Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK346AA | OT / RL |
administered with an expired pentacel with no reported adverse event; Initial information received on 02-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered with 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 vaccination(s) included Vaxelis. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) For Immunisation; Influenza Vaccine (Influenza) and Pneumococcal Vaccine (Pneumococcal Vaccine) for Immunisation. On 02-Dec-2025, the patient received 0.5ml expired dose (dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (lot UK346AA, expiry date 27-Nov-2025, strength standard, frequency once and formulation not reported) via intramuscular route in the right thigh for Immunisation, with no reported adverse event (expired product administered) (latency 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.
MMR; INFLUENZA; PNEUMOCOCCAL VACCINE