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Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.

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Title: Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.
Authors: Gandhi-Banga S; Epidemiology and Benefit Risk, Patient Safety and Pharmacovigilance, Sanofi, Toronto, ON, Canada., Serradell L; Epidemiology and Benefit Risk, Patient Safety and Pharmacovigilance, Sanofi, Lyon, France., Layton D; PEPI Consultancy Limited, Southampton, United Kingdom., Dreyfus J; Global Medical Epidemiology, Pfizer, Inc, New York, NY, United States., Praet N; Global Epidemiology Organization, Johnson and Johnson, Beerse, Belgium., Garofalo DC; Global Medical Epidemiology, Pfizer, Inc, New York, NY, United States., Bauchau V; Independent, Previously Vaccine Safety, GlaxoSmithKline (GSK), Wavre, Belgium., Kelly SP; Global Medical Epidemiology, Pfizer, Inc, New York, NY, United States., Li L; Epidemiology and Benefit Risk, Patient Safety and Pharmacovigilance, Sanofi, Morristown, NJ, United States.
Source: Frontiers in drug safety and regulation [Front Drug Saf Regul] 2025 Dec 01; Vol. 5, pp. 1651090. Date of Electronic Publication: 2025 Dec 01 (Print Publication: 2025).
Publication Type: Journal Article
Journal Info: Publisher: Frontiers Media S.A Country of Publication: Switzerland NLM ID: 9919033103806676 Publication Model: eCollection Cited Medium: Internet ISSN: 2674-0869 (Electronic) Linking ISSN: 26740869 NLM ISO Abbreviation: Front Drug Saf Regul Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.
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  Data: <searchLink fieldCode="AU" term="%22Gandhi-Banga+S%22">Gandhi-Banga S</searchLink>; Epidemiology and Benefit Risk, Patient Safety and Pharmacovigilance, Sanofi, Toronto, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Serradell+L%22">Serradell L</searchLink>; Epidemiology and Benefit Risk, Patient Safety and Pharmacovigilance, Sanofi, Lyon, France.<br /><searchLink fieldCode="AU" term="%22Layton+D%22">Layton D</searchLink>; PEPI Consultancy Limited, Southampton, United Kingdom.<br /><searchLink fieldCode="AU" term="%22Dreyfus+J%22">Dreyfus J</searchLink>; Global Medical Epidemiology, Pfizer, Inc, New York, NY, United States.<br /><searchLink fieldCode="AU" term="%22Praet+N%22">Praet N</searchLink>; Global Epidemiology Organization, Johnson and Johnson, Beerse, Belgium.<br /><searchLink fieldCode="AU" term="%22Garofalo+DC%22">Garofalo DC</searchLink>; Global Medical Epidemiology, Pfizer, Inc, New York, NY, United States.<br /><searchLink fieldCode="AU" term="%22Bauchau+V%22">Bauchau V</searchLink>; Independent, Previously Vaccine Safety, GlaxoSmithKline (GSK), Wavre, Belgium.<br /><searchLink fieldCode="AU" term="%22Kelly+SP%22">Kelly SP</searchLink>; Global Medical Epidemiology, Pfizer, Inc, New York, NY, United States.<br /><searchLink fieldCode="AU" term="%22Li+L%22">Li L</searchLink>; Epidemiology and Benefit Risk, Patient Safety and Pharmacovigilance, Sanofi, Morristown, NJ, United States.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Frontiers+Media+S%2EA%22">Frontiers Media S.A </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>9919033103806676 <i>Publication Model: </i>eCollection <i>Cited Medium: </i>Internet <i>ISSN: </i>2674-0869 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2226740869%22">26740869 </searchLink><i>NLM ISO Abbreviation: </i>Front Drug Saf Regul <i>Subsets: </i>PubMed not MEDLINE
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        Value: 10.3389/fdsfr.2025.1651090
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              Text: 2025 Dec 01
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