Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK038AA | OT / RA |
expired PENTACEL was administered to a patient with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who received 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. Concomitant medications included hepatitis A vaccine INACT (havrix) and measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella VACCINE LIVE (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (proquad), both for Immunisation. On 30-Jul-2025, the patient received 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 with lot UK038AA and expiry date 30-Jun-2025, frequency: once via intramuscular route in the right deltoid for Immunization 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.
HAVRIX; PROQUAD