Received Oct 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
arm was swollen; Covid arm; huge lump/just this one area where patient got the injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE MASS (huge lump/just this one area where patient got the injection) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE MASS (huge lump/just this one area where patient got the injection). At the time of the report, PERIPHERAL SWELLING (arm was swollen), VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE MASS (huge lump/just this one area where patient got the injection) outcome was unknown. No concomitant medication was reported. Patient had a similar reaction with prior Moderna Covid-19 vaccines. Information in regard to the prior Moderna Covid-19 vaccines were not provided. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Causality was not reported. This case was linked to MOD-2025-790380 (Patient Link).