Received May 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
PENTACEL trickled down their baby's thigh after the needle was pulled back, with no reported adverse event; PENTACEL trickled down their baby's thigh after the needle was pulled back, with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 4 months old and unknown gender patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] however some of it trickled down their baby's thigh after the needle was pulled back, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received less than 0.5 mL dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in the thigh NOS (not otherwise specified) for immunization however some of it trickled down their baby's thigh after the needle was pulled back, with no reported adverse event. Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.