I’ve been writing about how antivaxxers love to abuse and misrepresent reports made to the Vaccine Adverse Events Reporting System (VAERS), the reporting system jointly run by the CDC and FDA designed to pick up safety signals for vaccines, starting long before the pandemic. Indeed, the first time I ever wrote specifically about VAERS was in 2006, when the (in)famous père et fils duo of Mark and David Geier went dumpster diving into VAERS to try to “prove” that thimerosal-containing vaccines cause autism, something that “COVID-19 contrarians” did in 2021, with exactly the same sort of bad science. As I (and many others who routinely had combatted antivax disinformation before the pandemic) warned as COVID-19 vaccines neared release in late 2020, it didn’t take long for antivaxxers to adapt their old technique of misusing VAERS to find “associations” between vaccines and all sorts of bad things, leading me to proclaim 2021 to be the year that antivax weaponization of VAERS went mainstream. This background is important if you want to understand what antivax propagandist Del Bigtree and Robert F. Kennedy, Jr. are doing now, which is to weaponize v-safe to falsely portray COVID-19 vaccines as dangerous, following the same template that antivaxxers have long used to weaponize VAERS to portray childhood vaccines as unsafe. This weaponization takes the form of articles like:
- Breaking News: ICAN obtains CDC v-safe data (ICAN)
- CDC V-safe Data: Hundreds of Thousands of Americans Sought Medical Care After COVID Vaccination (Children’s Health Defense)
And Tweets like this:
To see how this is possible, you have to understand a bit about v-safe. V-safe is a system similar to VAERS that was created to look for safety signals from adverse events reported after COVID-19 vaccination. It was first intended for use by healthcare workers, who were among the first to get the new vaccines, but then offered to everyone receiving a COVID-19 vaccine. The main difference is that VAERS is a purely passive reporting system, whereas v-safe prompts users with a text message at predefined time points after vaccination with a COVID-19 vaccine. Each prompt provides a link for the vaccinee to to fill out a brief online questionnaire about their health, whether they have had COVID-19 recently, and whether they are experiencing any symptoms that might be an adverse event from the vaccine. I myself have participated in v-safe and dutifully answered the questionnaires every time I received a text message prompting me to do so.
What both VAERS and v-safe share in common is that they cannot determine causality. In VAERS, users can submit a report of basically any symptom or health condition that occurs after vaccination and is a purely passive reporting system. No report is made unless a vaccinee or healthcare provider, such as a physician or nurse, makes it. V-safe, in contrast, is more active in that it prompts vaccinees whether they have experienced any symptoms after vaccination. Here’s a brief explanation of the difference between the two reporting systems:
During the pandemic, the CDC rolled out a new app-based system for voluntary side-effect reporting related to only COVID-19 vaccines: v-safe. Initially created to monitor vaccine safety for the health care workers who were first to receive the vaccines, the program was extended to anyone getting a COVID shot. The app sends text reminders to fill out symptom diaries and answer basic questions about side effects.
“It’s really fabulous; we gathered a lot of safety data from a lot of people quickly,” Talaat says. Unlike VAERS, v-safe is not designed to capture reports of unusual events, but more common symptoms like fevers, chills, or sore throats. v-safe data has been useful in evaluating side effects for groups that were not included in the vaccine’s first clinical trials, such as pregnant women.
V-safe, as anyone who’s ever answered one of its questionnaires knows, uses a multiple-choice format and limits the selection of what questions can be answered, starting with a question asking how you’re feeling today, with three options: Good, fair, and poor. Here’s a brief video from the CDC that describes the process of filling out a v-safe questionnaire:
As you can see, v-safe focuses mainly on common symptoms, such as local symptoms from the injection, fever, chills, headache, body aches, and the like. It also asks whether you could work normally, had to miss work, or even needed to seek medical attention. There’s also encouragement to report adverse events to VAERS.
One of the things that interests me about v-safe and the new emphasis by the CDC on VAERS since COVID-19 vaccine were introduced is that it actually very much contrasts with the narrative of antivaxxers. Think about it. Antivaxxers claim that the government and medical profession don’t want to know about vaccine complications and injuries, that they actually want to hide anything bad about vaccines, but here we have considerable investment in two systems designed to ask people receiving the vaccines if anything bad happened to them afterward. It really is quite a jarring contrast.
Now let’s see how RFK Jr. spins ICAN’s “dashboard.” It isn’t promising that his website, Children’s Health Defense, chose to republish an article from The Epoch Times, one of the foremost spreaders of COVID-19 and antivaccine disinformation in the age of the pandemic:
Hundreds of thousands of Americans sought medical care after getting a COVID-19 vaccine, according to Centers for Disease Control and Prevention (CDC) data released on Oct. 3.
Some 782,900 people reported seeking medical attention, emergency room care and/or hospitalization following COVID-19 vaccination.
Another 2.5 million people reported needing to miss school, work or other normal activities as a result of a health event after getting a COVID-19 vaccine.
The reports were made to the CDC’s V-safe program, a new vaccine safety monitoring system to which users can report issues through smartphones.
