Sex: F
Vaccine: VARZOS
Symptoms: Differential white blood cell count abnormal, Full blood count abnormal, Giant cell arteritis, Granulocyte count, Granulocyte percentage
Clinical narrative: polymyalgia rheumatica; temporal arteritis; Information has been received from a 60-year-old female nurse with no pertinent medical history and no drug allergy who on 17-SEP-2009 was vaccinated subcutaneously with a standard dose of zoster vaccine live (Oka/Merck) (LOT# not reported). Concomitant therapy included HCTZ/triamterene, sertraline HCl (ZOLOFT), albuterol and sumatriptan succinate (IMITREX (sumatriptan succinate)). Within 2 days after vaccination, the patient experienced and was diagnosed with temporal arteritis and polymyalgia rheumatica. She was seen by physician and prescribed prednisone to treat the symptoms. The labs urine analysis white, blood cell differential ("CBC diff"), erythrocyte sedimentation rate ("sedimentary") and Lyme disease enzyme-linked immunosorbent assay ("Lyme") were performed, and results were pending. At this time of reporting, the patient was not recovered.  Temporal arteritis and polymyalgia rheumatic were considered to be disabling due to "severe muscle pain".  Follow-up information has been received on 04-NOV-2009.  A medical assistant reported that on 17-SEP-2009 the patient was administered the dose of zoster vaccine live (Oka/Merck) (LOT# 664443/0746Y). The patient did not receive any concomitant vaccinations at that time. On 28-SEP-2009, the patient was seen the physician by unspecified reason. The physician documented that the patient had "myalgia unspecified". On the same day, the creatine kinase blood test was 109. On 06-OCT-2009, the patient's urine analysis (UA) was negative, complete blood count (CBC) with differential revealed a white blood cell (WBC) count of 11.6 (high), sedimentation rate (sed rate) of 40. The patient had a Lyme's Disease test on 06-OCT-2009 (results unknown to the reporter). On 13-OCT-2009, the patient's sedimentation rate was 23. On the same day, the patient was referred to a rheumatologist. It was documented that on 28-OCT-2009, the patient's rheumatologist had increased the patient's prednisone to 30mg.  On  29-OCT-2009, the patient was seen by the physician. The physician documented that the patient had polymyalgia rheumatica. On the same day, the patient's UA was negative and CBC with differential revealed WBC count of 12.6 (high). The medical assistant stated that the patient did not have a scheduled follow-up visit with the physician.  Supplement information has been received on 16-NOV-2009 from the medical assistant and lab results.  The medical assistant reported that the patient had no illness at time of vaccination and had history of diverticulosis and exercise induced asthma. The dose received subcutaneously on 17-SEP-2009 in left arm was the patient's first dose of zoster vaccine live (Oka/Merck). On 28-SEP-2009, the patient had muscle soreness in upper arms and legs, had pain in temples, jaw and sides of the neck. Patient was prescribed prednisone, 20 mg bid and ibuprofen, 800 mg, tid. The labs revealed that on 06-OCT-2009 red blood count was 4.41 M/uL, granulocytes% was 83.5%, lymphocytes% was 10.6%, alkaline phosphatase (liver test) was 98iu/L (52-129), ALT (liver test) was 13iu/L (4-31), AST (liver test) was 14iu/L (6-32), hemoglobin was 13.0g/dL (12.3-15.3) and hematocrit was 38.0% (35.9-44.6). Others were normal except the labs which had reported in prior. The patient's outcome was not reported at this time of the report.  Follow up information was received from a lawyer on 16-AUG-2023, regarding a case in litigation and refers to the female patient. It was reported that the patient suffered from polymyalgia rheumatica and due to this, she was treated by medical providers and was still under their care. It was confirmed that the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  ; Sender's Comments: , MERCK0910USA02553:Mfr number