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.
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: FR-AFSSAPS-PS20220770. A 55-year-old female patient received BNT162b2 (COMIRNATY), on 22Dec2021 as dose 1, single (Lot number: FL7645) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 31Mar2021 (unspecified if ongoing), notes: Test performed on 31Mar2021. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (medically significant) with onset Dec2021, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Mar2021) Positive; Specialist consultation: (unspecified date) No details; Ultrasound Doppler: (unspecified date) without abnormality. Clinical Course: Lack of improvement at the time of reporting. No follow-up attempts are possible. No further information is expected.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||11 May 2022|
|LAB_DATA:||Test Date: 20210331; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: Otorhinolaryngology consultation; Result Unstructured Data: Test Result:No details; Test Name: Doppler ultrasound done of the vessels of the neck; Result Unstructured Data: Test Result:without abnormality|
|HISTORY:||Medical History/Concurrent Conditions: COVID-19 (Test performed on 31Mar2021.)|
|TODAYS_DATE:||10 May 2022|