In a promotional email (yes, I’m on ICAN’s email list, as I am on the email lists of several antivax groups in order to monitor what they’re doing), ICAN bragged:
This first batch of data includes the responses v-safe users provided to pre-populated ‘check-the-box’ fields. It does not include data from the fields that allowed free-text responses. It nonetheless reveals shocking information that should have caused the CDC to immediately shut down its Covid-19 vaccine program.
Among numerous alarming results, out of the approximate 10 million individuals that registered and submitted data to v-safe, 782,913 individuals, or over 7.7% of v-safe users, had a health event requiring medical attention, emergency room intervention, and/or hospitalization. Over 25% had an event that required them to miss school or work and/or prevented normal activities.
There were also 71 million reports of symptoms in the pre-populated fields from the approximately 10 million users. This is an average of over 7 symptoms reported per v-safe registrant. Reported symptoms include, for example, over 4 million reports of joint pain, a very concerning immune reaction. While around 2 million of these joint pain reports were mild, over 1.8 million of the reports were for moderate joint pain and over 400,000 were for severe joint pain. Since v-safe only included less than 4 percent of people that received a Covid-19 vaccine, tens of millions of Americans likely had an immune reaction to the Covid-19 vaccine in their joints that resulted in debilitating pain and potential long-term harm.
There were also approximately 13,000 infants under 2 years of age who were registered for v-safe. For these 13,000 children, there were over 33,000 symptoms experienced that were significant enough to report, with the most common symptoms being irritability, sleeplessness, pain, and loss of appetite. These are very concerning since babies cannot speak and hence these symptoms are how they often communicate that something is wrong.
Obviously, given how ICAN and RFK Jr., as anyone who knows anything about their history and the history of antivaxxers with respect to misrepresenting and weaponizing VAERS could have predicted, immediately weaponized raw v-safe reports, I can completely understand the reluctance of the CDC to release such data. For one thing, it suffers from the same sort of bias towards more severe symptoms that VAERS does, given that people are less likely to report minor symptoms than they are to report severe ones, particularly given that it includes only those individuals who actually signed up for the program and answered the questionnaire. Think about it: Ten million people do not represent that large a number. In comparison, according to Our World in Data, by August 1, 2022, the latest date in the dataset, nearly 262 million Americans had received at least one dose of a COVID-19 vaccine, with nearly 224 million having been “fully vaccinated” (i.e., having received at least two doses). As of today, it’s estimated that 620 million doses have been administered in the US.
ICAN does admit that this is only 4% of the population that has been fully vaccinated, but it makes an unfounded assumption, na ely that “tens of millions of Americans likely had an immune reaction to the Covid-19 vaccine in their joints that resulted in debilitating pain and potential long-term harm.” What’s the unfounded assumption? That muscle and joint pain after a vaccination results in long-term harm. How do we know that such pains rarely, if ever, result in long-term harm? We have safety studies! Scientists have actually looked at the data from VAERS and v-safe, for instance a study published in March in The Lancet Infectious Diseases, which noted, among other findings:
Injection-site pain (4 488 402 [66·2%] of 6 775 515 participants after dose one and 3 890 848 [68·6%] of 5 674 420 participants after dose two), fatigue (2 295 205 [33·9%] participants after dose one and 3 158 299 participants [55·7%] after dose two), and headache (1 831 471 [27·0%] participants after dose one and 2 623 721 [46·2%] participants after dose two) were commonly reported during days 0–7 following vaccination. Reactogenicity was reported most frequently the day after vaccination; most reactions were mild. More reports of being unable to work, do normal activities, or of seeking medical care occurred after dose two (1 821 421 [32·1%]) than after dose one (808 963 [11·9%]); less than 1% of participants reported seeking medical care after vaccination (56 647 [0·8%] after dose one and 53 077 [0·9%] after dose two).
This study included a period from December 2020 to June 2021, which encompassed nearly half of the total vaccinations administered overall as of today, and the authors concluded:
Safety data from more than 298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the US vaccination programme show that most reported adverse events were mild and short in duration.
A more recent study of COVID-19 vaccination in children using v-safe and VAERS published in August found a similar safety profile. This study also had the advantage of using another database that prospectively looks for adverse events after vaccination, the Vaccine Safety Datalink (VSD). An even more recent study supported this conclusion.
COVID-19 vaccines are reactogenic (that is, cause significant immune reaction). There’s no doubt about that, and I’ve experienced that reactiveness myself. Indeed, my personal experiences with the mRNA-based vaccines have generally involved feeling like crap for 24-36 hours after vaccination, experiences that have led me since the first dose to be very deliberate and careful about scheduling my vaccine. I generally try to pick a day when I can afford to be out for a day or so afterward, and that pickiness is the only reason why I have not yet received the bivalent booster. According to ICAN’s analysis, I was almost certainly one of the people reporting fatigue, pain at injection site, chills, muscle and joint aches, and headache to the database. Given that I’ve received both the primary series and two boosters, that means I’ve reported multiple events in the dataset for each of four doses of vaccine.
