§300aa–25 Recording and reporting of information

Summary

Health care providers who give any vaccine on the Vaccine Injury Table must write certain details in the patient’s permanent medical record or in a permanent office file a legal representative can view. They must record the date the vaccine was given, the vaccine manufacturer and lot number, the name and address (and job title if needed) of the person who gave the vaccine, and any other identifying vaccine information required by rules. Health care providers and vaccine manufacturers must report to the Secretary any event listed in the Vaccine Injury Table that happens within 7 days (or within a longer time shown in the Table or law), any reaction listed as a contraindication in the vaccine maker’s package insert, and other items the Secretary may require. Reports must state when after the shot the illness, injury, symptoms, or death occurred and include the maker and lot number. The Secretary had to issue the required rules within 180 days of December 22, 1987. Records held by the government that can identify a person may only be given to that person or their legal representative. “Identify” means the person’s and legal representative’s name, street address, phone number, and the medical records about the vaccine. Except for those identifying details, reported information is available to the public.