Symptomtext
expired dose of PENTACEL was administered with no reported adverse event; Initial information received on 28-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old female patient to whom expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient's concomitant medications included hepatitis A vaccine (Hepatitis A) for Immunisation. On 28-Dec-2022, the patient received an expired 0.5 ml (dose 4) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (frequency - once, strength - standard, lot - UJ590AAA and expiry date - 18-Dec-2022), with no reported adverse event (expired product administered) (latency: same day) via intramuscular route in the left thigh for immunization. Action taken: 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.