Reporte zur Charge UJ389AB

Symptomtext

A patient received only liquid DTaP-IPV portion without mixing the powder HIB portion, no AE; Initial information regarding an unsolicited valid non-serious case was received from nurse via Medical Information (Reference number- 00599798) and transmitted to Sanofi on 13-May-2021. This case involves a three-month-old female patient who received 0.5 mL 2nd dose which was only liquid dtap-ipv portion without mixing the powder hib portion of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389AB and expiry date: 09-Oct-2021) via an unknown route in the left thigh for prophylactic vaccination on 13-May-2021 (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for prophylactic vaccination. The caller would like to know if this will be considered a full vaccine for polio or not. This was a case of actual medication error case due to inappropriate reconstitution technique (latency same day). At the time of reporting, 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 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.