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Adverse Events Following Immunization Dr S.M.Zahraei Center for Disease Control Ministry of Health and Medical Education. Detect. Report. Respond. Investigate. TREND OF DIPHTHERIA IMMUNIZATION COVERAGE & CASES (1984 –2003 , I.R.IRAN).

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respond

Adverse Events Following Immunization

Dr S.M.Zahraei

Center for Disease Control

Ministry of Health and Medical Education

Detect

Report

Respond

Investigate

slide8

TREND OF HEPATITIS B IMMUNIZATION COVERAGE (1994 –2003,I.R.IRAN)

Prevalence rate of H.B :

Survey 1991 : 3 %

Survey 1999 : 1. 7 %

slide9
AEFI is 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
slide10

Coincidental

    • happens after immunization but not caused by it a chance association
  • Injection reaction
    • anxiety or pain of injection not vaccine
  • Unknown
    • cause can not be determined
cluster of aefi
Cluster of AEFI

>=2 cases of the same adverse event following immunizations related in time, geography or in the vaccine administered

  • Why is it important to monitor for clustering?
potential objectives for aefi surveillance system
Potential Objectives For AEFI Surveillance System
  • Detect, correct, and prevent programme errors
  • Identify problems with vaccine lots or brand
  • Prevent false blame from coincidental events
  • Maintain confidence by properly responding to parent/community concerns while increasing awareness (public and professional) about vaccine risks
slide13

Generate new hypotheses about vaccine reactions that are specific to the population

  • Estimate rates of occurrence on AEFI in the local population, compared with trial and international data (particularly for new vaccines being introduced)
which events to report
Which Events To Report?
  • Death, hospitalization, or other severe/unusual events
  • Toxic shock syndrome
  • Severe local reaction
  • Sepsis
  • Injection site abscess (bacterial/sterile)
  • BCG lymphadenitis
  • AEFIs causing concern or suspicion of vaccine involvement
which reports to investigate
Which Reports To Investigate?

Investigate if

  • possible programme error
  • serious event of unexplained cause
  • above expected rate (not just numbers)
  • potential damage to the immunization programme

Certain events (toxic shock syndrome, sepsis, abscess,and BCG lymphadenitis) are likely to arise from programme errors and must always be investigated

programme errors
Programme Errors
  • Non-sterile injection
    • infection
  • Incorrect preparation
    • abscess (inadequate shaking)
    • drug effect (use of drug instead of vaccine/diluent)
slide18

Injection in wrong site

    • local reaction/abscess (wrong tissue level)
    • nerve damage
  • Vaccine frozen
    • local reaction
  • Contraindication ignored
    • avoidable severe reaction
serious events
Serious Events
  • Anaphylactoid reaction (acute hypersensitivity reaction)
  • Anaphylaxis
  • Persistent (more than 3 hours) inconsolable screaming
  • Hypotonic hyporesponsive episode
  • Seizures, including febrile seizures(6-12 days for measles/MMR; 0-2 days for DTP)
  • Encephalopathy

(6-12 days for measles/MMR; 0-2 days for DTP)

serious events cont
Serious Events (cont…)
  • Acute flaccid paralysis
    • (4-30 days for OPV recipient; 4-75 days for contact)
  • Brachial neuritis
    • (2-28 days after tetanus containing vaccine)
  • Thrombocytopaenia
    • (15-35 days after measles/MMR)
  • Disseminated BCG infection
  • Osteitis/osteomyelitis
contraindications
Contraindications

True contraindications are rare

  • Current serious febrile illness
    • delay vaccine administration
  • History of severe AEFI after previous dose
  • Evolving neurological disease
    • avoid whole cell pertussis vaccine
    • (e.g. uncontrolled epilepsy)
  • Type 1 hypersensitivity to egg

