Received Jan 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | Unknown | — |
Acute disseminated encephalomyelitis; The patient received only three doses for post-exposure, and did not receive further doses; Clammy skin; Skin pale; Blood pressure rapidly increased; Literature citation. Case reference number US-BN-2026-000087 is a spontaneous literature case, title as stated above, identified on 14-Jan-2026, and concerns 58-year-old male patient. The aim of this literature case was to better specify clinical symptoms and diagnostic procedures regarding ADEM. The patient's medical history included back surgery. Family medical history was remarkable for diabetes mellitus and hypertension. The patient's concomitant medication details were not provided. On an unspecified date, as reported, the patient was bitten by a wild dog. On unspecified date in Mar-2015, unknown amount of time after the dog bite, the patient received the first dose of Rabies vaccine (brand name: unknown) along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number unknown), at an unknown dose, at an unknown route of administration, at unknown site of administration for postexposure prophylaxis. On unspecified date, unknown amount time after the vaccination, the patient experienced ill and faint. On unspecified date in Mar-2015, reported as three days later, the patient received the second dose of Rabies vaccine (brand name: unknown) along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number unknown), at an unknown dose, at an unknown route of administration, at unknown site of administration. On unspecified date in Mar-2015, reported as within minutes of receiving the second vaccine, the patient's skin became clammy, pale and his blood pressure rapidly increase. The patient was packed in the ice. On unspecified date in Mar-2015, unknown time after the second dose, the patient received the third dose of Rabies vaccine (brand name: unknown) along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number unknown), at an unknown dose, at an unknown route of administration, at unknown site of administration. On unspecified date in Mar-2015, unknown time after the third dose, the patient developed seizure and right arm and leg tremors. As reported, the patient received only three doses for post-exposure and did not receive further doses (explicitly coded as 'incomplete course of vaccination'). On unspecified date, while in the hospital, the patient stopped breathing, he also experienced numbness and decreased motor abilities in his legs and loss of vision on one side, which fully recovered within minutes as reported. On unspecified date, laboratory tests were performed, West Nile and Lyme disease were negative. Electroencephalograms awake (EEG) was essentially normal but showed a predominantly drowsy pattern. Brain magnetic resonance imaging (MRI) revealed mild cortical atrophy. Neurological examination showed significant declines in speech, including stuttering, short-term memory loss, and increased distractibility. The neurologist noted gait and motor changes, including muscle stiffness and tremors. He had an irregular, constant right arm and leg tremor, which varied in frequency, direction and amplitude. The tremor was suppressible and mildly entrainable. On unspecified date in Aug-2016, comprehensive neuropsychological testing was performed. General mental status (Montreal Cognitive Assessment (MoCA)) was below expectation, premorbid level of functioning (ACS Test of Premorbid Functioning (TOPF)) was borderline, Attention/concentration (Wechsler Adult Intelligence Scale 4th Edition (WAIS-IV Digit Span)) was deficient, Verbal Sustained Attention Test (VSAT) Speed was deficient, accuracy was deficient. Information processing speed Trail Making Test A was deficient with 3 errors and Stroop Word was deficient. Language Boston Naming Test (BNT) was deficient, and Animal Fluency was deficient. Visual-perceptual Rey Complex Figure Test (RCFT) Copy Deficient Clock Drawing was deficient WAIS-IV, Visual Puzzles was deficient. Verbal Memory Wechsler Memory Scale, 4th Edition (WMS-IV), Logical Memory Immediate recall was deficient, delayed recall was deficient and recognition was deficient. Verbal Learning Test, Revised (HVLT-R) Immediate recall was flat and deficient, Delayed recall was deficient, Recognition was deficient (due to False Positive errors). Executive functioning: Trail Making Test B was discontinued, WAIS-IV, Similarities was deficient, Controlled Oral Word Association Test (COWAT) Lexical fluency was deficient, Stroop Color-Word Naming Test was discontinued. Motor functioning Apraxia Examination was deficient bilaterally. Auditory attention was deficient, working memory for rote mental exercises was deficient for speed and for accuracy. Visual attention tracking was deficient due to slow processing speed, with 3 errors. Processing speed for single-word reading was deficient. Processing speed for single-word reading was deficient, and he was unable to complete a speeded color-naming task. Recognition memory was also within the deficient range. Immediate recall of short verbal prose was deficient with nil delayed recall and deficient recognition memory. Recall of culturally based general knowledge was borderline impaired. Performance was deficient on tasks of confrontation naming and semantic fluency. However, his speech during the evaluation was coherent and goal oriented. Visual-perceptual copy of a complex design demonstrated multiple omission errors. Executive functioning performance was deficient on tasks of abstract verbal reasoning and lexical fluency. The patient was unable to complete tasks of verbal inhibition and set-shifting/mental flexibility. Motor examination demonstrated persistent tremors, the patient had bilateral impairments of transitive and intransitive apraxia to command and imitation. Behavioral and psychiatric symptoms included symptoms of anxiety, irritability, and nighttime behaviors. There were significant declines in basic and instrumental activities of daily living. Overall, his neuropsychological profile revealed cognitive and functional declines. On an unknown date