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.
presumed cardiac failure; This is a spontaneous report from a contactable nurse. An 89-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm left on 10Feb2021 (at the age of 89 years) at single dose for COVID-19 immunization. The patient medical history included congestive heart failure, coronary artery disease, hypertension, hyperlipidemia, osteoarthritis, presence of prosthetic heart valve and allergies, all from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine besilate/benazepril hydrochloride, amlodipine, acetylsalicylic acid (ASPIRIN E.C.), atorvastatin, benazepril, carvedilol, ubidecarenone (COQ10), furosemide, acetaminophen and potassium chloride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient experienced presumed cardiac failure on 12Feb2021 at 03:30 with fatal outcome. The patient died on 12Feb2021. An autopsy was not performed.; Sender's Comments: Based on the current available information, the event Cardiac failure is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The patient medical history of congestive heart failure, coronary artery disease, hypertension, and hyperlipidemia provide plausible explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: presumed cardiac failure
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EL9261 | OT | LA |
| RECVDATE: | 02-23-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 02-12-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | SEN |
| OTHER_MEDS: | AMLODIPINE BENAZEPRIL; AMLODIPINE; ASPIRIN (E.C.); ATORVASTATIN; BENAZEPRIL; CARVEDILOL; COQ10 [UBIDECARENONE]; FUROSEMIDE; ACETAMINOPHEN; POTASSIUM CHLORIDE |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Allergy; Congestive heart failure; Coronary artery disease; Hyperlipidemia; Hypertension; Osteoarthritis; Prosthetic cardiac valve malfunction |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2021170473 |
| FORM_VERS: | |
| TODAYS_DATE: | 02-22-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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