Sex: F
Vaccine: RAB
Symptoms: Diarrhoea
Clinical narrative: The patient had diarrhea since the initial dose of RabAvert; Case reference number US-BN-2024-002222 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-1696) on 17-Jul-2024 and concerns a 22-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient had a contact with the dog, and the dog was not up to date with rabies vaccine.  On 14-Jun-2024, an unknown time after the animal contact, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration, for post exposure.  On the same day, as reported within 12 hours of the initial dose, the patient experienced diarrhea.   On 17-Jun-2024, an unknown time after the animal contact, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration.  On 21-Jun-2024, an unknown time after the animal contact, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration.  On 28-Jun-2024, an unknown time after the animal contact, the patient was vaccinated with the fourth dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration.  On 07-Jul-2024, the patient saw a primary care practitioner (PCP) went to the emergency room (ER) and received intravenous (IV) fluid.  As reported, the episodes occurred at least seven times per day for the last 32 days. The patient saw a gastrointestinal (GI) specialist who prescribed Bentyl (dicyclomine), to help slow down the muscles in the intestines.  At the time of the initial report, the patient was not recovered from the event of diarrhea, as reported continuing symptoms.  The reporter assessed the event of diarrhea as serious as reported due to seeking emergency room treatment, and possibly related to the RabAvert.  Additional information received from the agency on 22-Jul-2024 included corrected vaccination dates, and confirmation on seriousness assessment and is blended in the case narrative above.; Reporter's Comments: A 22-year-old female patient experienced diarrhea on the day 0 after the patient was vaccinated with the first dose of RabAvert for post exposure. Diarrhoea is listed for RabAvert according to the CCDS v2 and unexpected per prescribing information The patient's medical history and concomitant medication details were not provided. The outcome was not resolved. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to RabAvert. This case is considered as serious due to medical significance.; Sender's Comments: A 22-year-old female patient experienced diarrhea on the day 0 after the patient was vaccinated with the first dose of RabAvert for post exposure. Diarrhoea is listed for RabAvert according to the CCDS v2 and unexpected per prescribing informaiton. The patient's medical history and concomitant medication details were not provided. The outcome was not resolved. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to RabAvert. This case is considered as serious due to medical significance.