Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Computerised tomogram normal, Diabetes mellitus, Electrocardiogram abnormal, Gout, Haematocrit normal
Clinical narrative: Initial report received from an investigator on 12 August 2010 under the reference number FUF16. A 72-year-old female subject developed hypoglycemia 255 days after she received dose 1 intramuscular injection (site not provided) of MONOVALENT FLU A/H1N1 PRESERVATIVE-U, 7.5 mcg HA, lot number UD12414, reconstituted with PBS diluent (lot number UD12620 on 09 November 2009). The subject did not received AF03 adjuvant. The subject's medical history included headaches, chronic obstructive pulmonary disease (COPD), asthma, bilateral leg edema, high cholesterol, high triglycerides, gallbladder disease, arthritis of back, bilateral carpal tunnel syndrome, mild depression, bilateral knee replacement, gout, year round allergies, hives, obesity and Diabetes Mellitus. The subject was found unconscious in her home and taken to the hospital via ambulance. She was admitted for uncontrolled diabetes. Laboratory test results upon admission showed glucose 36, blood gas 7.31, pCO2 63, pO2 195, bicarb 31, WBC 6.4, hemoglobin 12.6, hematocrit 38.2, and UA revealed positive protein. Her EKG showed sinus bradycardia at rate of 43. A chest x-ray showed mild pulmonary congestion. The initial computed tomography (CT) of the head showed brain atrophy and chronic ischemic changes. She was treated with intravenous (IV) fluids, IV Dextrose to control her hypoglycemia, IV antibiotic and wound care for right foot cellulitis. The subject was admitted for a total of two days. On the day of discharge, 26 July 2010, the subject was transferred to a skilled nursing facility for 1 week due to having no one at home to take care of her. The discharge diagnosis was hypoglycemia secondary to glucotrol, Diabetes Mellitus Type 2, hypertension, possible sleep apnea syndrome, hypercarbia, gout, sinus bradycardia, chronic kidney disease and right leg cellulitis. She was discharged on the following medications, sliding scale insulin, LEVAQUIN 500 mg IV every 24 hours, Vitamin D daily, LASIX 40 mg daily, PROZAC 20 mg daily, allopurinol 100 mg daily, ZOCOR 20 mg daily, oxygen at 2 liters/minute via nasal cannula, hand held nebulizer with Albuterol and wound care to right leg. No action was taken regarding the study. The outcome was reported as recovered. According to the investigator, the event was not related to the study vaccine. Follow-up information was received from an investigator on 17 August 2010 and 18 August 2010 under the reference number FUF16. The subjects concomitant medications were as follows: oral furosemide 80 milligrams (mg) for diuretic, oral metformin 1000 mg for diabetes since 1999, oral KLOR-CON 10 milliequivalents (mEq) for low potassium since 2004, oral hydrocodone/acetaminophen 5/500 mg for pain since 2000, oral triamcinolone 1% for acne since 2005, oral hydroxyzine Hcl 10 mg for acne since 2005, fluoxetine Hcl 20 mg for depression since 2000, oral glipizide XL 5 mg for diabetes since 1995, oral naproxen 375 mg for pain since 2000, oral allopurinol 100 mg for gout since 2000, oral betamethasone 60 milliliters (ml) for acne since 1995, oral colchicine .6 mg for gout since 2000, oral ducosate 100 mg for constipation since 2000, oral (Aspirin) 81 mg for cardiac prophylactic since 2000, oral gemfibrozil 600 mg for hypercholesterolemia since 200 and oral ACTOA 30 mg for diabetes since 1995. According to the investigator, the event remained not related to the study vaccine. Unblinding information was received on 13 August 2010. Follow-up information was received 19 August 2010 from the investigator. The event of hypoglycemia began and ended on 24 July 2010 (previously reported as beginning 23 July 2010 and ending 26 July 2010) which changed the event latency to 257 days post vaccination. The symptom of "unconscious" (onset previous reported as July 2010) began and ended on 24 July 2010, The subject experienced an additional symptom of "altered state" which began and ended on 24 July (year reported as 2011). The start date for the concomitant medication Furosemide was unk/unk/1988. The subject had additional medical history of right lower extremities statis ulcer. The subject was hospitalized for three days beginning 24 July 2010 and discharged on 26 July 2010. According to the investigator, the event was not related to the study vaccine or concomitant medications. Follow-up information was received 30 August 2010 from the investigator. The study vaccine had been administered as an intramuscular right deltoid injection. The start date for the concomitant medication Furosemide was unk/unk/1980 (year previously reported as 1988). The event causality remained unchanged, and according to the investigator, the event was not related to the study vaccine or concomitant medications. Documents held by sender: None.