Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site pain, Vaccination site reaction, Vomiting
Clinical narrative: she started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter; Digestive issues; Vomiting; Nausea; myalgia; Fatigue; body aches; Joint pain; Headache; she had an injection site reaction that started 24-48 hours after receiving the vaccine and lasted for about 2 months; The muscle at the injection site remained inflamed and tender the whole time; The muscle at the injection site remained inflamed and tender the whole time; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDITIS (she started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), PROBIOTICS NOS, METFORMIN HYDROCHLORIDE (METFORMIN ER), DILTIAZEM HYDROCHLORIDE (DILTIAZEM XR), POTASSIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE), DIMETICONE (DIMETHICONE), MULTIVITAMIN [VITAMINS NOS] and ASCORBIC ACID, ZINC (VITAMIN C + ZINC) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE REACTION (she had an injection site reaction that started 24-48 hours after receiving the vaccine and lasted for about 2 months), VACCINATION SITE PAIN (The muscle at the injection site remained inflamed and tender the whole time) and VACCINATION SITE INFLAMMATION (The muscle at the injection site remained inflamed and tender the whole time). On 10-May-2021, the patient experienced MYOCARDITIS (she started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced MYALGIA (body aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), MYALGIA (myalgia) and FATIGUE (Fatigue). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Digestive issues), VOMITING (Vomiting) and NAUSEA (Nausea). The patient was hospitalized from 12-May-2021 to 14-May-2021 due to MYOCARDITIS. The patient was treated with OXYGEN in May 2021 for Adverse event, at a dose of 4 liter for 24 hours; HEPARIN (intravenous) in May 2021 for Myocarditis, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] in May 2021 for Myocarditis, at an unspecified dose and frequency and APIXABAN (ELIQUIS) in May 2021 for Myocarditis, at an unspecified dose and frequency. On 15-May-2021, MYOCARDITIS (she started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter) had resolved. In June 2021, VACCINATION SITE REACTION (she had an injection site reaction that started 24-48 hours after receiving the vaccine and lasted for about 2 months) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Digestive issues), MYALGIA (body aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), MYALGIA (myalgia) and FATIGUE (Fatigue) outcome was unknown and VACCINATION SITE PAIN (The muscle at the injection site remained inflamed and tender the whole time) and VACCINATION SITE INFLAMMATION (The muscle at the injection site remained inflamed and tender the whole time) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Echocardiogram: normal (normal) Normal. In May 2021, Electrocardiogram: normal (normal) Normal. In May 2021, Oxygen saturation: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (she started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter) to be related. No further causality assessments were provided for ABDOMINAL DISCOMFORT (Digestive issues), VACCINATION SITE REACTION (she had an injection site reaction that started 24-48 hours after receiving the vaccine and lasted for about 2 months), MYALGIA (body aches), ARTHRALGIA (Joint pain), HEADACHE (Headache), VOMITING (Vomiting), NAUSEA (Nausea), MYALGIA (myalgia), FATIGUE (Fatigue), VACCINATION SITE PAIN (The muscle at the injection site remained inflamed and tender the whole time) and VACCINATION SITE INFLAMMATION (The muscle at the injection site remained inflamed and tender the whole time).    Reporter said that she had an injection site reaction that started 24-48 hours after receiving the vaccine and lasted for about 2 months. The muscle at the injection site remained inflamed and tender the whole time. She also experienced headache, fatigue, body aches, myalgia, and joint pain in May-2021. She had digestive issues including nausea and vomiting as well. Around 10-May-2021, she said she started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter which prompted her to go to the emergency room. It kept getting worse. On 12-May-2021, she was admitted to the chest pain center for approximately 3 days. The hospital performed an echo, EKG, and cardiac pain profile and everything came back normal. Her oxygen stats were low so she was put on 4L of oxygen for 24 hours. She was given IV Heparin. The physicians at the hospital told her that it was myocarditis related to the vaccine. She was also put on additional blood thinners including Eloquis and Aspirin. She said that she may have received one IM and one IV pain killer while at the hospital. She was discharged after 3 days and approximately 2-3 weeks later, all her symptoms had resolved. She said that the cardiac related symptoms were 99 percent better upon her discharge from the hospital.  Company comment: This case concerns a 57-year-old, female patient with medical history of breast cancer, who experienced the expected event of myocarditis, which required hospitalization. The event occurred approximately 40 days after the first dose of mRNA-1273. The patient started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter which prompted her to go to the emergency room. The patient was admitted to the chest pain center for approximately 3 days. The hospital performed an echo, EKG, and cardiac pain profile and everything came back normal. Her oxygen stats were low so she was put on 4L of oxygen for 24 hours. She was given IV Heparin. The physicians at the hospital told the patient  that it was myocarditis related to the vaccine. She was also put on additional blood thinners including Eloquis and Aspirin. After discharge all symptoms had resolved. The rechallenge was negative. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-396695 (Patient Link).; Sender's Comments: This case concerns a 57-year-old, female patient with medical history of breast cancer, who experienced the expected event of myocarditis, which required hospitalization. The event occurred approximately 40 days after the first dose of mRNA-1273. The patient started experiencing all signs of myocarditis including chest pain, shortness of breath, and flutter which prompted her to go to the emergency room. The patient was admitted to the chest pain center for approximately 3 days. The hospital performed an echo, EKG, and cardiac pain profile and everything came back normal. Her oxygen stats were low so she was put on 4L of oxygen for 24 hours. She was given IV Heparin. The physicians at the hospital told the patient  that it was myocarditis related to the vaccine. She was also put on additional blood thinners including Eloquis and Aspirin. After discharge all symptoms had resolved. The rechallenge was negative. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.