Symptomtext
:Expired Act-Hib was administered without any reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number-00732218) and transmitted to Sanofi on 19-Aug-2021. This case is linked to case 2021SA279787(CLUSTER). This case involves a five-year-old female patient who was administered an expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered). The patient's medical history, past medical treatment(s), past vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) and MEASLES VACCINE LIVE , MUMPS VACCINE LIVE , RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination. On 09-Aug-2021, the patient received a second dose (0.5 ml) of suspect HIB (PRP/T) VACCINE (lot number: UJ398AA; expiry date: 06-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination. It was case of actual medication error due to expired vaccine used (latency: same day). It was reported, "Expired Act-Hib was administered, and she wants to know how to follow up? Expired ActHIB was given to 2 patients. Event Information o Treatment--none at this time o Dose # if series-3rd o List concomitant or "no other vaccines"- Kinrix, ProQuad o Pregnancy?NA. Last menstrual period. Due date. AE symptoms or no AE." No adverse events were reported at the time of this report. The outcome of the event was unknown. 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.