Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
medication error due to administration of an extra dose, patient already had their FLUZONE HD vaccine but they still asked for it with no reported adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 82 years old female patient who received 2 doses of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] in one day with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) and patient also received 0.5ml dose of same vaccine, (Strength: High Dose, Frequency Once) lot UT879BA and Expiry date 30-Jun-2026 via intramuscular route in the deltoid NOS (not otherwise specified) for immunisation, with no reported adverse event (extra dose administered) (Latency Same day). Reportedly, Pharmacist said that the patient was given with Fluzone HD, 30 minutes ago and their daughter came 10 minutes ago saying that the patient was confused. Patient already had their Fluzone HD vaccine from their provider's office earlier today but they still asked for it instead of getting their Covid vaccine. 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.