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Vaccine Adverse Event Reporting System (VAERS)
Preventive Medicine Data and Statistics

Users are reminded to submit a Medical Event Report on any adverse immunization reaction, particularly with the resumption of anthrax and smallpox immunizations. Users must also complete the FDA VAERS-1 form for FDA and NEHC, along with an Anthrax Supplemental form if associated with the administration of anthrax vaccine, per HA Policy 99-031. Check with your local hospital authorities to determine if there are additional local notification requirements.

REMEMBER!
No matter how you choose to report, if you are reporting a VAERS, submit BOTH a Medical Event Report and the FDA VAERS-1 Form.

Reporting Medical Events/VAERS via NDRS & SAMS

  1. Create a MER for the adverse vaccine reaction in the Medical Event Reports section using the ICD-9 diagnosis code of 979.9 by using either NDRS or SAMS. Any life-threatening reaction or any reaction thought to result from a contaminated vaccine lot must be reported within twenty-four (24) hours. Otherwise, ensure that the MER is exported within seven (7) days.
  2. Complete the VAERS form, and print out at least 3 copies. If you are using NDRS, the VAERS-1 form will automatically prompt you when completing the MER. If you are using SAMS or are unable to access within NDRS, you may download from the internet or.
    1. Please put the patient's Social Security Number and service on the margin of the CDC/FDA form. There is not a place provided for it but it's needed to help track the reports and complete supplemental anthrax immunization forms.
    2. Submit a copy to NEHC via mail, email or fax to be forwarded to the FDA.
      1. Mail: Address to: Commanding Officer, Navy and Marine Corps Public Health Center, Attn: Preventive Medicine Department, 620 John Paul Jones Circle, Suite 1100, Portsmouth VA 23708-2103
      2. Email: Must use a password-encrypted process, and address to: epi@nehc.mar.med.navy.mil
      3. Fax: Attn: PrevMed Dept at (757) 953-0685. Call (757) 953-0718 to advise that a fax is coming. If after hours, leave a message. The fax machine is secure within NEHC and faxes can be sent confidentially after hours.
    3. Maintain one copy in Record, per BUMED Note 6230.
    4. Keep one copy for your own files
  3. If the adverse event was associated with the administration of anthrax vaccine a supplemental anthrax form must be completed, in accordance with the Health Affairs Policy 99-031: Policy for Reporting Adverse Events Associated with the Anthrax Vaccine.


This page last updated on March 8th, 2009.
Content last reviewed on March 2nd, 2009.