Symptomtext
Intussusception diagnosed on 5/10 (15 days following the rota virus vaccine); Barium enema; Culture urine; Occult blood; Utrasound Abdomen; Urine analysis; Procalcitonin; Full blood count; Blood culture; C-reactive protein; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2651134-1. The original narrative from the sender is as follows: Intussusception was diagnosed on 10-May-2023 (15 days following the rotavirus vaccine). On 08-MAY-2023, CBC (complete blood count), CRP (C-reactive protein), CMP (complete metabolic panel), blood culture, procalcitonin, urinalysis, and urine culture was performed. On 10-MAY-2023, fecal occult blood, ultrasound abdomen, and reduction using barium enema procedure was performed. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event "Intussusception". Due to the nature of the event the causal relationship between Vaxelis and the events, "barium enema, blood culture, C-reactive protein, culture urine, full blood count, occult blood, procalcitonin, ultrasound abdomen, urine analysis" is not applicable. No further information is expected. COMPANY COMMENT: Intussusception was assessed as serious due to causing hospitalization and being life-threatening, whereas barium enema, blood culture, c-reactive protein, culture urine, full blood count, occult blood, procalcitonin, ultrasound abdomen, urine analysis, and urine culture were assessed as non-serious. Intussusception, CBC, CRP, CMP, blood culture, procalcitonin, urinalysis, and urine culture are unlisted for Vaxelis as per the Safety Information. Considering the current knowledge on Vaxelis and despite the co-suspect vaccines as confounding factor and lack of information in this case (no medical history), the causal relationship between Vaxelis and the reported event Intussusception cannot be excluded and is assessed as related. However, due to background incidence in the pediatric population, an independent event needs to be taken into consideration. Due to the nature of the events, the causal relationship between Vaxelis and barium enema, blood culture, C-reactive protein, culture urine, full blood count, occult blood, procalcitonin, ultrasound abdomen, urine analysis was assessed as not applicable.; Sender's Comments: Intussusception was assessed as serious due to causing hospitalization and being life-threatening, whereas barium enema, blood culture, c-reactive protein, culture urine, full blood count, occult blood, procalcitonin, ultrasound abdomen, urine analysis, and urine culture were assessed as non-serious. Intussusception, CBC, CRP, CMP, blood culture, procalcitonin, urinalysis, and urine culture are unlisted for Vaxelis as per the Safety Information. Considering the current knowledge on Vaxelis and despite the co-suspect vaccines as confounding factor and lack of information in this case (no medical history), the causal relationship between Vaxelis and the reported event Intussusception cannot be excluded and is assessed as related. However, due to background incidence in the pediatric population, an independent event needs to be taken into consideration. Due to the nature of the event, the causal relationship between Vaxelis and barium enema, blood culture, C-reactive protein, culture urine, full blood count, occult blood, procalcitonin, ultrasound abdomen, urine analysis was assessed as not applicable.