Sex: F
Vaccine: MEN
Symptoms: Death, Meningococcal infection, Neisseria test positive, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 16-year-old female subject who received Meningococcal ACWY vaccine. Co-suspect products included SOLIRIS for paroxysmal nocturnal hemoglobinuria. Concurrent medical conditions included paroxysmal nocturnal hemoglobinuria. On an unknown date, 183 days after receiving Meningococcal ACWY vaccine and Meningococcal B Recom vaccine + AIOH + OMV, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included meningococcal infection with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included meningococcal infection (fatal). The reported cause of death was meningococcal infection. The investigator considered that there was a reasonable possibility that the vaccination failure and meningococcal infection may have been caused by Meningococcal ACWY and Meningococcal B Recom vaccine + AIOH + OMV. Relevant Tests: Lab tests were performed on an unspecified date. The isolate initially was reported to be serogroup B, but subsequent testing at the Centers  for  Disease  Control  and  Prevention  (CDC) revealed that the strain actually was non-groupable. The isolate sequence type (ST-2578) was associated more commonly with asymptomatic carriage rather than invasive disease. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a 16-year-old female patient who was vaccinated with unspecified meningococcal ACWY (MenACWY) vaccine and unspecified meningococcal serogroup B (MenB-4C) vaccine (manufacturers unknown for both). This case corresponds to the meningococcal vaccines section of the article. The patient was a part of the study that provided data from the manufacturer who reported 16 cases of meningococcal disease (including 1 death) in 5207 person-years of eculizumab exposure between 2007 and 2014; the age range was 17 to 45 years, and all of them had received meningococcal vaccination. The patient had paroxysmal nocturnal hemoglobinuria. No information on patient's family history or concomitant medications was provided. On an unspecified date, the patient received unspecified meningococcal  ACWY  (MenACWY) and unspecified meningococcal  serogroup B (MenB-4C) vaccines (administration route and site unspecified; dosage unknown; batch number not provided for both). The patient had started SOLIRIS. Age of vaccinations was not provided. On an unspecified date, approximately 6 months after vaccinations and 1 month after eculizumab therapy, the patient developed meningococcal disease. The isolate initially was reported to be serogroup B, but subsequent testing at the Centers for Disease Control and Prevention (CDC) revealed that the strain actually was non-groupable. The isolate sequence type (ST-2578) was associated more commonly with asymptomatic carriage rather than invasive disease. On an unspecified date, the patient died despite apparently strong memory antibody response to the strain. Thus, a normally non-pathogenic strain led to fatal illness despite vaccination. It was unknown if an autopsy was performed. This case has been considered as suspected vaccination failure being full schedule was unknown. This case has been considered serious due to death/suspected vaccination failure. Treatment was unknown. The authors stated, "The CDC concluded that vaccination provides incomplete protection to eculizumab recipients". Additionally, the authors mentioned "FDA approved prescribing information includes a black-box warning for increased risk of meningococcal disease in recipients who take eculizumab".