Vaccine Adverse Event Reporting System

Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines.

VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.

VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA.

VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine.

This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.

Objectives of VAERS

The primary objectives of VAERS are to:

• Detect new, unusual, or rare vaccine adverse events;
• Monitor increases in known adverse events;
• Identify potential patient risk factors for particular types of adverse events;
• Assess the safety of newly licensed vaccines;
• Determine and address possible reporting clusters (e.g., suspected localized [temporally or geographically] or product-/batch-/lot-specific adverse event reporting);
• Recognize persistent safe-use problems and administration errors;
• Provide a national safety monitoring system that extends to the entire general population for response to public health emergencies, such as a large-scale pandemic influenza vaccination program.

VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), agencies of the U.S. Department of Health and Human Services (HHS). ¹⁾

CDC Shares Latest on Pharmacy Partnership, Reporting System Regulation | January 11, 2021 | by Linda Couch

Policy staff joined a few other association representatives on a regular check in call with CDC today. Dr. Ruth Link-Gelles, Doctoral Epidemiologist at the Centers for Disease Control and Prevention, gave an update on the CDC’s Pharmacy Partnership for Long-Term Care Program. And, the CDC’s Dr. John Su provided information on what the Vaccine Adverse Event Reporting System (VAERS) is, when to use it, and how to use it.

As explained by Dr. Su, VAERS a passive vaccine safety surveillance system. CDC depends on the general public, manufacturers, providers, and anyone to report on important things that happen after people are vaccinated. VAERS is not new; it was not created specifically for COVID, though it will be very valuable with the roll out of COVID vaccines. CDC is currently working on videos and other specific tools for long-term care providers.

VAERS is an early reporting system that is valuable in real time. If undesired or bad outcomes are happening, beyond what is generally expected to occur after a COVID-19 vaccination, steps can be taken immediately to better understand them and do something to correct problems. It’s also possible to track changes in patterns of reporting.

Dr. Su shared a table with strengths and limitations of VAERS, noting that the biggest limitation is that every adverse event reported in the system happened by definition to someone who was immunized; there is no comparison group consisting of people who were not immunized. So it’s never clear that the vaccine caused the adverse event.

LeadingAge members should know about VAERS, what must be reported vs. what is voluntary, and how to report. Healthcare providers are required to report within specified timeframes to VAERS any events on this table that occur. These include serious events like anaphylaxis, acute complications that require hospitalization, cases of COVID, vaccine errors and others. It is not always a given that the vaccine caused the event. Affordable housing providers are not requried to report to VAERS, but could help the CDC stay aware of side effects by encouraging residents to enroll cell phones in V-safe, a CDC texting and webform tool that allows people to report their own side effects after a COVID-19 vaccination.

Reporting can be done online directly or on a fillable PDF form that can be uploaded. The forms are available here. Aging services providers have not been a focus of VAERS rollout yet, so it is possible that events might have occurred that could have been reported. CDC is developing materials and videos specifically tailored to aging services providers; they should be available soon. Currently, printable posters and brochures as well as web buttons are available from the CDC website. ²⁾

Helpful Tips

Talk to your doctor about taking over-the-counter medicine, such as ibuprofen, acetaminophen, aspirin, or antihistamines, for any pain and discomfort you may experience after getting vaccinated. You can take these medications to relieve post-vaccination side effects if you have no other medical reasons that prevent you from taking these medications normally.

It is not recommended you take these medicines before vaccination for the purpose of trying to prevent side effects.

If You Received a Second Shot

Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days.

When to Call the Doctor

In most cases, discomfort from pain or fever is a normal sign that your body is building protection. Contact your doctor or healthcare provider:

• If the redness or tenderness where you got the shot gets worse after 24 hours
• If your side effects are worrying you or do not seem to be going away after a few days

If you get a COVID-19 vaccine and you think you might be having a severe allergic reaction after leaving the vaccination site, seek immediate medical care by calling 911. Learn more about COVID-19 vaccines and rare severe allergic reactions. Remember

• Side effects can affect your ability to do daily activities, but they should go away in a few days.
• The Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine both need 2 shots in order to get the most protection. You should get the second shot even if you have side effects after the first shot, unless a vaccination provider or your doctor tells you not to get it.
• You only need 1 shot of the Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine to get the most protection. Learn more about the different COVID-19 vaccines.
• It takes time for your body to build protection after any vaccination. People are considered fully vaccinated two weeks after their second shot of the Pfizer-BioNTech or Moderna COVID-19 vaccine, or two weeks after the single-dose J&J/Janssen COVID-19 vaccine. You should keep using all the tools available to protect yourself and others until you are fully vaccinated.
• After you are fully vaccinated for COVID-19, you may be able to start doing some things that you had stopped doing because of the pandemic. Learn more about what you can do when you have been fully vaccinated.
• We are still learning how vaccines will affect the spread of COVID-19. After you’ve been fully vaccinated against COVID-19, you should keep taking precautions in public places like wearing a mask, staying 6 feet apart from others, avoiding crowds and poorly ventilated spaces, and washing your hands often. CDC will continue to update recommendations as we know more.
• Video and Fact Sheet

