Report #2896299

Overview

Sex

Female

Age

18 yrs

State

MN

Recovered

Not recovered

Vaccinated

Mar 16, 2021

Onset

Mar 21, 2021

Days to onset

5

Hospital days

7

Symptoms (47)

Symptom narrative

Pancytopenia; suspected macrophage activation syndrome; Multisystem inflammatory syndrome (MIS); Sjögren's syndrome; Sore arm; This literature-non-study case was reported in a literature article and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME (Multisystem inflammatory syndrome (MIS)), PANCYTOPENIA (Pancytopenia) and SJOGREN'S SYNDROME (Sjögren's syndrome) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Concurrent medical conditions included Asthma exercise induced. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MULTISYSTEM INFLAMMATORY SYNDROME (Multisystem inflammatory syndrome (MIS)) (seriousness criteria hospitalization and medically significant). On 23-Mar-2021, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criteria hospitalization and medically significant). In June 2022, the patient experienced SJOGREN'S SYNDROME (Sjögren's syndrome) (seriousness criterion medically significant). The patient was hospitalized from 25-Mar-2021 to 31-Mar-2021 due to MULTISYSTEM INFLAMMATORY SYNDROME and PANCYTOPENIA. At the time of the report, MULTISYSTEM INFLAMMATORY SYNDROME (Multisystem inflammatory syndrome (MIS)), PANCYTOPENIA (Pancytopenia) and SJOGREN'S SYNDROME (Sjögren's syndrome) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature: 39.4 degree Celsius fevers up to. On 23-Mar-2021, Band neutrophil percentage: 5 % Reference range not provided. On 23-Mar-2021, Blood pressure measurement: 97/59 mmHg. On 23-Mar-2021, Body temperature: 40.3 degree Celsius persistent fevers up to 40.3 and 38.4 degree Celsius Temperature. On 23-Mar-2021, Computerised tomogram thorax: showed bilateral axillary and left supraclavicular lymphadenopathy, with no lung infiltrates or pulmonary embolism. On 23-Mar-2021, Eosinophil percentage: 2 % Reference range not provided. On 23-Mar-2021, Fibrin D dimer: 13.44 microgram per millilitre Reference range not provided. On 23-Mar-2021, Haemoglobin: 11.9 g/dL Reference range not provided. On 23-Mar-2021, Heart rate: 85 heart beats per minute Reference range not provided. On 23-Mar-2021, Influenza virus test: (Negative) Molecular test for influenza. On 23-Mar-2021, Lymphocyte percentage: 16 % Reference range not provided. On 23-Mar-2021, Monocyte percentage: 5 % Reference range not provided. On 23-Mar-2021, Neutrophil percentage: 72 % Reference range not provided. On 23-Mar-2021, Oxygen saturation: 98 % Reference range not provided. On 23-Mar-2021, Platelet count: 101 10^9/L Reference range not provided. On 23-Mar-2021, Procalcitonin (Unknown-0.5 ng/mL): 0.26 ng/mL Normal. On 23-Mar-2021, SARS-CoV-2 test: (Negative) Molecular test for SARS-CoV-2. On 23-Mar-2021, Serum ferritin: 1256 ng/mL Reference range not provided. On 23-Mar-2021, Streptococcus test: (Negative) Molecular test for Group A streptococcus. On 23-Mar-2021, Troponin: 0.005 ng/mL Reference range not provided. On 23-Mar-2021, White blood cell count: 2.3 10^9/L Reference range not provided. On 25-Mar-2021, Alanine aminotransferase: 24 international unit per litre Reference range not provided. On 25-Mar-2021, Aspartate aminotransferase: 60 international unit per litre Reference range not provided. On 25-Mar-2021, Blood alkaline phosphatase (48-95 international unit per litre): 158 international unit per litre Reference provided. On 25-Mar-2021, Blood lactate dehydrogenase (130-250 international unit per litre): 845 international unit per litre Reference provided. On 25-Mar-2021, Blood pH: 7.57. On 25-Mar-2021, Blood pressure measurement: 95/50 mmHg. On 25-Mar-2021, Body temperature: 39.5 degree Celsius Temperature. On 25-Mar-2021, C-reactive