Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Renal disorder, Type 1 diabetes mellitus, Vaccination site pain
Clinical narrative: Vaccination site pain; potential atrial fibrillation was noted; Inflammation on the heart was noted; shortness of breath; swollen lymph nodes that also appears all over her CTSCAN; Showing type 1 diabetes mellitus; enlargement of the right atrium/ pulmonary disease pattern; pulmonary disease pattern; issue on her kidney; face suddenly turns into beet red; developed a rash on the arm that spreads into her torso towards the stomach; fever was increasing and getting worst/fever in the afternoon with 102-104F; nauseous on the first day; left arm was sore; headache with a pain scale of 9/10; in the morning she have chills; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (potential atrial fibrillation was noted), CARDITIS (Inflammation on the heart was noted), DYSPNOEA (shortness of breath) and LYMPHADENOPATHY (swollen lymph nodes that also appears all over her CTSCAN) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced ATRIAL FIBRILLATION (potential atrial fibrillation was noted) (seriousness criterion medically significant), CARDITIS (Inflammation on the heart was noted) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), LYMPHADENOPATHY (swollen lymph nodes that also appears all over her CTSCAN) (seriousness criterion medically significant), TYPE 1 DIABETES MELLITUS (Showing type 1 diabetes mellitus), ATRIAL ENLARGEMENT (enlargement of the right atrium/ pulmonary disease pattern), LUNG DISORDER (pulmonary disease pattern), RENAL DISORDER (issue on her kidney), ERYTHEMA (face suddenly turns into beet red), RASH (developed a rash on the arm that spreads into her torso towards the stomach), PYREXIA (fever was increasing and getting worst/fever in the afternoon with 102-104F), NAUSEA (nauseous on the first day), MYALGIA (left arm was sore), HEADACHE (headache with a pain scale of 9/10) and CHILLS (in the morning she have chills). On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency; IBUPROFEN for Fever, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Carditis and Fever, at a dose of every 4 hours; DEXAMETHASONE SODIUM PHOSPHATE (DECADRON [DEXAMETHASONE SODIUM PHOSPHATE]) for Adverse event, at a dose of 2 mg and AZITHROMYCIN for Adverse event, at a dose of 250 mg. At the time of the report, ATRIAL FIBRILLATION (potential atrial fibrillation was noted), CARDITIS (Inflammation on the heart was noted), DYSPNOEA (shortness of breath), LYMPHADENOPATHY (swollen lymph nodes that also appears all over her CTSCAN), TYPE 1 DIABETES MELLITUS (Showing type 1 diabetes mellitus), ATRIAL ENLARGEMENT (enlargement of the right atrium/ pulmonary disease pattern), LUNG DISORDER (pulmonary disease pattern), RENAL DISORDER (issue on her kidney), ERYTHEMA (face suddenly turns into beet red), RASH (developed a rash on the arm that spreads into her torso towards the stomach), PYREXIA (fever was increasing and getting worst/fever in the afternoon with 102-104F), NAUSEA (nauseous on the first day), MYALGIA (left arm was sore), HEADACHE (headache with a pain scale of 9/10), CHILLS (in the morning she have chills) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: high (High) Elevated blood pressure. In August 2021, Body temperature: 102-104 (High) fever with 102-104 F. In August 2021, Computerised tomogram: abnormal (abnormal) Swollen lymph nodes. In August 2021, Electrocardiogram: abnormal (abnormal) Electrocardiogram abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The bloodwork of the patient continuously showed complete changes. Treatment activities for event was  also done with unspecified inhaler and icepack for fever.  Company comment: This case concerns of a 37 year old female with no reported relevant medical history who experienced unexpected events of Atrial Fibrillation, Carditis , lymphadenopathy,  Dyspnea , Type 1 DM, Right atrial enlargement Lung Disorder, Renal Disorder , Erythema   that occurred  on the same  day of the administration of the 1st dose of the Moderna Vaccine. This was also accompanied by other expected events Vaccination site pain, Fever, Headache , Chills , Myalgia, Nausea. and Rash.  The rechallenge was not applicable since the events happened after the 1st dose. The reporter's assessment was not provided.  The benefit-risk relationship of Moderna is not affected by this report.; Sender's Comments: This case concerns of a 37 year old female with no reported relevant medical history who experienced unexpected events of Atrial Fibrillation, Carditis , lymphadenopathy,  Dyspnea , Type 1 DM, Right atrial enlargement Lung Disorder, Renal Disorder , Erythema   that occurred  on the same  day of the administration of the 1st dose of the Moderna Vaccine. This was also accompanied by other expected events Vaccination site pain, Fever, Headache , Chills , Myalgia, Nausea. and Rash.  The rechallenge was not applicable since the events happened after the 1st dose. The reporter's assessment was not provided.  The benefit-risk relationship of Moderna is not affected by this report