Donna Faye McKenney v. HHS - Pneumococcal, Guillain-Barre syndrome (2025)
Case summary [AI summaries can sometimes make mistakes]
On November 22, 2019, Donna Faye McKenney, then 68, filed a petition alleging that a pneumococcal conjugate vaccine, Prevnar 13, administered on August 13, 2018 caused Guillain-Barre syndrome. She also received Shingrix that day, but Shingrix is not a covered vaccine and was not part of the compensable theory.
About 12 days after vaccination, Ms. McKenney developed tingling in her fingers and toes, abdominal pain, and progressive weakness.
Her illness progressed to hospitalization and respiratory failure requiring intensive care, and the record documented demyelinating and axonal features. Petitioner's expert, clinical immunologist and rheumatologist Dr.
David Axelrod, proposed molecular mimicry involving CRM197, the diphtheria-derived carrier protein in Prevnar 13, and peripheral nervous system targets. Respondent's neurologist, Dr.
Harold Moses Jr., accepted the GBS diagnosis and timing but disputed vaccine causation. Special Master Thomas L.
Gowen found the Althen factors satisfied and rejected the view that the case was merely a temporal association. Entitlement was granted on December 30, 2025; damages remained pending.
Theory of causation
Prevnar 13 pneumococcal conjugate vaccine August 13, 2018 at age 68 causing GBS; onset about 12 days. ENTITLEMENT GRANTED; damages pending. Theory: molecular mimicry involving CRM197/diphtheria carrier protein and peripheral nervous system targets. Petitioner expert Dr. David Axelrod; respondent expert Dr. Harold Moses Jr. Evidence included tingling, abdominal pain, progressive weakness, hospitalization, respiratory failure/ICU, demyelinating and axonal features. SM Thomas L. Gowen found all Althen prongs satisfied. Petition November 22, 2019; decision December 30, 2025.
Source PDFs
USCOURTS-cofc-1_19-vv-01799