Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Developed atria fib; Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Developed atria fib) and PERICARDITIS (Pericarditis) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer COVID-19 vaccine. In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In March 2024, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2024, the patient experienced ATRIAL FIBRILLATION (Developed atria fib) (seriousness criteria hospitalization and medically significant). In June 2024, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 03-Jun-2024 to 06-Jun-2024 due to PERICARDITIS, and then from 08-Jun-2024 to 13-Jun-2024 due to ATRIAL FIBRILLATION. The patient was treated with Metoprolol tartrate (Metoprolol) at an unspecified dose and frequency; Apixaban (Eliquis) at an unspecified dose and frequency; Indometacin (Indomethacin) at an unspecified dose and frequency and Colchicine at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Developed atria fib) outcome was unknown and PERICARDITIS (Pericarditis) had not resolved. The patient had a total of 6 COVID booster with the Pfizer been the first one when it came out. The first Moderna COVID vaccine patient had was in October 2023 and the last Moderna one was in March 2024. In June 2024 she developed pericarditis and was hospitalized (cardiac step-down care) from 03-Jun-2024 to 06-Jun-2024, then readmitted on 08-Jun-2024 until 13-Jun-2024 where she had developed atria fib. Patient was treated for an ongoing 4 months with Indomethacin and Colchicine. The patient was currently on Metoprolol and Eliquis (heart meds). The patient had an inquiry if mNEXSPIKE was a good option for her and cardiologist had advised her she should have it. No additional information was provided. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company Comment: The event of pericarditis could have contributed to the event atrial fibrillation. The benefit-risk relationship of the product is not affected by this report.