Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ADACEL being administered post excursion and to an individual less than 10 years of age with no reported adverse event; temperature excursion involving unopened ADACEL,The condition was 48.9F for 7 days due to a refrigerator malfunction with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA052418.  This case involves a 9 years old male patient who experienced temperature excursion involving unopened adacel,the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event and adacel being administered post excursion and to an individual less than 10 years of age with no reported adverse event after receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IPOL.  On 09-Feb-2023, the patient received a booster 0.5 ml once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot U7648AA via intramuscular route in (unknown strength, expiration date) Right deltoid for Immunization.  On 09-Feb-2023 the patient developed a non-serious temperature excursion involving unopened adacel, the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event (product storage error) (latency: same day) On an unknown date the patient developed a non-serious adacel being administered post excursion and to an individual less than 10 years of age with no reported adverse event (poor quality product administered) (latency: same day).  Reported a temperature excursion involving unopened ADACEL, TENIVAC and MENQUADFI and is requesting stability information. The condition was 48.9F for 7 days due to a refrigerator malfunction on 3FEB2023 (not human error). None of the products were supported by the extended stability data. Reporter also reports that 4 ADACEL doses were administered after the excursion.  Lab data not reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (temperature excursion involving unopened ADACEL,The condition was 48.9F for 7 days due to a refrigerator malfunction with no reported adverse event, ADACEL being administered post excursion and to an individual less than 10 years of age with no reported adverse event).  At time of reporting, the outcome was Unknown for the event temperature excursion involving unopened adacel,the condition was 48.9f for 7 days due to a refrigerator malfunction with no reported adverse event and was Unknown for the event adacel being administered post excursion and to an individual less than 10 years of age 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.