Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
reaction on arm below injection site/COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction on arm below injection site/COVID arm) in a 78-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 05-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. In 2025, the patient experienced VACCINATION SITE REACTION (reaction on arm below injection site/COVID arm). At the time of the report, VACCINATION SITE REACTION (reaction on arm below injection site/COVID arm) was resolving. No concomitant medication was reported. Patient had Covid-19 shot on 05-Nov-2025, first time had reaction on arm below injection site. It fits all description of Covid arm. On the day of reporting, the arm was feeling better but still visible, injection had small faded black and blue. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.