Reporte zur Charge UJ189AAA

Symptomtext

Pentacel was administered in error with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional and transmitted to Sanofi on 30-Nov-2020. This case involved a 4 year old male patient for whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered in error (product administration error). The patient's past vaccination(s) included ACTHIB. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and INFLUENZA VACCINE (INFLUENZA). On 19-Nov-2020, the health care professional stated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE (Lot number UJ189AAA expiration date: 06-Apr-2021) via an unknown route in the right arm was administered in error (product administration error). Only the liquid was administered. It was reported that the child was behind on his immunizations and reporter did not have a complete record of what patient had received but knew patient was up to date with his ActHIB so even though he didn't get that part he didn't need it. At the time of this 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 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.