Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
had a localized reaction in her arm (red swollen area); had a localized reaction in her arm (red swollen area); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (had a localized reaction in her arm (red swollen area)) and VACCINATION SITE SWELLING (had a localized reaction in her arm (red swollen area)) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. In 2025, the patient experienced VACCINATION SITE ERYTHEMA (had a localized reaction in her arm (red swollen area)) and VACCINATION SITE SWELLING (had a localized reaction in her arm (red swollen area)). At the time of the report, VACCINATION SITE ERYTHEMA (had a localized reaction in her arm (red swollen area)) and VACCINATION SITE SWELLING (had a localized reaction in her arm (red swollen area)) was resolving. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.