Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Periorbital oedema, Protein urine present, Proteinuria, Urine abnormality
Clinical narrative: Relapse of minimal change disease; Relapse of minimal change disease; This literature case was retrieved on 03-Feb-2018 (reference number: 723986), reported by other health professional, and concerned a 45-year-old female patient.  The patient's historical condition included minimal change disease (MCD) which was diagnosed on an unspecified date in Dec-2014, after the onset of symptoms: abrupt onset of bilateral hand, facial, and lower extremity oedema and frothy urine. The patient had no other significant past medical or allergy history and no signs of systemic infection. She was normotensive. The patient's concomitant medications were not reported.  On an unknown date, the patient's urinalysis (UA) showed three+ protein and urine protein to-creatinine ratio (UPCR) of 6.5 g/g. Serum albumin was 1.5 g/dL, total cholesterol 465 mg/ dL, white blood cell count (WBC) 6.79K/mm3, haemoglobin (Hgb) 14.5 g/dL , platelets 417K/mm3 , blood urea nitrogen (BUN) 20 mg/ dL, creatinine 1.0 mg/dL , aspartate transaminase (AST) 29 IUL/L , alanine transaminase (ALT) 20 IUL/L , complement factor C3 155mg/dL  and complement factor C4 was 29.3mg/dL . The patient's rapid plasma regains (RPR), hepatitis B and C serologies, and antinuclear antibodies (ANA) were negative.   After approximately two weeks, UPCR worsened to 12 g/g. A kidney biopsy showed MCD and oral prednisone was started in a dose of 1mg/kg daily in addition to Torsemide (torasemide) at a dose of 5 mg per day and rosuvastatin at a dose of 5mg per day.  Two weeks later, complete remission of proteinuria was documented and persisted after completing a six-month course of prednisone. The patient remained in complete remission until Oct-2016.  On an unknown date in Oct-2016, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.  On an unknown date in Oct-2016, just after receiving influenza virus vaccine polyvalent, the patient developed periorbital oedema and frothy urine. The patient denied any infections or non-steroidal anti-inflammatory drug (NSAID) use. She was normotensive. Renal and hepatic chemistries were normal with creatinine 0.7 mg/dL except for serum albumin of 3.0 g/dL. UA showed protein of 100 mg/dL and 24-hour proteinuria was 1.5 g. She was treated with oral prednisone at a dose of 50 mg per day.  On an unspecified date in 2016, within 21 day, the patient's proteinuria was resolved, and she recovered.  The reporter assessed the event as related to the influenza virus vaccine polyvalent. Relapse of MCD was attributed to influenza vaccination in the absence of other potential triggers of MCD.  The event of relapse of minimal change disease was assessed as serious due to the criterion of medical significance. by a physician.   In conclusion, this report suggested that influenza vaccination and the resulting stimulation of the immune system may cause MCD. This finding demanded further investigation in the pathophysiology of MCD and also required consideration of further vaccinations in this patient population.    Additional information received as literature abstract reported by other health professional on 28-Dec-2020: Report type was changed from 'spontaneous' to 'literature'. Authors, title, journal, year and volume for literature abstract were added. Race was added. Historical conditions 'oedema extremities', 'face oedema' and 'urine abnormality' were deleted. Laboratory tests 'alanine aminotransferase (ALT) ', 'aspartate aminotransferase (AST)', 'serum albumin of 1. 5 g/dL', 'cholesterol total', 'creatinine of 1.0 mg/dl', 'blood urea (BUN)', 'complement factor C3', 'complement factor C4', 'haemoglobin', 'platelets', 'urine protein/creatinine ratio (UPCR) ' and 'white blood cell count (WBC) ' were deleted. Suspect product was recoded from 'INN Flu Vaccine Seasonal' to 'Influenza virus vaccine'. Date of vaccination updated. Treatment medications 'torsemide' and 'rosuvastatin' were deleted. Start date and indication for prednisone were updated. The events of 'periorbital oedema', 'biopsy kidney abnormal', 'blood albumin decreased', 'blood cholesterol increased', 'complement factor c3 increased', 'face oedema', 'oedema extremities', 'platelet count increased', 'proteinuria', 'urine protein/creatinine ratio increased' and 'urine abnormality' were deleted. Medical confirmation was changes from 'No' to 'Yes'. Patient had prior history changed from 'Unk' to 'Yes'. Start and stop date for Relapse of minimal change disease updated and Condition aggravated added. Narrative was amended accordingly.  Company comment: A 45-year-old patient was administered influenza virus vaccine polyvalent. The patient's historical condition included minimal change disease (MCD) which was diagnosed on an unspecified date in Dec-2014. The patient remained in complete remission until Oct-2016. The patient developed minimal change disease relapse in Oct-2016, just after receiving influenza virus vaccine polyvalent. The reporter attributed the event to influenza vaccination in the absence of other potential triggers of MCD. Causality is assessed as possibly related for minimal change disease/condition aggravated.; Reporter's Comments: Relapse of MCD was attributed to influenza vaccination in the absence of other potential triggers of MCD.; Sender's Comments: A 45-year-old patient was administered influenza virus vaccine polyvalent. The patient's historical condition included minimal change disease (MCD) which was diagnosed on an unspecified date in Dec-2014. The patient remained in complete remission until Oct-2016. The patient developed minimal change disease relapse in Oct-2016, just after receiving influenza virus vaccine polyvalent. The reporter attributed the event to influenza vaccination in the absence of other potential triggers of MCD. Causality is assessed as possibly related for minimal change disease/condition aggravated.