Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK125AA | OT / LA |
inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 56 years old male patient for whom yellow fever vaccine - [YF-VAX], inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 27-Mar-2025, the patient received an unknown dose (0.5ml) of suspect yellow fever vaccine; Solution for injection with unknown strength (lot UK125AA with expiry date 30-Oct-2026) via subcutaneous route in the left arm for Immunization, inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event (product preparation error) (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.