Reporte zur Charge UJ316AAA

Symptomtext

a 16 month old received an expired dose of Acthib with no adverse event; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional. This case involves 16-month-old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ316AAA and expiry date unknown] via an intramuscular route in the left vastus lateralis on 24-Jun-2021 for prophylactic vaccination (expired product administered). Medical history, medical treatment, vaccination, and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). 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.