{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T07:36:57Z","timestamp":1777102617544,"version":"3.51.4"},"reference-count":36,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T00:00:00Z","timestamp":1706745600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Healthcare"],"abstract":"<jats:p>Background: Is pharmacovigilance at a moment of prominence for science, and in relation to governments\u2019 responsibilities towards their nations, as the new coronavirus pandemic has surprised everyone in a negative and lethal way? Objective: Evaluate pharmacovigilance as a resource for controlling and understanding adverse events caused by vaccines in use. Methods: This is a narrative review of the literature. Scientific articles available in databases, government bulletins and similar bodies were used. The search was carried out using the descriptors: \u201cPharmacovigilance AND COVID-19 in Brazil\u201d, \u201cVaccine Development AND COVID-19\u201d, \u201cVaccination Hesitancy AND COVID-19\u201d, \u201cPublic Health Surveillance AND COVID-19\u201d. The period from May 2021 to June 2022 was covered. Results: The occurrence of some adverse events was observed, including cases of allergy, myocarditis and rheumatoid arthritis. It is important to highlight that these adverse events were identified as rare, occurring in a small percentage of the vaccinated population. Despite these adverse events, the benefits of vaccines proved to be essential for controlling the pandemic. Conclusions: The information presented highlights the importance of pharmacovigilance to continuously monitor and evaluate the safety of vaccines, identifying any potential adverse events early. This balance between risk and benefit emphasizes the need for a careful and informed approach when making decisions about vaccination policies, prioritizing public health and population safety.<\/jats:p>","DOI":"10.3390\/healthcare12030371","type":"journal-article","created":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T09:04:21Z","timestamp":1706778261000},"page":"371","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacovigilance in Brazil: The Government Monitoring of Adverse Events Reported from COVID-19 Vaccine\u2014A Narrative Review"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8791-7721","authenticated-orcid":false,"given":"Mariana Carvalho de","family":"Moraes","sequence":"first","affiliation":[{"name":"Department of Social Sciences and Health, Faculty of Medicine, Universidad do Porto, 4200-319 Porto, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5160-7043","authenticated-orcid":false,"given":"Ivone","family":"Duarte","sequence":"additional","affiliation":[{"name":"Department of Social Sciences and Health, Faculty of Medicine, Universidad do Porto, 4200-319 Porto, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1377-9899","authenticated-orcid":false,"given":"Rui","family":"Nunes","sequence":"additional","affiliation":[{"name":"Department of Social Sciences and Health, Faculty of Medicine, Universidad do Porto, 4200-319 Porto, Portugal"}]}],"member":"1968","published-online":{"date-parts":[[2024,2,1]]},"reference":[{"key":"ref_1","unstructured":"Pharmacovigilance Risk Assessment Committee (2022). PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2), European Medicine Agency. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/other\/prac-strategy-measuring-impact-pharmacovigilance-activities_en.pdf."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"744","DOI":"10.1007\/s11096-018-0657-1","article-title":"An historical overview over pharmacovigilance","volume":"40","author":"Fornasier","year":"2018","journal-title":"Int. J. Clin. Pharm."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1056\/NEJMoa2001017","article-title":"A Novel Coronavirus from Patients with Pneumonia in China, 2019","volume":"382","author":"Zhu","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1016\/S0140-6736(20)30183-5","article-title":"Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China","volume":"395","author":"Huang","year":"2020","journal-title":"Lancet"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1080\/17441692.2020.1828982","article-title":"Sociocultural, behavioural and political factors shaping the COVID-19 pandemic: The need for a biocultural approach to understanding pandemics and (re)emerging pathogens","volume":"16","author":"Friedler","year":"2020","journal-title":"Glob. Public Health"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"164","DOI":"10.1177\/0840470420901532","article-title":"Pandemics, regional outbreaks, and sudden-onset disasters","volume":"33","author":"Gully","year":"2020","journal-title":"Healthc. Manag. Forum."