The VAERS Data needs some Perspective

We need to do more than look at the numbers.

VAERS has become a widely used acronym in recent discourse, although the database has been around for a few decades. It stands for Vaccine Adverse Even Reporting System, and its website states the following information:

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.

And its stated goals are as follows:

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.

With a massive vaccine campaign underway in an attempt to eradicate SARS-COV2, many people have relied on VAERS in order to report possible adverse events they may have experienced through vaccination. Considering that many of these vaccines are still in clinical trials and have not been given full approval yet, VAERS has been pivotal in providing signals to otherwise concerning events that may have occurred due to vaccination. As indicated above, VAERS’ intent is not to figure out cause and effect relationships between vaccines and adverse events, but to collect enough information to see if concerning signals pop up within the data.

Regardless of what data you look at, there’s no doubt that COVID vaccinations have led to the highest number of reported adverse events since the VAERS program was implemented. In fact, it seems that the number of adverse events reported this year may even be larger than all of the previous years combined.

The nature of VAERS requires that interpretation of its data depends upon a large level of speculation. There’s little ability to link direct causal relationships, and many of the data may be inputted voluntarily without any context. Therefore, an analysis of nuanced information requires a nuanced approach.

Over the course of 2021 tens of millions of Americans were vaccinated against COVID. Many were given 2 doses of either the Pfizer/BionNTech or the Moderna mRNA vaccines. Others took one dose of the J&J DNA-based vaccines.

In order to pull off such a feat in the middle of a pandemic and over the course of less than a year requires an extremely large undertaking. Many of our usual regulatory processes needed to be fast tracked to push the vaccines through as quickly as possible, and pharmaceutical giants needed to produce vaccines in giant quantities and less time. Many medical assistants who would normally administer a few shots a day are now administering shots all day every day for several weeks. Many vaccinations have been administered on a “one size fits all approach” instead of examining variables between individuals. A fast-tracked approach also means many of the typical side effects may not become apparent or will be missed during the smaller scale trials. Taken altogether we can see why VAERS reports can be appear so high when it comes to COVID vaccinations.

Population-wide Noise

Nonetheless, it doesn’t mean we can’t examine why such high reporting could be occurring. For one, many of these vaccines were and still are under Emergency Use Authorization (EUA) which would require collecting adverse data that may not have appeared during clinical trials where there were far fewer participants. Similar to new technology such as smartphones, you may test for the many ways you think people can break or damage their phones and still be surprised when they break in ways that were not accounted for. Larger numbers of people, in this case tens of millions, mean plenty more space for adverse events to occur.

It may also be an issue with people’s awareness of VAERS. Before the pandemic most people have never even heard of VAERS (I certainly didn’t). Even if people had experienced adverse events from previous vaccinations they may not know that they are able to report it, leading to a possible under reporting of side effects in prior years. But today many people who have gotten COVID vaccines may have been told to respond to adverse events reporting via an app or a text that linked to a reporting website. Far greater accessibility may allow more people to report reactions that they normally would not under normal circumstances.

Greater accessibility to reporting may mean that there’s a good possibility of under reporting previous vaccine adverse events and numbers may be artificially conflated. To add to the confusion, there are some people who have argued that fewer than 1% of all adverse events are not reported to VAERS, but that number requires heavy skepticism since it cannot be linked to a legitimate study. For now, we can only speculate on how nationwide vaccination campaigns can influence data, and unless we can get clearer data and studies speculate is all we can do at this point.

The Context of Human Error

One thing VAERS is absolutely not good at is contextualizing adverse events. Many of the questionnaires may not include things such as cross reactive medications, a person’s health status, or any activities someone may be engaging in that may affect their vaccination. Even if they do include this information, many of it may be left incomplete and would not contribute to elucidating any data.

If we look at vaccination procedures now versus previously, we can gain some insight into contextualizing the data.

As I stated previously, most medical professionals would possibly administer a few doses of a vaccine a day, and we can assume this would be higher during flu seasons. However, many of these people were made to spend their entire day administering vaccines. Many of us understand how monotonous, repetitive tasks may cause us to become more error prone, and giving shots is no exception. In this case, human errors may be contributing to adverse events.

A recent study by Li et. al. 2021 had researchers administer mRNA vaccines through intravenous injection into mice models. The researchers noted several indications of heart damage including myocarditis and apoptosis of cardiomyocytes, and the results of this study may help to add further contextualize human error when administering these vaccines.

All of the COVID vaccines are intended to be administered through intramuscular (IM) injections. However, someone may instead pierce a vein and administer the vaccine intravenuously. Something that would normally be a rare occurrence may happen much more frequently when someone’s sole job is to administer as many vaccines as possible, and the ramifications may mean that a far larger number of people than normal may have received IV injections, which could explain the number of myocarditis events reported to VAERS.

