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If a manufacturer is in receipt of such reports, they are required to send the report based on the regulations specified by the FDA. FAERS reports can be submitted online, through a consumer reporting form such as FDA 3500B, or through telephone.
What is the primary objective of the vaccine adverse event reporting system?
Detect new, unusual, or rare adverse events that happen after vaccination.
What are the side effects of the FDA vaccine?
Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.
What is the VAERS data use guide?
VAERS is used to continually monitor reports to determine whether any vaccine or vaccine lot has a higher than expected rate of events. Doctors and other vaccine providers are encouraged to report adverse events, even if they are not certain that the vaccination was the cause.
What is the purpose of the adverse event reporting system?
Reporting adverse events isnt just about patient safety. It also helps protect healthcare organizations from costly liability claims and financial losses caused by reduced reimbursement for the treatment of preventable conditions acquired while in hospital care.
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Call 1-800-FDA-1088 to report by telephone. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (Send only page 1 plus any continuation pages - do not send instruction pages).
Related links
Vaccine Adverse Event Reporting System (VAERS)
CDC and FDA will perform routine VAERS surveillance to identify potential new safety concerns for COVID-19 vaccines. This surveillance will include generating
by R Ball 2003 Cited by 555 Under the joint administration of CDC and FDA, VAERS accepts spontane- received RRV-TV vaccine (Figure 2). Infect Dis 2001;7:94551. 60.
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