Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
aneurysm; Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of ANEURYSM (aneurysm) and MYOCARDITIS (Myocarditis) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID -19 Vaccine (Dose 1). Past adverse reactions to the above products included No adverse effect with COVID -19 Vaccine. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANEURYSM (aneurysm) (seriousness criterion hospitalization) and MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Pacemaker) for Aneurysm and Surgery (Pacemaker) for Myocarditis. At the time of the report, ANEURYSM (aneurysm) and MYOCARDITIS (Myocarditis) outcome was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered ANEURYSM (aneurysm) and MYOCARDITIS (Myocarditis) to be related. No concomitant medication was reported. It was unknown if patient had allergies to medications, food, and other products. The events caused the patient to seek medical care at doctor's office. It was unknown if there any other factors that could have led to the adverse events. It was unknown that the patient experienced a similar event in the past. Patient got Myocarditis and an aneurysm after getting the 2nd Moderna jab. He had been hospitalized several times, had to have a pacemaker put in, and was now on 30 heart pills daily. Regulatory Agency ID: DCP-0461-25 This case was linked to US-MODERNATX, INC.-MOD-2025-792454 (E2B Linked Report).; Reporter's Comments: Myocarditis is listed for Spikevax and was assessed as related to suspected vaccine. Unspecified aneurism was also assessed as related, as it could be consequence of myocarditis, however missing information regarding medical history, events onset dates preclude proper medical assessment. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-792454:Multiple patients case