Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Medication error, Muscle contractions involuntary, Pain, Tendonitis
Clinical narrative: From initial information received on 6/30/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 30 year old female patient received her first dose of pre-exposure series IMOVAX RABIES administered on 2/24/04, a second dose of IMOVAX RABIES administered on 3/2/04, and a third dose of IMOVAX RABIES, administered on 3/16/04. Lot numbers as well as routes and sites of administration were not reported. The patient returned to the health department for her post-exposure series and received IMMUNOGLOBULIN HUMAN ANTIRABIES, administered in the left deltoid, as well as her fourth dose of IMOVAX RABIES, administered in the right deltoid on 4/20/04. She received four more doses of IMOVAX RABIES, all administered in the right deltoid, with the fifth dose administered on 4/22/04, the sixth dose administered on 4/27/04, a seventh dose administered on 5/5/04, and an eight dose administered on 5/18/04. Lot numbers as well as routes of administration for all vaccines listed above were not reported. Since the receipt of the initial dose of IMOVAX RABIES on 2/24/04, the patient experienced muscle contrcations in her right deltoid and biceps. Also, during and after receipt of the series, the patient experienced soreness in her right arm. Per the patient, the health department has filed a report and referred the patient to a family physician. She was scheduled for a visit on 6/10/04 and was diagnosed with deltoid tendonitis. Results from an MRI completed on 6/29/04 are pending. The patient is to follow up with the physician. Her recovery status was not reported. From additional information received on 7/12/04 through an internal e-mail, it was reported that this case involves a medical error. Reportedly, the patient received IMMUNOGLOBULIN HUMAN ANTIRABIES and five doses of IMOVAX RABIES as follow up treatment after receipt of a recalled IMOVAX RABIES dose during their pre-exposure series. This regimen does not conform to the detailed guidance document issued during the recall. From additional information received on 11/9/04 from the responsible physician, the patient's date of birth was provided. Per the reporter, no relevant laboratory data was obtained. The patient's symptoms were treated with physical therapy. The reporter also stated that he does not have the lot number information or the routes and sites of administration for the suspect products, as the patient was vaccinated by her employer. At the time of this report, the patietnt has not recovered and continues to experience low-level pain at the site of injection. From additional information received on 12/15/04 from the responsible physician, it was reported that the patient is making slow progress, but has still not fully recovered from these events. It was also reported that the patient is not on any medications at this time. From additional information received on 3/3/05 from the responsible physician, it was reported that the patient still experiences a pain, diagnosed as tendonitis, in her right arm, at the site of injection. No further information is anticipated, this case is considered closed.