Adverse Event Following Immunization

(AEFI) Monitoring and Reporting

Central Luzon Center For Health Development

Regional Epidemiology And Surveillance Unit- Field Health Service Information System (RESU-FHSIS)
Adverse Event Following Immunization (AEFI)
• ANY untoward medical occurrence which follows immunization
and which does NOT necessarily have a causal relationship with
the usage of the vaccine.
AEFIs may be classified based on seriousness, or by
cause.
1. Serious AEFI: events that results in any of the 2. Minor or Non-serious AEFI: not included or
following outcomes categorized as serious AEFIs, or do not pose a
a. death; potential risk to the health of the recipient
b. hospitalization or prolongation of an
existing hospitalization;
a. Local adverse events (such as pain,
c. persistent or significant disability or swelling, redness) and systemic reaction
incapacity; (fever, irritability, malaise, muscle pain,
d. congenital anomaly or birth defect; diarrhea) that are expected after
e. Or an event that may be life-threatening; immunization, which are usually self-
or limiting
f. requires intervention to prevent the above
outcomes; or b. May provide signal a potentially larger
problem with the vaccine or vaccination or
g. a medically important event or reaction have an impact on the vaccination
acceptability; in general.
CAUSE–SPECIFIC CATEGORIZATION OF ADVERSE EVENT
FOLLOWING IMMUNIZATION

I. Vaccine product related reaction

II. Vaccine quality defect-related reaction
III. Immunization error-related reaction
IV. Immunization anxiety-related reaction
V. Coincidental event

Source: WHO and Council for International Organizations of Medical Sciences (CIOMS)
AEFIs may be classified based on seriousness, or by
cause.
• 1. Vaccine product-related reaction: • 4. Immunization anxiety-related
due to one or more of the inherent reaction: factors may include older age
properties of the vaccine product. groups, the different vaccination
environments, the novelty of the
vaccines and their administration
• 2. Vaccine quality defect-related modalities.
reaction: due to one or more quality
defects of the vaccine product including
its administration device as provided by
the vaccine manufacturer. • 5. Coincidental event: something
other than the vaccine product,
immunization error or immunization
anxiety.
• 3. Immunization error-related
reaction: caused by inappropriate
vaccine handling, prescribing or
administration and so is preventable.
 AEFI Surveillance

- used for immunization program monitoring and evaluation, policy

formulation, decision making, advocacy and health promotion, and
planning for public health intervention.
 Objectives of AEFI SurveillancE

 To detect and timely identify problems with vaccines, which could be

due to the inherent properties of vaccines
 To detect, correct and prevent immunization error-related reactions
 To identify clustering or unusually high rates of AEFI even if they are
considered as mild
 Objectives of AEFI Surveillance

 To ensure that coincidental events do not negatively affect the

immunization program
 To ensure and facilitate causality assessment of coincidental, serious
and unexpected/unusual AEFIs
AEFI Surveillance
AEFI Surveillance
AEFI Surveillance
I. Detection and Reporting

II. Investigation

III. Causality Assessment

IV. Analysis

V. Feedback
I. Detection and Reporting
• The detection and reporting of AEFIs shall be a shared responsibility among DRUs,
including all health facilities, healthcare providers, and vaccine recipients.
• For newly introduced (novel) vaccines such as those for Covid-19, all AEFIs, regardless
of severity, that are suspected by the health care provider to be associated to the
vaccine, are immediately notifiable and shall be reported by the DRU using appropriate
reporting platform upon collection of the minimum required case details.
Source: A Manual of Procedure for Surveillance and Response to AEFI 2014 National Epidemiology Center Department of Health
AEFI Reporting
• A serious event of known or unknown causes; all
hospitalizations
• Cluster of minor cases
• Events associated with newly introduced vaccine
What to Report? • Suspected to be caused by immunization error
• Appears on the list of events defined for AEFI surveillance
• Causing a significant parental or public concern
• All deaths suspected to be caused by the vaccine

All health care providers (doctors, nurses, midwives) in hospitals

Who should report and to whom should they report? or non-hospital health facilities. Reports will be submitted to
their hospital or local ESU (DOH Central Office)

What form to use? Case Investigation Form. (https://bit.ly/AefiCif)

For non-serious AEFIs: Fill out CIF page 1 or report online for
initial report; DRU/ESU shall encode to VigiFlow For serious and
Non-serious AEFIs: Fill out CIF and submit to RESU AFTER
When to report? determining the final/valid diagnosis accompanied by complete
documents/records for workups done. If diagnosis is uncertain,
fill out CIF and submit on the day of patient discharge or 12
hours prior.

Cooperate by readily providing medical records as per Department Circular No. 2021-0247: Immediate Provision of Access to Medical Records by
Hospitals to Epidemiology and Surveillance Units to aid Investigation of Adverse Events Following Immunization
I. Detection and Reporting
II. Investigation
• The RESU of the region where the AEFI case was last admitted shall take the lead in
investigating and compiling the minimum required case files to proceed with the
causality assessment, as necessary and in close coordination with the respective
HESUs, LESUS, and Local Health Officers.
• The LESUs, with the assistance from the RESUs, shall immediately conduct
community case investigation for cases with complete clinical investigations and with
concluded AEFI case investigation, observing the AEFI case investigation guidelines.
• The protocols on the investigation of death following immunization including the
conduct of medical autopsy shall abide by the Department Memorandum No. 2021-
0425 (Interim Guidelines for the Conduct of Medical Autopsies for Deaths Following
Immunization with Covid-19 Vaccines)
Purpose of AEFI Investigations

1. To confirm a reported diagnosis of AEFI and clarify the details and outcome;
2. To determine whether unimmunized persons are experiencing the same medical event/s;
3. To investigate the link between the vaccine given and the AEFI;
4. To determine the contribution of operational aspects of the program to the reported AEFI;
5. To determine whether a reported event was isolated or part of a cluster;
6. To determine the cause of the AEFI so as to provide the best intervention/medical care and take any further
action deemed necessary.
 III. Causality Assessment
What is Causality Assessment?
- Refers to the systematic review of data about an AEFI case. It aims to determine the likelihood of a causal
association between the event and the vaccine(s) received. This process is a critical part of AEFI surveillance
and monitoring system and enhances public and health worker’s confidence in the national immunization
programmed.

Causality assessment is important for:

• Identification of vaccine related problems
• Identification of immunization error related problems
• Excluding coincidental events
• Detection of signals for potential for follow up, testing of hypothesis and research
• A basis for estimation of rates of serious AEFIs
• Comparison of AEFIs between vaccine brands
• Validation of pre-licensure safety data with comparison of post marketing surveillance safety data
III. Causality Assessment
Prerequisites for causality assessment AEFI

• Completed AEFI case investigation. Premature assessments with inadequate information could
mislead the classification of the event.

• Complete documents pertaining to the investigation such as hospital charts, laboratory and
autopsy findings should be available at the time of assessment.

• There must be a “valid diagnosis” for the unfavorable or unintended sign, abnormal laboratory
finding, symptom or disease in question.
IV. Analysis
• All concerned staff involved in the vaccination program shall endeavor to perform
routine pharmacovigilance analysis using vaccine safety data, within their scope of
service
V. Feedback
• Result of causality assessment conducted shall be documented and transmitted to
appropriate stakeholders
Thank you!