Reporte zur Charge UJ266AAA

Symptomtext

an expired dose of Acthib was given to patient yesterday with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Consumer/non-hcp (healthcare professional) via Medical Information (Reference number- 00632469) and transmitted to Sanofi on 08-Jun-2021. This case involves a 9 months old male patient who received a 0.5 mL expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ266AAA and expiry date: 05-Jun-2021) via intramuscular route in the right thigh (expired product administered) for prophylactic vaccination on 07-Jun-2021. The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation. The reporter asked for recommendations. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, the patient experienced no 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 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.