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Adverse event reports following Japanese encephalitis vaccination in the United States, 1999-2009
Nicole P Lindsey1, J Erin Staples, James F Jones
1Arboviral Diseases Branch, Centers for Disease Control and Prevention, 3150 Rampart Road, Fort Collins, CO 80521, United States. nplindsey@cdc.gov
Abstract:
We reviewed adverse events following receipt of inactivated mouse brain-derived Japanese encephalitis (JE) vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 1999 to 2009. During this period, VAERS received 300 adverse event reports following JE vaccination (24 per 100,000 doses distributed); 106 (35%) were classified as hypersensitivity reactions (8.4 per 100,000 doses) and four (1%) were classified as neurologic events (0.3 per 100,000 doses). Twenty-three (8%) reports described serious adverse events (1.8 per 100,000 doses distributed). There were no reports of encephalitis, meningitis, or Guillain-Barré syndrome. As reported previously, hypersensitivity reactions were common among persons receiving inactivated mouse brain-derived JE vaccine.
Insights
Adverse events from inactivated mouse brain-derived Japanese encephalitis (JE) vaccine were reviewed. Hypersensitivity reactions were common, but serious neurologic events like encephalitis were rare.
Area of Science:
- Vaccinology
- Immunology
- Public Health
Background:
- The inactivated mouse brain-derived Japanese encephalitis (JE) vaccine has been used to prevent JE virus infection.
- Understanding the safety profile of vaccines is crucial for public health initiatives.
Purpose of the Study:
- To analyze adverse events reported following the administration of the inactivated mouse brain-derived JE vaccine.
- To assess the frequency and types of adverse events, including serious events and specific neurological conditions.
Main Methods:
- A retrospective review of adverse event reports submitted to the U.S. Vaccine Adverse Event Reporting System (VAERS).
- Data collected from 1999 to 2009, focusing on reports associated with JE vaccination.
- Categorization of adverse events into hypersensitivity reactions, neurologic events, and serious adverse events.
Main Results:
- 300 adverse event reports were received following JE vaccination, with a rate of 24 per 100,000 doses.
- Hypersensitivity reactions constituted 35% of reports (8.4 per 100,000 doses).
- Four neurologic events (0.3 per 100,000 doses) and 23 serious adverse events (1.8 per 100,000 doses) were reported. No cases of encephalitis, meningitis, or Guillain-Barré syndrome were documented.
Conclusions:
- Hypersensitivity reactions are a common adverse event associated with the inactivated mouse brain-derived JE vaccine.
- The vaccine demonstrates a favorable safety profile regarding serious neurologic events.
- Continued surveillance through systems like VAERS is important for monitoring vaccine safety.
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