Received Mar 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Severe Neurological Reaction; This spontaneous case was reported by a non-health professional and describes the occurrence of NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) in a patient of an unknown age and gender 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 NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) (seriousness criterion medically significant). At the time of the report, NERVOUS SYSTEM DISORDER (Severe Neurological Reaction) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No Concomitant medications provided by the reporter. No treatment medications provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2023-732177 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-732177:S-R