Causality Argument

The syndromes transverse myelitis, optic neuritis, multiple sclerosis, or other central demyelinating diseases in adults, when examined individually in relation to hepatitis B vaccine, do not appear to have occurred at a greater than expected frequency, and the age distribution reflects the ages of hepatitis B vaccinees in the United States up to this point. The recent recommendation that infants and children receive hepatitis B vaccine will cause a change in the age distribution of vaccinees to younger ages. The possible relation between hepatitis B vaccine and central demyelinating diseases has not been investigated in controlled studies, however. The background incidence rate of these disorders is not particularly well established, nor is the true number of instances of these adverse events following hepatitis B immunization with the recombinant vaccines in use today. These problems preclude a reliable estimate of relative risk. Overall, however, the numbers of examples of adverse neurologic outcomes following receipt of hepatitis B vaccine are of concern, particularly those resulting in demyelinating neurologic disease. There is a need to look for these outcomes in prospective postmarketing surveillance studies, using large computerized data bases, that include appropriate control groups. A number of such prospective studies are under way, and they should be pursued for the occurrence of demyelinating diseases following receipt of hepatitis B vaccine.


The evidence is inadequate to accept or reject a causal relation between hepatitis B vaccine and optic neuritis, multiple sclerosis, or transverse myelitis.


Clinical Description

The general term for joint symptoms, arthropathy, refers to any abnormality of the joint. Arthropathy encompasses arthralgia (subjective pain in a joint or joints), stiffness (with arthralgia, commonly referred to as rheumatism), and arthritis (objective findings of swelling, redness, heat, and limitation of motion). According to the 1988 National Health Interview Survey, approximately 13 percent of respondents surveyed reported currently having "arthritis or any kind of rheumatism." Prevalence rates increased with age, with approximately 0.2 percent of persons under age 18 years reporting arthritis of any kind or arthralgia.

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