VAERS On-line Help

General

Specific Instructions

Step 1 of 5: Person Reporting the Event

Form Completed By
To be used by the person completing the form (e.g. parents/guardians, vaccine distributors, vaccine administrators, the person completing the form on behalf of the patient, or the health professional who administered the vaccine). Be sure to complete this box accurately since it is used for our operational and follow-up activities (i.e. processing requests for copies of a report).

Information Kept Confidential
The information highlighted will be used to perform program functions (i.e. duplicate checks, processing copy requests) and during follow-up activities (i.e. request of current health status or additional information about the case). This information will be redacted from public data sets and FDA's FOI.

Relation to Patient
If you are in the same facility as the vaccine provider select Vaccine Provider unless you are in a different physical address.

Have You Reported this Adverse Event Previously?
Check all appropriate boxes.

Step 2 of 5: Patient

Information Kept Confidential
The information highlighted will be used to perform program functions (i.e. duplicate checks, processing copy requests) and during follow-up activities (i.e. request of current health status or additional information about the case). This information will be redacted from public data sets and FDA's FOI.

Same as Form Completed By
Check this box to set the Patient's first name, middle initial, last name, address fields, city, state, postal code and phone number to the same values that were entered on Step 1.

Step 3 of 5: Vaccine Administration

Vaccine Purchased With
This section refers to how the person who gave the vaccine purchased it (e.g. source of funds), not to the patient's insurance.

Date/Time Vaccine Administered
Enter date and time as specifically as you can remember. If you do not know the exact time, please indicate "AM" or "PM" if possible

Any Illnesses at Time of Vaccination
Specify any short-term illnesses the patient had on the date the vaccine(s) was given (e.g. cold, flu, ear infection).

Pre-existing Physician-Diagnosed Allergies, Birth Defects, Medical Conditions at Time of Vaccination
List any pre-existing physician-diagnosed allergies, birth defects, medical conditions (including developmental and/or neurologic disorders) of the patient.

Information Kept Confidential
The information highlighted will be used to perform program functions (i.e. duplicate checks, processing copy requests) and during follow-up activities (i.e. request of current health status or additional information about the case). This information will be redacted from public data sets and FDA's FOI.

Same as Form Completed By
Check this box to set the first name, middle initial and last name fields of Vaccine Administrator or Responsible Physician to the first name, middle initial and last name values that were entered on Step 1.

Step 4 of 5: Adverse Event & Event Outcomes

Adverse Event Onset Date/Time
Enter date and time as specifically as you can remember. If you do not know the exact time, please indicate "AM" or "PM" if possible. If more than one adverse event occurred, give the onset date and time for the most serious event.

Describe Adverse Event(s) (Symptoms, Signs, Time Course) & Treatment, if Any
Describe the suspected adverse event. Such things as temperature, local and general signs and symptoms, time course, durations of symptoms, diagnosis, treatment and recovery should be noted.

Check All Appropriate Event Outcomes
Mark all that apply at the time of your submission. This box helps us to determine the severity of the report. If none of the options apply to this case mark None of the Above.

Patient Recovered
Check "YES" if the patient's health condition is the same as it was prior to the vaccine, "NO" if the patient has not returned to the pre-vaccination state of health, or "UNKNOWN" if the patient's condition is not known.

Relevant Diagnostic Tests & Laboratory Data
Include "negative" or "normal" results of any relevant tests performed as well as abnormal findings.

Step 5 of 5: Vaccines, Medications & Prior Adverse Events

All Vaccines Given on Same Date
List ONLY those vaccines given on the date provided in Box 10.

Any Other Vaccines within 4 Weeks Prior to Same Date
List any other vaccines that the patient received within 4 weeks prior to the date provided in Box 10.

Adverse Events Following Prior Vaccinations
List any suspected adverse events the patient, or the patient's brother(s) or sister(s), may have had to previous vaccinations. For the onset age of a patient, provide the age in months if less than two years old. Once the vaccine is selected, a list of the appropriate vaccine manufacturers will be displayed.

Other Medications
List any prescription or non-prescription medications the patient was taking when the vaccine(s) was given on the date provided in Box 10.