Received Nov 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | 1 | U8832CA | IM / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8832CA | OT |
inappropriate use (unknown intention) due to the administration of FLUBLOK to a four-year-old patient with no reported adverse event; Initial information received on 11-Nov-2025 along with live follow up regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old female patient who was inappropriately administered to 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. Concomitant medications included Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3) (MMRVaxPro) and Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Quadracel) for Immunisation. On 11-Nov-2025, the patient received 0.5mL dose of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot U8832CA, expiry date 31-May-2026, frequency once and strength standard) via intramuscular route in right thigh(vastus lateralis) foe Immunisation and inappropriate use due to the administration of flublok to a four-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, she stated they had not reached out to the parents, and was asking if there was any guidance, if she needed to be given a dose of another flu vaccine, side effects to watch for, or anything that they should tell the parents. 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.
MMRVaxPro; Quadracel