Symptomtext
Pentacel dose that was administered had expired with no reported adverse event; Initial information received on 03-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old male patient to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] dose that was administered had expired 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 ROTAVIRUS VACCINE for Prophylactic vaccination. On 03-Apr-2023, the patient received dose 3 at 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot UJ644AAA; expiry date: 02-Apr-2023) via unknown route in the right vastus lateralis for immunization with no reported adverse event (expired product administered) (latency: same day). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. 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.