Symptomtext
expired dose of ACTHIB was inadvertently administered with no reported adverse event; Initial information was received on 22-Jun-2021 regarding an unsolicited valid non-serious case from a physician. This case involves six-month-old female patient who was inadvertently given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ318ABA and expiry date: 18-Jun-2021] via an intramuscular route in the left vastus lateralis on 21-JUN-2021 for prophylactic vaccination (expired product administered). Medical history, medical treatment, vaccination, concomitant medications and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). At the time of report, 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 guidelines. 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.