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.
paralysis in both legs; extreme difficulty walking; horrible body aches; This is a spontaneous report from a contactable consumer (the patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0151), via an unspecified route of administration on 05Apr2021 at 10:30 as a single dose in the left arm for COVID-19 immunization. The patient's medical history was not reported. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6208) on 15Mar2021 at 09:30. There were no concomitant medications. Twelve hours after the vaccination the patient began to experience "symptoms;" she had horrible body aches. By 08Apr2021 she had extreme difficulty walking and went to a hospital. She experienced paralysis in both legs on 08Apr2021 with outcome of not recovered, extreme difficulty walking on 08Apr2021 with outcome of not recovered. The patient was hospitalized for paralysis of both legs and extreme difficulty walking. The patient also experienced horrible body aches on 05Apr2021 with outcome of recovered. The events required an Emergency Room visit and a Physician office visit. The patient was hospitalized for extreme difficulty walking from 08Apr2021 to 10Apr2021 and she was again hospitalized on 12Apr2021 to 15Apr2021. The patient underwent lab tests and procedures which included lumbar puncture on 14Apr2021 which revealed that she does not have Guillain-Barre.
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)) | 2 | COVID19 | PFIZER\BIONTECH | EW0151 | LA |
| RECVDATE: | 05-07-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 3 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210414; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:does not have Guillain-Barre |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2021445402 |
| FORM_VERS: | |
| TODAYS_DATE: | 05-05-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| 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.