Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Feeling abnormal
Clinical narrative: she felt off; Spondylitis ankylosing aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 40-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) for Ankylosing spondylitis.    The patient's past medical history included Weight gain, Seizure in 2020, Numbness, Tingling, Head pain, Ureteric compression (collapsed ureter tube, artery laying across) and Renal surgery (kidney surgery due to collapsed ureter tube, artery laying across which was due to gaining weight.) in 2020. Concurrent medical conditions included Migraine.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In July 2021, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (she felt off). At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) and FEELING ABNORMAL (she felt off) outcome was unknown.            No concomitant medication was reported. Patient was not enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported. This Case was Identified as part of retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation #QE-019993.  Company comment: This is a spontaneous case reported by a consumer. A 40-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Ankylosing spondylitis completed a two-dose primary series of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated (AESI) after receiving the second dose. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of feeling abnormal that was considered not related to mRNA-1273 per the reporter's assessment. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-633277 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer. A 40-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Ankylosing spondylitis completed a two-dose primary series of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated (AESI) after receiving the second dose. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of feeling abnormal that was considered not related to mRNA-1273 per the reporter's assessment. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.