“It does not have the level of detail and granularity needed to accurately assess whether those events are causally related. And you know, there’s no comparison group there, everybody in v-safe is vaccinated. And so it’s impossible to determine whether a vaccine caused a particular adverse event just based on v-safe data,” Belongia told us.
The system is part of a larger early alert reporting system that allows experts to monitor the safety of the vaccines. Belongia, and other experts, say v-safe has limitations. But he says the tool has been helpful to observe common side effects of the vaccines such as pain at the injection site, headache, muscle aches or fever.
“And what we’re seeing is largely consistent with what was seen in the clinical trials: that these symptoms are very common, they’re mild to moderate, they resolved over two to three days, and so there’s really nothing surprising there,” he said.
The data collected through v-safe is not accessible to the public in the way the data from other systems like the Vaccine Adverse Event Reporting System is. Instead, the information is communicated to the public through multiple studies that analyze v-safe data in the CDC’s Morbidity and Mortality Weekly Report and other journals, and in presentations to the Advisory Committee on Immunization Practices. According to the CDC, v-safe data have been presented in 11 meetings since the rollout of the vaccines — in December 2020; January, March, June, September and October 2021; and in January, April, May, June and September 2022.
Some findings of these studies are that the second dose of the primary series caused more participants to report mild and temporary symptoms or being unable to do normal activity, and that the second booster caused fewer of the expected side effects, such as pain at the site of injection, than the first one. According to the CDC, when the COVID-19 vaccines started to be administered, v-safe was critical in identifying early reports of a severe allergic reaction that occurs rarely after vaccinations.
One study, published in the Lancet Infectious Diseases in March, analyzed v-safe reports between Dec. 14, 2020, and June 14, 2021, after the administration of the Pfizer/BioNTech and the Moderna COVID-19 vaccines. According to its findings, less than 1% of v-safe users reported receiving medical care in the first week after getting a dose of the primary series of either vaccine, and a very small proportion (0.2% or fewer) reported an emergency room visit or hospitalization. Again, even those medical care visits are not necessarily caused by the vaccine and could be coincidental.
ICAN’s Misleading Analysis
Informed Consent Action Network is a Texas-based group founded by Del Bigtree, an anti-vaccination activist. The group has filed several vaccine-related lawsuits against the CDC, the Food and Drug Administration and the National Institutes of Health. ICAN sued the CDC in December 2021, and again in May 2022, following FOIA requests to obtain all data submitted to v-safe since Jan. 1, 2020. The v-safe program only started after the COVID-19 vaccines were authorized in December 2020.
In August, the CDC agreed to publish on its website the data collected from more than 10 million v-safe participants by Sept. 30. The database would cover reports submitted between Dec. 14, 2020, and July 31, 2022, and would omit any personal identifiers. The agency told Reuters “technical and administrative” issues prevented it from publishing the data on time. Instead, the CDC handed the data directly to ICAN, which published its own analysis on Oct. 3.
On its website, ICAN does not explain the methods used for its analysis. But it mentions the data are limited to the 10 million v-safe users and to the pre-populated fields checked by them, not the information users can add in text boxes. According to the group’s dashboard, the data are drawn from check-ins that occurred up to a year after a vaccine dose. The group also published five downloadable files with raw v-safe data.
FactCheck.org reached out to Aaron Siri and other representatives of Siri & Glimstad, who filed the FOIA litigation for ICAN, but we didn’t hear back from them. We also tried to access the raw data presented, but we couldn’t open the biggest file containing information regarding the health check-ins.
We were able to access one of the files containing symptoms and health impacts, which included 116,294 reports. Out of these reports, 1,046, or 0.9%, were reports of receiving medical care of any kind, and this included multiple reports from the same person over time. Out of those, only seven were for hospitalizations, two of which were for the same person on two consecutive days.
Belongia, the vaccine safety expert, told us the numbers provided by ICAN, including the more than 780,000 users who reported requiring medical care of any kind, are “uninterpetable.”
“We don’t know what the background rate in the population is from v-safe. What would that number have been in a group of people who hadn’t gotten the vaccine?” he said.
Since health problems, including hospitalizations, occur in the population every day, it’s not uncommon for them to happen after vaccination for reasons unrelated to the vaccine. That’s why it’s important to see if a particular event is happening more frequently after vaccination, which could indicate an issue.
The analysis doesn’t mention how long after vaccination a user required medical attention, but included responses up to a year after vaccination, which could explain the difference between ICAN’s numbers and the CDC’s published data. Siri told Reuters that ICAN thought it was important to look beyond one week, since some potential vaccine-related side effects could appear weeks after vaccination. But most side effects occur soon after vaccination, so including longer intervals would include more events that are unrelated to the vaccine.
A user may have gone to a doctor for a completely different reason six months after a vaccine, and, if following v-safe instructions properly, would report it to the system. That user would get a follow-up call from v-safe, for the agency to get more information. But as we said, v-safe doesn’t have the ability to know if any particular event, including a hospitalization, was caused by the vaccine or not.
“And so in order to answer questions like that, in terms of relative risk, you need something like the Vaccine Safety DataLink or VSD, which uses medical records from millions of people around the country, and immunization records to implement scientifically valid studies to determine if there’s an elevated risk after vaccination for particular adverse events,” Belongia said, referring to a network of nine integrated health care organizations, including his, that conducts active vaccine safety surveillance.
“What we’re actually seeing in the data is the exact opposite of what is being suggested by groups like ICAN — these vaccines are very safe. With, you know, a few very rare known exceptions,” Belongia said. “But overall, it’s very clear that the benefits of the vaccines greatly outweigh the risks.”
Editor’s note: SciCheck’s COVID-19/Vaccination Project is made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.org’s editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation. The goal of the project is to increase exposure to accurate information about COVID-19 and vaccines, while decreasing the impact of misinformation.
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