Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood chloride, Blood creatine phosphokinase, Blood lactic acid
Clinical narrative: MIS-A/Loss of consciousness; COVID-19; This literature-non-study case was reported in a literature article and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (MIS-A/Loss of consciousness) in a 3-decade-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (MIS-A/Loss of consciousness) (seriousness criteria hospitalization, medically significant and life threatening) and COVID-19 (COVID-19). The patient was treated with ADENOSINE (intravenous) at a dose of 12 milligram; NOREPINEPHRINE for Shock, at an unspecified dose and frequency; LEVETIRACETAM for Seizures, at an unspecified dose and frequency; METHYLPREDNISOLONE at an unspecified dose and frequency and DOBUTAMINE at an unspecified dose and frequency. At the time of the report, MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (MIS-A/Loss of consciousness) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (6-45 international unit per litre): 114 international unit per litre On presentation, 1399 international unit per litre Peak value and 942 international unit per litre Post intervention. On an unknown date, Aspartate aminotransferase (10-42 international unit per litre): 56 international unit per litre On presentation, 2008 international unit per litre Peak value and 209 international unit per litre Post intervention. On an unknown date, Blood chloride (2-4 litre per minute per square metre): 1.4 litre per minute per square metre. On an unknown date, Blood creatine phosphokinase (20-210 international unit per litre): 722 international unit per litre On presentation, 1337 international unit per litre Peak value and 174 international unit per litre Post intervention. On an unknown date, Blood lactic acid: 5.6 milliequivalent per litre. On an unknown date, Blood pressure measurement: 62/28 mmHg. On an unknown date, Body mass index: 44.85 kilogram per second per square metre. On an unknown date, Body temperature: 100 F. On an unknown date, C-reactive protein (0-10 milligram per litre): 223.88 milligram per litre On presentation, 223.88 milligram per litre Peak value and 46.21 milligram per litre Post intervention. On an unknown date, Catheterisation cardiac: revealed severe biventricularfailure and cardiogenic shock (cardiac output by Fick 3.4 L/min (normal 46 L/min), right ventricle 34/16, pulmonary artery 35/22 (mean 29) (normal 25/10(15)), pulmonary capillary wedge pressure 23 mm Hg (normal 611 mm Hg)).. On an unknown date, Computerised tomogram head: revealed subtle diffuse sulcal effacement concerning for intracranialoedema.. On an unknown date, Computerised tomogram thorax: showed low lung volumes with dependent bilateral airspace disease suspicious for atelectasis or aspiration.. On an unknown date, Drug screen: (Positive) positive for fentanyl.. On an unknown date, Echocardiogram: showed diffuse delta range slowing, suggestive of generalised cerebral dysfunction. and revealed ejectionfraction of 15%.. On an unknown date, Fibrin D dimer (0-230 ng/mL): 6692 ng/mL On presentation, 12 574 ng/mL Peak value and 3249 ng/mL Post intervention. On an unknown date, Heart rate: 200 beats per minute on cardiac monitor and 125 beats per minute. On an unknown date, Physical examination: was remarkable for comatose state, mydriasis ofpupils, and coarse, rhonchorous breath sounds throughout all lung fields.. On an unknown date, Platelet count (150-400 10^9/L): 112 000 10^9/L On presentation, 15 000 10^9/L Peak value and 87 000 10^9/L Post intervention. On an unknown date, Pulmonary arterial wedge pressure: 23 mmHg. On an unknown date, Respiratory rate: 30 breaths per minute. On an unknown date, SARS-CoV-2 test: Positive. On an unknown date, Serum ferritin (22-322): greater than 16500 ng/ml, greater than 16500 ng/ml and 1707 ng/mL. On an unknown date, Troponin (3-57 ng/L): 5298 ng/L On presentation, 11 295 ng/L Peak value and 1712 ng/L Post intervention. On an unknown date, White blood cell count (3.5-11.0 10^9/L): 4.2 10^9/L On presentation, 12.7 10^9/L Peak value and 8.5 10^9/L Post intervention.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient tested positive for SARS-CoV-2, 3 weeks prior to admission. The patient endorsed cough, fever and chills. The patient was unable to walk unassisted due to generalised weakness and he became increasingly tachypneic and lost consciousness. He was noted to become rigid and lost bladder continence and the patient had no prior history of seizures and he did not take any medications at home. The patient did not receive a booster dose. En route to the hospital, the patient developed supraventricular tachycardia. The patient's glasgow coma scale was noted to be 3 and underwent endotracheal intubation for airway protection.  