§300aa–25 Recording and Reporting of Information

Summary

Requires health care providers who give a vaccine on the Vaccine Injury Table to write certain details in the person’s permanent medical record (or an office file a legal representative can see). They must record 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 info the Secretary requires. Both providers and vaccine makers must report to the Secretary any event listed on the Vaccine Injury Table that happens within 7 days of vaccination (or within a longer period if the Table says so), any contraindicating reaction listed in the vaccine’s package insert, and any other things the Secretary requires. Reports must say the time periods after vaccination when illnesses, injuries, symptoms, or deaths occurred and must include the manufacturer and lot number. The Secretary had to make the rules for other required items within 180 days of December 22, 1987. Information the government has that could identify a person cannot be released to anyone except the person who got the vaccine or that person’s legal representative. Defined term — “information which may identify an individual”: the person’s name, street address, telephone number, the legal representative’s contact, and the person’s medical records about the vaccine. That term does not include the State or locality of vaccination, the vaccinator’s name, the date of vaccination, or details about reported illnesses, injuries, symptoms, or deaths. All other reported information is available to the public.