protein: 9.9 mg/dl Reference range not provided. On 25-Mar-2021, Chest X-ray: hazy retrocardiac opacity. On 25-Mar-2021, Haemoglobin: 9.5 g/dL Reference range not provided. On 25-Mar-2021, Heart rate: 96 heart beats per minute Reference range not provided. On 25-Mar-2021, Oxygen saturation: 97 % Reference range not provided. On 25-Mar-2021, PCO2: 16 mmHg Reference range not provided. On 25-Mar-2021, Platelet count: 98 10^9/L Reference range not provided. On 25-Mar-2021, Procalcitonin (Unknown-0.5 ng/mL): 0.80 ng/mL Reference provided. On 25-Mar-2021, White blood cell count: 2.5 10^9/L Reference range not provided. On 26-Mar-2021, Band neutrophil percentage: 44 % Reference range not provided. On 26-Mar-2021, Biopsy bone marrow: no malignancy, mildly hypocellular bone marrow with decreased erythropoiesis and adequate myelopoiesis, mild megakaryocytic hyperplasia, and decreased iron stores. On 26-Mar-2021, Borrelia test: (Negative) Test for Lyme disease. On 26-Mar-2021, Cytomegalovirus test: (Negative) Tests for CMV. On 26-Mar-2021, Epstein-Barr virus test: (Negative) Tests for EBV. On 26-Mar-2021, HIV test: (Negative) Tests for HIV. On 26-Mar-2021, Laboratory test: (Negative) Test for Anaplasma. On 26-Mar-2021, Lymphocyte percentage: 23 % Reference range not provided. On 26-Mar-2021, Monocyte percentage: 2 % decreased. On 26-Mar-2021, Neutrophil percentage: 30 % decreased. On 26-Mar-2021, Parasite blood test: (Negative) Test for Babesia. On 26-Mar-2021, Rheumatoid factor: (Negative) Tests for RF. On 26-Mar-2021, SARS-CoV-2 test: (Negative) Test for SARS-CoV-2. On 26-Mar-2021, Serum ferritin: 3032 ng/mL Reference range not provided. On 26-Mar-2021, White blood cell count: 1.5 10^9/L decreased. On 28-Mar-2021, Chest X-ray: showing worsening bilateral consolidation. On 29-Mar-2021, Antinuclear antibody: (Positive) positive at 2.72 (negative, <1.0 units), (Positive) extractable nuclear antigen SS-A/Ro IgG was >8.0 U (negative <1.0 U) and (Negative) SS-B/La IgG. On 29-Mar-2021, Double stranded DNA antibody: (Negative) Reference range not provided. On 29-Mar-2021, Haemoglobin: 9.4 g/dL improved. On 29-Mar-2021, Platelet count: 251 10^9/L improved. On 29-Mar-2021, SARS-CoV-2 antibody test: (Negative) Serology for SARS-CoV-2 nucleocapsid antibodies. On 29-Mar-2021, Serum ferritin: 562 ng/mL improved. On 29-Mar-2021, White blood cell count: 5.9 10^9/L improved. On 21-Apr-2021, Alanine aminotransferase: 51 international unit per litre Reference range not provided. On 21-Apr-2021, Aspartate aminotransferase: 31 international unit per litre Reference range not provided. On 21-Apr-2021, Eosinophil percentage: 4 % Reference range not provided. On 21-Apr-2021, Haemoglobin: 11.3 g/dL Reference range not provided. On 21-Apr-2021, Lymphocyte percentage: 33 % Reference range not provided. On 21-Apr-2021, Monocyte percentage: 10 % Reference range not provided. On 21-Apr-2021, Neutrophil percentage: 51 % Reference range not provided. On 21-Apr-2021, Platelet count: 239 10^9/L Reference range not provided. On 21-Apr-2021, Serum ferritin: 44 ng/mL Reference range not provided. On 21-Apr-2021, White blood cell count: 2.9 10^9/L Reference range not provided. In June 2022, Anti-cyclic citrullinated peptide antibody: (Negative) Reference range not provided. In June 2022, Antinuclear antibody: (Positive) 1:640 speckled pattern (positive >1:80) and SSA/Ro >240.0 U/mL (normal, <7.0 U/mL). In June 2022, Biopsy salivary gland: diagnosed with Sjögren's syndrome. In June 2022, Double stranded DNA antibody: (Negative) Reference range not provided. In June 2022, Rheumatoid factor (Unknown-12 international unit per millilitre): 63 international unit per millilitre normal, <12 IU/mL. On an unknown date, Full blood count: Nine months post-hospitalization Normal. On