chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose abnormal, Diabetes mellitus, Hyperglycaemia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with a history of warts treated by dermatologist, fracture foot and varicella post vaccine who on 17-MAR-2010, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 662300/0100Y). There was no pre existing illness. On 13-APR-2010, the patient experienced new onset diabetes mellitus and hyperglycemia. Serum glucose was 506. The patient was hospitalized for 24 hours and treated with IV fluids, insulin and education. On 20-APR-2010, hospital records and transfer/discharge summary was received. Service dates was 12-APR-2010 to 14-APR-2010. The diagnosis was diabetes mellitus. The patient presented with 1-2 week history of fatigue, polyuria, polydipsia, intermittent headache, abdominal pain and nausea, 8 lb weight loss. Insulin treatment was initiated. The patient was discharged home. Primary care physician medical records were received on 19-APR-2010. Service dates was 17-MAR-2010 to 12-APR-2010. Assessment was diabetes. The patient felt more tired, very thirsty, drinking lots of water and getting up at night to void multiple times. The patient did not feel well, and had dry tacky (oral) mucous membranes. The following lab tests were performed: serum glucose was 506 which was high, whole blood glucose was 330 which was high, urine ketones was positive, urinalysis showed glucose of 2000+, ketones large, sodium was 132 which was low, chloride was 93 which was low. The patient required an emergency room visit. No further information is available. Diabetes mellitus, hyperglycemia, fatigue, polyuria, polydipsia, intermittent headache, abdominal pain, nausea, very thirsty, does not feel well, dry tacky mucous membranes and drinking lots of water and getting up at night to void multiple times were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 385346. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of GARDASIL. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Blood chloride normal, Blood glucose increased, Blood sodium decreased, Diabetes mellitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with a history of warts treated by dermatologist, fracture foot and varicella post vaccine who on 17-MAR-2010, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 662300/0100Y). There was no pre existing illness. On 13-APR-2010, the patient experienced new onset diabetes mellitus and hyperglycemia. Serum glucose was 506. The patient was hospitalized for 24 hours and treated with IV fluids, insulin and education. On 20-APR-2010, hospital records and transfer/discharge summary was received. Service dates was 12-APR-2010 to 14-APR-2010. The diagnosis was diabetes mellitus. The patient presented with 1-2 week history of fatigue, polyuria, polydipsia, intermittent headache, abdominal pain and nausea, 8 lb weight loss. Insulin treatment was initiated. The patient was discharged home. Primary care physician medical records were received on 19-APR-2010. Service dates was 17-MAR-2010 to 12-APR-2010. Assessment was diabetes. The patient felt more tired, very thirsty, drinking lots of water and getting up at night to void multiple times. The patient did not feel well, and had dry tacky (oral) mucous membranes. The following lab tests were performed: serum glucose was 506 which was high, whole blood glucose was 330 which was high, urine ketones was positive, urinalysis showed glucose of 2000+, ketones large, sodium was 132 which was low, chloride was 93 which was low. The patient required an emergency room visit. No further information is available. Diabetes mellitus, hyperglycemia, fatigue, polyuria, polydipsia, intermittent headache, abdominal pain, nausea, very thirsty, does not feel well, dry tacky mucous membranes and drinking lots of water and getting up at night to void multiple times were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 385346. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of GARDASIL. