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Found 564 cases where Vaccine is RV1 and Symptom is Intussusception and Appearance Date from '2008-02-01' to '2014-12-31'

Case Details

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VAERS ID: 528141 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Female  
Location: Oklahoma  
Vaccinated:2014-03-24
Onset:2014-03-29
   Days after vaccination:5
Submitted: 2014-04-10
   Days after onset:12
Entered: 2014-04-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 22J73 / 1 LL / UN
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J013944 / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H06568 / 1 RL / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB405A / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Barium enema abnormal, Intussusception
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Ischaemic colitis (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Radiology suite confirmed ileocolic intuss. via barium enema
CDC Split Type:

Write-up: Patient had routine 2-mo immunizations on 3/24/14 -$g admitted to hospital for intussusception on 3/29/14 and treated successfully via barium enema.


VAERS ID: 530161 (history)  
Form: Version 1.0  
Age: 0.19  
Gender: Male  
Location: New York  
Vaccinated:2014-02-27
Onset:2014-04-16
   Days after vaccination:48
Submitted: 2014-05-05
   Days after onset:19
Entered: 2014-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 4394C / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J014280 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H50603 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB396A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Enema administration, Haematochezia, Intussusception, X-ray
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA000363

Write-up: This spontaneous report as received from a physician concerning a 3 month old male patient with no drug reactions/allergies and no pertinent medical history. On 27-FEB-2014 the patient was vaccinated with the first dose of ROTATEQ, oral (total dose was not reported). There was no concomitant medication. The physician reported that on 16-APR-2014, the patient developed intussusception and blood on his stools after receiving the first dose of either ROTATEQ or ROTARIX. The physician stated that she was not sure which product was administered to the patient and stated that she stocked both products in her office. The physician mentioned that the patient was sent to the emergency room from her office and was then hospitalized overnight at a medical center. The patient was treated with IV fluids and air enema. On an unknown date, an x ray and an unspecified blood work were performed (no result were provided). At the time of the report, in 2014, the patient recovered from intussusception. The physician considered intussusception as life threatening. The causality between intussusception and ROTATEQ was not provided. Lot number A41FB396A is an invalid lot number for ROTATEQ. Additional information has been requested.


VAERS ID: 531100 (history)  
Form: Version 1.0  
Age: 0.34  
Gender: Male  
Location: Georgia  
Vaccinated:2014-04-24
Onset:2014-04-29
   Days after vaccination:5
Submitted: 2014-05-16
   Days after onset:17
Entered: 2014-05-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ML5D7 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH832AB / 2 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H45098 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB412A / 2 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Crying, Haematochezia, Intussusception
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Intussusception
CDC Split Type:

Write-up: Pt. mom states bloody stool, uncontrollable crying.


VAERS ID: 531900 (history)  
Form: Version 1.0  
Age: 0.21  
Gender: Male  
Location: California  
Vaccinated:2014-04-21
Onset:2014-04-27
   Days after vaccination:6
Submitted: 2014-05-23
   Days after onset:26
Entered: 2014-05-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS F3542 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J014281 / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H08091 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB397A / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Appendicectomy, Barium enema abnormal, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium decreased, Blood urea normal, C-reactive protein increased, Culture stool, Explorative laparotomy, Flatulence, Haematochezia, Haematocrit normal, Haemoglobin decreased, Intestinal dilatation, Intussusception, Laboratory test, Mucous stools, Occult blood positive, Ultrasound abdomen abnormal, Urinary system X-ray, Urine analysis, Vomiting, White blood cell disorder, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Ischaemic colitis (broad), Chronic kidney disease (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Guaiac positive stool; CBC, 14.4/1.9/36; Chem 7, 133/5.2/102/23/14/0.4/93; C-reactive protein, 11.2.
CDC Split Type:

