Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old female patient to whom inadvertently administered a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f 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 HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 08-Feb-2023, the patient received 4th dose at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot number: UJ682AAA and expiry date: unknown) via intramuscular route in the right thigh (leg) for Immunization and on the same day inadvertently administered a dose of pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered), (product storage error).  It was reported. Registered nurse (RN) called for information on how to manage patients who were administered vaccines that had undergone temperature excursion, due to a refrigerator malfunction. This situation is reported as a medication error due to administration to the patient of a vaccine that had exceeded the stability data documented in the local labelling and additional supporting stability data. First time product used : No Still using product : No.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for both 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.