Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8781BA | OT / LA |
41 years old who was erroneously given the fluzone high dose with no reported adverse event; Initial information received on 06-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 41 years old female patient who was erroneously given the influenza USP trival A-B HIGH dose subvirion vaccine [fluzone HD] 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 pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20 and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix), both for Immunisation. On 06-Oct-2025, the patient erroneously given 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of high strength with lot UT8781BA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for Influenza (Influenza immunisation) with no reported adverse event (product administered to patient of inappropriate age) (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.
PREVNAR 20; BOOSTRIX