chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAPHEPBIP, HIBV, IPV, PNC, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Information received on 19 April 2007 from another manufacturer, report# WAES0703USA05137. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician and a licensed practical nurse concerning a 6 month old Caucasian female who on 24-NOV-2006 was vaccinated with her first dose oral of Rotateq (human-bovine) (LOT# not provided). On 30-JAN-2007, she was vaccinated with her second dose oral of Rotateq (human-bovine) (LOT# 656105/1232F). Concomitant vaccinations on 30-JAN-2007, included Hib conj vaccination (LOT# 653770/0407F), PEDIARIX (LOT# AC14B40CA), PREVNAR (LOT# B08670K), and IPOL (LOT# Z0456). On 23-MAR-2007 (51 days after vaccination), the patient developed hematochezia and intussusception and was hospitalized. An air contrast enema and abdominal x-ray were performed. On 24-MAR-2007, the patient recovered from intussusception. The licensed practical nurse reported that the intussusception was life-threatening and was an other important medical event. There was no product quality complaint involved. Additional information has been requested." To be noted that this case is an overdosage as the patient received the same day 2 different vaccines containing IPV: Pediarix and IPOL.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAPHEPBIP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Haematochezia, Intussusception, Medication error
Clinical narrative: Information received on 19 April 2007 from another manufacturer, report# WAES0703USA05137. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician and a licensed practical nurse concerning a 6 month old Caucasian female who on 24-NOV-2006 was vaccinated with her first dose oral of Rotateq (human-bovine) (LOT# not provided). On 30-JAN-2007, she was vaccinated with her second dose oral of Rotateq (human-bovine) (LOT# 656105/1232F). Concomitant vaccinations on 30-JAN-2007, included Hib conj vaccination (LOT# 653770/0407F), PEDIARIX (LOT# AC14B40CA), PREVNAR (LOT# B08670K), and IPOL (LOT# Z0456). On 23-MAR-2007 (51 days after vaccination), the patient developed hematochezia and intussusception and was hospitalized. An air contrast enema and abdominal x-ray were performed. On 24-MAR-2007, the patient recovered from intussusception. The licensed practical nurse reported that the intussusception was life-threatening and was an other important medical event. There was no product quality complaint involved. Additional information has been requested." To be noted that this case is an overdosage as the patient received the same day 2 different vaccines containing IPV: Pediarix and IPOL.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAPHEPBIP, HIBV, IPV, PNC, RV5
Symptoms: Overdose
Clinical narrative: Information received on 19 April 2007 from another manufacturer, report# WAES0703USA05137. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician and a licensed practical nurse concerning a 6 month old Caucasian female who on 24-NOV-2006 was vaccinated with her first dose oral of Rotateq (human-bovine) (LOT# not provided). On 30-JAN-2007, she was vaccinated with her second dose oral of Rotateq (human-bovine) (LOT# 656105/1232F). Concomitant vaccinations on 30-JAN-2007, included Hib conj vaccination (LOT# 653770/0407F), PEDIARIX (LOT# AC14B40CA), PREVNAR (LOT# B08670K), and IPOL (LOT# Z0456). On 23-MAR-2007 (51 days after vaccination), the patient developed hematochezia and intussusception and was hospitalized. An air contrast enema and abdominal x-ray were performed. On 24-MAR-2007, the patient recovered from intussusception. The licensed practical nurse reported that the intussusception was life-threatening and was an other important medical event. There was no product quality complaint involved. Additional information has been requested." To be noted that this case is an overdosage as the patient received the same day 2 different vaccines containing IPV: Pediarix and IPOL.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound scan
