The FDA introduces a centralized monitoring platform designed to merge multiple reporting systems and provide real-time safety data as advocates debate whether it resolves longstanding transparency concerns.
By yourNEWS Media Newsroom
Federal regulators have launched a new national system intended to modernize how adverse reactions to drugs, vaccines, and other regulated products are reported and analyzed, consolidating several previously separate databases into a single monitoring platform.
The U.S. Food and Drug Administration announced Tuesday the release of a new reporting tool described in its announcement of a new database. Officials said the platform is designed to provide the public with faster access to safety information while improving how regulators review reports submitted by patients, healthcare professionals, and manufacturers.
The platform, called the Adverse Event Monitoring System (AEMS), combines data from several federal reporting programs that previously operated independently. The system integrates information from the federal government’s long-running VAERS vaccine injury reporting database, along with additional safety systems used to track adverse events involving pharmaceuticals, biologics, cosmetics, and other regulated products.
According to federal officials, the new system is intended to streamline oversight of millions of safety reports submitted each year. The agency estimates that the combined reporting systems process roughly six million adverse-event submissions annually.
FDA Commissioner Marty Makary said the older reporting systems had become difficult to navigate and fragmented across several databases.
“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access,” Makary said in a statement.
Makary described the new system as “a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”
Federal officials also said the upgraded platform will deliver real-time updates to reported safety data, replacing older systems that published updates quarterly.
The monitoring system will continue expanding over the coming months. By May, the agency plans to incorporate additional databases tracking adverse events related to dietary supplements, medical devices, tobacco products, and human food products.
The system will also incorporate artificial intelligence tools designed to help analysts identify trends within the data. Reporting from Fox News indicated that the system is expected to use AI to evaluate safety reports submitted nationwide.
The AI effort follows earlier reporting by Wired that the Department of Health and Human Services has been developing an artificial intelligence program capable of reviewing vaccine injury reports and generating hypotheses about potential negative health outcomes linked to vaccines.
Reactions to the system’s launch from groups representing people who say they have suffered vaccine injuries were mixed, according to The Defender.
Christopher Dreisbach, legal affairs director for the advocacy organization React19, said the new system could improve federal monitoring if it ultimately resolves longstanding problems within existing reporting systems.
Dreisbach said the platform “has the potential to be a meaningful step forward” if it replaces what he described as a “Kafkaesque status quo.”
He said the existing system often creates a contradiction for individuals who report injuries.
Reports filed through VAERS, he said, are “frequently dismissed on the grounds that VAERS is ‘unreliable.’”
That dynamic, Dreisbach said, leaves injured individuals “in an impossible position: told to trust a system that, when it raises questions, is then discounted.”
Some researchers raised additional concerns about the role artificial intelligence may play in evaluating reports.
Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense, said increased reliance on automated analysis could make it more difficult to trace how decisions are made.
“Supplanting real intelligence with the artificial kind is always a cause for concern,” Jablonowski said. “Decisions made by humans are trackable, accountable and inquirable. With AI, it is not so easy to identify the genesis of decisions, and accountability doesn’t exist.”
The creation of the new reporting system comes amid broader calls for expanded transparency across federal health agencies.
During Senate confirmation hearings last year, Health Secretary Robert F. Kennedy Jr. pledged what he described as “radical transparency” within federal health agencies. After taking office, Kennedy also promised improvements in vaccine injury tracking.
Makary said the older monitoring systems created inefficiencies that limited effective oversight of regulated products.
“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,” he said.
Federal officials estimate the consolidated system will reduce operational costs by roughly $120 million over five years.
The new platform also arrives after scrutiny of the existing reporting infrastructure. A 2023 investigation published in The BMJ reported that federal regulators maintained two VAERS systems: one public database and a separate internal version containing updates and corrections, including deaths recorded after the initial injury reports.
The investigation also identified instances of disappearing reports and data inconsistencies.
In response to such concerns, React19 partnered with Children’s Health Defense and the independent database project OpenVAERS to create a system allowing individuals to monitor the status of reports filed with federal agencies. The initiative produced a separate online tool enabling people to track VAERS reports.
Supporters of the project said the effort was intended to help individuals monitor submissions after reporting injuries and address recurring issues such as disappearing reports or inaccuracies within the federal system.
Albert Benavides, founder of VAERSaware.com, said the earlier FDA drug reporting database known as FAERS had faced similar transparency criticisms. He said the newly introduced system appears to replicate many of the same design features.
“This new AEMS dashboard has all the same functionality, or lack of functionality, as the old FAERS dashboard. It looks like FDA has rebranded FAERS to AEMS but added a couple extra tabs for vaccines and cosmetics,” Benavides said.
