Information for health-care workers - managing adverse events
What to do in the event of an AEFI
Programme managers faced with the report of one or several AEFIs will need to investigate what has happened.
Checklist for programme/district manager
Be prepared (Steps to take before an event occurs)
- Read the documents: "Surveillance of adverse events following immunization: field guide for managers of immunization programmes" WHO/EPI/TRAM/93.2 and. “Immunization safety surveillance – guidelines for managers of immunization programmes on reporting and investigating adverse events following immunization.” WPRO/EPI/99.01
- Develop a standard case definition for AEFI and standard investigation procedures.
- Designate and train staff to conduct an AEFI investigation using the investigation form.
- Train staff on how to collect specimens.
- Inform all health workers/clinicians of the need to immediately report an AEFI which meets the case definition.
- Identify a person to notify WHO and UNICEF if a donated or UN-supplied vaccine is suspected.
- Identify a spokesperson for public communications.
Receiving a report
- Decide if the report is a genuine AEFI according to your definition, and whether it needs investigating and/or announcing to the public. (Consult with immunization programme managers at the next level of the health system if necessary).
- Arrange to travel to the location of the AEFI, or delegate responsibility to another trained person or team to do this.
Investigate and collect data
- Ask about the vaccine.
- Ask about immunization services.
- Ask about the patient.
- Observe the service in action.
- Observe the storage procedures for vaccines and diluents in the relevant location(s) (health unit refrigerator, district store etc.); are other drugs stored with the vaccine or diluent that may have mistakenly been used?
- Take an inventory of drugs/chemicals in storage at the location.
- Formulate a hypothesis as to the cause of the AEFI.
- from the patient (urine, blood, tissue specimens as appropriate); implicated vial(s) of the vaccine; and the syringes and needles. Note: most paralyzing agents implicated in many previous case histories are excreted in the urine.
- Know where and how to dispatch specimens for testing.
Analyze the data
- Obtain laboratory results.
- Review clinical findings.
- Review on-site investigation.
- Review epidemiological findings e.g. clustering of cases in time or space or by vaccine manufacturer or lot.
- Summarize and report findings.
- Consult WHO or other experts for assistance when needed.
- Communicate with health staff (e.g. treatment, information).
- Communicate findings and action to the public.
- Correct problem (based on the cause) by improving training, supervision, and/or distribution of vaccines/injection equipment.
- Replace vaccines if appropriate (always consult with national authorities, and, where appropriate, with WHO and UNICEF staff).