Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Rapid heartrate; Atrial fibrillation; Short of breath; Weakness; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. au3914b) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure with reduced ejection fraction on 10-Feb-2017, Duodenal ulcer haemorrhage on 04-Aug-2017, Total knee replacement on 14-Feb-2018 and Implantable cardioverter defibrillator insertion (ICD (Implantable cardioverter defibrillator) in place) on 15-Nov-2018. Previously administered products included for Product used for unknown indication: FLU VACCINE VII on 28-Sep-2023. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Ischemic cardiomyopathy since 24-Jun-2006, Pure hypercholesterolaemia since 05-Mar-2010, Coronary artery disease (Coronary artery disease involving native coronary artery of native heart without angina pectoris) since 12-Feb-2017, Insomnia since 02-Sep-2010, Asthma (unspecified asthma, uncomplecated) since 29-Jun-2017, Ventricular tachycardia (non sustained ventricular tachycardia) since 29-Jun-2017, Obstructive sleep apnea syndrome since 04-Aug-2017, Osteopenia (Osteopenia of right hip) since 27-Aug-2018, Spondylosis of unspecified site without mention of myelopathy (Spondylosis of lumber region without myelopathy or radiculopathy) since 27-Aug-2018, Sensorineural hearing loss (Sensorineural hearing loss (SNHL) of both ears) since 04-Mar-2021, Tinnitus (Tinnitus of both ears) since 18-Mar-2021, Artificial cardiac pacemaker user (Pacemaker-dependent due to native cardiac rhythm insufficient to support life), Arthritis (Arthritis to left hip) since 02-Jul-2021 and Premature ventricular contractions (PVCs (Premature ventricular contractions)) since 24-Aug-2022. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 18-Oct-2023, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), DYSPNOEA (Short of breath) and ASTHENIA (Weakness). On an unknown date, the patient experienced HEART RATE INCREASED (Rapid heartrate). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), DYSPNOEA (Short of breath) and ASTHENIA (Weakness) had not resolved and HEART RATE INCREASED (Rapid heartrate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Atrial fibrillation   Nonspecific intraventricular conduction delay   Low voltage, extremity leads   Borderline prolonged QT interval   When compared with ECG of 29-Jun-2023 8:55:20,   Significant change in rhythm: previously sinus.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No treatment medications were provided. Company comment: This spontaneous case concerns a 70-year-old male patient, with medical history of Coronary artery disease, Heart failure with reduced ejection fraction, Ischemic cardiomyopathy, Ventricular tachycardia, Pacemaker-dependent due to native cardiac rhythm insufficient to support life, Implantable cardioverter defibrillator(ICD) insertion, Premature ventricular contractions reported, who experienced the unexpected, serious AESI of atrial fibrillation which occurred the next day after SPIKEVAX 2023-2024 dose administration, which was the unknown dose of COVID-19 vaccination schedule. The event was accompanied by shortness of breath and weakness. Diagnostic tests included ECG with Atrial fibrillation; Nonspecific intraventricular conduction delay with low voltage on extremity leads; borderline prolonged QT interval and when compared with ECG performed app 3,5 months earlier a change in rhythm was observed, which previously was sinus. Underlying medical history of ischemic cardiomyopathy and heart failure accompanied by cardiac rhythm disorders treated with pacemaker and protected with ICD could contribute to event development. No further clinical information or details on etiologic and diagnostic work up with treatment were provided for medical review. Event outcome was unknown at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.