ATRIAL FIBRILLATION. At the time of the report, ARRHYTHMIA (Arrhythmia/ irregular heart beat) and ATRIAL FIBRILLATION (AFib) outcome was unknown and PAIN IN EXTREMITY (Arm is hurting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Heart rate: abnormal (abnormal) Irregular heart rate. Diagnosed with AFib..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included medications to lower heart rate at hospital.  The patient states that their physician had the Cardiac Lab values of the tests that were performed during hospitalization.  Patient described some symptoms including heart pounding at 200 beats per minute, pain, dizziness, feeling hot and sweaty before receiving the Moderna COVID-19 vaccine, on Oct 2019.  The patient had not been infected with COVID-19. The patient doesn´t have a history of Myocarditis/pericarditis.   This case was linked to MOD-2021-417305, MOD-2021-418016 (Patient Link).; Sender's Comments: This case concerns a 44-year-old, female patient with relevant medical history of palpitation, who experienced the unexpected events of Arrhythmia and Atrial Fibrillation. The events occurred approximately 25 days after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after second dose. This patient's underlying medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.