Evaluating the claims of unsafe Covid-19 vaccines based on what has been reported to VAERS objectively.
Vaccine safety is a polarized topic. Many either stay on the side of safe or unsafe vaccines when the reality isn’t so black and white. A vaccine is a type of drug. Like antibiotics, birth control pills, statins, and antidepressants, they all come with risks and hopefully more benefits.
That said, this article will examine if there’s any truth or validity in the claims that Covid-19 vaccines are unsafe based on what has been reported to the vaccine adverse event reporting system (VAERS), a passive surveillance system that monitors vaccine safety in the U.S. beyond clinical trials.
The unsafe Covid-19 vaccines narrative
In the rather popular DarkHorse podcast, three people— Bret Weinstein, Ph.D., evolutionary biologist, Robert Malone, MD, MS, one of the pioneers of mRNA vaccine, and Steve Kirsch, MS, founder of seven tech companies — discussed problems in how the pandemic is handled. One of the problems was vaccine safety based on VAERS data.
They brought up the graph below that showed a huge spike in post-vaccine deaths in 2021 compared to previous years in the U.S. And they emphasized that the Covid-19 vaccines are a reasonable and perhaps the only possible explanation for these deaths.
(In May 2021, Mr. Tucker Carlson also pushed the same narrative in his show, Tucker Carlson Tonight, where he announced that nearly 4000 people had died after getting the Covid-19 vaccine, based on VAERS data. Other sites have also made similar claims.)
Mr. Kirsch also said that this is an underestimate. So, “the public doesn’t know how many people have died from the vaccine,” he said. “It could be only 1% of reports that are actually reported…which means 5000 reports translate to 500,000 deaths [but] I don't think it’s that high…but it’s higher. I guarantee that it’s higher.”
Even that 5000 deaths “is more deaths than for all 70 other vaccines combined over the last 30 years,” Mr. Kirsch continued. The same applies to the reported adverse events from the Covid-19 vaccines: “it’s also more than all the other vaccines over 30 years combined.”
Mr. Kirsch also said that “nobody knows about this VAERS system, and people aren’t reporting. In fact, when doctors report in, they are told [to not] report this…We’ve had reports reversed from doctors without the doctor’s consent.”
The trio then discusses the censorship of this issue, where information is suppressed, and questions why everyone is staying silent about this danger signal present in VAERS.
Purpose of vaccine adverse events reporting system (VAERS)
Before we examine the underreporting and post-vaccine deaths issues in VAERS, let’s have a brief look into what VAERS is supposed to do.
Since we can’t include the entire population in clinical trials forever, VAERS was created in 1990 for the CDC and FDA to watch for any danger signals of the vaccine in the U.S. population beyond the clinical trials.
After all, participants enrolled in clinical trials may not reflect the general population. For example, in the Pfizer mRNA vaccine phase 2/3 clinical trial, the participants’ median age was 52 years, with only 4.4% being over 75 years and 0.003% being over 85 years. Although 46% of participants had at least one underlying medical condition (typically heart, lung, or liver diseases, obesity, or diabetes), only 0.1 % had dementia, 0.5 % had heart failure, and 1.0 % had cerebrovascular diseases. Plus, people with immune disorders — such as autoimmune diseases and late-stage cancers — were excluded.
This is why the safety profile of vaccines cannot be fully known from clinical trials alone. Real-world data are necessary, which is why surveillance systems such as VAERS are created.
As VAERS does not contain data from unvaccinated populations, VAERS cannot confirm if a vaccine caused something. In other words, without a comparison control group, we don’t know if the adverse events (including deaths) reported to VAERS are actually coincidences that would have happened regardless of the vaccine.
As the CDC and VAERS have cautioned, “While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable.”
Thus, the purpose of VAERS is to detect signals of possible vaccine adverse events, which may generate hypotheses and prompt further investigations.
VAERS underreporting
Anyone can report to VAERS, including patients, parents, and healthcare providers. Healthcare providers are also required by law to do so. But despite that, underreporting is an acknowledged limitation of VAERS.
Mr. Kirch and other critics of vaccine safety often mention that only 1% of vaccine-related adverse events are reported. This claim is based on a 2011 report from Harvard Pilgrim Health Care, Inc., which stated that “fewer than 1% of vaccine adverse events are reported.”
But this data can be misinterpreted easily. The Harvard report examined all possible reactions to the vaccine, even minor ones like pain and fever, which are common and expected that many doubt there’s a need to report them.
