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This is VAERS ID 320950

Case Details

VAERS ID: 320950 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2008-05-14
Onset:2008-07-04
   Days after vaccination:51
Submitted: 2008-07-31
   Days after onset:27
Entered: 2008-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anorexia, Appendicectomy, Decreased activity, Dehydration, Diarrhoea, Gastrointestinal hypomotility, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Platelet count increased, Prothrombin time prolonged, Surgery
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastro Esophageal Reflux
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hematocrit, 07Jul2008, 35%; Hemoglobin, 07Jul2008, 12.3g/dl; Partial prothrombin time, 07Jul2008 51sec; Platelet count, 07Jul2008, 531000/mm3; Prothrombin time, 07Jul2008, 11sec
CDC Split Type: B0530958A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 5-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included gastro esophageal reflux. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 19 March 2008. On 14 May 2008, the subject received 2nd dose of ROTARIX (oral, lot number not provided). On 4 July 2008, 51 days after vaccination with ROTARIX, the subject experienced intussusception but there was no more information in the clinical chart. On 6 July 2008, 53 days after vaccination with ROTARIX, the subject was admitted at emergency room with diarrhea, hypoactivity, hyporexia, dehydration and decreased gastrointestinal peristalsis. 12 hours later, the patient showed bloody stools and rectal tact with expulsion of abundant blood. The subject was hospitalized and surgery was done on 7 July 2008. Intestinal invagination was corroborated and corrected by taxis with appendectomy, without complication. The patient was discharged in good clinical conditions on 9 July 2008. Laboratory test were performed on 7 July 2008 and showed the following results: Hemoglobin: 12.3 g/dl; Hematocrit: 35%; Platelets: 531000/mm3; PT: 11sec; PTT: 51 sec. The subject was treated with AMIKACINE, RANITIDINE, METAMIZOLE and CISAPRIDE. On 9 July 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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