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Glucose urine present, Headache, Hyperglycaemia, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with a history of warts treated by dermatologist, fracture foot and varicella post vaccine who on 17-MAR-2010, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 662300/0100Y). There was no pre existing illness. On 13-APR-2010, the patient experienced new onset diabetes mellitus and hyperglycemia. Serum glucose was 506. The patient was hospitalized for 24 hours and treated with IV fluids, insulin and education. On 20-APR-2010, hospital records and transfer/discharge summary was received. Service dates was 12-APR-2010 to 14-APR-2010. The diagnosis was diabetes mellitus. The patient presented with 1-2 week history of fatigue, polyuria, polydipsia, intermittent headache, abdominal pain and nausea, 8 lb weight loss. Insulin treatment was initiated. The patient was discharged home. Primary care physician medical records were received on 19-APR-2010. Service dates was 17-MAR-2010 to 12-APR-2010. Assessment was diabetes. The patient felt more tired, very thirsty, drinking lots of water and getting up at night to void multiple times. The patient did not feel well, and had dry tacky (oral) mucous membranes. The following lab tests were performed: serum glucose was 506 which was high, whole blood glucose was 330 which was high, urine ketones was positive, urinalysis showed glucose of 2000+, ketones large, sodium was 132 which was low, chloride was 93 which was low. The patient required an emergency room visit. No further information is available. Diabetes mellitus, hyperglycemia, fatigue, polyuria, polydipsia, intermittent headache, abdominal pain, nausea, very thirsty, does not feel well, dry tacky mucous membranes and drinking lots of water and getting up at night to void multiple times were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 385346. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of GARDASIL. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Mucosal dryness, Nausea, Pollakiuria, Polydipsia, Polyuria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with a history of warts treated by dermatologist, fracture foot and varicella post vaccine who on 17-MAR-2010, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 662300/0100Y). There was no pre existing illness. On 13-APR-2010, the patient experienced new onset diabetes mellitus and hyperglycemia. Serum glucose was 506. The patient was hospitalized for 24 hours and treated with IV fluids, insulin and education. On 20-APR-2010, hospital records and transfer/discharge summary was received. Service dates was 12-APR-2010 to 14-APR-2010. The diagnosis was diabetes mellitus. The patient presented with 1-2 week history of fatigue, polyuria, polydipsia, intermittent headache, abdominal pain and nausea, 8 lb weight loss. Insulin treatment was initiated. The patient was discharged home. Primary care physician medical records were received on 19-APR-2010. Service dates was 17-MAR-2010 to 12-APR-2010. Assessment was diabetes. The patient felt more tired, very thirsty, drinking lots of water and getting up at night to void multiple times. The patient did not feel well, and had dry tacky (oral) mucous membranes. The following lab tests were performed: serum glucose was 506 which was high, whole blood glucose was 330 which was high, urine ketones was positive, urinalysis showed glucose of 2000+, ketones large, sodium was 132 which was low, chloride was 93 which was low. The patient required an emergency room visit. No further information is available. Diabetes mellitus, hyperglycemia, fatigue, polyuria, polydipsia, intermittent headache, abdominal pain, nausea, very thirsty, does not feel well, dry tacky mucous membranes and drinking lots of water and getting up at night to void multiple times were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 385346. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of GARDASIL. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thirst, Urine analysis abnormal, Urine ketone body present, Weight decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with a history of warts treated by dermatologist, fracture foot and varicella post vaccine who on 17-MAR-2010, was vaccinated with the third dose of GARDASIL IM into her left arm (lot # 662300/0100Y). There was no pre existing illness. On 13-APR-2010, the patient experienced new onset diabetes mellitus and hyperglycemia. Serum glucose was 506. The patient was hospitalized for 24 hours and treated with IV fluids, insulin and education. On 20-APR-2010, hospital records and transfer/discharge summary was received. Service dates was 12-APR-2010 to 14-APR-2010. The diagnosis was diabetes mellitus. The patient presented with 1-2 week history of fatigue, polyuria, polydipsia, intermittent headache, abdominal pain and nausea, 8 lb weight loss. Insulin treatment was initiated. The patient was discharged home. Primary care physician medical records were received on 19-APR-2010. Service dates was 17-MAR-2010 to 12-APR-2010. Assessment was