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.
7 AM 3/25/2021 - Patient called out to husband from the bathroom where she experienced a syncopal event, then passed out. An ambulance was called and she was revived for a short period of time. She was taken to Hospital where she coded 3 times. She was then life-flighted to second Hospital. According to the hospital records, tests conducted over the course of several days determined that she had no neurological activity. Initial reports in the records indicate pulmonary embolism, cardiac and respiratory arrest. She was on life support for the remainder of her time. Organ donation is being pursued at present and results of this are pending at time of this report submission. Date of death is unknown until organ retrieval is accomplished. Family will be contacted in the next few days to ask further questions about any other kinds of vaccine-related reactions that may have happened more immediately to days after the vaccination on 3/17/2021. A co-worker thought that she had shortness of breath for 3-4 days before this critical event occurred on 3/25/2021.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 045A21A | IM | LA |
| RECVDATE: | 03-31-2021 | RPT_DATE: |
| CAGE_YR: | 48 |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Events on 3/25/2021: -AP Chest X-Ray, CT angiography proved bilateral pulmonary emboli, TTE showed severely dilated right ventricle with reduced EF at 60-65%. Arterial line and IJ central line placed for pressor support. Intubated on a vent. -Labs collected on this date: D_Dimer elevated at 5000, Potassium at 2.7, elevated LFT's - AST = 439, ALT = 331. -Vasc doppler venous bilateral lower extremities showed no evidence of DVT in either leg. Venous flows in bilateral lower legs showed high pressure indicating right sided heart failure. -CT of head w/o contrast negative for intracranial hemorrhage, hydrocephalus, mass, or midline shift. Calvarium is intact. -MRI Brain w/o contrast negative for acute intracranial abnormalities. Event on 3/26/2021: EEG concerning for myoclonic seizures related to anoxic brain injury Event on 3/28/2021: MRI Brain w/o contrast showed new changes suggesting hypoxic/anoxic injury |
| V_ADMINBY: | PUB |
| OTHER_MEDS: | unknown at this time |
| CUR_ILL: | unknown at this time |
| HISTORY: | unknown at this time |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 03-31-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | unknown at this time |
| V_FUNDBY: |
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