Received Feb 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8419CA | OT |
inappropriate age at vaccine administration; 2-month old patient, was suppose to get VAXELIS but she was administered FLUZONE (pf) instead with no reported adverse event; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who was suppose to get diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid [Vaxelis] but she was administered fluzone (pf) instead with no reported adverse event and inappropriate age at vaccine administration after receiving influenza usp trival a-b high dose subvirion vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Feb-2025, the patient received 0.5 mL of suspect influenza usp trival a-b subvirion no preservative vaccine, Suspension for injection (lot UT8419CA, expiry date 30-Jun-2025; strength standard) via unknown route in unknown administration site for Immunization and Vaxelis not produced by Sanofi Pasteur (lot number, expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and 2-month old patient was suppose to get vaxelis but she was administered fluzone (pf) instead with no reported adverse event (wrong product administered),inappropriate age at vaccine 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.