{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:52:20Z","timestamp":1793332340285,"version":"4.5.0"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"12","license":[{"start":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T00:00:00Z","timestamp":1756857600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T00:00:00Z","timestamp":1756857600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drug Saf"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Yellow Card Vaccine Monitor (YCVM) was established by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to facilitate active monitoring of adverse drug reactions following COVID-19 vaccination and further characterise safety in populations under-represented in clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study explored the profile of individuals registered to the YCVM platform and the suspected adverse drug reactions reported following a COVID-19 vaccination on this data platform.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Using a stratified random selection approach, individuals were invited to register and actively contacted to seek further information on the vaccines received and adverse reactions they experienced. Exploratory analyses were conducted to characterise the demographics of individuals registered in the YCVM, and to summarise the adverse drug reaction data reported by recruited individuals between November 2020 and December 2022. Detailed analyses of the sub-cohort of pregnant and breastfeeding females were conducted to characterise these individuals. Data for two suspected adverse reactions, menstrual disorders and tinnitus, were extracted and analysed to demonstrate how YCVM supported regulatory assessment of these safety signals which originally arose from other data sources.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>36,604 individuals registered, with 30,281 reporting vaccination. Median (interquartile range) follow-up was 184 days (14\u2013367). Demographics of the recruited cohort reflected the vaccinated population and timing of invitations. 15,764 (52.1%) of those reporting vaccination reported experiencing at least one adverse reaction. However, nearly all were expected acute reactions and 4134 (13.7%) reported an event considered medically serious. The data raised no safety concerns in pregnant and breastfeeding females. Reporting of menstrual disorders appeared stimulated by media interest, as seen in spontaneous reporting systems. Data on the incidence of tinnitus were used to support regulatory action on this signal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Active surveillance using the YCVM provided a complementary data source for monitoring the safety of COVID-19 vaccines. However, further efforts are needed to recruit ethnic minorities. The technology developed has enhanced regulatory vigilance options and could be valuable in the future for actively monitoring the safety of innovative products used in small populations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s40264-025-01579-w","type":"journal-article","created":{"date-parts":[[2025,9,3]],"date-time":"2025-09-03T10:41:15Z","timestamp":1756896075000},"page":"1365-1385","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Implementation and Results of Active Vaccine Safety Monitoring During the COVID-19 Pandemic in the UK: A Regulatory Perspective"],"prefix":"10.1007","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-1265-0969","authenticated-orcid":false,"given":"Jenny","family":"Wong","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3488-9130","authenticated-orcid":false,"given":"Katherine","family":"Donegan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kendal","family":"Harrison","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tahira","family":"Jan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Cave","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phil","family":"Tregunno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,9,3]]},"reference":[{"key":"1579_CR1","doi-asserted-by":"publisher","DOI":"10.4324\/9781315166414","volume-title":"Vaccination programmes: epidemiology, monitoring, evaluation","author":"S Hahne","year":"2021","unstructured":"Hahne S, Bollaerts K, Farrington P. Vaccination programmes: epidemiology, monitoring, evaluation. 1st ed. London: Routledge; 2021. https:\/\/doi.org\/10.4324\/9781315166414.","edition":"1"},{"key":"1579_CR2","unstructured":"World Health Organization. Protocol template to be used as template for observational study protocols: cohort event monitoring (CEM) for safety signal detection after vaccination with COVID-19 vaccine. World Health Organization 2021."},{"key":"1579_CR3","doi-asserted-by":"publisher","first-page":"1011","DOI":"10.1007\/s40264-024-01449-x","volume":"47","author":"C Bellitto","year":"2024","unstructured":"Bellitto C, Luxi N, Ciccimarra F, L\u2019Abbate L, Raethje M, van Hunsel F, et al. What is the safety of COVID-19 vaccines in immunocompromised patients? Results from the European \u201cCOVID Vaccine Monitor\u201d active surveillance study. Drug Saf. 2024;47:1011\u201323. https:\/\/doi.org\/10.1007\/s40264-024-01449-x.","journal-title":"Drug Saf"},{"key":"1579_CR4","unstructured":"Kant A, Raethke M, Wuillaume F, Sabbe M, Koleti\u0107 ZM, Skvrce NM, et al. Covid-vaccine-monitor: study protocol for cohort event monitoring of safety of COVID-19 vaccines. In: EMA Early COVID-19 Vaccine Monitor (ECVM). VAC4EU. 2021. https:\/\/catalogues.ema.europa.eu\/sites\/default\/files\/document_files\/CVM_WP2_Protocol_v2.1_20210825.pdf. Accessed 8 Apr 2025."