For more serious vaccine reactions or adverse events, however, underreporting is not as extreme:
- A 1995 study found that 68% of poliomyelitis (severe nerve disorder) cases from the oral poliovirus vaccine were reported to VAERS (reporting sensitivity: 68%). But this number was <1% for non-severe rashes from the mumps/measles/rubella (MMR) vaccine. (This data can also be misused to say that only <1% of vaccine adverse events get reported).
- A 2001 study found that 47% of cases of rotavirus vaccine-associated intussusception (severe intestinal disorder) were successfully reported to VAERS (reporting sensitivity: 47%).
- A 2013 survey study in the U.S. found that 73% of healthcare providers were very or extremely likely to report a serious vaccine adverse event, whereas only 13% were keen to report a minor one.
- A 2020 study tracked the reporting sensitivity of anaphylaxis (severe allergic reaction) and Guillain–Barré syndrome (severe nerve disorder) from various vaccines. Results (see table below) showed that the reporting sensitivity of anaphylaxis ranges from 13–76% from seven different vaccines. For Guillain–Barré syndrome, the reporting sensitivity is 12% from the 2012–2013 influenza vaccine, 15–55% from the 2009 influenza vaccine, and 64% from the 2006–2015 human papillomavirus vaccine.
Thus, in general, less severe reactions are more likely to be massively underreported outside of clinical trials. But more severe reactions (or adverse events) are less likely to get massively underreported.
Yes, it’s just less prone to massive underreporting. In the end, VAERS is not a perfect system that will catch everything. Does this mean that the vaccine is less safe than what the available data suggest? Yes, but this isn’t enough to dismiss vaccines as unsafe drugs. ‘Less safe’ is relative, and it’s usually relative to an already rare phenomenon.
For example, in the context of current Covid-19 vaccines:
- The rate of anaphylaxis (severe allergic reaction) is 2.5–4.7 cases per million doses of the Pfizer and Moderna mRNA vaccines (≤0.0005%). Assuming a reporting sensitivity of 10-50% (a reasonable estimate based on the studies presented above), which also means underreporting rate of 50–90%, this rate would only be 0.001–0.005%.
- The rate of vaccine-induced thrombotic thrombocytopenia (VITT; severe blood vessel disorder) is 1 case per 26,000 to 127,000 doses of the AstraZeneca DNA vaccines (≤0.003%). A 10–50% reporting sensitivity would change this percentage to 0.006–0.03%.
- The rate of Guillain–Barré syndrome (severe nerve disorder) is 7.69 cases per million doses of the Johnson & Johnson DNA vaccines (0.00078%). A 10–50% reporting sensitivity would adjust the percentage to 0.0016–0.0078%.
(Please note that only the Guillain–Barré syndrome rate is based on what was reported to VAERS. The rates of anaphylaxis and VITT were determined based on further research, which means less degree of underreporting.)
(Another note is I’m not sure whether VAERS reports can be reversed without consent, as Mr. Kirsch claimed in the podcast, as I could not find any info about it. Maybe a few reports did get reverse due to random system errors, but I doubt that would make much of a difference in the overall numbers.)
So, admittedly, underreporting is inevitable with VAERS. Probably only <1% of the minor (non-severe) and 10–50% of serious (severe) vaccine reactions get reported. But serious vaccine reactions or adverse events are rare and will still be rare after accounting for underreporting.
Post-vaccine deaths
As mentioned above, the DarkHost podcast, Tucker Carlson Tonight, and many other sites have mentioned that about 4000–5000 people have died after getting the Covid-19 vaccine as of May 2021, based on VAERS reports.
While VAERS did receive that many reports of post-vaccine deaths between December 2020 and May 2021, that numerator alone is misleading without the denominator. In fact, about 250 million doses of Covid-19 vaccines were administered during that period, which means that the rate of post-Covid-19 vaccine deaths is about 0.002%.
In fact, the CDC expected 11,440 deaths as early as January 2021, given that about 1.3 million doses of vaccines were administered to patients in long-term care facilities. But only 129 post-vaccine deaths were reported to VAERS at that time, which is 88.7-fold (8870%) lower than expected.
(Although underreporting is expected, it would not be at an extreme rate, as discussed in the above section, especially when it comes to death.)
At present, the CDC is still transparent about post-vaccine deaths. The CDC website states that ~6000 post-vaccine deaths have occurred out of the 334 million doses given as of 13 July 2021. This gives the rate of 0.0018%:
The same can be said about the huge number of vaccine-related adverse events reported to VAERS in 2021 (ranging in the hundreds of thousands, although some of them are minor and non-severe). Given the sheer number of vaccines distributed during this pandemic, a sharp increase in reports of post-vaccine deaths and adverse events is expected. Moreover, the numerator (number of vaccine-related adverse events or deaths) is misleading without the denominator (number of vaccine doses given).
