Individual Case Safety Reports (ICSRs) Every country has representative who reports Medicines’ side effects to World Health Organizations (WHO). Each side effect related “a drug” (aka Primary Suspect Drug) must be reported to WHO. Valid ISCR: A Case created in the Safety system that includes the following four (4) minimum data elements: 1. Product…
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FDA’s Adverse Event Reporting System (FAERS) Public Website https://fis.fda.gov/hub/ offers dashboard by Product Report Statistics Demographic Reaction Cases Listings For Vaccines, VAERS click here The Vaccine Adverse Event Reporting System (VAERS) About (cdc.gov)
FDA Adverse Event Reporting System (FAERS) FAERS is a database that contains information on adverse event and medication error reports submitted to FDA. It contains over 9 million reports of adverse events from 1969 to the present. How did FDA collected this data? Reporting of adverse events and medication errors by healthcare professionals and consumers…
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