Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Presyncope, Pyrexia, Rash scarlatiniform, Red blood cell sedimentation rate normal
Clinical narrative: Ventricle enlargement; Hypotension; MIS-A; Nauseous; Near syncope; Substernal chest pain; Sweating/diaphoretic; Very pale; Felt very bad; Scarletina rash; Her face and ears became very red; Tiny bullae; Face and ears becomes edematous; Fever; Throat then had a red spotty appearance; Sharp abdominal pain; This spontaneous case was reported by a physician and describes the occurrence of RASH SCARLATINIFORM (Scarletina rash), PRESYNCOPE (Near syncope), CHEST PAIN (Substernal chest pain), PYREXIA (Fever), HYPERHIDROSIS (Sweating/diaphoretic), ERYTHEMA (Her face and ears became very red), BLISTER (Tiny bullae), PALLOR (Very pale), FEELING ABNORMAL (Felt very bad), VENTRICULAR ENLARGEMENT (Ventricle enlargement), HYPOTENSION (Hypotension), MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (MIS-A), NAUSEA (Nauseous) and EAR SWELLING (Face and ears becomes edematous) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A, 019B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Splenomegaly. Concomitant products included PREDNISONE for Myasthenia gravis.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization) and ABDOMINAL PAIN (Sharp abdominal pain). On 06-Sep-2021, the patient experienced RASH SCARLATINIFORM (Scarletina rash) (seriousness criterion hospitalization), ERYTHEMA (Her face and ears became very red) (seriousness criterion hospitalization), BLISTER (Tiny bullae) (seriousness criterion hospitalization), EAR SWELLING (Face and ears becomes edematous) (seriousness criterion hospitalization) and PHARYNGEAL ERYTHEMA (Throat then had a red spotty appearance). On 08-Sep-2021, the patient experienced PRESYNCOPE (Near syncope) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Substernal chest pain) (seriousness criterion hospitalization), HYPERHIDROSIS (Sweating/diaphoretic) (seriousness criterion hospitalization), PALLOR (Very pale) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt very bad) (seriousness criterion hospitalization) and NAUSEA (Nauseous) (seriousness criterion hospitalization). On an unknown date, the patient experienced VENTRICULAR ENLARGEMENT (Ventricle enlargement) (seriousness criterion hospitalization), HYPOTENSION (Hypotension) (seriousness criterion hospitalization) and MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (MIS-A) (seriousness criterion hospitalization). The patient was treated with ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency. On 04-Sep-2021, ABDOMINAL PAIN (Sharp abdominal pain) had resolved. On 07-Sep-2021, PHARYNGEAL ERYTHEMA (Throat then had a red spotty appearance) had resolved. At the time of the report, RASH SCARLATINIFORM (Scarletina rash), PYREXIA (Fever) and HYPERHIDROSIS (Sweating/diaphoretic) had resolved, PRESYNCOPE (Near syncope), ERYTHEMA (Her face and ears became very red), BLISTER (Tiny bullae), PALLOR (Very pale), FEELING ABNORMAL (Felt very bad), VENTRICULAR ENLARGEMENT (Ventricle enlargement), HYPOTENSION (Hypotension), MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (MIS-A), NAUSEA (Nauseous) and EAR SWELLING (Face and ears becomes edematous) outcome was unknown and CHEST PAIN (Substernal chest pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatine phosphokinase: normal (normal) Isoenzymes, liver functions, lactate, and D-Dimer were normal. In 2021, Blood culture: negative (Negative) Negative. In 2021, Blood immunoglobulin G: postive (Positive) Positive. In 2021, Blood immunoglobulin M: positive (Positive) Positive. In 2021, Blood pressure measurement: 108/66 (abnormal) abnormal. In 2021, C-reactive protein: 2.1 (normal) normal. In 2021, Computerised tomogram: normal (normal) Normal. In 2021, Culture urine: negative (Negative) Negative. In 2021, Electrocardiogram: normal (normal) normal. In 2021, Full blood count: normal (normal) normal. In 2021, Red blood cell sedimentation rate normal: 28 (normal) normal. In 2021, SARS-CoV-2 test: negative (Negative) Negative. In 2021, Serum ferritin: 155 (normal) normal. In 2021, White blood cells urine: abnormal (abnormal) 36 WBC/hpf. On 04-Sep-2021, Body temperature: 39.5 (abnormal) abnormal. On 07-Sep-2021, Blood creatine phosphokinase: 55-60 (abnormal) 55-60% abnormal. On 07-Sep-2021, Blood pressure measurement: 149/92 (abnormal) abnormal. On 08-Sep-2021, Blood pressure measurement: 94/74 (abnormal) abnormal (normally has about 130/80 blood pressures while on prednisone). On 08-Sep-2021, Chest X-ray: normal (normal) normal. On 08-Sep-2021, Echocardiogram: normal (normal) normal. On 09-Sep-2021, Echocardiogram: abnormal (abnormal) showed mild left ventricle enlargement. On 09-Sep-2021, Ejection fraction: 50-60 (abnormal) 50-60% abnormal. On 09-Sep-2021, Troponin T: 52 (normal) ng at 2:23, 57 (normal) (ng/L) In morning, 64 (normal) In afternoon, 66 (normal) ng at 15:21 and 53 (normal) ng at 18:10.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication includes IV fluids. EBV serology was negative for IgM, and positive for IgG VCA and NA. A large nasopharyngeal molecular panel for respiratory pathogens was negative, as were serologies for B. burgdorferi, Babesia, Ehrlichia, and Anaplasma. The rash started improving and the fever and diaphoresis resolved over the next 12 hours after hospital admission. An infectious etiology was suspected, but the patient had been largely sheltered from potential sources of infection. Per reporter the current case meets diagnostic criteria for MIS-A (fever for 4 days, scarletina rash, elevated inflammatory markers, abdominal pain, chest pain with hypotension, diaphoresis, and elevated troponin T) other than not having evidence of COVID-19. Company comment: This case concerns a 33-year-old, female patient with relevant medical history of myasthenia gravis, who experienced the unexpected events of rash This case concerns a 33-year-old, female patient with relevant medical history of myasthenia gravis, who experienced the unexpected events of rash scarlatiniform, blister, presyncope, pallor, feeling abormal, chest pain, pyrexia, abdominal pain, hyperhydrosis, erythema, swelling face, ear swelling, pharyngeal erythema, ventricular enlargement, hypotension, nausea and multisystem inflammatory syndrome in adults. The events occurred approximately 11 to 15 days after the third dose of Moderna COVID-19 Vaccine. The patient first experienced abdominal pain and pyrexia followed by nausea on the next day and occurrence of scarlatiniform rash, erythema, blister, sweeling face and ears and pharyngeal erythema. The patient also experienced substernal chest pain and was taken to ER. The patient had elevated troponine and left ventricle enlargement. Infectious workup was negative. The reported stated that the patient met criteria for Multisystem Inflammatory Syndrome in adults. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The medical history of myastenia gravis and use of prednisone remain a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.  This case was linked to MOD-2021-343729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received on 05-OCT-2021 with Event, Lab. data, Patient details, Concomitant and treatment medication updated.; Sender's Comments: This case concerns a 33-year-old, female patient with relevant medical history of myasthenia gravis, who experienced the unexpected events of rash scarlatiniform, blister, presyncope, pallor, feeling abormal, chest pain, pyrexia, abdominal pain, hyperhydrosis, erythema, swelling face, ear swelling, pharyngeal erythema, ventricular enlargement, hypotension, nausea and multisystem inflammatory syndrome in adults. The events occurred approximately 11 to 15 days after the third dose of Moderna COVID-19 Vaccine. The patient first experienced abdominal pain and pyrexia followed by nausea on the next day and occurrence of scarlatiniform rash, erythema, blister, sweeling face and ears and pharyngeal erythema. The patient also experienced substernal chest pain and was taken to ER. The patient had elevated troponine and left ventricle enlargement. Infectious workup was negative. The reported stated that the patient met criteria for Multisystem Inflammatory Syndrome in adults. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The medical history of myastenia gravis and use of prednisone remain a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.