Reporte zur Charge UJ

Symptomtext

patient administered expired dose of Pentacel vaccine/ NO AE; Initial information received on 22-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1-years-old patient who received vaccine 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: UJ, expiry date: 14-Feb-2021 via an unknown route at an unknown administration site) (expired product administered) on an unknown date for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, no adverse event was reported. Medical assistant asks for information regarding expiration of Pentacel and reports pontential adverse event and still not using product. 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 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.