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.
having pain where the bump or where the swollen lymph node is; had a "swollen lymph node under the arm" on the vaccination site; had a "swollen lymph node under the arm" on the vaccination site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FF2587, Expiration Date: 31Dec2021) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Kawasaki's disease" (ongoing), notes: Verbatim: Kawasaki's disease, Information for Other Conditions: diagnosed about 7 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot Number / Expiry Date: , Lot: FC3182, Exp: 21Oct2021, Route, Anatomical Location: Unknown by injection , No. of Previous Doses: 1), administration date: 20Aug2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset 12Sep2021, outcome "not recovered" and all described as "had a "swollen lymph node under the arm" on the vaccination site"; PAIN (non-serious), outcome "unknown", described as "having pain where the bump or where the swollen lymph node is". Follow-up attempts are completed. No further information is expected.
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 | FF2587 | LA |
| RECVDATE: | 03-12-2022 | 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: | |
| CUR_ILL: | Kawasaki's disease (Verbatim: Kawasaki's disease Information for Other Conditions: diagnosed about 7 years ago) |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202101198276 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-08-2022 |
| 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.