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Vaccine Safety Forum Summaries of Two Workshops (1997) / Chapter Skim
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CURRENT ADVERSE EVENT DETECTION AND RESPONSE PROCEDURES
Pages 5-8

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From page 5...
... VAERS requests physicians to report any adverse events observed following vaccination of their patients. Health care providers are required by law5 to report specific serious events occurring within 30 days after vaccination with a particular set of vaccines, as outlined in a published reportable events table.
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From page 6...
... in Oregon, Washington, and California, LLDB enables researchers to link vaccine exposures to medical outcomes and thereby to estimate the rates of occurrence of adverse events following vaccination as well as the background incidence. An elevated rate following vaccination, in comparison with the rate at other times, would suggest a possible causal relation to vaccination.
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From page 7...
... As an example, an epidemiologic analysis of selected reported necrologic adverse events associated with the administration of the hepatitis B vaccine was presented. The manufacturer reported that, although a causal association could not be entirely ruled out, it found no evidence from the analysis of postmarketing reporting data to suggest that Guillain-Barre syndrome, myelitis, transverse myelitis, multiple sclerosis, optic neuritis, or peripheral neuropathies were causally associated with the administration of the hepatitis B vaccine.
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From page 8...
... The adverse event reporting patterns for other final lots filled from the same bulk vaccine are also considered. Of greater concern is if elevated adverse event reports are received for several final lots from the same batch bulk material than if the number of reports for one lot is higher and that for the others is lower.
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Key Terms

  • adverse event
  • events associated
  • event reports
  • event reporting
  • vaers reports

  • following vaccination
  • events following
  • surveillance studies
  • rare adverse
  • vaccine adverse

  • final lots
  • detect rare
  • vaccine manufacturers
  • personnel review
  • bulk material

  • events observed
  • serious events
  • specific vaccine
  • requires hospitalization
  • background rate

  • represents incomplete
  • clinical trials
  • specific population
  • primarily responsible
  • labeled inaccurately

  • improve detection
  • life threatening
  • elevated adverse
  • event associated
  • conducting periodic


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