Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | 3L339 | — |
pain at injection site; several BEXSERO syringes having too much air and administered one dose which included the air bubble; 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 3L339, expiry date 30-SEP-2027) 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) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain, syringe issue 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: 23-JAN-2025 The reporter reported that patient had experienced problems with several Bexero syringes having too much air. The physician had have tried to expel the air with and without the syringe attached and suspect syringes have been discarded. The Physician now knows to save the suspect syringes if it happens again so attempted to enter both batch numbers into the M-ERP template, but it will not accept one of them. Two recent batches affected are: 3L339 and XX33P. They state that this has been happening intermittently with all batches since the new syringe presentation. They are aware of the documentation stating they did administer the vaccine with the air. They state that they did administer one dose which included the air bubble and the patient complained of lasting pain with the injection. The description of approximate size, shape, and color as 0.3-0.4 mL OF clear air. The physician explained that different from other syringes as vaccine cloudier, deposit more difficult to put in suspension, color was different but able to expel air from syringes. No visible damage present on the syringe and any temperature excursions during storage. The product at room temperature when particle observed at times out of fridge 10 to 15 minutes as per norm.; Sender's Comments: US-GSK-US2025009568:same reporter