Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Ultrasound bladder normal, Ultrasound scan, Urine analysis normal, White blood cell count normal
Clinical narrative: Initial report received from an investigator on 29 October 2010 under the reference number FUF16. A 72-year-old female subject experienced an irregular heart beat with weakness an unspecified amount of time after she had received a first dose intramuscular injection of H1N1, 7.5 mcg HA, lot number UD12414, reconstituted with 13S diluent (lot number UD12620) on 09 November 2009. The subject did not receive AF 3 adjuvant. The subject had a past medical history of hypertension, diabetes, gout, high cholesterol, acne, constipation, COPD, arthritis, depression, gall bladder disease, bilateral knee replacement, obesity, year round allergies, sleep apnea and chronic kidney disease. On an unknown date in the beginning of October 2010, the subject complained of weakness. Unspecified tests were conducted and the subject was admitted on an unknown date in October 2010 for a slow heart beat. Corrective treatments consisted of a pacemaker implant. The subject recovered and was discharged on an unknown date in October 2010. According to the investigator, the event was not related to the study products or concomitant medications and the subject continued in the study. Follow-up information was received 15 November 2010 from the investigator. The subject received the study vaccine on 10 November 2009 (previously reported as 09 November 2009). The event remained unrelated to the study vaccine and concomitant medications, and the subject continued in the study. Unblinding information was received 18 May 2010. Follow-up information received from the investigator on 17 November 2010. The SAE diagnosis was amended by the investigator from irregular heartbeat to Paroxysmal atrial fibrillation with sick sinus syndrome S/P pacemaker insertion (start/stop dates 10-10 October 2010). Weakness remained a symptom of the new SAE diagnosis. Stop dates for all concomitant therapies were reported as "unknown" by the investigator. It was reported the subject had fallen 1 month ago (date not provided) and continued to have multiple falls. Subsequent to the falls, the subject felt her legs were giving away, more so or the right. The falls led to an emergency room visit and after arriving to the emergency room, the subject had another episode of falling. Blood pressure at that time was 181/86, heart rate was 156 and patient was in full atrial fibrillation. The subject was admitted to the hospital on 10 October 2010 with respiratory rate of 20 and oxygen saturation of 81%. Blood sugar was 79 and creatinine was 120. On admission CAT scan of brain and chest x-ray were completed; however results not reported. An MRI of brain the following day revealed atherosclerotic disease. Diagnostic tests on 12 October 2010 included ultrasound of carotid arteries that revealed 40-50% left carotid stenosis; ultrasound of abdomen (result not reported); ultrasound of bladder revealing no abnormal defect; and lumbar spine serious (results not reported). Two days later on 14 October 2010, the subject underwent implantation of dual chamber pacemaker and temporary placement of dialysis catheter. The subject was discharged from the hospital on 15 October 2010. Discharge diagnosis was 1. paroxysmal atrial fibrillation with sick sinus syndrome status post pacemaker insertion; 2. acute renal failure; chronic kidney disease secondary to diabetes status post dialysis; 3. obstructive sleep apnea; 4. generalized weakness; 5. small stroke syndrome with no evidence of CVA; 6. peripheral "neuropathy" secondary to diabetes; "8." hyperlipidemia secondary to diabetes; and 9. obesity. The subject was discharged from the hospital to a skilled nursing facility on aspirin 81 mg daily, LOPID 600 mg daily, zinc sulfate 220 mg daily, multivitamin daily, NEURONTIN 300 mg at night, vitamin E 400 units, allopurinol 100 mg daily, LIPITOR 20 mg daily, PROZAC 20mg daily, levothyroxine 50 mcg daily, albuterol nebulizers, colchicine 0.6 mg daily, meclizine 25 mg bid, TYLENOL prn, VICODIN prn, KEFLEX 500 mg tid for 7 days, and insulin with sliding scale. The subject was reported as being recovered on 14 October 2010. According to the investigator, the SAE was not related to the clinic trial product, or the concomitant therapies. The SAE did not lead to the subject's study termination. Follow-up information received from the investigator on 30 November 2010 and 01 December 2010. The SAE diagnosis was amended by the investigator to "Paroxysmal" atrial fibrillation witch sick sinus syndrome, previously reported as "Paroxysmal" atrial fibrillation with sick sinus syndrome, S/P pacemaker insertion. The subject was taking 20 mg of concomitant medication fluoxetine HCL (dosage previously not reported). Laboratory data performed on 11 October 2010 revealed essentially normal BNP, CBC with hemoglobin of 10.2, white count of 6500 (essentially within normal limits), a urinalysis was negative for insidious content, and basic metabolic panel revealed BUN 120, potassium 6.2 and creatinine 5.9. Follow-up information was received 08 December 2010 from the investigator. The investigator amended the SAE diagnosis to "paroxysmal" atrial fibrillation (previously reported as paroxysmal atrial fibrillation with sick sinus syndrome which the investigator stated was the admit diagnosis). Complimentary investigations noted the subject had also been diagnosed with sick sinus syndrome (date not reported); however the investigator noted that sick sinus syndrome should be listed as a symptom of the Paroxysmal atrial fibrillation. The subject's BUN level was also confirmed to have been 120 as previously reported. The subject had no history of cardiac disease. The stop date for the symptom of weakness remained an unknown day in October 2010. According to the investigator, the event was not related to the study vaccine or concomitant therapies, and the subject continued in the study. Follow-up information was received 14 December 2010 from the investigator who confirmed sick sinus syndrome of the SAE which began 1) October 2010 and ended 14 October 2010. According to the investigator, the event was not related to the study vaccine or concomitant medications, and the subject continued in the study. This subject previously experienced tow other SAEs which had been captures in case numbers 2010-02780 and 2010-04344. Documents held by sender: None.