Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menopausal symptoms, Migraine, Urticaria
Clinical narrative: large welts and hives on legs/dose of covid 19 vaccine and humira was too close each other for that patient had an allergic reaction; increased migraines attributed to possible menopause; In 2021, the patient experienced increased migraines attributed to possible menopause; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large welts and hives on legs/dose of covid 19 vaccine and humira was too close each other for that patient had an allergic reaction) in a 45-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.    Concurrent medical conditions included Non-tobacco user, Abstains from alcohol, Migraine, Inflammation, Muscle spasms and Psoriatic arthritis. Concomitant products included MELOXICAM for Inflammation, SUMATRIPTAN for Migraine, CYCLOBENZAPRINE for Muscle spasms, MULTIVITAMIN [VITAMINS NOS] and CYCLOBENZAPRINE HCL for an unknown indication.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 28-Mar-2021, the patient experienced URTICARIA (large welts and hives on legs/dose of covid 19 vaccine and humira was too close each other for that patient had an allergic reaction) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced MIGRAINE (In 2021, the patient experienced increased migraines attributed to possible menopause). On an unknown date, the patient experienced MENOPAUSAL SYMPTOMS (increased migraines attributed to possible menopause). On 28-Mar-2021, URTICARIA (large welts and hives on legs/dose of covid 19 vaccine and humira was too close each other for that patient had an allergic reaction) had resolved. At the time of the report, MIGRAINE (In 2021, the patient experienced increased migraines attributed to possible menopause) and MENOPAUSAL SYMPTOMS (increased migraines attributed to possible menopause) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had other concomitant therapy of Immune Support Complex.  The patient reported that she had first Covid-19 vaccine and Humira injection close to each other and for that reason developed allergy reaction of large welts and hives on her legs and she was hospitalized. She mentioned that Humira had nothing to do with the allergic reaction that she experienced. Patient had migraines that were before taking Humira which had increased over the past year of 2021. She attributed migraines to possible menopause.  Causality for Humira 40mg/0.4ml (Solution for injection in pre-filled pen) : The reporter's causality for the event(s) of large welts and hives on legs/dose of covid 19 vaccine and humira was too close each other for that patient had an allergic reaction, was no reasonable possibility. The reporter's causality for the event(s) of increased migraines attributed to possible menopause unknown onset and increased migraines attributed to possible menopause onset in 2021 was not provided.  On 13-Jul-2021, blood test was performed and result not reported.  In response to the event "large welts and hives on legs/dose of covid 19 vaccine and humira was too close each other for that patient had an allergic reaction", humira was discontinued. In response to the events increased migraines attributed to possible menopause (Menopausal symptoms) and increased migraines attributed to possible menopause (Migraine aggravated), humira dose was not changed.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 45-year-old female patient with no relevant medical history, who was hospitalized due to the unexpected, serious (medically significant) event of Urticaria, 8 days after receiving the first dose of mRNA-1273 vaccine. The patient noted large welts and hives on legs which resolved on the same day. Clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was linked to MOD-2022-630369 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: No specific follow-up information recorded.; Sender's Comments: This is a spontaneous case concerning a 45-year-old female patient with no relevant medical history, who was hospitalized due to the unexpected, serious (medically significant) event of Urticaria, 8 days after receiving the first dose of mRNA-1273 vaccine. The patient noted large welts and hives on legs which resolved on the same day. Clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.