aefi

1. Adverse Events Following
Immunization (AEFI)

2. AEFI – Incidents...
Yemen 1997:
Insulin given to 70 infants
70 infants instead of
DPT vaccine resulting in 21 deaths
21 deaths
PROGRAMMATIC ERROR
Insulin
vial
Vaccine vials
TT DTP
Programmatic
error

3. Case Study -2

4. AEFI – Incidents...
December 2001:
OPV immunization halted in UP state, after rumors
circulated by hard-line religious clerics stating that:
“OPV vaccine could cause sterility”
Nov/Dec 2003 during PPI:
7 deaths reported in AP, 4 in one district.
All were investigated and none were due to vaccination.
4 Deaths following DPT in one district caused
concern – Program halted - 2002

5. Why vaccinations then ?
Immunization..,
• Reduces morbidity, life
long disabilities and
deaths.
• May cause Mild fever &
redness at site of injection
as the most common
effects.
• Serious side effects are
very rare.
An ounce of prevention is better than a pound of cure!
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6. •It hits unexpectedly
•Events quickly spin out of
control
•The outcome seems
uncertain
•The whole programme is
at risk!
AEFIs lead to CRISIS

7. Importance of knowing about AEFI
To minimize the impact of the unavoidable AEFIs by providing
quality immunization services.
Health workers should be prepared with technical and
communication skills to address public concerns about vaccination.
To be able to respond rapidly, clearly and effectively to protect the
beneficiaries and the faith of the community on the immunization
program.

8. Definition
A medical event that takes place after an
immunization, causes concern and is believed to be
caused by immunization

9. What is in vaccines – that lead to AEFIs
Vaccines contain
• Very small dose of a live, but
weakened form of a virus
(Measles)
• Very small dose of killed
bacteria
• Small parts of bacteria
• Small dose of a modified
toxin produced by bacteria.
(TT)
Also
• A small amount of
preservative (Thiomerosol)
• A small amount of an
antibiotic to preserve the
vaccine (OPV)
• Some vaccines may also
contain a small amount of an
aluminium salt (DPT)

10. Classification
• Vaccine reactions -
True
• Vaccine Quality related
• Program Errors - >
95% and Preventable
• Coincidental – Child
getting Measles after
DPT injection
• Injection reaction-
Among older children

12. These may be classified into two types:

13. MINOR REACTIONS
MINOR REACTIONS
Usually occur within a few hours of injection.
Resolve after short period of time and pose little danger.
These can be managed through reassurance and symptomatic
treatment like extra fluids, rest and Paracetamol.
Hence, there is no need to report these reactions as AEFIs on a
routine basis.
Two types:
Local reactions & Systemic reactions
Local reactions and fever should be anticipated in only 10% of the
vaccine recipients, except in the case of whole cell DPT which
produces fever in nearly 50%.

14. Vaccine
Local reactions Systemic reactions
(pain, swelling, redness) Fever > 38°C
Irritability, malaise and
systemic symptoms
BCG 90% – 95% – –
Hepatitis B
Adults up to 15%, Children up
to 5%
1 – 6% –
Hib 5 – 15% 2% – 10%
Measles/MR/MMR ~ 10% 5% – 15% 5% (Rash)
OPV None Less than 1% Less than 1%
Pertussis (DTwP) up to 50% up to 50% up to 55%
Pnemucoccal
conjugate
~ 20% ~ 20% ~ 20%
Tetanus/DT/aTd ~ 10% ~ 10% ~ 25
Treatment • Cold cloth at injection
site
• Paracetamol
• To report if abscess
develops
• To give extra oral fluids
• Made to wear cool
clothing
• Tepid sponge or bath
• Paracetamol
• To report if accompanied
by other symptoms
• Give extra oral fluids
• Paracetamol
• Report if accompanied
by other symptoms

15. SEVERE REACTIONS
SEVERE REACTIONS
These are rare.
Usually do not result in long-term problems.
Can be disabling.
Are life threatening.
E.g. Sepsis or Toxic Shock Syndrome (TSS), Anaphylaxis,
Encephalopathy, seizures etc. caused by the body's reaction to a
particular component in a vaccine.
These may indicate problem with a specific batch of vaccine.
However, these may also result from Vaccine quality defect-
related reaction and Immunization Error related-reaction.

17. An AEFI that is caused or precipitated by a vaccine that is due to
one
or more quality defects of the vaccine product including its
administration device as provided by the manufacturer.
E.g. Failure by the manufacturer to completely inactivate a batch of IPV
leads to cases of paralytic polio.
Or a contaminant introduced in the vaccine
while manufacturing.
(2 ) Programme error
An AEFI that is caused by inappropriate vaccine handling, prescribing or
administration. It is preventable.
E.g. Transmission of infection by contaminated multi-dose vial.

