Challenges in the US Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS), comanaged by the CDC and FDA, may not be operating as intended.

On the tablet, a sheet of paper and stickers with the inscription - FOIA, THE FREEDOM OF INFORMATION ACT | Dzmitry - stock.adobe.com

A study published in The BMJ found that VAERS may not be meeting its own standards, with inefficiencies in design, transparency concerns, limited user-friendliness and responsiveness, lack of publicly available data, inadequate staffing and delayed responses, inconsistencies in acknowledging adverse events (AEs), and challenges in updating reports.¹

VAERS was designed to collect reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for postmarket safety signals. The reporting system relies on voluntary AE reports from doctors and patients and mandatory reporting from vaccine manufacturers, who are required to report all AEs of which they are aware.

The study found publicly accessible VAERS databases on vaccines only included initial reports, while case updates and corrections were kept on a separate, back-end system, meant to protect patient confidentiality. However, investigators reported that the FDA’s AE reporting system (FAERS), which collects reports on drugs, maintains a publicly accessible database that gets updates, raising the question why the same is not true for VAERS.

Although neither the CDC nor the FDA provided an explanation as to why this information is not publicly available, “patients can submit formal requests under FOIA [Freedom of Information Act] to obtain the full record of their report,” said an FDA spokesperson in a statement.²

According to VAERS standards, reports for COVID-19 must be processed within days of receipt. However, an unprecedented 1.7 million reports since the rollout of COVID-19 vaccines suggests VAERS staffing was likely not meeting the demands of reviewing serious reports submitted, including reports of death.

FOIA documents suggest that the CDC has over 1000 fewer full-time employees than Pfizer, despite being responsible for handling AE reports for all manufacturers. Furthermore, other countries have acknowledged deaths “likely” or “probably” related to mRNA vaccination, while the CDC said it has reviewed nearly 20,000 reports—far more than other countries—but hasn’t acknowledged any deaths linked to mRNA vaccines.

The investigators also spoke with more than a dozen individuals, including physicians and a state medical examiner, who had filed VAERS reports of a serious nature on behalf of themselves or patients, but were never contacted by clinical reviewers, or were only contacted months later. Some of these individuals were told conflicting information about updating their report or were discouraged from making a report.

Between 2021 and 2022, a group of physicians and advocates met with FDA representatives to express their concerns about the reporting systems, to which the FDA responded that the agency “is actively engaged in safety surveillance of these vaccines to identify and address potential safety concerns” and that “physicians and epidemiologists from the FDA and CDC continuously screen and analyze data from VAERS for COVID-19 vaccines to identify potential signals that would indicate the need for further study,” in a statement.²

In serious cases, VAERS reporters are supposed to receive emails prompting them for updates. However, the reporters who the investigators spoke with did not receive confirmation emails, and when searching for their report on the database, found it remained unchanged. Similarly, reports of a successful treatment or improvement are not reflected in the public database.

Furthermore, Narayan Nair, MD, FDA division director for the division of pharmacovigilance, who oversees VAERS, acknowledged in a meeting with advocates that people get frustrated when they look for an updated report, find the original untouched, and feel like they’re “being ignored,” he said in a statement.² “They never see it on the front end, because we don't alter that initial report.”

Therefore, the study highlights critical flaws in this US reporting system, urging further examination, transparency, and improvements to ensure the system effectively serves its purpose in monitoring and addressing vaccine safety concerns.

References

1. Block J. Is the US’s vaccine adverse event reporting system broken? BMJ. Published online November 9, 2023. doi:10.1136/bmj.p2582

2. Is the US reporting system for vaccine safety broken? News release. EurekAlert! November 9, 2023. Accessed November 14, 2023. https://www.eurekalert.org/news-releases/1007473.