Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Gynaecomastia, Haemoptysis, Headache, Laboratory test, Nasal congestion
Clinical narrative: Initial report received on 02/Nov/2006 from the patient. A 45-year-old male patient, with no concurrent illnesses, asthma for 20 plus years, and pneumonia twice in 1993, had received a right deltoid dose of FLUZONE SV "2006-2007" USP, lot number U2217AA, on 23 October 2006. The route of administration was not reported. 48 hours post-immunziation, the patient developed a headache, nasal congestion, sore throat, hoarse voice, fever, and shortness of breath. He was evaluated in an urgent care center three days later, and a chest X-ray "showed markings". On 02 November 2006, it was reported that the patient had been experiencing for a couple of days, bloody sputum, severe cough, shortness of breath, and his left eye was very red. He was to have a follow-up visit with his physician on 03 November 2006. At the time of this report, the patient had not recovered. Follow-up information received on 17 November 2006. The patient also had a history of sleep apnea. He went to a pulmonologist for evaluation. His status is unknown. Laboratory results was provided. A lower respiratory culture taken on 03 November 2006, had a result of routine respiratory flora. A CT Chest was done on 03 November 2006 with the following impression: 1. The lungs are well expanded and clear. No emphysematous changes, no bronchiectasis, no pneumonia or pleural effusions are seen. 2. No medistinal or hilar adenopathy. Heart size is normal. 3. Upper abdominal viscera remarkable only in that there are few coarse calcifications in the pancreas, no gallstones are seen. Adrenals and top of kidneys clear. 4. Bilateral gynecomastia noted. Follow-up information received on 20 December 2006 from a health care professional. The vaccine had been administered intramuscularly per the patient. The reporter had not seen the patient in follow-up, but provided a copy of an evaluation by a pulmonary specialist. The patient was examined by a pulmonary specialist seven days post-vaccination for an initial evaluation complaining of cough and wheeze since October with some associated episodes of hemoptysis. The patient had been taking Medrol, Flovent, oral albuterol, Singulair, and Spiriva on an inconsistent basis. The episode of hemoptysis was reported as blood streaking and sputum after severe episodes of cough. There was no frank hemoptysis present. Per the reporter, "I am not convinced that the change in his symptoms are related to the vaccine. His first symptoms appeared as a child. They received during adolescence and recurred during his 20's. They have been persistent since 1993. He notes daily symptoms in the morning." The patient had a reflux component that had been recently treated with Aciphex. Physical exam was non-contributory. Impression was dyspnea, wheeze, cough, likely representating asthma (moderate chronic), history of atopy, obstructive sleep apnea syndrome, hemoptysis, and GERD. Pulmonary function testing was to be scheduled. Recovery status was not provided. Follow-up information received on 01 February 2007. There was no additional information. The reporter did not believe the signs and symptoms were due to the vaccine.