The Department of Health and Human Services has opened a specialized clinic in Maryland to evaluate patients experiencing health problems following vaccination, while announcing changes to medical records, physician reimbursement and the federal vaccine adverse-event reporting system.
By yourNEWS Media Newsroom
WASHINGTON — Health and Human Services Secretary Robert F. Kennedy Jr. announced Thursday, Oct. 8, that the National Institutes of Health has opened a clinic dedicated to evaluating and treating patients reporting health problems following vaccination, marking the beginning of a broader federal initiative to strengthen vaccine safety research and medical reporting.
The facility opened Monday, Oct. 5, on the NIH campus in Bethesda, Maryland, during a ceremony attended by Kennedy, NIH Director Dr. Jay Bhattacharya, federal health officials and representatives of patients who have reported vaccine-related injuries.
The clinic will combine patient evaluations with scientific research intended to investigate possible causes of adverse health outcomes, identify potential risk factors and develop approaches to treatment.
The opening fulfills a recommendation included in the Trump administration’s Make America Healthy Again strategy, which called for expanded federal research into vaccine injuries and improvements in the collection and analysis of safety information.
According to the Department of Health and Human Services’ official announcement Thursday, the initiative includes four coordinated measures involving NIH, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services and federal health information technology standards.
In addition to establishing the clinic, HHS plans to modernize the Vaccine Adverse Event Reporting System, require electronic health records to capture vaccine-related adverse events and propose Medicare reimbursement for physicians who spend time reporting suspected vaccine injuries.
Kennedy said the administration intends to improve the government’s response to people reporting medical problems after vaccination.
“We must listen to patients and families who report vaccine injuries—not dismiss or gaslight them,” Kennedy said.
“President Trump and I are building a health system that takes them seriously, follows the evidence, and uses what we learn to make vaccines safer. This is how we earn back trust in our public health institutions.”
The announcement represents an effort to connect clinical evaluations with federal safety monitoring, allowing researchers to examine patient experiences while improving the information available to physicians and public health agencies.
It is important to distinguish health problems occurring after vaccination from conditions established to have been caused by a vaccine. A medical event reported following immunization does not, by itself, establish a causal relationship.
Federal researchers will be responsible for investigating those relationships and identifying whether evidence supports a connection between a vaccine and a particular medical condition.
The new NIH facility is intended to provide a setting where patients with complex or unexplained symptoms can undergo medical evaluations while participating in research.
HHS said clinicians will examine individual medical histories, assess symptoms, investigate possible explanations and determine what treatments or additional testing may be appropriate.
The clinic will also allow researchers to study patterns across patients and identify questions requiring further scientific investigation.
Bhattacharya described the facility as part of a broader commitment to understanding reported injuries and improving vaccine safety.
The clinic is “dedicated to developing the science of preventing vaccine injuries, making vaccines safer, and most important of all, listening to the voices of people who have suffered vaccine injury, so that we can learn from them and learn from their experience to make vaccines safer,” Bhattacharya said in a video statement released Thursday.
The director emphasized the importance of directly involving patients in research, particularly those who believe their medical concerns have not been adequately investigated.
The NIH campus in Bethesda houses specialized clinical and research facilities where government physicians and scientists conduct studies involving complex medical conditions.
The new clinic will draw on those resources to evaluate people who report symptoms following immunization.
Officials have not publicly released comprehensive details concerning the clinic’s staffing, annual budget, patient capacity or eligibility requirements.
HHS also has not specified how many patients will initially be evaluated or when the first research findings might become available.
Those details will be important in determining the facility’s ability to accommodate patients and conduct long-term investigations.
The project follows earlier NIH research involving reports of neurological symptoms after COVID-19 vaccination.
During the pandemic, government researchers examined patients reporting persistent neurological complaints and other health problems after receiving vaccines.
Some patients subsequently alleged that the research was curtailed and that they were unable to obtain continued medical assistance.
According to earlier reporting on federal investigations of post-vaccination neurological symptoms, NIH researchers evaluated individuals reporting symptoms that developed after COVID-19 vaccination.
Those evaluations sought to identify possible medical explanations and determine whether particular conditions warranted further research.
Additional reporting on internal NIH communications described disagreements among federal researchers and administrators concerning the continuation of certain investigations.
The earlier work became a source of frustration for patients who believed their experiences had not received sufficient attention.
Kennedy referred to those concerns while announcing the new facility.
In a video released Thursday, he said patients who believe they experienced vaccine injuries, including parents of affected children, had struggled to obtain medical evaluations and recognition of their concerns.
He said those individuals “have been marginalized, vilified, demonized, and gaslighted, and they have not received the medical attention they need, and we have not done the studies that need to be done to understand who’s vulnerable to those kind of injuries.”
Kennedy said the new clinic represents a change in the administration’s approach to studying reported adverse reactions.
The facility’s opening was welcomed by Brianne Dressen, a participant in an AstraZeneca COVID-19 vaccine trial who has publicly described experiencing persistent health problems following vaccination.
Dressen previously received an evaluation at NIH in 2021.
