Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site papule, Vaccination site warmth, Vascular access site bruising, X-ray
Clinical narrative: Spondylitis ankylosing aggravated; Injection site got raised bump; Injection site got warm; Degenerative spine disease worsened; Slept most of the day; Numbness in toes; Radiculopathy worsened; Injection site got little pink; Swollen glands; Felt tired; Allergic cough; Spring allergy attack due to grass and flowers; Not feeling well; Vaccination site sore; Bruising because of the blood extraction and recurred bruising because of the blood extraction with Humira; This spontaneous case was reported by a physician and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 Hidradenitis suppurativa, Plaque psoriasis and Psoriatic arthritis.    The patient's past medical history included Alcohol use (A glass of wine a day) from 1984 to 2014, Tobacco user (Quarter of pack a day) from 1990 to 2017, Trouble falling asleep, Scoliosis, Ankylosing spondylitis, Degenerative disc disease (Degenerative Spine disease) and Radiculopathy. Previously administered products included for an unreported indication: IODINE (product used for unknown indication) and MORPHINE (product used for unknown indication). Concurrent medical conditions included Shellfish allergy (Manifested by giant welts all over the face and body, trouble breathing and itching), Drug allergy (Morphine allergy manifested by itching all over the body, hives and redness), Latex allergy (Manifested by swell up, hives and itching) and Iodine allergy (Manifested by swell up, hives and itching). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), METFORMIN for Diabetes, LOTEPREDNOL for Eye irritation, ATORVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism.   On 04-Apr-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. In February 2021, the patient experienced VASCULAR ACCESS SITE BRUISING (Bruising because of the blood extraction and recurred bruising because of the blood extraction with Humira). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site sore). On 02-Apr-2021, the patient experienced ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Spring allergy attack due to grass and flowers), MALAISE (Not feeling well), LYMPHADENOPATHY (Swollen glands) and FATIGUE (Felt tired). On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant), VACCINATION SITE PAPULE (Injection site got raised bump), VACCINATION SITE WARMTH (Injection site got warm), INTERVERTEBRAL DISC DEGENERATION (Degenerative spine disease worsened), SOMNOLENCE (Slept most of the day), HYPOAESTHESIA (Numbness in toes), RADICULOPATHY (Radiculopathy worsened) and VACCINATION SITE ERYTHEMA (Injection site got little pink). In March 2021, VASCULAR ACCESS SITE BRUISING (Bruising because of the blood extraction and recurred bruising because of the blood extraction with Humira) and VACCINATION SITE PAIN (Vaccination site sore) had resolved. On 04-Apr-2021, ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Spring allergy attack due to grass and flowers), MALAISE (Not feeling well), LYMPHADENOPATHY (Swollen glands) and FATIGUE (Felt tired) had resolved. At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated), INTERVERTEBRAL DISC DEGENERATION (Degenerative spine disease worsened) and RADICULOPATHY (Radiculopathy worsened) had not resolved and VACCINATION SITE PAPULE (Injection site got raised bump), VACCINATION SITE WARMTH (Injection site got warm), SOMNOLENCE (Slept most of the day), HYPOAESTHESIA (Numbness in toes) and VACCINATION SITE ERYTHEMA (Injection site got little pink) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Magnetic resonance imaging: abnormal (abnormal) Worsened Ankylosing Spondylitis, Degenerative Spine disease and Radiculopathy. In March 2021, Mycobacterium tuberculosis complex test: negative (Negative) Negative. In March 2021, X-ray: abnormal (abnormal) Worsened Ankylosing Spondylitis, Degenerative Spine disease and Radiculopathy. On 26-Mar-2021, Computerised tomogram: abnormal (abnormal) Worsened Ankylosing Spondylitis, Degenerative Spine disease and Radiculopathy.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Vaccination site sore) to be probably related and ALLERGIC COUGH (Allergic cough), SEASONAL ALLERGY (Spring allergy attack due to grass and flowers), MALAISE (Not feeling well), RADICULOPATHY (Radiculopathy worsened), VASCULAR ACCESS SITE BRUISING (Bruising because of the blood extraction and recurred bruising because of the blood extraction with Humira), LYMPHADENOPATHY (Swollen glands) and FATIGUE (Felt tired) to be not related. No further causality assessments were provided for ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated), VACCINATION SITE PAPULE (Injection site got raised bump), VACCINATION SITE WARMTH (Injection site got warm), INTERVERTEBRAL DISC DEGENERATION (Degenerative spine disease worsened), SOMNOLENCE (Slept most of the day), HYPOAESTHESIA (Numbness in toes) and VACCINATION SITE ERYTHEMA (Injection site got little pink).    No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.