{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T06:53:44Z","timestamp":1765608824873,"version":"3.48.0"},"reference-count":24,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008890","name":"University of Dundee","doi-asserted-by":"publisher","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}],"id":[{"id":"10.13039\/100008890","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,5,16]]},"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To describe the incidence of adverse events (AEs), reactogenicity symptoms, menstrual changes and overall self-rated improvement in health and well-being after COVID-19 vaccination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>VAC4COVID is an ongoing prospective, active observational, post-authorisation cohort safety study (PASS) of UK-approved vaccines for COVID-19 disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>\n                      The study is conducted through a secure website (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"www.vac4covid.com\">www.vac4covid.com<\/jats:ext-link>\n                      ) by MEMO Research, University of Dundee, UK.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>16\u2009265 adult (18 years or older) UK residents with a valid email address and internet access.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Any UK-authorised COVID-19 vaccination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The outcomes reported in this interim analysis include AEs, reactogenicity-type AEs (headache, fatigue, muscle or joint pain, fever, nausea, dizziness or local vaccine reaction), menstrual changes and reported improvement in overall health and well-being.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>11\u2009475 consented participants (mean age 54.8 years) provided follow-up data between 2 February and 5 October 2021 (mean follow-up duration 184 days), by which date 89.2% of participants had received two vaccine doses. 89.8% of 5222 participants who completed a follow-up questionnaire in the 7\u2009days after any COVID-19 vaccination reported no AEs. The risk of experiencing any event (not necessarily vaccine-related) requiring hospitalisation was less than 0.2%. 43.7% of post-vaccination follow-up records reported improvement in health and well-being. Reactogenicity-type reactions were more common in the week after the first dose of ChAdOx1 than BNT162b2 (7.8% vs 1.6%), but this relationship was reversed after the second dose (1.3% vs 3.1%). 0.3% of women reported menstrual symptoms after vaccination; no differences between vaccine type or dose order were detected.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The study provides reassuring data on low rates of AEs after COVID-19 vaccination. Differences in reactogenicity-type AE profiles between ChAdOx1 and BNT162b2 and between first and second doses of these vaccines were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN95881792\">ISRCTN95881792<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-060583","type":"journal-article","created":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T13:20:53Z","timestamp":1654089653000},"page":"e060583","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Adverse events and overall health and well-being after COVID-19 vaccination: interim results from the VAC4COVID cohort safety study"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"isrctn95881792","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5207-7032","authenticated-orcid":false,"given":"Amy","family":"Rogers","sequence":"first","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9174-777X","authenticated-orcid":false,"given":"Evelien","family":"Rooke","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5674-3784","authenticated-orcid":false,"given":"Steve","family":"Morant","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9207-1118","authenticated-orcid":false,"given":"Greg","family":"Guthrie","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6210-5620","authenticated-orcid":false,"given":"Alex","family":"Doney","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7767-472X","authenticated-orcid":false,"given":"Andrew","family":"Duncan","sequence":"additional","affiliation":[{"name":"Clinical Infection Research Group, NHS Lothian, Edinburgh, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3680-7127","authenticated-orcid":false,"given":"Isla","family":"Mackenzie","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4820-4240","authenticated-orcid":false,"given":"Rebecca","family":"Barr","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8726-306X","authenticated-orcid":false,"given":"Filippo","family":"Pigazzani","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Krists","family":"Zutis","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5189-6669","authenticated-orcid":false,"given":"Thomas M","family":"MacDonald","sequence":"additional","affiliation":[{"name":"MEMO Research, University of Dundee, Dundee, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,6,1]]},"reference":[{"key":"2025121222415638000_12.6.e060583.1","unstructured":"Ritchie H , Mathieu E , Rod\u00e9s-Guirao L . 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