Reporte zur Charge UJ423AA

Symptomtext

Patient received ACTHIB subcutaneously with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- 00576929) and transmitted to Sanofi on 26-Apr-2021. This case involves a 2 months old female patient who received a 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ423AA and expiry date: 20-May-2022) via subcutaneous route in the right thigh instead of intramuscular route (incorrect route of product administration) for prophylactic vaccination on 26-Apr-2021. Medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation. It was an actual medication error case due to inappropriate route of vaccination (latency: same day). The reporter wanted to know whether dose needs repeating. At the time of reporting, the patient experienced no specific 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 guidelines. 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.