Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | 031L20A | IM |
disorder of connective tissue; sjogren's syndrome; rheumatoid arthritis; strokes; small fiber neuropathy; severe vasculitis; raynaud's syndrome; fibromyalgia; trigeminal neuralgia; relapsing polychondritis; GI symptoms; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CONNECTIVE TISSUE DISORDER (disorder of connective tissue), SJOGREN'S SYNDROME (sjogren's syndrome), POLYCHONDRITIS (relapsing polychondritis), RHEUMATOID ARTHRITIS (rheumatoid arthritis) and CEREBROVASCULAR ACCIDENT (strokes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In March 2021, the patient experienced CONNECTIVE TISSUE DISORDER (disorder of connective tissue) (seriousness criterion hospitalization). In 2021, the patient experienced GASTROINTESTINAL DISORDER (GI symptoms) and HEADACHE (Headache). In 2022, the patient experienced POLYCHONDRITIS (relapsing polychondritis) (seriousness criterion medically significant). On an unknown date, the patient experienced SJOGREN'S SYNDROME (sjogren's syndrome) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (rheumatoid arthritis) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant), SMALL FIBRE NEUROPATHY (small fiber neuropathy), VASCULITIS (severe vasculitis), RAYNAUD'S PHENOMENON (raynaud's syndrome), FIBROMYALGIA (fibromyalgia) and TRIGEMINAL NEURALGIA (trigeminal neuralgia). The patient was hospitalized on sometime in March 2021 due to CONNECTIVE TISSUE DISORDER. The patient was treated with Surgery (Carpal tunnel release surgery) for Polychondritis. At the time of the report, CONNECTIVE TISSUE DISORDER (disorder of connective tissue), SJOGREN'S SYNDROME (sjogren's syndrome), POLYCHONDRITIS (relapsing polychondritis), RHEUMATOID ARTHRITIS (rheumatoid arthritis), CEREBROVASCULAR ACCIDENT (strokes), SMALL FIBRE NEUROPATHY (small fiber neuropathy), VASCULITIS (severe vasculitis), RAYNAUD'S PHENOMENON (raynaud's syndrome), FIBROMYALGIA (fibromyalgia) and TRIGEMINAL NEURALGIA (trigeminal neuralgia) had not resolved and GASTROINTESTINAL DISORDER (GI symptoms) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Antinuclear antibody: Positive. No concomitant medications provided by the reporter. It was reported that after first dose of vaccination patient experienced GI symptoms and bad headache. After second vaccination patient was admitted to emergency room in Mar-2021. In Mar-2021 patient had lesions from head to toe, malaise, utter fatigue, and patient symptom was progressed. Patient was unable to walk or hear or speak. On 08-Jul-2021 patient was diagnosed with disorder of connective tissue and anti-nuclear factor was detected. On 20-Jul-2021 it was reported that diagnosis of disorder of connective tissue, presence of anti-nuclear factor caused rapid onset of other symptom for patient such as patient was bald within 3 months, patient was bedridden, and patient was unable to see or walk. Patient experienced lesions all over her body with excruciating painful and patient voice was still not right. Patient lost all function of her left hand and patient needed a Carpal tunnel release surgery due to the event of relapsing polychondritis. Patient nerves were dying. It was reported that mixed undifferentiated affects not diagnosed yet. It was reported that patient had to have surgery because of Relapsing Polychondritis which took over her body. Patient experienced strokes. It was unknown if the patient experienced any additional symptoms or events. No treatment medications provided by the reporter.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Test Date: 20210708; Test Name: Anti nuclear factor; Test Result: Positive