Sex: F
Vaccine: RAB
Symptoms: Arrhythmia, Cardiac stress test, Electrocardiogram, Fatigue, Hot flush
Clinical narrative: Hot flashes; Heart arrhythmia; Feeling tired; Case reference number US-BN-2021-002111 is a spontaneous case report initially received from a consumer via regulatory authority (reference number: USBAV21-0368) on 20-Jul-2021, and concerns a female patient of unknown age.  The patient was a 12 year post menstrual.  The patient's concomitant medications included HRIG (immunoglobulin human anti-rabies, in 2000).  On an unspecified dates in 2000, the patient received five doses of rabies vaccine (unknown brand name, batch number was not provided), at an unknown dose, via unknown route of administration and after a possible bat bite.  On an unspecified date in 2000, the patient was feeling tired after receiving one or two received doses, as reported, without hot flashes or arrhythmia.  On an unspecified dates in Dec-2019, the patient was vaccinated with two doses of RabAvert (inactivated rabies virus, batch number was not provided), at doses reported as one injection per dose, administered intramuscularly, for post exposure prophylaxis after an opossum bit at work.  On unspecified date, an unknown amount of time after vaccination, the patient experienced hot flashes and heart arrhythmia. The patient reported that her clinician nurse told her that she already had some arrhythmia "awfully long time ago". However, the patient did not have hot flashes or arrhythmia after the first series in 2000, but only experienced tiredness after the first series. As reported, "the hot flashes started up again" after the second series.  On an unspecified date in Dec-2019, electrocardiogram and stress test were performed, and the patient was put on treadmill and on a scanner to scan her heart, but the results were not provided.   On an unspecified date in Mar-2020, the patient received metroprolol, which improved the arrhythmia. The patient's doctor stated that the patient had arrhythmia even before the second round of rabies vaccination.  The outcome for the event arrhythmia was resolving. The outcome of the event hot flashes was not provided.  The reporter assessed the events as related to RabAvert. The reporter did not provide seriousness assessment.  No further information was provided.; Reporter's Comments: Hot flush and arrhythmia are not listed and fatigue is listed for RabAvert according to the SmPC and Prescriber Information. Reportedly, the patient experienced reported events after with two doses of the second series of Rabies vaccine. The patient was postmenopausal, which is a confounding factor. Patient's concomitant medication includes HRIG. Based on provided information causality between suspect vaccine and all events is assessed as possibly related. The case is considered as non-serious.; Sender's Comments: Hot flush and arrhythmia are not listed and fatigue is listed for RabAvert according to the SmPC and Prescriber Information. Reportedly, the patient experienced reported events after with two doses of the second series of Rabies vaccine. The patient was postmenopausal, which is a confounding factor. Patient's concomitant medication includes HRIG. Based on provided information causality between suspect vaccine and all events is assessed as possibly related. The case is considered as non-serious.