chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, HPV4, MNQ, TTOX, HPV4, MNQ, TTOX
Symptoms: Pharyngolaryngeal pain, Photopsia
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA00708) on 19 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is in follow-up to report(s) previously submitted on 4/10/2007. Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot# 65532210091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included tetanus toxoid and MENACTRA. On 03-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. Follow up information from the physician indicated that at the time of vaccination, the physician was "unaware of the reactions the patient had experienced following exposure to the pertussis vaccine and sulfa as these occurred when the patient was a small child." The physician clarified that he did not consider the events to be life threatening, but confirmed that the patient would not receive additional doses of Gardasil. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be life threatening, and an other medical event. Additional has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, HPV4, MNQ, TTOX, HPV4, MNQ, TTOX
Symptoms: Hypotension, Paraesthesia oral, Throat irritation, Vision blurred
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA00708) on 19 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is in follow-up to report(s) previously submitted on 4/10/2007. Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot# 65532210091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included tetanus toxoid and MENACTRA. On 03-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. Follow up information from the physician indicated that at the time of vaccination, the physician was "unaware of the reactions the patient had experienced following exposure to the pertussis vaccine and sulfa as these occurred when the patient was a small child." The physician clarified that he did not consider the events to be life threatening, but confirmed that the patient would not receive additional doses of Gardasil. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be life threatening, and an other medical event. Additional has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, HPV4, MNQ, TTOX, HPV4, MNQ, TTOX
Symptoms: Hypotension, Paraesthesia, Paraesthesia oral, Vision blurred
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA00708) on 19 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "This is in follow-up to report(s) previously submitted on 4/10/2007. Information has been received from a physician, concerning a 14 year old female patient with a drug hypersensitivity to pertussis and a sulfonamide allergy, who on 03-APR-2007 was vaccinated with the first dose of Gardasil (Lot# 65532210091U) (dose and route not provided). Concomitant vaccines administered on 03-APR-2007 included tetanus toxoid and MENACTRA. On 03-APR-2007, the patient experienced blurry vision, tingling in her mouth and throat, and low blood pressure (not specified) "within 30 seconds of vaccination with Gardasil. The patient was given epinephrine and albuterol in the physician's office, and was then sent to the ER. Treatment in the ER included steroids (unspecified). The physician indicated that the patient recovered on the same day, 03-APR-2007. Follow up information from the physician indicated that at the time of vaccination, the physician was "unaware of the reactions the patient had experienced following exposure to the pertussis vaccine and sulfa as these occurred when the patient was a small child." The physician clarified that he did not consider the events to be life threatening, but confirmed that the patient would not receive additional doses of Gardasil. The physician considered the blurry vision, tingling of the mouth and throat, and low blood pressure to be life threatening, and an other medical event. Additional has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Lethargy, Rash
Clinical narrative: Faint and flushed within 5 min of vaccines then hives scattered all over with overlying flushed skin itching no swelling or wheezing. Palm sized hive at site of Varivax
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Chills, Cough, Dyspnoea, Flushing, Hypersensitivity
Clinical narrative: Faint and flushed within 5 min of vaccines then hives scattered all over with overlying flushed skin itching no swelling or wheezing. Palm sized hive at site of Varivax
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hypotension, Injection site urticaria, Lethargy, Rash, Sneezing
Clinical narrative: Faint and flushed within 5 min of vaccines then hives scattered all over with overlying flushed skin itching no swelling or wheezing. Palm sized hive at site of Varivax
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Faint and flushed within 5 min of vaccines then hives scattered all over with overlying flushed skin itching no swelling or wheezing. Palm sized hive at site of Varivax
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Chills, Cough, Flushing, Injection site urticaria, Sneezing
Clinical narrative: Faint and flushed within 5 min of vaccines then hives scattered all over with overlying flushed skin itching no swelling or wheezing. Palm sized hive at site of Varivax
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Flushing, Injection site urticaria, Pruritus, Syncope
