Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Injection site swelling, Joint swelling, Oedema peripheral, Pain
Clinical narrative: Information has been received from a health professional concerning a 47 year old white female smoker with a codeine allergy, penicillin allergy causing urticaria, no known food allergies, no prior history of joint problems and a history of right ankle fracture in October 2003, hysterectomy, open knee meniscectomy and polygonal cystectomy who was vaccinated with a 0.5mL first and second dose of varicella virus vaccine live (lot # 649273/0988P) on 9/30/05 at 14:30 in the right arm and on 10/31/05 at 16:00 in the left arm, respectively. There was no concomitant medication. There was no illness at the time of vaccination. In September 2005, after vaccination, she developed a local reaction with redness and swelling at the injection site and the right arm was painful. The symptoms subsided in a few days. It was also noted that the patient developed bruising. It was reported that the patient had no adverse reaction after the second dose of varicella virus vaccine live. Last week, in November 2005, the patient stated that her doctor had diagnosed her with septic arthritis in her right arm. The patient indicated that she experienced severe pain and swelling on the right side of her body except for her hip. As a result of the vaccination she was on treatment with prednisone 40mg daily. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the health professional and the patient's medical records indicated that on 11/1/05 at 10:00 or 11: 00, the day after vaccination with varicella virus vaccine live, the patient developed significant swelling and pain in all of the joints on the right side of her body. She did have an inoculation SC in her right shoulder area. The patient was sent to the emergency room on 11/14/05, where she was evaluated for a possible septic reaction. The patient stated that she was there for a work up to rule out infected joints. She said they were about the same since onset. She had no fever, none were red or hot, just some swelling of the right hand. The physician sent her to the emergency department to rule out septic joint. She had a sore throat on and off, no cough, no vomiting, no diarrhea, just hurting. At the time of evaluation the patient's pain level was an 8 out of 10. She was on therapy with acetaminophen (+) hydrocodone bitartrate and ibuprofen with no relief. The patient had erythema in the throat and telengiectasia post pharynx. Her neck was tender without significant anterior cervical adenopathy, the trachea midline was tender over the trachea and the neck was tender at the proximal end of SCM on the right. Her abdomen was tender deep RLQ. Her right hand was slightly warmer than the left. The right knee was slightly full in comparison to the left. It was noted that all systems were negative except for her chief complaint, history of present illness and past medical history. It was felt that the patient's problem was primarily arthritic and musculoskeletal in nature. The diagnosis at the emergency room was polyarthritis, possibly viral in nature. Laboratory findings were obtained on 11/14/05, including a rheumatoid factor which was negative. Her sedimentation rate was elevated at 53 MM/H, granulocyte X10-3 was high at 7.2 10-3uL, BUN was low at 6 MG/DL, alkaline phosphatase was high at 129 U/L. She had a positive ANA at a titer 1:320. Parvoviral titers and anti-CCP were performed, the results of which were not reported. On 11/14/05 at 14:55 the patient was placed on 40mg of prednisone in the emergency department and after she was on this dose for 5 days, she dropped the dose down to 20mg a day and had increasing symptoms. She was seen by the physician on 11/2/05 who increased her prednisone back to 40mg per day. During physical exam, the skin was clear of rash, there was no alopecia, sclerae were clear, mouth had no stomatitis, the pharynx was not injected, the neck was supple, there was no lymphadenopathy or bruit, the thyroid was normal, the lungs were clear to auscultation, there was no chest wall tenderness, the cardiac exam showed a regular rate and rhythm, the abdomen was soft and non-tender, there was no hepatosplenomegaly or masses, the neurological exam was non-focal, and the musculoskeletal exam showed cervical, thoracic and lumbar spine were normal. The right shoulder revealed full, although somewhat painful abduction. Her elbows had trace tenderness without swelling. There was tenderness without swelling noted in the right wrist, as well as in multiple MCP and PIP joints. There was some tenderness in her knees. There was trace tenderness in her ankles as well as MTP joints. The impression was that the patient had polyarticular inflammatory arthritis, which appeared to be an Arthus type reaction following her vaccination with varicella virus vaccine live, and most likely would be the precipitation of some type of systemic rheumatic condition, such as connective disease or rheumatoid arthritis. The patient was on treatment with acetaminophen (+) oxycodone hydrochloride PRN for pain. Due to the steroids, she was having trouble sleeping at night. The patient was also on therapy with fexofenadine hydrochloride. The patient was to continue on prednisone 40mg a day. After two weeks she was to reduce the dose to 30mg per day, thereafter 20mg per day. She was to continue acetaminophen (+) oxycodone hydrochloride 5.325, #30 written. She was to be placed on zolpidem tartrate 12.5mg at night for non-restorative sleep. If not effective, she was to try eszopiclone 3mg at night. She was to take alendronate sodium 70mg once a week on an empty stomach, calcium 1200mg per day. She was to return for a follow up in one month, at which time a DEXA scan was to be performed. It was noted that her family history included coronary artery disease, high cholesterol, diabetes mellitus, hypertension, cancer, no rheumatic diseases, and sarcoidosia (grandmother-bone, mother-lung). At the time of the report the patient's outcome was unknown. Polyarticular inflammatory arthritis was considered to be disabling and an other important medical event (OMIC). Additional information has been requested.