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.
Dosing error (pediatric use); A spontaneous report was received from a healthcare professional concerning a 17 year old patient who received first dose of Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Product administered to patient of inappropriate age. The patient's medical history, was not provided. Concomitant product use was not provided by the reporter. On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event Product administered to patient of inappropriate age. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, Product administered to patient of inappropriate age, was considered resolved.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 023M20A) with no associated AEs.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||14 August 2021|
|HISTORY:||Medical History/Concurrent Conditions: No adverse event (No adverse event reported.)|
|TODAYS_DATE:||11 August 2021|