Reporte zur Charge UJ399AAC

Symptomtext

dose of ACT-HIB was given to a patient, and realized afterwards it was expired with no reported AE; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from other-health care professional and physician and consumer via [medical information (MI) - 00799417]. This case involves 14 months old male patient who was vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX DTP) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), for prophylactic vaccination. On 05-Oct-2021, the patient received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (total, lot number: UJ399AAC and expiry date 02-Oct-2021) via unknown route in the leg, for prophylactic vaccination. It was reported "office manager states a dose of ACT-HIB (095 - ACT-HIB) was given to a patient, and realized afterwards it was expired. Vaccine expired on 02Oct2021. Looking for information in regards to any side effects to look out for, as well as if they need to re-vaccinate. A dose of ActHIB was administered to a patient in the leg. The Medical Assistant was attempting to enter the dose in the electronic medical record when the system rejected the dose because it expired on 02Oct2021. It was then that it was realized that an expired dose was administered to the patient. The caller is not able to see in the record which leg was used for the injection site, since the system would not allow the dose to be recorded". It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Outcome of event was unknown. 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.