},{"key":"1579_CR5","unstructured":"Trifir\u00f2 G, Moretti U, Luxi N, Giovanazzi A, Raethke M, Kant A, et al. Covid-Vaccine-Monitor: study protocol for Cohort Event Monitoring of safety of COVID-19 vaccines in special populations pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy, people with prior SARS-CoV-2 infection). In: Covid Vaccine Monitor (CVM) Project. VAC4EU. 2021. https:\/\/catalogues.ema.europa.eu\/sites\/default\/files\/document_files\/CVM_WP1_Protocol_v2.1_20210729.pdf. Accessed 8 Apr 2025."},{"issue":"4","key":"1579_CR6","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1007\/s40264-023-01281-9","volume":"46","author":"M Raethke","year":"2023","unstructured":"Raethke M, van Hunsel F, Thurin NH, et al. Cohort event monitoring of adverse reactions to COVID-19 vaccines in seven European countries: pooled results on first dose. Drug Saf. 2023;46(4):391\u2013404. https:\/\/doi.org\/10.1007\/s40264-023-01281-9.","journal-title":"Drug Saf"},{"issue":"6","key":"1579_CR7","doi-asserted-by":"publisher","first-page":"575","DOI":"10.1007\/s40264-023-01304-5","volume":"46","author":"F Ahmadizar","year":"2023","unstructured":"Ahmadizar F, Luxi N, Raethke M, et al. Safety of COVID-19 vaccines among the paediatric population: analysis of the European surveillance systems and pivotal clinical trials. Drug Saf. 2023;46(6):575\u201385. https:\/\/doi.org\/10.1007\/s40264-023-01304-5.","journal-title":"Drug Saf"},{"issue":"21","key":"1579_CR8","doi-asserted-by":"publisher","first-page":"2201","DOI":"10.1001\/jama.2021.5374","volume":"325","author":"J Chapin-Bardales","year":"2021","unstructured":"Chapin-Bardales J, Gee J, Myers T. Reactogenicity following receipt of mRNA-based COVID-19 vaccines. JAMA. 2021;325(21):2201\u20132. https:\/\/doi.org\/10.1001\/jama.2021.5374.","journal-title":"JAMA"},{"issue":"7","key":"1579_CR9","doi-asserted-by":"publisher","first-page":"939","DOI":"10.1016\/S1473-3099(21)00224-3","volume":"21","author":"C Menni","year":"2021","unstructured":"Menni C, Klaser K, May A, et al. Vaccine side-effects and SARS-CoV-2 infection after vaccination in users of the COVID Symptom Study app in the UK: a prospective observational study. Lancet Infect Dis. 2021;21(7):939\u201349. https:\/\/doi.org\/10.1016\/S1473-3099(21)00224-3.","journal-title":"Lancet Infect Dis"},{"key":"1579_CR10","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2024-093366","volume":"15","author":"A Evans","year":"2025","unstructured":"Evans A, Roy D, Davies M, Dhanda S, Morris D, Aurelius T, et al. Safety and utilisation of AZD1222 (ChAdOx1 nCoV-19) COVID-19 vaccine: a UK post-authorisation active surveillance study. BMJ Open. 2025;15: e093366. https:\/\/doi.org\/10.1136\/bmjopen-2024-093366.","journal-title":"BMJ Open"},{"issue":"7","key":"1579_CR11","doi-asserted-by":"publisher","first-page":"1310","DOI":"10.1016\/j.vaccine.2022.12.031","volume":"41","author":"T Myers","year":"2023","unstructured":"Myers T, Marquez P, Gee J, Hause A, Panagiotakopoulos L, Zhang B, et al. The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC\u2019s COVID-19 pandemic response. 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Accessed 2 Oct 2024."},{"key":"1579_CR15","unstructured":"Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance. Medicines and Healthcare products Regulatory Agency. 2021. https:\/\/www.gov.uk\/government\/publications\/report-of-the-commission-on-human-medicines-expert-working-group-on-covid-19-vaccine-safety-surveillance. Accessed 2 Oct 2024."},{"issue":"6","key":"1579_CR16","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1016\/S2352-4642(18)30103-2","volume":"2","author":"P Bryan","year":"2018","unstructured":"Bryan P, Seabroke S, Wong J, Donegan K, Webb E, Goldsmith C, et al. Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisation in the UK: a prospective surveillance study. 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Department of Health and Social Care. 2021. https:\/\/www.gov.uk\/government\/publications\/covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-jcvi-statement\/jvci-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-15-july-2021. Accessed 2 Oct 2024."},{"key":"1579_CR20","unstructured":"Joint Committee on Vaccination and Immunisation: interim advice on priority groups for COVID-10 vaccination. Department of Health and Social Care. 2021. https:\/\/www.gov.uk\/government\/news\/jcvi-issues-new-advice-on-covid-19-vaccination-for-pregnant-women. Accessed 2 Oct 2024."},{"key":"1579_CR21","unstructured":"Joint Committee on Vaccination and Immunisation (JCVI) advice on third primary dose vaccination. Department of Health and Social Care. 2021. https:\/\/www.gov.uk\/government\/publications\/third-primary-covid-19-vaccine-dose-for-people-who-are-immunosuppressed-jcvi-advice\/joint-committee-on-vaccination-and-immunisation-jcvi-advice-on-third-primary-dose-vaccination. Accessed 2 Oct 2024."