Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hypoaesthesia oral, Peripheral coldness, Tremor, Troponin
Clinical narrative: elevated blood pressure; elevated heart rate; severe chest pain; lots of fatigue; joint pain rotating around to different area; Cold hands and feet; Vomiting; Headache; Face was flushed; lips numb; body shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure) and HEART RATE INCREASED (elevated heart rate) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant past medical history was provided.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. 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 BLOOD PRESSURE INCREASED (elevated blood pressure) (seriousness criterion hospitalization prolonged), HEART RATE INCREASED (elevated heart rate) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA ORAL (lips numb) and TREMOR (body shaking). On 11-Apr-2021, the patient experienced FLUSHING (Face was flushed), VOMITING (Vomiting) and HEADACHE (Headache). On 17-Apr-2021, the patient experienced ARTHRALGIA (joint pain rotating around to different area) and PERIPHERAL COLDNESS (Cold hands and feet). On 14-May-2021, the patient experienced CHEST PAIN (severe chest pain) and FATIGUE (lots of fatigue). The patient was hospitalized on 11-Apr-2021 due to BLOOD PRESSURE INCREASED and HEART RATE INCREASED. The patient was treated with AMLODIPINE ongoing since an unknown date at an unspecified dose and frequency; LORAZEPAM (ATIVAN) ongoing since an unknown date at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency; HEPARIN ongoing since an unknown date at an unspecified dose and frequency; METOPROLOL SUCCINATE ongoing since an unknown date at a dose of 25 mg; AMLODIPINE ongoing since an unknown date at a dose of 5 mg and LORAZEPAM (ATIVAN) ongoing since an unknown date at a dose of .5 mg twice a day. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure), HEART RATE INCREASED (elevated heart rate), ARTHRALGIA (joint pain rotating around to different area) and FATIGUE (lots of fatigue) had not resolved and CHEST PAIN (severe chest pain), HYPOAESTHESIA ORAL (lips numb), TREMOR (body shaking), FLUSHING (Face was flushed), PERIPHERAL COLDNESS (Cold hands and feet), VOMITING (Vomiting) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood pressure measurement: 210/114 mmHg (High) elevated. On 09-Apr-2021, Heart rate: 115 (High) elevated. On 11-Apr-2021, Blood pressure measurement: 257/120 mmHg (High) elevated. On 11-Apr-2021, Heart rate: 118 (High) elevated. On 11-Apr-2021, Hepatic enzyme: elevated (High) highly elevated. On 17-Apr-2021, Blood pressure measurement: elevated mmHg (High) elevated. On 17-Apr-2021, Heart rate: elevated (High) elevated. On 17-Apr-2021, Hepatic enzyme: elevated (High) elevated. On 14-May-2021, Blood pressure measurement: 176/111 mmHg (High) elevated. On 14-May-2021, Electrocardiogram: lv damage (abnormal) changed from before ad LV damage. On 14-May-2021, Heart rate: 114 (High) elevated. On 14-May-2021, Troponin: elevated (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 09/Apr/2021,the patient was taken to emergency room with blood pressure increased and heart rate increased and was released from ER without being checked. On 11/Apr/2021, she was admitted, was given a bunch of medications and was sent home by 13/Apr/2021. On 17/Apr/2021 she went to facility, with elevated BP and HR, liver enzymes were still elevated along with other events and received medications. On 18/Apr/2021 blood tests, computerized tomography (CT) scan, troponin levels, electrocardiogram (ECG) were performed (results not provided) . She was released on 19/Apr/2021. On 14/May/2021, she woke up with severe chest pain, elevated BP, and elevated HR and went to ER where they indicated her troponin level was elevated, did another CT scan and transported her back to facility. The same day they did blood tests, CT scan, troponin levels (results not provided), and an ECG that changed from before with possible LV damage. She was released the same day. On 17/May/2021, she went to cardiology. She was to wear a Holter monitor for 30 days. She also saw a rheumatologist that wants her to get X-rays and a nerve conduction study for the joint pain.  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.; 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.