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.
Uncontrolled head movement; Facial twitch/ Uncontrolled eye twitches; Headache; it feels weird. She got an unusual 'sensation'. Her head feels weird; intermittent exotropia; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 5-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (medically significant), outcome "not recovered", described as "Uncontrolled head movement"; MUSCLE TWITCHING (medically significant), outcome "not recovered", described as "Facial twitch/ Uncontrolled eye twitches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels weird. She got an unusual 'sensation'. Her head feels weird"; STRABISMUS (non-serious), outcome "unknown", described as "intermittent exotropia". The reporter stated, "the most serious one that keeps continuing she (patient) has uncontrolled head movement, twitches (voice incomprehensive) she has facial twitch and she is having some uncontrolled eye twitches." The patient underwent the following laboratory tests and procedures: blood magnesium, blood phosphorus, blood urine, notes: Reporter stated, "Yes right at the hospital she had blood urine and a (voice incomprehensive)."; c-reactive protein, drug abuse, full blood count, metabolic function test, red blood cell sedimentation rate, toxicologic test, troponin, and urinalysis: all on (23Nov2021) results unknown. The reporter stated that the second dose was scheduled on 04Dec2021. 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 | FK5127 | Unknown | LA |
RECVDATE: | 12-16-2021 | 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: 20211123; Test Name: magnesium; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: phosphate; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: Blood urine; Result Unstructured Data: Test Result:Result unknown; Comments: Reporter stated, "Yes right at the hospital she had blood urine and a (voice incomprehensive)."; Test Date: 20211123; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: drug abuse; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: CBC; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: comprehensive metabolic panel; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: sedimentation rate; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: tox screening for urine; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: Troponin; Result Unstructured Data: Test Result:Result unknown; Test Date: 20211123; Test Name: urinalysis; Result Unstructured Data: Test Result:Result unknown |
V_ADMINBY: | |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC202101723385 |
FORM_VERS: | |
TODAYS_DATE: | 12-15-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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