{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T23:45:40Z","timestamp":1773099940187,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,3,30]],"date-time":"2023-03-30T00:00:00Z","timestamp":1680134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Since being designated as medicines by World Health Organization (WHO), blood components are subject to pharmacovigilance reporting. Using VigiBase, the WHO global database of individual case safety reports (ICSRs), we characterized reports of adverse reactions for all blood products.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>ICSRs involving blood products as the suspected medicine in VigiBase between 1968 and 2021 were extracted. MedDRA preferred terms and the International Society of Blood Transfusion haemovigilance definitions were used to stratify adverse reactions. Descriptive statistics were used to characterize ICSR demographics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 111,033 ICSRs containing 577,577 suspected adverse reactions with 6152 MedDRA preferred terms were reported for 34 blood products. There were 12,153 (10.9%) reports for blood components, 98,135 (88.4%) reports for plasma\u2010derived medicines, and 745 (0.7%) reports for recombinant products. The majority of reports (21.0% and 19.7%, respectively) were from patients aged 45\u201364 and over 65\u2009years. The Americas contributed the most ICSRs (49.7%). Top reported suspected adverse reactions were for the following MedDRA preferred terms: headache (3.5%), pyrexia (2.8%), chills (2.8%), dyspnoea (1.8%), and nausea (1.8%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>VigiBase already has a large number of reports on blood products. When compared to other existing haemovigilance databases, our study found reports from a broader range of countries and reporters. This may provide us with new perspectives, but for VigiBase to reach its full potential in haemovigilance some alterations in what is captured in reports are required.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.17336","type":"journal-article","created":{"date-parts":[[2023,3,30]],"date-time":"2023-03-30T15:41:17Z","timestamp":1680190877000},"page":"982-992","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Suspected adverse reactions reported for blood, blood components, and blood products in <scp>VigiBase<\/scp>"],"prefix":"10.1111","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2455-879X","authenticated-orcid":false,"given":"Washington T.","family":"Samukange","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology &amp; Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science Utrecht University  Utrecht the Netherlands"},{"name":"Major Policy and Coordination Division Paul Ehrlich Institut  Langen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting\u2010An","family":"Lu","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology &amp; Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science Utrecht University  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick C.","family":"Souverein","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology &amp; Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science Utrecht University  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helga","family":"Gardarsdottir","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology &amp; Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science Utrecht University  Utrecht the Netherlands"},{"name":"Department of Clinical Pharmacy University Medical Center Utrecht  Utrecht the Netherlands"},{"name":"Department of Pharmaceutical Sciences University of Iceland  Reykjavik Iceland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aukje K.","family":"Mantel\u2010Teeuwisse","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology &amp; Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science Utrecht University  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,3,30]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03539.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01313-6"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2011.11.002"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-10-833988"},{"key":"e_1_2_8_6_1","unstructured":"World Health Organization.A guide to establishing a national haemovigilance system.2016."},{"key":"e_1_2_8_7_1","unstructured":"World Health Organization.Action framework to advance universal access to safe effective and quality\u2010assured blood products 2020\u20132023.2020."},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.13048"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12447"},{"key":"e_1_2_8_10_1","unstructured":"World Health Organization.WHO model list of essential medicines 18th list.https:\/\/www.who.int\/medicines\/publications\/essentialmedicines\/18th_EML.pdf"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/009286150804200501"},{"key":"e_1_2_8_12_1","unstructured":"ISBT Working Party on Haemovigilance.Transfusion\u2010asscoiated cirsulatory overload (TACO) definition.https:\/\/www.isbtweb.org\/fileadmin\/user_upload\/TACO_2018_definition_March_2019.pdf"},{"key":"e_1_2_8_13_1","unstructured":"ISBT Working Party on Haemovigilance.Proposed standard definitions for surveillance of non infectious adverse transfusion reactions.https:\/\/www.isbtweb.org\/fileadmin\/user_upload\/Proposed_definitions_2011_surveillance_non_infectious_adverse_reactions_haemovigilance_incl_TRALI_correction_2013_TACO_correction_2018.pdf"},{"key":"e_1_2_8_14_1","unstructured":"ISBT Working Party on Haemovigilance.Standard for surveillance of complications related to blood donation.https:\/\/www.isbtweb.org\/fileadmin\/user_upload\/Donor_Standard_Definitions_Final_2014.pdf"},{"key":"e_1_2_8_15_1","unstructured":"International Council for Harmonisation.Post\u2010approval safety data management: definitions and standards for expedited reporting.https:\/\/database.ich.org\/sites\/default\/files\/E2D_Guideline.pdf"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16362"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12918"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03330.x"},{"key":"e_1_2_8_19_1","unstructured":"FunkMB HeidenM M\u00fcllerS.Haemovigilance report of the Paul\u2010Ehrlich\u2010Institut 2018. Assessment of the reports of serious adverse transfusion reactions pursuant to section 63i AMG (Arzneimittelgesetz German Medicines Act).2020."},{"key":"e_1_2_8_20_1","unstructured":"Funk MarkusB MargaretheHn SusanneM et al.Haemovigilance report of the Paul\u2010Ehrlich\u2010Institut 2019: assessment of the reports of serious adverse transfusion reactions and events pursuant to section 63i AMG (German Medicines Act).www.pei.de\/haemovigilance-report"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12367"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1159\/000516049"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/tme.12582"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-021-07235-0"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.13913"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.16078"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijerph19010413"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.320.7237.759"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.17336","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T20:21:30Z","timestamp":1692649290000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.17336"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,30]]},"references-count":27,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2023,5]]}},"alternative-id":["10.1111\/trf.17336"],"URL":"https:\/\/doi.org\/10.1111\/trf.17336","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,30]]},"assertion":[{"value":"2022-11-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-03-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-03-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}