Sex: F
Vaccine: RAB, UNK
Symptoms: Dizziness
Clinical narrative: After second dose of RabAvert patient complained of mild dizziness; Patient complained of mild dizziness; Case reference number US-BN-2023-001519 is a spontaneous case report initially received from a nurse (reference number: EUBAV23-1350) on 12-Sep-2023 and concerned a 51-year-old female patient.  The patient's medical history included generalized anxiety and *vaccine and injection apprehension.*  The patient's concomitant medication details were not provided.  *On 25-Aug-2023*, the patient was vaccinated with the first dose of RabAvert vaccine *(batch number: YRBA841A and for diluent: AD01A33B,expiration date: Apr-2024), intramuscularly, in the left deltoid region*, at an unknown dose for indication reported as pre-exposure prophylaxis, and with co-suspect Sanofi Pasteur TD vaccine, at an unknown dose, route or site of administration for unknown indication. Patient stayed in clinic for the mandatory observation for 30 minutes. Patient complained of mild dizziness.   Patient stated, shots (especially vaccines) make her nervous.  *On 01-Sep-2023*, seven days after the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert vaccine *(batch number: YRBA841A and for diluent: AD01A33B,expiration date: Apr-2024), intramuscularly, in the left deltoid region*, at an unknown dose. After administration of vaccine patient complained of mild dizziness. Patient stayed in clinic for the mandatory observation for one hour. On the same day, the patient recovered from the event of dizziness, did not have any further issues and was safe to drive herself.   At the time of this initial report, patient recovered from both events of 'dizziness'.  The reporter assessed both events of 'dizziness' as non serious. Causality assessment was not provided.  Additional information received on 06-Sep-2023 from Bavarian Nordic included local BN case ID.  Additional information received on 12-Sep-2023 from nurse included updated medical history and new events.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from nurse on 23-Oct-2023, new information included: updated medical history, patient's details, information about Rabavert vaccination, information for both events of dizziness.; Reporter's Comments: A 51-year-old female patient complained of mild dizziness, within 30 minutes after receiving the first dose of RabAvert (pre-exposure prophylaxis), given intramuscularly in the left deltoid region. Seven days later, the patient received the second dose of RabAvert, also intramuscularly in the left deltoid region. After the injection, the patient complained of mild dizziness again. The patient recovered within the same day. Dizziness is listed and labeled for RabAvert according to insert. The patient's relevant medical history included generalized anxiety and anxiety associated with vaccines. Concomitant medication details were not provided. Patient's underlying anxiety is a confounding factor for developing dizziness. However, due to the plausible temporal relationship and known safety profile of the vaccine, the causality for both reported episodes of dizziness is assessed as related to RabAvert. The case is non-serious.; Sender's Comments: A 51-year-old female patient complained of mild dizziness, within 30 minutes after receiving the first dose of RabAvert (pre-exposure prophylaxis), given intramuscularly in the left deltoid region. Seven days later, the patient received the second dose of RabAvert, also intramuscularly in the left deltoid region. After the injection, the patient complained of mild dizziness again. The patient recovered within the same day. Dizziness is listed and labeled for RabAvert according to insert. The patient's relevant medical history included generalized anxiety and anxiety associated with vaccines. Concomitant medication details were not provided. Patient's underlying anxiety is a confounding factor for developing dizziness. However, due to the plausible temporal relationship and known safety profile of the vaccine, the causality for both reported episodes of dizziness is assessed as related to RabAvert. The case is non-serious.