Valeria Hernandez v. HHS - DTaP, seizures leading to epilepsy (2023)

On January 30, 2017, Valeria Hernandez filed a petition on behalf of her minor daughter, S.H., alleging that vaccinations administered on May 22, 2015, caused seizures leading to epilepsy. S.H., born on January 19, 2015, received her four-month vaccines: Pediarix (containing diphtheria-tetanus-acellular pertussis, hepatitis B, and inactivated polio vaccine), Haemophilus influenzae type b (Hib), pneumococcal conjugate vaccine (Prevnar 13), and rotavirus vaccine.

S.H. had a history of a minor heart murmur and ventricular septal defect but was otherwise healthy. She had received the first doses of these vaccines at her two-month visit without incident.

Following her four-month vaccinations on May 22, 2015, S.H. reportedly experienced a seizure characterized by lip smacking, upward eye rolling, and arm and leg jerking. A second seizure-like event occurred shortly thereafter.

She was taken to an emergency department, where initial CT and laboratory tests were unremarkable. She was transferred to Kaiser Permanente Hospital, where a treating physician, Dr.

Christopher Chinnici, believed the seizures were vaccine-provoked, and neurologist Dr. Shelley Bose discussed vaccine-provoked seizures with the family.

S.H. was discharged on May 23, 2015, without further events. On May 26, 2015, S.H. experienced two more events described as eye deviation, lip smacking, and arm shaking upon waking.

She had no fever or lethargy, and her physical examination was normal. A 24-hour EEG showed no seizure activity.

Dr. Fuqua noted that these spells might or might not be seizures, as S.H. was not sleepy afterward.

S.H. was diagnosed with absence epilepsy. On May 28, 2015, she had another reported generalized tonic-clonic seizure, and phenobarbital treatment was initiated.

No further seizures were reported after May 28, 2015. Later EEG testing was normal.

In June 2015, Dr. Mi-Kyung Lee noted that the seizures persisted beyond 72 hours, initially attributed to vaccination.

Dr. Dean Sarco later suggested it was unclear if the seizures were vaccine-caused or due to mild epilepsy, suspecting an inherent increased seizure risk and recommending continued phenobarbital.

Genetic testing was normal. S.H. was weaned off phenobarbital in 2016, and later records did not indicate seizure-related developmental delay.

Petitioner's expert, pediatric neurologist Dr. Marcel Kinsbourne, focused on the DTaP component of Pediarix.

He proposed a cytokine-driven inflammatory response that lowered S.H.'s seizure threshold, causing afebrile seizures. He cited the close timing to vaccination, literature on post-vaccination seizures, and the concept that seizures can promote further seizures through inflammation.

Respondent's experts, pediatric neurologist Dr. Gregory Holmes and immunologist/pathologist Dr.

Herman Staats, contested these claims. Dr.

Holmes questioned whether the events were epileptic seizures, citing normal EEGs and lack of corroborating tests, and stated there was no evidence vaccines cause afebrile seizures without fever or susceptibility. Dr.

Staats argued that the proposed IL-1 beta/cytokine mechanism was biologically implausible for a one-hour onset, as vaccine-induced cytokine responses typically peak later. Special Master Daniel T.

Horner found that S.H. met the six-month severity requirement due to her extended phenobarbital treatment, indicating a medical judgment of ongoing vulnerability. However, he denied entitlement, finding that the petitioner failed all three prongs of the Althen test for causation-in-fact.

He found Dr. Kinsbourne's theory for afebrile seizures without genetic susceptibility or fever insufficiently reliable.

He also found the case-specific proof relied too heavily on temporal association and that the one-hour onset was medically incompatible with the proposed mechanism. The petition was dismissed on December 15, 2023, with no compensation awarded.

Petitioner's counsel was Curtis R. Webb, and respondent's counsel was Alexa Roggenkamp.