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Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a physician concerning a 6 month old Middle Eastern female who was vaccinated with a first and second dose of Rotavirus on 27-OCT-2006 and 29-DEC-2006, respectively. On 03-MAR-2007 the patient was hospitalized for intussusception, which required surgery, but no bowel resection. Subsequently, the patient recovered. No other information was provided. Additional information has been requested. 04/17/07-records received from facility for DOS 3/2-3/5/07 DC DX: Intussusception. Fever. Leukocytosis. 6 day HX of vomiting, has had no stool no diarrhea. Prior to admission fever 103.5. Weight down 14 ounces. Congestion with clear runny nose. Afebrile upon admission. 2nd day of admission passed mucusy stool with streaks of blood. PE: WNL, abdomen soft and nontender. Surgery reduction ileocecal intussusception and appendectomy | |||||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a retired physician concerning his granddaughter who was vaccinated with a 2 ml oral dose of Rotateq. Subsequently the patient was treated for intussusception. It was reported that a barium enema was performed. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Upon internal review, the patient''s intussusception was considered to be an other important medical event. Additional information is not expected. | |||||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? No Write-up: Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq on 19-OCT-2006 and 17-JAN-2007 (Lot# 655866/1110F), respectively. Concomitant vaccinee administered on 17-JAN-2007 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of IPOL, a dose of PedvaxHIB (manufacturer unknown) and a dose of Prevnar. It was reported that, according to the hospital discharge summary, 24 hours prior to presentation at the hospital, on 07-MAR-2007, the patient began with nausea, vomiting, abdominal pain and constipation. The patient was admitted to the hospital on 08-MAR-2007 and had episodes of vomiting, diarrhea, and bloody stools. The patient was diagnosed with ileocolic intussusception, which was initially encountered in the distal transverse colon. It was also noted by the physician on the discharge summary that the patient had rotavirus. The patient did not have surgery and the intussusception was reduced by an air contrast enema. The patient was discharged on 10-MAR-2007 and had recovered. The patient''s intussusception and rotavirus were considered to be other important medical events by the reporter. A lot check has been requested. Additional information has been requested. 04/12/07-records received from facility for DOS 03/08-03/10/2007. DC DX: Ileocolic intussusception. Diagnosed and treated with air contrast enema. Developed abdominal pain 24 hours prior to presentation with decreased PO intake, several episode of vomiting and an episode of diarrhea but no further bowel movements over 24 hours. Febrile to 38.3. PE bowel sounds present soft non distended tender to palpation no masses palpable. Rectal grossly bloody stool in rectal vault. | |||||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Unknown
Life Threatening? No Write-up: Patient developed intussusception 3/15/07 sent to hospital - reduced with barium air enema. 03/28/07-DC summary received. DC DX: Intussusception. Confirmed by ultrasound and successfully reduced with air contrast barium enema. | |||||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? Yes Write-up: Our son has been having severe bowel cramping ever since the first dose of the rotavirus vaccine RotaTeq. He has suffered from abdominal cramping, severe crying spells, problems passing bowel movements, decreased appetite, fussiness, and loss of sleep. After having the second dose of the vaccine, his symptoms worsened until he finally developed intussuception. The day he developed this adverse reaction he began the morning with his usual fussiness. He hadn''t slept well the night before and was having trouble being held and bending in the middle. As I tried to give him his morning feeding, he persistantly refused to nurse and became more and more fussy. He arched his back and his stomach became hard. He began screaming out in pain and essentially foaming at the mouth. Following a severe screaming and crying spell, he went into shock. His skin became cool and clammy and he went limp in my arms. We called the pediatrician and they told us to take a rectal temperature. While taking a rectal tempature he passed a large bowel movement containing jelly-like blood clots. We rushed him to the emeregency room where he began to wheeze and vomit up bile. They took an X-ray of his abdomin, and followed up the X-ray with an ultrasound. The ultrasound confirmed the bowel telescoping. They did an air contrast enema to reduce the obstruction and then kept him in the hospital for the next two days for monitoring. When we met with our pediatrician following the intussuception, he didn''t mention that it could be related to the rotavirus vaccine. He went ahead and administered the third dose of the vaccine about a month after our son''s hospitalization. Since the third dose of the vaccine, we have been back to the emergency room with the same symptoms, but the bowel twisting has resolved itself without further medical enemas. 