Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Respiratory tract congestion, Thyroid disorder, Ultrasound thyroid, Urticaria
Clinical narrative: SUSPICIOUS MATERIAL ON THYROID; PAIN; Unable to walk; Impaired healing; Spondylitis ankylosing aggravated; Pain in leg; HIVES ON SKIN; MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS; MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS; MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS; THOUGHT WAS DYING/HAD TO FORCE TO BREATH; Difficulty in standing; Joint range of motion decreased; Mobility decreased; Grip strength decreased; Cough; Respiratory tract congestion; Impending doom; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) and THYROID DISORDER (SUSPICIOUS MATERIAL ON THYROID) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D2114 and 020F2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and LEVOTHYROXINE for an unknown indication.    The patient's past medical history included Cardiac ablation in 2019, Goiter, Thyroid tumor, Tobacco user in 2015, Solitary kidney, Abstains from alcohol, Hysterectomy in 2005, Nephrectomy since 2019, Thyroid gland biopsy and Thyroidectomy on 02-Aug-2021. Previously administered products included for Drug use for unknown indication: CODEINE and MORPHINE. Past adverse reactions to the above products included Vomiting with CODEINE and MORPHINE. Concurrent medical conditions included Pain in leg, Kidney cancer stage III, Drug allergy (Allergy to pain medication), Drug allergy (ALLERGIC REACTION WITH THYROID MEDICATION), Ankylosing spondylitis and Diabetes. Concomitant products included METFORMIN for Diabetes, METOPROLOL for Heart disorder, THYROID (ARMOUR THYROID) for Thyroid disorder, PREDNISOLONE for an unknown indication.   On 12-Apr-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 19-Apr-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram,1 in 2 wk and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram,1 in 2 wk. 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,1 in 2 wk. 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 MUSCULAR WEAKNESS (MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS), MUSCLE SPASMS (MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS), PERIPHERAL SWELLING (MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS), DYSPNOEA (THOUGHT WAS DYING/HAD TO FORCE TO BREATH), DYSSTASIA (Difficulty in standing), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), MOBILITY DECREASED (Mobility decreased), GRIP STRENGTH DECREASED (Grip strength decreased), COUGH (Cough), RESPIRATORY TRACT CONGESTION (Respiratory tract congestion), ANXIETY (Impending doom), DISCOMFORT (Discomfort), PAIN IN EXTREMITY (Pain in leg) and URTICARIA (HIVES ON SKIN). On 26-Jul-2021, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant), GAIT INABILITY (Unable to walk) and IMPAIRED HEALING (Impaired healing). On 02-Aug-2021, the patient experienced THYROID DISORDER (SUSPICIOUS MATERIAL ON THYROID) (seriousness criterion medically significant). In August 2021, the patient experienced PAIN (PAIN). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In 2021, MOBILITY DECREASED (Mobility decreased) and ANXIETY (Impending doom) had resolved. On 29-Jul-2021, GAIT INABILITY (Unable to walk) and IMPAIRED HEALING (Impaired healing) had resolved. At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) and PAIN IN EXTREMITY (Pain in leg) had not resolved, THYROID DISORDER (SUSPICIOUS MATERIAL ON THYROID), PAIN (PAIN) and DYSPNOEA (THOUGHT WAS DYING/HAD TO FORCE TO BREATH) had resolved, MUSCULAR WEAKNESS (MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS), MUSCLE SPASMS (MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS), PERIPHERAL SWELLING (MUSCLE WEAKNESS AND SPASM and SWELLING THUMBS), DYSSTASIA (Difficulty in standing), JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased), GRIP STRENGTH DECREASED (Grip strength decreased), DISCOMFORT (Discomfort) and URTICARIA (HIVES ON SKIN) outcome was unknown and COUGH (Cough) and RESPIRATORY TRACT CONGESTION (Respiratory tract congestion) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2021, Ultrasound thyroid: suspicious material on her thyroid.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The event of SUSPICIOUS MATERIAL ON THYROID is not assessable.  The patient had Loss of personal independence in daily activities. 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 is a spontaneous case, reported by a consumer, concerning a 51-year-old female patient with relevant medical condition of Ankylosing spondylitis, Non-toxic goiter and Thyroid tumor, who experienced the unexpected serious (medically significant) adverse event of special interest Ankylosing spondylitis, and unexpected serious (medically significant) event of Thyroid disorder reported as suspicious material on the thyroid confirmed on the thyroid ultrasound. Ankylosing spondylitis occurred on the same day of the first mRNA-1273 vaccination, while the Thyroid disorder occurred 7 days after receiving the dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule. Patient experienced flare up of Ankylosing spondylitis after the first vaccination with associated severe pain. Patient had outpatient surgery to remove thyroid and was given Levothyroxine, however patient noted appearance of  hives on the skin after taking Levothyroxine. It was reported that the event Thyroid disorder had resolved, while Ankylosing spondylitis flare up was not resolved. The medical condition of Ankylosing spondylitis remains as a confounder for Ankylosing spondylitis flare up, while the medical condition of Non-toxic goiter and Thyroid tumor  remain as confounders for the event Thyroid disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-625438 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received included historical medication added. On 20-Apr-2022: Follow-up received included patient's history. Humira batch number and event start and stop date updated.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 51-year-old female patient with relevant medical condition of Ankylosing spondylitis, Non-toxic goiter and Thyroid tumor, who experienced the unexpected serious (medically significant) adverse event of special interest Ankylosing spondylitis, and unexpected serious (medically significant) event of Thyroid disorder reported as suspicious material on the thyroid confirmed on the thyroid ultrasound. Ankylosing spondylitis occurred on the same day of the first mRNA-1273 vaccination, while the Thyroid disorder occurred 7 days after receiving the dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 30 days which falls within the recommended vaccine dosing schedule. Patient experienced flare up of Ankylosing spondylitis after the first vaccination with associated severe pain. Patient had outpatient surgery to remove thyroid and was given Levothyroxine, however patient noted appearance of  hives on the skin after taking Levothyroxine. It was reported that the event Thyroid disorder had resolved, while Ankylosing spondylitis flare up was not resolved. The medical condition of Ankylosing spondylitis remains as a confounder for Ankylosing spondylitis flare up, while the medical condition of Non-toxic goiter and Thyroid tumor  remain as confounders for the event Thyroid disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report.