Reporte zur Charge UJ354AB

Symptomtext

8 week old child received the Pentacle vaccine (both parts mixed correctly together) and then also was given another ActHIB dose separately. So, ended up with Hib from Pentacel and separately, no ae; Initial information regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00496085) and transmitted to Sanofi on 26-Feb-2021. This case involves a 8 weeks old female patient who was vaccinated with 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB], powder and solvent for solution for injection (lot UJ354AB and expiration date : 08-JUL-2021) via intramuscular route in the left leg and a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], suspension for injection (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date and reported that the patient received the pentacle vaccine (both parts mixed correctly together) and then also was given another acthib dose separately. So, ended up with hib from pentacel and separately (extra dose administered). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It was a case of actual medication error due to extra dose administered (same day latency). Also reported that after getting 2 does of ACTHIB at once and they would to know if there are any safety concerns. Caller asked what to look out for in specific if a patient got 2 doses of ActHIb on the same day? Offered to escalate, caller declined. It was not reported whether the patient had any 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 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 batch number (PENTACEL) for this case.