Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
hives/spots on the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/spots on the vaccination site) in a 6-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 15-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced URTICARIA (hives/spots on the vaccination site). At the time of the report, URTICARIA (hives/spots on the vaccination site) was resolving. No concomitant medications were provided. It was reported that the patient received the pediatric version of Spikevax on 15-Oct-2025. The patient had non-stop hives that did not respond to steroids or antihistamines. The first spots on the vaccination site were noticed. The patient was up to date with all vaccines since the age of two and she was now six years old. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.