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.
Patient reported symptomatic (non-severe) case of COVID-19 August 2021 and recovered fully. She reported receiving Pfizer COVID vaccine 9/3/21 and second dose 9/15/21. She present to the emergency department of my hospital 10/23/21 with chest pain and dyspnea for 48h. Was feeling completely well prior to onset of chest discomfort. Symptoms were mild. No sick contacts or family members. ED evaluation remarkable for normal exam, no hypoxia, normal blood pressure. EKG with diffuse ST elevation. Troponin elevated at 20. CTA chest negative for PE or pneumonia. SARS-CoV-PCR positive but thought to be persistent positive rather than reinfection because of lack of clinical symptoms, recent COVID-19 and recent vaccination. Cardiologist consulted, thought acute coronary syndrome unlikely based on age and lack of risk factors. STAT Echo resulted depressed EF 40-45%. Simultaneously she had become increasingly tachycardic and EKG appeared more ischemic. Cardiac cath lab was activated and she was about to be transported when she suffered cardiac arrest. Initial rhythm was VT. Received ACLS protocol CPR x 65 minutes including multiple cardioversion, amiodarone, lidocaine, magnesium and other antiarrhythmics. Unfortunately she was not able to be resuscitated and died. Cause of death possible acute myocarditis.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||28 October 2021|
|DATEDIED:||22 October 2021|
|LAB_DATA:||See above. CBC, BMP. Troponin elevated at 20. CRP significantly elevated. CTA chest negative for PE. EKG with ST elevations. Echocardiogram with depressed EF 40-45%. SARS-CoV-2 positive.|
|CUR_ILL:||COVID-19 August 2021|
|TODAYS_DATE:||28 October 2021|