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA01807. The initial reporter to this manufacturer had been the FDA, VAERS# 275776. Verbatim from the report: "Information has been received from the FDA (VAERS# 275776) through the CDC concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq (human-bovine) (lot# 654663/0942F). Concomitant vaccination administered that day included an IM dose of PEDIARIX (lot# AC2B069AA), and IM dose of ACTHIB (lot# UF063AA) and a dose of PREVNAR (lot# B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent an ultrasound which had findings consistent with intussusception. It was reportedly most likely ileal colonic and extended at least to the mis traverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. An air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediate reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. Additional information has been requested." ActHIB lot# UF063A corresponds to lot# Z1078-2.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ascites, Intubation, Intussusception, Large intestinal obstruction reduction, Sedation
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA01807. The initial reporter to this manufacturer had been the FDA, VAERS# 275776. Verbatim from the report: "Information has been received from the FDA (VAERS# 275776) through the CDC concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq (human-bovine) (lot# 654663/0942F). Concomitant vaccination administered that day included an IM dose of PEDIARIX (lot# AC2B069AA), and IM dose of ACTHIB (lot# UF063AA) and a dose of PREVNAR (lot# B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent an ultrasound which had findings consistent with intussusception. It was reportedly most likely ileal colonic and extended at least to the mis traverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. An air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediate reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. Additional information has been requested." ActHIB lot# UF063A corresponds to lot# Z1078-2.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Small intestinal intussusception reduction, Ultrasound abdomen abnormal
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA01807. The initial reporter to this manufacturer had been the FDA, VAERS# 275776. Verbatim from the report: "Information has been received from the FDA (VAERS# 275776) through the CDC concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq (human-bovine) (lot# 654663/0942F). Concomitant vaccination administered that day included an IM dose of PEDIARIX (lot# AC2B069AA), and IM dose of ACTHIB (lot# UF063AA) and a dose of PREVNAR (lot# B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent an ultrasound which had findings consistent with intussusception. It was reportedly most likely ileal colonic and extended at least to the mis traverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. An air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediate reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. Additional information has been requested." ActHIB lot# UF063A corresponds to lot# Z1078-2.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ascites, Barium double contrast, Intubation, Intussusception, Sedation
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA01807. The initial reporter to this manufacturer had been the FDA, VAERS# 275776. Verbatim from the report: "Information has been received from the FDA (VAERS# 275776) through the CDC concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq (human-bovine) (lot# 654663/0942F). Concomitant vaccination administered that day included an IM dose of PEDIARIX (lot# AC2B069AA), and IM dose of ACTHIB (lot# UF063AA) and a dose of PREVNAR (lot# B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent an ultrasound which had findings consistent with intussusception. It was reportedly most likely ileal colonic and extended at least to the mis traverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. An air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediate reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. Additional information has been requested." ActHIB lot# UF063A corresponds to lot# Z1078-2.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound scan abnormal
