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.
Loss of consciousness; abdominal pain; stools watery; penis injury; Vasovagal reflex; This is a spontaneous report from a contactable other HCP Regulatory authority. Regulatory authority report number is v21121598. The patient was a 31-year 9-month-old male. Body temperature before vaccination was 36.4 centigrade. On 08Apr2021 at 14:00 at age of 31-year-old, the patient received the second dose of bnt162b2 (COMIRNATY, Lot# ER2659, Expiration date 31Jun2021) via an unspecified route of administration as single dose for COVID-19 immunization. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc). Concomitant medication was not reported. On 09Apr2021 at 00:00AM.(the date after the vaccination), the patient experienced Vasovagal reflex. The course of the event was as follows: On 08Apr2021, the patient received the 2nd dose of the vaccine. On 09Apr2021 at about 0:00, the patient experienced abdominal pain and stools watery. After that the patient lost consciousness. When the patient noticed, the patient lay in a bathroom. At that time, the patient suffered penis injury. The patient visited the emergency outpatient service. The injured site was protected from being dried with petroleum jelly. On the next day, the patient visited and was put 8 stiches in the injured site. On 09Apr2021 (the day after the vaccination), the outcome of events were recovering. The reporter classified the events as non-serious and assessed that the event was the causality between the event and bnt162b2 as unassessble. There was no other possible cause of the event such as any other diseases.
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))||2||COVID19||PFIZER\BIONTECH||ER2659||Unknown||Unknown|
|LAB_DATA:||Test Date: 20210408; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None|
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