Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK168AB | OT |
the liquid dripped all over her hands with no reported adverse event; the liquid dripped all over her hands with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender physician and the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] dripped all over her hands with no reported adverse event. On an unknown date, the suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength) with lot UK168AB and expiry date 31-Oct-2025 for Immunization dripped all over physician hands with no reported adverse event (accidental exposure to product) (exposure via skin contact). Reportedly, Bottle leaked. Replacement requested. HCP (Healthcare professional) stated she had pentacel and that when she went to pull up the liquid to use with a patient, the bottle leaked everywhere. HCP stated that it wasn't from the needle, that it was from the bottle itself and that she was unable to use it. HCP stated she did not notice a crack in the bottle, that the leak was not coming from the needle. HCP stated that, initially, she was unable to determine where the leak was coming from, that she has seen leaks before if a needle wasn't on tight enough. HCP stated she took the needle out and put it back in, but the leaking continued. HCP stated it was then that she noticed the leak was coming from "the soft portion in the center" of the bottle. HCP stated the liquid dripped all over her hands. HCP stated she pulled a second bottle from the same box and it worked fine 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