Age: 8.0
Sex: F
Vaccine: RAB
Symptoms: Laboratory test abnormal, Meningitis, Muscle rigidity, Nasopharyngitis, Sepsis
Clinical narrative: This child had viral infection, rigid muscles, severe headache, weakness, streptococcal throat, allergies, and head cold. An initial report was received from an 8 year old female patient's mother. She said her daughter was hospitalized on 06/12/00 for meningitis and septicemia following postexposure to RabAvert administration. According to the patient's mother, the patient received a complete postexposue series including 5 doses of RabAvert and human rabies immune globulin. The first 4 doses of RabAvert were from lot# 233011 (dates unknown), and the fifth dose of RabAvert was from lot # 261011 (lot recalled because of some cracked vials). The 5th dose of RabAvert was given on 05/26/00. According to the mother, on 06/2/00, the patient was admitted tot he hospital with rigid muscles, a severe headache, and weakness (she could not stand). She was diagnosed with meningitis and septicemia. The patient was hospitalized for 4 days and received antibiotics and IV fluids. During the hospitalization, she underwent a number of tests including a lumbar puncture to determine the cause of the meningitis and septicemia. An exotic disease specialist also saw her; however, the cause was not determined. The mother reported that, prior to this event, the patient was a healthy child. Following the event, the patient's health had been poor. She had streptococcal throat three times in the last year, and had lots of allergies which she did not have prior to this event. According to the mother, the patient's immune system had not recovered. The mother said she had also discussed this event with the pharmacist at the hospital, as well as the patient's pediatrician. She was concerned that this event might have occurred secondary to the administration of the recalled RabAvert. The mother reported that the child's pediatrician had relayed to her that he did not think that the meningitis was related to the recalled RabAvert. Follow up info was received on 04/24/01 from the patient's pediatrician. According to the pediatrician, the patient was admitted to the hospital with symptoms suggestive of possible meningitis. An infectious disease consultant was called and many studies were performed to rule-out meningitis and septicemia. There was no concrete evidence of meningitis. The lumbar puncture was negative, "it didn't look bacterial or viral". Culture were negative. There was a borderline elevation of IgG (=64) for Rocky Mountain Spotted Fever, suggestive of questionable past infection. The lyme disease index on cerebral spinal fluid was 1:3, (borderline elevated), but other lyme test were negative. The pediatrician's opinion was that if the tests were not clear, they were essentially negative. The patient's throat "looked bad", so empirically the pediatrician treated her with Penicillin and she got better. He thought that  the symptoms were most likely a viral infection, and still thinks so. On follow up, the patient "was OK. Her mother thought she was never right, but there's nothing that a doctor would think there was anything wrong." The pediatrician thought the patient was well, and had recovered. She had a couple of head colds and streptococcal throat, and the pediatrician did not think this was anything out of the ordinary for an 8 year old. The pediatrician did not have any information on the rabies vaccine which was given at the hospital, or the lot numbers. He was told that the patient had a dog bite. The pediatrician thought that the patient did not have any alteration in her immune system, and that "her symptoms added up to infection, but all the studies came up negative. There was no clinical correlation with any findings. No encephalic pattern, nothing to suggest infection, toxin, or any vaccine related effect in this case. No sign of encephalitis or meningitis. If it was a vaccine effect, there might be encephalitis or meningitis." The pediatrician stated that June was usually a prime month for conditions of encephalitis going around in the community, but he did not specifically remember whether there was any disease with symptoms like those seen in this case prevalent in the community at the time of the patient's hospitalization.  The pediatrician said, when directly questioned by the Drug Safety physician, that he did not think the patient had meningitis, septicemia, or immune dysfunction, and did not think that any of the adverse events were related to RabAvert.