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.
blood clots in both legs; swelling in both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jul2021 14:00 (Lot number: EW0198) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: THROMBOSIS (caused and prolonged hospitalization, medically significant, life threatening) with onset 05Jul2021 13:00, outcome "recovered with sequelae", described as "blood clots in both legs"; PERIPHERAL SWELLING (hospitalization, life threatening) with onset 05Jul2021 13:00, outcome "recovered with sequelae", described as "swelling in both legs". The patient was hospitalized and prolonged hospitalization for thrombosis (hospitalization duration: 7 day(s)); for peripheral swelling (hospitalization duration: 7 day(s)). The events "blood clots in both legs" and "swelling in both legs" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of thrombosis, peripheral swelling. Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No List of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. Once properly diagnosed after swelling in both legs had to undergo surgery to remove blood clots in both legs just in time before clots moved to his heart or brain. Surgery to rmove blood clots. The patient had no known allergy.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EW0198 | RA |
| RECVDATE: | 03-05-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 7 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: known allergies: No other medical history: None |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202200334924 |
| FORM_VERS: | |
| TODAYS_DATE: | 03-02-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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