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.
Dizziness; vomiting; inflammation in head inner ear and on optic nerve endings; inflammation in head inner ear and on optic nerve endings; inflammation in head inner ear and on optic nerve endings; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable consumer (patient) via a regulatory authority. A non-pregnant 16-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD0810), via an unspecified route of administration, administered in arm left on 19Aug2021 15:45 (at the age of 16-year-old) as single dose for COVID-19 immunisation. None relevant medical history and concurrent conditions, relevant past drug history/known allergies. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FA9093) administrated in arm left on 19Jun2021 11:30 (at the age of 15-year-old) for COVID-19 immunisation. The patient experienced dizziness, vomiting, inflammation in head inner ear and on optic nerve endings on 23Aug2021, and was hospitalized from 23Aug2021 to 26Aug2021. The patient received treatment including IV fluids, nausea medication. The AEs result in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events "dizziness", "vomiting" and "inflammation in head inner ear and on optic nerve endings" was recovering.
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(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)) | 2 | COVID19 | PFIZER\BIONTECH | FD0810 | LA |
| RECVDATE: | 10-13-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 3 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| 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: | CAPFIZER INC202101292915 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-12-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.