Received Jan 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Loss of Vision in Right eye; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (Loss of Vision in Right eye) in a 78-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 20-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 23-Nov-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced BLINDNESS UNILATERAL (Loss of Vision in Right eye) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (Loss of Vision in Right eye) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: Company Comment: Patient´s age could be a confounder factor for the event. The benefit-risk relationship of the product is not affected by this report.