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.
Dose 1 given on 5/28/21 and dose 2 given on 6/22/2021. By report the patient developed weakness which progressed to ataxia over the ensuing 3 months. This was also associated with tinnitus. He was noted about 2 months after his second dose to have progression of symptoms with abnormal neurologic exam which prompted inpatient admission. MRI brain showed multifocal hemorrhagic lesions in the cerebral white matter, brainstem and cerebellum with greatest involvement in the left pons. Multifocal short segment enhancing lesions throughout the spinal cord. Patient was admitted for diagnostic work up and initiated on steroids with some symptomatic improvement when on hospital day 10 he had an acute event thought to be a stroke. CTA showed new areas of brainstem intraparenchymal hemorrhage including the dorsal right pons and right-sided cerebellar peduncles.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | ew0191 | IM | UN |
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EW0196 | IM | UN |
| RECVDATE: | 10-08-2021 | RPT_DATE: |
| CAGE_YR: | 15 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | Y |
| RECOVD: | N |
| LAB_DATA: | MRI brain with and without contrast, MRI cervical/thoracic/lumbar spine (9/17/2021) MRA head without contrast (9/25/21) CT Chest/Abd/Pelvis (9/25/21) CTA Escape (9/26/21) CT Head without contrast (9/26/21) CT head low dose (9/29/21 and 10/1/21) CT Head without contrast (10/3/21) MRI Brain with and without contrast (10/6/2021) MRA head without contrast (10/7/21) MRI Thoracic/cervical spine (10/7/21) |
| V_ADMINBY: | |
| OTHER_MEDS: | None known |
| CUR_ILL: | No other illnesses reported |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-08-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | No known drug 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.