Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
A-fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A-fib) in a 75-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (received Moderna's vaccines). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced ATRIAL FIBRILLATION (A-fib) (seriousness criterion medically significant). The patient was treated with Apixaban (Eliquis) for Anticoagulant therapy, at an unspecified dose and frequency and Surgery (Afib surgery) for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (A-fib) outcome was unknown. No concomitant medication was reported. The patient had undergone Afib surgery in March 2024. He had received Moderna's vaccines and booster back in 2023 and the last one was in 28-Aug-2024 - 5 months after the Afib surgery. He was on a blood thinner- Eliquis. Patient had called his pharmacist, doctor, and cardiologist but they all told him the same thing, that it was up to him to take the vaccine or not. The patient was concerned about the safety of the mNEXSPIKE. He had read that the side effects include inflammation of heart tissue. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company comment: Patient's advanced age as risk factor for atrial fibrillation. The benefit-risk relationship of product is not affected by this report.