Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | XX33P | — |
Pain at injection site; several Bexsero syringes having too much air and administered one dose which included the air bubble; administer one dose which included the air bubble in the syringe; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: Pain at injection site), syringe issue (Verbatim: several Bexsero syringes having too much air and administered one dose which included the air bubble), incomplete dose administered (Verbatim: administer one dose which included the air bubble in the syringe) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain was resolved and the outcome of the syringe issue, incomplete dose administered and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain and syringe issue 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: 24-JAN-2025 The healthcare professional reported that they did inject one dose of Bexsero with the air bubble in the syringe and the patient complained of pain upon injection and for several hours after, which led to syringe issue and incomplete dose administered They have experienced problems with several Bexsero syringes having too much air and had tried to expel the air with and without the syringe attached and the suspect syringes had been discarded. The HCP now knew to save the suspect syringes if it happens again. They stated that this had been happening intermittently with all batches since the new syringe presentation. They are aware of the documentation stating they may administer the vaccine with the air. The defect was discovered during preparation for administration and only one dose was administered. The vaccine syringe is included in the product complaint. This case is linked with US2025008843, reported by same reporter.; Sender's Comments: US-GSK-US2025008843:same reporter