Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: Severe adverse effects; off balance; brain fog; sore arm at injection site; lost 5 lbs; loose bowels; headache; right armpit itchy with small welt; nauseous; chills; Palpitations; Lower left jaw pain; Chest pain; anxiety; teeth very sensitive to temperatures; energy waning; little appetite; increased urination; ear ringing; sore arm; tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Severe adverse effects), PALPITATIONS (Palpitations), PAIN IN JAW (Lower left jaw pain), CHEST PAIN (Chest pain) and ANXIETY (anxiety) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Suspected COVID) in November 2019. Concurrent medical conditions included Blood pressure high since 2010, High cholesterol since 2006, Ocular hypertension since 1990, Meniere's disease since 2012, Mitral valve prolapse (At birth), Drug allergy (Benadryl IM), Drug allergy (Levoflaxcin), Drug allergy (Bromfed), Drug allergy (Betimol), Drug allergy (Alphagan), Drug allergy (Azopt), Drug allergy (Timilol eye drops), Drug allergy (Lovostatin), Drug allergy (Zocor), Drug allergy (Lisinopril), Drug allergy (Tetracycline) and Drug allergy (Amoxycillin). Concomitant products included NIFEDIPINE for Blood pressure high, EZETIMIBE (ZETIA) for High cholesterol, LATANOPROST, TIMOLOL MALEATE (ISTALOL) and NETARSUDIL MESILATE (RHOPRESSA) for Ocular hypertension, FISH OIL, CENTRUM SILVER WOMEN 50+, LIPO FLAVONOID PLUS, UBIDECARENONE (QUNOL LIQUID COQ10), MAGNESIUM, VITAMIN E NOS and VITAMIN D NOS for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Palpitations), PAIN IN JAW (Lower left jaw pain), CHEST PAIN (Chest pain), ANXIETY (anxiety), DENTAL DISCOMFORT (teeth very sensitive to temperatures), ASTHENIA (energy waning), DECREASED APPETITE (little appetite), POLLAKIURIA (increased urination), TINNITUS (ear ringing), URTICARIA (right armpit itchy with small welt), NAUSEA (nauseous) and CHILLS (chills). On 02-Mar-2021, the patient experienced DIARRHOEA (loose bowels) and HEADACHE (headache). On 04-Mar-2021, the patient experienced WEIGHT DECREASED (lost 5 lbs). On 05-Mar-2021, the patient experienced BALANCE DISORDER (off balance), FEELING ABNORMAL (brain fog) and VACCINATION SITE PAIN (sore arm at injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Severe adverse effects). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 1 UNK. On 04-Mar-2021, PALPITATIONS (Palpitations), PAIN IN JAW (Lower left jaw pain), CHEST PAIN (Chest pain) and ANXIETY (anxiety) had resolved. At the time of the report, VACCINATION COMPLICATION (Severe adverse effects), PAIN IN EXTREMITY (sore arm), DENTAL DISCOMFORT (teeth very sensitive to temperatures), ASTHENIA (energy waning), DECREASED APPETITE (little appetite), POLLAKIURIA (increased urination), TINNITUS (ear ringing), DIARRHOEA (loose bowels), BALANCE DISORDER (off balance), FEELING ABNORMAL (brain fog), WEIGHT DECREASED (lost 5 lbs), URTICARIA (right armpit itchy with small welt), NAUSEA (nauseous), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (sore arm at injection site) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Blood pressure measurement: increased (High) Blood pressure increased. On 01-Mar-2021, Blood pressure measurement: 172/102 (High) very high. On 01-Mar-2021, Heart rate: 55 (normal) in normal range. On 02-Mar-2021, Blood pressure measurement: 162/73 (High) High. On 02-Mar-2021, Heart rate: 76 (High) Normal is around 60. On 03-Mar-2021, Blood pressure measurement: 144/68 (abnormal) abnormal and 199/84 (High) High. On 03-Mar-2021, Blood test: low (Low) Low lymphocytes. On 03-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) concluded patient did not have a heart attack. On 03-Mar-2021, Heart rate: 71 (normal) normal and low (Low) Pulse remained low in 50's & 60's. On 03-Mar-2021, X-ray: inconclusive (Inconclusive) concluded patient did not have a heart attack. On 08-Mar-2021, Cardiac stress test: normal (normal) normal.         This case was linked to MOD-2021-066433.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email address provided On 18-May-2021: Lab data, medical history and concomitant medication added from adverse reaction form. Treatment information updated for dose 1.; Sender's Comments: Very limited information regarding this event has been provided at this time after the first dose of the vaccine.  Further information has been requested.