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.
Approximately 2 weeks post vaccination developed rapid AF, CHF. Admitted to Medical Center. Discharged home on hospice. Patient died at home on 2/13/2021. Reported to this reporter at second dose clinic on 2/16/21. Other details not known. Unknown if related to vaccine.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EN 5318 | IM | LA |
| RECVDATE: | 02-16-2021 | RPT_DATE: |
| CAGE_YR: | 82 |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 02-13-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 10 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Primary diagnosis of systolic CHF, mitral valve regurgitation, renal failure with tubular necrosis, abnormal liver function tests, elevated troponin, anemia, thrombocytopenia, atrial fibrillation/flutter, essential hypertension, CAD, dyslipidemia. Work-up with TCU admission. Discharged home on hospice. |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | Symbicort inhaler 2 puffs BID Cardura 8 mg PO daily Oxygen at night |
| CUR_ILL: | OSA started on oxygen at night Dysphagia - work up |
| HISTORY: | Sleep apnea Joint inflammation Hypoxia Past history of MI Hyperlipidemia Back pain Alcohol abuse Hearing loss Nodular hyperplasia of the prostate Asthma TIA Atrial fibrillation, new onset |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 02-16-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | None Known |
| V_FUNDBY: |
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