Based on the information received on 02 December 2016 the case was initially considered as non-serious now became serious because of hospitalization. Also this case became medically confirmed. Initial unsolicited report received from a consumer (claims representative) on 30 September 2016. This case involves a 66-year-old female patient who was vaccinated with a dose of FLUZONE HD (dose, dose in series, expiry date of product, route and site of administration were not reported; batch number was reported as unknown) on 10 November 2015. The patient's medical history and concomitant medications were unknown to the reporter. On 10 November 2015, in the evening of the day of vaccination, the patient experienced difficulty breathing. Laboratory data and corrective treatment was unknown. The outcome of the event was unknown. Follow up information received from consumer on 31 Oct 2016. The patient vaccinated with a 0.5 ml dose of FLUZONE HD (batch number: UI486AA, expiry date: 24 May 2016) intramuscularly in right arm on 10 Nov 2015 at 7:30 PM. The patient had no drug allergies, had no cancer, leukemia, AIDS, or any other immune system problem seizure, brain disorder, GB syndrome nervous system problem, and did not take any corrective treatment. No adverse event occurred for previous vaccination (unspecified) and a tetanus booster. The patient was smoker. The patient did not receive a transfusion of blood and blood product, including antibiotics. The patient was not sick at the time of vaccination. The patient did not receive any concomitant vaccine. On 10 Nov 2015, same day (in the evening) few hours, following the vaccination the patient had difficulty breathing. List of documents held by sender: none. Follow up report received from a medical doctor on 02 December 2016. It was reported as the patient past medical history of heavy tobacco and positive for zoster and pancreatitis, prior uterine cancer and allergy to codeine the patient family history is positive for colon cancer, prostate cancer the patient social history reported as no alcohol and she admits to 1-1/2 packs of cigarettes for 58 years and the patient surgical history was reported as prior lysis of adhesions, prior vein stripping, prior abscess. It was reported that after getting vaccinated with flu shot, on an unknown date six hours later the patient developed acute shortness of breath and chest tightness, and it was reported as the patient was admitted in hospital on 11 November 2015 and she was brought in and developed some nausea associated with this, reported as symptoms were slow to respond and the patient was admitted for observation and ongoing ruled out and after the hospital admission the patient was diagnosed with reported as chronic obstructive pulmonary disease exacerbation, mild to moderate, conjunctivitis, chest pressure, rule out acute coronary syndrome and it was reported as the patient was having some increasing shortness of breath with some mild chest discomfort in hospitalization, and on an unknown date the patient developed probably delay flu shot reaction, it was reported as the patient will be in the hospital longer than a 2 day stay to rule out a more serious cardiac condition and it was reported as the patient was seen by the cardiologist. The patient lab tests were reported as physical examination temperature 98.7, pulse 90, respiratory rate was initially 28, blood pressure 131/93 , she is 92 percent on room air, general obese white female in mild-to-moderate distress, HEENT: normocephalic and atraumatic, she has green conjunctival discharge from both eyes and injected conjuctivae, her oropharynx was clear and Neck-supple, Heart regular, no murmurs, rubs, or gallops, Chest-poor air movement, some scattered wheezing, Abdomen-Obese, soft, nontender, hypoactive bowel sounds, Extremities-trace edema, no cyanosis or clubbing. White blood cell count 9.4, hemoglobin 15.9, hematocrit 47.1, platelet count 230, sodium 138, potassium 4.0, chloride 102, bicarbonate 29, BUN (blood urea nitrogen) 13, creatinine 0.69, glucose 112, LFTs (liver function test) are normal, troponin is less than 0.003, BNP (brain natriuretic peptide) 17, EKG (electrocardiogram) - sinus rhythm with some arrhythmia, no ST or T wave changes, Chest x ray, preliminary read: increased markings inferiorly bilateral but not markedly different from her June 2015 radiograph. The patient serial cardiac enzymes was negative Lexiscan Cardiolite stress test was performed on 12 November 2015 and read as possible mild lateral wall ischemia, however computer analysis did not identify this as significant finding, Cardiac cath showed normal coronary arteries, two-D echo, CT chest with IV contrast, chest x-ray showed density right cardiophrenic angle and two view chest recommended. The patient corrective treatment includes admit to telemetry continue oral prednisone, the patient was given a dose of ceftriaxone in the emergency room and transition her to azithromycin, nebulizer treatment, the patient needs Formal PFTs and smoking cessation nicotine for supplement for her while in house, antibiotic eye drops for her conjunctivitis, and the patient was placed on steroids due to wheezing on presentation due to COPD exacerbation, and the patient was prescribed the discharge medications prednisone taper as instructed, PROTONIX 40 mg by mouth daily and follow up with PMD in one week. The outcome of the events were unknown, and the patient was discharged from hospital on 13 November 2015 with stable condition and discharge diagnoses of probably delay flu shot reaction, abnormal stress test. Cardiac cath negative for significant coronary artery disease, chronic obstructive pulmonary disease exacerbation in the setting of 1 and tobacco abuse. List of documents held by sender: none. Sender's Comments: The reported events are consistent with hypersensitivity reaction. The time to onset is compatible with the role of vaccine. The patient had medical history of Chronic obstructive pulmonary disease. Complementary investigations exploring alternative causes particularly infectious to trigger exacerbation of pre-existing disease, patient's previous immunisation and tolerance, immune status at the time of vaccination, concomitant medications are needed to assess the case further. Based on the available information, a role of the vaccination cannot be established.