Reporte zur Charge UJ328ADA

Symptomtext

15 month old male patient received expired dose of ACT-HIB vaccine with no reported AE; Initial information received on 30-Jun-2021 regarding an unsolicited valid non-serious case received from a other health professional via physician. This case involves a 15 month old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation. On 30-Jun-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ328ADA and expiry date: 29-Jun-2021) (Frequency: once) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that Nurse reports that today (6/30/2021), a 15 month-old male child received an ACTHIB vaccine that was then noted to have expired yesterday. 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 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.