Clinical narrative: Faint and flushed within 5 min of vaccines then hives scattered all over with overlying flushed skin itching no swelling or wheezing. Palm sized hive at site of Varivax
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Bacteria stool identified, Carbon dioxide decreased, Culture stool positive, Gastrointestinal haemorrhage, Haematocrit decreased
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haemoglobin decreased, Heart rate increased, Intensive care, Intestinal resection, Intussusception
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Lethargy, Livedo reticularis, Red blood cell count decreased, Surgery, Swelling
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Gangrene, Life support, Peritonitis, Rectal haemorrhage, Small intestinal resection
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception, Small intestinal resection
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Bacteria stool identified, Carbon dioxide decreased, Gastrointestinal haemorrhage, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Heart rate increased, Intussusception, Lethargy, Life support, Livedo reticularis
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Rectal haemorrhage, Red blood cell count decreased, Small intestinal resection, Stool analysis abnormal, Swelling
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00977. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a health professional concerning a 9 week old male, with no medical history and no allergies, who on 23-MAR-2007 at 10:00AM (also reported as 9:30AM) was vaccinated PO with a first 2 ml oral dose of Rotateq (Lot# 655484/1032F). There was no illness at the time of vaccination. Concomitant vaccines administered on the same day included a dose of Daptacel (Lot# C2553AA) administered IM in the right leg, IPOL (Lot# Y1031-2) administered IM in the left leg, a dose of Comvax (Lot# 655210/1242F) administered IM in the right leg, and a dose of Prevnar (Lot# B08670C) administered IM in the left leg. On 28-MAR-2007 at 9:00AM, 5 days after administration of the Rotateq, the patient developed rectal bleeding and was taken to the emergency room. The patient was air lifted from the emergency room to the hospital and was admitted. A small bowel resection was performed on 03-APR-2007. The reporter did not have any additional information about the patient's diagnosis. The patient was placed on antibiotic therapy and at the time of the report was still on life support in critical condition. No product quality complaint was involved. No other information was provided. There was no adverse events following prior vaccinations of the patient or his siblings." "Follow-up information was received indicated that the patient presented with a GI bleed 3 days post vaccination and became lethargic and mottled, and had severe swelling. The patient was taken to the emergency department on 28-MAR-2007. On arrival, his heart rate was 180-200; C. diff was positive in stool; RBC-2.47; HGB/HCT=7.8/21.5; and C02=18. He was later found with acute intussusception and the bowel was resected. At the time of the report, the patient was in the PICU. The reported also considered the event to be life-threatening and disabling and other important medical event. Lot check have been requested. Additional information has been requested."
Age: 0.61
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Abdominal pain, Abnormal behaviour, Barium double contrast, Haematocrit decreased, Haemoglobin normal
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00385. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 7-month-old male who on 15-MAR-2007, at 1145, was vaccinated PO with the second 2.0 mL dose of Rotateq (lot# 653980/0285F). Illness at the time of vaccination included a cough. Vaccines administered on 27-Feb-2007, at 1500, included the third IM dose of ActHib (Lot# UE928AA), the third IM dose of Pediarix (Lot# AC21B066AA) and the third IM dose of Prevnar (Lot# B3625F). The physician reported that on 26-MAR-2007, at 2200, 11 days after receiving the second dose, the patient presented with abdominal pain. An abdominal ultrasound was compatible with ileocolic intussusception. The patient was taken to the Emergency Room (ER) where he had successful hydrostatic reduction with a contrast enema. The patient was hospitalized for one day. On 27-MAR-2007, the patient was noted to be recovered." "Additional follow-up information received via medical records indicated that the patient had no known allergies, no significant medical history, illnesses or hospitalizations and presented to the ER on 26-MAR-2007 with a history of wincing, biting lip, wiggling and bending at the hips then becoming lethargic ovary 3-10 minutes for seven hours. The patient did not have any fever, nausea, vomiting, diarrhea, hematemesis, change in bowel habits, melena, abdominal distention or bloody stools. He had not decreased urine output. The patient had no history of any activity similar to his current events. On examination, the patient was well developed, well nourished and in no acute distress. His abdomen was soft, nondistended and nontender without masses or organomegaly. A WBC was 12.96, Hbg 9.8, Hct 29.6 and platelets were 302. An abdominal ultrasound revealed ileocecal intussusception which was successfully reduced." "The physician also considered the intussusception to be an other important medical event. Additional information has been requested."
