Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Covid; a-flutter; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (a-flutter) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In July 2025, the patient experienced ATRIAL FLUTTER (a-flutter) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (Covid). The patient was treated with Apixaban (Eliquis) in 2025 for Atrial flutter, at an unspecified dose and frequency. In 2025, ATRIAL FLUTTER (a-flutter) had resolved. At the time of the report, COVID-19 (Covid) had resolved with sequelae. No concomitant medication was reported. Patient got Covid after receiving vaccine. Specific dates were not provided. Patient was diagnosed with a-flutter in Jul-2025 and placed on Eliquis. It was unknown if the patient experienced any additional symptoms/events. Causality not reported. Reporter did not allow further contact; Reporter's Comments: Atrial flutter was assessed as not related to suspected vaccine due to lack of temporal plausibility. COVID-19 infection was assessed as confounding factor. Missing information regarding medical history and concomitant medications preclude proper medical assessment. The benefit-risk relationship of product is not affected by this report.