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA01807. The initial reporter to this manufacturer had been the FDA, VAERS# 275776. Verbatim from the report: "Information has been received from the FDA (VAERS# 275776) through the CDC concerning a 12 week old female with no medical history or allergies who on 19-MAR-2007 was vaccinated with a first PO dose of Rotateq (human-bovine) (lot# 654663/0942F). Concomitant vaccination administered that day included an IM dose of PEDIARIX (lot# AC2B069AA), and IM dose of ACTHIB (lot# UF063AA) and a dose of PREVNAR (lot# B08672E). On 27-MAR-2007 the patient experienced intussusception and was hospitalized. On 27-MAR-2007 the patient underwent an ultrasound which had findings consistent with intussusception. It was reportedly most likely ileal colonic and extended at least to the mis traverse colon. There was a small amount of abdominal ascites. There was no pyloric stenosis. An air reduction was performed. The pressure was maintained between 80 and 120 mm Hg. The intussusception was initially in the proximal transverse colon and immediately reduced to the cecum. However the final reduction could not be achieved despite multiple attempts. At that point anesthesis was called and the patient was intubated and sedated. Repeat insufitation resulted in fairly immediate reduction in the rematin intussusception with filing of the small bowel. The physician could not identify the terminal ileum but there was clear fill of the small bowel. The intussusception was successfully reduced. The patient recovered from intussusception. Additional information has been requested." ActHIB lot# UF063A corresponds to lot# Z1078-2.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Haematochezia, Muscle spasms, Surgery, Vomiting
Clinical narrative: Information received on 19 April 2007 from another manufacturer, report# WAES0704USA01857. The initial reporter to this manufacturer had been the FDA, VAERS# 275941. Verbatim from the report: "Information has been received from the FDA (VAERS# 275941) through the CDC concerning a 6-month-old female with no pre-existing physician-diagnosed allergies, birth defects, or medical conditions who on 04-APR-2007 at 4:00PM was vaccinated PO with the fourth dose of Rotateq (human-bovine). There was no illness at the time of vaccination. Concomitant therapy that day included a fourth dose of PEDIARIX (Lot# AC21V101AA) administered IM, a fourth dose of ACTHIB (Lot# UF088AA) administered IM, and a fourth dose of PREVNAR (Lot# B08684F) administered IM. There were no other concomitant therapies. On 05-APR-2007 at 17:00, the patient experienced vomiting. On 06-APR-2007, the patient experienced bloody stools, cramps, and abdominal pain and was hospitalized. On 06 April 2007, the patient had surgery. Additional information has been requested."
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastroenteritis viral, Haematochezia, Insomnia, Intestinal obstruction, Intestinal resection
Clinical narrative: Information received on 19 April 2007 from another manufacturer, report# WAES0704USA01857. The initial reporter to this manufacturer had been the FDA, VAERS# 275941. Verbatim from the report: "Information has been received from the FDA (VAERS# 275941) through the CDC concerning a 6-month-old female with no pre-existing physician-diagnosed allergies, birth defects, or medical conditions who on 04-APR-2007 at 4:00PM was vaccinated PO with the fourth dose of Rotateq (human-bovine). There was no illness at the time of vaccination. Concomitant therapy that day included a fourth dose of PEDIARIX (Lot# AC21V101AA) administered IM, a fourth dose of ACTHIB (Lot# UF088AA) administered IM, and a fourth dose of PREVNAR (Lot# B08684F) administered IM. There were no other concomitant therapies. On 05-APR-2007 at 17:00, the patient experienced vomiting. On 06-APR-2007, the patient experienced bloody stools, cramps, and abdominal pain and was hospitalized. On 06 April 2007, the patient had surgery. Additional information has been requested."
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Sleep disorder, Vomiting, X-ray abnormal
Clinical narrative: Information received on 19 April 2007 from another manufacturer, report# WAES0704USA01857. The initial reporter to this manufacturer had been the FDA, VAERS# 275941. Verbatim from the report: "Information has been received from the FDA (VAERS# 275941) through the CDC concerning a 6-month-old female with no pre-existing physician-diagnosed allergies, birth defects, or medical conditions who on 04-APR-2007 at 4:00PM was vaccinated PO with the fourth dose of Rotateq (human-bovine). There was no illness at the time of vaccination. Concomitant therapy that day included a fourth dose of PEDIARIX (Lot# AC21V101AA) administered IM, a fourth dose of ACTHIB (Lot# UF088AA) administered IM, and a fourth dose of PREVNAR (Lot# B08684F) administered IM. There were no other concomitant therapies. On 05-APR-2007 at 17:00, the patient experienced vomiting. On 06-APR-2007, the patient experienced bloody stools, cramps, and abdominal pain and was hospitalized. On 06 April 2007, the patient had surgery. Additional information has been requested."
