Received Aug 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | IM |
GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) in a 61-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2023, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2023, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (GBS - loss of function in extremities 8 days post 2nd moderna covid vaccination) had resolved with sequelae. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. The patient did not know the details of medication and reason for taking the medicine. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.