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 received second dose of Pfizer (tozinameran-tris-sucrose) vaccine on May 10, 2022. On May 17, 2022 patient started experiencing severe lower abdominal pain and decreased bowel movements. Patient started having nausea and vomiting the morning of May 21, 2022. Patient saw his PCP and received a sample of Trulance 3mg to take for the constipation. Patient took the first and only dose the morning of May 21, 2022 and had a bowel movement that was green/black in color. Patient came to the ER May 21, 2022 at 1656 due to this. Scans were done and it was found patient had acute appendicitis with severe surrounding inflammation as well as large fecalith with possible perforation. Patient taken emergently to OR for laparoscopic appendectomy.
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||FK9893||IM||RA|
|LAB_DATA:||Blood count, CBC, Urinalysis, CT of abdomen and pelvis without contrast|
|OTHER_MEDS:||Zyrtec 10mg as needed|