Description of Events Supposedly Attributable to Vaccination or Immunization identified through active pharmacovigilance in adults in the city of Rosario

Abstract

Since the onset of the COVID-19 pandemic in 2020, pharmacovigilance has become crucial for evaluating vaccine safety. The World Health Organization (WHO) and the Pan American Health Organization (PAHO) have urged the establishment of robust and reliable surveillance systems to enable early detection of Events Supposedly Attributable to Vaccination or Immunization (ESAVI) and effective management of associated risks. This study focuses on identifying ESAVI reported in an active pharmacovigilance analysis of vaccines administered to adults as part of the national vaccination schedule and the campaign against COVID-19 in the city of Rosario, Argentina, from January 2021 to November 2023. A descriptive study was conducted in five primary care centers, involving 183 participants, with a majority of women (76.5%) and an average age of 43 years. A total of 301 reports were submitted to the Argentine Integrated Health Information System (SISA), including 536 ESAVI, which were classified as non-serious, primarily related to the application technique, and generally required only analgesics. The findings highlight the importance of identifying interventions that promote safe vaccination, thereby strengthening public confidence and acceptance of
immunization.