Age: 0.61
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Intussusception, Platelet count normal, Ultrasound abdomen abnormal, White blood cell count increased
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA00385. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 7-month-old male who on 15-MAR-2007, at 1145, was vaccinated PO with the second 2.0 mL dose of Rotateq (lot# 653980/0285F). Illness at the time of vaccination included a cough. Vaccines administered on 27-Feb-2007, at 1500, included the third IM dose of ActHib (Lot# UE928AA), the third IM dose of Pediarix (Lot# AC21B066AA) and the third IM dose of Prevnar (Lot# B3625F). The physician reported that on 26-MAR-2007, at 2200, 11 days after receiving the second dose, the patient presented with abdominal pain. An abdominal ultrasound was compatible with ileocolic intussusception. The patient was taken to the Emergency Room (ER) where he had successful hydrostatic reduction with a contrast enema. The patient was hospitalized for one day. On 27-MAR-2007, the patient was noted to be recovered." "Additional follow-up information received via medical records indicated that the patient had no known allergies, no significant medical history, illnesses or hospitalizations and presented to the ER on 26-MAR-2007 with a history of wincing, biting lip, wiggling and bending at the hips then becoming lethargic ovary 3-10 minutes for seven hours. The patient did not have any fever, nausea, vomiting, diarrhea, hematemesis, change in bowel habits, melena, abdominal distention or bloody stools. He had not decreased urine output. The patient had no history of any activity similar to his current events. On examination, the patient was well developed, well nourished and in no acute distress. His abdomen was soft, nondistended and nontender without masses or organomegaly. A WBC was 12.96, Hbg 9.8, Hct 29.6 and platelets were 302. An abdominal ultrasound revealed ileocecal intussusception which was successfully reduced." "The physician also considered the intussusception to be an other important medical event. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 15-JAN-2007 was vaccinated with the first dose of Rotateq (Lot# 654664/0726F). Concomitant vaccinations administered that day included PEDVAXHIB (Lot # 652502/0719R), PREVNAR (Lot # B08684H), PEDIARIX (Lot # AC21B059DA). Other concomitant medication included TYLENOL. There was no illness at time of vaccination. The patient experienced a one day history of bloody stools and emesis with decreased appetite. On 21-JAN-2007, the patient developed intussusception and was hospitalized. The patient was admitted on 21-JAN-2007 to 25-JAN-2007. The patient had an x-ray performed (results not provided). The patient had an abdominal ultrasound which revealed intussusception. An air contrast barium enema failed x 4. Previously it was reported that six days later, the patient required surgery. The patient's hospitalization lasted 5 days. Surgery consult was done and the patient was taken to the operating room for an exploratory lapratomy and ileocecectomy with primary anastomosis. During surgery there was diffuse purulent fluid found in peritoneum with necrotic intussusception. The patient progressed well and was discharged home. The final diagnosis was intussusception, surgically reduced. Subsequently, the patient recovered from intussusception (date not specified). The records of testing prior to release of the lot in question (lot # 654664/0726F) has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium double contrast, Barium enema, Decreased appetite, Gastrointestinal necrosis, Haematochezia
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 15-JAN-2007 was vaccinated with the first dose of Rotateq (Lot# 654664/0726F). Concomitant vaccinations administered that day included PEDVAXHIB (Lot # 652502/0719R), PREVNAR (Lot # B08684H), PEDIARIX (Lot # AC21B059DA). Other concomitant medication included TYLENOL. There was no illness at time of vaccination. The patient experienced a one day history of bloody stools and emesis with decreased appetite. On 21-JAN-2007, the patient developed intussusception and was hospitalized. The patient was admitted on 21-JAN-2007 to 25-JAN-2007. The patient had an x-ray performed (results not provided). The patient had an abdominal ultrasound which revealed intussusception. An air contrast barium enema