Age: 0.42
Sex: F
Vaccine: FLUX
Symptoms: Biopsy skin, Biopsy skin abnormal, Blister, Blood immunoglobulin G, Eosinophil percentage increased
Clinical narrative: Bullous pemphigoid of infancy; This literature case was received on 16-Aug-2021 and concerned a 5-month-old, female patient.   The aim of this conference abstract was to highlight clinical presentation, diagnosis, and management of bullous pemphigoid (BP), a rare disease in infancy.  The patient had no relevant medical history and was healthy. The patient's concomitant medications were not reported.   On an unspecified date, reported as recently prior to presentation, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration and anatomical location: not reported) for influenza vaccination. The batch number was not reported.  On an unspecified date, unknown amount of time after receiving influenza virus vaccine polyvalent, the patient presented with five-day history of pruritic vesicles and bullae on the trunk, extremities, palms and soles. Laboratory work-up revealed a leukocytosis with peripheral eosinophilia (white blood cell count (WBC) was 30.5 cells/mm3 and eosinophils 24%) Lesional skin biopsy demonstrated a subepidermal blister with numerous eosinophils. Direct immunofluorescence (DIF) of perilesional skin revealed linear deposition of immunoglobulin G (IgG) and complement 3 (C3) along the dermoepidermal junction. Enzyme-linked immunosorbent assay (ELISA) was positive for BP (BP180 >100) and the patient was diagnosed with BP of infancy.   On an unspecified date, the patient commenced treatment with systemic steroids (prednisolone at a dose of 2 mg/kg/day). Skin findings significantly improved within two days.   At the time of initial reporting, the patient was recovering from the event. The patient remained in remission while tapering off prednisolone.  The reporter did not provide causality assessment. It was reported that numerous cases have been reported in association with recent vaccinations. Some authors posit vaccines may unmask subclinical BP by inducing a nonspecific immune activation, while others believed the trauma from injection can generate T-helper (Th) 17 cell activation and release of proinflammatory cytokines, leading to bullae formation.  The event of 'bullous pemphigoid' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 5-month-old, female patient developed bullous pemphigoid (BP) an unknown amount of time after vaccination with the suspect product influenza virus vaccine polyvalent. The patient had no relevant medical history and was healthy. The patient's concomitant medications were not reported. Enzyme-linked immunosorbent assay (ELISA) was positive for BP. Due to unclear temporal relationship, causality for the reported event is unassessable.; Sender's Comments: A 5-month-old, female patient developed bullous pemphigoid (BP) an unknown amount of time after vaccination with the suspect product influenza virus vaccine polyvalent. The patient had no relevant medical history and was healthy. The patient's concomitant medications were not reported. Enzyme-linked immunosorbent assay (ELISA) was positive for BP. Due to unclear temporal relationship, causality for the reported event is unassessable.