Reporte zur Charge UT8155LA

Symptomtext

half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm with no adverse event; leaked on the patient's arm with no adverse event; Initial information was received on 25-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 23 years old female patient who experienced half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm and leaked on the patient's arm with no adverse event after receiving influenza quadrival A-B vaccine [Fluzone quadrivalent]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Oct-2023, the patient received a 0.5 ml, once dose of suspect influenza quadrival A-B vaccine Suspension for injection (lot UT8155LA, expiration date: 30-Jun-2024, strength: standard) via Left arm in unknown administration site for Immunization. On 25-Oct-2023, half of the medication leaked out from the part where the needle is attached to the syringe on the patient's arm with no adverse event (accidental exposure to product) and leaked on the patient's arm with no adverse event (exposure via skin contact) (unknown latency) following the administration of influenza quadrival A-B vaccine. Reportedly, none of the vaccine was administered to the patient. Caller is requesting for the replacement of the affected FLUZONE QIV pre-filled syringe, she mentions that they have a contract with Vaxcare and they were instructed to reach out to the manufacturer for replacement. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. 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.