§300aa–25 Recording and Reporting of Information

Summary

Health care providers must put certain details about any vaccine listed on the Vaccine Injury Table into the patient’s permanent medical record (or an office file a legal representative can see). The record must show the date given, the vaccine maker and lot number, the name and address and, if needed, the job title of the person who gave it, and any other ID information the Secretary requires. Providers and vaccine makers must report to the Secretary any event on the Vaccine Injury Table (including those listed in 42 U.S.C. 300aa–14(b)) that happens within 7 days of a vaccine or within a longer time if the Table or section says so, any serious reaction listed in the vaccine’s package insert, and other items the Secretary may require. Reporting began 90 days after December 22, 1987, and the Secretary had to issue additional rules within 180 days of that date. Reports must include the time periods when problems occurred and the vaccine maker and lot number. Identifying information held by federal, state, or local governments may only be given to the person who got the vaccine or that person’s legal representative. “Identifying information” means name, street address, phone number, and the person’s medical records about the vaccine. It does not include the State or locality of vaccination, the vaccinator’s name, the vaccination date, or details about reported illnesses, injuries, symptoms, or deaths. Except for identifying details, the rest of the reported information is public.