Symptomtext
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00596556) and transmitted to Sanofi on 11-May-2021. This case involves a two-year-old female patient who received an expired 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ178AA and expiry date: 04-May-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 11-May-2021 (expired product administered). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. This was a case of actual medication error due to expired vaccine used (latency same day). At the time of reporting, no adverse event was reported. The reporter requested guidance on how to proceed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.