Adverse Events Following Immunization (AEFI)

Dr. Vikash Keshri

Learning Objectives:

• Identify common adverse events.

• How to Prevent Adverse Event From Occurring.

What do you understand by term

Vaccine.....

What is Vaccine ???

– Biological substance that is administered toindividuals to elicit immunity (protection) against aspecific disease.

– They may also contain preservatives, adjuvant andantibiotics

– Vaccines produce immune reaction once inside bodywhich produces immunity.

– Immunity may be temporary or permanent, short orlong term.

There is no vaccine which is 100% safe,

100% effective and without any risks.

AEFI:

“ An Adverse Event Following Immunization (AEFI) is a medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization”.

• May occur because of:

– Program error or

– Sensitivity to vaccine or it may occur

– Coincidentally.

• AEFIs must be taken seriously and the management must be rapid and professional.

• Common, minor side effects, such as:

Mild fever, pain, swelling or redness at the site of the injection, and irritability usually resolve without any serious consequences.

COMMON, MINOR REACTIONS

Vaccine

Local reaction

(pain, swelling,

redness)

Fever > 38oC

Irritability, malaise &

non specific

symptoms

BCG Common -- --

Hib 5% - 15% 2% - 10% --

Hepatitis BAdult up to 15%

Children up to 5%1% - 6% --

Measles/MMR Up to 10% 5% - 15% Up to 5% (rash)

Polio (OPV) -- Less than 1% Less than 1% *

Tetanus/DT/Td Up to 10% ** Up to 10% Up to 25%

Pertussis

(DPT - whole cell) cUp to 50% Up to 50% Up to 60%

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

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

What is ‘in’ vaccines that could 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 (Thiomerosal)

• A small amount of an antibiotic to preserve the vaccine (OPV)

• Some vaccines may also contain a small amount of an aluminium salt (DPT)

Types of AEFI:

AlgeriaIndia

Turkey

Yemen1997

Programmatic

error

Insulin given to 70 infants instead of DPT

vaccine resulting in 21 deaths

Insulin vial

Vaccine vials

TT DTP

Minor Reaction due to vaccination

AEFI: Rare, more serious reactions

• Serious reactions are rare

Include seizures, thrombocytopenia, hypotonic hypo responsive episodes, persistent inconsolable screaming

In most cases they are self-limiting and lead to nolong-term problems

Anaphylaxis, while potentially fatal, is treatablewithout any long-term effects

Reactions due to Vaccines:

How to minimize AEFIs ?

• Use a separate site for each vaccine.

• Use auto-disable syringes for all immunization injections.

• Use new disposable syringe for each reconstitution.

• Always check the label for the name of vaccine/diluent, expiry date and VVM.

• Shake the T series and Hep-B vaccine vials before drawing the dose.

• Reconstitute vaccines only with diluents supplied by the manufacturer for that Vaccine

• Record the time of reconstitution of vaccine on the vial label.

• Use Measles and BCG vaccine within 4 hours of reconstitution.

• If they could not be used with in stipulated time then discard the reconstituted vials..

• Never carry and use reconstituted vaccine from one session site to another.

• Do not store other drugs or substances in the ILR. These refrigerators are only meant for vaccines.

• After injection, do not attempt to re-cap or bend the needle.

• Ask the beneficiaries to wait for half an hour after vaccination to observe for anyAEFI.

• Leave the list of children vaccinated in a session with the AWW/ASHA and request them to be alert and report AEFIs. Share contact details of self and PHC.

Simple ways to improve injection safety

• Keep hands clean before giving injections

• Use sterile injection equipment, every time

• Prevent the contamination of vaccine and injection equipment

• Assume all used equipment is contaminated

• Practice safe disposal of all medical sharps waste

• Prevent needle-stick injuries

What is a safe injection?

A safe injection is an injection that does not cause harm to the recipient, the provider, or the community.

Keep hands clean before giving injections

• Wash or disinfect hands prior to preparing injection material.

• Avoid giving injections if the skin at the site of injection of the recipient is infected or compromised by local infection (such as a skin lesion, cut, or weeping dermatitis).

• Cover any small cuts on the service provider’s skin.

Prevent the contamination of vaccine and injection equipment

• Prepare each injection in a designated clean area where contamination from blood or body fluid is unlikely.

• If the injection site is dirty, wash with clean water

• Always pierce the rubber cap of the vial with a sterile needle.

• Follow product-specific recommendations for use, storage, and handling of a vaccine.

• Do not touch the needle or rubber cap of vial with your finger.

• Discard any needle that has touched any non-sterile surface.

Prevent needle-stick injuries

• Do not recap or bend needles.

• Collect sharps in a puncture proof container (Hub

cutter).

• Anticipate sudden movement of the child.

Assume all used equipment is contaminated:

Cut the used syringe at the hub immediately after

use.

AEFI system is NOT meant

to apportion blame to the field staff

but rather to assist and further support staff in providing high quality immunization services