Published on in Vaccine Update for Healthcare Providers
Do you know …
- When are you legally required to submit a VAERS report?
- Who, other than healthcare providers, is required to submit to VAERS?
- How can VAERS be used as a practice tool?
Most healthcare providers are familiar with the Vaccine Adverse Events Reporting System, more commonly referred to as VAERS. Most healthcare providers are also familiar with how VAERS data can be misconstrued to suggest vaccine safety concerns. At no time has this been more apparent than during the COVID-19 pandemic as VAERS reports have been held up as evidence that the new COVID-19 vaccines are not safe. But, VAERS is also an important tool for providers and public health officials as COVID-19 vaccines are released. So, let’s take a deeper dive and see if you got the answers to the above questions right.
A brief history of VAERS
VAERS resulted from the National Childhood Vaccine Injury Act of 1986. It launched in 1990 and is co-managed by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). This passive surveillance system was put in place to identify:
- New or unexpected side effects following vaccination
- Higher than expected occurrences of side effects
- Patterns of individuals with particular characteristics who experience side effects
- Unexpected clustering of events, such as might occur from issues with specific vaccine lots or in certain geographic regions
- Common vaccine administration errors
The system is designed such that anyone can report occurrences, increasing the opportunity to gather reports, and it is particularly important for monitoring newly approved vaccines, as some events will only be identified when greater numbers of individuals are vaccinated than typically included in clinical trials. These features of VAERS make it an important tool during the COVID-19 pandemic.
VAERS was designed to be the “canary in the coal mine,” meaning it offers a quick way to identify potential vaccine safety concerns. As such, it can never be used to prove causation. First, VAERS is a passive surveillance system, meaning reports will only be submitted in some instances when an event occurs. Second, the system only collects reports about something that happened after a person was vaccinated. This means the system does not have other critical pieces of information needed to show causality, such as:
- People who were vaccinated but did not experience the side effect or adverse event
- People who did not receive the vaccine but experienced a similar event
The inability of VAERS to prove causation is probably the most common misconception about the system, particularly since VAERS data are often misused as evidence of vaccine safety concerns by people intentionally seeking to sow doubt about vaccines. However, once potential safety concerns are identified in VAERS, they will be evaluated in other ways that can determine causation, including using systems such as the CDC’s Vaccine Safety Datalink (VSD) and Clinical Immunization Safety Assessment (CISA). Likewise, clinical trial data may be revisited, and researchers at pharmaceutical companies or academic institutions may design studies to further investigate the concern. By identifying a concern and having multiple groups study it in different ways, concerns identified in VAERS can quickly be further investigated. A recent example of how these systems work together is the pause in use of the J&J/Janssen vaccine while reports of thrombosis with thrombocytopenia syndrome (TTS) were further evaluated.
Who must file VAERS reports, how and when?
While anyone can submit a report to VAERS, some people are required to, including:
- Healthcare providers
- Vaccine manufacturers
Healthcare providers are required to report the following:
- Adverse events listed by the manufacturer as a contraindication for future doses.
- Adverse events listed in the VAERS Table of Reportable Events Following Vaccination — This five-page table is sorted by vaccine and lists both the event and the time interval after vaccination.
- (Suggested, not required) Vaccine administration errors.
- (Suggested, not required) Any clinically significant adverse event that follows receipt of a vaccine, regardless of theories about causation.
- For COVID-19, providers must report any of the following that occur after receipt of COVID-19 vaccine: vaccine administration errors regardless of whether an adverse event occurs, cases of multi-inflammatory syndrome (MIS-C or MIS-A), and disease that results in hospitalization or death.
Vaccine manufacturers are required to report all adverse events that they become aware of, including “serious and unexpected” events that occur in other countries (Shimabukuro TT, Nguyen M, Martin D, and DeStefano F. Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS). Vaccine. 2015 Aug 26;33(36):4398-4405.)
Reports to VAERS can be completed using an online form (preferred method) or writable PDF that can be uploaded. Methods and directions are detailed on the FDA’s event reporting page. This page also includes a checklist of information needed to complete the form. While the form can be submitted without all information, it is recommended to complete as much as possible. Submission of VAERS reports does not require patient consent related to HIPAA, as VAERS is considered a public health activity. While a deadline for reporting has not been established, for the system to work most effectively, submissions should be completed as soon after the event as feasible.
What happens when a VAERS report is submitted?
Once submitted, a case number is assigned and the report goes to a private contract agency overseen by both the CDC and FDA. Each report is coded by trained staff using the Medical Dictionary for Regulatory Activities. One aspect of coding includes determination of the event as “serious” or “non-serious.” Serious events include those which caused a life-threatening health situation, hospitalization, lasting disability, or death.
If the report is deemed serious, the agency will seek related health records, such as lab reports, hospital discharge summaries, and death certificates and autopsy reports, if applicable. If the patient has not recovered at the time the report is submitted, and follow-up information is not provided at a later date, a letter requesting more information will be sent one year after the original submission.
Each report is added to a database, from which the CDC and FDA receive updated data each business day. Original reports and supporting documentation are maintained in a separate image library that can be used by the CDC and FDA for researching cases. In addition, de-identified reports are available to the public via the CDC’s Wide-ranging Online Data for Epidemiologic Research (WONDER) tool.
CDC and FDA physicians and scientists analyze reports using a variety of qualitative and quantitative methods, such as evaluating trends over time, performing disproportionality analyses for frequency of side effects associated with a particular vaccine, and completing clinical reviews to ensure report quality and identify concerning patterns or unexpected events.
Why VAERS is an important tool for providers
While mandatory reporting and a continued need to correct information about the limitations of VAERS may make providers associate VAERS with frustration, the reality is that this system is a useful tool that can benefit providers in a few ways, as demonstrated by these scenarios related to COVID-19:
- “I had vaccine x and since then, my pre-existing condition has been out of control. I am also physically exhausted and not sleeping well.”
- “I have several patients who have developed unexpected side effect b within days of receiving vaccine x.”
In the first example, this patient is experiencing a worsening of a pre-existing condition following vaccination. As you try to help this patient, it is likely that you would take a history and depending on the situation, order some tests. But, would you consider suggesting submission of a VAERS report? Given that the patient’s worsening condition follows receipt of a vaccine, a VAERS report, while not required, would be appropriate, particularly since COVID-19 vaccines are new. In this case, submitting a VAERS report not only contributes to the necessary data collection that will inform the learning curve about these new vaccines, but it will also likely reassure your patient that you are listening to them and working to get to the bottom of what is happening. Too often, patients feel as though their concerns related to vaccine safety are glossed over, but using VAERS as the surveillance tool it was intended to be can help patients feel more confident in your efforts.
In the second example, you or your colleagues have made a practice-based observation that varies from the expected vaccine side effect profile and can’t be easily explained. Would you consider submitting VAERS reports for each of these cases? Depending on the clinical significance of the event, you might. But even if the event is not clinically severe, a cluster of cases or troublesome pattern would be worth submitting to VAERS, via individual case reports. Not only will this add to the accumulating database, it can serve as a quick way to submit your observations as part of the bigger picture.
If providers commit to submitting unexpected consequences of vaccination, VAERS will become an even more robust system of surveillance, which will lead to a better understanding of side effects and, thereby, contribute to increased confidence in vaccine safety for everyone.
Resources for additional information
Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.
You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. You should not use it to replace any relationship with a physician or other qualified healthcare professional. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult your physician or, in serious cases, seek immediate assistance from emergency personnel.