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.
About 3 hours after receiving the vaccine, he presented in cardiogenic shock with tachycardia and hypotension. He was found to have severe LV dysfunction and is currently on ECMO. I would like to stress that he did have symptoms preceding receiving the vaccine, but felt that given the clinical decompensation that it should be reported and investigated.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FK5618 | IM | LA |
| RECVDATE: | 11-11-2021 | RPT_DATE: |
| CAGE_YR: | 7 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Initial TTE - 11/10/21 Summary * Structurally normal heart. * Moderate tricuspid regurgitation. * Moderate mitral regurgitation. * Normal RV pressures based on TR jet velocity and septal contour. * Normal LV size and wall thickness though moderately depressed systolic function (mmode SF 26%, mmode EF 49%, 2D EF 42%, Bullet EF 42%). * Trivial pericardial effusion posteriorly, along RV free wall. Echo 11/11/21 - Summary * Patient with history of ECMO placement (November 10, 2021). Transesophageal echocardiogram to evaluate ECMO cannulae. * Globally qualitatively severely depressed biventricular systolic function. * Aortic cannula tip is in mid ascending aorta. * Trivial+ aortic insufficiency. * Moderate mitral valve regurgitation from central coaptation defect. * Venous cannula tip in the RA and IVC junction. 11/10/21 - SARS-CoV-2 antibodies negative; Respiratory panel negative; Lyme screen negative |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | Tylenol, motrin, zyrtec, zofran, miralax |
| CUR_ILL: | Yes, abdominal pain preceded the vaccination on 11/5 and diarrhea on 11/7. He had increased fatigue/lethargy prior to receiving the vaccine. |
| HISTORY: | none |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 11-11-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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