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This is VAERS ID 312275

(NOTE: This result is from the 4/14/2017 version of the VAERS database)

Case Details

VAERS ID: 312275 (history)  
Form: Version .0  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2008-02-26
Onset:2008-03-01
   Days after vaccination:4
Submitted: 2008-05-13
   Days after onset:72
Entered: 2008-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / IM
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / - - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal mass, Abdominal pain, Blood calcium decreased, Blood potassium increased, Blood sodium normal, Gastrointestinal hypomotility, Gastrointestinal tube insertion, Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intestinal perforation, Intestinal resection, Intussusception, Lymphocyte count decreased, Mucous stools, Platelet count normal, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray 02Mar2008 See text; Calcium 06Mar2008 7.5mEq/L 8.8 (low) 11.2 (high); Hematocrit 02Mar2008 30.7% 29 (low) 42 (high); Hemoglobin 02Mar2008 9.6g/dl 10 (low) 13 (high); Lymphocyte percentage 02Mar2008 18% 41 (low) 71 (high); Platelet count 02Mar2008 179000/mm3 300000 (low) 700000 (high); Potassium 06Mar2008 5.9mEq/L 3.5 (low) 4.5 (high); Sodium 06Mar2008 141mEq/L 135 (low) 145 (high); White blood cell count 02Mar2008 18700/mm3 10000 (low) 15000 (high)
CDC Split Type: B0519415A

Write-up: This case was reported by a physician in the time frame of a study and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject had no relevant medical history or allergies. Concurrent vaccination included DTPa-IPV-HIB (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008; hepatitis B vaccine recombinant (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008 and pneumococcal vaccine, unspecified (manufacturer unspecified; intramuscular; unknown) given on 26 February 2008. On 26 February 2008 the subject received the 1st dose of ROTARIX (oral). On 1 March 2008, 4 days after vaccination with the 1st dose of ROTARIX, the subject experienced 4 vomiting, mucosanguinolent stools and abdominal distension. The subject was hospitalized. On 2 March 2008, laboratory tests were performed and showed the following: Hemoglobin 9.6 g/dL (normal range: 10-13); Leucocytes count: 18700/mm3 (normal range: 10000-15000); Platelets count: 179000/mm3 (normal range: 300000-700000); Hematocrit: 30.7% (normal range: 29-43); Lymphocytes percentage: 18% (normal range: 41-71). Abdominal X-ray was performed and showed big distension of intestinal loops and lack of air in rectal ampulla. Intussusception was suspected. The subject was sent to another hospital with pediatric attention. She was admitted at this hospital on 04 March 2008 with dates of more abdominal distension, nasogastric tube with billar material drainage, diminished peristalsis, painful abdominal mass on left side and more sanguinolent stools. Surgery was performed on 04 March 2008; intussusception in ileocecocolic position was found with small perforation (2cm). Resection of ischemic segment with term to term anastomosis (ileal-transverse-colon) was done without complication. After that the subject showed good recuperation without sepsis or complications. On 6 march 2008, laboratory tests were performed and showed the following: Sodium: 141 mEq/L (normal range: 135-145); Potassium: 5.9 mEq/L (normal range: 3.5-4.5); Calcium: 7.5 mEq/L (normal range: 8.8-11.2). On 11 March 2008, finally oral acceptance started. On 14 March 2008, the subject was discharged in good clinical condition without sequels. The subject was treated with Ranitidine, Amikacine, Ampicillin, Metamizole, nalbuphine, buprenorphine, Ketorolac, paracetamol, cefotaxime and metronidazole. On 14 March 2008, the events were resolved. The physician considered the events were disabling and life threatening. The physician considered the events were possibly related to vaccination with ROTARIX.


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