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

Abstract

Introduction. In Montenegro, vaccination against COVID-19 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. Materials and methods. For the purpose of this study, there were collected data from national adverse events reporting form for Gam-COVID-Vac 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 were recorded. The mean age of vaccinated individuals who reported adverse effects was 40.79±11.35 years. Totally, 79.55% females versus 20.45% males reported side effects post-vaccination. The most common adverse reaction was pyrexia (79.55%). Other very common adverse effects were as follows: injection site pain (38.18%), headache (33.18%), myalgia (32.27%), malaise (31.82%), fever (30.45%), arthralgia (22.73%) as well as 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 labial herpes. Serious adverse effects were recorded in 8 cases including tinnitus, thrombophlebitis, hypotension, chest pain, palpitations and peripheral cyanosis related to specific comorbidities. Conclusions. After the administration of Gam-COVID vaccine, the population in Montenegro experienced mild to moderate adverse effects, with rare serious transient adverse effects related to specific comorbidities. The data presented here on investigating Gam-COVID-Vac caccine verified good safety profile and high tolerability evidenced by the statistics analysis as lacked COVID-19-associated hospitalizations or deaths.