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Introduction: Hepatitis B Vaccine (HBV) is a safe and effective vaccine that is nowadays recommended for all infants at birth as well as adults who could be exposed to hepatitis B virus. HBV can provide lifetime protection against hepatitis B virus infection. Despite its highly effective disease prevention, HBV can also cause adverse effects for the vaccinated population. A vast majority of Iran's population are vaccinated with recombinant hepatitis B vaccine (rHBV) which is manufactured by the Production and Research Complex of Pasteur Institute of Iran. Methods:  The reported adverse events of rHBV, obtained from Diseases Management Center of Iran’s Ministry of Health were compared with those in The Vaccine Adverse Event Reporting System (VAERS, a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention) during 2015 to 2017. Results: The most common adverse events after administration of rHBV, manufactured by Pasteur Institute of Iran was injection site reactions and no life threatening adverse event was observed. Conclusion: Despite reports by VAERS indicating that HBV can cause adverse events and even death in the United States, no such adverse effects were observed in rHBV manufactured in Iran.

Keywords: AEFI, rHBV, VAERS, CDC, Pasteur Institute of Iran

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