Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8832CA | OT / LA |
made an error and provided Flublok to a 5 year old child with no reported adverse event; Initial information received on 27-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 5 years old male patient who was administered by an error 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. On 26-Sep-2025, the patient received 0.5mL of suspect Influenza Trivalent Recombinant Vaccine, Solution for injection (lot U8832CA, expiry date 31-May-2026, strength standard and frequency once) via intramuscular route in the left deltoid for Influenza and by an error it was administred to a 5 year old child with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, pharmacist explained that she was giving Flublok to the patient's mother and brother who were in the correct age for the vaccine and accidentally brought in a 3rd syringe of Flublok instead of an MMRvaccine and gave it to the child. Lot: U8823AA; Expiry date 31-May-2026. 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.