Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Protein C, Protein S, Prothrombin fragment 1.2, Prothrombin level, Pruritus
Clinical narrative: Hoarseness; nausea/Vomiting; Intense itching of my lower limbs is intolerable at times.; hives/urticaria; local erythema; vomiting; system-wide inflamation,I continue to have inflamation; Feeling of heaviness in abdomen and in lower extremities and feet and feeling of heaviness in abdomen and chest; connective tissues in many body locations have become affected; Muscles have lumps; diffiulty climbing stairs or descending stairs.; Sitting causes deep aches and pains in my back; great diffiulty getting into and out of my car; cognition is not great; more forgetful; irritated; Muscle aches,deep aches and pain; Extreme fatigue caused napping from 3-5 hours a day,tiredness; coagulation defects/circulatory system clotting; adverse effects on the lymphatic system/lymph system congestion and drainiage; Sore injection site; Shoulder joint hurt (felt like nerve twinging)/Intense pain in joints throughout the body; Severe swelling around knees,The swelling my knees continues.; feeling of not being able to take a complete breath; pain/extreme pain and pain throughout my body; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarseness), NAUSEA (nausea/Vomiting), PRURITUS (Intense itching of my lower limbs is intolerable at times.), URTICARIA (hives/urticaria), ERYTHEMA (local erythema) and VOMITING (vomiting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codiene), Allergy to vaccine and Sulfonamide allergy. Concomitant products included MELOXICAM for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DYSPNOEA (feeling of not being able to take a complete breath), JOINT SWELLING (Severe swelling around knees,The swelling my knees continues.) and MYALGIA (pain/extreme pain and pain throughout my body). On 26-Feb-2021, the patient experienced DYSPHONIA (Hoarseness) (seriousness criterion hospitalization prolonged), NAUSEA (nausea/Vomiting) (seriousness criterion hospitalization prolonged), PRURITUS (Intense itching of my lower limbs is intolerable at times.) (seriousness criterion hospitalization prolonged), URTICARIA (hives/urticaria) (seriousness criterion hospitalization), ERYTHEMA (local erythema) (seriousness criterion hospitalization prolonged), VOMITING (vomiting) (seriousness criterion hospitalization prolonged), VACCINATION SITE PAIN (Sore injection site) and ARTHRALGIA (Shoulder joint hurt (felt like nerve twinging)/Intense pain in joints throughout the body). On 01-Mar-2021, the patient experienced COAGULOPATHY (coagulation defects/circulatory system clotting), LYMPHATIC DISORDER (adverse effects on the lymphatic system/lymph system congestion and drainiage) and FATIGUE (Extreme fatigue caused napping from 3-5 hours a day,tiredness). On 08-Mar-2021, the patient experienced MYALGIA (Muscle aches,deep aches and pain). On an unknown date, the patient experienced INFLAMMATION (system-wide inflamation,I continue to have inflamation), DISCOMFORT (Feeling of heaviness in abdomen and in lower extremities and feet and feeling of heaviness in abdomen and chest), CONNECTIVE TISSUE DISORDER (connective tissues in many body locations have become affected), MUSCLE MASS (Muscles have lumps), GAIT DISTURBANCE (diffiulty climbing stairs or descending stairs.), BACK PAIN (Sitting causes deep aches and pains in my back), MOBILITY DECREASED (great diffiulty getting into and out of my car), COGNITIVE DISORDER (cognition is not great), MEMORY IMPAIRMENT (more forgetful) and IRRITABILITY (irritated). The patient was hospitalized from 03-Apr-2021 to 16-Aug-2021 due to DYSPHONIA, ERYTHEMA, NAUSEA, PRURITUS, URTICARIA and VOMITING. At the time of the report, DYSPHONIA (Hoarseness), NAUSEA (nausea/Vomiting), PRURITUS (Intense itching of my lower limbs is intolerable at times.), URTICARIA (hives/urticaria), ERYTHEMA (local erythema), VOMITING (vomiting), DYSPNOEA (feeling of not being able to take a complete breath), JOINT SWELLING (Severe swelling around knees,The swelling my knees