Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | UNK | — |
he felt a little off; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (he felt a little off) in a male patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. UNK) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 31-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 31-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced MALAISE (he felt a little off). At the time of the report, MALAISE (he felt a little off) outcome was unknown. No concomitant medications provided by the reporter. It was received that the patient received updated Moderna Covid shot on 31-Oct-2025 at an unknown location. It was received that post vaccination the patient felt a little off after the vaccination. No treatment medications provided by the reporter.