Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal odour, Oedema mouth, Oxygen saturation decreased, Paraesthesia, Paraesthesia oral
Clinical narrative: Initial report received from a consumer on 10 June 2014. Based upon follow-up information received from the physician on 15 December 2014, the case has been upgraded to serious. A female patient, who had no medical history and no concomitant medications received an intramuscular dose of FLUZONE HD in the left deltoid (batch number: U4714AA) on 7 October 2013. The patient had flu vaccines every year since the late 70's and never had reaction. On 7 October 2013, 2 hours post vaccination, patient experienced swelling of eyes, runny nose, lump in throat, and had low oxygen status. She also had "an awful taste in mouth and odor in nose". It was stated that she had low oxygen for which she required Oxygen at 2 L/M when at her home at altitude of 7500. While when she travels to lower altitude she does not require oxygen. The patient required "ER Visit". Laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Follow-up information was received from the physician on 15 December 2014, which included physician office notes, and upgraded the case to serious. According to the reporter, the vaccine was not given by the primary care physician, but was given in a local pharmacy. On 07 October 2013, the patient presented to her physician with complaints of throat swelling and allergic reaction to an influenza vaccine received earlier that day at a pharmacy. She presented with tingling and mild swelling in and around her mouth and throat, with mild tenderness in her arm. No stridor, difficulty breathing, or injection site inflammation were noted. Relevant medical history included allergic rhinitis, hypertension, menopause, osteoarthritis, mild renal insufficiency, type 2 diabetes, carotid IMT, colon polyp (noted on colonoscopy in 2004); she also had a history of chronic back pain and was scheduled for surgery three weeks post-vaccination. Surgical history included hysterectomy, tonsillectomy, and cholecystectomy. History of occasional alcohol use. Concomitant medications included multivitamins, aspirin, Ginkgo Biloba, fish oil, vitamin D3, cinnamon, FLONASE, pravastatin, TYLENOL, tramadol, and Lisinopril. Sulfa drugs and codeine caused GI upset. The patient had taken BENADRYL prior to visiting the physician. Vital signs upon exam were as follows: blood pressure 183/88, heart rate 57, respiratory rate 16, and oxygen 80% on room air. Lungs were clear to auscultation. The patient was treated with 3 liters of oxygen, at which time her oxygen level came up to 94%. She was also given one dose of intramuscular epinephrine. After the patient was taken off oxygen for 10 minutes, her oxygen level had again fallen to 83% on room air, repeat blood pressure 179/81. She was given an intramuscular injection of DECADRON and CLARITIN. After careful monitoring in the office for 45 minutes, she was discharged to home with an order for home oxygen at 2 liters/minute. Per the physician, the low oxygen level and hypoxia was concerning, but because she was completely comfortable without signs of shortness of breath, it was suspected that this was a chronic condition for her. It was also noted that she had been exposed to second hand smoke for many years. She was instructed to follow-up with the physician in 3 days. In an office note dated 10 October 2013, all symptoms of allergic reaction had resolved. It was also noted that the patient's residence was at 7400 feet. Vital signs at that visit were as follows: blood pressure 159/88, temperature 96.4, heart rate 42, respiratory rate 14, oxygen 81% on room air, 78% with activity, and 95% on 2 liters of oxygen. An ECG showed normal sinus rhythm with LAD and evidence of poor R wave progression consistent with a possible anterior infarct and silent ischemia. The plan was to order additional testing and have the patient follow-up with a cardiologist. List of documents held by sender: Physician office notes.