Reporte zur Charge UJ181AAA/U6601A

Symptomtext

one year old patient was given ActHIB with expired diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (MI) (Reference number- 00515331) and transmitted to Sanofi on 11-Mar-2021. This case involves a 1 years old male patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for Immunisation. On 11-Mar-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ181AAA/U6601AA, expiry date-Diluent- 07-MAR-2021/ Powder-18-MAR-2021 via intramuscular route in the left thigh for prophylactic vaccination. Additional Description of event Adverse events :HCP reporting one year old patient was given ActHIB with expired diluent. It was not reported if the patient experienced any 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 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.