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This is VAERS ID 384492

History of Changes from the VAERS Wayback Machine

First Appeared on 4/7/2010

VAERS ID: 384492
VAERS Form:
Age:0.3
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
Entered:2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC - / 1 UN / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 8/31/2010

VAERS ID: 384492 Before After
VAERS Form:
Age:0.3
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
Entered:2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
PNC: PNEUMO (PREVNAR) / WYETH PHARMACEUTICALS, INC PFIZER/WYETH - / 1 UN / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 5/13/2013

VAERS ID: 384492 Before After
VAERS Form:
Age:0.3
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
Entered:2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM
ROTH1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - - / PO
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 6/14/2014

VAERS ID: 384492 Before After
VAERS Form:
Age:0.3
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
Entered:2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 2/14/2017

VAERS ID: 384492 Before After
VAERS Form:
Age:0.3 0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
Entered:2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     Extended hospital stay? No
Previous Vaccinations:
Other Medications:
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.


Changed on 4/14/2017

VAERS ID: 384492 Before After
VAERS Form:
Age:0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
Entered:2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - - / PO

Administered by: Other      Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 9/14/2017

VAERS ID: 384492 Before After
VAERS Form:(blank) 1
Age:0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
Entered:2010-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 2 AR / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 2 AR / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 2 AR / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 2 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA392A / - UNK - MO / PO

Administered by: Other      Purchased by: Other
Symptoms: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 2/14/2018

VAERS ID: 384492 Before After
VAERS Form:1
Age:0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
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: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 6/14/2018

VAERS ID: 384492 Before After
VAERS Form:1
Age:0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
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: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 8/14/2018

VAERS ID: 384492 Before After
VAERS Form:1
Age:0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
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: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 9/14/2018

VAERS ID: 384492 Before After
VAERS Form:1
Age:0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
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: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.


Changed on 10/14/2018

VAERS ID: 384492 Before After
VAERS Form:1
Age:0.28
Sex:Female
Location:Foreign
Vaccinated:2007-12-11
Onset:2008-01-09
Submitted:2010-04-07
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: Condition aggravated, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Intussusception, Irritability, Pain, Pyrexia, Vomiting, Weight decreased, Enema administration, Ultrasound abdomen abnormal, Body temperature normal

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days: 0     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.

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