Source: VAERS.HHS.GOV
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.
Hemorrhage; Bleeding from penis; This is a spontaneous report from a contactable nurse (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: TJ4X3FYW), via an unspecified route of administration on 26May2021 at 12:45 (also reported as 00:30) (at the age of 64-years-old) at 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated at a hospital and experienced hemorrhage and bleeding from penis on 26May2021 at 18:30. The outcome of the events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event "hemorrhage and bleeding from penis" with BNT162b2 can not be completely exclude. 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.)
Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | TJ4X3FYW | Unknown | Unknown |
RECVDATE: | 06-12-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | U |
LAB_DATA: | |
V_ADMINBY: | OTH |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | ZAPFIZER INC2021619377 |
FORM_VERS: | |
TODAYS_DATE: | 06-11-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.