Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Balance disorder, Dizziness, Fatigue, Gait disturbance, Laboratory test abnormal
Clinical narrative: From initial information received on 2/6/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 38 year old female patient received a 8.34ml dose of IMOGAM USP, lot number X0480-2, administered in the left and right buttocks, route of administration not reported, and a dose of IMOVAX RABIES, lot number T1099-2, administered IM in the left deltoid on 12/12/03. Two days later, on 12/14/03, the patient developed vertigo, tinnitus, loss of balance, fatigue, and malaise. She did not experience any rash, myalgia, or fever. Reportedly, the symptoms are not improving or exacerbating since the onset date. Diagnostic studies are pending and it was reported that nystagmus was present. The patient received another 1cc dose of IMOVAX RABIES, lot number 9R4D60, expiration date 4/25/04, administered IM in the right deltoid on 12/15/03 as well as a 1cc dose of IMOVAX RABIES, lot number W1419-3, expiration date 12/6/05, administered IM in the right deltoid on 12/26/03 and a 1cc dose of lot number W1419, expiration date 12/5/06, administered IM in the left deltoid on 1/8/04. The patient's pre-existing medical history includes pituitary microadenoma, which has not changed in size over the past five years. Reportedly, the patient has not experienced any reactions following prior immunizations. The patient did not recover from these events. Additional information has been requested. From additional information received on 5/21/04 from the reporting physician, it was reported that symptoms still persist four months after the vaccination. She had symptoms for a day after shots one and two then it cleared up until after the fourth and have not let up. The patient has still not recovered from these events. From additional information received on 1/13/05 from a physician, a consultation report was provided. The patient was seen on 5/27/04 for opinion and management of her dizziness, which has been present since the tail end of a rabies vaccination course. The patient is a veterinary assistant who was exposed to rabies and underwent a rabies vaccination course in December 2003. Towards the end of her course, she described feeling a swimming motion like she was on a boat, a feeling of motion sickness and sensation of vertigo if she moved too quickly. She underwent some vestibular rehabilitation and seemed to be helped by this. She went on a trip and was given a scopolamine patch for the trip because she was involved in some snowmobiling. After the trip was over and the scopolamine patch was removed, she once again started to get her sensation of imbalance if she moved too quickly. She had some more vestibular rehabilitation and things got better. She filled out a complete dizziness inventory, went through a neuro-otological examination, and reviewed her audiometric findings. Upon examination, her Romberg was noted to be quite unsteady with eyes closed. The patient had a tendency to step towards the right hand side when trying to do a tandem gait. Her Fukuda stepping test elicited no rotation. The patient's Dix-Hallpike maneuvers were negative. The rest of her neuro-otologic examination was within normal limits. There was no nystagmus to be seen. Audiometric testing was within normal limits. The physician discussed these findings with the patient and gave a diagnosis of imbalance, possibly due to decreased vestibular input bilaterally. Reportedly, this was leading to some symptoms that would be similar to oscillopsia or a maldebarkment syndrome. The consulting physician felt that the symptoms seemed to be temporally linked to either the rabies vaccine itself or to the vaccination. The reporter noted that the patient has also been complaining of some non-objective, non-pulsatile tinnitus. This also could be from a peripheral or central cause. Her audiometric testing was felt to be quite normal and the physician felt that a central cause was more likely. The patient was scheduled to have an ENG done and was to continue vestibular rehabilitation. At the time of the report, the patient had not recovered from these events. From additional information received on 3/28/05 from the responsible physician, a copy of the patient's medical records from an ENT consult were provided. The patient had an ENG performed on 1/7/04. It was noted that there was a slight decrease in her caloric response on the left-hand side compared to the right, but both sides had a reasonably strong caloric response and the consulting physician did not feel this was significant. The patient's complaints were mainly central in nature. The physician felt that the patient's symptoms may in fact represent a partially treated case of primary rabies. At the time of the consultation, the physician felt that the patient was quite asymptomatic. In the information submitted by the responsible physician on 3/28/05, it was noted that the patient's condition is unchanged and is felt to be likely to change at this point. Her problems with balance, tinnitus, and vertigo persist and she has not recovered. Based upon the additional information provided on 3/28/05, this case was upgraded to serious as per medical judgement. No further information is anticipated, this case is considered closed. (OMIC)