Symptomtext
temperature excursion due to refrigerator data logger malfunction low of 15.22 F 47 min with no ae; product being administered not suitable to use post temperature excursion with no adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 9-month-old female patient who reported HIB (PRP/T) VACCINE [ACT-HIB] product being administered not suitable to use post temperature excursion with no adverse event and temperature excursion due to refrigerator data logger malfunction low of 15.22 f 47 min with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Immunization; Polio Vaccine Inactive (IPV) for Immunization; and Hepatitis B Vaccine (Hepatitis B Vaccine) for Immunization. On an unknown date, it was reported that temperature excursion occurred due to refrigerator data logger malfunction low temperature of 15.22 Fahrenheit and time 47 min with no ae (product storage error). On 08-Jun-2022, the patient received suspect ACT-HIB vaccine post temperature excursion at dose 0.5ml once intramuscular (lot uj633aaa, expiry date: 30-Nov-2022) via intramuscular route in unknown administration site for prophylactic vaccination (poor quality product administered, latency: same day). Action taken: Not applicable. At time of reporting, the outcome was Unknown for both 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 guidelines. 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.