Sex: F
Vaccine: FLU3
Symptoms: Nausea, Overdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dyspnea in a elderly female patient who received BREO ELLIPTA inhalation powder (batch number R804588, expiry date unknown). Co-suspect products included VENTOLIN HFA inhaler (batch number VM9G, expiry date unknown). On an unknown date, the patient started BREO ELLIPTA 200 ug 1 puff(s) once  daily and VENTOLIN HFA at an unknown dose and frequency. On an unknown date, an unknown time after starting BREO ELLIPTA and VENTOLIN HFA, the patient experienced dyspnea (serious criteria hospitalization), nocturnal awakening, thrush, taste metallic, lack of drug effect, overdose and inappropriate schedule of drug administration. The action taken with BREO ELLIPTA was unknown. The action taken with VENTOLIN HFA was unknown. On an unknown date, the outcome of the dyspnea, nocturnal awakening, thrush, taste metallic, lack of drug effect, overdose and inappropriate schedule of drug administration were unknown. It was unknown if the reporter considered the dyspnea, nocturnal awakening, thrush, taste metallic and lack of drug effect to be related to BREO ELLIPTA and VENTOLIN HFA. Additional details: This case was reported by the patient via the GSK Call Center. The patient stated she was having difficulty breathing, was hospitalized and released last week. She also reported shortness of breath. The patient said she often woke up in the middle of the night and used her VENTOLIN 6 to 8 times. The patient also stated that when she started using the BREO ELLIPTA, she was not taking the medication the same time every day, but she did now. It was clarified that the patient mentioned lack of effect and said nothing was working for her, but she was not specific. She even noted that her doctor was not working. It was clarified that the patient also mentioned thrush during the call. The patient wanted to know if the metallic taste in her mouth was because of the medications she was taking and was transferred to a product representative. The patient denied permission to contact their physician. Follow-up information was received on 29 January 2018 from the patient via call center representative. It was reported that last March 2017, while at her brother's house, the patient started feeling dizzy (new event, dizziness, hospitalization) and was about to call 911. That was the last thing she remembered until she woke up in the hospital three days later on life support (new event, life support, hospitalization, medically significant). She reported that she died and they were able to revive her. Prior to the  hospitalization, she had seen her health care provider (HCP) a few days before and upon checking out she was told there was no reason to make a follow up appointment.  She  reported  that  she  was  taking  ANORO  as  a daily  medication  before  the  hospitalization.  She  has  continued  to  receive  prescription  from  the  provider  and  stated  she  was seen recently for her flu shot. Since then she has felt "sick" and nauseated. She attributes these symptoms to receiving the flu vaccine. Caller mentioned taking SPIRIVA but it was unclear when she actually took it. Permission to contact for follow up was denied.