42 U.S.C. § 300aa–25 — Recording and reporting of information

submitted 82 years ago by Pub. L. 99-660 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 521 words · no verdicts yet

in plain englishAI-generated · not legal advice

Health care providers must record details every time they give a listed vaccine, like the date, manufacturer, lot number, and who gave it. Providers and manufacturers must report certain bad reactions to the Secretary. Personal identifying information stays private, but most other vaccine information is public.

(a) General rule: Every health care provider who gives a vaccine listed in the Vaccine Injury Table must record, in the patient's permanent medical record (or a permanent office log the patient's legal representative can ask to see): (1) the date the vaccine was given; (2) the vaccine's manufacturer and lot number; (3) the name, address, and (if relevant) title of the provider who gave it; and (4) any other identifying details about the vaccine the Secretary requires by regulation. (b) Reporting: (1) Every health care provider and vaccine manufacturer must report to the Secretary: (A) any reaction listed in the Vaccine Injury Table — including the reactions in section 300aa–14(b) — that happens within 7 days of getting a listed vaccine, or within a longer period if the Table or that section sets one; (B) any reaction to a vaccine that the manufacturer's own package insert warns could happen; and (C) anything else the Secretary requires by regulation. Reports under (A) and (B) had to start 90 days after December 22, 1987, and the Secretary had to publish a notice of this reporting duty in the Federal Register as soon as practical. (2) A report about a vaccine must include the time period after the vaccine was given during which the illness, disability, injury, condition, or death (and its symptoms) happened, plus the vaccine's manufacturer and lot number. (3) The Secretary had to issue the regulations mentioned in (1)(C) within 180 days of December 22, 1987. (c) Release of information: (1) Information the federal, state, or local government holds under this section that could identify a person cannot be released under section 552 of title 5 (the public records law) or otherwise — except to (A) the person who got the vaccine, or (B) that person's legal representative. (2) For this rule, "information which may identify an individual" means only the name, address, and phone number of the vaccinated person and their legal representative, plus that person's medical records about the vaccination. It does not include the place and state where the vaccine was given, the provider's name, the vaccination date, or information about any resulting illness, injury, or death and its symptoms. (3) Except as described in (1), all information reported under this section must be made available to the public.

the actual law source: uscode.house.gov ↗public domain

(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, and

(4)

any other identifying information on the vaccine required pursuant to regulations promulgated by the Secretary.

(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, and

(C)

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.

(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.

Source credit: (July 1, 1944, ch. 373, title XXI, § 2125, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3774; amended Pub. L. 100–203, title IV, § 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)

history & why it existsrecord from the source credit

1944Enacted · Pub. L. 99-660 · 100 Stat. 3774
1987Amended · Pub. L. 100-203 · 101 Stat. 1330

A history note hasn’t been published yet. The record shows enactment by Pub. L. 99-660 on 1944-07-01.

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