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Abstract:
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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 help to the vaccine community, including healthcare professionals, in maintaining confidence in vaccines by promoting vaccination, setting expectations for vaccines regarding what might occur after vaccination. In this poster, we will provide technical details on how reactogenicity data is collected and analyzed. We will review CDISC Therapeutic Area Data Standards User Guide for Vaccines for data structure, and provide sample reactogenicity summaries that are available in public.
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