Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3053253 | IM |
fainted; convulsions; blurry vision; eyes rolled back in head; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) and SEIZURE (convulsions) in a 9-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3053253) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 06-Oct-2025, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), SEIZURE (convulsions) (seriousness criterion medically significant), VISION BLURRED (blurry vision) and EYE MOVEMENT DISORDER (eyes rolled back in head). On 06-Oct-2025, SYNCOPE (fainted), SEIZURE (convulsions), VISION BLURRED (blurry vision) and EYE MOVEMENT DISORDER (eyes rolled back in head) had resolved. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.