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With the increasing availability of electronic health records (EHR) near real\u2010time vaccine safety surveillance using these data has emerged as an option. We reviewed methods currently used to inform development of similar systems for countries considering their introduction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Medline, EMBASE and Web of Science were searched, with additional searches of conference abstract books. Questionnaires were sent to organizations worldwide to ascertain unpublished studies. Eligible studies used EHR and regularly assessed pre\u2010specified AE to vaccine(s). Key features of studies were compared descriptively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>From 2779 studies, 31 were included from the USA (23), UK (6), and Taiwan and New Zealand (1 each). These were published\/conducted between May 2005 and April 2015. Thirty\u2010eight different vaccines were studied, focusing mainly on influenza (47.4%), especially 2009 H1N1 vaccines. Forty\u2010six analytic approaches were used, reflecting frequency of EHR updates and the AE studied. Poisson\u2010based maximized sequential probability ratio test was the most common (43.5%), followed by its binomial (23.9%) and conditional versions (10.9%). Thirty\u2010seven of 49 analyses (75.5%) mentioned control for confounding, using an adjusted expected rate (51.4% of those adjusting), stratification (16.2%) or a combination of a self\u2010controlled design and stratification (13.5%). Guillain\u2010Barr\u00e9 syndrome (11.9%), meningitis\/encephalitis\/myelitis (11.9%) and seizures (10.8%) were studied most often.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Near real\u2010time vaccine safety surveillance using EHR has developed over the past decade but is not yet widely used. As more countries have access to EHR, it will be important that appropriate methods are selected, considering the data available and AE of interest. \u00a9 2016 The Authors. <jats:italic>Pharmacoepidemiology and Drug Safety<\/jats:italic> Published by John Wiley &amp; Sons Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3966","type":"journal-article","created":{"date-parts":[[2016,1,28]],"date-time":"2016-01-28T10:55:06Z","timestamp":1453978506000},"page":"225-237","source":"Crossref","is-referenced-by-count":31,"title":["Near real\u2010time vaccine safety surveillance using electronic health records\u2014a systematic review of the application of statistical methods"],"prefix":"10.1002","volume":"25","author":[{"given":"Andreia","family":"Leite","sequence":"first","affiliation":[{"name":"Faculty of Epidemiology and Population Health London School of Hygiene &amp; Tropical Medicine  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nick J.","family":"Andrews","sequence":"additional","affiliation":[{"name":"Statistics, Modelling and Economics Department Public Health England  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara L.","family":"Thomas","sequence":"additional","affiliation":[{"name":"Faculty of Epidemiology and Population Health London School of Hygiene &amp; Tropical Medicine  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,1,28]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2012.07.007"},{"key":"e_1_2_9_3_1","first-page":"423","volume-title":"Pharmacoepidemiology","author":"Chen RT","year":"2011"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1359-6446(04)03234-9"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1538-5442(01)70025-9"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1586\/erv.10.20"},{"key":"e_1_2_9_7_1","first-page":"137","volume-title":"Pharmacoepidemiology","author":"Dal Pan GJ","year":"2011"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1586\/14760584.2014.866895"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1590\/S0034-89102011000100020"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.ede.0000155506.05636.a4"},{"key":"e_1_2_9_11_1","first-page":"852","volume-title":"Pharmacoepidemiology","author":"Kulldorff M.","year":"2011"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-1722I"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280211413452"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3180616c0a"},{"key":"e_1_2_9_15_1","unstructured":"Brighton Collaboration.Newsletter.2015;.https:\/\/brightoncollaboration.org\/public\/newsletter.html(accessed 19 June 2015)."},{"key":"e_1_2_9_16_1","unstructured":"World Health Organization.The Global Advisory Committee on Vaccine Safety.2015;http:\/\/www.who.int\/vaccine_safety\/committee\/en\/(accessed 19 May 2015)."},{"key":"e_1_2_9_17_1","unstructured":"Brighton Collaboration.Who we are.2015;https:\/\/brightoncollaboration.org\/public\/who\u2010we\u2010are.html(accessed 19 May 2015)."},{"key":"e_1_2_9_18_1","unstructured":"ADVANCE.About ADVANCE.2015;http:\/\/www.advance\u2010vaccines.eu\/(accessed 2015\u201005\u201019)."},{"key":"e_1_2_9_19_1","unstructured":"Government Digital Service.Medicines & Healthcare products Regulatory Agency.2015;https:\/\/www.gov.uk\/government\/organisations\/medicines\u2010and\u2010healthcare\u2010products\u2010regulatory\u2010agency(accessed 19 May 2015)."},{"key":"e_1_2_9_20_1","unstructured":"Centers for Disease Control and Prevention.Vaccine Safety Datalink (VSD).2015;http:\/\/www.cdc.gov\/vaccinesafety\/Activities\/VSD.html(accessed 19 May 2015)."},{"key":"e_1_2_9_21_1","unstructured":"Statens Serum Institut.Statens Serum Institut.2015;http:\/\/www.ssi.dk\/english.aspx(accessed 19 May 2015)."},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.4161\/hv.3.5.4458"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3181b58b5c"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2009.05.036"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwp345"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e3181af8605"},{"key":"e_1_2_9_27_1","unstructured":"National Vaccine Advisory Committee (NVAC).Report on 2009 H1N1 vaccine safety risk assessment. 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