Sex: U
Vaccine: RAB
Symptoms: Cognitive disorder, Craniocerebral injury, Disability, Dizziness, Impaired work ability
Clinical narrative: Traumatic brain injury from the vaccine; Motor functions lost; Cognitive issues; Everything got worse again; Vertigo; Dizziness; Case reference number US-BN-2023-000620 is a spontaneous case report initially received from a consumer (reference number: USBAV23-0481) on 03-Apr-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified dates back in august, as reported, the patient was vaccinated with all the RabAvert shots as directed (batch number: unknown) at unknown dose, route and anatomical site of vaccination, for rabies pre/post exposure prophylaxis, as reported.  On an unknown date, an unknown time after the vaccination with RabAvert and reported as after last shot, the patient had bad adverse reactions including vertigo, dizziness, motor functions lost and cognitive issues.  After months of physical therapy and hard work, the patient got back 80 percent, as reported. Then, as reported, everything got worse again. The doctors said that the patient had a traumatic brain injury from the vaccine. It was also reported that the patient was back and forth on short term disability and leave from work.  The patient requested information on how long it could last, were reverse reactions permanent and hoped it could be figured out.  At the time of this report, the outcome of the reported events 'traumatic brain injury from the vaccine', 'motor functions lost', 'cognitive issues', 'everything got worse again', 'vertigo' and 'dizziness' was unknown.  The reporter assessed the events 'traumatic brain injury from the vaccine', 'motor functions lost', 'cognitive issues', 'everything got worse again', 'vertigo' and 'dizziness' as serious. The event 'traumatic brain injury from the vaccine' was also assessed as serious due to medical significance.   The reporter assessed the events 'traumatic brain injury from the vaccine', 'motor functions lost', 'cognitive issues',  'everything got worse again', 'vertigo' and 'dizziness' as related to RabAvert vaccine.  Additional information received on 03-Apr-2023 included the local case ID.; Reporter's Comments: A patient of unknown demographics had adverse reactions including vertigo, dizziness, motor functions lost and cognitive issues, unknown time after (reported as after last shot) the vaccination with RabAvert. Craniocerebral injury, motor dysfunction, cognitive disorder, impaired work ability and condition aggravated are all unlisted according to insert and unexpected per summary for RabAvert while vertigo and dizziness are listed and expected. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details were not provided. The event traumatic brain injury is currently assessed as not related due to biological implausibility of traumatic injury and vaccine. Lack of crucial information regarding this event is also making causality assessment challenging at this point. Causality for all other reported events is conservatively assessed as related at this point, since contributory role of suspect product cannot be fully excluded and due to known product safety profile for vertigo and dizziness. The case is considered serious due to its medical significance.; Sender's Comments: A patient of unknown demographics had adverse reactions including vertigo, dizziness, motor functions lost and cognitive issues, unknown time after (reported as after last shot) the vaccination with RabAvert. Craniocerebral injury, motor dysfunction, cognitive disorder, impaired work ability and condition aggravated are all unlisted according to insert and unexpected per summary for RabAvert while vertigo and dizziness are listed and expected. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details were not provided. The event traumatic brain injury is currently assessed as not related due to biological implausibility of traumatic injury and vaccine. Lack of crucial information regarding this event is also making causality assessment challenging at this point. Causality for all other reported events is conservatively assessed as related at this point, since contributory role of suspect product cannot be fully excluded and due to known product safety profile for vertigo and dizziness. The case is considered serious due to its medical significance.