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This is VAERS ID 334088

Case Details

VAERS ID: 334088 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-10-13
Onset:2008-10-15
   Days after vaccination:2
Submitted: 2008-12-05
   Days after onset:51
Entered: 2008-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Food intolerance, Haematochezia, Ileectomy, Intestinal anastomosis, Intussusception, Irritability, Mucous stools, Pharyngitis, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal infections (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? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 18Oct2008, air levels
CDC Split Type: B0548929A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX, (GlaxoSmithKline). Previous and/or concurrent vaccination included DTAP-IPV-HIB; manufacturer unspecified; intramuscular given on 13 October 2008; HEP B vaccine recombinant; manufacturer unspecified; intramuscular given on 13 October 2008. On 13 October 2008 the subject received 1st dose of ROTARIX (oral). On 15 October 2008, 2 days after vaccination with ROTARIX, the subject started with a pharyngeal infection, intolerance to oral feeding, gastrobiliary vomiting and current jelly stools. She received ambulatory treatment (not specified) without improvement. On 18 October 2008 the subject was hospitalized. Physical examination reported abdominal pain, abdominal distention, gastrobiliar vomiting and irritability. The abdominal x-ray showed air-fluid levels. The same day the subject underwent a surgery. Ileoileal intussusception was found and it was reduced by taxis without improvement. A ileal resection was performed (length 20 cm and termino-terminal anastomosis with good evolution). On 28 October the subject was discharged in good conditions. The subject was treated with omeprazole, metronadizole, cefotaxime, amikacin, METAMIZOL, KETOROLAC, and ALBUMINE. The physician considered the events were possibly related to vaccination with ROTARIX.


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