She subsequently co-founded React19, an organization that advocates for people reporting injuries following COVID-19 vaccination.
Dressen attended Monday’s opening ceremony and said the event represented an important development for patients seeking recognition and further research.
“I think it was the first time in years that the vaccine-injured have been heard by the health authorities,” Dressen told The Epoch Times.
“It is definitely a step in the right direction.”
Her comments reflect the perspective of patients and advocacy groups seeking more extensive medical investigations into symptoms they associate with vaccination.
Whether a particular patient’s condition was caused by a vaccine requires an individual medical assessment and, in many circumstances, additional scientific evidence.
The NIH initiative is intended to improve the evaluation of those questions rather than presume that every reported condition resulted from immunization.
The clinic was not the only measure announced Thursday.
HHS also outlined changes to the Vaccine Adverse Event Reporting System, commonly known as VAERS.
The reporting system is jointly administered by the CDC and the Food and Drug Administration.
It collects information about medical events occurring after vaccination from health professionals, patients, caregivers, vaccine manufacturers and other sources.
The reports help federal officials identify potential safety signals that may warrant further investigation.
VAERS is a passive surveillance system, meaning it depends substantially on reports submitted by individuals and organizations rather than continuously monitoring every vaccinated person.
Because reports can include events unrelated to vaccination, VAERS data cannot independently establish whether a vaccine caused a reported condition.
The system is primarily used to identify unusual patterns or possible safety concerns that researchers can investigate using more detailed clinical and epidemiological studies.
The official VAERS website explains how patients and health professionals can report adverse events and access vaccine safety information.
Kennedy has previously criticized aspects of the reporting system, arguing that its procedures are difficult to navigate and may discourage reporting.
Federal officials announced Thursday that the CDC is implementing a modernization effort intended to make submitting reports easier and improve the tools available for evaluating the information received.
The CDC solicited bids for a contract to overhaul the system in August.
On Sept. 28, the agency awarded a contract to support technological improvements, including greater accessibility on mobile devices.
The modernization is intended to streamline reporting and make information more useful to researchers and medical professionals investigating potential safety signals.
According to HHS, the CDC has also added QR codes linking to VAERS to Vaccine Information Statements distributed to patients and parents.
Those information statements are provided in connection with vaccinations and describe important information about particular vaccines, including potential side effects and other considerations.
Including a direct reporting link could make it easier for patients and caregivers to learn how to report a suspected adverse reaction.
The department expects the updated system to support more timely submissions and improve the ability of federal researchers to review reported medical events.
However, easier reporting could also increase the volume of submissions.
An increase in reported adverse events would not necessarily indicate that vaccines had become more dangerous, because changes in reporting practices and public awareness can influence the number of reports received.
Researchers must evaluate reports in the context of vaccination rates, background medical event rates and other available evidence.
Federal officials have not yet announced when the entire modernization project will be completed.
A separate measure involves the medical records used by hospitals, clinics and physicians.
HHS said electronic health records will be required to capture vaccine-related adverse events so that information can remain accessible when patients receive care from different providers.
The change will be incorporated into federal health information technology standards overseen by the Office of the National Coordinator for Health Information Technology.
Electronic health records contain information about medical diagnoses, medications, procedures, allergies and other aspects of patient care.
HHS wants clinicians to be able to document suspected vaccine-related adverse events in a form that can be retained and shared across health care settings.
The department said the change is intended to reduce the need for patients to repeatedly explain the same medical history when consulting different providers.
It could also help clinicians identify relevant information when evaluating symptoms or deciding whether additional treatment is appropriate.
More consistent documentation may provide researchers with better information about the timing and characteristics of reported events.
However, recording an event as occurring after vaccination does not automatically establish that vaccination caused it.
Clinical documentation must distinguish between a patient’s report, a suspected association and a medically established diagnosis.
The department has not publicly detailed the implementation schedule for the new electronic record requirements or whether health care providers will face additional costs to update their systems.
Those questions may become relevant as hospitals, medical practices and software companies prepare to comply with the standards.
HHS also announced a proposed change intended to encourage physicians to submit adverse-event reports.
The Centers for Medicare & Medicaid Services is proposing reimbursement for doctors who spend time documenting suspected vaccine injuries through VAERS.
The policy would allow eligible physicians to receive payment under Medicare for the work associated with preparing and submitting reports.
Federal officials said the proposal would bring vaccine adverse-event reporting more closely into line with other physician activities for which Medicare provides reimbursement.
The agency believes the change could reduce financial and administrative barriers that discourage medical professionals from reporting suspected reactions.
Submitting a detailed report may require a physician to review medical records, document symptoms, establish the timing of vaccination and provide other clinical information.
That work can consume time during an already busy medical practice.
By proposing reimbursement, CMS hopes to encourage more complete reporting and improve the information collected by the federal safety monitoring system.
The policy remains a proposal and has not yet been described as a finalized payment requirement.
Specific eligibility rules, reimbursement amounts and implementation dates will depend on the final policy.
The proposal could also influence how physicians approach suspected adverse reactions.
