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The document is a Vaccine Adverse Event Reporting System (VAERS) form used to report adverse events following vaccination. It includes sections for patient information, details about the vaccine administered, descriptions of adverse events, and relevant medical history. The form emphasizes confidentiality and provides instructions for completion, highlighting the legal requirement for healthcare providers to report certain vaccine reactions.

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How do you report an adverse reaction to a vaccine?

CDC and FDA encourage anyone who has (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. See reporting an adverse event to VAERS for more information. If you need further assistance, please email info@VAERS.org or call 1-800-822-7967.

What are the FDA requirements for reporting adverse events?

Initial reporting: Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.

How do I report an adverse event?

Related Information for Consumers. If you need information or if you have questions or comments about a medical product, please call the FDAs toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.

How do you report an adverse event?

.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.

What are the 4 criteria for adverse event reporting?

Information about the person who had the adverse reaction (such as age and gender); A description of the adverse reaction; The dose and name of the medicinal product suspected of causing the adverse reaction; The batch number of the medicinal product (indicated on the package);

What are the four main details required to report an adverse event?

Unexpected fatal or life-threatening suspected adverse events must be reported to the FDA as soon as possible but no later than within 7 calendar days of first being notified of the event.

What is the FDA adverse event reporting form?

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.

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