Symptomtext
Patient was administered expired vaccine/ no AE; Initial information was received on 24-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00655521) and transmitted to Sanofi on 24-Jun-2021. This case involves a one-year-old female patient who was vaccinated with 0.5 mL (once) dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ316AAB, expiry date 08-Jun-2021) via intramuscular route in left vastus lateralis on 24-Jun-2021 for prophylactic vaccination and reported that patient was administered expired vaccine with no adverse event (expired product administered). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. Caller wanted to know if the product was still active or do the patient need to be re-vaccinate. It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of reporting, patient had no adverse event. 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.