Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Post herpetic neuralgia, Product formulation issue, Protein urine absent, Rash pruritic
Clinical narrative: This report refers to an 88 years old male patient enrolled in clinical trial of ZOSTAVAX. During the course of the trials, the patient received the placebo (date unspecified). The patient was vaccinated with ZOSTAVAX (lot number, route and dose not reported) on 01-DEC-2006 (also reported as 01-DEC-2001). No other co-suspects were reported. No concomitant medications were reported. The patient had no reaction that could be tied to the ZOSTAVAX until late January 2007. The hospital had improperly attenuated the live shingles virus so when it entered his blood stream his immune system went to battle and developed antigens which had been eating on him starting with his right leg at the ankle and then appearing in below the knee causing swelling and fluid leakage including blood. It then started in his left leg below the knee complete with the swelling and leakage of fluid including blood. There was also considerable skin peeling on both legs. There was no cure so it was necessary to keep legs from getting infected and to keep them under pressure to reduce swelling, skin peeling and fluid leakage. Around the end of the first week of January 2007 a periodic but mild increase in body temperature and somewhat restless sleep were noticed. Blood pressure fell into the upper part of what was styled as hypertension. The last week of January 2007 a small itchy spot about the size of a quarter developed on the left side of the instep on right leg that felt dry and like medium grade sandpaper that reaction to the ZOSTAVAX. The itchy spot spread rather quickly to encircle right ankle and then proceeded to affect right leg below the knee. By the use of alcohol to prevent surface infection from scratching and some anti-itching cream, the patient managed to tolerate the discomfort. During February 2007 the right foot and right leg began to swell and in the first part of March 2007 the first sign of an itchy spot of rash appeared on left ankle. Like the right leg the rash on the left leg encircled the left ankle in short order but it never proceeded above the ankle area on the left leg, however, some swelling of the left foot did occur. It subsequently disappeared. The swelling on the right foot persisted. The patient experienced temperature increase, Blood Pressure registered in the medium to high hypertension range and by sleep was impaired, pain in legs and warm legs. In addition his right eye for a time became sensitive to pressure and since then his eyesight had suffered an appreciable decline. The patient was enduring all of the symptoms of a Shingles Attack. These symptoms began to appear about 40 to 50 days after getting ZOSTAVAX and had gotten progressively worse since that time. The patient was told that ZOSTAVAX had induced a self-antigen which had been attacking tissue in his legs and at least one kidney. The overall result being Edema pus sedimentation and inflammation of veins and arteries resulting in a potential Life Threatening Health Problem because Sedimentation had resulted in partial blockage of my vascular system in right leg. The patient went to see his primary physician on 06-SEP-2007 for the itchy rash on both ankles and swollen right leg below the knee, including what felt like an accumulation of water along the right side of his shin. A blood sample was taken and urine was checked for protein. There was no protein in the urine and when the results of the blood sample came back on 10-SEP-2007 everything was all right. Sonogram (Sonic Scan) (early in the afternoon 24-SEP-2007) showed life threatening two blockages, one in right groin area and one behind right knee. His eyesight had also been adversely affected. Another physician on 25-SEP-2007 confirmed the immediate danger and took a series of blood samples and gave a shot of LOVENOX and established a routine series of two 100 mg shots of LOVENOX each day plus 5 mg of COUMADIN once a day. On 28-SEP-2007, the patient also had a flare up of the shingles outbreak on left ankle. The outbreak appeared as small blisters as distinguish from the medium grade sandpaper exhibited by previous shingles outbreaks. On 09-OCT-2007, the symptoms of the return of gout were returning both to his joints and Trigger Finger to his right and left hand. On 22-OCT-2007 second Sonic scan of right leg and right groin was done and it appeared that both blockages previously noted were somewhat reduced. The patient had shingles itchy rash on both ankles, lower and upper legs, both arms, upper and lower back and across forehead and into his hair. His research indicated that live shingles virus injection into his had given what was called Post-herpetic Neuralgia (PHN) for the rest of his life. On 04-AUG-2008, the patient had his left eye operation to remove a cataract. The surgery went very well and the patient could see out of the without distortion and colors were bring. The cataract surgery on his right eye was scheduled for 19-NOV-2008. On 23-DEC-2011 (also reported as 23-DEC-2012), the son took the patient to emergency room at the hospital, and because of the condition of legs the hospital staff decided to keep the patient because the condition of both of his legs below the knee was considered to be dangerous source of infection. They didn't release him until 05-JAN-2012 and he was put on home care which caused a member of the Hospital Staff to come by his house every day to treat and wrap both of his legs below the knee. They now did all treatment at home. While at reporting time legs below the knee were not cured but under control. The patient still had itching skin in his hair, on his back and shoulders that is there all of the time. Probenecid, alcohol and anti-itchy cream, NEOSPORIN were also taken for treatment. Laboratory tests also included: Third Sonic scan (13-DEC-2007) of the clot arrears showed additional increased flow in the clot areas. Sonic scan (17-JAN-2008) was satisfying. Sonic scan (26-MAR-2008), the clot was gone but there was still a little venous coating on the inside of the veins in right leg. 25-SEP-2007 at 1:25 pm, the circumference of the calf of left leg was 14.825 inches and the circumference of the calf of right leg was 16.0 inches. 26-SEP-2007 at 1:05 pm, the circumference of the calf of left leg was 14.5 inches and the circumference of the calf of right leg was 15.25 inches. 