Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pulmonary pain, Respiratory tract congestion, Respiratory tract infection, Sneezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory infection in a 54-year-old female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included asthma, grass allergy (and bushes), allergy to plants and food allergy (had allergy shots as a child). Concomitant products included ADVAIR DISKUS, VENTOLIN HFA, PRIMATENE and SINGULAIR. On 31st August 2017, the patient received Influenza vaccine Quadrivalent. In November 2017, less than a year after receiving Influenza vaccine Quadrivalent and unknown after starting ADVAIR DISKUS and VENTOLIN HFA, the patient experienced respiratory infection (serious criteria GSK medically significant), cough and cold. On 9th January 2018, the patient experienced phlegm. On 13th January 2018, the patient experienced difficulty breathing and sore throat. On an unknown date, the patient experienced airway secretion excessive, sickness, pulmonary pain, sneezing, respiratory tract congestion, swallowing difficult, decreased immune responsiveness and lung disorder. The patient was treated with prednisone. On an unknown date, the outcome of the respiratory infection, difficulty breathing, sore throat and cough were recovering/resolving and the outcome of the airway secretion excessive, phlegm, sickness, pulmonary pain, sneezing, cold, respiratory tract congestion, swallowing difficult, decreased immune responsiveness and lung disorder were unknown. The reporter considered the respiratory infection, difficulty breathing, sore throat, phlegm, sickness, pulmonary pain, sneezing and cough to be unrelated to Influenza vaccine Quadrivalent. It was unknown if the reporter considered the airway secretion excessive, cold, respiratory tract congestion, swallowing difficult, decreased immune responsiveness and lung disorder to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: In 2003, the patient received ADVAIR DISKUS 250/50 and VENTOLIN HFA. The ADVAIR dose was increased to 500/50 for the past 4 to 5 years. The patient thought it was a cold initially and it progressively got worse. Six weeks later she had a respiratory infection and she was put on prednisone, cough suppressant, antibiotic with breathing treatments for her asthma. Her cough which started in November started to drain in her lungs and around 9th January 2018, she started to cough up phlegm (131 days after vaccination) and it got really bad. The patient was all clogged up everywhere and coughed so bad that she gasped for air and 135 days after vaccination, the patient could not breathe and it was hard to swallow for her due to a sore throat. The patient did not believe that her immune system adjusted to the cold weather and her immune system was run down from being sick before she did not seek a physician and then her condition was progressively worsened. The patient's lungs were hurt, clamped down and she also sneezed prior to her diagnosis. The patient reported that she was diagnosed with a respiratory infection in January that she believed started back in November 2017. The patient believed that the respiratory infection caused because she got the flu shot too early this year and it wasn't effective. The patient was told by her physician to take VENTOLIN 4 puffs 3 times per day after her diagnosis. She was told to take a cough suppressant three times per day and she had scheduled a follow-up appointment with her physician on 2nd February 2018. This case was linked to US2016GSK031482, reported by the same reporter for the same patient.