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.
Extreme hemorrhaging from penis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Extreme hemorrhaging from penis) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Prostate cancer, Macular degeneration and Kidney failure. Concomitant products included RIVAROXABAN (XARELTO), BICALUTAMIDE, METOPROLOL SUCCINATE, DUTASTERIDE, ALOPURINOL, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION AREDS) and hormone injection for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HAEMATURIA (Extreme hemorrhaging from penis). At the time of the report, HAEMATURIA (Extreme hemorrhaging from penis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count:. On an unknown date, Urine analysis normal:. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
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 (MODERNA))||1||COVID19||MODERNA||007M20A||Unknown||RA|
|LAB_DATA:||Test Date: 2021; Test Name: Platelet count; Result Unstructured Data: Normal; Test Date: 2021; Test Name: Urine test; Result Unstructured Data: Normal|
|OTHER_MEDS:||XARELTO; BICALUTAMIDE; METOPROLOL SUCCINATE; DUTASTERIDE; ALOPURINOL; PRESERVISION AREDS; hormone injection|
|HISTORY:||Medical History/Concurrent Conditions: Kidney failure; Macular degeneration; Prostate cancer|