Reporte zur Charge UJ426AAB

Symptomtext

ACTHIB was reconstituted with sterile water diluent instead of 0.4% saline with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via physician via the Medical Information (Reference number- 00628765) and transmitted to Sanofi on 04-Jun-2021. This case involves a 4 months old male patient who received 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] reconstituted with sterile water diluent instead of 0.4% saline (lot UJ426AAB, expiry: 03-Jul-2022, Injection) via intramuscular route in the right thigh for prophylactic vaccination on 24-May-2021 (Product preparation error) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination. It was a case of an actual medication error due to Wrong diluent used (latency same day) At the time of report, no adverse event was reported The caller reported that he was reviewing their vaccine log and noted that on 24-May-2021, a male child was administered a dose of ACT-HIB incorrectly. The caller wanted to know what to do now. The vaccine will be repeated. 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.