Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Bad sleep; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Bad sleep) and NAUSEA (nauseous) in a 44-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. No Medical History information was reported. In September 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In 2023, the patient experienced NAUSEA (nauseous). In September 2023, the patient experienced POOR QUALITY SLEEP (Bad sleep). In September 2023, POOR QUALITY SLEEP (Bad sleep) had resolved. At the time of the report, NAUSEA (nauseous) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. The patient height was reported as 66. The patient was receiving unspecified concomitant ongoing medication via oral route. It was reported that the poor sleep had occurred just the night after the dosing in the morning, and that by 36 hours later her sleep had returned to normal, and 48 hours later she had been feeling fine again. Treatment medication was not reported. This case was linked to MOD-2025-789942 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2025: Live significant follow up was received included, outcome of event poor sleep was updated, and the narrative was updated.