Reporte zur Charge UJ263AAA

Symptomtext

Patient recieved expired ActHIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00628862) and transmitted to Sanofi on 04-Jun-2021. This case involves a 3 years old male patient who received a 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ263AAA and expiry date: 02-Jun-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 03-Jun-2021. The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for immunization. The reporter asked Is the protocol to revaccinate or is there a grace period in the expiration date since it was expired by only 1 day, what is a live vaccine and Is ActHib a live vaccine. 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.