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.
Mild swelling of lower left eyelid; 1. Pain at injection site (sore upper arm) - immediate onset; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0176), via an unspecified route of administration, in arm left on 03May2021 18:15 (age at vaccination 49 years) as dose 1, single for covid-19 immunisation. Medical history included allergy to latex, benadryl, wellbutrin. The patient did not have Covid prior vaccination. No other vaccine was taken in four weeks. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC); ibuprofen; colecalciferol (VIT D); melatonin since an unknown date. The patient experienced Pain at injection site (sore upper arm) - immediate onset on 03May2021 at 18:15 and mild swelling of lower left eyelid beginning approximately 3.5 hours after injection on 03May2021 at 21:45 and lasting about an hour. No treatment was taken for the events. The patient was not tested for Covid post vaccination. The outcome of the event pain at injection site was recovering and for mild swelling of lower left eyelid was recovered on 03May2021. No follow-up attempts are possible. No further information is expected.
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(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)) | 1 | COVID19 | PFIZER\BIONTECH | EW0176 | Unknown | LA |
RECVDATE: | 11-18-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | |
V_ADMINBY: | |
OTHER_MEDS: | ZYRTEC [CETIRIZINE HYDROCHLORIDE]; IBUPROFEN; VIT D [COLECALCIFEROL]; MELATONIN |
CUR_ILL: | |
HISTORY: | Medical History/Concurrent Conditions: Latex allergy (latex, benadryl, wellbutrin) |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC2021499362 |
FORM_VERS: | |
TODAYS_DATE: | 11-17-2021 |
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.