1. Adverse Events Following Immunization, AEFI

2. AEFI
WHAT IS AN AEFI?
AEFI IS A MEDICAL INCIDENT AFTER AN IMMUNIZATION AND IS BELIEVED TO BE CAUSED BY THE IMMUNIZATION
BASICALLY TWO TYPES
AVOIDABLE AND UNAVOIDABLE

3. AEFI MODERN VACCINES ARE GENERALLY SAFE NOT ENTIRELY WITHOUT RISK
BENEFITS FAR OUTWEIGH RISKS

4. AEFI WHY MONITORING OF AEFI ARE IMPORTANT ? UPSETS PEOPLE
REFUSAL FOR FURTHER IMMUNIZATION

5. AEFI CLASSIFICATION OF AEFI VACCINE EFFECT PROGRAMME ERROR
COINCIDENTAL
INJECTION REACTION
UNKNOWN

6. AEFI THE USEFULLNESS OF MONITORING AEFI TO IDENTIFY PROGRAMME ERRORS
IDENTIFY VACCINE DEFECTS
TAKE CORRECTIVE MEASURES
INCREASE IMMUNIZATION ACCEPTANCE
IMPROVE THE QUALITY OF SERVICES

7. AEFI AEFI ARE DUE TO: VACCINE
EVENT CAUSED OR PRECIPITATED BY THE VACCINE WHEN GIVEN CORRECTLY, CAUSED BY THE INHERENT PROPERTIES OF THE VACCINE

8. AEFI PROGRAMME ERROR EVENT CAUSED BY AN ERROR IN VACCINE: PREPARATION
HANDLING
ADMINISTRATION

9. AEFI
COINCIDENTAL
EVENT THAT HAPPENS AFTER IMMUNIZATION BUT NOT CAUSED BY THE VACCINE – A CHANCE ASSOCIATION

10. AEFI INJECTION REACTION
EVENT FROM ANXIETY ABOUT, OR PAIN FROM THE INJECTION ITSELF RATHER THAN THE VACCINE
UNKNOWN
THE CAUSE OF THE EVENT CANNOT BE DETERMINED

11. AEFI SURVEILLANCE DETECTION AND REPORTING INVESTIGATION DATA ANALYSIS
CORRECTIVE ACTION
EVALUATION

12. HOW CAN AEFI’S BE DETECTED? WHAT MECHANISMS ARE AVAILABLE?

13. AEFI LIST OF AEFI LOCAL ADVERSE EVENTS CNS ADVERSE EVENTS
OTHER ADVERSE EVENTS

14. AEFI
LOCAL ADVERSE EVENTS
1.INJECTION SITE ABSCESS
STERILE
BACTERIAL

15. AEFI FORMATION OF A STERILE ABSCESS
WRONG ROUTE (SC INSTEAD OF DEEP IM)
NOT SHAKING THE VACCINE BOTTLE BEFORE DRAWING IN TO THE SYRINGE
WRONG DOSE (LARGER DOSE)

16. AEFI
2. LYMPHADENITIS
AT LEAST ONE LYMPH NODE 1.5 CM IN SIZE OR DRAINING SINUS OVER LYMPH NODE 2 – 6 MONTHS AFTER BCG ON THE SAME SIDE AS INOCULATION

17. AEFI 3. SEVERE LOCAL REACTION
REDNESS AND/OR SWELLING AT THE SITE WITH ONE OR MORE OF THE FOLOWWING
1. SWELLING BEYOND JOINT
2. LASTING MORE THAN 3 DAYS OR
3. REQUIRES HOSPITALIZATION

18. AEFI CNS ADVERSE EVENTS ACUTE PARALYTIC POLIOMYELITIS WITHIN 4-75 DAYS
RESIDUAL PARALYSIS AFTER 60 DAYS OR DEATH

19. AEFI 2. GBS 3. ENCEPHALOPATHY OCCURING WITHIN 30 DAYS
CASES OCCURING WITHIN 72 HOURS AFTER VACCINATION

20. AEFI 4. ENCEPHALITIS 5. MENINGITIS CASES OCCURING WITHIN 72 HOURS
WITHIN WEEKS
SEIZURES – AFEBRILE
- FEBRILE

21. AEFI OTHER ADVERSE EVENTS 1.ALLERGIC REACTION 2.ANAPHYLACTIC SHOCK
3.ARTHRALGIA
4.DISSEMINATED BCG-IT IS
5.HIGH FEVER

22. AEFI OTHER ADVERSE EVENTS(CONT)
6. HYPOTENSIVE EPISODE (SHOCK/COLLAPSE)
7. OSTEITIS/OSTEOMYELITIS
8. PERSISTENT SCREAMING
9. SEPSIS (SEVERE GENERALIZED ILLNESS CONFIRMED BY BLOOD CULTURE)

