Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 13 May 2022 / Approved: 18 May 2022 / Online: 18 May 2022 (11:06:19 CEST)

A peer-reviewed article of this Preprint also exists.

Ortiz-Prado, E.; Izquierdo-Condoy, J.S.; Fernandez-Naranjo, R.; Simbaña-Rivera, K.; Vásconez-González, J.; Naranjo, E.P.L.; Cordovez, S.; Coronel, B.; Delgado-Moreira, K.; Jimbo-Sotomayor, R. A Comparative Analysis of a Self-Reported Adverse Events Analysis after Receiving One of the Available SARS-CoV-2 Vaccine Schemes in Ecuador. Vaccines 2022, 10, 1047. Ortiz-Prado, E.; Izquierdo-Condoy, J.S.; Fernandez-Naranjo, R.; Simbaña-Rivera, K.; Vásconez-González, J.; Naranjo, E.P.L.; Cordovez, S.; Coronel, B.; Delgado-Moreira, K.; Jimbo-Sotomayor, R. A Comparative Analysis of a Self-Reported Adverse Events Analysis after Receiving One of the Available SARS-CoV-2 Vaccine Schemes in Ecuador. Vaccines 2022, 10, 1047.

Journal reference: Vaccines 2022, 10, 1047
DOI: 10.3390/vaccines10071047

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 like any other medical product can cause adverse events. Yet, in countries with poor epidemiological surveillance and monitoring systems, reporting vaccine-related adverse events is scarce. 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-reporting 32-questionnaire was conducted in Ecuador from April 1st to July 15th, 2021. Participants were invited by social media, radio, and TV to voluntarily participate in our study. A total of 6,654 participants were included in this study. A 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. Pain, inflammation at the injection site (20,01%), and headache (16,91%) were the most reported adverse events. Women addressed ESAVIs (64%), more often than men (36%). After receiving the first dose of any available COVID-19 vaccine, a total of 19,481 self-reported ESAVIs were informed (86.9% were mild, 11.6% moderate and 1.5% severe). In terms of 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, 6,757 self-reported ESAVIs were reported (87.0% 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 dose. 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 receive the first dose, were more prone to report ESAVIs.

Keywords

COVID-19; Vaccines; Adverse Events; Self-reporting; Pandemic

Subject

MEDICINE & PHARMACOLOGY, Other

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