Received Feb 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK112AAF | OT / LL |
administered an expired dose of pentacel with no reported adverse event; Initial information received on 06-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient to whom nurse administered an expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Pentacel) 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 Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for Immunisation. On 23-Oct-2025, the patient was administered an expired dose 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection (strength not reported) (lot UK112AAF ; expiry date: 30-Sep-2025) via unknown route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency: same day). Caller stated that they tried to go back into other patient's charts around that time to compare the expiration dates and see if it was a mistake, but they couldn't find any. Caller is asking if the patient is going to have to be revaccinated for the PENTACEL. Action taken: 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.
Prevnar