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.
PT woke up on April 1, 2021 not feeling well. Went to work that afternoon. Around 3:30 pm while working PT fainted. Upon waking she had a neurological response and the left side of her body (the opposite side of her vaccine injection) was shaking uncontrollably and she could barely walk. She was taken to ER and given an IV. She was given Toradol and Ativan to relieve symptoms. The final diagnosis was an Adverse Effect of the Covid 19 vaccine. She was sent home and the uncontrollable shaking lasted 2-3 days. PT still has tremors in her right arm when at rest, holding something and even more noticeable after exertion.
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(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 | ER2613 | SYR | LA |
| RECVDATE: | 10-08-2021 | RPT_DATE: |
| CAGE_YR: | 17 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | Y |
| RECOVD: | N |
| LAB_DATA: | Medical tests and medications given on April 1, 2021 XR CHEST 1 VIEW SARS-COV-2 (COVID-19), INFLUENZA A + B, MULTIPLEX NAA Ketorolac Inj 30 mg (TORADOL) LORazepam Inj 1 mg (ATIVAN) PT is a 17 year old female who is otherwise healthy is presenting for tremors after COVID vaccine. Vitals significant for almost a fever 99.1. On exam, she is awake and oriented but she is shaking. Does not appear to be seizure and just appears to be chills and tremors. Chest x-ray is clear. COVID swabbed her. Given supportive care including Toradol and Ativan and feels better. No tremors on reassessment. Likely side effect of the vaccine. Discharged home with off work order tomorrow. |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | nonw |
| CUR_ILL: | nonw |
| HISTORY: | none |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-08-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | nonw |
| V_FUNDBY: |
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