Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
multiple sclerosis/autoimmune disease; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (multiple sclerosis/autoimmune disease) 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (multiple sclerosis/autoimmune disease) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS (multiple sclerosis/autoimmune disease) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.