Symptomtext
syringe was leaking at the connection of the needle and syringe/ NO AE; syringe was leaking at the connection of the needle and syringe/ NO AE; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (Reference number- 00812927) and transmitted to Sanofi on 14-Oct-2021. This case was linked to case 2021SA342449 (CLUSTER). This case involves a 68-year-old female patient who experienced syringe was leaking at the connection of the needle and syringe (device leakage)(Vaccine underdose), while received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, concomitant medication, past medical treatment, vaccination and family history were not provided. On 14-Oct-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [frequency: once, Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, Strength: standard except for Fluzone HD ,lot UJ743AA, expiry date: 30-Jun-2022] via an unknown route at an unknown administration site for prophylactic vaccination. On 14-Oct-2021, the patient developed a non-serious syringe was leaking at the connection of the needle and syringe(device leakage)(Vaccine underdose), on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported"Caller requesting information regarding FLUZONE high dose (HD). Caller stated that when she went to administer the vaccine, the liquid came out around the place where you attached the needle. Caller stated that part of the liquid was still in the syringe, but she was not sure if any was entered into the patient. Caller wanted to know what to do. Agent warm transferred to MIS. Additional Description of event Adverse events: The caller stated that when she gave the vaccination of Fluzone HD Quad, some of the product leaked out of the patient's skin and a lot of it got on her pants. The syringe was leaking at the connection of the needle and syringe." Details of laboratory data not reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the events.