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.
Reduced mouth amplitude; Dark urine; Swollen and reddened eyes; Swollen and reddened eyes; Paleness; Heart rate above 130 bpm; Very low blood pressure (7x4); Began to lose movement in his legs and arms (Hyporeflex flaccid tetraparesis); Severe stomach pains; Fever of 39.8 degrees Centigrade; Lump appeared in the neck; Headaches; Dizziness; Weakness; Infection; Sepsis; This is a spontaneous report received from a contactable consumer (patient) via regulatory authority. A 12-year-old male patient received BNT162B2 (COMIRNATY; solution for injection; lot number: FG3530), via an unspecified route of administration, administered in the left arm on 24Sep2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 on an unspecified date prior to vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Sep2021 (1 day after the vaccination), the patient began to experience weakness, dizziness, and headaches. On 26Sep2021, a "lump" appeared in the neck and the patient had a fever of 39.8 degrees Centigrade, then he started having severe stomach pains. Symptoms progressed rapidly, he had very low blood pressure (7x4), heart rate above 130 bpm, paleness, swollen and reddened eyes, dark urine and then the patient began to lose movement in his legs and arms (Hyporeflex flaccid tetraparesis) and reduced mouth amplitude. All exams showed alterations, indicating infection, progressing to sepsis. On 04Oct2021, the patient was admitted urgently (due to sepsis), remaining in the hospital until 08Oct2021. Discharge Summary Reason for Admission: Adverse Effects of Antiviral Vaccines (Y590). The patient must undergo outpatient follow-up with Neurology, Immunology, Rheumatology and Infectology. The patient will proceed with physical-motor rehabilitation and 4-limb electroneuromyography exams. Since the vaccination, the patient has been tested for COVID-19. Nasal swab test on 02Oct2021 and 05Oct2021 were both negative. The outcome of the events was recovered on an unspecified date.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FG3530 | LA |
| RECVDATE: | 10-19-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 5 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Name: Blood pressure; Result Unstructured Data: Test Result:7x4; Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: Test Result:39.8 Centigrade; Test Name: Heart rate; Result Unstructured Data: Test Result:above 130 bpm; Test Name: Exams; Result Unstructured Data: Test Result:Alterations, indicating infection..; Comments: ..progressing to sepsis; Test Date: 20211002; Test Name: COVID-19 test (Nasal Swab); Test Result: Negative ; Test Date: 20211005; Test Name: COVID-19 test (Nasal Swab); Test Result: Negative |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination) |
| PRIOR_VAX: | |
| SPLTTYPE: | BRPFIZER INC202101368457 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-18-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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