Sex: F
Vaccine: RAB
Symptoms: Anxiety, Maternal exposure during pregnancy
Clinical narrative: Anxiety, freaking out, scary for the patient; Third time receiving RabAvert  for post-exposure prophylaxis, pregnant this time; Case reference number US-BN-2023-000016 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV23-0017) on 04-Jan-2023 and concerns a female patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury lep) (pcec); batch number: unknown), at an unknown dose or route or site of administration, for rabies post-exposure prophylaxis (to be confirmed).  On an unspecified date, an unknown amount of time after the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose or route or site of administration (to be confirmed).  On an unspecified date, an unknown time after the vaccination, the patient became pregnant. The patient's last menstrual period date, estimated delivery date (EDD), and corrected estimated date of delivery (CEDD) were not provided.  On an unspecified date, an unknown amount of time after the first dose of RabAvert, the patient was vaccinated for the third time with RabAvert (to be clarified) (batch number: unknown), at an unknown dose or route or site of administration.  On an unspecified date, an unknown amount of time after RabAvert, the patient experienced anxiety, was freaking out and it was scary for the patient. The patient wanted to know if there was a way that RabAvert vaccine could ever cause rabies.  At the time of this report, the outcome of the event of 'anxiety' was unknown.  The reporter did not provide seriousness and causality assessment for the event.   Additional information received on 05-Jan-2023 included the local case ID.; Reporter's Comments: A female patient of an unknown age became pregnant on an unspecified date, an unknown time after the vaccination with RabAvert for rabies post-exposure prophylaxis, which is considered as maternal exposure during pregnancy. Reportedly, on an unspecified date, an unknown amount of time after RabAvert, the patient experienced a non-serious event of anxiety. The event of anxiety is unlisted for RabAvert according to the guidelines, whilst maternal exposure during pregnancy is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event of anxiety was unknown. Since the contributory role of the suspect vaccine cannot be excluded with certainty, the event of anxiety has been considered as related to RabAvert. Maternal exposure during pregnancy has been considered as not related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: A female patient of an unknown age became pregnant on an unspecified date, an unknown time after the vaccination with RabAvert for rabies post-exposure prophylaxis, which is considered as maternal exposure during pregnancy. Reportedly, on an unspecified date, an unknown amount of time after RabAvert, the patient experienced a non-serious event of anxiety. The event of anxiety is unlisted for RabAvert according to the guidelines, whilst maternal exposure during pregnancy is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event of anxiety was unknown. Since the contributory role of the suspect vaccine cannot be excluded with certainty, the event of anxiety has been considered as related to RabAvert. Maternal exposure during pregnancy has been considered as not related to the suspect vaccine. This case is considered as non-serious.