Adverse Events Following Immunization Among Children Under Two Years of Age: A Prospective Observational Study From North India

Background: Vaccination is one of the most cost-effective child survival health interventions. A single serious adverse event following immunization (AEFI) or a cluster of events may lead to a loss of public confidence in the program and a major setback to immunization coverage. This study was conducted to assess the incidence of AEFIs in children less than two years of age. Material and Methods: A prospective community-based observational study was conducted in the North Indian state of Uttarakhand from October 2017 to February 2018. A total of 255 children who attended the selected sub-centres for immunization were finally included in the study. Follow-up home visits on the 8th and 30th day of vaccination were carried out to identify any occurrences of AEFIs. Results: Among 255 children, 212 AEFIs from 152 vaccinated subjects were reported. The majority of the AEFIs were reported in the age group 0-1 years. The incidence of AEFIs was 33.0 per 100 doses of vaccines administered. The most common AEFI reported was fever (101, 47.6%), followed by swelling (53, 25.0%). Among the vaccines, Pentavalent + oral polio vaccine (OPV) (48.8 per 100 doses) was majorly responsible for AEFIs, followed by diphtheria pertussis tetanus (DPT) + measles and rubella (MR) + OPV (46.6 per 100 doses). Conclusion: Our findings revealed that although the incidence of AEFI reported was high, all of them were minor and no serious AEFIs were identified. The awareness among health professionals and the public regarding the reporting of AEFIs should be continued to increase the safety profile of vaccines.