Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling hot, Flushing, Heart valve incompetence
Clinical narrative: Heart valve regurgitation; Anxiety; Facial flushing; Face red; abdominal cramp; feeling hot; tingling; myalgia; nausea; vomiting; chest pain; Panic attack; Breathing difficult; Chest heaviness; Feeling abnormal; Burning sensation; Swelling; Neuralgia; Ache; DIarrhea; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART VALVE INCOMPETENCE (Heart valve regurgitation), DYSPNOEA (Breathing difficult), PAIN (Ache), BURNING SENSATION (Burning sensation) and CHEST DISCOMFORT (Chest heaviness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029a21a and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (The burning feels like the nerve pain she experienced when she had shingles.). Family history included Autoimmune disorder NOS since an unknown date. Concurrent medical conditions included Allergy to antibiotic (Erythromycin/clyndamycin/arihromycin), Penicillin allergy, Sulfonamide allergy and Drug allergy (Nitrofuran derivatives). Concomitant products included MELOXICAM from 12-Mar-2021 to an unknown date for Bruising, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN, PREGABALIN (LYRICA) and HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) for an unknown indication.   On 02-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Ache), PYREXIA (Fever) and CHILLS (Chills). 02-Mar-2021, the patient experienced DIARRHOEA (DIarrhea). On 04-Mar-2021, the patient experienced NEURALGIA (Neuralgia). On 04-Mar-2021 at 4:00 PM, the patient experienced SWELLING (Swelling). On 05-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation). On 12-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling abnormal). On 14-Mar-2021, the patient experienced DYSPNOEA (Breathing difficult), CHEST DISCOMFORT (Chest heaviness) and PANIC ATTACK (Panic attack). On 14-Mar-2021 at 9:00 AM, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced HEART VALVE INCOMPETENCE (Heart valve regurgitation), ANXIETY (Anxiety), FLUSHING (Facial flushing), ERYTHEMA (Face red), ABDOMINAL PAIN (abdominal cramp), FEELING HOT (feeling hot), PARAESTHESIA (tingling), MYALGIA (myalgia), NAUSEA (nausea) and VOMITING (vomiting). The patient was treated with GABAPENTIN on 17-Mar-2021 at a dose of 600 milligram three times a day; PREGABALIN on 14-Apr-2021 at a dose of 50 milligram three times a day; PREGABALIN at a dose of 150 milligram three times a day; AMITRIPTYLINE at a dose of 10 milligram once a day and HYDROXYZINE at a dose of 25 milligram. On 14-Mar-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, HEART VALVE INCOMPETENCE (Heart valve regurgitation), DYSPNOEA (Breathing difficult), PAIN (Ache), BURNING SENSATION (Burning sensation), CHEST DISCOMFORT (Chest heaviness), FEELING ABNORMAL (Feeling abnormal), PANIC ATTACK (Panic attack), ANXIETY (Anxiety), FLUSHING (Facial flushing), ERYTHEMA (Face red), ABDOMINAL PAIN (abdominal cramp), FEELING HOT (feeling hot), PARAESTHESIA (tingling), MYALGIA (myalgia), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown, NEURALGIA (Neuralgia) and SWELLING (Swelling) had not resolved and DIARRHOEA (DIarrhea), PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Chest X-ray: unknown (Inconclusive) UNKNOWN. On 14-Mar-2021, Computerised tomogram: unknown (Inconclusive) UNKNOWN.         Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-079507 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Followup Received on 17-MAY-2021 : updated reporter details,updated Patient demographics,medical history, added new event Neuralgiaoutcome of event pyrexia,chills,diarrhoea, from unknown to recoveredoutcome of event swelling,rash from unknown to not recoveredcasuality of events Pain in extremity,pain,fever,diarrhoea,chills,swelling,neuralgia,rash updated from not provided to possibleadded new event Neuralgia On 20-May-2021: ADR & hypersensitivity forms was received contains no new information On 25-May-2021: Hypersensitivity Form; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079507:cross link to Dose 1