Received Jun 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | UNK | — |
Patient in hospital with infection; recurrent vomiting; high blood pressure; nausea; chills; vomiting; reaction to vaccine; This serious case was reported by a consumer via other manufacturer and described the occurrence of immunization reaction in a 11-year-old male patient who received Men B NVS (Bexsero) suspension for injection in pre-filled syringe for prophylaxis. Co-suspect products included pegcetacoplan (Empaveli) (batch number 2194196 with expiry date 31-OCT-2027) for nephritic syndrome and c3 glomerulopathy. The patient's past medical history included injection site erythema (on 30-APR-2026) and injection site pain (on 30-APR-2026). Concurrent medical conditions included nephritic syndrome (with dense deposit disease) and c3 glomerulopathy. Concomitant products included pegcetacoplan (Empaveli), amlodipine besilate (Norvasc), lisinopril, prednisone and mycophenolate mofetil (Cellcept). On 04-MAY-2026, the patient received Bexsero. On 07-MAY-2026, the patient started Empaveli (subcutaneous) 648 mg. On 04-MAY-2026, less than a day after receiving Bexsero and an unknown time after starting Empaveli, the patient experienced immunization reaction (Verbatim: reaction to vaccine) (serious criteria hospitalization), nausea (Verbatim: nausea) (serious criteria hospitalization), chills (Verbatim: chills) (serious criteria hospitalization) and vomiting (Verbatim: vomiting) (serious criteria hospitalization). On 07-MAY-2026, the patient experienced infection (Verbatim: Patient in hospital with infection) (serious criteria hospitalization), vomiting (Verbatim: recurrent vomiting) (serious criteria hospitalization) and blood pressure high (Verbatim: high blood pressure) (serious criteria hospitalization). The action taken with Empaveli was unknown. On 11-MAY-2026, the outcome of the immunization reaction was resolved (duration 7 days). The outcome of the infection, vomiting, blood pressure high, nausea, chills and vomiting were unknown. It was unknown if the reporter considered the immunization reaction, infection, vomiting, blood pressure high, nausea, chills and vomiting to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the immunization reaction, infection, vomiting, blood pressure high, nausea, chills and vomiting 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: 21-MAY-2026 The patient had no reported relevant medical history, concurrent conditions, or past medication use. The mother reported that the patient was treated with antibiotics and antihypertensive medications; however, details regarding the specific medications, the type of infection, and the exact hospitalization start date were not available. The patient's mom stated that injection site was red and hurting during infusion and stated after removing the injector that it still was pinching. There were no redness, swelling, itching, hives or bumps at the site. On 07-MAY-2026, the patient experienced infection, hypertension and vomiting. The patient was in the hospital with infection and threw up 10 minutes into dose of Empaveli. Patient had high blood pressure in the hospital. Patient was taking antibiotics and blood pressure medications, but the mother was unable to provide more information about what medications, type of infection and start of hospitalization. No changes were made to the dose of Empaveli or the use of the Empaveli injector. The company assessed vomiting, nausea, chills and immunisation reaction as related to Bexsero, based on close temporal relationship between vaccine administration and the onset of the events. The company assessed infection, and hypertension as not related to Bexsero. There was limited information on the events of infection, and hypertension which limited causality assessment. The patient's underlying condition of unspecified nephritic syndrome with dense deposit disease and C3 glomerulopathy represents a significant confounding factor for the development of hypertension. Additionally, hypertension might act as a contributing or confounding factor for vomiting. The batch number was not provided and we and unable to contact the reporter.; Sender's Comments: A case of Immunisation reaction, Infection, Vomiting, Hypertension, Nausea, Chills and Vomiting, less than a day after receiving Bexsero and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE in a 11-year-old male patient. Report is inconsistent with causal relation to the vaccine product, considering alternative risk factors (medical history of injection site erythema and injection site pain, concurrent medical conditions included nephritic syndrome and c3 glomerulopathy and concomitant pegcetacoplan).
C3 glomerulopathy; Nephritic syndrome (with dense deposit disease)
Medical History/Concurrent Conditions: Injection site erythema (on 30-APR-2026); Injection site pain (on 30-APR-2026)
EMPAVELI; NORVASC; LISINOPRIL; PREDNISONE; CELLCEPT; Empaveli
Test Date: 20260507; Test Name: blood pressure; Result Unstructured Data: (Test Result:high,Unit:unknown,Normal Low:,Normal High:)