Sex: U
Vaccine: MENB, MENB
Symptoms: Poor quality product administered, Wrong technique in product usage process
Clinical narrative: One dose from lot 55N34 and lot FH443 was administered to a patient with air bubble/liquid is like a coating on the inside of the syringe stopping the air from getting out.; One dose from lot 55N34 and lot FH443 was administered to a patient with air bubble/liquid is like a coating on the inside of the syringe stopping the air from getting out.; states that the suspect products/vaccines were viscous and thick/liquid is like a coating on the inside of the syringe stopping the air from getting out; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of poor quality vaccine administered in a patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included Men B NVS (Bexsero) (batch number 55N34) for prophylaxis.   On an unknown date, the patient received Bexsero (injection) and Bexsero. On an unknown date, an unknown time after receiving Bexsero and Bexsero, the patient experienced poor quality vaccine administered (Verbatim: One dose from lot 55N34 and lot FH443 was administered to a patient with air bubble/liquid is like a coating on the inside of the syringe stopping the air from getting out.), wrong technique in drug usage process (Verbatim: One dose from lot 55N34 and lot FH443 was administered to a patient with air bubble/liquid is like a coating on the inside of the syringe stopping the air from getting out.), product quality issue (Verbatim: states that the suspect products/vaccines were viscous and thick/liquid is like a coating on the inside of the syringe stopping the air from getting out) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the poor quality vaccine administered, wrong technique in drug usage process, product quality 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: 06-AUG-2024 The healthcare professional reported that there was large air bubble and abnormal consistency of liquid in three doses of suspect Bexsero vaccines (PFS).  One dose of Bexsero vaccine was from lot 55N34 and two doses were from lot FH443.  One dose from lot 55N34 and lot FH443 was administered to a patient with air bubble, which led to poor quality vaccine administered and wrong technique in drug usage process. One dose from lot FH443 was wasted.  The reporter stated that before administering the dose from lot FH443, she took the leur loc needle off of PFS and used another syringe with needle to remove air bubble and the dose was given to the patient measured the correct amount for a dose of vaccine.  One dose of lot FH443 was available to be returned to GSK for the quality team to inspect. The reporter stated that the suspect products or vaccines were viscous and thick and stated that liquid was like a coating on the inside of the syringe stopping the air from getting out and the vaccine liquid was stuck in a diagonal position on the sides of the inner syringe blocking the air bubble and causing medication to come out, which led to product quality issue. The reporter stated that usually the air bubbles were small and we can barely see them, but these suspect vaccines had a large air bubble that filled at least half of the syringe.  There was no any aspiration performed to remove the bubbles. The suspect vaccine were shaken gently with a back and forth motion.  There was no any visible damage present on the syringe. There were no any temperature excursions during storage and no suspect product was frozen. There was no suspect product protected from light. The vaccine was stored in temperature with 39.0 degree Fahrenheit (lowest) 40.1 degree Fahrenheit (Highest)  The vaccine product was not at room temperature when particle observed and the luer loc needle was used.