Report an Adverse Event Instructions

GENERAL INSTRUCTIONS

  • If you need additional help submitting a report, you may call the VAERS toll-free information line at 1-800-822-7967, or send an email to info@vaers.org.
  • Fill out the VAERS form as completely as possible. Submit a separate VAERS form for each individual patient.
  • If you do not know exact numbers, dates, or times, please provide your best guess. You may leave these spaces blank if you are not comfortable guessing.
  • You can get specific information on the vaccine and vaccine lot number by contacting the facility or clinic where the vaccine was administered.
  • Please report all significant adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event.
  • Healthcare professionals should refer to the VAERS Table of Reportable Events at www.vaers.hhs.gov/reportable.html for the list of adverse events that must be reported by law (42 USC 300aa-25).
  • Healthcare professionals treating a patient for a suspected vaccine adverse event may need to contact the person who administered the vaccine in order to exchange information and decide how best to complete and submit the VAERS form.

SPECIFIC INSTRUCTIONS

Items 2, 3, 4, 5, 6, 17, 18 and 21 are ESSENTIAL and should be completed.

  • Items 4 and 5: Provide dates and times as specifically as you can and enter as much information as possible (e.g., enter the month and year even if you don’t know the day).
  • Item 6: If you fill in the form by hand, provide age in years. If a child is less than 1 year old, provide months of age. If a child is more than 1 year old but less than 2 years old, provide year and months (e.g., 1 year and 6 months). If a child is less than 1 month of age when vaccinated (e.g., a birth dose of hepatitis B vaccine) then answer 0 years and 0 months, but be sure to include the patient’s date of birth (item 2) and date and time of vaccination (item 4).
  • Item 8: If the patient who received the vaccine was pregnant at time of vaccination, select "Yes" and describe the event, any pregnancy complications, and estimated due date if known in item 18. Otherwise, select "No" or "Unknown."
  • Item 9: List any prescriptions, over-the-counter medications, dietary supplements, herbal remedies, or other non-traditional/ alternative medicines being taken by the patient when the vaccine(s) was given.
  • Item 10: List any allergies the patient has to medications, foods, or other products.
  • Item 11: List any short-term or acute illnesses the patient had on the date of vaccination AND up to one month prior to this date (e.g., cold, stomach flu, ear infection, etc.). This does NOT include the adverse event you are reporting.
  • Item 12: List any chronic or long-standing health conditions the patient has (e.g., asthma, diabetes, heart disease).
  • Item 13: List the name of the person who is completing the form. Select the "Check if same as item 1" box if you are the patient or if you live at the same address as the patient. The contact information you provided in item 1 will be automatically entered for you. Otherwise, please provide new contact information.
  • Item 14: List the doctor or other healthcare professional who is the best person to contact to discuss the clinical details of the adverse event.
  • Item 15: Select the "Check if same as item 13" box if the person completing the form works at the facility that administered the vaccine(s). The contact information provided in item 13 will be automatically entered for you. Otherwise, provide new contact information.
  • Item 16: Select the option that best describes the type of facility where the vaccine(s) was given.
  • Item 17: Include only vaccines given on the date provided in item 4. Select a U.S.-licensed vaccine if applicable; otherwise scroll down to the bottom of the vaccine list, select the “Foreign” or “Other” options, and provide the vaccine name in the text box to the right. Choose the “Unknown” option at the bottom of the list if you do not know the vaccine name. The vaccine route options include:
    • Injection/shot (intramuscular, subcutaneous, intradermal, jet injection, and unknown)
    • Mouth
    • In nose/intranasal
    • Other (specify)
    • Unknown

    For body site, the options include:

    • Right arm
    • Left arm
    • Arm (side unknown)
    • Right thigh
    • Left thigh
    • Thigh (side unknown)
    • Nose
    • Other
    • Unknown

    For vaccines given as a series (i.e., 2 or more doses of the same vaccine given to complete a series), list the dose number for the vaccine in the last column named “Dose no. in series.”

  • Item 18: Describe the adverse event(s), treatment, and outcome(s). Include signs and symptoms, when the symptoms occurred, diagnosis, and treatment. Provide specific information if you can (e.g., if patient had a fever, provide the temperature).
  • Item 19: List any medical tests and laboratory results related to the adverse event(s). Include abnormal findings as well as normal or negative findings.
  • Item 20: Select "Yes" if the patient’s health is the same as it was prior to the vaccination or “No” if the patient has not returned to the same state of health prior to the vaccination, and provide details in item 18. Select “Unknown” if the patient’s present condition is not known.
  • Item 21: Select the result(s) or outcome(s) for the patient. If the patient did not have any of the outcomes listed, select "None of the above." Prolongation of existing hospitalization means the patient received a vaccine during a hospital stay and an adverse event following vaccination occurred that resulted in the patient spending extra time in the hospital. Life threatening illness means you believe this adverse event could have resulted in the death of the patient.
  • Item 22: List any other vaccines the patient received within one month prior to the vaccination date listed in item 4.
  • Item 23: Describe the adverse event(s) following any previous vaccine(s). Include patient age at vaccination, dates of vaccination, vaccine type, and brand name.
  • Item 24: Check all races that apply.
  • Item 25: Check the single best answer for ethnicity.
  • Item 26: For health department use only.
  • Items 27 and 28: Complete only for U.S. Military or Department of Defense related reports. In addition to active duty service members, Reserve and National Guard members, beneficiaries include: retirees, their families, survivors, certain former spouses, and others who are registered in the Defense Enrollment Eligibility Reporting System (DEERS).