Reporte zur Charge UJ679AAA/UJ667A

Symptomtext

received Act-Hib after the expiration date printed on the carton 07Apr2023 but the powder vial that they scanned had an expiration date of 28May2023 with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 1 years old male patient who received HIB (prp/t) vaccine [act-HIB] after the expiration date printed on the carton 07apr2023 but the powder vial that they scanned had an expiration date of 28may2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination. On 10-Apr-2023, the patient received 0.5 ml total dose 4 of suspect HIB (prp/t) vaccine Powder and solvent for solution for injection (batch number- UJ679AAA/UJ667ABA and expiration dates- 07-Apr-2023/28-May-2023/15-May-2023) via intramuscular route in the left thigh (strength: not provided) for Immunization. On 10-Apr-2023 the patient received act-hib after the expiration date printed on the carton 07apr2023 but the powder vial that they scanned had an expiration date of 28may2023 with no reported adverse event (expired product administered) (latency- same day) following the administration of hib (prp/t) vaccine. It was reported that they have 2 boxes of ACT-HIB where the lot numbers on the carton and powder vials match, but the expiration dates on the carton and powder vials do not match. The office manager also reports that due to this, 1 patient received ACT-HIB after the expiration date on the box; asks what they should do. Action taken- 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 guidelines. 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.