Symptomtext
an expired dose of ACTHIB was inadvertently administered with no AE; Initial information was received on 19-Jul-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Global Medical Information (Reference number- 00687962). This case involves a three-month-old female patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), IODINATED GLYCEROL (IPOL [IODINATED GLYCEROL]), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination. On 19-Jul-2021, the patient received a 0.5 mL of Second dose of suspect HIB (PRP/T) VACCINE (lot number: UJ359AAA and expiry date: 11-Jul-2021) via an intramuscular route in right leg for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported that, "nurse reporting an expired dose of ACTHIB was inadvertently administered. Caller with question on whether dose needs repeating." At the 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 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.