Reporte zur Charge UJ4D4AA

Symptomtext

received an expire vaccine of ACTHIB, with no reported adverse event; Initial information received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00864547). This case involves a 66 year old male patient who was vaccinated with the expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient past medical history included Stem cell transplant. The patient past medical treatment, vaccination and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP HEPB) for Prophylactic vaccination. On 18-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ4D4AA and expiry date: 04-Oct-2021) (Frequency once) via intramuscular route in the arm not otherwise specified (nos) for prophylactic vaccination. It was an actual medication error case due to expired product administered (latency on same day). It was reported "Caller states that a patient in her office received an ACTHIB vaccine that expired on 04OCT2021. asked how to proceed and asked for information on expired product to be emailed to her. Caller states that the patient received ACTHIB because he is a stem cell transplant recipient". At time of reporting, 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.