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.
bleeding from the penis; This is a spontaneous report from a contactable Nurse. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0142, via an unspecified route of administration in left arm on 05Jan2021 at single dose for covid-19 immunisation. Medical history included fracture displacement on 23Dec2020, atrial fibrillation, non-hodgkin's lymphoma, post surgical ortho care, semen bleeding, from an unknown date and unknown if ongoing, Covid positive on 06Nov2020 (he was Covid positive before and didn't want to get it again and give it to his wife). There were no concomitant medications. The patient underwent lab tests and procedures which included Covid test positive on 06Nov2020. The patient experienced bleeding from the penis on an unspecified date with outcome of unknown. Nurse wanted to know if there is information about interactions between blood thinners and the vaccine.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event penile haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Of note, semen bleeding was reported as medical history and no concomitant medications were reported; hence, the role of other possible medical conditions or medications cannot be ruled out. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||EL0142||Unknown||LA|
|LAB_DATA:||Test Date: 20201106; Test Name: Covid-19; Test Result: Positive|
|HISTORY:||Medical History/Concurrent Conditions: Atrial fibrillation; Bloody semen; COVID-19 virus test positive; Fracture displacement; Hypertension; Non-Hodgkin's lymphoma; Orthosis user (post surgical ortho care)|
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