Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK134AA | OT / LA |
Merck sterile water was used to reconstitute the vaccine and that the vaccine was administered to a patient with no reported adverse event; Merck sterile water was used to reconstitute the vaccine and that the vaccine was administered to a patient with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 19 years old female patient who was administered with Yellow Fever Vaccine - [Yf-Vax] which was reconstituted with merck sterile water 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 Water for injection (Sterile water). On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (lot UK134AA, expiry date 30-Nov-2025; strength not reported) via subcutaneous route in the left arm for Immunisation and patient who was administered with Yellow Fever Vaccine - Yf-Vax] which was reconstituted with merck sterile water with no reported adverse event (product preparation error) and (poor quality product administered). Action taken was not applicable. Reportedly, wanted to know if they use Merck's sodium chloride diluent, will it affect the vaccine. 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.
Sterile water