was most likely related to the laceration for which tetanus prophylaxis had been given. Seven cases of "joint pain and tenderness radiating to the shoulder with redness and swelling at the site of immunization" after Td immunization were reported on one form. No additional clinical information was provided. One case of erythema multiforme and migratory polyarthritis was reported in a child aged 1.5 years. Symptoms developed 5 days after immunization with Haemophilus influenzae type b (Hib) vaccine, DT, and OPV, but they resolved after 6 weeks; the child also had received acetaminophen. MSAEFI reports from 1979 to 1990 of individuals receiving one vaccine included four reports of joint inflammation (arthralgia or arthritis) following administration of DT. Follow-up was available for two of these individuals, and both recovered. Ninety-nine cases of joint inflammation were reported following Td immunization; of 39 patients available for follow-up, 27 recovered. Two cases of joint inflammation were reported following tetanus toxoid immunization; no follow-up information was available.

Controlled Observational Studies

None.

Controlled Clinical Trials

None.

Causality Argument

The biologic plausibility for a causal relation between diphtheria and tetanus toxoids and arthritis is based on the toxoid's potential to induce serum sickness. Arthritis is fairly common in the nonpediatric population who receives tetanus toxoid or Td. Evidence for an association between diphtheria or tetanus toxoid and arthritis is limited to case reports and case series. The inconclusive nature of the reports of arthritis observed in association with receipt of tetanus and diphtheria toxoids given either alone or in combination provides insufficient evidence for a causal relation. None of the cases included clinical, laboratory, or pathologic evidence for a mechanism of association.

Conclusion

The evidence is inadequate to accept or reject a causal relation between tetanus or diphtheria toxoid and arthritis.



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