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.
clonic convulsion; consciousness disturbed; Convulsion; JCS 10; encephalopathy; CK: 866; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. Regulatory authority report number is v21127173. A 12-year and 9-month-old male patient received BNT162B2 (COMIRNATY, Solution for injection Lot number FE8162, Expiration date 30Nov2021), via an unspecified route of administration on 12Sep2021 at 10:00 as dose 2, single (at the age of 12 years old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) was unknown as the patient did not receive the vaccination at the hospital. On 13Sep2021 at 06:00 (1 day after the vaccination), the patient experienced convulsion, consciousness disturbed and encephalitis/encephalopathy. On 13Sep2021 (1 day after the vaccination), the patient was admitted to the hospital and on 15Sep2021 (3 days after the vaccination), the patient was discharged from hospital. The course of the event was as follows: At 06:00 on 13Sep2021, clonic convulsion appeared for two minutes, and the patient was move to the hospital by ambulance. As JCS 10 continued, the patient was admitted to the hospital for investigation and treatment. CK: 866, T-Bil: 5.0, D-Bil: 0.3 and Lactate: 49. There were no other abnormalities founded in blood test. There were also no abnormalities on CT or cerebrospinal fluid test. The patient was diagnosed with encephalopathy, and steroid pulse was performed. From the night on 13Sep2021, the patient woke up, and condition turned to normal. On 15Sep2021 (3 days after the vaccination), the outcome of the events was recovered. The reporting other HCP classified the event as serious (Hospitalized) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FE8162 |
| RECVDATE: | 10-01-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Date: 20210917; Test Name: D-Bil; Result Unstructured Data: Test Result:0.3; Test Date: 20210917; Test Name: T-Bil; Result Unstructured Data: Test Result:5.0; Test Date: 20210917; Test Name: CK; Result Unstructured Data: Test Result:866; Test Date: 20210917; Test Name: Lactate; Result Unstructured Data: Test Result:49; Test Date: 20210917; Test Name: blood test; Result Unstructured Data: Test Result:no other abnormalities; Test Date: 20210917; Test Name: JCS; Result Unstructured Data: Test Result:10; Test Date: 20210917; Test Name: CT; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210917; Test Name: cerebrospinal fluid test; Result Unstructured Data: Test Result:no abnormalities |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101227851 |
| FORM_VERS: | |
| TODAYS_DATE: | 09-30-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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