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Global Training Network Programme World Health Organization WHAT IS AN ADVERSE EVENT FOLLOWING WHAT IS AN ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI)? IMMUNIZATION (AEFI)? A medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization Vaccine reaction - caused by vaccine’s inherent properties Programme error - caused by error in vaccine preparation, handling, or administration Coincidental - happens after immunization but not caused by it a chance association Injection reaction - anxiety or pain of injection not vaccine

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Global Training Network ProgrammeWorld Health Organization

WHAT IS AN ADVERSE EVENT FOLLOWING WHAT IS AN ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI)?IMMUNIZATION (AEFI)?

A medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization

Vaccine reaction - caused by vaccine’s inherent properties

Programme error - caused by error in vaccine preparation, handling, or administration

Coincidental - happens after immunization but not caused by it a chance association

Injection reaction - anxiety or pain of injection not vaccine

Unknown - cause cannot be determined

Global Training Network ProgrammeWorld Health Organization

VACCINE REACTIONSVACCINE REACTIONS

Common, minor reactionsvaccine stimulates immune systemsettle on their ownwarn parents and advise how to manage

Rare, more serious reactionsanaphylaxis (serious allergic reaction)vaccine specific reactions

Global Training Network ProgrammeWorld Health Organization

Irritability, malaise & systemic symptoms

COMMON, MINOR REACTIONSCOMMON, MINOR REACTIONS

Fever >38C

BCG

Hib

HepBMeasles/MMRPolio (OPV)

DTP(pertussis)

Tetanus

90-95%

5-15%

Adults: 15%; Children: 5%

~10%

-

Up to 50%

~10%*

-

2-10%

-

5-15%

<1%

Up to 50%

~10%

-

-1-6%

5% rash

<1%**

Up to 55%

~25%

* Rate of local reactions likely to increase with booster doses, up to 50-85%

** Symptoms include diarrhoea, headache, and/or muscle pains

Vaccine Local reaction (pain, swelling, redness)

Global Training Network ProgrammeWorld Health Organization

MANAGEMENT OF COMMON, MINOR REACTIONSMANAGEMENT OF COMMON, MINOR REACTIONS

Local reactioncold cloth at injection siteparacetamol

Fever >38°Cgive extra fluidstepid sponging paracetamol

Irritability malaise and systemic symptomsgive extra fluidsparacetamol

Global Training Network ProgrammeWorld Health Organization

RARE, MORE SERIOUS REACTIONSRARE, MORE SERIOUS REACTIONS

0.76-1.3 (1st dose)0.17 (subsequent doses)0.15 (contacts)

4-30 daysVaccine-associated paralytic poliomyelitis (VAPP)

Risk is higher for first dose, adults, and immunocompromised

OPV

333331-50

5-12 days15-35 days0-1 hour

Febrile seizuresThrombocytopaeniaAnaphylaxis

Measles/MMR

1-25

0-1 hour1-6 weeks

AnaphylaxisGuillain Barré syndrome

Hep B

Nil knownHib

100-10001-7002

2-6 months1-12 months1-12 months

Suppurative lymphadenitisBCG osteitisDisseminated BCG

BCG

Rate per million doses

Onset interval

ReactionVaccine

Global Training Network ProgrammeWorld Health Organization

RARE, MORE SERIOUS REACTIONS (2RARE, MORE SERIOUS REACTIONS (2))

1000-60 000

570570

200-1

0-24 hours

0-3 days0-24 hours

0-1 hour0-3 days

Persistent (>3 hrs) inconsolable screamingSeizuresHypotonic, hyporesponsive episode (HHE)Anaphylaxis/shockEncephalopathy

DTP

Nil extra to tetanus reactionsTetanus-diphtheria

5-101-66-10

2-28 days0-1 hour1-6 weeks

Brachial neuritisAnaphylaxisSterile abscess

Tetanus

Rate per million doses

Onset interval

ReactionVaccine

Global Training Network ProgrammeWorld Health Organization

RARE, MORE SERIOUS REACTIONS (3)RARE, MORE SERIOUS REACTIONS (3)

500-4000 in infants<6 months

5-20

7-21 days

0-1 hours

Post-vaccination Encephalitis

Allergic reaction/anaphylaxis

Yellow fever

10-1000

1-2.3

Serious allergic reaction

Neurological event

Japanese encephalitis

Rate per million doses

Onset intervalReactionVaccine

Global Training Network ProgrammeWorld Health Organization

RARE, MORE SERIOUS REACTIONSRARE, MORE SERIOUS REACTIONS

BCG

Hib

HepB

Measles/MMR/MR

Suppurative lymphadenitis BCG osteitis Disseminated BCG infection

1 in 1000 to 1 in 10 000 1 in 3000 to 1 in 100 million ~1 in 1 million

None known

Anaphylaxis 1 in 6-900 000

Febrile seizures Thrombocytopaenia Severe allergic reaction Anaphylaxis Encephalopathy

1 in 3000 1 in 30 000 ~1 in 100 000 ~1 in 1 million <1 in 1 million

Reaction Incidence

Global Training Network ProgrammeWorld Health Organization

RARE, MORE SERIOUS REACTIONS (2)RARE, MORE SERIOUS REACTIONS (2)

Tetanus

Pertussis (DTP-

whole cell)

Reaction IncidencePolio(OPV)

Vaccine associated paralytic poliomyelitis

Risk is higher for first dose, adults, and immunocompromised

1 in 2.4-3.3 million doses

1 in 750 000 first dose compared to 1 in 5.1 million for subsequent doses

Brachial neuritis Anaphylaxis

0.5-1 in 100 000 1 in 100 000 to 1 in 2 500 000

Persistent inconsolable screaming Seizures Hypotonic, hyporesponsive episode (HHE) Anaphylaxis Encephalopathy (Note: Risk may be zero)

1 in 15 to 1 in 1000 1 in 1750 to 1 in 12 500

1 in 1000 to 1 in 33 000

1-6 in million

0-1 in 1 million