There was no seriousness criteria reported. However, based upon the follow up information received on 8/11/04, this case is now considered serious (OMIC). From initial information received on 2/20/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 50 year old female patient received a FLUZONE vaccination, lot number U1148EA, administered in the right arm on 12/17/03. The patient stated that immediately following vaccination she had pain in her arm, and the pain worsened over six days. She was seen by an orthopedist and has been in physical therapy since 12/31/03. At the time of the report the patient has not recovered from this event. From additional information received on 7/21/04, it was reported that an x-ray of the right shoulder on 12/26/03 showed no bony pathology. The patient was diagnosed with right shoulder bursitis on an unspecified date. She was advised to see the orthopedic doctor again and was scheduled to have an ultrasound on 7/16/04. A follow up telephone call was placed to the physician on 7/22/04 and he reported that he had referred the patient to an orthopedic doctor in December 2003 and has not seen the patient that time. No additional information was provided. From additional information received on 8/11/04 from a health care professional, the patient's date of birth was reported as 2/1/1954. It was initially reported as 2/10/54. The patient was seen in the office on 12/26/03 for complaints of right shoulder pain. The patient started to experience the pain on 12/17/03 immediately after receiving her flu shot. The patient stated that it felt as though the needle hit the bone. Initially, the pain was primarily with abduction type maneuvers of that arm, but did okay beyond the arc of 90. However, it became more persistent and constant. The patient had initially been on ibuprofen for a back problem, but had recently switched to Naprosyn and noted that she had not had quite as much pain relief with that. The patient denied any numbness, tingling, or paresthesia symptoms. She rated her pain as an eight out of ten. She denied any change in pain with any cervical range of motion. The patient is left-handed and works as a veterinary technician and groomer. The patient also denied any history of erythema or soft tissue swelling noted around the shoulder. Examination on 12/26/03 revealed full cervical range of motion without pain. She was non-tender to palpation about the cervical spine. No paraspinal muscle spasm was noted. Spurling's was negative with rotation bilaterally. Scapulothoracic motion was normal. Left upper extremity range of motion was essentially full and non-tender to palpation. No laxity was noted. Right shoulder was non-tender at the AC joint. There was no pain with cross arm adduction maneuver. The patient did have some tenderness lateral to the acromion in the deltoid region, but the range of motion was active. She had full forward flexion and adduction. The patient was noted to have significant pain with abduction between the 0 and 90 degree range, beyond that she was without pain. Motor strength to the upper extremity was 5/5 to include external rotation strength. The patient was also noted to have pain with resisted abduction in a thumb down position as well as with resisted deltoid firing. She had a negative Speed test. Sensation was intact along all dermatomal patters. DTR was symmetric to the upper extremities. No atrophy was noted. An x-ray with AP, scapular Y and axillary view of the right shoulder showed no acute bony pathology. It also revealed an open AC joint-type one to two to acromion. The impression was right shoulder bursitis with no evidence on clinical examination or x-ray that injection entered the subacromial space. On 1/16/04, it was noted that per discussion with the primary physician, the patient recalled the issue of whether the needle could have entered the bursa. It was felt that it was possible, but very unlikely and, as mentioned above, there is no clinical or radiographic evidence to support or indicate an injection into the bursa. The patient was seen for a follow up visit on 2/2/04. At that time, the patient stated that her pain had improved, but she was still having difficulty with certain activities such as pushing herself out of a chair. The patient stated that she continues to work full time in her job grooming dogs. She also continues to participate in physical therapy and has made significant improvement. She begun a strengthening program and decreased her Motrin dose to 1200 milligrams daily. Physical examination showed non-focal tenderness to palpation over the arm. She had 5/5 external and internal rotation strength. She had no focal tenderness over the AC joint, but did have some tenderness in the biceps. There was no evidence of atrophy. Impingement testing was negative. The patient was noted to have full forward flexion, starting at 15 degrees of abduction, external rotation of 30 degrees, external rotation 90 degrees abduction and 90 degrees internal rotation to T6. Speed test was negative. The patient was seen again for a follow up visit on 4/16/04. Once again, she stated that her pain had improved since her last office visit two months prior. She is limited in her activities, but she had started doing more normal things such as yard work, doing raking and doing her work as a groomer. The patient stated that she felt she has made improvement, but that she did not feel 100% yet. Physical examination revealed non-focal tenderness over the AC joints and 5/5 strength testing that day. No evidence of biceps tendonitis was noted. The patient was recommended to continue with home exercise as well as to resume normal activities. It was not reported whether the patient recovered from these events.  Follow up on 11/12/04 states: "From additional information received on 11/01/04 from the responsible physician, it was reported that he has not seen this pt since 12/26/03 and is unaware of her recovery status. A telephone call was made to the pt's orthopedic MD's office on 11/01/04 in an attempt to obtain additional information for this case. The orthopedist's office returned the call on 11/02/04 and reported that the pt was last seen in their office on 04/16/04. She was to follow up with her physician on an as-needed basis, but has not been back to the office since. Her recovery status is unknown. No further information is anticipated, this case is considered closed." Follow up 12/06/04: The patient recovery status is unknown, follow up information submitted to VAERS on 11/10/04.