Sex: M
Vaccine: RAB
Symptoms: Bell's palsy, Facial paresis, Tension headache
Clinical narrative: Bell's palsy; Tension headache; Case reference number US-BN-2023-001727 is a spontaneous case report initially received from a consumer via agency (reference number: USBAV23-1792) on 27-Oct-2023 and concerns an adult male patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient was vaccinated with first, second and third doses of RabAvert (batch number: unknown) at unknown dose, route and site of administration, for post exposure to rabies. Details about exposure to rabies were unknown.   On unspecified date, an unknown amount of time after receiving the third dose, the patient experienced tension headache, reported as affecting the left side.  On unspecified date, the patient recovered from the event of tension headache.  On 20-Oct-2023, the patient was vaccinated with fourth dose of RabAvert (batch number: ARBB091BF8211966277302) at unknown dose, route or site of administration.   On unspecified date, reported as after receiving fourth rabies shot, the patient developed Bell's palsy. As reported, the patient felt weak from the lips to the eyebrows and went to the emergency room (ER). As reported, the patient was prescribed with steroids and the reporter asked if it would be ok.  At the time of the initial report, the outcome for the event of Bell's palsy was unknown.  The reporter did not provide seriousness assessment for the events of tension headache and Bell's palsy, however the event of Bell's palsy was assessed as serious due to criteria of medical significance. The reporter assessed the events of tension headache and Bell's palsy as related to RabAvert vaccination.  Additional information received on 30-Oct-2023 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A male patient experienced the non-serious event of tension headache, an unknown amount of time following vaccination with RabAvert. The headache resolved. An unknown amount of time later, the patient received his fourth dose of RabAvert, given via unknown route of administration. The patient experienced left-sided weakness from the lips to the eyebrows and went to the ER. Diagnosis was Bell's palsy (serious, medically significant event). The patient received corticosteroids. Outcome of the palsy was unknown. Bell's palsy and tension headache are unlisted and unlabeled for RabAvert. Medical history was unknown. Considering the suggestive temporal relationship, the events are assessed as related to RabAvert.; Sender's Comments: A male experienced the non-serious event of tension headache, an unknown amount of time following vaccination with RabAvert. The headache resolved. An unknown amount of time later, the patient received his fourth dose of RabAvert, given via unknown route of administration. The patient experienced left-sided weakness from the lips to the eyebrows and went to the ER. Diagnosis was Bell's palsy (serious, medically significant event). The patient received corticosteroids. Outcome of the palsy was unknown. Bell's palsy and tension headache are unlisted and unlabeled for RabAvert. Medical history was unknown. Considering the suggestive temporal relationship, the events are assessed as related to RabAvert.