Received Jul 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | — | IM |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | — | — |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | — | — |
Splenectomy; The patient received vaccine in inappropriate age; The patient received vaccine in inappropriate age; The patient received vaccine in inappropriate age; This serious case was reported by a consumer via call center representative and described the occurrence of splenectomy in a 68-year-old female patient who received Men B NVS (Bexsero) suspension for injection in pre-filled syringe for prophylaxis. Concurrent medical conditions included pancreatic cancer (Diagnosed prior to Bexsero immunization). In JUN-2021, the patient received the 1st dose of Bexsero (intramuscular, unknown deltoid). In JUN-2021, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: The patient received vaccine in inappropriate age). On 15-JUL-2021, the patient experienced splenectomy (Verbatim: Splenectomy) (serious criteria hospitalization). In AUG-2021, the patient experienced inappropriate age at vaccine administration (Verbatim: The patient received vaccine in inappropriate age). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: The patient received vaccine in inappropriate age). The outcome of the splenectomy was resolved. It was unknown if the reporter considered the splenectomy to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the splenectomy to be unrelated 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: 30-JUN-2026 The patient self-reported this case. The reporter was the patient. The patient was diagnosed with pancreatic cancer in June 2021, prior to Bexsero vaccination. The patient received her first Bexsero dose in June 2021 in preparation for a cancer-related splenectomy. The splenectomy was done on 15-Jul-2021. The patient was hospitalized for ten days due to the splenectomy. The patient received her second Bexsero dose in August 2021. The patient received the third dose six months after the first dose. Due to asplenia (AE), as recommended by her Cancer Center and the CDC, the patient received Bexsero in June 2022 and June 2024. The patient had injection site pain with each Bexsero vaccination. After the June 2022 Bexsero dose, the patient also had pain in her arm. The pain made it difficult for the patient to lift her arm. After the June 2024 Bexsero dose, the patient's arm pain and difficulty lifting her arm were worse than in June 2022. The pain and difficulty lifting her arm lasted several days. Another Bexsero dose was planned for that month. The batch number was not provided upon follow-up with the reporter.; Sender's Comments: A case of Splenectomy, an unknown time after vaccination with the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device, in a 68-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative etiology (splenectomy is a planned surgical procedure due to the underlying cancer). The company has assessed that the event Splenectomy was not caused by 2nd and 3rd dose of Bexsero vaccine. The event occurred prior to vaccine (2nd and 3rd dose) administration.
Pancreatic cancer (Diagnosed prior to Bexsero immunization)