Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Neutropenia, Neutrophil count
Clinical narrative: Neutrophils were low again; Dermographism; This spontaneous case was reported by a physician and describes the occurrence of MECHANICAL URTICARIA (Dermographism) and NEUTROPENIA (Neutrophils were low again) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1) on 27-Feb-2021, Moderna COVID-19 vaccine (Dose 2) in 2021, Moderna COVID-19 vaccine in November 2021, Moderna COVID-19 vaccine on 07-May-2022 and Moderna covid-19 vaccine on 07-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna covid-19 vaccine. Family history included Psoriasis (Father) since an unknown date. Concurrent medical conditions included Rheumatoid arthritis since September 2023.   In September 2023, the patient received dose of ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form every two weeks. On 12-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced MECHANICAL URTICARIA (Dermographism) (seriousness criterion medically significant). On 07-Mar-2024, the patient experienced NEUTROPENIA (Neutrophils were low again) (seriousness criterion medically significant). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) for Itching, at a dose of 180 milligram once a day. At the time of the report, MECHANICAL URTICARIA (Dermographism) and NEUTROPENIA (Neutrophils were low again) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2023, Neutrophil count: dipped to 28%. On 07-Mar-2024, Neutrophil count: Neutrophils were low again.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered MECHANICAL URTICARIA (Dermographism) and NEUTROPENIA (Neutrophils were low again) to be related.    Suspect product dosage text was reported as unknown. It was reported that patient had twin sister with no autoimmune disease. No concomitant medication was reported Patient had dermographism could not say exactly when it was started and started with a little itching. Thought it was new laundry detergent, etc., started with itching on her upper back between shoulder blades. Then she noticed sometime last year around November if she was in a hot tub or steam room or hot shower, skin looked red. She could not tell us if it started before Humira or not. She did not think of it as something serious at first and thought it was skin too dry or laundry detergent. In early November had a lot of bumps on her back that disappeared. Patient saw a dermatologist at that time. Might be a mild effect of Humira, suggested she take Allegra for itching which had completely resolved. She avoided hot showers. Dermatologist said it could be a side effect of COVID vaccination.  Company comment:  This is a spontaneous case concerning a 61-year-old, female patient with current condition of Rheumatoid arthritis treated with adalimumab, who experienced the unexpected serious (medically significant) events of Mechanical urticaria and neutropenia. The patient began with adalimumab one month before the administration of SPIKEVAX 2023-2024 vaccine, used as a sixth dose while she had a normal neutrophil value of 39%. About 2 months later, she had neutrophil level of 28% and continued low during the next months. Adalimumab is a strong confounder for the event.  The patient stated that is unclear when Dermographism has begun. It started with itching on her upper back between shoulder blades. Also, while being exposed to hot tub or steam room or hot shower, skin turned red. She took levocetirizine for itching which has completely resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 Vaccine is not affected by this report.   This case was linked to MOD-2024-763503 (Patient Link).