There was no conjunctivitis and skin rash identified. Extremities were cool to touch. The patient admitted to the medical intensive care unit.   The patient was treated with broad spectrum antibiotics for septic shock secondary to aspiration pneumonia. Infectious diseases, cardiology and neurology services were consulted.  The medical team decided against treatment with anakinra given clinical improvement. It was stated that patient was extubated on day 8 of his hospital admission.   The patient improved neurologically and was able to follow some commands although remained persistently weak due to critical illness myopathy. The patient remained on a gradual tapering regimen of methylprednisolone. Dobutamine was added to his inotropic regimen and diuresis was initiated.  It was stated that the detailed features that distinguish severe COVID-19-associated hyperinflammation from multisystem inflammatory syndrome in adults (MISA) is not yet known.   Company comment:This literature non-study case concerns a healthy man in his late 20s, with no prior history of seizures, not on any medications reported, who experienced the Life threatening, serious (medically significant/Hospitalization) unexpected AESI of Multisystem inflammatory syndrome in adults along with non-serious event of Covid-19 in the context of mRNA-1273 vaccination. He had received two doses of mRNA-1273 vaccine about 9 months prior to presentation. He was brought to the hospital after being found unconscious, he was tested positive for SARS-CoV-2, three weeks prior to admission. To start with he had cough, fever and chills, was unable to walk due to generalized weakness. Later became tachypneic and lost consciousness, noted to become rigid and lost bladder continence. En route to the hospital, he developed supraventricular tachycardia with a heart rate of the 200 beats per minute on cardiac monitor and was given 12 mg of intravenous adenosine which stabilized the heart rate. At the time of admission, his temperature was 100.7F, heart rate 125 beats/min, BP 62/28 mm Hg and respiratory rate of 30 breaths/min. His Glasgow Coma Scale was noted to be 3 and he underwent endotracheal intubation for airway protection. Physical examination was remarkable for comatose state, mydriasis of pupils, cool extremities, coarse, rhonchorous breath sounds with no conjunctivitis and skin rash. Initial labs showed elevated lactate of 5.6 mEq/L, acute kidney injury, transaminitis and SARS-CoV-2 positivity. He was started on norepinephrine for management of shock and admitted to the medical intensive care unit. His urine drug screen was positive for fentanyl. CT chest showed low lung volumes with dependent bilateral airspace disease suspicious for atelectasis or aspiration. He was started on levetiracetam for possible seizures and on broad spectrum antibiotics for septic shock secondary to aspiration pneumonia. Infectious diseases, cardiology and neurology services were consulted. He met the necessary criteria for MIS-A as per the Centers for Disease Control (CDC) definition. On day 3, he was given intravenous immunoglobulin (IG) and started on high dose methylprednisolone with which there was an improvement in the inflammatory markers. The medical team decided against treatment with anakinra given clinical improvement. CT brain showed subtle diffuse sulcal effacement concerning for intracranial oedema. EEG showed diffuse delta range slowing, suggestive of generalised cerebral dysfunction. He was extubated on day 8 of his hospital admission. He was noted to be in persistent shock requiring high-dose norepinephrine. Echocardiogram revealed ejection fraction of 15%.  A right heart catheterization done revealed severe biventricular failure and cardiogenic shock. Dobutamine was added to his inotropic regimen and diuresis was initiated. He improved neurologically and was able to follow some commands although remained persistently weak due to critical illness myopathy. He remained on a gradual tapering regimen of methylprednisolone. Complete blood count(WBC and platelets), liver function tests and  inflammatory markers ,were deranged on presentation which progressively worsened, started showing improvement post intervention. Author concludes that this patient met the CDC criteria for MIS-A (presence of fever, severe cardiac illness, encephalopathy, thrombocytopenia, hypotension, significantly elevated inflammatory markers and positive SARS-CoV-2 test by RT-PCR). There were no alternative diagnoses to explain his clinical presentation. An extensive workup revealed no other etiologies. Patients who have already been vaccinated may become infected or reinfected with SARS-CoV-2 and then develop MIS-C/A.