23. AEFI OTHER ADVERSE EVENTS(CONT) 10.TOXIC SHOCK SYNDROME
FEVER, VOMITTING AND WATERY DIARRHOEA- FEW HOURS AFTER IMMUNIZATION – OFTEN LEADING TO DEATH

24. Examples of types & frequency of AEFIs (in some common vaccines)

25. AEFI Avoiding Programme Errors
Use sterile needle & syringe for every injection
Reconstitute only with specific diluent
Discard reconstituted vaccines after six hours
Do not store drugs & other medicines in the same fridge as the vaccines and diluents
Train & supervise health workers to ensure safe injection practices
Monitor, Investigate and Act when AEFIs occur
Programme Error and their Consequences

26. AEFI Why monitor AEFI? No vaccines are 100% safe and without any risks
It is important to know the risks and how to handle such an event when it occurs
Informing people correctly on AEFI helps keep public’s confidence in the immunization programmes
Monitoring AEFI also helps improve the quality of service

27. AEFI Steps in AEFI surveillance Detection and reporting Investigation
Data analysis
Corrective and other actions
Evaluation
This slide outlines the basic steps to be taken when an AEFI is reported and you are called upon to investigate. An investigation of an AEFI follows the same principles of investigation, containment, and public health education just like for any other disease outbreak.
It is better to have a team formed, with clear cut job responsibilities during the investigation. For example, who is the team coordinator, who is the media focal person, who will do the data quality control, who will be responsible for the data analysis, and who will coordinate the public education activities. Once a team is formed, the team must have a clear idea as to what resources would be needed. But MOVE QUICKLY as investigation and response must be rapid and effective
However, while the team is being formed and resources gathered, the health worker at the local site, to the best of his abilities, must initiate investigation, provide treatment and support, and allay public fear and anger

28. AEFI Detection and reporting
Every individual that administers an immunization injection should know about AEFI
There should be a national system for detecting and reporting of AEFI
At least the following should be included in the national AEFI monitoring system- “trigger events”
All injection site abscesses
All cases of BCG lymphadenitis
All deaths suspected to be related to immunization
All hospitalisation suspected to be related to immunization
For those who are not aware, the WHO publication, “Surveillance of adverse events following immunization, Field guide for managers of immunization programmes,” (WHO/EPI/TRAM/93.02/REV.1) is an excellent resource book, as a guide for both the development of a national AEFI monitoring and reporting system as well as investigating an AEFI. If copies are required, contact WHO, EPI Programme, either in the respective WHO Regional Offices, or WHO/HQ, Geneva.
The four “trigger events” listed above, and some add a fifth one -’Other severe or unusual medical incidents that may be thought to related to immunization,” are important indicators. The basic idea is have these “trigger” events built into a routine reporting system so that they act as triggers to fire a response when something is reported. Most routine EPI do not conduct systematic AEFI investigations on a regular basis unless there is an adverse (real or false) reported.

29. AEFI Detection and reporting
The above basic categories act as “trigger” mechanisms for further course of action
The national monitoring system should define the flow of information and mechanisms for taking actions
While minor events may be recorded and reported as a routine activity to be analysed only at periodic times, sudden, unexplained deaths or large scale hospitalisation or a cluster of events reported following immunisation warrants immediate investigation
It is necessary for National Immunization Programmes to define their trigger events, the manner of reporting those events, and the process of responding when a trigger event actually is reported. It is essential to establish clear responsibilities among health workers at the local level, and at higher level, amongst public health experts and NIP programme functionaries.
Health workers must be trained and must be given clear guidelines as to what is to be reported normally, what is to be considered abnormal and, in the event of an abnormal event occurring, what actions to take place, who to contact and to whom to pass on the information.

30. AEFI Investigation AEFI investigation will attempt to
confirm or propose alternative diagnosis of the reported event
identify the specifications of the vaccine incriminated
examine the operational aspects of the programme
identify whether it was an isolated event or a cluster of events and, if a cluster, where the immunization was given and what vaccines were used
Preliminary investigation may be carried out by the local health worker, but serious AEFIs or clusters of AEFIs should be investigated by special teams from district or central level
An AEFI investigation follows the same principles of investigation as any disease outbreak investigation. Of course, the actions will differ slightly at different stages.

