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.
Vaccine administering error: At our COVID vaccination clinic, patient was accidentally given Moderna COVID vaccine (18 and up) 0.3 ml instead of 0.25ml as the 2nd COVID vaccine booster. Patient was contacted the same day and notified this vaccine administering error. Then patient was contacted again the next day to follow up. Patient did not have any other signs or symptoms except pain in the injection site.
|COVID19 (COVID19 (MODERNA))||4||COVID19||MODERNA||056M21A||IM||LA|
|OTHER_MEDS:||04/05/2022 ASPIRIN EC 81 mg 90 TAKE 1 TABLET BY MOUTH ONCE DAILY. 04/05/2022 HYDROCHLOROTHIAZIDE 12.5 mg 90 TAKE 1 CAPSULE BY MOUTH ONCE DAILY. 04/05/2022 GLIPIZIDE ER 5 mg 90 Take 1 tablet by mouth every day with breakfast 01/11/2022 NATUR|
|HISTORY:||Benign essential hypertension Hyperlipidemia History of cerebrovascular accident with residual deficit CKD stage G3a/A2, GFR 45-59 and albumin creatinine ratio 30-299 mg/g Left-sided weakness Type 2 diabetes mellitus without complication Vitamin D deficiency Depression, unspecified depression type Adjustment disorder with depressed mood Benign prostatic hyperplasia Hemiparesis Minimal cognitive impairment|
|ALLERGIES:||No Known Allergies.|