{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T00:23:47Z","timestamp":1777681427453,"version":"3.51.4"},"reference-count":17,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2022,7,15]],"date-time":"2022-07-15T00:00:00Z","timestamp":1657843200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Hosp Pharm"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:p>Aim: Implementation of a web-form based pharmacovigilance plan for the spontaneous notification of adverse events to the Comirnaty\u00ae COVID-19 vaccine during its administration to hospital healthcare professionals. Methods: An electronic pharmacovigilance form was developed containing 8 pre-defined event options, an open answer option for the description of other events and\/or symptoms, and a question about the overall intensity of symptoms. The adverse events reports were standardized according to physiological and pathological condition. Results: A total of 4119 adverse events notifications were obtained with a 45% rate of electronic notification. The most clinically relevant events reported were:tachycardia (n\u2009=\u200919), dyspnea (n\u2009=\u20097), chest pain (n\u2009=\u20096), facial\/labial edema (n\u2009=\u20096), lipothymia (n\u2009=\u20095), bronchospasm (n\u2009=\u20092), herpetic infection (n\u2009=\u20092), vasculitis (n\u2009=\u20092), arrhythmia (n\u2009=\u20091), difficult to control arterial hypertension (n\u2009=\u20091), gastritis (n\u2009=\u20091), and spontaneous abortion (n\u2009=\u20091). Regarding the intensity of symptoms (n\u2009=\u20092928), 70.0% were reported as mild, 25.8% as moderate, and 4.27% as severe, with higher intensity in the second dose compared to first dose. The highest frequency of severe events were reported in the groups from 40 to 59\u2009years in both vaccination periods. During the vaccination process, no hospitalizations and no deaths were notified and\/or recorded. Conclusion: In this real world study, comparing with Comirnaty clinical trials program, it was observed a higher frequency of adenomegaly and gastrointestinal disorders. Noteworthy, the notification of a case of miscarriage. The use of hospital pharmacy pharmacovigilance electronic forms, seemed to be relevant to notification adherence and to obtain a greater and faster knowledge of COVID-19 vaccine safety profile<\/jats:p>","DOI":"10.1177\/00185787221111725","type":"journal-article","created":{"date-parts":[[2022,7,15]],"date-time":"2022-07-15T04:03:18Z","timestamp":1657857798000},"page":"744-751","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Spontaneous Adverse Event Reporting by COVID-19 Vaccinated Healthcare Professionals Through an Electronic Form Implemented by the Hospital Pharmacy"],"prefix":"10.1177","volume":"57","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3454-7229","authenticated-orcid":false,"given":"Jo\u00e3o Paulo Garcia Lopes","family":"da Cruz","sequence":"first","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"},{"name":"iMed.ULisboa \u2013 Research Investigation for Medicines, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina da Concei\u00e7\u00e3o Ribeiro","family":"de Carvalho","sequence":"additional","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paula Alexandre","family":"da Cruz Silva","sequence":"additional","affiliation":[{"name":"Information and Safety of Medicines, Pharmacovigilance Unit of Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis Filipe Campos","family":"Guerreiro","sequence":"additional","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatiana Vedes","family":"Bento","sequence":"additional","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leila Vanessa Carmo Cardoso Martins","family":"Costa","sequence":"additional","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raquel Filipa Miguel Margarido Duarte","family":"Sim\u00f5es","sequence":"additional","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rui Pedro Pinheiro Gon\u00e7alves","family":"Marques","sequence":"additional","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana Cristina","family":"Castro Fernandes","sequence":"additional","affiliation":[{"name":"Pharmacy Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lu\u00eds Miguel Costa de Mendon\u00e7a","family":"Galaio","sequence":"additional","affiliation":[{"name":"Occupational Health Medical Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana Isabel B.","family":"Correia","sequence":"additional","affiliation":[{"name":"Occupational Health Medical Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ema Maria S.","family":"Leite Resende","sequence":"additional","affiliation":[{"name":"Occupational Health Medical Service of Centro Hospitalar Universit\u00e1rio Lisboa Norte, Hospital de Santa Maria, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jo\u00e3o Manuel Braz","family":"Gon\u00e7alves","sequence":"additional","affiliation":[{"name":"iMed.ULisboa \u2013 Research Investigation for Medicines, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,7,15]]},"reference":[{"key":"bibr1-00185787221111725","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2034577"},{"key":"bibr2-00185787221111725","unstructured":"Food and Drug Administration (FDA). 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