Symptomtext
expired dose of ACTHIB was inadvertently administered, with no reported adverse event; Initial information received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from a nurse and physician via Regulatory Authority (under reference 00697020). This case involved a 2 years old female patient who received an expired dose of HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) inadvertently (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, TETANUS VACCINE TOXOID (DTAP); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A) [not produced by Sanofi Pasteur] (Lot number and expiration date were not reported) via unknown route in an unknown route for prophylactic vaccination. On 26-Jul-2021, the patient received a 0.5mL dose of suspect ACT-HIB (lot UJ355AAA and expiration date: 24-JUL-2021; lot number (diluent) U6825AA and expiration date: 05-Dec-2021) via intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). It was reported that " what actions need to be taken." At time of reporting, the outcome was unknown for the reported event. 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.