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Tulin Shekar

Merck



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75 – Contributed Poster Presentations: Biometrics Section

Reactogenicity Adverse Events: Collection, Analysis, and Reporting Process in Vaccine Clinical Trials

Sponsor: Biometrics Section
Keywords: reactogenicity, adverse event, vaccine, data collection, analysis and reporting

Tulin Shekar

Merck

Vaccine reactogenicity is an integral part of vaccine trials. Reactogenicity adverse events are defined as adverse events that are expected and occur soon after vaccination. These adverse events may include pain, redness, swelling or induration for injected vaccines, and systemic symptoms, such as fever, myalgia, headache, or rash. Reactogenicity events provide important information after vaccination, such as educating the vaccine community, including health care professionals, in maintaining confidence in vaccines by promoting vaccination and setting expectations for vaccines regarding what might occur after vaccination. In this paper, we will provide technical details on how reactogenicity data is collected and analyzed, and we will review CDISC Therapeutic Area Data Standards User Guide for Vaccines for data structure.

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