Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Ultrasound scan, Urticaria
Clinical narrative: Cough; Respiratory tract congestion; Spondylitis ankylosing aggravated; Pain in leg/ Pain in left leg and dragged; Muscle weakness; Impending doom; Hives/ hives on skin; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F2114 and 006D2114) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and LEVOTHYROXINE for an unknown indication.    The patient's other relevant history reported: Difficult to bending forward from waist to pick up pen from floor/to bend at knees/reach up to high self/to get up off floor from lying on back/to look over shoulder without turning body, difficult to get up from armless dining room chair without using hands or other help/climb 12 to 15 steps without using handrail or walking aid /forced to get up and move.  The patient's past medical history included Abstains from alcohol, Grip strength decreased in 2021, Mobility decreased in 2021, Joint range of motion decreased in 2021, Activities of daily living impaired (difficulty putting on socks or tights without help/do full day's activities) on 26-Jul-2021, Difficulty in standing in 2021, Unable to walk in 2021, Solitary kidney, Hysterectomy in 2005, Cardiac ablation (Heart ablation.) in 2019, Nephrectomy in 2019 and Biopsy thyroid gland (Thyroid biopsy). Previously administered products included for Drug use for unknown indication: MORPHINE and Codeine. Past adverse reactions to the above products included Allergy with Codeine and MORPHINE. Concurrent medical conditions included Tobacco user since 2015, Pain in leg (Pain in left leg and dragged.) since 2021, Kidney cancer stage III, Nontoxic goiter (On teenage years was diagnosed.), Thyroid tumor (Several tumors on her left thyroid and a large one on her right thyroid.), Drug allergy (Codeine allergy manifested by break out in hives, throwing up.), Drug allergy (Morphine allergy manifested by break out in hives, throwing up), Drug allergy (Pain medications allergy manifested by break out in hives, throwing up), Leg dragging since 2021 and Ankylosing spondylitis. Concomitant products included METFORMIN for Diabetes, PARACETAMOL (TYLENOL) for Headache, METOPROLOL for Heart disorder, THYROID (ARMOUR THYROID) for Thyroid disorder, PREDNISOLONE for an unknown indication.   On 12-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 19-Apr-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient started LEVOTHYROXINE (unknown route) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in leg/ Pain in left leg and dragged), MUSCULAR WEAKNESS (Muscle weakness), ANXIETY (Impending doom) and URTICARIA (Hives/ hives on skin). On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant), COUGH (Cough) and RESPIRATORY TRACT CONGESTION (Respiratory tract congestion). In 2021, ANXIETY (Impending doom) had resolved. At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated), COUGH (Cough) and RESPIRATORY TRACT CONGESTION (Respiratory tract congestion) was resolving, PAIN IN EXTREMITY (Pain in leg/ Pain in left leg and dragged) had not resolved and MUSCULAR WEAKNESS (Muscle weakness) and URTICARIA (Hives/ hives on skin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2021, Ultrasound scan: Endocrinologist found suspicious material on her thyroid..         The Humira pen misfired, penetrated skin injection area and spilled/pen slipped and felt into the floor/heard a click and the medication leaked out on 27-Aug-2021, In 2021 had difficulty putting on socks or tights without help/do full day's activities/do physically demanding activities/could not comb hair, difficult to get up from armless dining room chair without using hands or other help/climb 12 to 15 steps without using handrail or walking aid /forced to get up and move, difficult to bending forward from waist to pick up pen from floor/to bend at knees/reach up to high self/to get up off floor from lying on back/to look over shoulder without turning body, difficult stand unsupported 10 minutes without discomfort had to lean, allergic reaction with thyroid medication, could not walk, patient could not hold wash cloth without help, cough/congestion, thought was dying/had to force to breath, hives on skin.  On 27-Aug-2021, she had with her HUMIRA pen that occurred. She stated that she administered the injection on her own. She was able to look at the window pen prior to injection, solution was clear, colorless and normal. She removed both caps straight off in order, cap one followed by cap two. The pen slipped away and felt into the floor. She heard a click and the medication leaked out. No injection received, yellow indicator came down into the win.  She broke out with hives on the skin after taking Levothyroxine.  COVID-19 vaccine caused the ankylosing spondylitis flare ups in joints for which had to stay in bed for three days, pain worsened, pain due to Moderna  vaccine, muscle weakness and spasm, swelling thumbs, needed heal for everything and Humira was helping for one week after injection then ankylosing spondylitis symptoms worsened.  The patient was treated with Tylenol.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-625405 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: The current document IRD is 02-Sep-2021 (version-0), to avoid the system hard validation error date 27-Oct-2021 replaced with 02-Sep-2021. Current condition was added. On 16-Nov-2021: Live Follow-up received contains: Medical history, Lab test and Concomitant medications added, Narrative updated. On 20-Apr-2022: Live Follow-up received contains: Medical history added, Concomitant medication added, Events updated and added, Narrative updated.  Company comment: This is a spontaneous case concerning a 51-year-old female patient with medical history of Ankylosing spondylitis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Ankylosing spondylitis (Spondylitis ankylosing aggravated), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course and relevant diagnostic tests were not provided in the case. The event was resolving at the time of the report. Medical history of Ankylosing spondylitis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 51-year-old female patient with medical history of Ankylosing spondylitis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Ankylosing spondylitis (Spondylitis ankylosing aggravated), after receiving the second dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course and relevant diagnostic tests were not provided in the case. The event was resolving at the time of the report. Medical history of Ankylosing spondylitis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.