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; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB. This is a report received from the Regulatory Authority. Regulatory authority report number was FR-AFSSAPS-RN20210174. A 93-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EM0477), intramuscular in the left arm on 13Jan2021 as a single dose for COVID-19 vaccination. Medical history included ongoing nursing home resident and cutaneous ulcer in Jan2021 (biology performed on 15Jan2021 was normal). The patient's medical history and concomitant medications were not reported. On 18Jan2021, the patient presented with a fever without a starting point of clinical infection, apart from a cutaneous ulcer treated at the beginning of Jan2021 without sign of recurrence. On 19Jan2021, the patient died, and the cause was unexplained. The clinicians did not hypothesize the causes of death. It was not reported if an autopsy was performed. The clinical outcome of the fever was not recovered at the time of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained
Symptoms
Death, Pyrexia
Vaccines
VAX DATE: 12 January 2021 |ONSET DATE: 17 January 2021 |DAYS TO ONSET: 5
Vaccine Type
Manufacturer
Vaccine Name
Dose
Route
Site
Lot
COVID19
PFIZERBIONTECH
COVID19 (COVID19 (PFIZER-BIONTECH))
1
OT
LA
EM0477
RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
18 January 2021
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
Test Date: 20210115; Test Name: biology; Result Unstructured Data: Test Result:normal
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
Living in nursing home
HISTORY:
Medical History/Concurrent Conditions: Ulcer skin (Biology normal on 15Jan20201)
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.