Symptomtext
expired diluent was used with Act Hib and was administered to a patient, with no AE; Initial information received on 02-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via physician via Medical Information (MI) number: 00667467. This case involves a six months old male patient who was administered with expired diluent used with HIB (PRP/T) VACCINE [ACT-HIB] by a physician (Expired product administered). The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVNAR 13] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] for prophylactic vaccination respectively. On 17-Jun-2021, the patient received a 0.5 ml second dose of suspect HIB (PRP/T) (HAEMOPHILUS TYPE B (HIB) VACCINE lot number UJ320AAB, expiry date: 13-Jun-2021 via an unknown route in the right thigh for prophylactic vaccination. It was case of an actual medication error due to expired vaccine used (latency: same day). It was reported "Medical Assistant (MA) says that expired diluent was used with Act-HIB and administered to a patient. She has questions about next steps. A patient was given Act-HIB vaccine in the right thigh. The Act-HIB expired on 13Jun2021 due to the diluent portion being expired on that date. Product used : Used and Still using product : No". 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 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.