A prospective study to assess the adverse events following immunization in paediatric population


  • Ambrish Gupta Department of Pharmacology, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India
  • Prashant Maheshwari Drug Safety Physician, Rainbow Medical Centre, Kanpur, Uttar Pradesh, India
  • Y. K. Rao Department of Paediatrics, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India




Adverse reactions, Causality, Paediatric patients, Vaccine


Background: The objective of current study was to analyse the pattern of adverse drug reactions due to different vaccines in paediatric patients.

Methods: A prospective observational study was carried out in paediatric department of GSVM medical college Kanpur to monitor vaccine adverse event and its causal association with vaccine. Patients of 0-10 year age group of either sex, who developed adverse event following vaccination, were included in study. Vaccine adverse event were recorded in the suspected ADRs reporting form of Indian Pharmacopoeia commission. Causality was evaluated using WHO-UMC assessment scale, outcome and seriousness as per W.H.O. To classify type of ADRs, Expanded Rawlins- Thompson’s classification system was used.

Results: Vaccine adverse reactions were more in female (53%) as compared to male (47%). Most common age group involved was 0-6 months; (79.41%) of total reactions. Fever (14.70 %) was most common reaction, followed by pain at inj. site (11.77%), and Convulsion (11.77). The causality of 67.65% vaccine adverse reactions was of possible type; 88.23 % reactions were of non-serious type. Type A reaction were more common and most of vaccine adverse reaction recovered (82.35%).

Conclusions: Vaccines can also cause different types of adverse reactions in paediatric patients. This Study emphasizes the need for an effective vaccine adverse event monitoring system among paediatric patients in every hospital to ensure safety of vaccine. Hence more educational awareness program should be plotted and more similar studies are needed to be conducted.

Author Biography

Ambrish Gupta, Department of Pharmacology, G.S.V.M. Medical College, Kanpur, Uttar Pradesh, India

drug safety physician


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How to Cite

Gupta, A., Maheshwari, P., & Rao, Y. K. (2017). A prospective study to assess the adverse events following immunization in paediatric population. International Journal of Basic & Clinical Pharmacology, 6(12), 2827–2831. https://doi.org/10.18203/2319-2003.ijbcp20175162



Original Research Articles