Gloria Massey Chinea v. HHS - Influenza, Guillain-Barré syndrome (GBS), Miller-Fisher variant (2019)

On March 15, 2019, Gloria Massey Chinea filed a petition alleging that she developed Guillain-Barré syndrome (GBS), Miller-Fisher variant, as a result of receiving an influenza vaccine on October 31, 2012. Petitioner was born on July 7, 1956.

Prior to the vaccination, Petitioner had a history of high cholesterol, hypertension, asthma, type 2 diabetes, and conductive hearing loss. She also experienced symptoms such as blurred vision, impaired hearing, urinary incontinence, leg pain, depression, stress, premenstrual tension syndrome, and fatigue in the year leading up to the vaccination.

In July 2012, she was diagnosed with shingles and treated with acyclovir and prednisone, followed by treatment for post-herpetic neuralgia in August 2012. On October 31, 2012, Petitioner received the Fluvirin influenza vaccine.

The contemporaneous medical records did not indicate any adverse reaction to the vaccine at that time. Petitioner saw her gynecologist on December 10, 2012, for an annual exam, and the records from this visit noted no complaints of weakness, fatigue, or other GBS precursors.

Petitioner's GBS symptoms began around January 28, 2013, with profound weakness, headaches, dizziness, balance issues, congestion, and voice problems. She presented to the emergency room on January 31, 2013, with generalized weakness, slurred speech, slow movements, absent deep tendon reflexes, and paresthesia of the hands and feet.

She was diagnosed with acute respiratory failure, intubated, and later diagnosed with GBS, Miller-Fisher variant. She tested positive for the GQ1B antibody and was treated with IVIG.

Petitioner was discharged on March 23, 2013, having made good progress. Petitioner alleged that her symptoms began earlier, around Thanksgiving 2012 (approximately November 22, 2012), or even earlier in November, citing fatigue, arm pain, voice hoarseness, difficulty swallowing, leg jerks, blurred vision, and tingling in her hands and toes.

Fact witnesses, including her husband, a social friend, her mother's doctor, and a professional acquaintance, testified to observing these symptoms in Petitioner during the fall and early winter of 2012. Petitioner's expert, Dr.

Lawrence Steinman, opined that the flu vaccine caused her GBS and that a "smoldering" or subacute form of GBS could explain the delayed onset, with symptoms beginning around Thanksgiving 2012 and progressing over several weeks. He proposed a molecular mimicry mechanism involving the hemagglutinin component of the vaccine.

Respondent's expert, Dr. Peter Donofrio, disagreed, attributing Petitioner's condition to a pre-existing upper respiratory tract infection or asthma attack and stating that the prolonged interval between vaccination and symptom onset was too long to support a vaccine causation theory.

Dr. Donofrio emphasized that GBS is typically an acute-onset disease with symptoms manifesting within six to eight weeks of vaccination, and Petitioner's alleged onset was nearly three months later.

Special Master Brian H. Corcoran found that while Petitioner experienced fatigue and other symptoms in the fall of 2012, these were not established as GBS-related or as the onset of GBS.

The Special Master found that Petitioner failed to establish that her GBS symptoms began within a medically reasonable timeframe following vaccination, as the onset was too remote from the vaccination date. The Special Master also found Dr.

Steinman's theory of a "smoldering" GBS unpersuasive and not supported by the medical literature. The petition for entitlement was denied.

The decision was later reviewed by Judge Elaine D. Kaplan, who affirmed the Special Master's decision.