Received Nov 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 233114-07302 | IM |
Redness and skin swelling around injection site; skin swelling around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and skin swelling around injection site) and VACCINATION SITE SWELLING (skin swelling around injection site) in a 45-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 233114-07302) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 23-Nov-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 23-Nov-2025, the patient experienced VACCINATION SITE ERYTHEMA (Redness and skin swelling around injection site) and VACCINATION SITE SWELLING (skin swelling around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness and skin swelling around injection site) and VACCINATION SITE SWELLING (skin swelling around injection site) had not resolved. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Event causality not reported.