Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Wrong technique in product usage process
Clinical narrative: vaccine leaked out between the syringe body and the LLA; Syringe issue; Product Complaint; drug dose administration interval too short; Accidental underdose; having difficulty removing the air bubble from the suspect syringes; blood appeared to seep past plunger tip back into vial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis.   On 09-SEP-2024, the patient received the 2nd dose of Bexsero (intramuscular). On 05-SEP-2024, the patient received the 1st dose of Bexsero (intramuscular, unknown arm). On 05-SEP-2024, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced incorrect vaccine administration technique (Verbatim: blood appeared to seep past plunger tip back into vial). On 09-SEP-2024, the patient experienced drug dose administration interval too short (Verbatim: drug dose administration interval too short), accidental underdose (Verbatim: Accidental underdose) and poor quality vaccine administered (Verbatim: having difficulty removing the air bubble from the suspect syringes). On an unknown date, the patient experienced syringe connection issue (Verbatim: vaccine leaked out between the syringe body and the LLA), syringe leak (Verbatim: Syringe issue) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the drug dose administration interval too short, accidental underdose, poor quality vaccine administered, syringe connection issue, syringe leak, incorrect vaccine administration technique and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the syringe connection issue and syringe leak to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the syringe connection issue and syringe leak to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 10-SEP-2024 The clinic contacted to report adverse events. The reporter reported that the patient had 1st dose of Bexsero administered intramuscularly, where blood appeared to seep past plunger tip back into vial. Shots was given either 05th September 2024 or 06th September 2024. 2nd dose of Bexsero was administered to customer on 09th September 2024, administered intramuscularly which led to drug dose administration interval too short. The vaccine was reported to be slightly leaking prior to administration. The nurse reported that needle looked to be slightly bent and not well sealed. No patient information was provided, and no patient side-effects have been reported. For the 1st suspect dose of Bexsero, after administration, the nurse stated that the syringe vacuumed sealed and drew blood into the syringe from the female patient arm when pulling the syringe out of the patient arm which led to incorrect vaccine administration technique. For the other 2 suspect doses of Bexsero, the nurse reported that they were having difficulty removing the air bubble from the suspect syringes, and the vaccine leaked out between the syringe body and the LLA. With the 2nd suspect dose, the vaccine leaked out and ran down the glass barrel of the syringe which led to syringe leak.; Sender's Comments:  US-GSK-US2024AMR113624:2nd dose case