Received Sep 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 3 | UK043AA | OT / LL |
expired dose of PENTACEL was administered to a patient with no reported adverse event; Initial information received on 03-Sep-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6 months old female patient who received expired dose of 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. Concomitant medications included hepatitis B vaccine and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar), both for Immunisation. On 03-Sep-2025, the patient received Dose 3 of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK043AA and expiry date 31-Aug-2025 via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (Latency same day) Action 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.
HEPATITIS B VACCINE; PREVNAR