Brenda Rae Smith v. HHS - Influenza, septic shock, neuropathy, and toxic encephalopathy (2022)

Brenda Rae Smith, a 46-year-old adult, filed a petition on October 25, 2018, alleging that the influenza vaccine she received on November 4, 2015, caused her to develop septic shock, neuropathy, and toxic encephalopathy. Ms.

Smith represented herself in this matter. The Secretary of Health and Human Services recommended that compensation be denied, stating that Ms.

Smith's claims lacked supporting evidence. After multiple status conferences and submissions of medical records, the case proceeded to adjudication.

The Special Master reviewed Ms. Smith's medical history, which included conditions such as attention deficit hyperactivity disorder, depression, anxiety, post-traumatic stress disorder, anemia, and prior hospitalizations for anxiety-related issues.

She underwent a paraesophageal hernia repair on October 20, 2015. During a hospitalization beginning November 2, 2015, Ms.

Smith was diagnosed with a tension pneumothorax with hydropneumothorax, which was treated by draining pus. A CT scan revealed upper abdominal gas, a fluid collection, an enlarged liver, hepatic steatosis, and a splenic laceration, attributed by her physician to the hiatal hernia.

She experienced confusion and agitation. On November 4, 2015, she received an influenza vaccine.

Her blood and pleural fluid cultures were positive for Beta Hemolytic Streptococcus. She experienced improvement but complained of right thigh pain seven days after the vaccination, which she attributed to an injection, though medical staff found no needle.

She was discharged on November 14, 2015, with diagnoses including left chest empyema, left chest pneumothorax, intra-abdominal abscess, leukocytosis, and anemia. Three days later, she was readmitted after being found unresponsive, with a report of an empty narcotic pain medication bottle.

The attending physician noted her condition was consistent with an opiate overdose. Her diagnoses included toxic encephalopathy, sepsis, abdominal abscess, anxiety, major depressive disorder, acute renal failure, and streptococcal bacteremia.

She was discharged on November 30, 2015, with gabapentin prescribed. Ms.

Smith asserted that her medical treatment costs exceeded $200,000. Subsequent medical records from December 2015 through October 2020 documented ongoing issues including abdominal pain, shortness of breath, chest discomfort, fatigue, renal failure, impaired cognition, lethargy, sepsis, streptococcal bacteremia, anxiety, radicular leg pain, paresthesias, insomnia, and chronic pain syndrome.

Some records noted encephalopathy due to infection, while later records from Dr. Scott Ecklund in 2018 listed the influenza vaccine under "allergies" with "encephalitis" and "neuropathy" as reported reactions, though the basis for these notations was not discussed.

Ms. Smith stated to Dr.

Ecklund that a rehab doctor felt her encephalopathy was vaccine-related. The Special Master applied the Althen standard for off-Table claims, requiring a medical theory connecting the vaccine to the injury, a logical sequence of cause and effect, and a proximate temporal relationship.

The Special Master found that Ms. Smith failed to provide a medical theory causally connecting the flu vaccine to her alleged injuries of septic shock, neuropathy, or toxic encephalopathy.

Treating physicians attributed her septic shock and encephalopathy to causes such as an abdominal abscess and infection, not the vaccine. While Ms.

Smith experienced right thigh pain six days after vaccination, this temporal association alone was insufficient to establish causation, especially without a medical theory or expert testimony. Similarly, her neuropathy and toxic encephalopathy claims lacked the required medical theory and logical sequence of cause and effect.

The Special Master concluded that Ms. Smith did not meet her burden of proof by a preponderance of the evidence and denied her petition for compensation.

Petitioner was represented pro se, and respondent was represented by Christine Becer of the United States Department of Justice. Special Master Christian J.

Moran issued the decision.