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 an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 04/05/2021, 04/26/2021, and 12/02/2021. They presented to hospital on 06/24/2022 with a strangulated ventral hernia and a small bowel obstruction. They were admitted same day. They experienced further complications of an anastomotic leak. They were transferred to a different hospital on 07/12/2022 for nursing care after their health continued to deteriorate. They transitioned to comfort care only. They tested positive for COVID-19 on 07/14/2022 and died on 07/15/2022. It is not well understood if the individual experienced COVID-19 symptoms since this was a medically complex situation and the individual had several underlying medical conditions.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EW0150 | SYR | LA |
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EW0169 | SYR | LA |
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | 32030bd | SYR | LA |
| RECVDATE: | 09-23-2022 | RPT_DATE: |
| CAGE_YR: | 66 |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 07-15-2022 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 22 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Chronic Kidney Disease, Osteoarthritis, Morbid Obesity with past gastric bypass; Hypothyroid (past thyroidectomy for non-follicular thyroid neoplasm), Hypertension, Likely Renal Cell Carcinoma (further work up not done); Lung Mass/nodule (further work up not done) At the time of the adverse event, they were experiencing complications related to a strangulated ventral hernia and a small bowel obstruction. |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 09-23-2022 |
| 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.