{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T13:33:03Z","timestamp":1760189583706,"version":"3.37.3"},"reference-count":42,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,11,20]],"date-time":"2017-11-20T00:00:00Z","timestamp":1511136000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To investigate the safety of trivalent seasonal influenza vaccine (TIVc) (Optaflu<jats:sup>\u00ae<\/jats:sup>), the first cell culture seasonal trivalent influenza vaccine available in Europe.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Codes and unstructured text in adult electronic healthcare records (The Health Improvement Network) were searched for a TIVc brand name or batch number and possible outcomes within a 3\u00a0month pre\u2010 to 6\u00a0month post\u2010TIVc exposure study period (2012\u20102015). The outcomes were severe allergic reactions, Bell's palsy, convulsions, demyelination, paresthesia, noninfectious encephalitis, neuritis (optic and brachial), vasculitis, inflammatory bowel disease, and thrombocytopenia. Risk periods were defined based on biologically plausible time frame postvaccination when an outcome caused by the vaccine might be expected to occur. Possible outcomes were adjudicated against outcome specific case definitions and a date of onset assigned by using electronic and other medical records. Observed (risk period) to expected (outside risk and preexposure periods) rate ratios, postexposure incidence, and plots of time from exposure to outcome were reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sixteen of 1011 events from 4578 exposures fulfilled a primary case definition and had a date of onset during the study period. Three were in observed time. The observed\u2010to\u2010expected rate ratios were (3.3, 95% CI 0.3, 31.7) for convulsions and (1.5, 95% CI 0.2, 14.9) for thrombocytopenia with 1 outcome each in observed time. There was 1 incident inflammatory bowel disease in observed, but none in expected, time.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The small sample size restricts interpretation; however, no hypothesis of an increased risk of a study outcome was generated. Adjudication of events against case definitions to reduce misclassification of onset and outcomes allowed use of precise risk periods.<\/jats:p><jats:p><jats:boxed-text content-type=\"box\" position=\"float\"><jats:caption><jats:title>KEY POINTS<\/jats:title><\/jats:caption><jats:p>\n<jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>This observational study did not generate a hypothesis of an association between the first cell\u2010culture seasonal influenza vaccination available in the European Union and any of the study outcomes (severe allergic reactions, Bell's palsy, convulsions, demyelination, paresthesia, noninfectious encephalitis, neuritis [optic and brachial], vasculitis, inflammatory bowel disease [IBD], and thrombocytopenia). The small sample size limits interpretation of the results.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>The review of each possible outcome identified from electronic healthcare records against case definitions was included to minimize misclassification of time and outcomes and allow the use of precise risk\u2010periods in an observed\u2010to\u2010expected within cohort analysis. Plots of time from exposure to outcome were included to assess the risk windows.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><\/jats:boxed-text><\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4347","type":"journal-article","created":{"date-parts":[[2017,11,20]],"date-time":"2017-11-20T05:16:44Z","timestamp":1511155004000},"page":"52-58","source":"Crossref","is-referenced-by-count":3,"title":["Observational safety study of specific outcomes after trivalent cell culture seasonal influenza vaccination (Optaflu<sup>\u00ae<\/sup>) among adults in THIN database of electronic UK primary healthcare records"],"prefix":"10.1002","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5081-3710","authenticated-orcid":false,"given":"Gillian C.","family":"Hall","sequence":"first","affiliation":[{"name":"Grimsdyke House  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul T.G.","family":"Davies","sequence":"additional","affiliation":[{"name":"Northampton General Hospital NHS Trust  Northampton UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. 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