Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, Product preparation error, Single component of a two-component product administered
Clinical narrative: administered pentacel but it was expired with no reported adverse event; administered pentacel but it was expired and also was only administered to component part of the vaccine with no reported adverse event; liquid portion of PENTACEL was administered, it was not reconstituted with the ACTHIB portion, with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] but it was expired, administered pentacel but it was expired and also was only administered to component part of the vaccine and liquid portion of pentacel was administered, it was not reconstituted with the acthib portion, 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 PNEUMOCOCCAL VACCINE and HEPATITIS B VACCINE for Prophylactic vaccination.  On 03-Mar-2023, the patient received dose 2 at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (Strength: standard) (lot number: UJ651AAA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh (leg) for Immunization and on the same day the patient was administered pentacel but it was expired with no reported adverse event (expired product administered), pentacel but it was expired and also was only administered to component part of the vaccine with no reported adverse event (single component of a two-component product administered) and liquid portion of pentacel was administered, it was not reconstituted with the acthib portion, with no reported adverse event (product preparation error).  It was reported, medical assistant (MA) calling for guidance moving forward. The caller noted that the liquid vaccine component that was administered was expired. The caller is not aware of any adverse reactions, or any treatment. The liquid vaccine portion expired on 25FEB2023. However, they misread the expiration date. Caller also requested information for when the DTAP-IPV liquid portion and ACTHIB portion of PENTACEL are administered separately when both are used prior to their expiration date. The caller requested this information for future reference should these be administered separately without being reconstituted.  This situation is reported as a medication error due to the inappropriate administration of an expired product to a patient and for not reconstituting the product as outlined in the prescribing information. It was determined that this was also a product technical complaint (PTC).  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for all the events.  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.