Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site ulcer, Swelling face
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of facial swelling in a 56-year-old female patient who received FLUARIX QUADRIVALENT (Batch number 59CK3, expiry date 30th June 2016). The patient's past medical history included baker's cyst (it was treated by injecting with Triamcinolone). Concurrent medical conditions included food intolerance, sulfonamide allergy (Sulpha allergy) and allergic reaction to antibiotics (Cephalosporin allergy). On 21st September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 22nd September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced facial swelling, red face, skin inflammation, injection site ulcer, injection site pain, flushing and injection site swelling. The patient was treated with BENADRY. FLUARIX QUADRIVALENT was discontinued. On 26th September 2015, the outcome of the facial swelling, red face, skin inflammation, flushing and injection site swelling were recovered/resolved. In October 2015, the outcome of the injection site ulcer and injection site pain were recovered/resolved. The reporter considered the facial swelling, red face, skin inflammation, injection site ulcer, injection site pain, flushing and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient stated that she takes the flu shot every year. The patient was not having any other medical conditions. The patient was not taking any other medicines concomitantly. The patient initially stated that she had a reaction to the flu shot (non-GSK vaccine) and she just wanted to get a package insert. She was also reacting to a Tuberculosis vaccine and to some of the inert ingredient so that she was looking for the package insert that lists the ingredients so that she could cross refer. The patient also has another injection and reaction to it, so she was trying to locate her allergy for which she was requesting package insert for the flu shot she received. However, the physician confirmed that at approximately 15.25, the patient received only FLUARIX QUADRIVALENT and experienced reactions after vaccination. On 22nd September 2015, the next day after vaccination, the patient woke up with one side of her face as bright red, swelling in her jaw and overall inflammation around her ear and jaw. The patient also had ulcerated sore on left deltoid. On day 2, 3 and 4 after vaccination, she always woke with red side of her face and then by day 2 it was looked like she had sunburn, she had red cheeks and red nose with flushing. It was flushed like if she had sunburn across her face. The patient also mentioned that her skin was little bit inflamed. She had very light swelling on the left side where she had the vaccination, swelling on her face. She stated that her skin was just slightly swollen but it was not bad it was just mild but was very red, which lasted for 4 to 5 days. The patient experienced all these adverse events from 22nd September 2015 to 26th September 2015 except ulcerated sore at injection site, which lasted for one month. On 12th November, the patient was fine. The patient consulted her physician and reported the reactions to her physician. The patient had another doctor who prescribed the BENADRYL but it was already over a month later. At the time of reporting, she did not take BENADRYL because it was already over. The pharmacy details were not available as the vaccine was given by a nurse in a medical group, which did not take from any pharmacy.