Source: VAERS.HHS.GOV
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.
01/13/2022 10-year-old male without significant past medical or surgical history presenting for evaluation of 6 days of fever, nausea/vomiting and decreased p.o. intake, diffuse abdominal pain, headache, fatigue, and migratory rash. Patient reportedly COVID-positive 12/6/2021, received initial COVID-vaccine in late November. Patient denying any chest pain, cough, or shortness of breath. Constellation of symptoms is concerning for Kawasaki versus MIS-C. Exam notable for diffuse rash with palmar involvement and early bullae/vesicles, straw berry tongue. There is no conjunctival injection, no perineal involvement. No focal neurologic deficits, diffuse abdominal tenderness without focality. Vital signs are stable hough notable for mild hypotension. Laboratory studies overall consistent with MISC (elevations in ESR/CRP, ferritin, etc. with elevations in troponin and BNP consistent with myocarditis. Electrolyte abnormalities including hyponatremia, hypokalemia, hypocalcemia consistent with inadequate oral intake and diarrhea. Hospital course: MIS-C associated with COVID-19, S/p CTX x2, negative blood cultures, S/p IVIG 1/14, Solumedrol 1/14-1/15, Transitioned to PO Prednisolone 1/16 Lovenox switched to ASA 1/1 Acute respiratory failure with hypoxia, Required HFNC on arrival to PICU, Stable on RA day of d/c. Myocarditis, LVEF 45-50% on 1/14 Discharge: Pt tolerating regular diet well. No N/V. Pt denies any pain. Rash to BLE and bilateral hands/arms improved. Follow up with PMD in one week, Rheumotology in one week, Cardiology in one month
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FL0007 | IM | RA |
| RECVDATE: | 05-11-2022 | RPT_DATE: |
| CAGE_YR: | 10 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 3 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | 1/13-sed rate 41, Ferritin: 358, Fibrinogen 469, D dimer: 2.27, B Type Natriuretic Peptide: 1407 1/14-PT 15.8, INR 1.3, D dimer 14.8, Potassium: 2.8, Troponin I: 0.32, EKG |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | UNKNOWN |
| CUR_ILL: | UNKNOWN |
| HISTORY: | NONE |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 05-11-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | NONE |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.