Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | U8767AA | OT / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
administration of fluzone np to a patient who was intended by the facility to receive flublok with no reported adverse event; Initial information along with live follow up received on 10-Oct-2025 both of which are processed together regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 54 years old male patient had administration of influenza USP trival A-B subvirion no preservative vaccine [Fluzone] who was intended by the facility to receive influenza trivalent recombinant vaccine [Flublok TIV] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Sep-2025 the patient had administration of 0.5 ml (dose 1) once of suspect influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) (lot: U8767AA; expiry date: 30-Jun-2026; strength: standard) via intramuscular route in the left deltoid for Immunization who was intended by the facility to receive influenza trivalent recombinant vaccine (Solution for Injection) with no reported adverse event (wrong product administered) (latency: same day). It was reported, "the patient has not reported any allergy to eggs." Action taken was 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.