Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital dermatitis, Peripheral swelling, Pruritus, Skin disorder, Therapeutic product effect decreased
Clinical narrative: SWELLING IN RIGHT HAND; SWELLING IN RIGHT KNEE AND HIP; JOINT PAIN IN RIGHT HAND, RIGHT KNEE AND HIP; Itchy skin/ possibly Itching due to Moderna vaccine; skin problems  / had skin problems and wondered if she had psoriatic arthritis.; Eczema outbreak; RINVOQ LESS EFFECTIVE; symptoms worsened following booster with periorbital dermatitis; ALLERGIES with RINVOQ (UPADACITINIB).; PERIORAL DERMATITIS SYMPTOMS WORSENED; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWELLING IN RIGHT HAND), JOINT SWELLING (SWELLING IN RIGHT KNEE AND HIP) and ARTHRALGIA (JOINT PAIN IN RIGHT HAND, RIGHT KNEE AND HIP) in a 73-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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concomitant products included OMALIZUMAB (XOLAIR) for Itching.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWELLING IN RIGHT HAND) (seriousness criterion medically significant), JOINT SWELLING (SWELLING IN RIGHT KNEE AND HIP) (seriousness criterion medically significant), ARTHRALGIA (JOINT PAIN IN RIGHT HAND, RIGHT KNEE AND HIP) (seriousness criterion medically significant), PRURITUS (Itchy skin/ possibly Itching due to Moderna vaccine), SKIN DISORDER (skin problems  / had skin problems and wondered if she had psoriatic arthritis.), ECZEMA (Eczema outbreak), THERAPEUTIC PRODUCT EFFECT DECREASED (RINVOQ LESS EFFECTIVE), PERIORBITAL DERMATITIS (symptoms worsened following booster with periorbital dermatitis), HYPERSENSITIVITY (ALLERGIES with RINVOQ (UPADACITINIB).) and PERIORAL DERMATITIS (PERIORAL DERMATITIS SYMPTOMS WORSENED). At the time of the report, PERIPHERAL SWELLING (SWELLING IN RIGHT HAND), JOINT SWELLING (SWELLING IN RIGHT KNEE AND HIP), ARTHRALGIA (JOINT PAIN IN RIGHT HAND, RIGHT KNEE AND HIP) and PERIORBITAL DERMATITIS (symptoms worsened following booster with periorbital dermatitis) outcome was unknown and PRURITUS (Itchy skin/ possibly Itching due to Moderna vaccine), SKIN DISORDER (skin problems  / had skin problems and wondered if she had psoriatic arthritis.), ECZEMA (Eczema outbreak), THERAPEUTIC PRODUCT EFFECT DECREASED (RINVOQ LESS EFFECTIVE), HYPERSENSITIVITY (ALLERGIES with RINVOQ (UPADACITINIB).) and PERIORAL DERMATITIS (PERIORAL DERMATITIS SYMPTOMS WORSENED) had not resolved.            In 2022, patient had experienced worsening of perioral dermatitis symptoms.  It was reported that patient had joint pain in the right hand, right knee and hip with both hips replaced. Patient had skin problems and wondered if she had psoriatic arthritis. Patient had seen some relief while using Rinvoq.  Patient had stopped the Rinvoq since Mar-2022 while addressing the skin condition. Patient symptoms worsened following booster with periorbital dermatitis. Patient had an outbreak of eczema that was not controlled. Also, there was a possible side effect from Moderna. Patient was treated by an allergist. Patient had itching possibly due to Moderna vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. COMPANY COMMENT: This is an spontaneous case concerning a 73-years-old female patient with  medical history of Co-suspect product included UPADACITINIB for Rheumatoid arthritis, OMALIZUMAB for Itching, Moderna COVID-19 Vaccine on 10-Mar, 7-Apr, 2021 and 12-Jan-2022 who experienced the unexpected (seriousness criterion medically significant) events of PERIPHERAL SWELLING, JOINT SWELLING, ARTHRALGIA, the unexpected non-serious of PRURITUS, SKIN DISORDER, ECZEMA, THERAPEUTIC PRODUCT EFFECT DECREASED, PERIORBITAL DERMATITIS (1st. episode), PERIORAL DERMATITIS (2nd. episode) and other expected event unknown days after  3rd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Significant follow up included: New events were added. On 08-Jun-2022: Significant follow up included: New event Allergy was added and concomitant medication was added.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 73-years-old female patient with  medical history of Co-suspect product included UPADACITINIB for Rheumatoid arthritis, OMALIZUMAB for Itching, Moderna COVID-19 Vaccine on 10-Mar, 7-Apr, 2021 and 12-Jan-2022 who experienced the unexpected (seriousness criterion medically significant) events of PERIPHERAL SWELLING, JOINT SWELLING, ARTHRALGIA, the unexpected non-serious of PRURITUS, SKIN DISORDER, ECZEMA, THERAPEUTIC PRODUCT EFFECT DECREASED, PERIORBITAL DERMATITIS (1st. episode), PERIORAL DERMATITIS (2nd. episode) and other expected event unknown days after  3rd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report