Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Platelet count normal, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a 64 year old female with a history of back pain on 27-FEB-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin, calcium (unspecified), vitamin D (unspecified) and a multivitamin (unspecified). On 01-MAR-2008, the patient experienced pain in her upper arms, wrists, and behind her knees after vaccination. The patient was referred to a rheumatologist and was diagnosed with myalgia and arthralgia and treated with TRAMADOL. It was noted that the patient had an unspecified abnormal blood test. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Follow-up information was received on 20-JUN-2008 from a physician concerning a 64-year-old, retired female who developed symptoms about 3 days after vaccinations. Since then, the patient had been complaining of daily stiffness lasting all day long and complained of significant pain and swelling on her right knee scored as 8-10 out of 10 and significant pain in her left shoulder. On 13-MAR-2008 the patient was seen in the office and was diagnosed with myalgia and arthralgia. On 14-MAR-2008, laboratory test were performed and the results showed that plasma creatine kinase test (CK) 43 U/L, serum C-reactive protein test (CRP) 0.17 mg/dl, white blood cell count (WBC) 5300 U/L, blood hemoglobin test 13.2 g/dL, whole blood hematocrit 40.2 % and erythrocyte sedimentation rate (ESR) 36. Rheumatoid arthritis latex is positive, confirmation with her rheumatoid factor was negative and antinuclear antibody screen was negative. On 08-APR-2008 after a full physical examination clinical diagnoses included right knee effusion, left shoulder bursitis, fatigue, bilateral knee osteoarthritis, left shoulder osteoarthritis, polyarthralgia and sicca symptoms. The patient underwent a right knee arthrocentesis and corticosteroid injection and a left shoulder corticosteroid injection. Both procedures were well to be tolerated and no complications were evident. The synovial fluid was sent to the lab for cell count, crystal analysis, and cultures. On 16-JUN-2008 the patient was seen in the office again, her right knee pain and effusion and left shoulder pain still persisted. Follow up information was from the patient who reported that "before receiving ZOSTAVAX (Merck) she was very healthy person". The patient also reported that she is still experiencing the pain in her knee where she can not bend it and she still can not raise her left arm, and the fatigue had gotten worse and she had been going to a physical therapist which has helped, but still has not been diagnosed with anything. The patient also reported that at this time she was on antibiotics because she has a urinary tract infection, but within the next week she is going to get a CAT scan and a Cystoscopy done to look at her kidneys. The patient also reported that her friend has similar symptoms that she has after received ZOSTAVAX (Merck) (WAE #08070USA01950). Additional information is not expected.