Reporte zur Charge UJ183AAQA

Symptomtext

The patient was administered an expired Act-HIb, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Agency (Reference number- 00515355) and transmitted to Sanofi on 11-Mar-2021. This case involves a one year old female patient who was administered a 0.5 ml dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ183AAQA; expiry date: 12-Feb-2021; Strength: standard, Single dose vial) via intramuscular route in unknown administration site for prophylactic vaccination on 22-Feb-2021 (expired product administered). Medical history, medical treatment(s), past vaccination(s) and family history were not provided. The patient's concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE [HEPA] for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency same day). The reporter stated, they administered an expired Act-HIB vaccine to a child that was expired for ten days. The reporter wanted to know if they need to revaccinate the patient. The reporter was not sure what site the vaccine was administered. They had to pull the shot out of the system because they had entered it as the wrong lot number. No further information was provided. At the time of report, no adverse event was reported. 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.