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 is a 61 y.o. male with history of hypospadias/epispadias who presents to the emergency department for evaluation of urinary issues. A few days ago the patient noticed burning pain in his penis with urination and some residual pain, urinary frequency, and difficulty holding in his urine. The symptoms came on subtly, but have progressively worsened. He urinated 2 times at night last night, which was very unusual. He called a doctor and was told to come in. No hematuria, cloudy urine, fever, chest pain, scrotal pain, penile drainage, nausea, vomiting, constipation, diarrhea, abdominal pain, flank pain, or rectal pain. He denies dietary or lifestyle changes. He is married and not concerned for sexually transmitted infection. As well, the patient has had 4-5 days of sore throat and cough, and was put on a z-pack by his telemedicine doctor 3 days ago. He has taken 2 days of that. He notes he initially had flu-type symptoms, but they have resolved. He has a COVID test scheduled for tomorrow. He has been vaccinated with the Johnson & Johnson COVID-19 vaccine. He had a physical exam 2 months ago, and he reports he had a normal prostate and PSA. He has no history of UTI.
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
|COVID19 (COVID19 (JANSSEN))||Unknown||COVID19||JANSSEN||Unknown||Unknown|
|LAB_DATA:||Positive for SARS-CoV-2 RNA by PCR Abnormal E Gene Ct cycles 18.4 Comment: Cycle threshold (Ct) values are not comparable between tests and may not be comparable between different lots of the same test. Currently there is no consensus as to whether or not particular Ct values correlate with a person being or not being infectious or risk level for disease severity. So, appropriate care should be taken with interpretation of Ct values. N2 Gene Ct cycles 20.6 Comment: Cycle threshold (Ct) values are not comparable between tests and may not be comparable between different lots of the same test. Currently there is no consensus as to whether or not particular Ct values correlate with a person being or not being infectious or risk level for disease severity. So, appropriate care should be taken with interpretation of Ct values. Resulting Agency MGHL Specimen Collected: 08/13/21 23:37 Last Resulted: 08/14/21 00:19|
|HISTORY:||Allergic rhinitis, cause unspecified Biliary stricture Common bile duct stone GERD Heartburn Hypospadias and epispadias and other penile anomalies Lumbago Mixed hyperlipidemia Motion sickness PONV Pruritus ani Chronic back pain|
|ALLERGIES:||The patient denies any known medication allergies.|
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