US: New Report Raises Concerns That CDC Vaccine Adverse Event Reporting System Is Broken

Authored by Megan Redshaw via The Epoch Times

The nation’s primary early warning system used to detect possible safety problems with vaccines is “overwhelmed,” raising concerns the system may be broken and isn’t being adequately managed by the Centers for Disease Control and Prevention (CDC), according to a new investigation.

The nation’s primary early warning system used to detect possible safety problems with vaccines is “overwhelmed,” raising concerns the system may be broken and isn’t being adequately managed by the Centers for Disease Control and Prevention (CDC), according to a new investigation.

The report published on Nov. 10 by The BMJ found the Vaccine Adverse Event Reporting System (VAERS) has received an unprecedented number of reports attributed to COVID-19 vaccines, and there aren’t enough staff to meet the requirements for reviewing and following up with serious reports, including deaths. Additionally, the investigation revealed that VAERS is neither transparent, user-friendly, nor responsive, and suggests the government essentially maintains two VAERS systems—only one of which the public can access.

Co-managed by the U.S. Food and Drug Administration (FDA) and CDC, VAERS collects reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination to capture post-marketing safety signals and determine if there are any unusual or unexpected reporting patterns for adverse events.

According to the CDC, healthcare providers are “strongly encouraged” to report any adverse event following vaccination to VAERS, even if they’re unclear whether the vaccine caused the adverse event. In contrast, vaccine manufacturers are required by law to report all adverse events that “come to their attention.”

Although VAERS accepts reports from anyone, knowingly filing a false VAERS report violates federal law and is punishable by fine and imprisonment. This allows VAERS to serve as an “early warning system to detect rare adverse events” and deters false reporting. Even so, VAERS has been shown to reflect only 1 percent of actual vaccine adverse events, according to a Harvard Pilgrim Health Care study.

CDC Isn’t Investigating Serious Adverse Events for COVID-19 Vaccines

According to the CDC,  in 2019—prior to the pandemic—VAERS received more than 48,000 reports of vaccine adverse events, 85 to 90 percent of which were mild. After the COVID-19 vaccine rollout, The BMJ found an “unprecedented” 1.7 million adverse events were reported to VAERS, with 1 million reported in 2021 and an additional 660,000 received thereafter. Nearly 1 in 5 cases met the criteria for a “serious” adverse event, and most reports were attributed to COVID-19 vaccines.

According to the VAERS Standard Operating Procedures for COVID-19, serious adverse events include reports of death, hospitalization, life-threatening illness, permanent disability and/or prolonged hospitalization, and congenital anomalies. Medical records are routinely requested for all serious reports, including deaths, and adverse events of special interest may undergo a more in-depth clinical review by the CDC.

If there is a significant increase in VAERS reports warranting clinical review, the standard operating procedures require additional CDC Immunization Safety Office staff to process cases. For events classified as “serious,” people who report to VAERS are supposed to receive email correspondence prompting them to provide updates, but The BMJ’s investigation shows these standards aren’t being followed.

The BMJ interviewed more than a dozen people, including physicians and a state medical examiner who filed VAERS reports for serious adverse events on behalf of themselves or patients and were either never contacted by the CDC or were contacted months later. Many never received confirmation emails when their reports were filed. Likewise, if a condition was successfully treated or was found to be unrelated to a vaccine, this was not reflected in the database.

Dr. Patrick Whelan, a rheumatologist and researcher at the University of California–Los Angeles, filed a report in 2022 on behalf of his 7-year-old patient after he experienced cardiac arrest and was intubated following COVID-19 vaccination. To Whelan’s knowledge, “nobody called or requested medical records.” The FDA said it followed up “soon after” receiving the report and made several requests for medical records. It also added that staff “might not reach out to medical providers unless they have specific questions about a case or VAERS report.”

Dr. James Gill, chief medical examiner for the state of Connecticut and forensic pathologist, filed a VAERS report after a 15-year-old boy died suddenly in 2021 from stress cardiomyopathy following his second dose of Pfizer’s COVID-19 vaccine. Although he completed a report online and received a temporary e-report number, the CDC never followed up. It wasn’t until Dr. Gill published the boy’s case report in February 2022 in the Archives of Pathology & Laboratory Medicine in February 2022 that the CDC responded—with a letter to the editor challenging Gill’s findings.

React19, a science-based non-profit comprised of 30,000 people injured by COVID-19 vaccines, reviewed 126 VAERS reports and found 22 percent were never given a permanent VAERS ID, and 1 of 3 reports filed disappeared from the system entirely, according to The BMJ.

An intensive care and emergency physician filed several reports on behalf of patients, including six deaths. According to The BMJ, she only received a request for medical records regarding one death and for only two patients admitted to the hospital.

When it comes to reports of death following COVID-19 vaccination, other countries have acknowledged that deaths were “likely” or “probably” related to mRNA vaccination, but the CDC has reviewed more than 20,000 preliminary death reports, which is significantly more than other countries, yet has not attributed a single death to mRNA vaccines, The BMJ stated.

“A BMJ investigation has raised concerns that the VAERS system isn’t operating as intended and that signals are being missed. As someone who has been studying and scrutinizing VAERS data for three years, I can confirm this observation,” researcher Jessica Rose told The Epoch Times in an email. Ms. Rose, a VAERS expert with a doctorate in computational biology, says these stories and experiences reflect the VAERS system’s deficiencies.

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