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.
heart pain; cardiac and respiratory arrest; cardiac and respiratory arrest; This is a spontaneous report from a contactable consumer or other non hcp received via regulatory authority. This consumer reported different fatal events for four patients. This is the first of four reports. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4175) via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunisation. Medical history included Nursing background, cardiac, intended for valve replacement surgery, diabetes mellitus (DM). The patient's concomitant medications were not reported. The patient was vaccinated on 03Jan2021 with the first dose. From the moment of the vaccine he complained about heart pain. Cardiopulmonary resuscitation (CPR) was performed by the persons on call without an electric shock, emergency services arrived after 5 minutes, resuscitation continued asystole on the monitor, received 4 doses of adrenaline IV, respiration through mask and ambu. After 20 minutes of resuscitation pupils do not respond to light, without heart sounds. The patient died from cardiac and respiratory arrest in Jan2021. It was not reported if an autopsy was performed. The outcome of event heart pain was unknown.; Sender's Comments: Linked Report(s) : IL-PFIZER INC-2021019632 Same reporter, same product, different patient/events.;IL-PFIZER INC-2021019633 Same reporter, same product, different patient/events.;IL-PFIZER INC-2021019634 Same reporter, same product, different patient/events.; Reported Cause(s) of Death: cardiac and respiratory arrest; cardiac and respiratory arrest
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.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EK4175 |
| RECVDATE: | 01-13-2021 | 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 Name: monitor; Result Unstructured Data: Test Result:asystole; Test Name: heart sounds; Result Unstructured Data: Test Result:without heart sounds; Test Name: pupils; Result Unstructured Data: Test Result:pupils do not respond to light |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Cardiac disorder (intended for valve replacement surgery); Diabetes mellitus; Mobility decreased |
| PRIOR_VAX: | |
| SPLTTYPE: | ILPFIZER INC2021019507 |
| FORM_VERS: | |
| TODAYS_DATE: | 01-13-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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