1. Global Training Network ProgrammeWorld Health Organization

2. Global Training Network ProgrammeWorld Health Organization 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 WHO Immunization Policy 1996

3. Global Training Network ProgrammeWorld Health Organization Anaphylactic reaction to neomicin, streptomycin or polymyxin B IPV Immunodeficiency, or immunodeficient household contact* OPV Encephalopathy within 7 days of administrationDTP Anaphylactic reaction to vaccine or vaccine constituent Severe febrile illness All vaccines ContraindicationVaccine * Risk benefit assessment when administered to HIV positive individuals Adopted from Plotkin pg 66-67

4. Global Training Network ProgrammeWorld Health Organization Anaphylactic reaction to common baker’s yeastHepatitis B Anaphylactic reaction to egg, immunodeficiencyYellow fever NoneHib Anaphylaxis, pregnancy, immunodeficiency*MMR ContraindicationVaccine * Risk benefit assessment when administered to HIV-positive individuals Adopted from Plotkin pg 66-67

5. Global Training Network ProgrammeWorld Health Organization A medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization u Vaccine reaction - caused by vaccine’s inherent properties u Programme error - caused by error in vaccine preparation, handling, or administration u Coincidental - happens after immunization but not caused by it è a chance association u Injection reaction - anxiety or pain of injection not vaccine u Unknown - cause cannot be determined

6. Global Training Network ProgrammeWorld Health Organization Common, minor reactions vaccine stimulates immune system settle on their own warn parents and advise how to manage Rare, more serious reactions anaphylaxis (serious allergic reaction) vaccine specific reactions

7. Global Training Network ProgrammeWorld Health Organization Irritability, malaise & systemic symptoms Fever >38C BCG Hib HepB Measles/ MMR Polio (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)

8. Global Training Network ProgrammeWorld Health Organization Local reaction cold cloth at injection site paracetamol Fever >38°C give extra fluids tepid sponging paracetamol Irritability malaise and systemic symptoms give extra fluids paracetamol

9. Global Training Network ProgrammeWorld Health Organization 0.76-1.3 (1 st 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 333 33 1-50 5-12 days 15-35 days 0-1 hour Febrile seizures Thrombocytopaenia Anaphylaxis Measles /MMR 1-2 5 0-1 hour 1-6 weeks Anaphylaxis Guillain Barré syndrome Hep B Nil known Hib 100-1000 1-700 2 2-6 months 1-12 months Suppurative lymphadenitis BCG osteitis Disseminated BCG BCG Rate per million doses Onset interval ReactionVaccine

10. Global Training Network ProgrammeWorld Health Organization 1000-60 000 570 20 0-1 0-24 hours 0-3 days 0-24 hours 0-1 hour 0-3 days Persistent (>3 hrs) inconsolable screaming Seizures Hypotonic, hyporesponsive episode (HHE) Anaphylaxis/shock Encephalopathy DTP Nil extra to tetanus reactions Tetanus-diphtheria 5-10 1-6 6-10 2-28 days 0-1 hour 1-6 weeks Brachial neuritis Anaphylaxis Sterile abscess Tetanus Rate per million doses Onset interval ReactionVaccine

11. Global Training Network ProgrammeWorld Health Organization 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

12. Global Training Network ProgrammeWorld Health Organization BCG Hib HepB Measles/ MMR/MR u Suppurative lymphadenitis u BCG osteitis u Disseminated BCG infection è 1 in 1000 to 1 in 10 000 è 1 in 3000 to 1 in 100 million è ~1 in 1 million u None known u Anaphylaxis è 1 in 6-900 000 u Febrile seizures u Thrombocytopaenia (low platelets) u Severe allergic reaction u Anaphylaxis u Encephalopathy è 1 in 3000 è 1 in 30 000 è ~1 in 100 000 è ~1 in 1 million è <1 in 1 million ReactionIncidence

13. Global Training Network ProgrammeWorld Health Organization Tetanus Pertussis ( DTP- whole cell) ReactionIncidence Polio (OPV) u Vaccine associated paralytic poliomyelitis u Risk is higher for first dose, adults, and immunocompromised è 1 in 2.4-3.3 million doses è 1 in 750 000 first dose compared to 1 in 5.1 million for subsequent doses u Brachial neuritis u Anaphylaxis è 0.5-1 in 100 000 è 1 in 100 000 to 1 in 2 500 000 u Persistent inconsolable screaming u Seizures u Hypotonic, hyporesponsive episode (HHE) u Anaphylaxis u Encephalopathy (Note: Risk may be zero) è 1 in 15 to 1 in 1000 è 1 in 1750 to 1 in 12 500 è 1 in 1000 to 1 in 33 000 è 1-6 in million è 0-1 in 1 million

14. Global Training Network ProgrammeWorld Health Organization WHO case definitions are used here Lack of standardized case definitions in the literature e.g. fever The Brighton collaboration developing case definitions for AEFI promoting global implementation of these definitions secretariat@brightoncollaboration.org http://brightoncollaboration.org

15. Global Training Network ProgrammeWorld Health Organization 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

16. Global Training Network ProgrammeWorld Health Organization 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/dizziness for anaphylaxis or vice versa Administration of adrenaline in a faint may be dangerous PROMPT MANAGEMENT IS VITAL!

17. Global Training Network ProgrammeWorld Health Organization 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

18. Global Training Network ProgrammeWorld Health Organization Disseminated BCG widespread infection, 1-12 months after BCG usually in immunocompromised individual confirm by isolation of Mycobacterium bovis BCG strain treat with antituberculous regimen including Rifampicin and Isoniazid Osteitis/osteomyelitis infection of the bone with M bovis BCG strain management as above

19. Global Training Network ProgrammeWorld Health Organization 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 of antituberculous drug systemic Rx is ineffective

20. Global Training Network ProgrammeWorld Health Organization

21. Global Training Network ProgrammeWorld Health Organization

22. Global Training Network ProgrammeWorld Health Organization 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

23. Global Training Network ProgrammeWorld Health Organization 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

24. Global Training Network ProgrammeWorld Health Organization 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, the possibility that measles vaccine was causative Risk is less than 1 case per million

25. Global Training Network ProgrammeWorld Health Organization Mainly associated with DTP Case definition Event of sudden onset occurring within 48 (usually less than 12) hours of vaccination and 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

26. Global Training Network ProgrammeWorld Health Organization 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. Vaccine associated paralytic poliomyelitis Occurs within 4-30 days of receipt of OPV or 4-75 days after contact with vaccine recipient

27. Global Training Network ProgrammeWorld Health Organization 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

28. Global Training Network ProgrammeWorld Health Organization 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 some days prior to this particular use. Cause: Non sterile injection: NOT ANAPHYLAXIS!!!

29. Global Training Network ProgrammeWorld Health Organization Vaccine BCG OPV Measles DTP Estimated rate of serious reactions 1/1000 to 1/50 000 doses 1/3 million doses for 1st dose OPV 1/1million doses 1/750 000 WHO web site - Dealing with adverse events - 2/19/99