Symptomtext
Pre-filled syringes were placed in the cooler, reported a temperature below 0?C, Human error: Yes Duration of excursion: 1 hour with no reported adverse event; products been administered post excursion patients with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 86 patients of unknown age and demographics who were administered Influenza Quadrival A-B vaccine [FLUZONE QUADRIVALENT] post excursion where pre-filled syringes were placed in the cooler, reported a temperature below 0?c, human error: yes duration of excursion: 1 hour with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2023, the patients received an unknown dose of suspect Influenza Quadrival A-B vaccine Suspension for injection of lot UT8040JA and expiry: 30-Jun-2024 via unknown route in unknown administration site for immunization. On an unknown date, it was reported that the pre-filled syringes of Influenza Quadrival A-B vaccine were placed in the cooler, reported a temperature below 0?C, human error: yes duration of excursion: 1 hour with no reported adverse event (product storage error) (unknown latency). On 13-Oct-2023, the patient had been administered Influenza Quadrival A-B vaccine post excursion patients with no reported adverse event (poor quality product administered) (latency: same day). No lab data was reported. 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.