Prevalence of Adverse Events Following Immunization (AEFI) among Children (0–16 Years) Receiving Routine Vaccines under the National Immunization Schedule: A Cross-Sectional Study in a Tertiary Hospital, June September 2025
Reg No: 465
DOI:
https://doi.org/10.56450/JEFI.2025.v3i2Suppl.092Keywords:
Adverse Events Following Immunization, National Immunization Schedule, Universal Immunization Program, Vaccine Safety, Children, IndiaAbstract
Introduction: India’s National Immunization Schedule (NIS) ensures universal access to vaccines against vaccine-preventable diseases 2. Although vaccines are safe, no vaccine is entirely without risk, and adverse reactions will occasionally occur following immunization 3. Adverse Events Following Immunization (AEFI) require robust monitoring to maintain public confidence and safety surveillance
Objectives: To estimate the prevalence of AEFI among children (0–16 years) receiving routine vaccines under NIS and to identify sociodemographic and vaccine-related factors associated with AEFI occurrence in a tertiary care setting
Methodology: A cross-sectional study was conducted from June to September 2025 at the Immunization Clinic of a tertiary hospital in West Bengal.
A total of 286 children (0–16 years) and their caregivers were recruited. Data were collected using a pre-tested structured questionnaire capturing: Sociodemographic profile, Vaccine type, dose, and site, Occurrence and type of AEFI within 7 days post-vaccination. Descriptive statistics were used to estimate prevalence, and the Chi-square test assessed associations between independent variables and AEFI occurrence, with p < 0.05 considered significant
Results: The overall prevalence of AEFI was 25.9% (n=74). The most common AEFI was fever (82.4%), followed by local swelling at the injection site (28.4%). Most AEFIs appeared within 24 hours of vaccination, with fever subsiding by day 3, while 5.4% of swelling cases persisted up to day 7.
A majority of AEFIs (63.5%) occurred in the 1 to below 9 month age group, followed by 16–24 months (16.2)
Conclusion: The study highlights that while most AEFIs are minor and self-limiting. Strengthening AEFI surveillance systems, and ensuring timely management and reporting are crucial to sustaining trust in India’s Universal Immunization Programme
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References
1. World Health Organization. (2020). Immunization Agenda 2030: A Global Strategy to Leave No One Behind. https://www.who.int/teams/immunization-vaccines-and-biologicals/strategies/ia2030
2. Ministry of Health & Family Welfare (India). Routine Immunization Manual for Medical Officers. New Delhi: Ministry of Health & Family Welfare; 2024.
3. National Vaccine Policy, New Delhi, Government of India, Ministry of Health and Family Welfare, 2011. Available at http://mohfw.nic.in/WriteReadData/l892s/10848111 97NATIONAL%20VACCINE%20POLICY%20BO OK.pdf Accessed on 18 Oct 2015.
4. Ministry of Health and Family Welfare. National AEFI Surveillance and Response Operational Guidelines 2024. New Delhi: Government of India; 2024.
5. Badur M, Pujari S, Yenepalli M, Kasala L, Chintham RJ. Study on the Pattern of Adverse Events Following Immunization in Children Aged $le 6$ Years: A Single-Center Experience. J Pediatr Assoc India. 2020;9(1):15-20
6. Mittal S, Rawat CM, Gupta A, Solanki HK, Singh RK. Adverse Events Following Immunization Among Children Under Two Years of Age: A Prospective Observational Study From North India. Cureus. 2023 Apr 30;15(4):e38356
7. Camargos SM, Oliveira MLS, Luvisaro BMO, Silva TPR, Souza JFA, Vimieiro AM, et al. Adverse event following immunization or vaccination in children in Minas Gerais: 2015 to 2020. Rev Bras Epidemiol. 2023; 26: e230056
8. Badur M, Pujari S, Yenepalli M, Kasala L, Chintham RJ. Study on the pattern of adverse events following immunization in children aged $leq6$ years: A single-center experience. J Pediatr Assoc India. 2020;9:15-9.
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Copyright (c) 2025 Dr Haritha H P, Dr Gitismita Naik, Dr Sunil Dash (Author)
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