31. AEFI
Investigation
Data on the patient(s); vaccine (lot number, expiry, manufacturer, lab results if any), storage, reconstitution practice, diluent used, general disease information in the area, similar disease episodes in unimnunized persons in the same locality, etc. should be collected
Collect samples of vaccines and diluents used (make sure vaccine sample collected are kept in the cold chain)
The slide is self-explanatory

32. AEFI: An example of an AEFI investigation
Background
It is reported that following a measles campaign in a primary school in District X, several children had convulsions. It was widely rumoured that the measles injection was responsible for it
Hypothesis
that the reported health event (convulsion) was an AEFI following measles vaccination
Define the case
You define your ‘case’ as any child in that primary school who received measles injection on that particular day and had convulsions.
As an example, the following slides will demonstrate the approach and process to an AEFI investigation.

33. AEFI: example contd.. Case investigation
Line list all children, with age & sex, who had received measles injection on that day
Find those that reported to have had convulsions
Find out all the details regarding the convulsions- onset time after immunization, manner of convulsion, recovery following the convulsion, concomitant medications, fever, any other health problems. Determine the quality of the vaccine (expiry, storage), reconstitution, diluent, injection process, etc.
Take samples of the vaccine vials used for lab testing
Scrutinise the stock entries, stock balance, etc.
Example of investigation, continued….

34. AEFI: example contd..
One child had an attack of fit half an hour after the immunization. Following this three other children had fainting spells in the same class. All recovered spontaneously although the child who had the first convulsion took longer to recover. Also, the first child sustained a minor cut on the forehead from the fall
Next day, five more children called in sick on grounds that they had also attacks of fits after the school
Example of investigation continued….

35. AEFI
Data analysis
Once the data is collected, it should be analysed as quickly as possible to determine whether the AEFI is
Programme related (incorrect dose of vaccine, wrong site, wrong diluent, improper storage & handling, use of other medicines as diluent, etc.)
Vaccine induced AEFI
Coincidental AEFIs (caused by something other than vaccine or programme errors)
Unknown
Laboratory support
If patient hospitalised, tests may confirm diagnosis
Testing vaccines often yield doubtful answers
Send case investigation report with vaccine for test
The slide is self explanatory

36. AEFI: example contd.. Data Analysis
You find that the vaccine used has not expired, was well maintained in the cold chain, correct diluent was used,
There was no evidence of contamination, the health workers always discarded reconstituted vaccine at the end of the session.
The medical history showed that the fits which the other children had were mere fainting spells, lasting only for a few moment, with spontaneous recovery. No subsequent attacks occurred
The index child had a true convulsion. No fever or other illnesses at that time.
This slide continues on the example of an AEFI investigation….

37. AEFI: example contd..
However, going over the medical history of the child, the health worker recalled that last year the same child had an episode of convulsion for which he had provided treatment. He had advised that the parents should consult a medical or a neurological expert for further management. On questioning, it was found that the parents did not have the time or the money to do that and it was felt that it would resolve naturally
Example of AEFI investigation..cotd..

38. AEFI Corrective and other actions
Action must not wait for investigation to be completed
Treat the patient(s) as the first response
Communicate, inform the public, parents, media people on the event, actions being taken & next steps
Once the investigation is completed, publicise the results
Take corrective actions, where necessary
Training of health workers & supervision to prevent avoidable AEFIs in future

39. AEFI: example contd.. Conclusion
From the available information, and based on the data analysis, you conclude that event was not an AEFI, but Coincidental.
Following this, you will take time to explain to the parents, teachers and the community about the event, your investigation and your final conclusions.
Example, contd…
The point to be highlighted here is that investigation without corrective actions is not good enough. Investigation must lead to improvement in the manner in which future activities would be carried out. It is also an opportunity to provide field workers the chance to learn to conduct such investigation and also provide them hands-on training.
The second point to be highlighted is that actions must NOT wait till investigation is complete. Patients are priority: treat them and make sure that all available support is given to them. Next is the general public or the parents. Give them enough information, show that you care about this as much as they do and that your interest in the welfare of their children is genuine and professional.

40. AEFI
Evaluation
Like any other surveillance systems, AEFI surveillance must also be evaluated periodically to examine its usefulness and to modify it if necessary
Issues to consider when evaluating a surveillance system are
timeliness, completeness, accuracy of the system
swiftness with which response was effected when a trigger event was reported
appropriateness of actions taken
potential for strengthening of immunization system
Finally, a surveillance system should be as flexible to make it more appropriate to changing needs. Evaluation of a surveillance system may not be necessary as an annual exercise, but periodically a group of experts must sit together to review the relevance and usefulness of the surveillance system and make changes, where appropriate or necessary.

41. AEFI
An ounce of prevention is always better than a pound of cure. Good training & close supervision of health workers, coupled with a functioning surveillance system for monitoring & reporting are the best guarantee against the likelihood of an event occurring at all
That is simple enough to need no further explanation.
Thank You