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In 2013, the Council for International Organizations of Medical Sciences (CIOMS) created a Working Group on Vaccine Safety (WG) to address unmet needs in the area of vaccine pharmacovigilance. Generating reliable data about specific vaccine safety concerns is becoming a priority due to recent progress in the development and deployment of new vaccines of global importance, as well as novel vaccines...
Introduction Duplicate case reports in spontaneous adverse event reporting systems pose a challenge for medical reviewers to efficiently perform individual and aggregate safety analyses. Duplicate cases can bias data mining by generating spurious signals of disproportional reporting of product-adverse event pairs. Objective We have developed a probabilistic record linkage algorithm for identifying...
In November 2012, the first cell cultured influenza vaccine, a trivalent subunit inactivated influenza vaccine (Flucelvax®, ccIIV3), was approved in the US for adults aged ≥18 years.To assess adverse events (AEs) after ccIIV3 reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.We searched VAERS for US reports after ccIIV3 among persons vaccinated...
BACKGROUNDHemolysis after intravenous immune globulins (IGIVs) is a known complication, but expanding indications and recent manufacturing changes warrant ongoing postmarketing surveillance. Characterization of post‐IGIV hemolysis to date has been limited to small case series.
STUDY DESIGN AND METHODSWe queried the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) from 2007...
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