Symptomtext
they mixed the ACT-HIB with sterile saline instead of using the diluent provided with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and a consumer via Global Medical Information (Reference number: 00721749) and transmitted to Sanofi on 12-Aug-2021. This case involves a 12-months old female patient for whom it was reported that they mixed the HIB (PRP/T) VACCINE [ACT-HIB] with sterile saline instead of using the diluent provided (product preparation issue). Past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) for and concomitant medication PARACETAMOL (HEPA [PARACETAMOL]). On an unknown date, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE (lot number: UJ522AAA and expiration date: 06-Aug-2022) via intramuscular route in right thigh for prophylactic vaccination. It was case of potential medication error due to inappropriate preparation of medication (latency: same day). No adverse events were reported at the time of this report. At the time of this report, outcome of the event was reported as 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.