Symptomtext
MENACTRA 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, with no adverse event; menactra one dose was administered post excursion, with no 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 2022SA373167, 2022SA372581 and 2022SA372123. This case involves a 17 years old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and it was found out that menactra 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, with no adverse event and menactra one dose was administered post excursion, with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Aug-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength: unknown) lot U7492AB, expiration date: 26-Oct-2023, via intramuscular route in the left arm as Immunisation. On 29-AUG-2022 the menactra one dose was administered post excursion, with no adverse event (poor quality product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This situation was reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard. On an unknown date the menactra 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, with no adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events (MENACTRA 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, with no adverse event, menactra one dose was administered post excursion, with no adverse event). At time of reporting, the outcome was Unknown for the all. 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.