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.
14 Sept 21: One day following initial vaccination: pleuritic chest pain, palpitations, body/joint aches 4 Oct 21: Headaches, fatigue, shortness of breath, joint pain, rt eye weakness, tingling sensation on head/groin area, testicle/abdomen discomfort. 27 Dec 21: Chest pain/tightness 25 Feb 22: Continued chest pain, reduced endurance 16 Mar 22: Continued chest pain, reduced endurance
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||FF2587||IM||RA|
|LAB_DATA:||Cardiology workup #1 (November 2021) :normal labs (exception elevated LDL 130, ESR 9 (March 2022), EKG, Holter monitor with PVC burden of 1%, adequate/normal Treadmill stress test, Echo ( % EF, no wall motion abnormalities), normal coronary CT angiography Cardiology workup #2 (February 2022): normal labs, EKG, Treadmill stress test, Echo (no wall motion abnormalities), normal coronary CT angiography June 2022: Parvovirus/EBV/CMV/HHV6, coxsackie/antiDNA, C1q - negative, June 2022: Cardiac MRI: No perfusion defect at LV myocardium, on cine imagines, there is no regional wall motion abnormality at LV myocardium, normal LV systolic function with LV enlargement. On delayed phase, there is focal subtle subepicardial LGE at segment 7,8,12 of LV myocardium. Recc clinical correlation.|
|CUR_ILL:||None, last vaccine over 6 months prior|