Adverse Events Following Immunisation

AEFI
Adverse Events Following Immunisation

Dr.K.Sudhakar,MD., Professor &HOD

Department of General Medicine.,GGH Guntur

Expert Committee member/Covid-19 Command Control room

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Covishield-Viral Vector Vaccine

•The gene for a pathogen protein is inserted into a different virus that can infect someone without causing disease

•The safe virus serves as a ‘platform’ or ‘vector’ to deliver the protein that triggers an immune response

•The safe virus is then injected as a vaccine

•Some replicate (reproduce) in the body and some do not

•A harmless Virus Vector transports Virus gene

•Current ex: Ebola, Zika, Dengue vaccines

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ChAd0x1 nCoV-19 Corona Virus Vaccine (Recombinant)

•Co-developed by University of Oxford & British Swedish company Astra Zenca, manufactured by Serum institute of India.

•Called as Covishield in India.

•Emergency authorisation to use given by UK, India, Argentina & Mexico.

•Scientists engineered a version of Adeno virus that infect chimpanzees to carry the gene responsible for the spike protein of the novel Corona Virus.

•Two doses /4-6 weeks apart– to get the desired effect.

•Eligibility-18years old and above

RISKS OF COVISHIELD- VERY COMMON –
May effect more than 1 in 10 people

Side effects

•Tenderness, pain, warmth, redness, itching, swelling or bruising at the

Injection site.

•Generally feeling unwell

•Feeling tired (fatigue)

•Chills or feeling feverish

•Headache

•Being sick (nausea)

•Joint pain or muscle ache

Management

•Cold application at the site of injection

•Tab Paracetamol

•Assurance

•Touch with health provider

RISKS OF COVISHIELD- COMMON –
May effect up to 1 in 10 people

Side effects

•A lump at the injection site

•Fever

•Being sick (nausea)

•Flu like symptoms: high fever, chills, running nose, sore throat & cough

Management

•Cold application at the site of injection

•Tab paracetamol

•Assurance

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RISKS OF COVISHIELD- UNCOMMON –
May effect up to 1 in 100 people

Side effects

•Feeling Dizzy

•Decreased Appetite

•Abdominal pain

•Enlarged lymph nodes

•Excessive sweating

•Itchy skin or Rash

Management

•Assurance

•Symptomatic treatment

RISKS OF COVISHIELD-

•Serious & unexpected side effects may occur

Like ANAPHYLAXIS

•Covishield vaccine is still being studied in Clinical trials.

Very common side effect

Treatment -Minor

•Swelling & redness

Cold cloth at injection site

Paracetamo (lf pain persists)

• For Fever >38C

Give extra oral fluids

Wear cool clothing

Tepid sponge or bath

Paracetamol 500mg SOS

Severe reactions

ANAPHYLAXIS

•Life threatening anaphylactic responses of sensitized humans occur with in minute after systemic exposure to specific antigen generally by injection.

•Vaccine induced anaphylaxis commonly due to thiomersal which is a vaccine preservative.

•Vaccine is contraindicated in people with past history of vaccine induced reactions and any allergic reactions.

•Vaccines induces anaphylaxis 1 in 100000.

•Covishield is a Viral vector vaccine which is a safe one.

Clinical manifestations- of anaphylaxis

1. Sensation of lump in the throat, Hoarseness of voice or stridor indicates laryngeal oedema.

2. Feeling of tightness of chest and audible wheezes indicates bronchial obstruction.

3. Followed by Vascular collapse or shock sometimes

Manifestations are mild to fatal

4. Flushing with diffuse erythema and a feeling of warmth

5. Intensely pruritic urticarial rash

6. Skin angioedema

7. Angioedema-of bowel wall cause sufficient intravascular volume depletion to precipitate cardiovascular collapse.

Management –of anaphylaxis
Early recognition is mandatory since Death can occur within minutes to hours after the first symptoms

1. For mild symptoms like Pruritus & Urticaria

Adrenaline 0.3ml to 0.5ml of 1:1000 (1mg/ml) to be given deep intramuscular or S.C

2. Repeated doses required at 5-20mts interval for a severe reaction and if needed Adrenaline 2.5ml diluted 1:10000 at a 5 -10mts interval by Intravenous route.

3. I.V infusion by Volume expanders : Normal Saline and Dopamine infusion for intractable hypotension.

Management-continued

4. Oxygen alone with cannula or with nebulized bronchodilator helpful

but severe hypoxia needs endotracheal intubation or tracheostomy.

5. Antihistamine like Diphenhydramine 50-100mg IM or IV and

Inj.Aminophyllin ,0.25-0.5g IV infusion are useful for urticaria -angioedema and bronchospasm (ancillary)

6. IV Steroids :0.5-1mg/kg of methyl prednisolone or Hydrocortisone 100mg BiD are not effective for acute event but may decreases the recurrence of bronchospasm, hypotension or urticaria.

Immunization error related reaction

•Errors in vaccine preparation, handling, storage or administration.

• They are preventable and detract from the overall benefit of the immunization program.

•Immunization errors can result in a cluster of events, defined as two or more cases of the same adverse event related in time, place or vaccine administered.

• These clusters are usually associated with a particular provider or health facility, or a vial of vaccine that has been inappropriately prepared or contaminated.

• Immunization errors can also affect many vials, for example, freezing vaccine during transport may result in an increase in local reactions.

Immunisation anxiety related reactions

Individuals can react in anticipation to and as a result of an injection of any kind. These reactions are not related to the vaccine, but to fear of the injection.

Four types are recorded