Z.S. v. HHS - DTaP, death (2022)

On December 10, 2015, Carla Adal and Matthew Shiel, as parents of the deceased minor Z.S., filed a petition for compensation under the National Vaccine Injury Compensation Program. They alleged that Z.S. received pneumococcal conjugate (PCV13), haemophilus B conjugate (HiB-OMP), and diphtheria-tetanus-acellular-pertussis, hepatitis B, and inactivated polio (DTaP-HepB-IPV) vaccines on November 18, 2014, and subsequently died on November 19, 2014.

Initially alleging causation-in-fact, the petitioners later clarified their request for entitlement based on a Vaccine Table encephalopathy. Z.S., a healthy 15-month-old infant, received her vaccinations around 9:30 a.m. on November 18, 2014.

Her parents reported that she was fussier than normal, lethargic, and seemed to be in pain, napping longer than usual. She was given Children's Tylenol for a fever.

The following morning, November 19, 2014, at 7:36 a.m., Ms. Adal called 911 reporting Z.S. was not breathing.

Upon arrival, emergency medical services found Z.S. unresponsive with signs of death, including dependent lividity and rigor mortis. An autopsy revealed moderate cerebral edema, but the cause and manner of death were listed as undetermined, with no unequivocal link to the vaccinations.

Petitioners' expert, Dr. Janice Ophoven, a pediatric forensic pathologist, opined that Z.S. suffered from an acute encephalopathy due to cerebral edema, which she considered a disease of the brain and a Table injury.

She based this on the autopsy findings of brain swelling, spongiosis, and the timing of the death relative to vaccination, while dismissing other potential causes like viral infection or positional asphyxia. Respondent's experts, Dr.

Sara Vargas, a pediatric pathologist, Dr. Sandra Alexandrescu, a pediatric neuropathologist, and Dr.

Max Wiznitzer, a pediatric neurologist, contested this opinion. They argued that the cerebral edema was likely postmortem, that Z.S. did not exhibit the clinical signs of a Table encephalopathy, such as a significantly decreased level of consciousness, and that other potential causes, including viral infection and asphyxia, were more likely.

Dr. Vargas noted signs suggestive of asphyxia and evidence of viral infection in the lungs.

Dr. Alexandrescu concluded that the brain changes were consistent with postmortem physiological swelling and not indicative of antemortem encephalopathy.

Dr. Wiznitzer testified that Z.S.'s symptoms were consistent with common post-vaccination reactions and did not meet the criteria for Table encephalopathy, which requires a significantly decreased level of consciousness.

Special Master Herbrina Sanders found that the petitioners failed to present preponderant evidence of a Table encephalopathy. The Special Master noted that the symptoms described by the parents, such as tiredness and fussiness, were common reactions to vaccination and did not meet the criteria for significantly decreased consciousness required by the Vaccine Injury Table.

The court also found that the evidence of cerebral edema was not sufficient to establish an antemortem encephalopathy, and that the mild to moderate edema noted at autopsy was more consistent with postmortem changes. Consequently, the petition was denied and dismissed.