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.
Dizzy; Nauseous; Neck hurts; Hot flashes; Site is still bleeding; This is a spontaneous report from a contactable consumer. This 27-year-old female consumer (patient) reported for herself. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 14Aug2021 12:00 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history included rubber sensitivity, COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had allergies with Latex. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Aug2021 12:00, the patient experienced dizzy, nauseous, neck hurts, hot flashes, site is still bleeding. The patient underwent lab tests and procedures which included sars-cov-1 test: positive; covid prior vaccination. The patient did not receive any treatment. All the events were reported as non-serious. Outcome of the event was not recovered, at the time of this report. Device Date was 14Aug2021. Follow-up attempts are completed. No further information is expected.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FA7485 | LA |
RECVDATE: | 09-21-2021 | 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 Name: COVID; Test Result: Positive ; Comments: if covid prior vaccination: Yes |
V_ADMINBY: | |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination Yes); Latex allergy. |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC202101048635 |
FORM_VERS: | |
TODAYS_DATE: | 09-20-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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