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.
12/30/2020 around 2:00 nausea, vomitting, diarrhea, and chills started. Insomnia x3 days. Patient states she felt "wired and worked up". Noises made her anxious. Patient states "everything smelled bad". Patient had hallucinations seeing the devil and satanic thoughts 12/31/2020 to 1/4/2021 when patient finally fell asleep. 1/5/21 patient woke up with a headache and took ibuprofen and used a heating pad with relief. Patient took melatonin 1/5/21 before bed to go to sleep. Diarrhea stopped 12/31/20. Nausea stopped 1/5/21.Vomitting stopped 12/31/2020. Chills stopped 1/5/21. Patient has been eating bananas and chicken noodle soup and drinking sweet tea. Patient not as nervous 1/6/21 when she woke up.
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|COVID19 (COVID19 (MODERNA))||1||COVID19||MODERNA||025L20A||IM||LA|
|LAB_DATA:||Urine and bloodwork done at emergency room on 1/4/21. Patient unsure of what tests were ran.|
|OTHER_MEDS:||Theophylline, Acyclovir, Gabapentin, Sertraline HCL, Lorazepam, Azithromycin, Famotidine , Zinc, Vitamin C|
|HISTORY:||Legally blind, lung cancer in remission in 5 years, colon cancer in remission for 4 years, diverticulosis, COPD, emphysema|