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Live follow up received by safety on 17-NOV-2022 has Email with FTA received and contains new updates. Reporter information, Literature information, lab data ,treatment medication and event details were updated; Sender's Comments: This literature non-study case concerns a healthy man in his late 20s, with no prior history of seizures, not on any medications reported, who experienced the Life threatening, serious (medically significant/Hospitalization) unexpected AESI of Multisystem inflammatory syndrome in adults along with non-serious event of Covid-19 in the context of mRNA-1273 vaccination. He had received two doses of mRNA-1273 vaccine about 9 months prior to presentation. He was brought to the hospital after being found unconscious, he was tested positive for SARS-CoV-2, three weeks prior to admission. To start with he had cough, fever and chills, was unable to walk due to generalized weakness. Later became tachypneic and lost consciousness, noted to become rigid and lost bladder continence. En route to the hospital, he developed supraventricular tachycardia with a heart rate of the 200 beats per minute on cardiac monitor and was given 12 mg of intravenous adenosine which stabilized the heart rate. At the time of admission, his temperature was 100.7F, heart rate 125 beats/min, BP 62/28 mm Hg and respiratory rate of 30 breaths/min. His Glasgow Coma Scale was noted to be 3 and he underwent endotracheal intubation for airway protection. Physical examination was remarkable for comatose state, mydriasis of pupils, cool extremities, coarse, rhonchorous breath sounds with no conjunctivitis and skin rash. Initial labs showed elevated lactate of 5.6 mEq/L, acute kidney injury, transaminitis and SARS-CoV-2 positivity. He was started on norepinephrine for management of shock and admitted to the medical intensive care unit. His urine drug screen was positive for fentanyl. CT chest showed low lung volumes with dependent bilateral airspace disease suspicious for atelectasis or aspiration. He was started on levetiracetam for possible seizures and on broad spectrum antibiotics for septic shock secondary to aspiration pneumonia. Infectious diseases, cardiology and neurology services were consulted. He met the necessary criteria for MIS-A as per the Centers for Disease Control (CDC) definition. On day 3, he was given intravenous immunoglobulin (IG) and started on high dose methylprednisolone with which there was an improvement in the inflammatory markers. The medical team decided against treatment with anakinra given clinical improvement. CT brain showed subtle diffuse sulcal effacement concerning for intracranial oedema. EEG showed diffuse delta range slowing, suggestive of generalised cerebral dysfunction. He was extubated on day 8 of his hospital admission. He was noted to be in persistent shock requiring high-dose norepinephrine. Echocardiogram revealed ejection fraction of 15%.  A right heart catheterization done revealed severe biventricular failure and cardiogenic shock. Dobutamine was added to his inotropic regimen and diuresis was initiated. He improved neurologically and was able to follow some commands although remained persistently weak due to critical illness myopathy. He remained on a gradual tapering regimen of methylprednisolone. Complete blood count(WBC and platelets), liver function tests and  inflammatory markers ,were deranged on presentation which progressively worsened, started showing improvement post intervention. Author concludes that this patient met the CDC criteria for MIS-A (presence of fever, severe cardiac illness, encephalopathy, thrombocytopenia, hypotension, significantly elevated inflammatory markers and positive SARS-CoV-2 test by RT-PCR). There were no alternative diagnoses to explain his clinical presentation. An extensive workup revealed no other etiologies. Patients who have already been vaccinated may become infected or reinfected with SARS-CoV-2 and then develop MIS-C/A.  The benefit-risk relationship of mRNA-1273 is not affected by this report.