Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Arthralgia, Swelling, Weight decreased
Clinical narrative: Ankylosing spondylitis pain/increase joint pain; INCREASE SWELLING; LEFT KNEE SORENESS/She had some problems with left knee as she experienced soreness when first gets up in the morning took her time to stabilize herself; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Ankylosing spondylitis pain/increase joint pain) in a 56-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 Ankylosing spondylitis.    The patient's past medical history included Bariatric surgery. Concurrent medical conditions included Ankylosing spondylitis.   In January 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 31-Mar-2021, the patient experienced ANKYLOSING SPONDYLITIS (Ankylosing spondylitis pain/increase joint pain) (seriousness criterion medically significant) and SWELLING (INCREASE SWELLING). In 2021, the patient experienced ARTHRALGIA (LEFT KNEE SORENESS/She had some problems with left knee as she experienced soreness when first gets up in the morning took her time to stabilize herself). In 2021, ANKYLOSING SPONDYLITIS (Ankylosing spondylitis pain/increase joint pain) and SWELLING (INCREASE SWELLING) had resolved. At the time of the report, ARTHRALGIA (LEFT KNEE SORENESS/She had some problems with left knee as she experienced soreness when first gets up in the morning took her time to stabilize herself) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight decreased: 100 Lost over 100 pounds weight.   No concomitant medication were reported. In 2021, the patient experienced left knee soreness. In February 2021, the patient experienced felt sick. On 01 Mar 2021, the patient experienced weight/bariatric surgery. On 31 Mar 2021, the patient experienced NEEDLE STICK INJURY MARK ON THUMB/INJECTED HUMIRA INTO THUMB/SITE HAD BUBBLE AND TURNED BLUISH, PEN WAS PLACED UPSIDE DOWN, AND PRESSED PLUM BUTTON/ONLY KEPT PEN FOR AROUND FIVE SECONDS BECAUSE REALIZED HAD NEEDLE STICK TO THUMB/PARTIAL INJECTION WAS RECEIVED ON THUMB, INCREASE SWELLING, PAIN IN THUMB and ANKYLOSING SPONDYLITIS PAIN/INCREASE JOINT PAIN. On 31 Mar 2021, the PEN WAS PLACED UPSIDE DOWN, AND PRESSED PLUM BUTTON/ONLY KEPT PEN FOR AROUND FIVE SECONDS BECAUSE REALIZED HAD NEEDLE STICK TO THUMB/PARTIAL INJECTION WAS RECEIVED ON THUMB resolved. In 2021, the INCREASE SWELLING and ANKYLOSING SPONDYLITIS PAIN/INCREASE JOINT PAIN resolved. On 26 Feb 2021, the patient had a break of 20 days of Humira due to bariatric surgery on 01 Mar 2021, and discharged from hospital on 03 Mar 2021 and patient lost over 100 pounds weight. Patient had issue with a Humira pen that occurred on 31 Mar 2021. Patient observed the medication to be clear, colorless and filled appropriately. Caps one and two were removed straight off in the correct order. Skin was squeezed, pen was placed firmly at the injection site, but upside down, and she pressed the plum button. Before going back to normal patient did not do another injection. After went into thumb her arms and elbows felt much better. It was unknown if patient was enrolled in a COVID 19 Vaccine trial. No treatment information was reported. 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 spontaneous case concerns a 56-year-old female patient with concurrent Ankylosing spondylitis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Ankylosing spondylitis (reported as Ankylosing spondylitis pain/increase joint pain) 30 days after receiving the second dose of mRNA-1273 vaccine. Patient was treated with Adalimumab (Humira).  Patient previously received a dose of mRNA-1273 vaccine as the first dose given 28 days prior to current vaccine. The concurrent Ankylosing spondylitis remains a confounder as it is a chronic progressive disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-621084 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old female patient with concurrent Ankylosing spondylitis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Ankylosing spondylitis (reported as Ankylosing spondylitis pain/increase joint pain) 30 days after receiving the second dose of mRNA-1273 vaccine. Patient was treated with Adalimumab (Humira).  Patient previously received a dose of mRNA-1273 vaccine as the first dose given 28 days prior to current vaccine. The concurrent Ankylosing spondylitis remains a confounder as it is a chronic progressive disease. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.