Adverse Events Associated with Childhood Vaccines Evidence Bearing on Causality (1994) / Chapter Skim
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10 Death
10 Death
Pages 274-304
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From page 274... ...
To facilitate review of this serious adverse event, the committee used a categorization scheme, which is discussed below. Because the vast majority of reports of death following vaccination reside in passive surveillance systems, the committee used the scheme to analyze data from a currently operating one, the Vaccine Adverse Event Reporting System (VAERS)
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for this report) ; · deaths that are a consequence of an adverse event that itself is causally related to a vaccine reviewed in this report; and · deaths temporally associated with vaccine administration and the cause of death is other than those listed above.
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Passive surveillance systems such as the Monitoring System for Adverse Events Following Immunization (MSAEFI) and VAERS contain many
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In later sections of this chapter, the committee discusses the data regarding death from adverse events that are causally related to vaccines. If the evidence is inadequate to accept or reject a causal relation between a vaccine and an adverse event, then in the committee's judgment
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However, had the committee identified reports of death following vaccination that did not fall into any of the other six categories, de facto those reports would have been placed into this category and causality would have been assessed for those reports. The committee found no reports of death that could be placed in this category, either in theory or by exclusion from the other causes listed above.
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From page 279... ...
Health care providers are obligated to report specific adverse reactions to vaccines covered by the National Vaccine Injury Compensation Program (see box entitled The Vaccine Injury Table; see Chapter 1 for more information on the compensation program) ; however, reports can be made regarding any reaction to any vaccine .
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Paralytic poliomyelitis vacc m e 24 hours 3 days 3 days 24 hours 1 5 days for measles, mumps and rubella vaccines; 3 days for DT, Td and tetanus toxoids 1 5 days for measles, mumps and rubella vaccines; 3 days for DT, Td and tetanus toxoids No limit in a nonimmunodeficient 30 days recipient in an immunodeficient recipient in a vaccine-associated community case 6 months Not applicable
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From page 281... ...
Department of Health and Human Services; however, VAERS will accept all reports of suspected adverse events after the administration of any vaccine. Aids to interpretation follow as footnotes.
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The death occurred 10 days following immunization with DPT, OPV, and MMR. Such VAERS reports were often very useful to the committee in its assessments of all adverse reactions reviewed, not just the reports of death.
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As a result, for 159 VAERS reports the diagnosis was confirmed or clarified by the FDA. Before analyzing the reports, the committee excluded 17 VAERS reports because for 16 reports the deaths followed administration of a vaccine or vaccines not under consideration by the present committee and one report concerned a miscarriage, which the committee classified as an adverse event in temporal relation to vaccination experienced by the woman who was vaccinated.
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influenzas No information type b meningitis 19 No information No information No No information 20 No information Yes-MD No Yes 21 No information No information No No information 22 No information Yes RN No No information 23 No information; Yes No No information drug company summary 24 Not sure; drug No information No Yes company report 25 No; drug company No No No information report 26 No information; No No No information drug company report 27 No information No information Yes, meningitis No information 28 No; drug company No information No No information duplicate reports
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DEATH 285 Were Lab Which Vaccines Age at theTime Since Receipt Tests Done? Were Given?
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Only 78 such deaths were reported to VAERS, suggesting not only that VAERS does not contain an excessive number of reports of SIDS following immunization but also that it does not pick up all cases of SIDS that occur within 7 days of vaccination. The remaining 52 VAERS reports of deaths following vaccinations were reviewed individually by members of the Vaccine Safety Committee and were classified into the categories discussed at the beginning of the chapter.
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From page 287... ...
That committee concluded that the evidence favors rejection of a causal relation between DPT and SIDS. "Studies showing a temporal relation between these events are consistent with the expected occurrence of SIDS over the age range in which DPT immunization typically occurs" (Institute of Medicine, 1991, p.
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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 51; 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)
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From page 289... ...
