Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 80777-0400-60 | IM |
dry heaves; red fevered face; puffy face; lethargic; no appetite; severe headaches; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), FLUSHING (red fevered face), SWELLING FACE (puffy face), LETHARGY (lethargic) and DECREASED APPETITE (no appetite) in a 73-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777-0400-60) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 29-Sep-2025, the patient experienced RETCHING (dry heaves), FLUSHING (red fevered face), SWELLING FACE (puffy face), LETHARGY (lethargic), DECREASED APPETITE (no appetite), HEADACHE (severe headaches), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, RETCHING (dry heaves), FLUSHING (red fevered face), SWELLING FACE (puffy face), LETHARGY (lethargic), DECREASED APPETITE (no appetite), HEADACHE (severe headaches), NAUSEA (nausea) and VOMITING (vomiting) was resolving. The concomitant medication was not reported by the reporter. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.