Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8804CA | OT / RA |
situation is pre-assessed as a medication error/an inappropriate use due to possible subcutaneous administration with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 72 years old male patient who received Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] and experienced a medication error/an inappropriate use due to possible subcutaneous administration 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 Tozinameran (Pfizer BioNTech COVID-19 vaccine) for Immunisation. On 25-Sep-2025, the patient received 0.5ml dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine, Suspension for injection in pre-filled syringe, Strength high dose, frequency once, expiry date lot UT8804CA in the right deltoid for immunisation, which was pre-assessed as a medication error/an inappropriate use due to possible subcutaneous administration with no reported adverse event (incorrect route of product administration) (latency Same day). Reportedly, Pharmacist inadvertently used 5/8" needle instead of a 1" for administration of FLUZONE HD in adult patient. He was asking if it is still effective or if it needs to be repeated. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusivey 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.
Pfizer BioNTech COVID-19 vaccine