Reporte zur Charge ENG2803A4

Symptomtext

Multiple Sclerosis; B-cell inflammatory response; Her IgG for the past 20 years has been very high (2300 range); mass was found to be polyclonal plasma cells which looked like Castleman's Disease/polyclonal plasma cells; had a benign 2cm mass in the right temporal lobe; metallic taste; 30 second head rush; cold sensation in her nose; focal seizures of the temporal lobe; d?j? vu; first dose of ENGERIX-B on May 26, 1999 and the second dose on July 27, 1999; This serious case was reported by a consumer via call center representative and described the occurrence of focal seizures in a 31-year-old female patient who received HBV (Engerix B) (batch number ENG2803A4) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 27-JUL-1999, the patient received the 2nd dose of Engerix B. On 27-JUL-1999, an unknown time after receiving Engerix B and an unknown time after receiving Engerix b, the patient experienced drug dose administration interval too long (Verbatim: first dose of ENGERIX-B on May 26, 1999 and the second dose on July 27, 1999). In AUG-1999, the patient experienced focal seizures (Verbatim: focal seizures of the temporal lobe) (serious criteria GSK medically significant), deja vu (Verbatim: d?j? vu) (serious criteria GSK medically significant), taste metallic (Verbatim: metallic taste), feeling abnormal (Verbatim: 30 second head rush) and feeling cold (Verbatim: cold sensation in her nose). In JUN-2001, the patient experienced brain neoplasm (Verbatim: had a benign 2cm mass in the right temporal lobe) (serious criteria GSK medically significant) and castleman's disease (Verbatim: mass was found to be polyclonal plasma cells which looked like Castleman's Disease/polyclonal plasma cells) (serious criteria GSK medically significant). On an unknown date, the patient experienced multiple sclerosis (Verbatim: Multiple Sclerosis) (serious criteria GSK medically significant) and hypergammaglobulinemia (Verbatim: B-cell inflammatory response; Her IgG for the past 20 years has been very high (2300 range)). The patient was treated with rituximab (Rituxan). The outcome of the focal seizures, deja vu, brain neoplasm, multiple sclerosis, castleman's disease, taste metallic, feeling cold, hypergammaglobulinemia and drug dose administration interval too long were unknown and the outcome of the feeling abnormal was resolved. It was unknown if the reporter considered the focal seizures, deja vu, brain neoplasm, multiple sclerosis, castleman's disease, taste metallic, feeling abnormal, feeling cold and hypergammaglobulinemia to be related to Engerix B. It was unknown if the company considered the focal seizures, deja vu, brain neoplasm, multiple sclerosis, castleman's disease, taste metallic, feeling abnormal, feeling cold and hypergammaglobulinemia to be related to Engerix B. Additional Information: GSK Receipt Date: 19-DEC-2023 The patient self-reported this case. The patient never received the 3rd dose of Engerix- B due to adverse events experienced by the patient following the 2nd dose. In August of 1999, the patient began experiencing a 30 second head rush, cold sensation in her nose, metallic taste and deja vu. She was subsequently diagnosed with focal seizures of the temporal lobe. In June 2001, the patient had a benign 2cm mass in the right temporal lobe. A biopsy was done, and the mass was found to be polyclonal plasma cells which looked like Castleman's Disease. The patient has B cell inflammatory response. Her Immunoglobulin G for the past 20 years has been very high 2300 range. In 2009, the patient was diagnosed with Multiple Sclerosis which is being treated with Rituxan. The reporter consented to follow up. The patient received the 2nd dose later than recommended interval, which led to lengthening of vaccination schedule.