Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Pancreatitis, Respiratory failure, Total lung capacity decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory failure in a 62-year-old female patient who received FLOVENT inhaler (batch number 3V4X, expiry date 31st October 2017) for product used for unknown indication. Co-suspect products included VENTOLIN HFA inhaler (batch number 9E6S, expiry date 31st January 2018) for product used for unknown indication. On an unknown date, the patient started FLOVENT 2 puff(s) at an unknown frequency and VENTOLIN HFA 2 puff(s) at an unknown frequency. On an unknown date, an unknown time after starting FLOVENT and VENTOLIN HFA, the patient experienced respiratory failure (serious criteria hospitalization and GSK medically significant), coma (serious criteria hospitalization and GSK medically significant), near death experience (serious criteria hospitalization and GSK medically significant), hernia repair (serious criteria GSK medically significant), Crohn's (serious criteria GSK medically significant) and cold. The action taken with FLOVENT was unknown. The action taken with VENTOLIN HFA was unknown. On an unknown date, the outcome of the respiratory failure, coma, near death experience, hernia repair, Crohn's and cold were unknown. The reporter considered the respiratory failure, coma, near death experience, hernia repair, Crohn's and cold to be unrelated to FLOVENT. It was unknown if the reporter considered the respiratory failure, coma, near death experience, hernia repair, Crohn's and cold to be related to VENTOLIN HFA. Additional details: The patient experienced pulmonary failure while taking FLOVENT HFA and VENTOLIN. As a result, the patient was hospitalized and went into a coma and almost died. The patient had also experienced a cold while on FLOVENT and VENTOLIN. The patient had surgery to repair a hernia while on VENTOLIN but was not sure if she was on FLOVENT at that time. The patient also had Crohn's surgery while on VENTOLIN. Follow-up information was received from a consumer via call center representative on 10 January 2017. Patient called the response center back to confirm they were on the FLOVENT inhaler prior to the previously described adverse events. Patient did not believe the FLOVENT contributed to the adverse events; however the patient was on the medication when events occurred. No further information was provided. Follow up information was received from consumer via call center representative on 31st January 2017: The reporter's contact details were updated. The patient was a smoker and she had quit smoking 5 years before reporting date. The patient explained that she believed that the Influenza vaccine Quadrivalent that she received on 8th October 2016 with the COMBIVENT medication, Prednisone, as well as getting over her cold at the time of her vaccine and her Crohn's disease might had all contributed to her present condition, rather than the FLOVENT medication. The product name of the flu vaccine was unknown. The patient also reported that she was on oxygen full time and only had 8 to 10 percent lung capacity. The patient was diagnosed with pancreatitis when she was hospitalized from 2nd November 2016 to 18th November 2016. The patient would not returning the follow up adverse event letter that she had received.