US Vaccine Adverse Event Reporting System Not Meeting Standards

Drug Topics November 16, 2023
Pearl Steinzor

VAERS was designed to collect reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for postmarket safety signals.

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

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...

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