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.
Presented with acute chest pain, awakening him from sleep, elevated troponin, cardiac arrhythmia. CMRI confirms myocarditis. Treated with lidocaine for ventricular arrhythmia, IVIG given, noted to have HTN discharged home on lisinopril. Troponin I peak 14.3, last level 9/8 0.83.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EW0217 | IM | LA |
| RECVDATE: | 10-13-2021 | RPT_DATE: |
| CAGE_YR: | 15 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 6 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | Troponin I elevated peak 14.3 last level 0.83 8/3-9/8), CRP elevated last level 28.5 9/5, cardiac MRI 9/8/2021: 1.Normal biventricular size and systolic function. LV EF 56% and RV EF 54% with good internal agreement in cardiac output. 2. LV septum measures at upper limits of normal at 12 mm (normal adult wall thickness < 13 mm). 3. Evidence of active myocarditis by original Lake Louise criteria, including positive findings on T2WI, T1WI, and late gadolinium enhancement. 4. No evidence of other nonischemic cardiomyopathy or cardiac infiltrative process. Serial EKGs and telemetry reveal sinus bradycardia accelerated idioventricular rhythm, polymorphic ventricular ectopy, ventricular runs. |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | BMI 35 |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-13-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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