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This is VAERS ID 337734

Case Details

VAERS ID: 337734 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2008-08-01
Onset:2008-12-25
   Days after vaccination:146
Submitted: 2009-01-20
   Days after onset:26
Entered: 2009-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Blood creatinine normal, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea normal, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin normal, Intussusception, Irritability, Laparotomy, Mucous stools, Nausea, Neutrophil percentage increased, Platelet count normal, Prothrombin time normal, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Activated partial thromboplast, 26Dec2008, 23.3Seconds; Blood glucose, 26Dec2008, 128mg/dL; Blood urea nitrogen, 26Dec2008, 13mg/dL; Creatinine, 26Dec2008, 0.3mg/dL; Hemoglobin, 26Dec2008, 12mg/dL; Neutrophil percentage, 26Dec2008, 77%; Platelet count, 26Dec2008, 400000IU; Potassium, 26Dec2008, 4.6meq/dL; Prothrombin time, 26Dec2008, 12.5Seconds; Sodium, 26Dec2008, 141mEq/dL; White blood cell count, 26Dec2008, 15800IU
CDC Split Type: B0553181A

Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in an 8-month-old male subject who was vaccinated with ROTARIX (oral) given on 9 June 2008. The subject was previously healthy; he had no relevant medical history or allergy. Previous vaccination included ROTARIX (GlaxoSmithKline). On 1 August 2008, the subject received the 2nd dose of ROTARIX (oral, lot number not provided). On 25 December 2008, 5 months after vaccination with the 2nd dose of ROTARIX, the subject experienced abdominal pain, nausea, vomiting and irritability. On 26 December 2008, the subject was admitted at ER. Physical exam reported vomiting, current jelly stool and decreased bowel sounds. The subject was hospitalised and the physician considered the events were clinically significant (or requiring intervention). Lab tests were performed and showed the following: Leucocytes: 15800 IU; Neutrophils: 77%; Platelets: 400000 IU; Hemoglobin: 12 mg/dL; Prothrombin time: 12.5 Seconds: Partial thromboplastin time: 23.3 Seconds; Sodium: 141 mEq/dL; Potassium: 4.6 mEq/dL; BUN: 13 mg/dL; Creatinine: 0.3 mg/dL; Glucose: 128 mg/dL. X-ray was performed and showed intestinal loops distention and bad gas distribution. Intussusception was suspected and confirmed by laparatomy on 27 December 2008. Ileocecocolic intussusception was found and reduced by taxis without complications. The subject was treated with Ranitidine. After recovery, the subject was discharged on 30 December 2008 in good clinical conditions. On 30 December 2008, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.


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