Reporte zur Charge U6573AA

Symptomtext

patient received expired dose of ACT-HIB vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (Reference number- 00559739) and transmitted to Sanofi on 13-Apr-2021. This case involves a 1-year-4-month-3 week male patient who received vaccine 0.5 mL HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with expired diluent (single dose vials, frequency: once, strength: standard, batch number: U6573AA,expiry date: 22-Mar-2021 via intramuscular route in left thigh) (expired product administered) on 24-Mar-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, concomitant medication and family history were not provided. No other vaccines received by patient. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported that patient received ACTHIB in which diluent expired but the powder doesn't expire until May. Reporter states that 3 different patients received the Act-HIB on 08-Apr, 24-Mar and 02-Apr. She requests to know what they should do, should they revaccinate. Box had batch: UJ143AAA and expiry date: 22-Mar-2021. At the time of reporting, No specific adverse event 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 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.