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Do we have any data on vaccine side effects from V-safe?

Vaccines

A: Yes. V-safe is a smartphone app from the CDC designed to help us monitor vaccine safety for people who get the vaccine outside of clinical trials—like most of us.

People who got the vaccine can report their side effects. Keep in mind that the data in V-safe are self-reported. Results are available through the CDC website. Let’s explore.

If you received the COVID-19 vaccine in the United States, you may have been given a flyer to read inviting you to participate in V-safe . V-safe is a voluntary, secure, self-reporting system that allows the CDC to collect data about side effects experienced after the vaccine. Participants are prompted by text message to report how they feel. The reporting is done through a smart phone app that presents a brief survey. The web-based survey is sent daily for the first week after vaccination, then once a week for six weeks, and then at three, six, and 12 months.

The CDC compiles data from V-safe and other sources to monitor and respond quickly to any adverse reactions to a vaccine. The data from V-safe are combined with reporting to VAERS (Vaccine Adverse Events Reporting System) and VDS (the Vaccine Data Safety Link). These databases are populated with reports from doctor’s offices, clinics, and caregivers who may report side effects from any vaccine. VAERS and VDS provide the CDC and FDA with vital information as they track responses to vaccinations given to adults and children. The systems were in existence long before V-safe . These systems provide crucial real-time data so the CDC and FDA can respond quickly to adverse reactions and side effects that are reported by the public.

Have I said these are self-reporting systems of side effects? Yes. Indeed they are. This is an important point. The side effects reported may not have been verified by a medical exam or healthcare evaluation. In general, the symptoms are based on the subjective reports of people who got the vaccine, or caregivers who observe the side effects.

Any physical experience may be reported and is not necessarily a side effect of the vaccine. A report in V-safe does not determine the safety or danger of a vaccine. For example, note that VAERS gives the number of people who experienced a headache and reported it (the numerator). It does not give the number of people who received the vaccine (the denominator). You can’t tell how many people had a headache out of all vaccines given. But scientists use the data to look for abnormal rates of symptoms and compare them to typical rates in the population to detect trends.

Anyone with access to the internet can see the result of V-safe reflected in VAERS at the CDC website. The information is updated every Friday. In the following steps, we will walk through obtaining access to the database. Let’s compare the top 3 side effects experienced by people after receiving the two major COVID-19 vaccines: Moderna and Pfizer.

Step 1. Log on to https://wonder.cdc.gov/vaers.html

Step 2. Read the disclaimer and “agree”. This is to assure that you understand self-reporting. You cannot investigate further without agreeing to the disclaimer.

Step 3. Choose the “Request Form” tab at the far left of the screen to begin your search. Note that the system will pull up to 75,000 data points. So narrow your search as much as possible to avoid a rejection of your query. The request form is difficult to navigate at first unless you are familiar with older search engines. But after a few tries, it makes sense.

Using these steps, I found the top 3 side effects reported as of the beginning of April among those who received Pfizer and Moderna vaccines. See the screenshots of search results accompanying this post for more details.

Pfizer vaccine recipients reported 100,797 side effects as of early April. Headache, pyrexia (fever) and chills were the top 3 symptoms reported.

Moderna vaccine recipients reported 119,139 side effects as of early April. Headache, fatigue and chills were the top 3 symptoms reported.

Thank you to all who use VSafe and VAERS to build this database. For just a few moments of your participation, scientists are able to respond quickly to concerning trends in vaccine side effects.

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