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intestinal resection, Intussusception, Surgery
Clinical narrative: Information received on 19 April 2007 from another manufacturer, report# WAES0704USA01857. The initial reporter to this manufacturer had been the FDA, VAERS# 275941. Verbatim from the report: "Information has been received from the FDA (VAERS# 275941) through the CDC concerning a 6-month-old female with no pre-existing physician-diagnosed allergies, birth defects, or medical conditions who on 04-APR-2007 at 4:00PM was vaccinated PO with the fourth dose of Rotateq (human-bovine). There was no illness at the time of vaccination. Concomitant therapy that day included a fourth dose of PEDIARIX (Lot# AC21V101AA) administered IM, a fourth dose of ACTHIB (Lot# UF088AA) administered IM, and a fourth dose of PREVNAR (Lot# B08684F) administered IM. There were no other concomitant therapies. On 05-APR-2007 at 17:00, the patient experienced vomiting. On 06-APR-2007, the patient experienced bloody stools, cramps, and abdominal pain and was hospitalized. On 06 April 2007, the patient had surgery. Additional information has been requested."
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA01848. The initial reporter to this manufacturer had been the FDA, VAERS# 275949. Verbatim from the report: "Information has been received from the FDA (VAERS# 275949) through the CDC concerning a 24 week old female with no medical history or allergies who on 16-FEB-2007 was vaccinated with a PO second dose of Rotateq (human-bovine) (lot# 654969/1016F). Concomitant vaccination administered that day included an IM second dose of PEDIARIX (lot# AC21B070AA), an IM second dose of ACTHIB (lot# UF051AA) and an IM second dose of PREVNAR (lot# B018646F). There was no illness at the time of vaccination. On 09-APR-2007 the patient presented with bloody diarrhea and was diagnosed with intussusception which was surgically reduced. It was reported that there was no association. The patient recovered. Additional information has been requested." ActHIB lot# UF051AA corresponds to lot# Z0990-2.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception, Surgery
Clinical narrative: Initial report received on 19 April 2007 from another manufacturer, report# WAES0704USA01848. The initial reporter to this manufacturer had been the FDA, VAERS# 275949. Verbatim from the report: "Information has been received from the FDA (VAERS# 275949) through the CDC concerning a 24 week old female with no medical history or allergies who on 16-FEB-2007 was vaccinated with a PO second dose of Rotateq (human-bovine) (lot# 654969/1016F). Concomitant vaccination administered that day included an IM second dose of PEDIARIX (lot# AC21B070AA), an IM second dose of ACTHIB (lot# UF051AA) and an IM second dose of PREVNAR (lot# B018646F). There was no illness at the time of vaccination. On 09-APR-2007 the patient presented with bloody diarrhea and was diagnosed with intussusception which was surgically reduced. It was reported that there was no association. The patient recovered. Additional information has been requested." ActHIB lot# UF051AA corresponds to lot# Z0990-2.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthritis, Uveitis
Clinical narrative: Information has been received from a physician concerning a 17 year old female with anxiety who on 09-MAR-2007 was vaccinated intramuscularly with Gardasil (Lot#654389/0961F). Concomitant therapy included Celexa. At the time of vaccination the patient had mild pharyngitis. On 16-MAR-2007 the patient developed bilateral uveitis. The patient was treated with unspecified oral steroids and a periocular kenolg injection. The physician reported that the patient was evaluated for sarcoid which was negative. The patient was also evaluated for arthritis, at the time of this report the results were pending. The uveitis was considered an other medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Uveitis
Clinical narrative: Information has been received from a physician concerning a 17 year old female with anxiety who on 09-MAR-2007 was vaccinated intramuscularly with Gardasil (Lot#654389/0961F). Concomitant therapy included Celexa. At the time of vaccination the patient had mild pharyngitis. On 16-MAR-2007 the patient developed bilateral uveitis. The patient was treated with unspecified oral steroids and a periocular kenolg injection. The physician reported that the patient was evaluated for sarcoid which was negative. The patient was also evaluated for arthritis, at the time of this report the results were pending. The uveitis was considered an other medical event. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Body temperature increased, Chills, Erythema, Hyperhidrosis, Induration
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA02289) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included Adacel also given on 02-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested."
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA02289) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included Adacel also given on 02-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested."
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA02289) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included Adacel also given on 02-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested."
