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Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
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7 Hepatitis A Vaccine
Pages 421-434

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From page 421...
... . Prior to the onset of typical hepatitis symptoms such as darkening urine, pale stools, and jaundice, individuals may experience less specific symptoms including abdominal pain, anorexia, fatigue, fever, malaise, myalgia, nausea, or vomiting (Lemon, 1985; Tong et al., 1995)
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From page 422...
... . In 1995–1996, inactivated vaccines for hepatitis A became available, and since 1999 the CDC has reported a significant decrease in HAV infection in the United States -- markedly a 76 percent decrease in 2003 when compared to 1990– 1997 (Wasley et al., 2005)
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From page 423...
... Mechanistic Evidence The committee identified two publications reporting the development of ADEM after administration of hepatitis A vaccine. The publications did not provide evidence beyond temporality, one too short based on the possible mechanisms involved (Huber et al., 1999; Rogalewski et al., 2007)
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From page 424...
... Causality Conclusion Conclusion 7.1: The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and ADEM. TRANSVERSE MYELITIS Epidemiologic Evidence No studies were identified in the literature for the committee to evaluate the risk of transverse myelitis after the administration of hepatitis A vaccine.
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From page 425...
... The committee assesses the mechanistic evidence regarding an as sociation between hepatitis A vaccines and MS as lacking. Causality Conclusion Conclusion 7.3: The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and MS.
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From page 426...
... The committee assesses the mechanistic evidence regarding an as sociation between hepatitis A vaccine and GBS as weak based on knowledge about the natural infection. Causality Conclusion Conclusion 7.4: The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and GBS.
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From page 427...
... Causality Conclusion Conclusion 7.5: The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and CIDP. BELL'S PALSY Epidemiologic Evidence No studies were identified in the literature for the committee to evaluate the risk of Bell's palsy after the administration of hepatitis A vaccine.
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From page 428...
... Causality Conclusion Conclusion 7.6: The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and Bell's palsy. ANAPHYLAXIS Epidemiologic Evidence No studies were identified in the literature for the committee to evaluate the risk of anaphylaxis after the administration of hepatitis A vaccine.
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From page 429...
... Causality Conclusion Conclusion 7.7: The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and anaphylaxis. AUTOIMMUNE HEPATITIS Epidemiologic Evidence No studies were identified in the literature for the committee to evaluate the risk of autoimmune hepatitis after the administration of hepatitis A vaccine.
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From page 430...
... The committee assesses the mechanistic evidence regarding an as sociation between hepatitis A vaccine and autoimmune hepatitis as weak based on knowledge about the natural infection. Causality Conclusion Conclusion 7.8: The evidence is inadequate to accept or reject a causal relationship between hepatitis A vaccine and autoimmune hepatitis.
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From page 431...
... TABLE 7-1 Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Hepatitis A Vaccine Studies Cases Contributing to Contributing to Epidemiologic the Epidemiologic Mechanistic the Mechanistic Causality Vaccine Adverse Event Assessment Assessment Assessment Assessment Conclusion Hepatitis A Acute Disseminated Encephalomyelitis Insufficient None Weak None Inadequate Hepatitis A Transverse Myelitis Insufficient None Weak None Inadequate Hepatitis A Multiple Sclerosis Insufficient None Lacking None Inadequate Hepatitis A Guillain-Barré Syndrome Insufficient None Weak None Inadequate Hepatitis A Chronic Inflammatory Disseminated Insufficient None Lacking None Inadequate Polyneuropathy Hepatitis A Bell's Palsy Insufficient None Lacking None Inadequate Hepatitis A Anaphylaxis Insufficient None Weak 1 Inadequate Hepatitis A Autoimmune Hepatitis Insufficient None Weak None Inadequate 431
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From page 432...
... American Journal of Public Health 79(4)
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From page 433...
... 1998. Hepa titis A virus infections associated with clotting factor concentrate in the United States.
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Key Terms

  • epidemiologic evidence
  • autoimmune hepatitis
  • transverse myelitis
  • causal relationship
  • provide evidence

  • literature reporting
  • acute disseminated
  • committee identified
  • identify literature
  • molecular mimicry

  • american journal
  • evidence beyond
  • chronic inflammatory
  • natural infection
  • concomitant administration

  • precipitating event
  • short based
  • disseminated encephalomyelitis
  • evidence linking
  • symptoms described

  • uriondo san
  • experimental evidence
  • beyond temporality
  • publications reporting
  • san juan

  • reporting clinical
  • publications referenced
  • mechanisms involved
  • evidence regarding
  • causality conclusion


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