diabetes. The patient felt more tired, very thirsty, drinking lots of water and getting up at night to void multiple times. The patient did not feel well, and had dry tacky (oral) mucous membranes. The following lab tests were performed: serum glucose was 506 which was high, whole blood glucose was 330 which was high, urine ketones was positive, urinalysis showed glucose of 2000+, ketones large, sodium was 132 which was low, chloride was 93 which was low. The patient required an emergency room visit. No further information is available. Diabetes mellitus, hyperglycemia, fatigue, polyuria, polydipsia, intermittent headache, abdominal pain, nausea, very thirsty, does not feel well, dry tacky mucous membranes and drinking lots of water and getting up at night to void multiple times were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID# is 385346. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of GARDASIL. Additional information will be provided upon finalization of this manufacturing investigation.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Abdominal X-ray, Crying, Diet refusal, Enema administration, Eosinophil percentage
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Haematochezia, Haematocrit decreased, Haemoglobin decreased, Intussusception, Lymphocyte count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Monocyte percentage, Platelet count increased, Ultrasound abdomen abnormal, Vomiting, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Abdominal pain, Crying, Enema administration, Intussusception, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Surgery, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Crying, Diet refusal, Eosinophil percentage
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Eosinophil percentage increased, Granulocyte percentage, Haematochezia, Haematocrit decreased, Haemoglobin normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Intussusception, Lymphocyte percentage, Monocyte percentage, Platelet count increased, Sleep disorder
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, RV5, UNK, DTAPIPVHIB, HEPA, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Urine output decreased, Vomiting, White blood cell count increased, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 19-APR-2010 a 12 week old male patient with a history of Normal Spontaneous Vaginal Delivery (NSVD) (no complications), family history of cardiac disease (fatal myocardial infarction (MI) in 15 year old uncle) and seborrheic dermatitis was vaccinated with a first dose of ROTATEQ (lot number 665021/1612Y) by mouth. Concomitant vaccinations given on the same day included a first dose of PENTACEL (Lot number C3591AA) IM in the right leg, a second dose of HAVRIX (lot number AHBVB818BA) in the left leg IM and a first dose of PREVNAR (lot number E15305) in the right leg IM. The patient experienced sudden onset of loud intermittent crying spells for 2 days, non bloody/non bilious emesis and refusal to take oral (PO) for 1 day. At 5:00 am on 20-APR-2010 the mother brought the baby to the emergency department where he had normal physical exam but an abdominal x-ray (prone and supine) suspicious for intussusception. An abdominal ultrasound at 9:30 am revealed ileocolic intussusception successfully reduced by subsequent air enema. The patient had a currant jelly stool (for 1 day) prior to ultrasound. The patient was observed for 24 hours with one further currant jelly stool and later normal stool and was able to take PO. There was no recurrence of intussusception. The patient also experienced sleep disturbance, vomiting for 1 day and decreased urine output. It was reported that the vaccinations had been delayed due to illness at 2 months. The patient was admitted overnight status post (s/p) air enema reduction. The patient progressed well and was discharged home. Laboratory test performed included: white blood cell count 19.5 with 69.7% granulocytes, 23.6% lymphocytes, 5.4% monocytes and 1.1% eosinophils; hemoglobin 10.5, hematocrit 31.1%, platelets 599. At the time of the report the patient's outcome for granulocyte count increased, sleep disorder and urine output decreased was unknown. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ROTATEQ. Additional information will be provided upon finalization of this manufacturing investigation. The listing indicated that one or more of the events required hospitalization and were considered life threatening. The original reporting source was not provided. The VAERS ID # 385839. No further information is available.
