Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was administered with no reported adverse event; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case from consumer or non-healthcare professional (MI Inquiry number: 00559284).  It was reported that expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ182AAA, expiry date: 08-Mar-2021) (Suspension For Injection) was administered to a one-year-old female patient via an intramuscular route for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL),  MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and HEPATITIS A VACCINE (HEPATITIS A).  At the time of report, no adverse event reported.  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 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. .   Initial information received on 13-Apr-2021 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 years old female patient who experienced expired dose of acthib was administered 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.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 31-Mar-2021, the patient received a dose  dose of suspect HIB (PRP/T) VACCINE lot UJ182AAA via intramuscular route in unknown administration site.  On 31-MAR-2021 the patient developed a non-serious expired dose of acthib was administered with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  (Other relevant tests included No lab data.)  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of ACTHIB was administered with no reported adverse event).  At time of reporting, the outcome was Not Applicable for the event expired dose of acthib was administered with no reported adverse 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.; Sender's Comments:  00559372: