Reporte zur Charge UJ175AAA

Symptomtext

administered ACTHIB to a patient but the diluent had expired 4 days prior/ no AE; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical assistant) via Medical Information (Reference number- 00378491). This case involves a 17 months old male patient who received a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] single-dose vial (lot: UJ175AAA, diluent expiry date: 26-Nov-2020, vaccine expiry date: 02-May-2021) via intramuscular route in the right outer thigh, on 30-Nov-2020 for prophylactic vaccination (expired product administered). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) and INFLUENZA VACCINE (FLU) for prophylactic vaccination. It was a case of an actual medication error due to expired vaccine used (latency: same day). Medical Assistant (MA) reports that they administered ACT-HIB on Monday to a patient but the diluent had expired 4 days prior. MA requests to know if there no contraindication or side effects. They discarded the expired diluent. Patient received a dose of ACT-HIB on 30 Nov 2020 for which the diluent had expired on 26-Nov-2020, although the ACT-HIB vial itself did not expire until 05 Feb 2021. MD name and dose number in series not available. Medical assistant did not have the lot number for the diluent vial. Product used: Used. 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.