{"package_id":"USCOURTS-cofc-1_14-vv-00848","decision_granule_id":"USCOURTS-cofc-1_14-vv-00848-0","petitioner_identifier":"Katie Smith","is_minor":0,"age_at_vaccination":23.0,"age_unit_raw":"years","vaccine_type":"Hepatitis B","vaccination_date":"2013-04-18","condition_raw":"Transverse Myelitis","condition_category":"transverse_myelitis","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2018-07-05","extraction_version":"gemini-v2","extracted_at":"2026-04-30T04:43:56.803702+00:00","number_of_concurrent_vaccines":1,"dose_number":3,"time_to_onset_days":67,"theory_of_causation":"Petitioner Katie Smith alleged that the Hepatitis B vaccine administered on April 18, 2013, caused her Transverse Myelitis (TM). This was an off-Table claim requiring proof of causation-in-fact under the Althen standard. Petitioner's expert, Dr. Ahmet Höke, proposed a theory of molecular mimicry, suggesting the vaccine could trigger an autoimmune response leading to TM. He cited case reports and studies linking vaccines, including Hepatitis B, to TM and other demyelinating diseases, and argued for a broad temporal window for onset due to sustained antibody levels. Respondent's expert, Dr. Timothy Vartanian, agreed with the TM diagnosis but argued that case reports are insufficient proof of causality and epidemiological data does not support a link. He contended that molecular mimicry typically occurs within 2-4 weeks post-vaccination, making Petitioner's symptom onset at 67 days too late. The Special Master found Petitioner's theory lacked specificity regarding the mechanism for TM and sufficient support for its application to this case, noting the speculative nature of a \"secondary event\" and the insufficient temporal relationship. Entitlement was denied.","is_death":0,"date_of_death":null,"petition_filed_date":"2014-09-12","case_summary":"On September 12, 2014, Katie Smith filed a petition under the National Vaccine Injury Compensation Program, alleging that the Hepatitis B vaccine she received on April 18, 2013, caused her to develop Transverse Myelitis (TM). The Special Master found that Petitioner failed to prove by a preponderance of the evidence that the vaccine caused her TM and denied entitlement to compensation. Petitioner, a 23-year-old mother, received the third dose of the Hepatitis B vaccine on April 18, 2013. Approximately 67 days later, on June 24, 2013, she presented with symptoms including shortness of breath, abdominal pain, and progressive numbness and weakness in her lower extremities, leading to a diagnosis of TM. Petitioner's medical records indicated that prior to her vaccination series, she was generally healthy, though she had a history of intermittent low back pain, particularly after an epidural during childbirth. She also reported occasional alcohol use and was a smoker. Her medical history included multiple emergency department visits for various issues, including back pain and a post-cesarean wound infection. Petitioner received the first dose of the Hepatitis B vaccine on October 15, 2012, the second on November 16, 2012, and the third on April 18, 2013. Between the first and third vaccinations, she had a medical visit for ear and eye problems. On June 24, 2013, Petitioner experienced sudden onset of abdominal pain radiating to her back, decreased sensation starting in her right lower extremity and progressing to bilateral numbness, and difficulty walking. Initial workups for abdominal causes were negative. A neurology consult suggested possible thoracic disc, TM, or aortic dissection, recommending MRI and CTA scans. MRIs of her cervical and thoracic spine showed a small focal disc protrusion at T7-T8, but no remarkable findings were observed. An MRI of her lumbar spine showed a central disc protrusion at L1-L2. A consulting physician noted that TM was the most rational diagnosis given her presentation but expressed concern that the thoracic spine MRI was normal and that there was no clear neurologic explanation for her symptoms. This physician also noted vague symptoms for a few days prior, including facial numbness and fatigue, and could not rule out a psychogenic cause. Petitioner's symptoms reportedly improved the following day, and she refused a lumbar puncture. Her brain MRI showed no significant findings. Her assessment concluded psychogenic leg weakness and an L1-2 disc protrusion that could not explain all symptoms. She was discharged on July 3, 2013, with instructions to follow up with a primary care physician and physical therapy. She returned to the