Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test normal, Oral disorder, Pain, Post inflammatory pigmentation change, Skin necrosis
Clinical narrative: This case was reported in a literature article and described the occurrence of fixed drug eruption in a 66-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus, hypertension, chronic obstructive pulmonary disease and coronary artery disease. On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season and the 2nd dose of Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season and not applicable after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced fixed drug eruption, bullous eruption (serious criteria GSK medically significant), post inflammatory hyperpigmentation, skin necrosis (serious criteria GSK medically significant), interface dermatitis, fixed drug eruption (serious criteria hospitalization), bullous eruption (serious criteria hospitalization and GSK medically significant), post inflammatory hyperpigmentation (serious criteria hospitalization), bullae (serious criteria hospitalization), skin plaque (serious criteria hospitalization), macule (serious criteria hospitalization), oral lesion (serious criteria hospitalization), skin necrosis (serious criteria hospitalization and GSK medically significant), interface dermatitis (serious criteria hospitalization) and erythema (serious criteria hospitalization). The patient was treated with clobetasol and prednisone. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the fixed drug eruption, bullous eruption, post inflammatory hyperpigmentation, skin necrosis, interface dermatitis, fixed drug eruption, bullous eruption, post inflammatory hyperpigmentation, bullae, skin plaque, macule, oral lesion, skin necrosis, interface dermatitis and erythema were recovered/resolved. The reporter considered the fixed drug eruption, bullous eruption, post inflammatory hyperpigmentation, skin necrosis and interface dermatitis to be related to Influenza vaccine Quadrivalent unspecified season. The reporter considered the fixed drug eruption, bullous eruption, post inflammatory hyperpigmentation, bullae, skin plaque, macule, oral lesion, skin necrosis, interface dermatitis and erythema to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was provided. This case was reported in a literature article and described the occurrence of generalized bullous fixed-drug eruption in a 66-year old female who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient was woman and had type 2 diabetes mellitus, hypertension, chronic obstructive pulmonary disease, and coronary artery disease. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient had received unspecified influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The age of the vaccination was not provided. On an unspecified date, at the age of 66 years, an unknown period after vaccination, the patient had developed bullous eruption and subsequently resulted in numerous hyperpigmented patches coalescing on the back, flanks, and buttocks that were consistent with post inflammatory hyperpigmentation. The events resolved after 7 days of topical clobetasol 0.05% ointment. 1 year later, on an unspecified date, the patient had received unspecified quadrivalent influenza vaccine intramuscularly (administration site unspecified; dosage unknown; batch number not provided). It was reported that it was the patient's 2nd influenza vaccination. The age of the vaccination was not provided. On an unspecified date, at the age of 67 years, an unknown period after vaccination, the patient presented with an exquisitely painful bullous eruption. 3 days after vaccination, the patient was presented to the hospital with multiple 2.5 to 5 cm well-demarcated red-brown hyperpigmented patches and plaques with a peripheral rim of erythema in a background of diffuse post inflammatory hyperpigmentation, some with overlaying flaccid bullae, located on bilateral hips and lower back. It was a proximal distribution rather than acral; no typical targets, and most lesions were macular rather than papular atypical targets. A thorough medication review failed to find any other recent medication changes. New bullae continued to appear across patient's groin, lower back, buttocks, axillae, and abdomen over the subsequent days. Although a few oral erosions involving the hard palate and vermilion lips were present, there was no evidence of ocular or genital mucosal involvement. There was complete sparing of the distal extremities including the palms and soles. The patient remained afebrile with a normal complete blood count and comprehensive metabolic panel. It was reported that the patient's 2nd influenza vaccination essentially served as a systemic provocation test, which was positive. The patient's biopsy found vacuolar interface dermatitis, with sub epidermal vesicle formation, epidermal necrosis, marked pigment incontinence, and dyskeratotic keratinocytes with a mild lymphoeosinophilic infiltrate. These findings were consistent with the biopsy results from 1 year prior. Histopathology found epidermal necrosis but with eosinophilic infiltrate body surface area less than 30% and involvement of only 1 mucosal surface. The event had slowly progressive course with only 1 mucosal surface. During this 2nd bullous eruption, the patient required use of both topical clobetasol ointment and an oral prednisone taper. Within 2 days of hospitalisation, new lesions continued to appear, covering 15% of patient's total body surface area. Subsequently, the patient was transferred to the burn intensive care unit for aggressive wound care. After 14 days, the patient was discharged in the burn intensive care unit, with complete resolution at 30 days. This case has been considered serious due to hospitalisation. The author considered the event of generalized bullous fixed-drug eruption related to unspecified influenza vaccine and unspecified quadrivalent influenza vaccine.  The authors stated, "Here we report a rare case of GBFDE occurring as a result of administration of the influenza vaccine. Our patient's reproducible bullous eruption and supportive biopsy results after receiving the influenza vaccine were consistent with GBFDE. The delayed onset of her eruption may have been related to intramuscular delivery of the offending drug. Progression despite initiation of oral prednisone warranted transfer to the burn intensive care unit where aggressive support prevented life-threatening fluid losses, electrolyte imbalances, and secondary infections. Further research into the pathophysiology and treatment are needed to reduce the morbidity and mortality of this condition." Lab Comments: Lab tests were performed on unspecified dates. The patient's biopsy found vacuolar interface dermatitis, with sub epidermal vesicle formation, epidermal necrosis, marked pigment incontinence, and dyskeratotic keratinocytes with a mild lymphoeosinophilic infiltrate. These findings were consistent with the biopsy results from 1 year prior. Histopathology found epidermal necrosis but with eosinophilic infiltrate body surface area less than 30% and involvement of only 1 mucosal surface.