Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052784 | IM |
swelling at injection site; red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE RASH (red rash at injection site) in a 40-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052784) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052784) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Nov-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 16-Nov-2025, the patient experienced VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE RASH (red rash at injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE RASH (red rash at injection site) was resolving. The concomitant medication was not reported by the reporter. The patient had swelling and red rash at the injection site. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.