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.
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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