Study of the pattern of adverse events following immunization of children in a tertiary care hospital
Keywords:Active surveillance, Vaccine safety, Vaccine surveillance, VAERS
Background: Success of an immunization programme depends upon awareness regarding usefulness and safety of vaccines. Widespread information on vaccine safety is very essential. Objective of study was to analyze pattern of Adverse Events Following Immunization (AEFI) in children.
Methods: Prospective, observational study was carried out at immunization OPD of B. J. Government Medical College and Sassoon General hospital, Pune, where children receiving routine immunization were analyzed & followed up through telephonic survey of parents. Vaccine Adverse Event Reporting System (VAERS) form was used to record AEFI.
Results: Total 1206 children, aged 0-6 years, received total of 3179 vaccine doses. 22.71% AEFI were reported. Most common AEFI per 1000 doses of all vaccinations was Fever, seen in less than 9 months of age group (84.67%). DPT vaccine was most common vaccine associated with AEFI and maximum (37.8%) adverse events were seen with 1st dose of DPT.
Conclusions: Reporting of AEFI with regular analysis and feedback should be an integral part of immunization programs.
National Vaccine Policy, New Delhi, Government of India, Ministry of Health and Family Welfare, 2011. Available at http://mohfw.nic.in/WriteReadData/l892s/1084811197NATIONAL%20VACCINE%20POLICY%20BOOK.pdf Accessed on 18 Oct 2015.
World Health Organization. Causality assessment of adverse event following immunization (AEFI): user manual for the revised WHO classification. 2013. Available at http://apps.who.int/iris/bitstream/10665/80670/1/9789241505338_eng.pdf?ua=1 Accessed on 15 Oct 2015.
Waldman EA. Surveillance of adverse effects following vaccination and safety of immunization programs. Rev Saude Publica. 2011;45(1):1-11.
Budhiraja S. Pharmacovigilance in vaccine. Indian J Pharmacol. 2010;42(2):116-9.
Karande S, Gogtay NJ, Kshirsagar NA. Efficacy and safety of vaccines in Indian children: a review. Paediatric and Perinatal Drug Therapy. 2003;5(3):124-34.
Vaccine Adverse Event Reporting System (VAERS): About VAERS program (FAQ). Available at http://vaers.hhs.gov/about/faqs. Accessed on 3 Jan 2014.
Chitkara AJ, Thacker N, Vashishtha VM, Bansal CP, Gupta SG. Adverse Event Following Immunization (AEFI) surveillance in India: position paper of Indian Academy of Pediatrics, 2013. Indian Pediatr. 2013;50:739-41.
CDC, Food and Drug Administration. Vaccine Adverse Event Reporting System. VAERS Form. Available at https://vaers.hhs.gov/resources/vaers_form.pdf Accessed on 27 Sep 2015.
Naranjo CA, Busto U, Sellars EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30:239-45.
Universal immunization program: Ministry of Health and Family Welfare. Government of India. 2009. Available at http://mohfw.nic.in/WriteReadData/l892s/Immunization_UIP.pdf. Accessed on 17 Sep 2014.
Joshi ND, Prajapati HK, Solanki KC, Sukhlecha A, Trivedi HR, Gajera MV, et al. Pattern of adverse events following immunization in an Indian teaching hospital. IJMSPH. 2013;2(1):62-8.
Carrasco-Garrido P, Gallardo-Pino C, Jiménez-García R, Tapias MA, de Miguel AG. Incidence of adverse reactions to vaccines in a paediatric population. Clin Drug Invest. 2004;24(8):457-63.
Zhou W, Pool V, John K, English-Bullard R, Ball R, Wise RP, et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS): United States, 1991-2001. MMWR Surveill Summ. 2003;52(1):1-24.
Hu Y, Li Q, Lin L, Chen E, Chen Y, Qi X, et al. Surveillance for Adverse Events following Immunization from 2008 to 2011 in Zhejiang Province, China. Clin Vaccin Immunol. 2013;20(2):211-7.
Zhang LP, Yu F, Jin BF, Wang Y, Xu HL, DU Y. Surveillance of adverse events following immunization in Minhang district of Shanghai from 2007 to 2010. Zhonghua Er Ke Za Zhi. 2012;50(11):859-64.
Mansoor O, Pillans PI. Vaccine adverse events reported in New Zealand 1990-5. N Z Med J. 1997;110(1048):270-2.
Israeli E. Gulf war syndrome as a part of the autoimmune (auto inflammatory) syndrome induced by adjuvant (ASIA) Lupus. 2012;21(2):190-4.
Stephan F, McLisa VD. Vaccine administration: Preventing serious shoulder injuries. J Am Pharm Assoc. 2013;53(2):102-3.
Mahajan D, Roomiani I, Gold M, Lawrence G, McIntyre P, Menzies R. et al. Annual report: surveillance of adverse events following immunization in Australia, 2009. Commun Dis Intell. 2010;34(3):259-76.
Jackson LA, Peterson D, Nelson JC, Marcy SM, Naleway AL. Vaccination site and risk of local reactions in children 1 through 6 years of age. Pediatrics. 2013;131(2):283-9.
Monteiro SAM, Takano OA, Waldman EA. Evaluation of the Brazilian surveillance system for adverse events following vaccination. Revista Brasileira de Epidemiologia. 2011;14(3):361-71.
Poland GA, Ovsyannikova IG, Jacobson RM. Adversomics: the emerging field of vaccine adverse event immunogenetics. Pediatr Infect Dis J. 2009;28(5):431-32.
Sugawara T, Ohkusa Y, Taya K, Yasui Y, Wada N, Sakano M, et al. Diarrhoea as a minor adverse effect due to oral polio vaccine. Jpn J Infect Dis. 2009;62:51-3.