Age: 12.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Heart rate increased, Pruritus, Radioallergosorbent test negative, Rash
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 12-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 5 in the literature article. Concurrent medical conditions included penicillin allergy. On an unknown date, 1 day after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included hospitalization, GSK medically significant and life threatening. Additional event(s) included generalized urticaria, pruritus, rash, syncope and lump feeling in throat. The subject was treated with epinephrine, antihistamine, H2 blocker, steroid (unspecified), antiemetic and lidocaine cream. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized urticaria (recovered/resolved), pruritus (recovered/resolved), rash (recovered/resolved), syncope (recovered/resolved) and lump feeling in throat (unknown). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized urticaria, pruritus, rash, syncope and lump feeling in throat may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab test performed on unknown date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, blood pressure measurement result was 117/72 mm Hg. On an unknown date, heart rate result was increased. On an unknown date, radioallergosorbent test result was negative for latex unknown. On an unknown date, skin test result was negative for latex unknown. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 12-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with allergy to penicillin. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified trivalent influenza vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 1 day after the vaccination, the patient developed generalized urticaria, pruritus and rash, heart rate increased, syncope, blood pressure of 117/72 mm Hg and "lump in throat". This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was inpatient (overnight). The patient was treated by epinephrine, parenteral antihistamine, parenteral H2-blocker, oral steroid, oxygen, antiemetic and lidocaine cream. At the time of reporting the outcome of the events was recovered. The patient was referred to allergist and a skin test and RAST were performed with negative results for latex. An epinephrine autoinjector was prescribed. The event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.