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.
Feeling dizzy upon getting up from bed; Daily frontal headaches; Eye twitching; This is a spontaneous report from a contactable reporter (Physician). A 11-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 at 10:15 (Lot number: FK5127) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication included: FLUZONE taken for Immunization, start date: 23Nov2021, stop date: 23Nov2021. The following information was reported: DIZZINESS (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Feeling dizzy upon getting up from bed"; HEADACHE (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Daily frontal headaches"; MUSCLE TWITCHING (non-serious) with onset 04Dec2021 at 08:00, outcome "not recovered", described as "Eye twitching". The events "Feeling dizzy upon getting up from bed", "Daily frontal headaches" and "Eye twitching" were evaluated at the emergency room visit and physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The known allergies was not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. After 24 hours of vaccination, patient started feeling dizzy upon getting up from bed and has daily frontal headaches with eye twitching. Since the vaccination, the patient had been tested for COVID-19.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||15 December 2021|
|LAB_DATA:||Test Date: 20211210; Test Name: Bionix Rapid Covid; Test Result: Negative ; Comments: Nasal Swab|
|HISTORY:||Medical History/Concurrent Conditions: Obesity|
|TODAYS_DATE:||14 December 2021|