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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

Seasonal Influenza Vaccine Safety: Reporting Adverse Vaccine Events to the Vaccine Adverse Event Reporting System (VAERS)

With flu season coming up, please remember to submit Adverse Vaccine Events (AVEs) from all vaccines to the Vaccine Adverse Event Reporting System (VAERS) in accordance with the Indian Health Manual1 and/or your local policies.

Healthcare providers are required by law to report the following AVEs that occur after administration of the seasonal influenza vaccine2:

  1. Anaphylaxis or anaphylactic shock (occurring within 7 days of administration)
  2. Shoulder Injury Related to Vaccine Administration (occurring within 7 days of administration)
  3. Vasovagal syncope (occurring within 7 days of administration)
  4. Guillain-Barré Syndrome (occurring within 42 days of administration)
  5. Any acute complication or sequelae (including death) of above events (interval - not applicable)
  6. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)

Instructions for documenting and reporting AVEs and Adverse Drug

Events can be found on the IHS Pharmacovigilance website.

  1. Visit Pharmacovigilance
  2. Click “Learn More” under Adverse Drug Events
  3. Click “Learn More” under Reporting Adverse Vaccine Events

Please remember to enter “IHS” in field #26 of the VAERS report
(this field is also called the immunization project report number).

References:

  1. Indian Health Service (n.d.). Indian Health Manual, Chapter 7, Reporting Adverse Drug Events and Medication Errors.
  2. Food and Drug Administration (n.d.). Report an Adverse Event to VAERS.