Symptomtext
expired dose of ACTHIB that was administered with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00635920) and transmitted to Sanofi on 10-Jun-2021. This case involved 18 month old female patient who administered second dose of 0.5ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot: UJ263AA, expiry date: 02-Jun-2021, strength: standard) via intramuscular route in right thigh on 09-Jun-2021 for prophylactic vaccination (expired product administered). The patient's past vaccination(s) included ACT-HIB on 27-Jan-2020 with First dose. Relevant medical history, medical treatment(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (daptacel) for prophylactic vaccination. This was an actual medication error case due to expired vaccine used (latency was same day). Receptionist stated that states that they knew that there was an ActHIB that was getting ready to expire so they placed an order to replace it 3 weeks in advance, however there was a delay and it did not get approved until yesterday, 09Jun2021. When the nurse pulled up the ActHIB vaccine and they double checked it, they did not catch the expired date. The dose is valid or needs to be re-administered. At the time of reporting, no adverse event 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.