Symptomtext
the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event; the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2022SA379788(CLUSTER). This case involves a 50 years old male patient to whom while administering INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Sep-2022, the patient received a 0.5 ml dose once of suspect INFLUENZA QUADRIVAL A-B VACCINE, unknown formulation (Exp: 30-Jun-2023, Lot UT7680KA) not reported via intramuscular route in the left arm for Immunization and product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event (incorrect dose administered) (Accidental exposure to product) (latency: same day). 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.