Importantly, recall that VAERS is not meant to show a cause-and-effect link, as authorities have repeatedly cautioned. After all, VAERS accepts reports regardless of whether they are likely or unlikely to be caused by the vaccines, and bad things — deaths, diseases, and illnesses — happen to people daily.
For example, in 2019, 2.85 million people died in the U.S., which gives an average of 7,800 deaths per day. So, one can imagine if the most vulnerable populations are prioritized for vaccination at a massive scale, a drastic spike in post-vaccine deaths (and other adverse events) will happen.
This isn’t the first time that post-vaccine death reports in VAERS have been misused. For example, during the 2015 measles outbreak in the U.S., claims of over 100 deaths caused by the measles vaccine circulated on the internet. The claim was based on VAERS data. But further examinations of health records, autopsy reports, and death certificates by the CDC and FDA found no causal relationship between the measles vaccine and post-vaccine deaths.
Is VAERS actually useful?
In the abovementioned 2001 study, cases of rotavirus vaccine-related intussusception (severe intestinal disorder) were found to be underreported to VAERS by about 50%. Even before such underreporting was discovered, however, the initial VAERS signal was enough to prompt authorities to suspend rotavirus vaccination for further investigations. And the rotavirus vaccine was soon withdrawn from the market in that same year in 1999. This is the only case of post-approval vaccine withdrawal thus far.
VAERS has also detected a small increase in febrile seizures (non-severe nerve disorder) incidents among young children who got the 2010–2011 influenza vaccine. Thankfully, all children recovered without any long-term health effects. Further studies, motivated by VAERS signal, have also verified such association with other influenza vaccines.
During the Covid-19 pandemic, initial reports of severe blood clots from the AstraZeneca and Johnson & Johnson (J&J) DNA-based vaccines to surveillance systems like VAERS instigated their suspension, slowing vaccine rollout. After thorough inspections, a new medical term was coined: vaccine-induced thrombotic thrombocytopenia (VITT). And we now know the prevalence, cause, and early signs of VITT and how to treat it.
The possible risk of myocarditis (non-severe heart inflammation) from the Pfizer and Moderna mRNA vaccines in young men was also first noted by VAERS, and authorities soon admitted the risk as legitimate. (For an update on mRNA vaccine-related heart inflammation, see here: Heart Inflammation From mRNA Vaccine: Probable Causes and Precautions.)
More recently, VAERS has also caught a possible link between the J&J DNA vaccine and Guillain–Barré syndrome, where 100 such reports were submitted as of 12 July 2021. During this time, about 13 million doses of the J&J vaccine were administered. The FDA has soon admitted that Guillain–Barré syndrome may occur within 42 days of getting the J&J vaccine.
(Despite the known risks of VITT, myocarditis, and Guillain–Barré syndrome, those Covid-19 vaccines are still being used in most countries because they offer substantially more benefits than risks.)
So, even with its limitations, VAERS is a useful system. Critics might argue VAERS may have missed some real vaccine adverse events. Assuming this is true (which we don’t know, though), such vaccine adverse events would be rarer than what has been detected. If VAERS can catch vaccine adverse events with incidence rates of, for example, ≤0.0007% (i.e., 100 reports of Guillain–Barré syndrome from 13 million doses of J&J vaccine) — or 0.0016–0.007% if the reporting sensitivity is 10–50% — the hypothetical vaccine adverse events that VAERS would miss should have an incidence rate of less than that.
Key points
Underreporting happens with the U.S. VAERS, but we need to be careful in noting that although <1% of minor vaccine reactions get reported, the underreporting rate of more serious vaccine reactions or adverse events is not that extreme. Based on existing studies, VAERS’s reporting sensitivity for serious vaccine adverse events is 10–50% — which also means a 50–90% underreporting rate — but even this percentage can be misleading. Note that such rates are relative to serious vaccine adverse events that are rare. Rare events will still be rare, even with a 90% underreporting rate.
While 6000 post-Covid-19 vaccine deaths have occurred in the U.S. as of July 2021, it’s crucial to note that the denominator is 334 million vaccine doses, equating to a rate of 0.0018%. Plus, VAERS is not meant to confirm that a vaccine caused something, but that doesn't stop people from assuming that Covid-19 vaccines have killed thousands of people in the U.S. About 7,800 people died in the U.S. every day in 2019, so it’s actually not surprising to see a spike in post-vaccine deaths in 2021 as mass vaccination is happening, especially in the vulnerable populations.
All that said, back to the intro, this article is not meant to say that vaccines are completely safe or unsafe. But the claims that the Covid-19 vaccines are unsafe based on what has been reported to VAERS are simply misleading.
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