Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: The lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes with no adverse event; Patient was administered Pentacel that was non-viable after temperature excursion with no reported AE; Initial information was received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old male patient who experienced patient was administered pentacel that was non-viable after temperature excursion with no reported ae and the lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13).  On 14-Feb-2023, the patient received a dose 4 of 0.5ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection lot UJ671AA of expiry date: 13-May-2023  via intramuscular route in the left vastus lateralis (with an unknown strength) for Immunization.  On 14-Feb-2023 the patient developed a non-serious event of "patient was administered pentacel that was non-viable after temperature excursion with no reported ae" (poor quality product administered) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  On an unknown date the patient developed a non-serious event of "the lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no adverse event" (product storage error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  No lab data was reported.  It was reported "The lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes. MA calling for stability. Extended stability data does not cover unopened products. MA requests for stability information be emailed. MA reports that patient's were administered the products post temperature excursion and would like guidance if the patient's need to get revaccinated. Informed MA she would also need to report an Adverse event and she understood. Warm transferred for further assist and to submit due to post administration of temperature excursion".  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered pentacel that was non-viable after temperature excursion with no reported ae and for the event the lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no 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.