Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8864CA | OT |
7 year old patient received a dose of flublok with no reported adverse event; Initial information received on 18-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 7 years unknown gender patient who received a dose of influenza trivalent recombinant vaccine [Flublok TIV] with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s), family history were not provided. On an unknown date, the patient received unknown dose of influenza trivalent recombinant vaccine solution for injection (strength: unknown) (batch number: U8864CA and expiry date: 30-Jun-2026) via unknown route in unknown administration site for influenza immunization with no reported adverse event (Product administered to patient of inappropriate age) (Latency same day). Action taken: not applicable This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.