Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Anisocytosis, Haematuria, Microcytic anaemia, Oedema peripheral, Pemphigoid
Clinical narrative: A report was received from a regulatory authority on 1/22/03, concerning a 72 year old male vaccinee who experienced a recurrence of pemphigoid reaction which led to hospitalization 2 days after receiving Fluvirin on 10/8/02. The vaccinee had a medical history of vitiligo phase bullous pemphigoid which was treated since July 2001 with mycophenotate mofetil and clobetasol propionate and then mycophenocate mofetil only, since March 2002 and finally stopped in July 2002. The disease was stable. There was no recurrence or pruritus. The vaccine also had a medical history of insulin dependent diabetes for 20 years and right eye cataract surgery. On 10/10/02, the vaccinee experienced a relapse of bullous pemphigoid with bulla on the right wrist and left knee. There was also significant pruritus and the vaccinee was hospitalized. The vaccinee was treated with mycophenocate mofetil, clobetasol propionate, descloradadine and hydroxyzine hydrochloride. Indirect immunofluroescence revealed circulating antibodies, anti-membrane type to bullous pemphigoid. In early December the vaccinee developed new bulla and numerous post-bullous erosions. The vaccinee also experienced oedema of the right leg. The mucous membranes were not affected. This led to the vaccinee being hospitalized again. Treatment with mycophenocate mofetil was continued along with local care and anti-histamines if required. At the end of December 2002 there was no new bullous eruption, and the erosions were on the way to scarring. There was a decrease in the oedema of the right leg. The vaccinee had not recovered at the time of the report. Laboratory data revealed important glomerular hematuria (urinary red blood cells 385 mega/l), proteinuria of 2.32 g/l and hypochromic, microcytic anemia 101 g/l with anisocytosis and poikilocytosis. The opinion of the nephrologist and a haemotologist is pending. The reporter has assessed the relationship of the vaccine to the recurrence of pemphigoid reaction as possible and there was insufficient information to determine the reporters causality assessment to the haematuria.  Follow up on 05/05/2003: "A follow up report was received from the regulatory authority giving haematology results and the nephrologist's opinion.  the vaccinee was diagnosed with renal problems in 1984 with a proteinuria of 1.13 g/L.  A renal biopsy revealed at that time IgA nephropathy with 40% sclerosed glomeruli and interstitial fibrosis compatible with Berger's disease for a diabetic patient.  The vaccinee is currently showing no deterioration in renal function (lower limit for his age).  Renal echography shows normal size kidneys, well differentiated and without dilatation.  Renal doppler showed no anomaly.  There is criteria for glomerular nephropathy as there was high albuminuria and microscopit haematuria in strip.  The nephrologist found it difficult to be connect the current proteinuria of 2 g/L only with the vaccinee's Berger's nephropathy.  The cause of the glomerular hawmaturia and anemia was due to persistence of hypochronic, microcytic anemia with normal serum iron and high ferritin.  Haemoglobin was at 105 g/L and mean corpuscular volume (MCV) was 61 fl. No marrow karyotype or myelogram was performed as the vaccines had no history of thrombopenia or white cell abnormalities.  As the vaccinee is North African and has a sister with microcytic anaemia tests for thalesomia are planned.  Results are not yet available.  On 03/31/2003 there were scars on the trunk and upper limbs with post-bullets erosions on the left lower limb.  The vaccinee experienced 1 or 2 bullae every 2 days on this same limb.  The vaccinee was being treated with corticotherapy, 40g/day and mycophenocate mofetil 2 g/day at the time of reporting."