Sex: M
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Nausea, Therapeutic response shortened
Clinical narrative: ANKYLOSING SPONDYLITIS SYMPTOMS RETURNED AFTER ABOUT TEN DAYS/NOT LASTING ENTIRE CYCLE OF HUMIRA; Wearing off effect; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS SYMPTOMS RETURNED AFTER ABOUT TEN DAYS/NOT LASTING ENTIRE CYCLE OF HUMIRA) in an adult male 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) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS SYMPTOMS RETURNED AFTER ABOUT TEN DAYS/NOT LASTING ENTIRE CYCLE OF HUMIRA) (seriousness criterion medically significant), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and NAUSEA (Nausea). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS SYMPTOMS RETURNED AFTER ABOUT TEN DAYS/NOT LASTING ENTIRE CYCLE OF HUMIRA), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication list was not provided. On unknown dates, the patient experienced ankylosing spondylitis symptoms returned after ten days/not lasting entire cycle of Humira and nausea. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of ANKYLOSING SPONDYLITIS SYMPTOMS RETURNED AFTER ABOUT TEN DAYS/NOT LASTING ENTIRE CYCLE OF HUMIRA unknown onset, NAUSEA and ANKYLOSING SPONDYLITIS SYMPTOMS RETURNED AFTER ABOUT TEN DAYS/NOT LASTING ENTIRE CYCLE OF HUMIRA unknown onset was not provided. Treatment information was not provided.  Company comment: This is a spontaneous case concerning a adult male patient of unknown age with relevant concurrent medical condition of ankylosing spondylitis. The patient has co-suspect medication of Adalimumab (Humira) for ankylosing spondylitis. The patient experienced the unexpected serious (medically significant) AESI event of ankylosing spondylitis, and the expected non-serious event of nausea. Therapeutic response shortened was also reported as non-serious. The events occurrence was unknown with respect to the first and second dose of mRNA-1273 vaccine administration. Allegedly the events were described as, ankylosing spondylitis symptoms returned after about ten days, not lasting the entire cycle of Adalimumab (Humira). No further clinical information was available for medical review. The outcome of the events was reported as unknown. The concurrent medical condition of ankylosing spondylitis remain confounder for the event ankylosing spondylitis. The co-suspect medication of Adalimumab (Humira) remain confounder for the event nausea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a adult male patient of unknown age with relevant concurrent medical condition of ankylosing spondylitis. The patient has co-suspect medication of Adalimumab (Humira) for ankylosing spondylitis. The patient experienced the unexpected serious (medically significant) AESI event of ankylosing spondylitis, and the expected non-serious event of nausea. Therapeutic response shortened was also reported as non-serious. The events occurrence was unknown with respect to the first and second dose of mRNA-1273 vaccine administration. Allegedly the events were described as, ankylosing spondylitis symptoms returned after about ten days, not lasting the entire cycle of Adalimumab (Humira). No further clinical information was available for medical review. The outcome of the events was reported as unknown. The concurrent medical condition of ankylosing spondylitis remain confounder for the event ankylosing spondylitis. The co-suspect medication of Adalimumab (Humira) remain confounder for the event nausea. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.