Sex: U
Vaccine: COVID19, RAB, COVID19, RAB
Symptoms: Brain injury
Clinical narrative: Brain injury; Central nervous issues; Mobility issues / Motor activity abnormal; Case reference number US-BN-2024-002484 is a spontaneous case initially received from other health professional via Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 2786263-1) on 09-Sep-2024 and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of RabAvert (batch number: unknown), at a dose of one dosage form, at an unknown route or site of administration, for unknown indication.  On an unspecified date, the patient was vaccinated with a booster dose of co-suspect Spikevax vaccine (elasomeran; batch number: unknown), at a dose of one dosage form, at an unknown route or site of administration, for COVID-19 prophylaxis.  On an unspecified date, an unknown amount of time after a dose of RabAvert vaccine, the patient experienced the events of brain injury, *central nervous system disorder, mobility issues / motor activity abnormal. As reported patient had both the shots and patient interpreted that may cause the brain injury and the treatment medications were not reported.*  *At the time of follow up report,* the patient did not recover from the event of brain injury, *while the outcome of the events central nervous system disorder, motor dysfunction was unknown*.  *The reporter assessed the events of brain injury, and motor dysfunction as serious due to criteria of medical significance, and the event of central nervous system disorder as serious due to criteria of disability. Causality assessment for the events brain injury, central nervous system disorder, motor dysfunction was not provided*.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from Moderna via Bavarian Nordic (reference number: BN_2024_02966) on 13-Sep-2024: New information included added reference number (MOD-2024-772672), events central nervous system disorder, motor dysfunction and confirmation on the treatment medications.; Reporter's Comments: A patient of unknown age or gender experienced serious events of brain injury, nervous system disorder and motor dysfunction (medical significance and disability) on an unspecified date, an unknown amount of time after the patient was vaccinated with a dose of RabAvert for unknown indication. Brain injury, motor dysfunction and nervous system disorder are unlisted and unexpected for RabAvert per CCDS v4 and RA. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with a booster dose of co-suspect Spikevax vaccine (elasomeran; batch number: unknown), at a dose of one dosage form, at an unknown route or site of administration, for COVID-19 prophylaxis. The patient did not recover from the event of brain injury, while the outcome of the events central nervous system disorder and motor dysfunction was unknown. Considering limited information provided on circumstances surrounding the events, relevant medical history and diagnostic work-up, the evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert, therefore the causality is assessed as not related. This case is considered as serious due to medical significance and disability.; Sender's Comments: A patient of unknown age or gender experienced serious events of brain injury, nervous system disorder and motor dysfunction (medical significance and disability) on an unspecified date, an unknown amount of time after the patient was vaccinated with a dose of RabAvert for unknown indication. Brain injury, motor dysfunction and nervous system disorder are unlisted and unexpected for RabAvert per CCDS v4 and RA. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with a booster dose of co-suspect Spikevax vaccine (elasomeran; batch number: unknown), at a dose of one dosage form, at an unknown route or site of administration, for COVID-19 prophylaxis. The patient did not recover from the event of brain injury, while the outcome of the events central nervous system disorder and motor dysfunction was unknown. Considering limited information provided on circumstances surrounding the events, relevant medical history and diagnostic work-up, the evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert, therefore the causality is assessed as not related. This case is considered as serious due to medical significance and disability.