failed x 4. Previously it was reported that six days later, the patient required surgery. The patient's hospitalization lasted 5 days. Surgery consult was done and the patient was taken to the operating room for an exploratory lapratomy and ileocecectomy with primary anastomosis. During surgery there was diffuse purulent fluid found in peritoneum with necrotic intussusception. The patient progressed well and was discharged home. The final diagnosis was intussusception, surgically reduced. Subsequently, the patient recovered from intussusception (date not specified). The records of testing prior to release of the lot in question (lot # 654664/0726F) has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intestinal anastomosis, Intussusception, Laparotomy, Purulent discharge, Surgery
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 15-JAN-2007 was vaccinated with the first dose of Rotateq (Lot# 654664/0726F). Concomitant vaccinations administered that day included PEDVAXHIB (Lot # 652502/0719R), PREVNAR (Lot # B08684H), PEDIARIX (Lot # AC21B059DA). Other concomitant medication included TYLENOL. There was no illness at time of vaccination. The patient experienced a one day history of bloody stools and emesis with decreased appetite. On 21-JAN-2007, the patient developed intussusception and was hospitalized. The patient was admitted on 21-JAN-2007 to 25-JAN-2007. The patient had an x-ray performed (results not provided). The patient had an abdominal ultrasound which revealed intussusception. An air contrast barium enema failed x 4. Previously it was reported that six days later, the patient required surgery. The patient's hospitalization lasted 5 days. Surgery consult was done and the patient was taken to the operating room for an exploratory lapratomy and ileocecectomy with primary anastomosis. During surgery there was diffuse purulent fluid found in peritoneum with necrotic intussusception. The patient progressed well and was discharged home. The final diagnosis was intussusception, surgically reduced. Subsequently, the patient recovered from intussusception (date not specified). The records of testing prior to release of the lot in question (lot # 654664/0726F) has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray
Clinical narrative: Information has been received concerning a 9 week old male with no medical history or allergies who on 15-JAN-2007 was vaccinated with the first dose of Rotateq (Lot# 654664/0726F). Concomitant vaccinations administered that day included PEDVAXHIB (Lot # 652502/0719R), PREVNAR (Lot # B08684H), PEDIARIX (Lot # AC21B059DA). Other concomitant medication included TYLENOL. There was no illness at time of vaccination. The patient experienced a one day history of bloody stools and emesis with decreased appetite. On 21-JAN-2007, the patient developed intussusception and was hospitalized. The patient was admitted on 21-JAN-2007 to 25-JAN-2007. The patient had an x-ray performed (results not provided). The patient had an abdominal ultrasound which revealed intussusception. An air contrast barium enema failed x 4. Previously it was reported that six days later, the patient required surgery. The patient's hospitalization lasted 5 days. Surgery consult was done and the patient was taken to the operating room for an exploratory lapratomy and ileocecectomy with primary anastomosis. During surgery there was diffuse purulent fluid found in peritoneum with necrotic intussusception. The patient progressed well and was discharged home. The final diagnosis was intussusception, surgically reduced. Subsequently, the patient recovered from intussusception (date not specified). The records of testing prior to release of the lot in question (lot # 654664/0726F) has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information is not expected.
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Cardiac enzymes increased, Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation
Clinical narrative: Vaccinated March 2007, Admitted to Cardiology in April 2007. Patient had chest pain: EKG with ST elevation, cath negative for CAD.
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Hypokinesia, Injection site inflammation, Myopericarditis, Pericardial effusion
Clinical narrative: Vaccinated March 2007, Admitted to Cardiology in April 2007. Patient had chest pain: EKG with ST elevation, cath negative for CAD.
