Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Therapeutic product effect decreased, Thyroidectomy, Urticaria, Wrong technique in product usage process
Clinical narrative: Device issue; Humira pen misfired; Penetrated skin injection area and spilled/pen slipped and fell into the floor/heard a click and the medication leaked out; Thyroid removed; Humira did help until the previous week; Covid-19 vaccine caused the ankylosing spondylitis flare ups in joints for which had to stay in bed for three days; Patient could not hold wash cloth without help; thought was dying/had to force to breath; Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab); Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab); Breathing difficult; Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab); Discomfort; Hives on skin; Allergic reaction with thyroid medication; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Covid-19 vaccine caused the ankylosing spondylitis flare ups in joints for which had to stay in bed for three days) and THYROIDECTOMY (Thyroid removed) in a 51-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and LEVOTHYROXINE for an unknown indication.    The patient's past medical history included Leg dragging. Concurrent medical conditions included Ankylosing spondylitis.   On 19-Apr-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 25-Aug-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) at an unspecified dose and LEVOTHYROXINE (unknown route) at an unspecified dose. In 2021, the patient experienced ANKYLOSING SPONDYLITIS (Covid-19 vaccine caused the ankylosing spondylitis flare ups in joints for which had to stay in bed for three days) (seriousness criterion medically significant), GRIP STRENGTH DECREASED (Patient could not hold wash cloth without help), ANXIETY (thought was dying/had to force to breath), PERIPHERAL SWELLING (Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab)), MUSCLE SPASMS (Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab)), DYSPNOEA (Breathing difficult), MUSCULAR WEAKNESS (Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab)), DISCOMFORT (Discomfort), URTICARIA (Hives on skin) and DRUG HYPERSENSITIVITY (Allergic reaction with thyroid medication). On 02-Aug-2021, the patient experienced THYROIDECTOMY (Thyroid removed) (seriousness criterion medically significant). In August 2021, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Humira did help until the previous week). On 27-Aug-2021, the patient experienced DEVICE ISSUE (Device issue), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Humira pen misfired) and INCORRECT DOSE ADMINISTERED (Penetrated skin injection area and spilled/pen slipped and fell into the floor/heard a click and the medication leaked out). In 2021, ANXIETY (thought was dying/had to force to breath) and DYSPNOEA (Breathing difficult) had resolved. At the time of the report, ANKYLOSING SPONDYLITIS (Covid-19 vaccine caused the ankylosing spondylitis flare ups in joints for which had to stay in bed for three days) was resolving and THYROIDECTOMY (Thyroid removed), GRIP STRENGTH DECREASED (Patient could not hold wash cloth without help), PERIPHERAL SWELLING (Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab)), MUSCLE SPASMS (Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab)), MUSCULAR WEAKNESS (Muscle weakness and spasm and swelling thumbs with humira 40mg/0.4ml (adalimumab)), DISCOMFORT (Discomfort), URTICARIA (Hives on skin), DRUG HYPERSENSITIVITY (Allergic reaction with thyroid medication), DEVICE ISSUE (Device issue), THERAPEUTIC PRODUCT EFFECT DECREASED (Humira did help until the previous week), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Humira pen misfired) and INCORRECT DOSE ADMINISTERED (Penetrated skin injection area and spilled/pen slipped and fell into the floor/heard a click and the medication leaked out) outcome was unknown.            No concomitant medications were reported.   The reporter's causality for the event(s) of humira pen misfired, penetrated skin injection area and spilled/pen slipped and fell into the floor/heard a click and the medication leaked out onset 27 aug 2021, humira pen misfired, penetrated skin injection area and spilled/pen slipped and fell into the floor/heard a click and the medication leaked out onset 27 aug 2021, difficulty putting on socks or tights without help/do full day's activities/do physically demanding activities, difficult to get up from armless dining room chair without using hands or other help/climb 12 to 15 steps without using handrail/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, pain in left leg and dragged onset in 2021, difficult stand unsupported 10 minutes without discomfort onset in 2021, allergic reaction with thyroid medication, could not walk, patient could not hold wash cloth without help, humira did help until the previous week, thought was dying/had to force to breath onset in 2021, hives on skin, pain worsened, pain due to moderna covid vaccine, thought was dying/had to force to breath onset in 2021, muscle weakness and spasm onset in 2021, muscle weakness and spasm onset in 2021, pain in left leg and dragged onset in 2021, difficult stand unsupported 10 minutes without discomfort onset in 2021, swelling thumbs and humira pen misfired, penetrated skin injection area and spilled/pen slipped and fell into the floor/heard a click and the medication leaked out onset 27-Aug-2021 was not provided.  No treatment details were 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 51-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious events of ankylosing spondylitis (AESI) and thyroidectomy. The event ankylosing spondylitis occurred an unknown time after the first dose of mRNA-1273, which presented as pain, difficulty with standing and carrying on with daily activities such as putting on socks, bending forward, bend at the knees, and look over shoulder without turning body. The event thyroidectomy occurred 7 days after the first dose of mRNA-1273, for which the patient was treated with levothyroxine. Information regarding clinical evaluation and diagnostic tests leading to thyroidectomy has not been disclosed. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome for ankylosing spondylitis was reported as resolving, and for thyroidectomy was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious events of ankylosing spondylitis (AESI) and thyroidectomy. The event ankylosing spondylitis occurred an unknown time after the first dose of mRNA-1273, which presented as pain, difficulty with standing and carrying on with daily activities such as putting on socks, bending forward, bend at the knees, and look over shoulder without turning body. The event thyroidectomy occurred 7 days after the first dose of mRNA-1273, for which the patient was treated with levothyroxine. Information regarding clinical evaluation and diagnostic tests leading to thyroidectomy has not been disclosed. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome for ankylosing spondylitis was reported as resolving, and for thyroidectomy was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.