Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Pain
Clinical narrative: Information has been received from a NP concerning a 53  year old female patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). The reporter noted that the patient did not respond to her first series of hepatitis B virus vaccine rHBsAg (yeast) vaccinations. The patient received the first IM dose of her second series of hepatitis B virus vaccine rHBsAg (yeast) vaccinations and complained about pain in her arm five to seven weeks later. Unspecified medical attention was sought. At the time of the report, the patient had not recovered from the pain in her arm. A product quality complaint was not involved. Additional information has been requested. This is a follow-up to report (s) previously submitted on 3/7/2005.  Information has been received from a nurse practitioner concerning a 53-year-old female with no allergies or medical history who on 31-JUL-2002 received a first dose in the left arm RECOMBIVAX HB (lot # 643169/0355M (pediatric dose times two).  On 05-SEP-2002 received a second dose in the right deltoid of RECOMBIVAX HB (lot # 643166/0249M) (pediatric dose times two), and on 07-FEB-2003 received a third dose of RECOMBIVAX HB (lot # 644712/1031M).  On 08-SEP-2003, an anti-HBs titer result was negative.  09-FEB-2004 at 15:00 p.m., the patient was vaccinated IM in the right arm with fourth dose of RECOMBIVAX HB (lot # 646147/0626N).  There was no illness at the time of vaccination.  The reporter noted that the patient did not respond to her first series of RECOMBIVAX HB.  The patient received the first dose of her second series of RECOMBIVAX HB and complained about pain in her arm five to seven weeks later.  Unspecified medical attention was sought.  At the time of the report, the patient had not recovered from the pain in her arm.  The patient had no adverse events following prior vaccination.  A product quality complaint was not involved.  Additional information has been received from the nurse practitioner who indicated that on 09-FEB-2004, the patient developed myofascial pain syndrome, tendonitis, and bursitis caused by inflammation from the injection.  Medical records from 03-JUN-2004 indicated that the patient had been evaluated at a physical medicine rehabilitation office for the persistent right shoulder pain radiating to the upper extremities.  The patient had been approximately managed with physical therapy and medications including DAYPRO and NEURONTIN.  The patient continued to have pain accompanied by tingling and numbness in the right upper extremity.  An MRI of the right shoulder showed some increased soft tissue signal around the shoulder indicating cellulitis and mildly increased signal in the distal infraspinatus tendon consistent with tendinosis.  A whole body bone scan was within normal limits.  Her grip strength in the right hand was 25 PSI and the left hand was 50 PSI.  Electrodiagnostic studies of the bilateral upper extremities were recommended to rule out brachial plexopathy.  Other diagnostic tests performed on 03-JUN-2004 included an electromyogram and a nerve conduction velocity study.  The impression of the tests revealed electrodiagnostic evidence of sensory compression neuropathy at the right wrist due to mild distal latency compared to the right radial distal sensory latency.  There was no electrodiagnostic evidence of ulnar, radia, or peripheral neuropathy at that time.  There was no electrodiagnostic evidence of cervical radiculopathy at that time.  There was no electrodiagnostic evidence of myopathy at the time.  Cellulitis of the right deltoid and right shoulder sprain and strain was noted.  The recommendations included the referral to a neurosurgeon and to an infectious disease specialist, continuing NEURONTIN, therapy with CELEBREX (200 mg BID), returning to work with modified lifting, pushing, or pulling duties of no more than 10 pounds, no overhead lifting, and to follow-up in two weeks.  At the time of the report, the patient had not recovered.  An anti-HBs titer result on 13-SEP-2004 was negative.  Follow-up information was received from the nurse practitioner who reported that the deltoid pain markedly improved.  Her range of motion and strength were good.  She was released to work without restrictions.  The patient was considered recovered as of 28-FEB-2005.  No further information is expected.