Symptomtext
screwed the needle onto the end and there was a needle malfunction; only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub; vaccine administered at subcutaneous route/ no AE; Initial information regarding an unsolicited valid non serious case was received from pharmacist via Agency (Reference number- 00880523) and transmitted to Sanofi on 01-Dec-2021. This case involves a 60-year-old female patient receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] who experienced screwed the needle onto the end and there was a needle malfunction (needle issue) and only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub (underdose) and vaccine administered at subcutaneous route (incorrect route of product administration). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Dec-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [injection, strength: standard, frequency: once, lot UT7377JA, expiry date: 30-Jun-2022] via subcutaneous route in the left deltoid for prophylactic vaccination. It was reported "Pharmacist states that she attempted to vaccinate a patient with FLUZONE QUADRIVALENT PFS. She attached a "Medical Needle Pro Edge Safety Device 25g x 1 inch needle" to the FLUZONE QUADRIVALENT PFS. The needle attached securely, however when the pharmacist attempted to administer the vaccine, only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub where the needle attaches to the syringe. The Pharmacist asks if she should reinject the patient or if the vaccine was valid." This case is medication error due to Inappropriate route of vaccination and vaccine underdose (latency same day). At time of reporting, no adverse event 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.