Symptomtext
dose of expired Pentacel was given to a patient with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 15 months old female patient who had dose of 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 with previous three doses in the series against DTaP, IPV, and hib. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation. On 26-Oct-2023, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ791AA, expiry date- 10-OCT-2023) via unknown route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency- same day). Reportedly, reporter asked, What information do you have for a Pentacel dose that was expired at the time of administration. This was the fourth dose in the series for the patient's vaccination against DTaP, IPV, and hib. The patient received Vaxelis for the previous three doses in the series. The dose was administered by a nurse. 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.