an unknown date, Serum ferritin: Nine months post-hospitalization, ferritin was normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case refers to Patient 11 from Table 1 who received Moderna COVID-19 vaccine. Concomitant medications were not reported. Patient had no history of COVID-19. Five days later (after vaccination), developed fevers, headaches, sore arm, and shortness of breath. On 23-Mar-2021, patient presented to the emergency room (ER) with shortness of breath, cough, myalgia, fatigue, and persistent fevers up. Vital signs were measured and lab investigations were performed. A CT scan of the chest was done and the patient was discharged. But the patient continued to feel ill. On 24-Mar-2021, physician suspected an adverse reaction to the COVID-19 vaccine. The next day, patient returned to the ER complaining of cough, sore throat, and chest heaviness. Vitals on presentation were measured, and patient was unable to speak in full sentences. Laboratory tests were performed and the patient was hospitalized. The following morning, patient was started on cefepime and doxycycline. On 27-Mar-2021, due to worsening oxygenation, patient was placed on high-flow nasal cannula (HFNC) oxygen. Hematology started methylprednisolone 50 mg intravenously every eight hours. The next day, oxygenation started to improve. On 29-Mar-2021, she was transitioned to prednisone 20 mg orally once daily. The next day, she was off supplemental oxygen. Laboratory tests improved. A pediatric rheumatology consultation found no clinical features suggestive of Sjögren's syndrome but suspected this illness represented macrophage activation syndrome. Over the subsequent months and follow-up visits with hematology and rheumatology, patient continued to have multiple somatic complaints. Nine months post-hospitalization, she continued to complain of ‘brain fog, fatigue, and dizziness'. Patient's blood work was normal. Patient moved away for college, but symptoms continued to evolve. Patient complained of dry eyes and mouth and bilateral hand pain with morning stiffness. In June 2022, she was diagnosed with Sjögren's syndrome. The patient was placed on hydroxychloroquine. More than two years after her original illness onset, she continued to feel unwell with ongoing dry eyes, joint pain, and intestinal issues, including diarrhea, constipation, and bloating. This is a descriptive case series prospectively identified and collected by the authors during formal or informal consultation from January to December 2021. The aims of this descriptive case series were twofold. First, to present detailed clinical case presentations of serious adverse event following immunization (AEFI) with COVID-19 vaccines seen at one rural healthcare system during the first year after the introduction of COVID-19 vaccines. Second, to review the medical literature regarding similarly reported cases. Author concluded that they encountered a variety of AEFI with COVID-19 vaccines, including myocarditis, demyelinating disease, encephalitis, Bell's palsy, burning mouth syndrome, MIS, ITP, pneumonitis, colitis, staphylococcal infection, and erythromelalgia. This detailed case series were presented to help clinicians consider a diagnosis of AEFI when no other explanation had been found after a thorough diagnostic evaluation. These described adverse events following COVID-19 vaccination do not imply causality. They hope this descriptive case series leads to further case-control studies from healthcare organizations to explore the possible risks, incidence, and causal relationships of such adverse events following COVID-19 vaccination. This case was linked to US-MODERNATX, INC.-MOD-2026-795547 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2026-795547:Patient Case Number 1 (22-year old male)

