Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | — |
Patient was saying his leg hurt; Trouble sleeping; This spontaneous case, initially received on 08-Oct-2025, was reported by a health professional and concerns a child male patient. Administration of company suspect drug: On 06-Oct-2025, the patient received Flucelvax (TIV) for Indication not reported, dose: not reported, route of administration: not reported, anatomical location: not reported. Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Patient was saying his leg hurt (outcome: Unknown), Trouble sleeping (outcome: Unknown). Two of her sons, received their flu shots (Flucelvax) on 06-Oct-2025. Both had the vaccine administered by their pediatrician in their thigh. For her younger son, he was saying his leg hurt for most of the night to the point where he had trouble sleeping. For her older son, his leg also hurt and the next day (07-Oct-25) the leg where he got the flu shot was hurting and the area just above his knee was also swollen. She was making him an appointment with his pediatrician on 08-Oct-25 to have his leg checked. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality for Patient was saying his leg hurt, Trouble sleeping.; Reporter's Comments: Due to the spontaneous nature of the case, events are considered related for reporting purposes.
Comments: None