18. (3) Injection Reaction
Vaccinated children or adults can react in anticipation to and as a
result of an injection of any kind. This reaction is unrelated to the
content of the vaccine .
E.g. Fainting, breath holding episodes,
in younger children, dizziness, light-headedness.
(4) Coincidental event
Coincidental events have only a temporal association with
vaccination and are not causally related.
It might occur as vaccines are mostly given at a age where
underlying diseases become evident, or due to many other causes.

19. E.g. Fever after vaccination but on investigation found to be due to
malaria, Pneumonia after OPV.
They are likely if:
ƒThe same or a similar event also affected others in the same age
group around the same time, but they did not receive the suspect
vaccine(s).
There is clinical/ laboratory evidence that the event is not related to
immunization.
Once an event is established as coincidental (e.g. pneumonia) no

20. True AEFIs
Mild Reactions
– Common
• Pain & swelling
• Fever
• Irritability & malaise
– They are self-limiting,
hardly requiring even
symptomatic
treatment
– It is important to
reassure parents
Severe Reactions
– Rare
– Most cases they are
self-limiting and do
not lead to long-term
problems
– Anaphylaxis, while
potentially fatal, is
treatable without any
long-term effects

21. Programmatic Error Adverse Event
Vaccine reconstituted with a wrong
diluent
Local reaction, abscess
Drug accidentally substituted for vaccine
or diluent
Effect of drug (e.g. insulin) even
death
Injection given in buttocks Sciatic nerve damage
Injection given using wrong technique Local reaction, abscess
Vaccine transported or stored improperly
Non potent vaccine, local
reaction
Contraindications ignored Serious vaccine reaction
Common Programmatic Errors

22. Events to be reported
immediately
• Death / Hospitalization
• Anaphylaxis
• TSS
• Anaphylactoid reaction
• AFP
• Encephalopathy
• Sepsis
• Cluster
• Persistent screaming
• HHE
• Injection site abscess
• Severe local reaction
• Seizures
• Brachial neuritis
• Thrombocytopenia
• Lymphadenitis
• Disseminated BCG infection
• Osteitis
Events to be reported
monthly
REPORTING

24. Patient &
Community
Sub center /
outreach
PHC /CHC
District
State
National Control Lab Vaccine
Manufacturer
DCG (I)
MoHFW
District Hospital/
UHC/
Other Institution
State FDA
District
FDA
Private
Practitioner
Channels and Timeline for reporting Serious AEFIs
Immediate
FIR – 2 4hours
FIR -24 hours
PIR 7 days
DIR 90 days
Vaccine sample
FIR – 24 hours
FIR -24 hours
PIR 7 days
DIR 90 days
Share Information
Immediately
Informs
Deaths
In consultation
with State
Immediate

26. Reporting formats and timelines
Type of Report Responsible Time line
FIR MO 24 hours to District
and 48 hours to GOI
PIR MO / DIO 7 days
DIR AEFI investigation
team
90 days

27. What causes a crisis?
• DON’T PANIC!
• THINK before you act, Then act
SWIFTLY
• Be clear, simple, straightforward
• BE HONEST AT ALL TIMES
Some golden rules
How to Handle!!!

28. Refer for prompt treatment
Inform concerned
supervisor / DIO
Assist in
Investigation
Keep contact with
parents & community
Role of health care worker

30. age-specific dose of adrenaline (1:1000) to be
administered
intramuscularly using tuberculin / insulin syringes

31. Health supervisors (HSs) ROLE IN AEFI

32. Prepare parents
for side effects
•Inform about
minor AEFIs
routinely, in a
non threatening
way
Long term plans

33. Educate the media – share – build a partnership

34. Monitoring AEFIs..,
Why Monitor?
• Helps to initiate timely corrective actions
• Helps keep public’s confidence in the
immunization programmes
• Helps to have a data base on AEFIs
• Helps to forecast and assess the risks

35. UNDERSTANDING BARRIERS TO REPORTING
• Not considering the event as related to immunization
• Not knowing about reporting system and process
• Lethargy - procrastination, lack of interest, inability to
find report form
• Fear that the report will lead to personal consequences
• Guilt about having caused harm and being responsible
for the event
• Uncertainty about reporting an event when not
confident about the diagnosis

36. • If people have no fear of vaccines, but
have fear of disease, they vaccinate their
children.
• If people have no fear of vaccines, but no
fear disease either, there is inertia.
• But if people have no fear of disease, but
fear of vaccines, they refuse vaccinations.
Behavior of the People ..,

38. THANK
YOU!!!!