Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK118AA | OT |
Yf-Vax was reconstituted with sterile water instead of supplied diluent with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 45 years old female patient and reporter stated that yellow fever vaccine - US [YF-VAX] was reconstituted with sterile water instead of supplied diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included typhoid vaccine (typhoid vaccine) and influenza vaccine (influenza), both for Immunisation. On 13-Nov-2024, the patient received standard dose of 0.5 ml of suspect yellow fever vaccine - US Solution for injection lot UK118AA and expiry date 30-Sep-2025 via unknown route in unknown administration site for Immunisation that was reconstituted with sterile water instead of supplied diluent 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.
TYPHOID VACCINE; INFLUENZA