FDA Launches New Consolidated Adverse Event Monitoring System

The U.S. Food and Drug Administration (FDA) has announced the launch of a new Adverse Event Monitoring System (AEMS) that consolidates adverse event reporting systems for different types of products licensed by the FDA, including the Vaccine Adverse Event Reporting System (VAERS) that was created under the 1986 National Childhood Vaccine Injury Act (NCVIA). The federal regulatory agency justified the move as a big step toward furthering its efforts to “modernize and provide radical transparency into the safety of regulated products.”¹

According to agency officials, the new platform will consolidate product safety reports into a single searchable interface, which they say will make it easier to review reports of adverse reactions, including injuries and deaths, linked to FDA-regulated products like prescription drugs, vaccines and other medical products. The system will replace several legacy reporting databases that for many years have been used to store vaccine, drug, and device adverse event reports.¹

FDA Commissioner Marty Markary, MD, MPH said in a Mar. 11, 2026 press release:

The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access.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 post market surveillance of products ranging from drugs and vaccines to cosmetics. We’re fixing the problem through a major modernization initiative. Starting today, the FDA will have a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.¹

Will the New AEMS System Accurately Count Vaccine Injuries and Deaths?

Medical product adverse events reported to previous electronic tracking systems were spread across multiple databases and, for vaccines, independent tracking systems were created based on VAERS data. For example, MedAlerts, was privately developed in 2003 by Steven M. Rubin, PhD and has been sponsored by the National Vaccine Information Center (NVIC) since 2006. It was the first publicly accessible database in the U.S. to monitor and independently analyze vaccine adverse event computer data collected by the U.S. Centers for Disease Control and Prevention (CDC) and the FDA from physicians in private practice and public health clinics and make it available to the public in a user-friendly format.

Upon learning of the consolidation of different adverse event reporting systems into one, NVIC Co-founder and President Barbara Loe Fisher, founding executive editor of The Vaccine Reaction, expressed hope that the new AEMS focusing on a number of different FDA licensed medical products would not result in vaccine-related health problems being buried inside the larger database and result in less transparency and awareness about vaccine injury and death reports. She said:

VAERS and the independent MedAlerts database played a big role during the government’s COVID pandemic response in raising public awareness about the risks associated with the mRNA COVID-19 biological. More than 1.6M reports of COVID shot reactions, injuries and deaths are featured on MedAlerts alone, which highlights the importance of VAERS. Only time will tell just how transparent, accurate and user friendly the new federal medical product adverse events reporting system using artificial intelligence will be, especially when it comes to monitoring vaccine adverse events. 

Under the previous adverse event reporting systems for FDA regulated medical products like vaccines,  published reports were issued quarterly by the CDC/FDA/. Under the new AEMS, which the agency acknowledges is powered by artificial intelligence (AI), reportedly data will be released in real time. The new public-facing “Adverse Event Look-up Tool” will enable users to search and filter reports directly through what agency officials describe as a more user-friendly online dashboard.²

“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 stated.¹

Providing Informed consent to individuals using FDA licensed products is dependent upon transparency about a product’s benefits and risks. Access to comprehensive post-licensure safety data in realtime could make it easier to independently review reports and identify potential safety signals.¹

Agency officials stated they anticipate that the new adverse event reporting system could reduce costs. According to the FDA, the agency currently processes about six million adverse event reports each year across seven separate product databases, a system that costs roughly $37 million annually. By consolidating those systems into a single platform, the agency estimates the new system could save taxpayers about $120 million over the next five years.²

“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.”¹

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