Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Fatigue, Gastrointestinal disorder, Haemorrhoids, Immediate post-injection reaction, Inflammation
Clinical narrative: Initial report was received 14 March 2011 from another manufacturer (Merck; Mfr control number WAES1012USA03297). The following is verbatim per the report: "Information has been received from a consumer concerning his wife who in 30-NOV-2010 was vaccinated with PNEUMOVAX 23 (lot # not reported). 2 hours after receiving the vaccine shot, the patient experienced extreme pain and lost total use of her right arm. The patient went to the emergency room that same night. Follow up information has been received from a physician concerning a 71 year old female smoker patient with arthrosclerosis, hypertension and osteoporosis who on 01-NOV-2010 was vaccinated with PNEUMOVAX 23 (lot # 667700/1153Z, expiration date 06-DEC-2011). Concomitant therapy included FLUZONE in the left arm during the same visit. On 01-NOV-2010 the patient developed immediately swelling, redness and warmth to the touch in the right upper arm and shoulder and had 3 to 6 weeks of inability to move the area due to weakness in the right arm and shoulder. The patient visited the emergency room on 01-NOV-2010 because of inflammatory response (swelling, redness and warmth). The inflammatory response gradually subsided after approximately 2 weeks. The patient was currently undergoing physical therapy for loss of range of motion and weakness in the right arm and had been treated with unspecified pain medications. The patient had blood tests, arthrocentesis, x-rays and magnetic resonance imaging (MRI) to evaluate the inability to move her right shoulder but results were not reported. The patient had visited a rheumatologist and two orthopedic physicians for follow-up. The physician also reported that in approximately 2001 (about 10 years ago) the patient received a previous vaccination with PNEUMOVAX 23 (lot # not reported). At the time of reporting, the outcome of extreme pain and inability to move area due to weakness was unknown. Follow-up information has been received from a physician concerning a 71 year old postmenopausal female smoker (1 pack per day for 40 years), occasional alcohol use, with osteoporosis, hypovitaminosis D, hyperplastic (metaplastic) colon polyp (September 2007 colonoscopy), hemorrhoids, diverticular disease of the colon, hypertension, and a history of fall with heel fracture, synovial cyst on the spine, and breast biopsy. Family history was positive for coronary heart disease/myocardial infarction (father) and breast cancer (sister and paternal aunt). On 01-NOV-2010, the patient presented with right shoulder pain, constant and progressive, "severe ache" that began about two hours after she received a dose of PNEUMOVAX 23 booster in the right deltoid, and a dose of FLUZONE vaccination in the left deltoid. The vaccines were given at approximately 1:00 pm. She also experienced pain on her left shoulder. Patient stated that the pain affected her sleep. It was noted that patient took 800 mg of ibuprofen that did not alleviate the discomfort, and it upset her stomach and caused some rectal bleeding of her hemorrhoids. It was noted that patient was prescribed PERCOCET, 1-2 tablets Q4 PRN. The patient also had chills, and that night she developed some nausea and vomiting (resolved). DVI guided arthrocentesis was performed on 01-NOV-2010, but not enough fluid was extracted for cell count, differentials, and crystals. Culture was negative. The patient's husband was concerned that he and his wife both received their pneumococcal injection "too high" and was concerned that it may have been injected directly into the shoulder joint. A physician indicated that "I have not seen vaccine related rotator cuff tear." X-ray on 02-NOV-2010 revealed no acute osseous abnormality, mild to moderate degenerative change of the acromioclavicular joint with mild degenerative change at the glenohumeral joint, and diffuse bony demineralization. On 04-NOV-2010, the patient developed abdominal cramping she described as "diarrhea like cramp without having diarrhea." Assessment: local and adjacent area reaction, "I do not think there is a septic joint." An x-ray did not demonstrate any fracture or dislocation. On 07-NOV-2010, a review of systems noted fever, chills, and malaise/fatigue. Differential diagnoses for arm pain included inflammatory reaction to vaccination, degenerative joint disease, neuropathic pain. On 09-NOV-2010, an MRI of the right shoulder revealed a large full-thickness tear of the supraspinatus with delamination of the torn tendon surface. Very little fluid could be aspirated with ultrasound-guided needle aspiration. MRI and needle aspiration suggested marked synovitis. A physician noted on 22-NOV-2010 that the patient definitely needs to see an orthopedic surgeon, that this was not going to get better with rest or time. He stated he did not think physical therapy was going to help and did not recommend a corticosteroid injection as that was not likely to help. The patient was seen by an orthopedist on 29-NOV-2010. X-rays revealed cystic change in the humeral head consistent with long-standing supraspinatus cuff tendonitis; mild type II acromion and some mild AC joint arthritic change. Review of the patient's MRI showed what appeared to be a full-thickness tear of the supraspinatus tendon with no significant retraction and more importantly no muscular atrophy or fatty infiltration; there was a fair amount of edema or swelling around the joint proper and this "may be an inflammatory response to her shot." Assessment: right shoulder rotator cuff tear. Strong recommendation included arthroscopic intervention with subacromial decompression and either arthroscopic and/or mini open rotator cuff repair. A sports medicine physician noted on 14-DEC-2010 that there was a lot of muscle atrophy noting that the rotator cuff tear was most likely a chronic tear. Blood work rules out any signs of infection due to the injection. Physician did not feel that the patient needed surgery right away, and that she may improve with physical therapy considering she was asymptomatic prior to the injection. It was reported in a physical therapy evaluation on 22-DEC-2010 that the patient was having GI difficulties for a couple of months that were undiagnosed, and reportedly had worsened within one week of her shoulder issue. On 11-JAN-2011 physical therapist noted the patient showed decreased pain and increased strength. On 25-JAN-2011 patient was noted to be progressing very well. On 03-MAR-2011, follow-up from a physician indicated that the patient's swelling, warm skin, pain and erythema eventually resolved her weakness and decreased mobility in the right arm and shoulder persisted as of 15-FEB-2011. The physician considered the patient's weakness, decreased mobility, and right shoulder rotator cuff tear to be disabling. All available medical records will be provided upon request. Additional information has been requested. Of note: the event of "Lung Disorder" had been coded by the other manufacturer; however, details regarding this event were not reported. Documents held sender: None.