27-SEP-2007 at 1:05 pm, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.75 inches. 28-SEP-2007 at 9:30 am, the circumference of the calf of left leg was 14.5 inches and the circumference of the calf of right leg was 15.375 inches. 29-SEP-2007 at 12:30 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.375 inches. 30-SEP-2007 at 11:30 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.375 inches. 01-OCT-2007 at 10:00 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.375 inches. 02-OCT-2007 at 7:00 pm, the circumference of the calf of left leg was 14.875 inches and the circumference of the calf of right leg was 15.75 inches. 03-OCT-2007 at 11:45 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.125 inches. 04-OCT-2007 at 11:50 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.50 inches. 05-OCT-2007 at 10:30 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.25 inches. 06-OCT-2007 at 10:00 am, the circumference of the calf of left leg was 14.875 inches and the circumference of the calf of right leg was 15.50 inches. 07-OCT-2007 at 7:00 pm, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.50 inches. 08-OCT-2007 at 10:00 am, the circumference of the calf of left leg was 14.625 inches and the circumference of the calf of right leg was 15.75 inches. 09-OCT-2007 at 10:00 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.305 inches. 10-OCT-2007 at 9:00 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 15.50 inches. 11-OCT-2007 at 12:05 pm, the circumference of the calf of left leg was 14.50 inches and the circumference of the calf of right leg was 15.625 inches. 12-OCT-2007 at 11:50 am, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 16.125 inches. 13-OCT-2007 at 5:05 pm, the circumference of the calf of left leg was 14.75 inches and the circumference of the calf of right leg was 16.125 inches. 14-OCT-2007 at 10:55 pm, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 16.875 inches. 20-OCT-2007 at 12:30 pm, the circumference of the calf of left leg was 14.875 inches and the circumference of the calf of right leg was 16.000 inches. 21-OCT-2007 at 1:15 pm, the circumference of the calf of left leg was 14.875 inches and the circumference of the calf of right leg was 15.750 inches. 22-OCT-2007 at 3:20 pm, the circumference of the calf of left leg was 14.875 inches and the circumference of the calf of right leg was 15.750 inches. 23-OCT-2007 at 1:00 pm, the circumference of the calf of left leg was 14.875 inches and the circumference of the calf of right leg was 15.50 inches. 24-OCT-2007 at 9:20 am, the circumference of the calf of left leg was 14.5 inches and the circumference of the calf of right leg was 15.50 inches. 25-OCT-2007 at 12:20 am, the circumference of the calf of left leg was 14.5 inches and the circumference of the calf of right leg was 15.375 inches. 26-OCT-2007 at 12:10 pm, the circumference of the calf of left leg was 14.625 inches and the circumference of the calf of right leg was 15.625 inches. 27-OCT-2007 at 11:15 am, the circumference of the calf of left leg was 14.750 inches and the circumference of the calf of right leg was 16.250 inches. 28-OCT-2007 at 5:10 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.125 inches. 29-OCT-2007 at 11:40 am, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.875 inches. 30-OCT-2007 at 1:20 pm, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.875 inches. 31-OCT-2007 at 3:00 pm, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.750 inches. 01-NOV-2007 at 3:00 pm, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.750 inches. 02-NOV-2007 at 11:15 am, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.625 inches. 03-NOV-2007 at 11:15 am, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.625 inches. 04-NOV-2007 at 1:15 pm, the circumference of the calf of left leg was 15.00 inches and the circumference of the calf of right leg was 15.75 inches. 05-NOV-2007 at 11:15 am, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.00 inches. 06-NOV-2007 at 5:30 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.00 inches. 07-NOV-2007 at 11:15 am, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 15.50 inches. 08-NOV-2007 at 3:15 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.00 inches. 09-NOV-2007 at 12:15 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.125 inches. 10-NOV-2007 at 12:15 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.125 inches. 11-NOV-2007 at 12:15 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 12-NOV-2007 at 12:15 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 13-NOV-2007 at 12:15 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 14-NOV-2007 at 4:45pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 15-NOV-2007 at 2:45 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 16-NOV-2007 at 5:45 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 17-NOV-2007 at 1:20 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 18-NOV-2007 at 1:30 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 19-NOV-2007 at 1:20 pm, the circumference of the calf of left leg was 15.25 inches and the circumference of the calf of right leg was 16.0 inches. 21-APR-2008 at 5 pm, the circumference of the calf of left leg was 15 and 1/4 inches and the circumference of the calf of right leg was 15 and 7/8 inches. 01-MAY-2008 at 10:30 am, the circumference of the calf of left leg was 14 and 7/8 inches and the circumference of the calf of right leg was 15 and 1/4 inches. 01-JUN-2008 at 10:30 am, the circumference of the calf of left leg was 14 and 1/2 inches and the circumference of the calf of right leg was 15 inches. 01-JUL-2008 at 9:00 am, the status of the calves of legs was about the same as 01-JUN-2008. 01-AUG-2008 at 10:00 am, the circumference of the calf of left leg was 14 inches and the circumference of the calf of right leg was 14 and 7/8 inches. 01-SEP-2008 at 10:00 am, the circumference of the calf of left leg was 14 inches and the circumference of the calf of right leg was 14 and 5/8 inches. 01-OCT-2008 at 10:15 am, the circumference of the calf of left leg was 14 inches and the circumference of the calf of right leg was 14 and 1/2 inches. 01-NOV-2008 at 10:15 am, the circumference of the calf of left leg was 14 inches and the circumference of the calf of right leg was 14 and 1/4 inches. Ultrasound Abdomen Scan (12-NOV-2007 at 3:25 pm), result not provided. The relatedness for the events was not provided for ZOSTAVAX. Additional information has been requested.