Publication:

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

Background Vaccines are pivotal health products that are used and administeredprophylactically to a large number of healthy individuals. A significant proportion ofvaccines are administered to the pediatric age group, particularly to the neonates andinfants as part of the national immunization programmes. As with any drug, untowardreaction can occur with the administration of vaccines. Most of the clinical trials withthe vaccines are conducted and validated in a relatively small sample size. Activemonitoring as part of the Pharmacovigilance programme is imperative to identifyrare or deferred adverse vaccine events (AVE).

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

Results 19.04% of children aged 1-5 years of age documented with adverse eventfollowing immunization (AEFI) (p=0.036). It was found that either a naïve or thefully immunized children suffered from the AEFI most of which was trivial. Feverwas the most common AEFI reported followed by an excess cry. The incidence offever 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 weredocumented in the neonates and the children 1-5 years of age which was statisticallysignificant. In addition, the study provides a scope for further research with referenceto the inter-age group variability. The immune mechanism behind such a differencealso needs to be explored.