Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK167AA | OT |
administration of an expired pentacel, with no reported adverse event; Initial information received on 12-Nov-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves patient of unknown demographics who was administration of an expired diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: no other immunizations On an unknown date in November 2025, the patient received a 0.5 ml dose (Dose 1) of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection strength: standard frequency: once of lot UK167AA and expiry date 31-Oct-2025 via unknown route in unknown administration site with no reported adverse event (expired product administered) (latency: on same day). 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.