- avoid yellow fever & influenza but can use vaccines made in chick fibroblasts

  • Symptomatic HIV
    • avoid BCG and yellow fever
contraindications1

Vaccine

Contraindication

All vaccines

Anaphylactic reaction to vaccine or vaccine constituent

Severe febrile illness

DTP

Encephalopathy within 7 days of administration

OPV

Immunodeficiency, or immunodeficient household contact*

IPV

Anaphylactic reaction to neomicin, streptomycin or polymyxin B

Contraindications

Adopted from Plotkin pg 66-67

* Risk benefit assessment when administered to HIV positive individuals

contraindications2

Vaccine

Contraindication

MMR

Anaphylaxis, pregnancy, immunodeficiency*

Hib

None

Hepatitis B

Anaphylactic reaction to common baker’s yeast

Yellow fever

Anaphylactic reaction to egg, immunodeficiency

Contraindications

Adopted from Plotkin pg 66-67

* Risk benefit assessment when administered to HIV-positive individuals

anaphylaxis
Anaphylaxis
  • Type 1 hypersensitivity reaction
  • Circulatory failure
  • Bronchospasm +/- laryngospasm/laryngeal oedema
    • respiratory distress
  • May include pruritis, flushing, angioedema, seizures, vomiting, abdominal cramps & incontinence
  • Occurs in previously sensitized individuals
anaphylaxis1
Anaphylaxis
  • Reported less from developing countries
    • Less sensitization?
    • Less reporting?
  • Anaphylaxis is rare (1/1 000 000 vaccinations)
  • Fainting is common
  • Untrained staff may misdiagnose fainting/dizzinessfor anaphylaxis or vice versa
  • Administration of adrenaline in a faint may bedangerous
      • PROMPT MANAGEMENT IS VITAL!
seizures
Seizures
  • Particularly associated with measles and DTP vaccination (pertussis component)
    • febrile seizures Temp >38
    • afebrile seizures Temp normal
  • Febrile seizures more common with pertussis
  • An association with non-febrile seizures has not been proven
adverse reactions to bcg
Adverse Reactions To BCG

Disseminated BCGits

  • widespread infection, 1-12 months after BCG
  • usually in immunocompromised individual
  • confirm by isolation of Mycobacterium bovisBCG strain
  • treat with antituberculous regimen including Rifampicin and Isoniazid

Osteitis/osteomyelitis

  • infection of the bone with M bovis BCG strain
  • management as above
adverse reactions to bcg1
Adverse Reactions To BCG

Suppurative lymphadenitis

  • occurs within 2-6 months of BCG vaccination
  • Case Definition
    • 1 lymph node> 1.5 cm in size/draining sinus over a lymph node
    • usually occurs in the axilla, on the same side as innoculation
  • Management
    • heals spontaneously over months
    • only treat if sticking to skin or draining
    • surgical drainage and local installation ofantituberculous drug
    • systemic Rx is ineffective
tetanus vaccine
Tetanus Vaccine

Brachial neuritis

  • Presents with pain in shoulder and upper arm
  • Followed by weakness +/- wasting of arm and shoulder muscles
  • Sensory loss not prominent
  • Occurs 2-28 days after vaccination
  • Possibly a manifestation of immune complex disease
  • Management is symptomatic
encephalopathy and encephalitis
Encephalopathy And Encephalitis

Possibly associated with measles & pertussis vaccine

  • Case definition of encephalopathy
    • 2 out of 3 of
      • seizures
      • alteration of consciousness lasting for one day or more
      • distinct change in behavior for one day or more
  • Temporal relationship
    • within 48 hrs with DTP
    • within 7-12 days after measles or MMR
encephalitis and measles vaccination
Encephalitis And Measles Vaccination
  • An analysis of claims for encephalitis following measles vaccine in the USA found clustering of events 8-9 days after vaccination (Wetbel 1998, Duclos 1998)
  • This supports, but does not prove, thepossibility that measles vaccine was causative
  • Risk is less than 1 case per million
hypotonic hypotesive episode
Hypotonic Hypotesive Episode
  • Mainly associated with DTP
    • Case definition
      • Event of sudden onset occurring within 48 (usually less than 12) hours of vaccinationand lasting from one minute to several hours
      • In a child < 10 years of age
  • ALL of the following must be present
    • limpness (hypotonic)
    • reduced responsiveness
    • pallor or cyanosis - or failure to observe/recall
  • Transient, self-limiting, NOT a contraindication to further vaccination
acute flaccid paralysis
Acute Flaccid Paralysis

Vaccine associated paralytic poliomyelitis

  • Occurs within 4-30 days of receipt of OPV or 4-75 days after contact with vaccine recipient

