Reporte zur Charge UJ401AA

Symptomtext

a 1 year-old female patient received Act-HIB, that vaccine was later noted to have expired prior to administration, with no reported adverse event; Initial information was received on 13-Sep-2021 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 year-old female patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB], that vaccine was later noted to had expired prior to administration (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX); PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination. On 20-Aug-2021, the patient received 0.5 mL (once, total) dose of suspect HIB (PRP/T) VACCINE [strength: standard] (lot UJ401AA and expiry date not reported) via an intramuscular route at the thigh for prophylactic vaccination. It was reported "Do they need to re-administer it? Was it still good? The Medical Information agent confirmed the spelling of demographics with the caller for accuracy". It was a case of an actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event reported. Outcome of 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.