Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea, Rash, Urticaria
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 dTpa vaccine. This case refers to patient 33 in the literature article. The subject's past medical history included allergic rhinitis. Concurrent medical conditions included asthma, egg allergy and sulfonamide allergy. On an unknown date, 2 hrs after receiving dTpa vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included generalized urticaria, erythema, rash, loss of consciousness with serious criteria of GSK medically significant, nausea and diaphoresis. The subject was treated with epinephrine, antihistamine, H2 Blocker, Steroid (Unspecified) and Bronchodilator. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included generalized urticaria (recovered/resolved), erythema (recovered/resolved), rash (recovered/resolved), loss of consciousness (recovered/resolved), nausea (recovered/resolved) and diaphoresis (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, generalized urticaria, erythema, rash, loss of consciousness, nausea and diaphoresis may have been caused by dTpa 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 44-year-old female patient who had received an unspecified Tdap (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with asthma, allergic rhinitis and sulfonamides and eggs allergies. 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 Tdap vaccine (dosage unknown; administration route and site unspecified; batch number not provided). On an unspecified date, 2 hours after the vaccination, the patient developed generalized urticaria, erythema and rash, measured decreased blood pressure, loss of consciousness, nausea and diaphoretic. This was classified as anaphylaxis by the emergency department doctor and the internist. 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 epinephrine, oral antihistamine, parenteral H2-blocker, parenteral steroid, intravenous therapy and bronchodilators. At the time of reporting the outcome of the events was recovered. The patient was referred to primary care physician. This 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. 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 decreased unknown.