Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK112AA | OT / LL |
A patient was administered an expired dose of Pentacel in the left thigh with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old male patient who was administered an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] in the left thigh with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine for Immunisation. On 14-Oct-2025, the patient received 0.5 ml expired dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, lot UK112AA, expiry date:30-Sep-2025 via unknown route in the left thigh for prophylactic vaccination [Immunisation] with no reported adverse event (expired product administered) (latency: same day). Reportedly, nurse manager called in because a patient was given an expired PENTACEL vaccine and she is asking if it is still okay to use since it was only 2 weeks expired. The caller wanted to know if they should give the patient another vaccine. 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.