Michael Wakileh v. HHS - Tdap, significant aggravation of multiple sclerosis (MS) (2025)

On March 30, 2021, Michael Wakileh filed a petition under the National Vaccine Injury Compensation Program, alleging that a Tdap vaccination administered on April 25, 2018, significantly aggravated his pre-existing Multiple Sclerosis (MS). Respondent argued against compensation, stating the case was not appropriate for compensation under the Vaccine Act.

The Special Master found that Petitioner failed to prove by a preponderance of the evidence that the Tdap vaccination significantly aggravated his MS, and thus, the petition was dismissed. Petitioner and Respondent agreed that Petitioner had MS prior to the vaccination, but disputed all six factors outlined in Loving v.

Secretary of Health & Human Services. Respondent specifically disagreed that Petitioner demonstrated a significant aggravation, that the Tdap vaccine could aggravate MS, or that there was a proximate temporal relationship between the vaccination and a significant aggravation.

Petitioner's medical records prior to vaccination were sparse, consisting of only two visits for unrelated issues. On April 25, 2018, Petitioner received a Tdap vaccine following a cat bite.

Three weeks later, on May 16, 2018, Petitioner sought care for dizziness and gait instability, attributing these symptoms to the vaccine. His examination showed a positive Romberg's sign and diminished sensation on his face, but normal reflexes and strength.

A VAERS report noted dizziness, altered gait, and decreased sensation, but stated all tests and examinations showed no deficits. Petitioner's initial declarations claimed immediate onset of symptoms, but he later retracted these statements, admitting he took liberties to make his condition appear worse and that symptoms appeared three or more days after vaccination.

The Special Master gave little weight to Petitioner's declarations due to inconsistencies and retractions, relying instead on medical records. Petitioner's first objective neurological symptom, nystagmus, was documented on March 7, 2019, ten months after vaccination.

An MRI on May 6, 2019, showed extensive MS lesions, some enhancing, consistent with active inflammation and end-stage MS. Petitioner's treating neurologist, Dr.

Sy, opined on July 29, 2019, that the Tdap shot was most likely related to the worsening of MS, but this opinion was based on Petitioner's history and not supported by a complete clinical history. Petitioner's expert, Dr.

William L. Conte, opined that the Tdap vaccination causally triggered symptoms and clinical worsening of MS, suggesting molecular mimicry as a mechanism.

Respondent's expert, Dr. Harold Moses, Jr., opined that the Tdap vaccination did not trigger or worsen Petitioner's MS, finding no evidence to support the claim and attributing the progression to the natural history of untreated MS.

Dr. Moses noted that Petitioner's first objective neurological symptom occurred ten months post-vaccination, which he deemed too late for a causal association.

The Special Master found that Petitioner failed to provide a sound and reliable medical theory explaining how the Tdap vaccine could significantly aggravate MS, rejecting the molecular mimicry theory as insufficient without specific linkage to the Tdap vaccine and Petitioner's condition. The Special Master also found that Petitioner failed to establish a logical sequence of cause and effect and a proximate temporal relationship, as the first objective neurological symptom appeared ten months after vaccination, and active lesions on MRI resolve within weeks, making them unlikely to be related to the vaccination over a year later.

Consequently, the petition was denied and dismissed.