Assessment of causality, severity and seriousness of adverse event following immunization in Iraqi : a retrospective study based on Iraqi pharmacovigilance database

Abstract EN

Immunization is one of the most cost-effective and successful public health applications.

The results of immunization are difficult to see as the incidence of disease occurrence is low while adverse effects following the immunization are noticeable, particularly if the vaccine was given to apparently healthy person.

There are High safety expectations of population regarding the vaccines, therefore they are more prone to hesitancy regarding presence of even small risk of adverse events which may lead to loss of public trust to the vaccination programs.Vaccine safety monitoring is needed as they are now administered to the general population and also available to special categories such as pregnant women and patients with different diseases whom not subjected to clinical trials as well as the incorrect administration rout and the presence of rare or delayed onset adverse events make the presence of surveillance system necessary.

The aim of the current study was to measure the distribution, percentage, and frequency of adverse reactions related to vaccines administration in Iraq and to assess the causality, severity, seriousness of these adverse reactions.

This study is a retrospective descriptive study for surveillance of vaccine safety conducted using Iraqi pharmacovigilance centre database from 2014 till the end of 2018.

This study conducted in period from 1st September 2018 till February 2019 and was in corporation with Iraqi pharmacovigilance center in Iraqi Ministry of Health.

2116 Adverse events were included and outcomes, severity, seriousness, and causality of adverse events were assessed.

Majority of adverse events following immunization cases (90.97%) were mild, non-serious (94.47%) and recovered (94.23%).

Most reports were for general disorders and administration site conditions and the majority were for elevated body temperature and injection site reactions.