Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Myocarditis/inflammation of the heart; inflammation of the lining of the outside of the heart; Neurological issues; psychological issues; vision issues; tinnitus; rashes; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/inflammation of the heart) and PERICARDITIS (inflammation of the lining of the outside of the heart) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis/inflammation of the heart) (seriousness criterion medically significant), PERICARDITIS (inflammation of the lining of the outside of the heart) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes). At the time of the report, MYOCARDITIS (Myocarditis/inflammation of the heart), PERICARDITIS (inflammation of the lining of the outside of the heart), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient had myocarditis, which was the inflammation of the heart, inflammation of the lining of the outside of the heart. Also had chest pain, shortness of breath, fluttering, neurological issues, psychological issues, vision issues, rashes and tinnitus. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:Master case