Symptomtext
ACT-HIB at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; ACT-HIB at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to cases 2022SA370866, 2022SA372086, 2022SA372080, 2022SA372584, 2022SA373534, 2022SA371564, 2022SA371948, 2022SA372095, 2022SA372123, 2022SA372180, 2022SA372199, 2022SA372581, 2022SA373167 and 2022SA372581. This case involves a 1 years old female patient who was administrated HIB (PRP/T) VACCINE [ACT-HIB] post excursion at a low of negative 5.1 C (Celsius) out of range for 12 minutes and a low of 1.3C out of range for 10 minutes and with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Aug-2022, the patient received 0.5 ml, total, dose 4 of suspect HIB (PRP/T) VACCINE, unknown formulation (lot UJ665AA, exp date: 11-Mar-2023) via intramuscular route in the right thigh as Immunization. On an unknown date the HIB (PRP/T) VACCINE [ACT-HIB] at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes (product storage error) and was administrated post excursion on 31-Aug-2022 with no reported adverse event (poor quality product administered) (latency: same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for 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.; Sender's Comments: US-SA-2022SA372080: