Symptomtext
temperature excursion due to a malfunction with the refrigerator,excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit,with no reported adverse event; vaccine was given post excursion to two patients, with no reported adverse event; Initial information received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2023SA060514(CLUSTER). This case involves a 11 years old male patient whose reported stated vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] exposed to temperature excursion due to a malfunction with the refrigerator, excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit and vaccine was given post excursion to two patients, 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 ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation. On 20-Feb-2023, the patient received a 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, solution for injection (lot: U7048AA, expiry date: 28-Feb-2024) via intramuscular route in right arm site ( strength: standard) as Immunization or TB skin test. On an unknown date the vaccine was exposed to temperature excursion due to a malfunction with the refrigerator,excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit (product storage error) and On 20-Feb-2023, the vaccine was given post excursion to two patients, with no reported adverse event (poor quality product administered) (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. First time product used : Yes Still using product : No Action taken with MENINGOCOCCAL VACCINE was 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 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.
