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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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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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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
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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 workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
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