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.
Vaccination received on 10/21/21. On 10/24 resident developed sudden change in mental status with hypertensive crisis requiring transfer to the Emergency Department.
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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.)
|COVID19 (COVID19 (PFIZER-BIONTECH))||3||COVID19||PFIZER\BIONTECH||fh8027||IM||LA|
|LAB_DATA:||Ct Scan revealed Vascular malformation in the central pons with acute hemorrhage.|
|OTHER_MEDS:||tylenol 650 mg PRN Artificial tears prn bid Bengay patch PRN to back and neck bisacodyl 10 mg prn vit d3 50,000 units q monday depakote 250 qhs depakote 125 mg qam finasteride 5 mg q daily fluoromethalone eye drops 0.1 % qhs Hydroxyzine 2|
|CUR_ILL:||no acute illnes at this time.|
|HISTORY:||Adjustment disorder with mixed anxiety and depressed mood F43.23 10/14/2020 Active ICD-10 Other specified depressive episodes F32.89 10/12/2020 Active ICD-10 Unspecified fracture of left femur, subsequent encounter for closed fracture with routine healing S72.92XD 05/04/2020 Active ICD-10 Other spondylosis with radiculopathy, cervical region M47.22 05/04/2020 Active ICD-10 Postpolio syndrome G14 05/04/2020 Active ICD-10 Unspecified fall, subsequent encounter W19.XXXD 05/04/2020 Active ICD-10 Difficulty in walking, not elsewhere classified R26.2 05/04/2020 Active ICD-10 Muscle weakness (generalized) M62.81 05/04/2020 Active ICD-10 Generalized anxiety disorder F41.1 05/04/2020 Active ICD-10 Lactose intolerance, unspecified E73.9 05/04/2020 Active ICD-10 Mixed irritable bowel syndrome K58.2 05/04/2020 Active ICD-10 Benign prostatic hyperplasia without lower urinary tract symptoms N40.0 05/04/2020 Active ICD-10 Mild cognitive impairment, so stated|