Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: On and off phenomenon, Osteoporosis, Parkinson's disease, Stoma site irritation, Therapeutic product effect incomplete
Clinical narrative: Broken left hip; Fell; Patient pulled the pump out of vest and irritated the site; Patient was on off time 90 percent of time; Duopa was not working as good since first starting; Confusion; Osteoporosis; Parkinson's disease progressed/ Parkinson's disease symptoms worsened; Patient pulled the pump out of vest and irritated the site; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken left hip), FALL (Fell) and STOMA SITE IRRITATION (Patient pulled the pump out of vest and irritated the site) in an 84-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 CARBIDOPA, LEVODOPA (DUOPA) gastroenteral suspension for Parkinson's disease.    No known allergies.  The patient's past medical history included Thyroidectomy (Thyroid cancer removal, two times) in 1990. Concurrent medical conditions included Non-tobacco user, Abstains from alcohol, Confusion, Scoliosis and Parkinson's disease. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, SAFINAMIDE MESILATE (XADAGO) for Parkinson's disease, THIAMINE HYDROCHLORIDE (B1) for Prophylaxis, VITAMIN D3 for Vitamin supplementation, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), FERROUS SULFATE, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]), LISINOPRIL, MIDODRINE HCL, EZETIMIBE (ZETIA), CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) and AMINO ACIDS NOS (PROTINEX) for an unknown indication.   On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2022, CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) dosage was changed to 1 dosage form. On 19-Jan-2022, CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Percutaneous) 1 dosage form. On 01-Feb-2022, the patient experienced HIP FRACTURE (Broken left hip) (seriousness criteria hospitalization and medically significant) and FALL (Fell) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced STOMA SITE IRRITATION (Patient pulled the pump out of vest and irritated the site) (seriousness criterion medically significant), ON AND OFF PHENOMENON (Patient was on off time 90 percent of time), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Duopa was not working as good since first starting), CONFUSIONAL STATE (Confusion), OSTEOPOROSIS (Osteoporosis), PARKINSON'S DISEASE (Parkinson's disease progressed/ Parkinson's disease symptoms worsened) and INTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT (Patient pulled the pump out of vest and irritated the site). The patient was hospitalized from 01-Feb-2022 to 19-Feb-2022 due to FALL and HIP FRACTURE. The patient was treated with Surgery (Left partial hip replacement surgery) for Hip fracture. On 01-Feb-2022, FALL (Fell) had resolved. On 19-Feb-2022, HIP FRACTURE (Broken left hip) had resolved. At the time of the report, STOMA SITE IRRITATION (Patient pulled the pump out of vest and irritated the site), CONFUSIONAL STATE (Confusion), PARKINSON'S DISEASE (Parkinson's disease progressed/ Parkinson's disease symptoms worsened) and INTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT (Patient pulled the pump out of vest and irritated the site) outcome was unknown and ON AND OFF PHENOMENON (Patient was on off time 90 percent of time), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Duopa was not working as good since first starting) and OSTEOPOROSIS (Osteoporosis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Bone scan: abnormal (abnormal) Had a bone scan that showed osteoporosis.         COMPANY COMMENT: This is an spontaneous case concerning a 84-years-old female patient with medical history of Thyroidectomy for cancer removal, two times) in 1990, Concurrent medical conditions included Non-tobacco user, Abstains from alcohol, Confusion, Scoliosis and Parkinson's disease, concomitant products included ASPIRIN  for Anticoagulant therapy, LEVOTHYROXINE for Hypothyroidism, XADAGO for Parkinson's disease, THIAMINE HYDROCHLORIDE for Prophylaxis, VITAMIN D3 for Vitamin supplementation, OMEPRAZOLE, FERROUS SULFATE, VITAMIN B12, LISINOPRIL, MIDODRINE HCL, EZETIMIBE, CARBIDOPA MONOHYDRATE, LEVODOPA and PROTINEX for an unknown indication  who experienced the unexpected  events of HIP FRACTURE, FALL seriousness criteria hospitalization and medically significant),  STOMA SITE IRRITATION (seriousness criterion medically significant), ON AND OFF PHENOMENON, THERAPEUTIC PRODUCT EFFECT INCOMPLETE, CONFUSIONAL STATE, OSTEOPOROSIS, PARKINSON'S DISEASE  and INTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT beginning 7 days after  receiving a  dose of  mRNA-1273 vaccine. The age, medical condition of Parkinson's disease and Duopa medication remain as confounders for events ON AND OFF PHENOMENON, CONFUSIONAL STATE and , PARKINSON'S DISEASE  (aggravated).  The OSTEOPOROSIS event is a contributing factor for HIP FRACTURE and FALL events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received: Stop date for Duopa, additional concomitant medications, event "Patient pulled the pump out of vest and irritated the site", stop date for hip fracture and hospitalization date was updated. On 19-May-2022: Follow up received: Additional dosage for co-suspect, concomitant indication, concomitant drug, event verbatim (Parkinson's disease), additional events (Confusion, Duopa was not working as good since first starting and Patient was on off time 90 percent of time) and reporter causality were updated.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 84-years-old female patient with medical history of Thyroidectomy for cancer removal, two times) in 1990, Concurrent medical conditions included Non-tobacco user, Abstains from alcohol, Confusion, Scoliosis and Parkinson's disease, concomitant products included ASPIRIN  for Anticoagulant therapy, LEVOTHYROXINE for Hypothyroidism, XADAGO for Parkinson's disease, THIAMINE HYDROCHLORIDE for Prophylaxis, VITAMIN D3 for Vitamin supplementation, OMEPRAZOLE, FERROUS SULFATE, VITAMIN B12, LISINOPRIL, MIDODRINE HCL, EZETIMIBE, CARBIDOPA MONOHYDRATE, LEVODOPA and PROTINEX for an unknown indication  who experienced the unexpected  events of HIP FRACTURE, FALL seriousness criteria hospitalization and medically significant),  STOMA SITE IRRITATION (seriousness criterion medically significant), ON AND OFF PHENOMENON, THERAPEUTIC PRODUCT EFFECT INCOMPLETE, CONFUSIONAL STATE, OSTEOPOROSIS, PARKINSON'S DISEASE  and INTENTIONAL MEDICAL DEVICE REMOVAL BY PATIENT beginning 7 days after  receiving a  dose of  mRNA-1273 vaccine. The age, medical condition of Parkinson's disease and Duopa medication remain as confounders for events ON AND OFF PHENOMENON, CONFUSIONAL STATE and , PARKINSON'S DISEASE  (aggravated).  The OSTEOPOROSIS event is a contributing factor for HIP FRACTURE and FALL events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.