Deaths That Are a Consequence of an Adverse Event That Itself Is Causally Related to a Vaccine Reviewed in This Report

The evidence favors acceptance of a causal relation between Td and GBS. The evidence establishes a causal relation between tetanus toxoid and anaphylaxis (see Chapter 5). A VAERS report described a 28-year-old woman who received a Td booster following laceration of her foot, developed GBS, and required mechanical ventilation. After initial improvement, she developed interstitial pneumonitis and progressive ventilatory failure, and she died 20 days after immunization. Postmortem examination revealed massive interstitial pneumonitis and no inflammatory infiltrates in the nervous system.

A study by Kovalskaya (1967) demonstrated that it is possible to sensitize mice to fatal anaphylactic reactions to DPT. Only two cases of death associated with the administration of tetanus toxoid given as a single antigen have been described, one by Regamey in 1965 and one by Staak and Wirth in 1973. In both cases, anaphylaxis was thought to be the cause of death.

Other Reports of Death Following Immunization

Available Data Were Insufficient to Allow a Judgment of Cause Three deaths associated with DT or Td were reported to VAERS between November 1990 and September 1992. One patient received DT, MMR, and OPV at 60 months of age and died 1 day after immunization; no further clinical details were provided, and a cause of death was not indicated. The other two reports are discussed in other sections in this chapter.

Deaths Associated with Vaccine Administration but Attributable to Inappropriate Handling, Contamination, Production Error, or Error of Medical Care Early reports of death associated with toxin-antitoxin mixtures of diphtheria toxin and diphtheria toxoid were shown to be related to inadequate inactivation of toxin (see Background and History in Chapter 5); modern techniques of toxoid preparation and testing have eliminated this problem.

Deaths Temporally Associated with Vaccine Administration and the Cause of Death Is Other Than Those Listed Above Korger and colleagues (1986) reported data collected over 15 years (1970-1984) in Marburg, Germany, regarding the adverse effects of the tetanus toxoid produced by Behring. Reports were made by practicing physicians, the Drug Commission of the German Medical Association, the Paul-Ehrlich-Institut, druggists, and patients from 1970 to 1984. Data were stored on computer, and the physi-



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