Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pain, Pain assessment, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: They are investigating for myo/pericarditis; The dysautonomia went into full blown POTS; Cytomegalovirus; It is like her immune system went haywire; Epstein Barr Virus; Dysautonomia; She has tinnitus all the time now; Has an exertion problem to where she can't do anything physically demanding; She couldn't breath, and had to get off the treadmill; She has palpitations; Her heart rate went to 160/tachycardia type situation; Her pain level is high; Had severe fatigue that is getting gradually better; This spontaneous case was reported by a consumer and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (The dysautonomia went into full blown POTS), CYTOMEGALOVIRUS INFECTION (Cytomegalovirus), IMMUNE SYSTEM DISORDER (It is like her immune system went haywire), EPSTEIN-BARR VIRUS INFECTION (Epstein Barr Virus) and AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomia) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028or5B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Immune system disorder: Hizentra. Past adverse reactions to the above products included No adverse event with Hizentra. Concurrent medical conditions included Immune system disorder (for which she has taken Hizentra for 2 years), Epstein-Barr virus infection, Cytomegalovirus infection, Dysautonomia and Ehlers-Danlos syndrome (history of a connective tissue disorder called Ehlers Danlos Syndrome.).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (The dysautonomia went into full blown POTS), CYTOMEGALOVIRUS INFECTION (Cytomegalovirus), IMMUNE SYSTEM DISORDER (It is like her immune system went haywire), EPSTEIN-BARR VIRUS INFECTION (Epstein Barr Virus), AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomia), TINNITUS (She has tinnitus all the time now), ASTHENIA (Has an exertion problem to where she can't do anything physically demanding), DYSPNOEA (She couldn't breath, and had to get off the treadmill), PALPITATIONS (She has palpitations), TACHYCARDIA (Her heart rate went to 160/tachycardia type situation), PAIN (Her pain level is high) and FATIGUE (Had severe fatigue that is getting gradually better). On an unknown date, the patient experienced MYOCARDITIS (They are investigating for myo/pericarditis). At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (The dysautonomia went into full blown POTS), CYTOMEGALOVIRUS INFECTION (Cytomegalovirus), IMMUNE SYSTEM DISORDER (It is like her immune system went haywire), EPSTEIN-BARR VIRUS INFECTION (Epstein Barr Virus), AUTONOMIC NERVOUS SYSTEM IMBALANCE (Dysautonomia), TINNITUS (She has tinnitus all the time now), ASTHENIA (Has an exertion problem to where she can't do anything physically demanding), DYSPNOEA (She couldn't breath, and had to get off the treadmill), PALPITATIONS (She has palpitations), TACHYCARDIA (Her heart rate went to 160/tachycardia type situation) and PAIN (Her pain level is high) had not resolved, FATIGUE (Had severe fatigue that is getting gradually better) was resolving and MYOCARDITIS (They are investigating for myo/pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Cardiac stress test: normal (normal) Normal. In April 2021, Heart rate: 160 (High) the electrical was normal but her heart rate went to 160. In April 2021, Magnetic resonance imaging heart: results pending Results pending. In April 2021, Pain assessment: high (High) high.         The patient had a history of serious health issues.  No concomitant medications reported. The patient had no history of COVID-19 infection as well as no history of Myocarditis/pericarditis. They were investigating for myo/pericarditis for which she had a heart MRI & is still awaiting the results. She had a stress test that the doctor said was normal, but not normal. She was only about to go for a couple of minutes, the electrical was normal but her heart rate went to 160, she couldn't breath, and had to get off the treadmill. The patient did not receive any corrective treatment for the events.  Company comment: This is a spontaneous case concerning a 58 year-old, female patient with a history of Autonomic nervous system imbalance, who experienced the non-serious unexpected, according CCDS, AESI of Postural orthostatic tachycardia syndrome and non-serious expected, according CCDS, AESI of myocarditis (the patient reported they are investigating for myopericarditis and MRI was performed, results pending). The event Postural orthostatic tachycardia syndrome occurred approximately 1 week after the second dose of mRNA-1273 vaccine and the event myocarditis on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Autonomic nervous system imbalance remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-408497 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 58 year-old, female patient with a history of Autonomic nervous system imbalance, who experienced the non-serious unexpected, according CCDS, AESI of Postural orthostatic tachycardia syndrome and non-serious expected, according CCDS, AESI of myocarditis (the patient reported they are investigating for myopericarditis and MRI was performed, results pending). The event Postural orthostatic tachycardia syndrome occurred approximately 1 week after the second dose of mRNA-1273 vaccine and the event myocarditis on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the second dose and no information on additional dosing is available. The medical history, of Autonomic nervous system imbalance remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.