Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U87678A | OT |
got the FLUZONE NP in error instead the prescribed FLUZONE HD with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 82 years old female patient who got the influenza USP trival A-B subvirion no preservative vaccine [Fluzone] in error instead the prescribed influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Immunodeficiency. On 20-Sep-2025, the patient received a dose of 0.5 ml once of suspect influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) (lot: U87678A; strength: standard) (expiry date: unknown) via unknown route in unknown administration site for Immunization instead of the prescribed influenza USP trival A-B high dose subvirion vaccine (Suspension for injection in pre-filled syringe) with no reported adverse event (wrong product administered) (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.
Immunocompromised