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Year : 2020  |  Volume : 9  |  Issue : 1  |  Page : 15-19

Study on the pattern of adverse events following immunization in children aged ≤6 years: A single-center experience

1 Department of Paediatrics, Sri Venkateswara Medical College, Tirupati, Andhra Pradesh, India
2 Department of Clinical Research, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India

Correspondence Address:
Dr. Manohar Badur
Department of Paediatrics, S. V. Medical College, SVRR General Hospital, Tirupati - 517 507, Andhra Pradesh
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jpai.jpai_4_20

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Objectives: This study was conducted to observe the incidence of adverse events following immunization (AEFI) in children ≤6 years of age. Material and Methods: An observational study was conducted in the department of pediatrics of our hospital from November 2018 to November 2019. A total of 20,414 children who attended the well-baby clinic for immunization over a period of one year were enrolled and observed for adverse events. Parents of the children were telephonically contacted for the observation of any type of adverse reaction that has followed by the administration of the vaccine. Results: Among 20,414 children, 8246 AEFI were reported during the study period. Majority of the AEFI were reported in the age group <1 week, followed by 6 weeks. Female children (56.7%) had reported more AEFI compared to male children (43.3%) with a ratio of 1.3:1 (F:M). The most common AEFI reported was fever (n = 4195 cases), followed by swelling (n = 2933 cases). Penta + IPV + OPV + Rota (38.2%) was majorly responsible for AEFI, followed by BCG + Hep-B + OPV (35.5%). Most of the AEFI (93.3%) were reported within 1 day of vaccine administration (n = 7691 cases). Conclusion: Our findings revealed that most of the adverse events were observed on day-1 after vaccine administration. Thus, after identifying the vaccines responsible for adverse events and the characteristics of the events, we may continue to consider vaccines as safe biological products. We also recommend that all AEFI should be documented and reported to the Central Drug Standard Control Organization (CDSCO) in real-time regarding vaccine use and awareness of vaccine safety.

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