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  • Aefi Standard Operating Procedures - World Health Organization

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Standard Operating Procedures (SOPs) Investigation of Adverse Events Following Immunization (AEFI)Table of Content S. No.TopicAbbreviationsGlossaryPage No.1.Types of AEFI2.Isolated and cluster of.

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How to use or fill out the AEFI Standard Operating Procedures - World Health Organization online

This guide aims to assist users in accurately completing the AEFI Standard Operating Procedures form as prescribed by the World Health Organization. Understanding each component of the form is essential to ensure proper documentation and reporting of adverse events following immunization.

Follow the steps to effectively complete the form.

  1. Click the ‘Get Form’ button to download and open the form in an appropriate editor.
  2. Begin by filling out the respondent's details in the designated fields at the top of the form, including name and contact information.
  3. In the section for AEFI types, select the category applicable to the event from the dropdown menu, ensuring it aligns with the types defined in the document.
  4. Provide a detailed description of the adverse event, including symptoms, timing, and any previous medical history relevant to the case.
  5. Complete the reporting section by selecting the channel of reporting - either routine or immediate reporting of serious AEFI.
  6. For serious AEFI, ensure to attach necessary supporting documents such as the First Information Report (FIR) and any preliminary findings.
  7. Once all fields are completed, review the information for accuracy and completeness before proceeding to save.
  8. Save the completed form to your device. Options may include downloading, printing, or sharing the form with relevant authorities.

Ensure proper documentation of AEFIs by completing the form accurately and submitting it online.

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An adverse event following immunization (AEFI) is any untoward medical occurrence in a vaccinee that follows immunization. It does not necessarily have a causal relationship with the vaccine or the immunization process.

A case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use.

AEFI reporting rates for most individual vaccines in 2020 were similar to 2019. The most commonly reported adverse events were injection site reaction (37.1%); pyrexia (18.1%); rash (15.8%); vomiting (7.6%); pain (7.4%); headache (5.7%); and urticaria (5.1%).

The ICH E2D guideline defines a spontaneous report as “an unsolicited communication by a health-care professional or consumer to a manufacturer, regulatory authority or other organization that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive ...

Mention the contents of an AEFI treatment kit. Injection adrenalin (1:1000) solution – 2 ampoules. Injection hydrocortisone (100 mg) – 1 vial. Disposable syringe ( type) having 0.01 ml graduations and 26G IM needle – 2 sets. Disposable syringe (5 ml) and 24/26G IM needle – 2 sets. Scalp vein set – 2 sets.

The event is serious and should be reported to FDA when the patient outcome is: Death. ... Life-threatening. ... Hospitalization (initial or prolonged) ... Disability or Permanent Damage. ... Congenital Anomaly/Birth Defect. ... Required Intervention to Prevent Permanent Impairment or Damage (Devices) ... Other Serious (Important Medical Events)

Spontaneous reporting is an inexpensive, flexible and very effective method of collecting information whereby health professionals voluntarily submit case reports of ADR; pharmaceutical companies or consumers to the national pharmacovigilance centres for evaluation in order to mitigate the impact of ADR on society [9].

What is a spontaneous report? 'Spontaneous reports' are so-called because they arise during a clinician's normal diagnostic appraisal of a patient, the clinician drawing the conclusion that a drug may be implicated in the causality of the clinical event.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Help Portal
Legal Resources
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232