Reporte zur Charge UJ112AAC

Symptomtext

expired dose of ActHIB was given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00549606) and transmitted to Sanofi on 06-Apr-2021. This case involves a patient with unknown demographics who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] lot UJ112AAC, expiry date- 21-JUN-2020 via unknown route in unknown administration site for prophylactic vaccination on 06-Apr-2021. Medical history, medical treatment(s), vaccination(s) and family history were not provided. It was the actual medication error due to expired vaccine used (latency same day). At the time of report there was 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 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. There will be no information available on the batch number for this case.