Sex: M
Vaccine: FLU3
Symptoms: Oedema, Papule, Parvovirus B19 test negative, Polymerase chain reaction, Post inflammatory pigmentation change
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 2-year-old male patient who received Influenza vaccine unspecified. Previously administered products included influenza (at the age of 9, 12 and 23 months). Concurrent medical conditions included exposure to communicable disease (The patient's household contact had experienced "flu" symptoms before current symptom onset). On an unknown date, the patient received Influenza vaccine unspecified at an unknown dose. On an unknown date, 91 days after receiving Influenza vaccine unspecified, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza B virus infection (serious criteria hospitalization), Stevens Johnson syndrome (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), nasal congestion (serious criteria hospitalization), rhinorrhea (serious criteria hospitalization), myalgia (serious criteria hospitalization), eruption facial (serious criteria hospitalization), pruritus facial (serious criteria hospitalization), skin lesion  (serious criteria hospitalization), tachycardia (serious criteria hospitalization), tachypnea (serious criteria hospitalization), papule (serious criteria hospitalization), skin plaque (serious criteria hospitalization), vesicles (serious criteria hospitalization), erythropapular rash (serious criteria hospitalization), lymphadenopathy cervical (serious criteria hospitalization), scleral hyperemia (serious criteria hospitalization), lip dry (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), keratinocyte necrosis (serious criteria hospitalization and GSK medically significant), interface dermatitis (serious criteria hospitalization), skin fragility (serious criteria hospitalization), skin erosion (serious criteria hospitalization), generalized eruption (serious criteria hospitalization) and post inflammatory hypopigmentation. The patient was treated with dexamethasone, ibuprofen, famotidine, diphenhydramine, azithromycin, acyclovir, clindamycin, piperacillin sodium, Piperacillin + Tazobactam, oseltamivir and Immunoglobulin. On an unknown date, the outcome of the vaccination failure, influenza B virus infection, fever, nasal congestion, rhinorrhea, myalgia, eruption facial, pruritus facial, skin lesion, tachycardia, tachypnea, papule, skin plaque, vesicles, erythropapular rash, lymphadenopathy cervical, lip dry, leukocytosis, keratinocyte necrosis, interface dermatitis, skin fragility, skin erosion and generalized eruption were recovered/resolved and the outcome of the Stevens Johnson syndrome was resolved with sequelae and the outcome of the scleral hyperemia and post inflammatory hypopigmentation were unknown. The reporter considered the vaccination failure, influenza B virus infection, Stevens Johnson syndrome, fever, nasal congestion, rhinorrhea, myalgia, eruption facial, pruritus facial, skin lesion, tachycardia, tachypnea, papule, skin plague, vesicles, erythropapular rash, lymphadenopathy cervical, scleral hyperemia, lip dry, leukocytosis, keratinocyte necrosis, interface dermatitis, skin fragility, skin erosion, generalized eruption and post inflammatory hypopigmentation to be related to Influenza vaccine unspecified. Additional information was provided. This case was reported in a literature article and described the vaccination failure in a 2-year-old male who was vaccinated with unspecified seasonal trivalent inactivated influenza vaccine (manufacturer unknown). The patient was a previously healthy boy. The patient's household contact had experienced "flu" symptoms before current symptom onset. No information on concomitant medication or concurrent condition was provided. On an unspecified date, at the age of 9, 12 and 23 months, the patient received 3 doses of unspecified seasonal trivalent inactivated influenza vaccine (administration route and site unspecified; batch number not provided) without incident. The patient's immunizations were up to date. On an unspecified date in the Winter of 2013, 3 months after vaccination, the patient presented with a 5-days history of fever, congestion, rhinorrhoea, myalgia, and a progressive pruritic facial eruption. 2 days before, his paediatrician had started dexamethasone, ibuprofen, famotidine, and diphenhydramine because of suspicion of an allergic skin eruption. There were no known medication exposures, including acetaminophen or ibuprofen, preceding the appearance of skin lesions. Over the next 2 days, skin lesions became widespread, prompting re-evaluation. Vital signs were significant for fever 101 degree F, tachycardia, and tachypnea with normal blood pressure. Skin examination revealed pink, annular, oedematous papules and plaques on the face, trunk, buttocks, and extremities, many with dusky, violaceous centres. Multiple tense vesicles and targetoid erythematous papules were located perianally. Rare serous vesicles were noted centrally, with negative Nikolsky and Asboe-Hansen signs. There was no skin tenderness. Additional findings included cervical lymphadenopathy, mildly injected sclera, and dry crusted lips. There was no genital or palmoplantar involvement. The remainder of the physical examination was unremarkable. Laboratory evaluation revealed leukocytosis (17 x 10E9/L) and high C-reactive protein (10 mg/L). Empiric therapy with azithromycin, acyclovir, and clindamycin was initiated while serologic titers and cultures (urine, skin, blood) were pending. Because of continued fever, piperacillin/tazobactam was added on hospital day 2. A nasopharyngeal swab was positive for influenza B and negative for mycoplasma and 18 other common respiratory pathogens according to a respiratory viral polymerase chain reaction (PCR) panel. Oseltamivir therapy was initiated and supportive care provided. Skin biopsy revealed necrotic keratinocytes within the epidermis and an interface dermatitis consistent with the erythema multiforme/Stevens-Johnson syndrome (EM/SJS) spectrum of inflammatory dermatoses. Immunofluorescence studies were negative for immunobullous disease. Antistreptolysin O (ASO), mycoplasma, parvovirus, herpes simplex virus (HSV), Epstein-Barr virus (EBV), and cytomegalovirus titres; surface bacterial and viral cultures; blood culture; and urine culture were negative, and acyclovir and antibiotics were subsequently discontinued. Despite supportive therapy, the patient's eruption rapidly progressed to involve more than 10% of his body surface area, with skin fragility and denudation, requiring transfer to intensive care. Wound care and fluid management continued, and given the progression of cutaneous disease, intravenous immunoglobulin (IVIg) 1 g/kg/d was administered for 3 days, resulting in defervescence and skin stabilization. The patient's lesions re-epithelialized and he was discharged on hospital day 7. He was well with minimal post inflammatory hypopigmentation noted 3 months after hospital discharge. During the following influenza season, after discussion with vaccine safety experts, the child received an unspecified inactivated quadrivalent influenza vaccine containing both influenza B lineages with close monitoring. He tolerated the vaccine well, without any reported adverse reaction after vaccination. The patient subsequently received two additional annual intranasal live attenuated trivalent influenza vaccines without incident. This case has been considered serious due to hospitalisation/vaccination failure. The authors commented, 'After considering available information, experts concluded that our patient's clinical event was consistent with SJS and that influenza B infection was the most likely cause.' The author stated, 'In our case, IVIg may have stabilized disease progression. Controlled clinical trials are needed to better support routine use of IVIg in the treatment of these disorders. Annual vaccination against influenza is recommended for individuals 6 months of age and older. 17 A history of EM, SJS, or TEN after influenza virus infection is not a specified precaution or contraindication, but patients with a similar history should be monitored closely in the post vaccination period. The lack of recurrence of SJS after influenza vaccination in our case may be of interest to providers facing a similar clinical dilemma in the future.'