Jessica Graffeo v. HHS - Influenza, acute respiratory failure, pneumonia, coma, death (2016)

Sheila Graffeo filed a petition on behalf of her deceased daughter, Jessica Graffeo, on December 17, 2013, seeking compensation under the National Vaccine Injury Compensation Program. The petition alleged that Jessica's acute respiratory failure, pneumonia, coma, and death were caused by her receipt of a Pneumovax 23 and an influenza (flu) vaccine on December 14, 2011.

Jessica was 26 years old at the time of vaccination and had a history of poorly controlled, insulin-dependent diabetes since childhood. The petitioner requested a ruling on the record as it existed.

The Special Master reviewed the medical records, which indicated that Jessica had been hospitalized on December 13, 2011, with nausea and vomiting, and was diagnosed with uncontrolled diabetes mellitus with ketoacidosis. She received the flu and pneumococcal vaccinations prior to discharge on December 14, 2011.

Four days later, on December 18, 2011, Jessica returned to the hospital with shortness of breath and fever, diagnosed with pneumonia, diabetic ketoacidosis, hypotension, and uncontrolled diabetes. She was intubated and transferred to another hospital, where her condition was assessed as acute respiratory failure with acute lung injury, possible ARDS, possible healthcare-acquired pneumonia with sepsis, acute renal failure, shock, SIRS, and elevated liver function tests.

The medical records from this hospitalization did not connect her condition to the flu vaccine. Jessica was discharged on February 6, 2012, with diagnoses of acute respiratory failure (resolved), Type 1 diabetes, and hypothyroidism.

Her rehabilitation diagnosis noted "debilitation following diabetic ketoacidosis resulting in an ICU stay and mechanical ventilation due to respiratory failure," with a contributing factor of a "long history of poorly controlled type 1 diabetes." No mention of the flu vaccine's role was made in these records. Jessica's medical history from 2012 through 2013 was marked by repeated hospitalizations and emergency room visits for symptoms similar to her previous ones, including renal failure, and she often failed to comply with dialysis treatments and insulin regimens.

She was last hospitalized on October 25, 2013, with acute DKA, progressing to hypotension and sepsis, requiring intubation. She passed away on November 2, 2013, after signing a "do not resuscitate" order.

The petitioner did not provide an expert report. Her own review of the record mentioned Acute Respiratory Distress Syndrome (ARDS) and Guillain-Barre Syndrome (GBS) as potential vaccine-related conditions, but the medical records did not support GBS as a diagnosis, and the information provided did not establish a causal link between the flu vaccine and Jessica's specific symptoms or death.

The respondent argued that the petitioner failed to meet the burden of proof under the Althen standard, asserting that no treating physician linked the vaccine to the injuries, Jessica's underlying diabetes was the more likely cause of her conditions, and the temporal relationship between the vaccination and her death was not medically acceptable. The Special Master found that the petitioner failed to establish a medical theory connecting the flu vaccine to Jessica's injuries, a logical sequence of cause and effect, or a proximate temporal relationship.

The Special Master noted that none of Jessica's treating physicians connected her illness or death to the flu vaccine and that her underlying health issues, particularly her diabetes, were the more likely cause of her symptoms and death. The petition was denied, and the case was dismissed.

Petitioner's counsel was Sheila Graffeo, pro se. Respondent's counsel was Gordon E.

Shemin. Special Master Brian H.

Corcoran issued the decision on April 20, 2016.