Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Non-high-density lipoprotein cholesterol, Oxygen saturation, Protein total normal, Respiratory rate
Clinical narrative: Vertigo; Blood pressure 195/130; Extreme weakness; Passed out; Pain in the base of neck/Pain in brainstem area of neck; Ear fullness; Pain entire right side of brain/head; Disoriented; dizziness; Off balance; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), VERTIGO (Vertigo), HYPERTENSION (Blood pressure 195/130) and ASTHENIA (Extreme weakness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Patient reported no acute or chronic illnesses and no allergies.). Concomitant products included VITAMIN D3 from 10-Jan-2021 to 07-Feb-2021 for an unknown indication.    On 29-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced BALANCE DISORDER (Off balance). On 01-Feb-2021 at 10:00 AM, the patient experienced DIZZINESS (dizziness). On 08-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant), ASTHENIA (Extreme weakness) (seriousness criterion hospitalization) and DISORIENTATION (Disoriented). On 08-Feb-2021 at 4:00 AM, the patient experienced VERTIGO (Vertigo) (seriousness criterion hospitalization) and HYPERTENSION (Blood pressure 195/130) (seriousness criterion hospitalization). On an unknown date, the patient experienced NECK PAIN (Pain in the base of neck/Pain in brainstem area of neck), EAR DISCOMFORT (Ear fullness) and HEADACHE (Pain entire right side of brain/head). The patient was hospitalized from 08-Feb-2021 to 11-Feb-2021 due to ASTHENIA and VERTIGO, then on 08-Feb-2021 due to HYPERTENSION and LOSS OF CONSCIOUSNESS. On 08-Feb-2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, VERTIGO (Vertigo), HYPERTENSION (Blood pressure 195/130), ASTHENIA (Extreme weakness), DIZZINESS (dizziness), NECK PAIN (Pain in the base of neck/Pain in brainstem area of neck), EAR DISCOMFORT (Ear fullness), BALANCE DISORDER (Off balance), DISORIENTATION (Disoriented) and HEADACHE (Pain entire right side of brain/head) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Anion gap (10-20): 7.7 (Low) 7.7 mmol/L. On 08-Feb-2021, Basophil count (0.2-1.4): 1.5 (High) 1.5%. On 08-Feb-2021, Blood calcium (8.5-10.1): 9.3 (normal) 9.3 mg/dl. On 08-Feb-2021, Blood chloride (96-108): 108 (normal) 108 mmol/L. On 08-Feb-2021, Blood creatinine (0.6-1.3): 0.7 (normal) 0.7 mg/dl. On 08-Feb-2021, Blood glucose (70-100): 94 (normal) 94 mg/dL. On 08-Feb-2021, Blood magnesium (1.6-2.6): 2.2 (normal) 2.2 mg/dl. On 08-Feb-2021, Blood phosphorus (2.5-4.9): 3.2 (normal) Normal. On 08-Feb-2021, Blood potassium (3.6-5.2): 3.7 (normal) 3.7 mmol/L. On 08-Feb-2021, Blood pressure measurement: 195/130 (High) BP at 1630: 193/104 BP at 1755: 132/82. On 08-Feb-2021, Blood sodium (133-143): 140 (normal) 140 mmol/L. On 08-Feb-2021, Blood thyroid stimulating hormone (0.36-3.74): 1.74 (normal) 1.74 mIU/L. On 08-Feb-2021, Blood urea (7-18): 9 (normal) 9 mg/dL. On 08-Feb-2021, Body temperature: 98.8 (normal) Time: 1630. On 08-Feb-2021, Carbon dioxide (21-32): 30 (normal) 30 mmol/L. On 08-Feb-2021, Chest X-ray: normal (normal) Impression: No radiographic evidence of acute cardiopulmonary disease.. On 08-Feb-2021, Computerised tomogram head: inconclusive (Inconclusive) Impression: No acute intracranial abnormality Intracranial atherosclerosis. On 08-Feb-2021, Electrocardiogram: normal (normal) normal sinus rhythm. On 08-Feb-2021, Haematocrit (31.2-41.9): 42.9 (High) 42.9%. On 08-Feb-2021, Haemoglobin (10.9-14.3): 14.4 (High) 14.4 gm/dl. On 08-Feb-2021, Heart rate: 88 (normal) Time: 1630  Pulse 59 @1755. On 08-Feb-2021, Mean platelet volume (7.5-11.2): 7.2 (Low) 7.2 fl. On 08-Feb-2021, N-terminal prohormone brain natriuretic peptide (<125-Unknown): 35 (normal) 35 pg/mL. On 08-Feb-2021, Oxygen saturation: 98 (normal) 98 - Room air  Time: 1630 98 - Room air Time: 