Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052583 | IM |
extremely large, massive hives all over body except for neck, face, bottom of feet, and genital area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (extremely large, massive hives all over body except for neck, face, bottom of feet, and genital area) in a 64-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052583) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052583) for COVID-19 prophylaxis. No Medical History information was reported. On 03-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 04-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced URTICARIA (extremely large, massive hives all over body except for neck, face, bottom of feet, and genital area). On 09-Oct-2025, URTICARIA (extremely large, massive hives all over body except for neck, face, bottom of feet, and genital area) had resolved. The concomitant medication was not reported by the reporter. Patient had extremely large, massive hives all over her body except for her neck, face, bottom of her feet, and genital area 36 hours after injection. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.; Reporter's Comments: Company Comment: The benefit-risk relationship of the product is not affected by this report.