Symptomtext
Pentacel was administered post expiration date with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (unknown age and unknown gender) to whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered post expiration date with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was administered unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, (lot UJ666AA; Expiration Date: 04-May-2023, Strength: not reported) via unknown route in unknown administration site for prophylactic vaccination post expiration date with no reported adverse event (expired product administered) (latency; same day). It was asked what is the grace period for inadvertently administering an expired vaccine; As well as, what would be the following steps regarding this unforeseen issue. Action taken : not applicable. Outcome : Unknown for the event pentacel was administered post expiration date with no reported adverse 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.