J. F. v. HHS - Tdap, autoimmune/inflammatory syndrome induced by adjuvants (‘ASIA’) with associated symptoms (2022)

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 September 9, 2022, and was reissued in redacted form on the same date.