Persistent crying in infants and children as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation

[...]because the definition itself defines a clinical entity without inference of a causal relation to a given exposure, the time interval between immunization and onset of the event cannot be part of the definition itself, but should be assessed as described in the guidelines. [...]it is the combin...

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Bibliographic Details
Published inVaccine Vol. 22; no. 5-6; pp. 586 - 591
Main Authors Bonhoeffer, Jan, Vermeer, Patricia, Halperin, Scott, Kempe, Anne, Music, Stanley, Shindman, Judy, Walop, Wikke
Format Journal Article
LanguageEnglish
Published Netherlands Elsevier Ltd 26.01.2004
Elsevier Limited
Subjects
Adverse Drug Reaction Reporting Systems - standards
Adverse events following immunization
Case definition
Child
Child, Preschool
Children & youth
Clinical trials
Collaboration
Crying
Crying - psychology
Data Collection - statistics & numerical data
Data Interpretation, Statistical
Guidelines
Humans
Immunization
Infant
Licenses
Parents & parenting
Population
Studies
Terminology as Topic
Crying
Case definition
Adverse events following immunization
Guidelines
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Summary:[...]because the definition itself defines a clinical entity without inference of a causal relation to a given exposure, the time interval between immunization and onset of the event cannot be part of the definition itself, but should be assessed as described in the guidelines. [...]it is the combination of these characteristics which concerns parents and thus affects their benefit to risk balance of the immunization by fearing long term sequelae of the episode.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2003.09.006