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.
Facial paralysis; Stroke; This is a spontaneous report from non-contactable consumer downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB DE-PEI-CADRPEI-2021012141 An 82-year(s)-old male patient received BNT162B2 (COMIRNATY, lot/batch no.: EL1491) Intramuscular on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included Diabetes mellitus. Concomitant medication was not reported. 3 day(s) after vaccination the patient developed Facial paralysis, lasting for 2 day(s) from 11Jan2021. The patient was hospitalized. On the morning of the 2nd day after the vaccination, the corners of the mouth and eyes were paralyzed. Parts of the face. Patient was immediately referred to the ambulance with suspicion. Stroke admitted to PRIVACY. The suspicion has not been confirmed. He is currently receiving cortisone infusions. I do not know more, as act. No Visit is possible. Contact with the clinic only took place twice briefly. The patient had not recovered at the date of reporting (also reported Facial paralysis: stop date 12Jan2021). Sender Comment: patient is a diabetic and is no longer quite healthy according to his age. Comirnaty/ Facial paralysis/ PEI/ D. Unclassifiable No follow-up attempts possible. No further information expected.
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