Case

Following a national immunization day in 1996, cases of paralysis were reported after receiving OPV. On laboratory analysis, the wild virus was found, showing that the children had been infected with wild poliovirus before immunization. The cases of poliovirus were coincidental, and not caused by the vaccine.

unproven associations and public concerns
Unproven Associations And Public Concerns
  • Influenza vaccine and Guillaine Barré Syndrome
  • MMR and autism, Crohn’s disease
  • Polio and HIV
  • Hepatitis B and multiple sclerosis
  • DTP and permanent brain damage
  • DTP and increased risk of mortality
  • Aluminium and macrophagic myofasciitis
  • Bovine spongiform encephalopathy (BSE)
  • Thiomerosal
  • Multiple vaccines given simultaneously
common more reactions
Common, more reactions

Local reaction

(pain, swelling, redness)

Irritability, malaise &

systemic symptoms

Vaccine

Fever >38C

-

90-95%

-

BCG

-

Hib

5-15%

2-10%

1-6%

-

HepB

Adults: 15%; Children: 5%

Measles/MMR

5% rash

~10%

5-15%

Polio

(OPV)

<1%

-

<1%**

~10%*

~10%

~25%

Tetanus

DTP

(pertussis)

Up to 50%

Up to 50%

Up to 55%

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

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

rare more frequent reactions
Rare, more frequent reactions

Vaccine

Reaction

Onset interval

Rate per million doses

BCG

Suppurative lymphadenitis

BCG osteitis

Disseminated BCG

2-6 months

1-12 months

1-12 months

100-1000

1-700

2

Hib

Nil known

Hep B

Anaphylaxis

Guillain Barré syndrome

0-1 hour

1-6 weeks

1-2

5

Measles

/MMR

Febrile seizures

Thrombocytopaenia

Anaphylaxis

5-12 days

15-35 days

0-1 hour

333

33

1-50

OPV

Vaccine-associated paralytic poliomyelitis (VAPP)

Risk is higher for first dose, adults, and immunocompromised

4-30 days

0.76-1.3 (1st dose)

0.17 (subsequent doses)

0.15 (contacts)

rare more frequent reactions1

Vaccine

Reaction

Onset interval

Rate per million doses

Tetanus

Brachial neuritis

Anaphylaxis

Sterile abscess

2-28 days

0-1 hour

1-6 weeks

5-10

1-6

6-10

Tetanus-diphtheria

Nil extra to tetanus reactions

DTP

Persistent (>3 hrs) inconsolable screaming

Seizures

Hypotonic, hyporesponsive episode (HHE)

Anaphylaxis/shock

Encephalopathy

0-24 hours

0-3 days

0-24 hours

0-1 hour

0-3 days

1000-60 000

570

570

20

0-1

Rare, more frequent reactions
rare more frequent reactions2

Vaccine

Reaction

Onset interval

Rate per million doses

Japanese encephalitis

Serious allergic reaction

Neurological event

10-1000

1-2.3

Yellow fever

Post-vaccination Encephalitis

Allergic reaction/anaphylaxis

7-21 days

0-1 hours

500-4000 in infants<6 months

5-20

Rare,more frequent reactions
slide44

CASE STUDIES

An outbreak of lymphadenitis three months after BCG immunization was traced to a switch to a different strain of vaccine. The investigation also highlighted a number of programme errors (vaccines not properly reconstituted, and injections not given intradermally).

Cause: Vaccine reaction compounded by programme errors

A one-year-old child died within 12 hours of receiving measles vaccine. It was reported as a possible anaphylaxis because of its rapid onset. Investigation found that the vaccine used was likely to have been reconstituted one day prior to this particular use.

Cause: Non-sterile injection, not anaphylaxis

case study
CASE STUDY

Four children died and a fifth was hospitalized after receiving measles vaccine from the same vial. Vaccine was not refrigerated, and was transported house to house for immunization. Reactions began four to five hours after vaccination, with vomiting, unconsciousness, and meningeal irritation. S. aureus was cultivated from the incriminated vial.

Cause: Non-sterile injection

slide46

Programmatic

error

Insulin given to70 infantsinstead of DTPvaccine with21 deaths

DTP

T T

Insulin vial

Vaccine vials

Turkey

India

Algeria

Yemen

1997