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This is VAERS ID 320508

Case Details

VAERS ID: 320508 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Male  
Location: Foreign  
Vaccinated:2008-02-22
Onset:2008-06-30
   Days after vaccination:129
Submitted: 2008-07-25
   Days after onset:25
Entered: 2008-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Anorexia, Appendicectomy, Cough, Decreased activity, Dehydration, Gastrointestinal hypomotility, Haematochezia, Intestinal malrotation, Intussusception, Irritability, Pallor, Pharmaceutical product complaint, Pyrexia, Rhinorrhoea, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Upper respiratory tract infection
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0530419A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 9-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included upper respiratory tract infection on 30 June 2008 but no more information was available in the chart. Concurrent vaccination included ROTARIX (GlaxoSmithKline) given on 22 November 2007. On 22 February 2008, the subject received 2nd dose of ROTARIX (1 ml, oral). Lot number not provided. On 30 June 008, 4 months after vaccinations with RORTARIX, the subject started with fever, clear rhinorrhea, cough, 3 bloody stools, vomiting, irritability, hyporexia and abdominal pain. the subject was admitted to emergency room on 30 June 2008 with fever, pallor, pharyngeal congestion, mild dehydration, tachycardia, hypoactive, abdominal pain in the pelvic fore, decreased gastrointestinal peristalsis, positive dance sign and rectal tact with expulsion of current jelly stool. Surgery was done on 30 June 2008: ileo-ileal intussusception with intestinal malrotation was found, corrected by taxis without intestinal resection; prophylactic appendectomy was done without complications. The subject was hospitalized for 3 days. Laboratory exams and X-rays results were not available in the clinical chart. The subject was treated with metronidazole, AMIKACINE, METAMIZOLE, RANITIDINE, metoclopramide and paracetamol. Post surgical evolution was favorable. On 2 July 2008, the subject was discharged with good clinical recuperation. The physician considered the events were unrelated to vaccination with ROTARIX.


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