Symptomtext
the diluent for the product was expired with no reported adverse event; Initial information was received on 08-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 1 years old male patient who was reported with diluent for the product was expired with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Oct-2022, the patient received suspect standard hib (prp/t) vaccine powder and solvent for solution for injection at a dose of 0.5 ml once (lot UJ594AA, expiry date - 30-Jan-2023) (diluent - Lot Number:U7171AB, Expiration Date: 26-Oct-2022) via intramuscular route in unknown administration site for Immunization. On 31-Oct-2022 the patient reported a non-serious event of the diluent for the product was expired with no reported adverse event (expired product administered) (latency: same day) following the administration of hib (prp/t) vaccine. Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable. At time of reporting, the outcome was Unknown for the 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 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.