In earlier interviews with CHD.TV, Benavides said federal reporting systems may undercount or obscure information about vaccine-related injuries and deaths.
Federal officials say a future phase of the AEMS rollout will focus on simplifying how safety reports are submitted. Sources cited by Fox News said the next update will include an interface designed to make it easier for individuals and clinicians to submit reports.
Government estimates suggest many incidents are never reported. An analysis cited by the FDA suggests that complex reporting procedures may prevent as many as 80 percent of potential reports from being submitted.
A 2011 Harvard report estimated that less than 1% of all adverse events were reported through VAERS.
Dreisbach said improvements to the reporting interface alone will not address deeper issues within the monitoring system.
“Streamlining is only one piece of what is needed,” he said.
“The bigger issue is follow-up and verification. Right now, individuals who file legitimate adverse-event reports rarely receive meaningful follow-up, and clinicians often assume that reporting leads to some sort of investigation — when in reality, most reports simply become entries in a database.”
“Fixing the front end without fixing the back end will not improve safety surveillance in a meaningful way.”
In a 2024 interview with The Defender, retired gastroenterologist Dr. Danice Hertz described her experience submitting injury reports following a reaction to Pfizer’s COVID-19 vaccine.
“It took three years and 11 reports to VAERS for someone to contact me from the CDC [Centers for Disease Control and Prevention] and request my records,” Hertz said.
After submitting her eleventh report in late 2023, Hertz said a CDC employee told her the agency had been “swamped with reports of injury.”
Speaking again after the launch of the new system, Hertz said the new database could improve monitoring if it ensures reports remain accessible.
“Reports to the new database must be permanent and not mysteriously drop out as many reports have done in the old VAERS system,” she said.
“Patients should be able to update their reports as their condition progresses and more information becomes available. This is not possible with the old systems. … Most importantly, if data is to be collected, the data must be taken seriously and acted upon. VAERS data was largely ignored.”
Concerns about federal monitoring systems were also raised during two U.S. House of Representatives hearings in 2024 examining vaccine injury reporting. During the March hearing, witnesses told lawmakers that weaknesses in the systems had jeopardized public health oversight during the COVID-19 vaccine rollout.
Jablonowski also pointed out that another federal monitoring database — the Vaccine Safety Datalink — was not included within the new platform.
He described the system as a near real-time monitoring program covering roughly 10 million people and containing detailed data on vaccinations, medical visits, prescriptions, and mortality records.
“A publicly available version of the VSD would relieve an enormous burden, and budgetary line item, from HHS,” he said. “A lot of good science can come from it, and it could bury the uncertainty surrounding hazards of vaccines.”
Benavides said structural features of the new system could also limit the usefulness of the database for researchers.
He said the platform removes the “free text narrative section” previously included in VAERS reports, which allowed individuals to describe symptoms and circumstances in their own words.
According to Benavides, that section often contained information such as vaccination history, laboratory results, underlying medical conditions, and medications that were not captured by standardized reporting fields.
He also said some search tools available in earlier systems are absent in the new interface.
“In this AEMS data dashboard, there is no longer an adverse event level like ‘Office visit,’ ‘Emergency Room,’ ‘Hospitalization,’ ‘Life Threatening,’ ‘Permanent Disability’ or ‘Death,’” Benavides said.
He said the date of death field commonly recorded in VAERS reports does not appear in the current interface and that vaccine lot number information is accessible only after navigating additional menu layers.
“The public is only allowed to view the minimal amount of data, like age, gender, vaccination date, onset date, vaccine name,” Benavides said.
He also said the system limits how much data can be exported at one time.
“Worst of all for any intermediate-to-expert user or analyst, queries and raw downloads are capped at no more than 10,000 records,” Benavides said.
Advocates representing individuals who report vaccine injuries said broader reforms may be needed for the new system to function effectively.
Orthopedic surgeon Dr. Joel Wallskog, who says he was injured following COVID-19 vaccination and now serves as co-chair of React19, said healthcare providers should be required to report adverse events.
“Reporting must be mandatory, and there must be a penalty for non-reporting,” Wallskog said. “If all of these issues are not taken into account in a new reporting system, the new system will once again fail.”
Dreisbach said individuals who report injuries ultimately want meaningful accountability within the monitoring system.
“Patients who experience adverse events want a system that works, not one that merely appears more modern,” Dreisbach said.
He called for greater transparency in how the new system processes reports and for expanded access to the data for researchers, clinicians, and the public.
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