Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Diarrhoea, Dysphonia, Dyspnoea
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 44-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 18 in the literature article. The subject's past medical history included anaphylaxis and allergic rhinitis. Concurrent medical conditions included asthma and drug allergy. On an unknown date, several minutes after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized pruritus, generalized rash, wheezing, shortness of breath, throat tightness, hoarse voice, cough, vomiting and diarrhea. The subject was treated with antihistamine, steroid (unspecified), oxygen and bronchodilator. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized pruritus (recovered/resolved), generalized rash (recovered/resolved), wheezing (recovered/resolved), shortness of breath (recovered/resolved), throat tightness (recovered/resolved), hoarse voice (recovered/resolved), cough (recovered/resolved), vomiting (recovered/resolved) and diarrhea (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized pruritus, generalized rash, wheezing, shortness of breath, throat tightness, hoarse voice, cough, vomiting and diarrhea may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 44-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 anaphylaxis, asthma, allergic rhinitis and aspirin allergy. 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, less than 30 minutes after the vaccination, the patient developed generalized pruritus and rash, wheeze, shortness of breath, throat tightening, hoarse voice, cough, vomiting and diarrhea. 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 emergency department. The patient was treated by parenteral antihistamine, oral steroid, oxygen and bronchodilators. At the time of reporting the outcome of the events was recovered. 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.