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.
This is a spontaneous report from a contactable consumer. This consumer reported different fatal events for four patients. This is the second of four reports. An 82-year-old female patient in a nursing home received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4238) via an unspecified route of administration on 04-Jan-2021 at a single dose for COVID-19 immunisation. Medical history included background of asthma, dementia, depression, gastrointestinal and heart failure. Concomitant medications were not reported. 4 Hours after the receipt of the vaccine, she was found in her room on the floor with a bruise on her forehead apparently from a fall, CPR was performed by nursing home staff. Staff performed CPR, asystole without heart sounds, CPR continued for 23 minutes without any change and death was declared. The events occurred in Jan 2021. The date of death was in Jan 2021. The outcome of events was fatal. It was unknown if an autopsy was performed. Sender's Comments: Linked Report(s): IL-PFIZER INC-2021019507 Same reporter, same product, different patient/events; Reported Cause(s) of Death: was found in her room on the floor with a bruise on her forehead apparently from a fall; was found in her room on the floor with a bruise on her forehead apparently from a fall.
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(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 | EK4238 |
| RECVDATE: | 01-14-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 01-01-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 202101; Test Name: heart sounds; Result Unstructured Data: Test Result:asystole without heart sounds |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Asthma; Dementia; Depression; Gastrointestinal disorder; Heart failure; Living in nursing home |
| PRIOR_VAX: | |
| SPLTTYPE: | ILPFIZER INC2021019632 |
| FORM_VERS: | |
| TODAYS_DATE: | 01-14-2021 |
| 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.