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.
Patient was vaccinated with her second dose on 12/8/21 at 4:45pm, by 12/11/21, she had a rash on her back, raised and very itchy. By 12/12/21, she complained of a headache and a tummy ache. The head and tummy pain has lasted from then until NOW, 12/19/21. On 12/18/21, she woke up with hives on her body. She had 3 on her left arm, 1 on her right arm, 1 on her lower abdomen, and 1 on her lower back. The entire week prior, she has complained she is cold (has the chills), has head and tummy pain, and incredibly itchy. The doctors here in Westford say there is no correlation to the vaccine, but she had a reaction to the first dose as well. I am worried I vaccinated too early from her being positive. But i was advised otherwise. I am also worried this will affect her long term, as she is not over this yet.
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||FK5127||SYR||LA|
|LAB_DATA:||NOTHING. Was seen 12/15/21 and they administered a COVID test, and a strep test. They told me she was fine, and she will get over "whatever this virus is, and to booster her in 6 months." I called 12/18/21, a NURSE called me back, and they told me the hives were from a BATH she took. And, they had zero to tell me why she had a rash on her back and nothing to say over the headache and tummy aches. "She will get over it" But, she was covid and strep negative, so we should be all set..... I'm not happy.|
|OTHER_MEDS:||Claritin daily Gummy vitamin daily|