Received Jun 22, 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 22-year-old male patient who was administered to Yellow Fever Vaccine - (YF-VAX) which was inadvertently reconstituted with sterile water instead of sterile saline with no adverse event. The patient's past medical history, past drugs, vaccination(s), and family history were not provided. On 09-Jun-2026, the patient received a 0.5 mL (dose 1) of Yellow Fever Vaccine - [YF-VAX], solution for injection (batch: UK407U1, expiry: 01-Jun-2026) (strength: unknown) via subcutaneous route in Left Armfor immunization [Immunisation]. According to the information received, three patients received the yellow fever vaccine on 09-Jun-2026; however, the vaccine was inadvertently reconstituted with sterile water instead of sterile saline (Product preparation issue, onset: 09-Jun-2026, latency: same day). The administration error was not identified until 10-Jun-2026. The physician assistant inquired whether reconstituting the vaccine with sterile water instead of sterile saline could pose any safety concerns, affect the integrity or effectiveness of the vaccine, or impact the patients' immune response. It was also noted that two of the patients who received the vaccine were in a higher-risk age group for visceral symptoms. The patients had already expressed concerns about receiving the vaccine, knowing that they could die from the vaccine. Action taken: not applicable. Disclaimer: 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.
Comments: NONE