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.
Left sided weakness of face, arm and left leg, onset 15 minutes after receiving vaccination Brought immediately to ED, subjective feeling of closing of throat. Given IM epinephrine 0.3mg x 1. Upon evaluation in the ED by tele-neurology consult, she received 88.5mg of alteplase on 12/20/20 at 1721 She was admitted to the Intensive Care Unit on 12/20/20 at 2208 Seen by neurology on 12/21/20 at 1227. Evaluation showed weakness on the left side but is noted that it could be effort-related. Neurologist noted that patient was treated with alteplase; CT angiogram showed no significant blockage or stenosis. Noted that this is could be related to a vasovagal effect, psychogenic or an acute ischemic stroke. As of 12/21/20 at 1615, attending provider noted left-sided paresthesia, left-sided tics and possible transient ischemic attack
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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 | EJ1685 | IM | LA |
| RECVDATE: | 12-21-2020 | RPT_DATE: |
| CAGE_YR: | 44 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 1 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | 12/20/20 at 1620 Blood glucose = 73 mg/dl 12/20/20 at 1620 White Blood Cells = 10.72 thousand/mm3 12/20/20 at 1758 Urinalysis: negative for infection 12/20/20 at 1758 Urine Toxicology: positive for amphetamine-methamphetamine 12/20/20 at 1636 CT of Head without contrast: negative for bleed 12/20/20 at 2018 CT Angiography of Head and Neck: no significant blockage or stenosis 12/21/20 at 1316 MRI of Brain without contrast: normal evaluation; without any evidence of acute ischemic stroke |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | Nexplanon birth control implant |
| CUR_ILL: | |
| HISTORY: | Thalassemia minor |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 12-21-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Egg-containing compound Latex Penicillins |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.