Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Guillain-Barré Syndrome (GBS); hyponatremia; new-onset renal failure; myelodysplastic syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barré Syndrome (GBS)), RENAL FAILURE (new-onset renal failure), MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome) and HYPONATRAEMIA (hyponatremia) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. LITERATURE REFERENCE: Concurrent medical conditions included Hypertension, Atrial fibrillation (atrial fibrillation status post Watchman procedure), Chronic back pain, Macrocytic anemia and Dyslipidemia. Concomitant products included Hydrochlorothiazide for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barré Syndrome (GBS)) (seriousness criteria hospitalization and medically significant), RENAL FAILURE (new-onset renal failure) (seriousness criterion medically significant), MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome) (seriousness criterion medically significant) and HYPONATRAEMIA (hyponatremia) (seriousness criterion hospitalization). The patient was hospitalized on sometime in 2021 due to GUILLAIN-BARRE SYNDROME and HYPONATRAEMIA. The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) in 2021 at a dose of 35 gram once a day. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barré Syndrome (GBS)) was resolving and RENAL FAILURE (new-onset renal failure), MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome) and HYPONATRAEMIA (hyponatremia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatinine: 1.7 mg/dl elevated. In 2021, Blood potassium: 3.1 millimole per litre Hypokalaemia. In 2021, CSF glucose: 52 mg/dl. In 2021, CSF protein: 80 mg/dl CSF total protein was high. In 2021, CSF red blood cell count: 5000000 cells per cubic millimetre. In 2021, CSF test: CSF appearance was clear, and CSF color was Xanthrochromic. In 2021, CSF white blood cell count: 60 % CSF polynuclear WBCs and 5000 cells per cubic millimetre. In 2021, Computerised tomogram head: negative for acute abnormalities. In 2021, Mononuclear cell percentage: 40 % CSF mononuclear cells. In 2021, Neurological examination: history and examination findings were consistent with GBS.. In 2021, Physical examination: Physical examination was remarkable for decreased strength in all extremities and absent deep tendon reflexes of Achilles and patellar tendons. The patient's muscular weakness was worse in her proximal muscles.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPONATRAEMIA (hyponatremia) to be not related. No further causality assessments were provided for GUILLAIN-BARRE SYNDROME (Guillain-Barré Syndrome (GBS)), RENAL FAILURE (new-onset renal failure) and MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome). Patient presented to the emergency department in early 2021 with progressive bilateral ascending weakness and numbness. The numbness started in her lower extremities and progressed to her upper extremities. She denied COVID-19 pneumonia associated symptoms, such as fever, shortness of breath, cough, nausea, vomiting, abdominal pain, and myalgia. She also confirmed no recent travel history. Neurology recommended lumbar puncture for cerebrospinal fluid (CSF) analysis, followed by initiation of IVIG. A lumbar puncture was performed. CSF findings were consistent with albuminocytologic dissociation, and a diagnosis of GBS was established. The patient underwent frequent monitoring of forced vital capacity and negative inspiratory force to assess pulmonary function. After completing treatment with IVIG, she was discharged to the inpatient rehabilitation facility after 1 week. While in the rehabilitation program, the patient was fully participatory with physical therapy and occupational therapy. Her lower extremity weakness improved, but she did not fully recover before discharge as she still had weakness and needed to use mobility devices. Nevertheless, the patient met all discharge goals within 3 weeks. Patient had other developments complicating her hospital course. She had new-onset neutropenic leukopenia and thrombocytopenia and worsening of her macrocytic anemia. Hematology was consulted and determined the neutropenia and thrombocytopenia were attributed to IVIG; however, it was recommended that reporter evaluated her macrocytic anemia for myelodysplastic syndrome in the outpatient setting. She also had mild to moderate hyponatremia and new-onset renal failure requiring a nephrology consult. It was determined that the hyponatremia was multifactorial as a result of GBS, poor oral solute intake, excessive water intake, and secondary to medication use (hydrochlorothiazide).; Reporter's Comments: The event hyponatremia was assessed as not related due to alternative explanation. The benefit-risk relationship of the product is not affected by this report.
Atrial fibrillation (atrial fibrillation status post Watchman procedure); Chronic back pain; Dyslipidemia; Hypertension; Macrocytic anemia
Hydrochlorothiazide
Test Date: 2021; Test Name: creatinine; Test Result: 1.7 mg/dL; Test Date: 2021; Test Name: hypokalemia; Result Unstructured Data: Test Result:3.1 mmol/L;Hypokalaemia; Test Date: 2021; Test Name: computed tomography brain scan; Result Unstructured Data: negative for acute abnormalities; Test Date: 2021; Test Name: CSF glucose; Test Result: 52 mg/dL; Test Date: 2021; Test Name: CSF total protein; Test Result: 80 mg/dL; Test Date: 2021; Test Name: CSF RBC; Test Date: 2021; Test Name: CSF test; Result Unstructured Data: CSF appearance was clear, and CSF color was Xanthrochromic; Test Date: 2021; Test Name: CSF polynuclear WBCs; Test Result: 60 %; Test Date: 2021; Test Name: CSF WBC; Test Date: 2021; Test Name: CSF mononuclear cells; Test Result: 40 %; Test Date: 2021; Test Name: neurological examination; Result Unstructured Data: history and examination findings were consistent with GBS.; Test Date: 2021; Test Name: Physical examination; Result Unstructured Data: Physical examination was remarkable for decreased strength in all extremities and absent deep tendon reflexes of Achilles and patellar tendons. The patient's muscular weakness was worse in her proximal muscles.