Symptomtext
temperature excursion due to the thermostat in the refrigerator being accidentally adjusted resulting in a low excursion, MENQUADFI, at a low of 33F out of range for a total of 21 hours with no reported adverse event; administered menquadfi post excursion with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2023SA147112. This case involves a 11 years old female patient who was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] post temperature excursion due to the thermostat in the refrigerator being accidentally adjusted resulting in a low excursion, at a low of 33F out of range for a total of 21 hours 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 Diphtheria vaccine Toxoid, Pertussis vaccine Acellular, Tetanus vaccine Toxoid (TDAP) and Meningococcal vaccine B RFHBP/NADA/NHBA OMV (BEXSERO) both for Prophylactic vaccination. On 04-May-2023, the patient received 0.5ml dose, total (strength: standard) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7595AC and expiry: 11-May-2025 via intramuscular route in the left arm for immunization. From 02-May-2023 to 08-May-2023, the non-serious event of temperature excursion occurred due to the thermostat in the refrigerator being accidentally adjusted resulting in a low excursion, of Meningococcal A-C-Y-W135 (T CONJ) vaccine, at a low of 33F out of range for a total of 21 hours with no reported adverse event (product storage error)(latency: unknown). On 04-May-2023, the patient developed a non-serious event administered Meningococcal A-C-Y-W135 (T CONJ) vaccine post excursion with no reported adverse event (poor quality product administered) (latency: same day). Action taken 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 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.