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.
TESTICLES SWELLED UP; ERECTILE DYSFUNCTION/PENIS WOULDN'T GET HARD; This spontaneous report received from a patient concerned a 44 year. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total, administered on beginning of AUG-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, approximately 7 days later the vaccination, the patient experienced testicular swelling and went to the emergency room and was admitted to the hospital (dates unspecified). The patient also consulted with urologist, but could not provide further information. The patient was hospitalized for 7 days (date of discharge was not reported). The testicles were swollen for approximately 3 weeks. On an unspecified date, the patient also experienced erectile dysfunction. The patient experienced that his penis was not getting hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from testicles swelled up, and had not recovered from erectile dysfunction/penis wouldn't get hard. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210931764-COVID-19 VACCINE AD26.COV2.S- erectile dysfunction/penis wouldn't get hard, testicles swelled up. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
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(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))||0||COVID19||JANSSEN||Unknown||Unknown|
|CUR_ILL:||Blood pressure high|
|HISTORY:||Comments: The patient had no known allergies.|