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 is a 9yo adopted male without significant past medical history. His two adoptive mother's are now separated and he spends time between both homes. Patient had suspected COVID 19 infection in November 2020 (not lab confirmed but symptomatic). He has not had clinically apparent COVID 19 infection in 2021 to mother's knowledge, but did have exposure to neighbor with symptoms consistent with COVID 19 (though their testing was reportedly negative) around the end of November 2021. Patient was vaccinated with his first dose of Pfizer-BioNTech COVID-19 vaccine on 12/17/21. Starting 12/20/21 he began to experience lethargy, abdominal pain, some emesis, diarrhea, subjective fever (no temp taken), malaise, decreased oral intake. He was under care at one parent's home. He was seen by PCP who recommended supportive care measure for suspected viral illness. On 12/24 he returned to the care of his other parent's home. He was then taken to the hospital for evaluation and found to have work up consistent with MIS-C.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||24 December 2021|
|LAB_DATA:||WBC 15.3; hgb 8.8; platelet 270, 78% neutrophils 14.7% lymphocytes; NA 127, K 3.3, Cl 92, CO2 22, BUN 15, Cr 0.7, Glucose 126, Ca 8.5, Tpro 5.7, Albumin 3.3, total Bili 0.6 (direct 0.2), AST 44, ALT 25, AlkPhos 92 BNP: 1163, Hs Toponin 194.34 (normal <45), Ferritin 971, CRP 164 mg/L, Procal 7.74 ng/mL; Fibrinogen 542 (normal <400); Echocardiogram with mild left ventricular dysfunction|
|CUR_ILL:||Suspected COVID exposure end of November|
|TODAYS_DATE:||24 December 2021|