Current illness

Asthma exercise induced

Lab data

Test Date: 20210325; Test Name: ALT; Result Unstructured Data: Test Result:24 [iU]/L;Reference range not provided; Test Date: 20210421; Test Name: ALT; Result Unstructured Data: Test Result:51 [iU]/L;Reference range not provided; Test Date: 202206; Test Name: cyclic citrullinated peptide; Test Result: Negative ; Test Date: 20210329; Test Name: ANA screen; Test Result: Positive ; Test Date: 202206; Test Name: ANA screen; Test Result: Positive ; Test Date: 20210329; Test Name: extractable nuclear antigen SS-A/Ro IgG; Test Result: Positive ; Test Date: 202206; Test Name: extractable nuclear antigen SS-A/Ro IgG; Result Unstructured Data: SSA/Ro >240.0 U/mL (normal, <7.0 U/mL); Test Date: 20210329; Test Name: SS-B/La IgG; Test Result: Negative ; Test Date: 20210325; Test Name: AST; Result Unstructured Data: Test Result:60 [iU]/L;Reference range not provided; Test Date: 20210421; Test Name: AST; Result Unstructured Data: Test Result:31 [iU]/L;Reference range not provided; Test Date: 20210323; Test Name: Bands; Test Result: 5 %; Test Date: 20210326; Test Name: Bands; Test Result: 44 %; Test Date: 20210326; Test Name: Bone marrow biopsy; Result Unstructured Data: no malignancy, mildly hypocellular bone marrow with decreased erythropoiesis and adequate myelopoiesis, mild megakaryocytic hyperplasia, and decreased iron stores; Test Date: 202206; Test Name: salivary gland biopsy; Result Unstructured Data: diagnosed with Sjögren's syndrome; Test Date: 20210325; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:158 [iU]/L;Reference provided; Test Date: 20210325; Test Name: LDH; Result Unstructured Data: Test Result:845 [iU]/L;Reference provided; Test Date: 20210325; Test Name: venous blood gas pH; Result Unstructured Data: 7.57; Test Date: 20210323; Test Name: BP; Result Unstructured Data: 97/59 mmHg; Test Date: 20210325; Test Name: BP; Result Unstructured Data: 95/50 mmHg; Test Date: 20210321; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Cel;fevers up to; Test Date: 20210323; Test Name: Body temperature; Result Unstructured Data: Test Result:40.3 Cel;persistent fevers up to 40.3; Test Date: 20210323; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Cel;Temperature; Test Date: 20210325; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 Cel;Temperature; Test Date: 20210326; Test Name: Test for Lyme disease; Test Result: Negative ; Test Date: 20210325; Test Name: Chest radiograph; Result Unstructured Data: hazy retrocardiac opacity; Test Date: 20210328; Test Name: Chest radiograph; Result Unstructured Data: showing worsening bilateral consolidation; Test Date: 20210323; Test Name: CT scan of chest; Result Unstructured Data: showed bilateral axillary and left supraclavicular lymphadenopathy, with no lung infiltrates or pulmonary embolism; Test Date: 20210325; Test Name: CRP; Test Result: 9.9 mg/dL; Test Date: 20210326; Test Name: Tests for CMV; Test Result: Negative ; Test Date: 20210329; Test Name: anti-dsDNA antibodies; Test Result: Negative ; Test Date: 202206; Test Name: anti-dsDNA antibodies; Test Result: Negative ; Test Date: 20210323; Test Name: eosinophils; Test Result: 2 %; Test Date: 20210421; Test Name: eosinophils; Test Result: 4 %; Test Date: 20210326; Test Name: Tests for EBV; Test Result: Negative ; Test Date: 20210323; Test Name: D-dimer; Result Unstructured Data: Test Result:13.44 ug/mL;Reference range not provided; Test Name: complete blood count; Result Unstructured Data: Nine months post-hospitalization Normal; Test Date: 20210323; Test Name: Hb; Result Unstructured Data: Test Result:11.9 g/dL;Reference range not provided; Test Date: 20210325; Test Name: Hb; Result Unstructured Data: Test Result:9.5 g/dL;Reference range not provided; Test Date: 20210329; Test Name: Hb; Result Unstructured Data: Test Result:9.4 g/dL;improved; Test