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Is the US’s Vaccine Adverse Event Reporting System broken? BMJ investigation Concerns Vaccine Adverse Event Reporting System (VAERS) system isn’t operating as intended Capturing post-market safety signals Signals are being missed? Robert Sullivan, anaesthesiologist, Maryland Very fit and well, 49 Second dose of covid vaccine Two weeks Collapsed at home on treadmill Diagnosis of sudden onset pulmonary hypertension Rare in middle aged men Dr. Sullivan filed a VAERS report Submission process was a glitchy race against the clock. “The format is cumbersome and it times you out” Dr. Sullivan received email “e-report” number VAERS is supposed to be user friendly, responsive, and transparent. Unprecedented ( million reports) number of reports since the rollout of covid vaccines Vast majority of recent reports, covid vaccines Nearly one in five meet the criteria of serious. Pre pandemic, 60 000 adverse event reports each year. Staffing levels failed to keep pace Signs that the system is overwhelmed, reports aren’t being followed up, and signals are being missed. The BMJ spoken to physicians and a state medical examiner, who filed serious reports, and were never contacted by clinical reviewers or were contacted months later. VAERS database includes only initial reports, case updates and corrections are kept on a separate, back end system. (a private, back end system containing all updates and corrections—such as a formal diagnosis, recovery, or death) (to protect patient confidentiality) Patients, doctors, and public only have access to incomplete and uncorrected version. Marie Lindquist, former director Uppsala Monitoring Centre, Sweden Good pharmacovigilance requires prompt data collection, review by people with clinical expertise, and adequate follow-up “We know that even the best clinical trials won’t detect [rare adverse events]” CDC has reviewed nearly 20 000 preliminary reports of death using VAERS Has not acknowledged a single death linked to mRNA vaccines. February 2021 Pfizer analysis of adverse event reports Had onboarded 600 additional full time employees to handle the volume and planned to employ a total of 1800 Dr. Patrick Whelan, rheumatologist and researcher, University of California Los Angeles 2022, reported a 7 year old boy, had a cardiac arrest after covid vaccination. “I assumed that, since it was a catastrophic event, the safety committee would want to hear about it right away,” To his knowledge, nobody called or requested medical records. Dr. James Gill, medical examiner and forensic pathologist, Connecticut June 2021, VAERS report, first of his 25 year career 15 year old boy who died suddenly days after a second jab Autopsy “stress cardiomyopathy following second dose of the Pfizer-BioNTech covid-19 vaccine.” Dr. Gill can’t recall getting any calls from VAERS after he filled out the online form, still has only a temporary “e-report” number. November 2022, React19 30 000 people who have experienced prolonged illness after covid vaccination, reviewed 126 VAERS reports among its ranks. One in three of the reports they looked for didn’t show up in the publicly searchable database Dr. Helen, intensive care and emergency physician Filed reports on behalf of several patients, including six who died Received a request for medical records for just one of the deaths “You’re not meeting your defined definition of follow-up,” “There’s a breakdown in your system.” “the FDA is not naming additional adverse reactions to the vaccines because the passive surveillance systems aren’t displaying it. But the passive surveillance systems aren’t displaying it because physicians are blinded to the adverse reactions in their patients, and thus aren’t reporting them.” FDA responded by email “is actively engaged in safety surveillance of these vaccines to identify and address potential safety concerns” “physicians and epidemiologists from the FDA and CDC continuously screen and analyse data from VAERS for covid-19 vaccines to identify potential signals that would indicate the need for further study.” FDA Adverse Event Reporting System (FAERS) Collects reports on drugs, does maintain a publicly accessible database that gets updated Harlan Krumholz, cardiologist and researcher, Yale “We are working hard to understand the experience, clinical course, and potential mechanisms of the ailments reported by those who have had severe symptoms arise soon after the vaccination,” “There are so many people whose lives have been changed dramatically—but what I don’t know is how many or why.”