Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Psoriasis
Clinical narrative: COVID-19; Discomfort; Foot pain; Joint swelling; Neuropathy peripheral; Pain; Pain in joint involving lower leg; Psoriasis; Stiff joints; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (NEUROPATHY SYMPTOMS IN THE BALLS OF FEET) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.  The patient's past medical history included Joint swelling (TWO SWOLLEN JOINTS IN FEET), Pain in joint involving lower leg (TWO TENDER JOINTS IN FEET), Discomfort, Pain and Joint stiffness (TWO STIFF JOINTS IN FEET).  On 26-Mar-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In March 2020, the patient experienced JOINT SWELLING (TWO SWOLLEN JOINTS IN FEET), JOINT STIFFNESS (TWO STIFF JOINTS IN FEET), the first episode of PAIN (Pain), the first episode of DISCOMFORT (Discomfort), PAIN IN EXTREMITY (FEELING A TWINGE ON BOTTOM OF FOOT TOWARD HEEL ON WALK) and ARTHRALGIA (TWO TENDER JOINTS IN FEET). In 2020, the patient experienced PSORIASIS (PSORIASIS LOOK LIKE SCAR/RED/DRY/SUPERFICIAL PATCHES). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (NEUROPATHY SYMPTOMS IN THE BALLS OF FEET) (seriousness criterion medically significant), COVID-19 (COVID), the second episode of PAIN (Pain) and the second episode of DISCOMFORT (Discomfort). At the time of the report, NEUROPATHY PERIPHERAL (NEUROPATHY SYMPTOMS IN THE BALLS OF FEET), the last episode of PAIN (Pain) and the last episode of DISCOMFORT (Discomfort) outcome was unknown, JOINT SWELLING (TWO SWOLLEN JOINTS IN FEET), JOINT STIFFNESS (TWO STIFF JOINTS IN FEET), PAIN IN EXTREMITY (FEELING A TWINGE ON BOTTOM OF FOOT TOWARD HEEL ON WALK) and ARTHRALGIA (TWO TENDER JOINTS IN FEET) had not resolved, COVID-19 (COVID) had resolved and PSORIASIS (PSORIASIS LOOK LIKE SCAR/RED/DRY/SUPERFICIAL PATCHES) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medication was reported.  On unknown dates, the patient experienced NEUROPATHY SYMPTOMS IN THE BALLS OF FEET, COVID, PAIN and DISCOMFORT. In 2020, the patient experienced PSORIASIS LOOK LIKE SCAR/RED/DRY/SUPERFICIAL PATCHES and NO IMPROVEMENT WITH PSORIATIC ARTHRITIS SINCE STRTING THERAPY. In March 2020, the patient experienced TWO SWOLLEN JOINTS IN FEET, TWO STIFF JOINTS IN FEET, TWO TENDER JOINTS IN FEET, PAIN, FEELING A TWINGE ON BOTTOM OF FOOT TOWARD HEEL ON WALK and DISCOMFORT. On unknown dates, COVID, PAIN and DISCOMFORT resolved.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  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 was reported by a consumer. A 56-year-old female patient experienced medically significant event of neuropathy peripheral (onset date not provided) in the context of vaccination with first dose of mRNA-1273, administered on an unknown date. Additionally, patient experienced non serious events of joint swelling, joint stiffness, pain, discomfort, arthralgia, pain in extremity, psoriasis and COVID-19 (AESI). As vaccination date was not provided, latency cannot be assessed. Relevant concurrent medical condition included psoriatic arthritis in treatment with Adalimumab. Relevant past medical history included joint swelling, joint stiffness, pain, discomfort and arthralgia. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of psoriatic arthritis could be a contributory factor for all the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Sender's Comments: This spontaneous case was reported by a consumer. A 56-year-old female patient experienced medically significant event of neuropathy peripheral (onset date not provided), in the context of vaccination with first dose of mRNA-1273 administered on an unknown date. Additionally, patient experienced non serious events of joint swelling, joint stiffness, pain, discomfort, arthralgia, pain in extremity, psoriasis and COVID-19 (AESI). As vaccination date was not provided, latency cannot be assessed. Relevant concurrent medical condition included psoriatic arthritis in treatment with Adalimumab. Relevant past medical history included joint swelling, joint stiffness, pain, discomfort and arthralgia. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of psoriatic arthritis could be a contributory factor for all the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.