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.
unknown cause of death; This is a spontaneous report received from healthcare professional via Health Authority. A 85-year-old female patient received the second dose of bnt162b2 (BNT162B2; batch/lot number: EK4240), at unknown vaccination age via an unspecified route of administration on an unspecified date (reported time range of 1 day) as a single dose for covid-19 immunisation. Medical history included asthma, diabetes, lipids in the blood (lipids abnormal), osteoporosis, Hashimoto, ischemic heart disease (IHD), and orthopedic procedure in the days before recipient of the vaccine. It was unknown if the patient was pregnant at the time of vaccination. The patient received the first dose of bnt162b2 (BNT162B2; unknown lot number and expiration date), at unknown vaccination age via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced a circumstance of unknown cause of death on an unspecified date. The outcome of the event was fatal. This case is a report for deaths in the vicinity of receiving a vaccine against Corona. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Sender's Comments: A reasonable possibility that the event unknown cause of death is related to vaccination with BNT162B2 cannot be completely excluded until further information regarding clinical course and death cause is provided. Underlying comorbidities in this elderly patient may be contributory. 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: Unknown cause of death
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EK4240 |
| RECVDATE: | 04-02-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Asthma; Diabetes; Hashimoto's disease; Ischemic heart disease; Lipids abnormal; Orthopedic procedure (In the days before recipient of the vaccine); Osteoporosis |
| PRIOR_VAX: | |
| SPLTTYPE: | ILPFIZER INC2021330288 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-30-2021 |
| 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.