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Guidelines for Monitoring Reporting and Managing Adverse Events Following Immunization (AEFI) in Kenya

Vaccines are vital public health tools that protect individuals and communities against diseases. Immunization has eradicated diseases like smallpox and significantly reduced illnesses such as tetanus and measles. Vaccines are safe and effective when used as intended; however, like other pharmaceutical products, vaccines are not entirely free of risk. The success of immunization depends on maintaining public trust, which requires transparent monitoring and management of adverse events following immunization (AEFI).

What is an AEFI?

An adverse event following immunization (AEFI) is an unwanted or unexpected health effect that happens after someone receives a vaccine, which may or may not be caused by or related to the vaccine.

It may be any unfavorable or unintended sign, abnormal laboratory finding symptom, or disease.

Why Monitor AEFI?

Monitoring and managing AEFI are crucial to:

• Identify, address, and communicate potential vaccine-related risks promptly.
• Ensure patient safety.
• Maintain public confidence in immunization programs.

Responding to an AEFI

Once an AEFI has been detected, relevant actions should be taken, including:

• Management of AEFI as per presentation and according to standard guidelines
• Reporting of AEFI
• Investigation of serious and Cluster AEFI
• Causality assessment
• Communicating to stakeholders, including caregivers and the community

How to Report and Manage AEFI

Healthcare providers are encouraged to report all adverse events following immunization using the AEFI forms (White Forms) available in the Pharmacovigilance Electronic Reporting System (PvERS) platform or the hard copy manuals provided at the facilities within the stipulated timelines.

The general public or patients are encouraged to report via the USSD code *271# and follow the prompts or call/text the number +254795743049.

MAHs shall report in the ICH-E2B format through an XML file via email at pv@pharmacyboardkenya.org or report directly by filling out the relevant form or uploading the ICH-E2B XML file on the PvERS.

While adverse events are rare, transparency in the monitoring and management of AEFIs demonstrates the commitment of healthcare systems to patient safety. Collaboration of various stakeholders is key to an efficient and responsive AEFI monitoring system.

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