Received Nov 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
discomfort in my arm; big red spot; it's really tender; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in my arm), ERYTHEMA (big red spot) and TENDERNESS (it's really tender) in a female patient of an unknown age 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 21-Nov-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. In November 2025, the patient experienced LIMB DISCOMFORT (discomfort in my arm), ERYTHEMA (big red spot) and TENDERNESS (it's really tender). At the time of the report, LIMB DISCOMFORT (discomfort in my arm), ERYTHEMA (big red spot) and TENDERNESS (it's really tender) had not resolved. No concomitant medications provided by the reporter. It was reported that the patient was vaccinated 72 hours ago with mNEXSPIKE and after that the patient experienced some discomfort in her arm and a big red tender spot. The patient pharmacist told her that symptom should have been gone by now. The patient asked that if she had a reaction and what she should do. No treatment medications provided by the reporter.