Sex: F
Vaccine: FLUX
Symptoms: Headache, Malaise, Muscle spasms, Myalgia, Neck pain
Clinical narrative: This case was reported by a consumer (patient) and described the occurrence of esophageal ring in a female patient who received ADVAIR multi dose powder inhaler for asthma. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, gastroesophageal reflux disease and high cholesterol. Co-suspect medication included ZEASORB. Concurrent medications included Albuterol, Pravastatin, Lorazepam, montelukast sodium, ZYRTEC, Erythromycin, Prednisone, doxycycline, FLONASE, Methylprednisolone, Hydroxyzine, TYLENOL, Multivitamin, Triamcinolone and PROTONIX. On an unknown date, the patient started ADVAIR (250/50 mcg) (inhaled) at 1 puff(s) twice per day. At an unknown time after starting ADVAIR, the patient experienced esophageal ring, gastrointestinal problems, rash, hive, dermatitis, skin tag, rosacea, itching, gallbladder exeresis, infection, abdominal wound, mosquito bite, pain, headache, neck pain, inability to hold neck up, burning pain in breast, bronchitis, shortness of breath, lightheadedness and anxiety. The patient was hospitalised. Treatment with ADVAIR was continued. At the time of reporting, the events were improved. The patient reported multiple medical issues while on ADVAIR. The patient does not relate any of the events to ADVAIR. The patient developed an esophageal ring and has had some skin problems (rash, hives, dermatitis, skin tags, rosacea and itching). The patient noted switching shampoo and soap and the itching resolved. The patient had her gallbladder removed in 2010 and developed an infection; the patient had a 6 inch wound in her abdomen for 3 months and was hospitalized. The patient recently was bitten by a mosquito and has been feeling "achy and headachy". The patient had her thyroid checked and it was "ok". The patient's neck is currently hurting. In May 2014 the patient developed a rash under her right breast and was given ZEASORB powder for the rash. After using ZEASORB she developed a burning pain in her right breast that was "excruciating for a couple days". After 2-3 days she discontinued ZEASORB but the pain still "comes and goes". The patient also had bronchitis earlier this year and has been on Prednisone tapers. The patient still feels short of breath even while on ADVAIR and noted she will use some Albuterol. The patient has been feeling lightheaded for the past couple days. The patient has been on ADVAIR since around 2000. No further information was provided. Follow-up information from the patient, via agency, was received on 21 July 2014. It was reported that the patient took FLONASE 50 mcg from 05 May 2006 to 11 October 2007. On 21 May 2014 (no start date previously reported), the patient started ADVAIR 250/50 mcg. On an unknown date, the patient experienced bronchitis (previously reported) and body rash. It was reported "this last winter", the patient had bronchitis and rash on her body. She did not want to reveal on what part of her body it was on. At the time of reporting, the outcome of the events of bronchitis and body rash was unknown. Follow up was received from the patient on 9 September 2014 via agency. The patient started ADVAIR in 2002 (previously reported as 21 May 2004). The patient reported that "she had bronchitis and shortness of breath [both events previously reported] and was not getting better." On an unknown date, "her doctor increased her ADVAIR to 500/50mcg and told her to take 2 puffs twice a day of the 250/50mcg." The patient got "really sick and had bad pains in her belly button area and went to the emergency room on 19 September 2014. They sent her home stating it was gas." On 2 September 2014, the patient "started up with bad pains again, vomiting, and green bowel movements. Called the nurse on duty and was told to take one puff twice a day then two puffs twice a day and alternate." The patient reported that "she only took one puff twice a day of the ADVAIR 250/50mcg because she believed taking two puffs twice a day made her sick." At the time of reporting, the outcome of the bronchitis, shortness of breath, lack of effect, overdose, sick, pain at belly button, gas, vomiting, and green bowel movement were improved. The patient reported that she was "starting to feel better." Follow up was received from the patient on 11 September 2014. At the time of reporting, concurrent medications included PROTONIX, pravastatin, and lorazepam. The patient reported medical history included many upper gastrointestinal procedures. In 2013, the patient received seasonal influenza vaccine unspecified (unknown route). In 2014, the patient experienced bronchitis. "On 1 August 2014, the nurse of her doctor told her to just take two puffs of the ADVAIR diskus 250/50 twice daily until paperwork could be filled out so she could be increased to ADVAIR Diskus 500/50mcg. She took ADVAIR in this way until 19 August 2014, when she went to the emergency room for diarrhea, stomach pain, and cramping on the right side of her belly button. At the emergency room, they did blood work and a computerized tomography (CAT scan). She got sent home that day and a few days later she got sick again. She had cramping on the side of her belly button, she went to the emergency room where they told her they thought it was gas. She also had diarrhea and severe vomiting four to five times. She was vomiting clear liquid, and the doctors thought she might have diverticulitis, appendicitis, or an ulcer, but her GI (gastrointestinal) nurse said that she did not have those conditions. The patient also mentioned that when she was vomiting her esophagus felt dry and she felt dry in her chest area. She also had shortness of breath because she is not over the bronchitis. The patient also reports that she did not pass gas for a month in August 2014. They did not realize that her symptoms were due to an overdose of the ADVAIR. The patient states that the nurse at her physician's office said that they tell patients to take two puffs twice a day all of the time, and that the other patients are able to handle that dosing. At the end of August, the patient was switched to ADVAIR Diskus 500/50 one puff twice daily. Patient also reports that she has had muscle pains and spasms in her leg after taking ADVAIR Diskus, as well as chest pain in the right and left side of her heart. Patient is applying to get disability." At the time of reporting, the outcome of the bronchitis, shortness of breath, lack of effect, overdose, sick, pain at belly button, gas, vomiting, and green bowel movement were reported previously as improved. At the time of reporting, the outcome of diarrhea, stomach pain, abdominal cramp r side, dry chest, dryness of esophagus, leg muscle pain, leg muscle spasm, and chest pain were unknown. The patient reported another case for ADVAIR 250/50mcg. See case A1089139A for details on the other case.