Naomi Delgado v. HHS - Pneumococcal, asthma or significant aggravation of preexisting asthma (2025)
Case summary [AI summaries can sometimes make mistakes]
Naomi Delagado, an adult, received a Prevnar 13 vaccine on June 15, 2015. She alleged that the vaccine caused her to develop asthma or significantly aggravated a pre-existing, controlled asthma condition.
Prior to the vaccination, Ms. Delagado had a history of respiratory issues, including possible asthma and bronchiectasis, with documented episodes of cough, shortness of breath, and wheezing treated with steroids and inhalers between 2003 and 2008.
While she asserted she was asymptomatic for several years before the vaccine, medical records and expert opinions indicated she likely had pre-existing asthma. Four days after the vaccination, Ms.
Delagado presented with severe asthma symptoms, including wheezing and coughing, leading to hospitalization and a diagnosis of status asthmaticus. Her condition worsened significantly post-vaccination, requiring new treatments like Xolair, which are used for severe asthma.
The court considered whether the vaccine caused her asthma or significantly aggravated it. Petitioner's experts proposed theories involving vaccine-triggered allergic sensitization and IgE upregulation, potentially due to vaccine components like aluminum adjuvant or CRM 197.
Respondent's experts argued against causation, emphasizing Ms. Delagado's pre-existing asthma, the possibility of viral triggers for her symptoms, and the lack of a clear biological mechanism linking the vaccine to chronic, severe asthma.
Ultimately, the court found that Ms. Delagado failed to prove by a preponderance of the evidence that the vaccine caused her asthma or significantly aggravated it, noting that her condition worsened but that the link to the vaccine was not sufficiently established, particularly given her history of respiratory issues and similar exacerbations prior to vaccination.
The petition was denied.
Theory of causation
Prevnar 13 on June 15, 2015, adult exact age not stated, alleged to cause asthma or significantly aggravate controlled/preexisting asthma. DENIED. Petitioner had prior respiratory history including cough, shortness of breath, wheezing, possible asthma, and bronchiectasis. Petitioner advanced an off-Table respiratory aggravation theory; respondent disputed causation and significant aggravation. Special Master denied entitlement on October 23, 2025.
Source PDFs
USCOURTS-cofc-1_17-vv-01382