Age: 68.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Neuralgia, Pain in extremity, Surgery
Clinical narrative: Date 2009 October 6 Received seasonal flu shot in upper left arm. October 8 Left index finger and thumb became numb. October 9 Pain started in left arm below shot site. October 11 Started applying heat and Ice packs. October 12 Consulted a chiropractor. October 14 Consulted a chiropractor. October 15 Arm became sore. October 16 Consulted a chiropractor. October 17 Pain worsened. October 19 Consulted a chiropractor, attempted to get an MRI but arm went into a painful spasm. October 22 MRI completed. October 26 Pain worsened, Consulted a chiropractor. October 28, Consulted a chiropractor. October 30 Consulted a chiropractor. November 1 Horrible Pain in arm. November 6 Consulted a chiropractor, applied LIDODERM patch. November 10 Less pain but armed started itching and feeling heavy. November 13 Consulted neurosurgeon - prescribed B6 complex. November 16 Consulted a chiropractor. November 18 Consulted a chiropractor. November 20 Itching lessened. December During month pain and itching eased but numbness in finger and thumb continued. January No change. February 6,10,15&17 Consulted a chiropractor. February 18 Pain and itching ceased numbness remained. March 2 Itching resumes. March 10 Consulted a surgeon who conducted a nerve testing using a pressure sensitive sensory device. March 22 Saw surgeon who referred me for an EMG test. March 24 Lab studies done. March 29 EMG test conducted. April 16 Saw surgeon again. May 10 Saw surgeon, who then set surgery date. May 20 Outpatient surgery of the left arm. June 10 At the filing of this report the numbness in the left hand is not resolved. The surgeon stated that it may take months for the nerves to regain their conductivity and full function of the hand realized. Full function may not be achieved and I may be permanently disabled.
Age: 68.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Electromyogram abnormal, Hypoaesthesia, Laboratory test, Muscle spasms, Nerve conduction studies abnormal
Clinical narrative: Date 2009 October 6 Received seasonal flu shot in upper left arm. October 8 Left index finger and thumb became numb. October 9 Pain started in left arm below shot site. October 11 Started applying heat and Ice packs. October 12 Consulted a chiropractor. October 14 Consulted a chiropractor. October 15 Arm became sore. October 16 Consulted a chiropractor. October 17 Pain worsened. October 19 Consulted a chiropractor, attempted to get an MRI but arm went into a painful spasm. October 22 MRI completed. October 26 Pain worsened, Consulted a chiropractor. October 28, Consulted a chiropractor. October 30 Consulted a chiropractor. November 1 Horrible Pain in arm. November 6 Consulted a chiropractor, applied LIDODERM patch. November 10 Less pain but armed started itching and feeling heavy. November 13 Consulted neurosurgeon - prescribed B6 complex. November 16 Consulted a chiropractor. November 18 Consulted a chiropractor. November 20 Itching lessened. December During month pain and itching eased but numbness in finger and thumb continued. January No change. February 6,10,15&17 Consulted a chiropractor. February 18 Pain and itching ceased numbness remained. March 2 Itching resumes. March 10 Consulted a surgeon who conducted a nerve testing using a pressure sensitive sensory device. March 22 Saw surgeon who referred me for an EMG test. March 24 Lab studies done. March 29 EMG test conducted. April 16 Saw surgeon again. May 10 Saw surgeon, who then set surgery date. May 20 Outpatient surgery of the left arm. June 10 At the filing of this report the numbness in the left hand is not resolved. The surgeon stated that it may take months for the nerves to regain their conductivity and full function of the hand realized. Full function may not be achieved and I may be permanently disabled.
Age: 68.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Pruritus, Sensation of heaviness, Surgery
Clinical narrative: Date 2009 October 6 Received seasonal flu shot in upper left arm. October 8 Left index finger and thumb became numb. October 9 Pain started in left arm below shot site. October 11 Started applying heat and Ice packs. October 12 Consulted a chiropractor. October 14 Consulted a chiropractor. October 15 Arm became sore. October 16 Consulted a chiropractor. October 17 Pain worsened. October 19 Consulted a chiropractor, attempted to get an MRI but arm went into a painful spasm. October 22 MRI completed. October 26 Pain worsened, Consulted a chiropractor. October 28, Consulted a chiropractor. October 30 Consulted a chiropractor. November 1 Horrible Pain in arm. November 6 Consulted a chiropractor, applied LIDODERM patch. November 10 Less pain but armed started itching and feeling heavy. November 13 Consulted neurosurgeon - prescribed B6 complex. November 16 Consulted a chiropractor. November 18 Consulted a chiropractor. November 20 Itching lessened. December During month pain and itching eased but numbness in finger and thumb continued. January No change. February 6,10,15&17 Consulted a chiropractor. February 18 Pain and itching ceased numbness remained. March 2 Itching resumes. March 10 Consulted a surgeon who conducted a nerve testing using a pressure sensitive sensory device. March 22 Saw surgeon who referred me for an EMG test. March 24 Lab studies done. March 29 EMG test conducted. April 16 Saw surgeon again. May 10 Saw surgeon, who then set surgery date. May 20 Outpatient surgery of the left arm. June 10 At the filing of this report the numbness in the left hand is not resolved. The surgeon stated that it may take months for the nerves to regain their conductivity and full function of the hand realized. Full function may not be achieved and I may be permanently disabled.
