Marianne Simeneta v. HHS - Pneumococcal, Guillain-Barré Syndrome (2025)

Marianne Simeneta, a 64-year-old woman, filed a petition alleging that a Prevnar 13 pneumococcal conjugate vaccine administered on August 1, 2015, caused her to develop Guillain-Barré Syndrome (GBS). The respondent argued against compensation.

The court found that Ms. Simeneta presented sufficient evidence to establish entitlement to compensation.

The parties agreed that Ms. Simeneta developed GBS in August 2015 and had no prior neurological symptoms.

The primary dispute centered on whether her symptoms on August 15, 2015, were allergic or indicative of an upper respiratory infection (URI), and crucially, whether the vaccine caused her GBS. The court determined that Ms.

Simeneta's symptoms were more consistent with allergic sinusitis and that there was no preponderant evidence of a respiratory infection. The court accepted the theory of molecular mimicry as a sound and reliable mechanism by which the Prevnar 13 vaccine can cause GBS, satisfying the first prong of the Althen test.

The court found a logical sequence of cause and effect, noting that Ms. Simeneta's treating physicians believed her GBS was vaccine-related and that no alternative cause was sufficiently supported.

The court also found a proximate temporal relationship, with symptom onset approximately 18 days after vaccination, which is within the medically accepted timeframe for GBS following vaccination. Therefore, the court ruled that Ms.

Simeneta is entitled to compensation, with damages to be determined in a separate order. Damages were later resolved by proffer.

In a decision filed March 14, 2025, Special Master Dorsey awarded Ms. Simeneta $195,480.00, consisting of $195,000.00 for pain and suffering and $480.00 for past unreimbursable expenses.