vaers adverse event reporting

option 1: submit a vaers report onlineexternal icon (preferred) the online vaers report must be completed and submitted in the same session; it cannot be saved and edited at a later time. when ready, return to the vaers writable pdf web page (use link above) and follow step 2 instructions to upload the form. more information on reporting an adverse event to vaersexternal icon. these reports help cdc and fda detect new or unusual adverse events that could indicate a problem with a vaccine. everyone is encouraged to report possible adverse events after vaccination to vaers, even if they are not sure whether the vaccine caused the problem. the program is separate from vaers, and administered by the health resources and service administration.




reporting an adverse event to vaers does not create a claim for compensation with the vicp. healthcare providers who administer covid-19 vaccines are required by law to report the following to vaers: healthcare providers are encouraged to report to vaers any additional clinically significant aes following vaccination, even if they are not sure whether the vaccine caused the event. cdc and fda encourage anyone who experiences (or is made aware) of an adverse event after vaccination to report it to vaers, even if they are not sure the vaccine caused the problem: by the code of federal regulations (cfr) title 21external icon, an adverse event is defined as serious if it involves any of the following outcomes: each vaers report is assigned a vaers identification number. vaers will send the identification number to the reporting individual in a confirmation letter (electronically or by mail, depending on communications preferences listed on the original report). other than the confirmation letter, vaers will only reach out to the reporting individual for additional information if “essential fields” of the vaers form are not filled out. additional information requests are sent electronically or by mail and will explain what information is missing from the report and how the reporter can update it. the medical records are added to the permanent record under the vaers id, compliant with privacy standards.

the vaccine adverse event reporting system (vaers) is a national program managed by the u.s. centers for disease control and prevention (cdc) and the u.s. food and drug administration (fda) to monitor the safety of all vaccines licensed in the united states. vaers cannot determine if a vaccine caused an adverse event but can determine if further investigation is needed. cdc and fda encourage anyone who experiences an adverse event after receiving a vaccine to report to vaers.

the national childhood vaccine injury act (ncvia) requires health care providers to report any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine or any adverse event listed in the reportable event table. health care providers also are encouraged to report any clinically significant adverse event that occurs in a patient following a vaccination, even if they are unsure whether a vaccine caused the event. the new jersey department of health works to ensure that citizens receive appropriate levels of care in every regulated facility.

the vaccine adverse event reporting system (vaers) is a passive reporting system, meaning it relies on individuals to send in reports of their experiences. important: if you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1. cdc and fda do not provide information provided to vaers which identifies a person who received the vaccine or vaccines will not be made available to the public. de-identified vaers data, .

vaers is co-managed by the centers for disease control and prevention (cdc) and the u.s. food and drug administration (fda). vaers accepts and analyzes reports vaers is the national vaccine safety monitoring system that accepts reports of adverse events after vaccination. the system can quickly detect potential in general, you should report any side effect or health problem after vaccination that is concerning to you. under the national childhood vaccine injury act (, .

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