Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Swelling, Vaccination site movement impairment, Vertigo
Clinical narrative: couldn't breath; head started spinning where she saw white spots; passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing; Pasty and sweating; Patient was white; developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm; rash got redder on the stomach area/rash on stomach would not go away; couldn't hear; swelling; Very sore left arm/right arm hurt; could not get out of bed; redness; brain fog; Nauseated; Chills all day; Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it; Dizzy; Out of breath; passed out; Felt tired all day/very tired; Hard to lift her arm; Felt like she was "punched in the arm"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had history of high cholesterol.  Concurrent medical conditions included Drug allergy. Concomitant products included VITAMINS NOS for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm; Felt like she was "punched in the arm"). On 10-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), DYSPNOEA (Out of breath), DIZZINESS (Dizzy) and FATIGUE (Felt tired all day/very tired). On 17-Feb-2021, the patient experienced ERYTHEMA (Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it). On an unknown date, the patient experienced DEAFNESS (couldn't hear), SWELLING (swelling), PAIN IN EXTREMITY (Very sore left arm/right arm hurt), DYSPNOEA (couldn't breath), VERTIGO (head started spinning where she saw white spots), BREATH HOLDING (passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing), HYPERHIDROSIS (Pasty and sweating), GENERAL PHYSICAL CONDITION ABNORMAL (Patient was white), NEOPLASM SKIN (developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm), RASH ERYTHEMATOUS (rash got redder on the stomach area/rash on stomach would not go away), MOBILITY DECREASED (could not get out of bed), ERYTHEMA (redness), FEELING ABNORMAL (brain fog), NAUSEA (Nauseated) and CHILLS (Chills all day). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; PARAFFIN (LUBRIDERM [PARAFFIN]) for Adverse event, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. On 13-Feb-2021, LOSS OF CONSCIOUSNESS (passed out), DYSPNOEA (Out of breath), VACCINATION SITE MOVEMENT IMPAIRMENT (Hard to lift her arm; Felt like she was "punched in the arm") and DIZZINESS (Dizzy) had resolved. At the time of the report, DEAFNESS (couldn't hear), SWELLING (swelling), PAIN IN EXTREMITY (Very sore left arm/right arm hurt), DYSPNOEA (couldn't breath), VERTIGO (head started spinning where she saw white spots), BREATH HOLDING (passed out in the kitchen chair where her eyes were wide open and her husband couldn't feel her breathing), HYPERHIDROSIS (Pasty and sweating), GENERAL PHYSICAL CONDITION ABNORMAL (Patient was white), NEOPLASM SKIN (developed a growth in her right leg in the shin that was cancerous/developed another cancerous growth on right forearm), RASH ERYTHEMATOUS (rash got redder on the stomach area/rash on stomach would not go away), MOBILITY DECREASED (could not get out of bed), ERYTHEMA (redness), FEELING ABNORMAL (brain fog), NAUSEA (Nauseated) and CHILLS (Chills all day) outcome was unknown and ERYTHEMA (Red bump on the corner of a tattoo on her thigh/tattoo on thigh became red around it) and FATIGUE (Felt tired all day/very tired) had resolved.            Concomitant medication included unknown cholesterol medication. Treatment for the event included ice and orange juice. It was reported that the red bump went away on an unknown date. On an unknown date, blood pressure measurement was high; CT scan, blood work, and electrocardiogram were normal.  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.   This case was linked to MOD21-035540, MOD-2021-021611 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Added lab data and new 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.