Articles with "eudravigilance" as a keyword



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Oral side effects of COVID‐19 vaccines in 32 European countries: Analysis of EudraVigilance reports

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Published in 2023 at "Journal of Medical Virology"

DOI: 10.1002/jmv.28771

Abstract: The recent reports of oral side effects (SEs) following COVID‐19 vaccination warrant further investigation into their prevalence, severity, and aetiology. This study was conducted to synthesize the first‐ever population‐level evidence about oral SEs of COVID‐19… read more here.

Keywords: eudravigilance; oral ses; covid vaccines; side effects ... See more keywords
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Patient Reporting in the EU: Analysis of EudraVigilance Data

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Published in 2017 at "Drug Safety"

DOI: 10.1007/s40264-017-0534-1

Abstract: IntroductionNew pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and… read more here.

Keywords: eudravigilance; legislation; patient reports; patient reporting ... See more keywords
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Spontaneous reports of vaccination errors in the European regulatory database EudraVigilance: A descriptive study.

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Published in 2018 at "Vaccine"

DOI: 10.1016/j.vaccine.2018.11.003

Abstract: BACKGROUND Among all post-marketing medication error reports submitted to EudraVigilance, vaccines are the most frequently reported medicinal products. This study aims to describe the characteristics of vaccination errors submitted to Eudravigilance between 2001 and 2016.… read more here.

Keywords: eudravigilance; age; submitted eudravigilance; drug ... See more keywords
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Unresolved gustatory, olfactory and auditory adverse drug reactions to antibiotic drugs: a survey of spontaneous reporting to Eudravigilance

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Published in 2019 at "Expert Opinion on Drug Safety"

DOI: 10.1080/14740338.2019.1676724

Abstract: ABSTRACT Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly… read more here.

Keywords: eudravigilance; drug reactions; gustatory olfactory; drug ... See more keywords