Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diarrhoea, Gastrointestinal disorder, Intestinal operation, Intussusception
Clinical narrative: Pt began with GI sx of loose stools; Diagnosed with intussusception on 6/19/23.; Pt began with GI sx of loose stools on  6/14/23; He underwent surgical correction on 6/20/23; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-OCT-2023 with the following VAERS primary ID 2658278-1. The original narrative from the sender is as follows:  Pt began with GI sx of loose stools on 6/14/23 and was diagnosed with intussusception on 6/19/23. He underwent surgical correction on 6/20/23.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Pt began with GI sx of loose stools on 6/14/23", and  was "diagnosed with intussusception on 6/19/23". The causal relationship between Vaxelis and the event "He underwent surgical correction on 6/20/23" was assessed as not applicable, due to the nature of this event.  No further information is expected.  COMPANY COMMENT: Gastrointestinal disorder, Intussusception and Diarrhoea were assessed as serious due to hospitalization, whereas Intestinal operation was assessed as serious due to being considered medically significant.  Diarrhoea is listed, whereas Gastrointestinal disorder, Intussusception and Intestinal operation are unlisted for Vaxelis as per the Reference Safety Information (CCDS). Of note, Intussusception is listed for the co-suspect vaccine RotaTeq.  Considering the current knowledge on Vaxelis (Diarrhoea is listed as per CCDS) and the onset latency (events occurred 3 days after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history), the causal relationship between Vaxelis and the reported events Gastrointestinal disorder, Intussusception and Diarrhoea cannot be excluded and is assessed as related.  The causal relationship between Vaxelis and the event Intestinal operation is assessed as not applicable, due to the nature of this event.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Gastrointestinal disorder, Intussusception and Diarrhoea were assessed as serious due to hospitalization, whereas Intestinal operation was assessed as serious due to being considered medically significant.  Diarrhoea is listed, whereas Gastrointestinal disorder, Intussusception and Intestinal operation are unlisted for Vaxelis as per the Reference Safety Information (CCDS). Of note, Intussusception is listed for the co-suspect vaccine RotaTeq.  Considering the current knowledge on Vaxelis (Diarrhoea is listed as per CCDS) and the onset latency (events occurred 3 days after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history), the causal relationship between Vaxelis and the reported events Gastrointestinal disorder, Intussusception and Diarrhoea cannot be excluded and is assessed as related.  The causal relationship between Vaxelis and the event Intestinal operation is assessed as not applicable, due to the nature of this event.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.