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.
deafness; Ulcer; Sore throat; Migraine; Dry nose; Tension; Unable to swallow; Suspected COVID-19; Deafness both ears; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109271333456350-X4NMQ, Safety Report Unique Identifier GB-MHRA-ADR 26000022. A 15-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on 22Sep2021 (age at vaccination 15-year-old) as DOSE 1, SINGLE for covid-19 immunization. Patient was not pregnant. Patient was not currently breastfeeding. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced deafness, on 22Sep2021 experienced deafness both ears, on 24Sep2021 experienced sore throat, ulcer, on 23Sep2021 experienced migraine, dry nose, tension, unable to swallow, suspected covid-19. It was reported as, by deafness in Both ears I mean my ears won't pop. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No causality was provided for deafness, deafness bilateral, oropharyngeal pain, migraine, nasal dryness, tension, dysphagia, ulcer and suspected COVID-19. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 26Sep2021. No - Negative COVID-19 test. The outcome of events suspected covid-19, deafness were unknown, for events deafness both ears, sore throat, dry nose, tension, unable to swallow, ulcer were not recovered and for event migraine was recovered on 25Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||Unknown||Unknown|
|LAB_DATA:||Test Date: 20210926; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test|