Yesterday, the Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System (AEMS), a new platform for assessing adverse event reports made to the FDA for drugs, biologics, vaccines, cosmetics, and animal foods.

The platform replaces the existing VAERS (Vaccine Adverse Event Reporting System), FAERS (FDA Adverse Event Reporting System for drugs, biologics, cosmetics, and color additives), and AERS (Adverse Event Reporting System for animal drugs and foods).

In May, the FDA will expand AEMS to analyze reports on human food and dietary supplements, medical decides, and tobacco products and nicotine delivery systems.

“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics,” said FDA Commissioner Marty Makary, MD, MPH, earlier this week in a press release.

Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.

“We’re fixing the problem through a major modernization initiative,” he added. “Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”

AI-driven platform to run in real time

The FDA said all adverse events will be displayed in a single streamlined dashboard. And, unlike the prior systems, which reported adverse events quarterly, AEMS will run in real time.

“By the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products, consistent with meeting agency obligations not to release individually identifiable patient or consumer information,” the agency said.

But it’s unclear how events will be assessed for credibility or how and if claims will be verified in the context of real-time reporting. 

The FDA said there are typically 6 million adverse event reports each year, but the old system cost $37 million per year to operate. The new system will save $120 million over five years, but the FDA gave few other details.

Artificial intelligence (AI) will power the new platform, the FDA said.

“Consolidating the FDA’s adverse event systems and converting to real-time publication was challenging, but made possible by a highly aggressive schedule,” said FDA’s Chief AI Officer Jeremy Walsh. “The team executed with perfection and delivered the biggest technical transformation in agency history. This is the new FDA.” 

VAERS was created in 1990 and was run by both the FDA and the Centers for Disease Control and Prevention.