1755. On 08-Feb-2021, Respiratory rate: 18 (normal) Time: 1630  Resp rate 16 @1755. On 08-Feb-2021, Thyroxine (0.7-1.46): 0.98 (normal) 0.98 ng/dL. On 09-Feb-2021, Alanine aminotransferase (12-78): 19 (normal) 19 units/L. On 09-Feb-2021, Anion gap (10-20): 8.5 (Low) 8.5 mmol/L. On 09-Feb-2021, Aspartate aminotransferase (15-37): 24 (normal) 24 units/L. On 09-Feb-2021, Bilirubin conjugated (0.0-0.3): 0.2 (normal) 0.2 mg/dL. On 09-Feb-2021, Blood albumin (3.4-5.0): 4.0 (normal) 4.0 gm/dL. On 09-Feb-2021, Blood alkaline phosphatase (45-117): 73 (normal) 73 units/L. On 09-Feb-2021, Blood bilirubin (0.0-1.0): 0.6 (normal) 0.6 mg/dL. On 09-Feb-2021, Blood calcium (8.5-10.1): 8.3 (Low) 8.3 mg/dl. On 09-Feb-2021, Blood chloride (96-108): 112 (High) 112 mmol/L. On 09-Feb-2021, Blood creatinine (0.6-1.3): 0.6 (normal) 0.6 mg/dl. On 09-Feb-2021, Blood glucose (70-100): 86 (normal) 86 mg/dL. On 09-Feb-2021, Blood potassium (3.6-5.2): 3.5 (Low) 3.5 mmol/L. On 09-Feb-2021, Blood sodium (133-143): 142 (normal) 142 mmol/L. On 09-Feb-2021, Blood urea (7-18): 8 (normal) 8 mg/dL. On 09-Feb-2021, Carbon dioxide (21-32): 25 (normal) 25 mmol/L. On 09-Feb-2021, Eosinophil count: 8.1 (High) 8.1%. On 09-Feb-2021, Haematocrit (31.2-41.9): 36.7 (normal) 36.7%. On 09-Feb-2021, Haemoglobin (10.9-14.3): 12.5 (normal) 12.5 gm/dl. On 09-Feb-2021, Lipase (65-230): 176 (normal) 176 units/L. On 09-Feb-2021, Mean platelet volume (7.5-11.2): 7.2 (Low) 7.2 fl. On 09-Feb-2021, Protein total normal (6.4-8.2): 7.0 (normal) 7.0 gm/dl. On 09-Feb-2021, Serum ferritin (3-244): 51.1 (normal) 51.1 ng/mL. On 09-Feb-2021, Ultrasound Doppler: normal (normal) Impression: No significant atherosclerotic plaque is identified.  Based on velocities and waveforms, there are no hemodynamically significant stenoses.. On 09-Feb-2021, Vitamin D (30-100): 25.59 (Low) Adult range:  Deficiency <20 ng/mL Insufficiency 20-20 ng/mL Sufficiency 30-100 ng/mL. On 10-Feb-2021, Alanine aminotransferase (12-78): 19 (normal) 19 units/L. On 10-Feb-2021, Anion gap (10-20): 8.2 (Low) 8.2 mmol/L. On 10-Feb-2021, Aspartate aminotransferase (15-37): 18 (normal) 18 units/L. On 10-Feb-2021, Blood albumin (3.4-5.0): 3.6 (normal) 3.6 gm/dL. On 10-Feb-2021, Blood alkaline phosphatase (45-117): 70 (normal) 70 units/L. On 10-Feb-2021, Blood bilirubin (0.0-1.0): 0.7 (normal) 0.7 mg/dL. On 10-Feb-2021, Blood calcium (8.5-10.1): 8.5 (normal) 8.5 mg/dl. On 10-Feb-2021, Blood chloride (96-108): 109 (High) 109 mmol/L. On 10-Feb-2021, Blood cholesterol (0-200): 199 (normal) 199 mg/dl. On 10-Feb-2021, Blood creatinine (0.6-1.3): 0.8 (normal) 0.8 mg/dl. On 10-Feb-2021, Blood glucose (70-100): 83 (normal) 83 mg/dL. On 10-Feb-2021, Blood potassium (3.6-5.2): 4.2 (normal) 4.2 mmol/L. On 10-Feb-2021, Blood sodium (133-143): 141 (normal) 141 mmol/L. On 10-Feb-2021, Blood triglycerides (0-150): 93 (normal) 93 mg/dl. On 10-Feb-2021, Blood urea (7-18): 8 (normal) 8 mg/dL. On 10-Feb-2021, Carbon dioxide (21-32): 28 (normal) 28 mmol/L. On 10-Feb-2021, Hepatobiliary scan: normal (normal) Impression: Patent cystic duct.  Normal gallbladder injection fraction.. On 10-Feb-2021, High density lipoprotein (36-86): 54 (normal) 54 mg/dL. On 10-Feb-2021, Low density lipoprotein (<100-Unknown): 133 (High) 133 mg/dL. On 10-Feb-2021, Magnetic resonance imaging: normal (normal) Impression: No acute intracranial abnormality. On 10-Feb-2021, Non-high-density lipoprotein cholesterol: 145 (Inconclusive) Goal ranges depend on risk factors.. On 10-Feb-2021, Protein total normal (6.4-8.2): 6.4 (normal) 6.4 gm/dl. On 10-Feb-2021, Total cholesterol/HDL ratio (0.0-4.3): 3.7 (normal) 3.7. On 10-Feb-2021, Ultrasound abdomen: normal (normal) Impression: Normal complete abdominal ultrasound.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included escitalopram.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.