Received Jun 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK407U1 | SC / LA |
vaccine was inadvertently reconstituted with sterile water instead of sterile saline with no ae; Initial information received on 10-Jun-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a 67-year-old male patient for whom vaccine (yellow fever vaccine (YF-VAX)) was inadvertently reconstituted with sterile water instead of sterile saline with no ae (adverse event). The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 09-Jun-2026, the patient received yellow fever vaccine solution for injection (strength: standard) Dose 0.5ml 1x(once) subcutaneously in Left Arm (Lot Number:UK407U1, Expiration Date: 01-Jun-2027) for immunization, vaccine was inadvertently reconstituted with sterile water instead of sterile saline with no ae (Product preparation issue) (latency same day). Action taken: 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 medication 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.
Comments: NONE