3/23/07 Received ER medical records which reveal patient experienced nasal congestion, pulling at left ear & irritability for approx 3 days prior to being seen in ER on 3/18/07. Exam revealed reddened left TM. PMH: s/p IS 3 wks ago. FINAL DX: left otitis media. 4/13/07 Received medical records from treating hospital which reveals patient experienced jaw clenching, diaphoresis, screaming, pallor, gen fussiness & bloody stools. In ER had bilious vomiting. Held overnight s/p IS reduction by enema. Progressed well & d/c to home. FINAL DX: Intussusception, reduced by air contrast enema. | |||||||||||||||||||||||||||||||||||
Administered by: Other Purchased by: Other
Life Threatening? Yes Write-up: Information has been received from a physician concerning a 3 month old patient who was vaccinated with the first dose of Rotateq. Subsequently, the patient experienced intussusception and was hospitalized. Intussusception was considered to be immediately life-threatening and an other important medical event. The outcome was not reported. Additional information has been requested. 4/6/07 Received medical records from both hospitals today which reveal: Hospital #1 ER - seen 3/10/07 for blood in stool night before & that AM. Also vomited that AM. Was seen by PCP on 3/9 & thought to be possible allergy, tx w/benadryl. After second bloody stool, went to ER. Dx w/acute GI bleed. Tx w/IVF & transferred to higher level of care. Hospital #2 Admission 3/10/07-3/13/07. Received into PICU & surg consult obtained. Exam revealed patient to be lethargic & mildly dehydrated despite prior IVFs. Abdomen was soft, nondistended w/+BS but also with a palpable mass along the left side of the abdomen, LLQ. Rectal exam revealed mucosal mass almost protruding from rectum. Air contrast enema x2 failed to reduce. Patient taken to OR for exp lap, reduction of right colon-ileocecal IS w/difficulty due to edematous & ischemic cecum & appendectomy. Patient progressed well & was able to tolerate oral diet prior to d/c on 3/13/07. FINAL DX: Ileocecal intussusception, surgically reduced. | |||||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: INTUSSUSCEPTION, BOWEL PERFPRATION 5/25/07 Received hospital medical records which reveal patient experienced bloody stools x 4 days prior to admit 3/22/07-4/6/07. Patient to OR after bowel perforation for exp lap & colostomy was done. ID consult done & started on multiple IV antibiotics. Initially vented but able to extubate quickly. To cath lab on 3/29 for dilation of coarctation. Transfused for low H/H. Tolerated oral feedings as well as NGT feedings. GI consult revealed GERD & delayed gastric emptying. Progressed well & was d/c to home w/close f/u by multiple specialties. FINAL DX: Intussception; bowel perforation secondary to BE; exp lap & colostomy. | |||||||||||||||||||||||||||||||||||
Administered by: Private Purchased by: Private
Life Threatening? Yes Write-up: Child developed an ileocolic intussusception 3/5/07. To surgery on 3/6/07. 04/03/07-records received from facility DC DX: Intussusception. Colicky abdominal pain. No bloody stool. Acute bilious vomiting. Surgical procedure:laparotomy, reduction of intussusception, appendectomy. Post operative diagnosis:ileocolic intussusception. | |||||||||||||||||||||||||||||||||||
Administered by: Private Purchased by: Public
Life Threatening? No Write-up: Unsure - dad reported patient brought to ER for abdominal pain and was diagnosed with intussusception and had it surgically repaired at facility reported. Patient never seen here for that04/24/07-records received from facility for DOS 03/14-03/15/07. DC DX: Intussusception Ileocolic. HX of emesis and bloody stools. Gastrografin enema water soluble attempt unsuccessful. Exploratory laparotomy with manual reduction of intussusception. Incidental appendectomy. problem. | |||||||||||||||||||||||||||||||||||
Administered by: Unknown Purchased by: Unknown
Life Threatening? No Write-up: 3/18/07 went to Hospital ER for vomiting and bloody diarrhea. Diagnosed with intussusception. Treated with reduction twice. Hospitalized 3/18-3/20/07. 04/02/07-ER and Diagnostic records received from facility. US:Instussusception identified in left upper quadrant of abdomen. Reduction with therapeutic enema. Recurrance seen on US in small ileocolic intussusception at level of cecum. Second therapeutic enema. Presented with abdominal pain positive bloody stools, nonbilious emesis. Labs: WNL. | |||||||||||||||||||||||||||||||||||
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https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=7&SYMPTOMS=_Intussusception_%2810022863%29&VAX=RV5
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