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This is VAERS ID 380132

Case Details

VAERS ID: 380132 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Male  
Location: Foreign  
Vaccinated:2008-01-24
Onset:2008-01-29
   Days after vaccination:5
Submitted: 2010-02-12
   Days after onset:745
Entered: 2010-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (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, Gastrointestinal hypermotility, Haematochezia, Intestinal obstruction, Intussusception, Irritability, Laboratory test abnormal, Laparotomy, 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 dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal x-ray, 30Jan2008, Abnormal
CDC Split Type: B0631993A

Write-up: This case was reported by a physician and described the occurrence of ileocolic intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous and/or concurrent vaccination included bacillus calmette-guerin vaccine (non-gsk); non-GSK manufacturer; intradermal; given on 12 September 2007; DTAP-IPV-HIB; manufacturer unspecified; intramuscular; given on 12 November 2007 and 24 January 2008; HEP B; manufacturer unspecified; intramuscular; given on 12 September 2007 and 12 November 2007. The subject was healthy. On 24 January 2008, the subject received 1st dose of ROTARIX (oral), lot number not provided. On 29 January 2008, 5 days after vaccination with ROTARIX, the subject experienced abdominal pain with bloody stools, increased peristalsis, abdominal distension and irritability. He was brought to the emergency ward. The morcilla sign was positive. On 30 January 2008, the abdomen X-ray showed fluid levels and dilated bowel loops as well as non-specific abnormalities and intestinal obstruction. A laparatomy was performed and ileocolic intussusception was found and treated by taxis without complications. The subject was hospitalised for 5 days and the physician considered the events were clinically significant (or requiring intervention). On 2 February 2008, the events were resolved and the subject was discharged from hospital in good conditions. The physician considered the events were almost certainly related to vaccination with ROTARIX. No further information was available. This case has therefore been closed.


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