Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient administered an ACT-HIB vaccination that contained a diluent which had expired on 07-MAR-2022,with no reported adverse events; Initial information was received on 18-MAR-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 1 years old female patient who experienced patient administered an act-hib vaccination that contained a diluent which had expired on 07-mar-2022,with no reported adverse events 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.  Concomitant medications included-Varicella zoster vaccine and Pentacel for Immunisation  On an unknown date, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot- UJ423AAA, expiry-07-MAR-2022) via intrarmascular route in vastus Lateralis (strength and formulation: unknown) for immunization.   On 18-MAR-2022, patient developed non-serious event "patient administered an act-hib vaccination that contained a diluent which had expired on 07-mar-2022,with no reported adverse events" (expired product administered) (unknown latency) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was 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 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.Initial information was received on 18-MAR-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 1 years old female patient who experienced patient administered an act-hib vaccination that contained a diluent which had expired on 07-mar-2022,with no reported adverse events 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.  Varicella zoster vaccine and Pentacel for Immunisation  On an unknown date, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine (lot- UJ423AAA, expiry-07-MAR-2022) via intrarmascular route in vastus Lateralis (strength and formulation: unknown) for immunization.   On 18-MAR-2022, patient developed non-serious event "patient administered an act-hib vaccination that contained a diluent which had expired on 07-mar-2022,with no reported adverse events" (expired product administered) (unknown latency) following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable. At time of reporting, the outcome was 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 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.