Reporte zur Charge U72688AB

Symptomtext

administering MENACTRA to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event.; refrigerator with vaccines previously experienced a temperature excursion that reached 37.2C with no reported adverse event.; Initial information received on 07-Jun-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 11 years old female patient who experienced administering menactra to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event and refrigerator with vaccines previously experienced a temperature excursion that reached 37.2 Celsius with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra]. 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 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination. On 07-Jun-2022, the patient received a dose: 1 of 0.5 ml total once of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine lot U72688AB, 01-Jul-2023, strength: standard, via intramuscular route in left deltoid for Immunization. On 07-Jun-2022(Latency: same day) administered menactra to a patient after a temperature excursion where product was deemed not suitable for use with no reported adverse event (Product temperature excursion issue) and refrigerator with vaccines previously experienced a temperature excursion that reached 37.2 Celsius with no reported adverse event. (product storage error). Action taken was not applicable. Outcome: Unknown. 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.