Sex: F
Vaccine: FLUX, UNK, UNK, UNK
Symptoms: Asthma, Condition aggravated, Cough, Drug ineffective, Dyspnoea
Clinical narrative: Associated shortness of breath and severe wheezing, Tripod breathing; Severe wheezing, inspiratory and expiratory wheezing throughout all lobes, nighttimes wheezing; Severe persistant asthma with acute exacerbations; Post-tussive emesis after severe coughing fits; feels nowminimally effective; Reports intermittent cough, nighttime coughing, coughing fit; This case was reported by a consumer via patient support programs and described the occurrence of cough aggravated in a 22-year-old female patient who received fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder (batch number Unknown, expiry date unknown) for product used for unknown indication.   Co-suspect products included salbutamol sulphate (Ventolin Hfa) inhaler (batch number Unknown, expiry date unknown) for product used for unknown indication and salbutamol sulphate (Albuterol Sulfate) nebuliser solution for product used for unknown indication.   Concurrent medical conditions included asthma aggravated. Concomitant products included azithromycin, ethinyloestradiol + norgestimate (Ortho Cyclen) and prednisone.   On an unknown date, the patient started Advair Diskus (unknown) 100/50 mcg at an unknown dose and frequency, Ventolin Hfa (unknown) 90 ug 2 puff(s) as needed and Albuterol Sulfate (inhaled) 2.5/3 mg/ml at an unknown dose once daily. In July 2017, an unknown time after starting Advair Diskus, Ventolin Hfa, Albuterol Sulfate and azithromycin, the patient experienced cough aggravated. On an unknown date, the patient experienced shortness of breath, wheezing, asthma aggravated, post-tussive vomiting and lack of drug effect. The patient was treated with antihistamine (Antihistamines). The action taken with Advair Diskus was unknown. Ventolin Hfa was continued with no change. Albuterol Sulfate was discontinued (Dechallenge was unknown). On an unknown date, the outcome of the cough aggravated, shortness of breath, wheezing, asthma aggravated, post-tussive vomiting and lack of drug effect were unknown.   It was unknown if the reporter considered the cough aggravated, shortness of breath, wheezing, asthma aggravated and post-tussive vomiting to be related to Advair Diskus, Ventolin Hfa and Albuterol Sulfate.  Additional details: The case was reported by the patient via GSK patient Assistance program on 14 February 2020. This report was of 22 year female patient with previous medical history as asthma presented for severe cough. The patient had no known allergies. Patient does not smoke tobacco, marijuana, or other substances. Patient reported intermittent cough since July 2017, significantly worse in last few weeks that was nonproductive. Associated shortness of breath and severe wheezing. Nighttime coughing fits every night. She was now having to use albuterol inhaler at least once a day, feels now minimally effective (Previously improved symptoms). The patient had also started antihistamines daily during the last 1 weeks. She denied rhinorrhea, itchy/watery eyes, congestion, itching of ears or throat, fever, chills, night sweats. The patient had no chest pain and no unintentional weight change. Received seasonal flu vaccine on 22 Sep 2017. Patient done last purified protein derivative (PPD) on 18 Oct 2017 (negative- no history positive PPD). She denied emergency room (ER) visits or hospitalizations. No chest X-ray or other chest imaging previously. Patient admits having intermittent post-tussive emesis after severe coughing fits. It was reported inspiratory and expiratory wheezing throughout all lobes and tripod breathing. Patient was advised to start Advair diskus aerosol powder breath activated 100-50 mcg/ dose, 1 puff rinsed mouth with water after use, inhalation, twice a day, 30 days. Patient also advised to start promethazine- DM syrup 6.25-15 mg/5 ml, 5 ml as needed, orally, every 6 hours as needed for cough for 10 days. Start tessalon perles capsules, 100 mg, 1 capsule as needed, orally, 3 times a day for 10 days. No further details were reported.   Upon clarification received ON 1st April 2020 the corrections were made as follows: Influenza vaccine Quadrivalent unspecified season was added as suspect and link to all event except lack of drug effect.      Lab Comments: Screening for HIV