FDA Data Dashboard Shows Adverse Events Related to COVID-19 Products

March 16, 2021 - The FDA has launched the FDA Adverse Event Reporting System (FAERS), a public data dashboard showing human adverse event reports for drugs and therapeutic products used under emergency use authorization (EUA) during COVID-19.

The COVID-19 EUA FAERS Public Dashboard provides weekly updates of adverse event reports submitted to FAERS.

“The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user-friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers,” FDA stated.

The FDA noted that there are some limitations to the data shown in the FAERS dashboard. For example, while FAERS contains reports on a particular drug or biologic, this doesn’t mean that the drug or biologic caused the adverse event. The agency also emphasized that the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic.

Additionally, the FDA stated that there are duplicate and incomplete reports in the system, with some reports missing all the necessary information. The agency also pointed out that the existence of a report does not establish causation, and that there is no certainty that a suspected drug caused the event in any given report.

“While consumers and healthcare professionals are encouraged to report adverse events, the event may have been related to the underlying disease being treated, or caused by some other drug being taken concurrently, or occurred for other reasons. The information in these reports reflects only the reporter's observations and opinions,” FDA said.

The organization was also sure to note that submission of a report doesn’t mean that the information included in it has been medically confirmed, nor is it an admission from the reporter that the drug caused or contributed to the event.

Moreover, the information in the reports can’t be used to estimate the occurrence rates of the events reported, and patients should talk to their doctors before stopping or changing how they take their medications.

Despite these limitations, the FDA believes that the FAERS dashboard offers healthcare stakeholders more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products – including those granted EUA during the pandemic.

“Improving data access and transparency are core concepts that drove the development of this FAERS Dashboard.  The FDA anticipates that this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public,” FDA concluded.

“Complete and detailed reports are immensely helpful to the agency when identifying safety signals and choosing particular products for further scrutiny.”

During the pandemic, healthcare leaders have turned to data dashboards to track and monitor the massive amounts of information related to COVID-19. Recently, a team from Johns Hopkins developed a data dashboard that shows how states are prioritizing people with disabilities in the COVID-19 vaccine rollout.

The tool can also help people with disabilities determine when they’re eligible for shots, as well as provide policymakers with data to improve the system.

“The prioritization schemes aim to reduce infection and mortality but access and accessibility has to also be part of that equation,” said Bonnielin Swenor, director of the Johns Hopkins Disability Health Research Center.

“There are certain members of the disability community that as of this moment don’t have access to the information or can’t get to the vaccination sites. The path forward has to include accessibility, or we’re never going to reach equity in the pandemic response, as over a quarter of the population has a disability.”