},{"key":"1579_CR22","unstructured":"Yellow Card Vaccine Monitor\u2014Invitation letters. Medicines and Healthcare products Regulatory Agency. https:\/\/vaccinemonitor-yellowcard.mhra.gov.uk\/resources\/invitationletter. Accessed 15 Oct 2024."},{"key":"1579_CR23","unstructured":"Understanding MedDRA. The Medical Dictionary for Regulatory Activities. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. https:\/\/files.meddra.org\/www\/Website%20Files\/Fact%20Sheets\/meddra2023.pdf. Accessed 2 Oct 2024."},{"key":"1579_CR24","unstructured":"ICH Harmonised Tripartite Guideline. Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety reports E2B(R2) Step 4 version. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 2001 https:\/\/admin.ich.org\/sites\/default\/files\/inline-files\/E2B_R2_Guideline.pdf. Accessed 2 Oct 2024."},{"key":"1579_CR25","unstructured":"Management of Safety Information from Clinical Trials. Report of CIOMS Working Group VI. The Council for International Organizations of Medical Sciences (CIOMS). 2005. https:\/\/cioms.ch\/wp-content\/uploads\/2017\/01\/Mgment_Safety_Info.pdf. Accessed 6 Oct 2024."},{"key":"1579_CR26","unstructured":"Guidance COVID-19 vaccination: a guide on pregnancy and breast feeding. UK Health Security Agency. 2023. https:\/\/www.gov.uk\/government\/publications\/covid-19-vaccination-women-of-childbearing-age-currently-pregnant-planning-a-pregnancy-or-breastfeeding\/covid-19-vaccination-a-guide-on-pregnancy-and-breastfeeding#:~:text=The%20Joint%20Committee%20on%20Vaccination,This%20includes%20pregnant%20women. Accessed 6 Oct 2024."},{"issue":"1","key":"1579_CR27","doi-asserted-by":"publisher","first-page":"2293550","DOI":"10.1080\/21645515.2023.2293550","volume":"20","author":"M Serhan","year":"2024","unstructured":"Serhan M, Psihogios A, Kabir N, Bota AB, Mithani SS, Smith DP, et al. A scoping review of active, participant centred, digital adverse events following immunization (AEFI) surveillance of WHO approved COVID-19 vaccines: a Canadian immunization Research Network study. 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Accessed 6 Oct 2024."}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-025-01579-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-025-01579-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-025-01579-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T05:19:57Z","timestamp":1762838397000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-025-01579-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,3]]},"references-count":36,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12]]}},"alternative-id":["1579"],"URL":"https:\/\/doi.org\/10.1007\/s40264-025-01579-w","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2024.11.06.24316782","asserted-by":"object"}]},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,3]]},"assertion":[{"value":"18 June 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"3 September 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study did not receive any funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The authors have no competing interests to declare that are relevant to the content of this study. At the time of the study, all authors were employed by the Medicines and Healthcare products Regulatory Agency (MHRA), which is an Executive Agency of the UK Department of Health and Social Care (DHSC).\u00a0The MHRA has statutory responsibility to monitor the safety of medicinal products on the UK market, and the study was undertaken independently of the Department of Health and Social Care.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All data generated or analysed during this study are included in this published article (and its supplementary information files). The Agency provides information to the public in line with requirements of the Freedom of Information Act. In addition, organisations and individuals can apply for Yellow Card data for research purposes. Applications include provision of a protocol and will be considered by the UK Commission of Human Medicine's (CHM) Pharmacovigilance Expert Advisory Group.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"No ethical approval was required. Research Ethics Committee of UK Health Research Authority (HRA) waived ethical approval for this work. No identifiable information about individuals was disclosed in the manuscript and all findings are reported in aggregated form.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"PT, KH, TJ and KD were involved in the design and implementation of the YCVM. TJ extracted the data from the YCVM platform for this study. JW conducted the analysis of the data and with critical input from KD. All authors were involved in the interpretation of the data analysis. The first draft of the manuscript was written by JW and KD. All authors reviewed and contributed to further drafts and had approved the final version of the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}