Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UJ981AA | OT / RL |
expired dose of PENTACEL was inadvertently administered with no adverse event; Initial information received on 21-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient and expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was inadvertently administered to him with no 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 rHBsAg (yeast) (Engerix); Influenza vaccine (Flu); Pneumococcal vaccine conj 7v (CRM197) (Prevnar); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); and Varicella zoster vaccine live (Oka/Merck) (Varivax) all for Immunisation. On 21-Feb-2025, the patient was inadvertently administered an expired dose once 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) (lot: UJ981AA; expiry date: 11-Feb-2025) (strength unknown) via intramuscular route in the right thigh for Immunisation (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.
Engerix; Flu; Prevnar; Mmr; Varivax