Epidemiological Evaluation of Events Allegedly Attributable to COVID-19 Vaccination: A Cross-Sectional Study in the Brazilian Amazon

Abstract

The emergence of SARS-CoV-2, leading to the widespread outbreak of COVID-19, has unveiled a spectrum of symptoms and severe health complications, challenging healthcare systems and impacting millions of lives worldwide. To analyze events allegedly attributable to vaccination or immunization (ESAVI) against SARS-CoV-2 (COVID-19) in the municipality of Santarém, in the interior of the state of Pará, an epidemiological, descriptive study was conducted using data from e-SUS Notifica in Santarém/PA from January 2021 to January 2022. The analyzed data for ESAVI cases included the administered immunobiologicals (Coronavac, Covishield, and Comirnaty), the type of event, case progression, time in days between immunobiological administration, and symptom onset, causality, and classification of ESAVI according to the vaccine package inserts. The incidence rate of ESAVI due to the COVID-19 vaccine was 17 per 100,000 doses administered in the municipality. According to the ESAVI classification, 14.0% were classified as Serious ESAVI (ESAVIG) (IR: 8.12 per 100,000 doses administered), with 100% of these events resulting in full recovery without sequelae, and 82.4% of reported cases were classified as Non-Serious ESAVI (ESAVING) (IR: 47.78), of which 3.60% were immunization errors (IR: 2.08 IE per 100,000 doses). This study fosters discussion on the importance of accurate recording of ESAVI related to COVID-19 vaccines, demonstrating their safety for the population.