National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

This is VAERS ID 384492

Case Details

VAERS ID: 384492 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Female  
Location: Foreign  
Vaccinated:2007-12-11
Onset:2008-01-09
   Days after vaccination:29
Submitted: 2010-04-07
   Days after onset:818
Entered: 2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 AR / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Body temperature normal, Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Enema administration, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Ultrasound abdomen abnormal, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (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), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Racecadotril; Ibuprofen;Paracetamol; Hydration therapy
Current Illness: Bloody diarrhea; fever; mucous diarrhea; reflux unspecified; vomiting; weight loss
Preexisting Conditions: Subject born at 40 weeks and 4 days of amenorrhea, birth weight 3.27 kg, birth height 49.5 cm, birth cranial perimeter 34.5 cm. No known allergies. At the time of event, there were gastroenteritis cases in the family.
Allergies:
Diagnostic Lab Data: Blood pressure, 09Jan2008, 107/77; Body temperature, 09Jan2008, normal; Heart rate, 09Jan2008, 156bpm; Ultrasound abdomen, 09Jan2008, see text; 09 January 2008, Abdominal ultrasound scan: suspicion of intussusception of intestine
CDC Split Type: B0645474A

Write-up: This case was reported by a foreign regulatory authority (reference PV20080062) and described the occurrence of intussusception of intestine in a 4-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline, PREVENAR, non-gsk and PENTAVAC, non-gsk. The subject was born at 40 weeks and 4 days of amenorrhea (birth weight 3.27 kg, birth height 49.5 cm and birth cranial perimeter 34.5 cm). She had no known allergy. Medical condition included unspecified reflux. At the time of the events, there were gastroenteritis cases in the subject''s family. The subject weighted 7.18 kg. On 11 December 2007, the subject received an unspecified dose of ROTARIX (batch A41CA392A oral), a 2nd dose of PREVENAR (intramuscular, batch and injection site unknown), and a 2nd dose of PENTAVAC (intramuscular, batch and injection site unknown). On 08 January 2008, a physician was consulted for acute diarrhea with several vomiting and fever at 38.7 degrees Celsius. Diarrhea had become a mucous bloody diarrhea (10 liquid stools per day; with a weight loss of four percent (incidental events). TIORFAN, ADVIL, DOLIPRANE and oral rehydration solution were prescribed. Vomiting and diarrhea persisted. On 09 January 2008, 29 days after vaccination with PENTAVAC, PREVENAR and ROTARIX, the subject was admitted to emergency service for bloody diarrhea and pain. On admission, blood pressure was at 107/77, heart rate at 156 bpm and body temperature was normal. The subject was irritable and tired. There was no sign of dehydration. The rest of physical examination was normal. At abdominal ultrasound scan, acute intussusception of intestine was suspected. The subject was hospitalized and intussusception was reduced by hydrosoluble enema. Intussusception of intestine resolved at an unspecified date. Outcome of pain, blood in stool, irritability and fatigue was unspecified. According the foreign method of assessment, the relationship between vaccinations with ROTARIX, PREVENAR and PENTAVAC and intussusception was dubious.


New Search

Link To This Search Result:

https://www.medalerts.org/vaersdb/findfield.php?IDNUMBER=384492


Copyright © 2019 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166