Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac function test, Chest X-ray, Computerised tomogram, Echocardiogram
Clinical narrative: Passed out, blacked out, landed flat on her face, hospitalized due to the events; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Nerve pain in July 2020, Carpal tunnel syndrome, Broken foot (40 years prior to reporting time.), Lung operation NOS in July 2020, Hip replacement in 2017, Hip replacement in December 2020, Bladder operation NOS in November 2020, Foot surgery, Knee surgery NOS, Shoulder operation NOS and Tubal ligation. Concurrent medical conditions included Allergy to antibiotic and Allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], SERTRALINE, GABAPENTIN and ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) (seriousness criterion hospitalization). The patient was hospitalized from 17-Apr-2021 to 19-Apr-2021 due to LOSS OF CONSCIOUSNESS. On 19-Apr-2021, LOSS OF CONSCIOUSNESS (Passed out, blacked out, landed flat on her face, hospitalized due to the events) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Cardiac function test: normal (normal) normal. On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal, normal (normal) normal and normal (normal) CT Scan Head/Brain with Contrast. On an unknown date, Echocardiogram: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Primary Care Physician scheduled an MRI and Carotid Artery Ultrasound after a week from the reporting time. She was also placed on a heart monitor for 30 days. This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness.  Event latency 5 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 68-year-old female hospitalized with a serious unexpected event of Loss of consciousness.  Event latency 5 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.