Write-up: 4/21 - 10 week old male went for well care visit and got immunizations below. 4/28 - See H and P on additional sheet. Also progress in house. Patient is an 11 week old ex 37.4 week male infant. Prenatal care obtained, pregnancy reportedly unremarkable, infant born at Hospital. BW 2722 g. DC weight 2637 g. Baby exclusively formula fed with Enfamil GentleEase. Patient was well until approx 0300 on 4/27/14 when he vomited up his 0300 feed of 3 oz. His last "good feed" had been at 2100 the evening prior - 6oz. Parents later tried offering another 2 oz which he also vomited up. The called the advice RN who suggested PEDIALYTE via syringe. Parents tried all morning and initially it seemed to work, however he had an emesis at 1500 that appeared to be the entire volume of PEDIALYTE he had previously consumed. At that time he also had a ''wet fart'' that was bloody and mucous-like. Parents took him to hospital for evaluation at approx 1730 pm. There his stool guaiac was grossly positive. Labs as follows: CBC 14.4/1.9/36 Chem-7 133/5.2/102/23/14/0.4/93 C-reactive protein elevated at 11.2. Urine bag sample is pending. Stool cultures pending. ED unable to obtain IV access. Office contacted Pedi HBS for transfer and admission. KUB requested by MD. Reportedly unremarkable save a dilated loop of bowel in RUQ. No free air, no pneumatosis intestinalis. Allergies: No Known Allergies. Patient is a 5KG week old boy admitted at 1 AM from hospital with emesis. The emesis was copious, non-bilious, blood tinged. No pain to mom and dad''s recall. Has a 2 year old brother but no-one else ill in family. On exam he is afebrile, pulse 150, peeking out from blanket burrito. Well rehydrated with moist mucosa and Flat fontanelle. Abdomen soft, non-tender. No hernias. Normal anus. No labs recorded. We proceeded to UGI: Normal sized stomach (not large like seen with HPS). Normal ligament of Treitz location. Normal infant reflux. A/P: 11 week old with emesis. No evidence of the common surgical etiologies for this age such as HPS, volvulus, or incarcerated hernia. We then headed to US where intussusception was discovered. Proceeded on to BAE where intussusception confirmed but could not be reduced. To OR for laparoscopic, possible open reduction of intussusception with incidental appendectomy. 11 week old male presented with emesis and hematochezia. Malrotation and pyloric stenosis were ruled out with upper GI. Ultrasound showed intussusception, which was unable to be reduced by contrast enema. The patient was therefore taken to the operating room for laparoscopic exploration. Intraoperatively it was found that his intussusception had already reduced. Appendectomy was performed incidentally. Post-operatively, the infant had 2 normal stools and consistently passed gas. He tolerated regular feeds and was discharge home with parents, who are well aware of signs to watch for should he develop recurrent intussusception.


VAERS ID: 535973 (history)  
Form: Version 1.0  
Age: 0.36  
Gender: Male  
Location: Florida  
Vaccinated:2014-06-30
Onset:2014-07-05
   Days after vaccination:5
Submitted: 2014-07-08
   Days after onset:3
Entered: 2014-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS ML5D7 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J013944 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H35260 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB420A / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Decreased appetite, Faeces discoloured, Intensive care, Intestinal obstruction, Intussusception, Occult blood positive, Rectal haemorrhage, Somnolence, Ultrasound abdomen abnormal, Urinary system x-ray abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: NO
Preexisting Conditions: UMBILICAL HERNIA - 553.1
Allergies:
Diagnostic Lab Data: KUB & Ultra Sound
CDC Split Type:

Write-up: This 4 month old has increased sleepiness and decreased appetite followed by onset of bright red blood per rectum. He than had 2 bowel movements, which were described as melanotic or very dark stool that was heme-positive. At an outside hospital, he had 2 episodes of emesis, which had bilious tinge. He was transfered to ICU at the hospital. KUB and ultrasound were obtained. KUB was suggestive of bowel obstruction. Ultrasound was notable for intussusception. The patient did undergo a hydrostatic reduction and was found to have an ilecolonic intussuseption to the level of the splenic flexure. Parents report no fever or diarrhea. Patient did receive the Rotarix vaccine on June 30, 2014. The patient is shedding virus in the stool. The child is otherwise well grown and healthy without any signficant clinical symptoms prior to the hours, according to the parents.


VAERS ID: 537517 (history)  
Form: Version 1.0  
Age: 0.18  
Gender: Female  
Location: California  
Vaccinated:2014-07-18
Onset:2014-07-21
   Days after vaccination:3
Submitted: 2014-07-23
   Days after onset:2
Entered: 2014-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS E2297 / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UI097AA / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H45394 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB407A / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Ultrasound positive for intussusception and reduced via air enema.
CDC Split Type:

Write-up: Intussusception.