continues.), VACCINATION SITE PAIN (Sore injection site), ARTHRALGIA (Shoulder joint hurt (felt like nerve twinging)/Intense pain in joints throughout the body), MYALGIA (Muscle aches,deep aches and pain) and MYALGIA (pain/extreme pain and pain throughout my body) had not resolved, INFLAMMATION (system-wide inflamation,I continue to have inflamation), DISCOMFORT (Feeling of heaviness in abdomen and in lower extremities and feet and feeling of heaviness in abdomen and chest), CONNECTIVE TISSUE DISORDER (connective tissues in many body locations have become affected), MUSCLE MASS (Muscles have lumps), GAIT DISTURBANCE (diffiulty climbing stairs or descending stairs.), BACK PAIN (Sitting causes deep aches and pains in my back), MOBILITY DECREASED (great diffiulty getting into and out of my car), COGNITIVE DISORDER (cognition is not great), MEMORY IMPAIRMENT (more forgetful) and IRRITABILITY (irritated) outcome was unknown and COAGULOPATHY (coagulation defects/circulatory system clotting), LYMPHATIC DISORDER (adverse effects on the lymphatic system/lymph system congestion and drainiage) and FATIGUE (Extreme fatigue caused napping from 3-5 hours a day,tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Activated protein C resistance test: 4.9 (normal) ACTIVATED PROTEIN C RESISTANCE 4.9 ratio N > OR = 2.1 F. On 21-Apr-2021, Antithrombin III (80-135): 94 (normal) ANTITHROMBIN III ACTIVITY 94 % normal N 80-135 F. On 21-Apr-2021, Blood cholesterol: 194 (High) CHOLESTEROL-Total-194 mg/dl HDL CHOLESTEROL 62 mg/dl NON HDL CHOLESTEROL 132 mg/dl  TRIGLYCERIDES 162 mg/dl LDL-CHOLESTEROL 104 mg/dl. On 21-Apr-2021, Blood fibrinogen: 0.23 (normal) D-DIMER, QUANTITATIVE 0.23 N F and 271 mg/dl (normal) FIBRINOGEN ACTIVITY, CLAUSS 271 mg/dL. On 21-Apr-2021, Blood homocysteine: 9.5 (normal) HOMOCYSTEINE 9.5 umol/L. On 21-Apr-2021, Blood immunoglobulin G: <20 (Inconclusive) PROTHROMBIN ANTIBODY (IGG) <20 G units <20 F. On 21-Apr-2021, Full blood count: normal (normal) WHITE BLOOD CELL COUNT 6.3 N F Million/u 3.80-5.10 L RED BLOOD CELL COUNT 4.67 N F HEMOGLOBIN 14.8 g/dL N 11.7-15.5 F HEMATOCRIT 42.7 % N 35.0-45.0 F MCV 91.4 fL N 80.0-100.0 F MCH 31.7 pg N 27.0-33.0 F MCHC 34.7 g/dL N 32.0-36.0 F RDW 13.5 % N 11.0-15.0 F Thousand/ 140-400 uL PLATELET COUNT 197 N F MPV 10.2 fL N 7.5-12.5 F ABSOLUTE NEUTROPHILS 3805 cells/uL N 1500-7800 F ABSOLUTE LYMPHOCYTES 1556 cells/uL N 850-3900 F ABSOLUTE MONOCYTES 460 cells/uL N 200-950 F ABSOLUTE EOSINOPHILS 410 cells/uL N 15-500 F ABSOLUTE BASOPHILS 69 cells/uL N 0-200 F NEUTROPHILS 60.4 % N F LYMPHOCYTES 24.7 % N F MONOCYTES 7.3 % N F EOSINOPHILS 6.5 % N F BASOPHILS 1.1. On 21-Apr-2021, Lipoprotein (a) (75-125): 24 (Low) Lipoprotein test  done. 24 nmol/L. On 21-Apr-2021, Plasmin inhibitor (85-156): 101 (normal) ALPHA 2 ANTIPLASMIN 101 % N 85-156 F. On 21-Apr-2021, Plasminogen activator inhibitor (4-43): 9 (normal) PLASMINOGEN ACTIVATOR 9 ng/mL N 4-43 INHIBITOR (PAI-1) F. On 21-Apr-2021, Protein C (70-180): 74 (normal) PROTEIN C, ACTIVITY 74 % normal N 70-180 F. On 21-Apr-2021, Protein S (60-140): 72 (normal) PROTEIN S, ACTIVITY 72 % normal N 60-140 F. On 21-Apr-2021, Prothrombin fragment 1.2 (41-372): 233 (normal) PROTHROMBIN FRAGMENT 1.2 233 pmol/L N F. On 21-Apr-2021, Prothrombin level (70-150): 63 (Low) COAG FACTOR II ACTIVITY 63 % normal L 70-150 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  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.  Very limited information regarding the cause of Hospitalization has been provided. There is a discrepancy in SD regarding dates of Hospitalization. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received information contains: medical history, lab data, concomitant medication, events outcome updated On 17-Aug-2021: Upgraded to serious. Additional events and laboratory details added.; 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.  Very limited information regarding the cause of Hospitalization has been provided. There is a discrepancy in SD regarding dates of Hospitalization. Further information has been requested.