Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Nausea, Nervousness, Ovarian cyst, Retching
Clinical narrative: Information has been received from a 50 year old female consumer who, at approximately 47 years of age, in February 2001 (also reported as 3/2001), was vaccinated with a first dose of varicella virus vaccine live. In May 2001 the pt was vaccinated with a second dose of varicella virus vaccine live. The reporter indicated that her lymphocyte % dropped from a pre injection baseline of 25 to 19 after first injection, "then 81" then 14 post the second injection. There were WBC and various WBC diff abnormalities over a two year period. In addition, diarrhea was diagnosed as a collagenous colitis and an autoimmune disorder was diagnosed. The reporter indicated she did not have any symptoms of this until after the second injection. It was reported that "I was already immune 2.29" and that she was always a nervous wreck, nauseous, without appetite, diarrhea and fatigue. This has been getting progressively worse since the second vaccine. The reporter indicated "I absolutely believe I had a serious reaction to this vaccine." Upon internal review the collagenous colitis and autoimmune disorder were considered to be other important medical events (OMIC). Additional info has been requested. Follow up on 03/03/04 states: Follow up information from a physician indicated that the pt had "some type of colitis' that she felt was probably unrelated to vaccine. She reported that she thought it was more of a host issue, but the pt felt the vaccine "triggered her immune system".  The physician also reported that the pt had a remote past history of colitis and that this may be a recurrence of a pre-existing medical condition. The pt reported that this colitis was after a rabies vaccination. There was lab work indicating a decreased lymphocyte count after a normal baseline, but the pt's labs were often variable and it was not conclusive. Upon internal review the collagenous colitis and autoimmune disorder were considered to be other important medical events (OMIC).  Additional information is expected." Follow up information indicated that the patient is a 47 year old white female with a history irritable bowel syndrome and depression. She was enrolled as a healthy control in a study. On 07-Mar-2001 and 30 May 2001 the patient was vaccinated SC in the left deltoid with a first (lot 6376671/1509K) and second (lot #637667/1506K) dose respectively of varicella virus vaccine live. There was no illness at the time of vaccination. Baseline lab work was done on 14-Feb-2001. Additional labs were done on the following dates: 18-Apr-2001, 16-Jul-2001, 26-Mar-2002, 20-Mar-2003, 29-Apr-2003 and 09-Jun-2003. Please see laboratory section for all corresponding lab results. At the time of the first dose it was reported that the patient was feeling good. On 16-Jul-2001 the patient reported tenderness, erythema, and induration at the left deltoid injection site from 07-Jun-2001 to 12-Jun-2001. No other symptoms were reported at this time. In June 2003 the patient reported that her loose stools began approximately 06-Jul-2002. (also reported as 01-Jul-2001) In December 2001 the patient had an increase in bowel movements from 3 to 6 to 7 daily. She was also waking up at night with abdominal pain, diarrhea, weakness and dry heaves that would continue into the a.m. It was reported that on 11-Mar-2003 the gastrointestinal physician diagnosed irritable bowel syndrome. (Conflicting information indicated this as a medical history). On 22-Mar-2002 the patient had a colonoscopy that confirmed collagenous colitis. Antispasmodic medication was prescribed. It was reported that this wa affective for a brief time- In May 2002 the patient started on "endocort", but it was discontinued due to severe side effects. The diarrhea remained consistent. Masalamine (ASACOL) was prescribed due to nausea, but the diarrhea continued. In June 2002 a cat scan was done and showed a left ovarian cystl. In August 2002 the patient had diarrhea 8-10 times daily and was started, again, on "endocort". It was reported that the patient's menstural cycle started, but continued "x 30 days". The "endocort" was discontinued. In September 2002 the diarrhea (watery stools) increased to 10-13 daily. In October 2002 a pap smear revealed "high grade sqamous intrepitheial lesion", In Novemeber 2002 a cone biopsy was performed. In December 2002 the patient had severe diarrhea, depression, dry heaving and a uterine infection. Ciprofloxacin hydrochloride (CIPRO) was started. The report indicated that diarrhea continued from January 2003 to the present. The report indicated that no "plausible biologic connection between the vaccine and the patient sympotms can be identified. The physician indicated that the collaenous collitis was a severe serious event that required intervention and was ongoing. She considered it unlikley to be related. Follow-up information was received on 03-Ma-2004 which pertained to events that occurred one year following adminstration of varicella virus vaccine live. This information contained the following adverse experience: ovarian cyst (2002). Upon internal review the collagenous colitis and autoimmune disorder were considered to be other important medical events. Additional information is expected. (OMIC)