Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8779NA | OT / RL |
vaccine was administered subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old female patient who received influenza USP TRIVAL A-B SUBVIRION no preservative vaccine [Fluzone] subcutaneously instead of intramuscularly 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 Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) for Immunisation. On 09-Sep-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B SUBVIRION no preservative vaccine Suspension for injection with standard strength (expiry date- 30-JUN-2026 and lot UT8779NA) once via subcutaneous route in the right thigh instead of intramuscular route with no reported adverse event (incorrect route of product administration) (latency- same day). Reportedly, care coordinator is inquiring about the effectiveness of FLUZONE NP that was administered to a 15-month-old patient using a 5g needle which is smaller than the usual 1-inch needle. The care coordinator also mentioned that since a smaller needle was used, they are assuming that the vaccine was administered subcutaneously instead of intramuscularly. 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.
Pentacel