Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK133AB | OT |
possible administration of YF-VAX that was incorrectly reconstituted with sterile water instead of the saline diluent that it comes with, with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administered with yellow fever vaccine - [YF-Vax] which was incorrectly reconstituted with sterile water instead of the saline diluent that comes with vaccine, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Mar-2025, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection, Unknown strength and lot UK133AB with expiry date 31-Oct-2025 via unknown route in unknown administration site for Immunization, which was possibly incorrectly reconstituted with sterile water instead of the saline diluent that comes with vaccine, with no reported adverse event (product preparation issue) (latency same days). 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.