---
kind: "section"
citation: "42 U.S.C. § 300aa–25"
title: "42"
title_heading: "The Public Health and Welfare"
number: "300aa–25"
heading: "Recording and reporting of information"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/300aa-25"
units:
  - "Chapter 6A — Public Health Service"
  - "Subchapter XIX — Vaccines"
  - "Part 2"
  - "Subpart c — assuring a safer childhood vaccination program in united states"
---

# §300aa–25. Recording and reporting of information

- (a) **General rule—** Each [health care provider](/usc/42/300aa–33.md?p=1) who administers a vaccine set forth in the [Vaccine Injury Table](/usc/42/300aa–33.md?p=6-B) 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](/usc/42/300aa–33.md?p=2) shall have access upon request) with respect to each such vaccine—
  - (1) the date of administration of the vaccine,
  - (2) the vaccine [manufacturer](/usc/42/300aa–33.md?p=3) and lot number of the vaccine,
  - (3) the name and address and, if appropriate, the title of the [health care provider](/usc/42/300aa–33.md?p=1) administering the vaccine, and
  - (4) any other identifying information on the vaccine required pursuant to [regulations](/usc/42/201.md?p=d) promulgated by the [Secretary](/usc/42/201.md?p=c).
- (b) **Reporting—**
  - (1) Each [health care provider](/usc/42/300aa–33.md?p=1) and vaccine [manufacturer](/usc/42/300aa–33.md?p=3) shall report to the [Secretary](/usc/42/201.md?p=c)—
    - (A) the occurrence of any event set forth in the [Vaccine Injury Table](/usc/42/300aa–33.md?p=6-B), including the events set forth in [section 300aa–14(b) of this title](/usc/42/300aa–14.md?p=b) 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](/usc/42/300aa–33.md?p=3)’s package insert, and
    - (C) such other matters as the [Secretary](/usc/42/201.md?p=c) may by regulation require.

    Reports of the matters referred to in subparagraphs [(A)](#b-1-A) and [(B)](#b-1-B) shall be made beginning 90 days after December 22, 1987. The [Secretary](/usc/42/201.md?p=c) 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)](#b-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](/usc/42/300aa–33.md?p=3) and lot number of the vaccine.
  - (3) The [Secretary](/usc/42/201.md?p=c) shall issue the [regulations](/usc/42/201.md?p=d) referred to in [paragraph (1)(C)](#b-1-C) within 180 days of December 22, 1987.
- (c) **Release of information—**
  - (1) Information which is in the [possession](/usc/42/201.md?p=g) of the Federal Government and [State](/usc/42/201.md?p=f) and local governments under this section and which may identify an individual shall not be made available under [section 552 of title 5](/usc/5/552.md), or otherwise, to any person except—
    - (A) the person who received the vaccine, or
    - (B) the [legal representative](/usc/42/300aa–33.md?p=2) of such person.
  - (2) For purposes of [paragraph (1)](#c-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](/usc/42/300aa–33.md?p=2) and the medical records of such person relating to the administration of the vaccine, and shall not include the locality and [State](/usc/42/201.md?p=f) of vaccine administration, the name of the [health care provider](/usc/42/300aa–33.md?p=1) 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)](#c-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.)

## Notes

### Editorial Notes

### Codification

In subsec. (b)(1), (3), “December 22, 1987” was substituted for “the effective date of this subpart” on authority of section 323 of Pub. L. 99–660, as amended, set out as an Effective Date note under section 300aa–1 of this title.

### Amendments

1987—Subsec. (b)(1), (3). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.

### Statutory Notes and Related Subsidiaries

### Effective Date

Subpart effective Dec. 22, 1987, see section 323 of Pub. L. 99–660, set out as a note under section 300aa–1 of this title.