in Aug-2016, follow up neuroimaging showed brain MRI was unremarkable. The patient's dopamine transporter single-photon emission computed tomography (DAT SPECT) scan was normal, indicating that his Parkinsonism was not due to substantia nigra insufficiency. On neurobehavioral examination, he was again noted to have parkinsonian features, impaired mental and functional abilities, and psychiatric symptoms. Cogwheel rigidity was present bilaterally. Startle myoclonus and right-sided intention tremor were observed, accompanied by rest tremors in the right upper extremity. He had a stooped, shuffling gait and en-bloc turning, with decreased dominant arm swing. Ambulation was slowed approximately 2.5-fold. No sensory abnormalities were noted. The patient's MoCA score remained impaired (6/30), though with partially intact orientation (4/6). The demonstrated word-finding and comprehension difficulties in casual conversation. He frequently got lost and had ongoing difficulties with staying oriented and sustaining attention. The patient had poor memory, estimating that he could recall approximately 30% of his daily activities. He developed changes in sleep patterns and mild symptoms of paranoia, marked by concerns about people taking things from him. On unspecified date, the patient's diagnosis was concluded as post-vaccination acute disseminated encephalomyelitis (ADEM). This diagnosis was made based on the clinical features and the temporal correlation of symptoms with rabies vaccine (brand name: unknown) At the time of initial report, it is unknown if the patient recovered from the events of acute disseminated encephalomyelitis, clammy, pale skin and blood pressure increased. The reporter did not provide seriousness for the events of acute disseminated encephalomyelitis, clammy, pale skin and blood pressure increased; however the event of acute disseminated encephalomyelitis was considered as serious due to the criteria of medically significant. The reporter assessed the event of acute disseminated encephalomyelitis as related to Rabies vaccination, while the causality for events clammy, pale skin and blood pressure increased was not reported. No further information was provided.; Reporter's Comments: A 58-year-old male patient received only three doses of Rabies vaccine for post-exposure and did not receive further dose, which is considered as incomplete course of vaccination. Reportedly, within minutes of receiving the second vaccine, the patient developed non-serious events of skin became clammy, pale and blood pressure rapidly increase. An unknown time after the third dose, the patient developed seizure and right arm and leg tremors. Also, the patient stopped breathing, he also experienced numbness and decreased motor abilities in his legs and loss of vision on one side. On unspecified date, the patient's diagnosis was concluded as post-vaccination acute disseminated encephalomyelitis (medical significance). This diagnosis was made based on the clinical features and the temporal correlation of symptoms with rabies vaccine. Acute disseminated encephalomyelitis, cold sweat, pallor and blood pressure increased are unlisted and unexpected for Rabies vaccine per CCDS v6 and USPI, whilst incomplete course of vaccination is considered as listed per company convention. The patient's medical history included back surgery. Family medical history was remarkable for diabetes mellitus and hypertension, and concomitant medication details were not provided. The outcome was unknown. Temporal relationship and biological plausibility are compatible. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A 58-year-old male patient received only three doses of Rabies vaccine for post-exposure and did not receive further dose, which is considered as incomplete course of vaccination. Reportedly, within minutes of receiving the second vaccine, the patient developed non-serious events of skin became clammy, pale and blood pressure rapidly increase. An unknown time after the third dose, the patient developed seizure and right arm and leg tremors. Also, the patient stopped breathing, he also experienced numbness and decreased motor abilities in his legs and loss of vision on one side. On unspecified date, the patient's diagnosis was concluded as post-vaccination acute disseminated encephalomyelitis (medical significance). This diagnosis was made based on the clinical features and the temporal correlation of symptoms with rabies vaccine. Acute disseminated encephalomyelitis, cold sweat, pallor and blood pressure increased are unlisted and unexpected for Rabies vaccine per CCDS v6 and USPI, whilst incomplete course of vaccination is considered as listed per company convention. The patient's medical history included back surgery. Family medical history was remarkable for diabetes mellitus and hypertension, and concomitant medication details were not provided. The outcome was unknown. Temporal relationship and biological plausibility are compatible. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered related.
Medical History/Concurrent Conditions: Back surgery
Test Date: 201608; Test Name: DAT SPECT scan; Result Unstructured Data: Test Result:/ ;DAT SPECT scan was normal, indicating that his Parkinsonism was not due to substantia nigra insufficiency; Comments: /; Test Name: EEG (awake); Result Unstructured Data: Test Result:/ ;EEG was essentially normal but showed a predominantly drowsy pattern.; Comments: /; Test Name: Lyme disease test; Result Unstructured Data: Test Result:/ ;negative; Comments: /; Test Name: Brain MRI; Result Unstructured Data: Test Result:/ ;revealed mild cortical atrophy; Comments: /; Test Date: 201608; Test Name: Brain MRI; Result Unstructured Data: Brain MRI was unremarkable.; Comments: /; Test Name: Neurological examination; Result Unstructured Data: Test Result:/ ;significant declines in speech, including stuttering, short-term memory loss and increased distractibility, gait and motor changes, including muscle stiffness and tremors, irregular, constant right arm and leg tremor; Comments: /; Test Name: West Nile test; Result Unstructured Data: Test Result:/ ;negative; Comments: /