Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK134AA | OT / LA |
YF-VAX was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 27-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 31 years old male patient who received YELLOW FEVER VACCINE - [YF-VAX] was reconstituted with sterile water and administered to a patient 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and TYPHOID VACCINE (TYPHOID VACCINE) both for Immunisation. On 31-Jan-2025, the patient received 0.5 ml of suspect YELLOW FEVER VACCINE - Solution for injection (lot UK134AA and expiry 30-Nov-2025) (strength: unknown) was reconstituted with sterile water and administered to a patient with no reported adverse event (product preparation error) (latency same day) via subcutaneous route in the left arm for immunization. Reportedly:- Nurse explains that he was doing inventory and he noticed that there was 1 extra saline diluent for YF-VAX, and so he has reason to believe that YF-VAX was administered to the patient with sterile water. He states that they will be in contact with the patient. He asks if YF-VAX reconstituted with sterile water would have provided any protection for the patient. 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.
TDAP; TYPHOID VACCINE