{"package_id":"USCOURTS-cofc-1_13-vv-00799","decision_granule_id":"USCOURTS-cofc-1_13-vv-00799-3","petitioner_identifier":"J. F.","is_minor":1,"age_at_vaccination":14.09,"age_unit_raw":"years","vaccine_type":"Tdap","vaccination_date":"2011-06-18","condition_raw":"autoimmune/inflammatory syndrome induced by adjuvants (‘ASIA’) with associated symptoms","condition_category":"other","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2022-10-07","extraction_version":"gemini-v2","extracted_at":"2026-04-30T04:41:02.612650+00:00","number_of_concurrent_vaccines":1,"dose_number":null,"time_to_onset_days":0,"theory_of_causation":"Petitioner J. F., born May 19, 1997, received a Tdap vaccination on June 18, 2011. The petition alleged that this vaccination caused autoimmune/inflammatory syndrome induced by adjuvants (ASIA), a condition not listed on the Vaccine Injury Table. Petitioner's expert, Dr. Yehuda Shoenfeld, opined that the aluminum adjuvant in the Tdap vaccine triggered ASIA, a syndrome he described as a collection of symptoms and signs in a genetically susceptible person that precedes a full-blown autoimmune disease. Respondent's experts, Drs. Edward W. Cetaruk, J. Lindsay Whitton, and Carlos D. Rose, challenged the scientific validity and medical recognition of ASIA, arguing that its diagnostic criteria were overly broad and lacked scientific support. The Special Master found that petitioner failed to establish a sound and reliable medical theory of causation under Althen prong one, concluding that ASIA is not a recognized medical condition and that the link between the vaccine's adjuvant and petitioner's symptoms was not persuasively demonstrated. The petition was denied. Petitioner was represented by Renee J. Gentry, and respondent by Jennifer Leigh Reynaud. Special Master Daniel T. Horner issued the decision on October 7, 2022.","is_death":0,"date_of_death":null,"petition_filed_date":"2013-10-15","case_summary":"On October 15, 2013, J. F., born May 19, 1997, through her parents, filed a petition alleging anaphylaxis as an injury caused by a Tetanus diphtheria acellular pertussis (Tdap) vaccination received on June 18, 2011. The petition was later amended on February 21, 2014, to allege autoimmune/inflammatory syndrome induced by adjuvants (ASIA) with associated symptoms, a condition not listed on the Vaccine Injury Table. As ASIA is an \"off-Table\" condition, J. F. bore the burden of proving causation-in-fact under the Althen test. Petitioner's medical records detail a complex and lengthy history of various symptoms including headaches, fatigue, joint pain, gastrointestinal issues, and neurological complaints, with numerous specialists consulted over several years. Petitioner's expert, Dr. Yehuda Shoenfeld, opined that J. F. suffered from ASIA, triggered by the aluminum adjuvant in the Tdap vaccine. Respondent's experts, Drs. Edward W. Cetaruk, J. Lindsay Whitton, and Carlos D. Rose, contested the validity of ASIA as a medical diagnosis and theory of causation, citing its lack of recognition in the medical community, broad and shifting diagnostic criteria, and insufficient scientific support. The Special Master found that petitioner failed to establish a sound and reliable medical theory of causation under Althen prong one, as ASIA was not a recognized medical condition and the link between the Tdap vaccine's adjuvant and petitioner's symptoms was not persuasively demonstrated. Consequently, the petition was denied. Petitioner was represented by Renee J. Gentry of the Vaccine Injury Clinic, George Washington University Law School, and respondent was represented by Jennifer Leigh Reynaud of the U.S. Department of Justice. The decision was issued by Special Master Daniel T. Horner on October 7, 2022, and was reissued in redacted form on the same date.","is_minor_inferred":0,"is_pediatric_broad":1,"special_master":"Daniel T. Horner","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Renee J. Gentry","petitioner_attorney_firm":"Vaccine Injury Clinic, George Washington University Law School","petitioner_attorney_location":"Washington, DC","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|renee-gentry|","firm_canonical_key":"vaccine-injury-clinic-george-washington-university-law-school","package_title":"F. v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00799","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00799.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_13-vv-00799.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_13-vv-00799-0","title":"F. v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 02/22/2016) regarding 60 DECISION of Special Master - Interim Attorney's Fees Signed by Special Master Laura D Millman. (tlf) Copy to parties.","date_issued":"2016-03-16","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"},{"granule_id":"USCOURTS-cofc-1_13-vv-00799-1","title":"F. v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 04/24/2017) regarding 87 DECISION of Special Master - Interim Attorney's Fees Signed by Special Master Laura D Millman. (tlf) Copy to parties.","date_issued":"2017-05-26","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"},{"granule_id":"USCOURTS-cofc-1_13-vv-00799-2","title":"F. v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 8/25/2020) regarding 143 DECISION of Special Master - Interim Attorney's Fees. Signed by Special Master Daniel T. Horner. (tkp) Service on parties made.","date_issued":"2020-09-21","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"},{"granule_id":"USCOURTS-cofc-1_13-vv-00799-3","title":"F. v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 9/09/2022) regarding 203 DECISION of Special Master. Signed by Special Master Daniel T. Horner. (mly) Service on parties made.","date_issued":"2022-10-07","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_13-vv-00799/granules/USCOURTS-cofc-1_13-vv-00799-3/pdf","pdf_bytes":662570,"triage_decision":"keep","triage_reason":"docketText matches keep keyword 'decision of special master'","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_13-vv-00799/USCOURTS-cofc-1_13-vv-00799-3"},{"granule_id":"USCOURTS-cofc-1_13-vv-00799-4","title":"F. v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 10/31/2023) regarding 213 DECISION of Special Master - Fees Signed by Special Master Daniel T. Horner. (jm) Service on parties made.","date_issued":"2023-12-07","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"}]}