This document discusses adverse events following vaccination (AEFV), including definitions, classifications, common reactions, emergency management, controversies, and legal issues. It emphasizes that vaccines are largely safe, but serious adverse outcomes are usually due to programmatic or human errors. It concludes that vaccines should only be used as recommended and medical staff must be prepared to handle any adverse events.

1. DR. YAGNESH POPAT OM BABYCARE HOSPITAL RAJKOT Prepadness for AEFV & Medicolegal aspects

2. AEFV: Adverse Events Following Vaccination It is an untoward, temporally associated event following immunization that might or might not be caused by the vaccine or the immunization process.

3. Introduction These events may be recognized during clinical trials or during post marketing surveillance – eg. Intussusception following Rotashield vaccine, febrile seizures following Proquad vaccine and GBS following meningococcal conjugate vaccines.

4. Importance: Tolerance to vaccine associated adverse events is generally lower as these are administered to healthy children. Vaccine associated adverse events are more likely to be noticed and communicated and can often significantly impact immunization programs as noticed with measles, MMR and pertussis vaccines. Unpredictable Always observe for 15 min after vaccination

5. CLASSIFICATION: Adverse vaccine reaction (vaccine induced ) Trigger reaction (vaccine potentiated) Programmatic errors Injection reaction

6. Adverse vaccine reaction (vaccine induced ): Here the vaccine is causally related to the reaction- eg. VAPP due to oral polio vaccine, anaphylaxis.

7. Trigger reaction (vaccine potentiated): Here the reaction is triggered by the vaccine. eg. Febrile seizure following vaccination in a predisposed child.

8. Programmatic errors: These are most common cause for serious adverse events and death following vaccination. Deaths following measles vaccination due to toxic shock syndrome resulting from improper reconstitution and storage of measles vaccine is the most recent example of this phenomenon.

9. Injection reaction: Examples include syncope due to pain of vaccination, injection site abscesses, sciatic nerve damage due to gluteal injection and transmission of blood borne pathogens such as HIV/HBV/HCV.

10. AEFV Serious adverse events (SAE): - fatal or life threatening - persistent or significant disability - prolong hospitalisation - leads to birth defects/congenital anomalies Non serious events:

11. Adverse vaccine reaction Local reaction Systemic reaction Allergic reaction

12. Local Reactions: Common Pain, erythema and induration. More with whole cell pertusis vaccines and aluminiun adjuvanted (DTPw, DTaP, DT, Td, TDap, TT Hep B, Hep A, inactivated combination vaccines, HPV and PCV7) vaccines. Frequency of local reactions increase with subsequent doses and frequently administered doses (TT). Local reactions may be partly ameliorated by ice application and paracetamol.

13. Systemic Reactions: Fever is the most common systemic reaction and like local reactions, fever is more common with whole cell pertussis vaccines and aluminium adjuvanted vaccines. However unlike local reactions it usually declines with increasing age and increasing number of doses. Administration of paracetamol at the time of vaccinaton and later on a regular basis is helpful and indicated especially in children predispoded to febrile seizures. Fever due to vaccination does not usually last for more than 48 hours and any fever persisting beyond this time should be evaluated for other causes.

14. Allergic reaction Includes generalized urticaria, wheezing, swelling of mouth & throat, difficulty in breathing, hypotension & shock 1 per 10,00,000 vaccines Rarely due to vaccine antigen, commonly due to other vaccine constituent like animal protein, stabilizer, antimicrobial or preservatives.

15. Information Provide relatives with sufficient information about side effects / adverse events that may arise. verbal, brochure, video, resource kits Internet or hotline resource

16. Consent

17. Consent Only verbal consent is sufficient

18. Preparation

19. Resuscitation Equipment Oxygen Ambu bag & mask Endotracheal tubes Laryngoscope Iv assess devices & Iv fluids Drugs: Adrenaline, Hydrocortisone, Antihistime, Inotropes etc

20. Emergency management of anaphylaxis: Administer epinephrine (1:1000 solution) 0.01 ml/kg/dose (max 0.5ml) intramuscular in anterolateral thigh. set up IV access. lay patient flat and elevate legs if tolerated. Give high flow oxygen and airway/ventilation if needed. if hypotensive also, set up additional wide bore access and give IV normal saline 20 ml/kg under pressure over 1-2 minutes.

21. Emergency management of anaphylaxis: continued …. IM adrenaline may be repeated after 3-5 minutes if required. oral antihistaminics may be given to ameliorate skin symptoms but IV antihistaminics are not recommended. Oral or injectable corticosteroids equivalent to prednisone 1-2 mg/kg may be given but benefit is yet unproven.

22. CONTROVERSIES IN VACCINE SAFETY Vaccines and Autism Safety of Thiomersol (50 % Ethyl mercury)

23. Medico legal issues Indian law is silent. - Introduction of new vaccine. - National regulatory authority. - waste management. - advertisement. - Liability/ negligence - Magic remedial act

24. Liability/negligence Immediate care: Person who injects Immediate reaction/ anaphylaxis: Doctor in charge Long term complication: Company

25. VACCINE ASSOCIATED ADVERSE EVENT REPORTING SYSTEM (VAERS) Required for generation further data Exists in most developed countries Practically non existant in India Report on www.iapcoi.com All SAE irrespective of causal association, non serious adverse events that are unexpected in nature, severity, frequency or outcome, vaccine failures, and all usage in pregnancy.

26. CONCLUSION

27. CONCLUSION Vaccines are largely safe. Serious outcomes are usually programmatic/ human errors. It is therefore extremely important to use vaccines strictly as per recommendation and be prepared to handle any eventuality.

28. Don’t feel lonely

29. Call for assistance

30. GURU

31. THANK YOU

33. THANK YOU

34. DR. YAGNESH POPAT OM BABYCARE HOSPITAL RAJKOT

35. Conclusion

36. DR. YAGNESH POPAT om babycare hospital Rajkot OM BABYCARE HOSPITAL RAJKOT DR. YAGNESH POPAT