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.
NUMBNESS IN FINGERS; PAIN IN FINGERS; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority (RO-NMA-2021-SPCOV12696) on 12-OCT-2021 concerned a 45 year old female of unspecified race and ethnic origin. The patient's weight was 75 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-05 expiry: Unknown) dose of 1 dosage forms, 1 total administered on 06-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 07-SEP-2021, the patient experienced headache. On an unspecified date, the patient experienced numbness in fingers, and pain in fingers. Laboratory data (dates unspecified) included a Fibrin D dimer test (NR: not provided) with a result of 800 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from numbness in fingers, and pain in fingers. This report was serious (Disability Or Permanent Damage).
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