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Body temperature fluctuation, Body temperature increased, Chills, Erythema, Hyperhidrosis
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA02289) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included Adacel also given on 02-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested."
Age: 46.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Induration, Myalgia, Pyrexia
Clinical narrative: This case was received from another manufacturer (reference number WAES0704USA02289) on 26 April 2007. The following information is verbatim as it appears in the other manufacturer's report: "Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included Adacel also given on 02-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested."
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Raised, swollen, hot to touch, fever, yellow drainage
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Migraine, Pain, Photophobia
Clinical narrative: Increased temperature of 102 at times. Migraine, light sensitivity, body aches, chills. temperature lasting only few hours, migraine headache lasting approx 12 hours and patient continues to have migraine headache at time of reporting. Patient seen by military provider no tx at this time. Pt instructed rescue primary PCP if symptoms persist or worsen.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Mother noticed redness, swelling and itching this AM at injection site. Benadryl given per DR.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a school nurse concerning an approximately 16 year old female who on an unspecified date was vaccinated with a dose of Gardasil. Approximately 5 minutes after receiving the dose, the patient experienced a fainting spell and a seizure. Unspecified medical attention was sought. Subsequently, the patient recovered. Upon internal review, the patient's seizure was considered an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Cyanosis, Heart rate increased, Oxygen saturation, Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 12 month old male patient who on 25-JAN-2007 was vaccinated with ProQuad (LOT# 655748/1094F). There was no concomitant medication. On 01-FEB-2007 the patient developed a fever of 103F. On 02-FEB-2007 the patient experienced tachycardia with a heart rate of 208, turned blue around the lips and hands, and had periods of no breathing ("aptic episodes"). Also, the nurse mentioned that the patient's oxygen levels on room temperature air was 97% at the doctors office on 02-FEB-2007. That evening, the patient was admitted to the hospital. He was ordered on oxygen and observation at the hospital. Subsequently, the patient's symptoms resolved and he was discharged on 04-FEB-2007. The events were considered to be immediately life-threatening and other important medical events. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Respiratory arrest, Tachycardia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 12 month old male patient who on 25-JAN-2007 was vaccinated with ProQuad (LOT# 655748/1094F). There was no concomitant medication. On 01-FEB-2007 the patient developed a fever of 103F. On 02-FEB-2007 the patient experienced tachycardia with a heart rate of 208, turned blue around the lips and hands, and had periods of no breathing ("aptic episodes"). Also, the nurse mentioned that the patient's oxygen levels on room temperature air was 97% at the doctors office on 02-FEB-2007. That evening, the patient was admitted to the hospital. He was ordered on oxygen and observation at the hospital. Subsequently, the patient's symptoms resolved and he was discharged on 04-FEB-2007. The events were considered to be immediately life-threatening and other important medical events. There was no product quality complaint involved. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Cellulitis, Erythema, Rash
Clinical narrative: Information has been received from a physician concerning a 6 month old male with no pre-existing allergies, birth defects, or medical conditions who on 29-MAR-2007 at 6:00PM was vaccinated PO with a third dose of Rotateq (Lot # 656189/1239F). There was no illness at the time of vaccination. Concomitant therapy that day at 6:00PM included a third dose of IPOL (Lot # Z0326-2) administered IM in the left thigh, a third dose of Prevnar (Lot # B08640H) administered IM in the right thigh, and a third dose of Tripedia (Lot # C2552AA) administered IM in the left thigh. On 30-MAR-2007, one day after vaccination, the patient developed a rash around his rectum. The patient was seen 3 days later and had severe perirectal erythema. This was treated as cellulitis with improvement. No diarrhea was noted. The outcome was recovered on 09-APR-2007. There were no relevant diagnostic tests or laboratory date. There were no adverse events following prior vaccinations. The reporter considered the event to be an other important medical event. No additional information is expected.
