Sex: U
Vaccine: FLU4
Symptoms: Accidental underdose, Device loosening, No adverse event, Product administration error, Product complaint
Clinical narrative: content leaked out, other dose administered; plunger issue/syringe leak/looked like the plunger was loose/content leaked out; Pharmaceutical product complaint; This case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 9722R, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe issue and pharmaceutical product complaint were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The reporter reported that the patient received a dose of Flulaval pre filled syringe where the vaccine ran out while she was depressing the plunger. The one nurse shared that it looked like it leaked out below the where you attach the syringe. The reporter started to report this as a quality issue at the GRC, case #01528098, on 13th October 2022. At that time, the reporter had limited information and it was not clear if this happened while the nurses were preparing the vaccine dose or while they were administering the dose. The reporter finally received feedback from the nurses that administered the vaccines, and they shared that the incidents happened while they were administering the vaccines.  The nurses said that it looked like the plunger was loose. Two times the vaccine contents leaked out of the top and 2 times the vaccine contents leaked out of the bottom.  The nurses shared that each time they felt that the patient did not receive any of the dose and it was a failed attempt, so they threw the dose away and administered another dose. The reporter shared that the patient did not have any reaction to the dose given. Although the patient did not have reactions to the vaccine dose given, the reporter reporting this in case it falls into the category of maladministration. The reporter did not consent to follow up. This was two of four cases, reported by the same reporter. Additional Supportive Information: The vaccine leaked out and had plunger issue, looked like the plunger was loose and other dose was administered, which led to accidental underdose, syringe issue and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2022AMR154589:Same Reporter US-GSK-US2022AMR154684:Same Reporter US-GSK-US2022AMR154685:Same Reporter