Carolann Sinclair v. HHS - Prevnar-13, Guillain-Barré Syndrome (GBS) and subsequent PRES (2026)
Case summary [AI summaries can sometimes make mistakes]
On February 10, 2022, Carolann Sinclair filed a petition alleging that a Prevnar-13 pneumococcal vaccine administered on February 12, 2019 caused Guillain-Barre syndrome and posterior reversible encephalopathy syndrome. She was 65 years old at vaccination.
About two weeks after vaccination, Ms. Sinclair began experiencing tingling in her fingers and toes, headaches, and back pain.
Her symptoms progressed to numbness, weakness, facial droop, and difficulty walking, and she was diagnosed with GBS and later PRES. Treating records considered the vaccination as a possible precipitating factor and other potential causes were evaluated.
Petitioner's neurologists, Dr. John Hixson and Dr.
Lawrence Steinman, advanced a molecular-mimicry theory, focusing on Prevnar-13 components and potential immune cross-reactivity with peripheral nervous system targets. Respondent's neurologists, Dr.
Dara Jamieson and Dr. Robert Fujinami, disputed both the epidemiologic support and the proposed mechanism, arguing the illness was coincidental.
The Special Master found petitioner's theory reliable enough, accepted the timing as medically appropriate, and found a logical sequence of cause and effect supported by treating-physician impressions and exclusion of other etiologies. Entitlement was granted on March 2, 2026, with damages to be determined separately.
Theory of causation
Adult petitioner, age 65; Prevnar-13 vaccine February 12, 2019; GBS and PRES beginning about 14 days later. ENTITLEMENT GRANTED, damages pending. Theory: molecular mimicry involving Prevnar-13 components. Petitioner experts Dr. John Hixson and Dr. Lawrence Steinman; respondent experts Dr. Dara Jamieson and Dr. Robert Fujinami. SM found reliable theory, logical sequence, and medically acceptable timing. Petition filed February 10, 2022; entitlement March 2, 2026.
Source PDFs
USCOURTS-cofc-1_22-vv-00140