Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Ankle fracture, Asthenia, Bedridden, Gait disturbance, Hypersomnia
Clinical narrative: Severe side effect; Couldn't get out of bed/stuck in bed/Bed ridden; Couldn't walk; Tried to walk and ended up breaking her ankle; Lethargic; In a stupor; Sleeps 24 hours a day; She lost muscle; Couldn't move it; She couldn't get out of bed; The patient had gained weight; When she first took it she had arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe side effect), BEDRIDDEN (Couldn't get out of bed/stuck in bed/Bed ridden), GAIT DISTURBANCE (Couldn't walk), ANKLE FRACTURE (Tried to walk and ended up breaking her ankle) and LETHARGY (Lethargic) in an 87-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.     The patient's past medical history included Thrombosis. Concurrent medical conditions included Heart disorder, Hypertension and Vascular disorder. Concomitant products included GABAPENTIN and LOSARTAN for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe side effect), BEDRIDDEN (Couldn't get out of bed/stuck in bed/Bed ridden), GAIT DISTURBANCE (Couldn't walk), ANKLE FRACTURE (Tried to walk and ended up breaking her ankle), LETHARGY (Lethargic), STUPOR (In a stupor), HYPERSOMNIA (Sleeps 24 hours a day), MUSCLE ATROPHY (She lost muscle), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move it), ASTHENIA (She couldn't get out of bed), WEIGHT INCREASED (The patient had gained weight) and VACCINATION SITE PAIN (When she first took it she had arm pain). At the time of the report, VACCINATION COMPLICATION (Severe side effect), BEDRIDDEN (Couldn't get out of bed/stuck in bed/Bed ridden), GAIT DISTURBANCE (Couldn't walk), ANKLE FRACTURE (Tried to walk and ended up breaking her ankle), LETHARGY (Lethargic), STUPOR (In a stupor), HYPERSOMNIA (Sleeps 24 hours a day), MUSCLE ATROPHY (She lost muscle), VACCINATION SITE MOVEMENT IMPAIRMENT (Couldn't move it), ASTHENIA (She couldn't get out of bed), WEIGHT INCREASED (The patient had gained weight) and VACCINATION SITE PAIN (When she first took it she had arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: patient gained weight (High) The patient gained weight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had gained more weight recently. Reporter doesn't know the date of the second dose administration. No Treatment information was reported. Patient had been stuck in bed and her doctor said she lost muscle and tried to walk and ended up breaking her ankle. The height of the patient was 182.88 cm (6 feet). Company comment- This is a spontaneous case concerning an 87-year-old female patient with no relevant medical conditions who experienced the AESI hypersomnia along with other non-serious events after a first dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the events. Patient couldn´t get out of bed and walk; she tried to walk and ended up breaking her ankle.  This caused her to be bedridden.  She is lethargic, in a stupor and sleeps 24 hours a day.  Patient´s age can be considered a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an 87-year-old female patient with no relevant medical conditions who experienced the AESI hypersomnia along with other non-serious events after a first dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the events. Patient couldn´t get out of bed and walk; she tried to walk and ended up breaking her ankle.  This caused her to be bedridden.  She is lethargic, in a stupor and sleeps 24 hours a day.  Patient´s age can be considered a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.