How do we know Vaccines are safe
You may have wondered how your pharmacist or doctor knows your vaccines are safe. When a drug or vaccine is first being studied, it undergoes extensive clinical testing and monitoring to ensure that the treatment is safe and effective for treating the intended illness. During this testing, certain common side effects may be reported. Some of the most common side effects of vaccines include arm soreness at the site of injection, fever, or fatigue. Your healthcare provider will give you information on common side effects associated with a vaccine prior to administering it to you.
However, did you know that there is a national system that continues to collect information on vaccine side effects after the vaccine has been approved by the FDA?
Vaccine Adverse Event Reporting System (VAERS) Overview
The Vaccine Adverse Event Reporting System, known commonly as VAERS, is a system used by the Centers for Disease Control (CDC) to collect, analyze, and report on potential side effects of vaccines. Information is collected through reports submitted to VAERS through an online platform. The system is intended to be an early warning tool, so that potential safety concerns can be identified as quickly as possible.
Anyone can submit a report to VAERS, including members of the public, healthcare providers, and manufacturers of vaccines. Submitting a report to VAERS does not necessarily mean that the vaccine caused the side effect but allows for collecting information on side effects or medical events that occur after receiving a vaccine.
VAERS reports include information such as:
- Type of vaccine received
- Date of vaccination
- Description of the adverse event (side effect or medical event)
- Demographic information
- Medical history (including illnesses, medications, and any past history of adverse events following a vaccine)
Healthcare providers, including pharmacists, nurses and physicians, as well as manufacturers of vaccines are legally required to report certain serious adverse events. All other reporting is voluntary.
How can I report a side effect to VAERS?
You can obtain a form to print and fill out, or you can fill it out online.
After Reports are Submitted
After reports are submitted to VAERS, staff for the CDC and FDA review all information to categorize reports as serious or non-serious. Serious reports are those that were life-threatening or led to hospitalization or death. The non-serious category includes everything else, such as fever, tiredness, or soreness at the site of injection.
Staff review all data for any potential "signals," which is a pattern or rise in reported side effects for a certain vaccine. Finding a signal does not mean that the vaccine caused the side effect but means that more investigation or study is needed to decide whether there is an actual safety risk.
VAERS is an important method for monitoring the safety of a vaccine after it becomes available to the public. Ask your healthcare provider if you have any questions about potential side effects before or after receiving a vaccine.