Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Off label use
Clinical narrative: Mobility decreased; Off-label use; This spontaneous case was reported by a physician and describes the occurrence of MOBILITY DECREASED (Mobility decreased) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) 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 an unknown indication.    The patient's past medical history included Alcohol use (Quit/Wine beer mixed drinks), Jejunostomy tube insertion (INTESTINAL TUBE (JEJUNAL) PLACEMENT) on 01-Nov-2016 and Percutaneous endoscopic gastrostomy (ORIGINAL PEG TUBE PLACEMENT) on 01-Nov-2016. Previously administered products included for Product used for unknown indication: AMANTADINE, Probiotic pearls, Miralax and azilect. Concurrent medical conditions included Seasonal allergy. Concomitant products included LORATADINE for Allergy, AMOXICILLIN and CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for Bladder infection, METFORMIN for Diabetes, ATROPINE and BOTULINUM TOXIN TYPE A (BOTOX BTX A) for Drooling, CICLOSPORIN (RESTASIS) for Dry eyes, ONDANSETRON for Nausea, PRAMIPEXOLE and ISTRADEFYLLINE (NOURIANZ) for Parkinson's disease, GABAPENTIN for Restless legs, TRAZODONE for Sleep problem, CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE (FOLBEE) for Supplementation therapy, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM VITAMIN D3 [CALCIUM CITRATE;COLECALCIFEROL]), VITAMIN D3, NAPROXEN SODIUM (ALEVE), CINNAMOMUM BURMANNI, CINNAMOMUM SPP. (CINNAMON [CINNAMOMUM BURMANNI;CINNAMOMUM SPP.]), CARBIDOPA, LEVODOPA (RYTARY), VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and PARACETAMOL (TYLENOL) for an unknown indication.   On 01-Nov-2016, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) 1 dosage form. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MOBILITY DECREASED (Mobility decreased) (seriousness criterion hospitalization prolonged) and OFF LABEL USE (Off-label use). At the time of the report, MOBILITY DECREASED (Mobility decreased) and OFF LABEL USE (Off-label use) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  For the event Off label use, causality is assessed as Not Applicable; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  For the event Off label use, causality is assessed as Not Applicable