Diarrhea as an adverse event following immunization [AEFI]
Table of Contents
Authors: Brighton Collaboration
Location: United States
Purpose #
Diarrhea is a common medical condition characterized by increased frequency of bowel movements and increased liquidity of stool. Although acute diarrhea is typically self-limiting, it can be severe and can lead to profound dehydration, which can result in abnormally low blood volume, low blood pressure, and damage to various organs. Acute diarrhea remains a major cause of infant mortality globally, with over 2 million deaths attributed to it each year, mostly in the developing world. Children and the elderly are particularly prone to dehydration secondary to diarrhea. Diarrhea is also a commonly reported AEFI in both passive surveillance systems and clinical trials, for both oral and non-oral vaccines. The lack of a commonly accepted, standardized definition for diarrhea as an AEFI hinders comparability and uniform reporting across various study settings or surveillance systems.
The definition #
Need for developing a case definition and guidelines for diarrhea as an adverse event following immunization [AEFI]:
Diarrhea, also spelled diarrhoea, is a common medical condition that is characterized by increased frequency of bowel movements and increased liquidity of stool [1], [2]. Although acute diarrhea is typically self-limiting, it can be severe and can lead to profound dehydration, which can lead to abnormally low blood volume, low blood pressure, and damage to the kidneys, heart, liver, brain and other organs. Acute diarrhea remains a major cause of infant mortality around the world. Over 2 million deaths are attributed to acute diarrhea each year world-wide, most of them in the developing world. [3], [4], [5]. Children and the elderly are particularly prone to dehydration secondary to diarrhea.
Diarrhea has been defined over time by various scientific groups and health organizations in different ways, such as: “the passage of loose unformed stools” [6] or “three looser-than normal stools in a 24-h period” [7], [8] with emphasis on the consistency of stools rather than the number [9]. In epidemiological studies, diarrhea is usually defined as the passage of three or more loose or watery stools in a 24-h period, a loose stool being one that takes the shape of a stool container [8], [9], [10], [11], [12], [13], [14], [15], [16].
Diarrhea is also a commonly reported AEFI in both passive surveillance systems and clinical trials, for both oral and non-oral vaccines [14], [17], [18], [19], [20], [21], [22], [23], [24], [25]. The lack of a commonly accepted, standardized definition for diarrhea as an AEFI hinders comparability and uniform reporting of diarrhea across various study settings or surveillance systems.
Machine-readable definition #
The definition is available in JSON format following the Open Syndrome v1.0 specification:
{
"$schema": "https://opensyndrome.org/schema/v1/schema.json",
"@context": "https://opensyndrome.org/schema/v1/context.jsonld",
"@type": "osd:CaseDefinition",
"category": "suspected",
"definition_type": "case_definition",
"description": "Diarrhea is a common medical condition characterized by increased frequency of bowel movements and increased liquidity of stool. Although acute diarrhea is typically self-limiting, it can be severe and can lead to profound dehydration, which can result in abnormally low blood volume, low blood pressure, and damage to various organs. Acute diarrhea remains a major cause of infant mortality globally, with over 2 million deaths attributed to it each year, mostly in the developing world. Children and the elderly are particularly prone to dehydration secondary to diarrhea. Diarrhea is also a commonly reported AEFI in both passive surveillance systems and clinical trials, for both oral and non-oral vaccines. The lack of a commonly accepted, standardized definition for diarrhea as an AEFI hinders comparability and uniform reporting across various study settings or surveillance systems.",
"human_readable_definition": "Need for developing a case definition and guidelines for diarrhea as an adverse event following immunization [AEFI]:\n\nDiarrhea, also spelled diarrhoea, is a common medical condition that is characterized by increased frequency of bowel movements and increased liquidity of stool [1], [2]. Although acute diarrhea is typically self-limiting, it can be severe and can lead to profound dehydration, which can lead to abnormally low blood volume, low blood pressure, and damage to the kidneys, heart, liver, brain and other organs. Acute diarrhea remains a major cause of infant mortality around the world. Over 2 million deaths are attributed to acute diarrhea each year world-wide, most of them in the developing world. [3], [4], [5]. Children and the elderly are particularly prone to dehydration secondary to diarrhea.\n\nDiarrhea has been defined over time by various scientific groups and health organizations in different ways, such as: “the passage of loose unformed stools” [6] or “three looser-than normal stools in a 24-h period” [7], [8] with emphasis on the consistency of stools rather than the number [9]. In epidemiological studies, diarrhea is usually defined as the passage of three or more loose or watery stools in a 24-h period, a loose stool being one that takes the shape of a stool container [8], [9], [10], [11], [12], [13], [14], [15], [16].\n\nDiarrhea is also a commonly reported AEFI in both passive surveillance systems and clinical trials, for both oral and non-oral vaccines [14], [17], [18], [19], [20], [21], [22], [23], [24], [25]. The lack of a commonly accepted, standardized definition for diarrhea as an AEFI hinders comparability and uniform reporting of diarrhea across various study settings or surveillance systems.",
"id": "https://opensyndrome.org/definitions/diarrhea-case-definition",
"inclusion_criteria": [
{
"logical_operator": "AND",
"name": "Diarrhea",
"type": "criterion",
"values": [
{
"attribute": "stool_frequency_24h",
"name": "Passage of three or more stools in a 24-h period",
"operator": "\u003e=",
"type": "symptom",
"value": 3
}
]
}
],
"keywords": [
"diarrhea",
"dehydration",
"infant mortality"
],
"language": "English",
"location": "United States",
"open_syndrome_version": "1.0.0",
"organization": "Brighton Collaboration",
"published_at": "2026-03-18T08:11:16Z",
"published_by": [
"Open Syndrome Initiative"
],
"published_in": "https://opensyndrome.org",
"references": [
{
"url": "https://brightoncollaboration.org/diarrhea/"
}
],
"scope": "broad",
"status": "published",
"target_public_health_threats": [
"diarrhea"
],
"title": "Diarrhea as an adverse event following immunization [AEFI]",
"version": "1.0.0"
}
Using the Definition #
Healthcare organizations can implement this definition through:
- Direct integration with surveillance systems
- API endpoints for real-time validation
- Manual case verification processes
Next Steps #
We encourage:
- Clinical feedback on the definition criteria
- Technical feedback on the implementation format
- Suggestions for additional symptoms or signs
- Reports of implementation experiences
Get Involved #
We welcome contributions and feedback from the community.