Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | U8862EA | OT / LA |
subcutaneous administration of fluzone hd with no reported ae; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 67 years old male patient who received Influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] via subcutaneous route 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, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix) for Immunisation. On 27-Oct-2025, the patient received 0.5 ml of dose 1 of Influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- high dose, expiry date- 30-JUN-2026 and lot U8862EA) once via subcutaneous route in the left deltoid for Immunization with no reported ae (incorrect route of product administration) (latency- same day). 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.
Boostrix