Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Femur fracture, Hypotension, Incoherent, Infusion
Clinical narrative: Broke right femur; Worsens Parkinson's symptoms; Urinary tract infection; Lower extremities weakness of; Low blood pressure; Infusion; Postoperative complication; Incoherent; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Broke right femur) and PARKINSON'S DISEASE (Worsens Parkinson's symptoms) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 028L20A and 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products CARBIDOPA, LEVODOPA (DUOPA) gastroenteral suspension for an unknown indication and MORPHINE for an unknown indication.    The patient's past medical history included Spasms, Back surgery and Surgery. Previously administered products included for Drug use for unknown indication: SULFAMETHOXAZOLE (Allergy with sulfa manifested by rash) and CODEINE PHOSPHATE (Allergy with codeine manifested by vomiting/phosphate powder allergy). Past adverse reactions to the above products included Drug allergy with CODEINE PHOSPHATE and SULFAMETHOXAZOLE. Concurrent medical conditions included Non-tobacco user and Abstains from alcohol. Concomitant products included DROXIDOPA (NORTHERA), NAPROXEN SODIUM (ALEVE), ARIPIPRAZOLE, METHOCARBAMOL, CANNABIS SATIVA (CBD COMPLEX), CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE [CALCIUM CARBONATE;COLECALCIFEROL]), QUETIAPINE FUMARATE, BETAXOLOL HYDROCHLORIDE (BETOPTIC), TRAVOPROST (TRAVATAN), MIRTAZAPINE, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), LEVOTHYROXINE SODIUM, LORAZEPAM, PROBIOTIC 10 [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS BREVIS;LACTOBACILLUS BULGARICUS;LACTOBACILLUS CASEI;LACTOBACILLUS PARACASEI;LACTOBACILLUS PLANTARUM;LACTOBACILLUS RHAMNOSUS;LACTOBACILLUS SALIVARIUS], CARBIDOPA, ASCORBIC ACID, COPPER GLUCONATE, FISH OIL, TOCOPHEROL, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (OCUVITE ADULT 50+ [ASCORBIC ACID;COPPER GLUCONATE;FISH OIL;TOCOPHEROL;XANTOFYL;ZEAXANTHIN;ZINC OXIDE]) and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for an unknown indication.   On 28-Jul-2020, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Intestinal use) at an unspecified dose. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Sep-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started MORPHINE (unknown route) at an unspecified dose. On 08-Oct-2021, the patient experienced FEMUR FRACTURE (Broke right femur) (seriousness criteria hospitalization, disability and medically significant). In October 2021, the patient experienced INCOHERENT (Incoherent). On an unknown date, the patient experienced PARKINSON'S DISEASE (Worsens Parkinson's symptoms) (seriousness criterion medically significant), URINARY TRACT INFECTION (Urinary tract infection), MUSCULAR WEAKNESS (Lower extremities weakness of), HYPOTENSION (Low blood pressure), INFUSION (Infusion) and POST PROCEDURAL COMPLICATION (Postoperative complication). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Oct-2021, FEMUR FRACTURE (Broke right femur) had resolved. In October 2021, INCOHERENT (Incoherent) had resolved. At the time of the report, PARKINSON'S DISEASE (Worsens Parkinson's symptoms), HYPOTENSION (Low blood pressure) and INFUSION (Infusion) had not resolved, URINARY TRACT INFECTION (Urinary tract infection) and MUSCULAR WEAKNESS (Lower extremities weakness of) was resolving and POST PROCEDURAL COMPLICATION (Postoperative complication) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, X-ray: Broken right femur. On an unknown date, Blood pressure measurement: Low. On an unknown date, X-ray: Three weeks post surgery and stated the placement of rods and screws were still in place..         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Memory impairment, Delusion, Confusional state, Gait disturbance, Mental status changes and Tremor subsumed under Parkinson's disease. Asthenia, Dehyration, Pain, Anxiety and Physical disability subsumed under Post procedural complication Loss of personal independence in daily activities, Bedridden, fall subsumed under fracture femur.  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.  Route of administration for Duopa provided as Percutaneous J-tube.  Company comment: This spontaneous case concerns an 85-years-old female patient, with medical history reported, who experienced the unexpected serious (hospitalization, disability and medically significant) event of femur fracture which occurred 28 days after the third dose mRNA-1273 vaccination. The patient also experienced unexpected serious (medically significant) event of Parkinson's disease in context to third dose of vaccination. It was reported that patient had fall with fractured right femur treated with unknown surgery and visited physical therapy three times a week and occupational therapy two times a week. She received unknown nasal pain medication given by the paramedic. Post-surgery for femur, hospital staff had trouble arousing patient, even with chest compressions.  The events fracture femur was resolved, and event Parkinson's disease was not recovered. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2021-623359 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Significant follow-up appended(event, seriousness updated); Sender's Comments: This spontaneous case concerns an 85-years-old female patient, with medical history reported, who experienced the unexpected serious (hospitalization, disability and medically significant) event of femur fracture which occurred 28 days after the third dose mRNA-1273 vaccination. The patient also experienced unexpected serious (medically significant) event of Parkinson's disease in context to third dose of vaccination. It was reported that patient had fall with fractured right femur treated with unknown surgery and visited physical therapy three times a week and occupational therapy two times a week. She received unknown nasal pain medication given by the paramedic. Post-surgery for femur, hospital staff had trouble arousing patient, even with chest compressions.  The events fracture femur was resolved, and event Parkinson's disease was not recovered. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.