Updated Mar. 16, 2021

Johnson & Johnson’s Janssen COVID-19 Vaccine: CDC and FDA have recommended a pause in the use of Johnson & Johnson’s J&J/Janssen COVID-19 Vaccine in the United States out of an abundance of caution, effective Tuesday, April 13. The Advisory Committee on Immunization Practices (ACIP) will hold its second emergency meeting to discuss J&J/Janssen COVID-19 Vaccine on April 23, 2021. People who have received the J&J/Janssen COVID-19 Vaccine within the past three weeks who develop severe headache, abdominal pain, leg pain, or shortness of breath should seek medical care right away. ³⁾

The Chloroquine Wars Part XLVIII Substack - Rounding the Earth by Mathew Crawford - July 26, 2021

Not only does the PRR need to get out of line for a safety signal to be generated, the use of 'and' instead of 'or' means that other additional criteria must also be satisfied before the CDC self-reports a safety signal! And the chi-squared criterion isn't helping the situation. Those unfamiliar with statistics will not recognize the problem, but when the different vaccines all result in similar problems (like myocarditis or blood clots, as has been noted), the chi-squared statistics will remain muted. In fact, chi-squared statistics are not even supposed to be used on data that is likely to be correlated when causal. Presumption of a negative test result is not a reasonable test standard. It's as if nobody at all thought about the possibility that the spike protein being an underlying thread among the vaccines could possibly be important.

So, when you define away the problems on paper, they just cease to exist?

Calling this a safety system is decidedly unsafe. Even worse—given that numerous academics, including statisticians, reviewed this document, it is hard to believe that the scale invariance embedded in the definition of PRR, or the logic that includes meeting multiple criteria at the same time, went unnoticed. It certainly appears that the CDC's goal was to establish an illusion of safety, and a reason to ignore the true signs of danger. At best, they unfathomably hired nobody whose job it was to remain independently-minded who could clue them in? ⁴⁾

Tommy's Podcast Published March 2, 2022

Dr. Jessica Rose & Matthew Crawford - VAERS, World Economic Forum, Quantum A.I. ⁵⁾

CDC Vaccine Safety Monitoring: A Tale of ‘Broken Promises, Stonewalling and Double Standards’

The Epoch Times by By Zachary Stieber - October 3, 2022

Newly obtained emails show the Centers for Disease Control and Prevention (CDC) made a false statement on COVID-19 vaccine safety monitoring in 2021, months before agency officials gave false statements on the matter to The Epoch Times.

The emails also show top officials in the agency discussing performing safety monitoring on a key database for myocarditis, a form of heart inflammation that has been linked to the vaccines from Pfizer and Moderna.

The CDC promised in 2021 in a set of operating procedures to perform a type of analysis called Proportional Reporting Ratio (PRR) on reports of adverse reactions following COVID-19 vaccination.

The reports are submitted to the Vaccine Adverse Event Reporting System (VAERS), which officials have described as “the nation’s early warning system” for post-vaccination adverse events. The CDC also said in an updated set of operating procedures in 2022 that it would perform the analysis.

But the CDC has made false statements three times this year on PRRs, initially saying such analysis was outside the agency’s purview, then saying the analysis was performed starting in 2021, then saying the analysis did not begin until 2022.

The newly obtained emails show that an official falsely said the CDC does not perform PRR analysis to an editor in 2021.

The emails were obtained by The Epoch Times and an independent researcher through FOIA requests.

“The CDC claims to be vigilantly and transparently monitoring the safety of COVID-19 vaccines, but when it comes to Proportional Reporting Ratio (PRR) analysis, the CDC’s broken promises, inconsistent statements, stonewalling, and double standards tell a different story,” Mary Holland, president and general counsel of Children’s Health Defense, told The Epoch Times via email.

Holland said:

“When asked about PRR analysis in connection with COVID vaccines — through FOIA, media, and congressional requests — CDC has made conflicting statements, some of them false. When confronted about the statements, the CDC claimed, essentially, that PRR analysis is not worth doing. And for the few months of PRR the CDC now says it has completed, the CDC has failed to make the results public, despite requests from multiple sources.”

“Children’s Health Defense calls on the CDC to do the right thing: do the analysis, and make the results available,” she added.

Timeline of CDC emails and statements. Some are being reported for the first time in this story, which continues below. ⁶⁾

Exclusive: Proof that the CDC is deliberately ignoring the safety signals from the COVID vax Substack by Steve Kirsch - October 3, 2022

It was immediately clear to me when I first read this document in early July 2021, that the formulas they used to trigger safety signals were flawed.

I tried to bring this to the attention of the CDC and the outside committee of the CDC. The CDC ignored me and the outside committee members refused to consider my emails and the two that replied said to submit it as a public comment which I did months later when they opened the window for public comments. See Comment tracking number: ksy-ckr3-73lv. Let me summarize the key points for you in a nutshell:

1. PRR is defined on page 16 in the CDC document as follows (and note they should have capitalized all the letters in the formula):

2. A “safety signal” is defined on page 16 in the CDC document as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE following receipt of the specific vaccine of interest. This is the famous “and clause.” Here it is from the document

3. Only someone who is incompetent or is deliberately trying to make the vaccines look safe would use the word “and” in the definition of a safety signal. Using “and” means that if any one of the conditions isn’t satisfied, no safety signal will be generated. As noted below, the PRR will rarely trigger which virtually guarantees that most events generated by an unsafe vaccine will never get flagged.

4. The PRR value for the COVID vaccines will rarely exceed 1 because there are so many adverse events from the COVID vaccine because it is so dangerous (i.e., B in the formula is a huge number) so the numerator is always near zero. Hence, the “safety signal” is rarely triggered because the vaccine is so dangerous. ⁷⁾