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.
I developed severe tinnitus (constant ringing in my ears) approximately 3 weeks after my last dose of the vaccine. Last dose was administered on December 21, 2021. The tinnitus was extremely disruptive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 at 15:30 as dose 3 (booster), single (Lot number: FE3594) at the age of 44 years intramuscular, in right arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 44-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 04Feb2021, when the patient was 44-year-old, for Covid-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jan2022, outcome "recovering", described as "I developed severe tinnitus (constant ringing in my ears) approximately 3 weeks after my last dose of the vaccine. Last dose was administered on December 21, 2021. The tinnitus was extremely disruptive". The event "i developed severe tinnitus (constant ringing in my ears) approximately 3 weeks after my last dose of the vaccine. last dose was administered on December 21, 2021. the tinnitus was extremely disruptive" required physician office visit. Therapeutic measures were taken as a result of tinnitus. Additional information: patient took other medications in two weeks was atorvastatin, I developed severe tinnitus (constant ringing in my ears) approximately 3 weeks after my last dose of the vaccine. Last dose was administered on 21Dec2021. The tinnitus was extremely disruptive and debilitating. The tinnitus is slowly improving, 4 months later.
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)) | 3 | COVID19 | PFIZER\BIONTECH | FE3594 | OT | RA |
| RECVDATE: | 06-10-2022 | 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: | |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | ATORVASTATIN |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Penicillin allergy |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202200806315 |
| FORM_VERS: | |
| TODAYS_DATE: | 06-09-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| 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.