Age: 0.51
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, IPV, PNC, RV5
Symptoms: Cellulitis, Erythema, Perianal erythema, Rash
Clinical narrative: Information has been received from a physician concerning a 6 month old male with no pre-existing allergies, birth defects, or medical conditions who on 29-MAR-2007 at 6:00PM was vaccinated PO with a third dose of Rotateq (Lot # 656189/1239F). There was no illness at the time of vaccination. Concomitant therapy that day at 6:00PM included a third dose of IPOL (Lot # Z0326-2) administered IM in the left thigh, a third dose of Prevnar (Lot # B08640H) administered IM in the right thigh, and a third dose of Tripedia (Lot # C2552AA) administered IM in the left thigh. On 30-MAR-2007, one day after vaccination, the patient developed a rash around his rectum. The patient was seen 3 days later and had severe perirectal erythema. This was treated as cellulitis with improvement. No diarrhea was noted. The outcome was recovered on 09-APR-2007. There were no relevant diagnostic tests or laboratory date. There were no adverse events following prior vaccinations. The reporter considered the event to be an other important medical event. No additional information is expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Heart rate decreased, Herpes zoster, Loss of consciousness
Clinical narrative: Information has been received from a medical receptionist concerning a 65 year old male with "sleeping issues" who on 26-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (lot # 656413/1477). Suspect therapy included lisinopril (manufacturer unknown), tablet (dose , duration and induration not reported). Other concomitant therapy Advair and Voltaren. There was no illness at the time of vaccination. The patient's wife reported that on the day of vaccination (after vaccination) the patient "didn't feel very good." On 11-MAR-2007 the patient reportedly passed out and stopped breathing. EMS was called and the patient was admitted to the hospital. It was also reported that the patient's heart rate dropped to 25. The patient did not have a detectable heart problem. On 15-MAR-2007 the patient was discharged from the hospital. On 22-MAR-2007 it was noted that the patient developed shingles on the left thigh and abdomen (the rash was described as both a shingles like rash and a varicella like rash but was diagnosed by the physician as shingles on 29-MAR-2007). Subsequently the patient was "recently" seen in the office and he was doing better but he still wasn't feeling great and still had some of the shingles rash. The patient was also still feeling "fluttering" in his neck and was sometimes lightheaded. The patient was still recovering from his hospitalization. On 01-MAY-2007 the patient passed out again and was hospitalized. The patient's status at that time was unknown. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Respiratory arrest
Clinical narrative: Information has been received from a medical receptionist concerning a 65 year old male with "sleeping issues" who on 26-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (lot # 656413/1477). Suspect therapy included lisinopril (manufacturer unknown), tablet (dose , duration and induration not reported). Other concomitant therapy Advair and Voltaren. There was no illness at the time of vaccination. The patient's wife reported that on the day of vaccination (after vaccination) the patient "didn't feel very good." On 11-MAR-2007 the patient reportedly passed out and stopped breathing. EMS was called and the patient was admitted to the hospital. It was also reported that the patient's heart rate dropped to 25. The patient did not have a detectable heart problem. On 15-MAR-2007 the patient was discharged from the hospital. On 22-MAR-2007 it was noted that the patient developed shingles on the left thigh and abdomen (the rash was described as both a shingles like rash and a varicella like rash but was diagnosed by the physician as shingles on 29-MAR-2007). Subsequently the patient was "recently" seen in the office and he was doing better but he still wasn't feeling great and still had some of the shingles rash. The patient was also still feeling "fluttering" in his neck and was sometimes lightheaded. The patient was still recovering from his hospitalization. On 01-MAY-2007 the patient passed out again and was hospitalized. The patient's status at that time was unknown. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Initial report received on 24 April 2007 from a healthcare professional. A seven-month-old female patient had received a second dose, left thigh, intramuscular injection of Daptacel, lot number C2552AA; a second dose, left thigh, intramuscular injection of IPOL, lot number 20324 (not a valid manufacturer lot number); a second dose, right thigh injection of Comvax, lot number 0999-F; a second dose, right thigh injection of Prevnar, lot number B08668; on 21 March 2007. On the same day that the patient was vaccinated, she developed a fever of 104.4 degrees Farenheit. She was evaluated in an emergency room and discharged. Two days later, she as re-evaluated and subsequently admitted to the hospital for a sepsis workup. The fever resolved, and the patient was discharged following a three day hospitalization. The patient recovered from the event.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception
