Sex: M
Vaccine: RAB
Symptoms: Anxiety, Deafness, Nervous system disorder, Optic neuritis, Tinnitus
Clinical narrative: This is a spontaneous case report initially received from a health care professional via Med Communications (reference number: USBAV21-0598) on 29-Nov-2021 and concerns a male patient of an unknown age. The patient's medical history was not provided. Past vaccines included vaccination series with Human Rabies Immune Globulin (HRIG, Sanofi) and rabies vaccine (from Novartis). The patient's concomitant medication details were not provided. On 28-Oct-2021, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine; batch number: ARBA851A; expiry date: Jan-2024) at a dose reported as one vaccine per dose, intramuscularly in the deltoid, for post exposure immunization. On 31-Oct-2021 the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine; batch number: not provided) at a dose reported as one vaccine per dose, intramuscularly in the deltoid, for post exposure immunization. On 06-Nov-2021, 10 days after the first vaccination dose of RabAvert, the patient started to experience tinnitus. On 16-Nov-2021, the symptoms of tinnitus became clearer. On an unspecified date in 2021, patient suspected himself to had developed neurological issues with cranial nerve number eight and stated that if you can have optic neuritis, you could have inflammation of acoustic nerve/ auditory nerve/ cranial nerve 8. On an unspecified date in 2021, the patient experienced anxiety due to tinnitus. The patient reported that tinnitus was with him all the time. It was reported that no treatment was given for the events. No laboratory tests were performed. The outcome for all the events was reported as ongoing. The reporter did not provide seriousness assessment. The event of 'optic neuritis' was considered serious due to optic neuritis being medically significant. The reporter assessed all the events as related to RabAvert. The doctors suspected the event of tinnitus was more hearing loss from age. Additional information received from Bavarian Nordic on 30-Nov-2021: Added local BN case ID. No further information was provided; Reporter's Comments: An adult male patient experienced non-serious event of tinnitus ten days after the first vaccination and seven days after the second vaccination with RabAvert (post-exposure). On an unspecified date the patient experienced anxiety due to tinnitus and suspected himself to had developed neurological issues with cranial nerve number eight and stated that if one can have optic neuritis (serious due to medical significance), then one could have inflammation of acoustic nerve/ auditory nerve/ cranial nerve 8. It is not clear if the patient developed optic neuritis. Optic neuritis, tinnitus, anxiety, vestibular neuronitis and nervous system disorder are unlisted for RabAvert according to the USPI and Global Prescriber Information version 6. The patient's relevant medical history and concomitant medications were not reported. Considering the lack of information and plausible temporal relationship for tinnitus, causality for all events is conservatively assessed as related to the suspect product.; Sender's Comments: An adult male patient experienced non-serious event of tinnitus ten days after the first vaccination and seven days after the second vaccination with RabAvert (post-exposure). On an unspecified date the patient experienced anxiety due to tinnitus and suspected himself to had developed neurological issues with cranial nerve number eight and stated that if one can have optic neuritis (serious due to medical significance), then one could have inflammation of acoustic nerve/ auditory nerve/ cranial nerve 8. It is not clear if the patient developed optic neuritis. Optic neuritis, tinnitus, anxiety, vestibular neuronitis and nervous system disorder are unlisted for RabAvert according to the USPI and Global Prescriber Information version 6. The patient's relevant medical history and concomitant medications were not reported. Considering the lack of information and plausible temporal relationship for tinnitus, causality for all events is conservatively assessed as related to the suspect product.