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.
Death unexplained; tired; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-LY20210170. A 92-years-old female patient received her first dose bnt162b2 (COMIRNATY), lot number: EM0477, intramuscular on 15Jan2021 at single dose for covid-19 immunisation. Medical history included basedow's disease from an unknown date and unknown if ongoing. Usual treatment was L Throxine. The patient's concomitant medications were not reported. On 15Jan2021, the patient received a first dose of bnt162b2 vaccine, her neighbors saw her in the evening and she reported being tired. On 17Jan2021 the neighbors heard a falling noise and found the deceased patient. The patient died unexplained on 17Jan2021. The outcome of event tired was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained
Symptoms
Death, Fatigue
Vaccines
VAX DATE: 14 January 2021 |ONSET DATE: 14 January 2021 |DAYS TO ONSET: 0
Vaccine Type
Manufacturer
Vaccine Name
Dose
Route
Site
Lot
COVID19
PFIZERBIONTECH
COVID19 (COVID19 (PFIZER-BIONTECH))
1
OT
EM 0477
RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
16 January 2021
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
Medical History/Concurrent Conditions: Basedow's disease
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.