Maria Perez v. HHS - tetanus, Guillain-Barré syndrome (“GBS”) (2015)

Maria Perez, born in 1938, received a tetanus vaccination on February 2, 2009. She filed a petition alleging that this vaccination caused her to develop Guillain-Barré syndrome (GBS), specifically the axonal form.

Her medical history included diabetes, GERD, severe arthritis, hypertension, and gallbladder disease. Prior to the tetanus shot, she had been treated for a shoulder abscess, staph bacteremia, and cellulitis, and received a flu vaccination in December 2008.

Following the tetanus vaccination, she experienced symptoms including tingling, numbness, weakness, dizziness, difficulty swallowing, and double vision, leading to hospitalization and a diagnosis of GBS. The court considered two main theories: Petitioner's expert, Dr.

Steinman, proposed that the tetanus vaccine acted as a trigger for an underlying immune process, possibly related to toll-like receptors, which eventually led to GBS. Respondent's expert, Dr.

Leist, argued that Petitioner's GBS was more likely caused by a gastrointestinal illness she experienced approximately seven days before the onset of neurological symptoms. The court found that Petitioner failed to establish a legally probable medical theory connecting the tetanus vaccine to her GBS, citing a lack of scientific support for the proposed 'trigger' mechanism and an 'analytical gap' in the expert's reasoning.

The court also noted the intervening gastrointestinal illness as a more likely cause and the significant time lag of eight weeks between vaccination and symptom onset. Ultimately, the court denied the claim, finding that Petitioner did not meet the burden of proof under the Althen standard for causation.