Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Bronchospasm, Burning sensation, Cough, Dyspnoea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a 54-year-old female patient who received FLUARIX QUADRIVALENT. Previously administered products included Flu vaccine with an associated reaction of hypersensitivity (allergy to sulfa components). Concurrent medical conditions included allergy (allergy to sulfa components). On 22nd September 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT. On 22nd September 2015, 5 min after receiving FLUARIX QUADRIVALENT, the patient experienced anaphylaxis (serious criteria GSK medically significant, life threatening and other), red face (serious criteria life threatening and other), mottled pigmentation (serious criteria life threatening and other), palpitation (serious criteria life threatening and other), heart rate increased (serious criteria life threatening and other), mucus discharge (serious criteria life threatening and other), cough (serious criteria life threatening and other), bronchospasm (serious criteria life threatening and other), shortness of breath (serious criteria life threatening and other), sweating (serious life threatening and other), pruritus (serious criteria life threatening and other), eye pruritus (serious criteria life threatening), oral pruritus (serious criteria life threatening), flushing (serious criteria life threatening and other) and hypertension (serious criteria life threatening and other). On an unknown date, the patient experienced ptosis and facial pain. The patient was treated with ZYRTEC, PEPCID, Albuterol and prednisone. On an unknown date, the outcome of the anaphylaxis was recovered/resolved and the outcome of the red face, mottled pigmentation, cough, bronchospasm, sweating, pruritus, eye pruritus, oral pruritus, flushing, hypertension, ptosis and facial pain were unknown and the outcome of the palpitation, heart rate increased, mucus discharge and shortness of breath were recovering/resolving. It was unknown if the reporter considered the anaphylaxis, red face, mottled pigmentation, palpitation, heart rate increased, mucus discharge, cough, bronchospasm, shortness of breath, sweating, pruritus, eye pruritus, oral pruritus, flushing, hypertension, ptosis and facial pain to be related to FLUARIX QUADRIVALENT. Additional detail were provided as follows: The patient (reporter) reported that she had a reaction to a dose of FLUARIX QUADRIVALENT. This case previously reported to a physician. The patient stated that approximately 17 years ago she reacted to a flu vaccine of an unknown brand and mentioned that she was allergic to sulfa components. As per the patient, because of her previous reaction, on 22nd September 2015, she was given the FLUARIX QUADRIVALENT vaccination in the emergency room as a precaution. Within five to ten minutes she became anaphylactic, red, mottled, flushed, experienced palpitations with a heart rate between 100-130, hypertensive, experienced coughing, bronchial spasms, shortness of breath, sweating, itching and extra mucus. According to the patient, she was given an intravenous ZYRTEC, CLARITIN, PEPCID, Albuterol inhaler, a five day course of prednisone and used a nebulizer. The patient was in the emergency room for six hours but not hospitalized and she was unaware of the dosage of FLUARIX QUADRIVALENT she received. According to the patient twelve hours later she had a rebound reaction. At the time of reporting, she felt that her itching was unchanged and continued on her back, nether-parts, mouth and eyes, and described as feeling like she was on fire. Her flushing and sweating was the same. She continued to have extra mucus but her troubled breathing and also her palpitations were better with her last occurrence being 23rd September 2015. She stated that at one point her heart was pounding in her eardrums and woke her. Less than a week after vaccination, the patient's left eye was drooping and she had pain in her left cheek. The patient did not have the lot number, expiration date or dose of the FLUARIX QUADRIVALENT. The patient was an emergency room technician within the hospital in which she was calling. The patient was slightly difficult to refocus. The patient did state that she felt that she had this reaction because of the flu shot but did not qualify the causality. The patient also did not know the responsible physician for the emergency room although she said it should be noted in the records.