Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Agatston score, Atrial fibrillation, Cardiovascular examination, Electrocardiogram, Heart rate
Clinical narrative: atrial fibrillation; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. NDC: 8077-0102-95) for COVID-19 prophylaxis.     Family history included Stroke (grandmother at the age of 69yrs).    On 13-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 14-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2024 due to ATRIAL FIBRILLATION. The patient was treated with DILTIAZEM in April 2024 at a dose of 120 milligram once a day and APIXABAN (ELIQUIS) in April 2024 at a dose of 5 milligram twice a day. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2023, Agatston score: calcium screening was also negative, receiving an Agatston calcium score of 0, stating the "risk of coronary artery disease is very low, generally less than 5%". On 18-Jul-2023, Cardiovascular examination: results were all negative for stroke risk, peripheral arterial disease, abdominal aortic aneurysm. On 18-Jul-2023, Electrocardiogram: Normal. In March 2024, Heart rate: rapid, irregular heartbeat within 24hrs of vaccine administration. In 2024, Heart rate: A month later, another longer episode.     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. Company comment: This is a spontaneous case concerning a 67-year-old female patient with family history of stroke reported, who experienced the unexpected serious (due to medically significant and hospitalization) events of atrial fibrillation that occurred the next day after vaccination with dose of mRNA-1273.815 (SPIKEVAX 2023-2024). Treatment with apixaban and diltiazem was applied. As reported when patient had received vaccine, patient felt an odd sensation like it was circulating in bloodstream. Patient had never felt anything like it with any other injection. Within 24 hrs, patient experienced strange, rapid, irregular heartbeat. Symptoms lasted a couple of hours. The patient had another longer episode of AF month later.At the time of the report AF was not resolved. Due to close temporal association the event is assessed as related to vaccine. The benefit-risk relationship of the mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.    Concomitant medication was not reported. The patient had no medical history, concomitant disease, or risk factor. Patient had no history of hypertension. When patient had received vaccine, patient felt an odd sensation like it was circulating in bloodstream. Patient had never felt anything like it with any other injection. Within 24 hrs, patient experienced strange, rapid, irregular heartbeat. Symptoms lasted a couple of hours. Patient had bought a monitor. A month later, patient had another longer episode which was documented on device and went to the emergency room to have it officially verified. From emergency room, patient was admitted to hospital on 14-Apr-2024 and was given IV medications to correct atrial fibrillation. Patient had undergone a great deal of testing during that time. Patient was discharged with treatment drugs Diltiazem and Eliquis. The patient did not experience any additional symptoms/events. It was unknown if there were additional lab data/results available.