Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (MRESVIA) | MODERNA | UNK | — | IM |
nausea; emesis; headache; shaking chills; shaking; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea), VOMITING (emesis), HEADACHE (headache) and CHILLS (shaking chills) in a 77-year-old female patient who received mRNA-1345 (mRESVIA PFS) for Respiratory syncytial virus immunisation. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for Respiratory syncytial virus immunisation. No Medical History information was reported. On 03-Dec-2025, the patient received dose of mRNA-1345 (mRESVIA PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 03-Dec-2025, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant), VOMITING (emesis) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), CHILLS (shaking chills) (seriousness criterion medically significant) and TREMOR (shaking). At the time of the report, NAUSEA (nausea), VOMITING (emesis), HEADACHE (headache), CHILLS (shaking chills) and TREMOR (shaking) had not resolved. For mRNA-1345 (mRESVIA PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medications provided by the reporter. The patient experienced symptom of severe nausea and emesis, headache, shaking chills. It was unknown if the patient experienced any additional symptoms/events. No treatment medications provided by the reporter.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.