Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: X-ray normal
Clinical narrative: Initial report received on 07 October 2008 from a physician.  A 41-year-old male patient, with no concurrent illnesses, no known allergies, and no use of other medications, had received a first 0.5 mL intramuscular left deltoid injection of ADACEL (Lot # C2767AA) on 29 April 2008.  The size of needle used for the administration of the ADACEL was unknown.  Approximately four hours post-vaccination, the patient experienced soreness at the left deltoid injection site which persisted.  The site appeared to be normal, but the soreness did not resolve.  The patient subsequently required medical evaluation and an x-ray of the left arm was performed which was reported to be negative.  At the time of this report, the patient had not recovered.  Follow up information was received on 24 November 2008 from a health care professional.  The patient was seen in the office on 03 October 2008.  During the visit the doctor assessed the site as "normal in appearance".  The patient's neurological exam was normal, therefore no neurological tests were performed.  The patient had an X ray of the left humerus on 06 October 2008 to assess for calcifications or other injury.  The results were within normal limits.  The patient was scheduled for a follow up appointment on 20 November 2008.  No further information was provided.  Follow-up information received on 12 December 2008 from a physician.  At the time of the vaccination on 29 April 2008, the patient was taking Sertraline and Xanax for chronic generalized anxiety and depression which continues.  The patient had not recovered at the time of the office visit on 03 October 2008.  The patient was re-evaluated by neurology on 20 November 2008 and an Magnetic Resonance Imaging test of the left upper extremity was "ordered."  The results of the MRI were still pending at the time of this report.  The physician did not feel the events were related to any immunization issues.  The reporter stated "see attached office visit notes", but there were no office visit notes provided.  At the time of this report, the patient had not recovered.  Follow-up information received on 29 December 2008 from a physician.  The patient was never seen by neurology, as no neurological deficits had been noted.  The physician's notes for an office visit on 02 December 2008 were provided.  According to these notes, the patient continued to have pain in his left deltoid, seven and a half months after initial onset, which was four to five days (not four hours as previously reported) after having received ADACEL on 19 April 2008 (not 29 April 2008, as previously reported).  At the worst, the pain was perhaps a four or five out of ten.  The discomfort did seem to be worse when trying to lift heavy objects or raise them above shoulder height.  The pain did not awaken the patient at night.  He hadn't really had to take any analgesics for the pain, which was extremely persistent and annoying.  Examination of the extremity was normal except for the mildly diffuse tenderness over the left deltoid, more so towards the anterior portion, extending slightly into the biceps insertion area.  An MRI of the region was planned to see if there was any evidence of myolitis or subtle bony injury not picked up by the x-ray.  The physician noted that the exam was not perfectly compatible with rotator cuff pathology and the timing did seem to implicate the injection, although it was somewhat delayed, in terms of normal and expected immediate soreness.  Anagelsia was not required at the time of the exam.  An MRI of the left upper extremity was performed on 11 December 2008.  This was a negative examination.  Specifically, no evidence of soft tissue mass was appreciated around the deltoid muscle.  At the time of the report, the patient remained unrecovered and was referred to orthopaedics for consultation of related or unrelated source of continued pain at the injection site.  Follow-up information received on 27 January 2008 from a physician.  The patient was evaluated by orthopedics on 30 December 2008 and he received an injection of KENALOG in the left shoulder secondary to impression of "bursitis/tendonitis."  The patient was to have a follow-up visit with the orthopedic physician the end of January, but the reporter had not heard back from the patient regarding this visit.  The recovery status was not provided.  From this new information, this case is being upgraded to serious.  Documents held by sender: MD's notes and MRI results