Age: 0.45
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test, Diarrhoea, Stool analysis, Urine analysis, Vomiting
Clinical narrative: Vomiting and diarrhea severely. Was taken to hospital for IV hydration and monitoring x2 days.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Discomfort, Eye swelling, Lip swelling, Pyrexia, Rash generalised
Clinical narrative: Within 4 hrs of receiving several immunization, patient became drowsy uncomfortable with full body rash, hives, lips and eyes swelling, low grade fever; lasted approximately 2 days.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Somnolence, Urticaria
Clinical narrative: Within 4 hrs of receiving several immunization, patient became drowsy uncomfortable with full body rash, hives, lips and eyes swelling, low grade fever; lasted approximately 2 days.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Auricular swelling, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Severe pain at site plus great swelling visible to anyone fron site to left side of neck up into ear area.  Lasted through 06/13/2010.  Began to subside 06/12/2010.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood creatinine decreased, Blood urea decreased, Headache, Platelet count normal, Pyrexia
Clinical narrative: Less than 24 hrs after Tdap and meningococcal vaccine received, pt began with vomiting, severe headache, Temp of 104 degrees.  Went to ER.  Given IV fluids & was in ER 5 hrs.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting, White blood cell count
Clinical narrative: Less than 24 hrs after Tdap and meningococcal vaccine received, pt began with vomiting, severe headache, Temp of 104 degrees.  Went to ER.  Given IV fluids & was in ER 5 hrs.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Irritability postvaccinal
Clinical narrative: Infant presented with moderate fussiness at approximately 2 pm (about 3 1/2 hours after vaccination). No fever. After a dose of Acetaminophen she fell asleep with less fussiness.
Age: 16.0
Sex: F
Vaccine: HEPA, IPV, MMR, TDAP
Symptoms: Eyelid disorder, Feeling hot, Hyperhidrosis, Pallor, Tremor
Clinical narrative: CLIENT RECEIVED VACCINES TDAP, HEPATITIS A, MMR, AND POLIO. 10 OR 15 MIN AFTER VACCINATION CLIENT'S MOTHER COMES BACK FROM ANOTHER AREA INTO THE LOBBY AND SEES HER DAUGHTER'S WAS UNRESPONSIVE, EYES CLOSED, BODY SHAKING ALL OVER.  CALLED FOR A NURSE AND NURSE ARRIVED.  CLIENT STILL UNRESPONSIVE WITH EYES CLOSED SITTING IN A CHAIR AND BODY STILL SHAKING EVERYWHERE.  ONE MIN LATER CLIENT STARTED TO GRADUALLY OPEN EYES AND BREATHING RESUMING BACK TO NORMAL.  VITAL SIGNS TAKEN AND STABLE.  PATIENT PALE IN COLOR AND HEAVILY PERSPIRING AND STATED SHE WAS VERY HOT.  WAS PLACED IN WHEEL CHAIR BY NURSE FOR SUPPORT AND MOVED TO ANOTHER ROOM AWAITING THE AMBULANCE TO GO TO MEDICAL CENTER.