Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Diplopia, Fatigue, Feeling hot, Freezing phenomenon, Gait disturbance
Clinical narrative: Cellulitis left calf; Scratch of left calf; difficulty in walking; cognitive issues; unable to taste food; Double Vision; pain in right jaw; losing eye sight; not remembering to eat or take medications; hot sensation on leg; weeping fluid from extremities; difficulty moving; swelling of the left lower extremity; fluttering in right eye; little tremors; sweat; body soreness; Numbness of head; tingling in head; blurred vision; freezing; headache; fatigue; Fever; Sepsis; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (Cellulitis left calf), SEPSIS (Sepsis) and SCRATCH (Scratch of left calf) in a 61-year-old male 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 CARBIDOPA, LEVODOPA (DUOPA) suspension for Parkinson's disease.    The patient's past medical history included COVID-19 virus test positive in April 2020, Weight loss (lost total of 15 pounds sue to poor eating habits; gained 6-7 pounds since) from August 2020 to December 2020 and Dementia. Previously administered products included for Product used for unknown indication: dicyclomine, gabapentin, lisinopril, oxycodone, zolpidem and metamucil. Concurrent medical conditions included Giant cell arteritis since February 2019, Chronic kidney disease stage 3, Dementia, Blood pressure high, High cholesterol, Drug allergy (linsinopril and 2-3 unknown medications), Nonsmoker, Living in care (assisted living facility) and Parkinson's disease. Concomitant products included PREDNISONE for Giant cell arteritis, CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for Parkinson's disease, CYCLOBENZAPRINE for Product used for unknown indication, AMLODIPINE, IRBESARTAN, TRAMADOL, ATORVASTATIN, DOCUSATE SODIUM, SENNOSIDE A+B (LAXATIVE STOOL SOFTENER WITH SENNA), LORAZEPAM, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX), BENZONATATE, PRAMIPEXOLE, FLUCONAZOLE (FLUZONE [FLUCONAZOLE]), CLONIDINE, METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) for an unknown indication.   On 02-May-2018, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Enteral) 100 milligram. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced CELLULITIS (Cellulitis left calf) (seriousness criteria hospitalization and medically significant). In April 2021, the patient experienced SCRATCH (Scratch of left calf) (seriousness criterion hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion medically significant), GAIT DISTURBANCE (difficulty in walking), COGNITIVE DISORDER (cognitive issues), AGEUSIA (unable to taste food), DIPLOPIA (Double Vision), PAIN IN JAW (pain in right jaw), VISUAL ACUITY REDUCED (losing eye sight), MEMORY IMPAIRMENT (not remembering to eat or take medications), FEELING HOT (hot sensation on leg), SECRETION DISCHARGE (weeping fluid from extremities), MOBILITY DECREASED (difficulty moving), PERIPHERAL SWELLING (swelling of the left lower extremity), BLEPHAROSPASM (fluttering in right eye), TREMOR (little tremors), HYPERHIDROSIS (sweat), PAIN (body soreness), HYPOAESTHESIA (Numbness of head), PARAESTHESIA (tingling in head), VISION BLURRED (blurred vision), FREEZING PHENOMENON (freezing), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (Fever). The patient was hospitalized from 08-Apr-2021 to 11-Apr-2021 due to CELLULITIS and SCRATCH. At the time of the report, CELLULITIS (Cellulitis left calf) and SCRATCH (Scratch of left calf) was resolving, SEPSIS (Sepsis), AGEUSIA (unable to taste food) and HYPERHIDROSIS (sweat) had resolved and GAIT DISTURBANCE (difficulty in walking), COGNITIVE DISORDER (cognitive issues), DIPLOPIA (Double Vision), PAIN IN JAW (pain in right jaw), VISUAL ACUITY REDUCED (losing eye sight), MEMORY IMPAIRMENT (not remembering to eat or take medications), FEELING HOT (hot sensation on leg), SECRETION DISCHARGE (weeping fluid from extremities), MOBILITY DECREASED (difficulty moving), PERIPHERAL SWELLING (swelling of the left lower extremity), BLEPHAROSPASM (fluttering in right eye), TREMOR (little tremors), PAIN (body soreness), HYPOAESTHESIA (Numbness of head), PARAESTHESIA (tingling in head), VISION BLURRED (blurred vision), FREEZING PHENOMENON (freezing), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood culture: positive (Positive) Positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative. In April 2021, White blood cell count: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was positive for COVID-19 in April 2020 and since then, had 10 additional tests on unknown dates which were all negative. Treatment for left leg cellulitis included 11 unknown multiple intravenous antibiotics, paracetamol, and an unknown pain medication while in the hospital.  The patient was discharged to home on ciprofloxacin.  The patient underwent physical therapy on uknown dates.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.