VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. 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. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
The next morning, I noticed swelling and hardening of my lymph nodes in my left armpit. A lot of tenderness. It lasted probably a week. Each day being a little better than the first day. After about maybe 2 weeks after the shot, I noticed that my left breast implant felt hard. It was swollen and it was very painful. I got an MRI to see what was going on and I went and saw Dr. (plastic surgeon). The swelling of the implant, it was swelling on the top of the implant. She was not familiar with this happening to anyone else. They were shocked when they saw my breast in the office. When sleeping at night, it would be so painful it would wake me up. Right breast remained normal during these health events.
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||EL9267||IM||LA|
|LAB_DATA:||MRI- showed that I did have capsular contracture in my left breast|
|OTHER_MEDS:||Simvastatin 40mg 1xday Valtrex 500mg 1xday Irbesartan 150mg 1xday Progesterone 100mg 1xday Estradiol patch 0.0375mg 2xweekly Align probiotic Vitamin C 500mg 2xday Vitamin D3 50mg 2xday Calcium 500mg 1xday|
|HISTORY:||High Blood Pressure High Cholesterol|
|PRIOR_VAX:||1st COVID Pfizer vaccination on 01/21/2021 - The next morning, I noticed swelling and hardening of my lymph nodes in my left arm|
|ALLERGIES:||One episode with Dilaudid after surgery|