Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test, Ocular hyperaemia, Palpitations, Pharyngeal oedema, Rash generalised
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in a 27-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 28 in the literature article. Co-suspect products included influenza vaccine. On an unknown date, 2 hrs after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized erythema, generalized rash, eye red, eye pruritus, palpitation, throat swelling and chest heaviness. The subject was treated with antihistamine and acetaminophen. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized erythema (recovered/resolved), generalized rash (recovered/resolved), eye red (recovered/resolved), eye pruritus (recovered/resolved), palpitation (recovered/resolved), throat swelling (recovered/resolved) and chest heaviness (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized erythema, generalized rash, eye red, eye pruritus, palpitation, throat swelling and chest heaviness may have been caused by Flu seasonal TIV Dresden and monovalent influenza vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 27-year-old female patient who had received an unspecified monovalent influenza vaccine (manufacturer unknown) and an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. 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 2011, the patient received an unspecified dose of an unspecified monovalent influenza vaccine and an unspecified trivalent influenza vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, 2 hours after the vaccination, the patient developed generalized erythema and rash, red itchy eyes, increased heart rate, palpitations, throat swelling and "chest heaviness". This was classified as anaphylaxis by the emergency department doctor. According to the authors the case was considered as Brighton level 1 and setting of initial evaluation was emergency department. The patient was treated by oral antihistamine and acetaminophen. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. 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.