Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy skin abnormal, Blister, Blood fibrinogen normal, Blood immunoglobulin A abnormal, Blood immunoglobulin G normal
Clinical narrative: Report received from a literature case on 27-JAN-2009. A 54 year old female patient (Initials and Date of Birth: unknown) received influenza vaccination intramuscularly on an unknown date. Batch number and brand of vaccine is unknown. Her past medical history includes osteoporosis, hyperlipidaemia and depression. Concomitant medications included alendronate, calcium, Vitamin D, rosuvastatin and sertraline. She has been taking rosuvastatin for a duration of 5 months and all other medication for over 1 year. A recent change in her medications included the substitution of generic sertraline for brand name ZOLOFT. She denied any other changes in her medications, use of herbal supplements or other over the counter medications. She denied fever, chills, upper respiratory or gastrointestinal symptoms, or mucous membrane involvement. On an unknown date, the patient presented with a two week history of a severely pruritic, vesiculobullous eruption on her legs, arms and lower abdomen that developed 2 days after she had received an influenza vaccination. The rash began as tiny pink papules and then formed vesicles. Physical examination revealed symmetrically distributed discrete, pink papules, vesicles and bullae over her lower extremities, hands, forearms and lower abdomen with particular concentration on the medial surfaces of her calves. She had no conjunctival injection, involvement of mucous membranes, palms or soles. Microscopic examination of a biopsy from the left calf revealed a subepidermal blistering process with neutrophils. Direct immunofluorescence revealed linear deposits of immunoglobulin A (IgA) along the basement membrane zone. The test was negative for immunoglobulin G, immunoglobulin M, C3 (complement factor 3) and fibrinogen. This findings in conjunction with the histology were most suggestive of linear IgA bullous dermatosis (LABD). The patient was treated with diphenhydramine and cetirizine by her primary care physician but continued to get new lesions. She had not tried topical corticosteroids or any other treatments. She discontinued rosuvastatin and switched back to brand name ZOLOFT (sertraline) with no improvement. The eruption cleared after two courses of prednisone followed by a mid potency topical corticosteroid and did not recur when she restarted generic sertraline and rosuvastatin. The eruption lasted 6 weeks in total. Case outcome: patient recovered. Case underwent manual correction in preparation for data migration: key vaccine added. Automated Data Corrections (01-JUN-2016 14:31:13): Set IME events to serious for Spontaneous and PMS cases (significant change). Set missing "As Reported" for MedDRA coded laboratory tests to preferred terms. Correct units of measurement for laboratory tests. Create history record and set the last received date for corrected cases. Reporter's Comments: The reporter considered that the event was triggered by the influenza vaccination. The case was reported as serious due to medical significance. Sender's Comments: The company considered event causality possible to influenza vaccination. The patient had several medical conditions and was taking concomitant medications. Information derived from this AE report does not change the current safety profile of the product.