VAERS ID: 539638 (history)  
Form: Version 1.0  
Age: 0.35  
Gender: Male  
Location: Louisiana  
Vaccinated:2014-07-24
Onset:2014-07-26
   Days after vaccination:2
Submitted: 2014-08-12
   Days after onset:17
Entered: 2014-08-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 9EA47 / 2 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. K001124 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H45100 / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB418A / 2 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Barium enema, Computerised tomogram abdomen abnormal, Crying, Enema administration, Intussusception, Irritability, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: CT scan - abd.
CDC Split Type:

Write-up: Presented to E.R. on 7/26 evening with hx of crying, irritability and bilious vomiting 15 x''s approx. 10-12 hrs. Workup/CT abd revealed intussusception 5-6cm. A.M. of 7/27 pt. was transferred to hosp. via ambulance. Barium enema performed and intussusception resolved without surgery. D/c''d home on 7/28/14.


VAERS ID: 542759 (history)  
Form: Version 1.0  
Age: 0.21  
Gender: Male  
Location: Minnesota  
Vaccinated:2014-08-22
Onset:2014-08-27
   Days after vaccination:5
Submitted: 2014-08-27
   Days after onset:0
Entered: 2014-09-05
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS B23P9 / 1 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J016187 / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H33597 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB416A / 1 MO / PO

Administered by: Public       Purchased by: Private
Symptoms: Abdominal X-ray, Intussusception, Ultrasound abdomen, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Abdominal ultrasound/Xray
CDC Split Type:

Write-up: Intussusception - fluoroscopically reduced. Presented with vomiting.


VAERS ID: 543420 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: California  
Vaccinated:2014-01-14
Onset:2014-01-19
   Days after vaccination:5
Submitted: 2014-08-12
   Days after onset:204
Entered: 2014-09-11
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS FF723 / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UH872AA / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G57035 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB374A / 1 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: At the time of reporting, there were no concomitant medications or relevant medical history. The subject had no known drug allergies. There were no reported adverse reactions to previous vaccinations.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1057509A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-IPV/HepB; GlaxoSmithKline; unknown; unknown given on 14 January 2014; Hib (non-gsk); non-GSK manufacturer; unknown; unknown given on 14 January 2014; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 14 January 2014. On 14 January 2014 at 09:36 the subject received 1st dose of ROTARIX (1 ml, oral). On 19 January 2014, 5 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the physician considered the event was life threatening and clinically significant (or requiring intervention). At the time of reporting the event was resolved. The vaccination course with ROTARIX was discontinued. The physician considered the event was probably related to vaccination with ROTARIX.


VAERS ID: 543421 (history)  
Form: Version 1.0  
Age: 0.37  
Gender: Male  
Location: Maryland  
Vaccinated:2014-02-21
Onset:2014-02-25
   Days after vaccination:4
Submitted: 2014-08-12
   Days after onset:167
Entered: 2014-09-11
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS 7449K / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J011964 / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H34511 / 2 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FB424A / 2 MO / PO

Administered by: Private       Purchased by: Other
Symptoms: Intussusception, Screaming, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
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: At the time of reporting, it was unknown if there were concomitant medications or relevant medical history. On follow up, the physician reported no tobacco use or alcohol use.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A1063379A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On 21 February 2014 the subject received a dose of ROTARIX (oral). On 25 February 2014, 4 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was taken to the emergency room on 25 February 2014 and "had surgery to correct" the intussusception on 26 February 2014. No further details were available at the time of reporting. The subject was hospitalised and the physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). GSK considered this case medically serious. On 26 February 2014, the event was resolved. Follow up was received from the physician on 26 February 2014. The physician reported the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline) as the second dose in the rotavirus series. Concurrent vaccination included Hib; manufacturer unspecified; intramuscular; unknown given on 21 February 2014; DTaP-IPV/HepB; GlaxoSmithKline; intramuscular; unknown given on 21 February 2014; pneumococcal vaccines (non-gsk); manufacturer unspecified; intramuscular; unknown given on 21 February 2014. There was no history of alcohol or tobacco use per the physician. The physician confirmed that the subject received ROTARIX on 21 February 2014. On 25 February 2014, the subject experienced intussusception, vomiting, and screaming. On 26 February 2014, the outcome of the events were unresolved. The physician reported that the subject had surgery as treatment. The physician considered the events to be serious. Follow-up received on 17 July 2014 from physician via the targeted follow-up questionnaire. As previously reported the ROTARIX vaccine was administered correctly along with concomitant vaccinations. ROTARIX was administered by a nurse at the physician''s office. The subject experienced intussusception on 25 February 2014 and resolved on 27 February 2014 (previously reported as 26 February 2014). At the time of this report the subject had completed the ROTARIX vaccination series. No other information was provided.


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