Side effects following administration of the Gam-COVID-Vac in Montenegro

Abstract

Abstract
 Introduction: In Montenegro, vaccination against COVID infection began with the use of Gam-COVID-Vac, which was not approved for emergency use before the end of clinical trials, by the Food and Drug Administration and the European Medicines Agency. Therefore, it is necessary to emphasize the adverse effects.
 Methods: For the purpose of this study, we collected data from national adverse events reporting form for Gam-COVID Vac were obtained from the Health Institution Pharmacy of Montenegro - Montefarm, as the holder of permits for these vaccines.
 Results: For the period March 1, 2021 to February 13, 2022, after administration of 16,756 doses of vaccine Gam - COVID, a total of 220 case reports, or 716 adverse effects. The mean age of vaccinated individuals who reported adverse effects was 40.79 11.35. Totally 79,55% of females versus 20,45% of males reported side effects after vaccination. The most common adverse reaction was raised temperature [79.55%]. Other very common adverse effects were: injection site pain [38.18%], headache [33.18%], myalgia [32.27%], malaise [31.82%], fever [30.45%], arthralgia [22.73%] and swelling and redness at the site of application [15.91%]. Less common adverse effects were nausea, pain in extremity, diarrhea, dizziness, fatigue, sore throat and herpes simplex. Serious adverse effects were recorded in 8 cases including tinnitus, thrombophlebitis, hypotension, chest pain, palpitations and peripheral cyanosis.
 Conclusions: After the administration of Gam - Covid vaccine, the population in Montenegro experienced mild to moderate adverse effects, with rare serious adverse effects of a transient nature, as indicated by the statistic that there were no hospitalizations or deaths.