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.
Consciousness disturbed; Dizziness; Fall down; physical deconditioning; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21129128. The patient was a 14-year and 9-month-old male (age at the vaccination). Body temperature before vaccination was 36.5 degrees Centigrade on 03Oct2021. The patient's concomitant medications were not reported. There were no 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). On 03Oct2021 (the day of the vaccination), the patient received the first dose of bnt162b2(COMIRNATY, Lot number FH3023, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Oct2021 at 09:50 (2days after the vaccination), the patient experienced Consciousness disturbed. On 05Oct2021 (2 days after the vaccination), the patient was admitted to the hospital and discharged on 06Oct2021. On 06Oct2021 (3 days after the vaccination), the outcome of the event was recovering. Clinical source: Coronavirus vaccination was provided on 03Oct2021. On 04Oct2021, the patient experienced physical deconditioning. Since the symptoms had subsided by the morning on 05Oct2021, the patient went to school. However, the patient recognized dizziness and fell down. As consciousness disturbed was also noted, the patient was emergently transferred to the hospital by an ambulance. Head CT, electroencephalography, and electrocardiography showed no abnormal. A possibility of organic disease was considered unlikely, and association with COMIRNATY vaccination was suggested. The condition had improved by 06Oct2021, and the patient was discharged. The reporting physician classified the event as serious(caused hospitalization from 05Oct2021 to 06Oct2021 ) and assessed the causality between the event and bnt162b2 as un-assessable. There was no other possible cause of the event such as any other diseases.
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FH3023 |
| RECVDATE: | 10-27-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 1 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20211003; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination.; Test Date: 20211005; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormal; Test Date: 20211005; Test Name: electrocardiography; Result Unstructured Data: Test Result:no abnormal; Test Date: 20211005; Test Name: electroencephalography; Result Unstructured Data: Test Result:no abnormal |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101353184 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-26-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.