(a) General rule
Each health care provider who administers a vaccine set forth in
the Vaccine Injury Table to any person shall record, or ensure that
there is recorded, in such person's permanent medical record (or in
a permanent office log or file to which a legal representative
shall have access upon request) with respect to each such vaccine -
(1) the date of administration of the vaccine,
(2) the vaccine manufacturer and lot number of the vaccine,
(3) the name and address and, if appropriate, the title of the
health care provider administering the vaccine
(4) any other identifying information on the vaccine required
pursuant to regulations promulgated by the Secretary, and
(5) the age, gender, height, and weight of each person
vaccinated to calculate the body mass index of such person.
(b) Reporting
(1) Each health care provider and vaccine manufacturer shall
report to the Secretary -
(A) 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,
(B) the occurrence of any contraindicating reaction to a
vaccine which is specified in the manufacturer's package insert,
(C) the information recorded under subsection (a)(5), and
(D) such other matters as the Secretary may by regulation
require.
Reports of the matters referred to in subparagraphs (A) and (B)
shall be made beginning 90 days after December 22, 1987. The
Secretary shall publish in the Federal Register as soon as
practicable after such date a notice of the reporting requirement.
(2) 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.
(3) The Secretary shall issue the regulations referred to in
paragraph (1)(C) within 180 days of December 22, 1987.
(4) Each health provider shall also report to the relevant
department of the State in which such health care provider practices
the data collected under subsection (a)(5).
(c) Release of information
(1) Information which is in the possession of the Federal
Government and State and local governments under this section and
which may identify an individual shall not be made available under
section 552 of title 5, or otherwise, to any person except -
(A) the person who received the vaccine, or
(B) the legal representative of such person.
(2) 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.
(3) Except as provided in paragraph (1), all information reported
under this section shall be available to the public.