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This is VAERS ID 335080

Case Details

VAERS ID: 335080 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-10-23
Onset:2008-11-20
   Days after vaccination:28
Submitted: 2008-12-11
   Days after onset:21
Entered: 2008-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal mass, Abdominal pain, Appendicectomy, Appendicitis, Haematochezia, Haemoglobin normal, Inappropriate schedule of drug administration, Intussusception, Irritability, Lymphadenitis, Pallor, Platelet count increased, Surgery, Vomiting, White blood cell count, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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), Hypotonic-hyporesponsive episode (broad), Medication errors (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 21Nov2008, see text; Hemoglobin, 21Nov2008, 10.4g/dl; Leukocyte count NOS, 21Nov2008, 17000/mm3; Platelet count, 21Nov2008, 505000/mm3
CDC Split Type: B0549709A

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. The subject was on no other medication and had no relevant medical history or known allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 19 August 2008. Concurrent vaccination included combined DTaP-IPV-HIB (manufacturer unspecified) given on 23 October 2008; pneumococcal vaccine (non-GSK manufacturer) given on 23 October 2008. On 23 October 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 20 November 2008, 28 days after vaccination with ROTARIX, the subject started with irritability, abdominal pain, vomiting and bloody stools. The patient was admitted at ER on 21 November 2008 and showed at physical exam irritability, pallor, abdominal pain to palpation right side with abdominal mass, bowel sounds decreased and rectal tact with empty ampulla and bloody stains. The subject was hospitalised. Diagnosis of intussusception was made by clinical features. Surgery was performed and showed cecocolic intussusception, mesenteric adenitis and appendicitis. Intussusception was reduced by taxis with a prophylactic appendectomy without complications. Tests were performed on 21 November 2008 and showed the following results: Abdominal X-ray: air-fluid levels. Hemoglobin: 10.4 g/dl; Leukocytes: 17000/mm3; Platelets: 505000/mm3. The subject was treated with Acetaminophen, Ampicillin and amikacin. On 25 November 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were possibly related to vaccination with ROTARIX. No additional information requested therefore the case has been closed.


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