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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
clinical course was consistent with overwhelming bacterial or viral infection. Culturing was inadequate, and no cause of death was established. Hirayama (1983) described complications from measles vaccine reported as part of a compensation system established by the Preventive Vaccination Law in Japan in 1976. During the time period covered by the article (1978 to approximately 1982), 2.15 million individuals were inoculated with the Schwarz measles vaccine and 1.39 million individuals were inoculated with the Biken-CAM live attenuated measles vaccine. The authors estimated that during the 18 days following administration of the vaccine in children younger than 1 year of age, the combined risk of acute neurologic disease and sudden death was 9.8 per 100,000 doses per year. The annual background incidence of acute neurologic disease and sudden deaths was 200 per 100,000 infants younger than 1 year.
The evidence is inadequate to accept or reject a causal relation between measles vaccine and encephalitis, encephalopathy, or residual seizure disorder (see Chapter 6). In the committee's judgment the evidence is inadequate to accept or reject a causal relation between measles vaccine and death from encephalitis, encephalopathy, and residual seizure disorder.
Summary statistics from MSAEFI from 1979 to 1990 showed 3 deaths after administration of measles vaccine, 16 deaths after administration of MMR alone, and 8 deaths after administration of MMR in conjunction with DPT and OPV. No other data regarding deaths were obtained from MSAEFI. The committee identified 32 reports in VAERS (submitted between November 1990 and July 1992) of death in association with administration of measles and mumps vaccines. One of these was in association with measles vaccine, one with mumps vaccine, one with measles-mumps vaccine, and nine with MMR. Twenty reports were of MMR administered in conjunction with other vaccines. The vaccinees ranged in age from 2 months to 15 years, and the interval from the time of vaccination to death ranged from 1 day to at least 56 days. Missing data from some VAERS reports precludes the listing of more precise information concerning the age of the child or the interval from the time of vaccination to death.
Deaths Associated with Vaccine Administration but Attributable to Inappropriate Handling, Contamination, Production Error, or Error of Medical Care Sokhey (1991) reported the results of a monitoring effort following immunization in India for the year 1990. The monitoring effort covered a number of childhood vaccines, although only the events possibly associated with measles vaccines are described here. There were apparently five separate locations where children received the measles vaccine, and 9 of 54 children died after receiving the vaccine. The authors attributed the deaths of eight children to toxic shock syndrome (TSS). In one incident, 6 of the 12 immunized children died within 24 hours of receiving the vaccine (the