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.
Dose received: 3; Chills; Fever of 101.9; Vomiting; Can't stay awake; This is a spontaneous report from non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A 32-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 22Dec2021 at 14:30 (Lot number: FE3594) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0162, Anatomical location: Left arm), administration date: 13Apr2021, when the patient was 31 years old, and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0172, Anatomical location: Left arm), administration date: 04May2021, when the patient was 31 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Fever of 101.9"; VOMITING (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Vomiting"; SOMNOLENCE (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Can't stay awake". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, vomiting and somnolence. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No follow-up attempts are possible. No further information is expected.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | FE3594 | Unknown | LA |
RECVDATE: | 12-31-2021 | 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: | Test Date: 202112; Test Name: Body temperature; Result Unstructured Data: Test Result:101.9 |
V_ADMINBY: | PVT |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC202101848421 |
FORM_VERS: | |
TODAYS_DATE: | 12-27-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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