Age: 81.0
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Drug interaction, Dry mouth, Dry throat, Therapeutic response unexpected, Vomiting
Clinical narrative: Dry Mouth and Throat / complaints of dryness; Dry Mouth and Throat / complaints of dryness; Vomiting this morning approximately 1-2 hours followin suspect Breo dose; caller asked if there was a drug interaction with flu vaccine; device helps with drying up his mucous secretions from COPD; This case was reported by a consumer via call center representative and described the occurrence of dry mouth in a 81-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta) inhalation powder for an unknown indication and tiotropium bromide (Spiriva) (batch number CG3H, expiry date 31st January 2021) for an unknown indication.   The patient's past medical history included chronic obstructive pulmonary disease.   On 26th September 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient started Breo Ellipta at an unknown dose and frequency and Spiriva (inhaled) 1 puff(s) once daily (1 puff(s) daily). On 26th September 2019, unknown after receiving Influenza vaccine Quadrivalent 2019-2020 season and Breo Ellipta, the patient experienced drug interaction and unexpected therapeutic effect. On 27th September 2019, the patient experienced dry mouth, dry throat and vomiting. The action taken with Spiriva was unknown. On an unknown date, the outcome of the dry mouth, dry throat, drug interaction and unexpected therapeutic effect were unknown and the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vomiting to be related to Influenza vaccine Quadrivalent 2019-2020 season and Breo Ellipta. It was unknown if the reporter considered the dry mouth, dry throat and unexpected therapeutic effect to be related to Breo Ellipta.  Additional information received were as follows: The age at vaccination was not reported. The caller reported being a fairly new user and began product a few weeks ago.  The caller reported inhaling Breo daily dose before bed and then waking up in the mornings with complaints of a dry mouth and throat. The caller reported suspect device helped with drying up his mucous secretions from COPD which was unexpected benefit.  Due to dry mouth and throat, the caller reported doing an experiment by switching dosing intervals by skipping last night's Breo dose by taking it this morning and taking Spiriva last night before bed. The caller reported no complaints of dryness in the morning of the reporting date, but he reported vomiting this morning approximately 1 to 2 hours following suspect Breo dose.  The caller also reported receiving unspecified manufacturer of flu vaccine a day before the reporting date with no complaints. The reporter consented to follow up. The caller reported typically taking Spiriva in the morning of the reporting date and Breo before bed, except the night before the reporting date and on the morning of the reporting date when he reversed routine. The caller asked if there was a drug interaction with flu vaccine and Breo.  The flu vaccine was added as suspect vaccine although the patient mentioned no complaints or side effects from vaccine.