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.
dark blood clot coming out of his penis; Gross Hematuria; dark urine; Redness arm; Sore Arm; Swelling arm; A spontaneous report was received from a healthcare professional who was also a 72-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness arm/ vaccination site erythema, sore arm/ vaccination site pain, swelling arm/ vaccination site swelling, gross hematuria/ hematuria, dark blood clot coming out of his penis/ hemorrhage urinary tract, and dark urine/ chromaturia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced the events redness, sore arm and swelling. On 20 Jan 2021, the patient experienced the events gross hematuria, with dark blood clot coming out of his penis. The patient had urine analysis (no results provided), and was still urinating dark urine. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of the events, vaccination site erythema, vaccination site pain, and vaccination site swelling, were considered recovered on an unspecified date. The outcomes of the events, hematuria, hemorrhage urinary tract, and chromaturia, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
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|COVID19 (COVID19 (MODERNA))||1||COVID19||MODERNA||013L20A||OT||Unknown|
|HISTORY:||Medical History/Concurrent Conditions: No adverse event (No reported medical history.)|