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The U.S. Food and Drug Administration (FDA) on Tuesday launched a new database that the agency said will increase efficiency and transparency, and provide the public with real-time data for the first time.
The new platform merges the FDA’s previously separate adverse event reporting systems for drugs, vaccines and other products.
Some advocates for the vaccine-injured applauded the launch of the FDA Adverse Event Monitoring System (AEMS). But others said the new database does little to solve long-standing problems with the federal government’s follow-up and verification of adverse event reports.
The FDA said AEMS reports will be updated in real time, not quarterly.
“The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access,” FDA Commissioner Marty Makary said in a statement.
Makary described AEMS as “a single, intuitive adverse event platform that will better serve agency scientists, researchers, and the public.”
AEMS includes data from the Vaccine Adverse Event Reporting System (VAERS); the FDA Adverse Event Reporting System (FAERS), which contains reports for drugs, biologics, cosmetics and color additives; and the Adverse Event Reporting System (AERS), which contains reports for animal drugs and foods.
By May, AEMS will also include reports now housed in separate databases, concerning adverse events related to human foods and dietary supplements, tobacco products and medical devices. According to the FDA, these databases together processed 6 million adverse event reports per year.
AEMS will be backed by artificial intelligence (AI), according to Fox News.
Last month, Wired reported that the U.S. Department of Health and Human Services (HHS), which oversees the FDA, was developing a generative AI tool to identify patterns in vaccine injury reports and “generate hypotheses on the negative effects of vaccines.”
Christopher Dreisbach, legal affairs director for React19, an advocacy group for COVID-19 vaccine injury victims, said AEMS “has the potential to be a meaningful step forward” if it replaces a “Kafkaesque status quo.”
Dreisbach was referring to vaccine injury reports submitted to VAERS that are “frequently dismissed on the grounds that VAERS is ‘unreliable.’”
He said that contradiction “has left injured individuals in an impossible position: told to trust a system that, when it raises questions, is then discounted.”
Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense (CHD), questioned the new platform’s reliance on AI.
“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.”
VAERS long plagued by transparency concerns
During U.S. Senate confirmation hearings last year, U.S. Health Secretary Robert F. Kennedy Jr. promised “radical transparency” at federal health agencies. Soon after his confirmation, Kennedy pledged better vaccine injury tracking.
Makary said the FDA’s prior 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,” he added.
According to the FDA, AEMS will save the agency approximately $120 million over the next five years.
VAERS has faced scrutiny over transparency concerns. A 2023 investigation by The BMJ revealed that the federal government operates two VAERS systems — one for the public, and a private back-end system that contains corrections and updates, including deaths that occurred after an initial injury.
The BMJ investigation also identified other deficiencies, including disappearing reports and data.
In 2024, React19 teamed with CHD and OpenVAERS — a website that provides tools for more easily accessing and searching VAERS data — to develop a tool to track VAERS reports.
Citing frequently disappearing reports and widespread errors in VAERS, the organizations said the new tool would enable vaccine-injured people to follow what happens to the reports they submit.
According to Albert Benavides, founder of VAERSaware.com, the FDA’s FAERS database had problems similar to those associated with VAERS. He said the new AEMS does little to address transparency concerns.
“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 previous interviews with CHD.TV, Benavides suggested that VAERS administrators intentionally undercounted or obscured data on vaccine-related injuries and deaths.
Old systems were difficult to use and inefficient — will AEMS be any better?
Fox News quoted unnamed FDA sources who said the next phase of the AEMS rollout will include a user-friendly front-end system “that makes it easy for reports to be submitted.”
The FDA cited estimates suggesting that 80% of reports were never entered into its databases “due to the complexity of filing a report.” A 2011 Harvard report found that less than 1% of all adverse events were reported to VAERS.
Dreisbach said, “Streamlining is only one piece of what is needed.” He added:
“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, Dr. Danice Hertz, a retired gastroenterologist injured by Pfizer’s COVID-19 vaccine, said, “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.”
After submitting her 11th report in late 2023, Hertz said the CDC employee who spoke with her said the agency was “swamped with reports of injury.”
In a follow-up interview today, Hertz welcomed the launch of AEMS, but said reports to the new database “must be permanent and not mysteriously drop out as many reports have done in the old VAERS system.”
She added:
“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.”
The lack of follow-up on reports submitted to VAERS was the subject of two 2024 U.S. House of Representatives hearings. At the second of the two hearings, in March 2024, witnesses told Congress that inadequate vaccine safety surveillance systems “jeopardized” Americans’ health during the COVID-19 vaccine rollout.
Jablonowski noted that a key adverse event database — Vaccine Safety Datalink (VSD) — is not included within AEMS. He said:
“The VSD is a near-real-time monitoring of about 10 million people — children and adults — that contains data on vaccination, demographics, birth details, medical encounters (visits, diagnoses and lab results), pharmacy records and mortality.
“A publicly available version of the VSD would relieve an enormous burden, and budgetary line item, from HHS. A lot of good science can come from it, and it could bury the uncertainty surrounding hazards of vaccines.”
Design of new AEMS database raises concerns
Benavides said the structure and design of the new AEMS database fall short of the government’s promises of radical transparency. He said AEMS is missing the “free text narrative section” that was “customary in VAERS reports.”
This section displayed the text freely entered by anyone who submitted a VAERS report — text which Benavides said allowed the public to provide information not requested or captured by the other, closed-ended questions in the VAERS submission form.
Benavides said information entered in the free text section typically included “vaccine history, laboratory results, current illness and concomitant medications.”
Certain search options that were available within the VAERS database are also not available in AEMS, according to Benavides.
“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 — customarily included in most VAERS reports — is “non-existent” in the new platform. And the vaccine lot number information is “buried under an additional layer of clicks.”
“The public is only allowed to view the minimal amount of data, like age, gender, vaccination date, onset date, vaccine name,” Benavides said.
Benavides said that, as structured, AEMS will also hamper the efforts of researchers, as it limits the number of reports they can download 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.
Dr. Joel Wallskog, an orthopedic surgeon injured by COVID-19 vaccines and co-chair of React19, said medical providers and healthcare organizations must be required to submit adverse event reports to AEMS for the new platform to succeed.
“Reporting must be mandatory, and there must be a penalty for non-reporting. If all of these issues are not taken into account in a new reporting system, the new system will once again fail,” Wallskog said.
“Patients who experience adverse events want a system that works, not one that merely appears more modern,” Dreisbach said. He called for more transparency in how AEMS operates, greater accessibility for researchers, clinicians and the public, and “accountability in how reports are followed up and classified.”
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