Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Laboratory test abnormal, Muscle twitching, Myalgia, Pyrexia
Clinical narrative: From initial information received on 6/23/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 15 year old female patient received a first dose of IMOVAX RABIES, lot number not reported, administered in the right deltoid, and a first dose of IMMUNOGLOBULIN HUMAN ANTIRABIES , lot number not reported, administered in the gluteal area and left deltoid on 6/11/04 as part of a post-exposure series. Reportedly, the patient had been exposed to a possibly rabid puppy. Within 24 hours of vaccination, on 6/12/04, the patient experienced a sore right arm and generalized muscle aches. On 6/14/04 and 6/18/04, the patient received her second and third doses of IMOVAX RABIES, lot numbers not reported, in the right deltoid. After both of these doses, she experienced soreness in her entire right arm. Brain samples of the puppy were sent in for testing, but whether the puppy died from distemper or rabies could not be definitively determined. Further testing will be done, but it is not known if these tests will be reliable. The recovery status of the patient was not reported. From additional information received on 7/22/04 from the patient's mother, it was reported that the lot number for the second and third doses of IMOVAX RABIES was W0046. The lot number for the first dose of IMOVAX RABIES is still unknown. Per the mother, the patient's doctor feels that the patient is experiencing an immune complex like reaction, which is an autoimmune reaction to the vaccine or RIG product. The patient's condition has improved. She had experienced numbness in her hands and feet, but these symptoms have subsided. She also had joint pain in her legs and feet and these symptoms are subsiding. Per the patient's mother, she is still experiencing tiredness. From additional information received on 8/27/04 from the patient's parent, it was reported that the patient has experienced periodic episodes of chest pain and tightness, sometimes felt on her back below her shoulder. One episode of muscle twitching below her cheek occurred on 7/7/04. The parent also reported that her daughter has had periodic episodes of low grade fever ranging from 98.8 - 100.0 degrees F and a throbbing feeling on the underside of her arm approximately two inches below the axillary area. The parent also stated that her daughter has periodic episodes of numbness in her right arm and hand, which occurred during sleep but subsided when the patient moved her arm. It was reported that the patient also had a lot of mucous in her throat and was clearing her throat a lot. The patient's recovery status was not reported. From additional information received on 11/4/04 from the responsible physician, it was reported that the patient's pulmonary function tests, ESR and CRP were within normal limits. The patient recovered from these events. No other information was provided at this time. From additional information received on 12/20/04 from a physician, it was reported that the lot number and route of administration are unknown. The patient was not bitten by the animal. It is the physician's understanding that the brain samples from the puppy were negative for rabies. No further information is anticipated, this case is considered closed.