Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Photophobia, Somnolence, X-ray
Clinical narrative: This case was reported by a consumer via patient support program and described the occurrence of headache in a 77 year old female. BREO helped improve the patient's breathing and condition. The patient did have a few headaches the first four days but could literally feel the change once the headaches passed. (US2014GSK049183: same patient, same reporter). Follow up information received from consumer on 16th November 2017: The patient's concurrent medical conditions included asthma (diagnosed in 1998), chronic bronchitis, sinusitis, chronic obstructive pulmonary disease (diagnosed in 2010) and difficulty breathing. Co-suspect products included BREO ELLIPTA inhalation powder (batch number R796895, expiry date September 2018) for chronic obstructive pulmonary disease and asthma, ADVAIR unknown for chronic obstructive pulmonary disease, potassium chloride unknown for chronic obstructive pulmonary disease and SPIRIVA for chronic obstructive pulmonary disease. On 17th October 2017, the patient had her annual physical examination including mammogram, bone density x-rays and blood check. The patient received senior dosage flu shot and had her potassium increased. Her physician changed SPIRIVA and ADVAIR to SPIRIVA and BREO. The physician explained how the combination of medication in BREO would help improve breathing. The patient had always had a good rapport with her physician and believed what he told her and willingly accepted what he said she need in the way of medication. On 18th October 2017, the patient put aside ADVAIR and took SPIRIVA followed by first dose of BREO. The patient noticed difference with the first usage of the new combination and became tired and sleepy by noon. On 19th October 2017, the patient used SPIRIVA and BREO first thing in the morning. The patient again began feeling extra tired and short of breath. In addition, the patient also felt pressure behind her eyes and by 10 a.m. had a headache, irregular breathing, and her chest was very tight. On 20th October 2017, the patient woke up and was able to inhale and take a deep breath comfortably. She had great feeling and used SPIRIVA with BREO as usual. The patient noticed her nose was more open for breathing but her eyes still had the pressure around them, felt tired and eyes bothered in the sun and indoor lighting. By 5 p.m., the headache was back. On 21st October 2017, the patient woke up coughing hard did not know why but took SPIRIVA and BREO. The coughing continued all morning and still had very little energy, felt tired and her eyes were still bothering me. The patient remembered that she did not like the lethargic feeling. At 9 p.m., the patient went to refill the dog's water bowl. She was able to breathe deeply but I sounded out of breath and it seemed her heart was pounding as if she had been exercising. She checked her pulse or oxygen rate and her oxygen was 94 percent and pulse rate was 84. Then after she had picked up the water bowl, walked to the sink, cleaned and filled the bowl, walked and put the bowl in its spot (about 15), her oxygen was 84 percent and pulse rate was 86 that was not really a problem. On 22nd October 2017, the patient woke up and felt okay, slept easily, did not cough but still felt tired. The patient took the SPIRIVA and BREO, fed the dog and cats and did some wash and easy chores. The patient did not remember having any other problems. The outcome of the difficulty breathing, sleepiness, irregular breathing, chest tightness, pain behind eyes, eyes sensitive to sunlight, cough, lethargy, energy decreased, heart pounding and oxygen saturation decreased were recovered. On 23rd October 2017, the patient took the SPIRIVA or BREO with nothing bothering her. She felt good all day and by 1 p.m. had all her regular energy back and hoped for the same the next day. Since then she had nothing but good days. Her eyes finally felt normal, light did not bother her and her headache was gone and had stayed away. It was strange having the problems she had the first four days and she honestly did not know why. Perhaps it was the combination of annual flu shot, upper the potassium dosage, and switching to BREO. She really liked how her ability to inhale deeply and breathe more easily has improved since using BREO. The outcome of the tiredness was recovered. It was unknown if the reporter considered the headache, difficulty breathing, tiredness, sleepiness, irregular breathing, chest tightness, pain behind eyes, eyes sensitive to sunlight, cough, lethargy, energy decreased, heart pounding and oxygen saturation decreased to be related to Influenza vaccine Quadrivalent, BREO ELLIPTA, ADVAIR and potassium chloride.