Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea, Electrocardiogram, Inappropriate schedule of product administration
Clinical narrative: shortness of breath so severe; patient reports experincing chest pain since November 2021; Patient tested Covid-19/ Patient experienced symptoms of Covid-19; Greater than 35 days between the patients first and second Primary Series doses of the Moderna Covid-19 vaccine.; shaky right hand; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath so severe), CHEST PAIN (patient reports experincing chest pain since November 2021), TREMOR (shaky right hand), COVID-19 (Patient tested Covid-19/ Patient experienced symptoms of Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between the patients first and second Primary Series doses of the Moderna Covid-19 vaccine.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 009D21A) for COVID-19 vaccination.     No Known drug allergies provided. Patient has no History of Myocarditis or pericarditis.  Concurrent medical conditions included Depression and High cholesterol. Concomitant products included LEVOTHYROXINE, PROPRANOLOL, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE and MONASCUS PURPUREUS (RED YEAST RICE) for an unknown indication.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between the patients first and second Primary Series doses of the Moderna Covid-19 vaccine.). In September 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (shaky right hand). On 09-Oct-2021, the patient experienced COVID-19 (Patient tested Covid-19/ Patient experienced symptoms of Covid-19). In November 2021, the patient experienced DYSPNOEA (shortness of breath so severe) and CHEST PAIN (patient reports experincing chest pain since November 2021). At the time of the report, DYSPNOEA (shortness of breath so severe) and CHEST PAIN (patient reports experincing chest pain since November 2021) had not resolved and TREMOR (shaky right hand), COVID-19 (Patient tested Covid-19/ Patient experienced symptoms of Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between the patients first and second Primary Series doses of the Moderna Covid-19 vaccine.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Electrocardiogram: negative (Negative) Negative. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.         Patient did not experience any similar events in the past. Patient experienced COVID-19 symptoms on 08 Oct 2021. Symptoms included, Fever, Shortness of breath, Runny nose, Fatigue. Patient was not hospitalized due to COVID-19. Patient went to his Primary Care Physician and his Neurologist  The reporter reported that the symptoms had been worsened.  No treatment medication information was provided.  Company Comment: This spontaneous case concerns a 44-year-old, male patient with concurrent high cholesterol and depression and concomitant medications of DEXTROAMPHETAMINE/AMPHETAMINE (Adderall), Fluoxetine, Propranolol and Levothyroxine all for unknown indications, who experienced the unexpected, non-serious adverse event of special interest COVID-19 and other non-serious events of Dyspnoea, Chest pain and Tremor. Inappropriate schedule of product administration was reported as an additional event. The patient was diagnosed with COVID-19 approximately a month after completion of primary vaccine series, presenting with fever, shortness of breath, runny nose and fatigue. Clinical course and treatment details were not specified, although it was mentioned that he was not hospitalized. The patient also experienced shaking of the right hand a week following vaccination. Information was not provided on the course of the symptom and if there was any immediate medical consult done. Approximately 2 months post-vaccination, chest pain and shortness of breath occurred, and observed decreased endurance on an unspecified exact date. He was seen by a primary physician and was referred to a neurologist where electrocardiography and magnetic resonance imaging were done; but results were negative. The physician associated the symptoms to his ongoing depression. At the time of reporting, the non-serious events are still ongoing. The patient's depression remains a confounder for the dyspnea, chest pain and tremor; while high cholesterol could be a risk factor for the dyspnea and chest pain. Additionally, the concomitant medications remain as confounders for the chest pain and tremor. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 44-year-old, male patient with concurrent high cholesterol and depression and concomitant medications of DEXTROAMPHETAMINE/AMPHETAMINE (Adderall), Fluoxetine, Propranolol and Levothyroxine all for unknown indications, who experienced the unexpected, non-serious adverse event of special interest COVID-19 and other non-serious events of Dyspnea, Chest pain and Tremor. Inappropriate schedule of product administration was reported as an additional event. The patient was diagnosed with COVID-19 approximately a month after completion of primary vaccine series, presenting with fever, shortness of breath, runny nose and fatigue. Clinical course and treatment details were not specified, although it was mentioned that he was not hospitalized. The patient also experienced shaking of the right hand a week following vaccination. Information was not provided on the course of the symptom and if there was any immediate medical consult done. Approximately 2 months post-vaccination, chest pain and shortness of breath occurred, and observed decreased endurance on an unspecified exact date. He was seen by a primary physician and was referred to a neurologist where electrocardiography and magnetic resonance imaging were done; but results were negative. The physician associated the symptoms to his ongoing depression. At the time of reporting, the non-serious events are still ongoing. The patient's depression remains a confounder for the dyspnea, chest pain and tremor; while high cholesterol could be a risk factor for the dyspnea and chest pain. Additionally, the concomitant medications remain as confounders for the chest pain and tremor. The benefit-risk relationship of mRNA-1273 is not affected by this report.