The pharmacovigilance of vaccines is defined as the science and activities relating to the detection, assessment, understanding, prevention and communication of adverse events of immunization, or any other vaccine, or issues related with immunization. The strengthening of pharmacovigilance is very important in every country because it helps professional health care workers to avoid the problems with immunization, protect the health of people from adverse events during immunization. The success of the immunization system is reducing morbidity and mortality related to the vaccine. The vaccines are biological products used to prevent infectious diseases, but sometimes the vaccines can cause some AEFI (Adverse Events Following Immunization). The detection of adverse events following correct immunization is one very important step for prevention of problems in the immunization system. The vaccines are injected into an infant body on the day of their birth and the safety of these products is vital. In Albania, the Pharmacovigilance department is established as the structure of the National Center of Drug Control. The strengthening of pharmacovigilance in Albania and other countries is necessary, because this will help to identify the risk and the risk factors, and to avoid or minimize the harms.