Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Four doses of RabAvert were administered on the same day; Stomach cramps/stomach pain; Vomiting; Smelly diarrhoea/loose stool; Case reference number US-BN-2022-000916, initially downloaded from on 11-Apr-2022, is a spontaneous case received from a health professional via Health authority (ID: 2204939-1) and concerns a 2-years-old male patient.  The patient's concurrent condition included gastric problems.  The patient was not taking any concomitant medications.  On 15-Feb-2022, the patient was vaccinated with four doses of RabAvert (inactivated rabies virus vaccine; batch number: ARBA234, ARBA851C, ARBA911D and ARVS911B) at an unknown dose or anatomical location, route reported as injection (SYR), for unknown indication (explicitly coded as 'overdose').  On 23-Feb-2022, eight days after vaccination with RabAvert (one week as reported), the patient experienced vomiting, smelly diarrhoea and stomach cramps lasting close to a week.   On 28-Feb-2022, a stool sample was taken for testing (results were not provided). Doctor prescribed Pepcid for time being.  On an unspecified date in 2022, an unknown amount of time after vaccination with RabAvert, reported as two weeks later, the patient experienced again vomiting and loose stool.  On an unspecified date in 2022, an unknown amount of time after vaccination with RabAvert, reported as one week after that, the patient experienced severe stomach pain, vomiting and diarrhoea  that lasted for close to one week.  At the time of initial report, the patient had not recovered from the events.  The reporter assessed the events as non-serious. The causality assessment was not provided.  Non significant correction performed on 27-Apr-2022 to correct narrative.  No further information was provided.; Reporter's Comments: A 2-year-old-male patient was vaccinated with four doses of RabAvert for unknown indication, which is considered as overdose. Reportedly, on the day 8 after the vaccination, the patient experienced non-serious events of vomiting, smelly diarrhoea and stomach cramps. The events of vomiting, diarrhoea and abdominal pain upper are considered as listed for RabAvert according to the Datasheet v6, whilst the event of overdose is considered as listed per company convention. The patient's concurrent condition included gastric problems and was not taking any concomitant medications. Reportedly, the patient had not recovered from the events. The patient's concurrent condition of gastric problems confounded the causality for the events. Nevertheless, since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of vomiting, diarrhoea and abdominal pain upper have been considered as related to RabAvert. Overdose has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 2-year-old-male patient was vaccinated with four doses of RabAvert for unknown indication, which is considered as overdose. Reportedly, on the day 8 after the vaccination, the patient experienced non-serious events of vomiting, smelly diarrhoea and stomach cramps. The events of vomiting, diarrhoea and abdominal pain upper are considered as listed for RabAvert according to the Datasheet v6, whilst the event of overdose is considered as listed per company convention. The patient's concurrent condition included gastric problems and was not taking any concomitant medications. Reportedly, the patient had not recovered from the events. The patient's concurrent condition of gastric problems confounded the causality for the events. Nevertheless, since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of vomiting, diarrhoea and abdominal pain upper have been considered as related to RabAvert. Overdose has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.