With that background, now let’s take a look at the “dashboard” provided by ICAN:
Helpfully, ICAN has provided a searchable front end to the database. You can also download the actual dataset for yourself, which I plan to do when I get a chance. (One of the files is well over 5 GB in size.) If you want to download the dataset yourself, the link is here, but I warn you: You’ll need a throwaway email address, as ICAN requires an email address before it gives access. Fortunately, since I already have a throwaway Yahoo! account that I use for just such mailing lists, this was not a problem. I’m hoping that someone with better data visualization and analysis skills than myself will download the dataset and see if they can figure out what ICAN did to generate its dashboard. It’s also not clear to me whether these are the original data files or files curated by ICAN; so there’s that issue too.
I’ll conclude by putting the various systems for monitoring vaccine safety into perspective. Antivaxxers have long loved to misrepresent VAERS as the be-all and end-all of vaccine safety monitoring, despite its very clear problems and the fact that it was never designed to determine actual prevalence of vaccine injuries, but rather to serve as a “canary in the coal mine,” in which an uptick in reports generates hypotheses regarding the relationships between specific vaccines and specific adverse events that scientists can investigate further using more suitable datasets, such as the VSD. As you can probably see by now, v-safe is like VAERS on steroids in that it cannot be assumed to be a representative sample of persons undergoing vaccination plus the added bias that it actively seeks reports at regular intervals after vaccination going out more than six months.
As I like to point out, antivaxxers always cite VAERS (and now v-safe) and only rarely, if ever, cite other, much better and more reliable, vaccine safety monitoring databases, such as the Vaccine Safety Datalink (VSD), the Clinical Immunization Safety Assessment (CISA) project, or FDA’s Post-licensure Rapid Immunization Safety Monitoring System (PRISM) Antivaxxers also seem to like to represent VAERS simultaneously as the best system to find adverse events (AEs) from vaccines, even while also claiming it’s awful due to underreporting, which means (to them) that all the horrible things in VAERS are really a lot more common than “they” want you to think. Now that they’ve weaponized v-safe too, they’re using a similar misleading argument in that they claim that the adverse events reported in v-safe must be much more common than “they” want you to know, because less than 5% of vaccinees participated in v-safe.
I think it’s worth reiterating that VAERS and v-safe were never intended to provide an accurate estimate of the frequency of adverse events related to vaccines, but rather to serve as an early warning system for possible new vaccine-related adverse events. In other words, VAERS and v-safe are a hypothesis-generating, not hypothesis testing, systems. The hypotheses generated from the signals in both systems first must be compared to the base rate of conditions in the general population and then tested using better systems and datasets, such as the VSD. In contrast to VAERS and v-safe, these systems are much more reliable reporting systems in that electronic health records are actively monitored for adverse events after vaccination in order to identify potential signals; there is a lot less bias that way and a lot less potential for misreporting.
As I’ve pointed out more times than I can remember now, before any of the COVID-19 vaccines started rolling out in the US under an emergency use authorization (EUA) nearly two years ago, those of us with long experience deconstructing antivaccine disinformation were warning that VAERS would be weaponized to portray COVID-19 vaccines as deadly. It was entirely to be expected based on the previous misuse of VAERS to falsely link vaccines to autism, premature ovarian insufficiency and infertility, death (including sudden infant death syndrome), and many other health outcomes that we know not to be related to vaccines. So why wouldn’t they do it with COVID-19 vaccines? They did, of course, and in terms of antivaccine disinformation 2021-22 have certainly been the years when the public, news media, and public health officials had their faces rubbed in what we had been describing before the pandemic and warning about as the vaccines rolled out.
In fact, it’s actually taken antivaxxers longer than I had expected to get around to trying to do with v-safe data what they’ve been doing with VAERS data for two decades: Weaponize it. The difference of course, is that VAERS data have always been publicly searchable through a CDC-run website, while v-safe data were not and remained available only to researchers; that is before now.
Antivaxxers could—and did—immediately go to work weaponizing VAERS against the COVID-19 vaccine beginning soon after the first dose was administered outside the auspices of a clinical trial to claim. Within a couple of weeks, antivaxxers were weaponizing VAERS to deceptively claim that the vaccines were causing Bell’s palsy and then, within weeks, that they were killing hundreds of people. By spring, antivaxxers were using VAERS to claim that COVID-19 was a “depopulation” plot that had killed tens of thousands of people. These days, that’s no longer enough, as people like Steve Kirsch are claiming that the vaccines have killed a half million people in the US alone, although admittedly these days he’s using a method even less rigorous than dumpster diving in the VAERS database. RFK Jr.’s claim a week and a half ago based on VAERS that the vaccines have killed “only” 31,000 seems almost semi-reasonable by comparison. I feel obligated to remind people again of the base rate fallacy and how, by random chance alone we’d expect many times more people to have died within a few months of vaccination just because 2.8 million people die in the US every year.
Now that antivaxxers like Del Bigtree have access to v-safe data through August 1, 2022, I fully expect them to go wild and try to present it in ways designed to deceptively make the COVID-19 vaccines look as bad as possible. It’s what they’ve done with VAERS for longer than I’ve been paying attention to the antivaccine movement. There’s no reason to expect that they won’t continue to do it with v-safe.