Sex: M
Vaccine: FLUX
Symptoms: Paralysis, Prostatic disorder
Clinical narrative: Guillain-Barre Syndrome (GBS); Completely paralyzed on his left side (similar to the symptoms of a stroke / could not, for example, lift his left leg; Allergic to the flu vaccine; Facial nerve damage; Numbness in his left arm and/or left leg; Prostate problems; Issues with milk; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 73-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included chronic bronchitis, chronic obstructive pulmonary disease and upper respiratory disorder.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Advair, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), paralysis (serious criteria GSK medically significant), allergy to vaccine, nerve damage, numbness, prostatic disorder and milk allergy. The patient was treated with fluticasone propionate, salmeterol xinafoate (Advair), tiotropium bromide (Spiriva) and oxygen. On an unknown date, the outcome of the guillain barre syndrome was resolved with sequelae and the outcome of the paralysis, allergy to vaccine, nerve damage, numbness, prostatic disorder and milk allergy were unknown.   The reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the paralysis, allergy to vaccine, nerve damage, numbness, prostatic disorder and milk allergy 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 calling because his pulmonologist was switching him from Advair and Spiriva to Trelegy. He had not started taking Trelegy till the time of reporting. He was calling to ask questions about Trelegy.  He did not specify if he was using Advair HFA or Advair Diskus.  When the reporter and the patient was reading together (from the package insert) the possible side effects of Trelegy and read that bronchitis was a possible side effect. The mentioned that, he did have bronchitis.  The reporter told him that, he/she would need to make a report that he had bronchitis since he was using Advair but he indicated that it was chronic bronchitis/COPD and indicated that it was pre-existing.   The patient said he had upper respiratory issues which was why he using Advair, Spirivia and oxygen.  He said he was on oxygen 24 hours a day 7 day a week.   The patient indicated that he had not experienced any side effects from Advair.  When the reporter and the patient was reading together were reading together (from the package insert) the possible side effects of Trelegy and read influenza was a possible side effect, the patient stated that he was allergic to the flu vaccine (due to egg).  The patient stated that, 25-30 years he developed Guillain-Barre Syndrome (GBS) from the flu shot.  He said that he did not have any information regarding the name of the shot (or the lot number) because it happened in the 1970's.   The patient stated that, when he had GBS he had facial nerve damage and was completely paralyzed on his left side (similar to the symptoms of a stroke victim) and could not, for example, lift his left leg.  The reporter asked if he was fully recovered and the answer was no.  The patient said that periodically he still would have numbness in his left arm and/or left leg.   The reporter also mentioned that, he had concerns about starting Trelegy because Trelegy literature said to talk to your health care provider about all your medical conditions including if you have prostate problems or were allergic to milk and the mentioned that, he did have prostate problems and issues with milk.  The reporter failed to probe to see if these issues developed prior to starting Advair. The reporter was consented to follow up.