Retrospective Qualitative and Quantitative Analysis of Adverse Events Following Vaccination

    Published on:July/2018
    Journal of Young Pharmacists, 2018; 10(3):326-329
    Original Article | doi:10.5530/jyp.2018.10.72

    Hardik Patel1, Samidh Shah2, Mira Desai 3, V Kalaiselvan 4, G.N Singh5

    1Tutor, 2Assistant Professor, 3Professor and Head, Department of Pharmacology, B. J. Medical College, Ahmedabad- 380016, Gujarat, INDIA.

    4Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare (Govt. of India), Ghaziabad, INDIA.

    5Secretary-cum-Scientific Director, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare (Govt. of India), Ghaziabad, INDIA.


    Background: Vaccination is an essential component of the public health programs. A small minority of persons may experience mild, time limited adverse reactions, however, in rare cases, it may be serious. Hence there is a need of a surveillance program to monitor, record and analyze adverse event following immunization (AEFI). Method: All AEFIs in year 2015-2016 reported to NCC-PvPI were included in analysis. The data were entered in Excel sheet and analyzed for age group, gender, reporter detail, month wise reporting, seriousness, suspected vaccine and body system organ classification. Quality of AEFI was checked by completeness score as per WHO criteria. Result: The NCC-PvPI received 637 reports with 794 AEFIs. Majority of AEFIs were noted in infants (55%) and the main source of AEFI reporters were physicians (88%).The quality of reports were satisfactory with average completeness score 0.88. Category “body as a whole” (48.49%) was the commonest clinical manifestation and most common AEFI was fever (43.95%). DPT/Haemophilus influenza type B/Polio vaccine was most common causal vaccine (n=155). Approximately 13% AEFIs were serious in nature with seven deaths. Conclusion: The system of AEFI reporting in India is slowly gaining momentum. Majority of AEFIs were mild. However, serious AEFI needs detail reporting, follow up, investigation for causality assessment and identify risk factors. Organized training of health care professionals in AEFI reporting and targeted spontaneous reporting of vaccine AEFI will be helpful in this regard.

    Key words: Adverse event following immunization (AEFI), Vaccine, Pharmacovigilance.

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