Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Drug dose omission, Dysphonia, Fatigue, Haemoptysis, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of bronchitis in a 59-year-old female patient who received Seasonal QIV Dresden (Influenza vaccine). Co-suspect products included ANORO ELLIPTA inhalation powder (batch number 7ZP4425, expiry date June 2019 for chronic obstructive pulmonary disease. The patient's past medical history included retention carbon dioxide, oxygen saturation decreased, feeling unwell (patient was placed on bi-pap and antibiotic spent a week in hospital then 1 week in skilled nursing facility), x-ray, bilevel positive airway pressure and living in nursing home (1 week). Previously administered products included PROVENTIL with an associated reaction of heart rate increased. Concurrent medical conditions included headache and muscle spasm. Concomitant products included CLARITIN, cyclobenzaprine, Levalbuterol, melatonin, prednisone, SINGULAIR, VALIUM, Vitamin D3, XOPENEX, ZOFRAN, SPIRVA, DULERA and Pneumonia Shot. On 5th October 2017, the patient received Influenza vaccine and ANORO ELLIPTA (inhaled) 1 puff(s) once daily. On 5th October 2017, less than a day after receiving Influenza vaccine and ANORO ELLIPTA and less than a day after starting Influenza vaccine and ANORO ELLIPTA, the patient experienced bronchitis. On 8th October 2017, the patient experienced phlegm, hoarseness, nausea, appetite absent, breast pain, chest pain, gagging, runny nose, tiredness and vomiting. On 17th November 2017, the patient experienced feeling unwell. On 28th November 2017, the patient experienced missed dose. On an unknown date, the patient experienced blood streaked sputum and scab. The patient was treated with azithromycin. ANORO ELLIPTA was interrupted (Dechallenge was positive). On an unknown date, the outcome of the bronchitis and blood streaked sputum were recovered/resolved and the outcome of the feeling unwell, scab and missed dose were unknown and the outcome of the phlegm, hoarseness, nausea, appetite absent, breast pain, chest pain, gagging, runny nose, tiredness and vomiting were recovering/resolving. It was unknown if the reporter considered the bronchitis, feeling unwell, blood streaked sputum and scab to be related to Influenza vaccine and ANORO ELLIPTA. The reporter considered the phlegm, hoarseness, nausea, appetite absent, breast pain, chest pain, gagging, runny nose, tiredness and vomiting to be possibly related to Influenza vaccine and ANORO ELLIPTA. Additional details were provided as follows: Additional concomitant medications included unspecified antibiotic, prenatal vitamin, unspecified pain medication as needed, and unspecified nasal spray. Caller was recently prescribed ANORO which patient has started on 5th October 2017. The patient had recently been in the hospital for carbon dioxide retention and low oxygen saturation levels. She was also placed on an antibiotic and her prednisone was increased to 20 milligram from 10 mg. She noted a x-ray was done at that time. She spent a week in the hospital on bilevel positive airway pressure (BiPAP) and then another week at a skilled nursing facility on BiPAP. The patient saw her physician on 5th October 2017, and was told to start ANORO by her pulmonologist. She has been prescribed ANORO by her primary care physician in August but never started it. She was previously taking SPIRIVA and DULERA. The patient also stated that, at the 5th October 2017 visit, she got a flu shot. She saw him on 13th October 2017, as a follow-up appointment and was given doxycycline but she was not sure why. On 18th October 2017, she received a pneumonia shot. On 17th November 2017, she was not feeling well, went back to the pulmonologist and an x-ray showed bronchitis. She was given azithromycin and told to continue on her usual 10 mg of prednisone. She also noted prior to this visit with the bronchitis diagnosis she had got a capsule lodged in her throat. The patient stated she was sticking her finger in her throat trying to get it out, drinking and coughing. She stated it finally went down and believed it broke and was cutting her. She was having some blood tinged sputum and she also coughed up what she thought was a scab. The patient did not take her ANORO on 28th November 2017 because she thought that was what was causing the excess phlegm and she felt like she was full of it. She also noted hoarseness, cough, nausea, lack of appetite, the pain in her right breast area that went around her chest were all related to the ANORO. Additional adverse events reported included gagging, runny nose, tired, and vomiting phlegm. She noted she did not have all that with SPIRIVA and DULERA, which was what she took on 28th November 2017. The patient was encouraged to contact and speak with her pulmonologist who she had an appointment with on 7th December 2017.