When analyzed by those investigators, none of the deaths appeared to be causally related to the administration of tetanus toxoid, although one case was reported as "circulatory collapse in a patient with bronchial asthma." Clinical details of this case were not provided in the report. In one of the three deaths associated with DT or Td reported to VAERS between November 1990 and September 1992, the cause of death in a 9month-old child who received DT was reported as "Wilms tumor with nephrotic syndrome." The other two reports are discussed in the sections on deaths that are a consequence of an adverse event that is itself causally related to a vaccine reviewed in this report and on deaths for which the available data were insufficient to allow a judgment of cause.
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However, the risk of death from anaphylaxis following receipt of DT, Td, or tetanus toxoid would appear to be extraordinarily low. The evidence favors acceptance of a causal relation between DT, Td, and tetanus toxoid and death from GBS.
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From page 291... ...
, but insufficient information was provided to classify these as SIDS. Deaths That Are a Consequence of Vaccine-Strain Viral Infection Several articles have reported the death from measles infection of immunocompromised children following administration of live attenuated measles vaccine.
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The committee identified no reports of death from these adverse events that occurred in temporal relation to vaccination. Other Reports of Death Following Immunization The committee does not consider the apparent increased relative risk of death following administration of high-titer Edmonston-Zagreb or Schwarz strain measles vaccine such as has been seen in clinical trials conducted in Senegal (Garenne et al., 1991)
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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.
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Deaths Temporally Associated with Vaccine Administration, and the Cause of Death Is Other Than Those Listed Above Miller (1982) described a case series of 10,035 children who were vaccinated between 1970 and 1980 in Oxford, England, with the Beckenham 31 and Schwarz measles vaccine strains.
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The evidence is inadequate to accept or reject a causal relation between measles and mumps vaccines and death from causes other than those listed above. Risk-Modifying Factors There is evidence that some severely immunocompromised children, such as those with severe combined immunodeficiency syndrome, dysgammaglobulinemia, or leukemia, are susceptible to overwhelming measles infection and subsequent death, even from attenuated measles vaccine.
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From page 296... ...
Three deaths labeled sudden death followed administration of OPV and one labeled fever and sudden death followed administration of IPV. Passive surveillance systems such as MSAEFI and VAERS contain many reports of SIDS occurring within 24 or 48 hours following vaccination, but these case reports are not necessarily evidence of an association or a causal relation, because cases will occur in the 24- to 48-hour period following vaccination by chance alone.
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It is interesting to note that all the deaths in the United States reported in the literature occurred in immunodeficient or immune-suppressed people. This suggests that immunodeficiency is a riskmodifying factor that increases the case fatality rate of polio.
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contained 1 report of death following OPV only, 267 following OPV plus other vaccines, and 1 following IPV and other vaccines. Many VAERS reports contain insufficient data to assess a causal relation between polio vaccines and death.
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is less than that for these adverse events associated with any other cause. The possible causal relation between polio vaccines and SIDS has rarely been studied.
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Although there is no direct evidence of fatal anaphylaxis following hepatitis B vaccination, in the committee's judgment hepatitis B vaccine could cause fatal anaphylaxis. There is no evidence or reason to believe that the case fatality rate for vaccine-associated anaphylaxis would differ from the case fatality rate for anaphylaxis associated with any other cause.
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There are reports in VAERS of SIDS occurring in temporal relation to Hib vaccine administration. As part of an investigation of VAERS reports of death following administration of Hib vaccines, the CDC has preliminary data suggesting that Hib vaccines do not appear to be causally related to SIDS (R.
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There is no evidence or reason to believe that the case fatality rate from PRP-associated Hib disease would differ from the case fatality rate from Hib disease not associated with PRP vaccine. Conclusion The evidence favors acceptance of a causal relation between PRP vaccine and death from early-onset Hib disease in children 18 months of age or older who receive their first Hib immunization with unconjugated PRP vaccine.
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et al. Disseminated measles infection following vaccination in severe combined immune deficiency syndrome.
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Adverse events following immunization: 1990. Indian Pediatrics 1991;28:593-607.
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