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:
Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause.
Reports may include incomplete, inaccurate, coincidental and unverified information.
The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.
VAERS data is limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available.
VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information.
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.
had a reaction and is hospitalized in serious condition / the patient had died; This is a spontaneous report from a contactable consumer received through COVAES portal (firstly by logistic colleague). A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date (age at the vaccination: 17-years-old) as DOSE 1, SINGLE for covid-19 immunisation. At the time of vaccination, pregnancy was reported as unknown. Medical history included raynaud's phenomenon from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Other vaccine in four weeks was reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. The reporter reported an adverse event that occurred in the school where she worked, a student took the 1st dose of the pfizer vaccine and she had a reaction and was hospitalized in serious condition in the hospital. The reporter informed that the patient had died on an unspecified date for an unspecified reason. Treatment AE was reported as unknown. It was unknown if any autopsy was performed.; Reported Cause(s) of Death: had a reaction and is hospitalized in serious condition / the patient had died
Symptoms
Death
Vaccines
VAX DATE:|ONSET DATE: |DAYS TO ONSET:
Vaccine Type
Manufacturer
Vaccine Name
Dose
Route
Site
Lot
COVID19
PFIZERBIONTECH
COVID19 (COVID19 (PFIZER-BIONTECH))
1
unknown
RECVDATE:
09 September 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
Medical History/Concurrent Conditions: Raynaud's syndrome
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.