hospital on July 10, 2013, with complaints of abdominal pain and inability to urinate, and was transferred for neurosurgery evaluation. At Sacred Heart Hospital, an MRI of her thoracic spine demonstrated a spindle-shaped area of demyelination and inflammation at T6-T8. She was diagnosed with subacute TM, paraparesis, and bowel and bladder dysfunction, and discharged to rehabilitation on July 13, 2013. She continued to experience residual symptoms, including bowel and bladder problems, pain, and weakness, through at least 2017. Petitioner testified that her symptoms began approximately five days before her hospital admission, including facial numbness, headaches, and fatigue, followed by numbness in her right foot, progressing to numbness in her waist and abdomen, blurry vision, and inability to walk properly. She was taken to the hospital, where she reported being completely paralyzed by the time she arrived. Petitioner's expert, Dr. Ahmet Höke, proposed a theory of molecular mimicry, suggesting that the Hepatitis B vaccine could trigger an autoimmune response leading to TM. He cited case reports and studies linking vaccines, including the Hepatitis B vaccine, to TM and other demyelinating diseases like Multiple Sclerosis (MS). Dr. Höke argued that the temporal window for onset could be broader than typically accepted, extending beyond 8 weeks, due to sustained antibody levels. Respondent's expert, Dr. Timothy Vartanian, agreed with the diagnosis of TM but disputed the causal link to the vaccine. He argued that case reports are not proof of causality and that epidemiological studies do not support a link between the Hepatitis B vaccine and TM. Dr. Vartanian emphasized that peak immune responses and molecular mimicry typically occur within 2-4 weeks post-vaccination, making Petitioner's symptom onset at 67 days too late to be causally related. He concluded that Petitioner's TM was idiopathic. The Special Master found that Petitioner's theory, while referencing molecular mimicry, was vague regarding the specific mechanism for TM and lacked sufficient support for applying the theory to this case. The Special Master noted that Dr. Höke's reliance on a \"secondary event\" to explain antibody access to the central nervous system was speculative and unsupported. Furthermore, the Special Master found that the temporal relationship between Petitioner's vaccination and symptom onset (67 days) was too long to be consistent with the molecular mimicry theory as presented, especially when contrasted with Dr. Vartanian's expert opinion that such events typically occur within 2-4 weeks. The Special Master concluded that Petitioner failed to establish by a preponderance of the evidence that the Hepatitis B vaccine caused her TM, denying entitlement.","is_minor_inferred":0,"is_pediatric_broad":0,"special_master":"Herbrina Sanders Young","petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":"Diana L. Stadelnikas; Three Diana L. Stadelnikas","petitioner_attorney_firm":"Maglio","petitioner_attorney_location":"Sarasota, FL","adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":"|diana-stadelnikas|three-stadelnikas|","firm_canonical_key":"maglio-christopher-and-toale","package_title":"SMITH v. SECRETARY OF HEALTH AND HUMAN SERVICES","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00848","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00848.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00848.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_14-vv-00848-0","title":"SMITH v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 07/05/2018) regarding 78 DECISION of Special Master. Signed by Special Master Herbrina Sanders. (kel) Service on parties made.","date_issued":"2018-08-14","pdf_url":"https://api.govinfo.gov/packages/USCOURTS-cofc-1_14-vv-00848/granules/USCOURTS-cofc-1_14-vv-00848-0/pdf","pdf_bytes":530996,"triage_decision":"keep","triage_reason":"docketText matches keep keyword 'decision of special master'","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_14-vv-00848/USCOURTS-cofc-1_14-vv-00848-0"},{"granule_id":"USCOURTS-cofc-1_14-vv-00848-1","title":"SMITH v. SECRETARY OF HEALTH AND HUMAN SERVICES","docket_text":"PUBLIC DECISION (Originally filed: 01/24/2019) regarding 86 DECISION of Special Master - Fees Signed by Special Master Herbrina Sanders. (jm) Service on parties made.","date_issued":"2019-02-12","pdf_url":null,"pdf_bytes":null,"triage_decision":"skip","triage_reason":"fees-only decision (attorney compensation)","download_status":"skipped"}]}