Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
malaise; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 07-Nov-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 07-Nov-2025, the patient experienced MALAISE (malaise) and NAUSEA (nausea). In November 2025, MALAISE (malaise) and NAUSEA (nausea) had resolved. The patient's date of birth was reported. The patient had no medical history, concomitant disease or risk factor. No concomitant medications were reported. The patient had nausea, malaise and no fever. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment information was provided.