A Comparative Analysis of a Self-Reported Adverse Events Analysis after Receiving One of the Available SARS-CoV-2 Vaccine Schemes in Ecuador

Esteban Ortiz-Prado; Juan S Izquierdo-Condoy; Raul Fernandez-Naranjo; Katherine Simbaña-Rivera; Jorge Vásconez-González; Eddy P Lincango Naranjo; Simone Cordovez; Barbara Coronel; Karen Delgado-Moreira; Ruth Jimbo-Sotomayor

doi:10.3390/vaccines10071047

A Comparative Analysis of a Self-Reported Adverse Events Analysis after Receiving One of the Available SARS-CoV-2 Vaccine Schemes in Ecuador

Vaccines (Basel). 2022 Jun 30;10(7):1047. doi: 10.3390/vaccines10071047.

Affiliations

¹ One Health Research Group, Faculty of Health Science, Universidad de Las Américas, Quito 170507, Ecuador.
² Health Management and Research Area, Universidad Internacional Iberoamericana, Campeche 24560, Mexico.
³ Facultad de Ciencias Médicas, Universidad Central del Ecuador, Quito 100201, Ecuador.
⁴ Centro de Investigación para la Salud en América Latina (CISeAL), Pontificia Universidad Católica del Ecuador, Quito 17012184, Ecuador.

Abstract

The COVID-19 pandemic has put a lot of pressure on health systems worldwide. Mass vaccination against SARS-CoV-2 has reduced morbidity and mortality worldwide. Despite their safety profiles, vaccines, as with any other medical product, can cause adverse events. Yet, in countries with poor epidemiological surveillance and monitoring systems, reporting vaccine-related adverse events is a challenge. The objective of this study was to describe self-reported vaccine adverse events after receiving one of the available COVID-19 vaccine schemes in Ecuador. A cross-sectional analysis based on an online, self-reported, 32-item questionnaire was conducted in Ecuador from 1 April to 15 July 2021. Participants were invited by social media, radio, and TV to voluntarily participate in our study. A total of 6654 participants were included in this study. Furthermore, 38.2% of the participants reported having at least one comorbidity. Patients received AstraZeneca, Pfizer, and Sinovac vaccines, and these were distributed 38.4%, 31.1%, and 30.5%, respectively. Overall, pain or swelling at the injection site 17.2% (n = 4500) and headache 13.3% (n = 3502) were the most reported adverse events. Women addressed events supposedly attributable to vaccination or immunization [ESAVIs] (66.7%), more often than men (33.2%). After receiving the first dose of any available COVID-19 vaccine, a total of 19,501 self-reported ESAVIs were informed (87.0% were mild, 11.5% moderate, and 1.5% severe). In terms of the vaccine type and brand, the most reactogenic vaccine was AstraZeneca with 57.8%, followed by Pfizer (24.9%) and Sinovac (17.3%). After the second dose, 6776 self-reported ESAVIs were reported (87.1% mild, 10.9% moderate, and 2.1% severe). AstraZeneca vaccine users reported a higher proportion of ESAVIs (72.2%) in comparison to Pfizer/BioNTech (15.9%) and Sinovac Vaccine (11.9%). Swelling at the injection site, headache, muscle pain, and fatigue were the most common ESAVIs for the first as well as second doses. In conclusion, most ESAVIs were mild. AstraZeneca users were more likely to report adverse events. Participants without a history of COVID-19 infection, as well as those who received the first dose, were more prone to report ESAVIs.

Keywords: COVID-19; SARS-CoV-2; adverse events; pandemic; self-reporting; vaccines.

Grants and funding

This work did not receive a formal grant. However, it received financial support associated with the publication fee from the University of the Americas in Quito, Ecuador.