Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK023AA | OT |
administration of expired vaccine with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 6 months old male patient who administered 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. On 12-May-2025, the patient received a dose of 0.5 ml of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK023AA and expiry date 30-Apr-2025) (strength not reported) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Caller reported that pentacel was given to 3 different patients past the expiration date. The first injection occurred on 30-Apr-2025, the second on 12-May-2025 and the last injection was on 14-May-2025. 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.; Sender's Comments: US-SA-2025SA142769: