E.R. v. HHS - MMR, reactivation of varicella virus (2021)

On February 2, 2015, James and Brandy Riley filed a petition on behalf of their daughter, E.R., alleging that she suffered from the reactivation of the varicella virus due to three vaccines administered on February 20, 2012: varicella, measles-mumps-rubella (MMR), and diphtheria-tetanus-acellular pertussis (DTaP). E.R., who was four years old at the time, developed a red blister on her upper lip eleven days after vaccination, which persisted and was diagnosed by her pediatrician as a likely herpes simplex virus (HSV) infection, or "fever blister." Over the next year, E.R. continued to suffer from recurrent blistering outbreaks around her mouth and nose, leading to an immunology evaluation.

Petitioners argued that these blisters were a vaccine-induced varicella reactivation. The respondent, the Secretary of Health and Human Services, contended that the evidence preponderated in favor of an HSV infection, citing the diagnoses of treating physicians, the response to acyclovir treatment, and the clinical presentation being more consistent with HSV.

The public decision does not describe the specific onset of symptoms beyond the initial blister appearing approximately one to two days after vaccination. Diagnostic testing for HSV, including PCR and antibody tests, was often inconclusive or negative.

Similarly, testing for varicella-zoster virus (VZV) was negative. E.R. was noted to have a functional Natural Killer (NK) cell deficiency, which both parties' experts agreed predisposed her to recurrent viral infections, particularly HSV.

Petitioner's expert, Dr. Vera Byers, opined that the vaccines likely caused or contributed to E.R.'s chronic HSV infection, suggesting the varicella component of the Proquad vaccine played a role, possibly by triggering a latent vaccine strain of VZV.

Respondent's expert, Dr. Hayley Gans, countered that E.R.'s presentation was most consistent with HSV due to her immunodeficiency and the typical presentation of HSV reactivation, which commonly occurs in the orolabial area and responds to acyclovir.

Dr. Gans also argued that VZV reactivation typically presents differently and has a longer onset timeframe after vaccination than observed in E.R.'s case.

Chief Special Master Brian H. Corcoran reviewed the briefs and medical records.

He found that the evidence preponderated in favor of E.R. suffering from an HSV infection, not varicella reactivation. Special Master Corcoran noted that while HSV testing was inconclusive, the clinical diagnoses by multiple treating physicians, coupled with the response to acyclovir treatment calibrated for HSV, supported this conclusion.

He also found that the timing of E.R.'s symptoms, appearing one to two days post-vaccination, was not a medically acceptable timeframe for varicella reactivation, distinguishing it from prior cases where compensation was awarded for varicella reactivation. The Special Master concluded that Petitioners failed to establish that E.R. suffered from a varicella infection or reactivation, and therefore failed to prove causation.

The claim was dismissed on the papers without a hearing. Petitioner's counsel was Mark Sadaka of Sadaka Associates LLC.

Respondent's counsel was Lara Englund of the U.S. Dep’t of Justice.