WASHINGTON, D.C. — The Department of Health and Human Services is expanding federal oversight of reported health problems following vaccination through a new National Institutes of Health clinic, proposed physician reporting payments and changes to electronic medical records, seeking to improve the detection and investigation of potential vaccine-related injuries.
The measures involve four federal health agencies and are intended to strengthen how suspected adverse events are documented, evaluated and monitored across the healthcare system.
The initiative includes a new NIH clinic that opened October 5 at the agency’s Bethesda, Maryland, campus. The facility will provide specialized evaluations for patients experiencing health problems following vaccination while supporting research into possible causes and treatment approaches.
NIH clinicians and researchers will examine patient experiences and investigate whether reported conditions may be associated with vaccination.
The distinction is central to vaccine safety monitoring: A health problem occurring after vaccination does not, by itself, establish that the vaccine caused it.
HHS Secretary Robert F. Kennedy Jr. said the changes are intended to improve the federal government’s response to patients reporting suspected vaccine injuries.
“We must listen to patients and families who report vaccine injuries—not dismiss or gaslight them,” Kennedy said.
The Centers for Medicare & Medicaid Services has separately proposed reimbursing physicians for time spent submitting suspected vaccine injury reports to the Vaccine Adverse Event Reporting System, or VAERS.
The proposed policy would introduce Medicare reimbursement for physician reporting activities, which HHS said could reduce administrative barriers and encourage more consistent documentation.
VAERS collects reports from healthcare professionals, patients, caregivers, vaccine manufacturers and other sources to identify potential vaccine safety concerns.
The reporting system is designed to detect signals that may warrant additional investigation. Reports alone cannot establish whether a vaccine caused a particular medical condition.
HHS is also introducing electronic health record requirements intended to ensure that vaccine-related adverse events are documented and accessible across healthcare providers.
The standards, overseen by the federal health information technology office, are designed to preserve relevant patient information when individuals receive treatment from different clinicians or facilities.
Federal officials said the changes could reduce repeated reporting by patients and provide healthcare professionals with more complete medical histories when evaluating suspected adverse events.
The Centers for Disease Control and Prevention is simultaneously modernizing VAERS to simplify reporting and improve access to safety information.
CDC solicited bids for the modernization project in August and awarded a contract September 28 to expand mobile accessibility and improve tools used by researchers and medical professionals.
Earlier in 2026, the agency also added QR codes linking to VAERS information to Vaccine Information Statements distributed to patients and parents.
The modernization effort is intended to make reporting easier while improving the federal government’s ability to examine patterns that could indicate potential safety concerns.
Together, the measures connect clinical evaluation, physician reporting, electronic medical records and federal surveillance systems.
The changes establish additional mechanisms for collecting and investigating reports of health problems following vaccination, while determining whether specific conditions are vaccine-related will continue to require scientific evaluation.
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