Initial and follow-up information has been received from a medical assistant and medical records concerning a 67 year old female with arthritis in the right thumb, gastrooesophageal reflux disease, sleep apnoea, osteopenia, back pain, mitral valve prolapse, penicillin allergy and allergy to clindamycin, cyclobenzaprine, erythromycin, amoxicillin, methocarbamol, latex, and diazepam, and a history of herniated disc 30 + years ago, plantar fasciitis, and left wrist surgery for De Quervain's tenosynovitis, who on 20-MAY-2008 was vaccinated intramuscularly into left arm with first 0.5 ml dose of PNEUMOVAX (lot # 661041/0235X). Concomitant therapy included FOSAMAX, PRILOSEC OTC, trazodone HCl and RETIN A. It was reported that on that night the patient could not move her arm and developed pain at the wrist, shoulder, elbow, neck, and across her back. The patient stated that the pain was so severe that she was crying. She could not lay on the left side since her arm was so tender to the touch. The patient also stated that she had a "burning" in the left shoulder and the she developed headache. There was no redness or swelling noted, but here was a [[name]] white bump at the injection site that lasted for days and then a scab appeared. On 27-Jun-2008, the patient was seen at the office for persistent complaints of soreness in the left arm, difficulty sleeping on the left side, and a headache. At the time of this report the patient was still recovering from her experiences. No additional information available. Follow-up information obtained from medical records reported that on 20-MAY-2008 at 2:00 pm the patient was vaccinated with a dose of PNEUMOVAX. The patient reported " That evening I knew that the reaction I was having to the shot was not typical for me. I couldn't move my arm from my side. There was pain at the site of the shot, at shoulder, elbow, and wrist joints, in the muscles of the shoulder, up the neck on the left side and across my upper back. In addition I had a headache. I needed help dressing and undressing and had difficulty sleeping due to the pain. The pain was so severe I cried. There was no redness or swelling at the site but a [[name]] white bump was visible for days afterwards and a [[name]] scab appeared several days after I had received the shot." On [[name]] 21 the patient reported " Soreness in areas mentioned above, lethargic, tired, headache, couldn't move arm, needed help dressing and undressing, was only able to sit in a recliner chair and read." The patient telephoned the physicians office and was instructed to ice the area. The patient reported "Over the next days gradually I was able to raise my arm. The area was always tender, painful. Painful joint in left arm. Unable to sleep on left side due to pain and discomfort. " On 31-MAY-2008 the patient reported " After little sleep and crying with pain," she went to the physicians office. The patient reported being tired, having a sore arm and left leg joints. The patient had blood tests done and was prescribed etodolac. The physician reported that the patient had tenderness to palpation across entire upper back, shoulders, neck, arms and into hips- muscular and complaints of joints pains. She had no joint swelling or effusion evident. Her muscle strength and tone were appropriate for her age. The physicians impression was arthralgia/myalgia post immunization. on 04-JUN-2008 she reported sore arm, shoulder, neck, and headache in the morning. She began taking "med." On 06-JUN-2008 she reported being tired, had a headache and sore arm. On 10-JUN-2008 the patient reported sore shoulders and left wrist. On 11-JUN-2008 she reported severe pain in the right knee that awakened her. Her arm was very sore to the elbow with burning in her shoulder. On 13-JUN-2008 she awoke with a headache, and sore arm in the early morning. On 14-JUN-2008 to 22-JUN-2008 the patient worked using her arms and hands a great deal. She reported that this activity seemed to make no difference. Some days there was no discomfort. On 16-JUN-2009 a  rash started on her face, and her lips were swollen and peeling around the perimeter of her mouth. On 18-JUN-2008 her shoulder was sore, was worse on the 19th, and she lost sleep due to pain on the 20th. She continued to take "meds" as needed. On 25-JUN-2008 the patient reported learning that skin rash was a side effect to etodolac, so she discontinued the medication. She reported that the pattern of soreness continued, sometimes it was a burning sensation and sometimes it felt like an "open wound." On 25-JUN-2008 the patient saw the physician who agreed that etodolac should be discontinued. The patient reported to the physician that she was having very painful soreness in the left shoulder ongoing for a month. The physician impression was a minor diagnosis of dermatitis, a possible reaction to etodolac, and a minor diagnosis of shoulder pain. The physician reported that this was a very atypically [[name]] reaction to a vaccine. He reported no physical symptoms were seen except "TTP." The physician prescribed TYLENOL and ice as needed for discomfort. The patient reported being very tired and her arm was very sore after the exam. On 27-JUN-2008 her arm was sore. It was difficult to sleep on her left side. She had a headache. The rash on her face was sore, red, and peeling, she was using NEOSPORIN on it. Between 02-JUL-2008 and 05-JUL-2008 the patient was traveling and felt twinges of pain from time to time. She had soreness when she was trying to sleep on the left side one night. She had discontinued the etodolac. She was using ibuprofen from time to time more for plantar fasciitis. The patient reported "The rash seems unrelated to the medication." On 05-SEP-2008 the patient was seen by the physician to review her immunization reaction. The physician reported that the patient had been seen " regarding her complex of symptoms on 31-MAY-2008 at which time her CBC, ESR, CMP, and CRP were all normal." She reported continuing to have symptoms in her upper back and left shoulder primarily in the deltoid region." The physician reported that on physical exam " bilateral upper extremities were normal. Left shoulder was 'TTP' especially at distal deltoid insertion, no axillary LAD. Left trapezius with significant spasm, and L>R rhomboid TTp, neck range of motion (ROM) full with pain on side bending and rotation in bilateral trapezius region." The physician reported that the arthralgia/myalgia post immunization was ongoing but improved. The patient would be referred to rheumatology for further evaluation. The patient was offered muscle relaxers for her spasm which she declined. On 06-NOV-2008 the patient was seen by a physician for evaluation of her joint pain. The patient reported that she had been having left shoulder pain that came on after PNEUMOVAX. However she stated that " that was not really why she was here as the left shoulder pain had gotten somewhat better over time." She was mainly there because of her concerns about arthritis of her hands. The physician reported that the patient had Heberden's and Bouchard's nodes and that they are worsening. There was some degree of pain associated with this, especially in the cold although in general the pain was mild. The symptoms were reported to have come on two years ago. The patient reported that the hand pain would tend to come and go and there are days that she is pain free and usually when there is pain it is mild. The patient was not on any medication for these symptoms and she mentioned that she tends to be sensitive or allergic to various different medications. The patient reported to the physician that following her vaccination with PNEUMOVAX she developed left shoulder pain. She reported that at first it was severe but over time it had settled down and she stated now it tends to come and go. She also mentioned that she had more chronic pain on the left upper back a[[name]] the trapezius but that had been present for years and that seems to bother her as much as the left upper arm pain. The patient reported that she had not had headaches much at all except occasionally she might wake up with one. The physicians impression was " it is possible that the pain might be related to PNEUMOVAX but this is somewhat unusual. I am wondering if it is coincidental and that perhaps her left shoulder pain is due to rotator cuff disease of other cause of shoulder pain but this is difficult to know." A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available. Medical records available upon request.