Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Psoriasis
Clinical narrative: Bell's palsy; Skin was not clearing up with Humira (Adalimumab); This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis.   On 19-May-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and PSORIASIS (Skin was not clearing up with Humira (Adalimumab)). At the time of the report, BELL'S PALSY (Bell's palsy) had resolved and PSORIASIS (Skin was not clearing up with Humira (Adalimumab)) had not resolved.            No known allergies. No concomitant drugs taken. The stop date for event Bell's palsy was reported as 2022. The causality for event skin disorder for co-suspect Humira was reported as not related and that for Bell's palsy as not reported.  No treatment information reported.  Company Comment: This is a spontaneous case concerning a 44-year-old female patient with concurrent medical condition of Moderate to severe chronic plaque Psoriasis treated with co-suspect drug Adalimumab (Humira), who experienced the expected serious (medically significant) ADR of Bell's palsy and unexpected non-serious event of Plaque psoriasis ("skin was not clearing up with Humira"), both of which occurred unknown number of days after receiving the second dose of mRNA-1273 Vaccine. There is no available information regarding clinical course and treatment medication. The patient's concurrent medical condition of chronic plaque psoriasis remains a confounder for event Plaque psoriasis as this can be symptom of its chronic nature. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 44-year-old female patient with concurrent medical condition of Moderate to severe chronic plaque Psoriasis treated with co-suspect drug Adalimumab (Humira), who experienced the expected serious (medically significant) ADR of Bell's palsy and unexpected non-serious event of Plaque psoriasis ("skin was not clearing up with Humira"), both of which occurred unknown number of days after receiving the second dose of mRNA-1273 Vaccine. There is no available information regarding clinical course and treatment medication. The patient's concurrent medical condition of chronic plaque psoriasis remains a confounder for event Plaque psoriasis as this can be symptom of its chronic nature. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.