Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Joint range of motion decreased
Clinical narrative: Sleep disorder; Swollen fingers; Sun eats her skin; Dizziness; Fatigue; Joint pain; Lesions on spinal cord; Could not move fingers; Vomiting; Joint pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL CORD DISORDER (Lesions on spinal cord) in a 53-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) for Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 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. On 21-Jul-2021, the patient experienced VOMITING (Vomiting), the first episode of ARTHRALGIA (Joint pain), PYREXIA (Fever) and CHILLS (Chills). On 07-Dec-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Could not move fingers). On an unknown date, the patient experienced SPINAL CORD DISORDER (Lesions on spinal cord) (seriousness criterion medically significant), SLEEP DISORDER (Sleep disorder), PERIPHERAL SWELLING (Swollen fingers), PHOTOSENSITIVITY REACTION (Sun eats her skin), DIZZINESS (Dizziness), FATIGUE (Fatigue) and the second episode of ARTHRALGIA (Joint pain). On 26-Jul-2021, VOMITING (Vomiting), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, SPINAL CORD DISORDER (Lesions on spinal cord), JOINT RANGE OF MOTION DECREASED (Could not move fingers), SLEEP DISORDER (Sleep disorder), PERIPHERAL SWELLING (Swollen fingers), PHOTOSENSITIVITY REACTION (Sun eats her skin), DIZZINESS (Dizziness), FATIGUE (Fatigue) and the last episode of ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On unknown dates patient experienced events such as lesions on spinal cord, sleep disorder, joint pain, swollen fingers, fatigue, dizziness, sun eating her skin and coordination felt off.  On 21JUL2021, after the vaccine patient had events that resolved by 26JUL2021. On 07DEC2021, patient could not move fingers.  Stated coordination is off and she walks into walls / Body too heavy to carry is manifested under Spinal cord disorder.  Reporters causality for events with Humira was not provided.  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 53-year-old female patient with relevant medical condition of Psoriatic arthritis treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) event of Spinal cord disorder, reported as lesions on spinal cord, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. It was reported that the patient also experienced  impaired coordination, sleep disorder, joint pain, swollen fingers with limited range of motion, fatigue, dizziness, photosensitivity reaction with photodamaged skin, vomiting, fever and chills. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event Spinal cord disorder was unknown. The autoimmune disease Psoriasis with co-suspect drug Adalimumab remain as risk factors for the Spinal cord disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Significant follow up. New events updated.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 53-year-old female patient with relevant medical condition of Psoriatic arthritis treated with co-suspect drug Adalimumab, who experienced the unexpected serious (medically significant) event of Spinal cord disorder, reported as lesions on spinal cord, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. It was reported that the patient also experienced  impaired coordination, sleep disorder, joint pain, swollen fingers with limited range of motion, fatigue, dizziness, photosensitivity reaction with photodamaged skin, vomiting, fever and chills. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event Spinal cord disorder was unknown. The autoimmune disease Psoriasis with co-suspect drug Adalimumab remain as risk factors for the Spinal cord disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report.