Reporte zur Charge UJ206ABA

Symptomtext

Expired Pentacel given to 3 consumers with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the consumer or other non-professional via Agency (Reference number- 00581215) and transmitted to Sanofi on 28-Apr-2021. This case involves 3 child (age and gender unspecified) patients who had received expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: UJ206ABA, expiry date: 24-Apr-2021 and other dosing details were not reported] on 27-Apr-2021 for prophylactic vaccination (expired product administered). Medical history, medical treatment, vaccination, family history and concomitant medication were not reported. It was a case of actual medication error due to expired vaccine used. It was reported that, community health service manager refused to provide information of the 3 consumers who received the expired Pentacel. She stated that they called the parents and the parents stated they are not bringing their children back to receive another vaccine. Product used: Used At the time of report, no adverse event was reported. 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.