As indicated by Li et. al. 2021:

Both Pfizer/BioNTech and Moderna have clearly stated that their vaccines should only be given via IM route [30, 31]. However, current CDC [6] and WHO guidelines [5] no longer recommend precautionary measures during IM vaccine administration. Brief aspiration for blood return during intramuscular injection of medication as a preventive measure against accidental IV injection was previously present in most guidelines [32]. This practice becomes controversial as scientific evidence of the perceived benefit of this procedure is lacking for IM injection of vaccine. The CDC Pink Book 2020 [6] and WHO 2015 position paper [5] have recommended against aspiration prior to vaccine injection so as to minimize pain [33]. The veins and arteries within the reach of a syringe needle in the deltoid region are considered too small to allow a rapid IV injection of vaccine without blowing out the vessel [6]. However, this speculation also lacks supportive scientific evidence. Another possibility of getting a high blood mRNA vaccine level is the rapid movement of the vaccine through the lymphatic system into the venous circulation. Thus changing the vaccine injection site from deltoid to the vastus lateralis muscle of lateral mid-thigh may reduce the amount of vaccine lipid nanoparticles reaching the venous circulation due to enhanced uptake by the dendritic cells and macrophages at the regional inguinal, iliac and paraaortic lymph nodes.

There’s an important distinction between an IM and an IV injection, and the error in administering the vaccines via IV can have serious ramifications. As noted, aspiration may play a critical role when administering injections. Aspiration is when the plunger of a syringe is pulled up after the needle is injected into the target site. Pulling up the plunger allows a medical professional to see whether or not blood will collect into the syringe; no blood means the needle is within the muscular region, blood means the needle may have punctured a blood vessel and thus would indicate an IV injection.

This study may indicate that the large number of myocarditis and possibly other serious adverse events we are witnessing may be due to human error. What’s worse is that this would be an easy error to correct for if medical professionals aspirated before injection, especially considering the novelty of these vaccines and lack of long term data.

There have been reports of higher rates of myocarditis in vaccinated groups under the age of 18. If human injection error may be a cause, healthcare professionals need to make careful considerations. Teen boys are more likely to have a larger number of blood vessels and thus greater blood circulation, which may contribute to the higher number of myocarditis seen in boys over girls. Children also have smaller arms and may need smaller needles when conducting injections. We already have evidence that larger needles may be more beneficial in obese patients since it enables the injection to pass through thicker layers of adipose. But this once again adds more complexity to a highly concerning situation.

Children are far less likely to suffer severe effects from COVID infections, and yet there has been a large push to get as many children vaccinated as possible. There are now even suggestions that the vaccines are safe for 5-11 year olds, and California governor Gavin Newsom is now mandating vaccines for all school children. There’s large risks involved with the uncertainty of COVID, but there remains many uncertainties when it comes to these vaccines. When nuanced, well-thought vaccination procedures are not occurring we may be causing severe, irreparable harm to millions of Americans, especially children.

Human error is a preventable error, and more caution should be taken to make sure that we reduce the level of human errors as much as possible.

There’s a Reason things go Unreported

A few weeks ago Nicki Minaj made some comments on Twitter that caused the entirety of social media to erupt. It brought humor to everyone from all walks of life, with everyone laughing at the absurdity of her statements. It was one moment where both sides of the vaccine debate were in agreement about the lunacy of what she said.

So what did Nicki Minaj tweet? Her relative’s friend’s testicles supposedly became enlarged after receiving a COVID vaccine. Such a statement was deemed so ridiculous that it became the center of media attention, with so many late night pundits, news anchors, and even many podcast hosts making fun of such a claim.

I will admit that it seemed funny at first, and I will not lie that I thought that it was such a ludicrous statement that could not have possibly happened. But I then began to think about it, why I thought it was funny, and realized how wrong it was for I, and millions of other people, to have made fun of the idea.

The situation seems hilarious because it touches on a personal aspect; the status of one’s genitalia, and how something so innocuous seeming as a shot can cause changes to one’s private parts. It embodies a private circumstance, one that is most likely to lead to ridicule and shame if anyone were to find out. And it’s with that reason that the situation seems hilarious, and it’s with that reason why we should be ashamed for laughing.

Many cultures have become more concerned about victims and reporting statistics. A large number of sexual assault and domestic violence cases are under reported, as many victims may feel ashamed that a horrific incident has occurred and fear being judged for reporting it to the proper authorities.

