Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 57-year-old female patient who received Influenza vaccine Quadrivalent for prophylaxis. Co-suspect products included BREO ELLIPTA inhalation powder (batch number R826047, expiry date 31st July 2019) for asthma, DULERA for an unknown indication and prednisone for an unknown indication. Previously administered products included ADVAIR (Patient was previously on Advair earlier for 10 years.). Concomitant products included amlodipine. On 11th September 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On 10th January 2018, the patient started BREO ELLIPTA (inhaled) 1 puff(s) once daily (1 puff(s) daily). On an unknown date, the patient started DULERA at an unknown dose and frequency and prednisone at an unknown dose and frequency. On 6th January 2018, 117 days after receiving Influenza vaccine Quadrivalent 2017-2018 season and not applicable after starting BREO ELLIPTA, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization) and asthma aggravated (serious criteria hospitalization). On 10th January 2018, the patient experienced dizziness (serious criteria hospitalization), chest pain (serious criteria hospitalization) and palpitation (serious criteria hospitalization). In January 2018, the patient experienced pleurisy (serious criteria hospitalization). On an unknown date, the patient experienced increased blood pressure (serious criteria hospitalization), pulse increased, tremor (serious criteria hospitalization), exertional dyspnea (serious criteria hospitalization), cough (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), heart disorder (serious criteria hospitalization), heart fluttering (serious criteria hospitalization and GSK medically significant), lower respiratory tract infection bacterial (serious criteria hospitalization and GSK medically significant), tonsillitis (serious criteria hospitalization), cellulitis of leg (serious criteria hospitalization and GSK medically significant), swelling of feet (serious criteria hospitalization and GSK medically significant) and loss of voice (serious criteria hospitalization). The patient was treated with LEVAQUIN. BREO ELLIPTA was discontinued on 14th January 2018. On an unknown date, the outcome of the vaccination failure, pulse increased and exertional dyspnea were unknown and the outcome of the influenza, asthma aggravated, increased blood pressure, dizziness, tremor, cough, difficulty breathing, heart disorder, chest pain, palpitation, heart fluttering, lower respiratory tract infection bacterial, tonsillitis, cellulitis of leg, swelling of feet, loss of voice and pleurisy were recovered/resolved. The reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2017-2018 season. It was unknown if the reporter considered the asthma aggravated, increased blood pressure, pulse increased, dizziness, tremor, exertional dyspnea, cough, difficulty breathing, heart disorder, chest pain, palpitation, heart fluttering, lower respiratory tract infection bacterial, tonsillitis, cellulitis of leg, swelling of feet, loss of voice and pleurisy to be related to Influenza vaccine Quadrivalent 2017-2018 season. It was unknown if the reporter considered the increased blood pressure, dizziness, cough, heart disorder, chest pain, palpitation, heart fluttering, lower respiratory tract infection bacterial, tonsillitis, cellulitis of leg, swelling of feet, loss of voice and pleurisy to be related to BREO ELLIPTA. Additional details were provided as follows: The patient reported that she was hospitalized in 6th to 11 January, 2018 for being really sick with the flu. The patient received the flu shot in September 2017 but could not recall the name of the vaccine but she believed that the flu shot did not work. She was taking DULERA at the time and the flu kicked up her asthma with a vengeance and she had asthma exacerbation. Her blood pressure and pulse was elevated and she was starting to get dizzy and they put her on 60 mg of Prednisone. She was shaky and her peak flows were hideous and she had dyspnea on exertion. She was coughing her head off and she was sleeping straight up because she could not breathe so they recommended to start the BREO ELLIPTA. She experienced a lot of cardiac issues after starting the BREO ELLIPTA in the hospital, her blood pressure elevated and dizziness after starting the BREO ELLIPTA. She had chest pain and palpitations. These symptoms started within a half hour of starting treatment with BREO ELLIPTA. She continued to have cardiac issues after stopping the BREO ELLIPTA into February and April and maybe May like weird little flutters. She would have a computerized tomography of the chest the day after reporting because something still did not look right. She ended up in the hospital again in June with a gram negative in the lungs and tonsillitis, ankle cellulitis. The patient also reported that she had a repeat eye surgery to her left eye on April 6, 2018 so she could not drive until it healed. She was taking the bus because she could not drive. She was walking through a puddle and within a day or two she was developing the beginning of the swelling of foot cellulitis. By a week she was trying four different medications and she ended up in the hospital for 4 days and they put her on LEVAQUIN. She ended up in the hospital a month later with ankle cellulitis because she believes that her initial infection was not resolved. The patient just restarted treatment with BREO ELLIPTA this morning and took her first dose at 8:00 AM and has experienced no symptoms. The patient had denied permission to contact their physician. The patient believed that getting the flu really screwed up her lungs and that why she was experiencing all of these breathing issues and that many of her symptoms were related to the maximum doses of Prednisone and the flu shot not working for her. The patient's first hospital stay with cellulitis was from 23rd to 25th May in 2018 and her second hospital stay was from June 29 - July 4th, 2018. The patient indicated that she had a follow-up eye surgery that was a recurrence of disease from a previous surgery but it had since resolved and was not related to the BREO ELLIPTA. No additional details were available. The patient also reported that she had chest pain from hacking and coughing so hard which she explained was pleurisy and this condition started in the hospital and it got worse afterwards but it had since resolved now. The patient actually asking questions about dosage related issues. The patient had a prior problem with this medication when was very sick with the flu, and it was on other medication, so the patient did have some problems with BREO in the past. So then representative went through a series of questions to, know, understand better what the side effects and issues were. The patient restarted on that medication, and it had been perfectly fine.