Date: 20210421; Test Name: Hb; Result Unstructured Data: Test Result:11.3 g/dL;Reference range not provided; Test Date: 20210323; Test Name: HR; Result Unstructured Data: Test Result:85 {beats}/min;Reference range not provided; Test Date: 20210325; Test Name: HR; Result Unstructured Data: Test Result:96 {beats}/min;Reference range not provided; Test Date: 20210326; Test Name: Tests for HIV; Test Result: Negative ; Test Date: 20210323; Test Name: Molecular test for influenza; Test Result: Negative ; Test Date: 20210326; Test Name: Test for Anaplasma; Test Result: Negative ; Test Date: 20210323; Test Name: lymphocytes; Test Result: 16 %; Test Date: 20210326; Test Name: lymphocytes; Test Result: 23 %; Test Date: 20210421; Test Name: lymphocytes; Test Result: 33 %; Test Date: 20210323; Test Name: monocytes; Test Result: 5 %; Test Date: 20210326; Test Name: monocytes; Test Result: 2 %; Test Date: 20210421; Test Name: monocytes; Test Result: 10 %; Test Date: 20210323; Test Name: neutrophils; Test Result: 72 %; Test Date: 20210326; Test Name: neutrophils; Test Result: 30 %; Test Date: 20210421; Test Name: neutrophils; Test Result: 51 %; Test Date: 20210323; Test Name: SPO2; Test Result: 98 %; Test Date: 20210325; Test Name: SPO2; Test Result: 97 %; Test Date: 20210326; Test Name: Test for Babesia; Test Result: Negative ; Test Date: 20210325; Test Name: pCO2; Result Unstructured Data: Test Result:16 mm[Hg];Reference range not provided; Test Date: 20210323; Test Name: PLT; Result Unstructured Data: Test Result:101 10*9/L;Reference range not provided; Test Date: 20210325; Test Name: PLT; Result Unstructured Data: Test Result:98 10*9/L;Reference range not provided; Test Date: 20210329; Test Name: PLT; Result Unstructured Data: Test Result:251 10*9/L;improved; Test Date: 20210421; Test Name: PLT; Result Unstructured Data: Test Result:239 10*9/L;Reference range not provided; Test Date: 20210323; Test Name: procalcitonin; Result Unstructured Data: Test Result:0.26 ng/mL;Normal; Test Date: 20210325; Test Name: procalcitonin; Result Unstructured Data: Test Result:0.80 ng/mL;Reference provided; Test Date: 202206; Test Name: RF; Result Unstructured Data: Test Result:63 [iU]/mL;normal, <12 IU/mL; Test Date: 20210326; Test Name: Tests for RF; Test Result: Negative ; Test Date: 20210329; Test Name: SARS-CoV-2 nucleocapsid antibodies; Test Result: Negative ; Test Date: 20210323; Test Name: Molecular test for SARS-CoV-2; Test Result: Negative ; Test Date: 20210326; Test Name: Test for SARS-CoV-2; Test Result: Negative ; Test Name: Ferritin; Result Unstructured Data: Nine months post-hospitalization, ferritin was normal; Test Date: 20210323; Test Name: Ferritin; Result Unstructured Data: Test Result:1256 ng/mL;Reference range not provided; Test Date: 20210326; Test Name: Ferritin; Result Unstructured Data: Test Result:3032 ng/mL;Reference range not provided; Test Date: 20210329; Test Name: Ferritin; Result Unstructured Data: Test Result:562 ng/mL;improved; Test Date: 20210421; Test Name: Ferritin; Result Unstructured Data: Test Result:44 ng/mL;Reference range not provided; Test Date: 20210323; Test Name: Molecular test for Group A streptococcus; Test Result: Negative ; Test Date: 20210323; Test Name: Troponin; Result Unstructured Data: Test Result:0.005 ng/mL;Reference range not provided; Test Date: 20210323; Test Name: WBC; Result Unstructured Data: Test Result:2.3 10*9/L;Reference range not provided; Test Date: 20210325; Test Name: WBC; Result Unstructured Data: Test Result:2.5 10*9/L;Reference range not provided; Test Date: 20210326; Test Name: WBC; Result Unstructured Data: Test Result:1.5 10*9/L;decreased; Test Date: 20210329; Test Name: WBC; Result Unstructured Data: Test Result:5.9 10*9/L;improved; Test Date: 20210421; Test Name: WBC; Result Unstructured Data: Test Result:2.9 10*9/L;Reference range not provided