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Ventricular hypokinesia
Clinical narrative: Vaccinated March 2007, Admitted to Cardiology in April 2007. Patient had chest pain: EKG with ST elevation, cath negative for CAD.
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation, Hypokinesia, Troponin increased
Clinical narrative: Vaccinated March 2007, Admitted to Cardiology in April 2007. Patient had chest pain: EKG with ST elevation, cath negative for CAD.
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Ultrasound scan abnormal
Clinical narrative: Vaccinated March 2007, Admitted to Cardiology in April 2007. Patient had chest pain: EKG with ST elevation, cath negative for CAD.
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Vaccinated March 2007, Admitted to Cardiology in April 2007. Patient had chest pain: EKG with ST elevation, cath negative for CAD.
Age: 18.0
Sex: M
Vaccine: HEPAB, JEV, SMALL, TYP
Symptoms: Dizziness, Nausea
Clinical narrative: NAUSIA AND DIZZINESS
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram, Electrocardiogram ST segment elevation, Pericarditis, Troponin increased
Clinical narrative: Patient admitted on 29 Jan 2007 by Dr. for pericarditis.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever to 103 24 hours after the immunization febrile seizure lasting 5 minutes at that time and again in 30 minutes. Treated with antipyretics. No current sequelae or symptoms at this time
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Carpal tunnel syndrome, Electromyogram normal, Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Initial report received from a health care professional on 02 November 2006. A 42 year old, male patient experienced pain and paraesthesia after he received an injection of Fluzone (lot number U2194AA) in the left deltoid (route and date of administration not reported). The pain was severe that he took Vicodin. The patient was referred to a neurologist. At the time of the report, the patient did not recover. Follow-up information received on 27 December 2006. Fluzone SV 2006-2007 was administered intramuscularly on 16 October 2006. Immediately post-vaccination, the patient experienced numbness and tingling of the chest wall and arm pain. The patient continues with pain. He had improved markedly and then symptoms reappeared. He was treated with therapy, a prednisone dose pack, and Darvocet. Unspecified x-rays were negative, and an EMG was negative. The patient was to follow-up with a neurologist. At the time of this report, the patient had not recovered. Follow-up information received on 20 April 2007. The patient had an EMG performed on 17 November 2006. The referring neurologist had the following impression: Musculoskeletal pain with a suggestion of possible very subtle brachial neuritis which was completely improved. The EMG nerve conduction study did not show any suggestion of neuritis when done. He has a very subtle left arm median neuropathy as seen in carpal tunnel syndrome. This would require further follow-up before any interventions. This case is upgraded to serious adverse event internally based on follow-up information.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination abnormal, Neuropathy, Pain in extremity, Paraesthesia, Radiculitis brachial
Clinical narrative: Initial report received from a health care professional on 02 November 2006. A 42 year old, male patient experienced pain and paraesthesia after he received an injection of Fluzone (lot number U2194AA) in the left deltoid (route and date of administration not reported). The pain was severe that he took Vicodin. The patient was referred to a neurologist. At the time of the report, the patient did not recover. Follow-up information received on 27 December 2006. Fluzone SV 2006-2007 was administered intramuscularly on 16 October 2006. Immediately post-vaccination, the patient experienced numbness and tingling of the chest wall and arm pain. The patient continues with pain. He had improved markedly and then symptoms reappeared. He was treated with therapy, a prednisone dose pack, and Darvocet. Unspecified x-rays were negative, and an EMG was negative. The patient was to follow-up with a neurologist. At the time of this report, the patient had not recovered. Follow-up information received on 20 April 2007. The patient had an EMG performed on 17 November 2006. The referring neurologist had the following impression: Musculoskeletal pain with a suggestion of possible very subtle brachial neuritis which was completely improved. The EMG nerve conduction study did not show any suggestion of neuritis when done. He has a very subtle left arm median neuropathy as seen in carpal tunnel syndrome. This would require further follow-up before any interventions. This case is upgraded to serious adverse event internally based on follow-up information.