Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site discomfort, Arthralgia, Asthenia, Chills, Diarrhoea
Clinical narrative: Left arm does not have strength/she cannot reach out for objects with her left arm/quality of life is gone; The arm is restricting her normal activities so she can't even go to work,cant move her arm,cant use arm,couldn't move her arm past 45°; She also had frozen shoulder at injection site; When she moves muscle, it hurts; Chills; Diarrhea; Pain keeps patient up at night; Ache; Her arm is still very sore at injection site/Arm is killing. Throbbing pain; Shoulder pain; Painful to touch; Needle when she got the vaccine hit the bone and did damage; She also reports having fever that went away in 7 days; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (Left arm does not have strength/she cannot reach out for objects with her left arm/quality of life is gone) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012l20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood disorder. Concurrent medical conditions included Pulmonary embolism, Pulmonary hypertension and Blood pressure high. Concomitant products included WARFARIN SODIUM (COUMADIN), FAMOTIDINE, ALPRAZOLAM (XANAX), WARFARIN and NORETHINDRONE [NORETHISTERONE] for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ADMINISTRATION SITE DISCOMFORT (Needle when she got the vaccine hit the bone and did damage), HYPERAESTHESIA (Painful to touch), PAIN (Ache) and VACCINATION SITE PAIN (Her arm is still very sore at injection site/Arm is killing. Throbbing pain). 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), INSOMNIA (Pain keeps patient up at night), ARTHRALGIA (Shoulder pain) and CHILLS (Chills). On an unknown date, the patient experienced ASTHENIA (Left arm does not have strength/she cannot reach out for objects with her left arm/quality of life is gone) (seriousness criterion disability), MOBILITY DECREASED (The arm is restricting her normal activities so she can't even go to work,cant move her arm,cant use arm,couldn't move her arm past 45°), PERIARTHRITIS (She also had frozen shoulder at injection site), MYALGIA (When she moves muscle, it hurts) and PYREXIA (She also reports having fever that went away in 7 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL) at an unspecified dose and frequency. On 20-Feb-2021, DIARRHOEA (Diarrhea), PAIN (Ache) and CHILLS (Chills) had resolved. At the time of the report, ASTHENIA (Left arm does not have strength/she cannot reach out for objects with her left arm/quality of life is gone), ADMINISTRATION SITE DISCOMFORT (Needle when she got the vaccine hit the bone and did damage), MOBILITY DECREASED (The arm is restricting her normal activities so she can't even go to work,cant move her arm,cant use arm,couldn't move her arm past 45°), HYPERAESTHESIA (Painful to touch), PERIARTHRITIS (She also had frozen shoulder at injection site), INSOMNIA (Pain keeps patient up at night), ARTHRALGIA (Shoulder pain) and MYALGIA (When she moves muscle, it hurts) outcome was unknown, VACCINATION SITE PAIN (Her arm is still very sore at injection site/Arm is killing. Throbbing pain) had not resolved and PYREXIA (She also reports having fever that went away in 7 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included two unspecified high blood pressure medications.  Patient want to know the direction what to take and how long it will take. Patients stated that, she needs answers because her living counts on it. Patient reported that she was going to start Celebrex as treatment medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up was received and reported term updated for the event mobility decreased, administration site discomfort. On 28-Jul-2021: Follow up received and included additional events of left arm does not have strength, she cannot reach out for objects with her left arm, quality of life is gone. Case was upgraded from non serious to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.