Guide to Interpreting VAERS Data
Evaluating VAERS Data
When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is
not documentation that a vaccine caused the event.
VAERS Data Limitations
Millions of vaccines are given each year to children less than 1 year old in the United States, usually between 2 and 6 months of age. At this age, infants are at greatest risk for certain medical adverse events, including high fevers, seizures, and sudden infant death syndrome (SIDS). Some infants will experience these medical events shortly after a vaccination by coincidence.
These coincidences make it difficult to know whether a particular adverse event resulted from a medical condition or from a vaccination. Therefore, vaccine providers are encouraged to report all adverse events following vaccination, whether or not they believe the vaccination was the cause.
When reviewing data from VAERS, please keep in mind the following limitations:
VAERS is a passive reporting system, meaning that reports about adverse events are not automatically collected, but require a report to be filed to VAERS. VAERS reports can be submitted voluntarily by anyone, including healthcare providers, patients, or family members. Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors.
"Underreporting" is one of the main limitations of passive surveillance systems, including VAERS. The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events. The degree of underreporting varies widely. As an example, a great many of the millions of vaccinations administered each year by injection cause soreness, but relatively few of these episodes lead to a VAERS report. Physicians and patients understand that minor side effects of vaccinations often include this kind of discomfort, as well as low fevers. On the other hand, more serious and unexpected medical events are probably more likely to be reported than minor ones, especially when they occur soon after vaccination, even if they may be coincidental and related to other causes.
A report to VAERS generally does not prove that the identified vaccine(s) caused the adverse event described. It only confirms that the reported event occurred sometime after vaccine was given. No proof that the event was caused by the vaccine is required in order for VAERS to accept the report. VAERS accepts all reports without judging whether the event was caused by the vaccine.
There are multiple, complementary systems that CDC and FDA use to capture and validate data from different sources. VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also referred to as “safety signals.”
- If a possible safety signal is found in VAERS, further analysis is performed with other safety systems, such as the CDC’s Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment (CISA) Project, or in the FDA BEST (Biologics Effectiveness and Safety) system.
- These safety systems are designed to identify the true problems with vaccines. Only a minority of the VAERS reporting are able to pass the safety systems.
These systems are less impacted by the limitations of spontaneous and voluntary reporting in VAERS and can better assess possible links between vaccination and adverse events.
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As an example of the safety systems isolating problems in the reporting of VAERS...
They identified that the
risk of myocarditis to be 16 times greater among those infected with COVID-19 than the uninfected, suggesting that
full vaccination is helpful in preventing myocarditis and other complications of the disease.
Furthermore, there are other illnesses, diseases, and injuries identified by the safety systems that show vaccinated individuals
outperform those not vaccinated against Covid...continue to outperform when both groups have reinfections.
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