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Initial report received from a health care professional on 02 November 2006. A 42 year old, male patient experienced pain and paraesthesia after he received an injection of Fluzone (lot number U2194AA) in the left deltoid (route and date of administration not reported). The pain was severe that he took Vicodin. The patient was referred to a neurologist. At the time of the report, the patient did not recover. Follow-up information received on 27 December 2006. Fluzone SV 2006-2007 was administered intramuscularly on 16 October 2006. Immediately post-vaccination, the patient experienced numbness and tingling of the chest wall and arm pain. The patient continues with pain. He had improved markedly and then symptoms reappeared. He was treated with therapy, a prednisone dose pack, and Darvocet. Unspecified x-rays were negative, and an EMG was negative. The patient was to follow-up with a neurologist. At the time of this report, the patient had not recovered. Follow-up information received on 20 April 2007. The patient had an EMG performed on 17 November 2006. The referring neurologist had the following impression: Musculoskeletal pain with a suggestion of possible very subtle brachial neuritis which was completely improved. The EMG nerve conduction study did not show any suggestion of neuritis when done. He has a very subtle left arm median neuropathy as seen in carpal tunnel syndrome. This would require further follow-up before any interventions. This case is upgraded to serious adverse event internally based on follow-up information.
Age: 54.0
Sex: F
Vaccine: HEPAB, MMR, TTOX
Symptoms: Antinuclear antibody increased, Antinuclear antibody positive, Argininosuccinate synthetase deficiency, Arthralgia, Back pain
Clinical narrative: Information has been received from a health professional concerning a 54 year old female with a history of penicillin allergy and mechanical low back pain who on 11-APR-2006 was vaccinated with dose of MMR II (lot # 649808/0488R). Concomitant vaccination included a dose of TWINRIX and tetanus toxoid. It was reported that the patient was vaccinated for overseas travel. Other concomitant medication included baby aspirin, calcium and ibuprofen. On 27-APR-2006 the patient developed swollen painful knees and was treated with anti inflammatory medications. On 28-APR-2006 she had red, swollen and painful wrists, hands and elbows. She was started on prednisone on 09-MAY-2006 for her painful joints and swollen hands. There was no product quality complaint involved. Additional information from the physician that indicated on 27-APR-2006 the patient woke up in th morning with severe pain in the right knee. She also complained of numerous other body aches that are associated with yoga. The patient denied any significant injury or trauma. She has had increased pain in her bands and wrist with numbness along the fourth and fifth digits bilaterally. The patient states at her job she dose a fair amount of hand work, no excessive keyboarding. No rashes or bruises were noted and vital signs were stable. The upper extremities were palpated. There was no pain over the ulnar tunnel. There was no pain tapping over the carpal tunnel. She had a negative Phalen's and negative Tinel's sign. She had normal strength distally. Normal sensation was noted distally. The knee was palpated and there was no laxity of the medical of lateral collateral ligaments and the ACL and PCL appeared intact. The impression was right knee pain and probable ulnar palsy. The physician suspected that the patient may have inflamed the ulnar nerve with her numbness and problems that she was having with her hand. The patient was treated conservatively; RELAFEN 75 BID was provided. Physical therapy was referred to help "calm down some of the inflammation". The patient was given recommendations to use an ACE wrap on her leg and hand. The physician also prescribed trazodone 50 mg Q HS to help her with sleep. On 01-MAY-2006 the physician spoke with the patient who was "doing better". The patient thought "it was related to vaccine for her international trip". She was till not 100%, but improving with physical therapy. She was seen at the clinic on 22-MAY-2006 and her knees were still swollen and she continued to take prescription anti inflammatory medications. At the time of the report the patient was recovering. The patient's experiences were considered to be disabling. Additional information has been requested.