Symptomtext
ACT-HIB vaccine which had expired on 11-Jul-2022 was administered to a patient with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient and it was reported that HIB (PRP/T) VACCINE [ACT-HIB] vaccine which had expired on 11-Jul-2022 was administered to a patient 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 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX). On 29-Jul-2022, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE, (frequency: once), with an unknown formulation and strength ( lot: UJ521AAA ; expiry date: 11-Jul-2022) (diluent lot: U6999AB ; expiry date: 11-Jul-2022) via intramuscular route in the left vastus lateralis for immunization. It was reported that an Act-hib vaccine which had expired on 11-Jul-2022 was administered to a patient with no reported adverse event (Expired product administered) (onset date: 29-Jul-2022; latency: same day) Action taken : Not applicable. Outcome: 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.