Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin E, Eosinophil count, Eosinophil percentage, Pruritus
Clinical narrative: Chronic pruritus after Moderna vaccination; This literature-non-study case was reported in a literature article and describes the occurrence of PRURITUS (Chronic pruritus after Moderna vaccination) in a 62-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Chronic pruritus after Moderna vaccination) (seriousness criterion medically significant). The patient was treated with ABROCITINIB at a dose of 12 weeks. At the time of the report, PRURITUS (Chronic pruritus after Moderna vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin E: Elevated after immune stimulus and decreased after treatment.. On an unknown date, Eosinophil count: Elevated after immune stimulus and treatment. On an unknown date, Eosinophil percentage: Normal.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patients were enrolled between 2019 and 2022. Circulating plasma biomarkers from adult patients with immune-stimulated Chronic pruritus (CP) were compared against those from 14 age, sex, and race matched healthy controls. Inclusion criteria included a diagnosis of CP by a board-certified dermatologist and a Worst Itch Numeric Rating Scale score of at least 6. Healthy controls included patients with clinically healthy skin and no pruritus. The normal range of IgE was defined as less than 100 kU/L and increased blood eosinophils was defined as an absolute eosinophil count greater than 0.3 K/mm3, or eosinophil percentage greater than 4%.  Fifteen patients, 11 male and 4 female, were included in this cohort. The median age was 70 years old, and 14 patients. Five patients had a history of atopy with the presence of at least 2 of 3 prior diagnoses with asthma, allergic rhinitis, or atopic dermatitis prior to developing CP. Patients developed CP after treatment with programmed cell death protein 1 inhibitors pembrolizumab, nivolumab, and cemiplimab. One patient developed CP after R-CHOP, within 1 year. CP also occurred after messenger RNA COVID-19 vaccination and Tdap vaccination.   Auther concluded that this study revealed triggers of CP development and describes alterations in blood Th2 markers in patients with CP, including IgE, increased blood eosinophils, and cytokines IL-5 and thymic stromal lymphopoietin.  For the patient Worst itch-numerical score rating change from 10 to 0 with successful treatment.  Company comment: This literature-non-study case concerns a 62-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Pruritus, which occurred on an unknown date after SPIKEVAX NOS vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. As reported, the patient experienced chronic pruritus for 8 months. Lab work showed blood immunoglobulin E and decreased after treatment, eosinophil absolute count was elevated, and eosinophil percentage were normal. Successful treatment was achieved ABROCITINIB for 12 weeks. The event was finally resolved. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-771039 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771039:Patient 2 of 2