Reporte zur Charge UJ402AAA,UJ413A

Symptomtext

the patient only received the DTaP-IPV liquid portion of Pentacel; the patient did not receive the HIB powder portion, no AE; Initial information received on 14-May-2021 regarding an unsolicited valid non-serious case from a other health professional and physician via Media Information (reference number 00601852). This case involves a 15 months old male patient who received only dtap-ipv liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and did not receive the hib powder portion (lot UJ402AAA,UJ413AA and expiration date :09-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination on 06-May-2021 (product preparation issue). The patient's past vaccinations included first, second and third dose of Pentacel (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on 12-Mar-2020, May-2020 and Jul-2020 respectively. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included a dose of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination . It was an actual medication error due to inappropriate reconstitution technique (same day latency). Caller stated that a patient was supposed to receive PENTACEL but the patient only received the DTaP-IPV liquid portion of PENTACEL; the patient did not receive the HIB powder portion and wants to confirm that counts as a full dose of DTaP-IPV and was looking for guidance on documentation. Also Caller states a patient was supposed to receive PENTACEL but the patient only received the DTaP-IPV liquid portion of PENTACEL; the patient did not receive the HIB powder portion; there was some confusion about giving both vials, so only the liquid portion was given to the patient. Referred caller to the Pentacel Reconstitution Video. Caller reported that they checked in with the patient's mom and the child was doing great; they recommended to patient's mom to get the HIB component. 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.