A study of adverse vaccine events among pediatric age group in a tertiary medical college hospital

Gramle Amol, Asmita Narayan, R. Shubha


Background: Vaccines are pivotal health products that are used and administered
prophylactically to a large number of healthy individuals. A significant proportion of
vaccines are administered to the pediatric age group, particularly to the neonates and
infants as part of the national immunization programmes. As with any drug, untoward
reaction can occur with the administration of vaccines. Most of the clinical trials with
the vaccines are conducted and validated in a relatively small sample size. Active
monitoring as part of the Pharmacovigilance programme is imperative to identify
rare or deferred adverse vaccine events (AVE).

Methods: A prospective, single center, observational, naturalistic study on report
forms in pediatric age group, who may develop AVE in Sapthagiri Institute of
Medical Sciences and Research Center, Bengaluru, was conducted during the study
time widow, from February 20, 2014, to April 20th, 2014. Children under 5 years of
age were included in the study. All children more than 5 years of age were excluded
from the study. The causality assessment were attempted to be recorded as per the
Naranjo score, which is used to quantitatively evaluate the association between AVE
and vaccines.

Results: 19.04% of children aged 1-5 years of age documented with adverse event
following immunization (AEFI) (p=0.036). It was found that either a naïve or the
fully immunized children suffered from the AEFI most of which was trivial. Fever
was the most common AEFI reported followed by an excess cry. The incidence of
fever reported was substantially high following the DPT vaccine.
Conclusions: All the AEFI received through the telephonic calls were documented.
There was no mortality or a major adverse event reported. Maximum AEFI were
documented in the neonates and the children 1-5 years of age which was statistically
significant. In addition, the study provides a scope for further research with reference
to the inter-age group variability. The immune mechanism behind such a difference
also needs to be explored.


Vaccines, Adverse vaccine events, Neonates

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