Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fall, Incomplete course of vaccination, Lumbar vertebral fracture
Clinical narrative: Sustaining L2 and L3 fractures; Atrial fibrillation; Fall; Patient was not able to keep the appointment for the second dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LUMBAR VERTEBRAL FRACTURE (Sustaining L2 and L3 fractures), ATRIAL FIBRILLATION (Atrial fibrillation) and FALL (Fall) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac). Concomitant products included SOTALOL, AMLODIPINE, WARFARIN, ATORVASTATIN, CLOPIDOGREL, FERROUS SULFATE, CALCIUM CARBONATE (GAVISCON ACID BREAKTHROUGH FORMULA), ISOSORBIDE MONONITRATE, LOSARTAN, METFORMIN, NITROGLYCERIN, OMEPRAZOLE, TAMSULOSIN, VITAMIN E NOS and ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LUMBAR VERTEBRAL FRACTURE (Sustaining L2 and L3 fractures) (seriousness criteria hospitalization and medically significant), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization prolonged and medically significant), FALL (Fall) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Patient was not able to keep the appointment for the second dose). The patient was hospitalized for 18 days due to ATRIAL FIBRILLATION, FALL and LUMBAR VERTEBRAL FRACTURE. At the time of the report, LUMBAR VERTEBRAL FRACTURE (Sustaining L2 and L3 fractures), ATRIAL FIBRILLATION (Atrial fibrillation), FALL (Fall) and INCOMPLETE COURSE OF VACCINATION (Patient was not able to keep the appointment for the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided. SD narrative: A patient called on 18MAY2021 to report that she received the first dose of the Moderna COVID-19 vaccine (Lot #: 040A21A, Expiration Date: Unknown by Caller) in her "right upper arm" on 16MAR2021. The second dose was scheduled for 13APR2021. The patient was not able to keep the appointment for the second dose, as she has been under the care of a medical team after falling and sustaining L2 and L3 fractures. She was initially hospitalized for 18 days and developed atrial fibrillation during the hospitalization. She returned to the hospital one week after discharge and subsequently had a pacemaker placed. She would like to know if she can receive the second dose of the vaccine or if the first dose should be repeated due to the time that has passed since the first dose.  Limited information regarding the events, including the circumstances that resulted in the fall and back injury, has been provided at this time and a causal relationship cannot be excluded for the fall, back injury and AF.  The case This report also includes an event of incomplete course of vaccination.  There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the events, including the circumstances that resulted in the fall and back injury, has been provided at this time and a causal relationship cannot be excluded for the fall, back injury and AF.  The case This report also includes an event of incomplete course of vaccination.  There were no AEs specifically associated with this medication error