{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T07:32:15Z","timestamp":1762068735934,"version":"build-2065373602"},"reference-count":51,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2022,9,23]],"date-time":"2022-09-23T00:00:00Z","timestamp":1663891200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"NFARMED\u2014National Authority of Medicines and Health Products, I.P.","award":["UIDB\/00709\/2020","UIDP\/00709\/2020"],"award-info":[{"award-number":["UIDB\/00709\/2020","UIDP\/00709\/2020"]}]},{"name":"CICS-UBI projects","award":["UIDB\/00709\/2020","UIDP\/00709\/2020"],"award-info":[{"award-number":["UIDB\/00709\/2020","UIDP\/00709\/2020"]}]},{"name":"Portuguese Foundation for Science and Technology\/MCTES","award":["UIDB\/00709\/2020","UIDP\/00709\/2020"],"award-info":[{"award-number":["UIDB\/00709\/2020","UIDP\/00709\/2020"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Coronavirus disease 2019 is an acute respiratory disease caused by the severe acute respiratory syndrome coronavirus 2. As the virus spreads rapidly, it has become a major public health emergency, which has led to rapid vaccines development. However, vaccines can present harmful and unintended responses, which must be notified to the National Pharmacovigilance System. The aim of this study is to characterize the adverse drug reactions (ADRs) of these vaccines notified in the region covered by the Regional Pharmacovigilance Unit (RPU) of Beira Interior, in Portugal, between 1 and 31 December 2020. During this period, 4 vaccines were administered: Comirnaty\u00ae, Spikevax\u00ae, Vaxzevria\u00ae and Jcovden\u00ae. The RPU of Beira Interior received 2134 notifications corresponding to 5685 ADRs, of which 20.34% (n = 434) of the notifications were considered serious reactions. Of these, 9.52% (n = 42) resulted in hospitalization and 0.45% (n = 2) resulted in death. Among the ADRs notified, reactions at or around the injection site, myalgia, headaches and pyrexia were the most commonly notified. Most ADRs were resolved within a few hours or days without sequelae. These ADRs are in accordance with clinical trials, the summary of product characteristics (SmPC) of each vaccine and ADR notifications from other countries. However, further studies are needed to confirm these results.<\/jats:p>","DOI":"10.3390\/jcm11195591","type":"journal-article","created":{"date-parts":[[2022,9,26]],"date-time":"2022-09-26T01:41:58Z","timestamp":1664156518000},"page":"5591","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["COVID-19 Vaccines Adverse Reactions Reported to the Pharmacovigilance Unit of Beira Interior in Portugal"],"prefix":"10.3390","volume":"11","author":[{"given":"Carina","family":"Amaro","sequence":"first","affiliation":[{"name":"Health Science Faculty, University of Beira Interior, 6201-001 Covilh\u00e3, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5225-6222","authenticated-orcid":false,"given":"Cristina","family":"Monteiro","sequence":"additional","affiliation":[{"name":"UFBI-Pharmacovigilance Unit of Beira Interior, University of Beira Interior, 6201-001 Covilh\u00e3, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3333-5977","authenticated-orcid":false,"given":"Ana Paula","family":"Duarte","sequence":"additional","affiliation":[{"name":"UFBI-Pharmacovigilance Unit of Beira Interior, University of Beira Interior, 6201-001 Covilh\u00e3, Portugal"},{"name":"CICS-UBI-Health Sciences Research Centre, University of Beira Interior, 6201-001 Covilh\u00e3, Portugal"}]}],"member":"1968","published-online":{"date-parts":[[2022,9,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1016\/j.cca.2020.05.044","article-title":"COVID-19: Transmission, prevention, and potential therapeutic opportunities","volume":"508","author":"Lotfi","year":"2020","journal-title":"Clin. 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