Reporte zur Charge UJ340AA

Symptomtext

A patient received the sterile diluent and its states on the bottle not to give it alone, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00557535) and transmitted to Sanofi on 12-Apr-2021. This case involves a two-month-old female patient who received 0.5 mL of the sterile diluent and its states on the bottle not to give it alone of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ340AA and expiry date: 21-Jun-2022) via an intramuscular route in the left thigh for prophylactic vaccination on 09-Apr-2021 (product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s), family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for prophylactic vaccination. The caller would like to know the reason that why the Dtap and IPV variants cannot be given alone. This was a case of actual medication error 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 holders 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.