Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dissociation, Dizziness, Dysarthria
Clinical narrative: thought she was suffering from a stroke; anemia; double vertigo; blood clots, thick blood; dissociated; liver spazzed; slurring words; could not speak; possible underlying autoimmune disorder where genetic composition may have triggered this; malabsorption; looked very pale; heart disease; blood pressure was elevated, blood pressure was 190/130,  uncontrolled and unspecified hypertension; severe vasculitis on the right side of brain; Thyroid calcification/thyroid had a lot of calcium build up; interstitial markings on lungs/doctor stated looked like COVID lungs; hands were so swollen that could not clench it; face was swollen; electrical shooting pain from the right brain stem of the neck; vision was blurry; stuttering; paranoid; confused; not able to recognize her daughter; hands were very stiff; stomach was bloated/looked 6 months pregnant; lethargic; bile dumps which then leads to inflammation of her intestines; clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red; stomach was inflamed; period started 10 days early, which is completely abnormal for her menstrual cycle; severe ovarian pain that was up very high; could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes; irritable; migraine; stabbing pain; kidney pain; period pain; lightheaded; pimple in the back of her head; headache; chills; fatigue, tired; fever of 102.6F/fever which lasted another 12 hours; nausea; body aches, muscles started to ache; diarrhea; significant abdominal pain from the cramping due to heaving from the nausea; cramping/lot of cramping in the groin and thigh area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke), HYPERTENSION (blood pressure was elevated, blood pressure was 190/130,  uncontrolled and unspecified hypertension), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain), AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this), THROMBOSIS (blood clots, thick blood) and INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gallbladder removal.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MUSCLE SPASMS (cramping/lot of cramping in the groin and thigh area), ABDOMINAL PAIN (significant abdominal pain from the cramping due to heaving from the nausea), DIARRHOEA (diarrhea), PYREXIA (fever of 102.6F/fever which lasted another 12 hours), NAUSEA (nausea), MYALGIA (body aches, muscles started to ache), CHILLS (chills) and FATIGUE (fatigue, tired). On 10-Apr-2021, the patient experienced HEADACHE (headache). On 12-Apr-2021, the patient experienced ACNE (pimple in the back of her head). On 13-Apr-2021, the patient experienced MENSTRUAL DISORDER (period started 10 days early, which is completely abnormal for her menstrual cycle), ADNEXA UTERI PAIN (severe ovarian pain that was up very high), FEELING ABNORMAL (could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes), IRRITABILITY (irritable), MIGRAINE (migraine), PAIN (stabbing pain), RENAL PAIN (kidney pain), DYSMENORRHOEA (period pain), DIZZINESS (lightheaded), GASTRITIS (stomach was inflamed), GASTROINTESTINAL INFLAMMATION (bile dumps which then leads to inflammation of her intestines) and HEAVY MENSTRUAL BLEEDING (clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red). On 14-Apr-2021, the patient experienced LETHARGY (lethargic). On 15-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (hands were very stiff), ABDOMINAL DISTENSION (stomach was bloated/looked 6 months pregnant), PERIPHERAL SWELLING (hands were so swollen that could not clench it), SWELLING FACE (face was swollen), NECK PAIN (electrical shooting pain from the right brain stem of the neck), VISION BLURRED (vision was blurry), DYSPHEMIA (stuttering), PARANOIA (paranoid), CONFUSIONAL STATE (confused) and MEMORY IMPAIRMENT (not able to recognize her daughter). On 16-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke) (seriousness criterion hospitalization), HYPERTENSION (blood pressure was elevated, blood pressure was 190/130,  uncontrolled and unspecified hypertension) (seriousness criterion hospitalization prolonged), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain) (seriousness criterion medically significant), INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs) (seriousness criterion medically significant), PALLOR (looked very pale), CARDIAC DISORDER (heart disease) and THYROID CALCIFICATION (Thyroid calcification/thyroid had a lot of calcium build up). On 19-Apr-2021, the patient experienced AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this) (seriousness criterion medically significant) and MALABSORPTION (malabsorption). On an unknown date, the patient experienced THROMBOSIS (blood clots, thick blood) (seriousness criteria disability and medically significant), ANAEMIA (anemia), VERTIGO (double vertigo), DISSOCIATION (dissociated), LIVER DISORDER (liver spazzed), DYSARTHRIA (slurring words) and APHASIA (could not speak). The patient was hospitalized from 16-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT and HYPERTENSION. On 10-Apr-2021, PYREXIA (fever of 102.6F/fever which lasted another 12 hours) and CHILLS (chills) had resolved. On 12-Apr-2021, MUSCLE SPASMS (cramping/lot of cramping in the groin and thigh area), MYALGIA (body aches, muscles started to ache) and FATIGUE (fatigue, tired) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (thought she was suffering from a stroke), CENTRAL NERVOUS SYSTEM VASCULITIS (severe vasculitis on the right side of brain), AUTOIMMUNE DISORDER (possible underlying autoimmune disorder where genetic composition may have triggered this), THROMBOSIS (blood clots, thick blood), INTERSTITIAL LUNG DISEASE (interstitial markings on lungs/doctor stated looked like COVID lungs), IRRITABILITY (irritable), PAIN (stabbing pain), DIZZINESS (lightheaded), MUSCULOSKELETAL STIFFNESS (hands were very stiff), ABDOMINAL DISTENSION (stomach was bloated/looked 6 months pregnant), GASTRITIS (stomach was inflamed), PERIPHERAL SWELLING (hands were so swollen that could not clench it), SWELLING FACE (face was swollen), NECK PAIN (electrical shooting pain from the right brain stem of the neck), VISION BLURRED (vision was blurry), DYSPHEMIA (stuttering), PARANOIA (paranoid), CONFUSIONAL STATE (confused), MEMORY IMPAIRMENT (not able to recognize her daughter), PALLOR (looked very pale), CARDIAC DISORDER (heart disease), MALABSORPTION (malabsorption), ANAEMIA (anemia), VERTIGO (double vertigo), THYROID CALCIFICATION (Thyroid calcification/thyroid had a lot of calcium build up), GASTROINTESTINAL INFLAMMATION (bile dumps which then leads to inflammation of her intestines), LETHARGY (lethargic), ACNE (pimple in the back of her head), DIARRHOEA (diarrhea), DISSOCIATION (dissociated), LIVER DISORDER (liver spazzed), DYSARTHRIA (slurring words), APHASIA (could not speak), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown, HYPERTENSION (blood pressure was elevated, blood pressure was 190/130,  uncontrolled and unspecified hypertension) and FEELING ABNORMAL (could feel her hormones whooshing through her veins/foggy head/feeling funky/ felt stoned/ daydream dazes) had not resolved, MENSTRUAL DISORDER (period started 10 days early, which is completely abnormal for her menstrual cycle), ADNEXA UTERI PAIN (severe ovarian pain that was up very high), RENAL PAIN (kidney pain), DYSMENORRHOEA (period pain), HEAVY MENSTRUAL BLEEDING (clots the size of golf balls/soaked through a 24 count box of super tampons in 24 hours/period was very bright red) and ABDOMINAL PAIN (significant abdominal pain from the cramping due to heaving from the nausea) had resolved and MIGRAINE (migraine) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.6 (High) fever of 102.6F. In April 2021, Neurological examination: abnormal (abnormal) neurological damage to the hippocampus of the central cranial. On 16-Apr-2021, Blood pressure measurement: 190/130 (abnormal) 190/130 and 175/99 (abnormal) 175/99 after treatment with Metoprolol. On 16-Apr-2021, Chest X-ray: interstitial markings of her lungs (abnormal) interstitial markings of her lungs. On 16-Apr-2021, Computerised tomogram: interstitial markings of her lungs (abnormal) interstitial markings of her lungs. On 16-Apr-2021, Magnetic resonance imaging: severe vasculitis on the right side of her brain (abnormal) severe vasculitis on the right side of her brain. On 16-Apr-2021, Neurological examination: 3/5 tests failed (abnormal) 3/5 tests failed. On 19-Apr-2021, Stool analysis: abnormal (abnormal) showed she was putting out too much potassium, magnesium. On 28-Apr-2021, Blood pressure measurement: 145/90 (abnormal) 145/90. On 28-Apr-2021, Heart rate: 90 (High) was not coming under  90 bpm. On 28-Apr-2021, Magnetic resonance imaging: blood clots, thick blood, anemia (abnormal) blood clots, thick blood, anemia.         Action taken with mRNA-1273 in response to the events was not Applicable.  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.   This case was linked to MOD-2021-095842 (Patient Link).; 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.