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.
15 Min post pediatric Pfizer vaccination, patient had a hive reaction on her face and hands and reported her ?throat was itchy?. RN administered 25mg IM Benadryl. 911 was called while VS were taken. BP 104/80 HR 83 Regular, SpO2 100%, RR 16. No breathing difficulties noted. Patient was observed and stated she stated felt a lot better . EMS arrived. Report and care of patient transferred to EMS. EMS recommended patient should go to the ER, however Mother refused and stated she would prefer to take her daughter to doctor.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||15 November 2021|
|LAB_DATA:||VS taken prior to EMS arrival|
|TODAYS_DATE:||15 November 2021|
|ALLERGIES:||None Mom reported|