42 U.S.C. § 300aa: Recording and reporting of information

the date of administration of the vaccine, the vaccine manufacturer and lot number of the vaccine, the name and address and, if appropriate, the title of the health care provider administering the vaccine, and any other identifying information on the vaccine required pursuant to regulations promulgated by the Secretary. the occurrence of any event set forth in the Vaccine Injury Table, including the events set forth in section 300aa–14(b) of this title which occur within 7 days of the administration of any vaccine set forth in the Table or within such longer period as is specified in the Table or section, the occurrence of any contraindicating reaction to a vaccine which is specified in the manufacturer’s package insert, and such other matters as the Secretary may by regulation require. A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of such vaccine within which vaccine-related illnesses, disabilities, injuries, or conditions, the symptoms and manifestations of such illnesses, disabilities, injuries, or conditions, or deaths occur, and the manufacturer and lot number of the vaccine. The Secretary shall issue the regulations referred to in paragraph (1)(C) within 180 days of December 22, 1987 . the person who received the vaccine, or the legal representative of such person. For purposes of paragraph (1), the term “information which may identify an individual” shall be limited to the name, street address, and telephone number of the person who received the vaccine and of that person’s legal representative and the medical records of such person relating to the administration of the vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider who administered the vaccine, the date of the vaccination, or information concerning any reported illness, disability, injury, or condition resulting from the administration of the vaccine, any symptom or manifestation of such illness, disability, injury, or condition, or death resulting from the administration of the vaccine. Except as provided in paragraph (1), all information reported under this section shall be available to the public.