},{"key":"ref_7","first-page":"e2313","article-title":"COVID-19 vaccines and variants of concern: A review","volume":"32","year":"2021","journal-title":"Rev. Med. Virol."},{"key":"ref_8","unstructured":"(2023, August 28). Brasil. Secretaria de Sa\u00fade da Bahia. Eventos Adversos P\u00f3s-Vacina\u00e7\u00e3o, Available online: http:\/\/www.saude.ba.gov.br\/suvisa\/vigilancia-epidemiologica\/%20eventos-adversos-pos-vacinacao\/."},{"key":"ref_9","unstructured":"World Health Organization (2023, August 28). Diagnostics Laboratory Emergency Use Listing. Available online: https:\/\/cdn.who.int\/media\/docs\/default-source\/in-vitro-diagnostics\/200703-pqt-ivd-352-v2-eul-immunoassay-requirements-ncov.pdf?sfvrsn=bdf71066_2&download=true."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1016\/S0140-6736(98)03148-1","article-title":"150 years of pharmacovigilance","volume":"351","author":"Routledge","year":"1998","journal-title":"Lancet"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"1358","DOI":"10.1016\/S0140-6736(61)90927-8","article-title":"Thalidomide and congenital abnormalities","volume":"278","author":"Mcbride","year":"1961","journal-title":"Lancet"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"575","DOI":"10.1007\/978-1-62703-131-8_36","article-title":"The thalidomide disaster, lessons from the past","volume":"947","author":"Ridings","year":"2013","journal-title":"Methods Mol. Biol."},{"key":"ref_13","unstructured":"Instituto Butantan (2023, August 28). Quais s\u00e3o as Diferen\u00e7as Entre as Vacinas Contra COVID-19 que Est\u00e3o Sendo Aplicadas no Brasil? Portal do Butantan, Available online: https:\/\/butantan.gov.br\/covid\/butantan-tira-duvida\/tira-duvida-noticias\/quais-sao-as-diferencas-entre-as-vacinas-contra-covid-19-que-estao-sendo-aplicadas-no-brasil."},{"key":"ref_14","unstructured":"Leonardi, E. (2023, August 30). Farmacovigil\u00e2ncia-ANVISA e Oms Inovam na Notifica\u00e7\u00e3o de Eventos Adversos. ICTQ. Available online: https:\/\/ictq.com.br\/industria-farmaceutica\/821-farmacovigilancia-anvisa-e-oms-inovam-na-notificacao-de-eventos-adversos."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1991","DOI":"10.1016\/j.clinthera.2018.07.012","article-title":"Pharmacovigilance: An Overview","volume":"40","author":"Beninger","year":"2018","journal-title":"Clin Ther."},{"key":"ref_16","unstructured":"Henze, R. (2023, August 30). Quais s\u00e3o os Efeitos Colaterais Mais Comuns das Vacinas Contra a COVID-19?. Available online: https:\/\/www.selecoes.com.br\/coronavirus\/vacinas-contra-a-covid-19-quais-sao-os-efeitos-colaterais-mais-comuns\/."},{"key":"ref_17","unstructured":"(2023, August 30). Brasil. Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria. Farmacovigil\u00e2ncia, Available online: https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2020\/confira-o-painel-de-notificacoes-de-farmacovigilancia."},{"key":"ref_18","unstructured":"(2023, August 30). Brasil. Evento Adverso: O Que a Anvisa Faz Com a Sua Notifica\u00e7\u00e3o. ANVISA, Available online: https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2021\/evento-adverso-o-que-a-anvisa-faz-com-a-sua-notificacao."},{"key":"ref_19","unstructured":"Alegretti, L. (2022, November 28). Vacina Contra COVID-19: Quais os Efeitos Colaterais Mais Comuns e Por Que N\u00e3o h\u00e1 Motivo Para se Preocupar. BBC News Brasil. 19 Jun 2021. Available online: https:\/\/www.bbc.com\/portuguese\/geral-57435543."},{"key":"ref_20","unstructured":"Instituto Butantan (2022, November 28). N\u00e3o Vacinados Representam 75% das Mortes por COVID-19, diz Estudo Brasileiro. Portal do Butantan, Available online: https:\/\/butantan.gov.br\/noticias\/nao-vacinados-representam-75-das-mortes-por-covid-19-diz-estudo-brasileiro?fbclid=IwAR1yIBgJK5vtpLpkFq1eTq36mxMAz%20SD2F82hVDu56DDHAHtw7DJdLO10Ovk."},{"key":"ref_21","unstructured":"(2021, August 02). Brasil. Protocolo de Vigil\u00e2ncia Epidemiol\u00f3gica de Eventos Adversos p\u00f3s-Vacina\u00e7\u00e3o. Estrat\u00e9gia de Vacina\u00e7\u00e3o Contra o V\u00edrus SARSCoV-2 (COVID-19). Bras\u00edlia-DF: Minist\u00e9rio da Sa\u00fade, Available online: https:\/\/www.gov.br\/saude\/pt-br\/coronavirus\/vacinas\/pni."},{"key":"ref_22","unstructured":"(2022, November 28). Brasil. Boletim Epidemiol\u00f3gico Especial, no. 68. Doen\u00e7a pelo Coronav\u00edrus COVID-19. Semana Epidemiol\u00f3gica 24 (13\/6 a 19\/6\/2021). Bras\u00edlia-DF: Minist\u00e9rio da Sa\u00fade, Available online: https:\/\/www.gov.br\/saude\/pt-br\/centrais-de-conteudo\/publicacoes\/boletins\/epidemiologicos\/covid-19\/2021\/68_boletim_epidemiologico_covid.pdf."