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.
Post vaccination satellite lesions; Hypoaesthesia; Severe pain in administration site (Left upper limb); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB and received via Regulatory Authority ES-AEMPS-714048. A 26-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot # unknown) at single dose at left upper limb on 08Jan2021 for covid-19 immunisation, as being a health care professional or social health center staff. Medical history included asthma, Covid-19. Pre vaccination, the patient has been tested for COVID-19: Ag positive on 18Nov2020, confirmed by positive PCR on 03Dec2020. On 18Nov2020 she attended in the emergency room for dyspnea, without serious findings and a diagnosis of SARS-CoV-2 infection. She did not consult again nor did required hospitalization. The patient's concomitant medications were not reported. On 08Jan2021, the patient experienced post vaccination satellite lesions, hypoaesthesia in arm, severe pain in administration site (left upper limb). On 08Jan2021, few hours after vaccination, the patient experienced hypoaesthesia in arm that was initially identified as plexitis. Neurology assessment and stay in observation beds. In reevaluation persisted mild hypoesthesia with no evidence of plexitis. The patient was hospitalized for the events. The outcome of recovered on 08Jan2021. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to be obtained.
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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.