Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphagia, FEV1/FVC ratio decreased, Forced expiratory volume decreased, Forced vital capacity decreased
Clinical narrative: cellulitis; diastolic heart failure; Asthma aggravated; reflux; anxiety; peripheral edema; condition aggravated; Oropharyngeal dysphagia; Airways obstruction; Allergic rhinitis; white sputum production / cough; mucus production; This case was reported by a physician via patient support programs and described the occurrence of cellulitis in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient had a Family History of heart disorder (patient's brother), cancer (patient's father), diabetes mellitus (patient's mother) and chronic obstructive pulmonary disease (patient's sister). Previously administered products included Pneumococcal vaccine (received on 7th June 2017) and Fluvirin 2016-2017 (received on 19th October 2017). Concurrent medical conditions included asthma chronic, chronic obstructive pulmonary disease, productive cough and pollen allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced cellulitis (serious criteria GSK medically significant), diastolic heart failure (serious criteria GSK medically significant), asthma aggravated, reflux gastritis, anxiety, peripheral edema, condition aggravated, oropharyngeal dysphagia, airways obstruction, allergic rhinitis, sputum and mucus discharge. The patient was treated with fluticasone furoate (Arnuity Ellipta), fluticasone furoate (Arnuity Ellipta), salbutamol sulphate (Albuterol Sulfate), fluticasone furoate, vilanterol trifenatate (Breo Ellipta), thyroxine sodium (Levothyroxine), omeprazole, simethicone, omalizumab (Xolair), furosemide (Lasix), formoterol fumarate + glycopyrronium bromide (Bevespi), acetylsalicylic acid (Aspir 81), atorvastatin, cyanocobalamin, colestyramine (Cholestyramine), hydrocortisone, lidocaine, loperamide, losartan, melatonin, minerals nos + vitamins nos (Multiple Vitamins-Minerals), potassium chloride, sertraline, montelukast sodium (Singulair), tiotropium bromide (Spiriva), theophylline (Theo-24), trazodone hydrochloride (Trazodone Tablet), dextromethorphan + guaifenesin (Tussin Dm) and alprazolam (Xanax). On an unknown date, the outcome of the cellulitis, diastolic heart failure, asthma aggravated, reflux gastritis, anxiety, peripheral edema, condition aggravated, oropharyngeal dysphagia, airways obstruction, allergic rhinitis, sputum and mucus discharge were unknown.   It was unknown if the reporter considered the cellulitis, diastolic heart failure, asthma aggravated, reflux gastritis, anxiety, peripheral edema, condition aggravated, oropharyngeal dysphagia, airways obstruction, allergic rhinitis, sputum and mucus discharge to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was never smoked tobacco and consumed alcohol, but the patient was passive smoke exposure. The patient used caffeine as one cup a day. In 2018, the patient had a severe local reaction after the influenza vaccine, cellulitis, reflux, coughing at night, anxiety, peripheral edema and diastolic heart failure. The chronic therapy for the patient's asthma had included dual long-acting bronchodilator therapy with Bevespi and inhaled steroid therapy with Arnuity.  She uses nebulized albuterol as needed. She will occasionally use an albuterol metered-dose inhaler as well. Patient does have a chronic cough with white sputum production The patient performed video swallow study for the oropharyngeal dysphagia. The patient with mild to moderate asthma with a component of COPD and the etiology appears to be allergic asthma. The previous pulmonary function tests had shown moderate airways obstruction.  The patient's recent FEVl was mildly reduced at 74%. The patient is mostly bothered with an increased cough and sputum production and continued the Bevespi, Arnuity and albuterol as needed. The patient's cough was associated with daily mucus production. The respiratory system was positive for the asthma, cough and sputum. The patient's physical exam, which was constitutional head/face eyes, ears, nose or mouth or throat, nasopharynx  neck exam, lymph detail cardiovascular, vascular respiratory, abdomen, skin back or spine musculoskeletal extremity neurological and psychiatric were normal. The reporter also mentioned on 22nd August 2018, the symptoms worsened. The patient did not have chills, fatigue, fever, malaise, night sweats, weight gain and weight loss. This case has been linked with case US2019AMR158895 (pharma case), reported by the same reporter.      Lab Comments: The patient had respiratory test was found to be positive for Asthma, Cough, Sputum.  The patient had other physical examination was found to be negative. On an unknown date, blood pressure, pulse, swallowing test  and oxygen saturation were performed