Received Aug 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 4CA28C1 | OT |
drawing up ADACEL from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no ae; drawing up ADACEL from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no ae; drawing up ADACEL from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no ae; Initial information received on 07-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female nurse who was drawing up diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Aug-2025, the nurse who was drawing up diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, lot 4CA28C1, expiry date- 31-MAR-2027) once from the vial there was a lot of internal pressure in the vial, and it caused the adacel to spray out and abruptly splashed on the nurse, fluid splashed in her left eye, eye lash, eye brow, and skin with no reported adverse event (accidental exposure to product) (occupational exposure to product) (latency- same day). Reportedly, Number of units affected - 1 VIAL. The product was available for return. The needle used was safety needle, not sure exact size. Clear location of the leakage: out of the vial stopper from the puncture mark. She did go to occupational health and they took care of her there. Action taken was 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 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.