Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bone pain, Fall, Fractured sacrum, Inflammation
Clinical narrative: Total of 3 falls; a little off balance/lost her balance; inflammation; Cold (congestion); Broke sacrum and pelvic; broke her pelvis; Broke sacrum and pelvic; pain in right femur; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC FRACTURE (Broke sacrum and pelvic; broke her pelvis) in a 69-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 AMANTADINE HYDROCHLORIDE (GOCOVRI) capsule for Dyskinesia.    The patient's past medical history included Breast cancer in 2002, Fall (A number of falls but none in the 3-6 months prior to the start of Gocovri; had fallen at work, hit her head and lost consciousness), Concussion (Fell at work and hit her head and lost consciousness), Loss of consciousness (Fell at work and hit her head and lost consciousness; had a concussion), Stereotypy, Corrective lens user and Hip replacement. Concurrent medical conditions included Drug allergy (Patient was allergic to erythromycin), Drug allergy (Patient was allergic to hydrocodone), Drug allergy (Patient was allergic to meperidine and related), Drug allergy (Patient was allergic to morphine and related), Drug allergy (Patient was allergic to naloxone), Drug allergy (Patient was allergic to prochlorperazine edisylate), Drug allergy (Patient was allergic to propoxyphene), Drug allergy (Patient was allergic to methadone), Dyskinesia and Parkinson's disease. Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for Parkinson's disease, MAGNESIUM and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for Supplementation therapy, RASAGILINE for an unknown indication.   On 09-Dec-2019, the patient started AMANTADINE HYDROCHLORIDE (GOCOVRI) (Oral) 274 milligram once. On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FRACTURED SACRUM (Broke sacrum and pelvic). In April 2021, the patient experienced PELVIC FRACTURE (Broke sacrum and pelvic; broke her pelvis) (seriousness criterion medically significant). In 2021, the patient experienced BONE PAIN (pain in right femur). On an unknown date, the patient experienced FALL (Total of 3 falls), BALANCE DISORDER (a little off balance/lost her balance), INFLAMMATION (inflammation) and NASOPHARYNGITIS (Cold (congestion)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PELVIC FRACTURE (Broke sacrum and pelvic; broke her pelvis), FALL (Total of 3 falls), BALANCE DISORDER (a little off balance/lost her balance), FRACTURED SACRUM (Broke sacrum and pelvic), INFLAMMATION (inflammation), NASOPHARYNGITIS (Cold (congestion)) and BONE PAIN (pain in right femur) outcome was unknown. Not Provided          04/02/2021 Computerized tomogram.   --/--/2021 Magnetic resonance imaging.   04/02/2021 X-ray , Not conclusive  On an unspecified date, during the last week in MAR-2021, the patient broke her sacrum. The patient fell while she was helping her husband cut down a tree and was pulling a rope so the branches would not go into the neighbor's yard. The rope gave away and she fell backwards on rocks on her sacrum.   She was seen in the ER (emergency room) and was given a shot to reduce the inflammation.  Company Comment: Based on reporter's causality and patient´s concomitant condition (Parkinson´s disease and dyskinesia) the events Fall, balance disorder, Pelvic fracture, Fractured sacrum, Inflammation and Bone pain are assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product, and the start date of the event nasopharyngitis, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-Significant follow up; Sender's Comments: Based on reporter's causality and patient´s concomitant condition (Parkinson´s disease and dyskinesia) the events Fall, balance disorder, Pelvic fracture, Fractured sacrum, Inflammation and Bone pain are assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product, and the start date of the event nasopharyngitis, a causal relationship cannot be excluded.