Current federal guidance encourages health professionals to report clinically significant events occurring after vaccination, even when they are uncertain whether the vaccine caused the condition.
Certain events must be reported under federal law when they meet established requirements.
The VAERS guidance for health care professionals explains the reporting obligations and the importance of submitting complete information.
The system relies on clinicians to provide accurate descriptions of patients’ medical conditions while acknowledging uncertainty about causation.
CMS officials expect reimbursement to encourage more physicians to participate consistently in that process.
HHS described the four initiatives as complementary components of a single effort.
The NIH clinic will evaluate patients and conduct research.
Modernized VAERS technology is intended to improve the submission and review of reports.
Electronic health records will preserve relevant information across medical settings.
The proposed Medicare reimbursement policy is designed to encourage physicians to document and report suspected adverse events.
Federal officials believe linking those activities could help identify potential safety concerns and improve patient care.
The initiative was recommended in the Make America Healthy Again Commission’s September 2025 strategy, which called for expanded research into factors affecting chronic disease and children’s health.
The commission, chaired by Kennedy, identified vaccine injury research as an area requiring additional federal attention.
The new clinic represents an initial step toward implementing that recommendation.
The announcement also comes amid continuing debate about how public health agencies evaluate vaccine safety.
Vaccines undergo clinical testing before authorization or approval and remain subject to safety monitoring after entering widespread use.
Some adverse reactions, including severe allergic reactions, are medically established but uncommon.
Different vaccines have different safety profiles, and the risks of particular adverse events depend on the product and the population receiving it.
Federal health agencies maintain that vaccination has prevented substantial illness, hospitalization and death from infectious diseases.
According to HHS guidance on vaccine side effects, most adverse reactions are mild, while serious reactions can occur rarely.
The existence of recognized vaccine risks makes ongoing monitoring important.
At the same time, reports of symptoms following vaccination must be examined carefully because illnesses and medical emergencies also occur in people who have been vaccinated for reasons unrelated to the vaccine.
Researchers use controlled studies, medical record reviews and other analytical methods to evaluate whether reported events occur more frequently than would otherwise be expected.
Those investigations can help distinguish coincidental medical problems from possible vaccine-associated conditions.
The NIH clinic may contribute to that process by allowing researchers to examine patients directly rather than relying only on reports submitted to surveillance systems.
The federal government also maintains separate programs that provide compensation for certain vaccine-related injuries.
The National Vaccine Injury Compensation Program covers specified vaccines under federal law, while the Countermeasures Injury Compensation Program applies to certain products used in public health emergencies.
Those programs operate separately from VAERS and have their own eligibility requirements and review procedures.
The Health Resources and Services Administration’s vaccine compensation data provide information on claims, decisions and awards.
Receiving compensation does not necessarily mean federal officials determined that a particular vaccine caused an injury, because some claims are resolved through settlements without such a finding.
The new NIH clinic is a research and clinical care initiative, not a replacement for either compensation program.
HHS has not announced that patients evaluated at the clinic will automatically qualify for compensation or other federal benefits.
The opening also does not change the legal requirements governing vaccine manufacturers, existing compensation claims or the approval of vaccines.
Instead, officials are presenting the clinic as a resource intended to improve the scientific understanding of reported injuries and help patients obtain appropriate medical evaluations.
The involvement of patient advocates could provide additional information about symptoms and experiences that have not been adequately investigated.
However, the scientific value of the initiative will depend on how researchers evaluate competing explanations, select participants, measure health outcomes and publish their findings.
The department has not yet released detailed research protocols for the clinic.
Questions also remain about how patients will be referred, whether the facility will accept individuals from across the country and what criteria will determine eligibility for evaluation.
The federal announcement did not specify whether the clinic will focus primarily on COVID-19 vaccines or examine reported reactions associated with a broader range of immunizations.
Its stated mission encompasses health problems following vaccination generally.
HHS has emphasized that the effort should improve both patient care and the evidence used to assess vaccine safety.
Kennedy and Bhattacharya described the clinic as an opportunity to examine reported medical problems while giving patients greater involvement in the research process.
The other policy measures are intended to improve the quality and accessibility of information across the health care system.
The CDC’s reporting modernization is already underway, while the proposed physician reimbursement policy will require further consideration before implementation.
The electronic health record changes will also need to be incorporated into applicable standards and clinical systems.
Together, the initiatives represent a significant federal investment in examining suspected vaccine-related injuries and improving how medical information is collected.
Whether they identify previously unrecognized safety risks, improve treatment options or strengthen existing evidence will depend on the research and reporting results produced over time.
For now, the NIH clinic is open in Bethesda, and federal health officials have committed to coordinating patient evaluations, medical documentation and safety surveillance more closely.
The administration says the objective is to provide more reliable evidence about potential vaccine injuries while ensuring that patients reporting health problems receive appropriate attention from medical professionals.
The next steps will involve establishing the clinic’s research operations, implementing technological improvements to VAERS and determining how the proposed reporting and reimbursement policies will function in clinical practice.
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