The adverse events from a vaccine should by no means be considered comparable to sexual assault or domestic violence, but when people who feel that they have been wronged find themselves unable to alert those whose sole purpose is to collect data on these instances then we may miss out on vital pieces of information. Many people may not feel comfortable about reporting their issues and the crimes or events go unresolved.

It is difficult for many people to report uncomfortable issues to their doctors, let alone their friends or family. Something that may seem out of the ordinary, such as a lump or strange pain may not be discussed about with healthcare professionals in case these may be signs of more serious illnesses. Take then, an instance of an abnormality that occurs with ones privates. How many of us will openly discuss abnormalities or strange growths to friends, family, or medical professionals? Whether or not we have rampant stigmatization, people generally do not feel comfortable discussing issues about their genitals, and leaving many of these issues unresolved can have serious health consequences and disregard possible underlying issues.

Take the instance of women and teens who may feel it is socially unacceptable to discuss their menstrual cycle. We have gotten much better as a society, but there’s no doubt that many women may not feel comfortable about discussing their periods so openly. What happens then, when many young women receive a vaccine and begin to experience irregular menstrual bleeding? Should the woman be concerned about people finding out? Does she feel that she can report it to the proper institutions so that this may be something that can be looked into?

A recent article in the British Medical Journal (BMJ) indicated that over 30,000 reports of irregular menstrual bleeding has been reported to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in women after receiving COVID vaccines. Similar to VAERS, there’s no way of knowing whether or not this has a causal relationship to the COVID vaccines.

What is striking here is that this was not something that was being looked at during clinical trials. Also, once again the mantra of “safe and effective” seems to run abound, and many women who experience adverse events may not feel comfortable reporting irregular bleeding when the atmosphere being presented by the mainstream media and healthcare officials treat any adverse event as impossible or absurd. Whether or not these are related, they should be looked into, and if women do not feel as if they are able to report their adverse events we may be under reporting something very serious.

In the case of Nicki Minaj’s scenario, the question of whether or not the friend’s testicular enlargement came from the vaccine is not the main concern. The main concern should be whether or not men who experience these events feel as if they can report such a claim without ridicule and humiliation. We have seen what can happen when social media takes situations and elevates it to such a high degree, but the consequences may lead people to be less forthcoming and trustworthy of reporting side effects for fear of being humiliated if anyone finds out. Men who feel as if something is wrong should not also feel that they cannot report their personal experiences to VAERS.

Not only do we need transparency, but we also need empathy. We need people to feel comfortable about reporting their issues, and we need institutions and cultural systems to not gaslight and denigrate those who want to report adverse events. VAERS does not indicate causal relationships, but it should always make sure that it can collect as much information as possible, and patients should absolutely feel comfortable reporting any adverse events without fear of ridicule for what they are experiencing. When we see a lack of information being reported, we need to understand that there may be reasons that data may not be present, and we should prevent ourselves from dismissing things that may seem absurd, for the most absurd thing to assume is to assume that absurd things cannot happen.

VAERS: Welcome to Complex Systems

It is very clear that the VAERS data contains plenty of information. It is also very clear that VAERS is a mountain of nuances, variables, and context. Vaccinating millions of Americans over the course of a few months may mean we are likely to see elevated reports to VAERS. We also cannot exclude the influence of human error, especially when VAERS may not take this into consideration when examining adverse events. We also need to make sure that we do not discount any form of reporting, and that people, irrespective of what their adverse events are, feel comfortable in reporting their events. We need to understand the VAERS data, but the data requires an understanding of perspectives, and until all variables are taken into account, and all aspects checked for causal relationships, we must approach it with good faith skepticism and leave nothing unaccounted.

Note: One of my links contain slides from US Senator Ron Johnson. I have only linked these slides because I have not been able to put the data together myself. If there seems to be errors with the data presented in the slides please let me know.

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In-Text Citation- I’m only including the Li et. al 2021 study and the BMJ editorial to save space.

1. Li et al. 2021. Intravenous injection of COVID-19 mRNA vaccine can induce acute myopericarditis in mouse model Taken from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8436386/

2. Male, V. 2021. Menstrual changes after covid-19 vaccination Taken from https://www.bmj.com/content/374/bmj.n2211

Additional Information:

Dr. John Campbell has been one of the few people to have alerted his viewers to aspirating during vaccine injections many months beforehand. Check out his Youtube channel if you’re interested. Here’s a video discussing aspiration from 5 months ago.

Aspiration Controversy

Apparently this has been a very controversial topic in healthcare, and the practice seems to have been neglected. Here’s an article discussing the issue:

• Sepah et. al. 2017. Aspiration in injections: should we continue or abandon the practice? Taken from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5333604/