Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Rheumatoid factor positive
Clinical narrative: This case was reported in a literature article and described the occurrence of autoimmune disorder in a 45-year-old female subject who received Hepatitis B vaccine. On an unknown date, 14 days after receiving Hepatitis B vaccine, the subject developed autoimmune disorder. Serious criteria included GSK medically significant. Additional event(s) included fibromyalgia. The outcome of autoimmune disorder was unknown. The outcome(s) of the additional event(s) included fibromyalgia (unknown). The investigator considered that there was a reasonable possibility that the autoimmune disorder and fibromyalgia may have been caused by Hepatitis B vaccine. Relevant Tests: The patient was found to be positive anti-rheumatoid factor and anti-Sm antibodies as well as negative for anti-nuclear and anti-myelin basic protein antibodies. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Antinuclear antibody result was Positive absent. On an unknown date, Antinuclear antibody result was Negative absent. On an unknown date, CSF myelin basic protein result was Negative absent. On an unknown date, Rheumatoid factor result was Positive absent. Additional information received: This case was reported in a literature article and it described the occurrence of fibromyalgia in a 45-year-old female patient who had received unspecified hepatitis B virus vaccine (manufacturer unknown). No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, between 1990 and 2008, the patient received between 1 and 3 doses of an unspecified hepatitis B vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). The authors reported all the patients followed the schedule recommended by the Centers for Disease Control and Prevention protocols (0, 1 and 6 months). On an unspecified date, 14 days after the last vaccination, the patient developed fibromyalgia. The authors did not specify the symptoms that the patient presented; but they mentioned that they included constitutional and systemic, neurological, psychiatric, musculoskeletal and gastrointestinal symptoms. The authors commented that they thought this was a case of autoimmune (auto-inflammatory) syndrome induced by adjuvants as it complied with 2 of the major suggested criteria for this condition (exposure to an external stimuli and appearance of typical clinical manifestations). The patient was found to be positive anti-rheumatoid factor and anti-Sm antibodies as well as negative for anti-nuclear and anti-myelin basic protein antibodies. Treatment was unknown. Outcome of the events was unspecified at the time of reporting. The authors believed that this was a case of autoimmune (auto-inflammatory) syndrome induced by the adjuvants in the vaccine. The authors concluded that "this study suggests an association between immunizations with hepatitis B vaccines or to one of its components to chronic fatigue syndrome and fibromyalgia, as part of the autoimmune (auto-inflammatory) syndrome induced by adjuvants. Although a causal association could not be proven, a temporal association was clearly evident in this cohort. An important point to stress is that this temporal association may last longer than is usually expected and in our cohort was observed up to a year following immunization. Several risk factors were noted such as the appearance of adverse event during immunization which may imply an increased risk of developing post-immunization diseases or the presence of autoimmune susceptibility documented by personal or family history or the presence of autoantibodies. Last but not least, the between autoimmune (auto-inflammatory) syndrome induced by adjuvants criteria were fulfilled in all patients eluding the plausible link between autoimmune (auto-inflammatory) syndrome induced by adjuvants and chronic fatigue syndrome and fibromyalgia. Further studies are needed to support our observation and possibly shed more light on genetic, autoimmune and vaccine ingredient related risk factors". This case is 1 of the 19 valid cases reported in the same literature article (see case US2015GSK100322).