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.
T1D; This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Jul2021 10:00 (Batch/Lot Number: EW0178) at the age of 15 years old as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. There were no concomitant medications (other medications in two weeks none). Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) received by the patient on 21Jun2021 10:00 (Batch/Lot Number: EW0167) administered in left arm as dose 1, single (at the age of 15 years old) for COVID-19 immunization. No other vaccine received in four weeks. The patient experienced T1D (Type 1 Diabetes Mellitus) on 16Aug2021 12:00. The patient was hospitalized for T1D for 3 days. Therapeutic measures were taken as a result of T1D which included insulin. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient has no history of COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. Outcome of the event was recovered/resolved with sequelae (recovered with lasting effects).
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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)) | 2 | COVID19 | PFIZER\BIONTECH | EW0178 | LA |
| RECVDATE: | 10-19-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 3 |
| X_STAY: | U |
| DISABLE: | Y |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202101310886 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-16-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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