Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Laboratory test, Loss of consciousness, Myalgia
Clinical narrative: Passed out by bed; she was on the floor and could not move.; muscles pain; Fatigue; Fell on the floor; she was not feeling good and went to bed; chills; shoulder pain; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out by bed), HYPOKINESIA (she was on the floor and could not move.) and FALL (Fell on the floor) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 006M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery in February 2021 and Heart valve replacement (aortic and mitral valves) on 23-Sep-2019. Concurrent medical conditions included Psoriasis (Dermal Psoriasis) since 2009, Diabetes mellitus (diet controlled) since 1990, Penicillin allergy and Drug allergy (Fentanyl). Concomitant products included TORSEMIDE for Edema, APIXABAN (ELIQUIS) from 01-Feb-2021 to an unknown date for Heart valve replacement, SECUKINUMAB (COSENTYX) for Psoriasis, METOPROLOL SUCCINATE from 23-Sep-2019 to an unknown date and POTASSIUM CHLORIDE from 23-Oct-2019 to an unknown date for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced CHILLS (chills) and ARTHRALGIA (shoulder pain). On 25-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out by bed) (seriousness criteria hospitalization and medically significant), HYPOKINESIA (she was on the floor and could not move.) (seriousness criterion hospitalization), FALL (Fell on the floor) (seriousness criterion medically significant), FEELING ABNORMAL (she was not feeling good and went to bed) and FATIGUE (Fatigue). On 26-Aug-2021, the patient experienced MYALGIA (muscles pain). The patient was hospitalized from 25-Aug-2021 to 26-Aug-2021 due to HYPOKINESIA and LOSS OF CONSCIOUSNESS. On 26-Aug-2021, LOSS OF CONSCIOUSNESS (Passed out by bed) had resolved with sequelae. At the time of the report, HYPOKINESIA (she was on the floor and could not move.) and ARTHRALGIA (shoulder pain) had resolved, FALL (Fell on the floor), FEELING ABNORMAL (she was not feeling good and went to bed) and CHILLS (chills) outcome was unknown and MYALGIA (muscles pain) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LOSS OF CONSCIOUSNESS (Passed out by bed) to be related. No further causality assessments were provided for HYPOKINESIA (she was on the floor and could not move.), FALL (Fell on the floor), FEELING ABNORMAL (she was not feeling good and went to bed), CHILLS (chills), ARTHRALGIA (shoulder pain), MYALGIA (muscles pain) and FATIGUE (Fatigue).    On 24-Aug-2021, Patient received 3rd shot of Moderna vaccine and had some shoulder pain on that night.  On 25-Aug-2021, at 11 am patient felt tired and went to bed and at 11.30 get out of bed to go to bathroom and fell on the floor and could not get up or follow instruction. Ambulance was called to take to the hospital and patient could not remember anything until 8 pm.  Patient had a treatment of  physical therapy on 26-AUG-2021.  Company comment: 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. However, the patient's concomitant medication is a confounder.   This case was linked to MOD-2021-300984, MOD-2021-301025 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Included medical history, allergies, concomitants medications and additional events, case upgraded 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. However, the patient's concomitant medication is a confounder.