Received May 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK324AB | SC / LA |
some of the YF-VAX leaked onto the patient's arm during administration/leaked product went down approximately 8 inches on her arm,with no reported adverse event; some of the YF-VAX leaked onto the patient's arm during administration/leaked product went down approximately 8 inches on her arm,with no reported adverse event; Initial information received on 21-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse (healthcare professional). This case involves a 79-year-old female patient as some of the yellow fever vaccine (YF-VAX) leaked onto the patient's arm during administration/leaked product went down approximately 8 inches on her arm,with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 21-Apr-2026, the patient received yellow fever vaccine (YF-VAX) Solution for injection dose 0.5 ml subcutaneously in left arm (Strength = standard) for immunization. During the injection, the vaccine liquid leaked onto the patient's arm, with the leaked product running down approximately 8 inches on her arm [(Accidental exposure to product and Exposure via skin contact, onset: 21-Apr-2026, latency: same day)] (batch: UK324AB, expiry date: 30-Nov-2026). The nurse noted this was unusual, as she typically administers the vaccine with an arm squeeze, but in this case, an excessive amount leaked out after the needle was removed. It was reported "The leaked product went down approximately 8 inches on her arm. Caller was not aware of any adverse reactions at the time of the call. Caller did not believe the syringe was loose. When she reached up to place the band aid after removing the needle from the patient arm, the vaccine kept leaking down. Caller was unsure how much leaked down the patient arm, but it continued to leak until she touched it with a cotton ball. Nurse was concerned that the patient may not have adequate protection when traveling to a high risk area." Action taken: not reported. 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