Reporte zur Charge U5256AA

Symptomtext

patient given Dtap-IPV portion of that same Pentacel with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who was given Dtap-IPV portion of that same DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation. On 12-Sep-2022, the patient received a fifth dose, once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U5256AA, 27-Apr-2023) via intramuscular route in unknown administration site for immunization patient given only Dtap-IPV portion of that same Pentacel with no reported adverse event (single component of a two-component product administered) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event patient given dtap-ipv portion of that same pentacel with no reported 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 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.