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This is VAERS ID 322076

Case Details

VAERS ID: 322076 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2008-03-18
Onset:2008-04-06
   Days after vaccination:19
Submitted: 2008-08-13
   Days after onset:129
Entered: 2008-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Dyspnoea, Enema administration, Febrile convulsion, Haematochezia, Intestinal resection, Intussusception, Necrosis, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea, Surgery, X-ray abnormal
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, 06Apr2008, see text
CDC Split Type: B0532333A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history. Previous and/or concurrent vaccination included DTaP-IPV-HIB (manufacturer unspecified, intramuscular) given on 15 May 2008; DTaP-Hep B-IPV (manufacturer unspecified, intramuscular) given on 15 February 2008; Hep B (manufacturer unspecified, intramuscular) given on 15 November 2007 and 15 January 2008; ROTARIX (GlaxoSmithKline, oral) given on 15 January 2008; pneumococcal vaccine, unspecified (manufacturer unspecified, intramuscular) given on 15 February 2008 and 15 May 2008; tuberculosis vaccine (manufacturer unspecified, intradermal) given on 15 November 2007. On 18 March 2008, the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 6 April 2008, 19 days after vaccination with ROTARIX, the subject was taken to emergency room with pharyngeal pain, rhinorrhea, mild respiratory difficulty, fever and febrile seizures. The subject experienced bloody stools like black currant jelly giving the diagnosis of intestinal intussusception which was confirmed by abdominal x-ray. The surgery was done on 7 April 2008 and showed ileo-cecal intussusception in the last portion of ileon with 5 cm of necrosis. A terminal resection with a prophylactic appendectomy was performed without complication. The patient had good response and favorable evolution. Abdominal radiography performed showed fluid levels and dilated bowel loops but the x-ray did not show abnormalities, visible intussusception or soft tissue mass. Air or liquid contrast Enema performed did not demonstrate invagination of the intestine. Abdominal ultrasound was not done in diagnostic procedures. The physician considered the events were clinically significant (or requiring intervention). On 12 April 2008, the events were resolved and the patient was discharged. The physician considered the events were unrelated to vaccination with ROTARIX. No further information expected therefore the case has been closed.


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