Received Dec 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
onset of full body chronic hives; Large swelling at the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Large swelling at the site) and URTICARIA (onset of full body chronic hives) in a 6-year-old female patient who received mRNA-1283 (MNEXSPIKE 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-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 15-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced INJECTION SITE SWELLING (Large swelling at the site). On 20-Oct-2025, the patient experienced URTICARIA (onset of full body chronic hives). The patient was treated with Prednisone (oral use) in October 2025 for Hives, at a dose of UNK, Steroid. On 18-Oct-2025, INJECTION SITE SWELLING (Large swelling at the site) had resolved. At the time of the report, URTICARIA (onset of full body chronic hives) had not resolved. The action taken with mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events. The hives had persisted up to the present and had not responded to antihistamines and prednisone oral steroid. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.