Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
autoimmune disease; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (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 AUTOIMMUNE DISORDER (autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (autoimmune disease) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were provided. The patient wanted to receive the COVID booster. But the vaccine was not available. She had always received the Moderna vaccine and had managed to stay safe from COVID. Patient had an autoimmune disease. Patient was feeling frustrated about not being able to get the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.