Received Nov 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | UNK | LA |
infection in injection site; Severe headache; fatigue; low blood pressure; nausea; dizziness; Local swelling; redness; Pain; This serious case was reported by a nurse via sales rep and described the occurrence of injection site infection in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. On 10-OCT-2025, the patient received the 1st dose of Bexsero (left deltoid). On 12-OCT-2025, 2 days after receiving Bexsero, the patient experienced injection site infection (Verbatim: infection in injection site) (serious criteria hospitalization), headache (Verbatim: Severe headache) (serious criteria hospitalization), fatigue (Verbatim: fatigue) (serious criteria hospitalization), low blood pressure (Verbatim: low blood pressure) (serious criteria hospitalization), nausea (Verbatim: nausea) (serious criteria hospitalization), dizziness (Verbatim: dizziness) (serious criteria hospitalization), local swelling (Verbatim: Local swelling) (serious criteria hospitalization), erythema (Verbatim: redness) (serious criteria hospitalization) and pain (Verbatim: Pain) (serious criteria hospitalization). On 22-OCT-2025, the outcome of the injection site infection, headache, fatigue, low blood pressure, nausea, dizziness, local swelling, erythema and pain were resolved (duration 10 days). It was unknown if the reporter considered the injection site infection, headache, fatigue, low blood pressure, nausea, dizziness, local swelling, erythema and pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the injection site infection, headache, fatigue, low blood pressure, nausea, dizziness, local swelling, erythema and pain 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: 25-NOV-2025 The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Injection site infection, Headache, Fatigue (BCWG Level 3b), Hypotension, Nausea, Dizziness, Swelling, Erythema and Pain, 2 days after receiving Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE, in a 17-year-old female patient. Causal association is indeterminate. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow-up information has been sought.
Test Date: 20251012; Test Name: blood pressure; Result Unstructured Data: (Test Result:low,Unit:unknown,Normal Low:,Normal High:)