Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UJ876AA | OT |
administration of expired pentacel with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who was administered with 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 Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) for Immunisation. On 27-Jan-2025, the patient received an expired 0.5ml (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) Vaccine, Powder and suspension for suspension for injection, Unknown Strength, Expiry date 19-Mar-2024 and lot UJ876AA via intramuscular route in unknown administration site for Immunization with no reported adverse event (Expired vaccine used) (Latency same day). Reportedly, A nurse called to inform that a patient had been given expired Pentacel. She wanted to get a recommendation of what to do next after this event. Nurse is unsure of the treatment that was provided. They said that patient was fine. 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.
Prevnar 13