Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.) in a 29-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 17-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced SYNCOPE (Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Thinks she fainted 10-15 minutes after administration./Felt dizzy and nauseas after recovering from fall/she fainted 10-15 minutes after administration. Fell down part of an elevator but doesn't remember how.) was resolving. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was reported that the patient thought she had fainted 10-15 minutes after administration. The patient had fallen down part of elevator but did not remember how. After recovering from the fall, the patient had felt dizzy and nauseous. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.