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This is VAERS ID 320287

Case Details

VAERS ID: 320287 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2008-04-14
Onset:2008-05-04
   Days after vaccination:20
Submitted: 2008-07-23
   Days after onset:80
Entered: 2008-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Band neutrophil count decreased, Gastrointestinal necrosis, Haematochezia, Haematocrit normal, Haemoglobin normal, Intussusception, Irritability, Lymphocyte count normal, Neutrophil count increased, Pharyngeal erythema, Platelet count normal, Pyrexia, Surgery, Vomiting, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Band neutrophil count, 05May2008, 2%; Hematocrit, 05May2008, 32.1%; Hemoglobin, 05May2008, 11.2g/dl; Leukocyte count NOS, 05May2008, 15500/mm3; Lymphocytes, 05May2008, 4000/mm3; Neutrophil count, 05May2008, 10500/mm3; Platelet count, 05May2008, 458000/mm3.
CDC Split Type: B0529599A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 6-month-old male subject who was vaccinated with ROTARIX, GlaxoSmithKline. The subject was on no other medications and had no relevant medical history and no allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 13 February 2008. On 14 April 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 4 May 2008, 20 days after vaccination with ROTARIX, the subject started with irritability, colic pain, vomiting (5) and fever. The subject was hospitalized on 4 May 2008 with hyperemic pharynx and without evidence of abdominal complication. Later, the patient experienced tympanic abdomen, persistent pain, abdominal distension and bloody stools. Surgery was done on 5 May 2008. Invagination ileo-ileo-colic with intestinal necrosis was found and corrected by taxis. Intestinal resection of necrosed segment and term to term anastomosis at 4 cm of ileocaecal valve was performed. Necrotic segment was 20 cm. Post surgical evolution showed cough and surgical site infection with good response to antibiotics treatment, without more complication. Laboratory tests performed on 5 May 2008 showed the following: Hemoglobin: 11.2 g/dl, hematocrit: 32.1%, leukocytes: 15500/mm3, neutrophils: 10500/mm3, lymphocytes: 4000/mm3, bands: 2%, platelets: 458000/mm3. The subject was treated with paracetamol, metronidazole and amikacin. Clinical recuperation was favorable, the subject evolved in good clinical conditions. The date of discharge was not available in the chart. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.


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