Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 Vaccines

The rapid development of effective vaccines against COVID-19 is an extraordinary achievement. However, no medical product can ever be considered risk-free. Several countries have a pharmacovigilance system that detects, assesses, understands, and prevents possible adverse effects of a drug. To benef...

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Main Authors: Francesco Branda, Davide Tosi
Format: Article
Language:English
Published: MDPI AG 2022-07-01
Series:Information
Subjects:
Online Access:https://www.mdpi.com/2078-2489/13/7/329
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author Francesco Branda
Davide Tosi
author_facet Francesco Branda
Davide Tosi
author_sort Francesco Branda
collection DOAJ
description The rapid development of effective vaccines against COVID-19 is an extraordinary achievement. However, no medical product can ever be considered risk-free. Several countries have a pharmacovigilance system that detects, assesses, understands, and prevents possible adverse effects of a drug. To benefit from such huge data sources, specialists and researchers need advanced big data analysis tools able to extract value and find valuable insights. This paper defines a general framework for a pharmaceutical data analysis application that provides a predefined (but extensible) set of functions for each data processing step (i.e., data collection, filtering, enriching, analysis, and visualization). As a case study, we present here an analysis of the potential side effects observed following the administration of the COVID-19 vaccines. The experimental evaluation shows that: (i) most adverse events can be classified as non-serious and concern muscle/joint pain, chills and nausea, headache, and fatigue; (ii) the notification rate is higher in the age group 20–39 years and decreases in older age groups and in very young people.
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spelling doaj.art-5cad561029e74efb9e367cf32bf6f9482023-12-03T15:11:12ZengMDPI AGInformation2078-24892022-07-0113732910.3390/info13070329Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 VaccinesFrancesco Branda0Davide Tosi1Department of Computer Science, Modeling, Electronics and Systems Engineering (DIMES), University of Calabria, 87036 Rende, ItalyDepartment of Theoretical and Applied Sciences (DiSTA), University of Insubria, 21100 Varese, ItalyThe rapid development of effective vaccines against COVID-19 is an extraordinary achievement. However, no medical product can ever be considered risk-free. Several countries have a pharmacovigilance system that detects, assesses, understands, and prevents possible adverse effects of a drug. To benefit from such huge data sources, specialists and researchers need advanced big data analysis tools able to extract value and find valuable insights. This paper defines a general framework for a pharmaceutical data analysis application that provides a predefined (but extensible) set of functions for each data processing step (i.e., data collection, filtering, enriching, analysis, and visualization). As a case study, we present here an analysis of the potential side effects observed following the administration of the COVID-19 vaccines. The experimental evaluation shows that: (i) most adverse events can be classified as non-serious and concern muscle/joint pain, chills and nausea, headache, and fatigue; (ii) the notification rate is higher in the age group 20–39 years and decreases in older age groups and in very young people.https://www.mdpi.com/2078-2489/13/7/329pharmacovigilancebig data analysisvaccine adverse eventvaccine safetyCOVID-19SARS-CoV-2
spellingShingle Francesco Branda
Davide Tosi
Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 Vaccines
Information
pharmacovigilance
big data analysis
vaccine adverse event
vaccine safety
COVID-19
SARS-CoV-2
title Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 Vaccines
title_full Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 Vaccines
title_fullStr Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 Vaccines
title_full_unstemmed Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 Vaccines
title_short Comparing Worldwide, National, and Independent Notifications about Adverse Drug Reactions Due to COVID-19 Vaccines
title_sort comparing worldwide national and independent notifications about adverse drug reactions due to covid 19 vaccines
topic pharmacovigilance
big data analysis
vaccine adverse event
vaccine safety
COVID-19
SARS-CoV-2
url https://www.mdpi.com/2078-2489/13/7/329
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