Tamara Chavez, Parent of T.C. v. HHS - DTaP, early infantile epilepsy/epileptic encephalopathy, intractable seizures, GERD, global developmental delay, neurological movement disorder (2022)

On November 9, 2016, Tamara Chavez filed a petition under the National Vaccine Injury Compensation Program on behalf of her minor child, T.C. The petition alleged that Pediarix (containing diphtheria-tetanus-acellular pertussis, hepatitis B, and inactivated poliovirus), pneumococcal conjugate, Haemophilus influenzae type b (Hib), and rotavirus vaccinations administered on November 13, 2013, caused T.C. to develop early infantile epilepsy resulting in encephalopathy, intractable seizures, gastroesophageal reflux, global developmental delay, and a neurological movement disorder.

Respondent argued against compensation. Special Master Nora Beth Dorsey denied entitlement on July 19, 2022, finding that the petitioner had not proven by a preponderance of the evidence that the vaccinations caused T.C.'s condition.

T.C. was born on September 9, 2013. She received her first vaccination, hepatitis B, on September 13, 2013, without noted adverse reaction.

She received a second hepatitis B vaccine on October 25, 2013, also without noted adverse reaction. On November 13, 2013, at her two-month visit, T.C. received Pediarix, pneumococcal conjugate, Hib, and rotavirus vaccines, with no immediate adverse reaction noted.

On December 14, 2013, T.C. presented with constipation, feeding difficulties, and exotropia, though her neurological exam was normal. On January 13, 2014, she received DTaP, Hib, and rotavirus vaccines, with her development noted as age-appropriate but with congestion and exotropia.

On January 20, 2014, she received the IPV vaccine. Later in January 2014, T.C.'s condition changed.

On January 26, 2014, she was seen for crying spells and a low-grade fever, diagnosed with an upper respiratory infection. On January 29, she presented with congestion, ophthalmology concerns, and head lag.

On January 30, she experienced an episode of body tensing during feeding, described as constant twitching or shivering movements that had reportedly occurred since birth. She was observed thrashing and not making eye contact.

EEG testing revealed markedly abnormal activity consistent with epileptiform activity. Brain CT and MRI scans were unremarkable.

T.C. was diagnosed with new-onset epilepsy, later refractory epilepsy, and treated with various medications. Over time, she developed infantile spasms, severe diffuse epileptic encephalopathy, dysphagia, GERD, global developmental delay, feeding problems requiring tube placement, and ventilator dependence.

Genetic testing identified a maternally inherited chromosome 9 deletion of uncertain significance involving PSAT1. Later testing revealed a de novo GABRB2 missense variant, P252L, also of uncertain clinical significance.

Literature indicated that GABRB2 variants can be associated with developmental and epileptic encephalopathy. Petitioner's expert, Dr.

Alan S. Levin, opined that vaccine antigens and adjuvants caused proinflammatory cytokine release, compromised the blood-brain barrier, and lowered neuronal seizure thresholds, triggering T.C.'s seizure disorder, which he believed had a genetic propensity.

He argued that symptoms began after vaccinations, though his timing opinions shifted and sometimes relied on incorrect vaccination dates. Respondent's expert, Dr.

Max Wiznitzer, disagreed, stating that routine vaccination does not produce sufficient cytokine activity to compromise the blood-brain barrier or cause epileptic encephalopathy. He found T.C.'s course more consistent with a genetic epileptic encephalopathy from the GABRB2 variant, noting that her symptoms predated significant post-vaccination windows and coincided with an upper respiratory infection.

Special Master Dorsey denied entitlement, finding that petitioner failed to establish a reliable medical theory connecting the vaccinations to T.C.'s seizure disorder and encephalopathy (Althen Prong One). She found no logical sequence of cause and effect, noting that treating physicians did not attribute T.C.'s condition to vaccination, and that an upper respiratory infection and the GABRB2 abnormality were competing explanations (Althen Prong Two).

She also found that T.C.'s abnormal movements were present since birth and that exotropia, noted before the onset of significant seizure activity, occurred outside a medically appropriate vaccine-causation window (Althen Prong Three). The petition was dismissed, and no compensation was awarded.

Petitioner was represented by Patricia Finn of Patricia Finn, P.C., and respondent was represented by Andrew Henning.