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"2092","DOI":"10.1056\/NEJMoa2104840","article-title":"Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination","volume":"384","author":"Greinacher","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"2202","DOI":"10.1056\/NEJMoa2105385","article-title":"Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination","volume":"384","author":"Scully","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"2448","DOI":"10.1001\/jama.2021.7517","article-title":"US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia after Ad26.COV2.S Vaccination, March 2 to April 21, 2021","volume":"325","author":"See","year":"2021","journal-title":"JAMA"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"2124","DOI":"10.1056\/NEJMoa2104882","article-title":"Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination","volume":"384","author":"Schultz","year":"2021","journal-title":"N. Engl. J. Med."},{"key":"ref_27","unstructured":"Centers for Disease Control and Prevention (2023, August 30). Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine. CDC Newsroom, Available online: https:\/\/www.cdc.gov\/media\/releases\/2021\/s0413-JJ-vaccine.html."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"680","DOI":"10.15585\/mmwr.mm7018e2","article-title":"Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine\u2014United States, March\u2013April 2021","volume":"70","author":"Shay","year":"2021","journal-title":"MMWR Morb. Mortal. Wkly. Rep."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1629","DOI":"10.1111\/all.14739","article-title":"EAACI statement on the diagnosis, management and prevention of severe allergic reactions to COVID-19 vaccines","volume":"76","author":"Sokolowska","year":"2021","journal-title":"Allergy"},{"key":"ref_30","unstructured":"Centers for Disease Control and Prevention (2023, August 30). Myocarditis and Pericarditis after mRNA COVID-19 Vaccination. CDC, Available online: https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/vaccines\/safety\/myocarditis.html."},{"key":"ref_31","first-page":"e491","article-title":"Pityriasis rosea following CoronaVac COVID-19 vaccination: A case report","volume":"35","author":"Erdem","year":"2021","journal-title":"J. Eur. Acad. Dermatol. Venereol."},{"key":"ref_32","unstructured":"International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (2023, August 30). Pharmacovigilance Planning: E2E\u2013Current Step 4 Version. Available online: https:\/\/www.ich.org\/page\/efficacy-guidelines."},{"key":"ref_33","unstructured":"(2023, September 02). Brasil. Boletim Epidemiol\u00f3gico. Situa\u00e7\u00e3o Epidemiol\u00f3gica dos Eventos Adversos p\u00f3s-Vacina\u00e7\u00e3o Contra a COVID-19, Bras\u00edlia-DF: Minist\u00e9rio da Sa\u00fade; Volume 52 | N\u00b0 9|Mar. 2021. Available online: https:\/\/sbim.org.br\/images\/files\/notas-tecnicas\/boletim-epidemio-09v52-eapv-covid19-210315.pdf."},{"key":"ref_34","unstructured":"Jaguraba, M. (2023, August 30). Vacina\u00e7\u00e3o: PNI do Brasil \u00e9 um dos Melhores do Mundo. Vatican News. Available online: https:\/\/www.vaticannews.va\/pt\/mundo\/news\/2018-07\/vacinacao-pni-do-brasil-um-dos-melhores-do-mundo.html."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"1316","DOI":"10.1056\/NEJMp1608967","article-title":"Vaccine refusal revisited\u2013the limits of public health persuasion and coercion","volume":"375","author":"Colgrove","year":"2016","journal-title":"N. Engl. J. Med."},{"key":"ref_36","unstructured":"Carbinatto, B. (2023, August 30). Por que Sequenciar o Genoma Do Novo Coronav\u00edrus \u00e9 Importante. Super Interessante. Available online: https:\/\/super.abril.com.br\/ciencia\/por-que-sequenciar-o-genoma-do-novo-coronavirus-e-importante\/."}],"container-title":["Healthcare"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2227-9032\/12\/3\/371\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T13:53:02Z","timestamp":1760104382000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2227-9032\/12\/3\/371"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,1]]},"references-count":36,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,2]]}},"alternative-id":["healthcare12030371"],"URL":"https:\/\/doi.org\/10.3390\/healthcare12030371","relation":{},"ISSN":["2227-9032"],"issn-type":[{"value":"2227-9032","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2,1]]}}}