Clinical narrative: Intussusception  5/15/07 Received vax records from reporter.  Lot numbers corrected in VAERS database.  RO lot number & dose confirmed by vax records.  5/25/07 Received medical records from hospital which reveal patient experienced emesis, bloody stools, abdominal pain & lethargy.  IS at right hepatic flexure diagnosed by abd US & reduced by barium enema.  Admitted 4/27 & d/c later same day after observation s/p IS reduction. Consult by peds surgery done. FINAL DX: Intussusception.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inappropriate schedule of drug administration, Medication error, Skin warm, Swelling
Clinical narrative: Pt received Zostavax SQ on 3/9/07. Pt called 3/12/07 to report a lager area on arm that is swollen, warm and red pt put on Benadryl PO Examined on 3/13/07 improved with Benadryl
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Pediarix, Prevnar, ActHib and Rotateq given on 4/25/07 about 12 noon developed irritability and redness of sites of all 3 vaccines at 1400 Tylenol given at 1600 expressive crying working at 1800. Resolved by 4/26/607 an (Noted low grade fever 4/26/07 at 1630)
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: Two weeks after receiving Gardasil vaccine pt developed leg/arm pain. Blood test showed + R.A. After course of steroids, blood test normalized. Rheumatologist suggested to pt to not get second Gardasil vaccine.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Rheumatoid factor increased
Clinical narrative: Two weeks after receiving Gardasil vaccine pt developed leg/arm pain. Blood test showed + R.A. After course of steroids, blood test normalized. Rheumatologist suggested to pt to not get second Gardasil vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Patient had 1-2 episode of emesis for 10-12 days after Rotavirus administration
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Report to Dr. 4-16-07 by School nurse that area of injection was red w/swelling.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal distension, Crying, Diarrhoea, Gastrointestinal tract mucosal discolouration
Clinical narrative: 04/20/07 watery diarrhea, distension and crying. 4/24/07 watery stools continue, some w/yellow mucoids, 4/30/07 office visit. Still 8-10 diarrheal stools/day. 5/1/07 stools decreasing in frequency and increasing in thickness.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Hardness, swelling and redness in Rt arm. Started Saturday and worsening swell. Seen in ER Sun given Atox.
Age: 87.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red swollen area over (R) arm. Area is red and swollen and warm. Area is nontender to touch. Rx for Augmentin 875 mg T bid #20 to be filled if not better in the next 24 period
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pharyngolaryngeal pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Fever 102F and sore throat 24 hour after vaccine about erythema and swelling both arm 1st day with mild tenderness.
Age: 11.0
Sex: M
Vaccine: MNQ, TD, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Large (5 cm x 5 cm) localized reaction-right deltoid 2 hr after Varicella vaccine
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Sore, swollen arm, sore swollen arm pit left arm - where shot was given, fever of 102 deg for 2 days, fever of 100 deg for 1 day, achiness - Flu like symptoms for 3 days, Took Advil 600mg every 6-8 hours.
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Sore, swollen arm, sore swollen arm pit left arm - where shot was given, fever of 102 deg for 2 days, fever of 100 deg for 1 day, achiness - Flu like symptoms for 3 days, Took Advil 600mg every 6-8 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Varicella
Clinical narrative: Pt acquired chicken pox within 5-7 days of vaccine
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Urticaria
Clinical narrative: Seen in office on 5/2/07 due to hive like rash on arms, face 1 hour after receiving Menactra on 5/1/07 Benadryl given with relief of rash. Rash reoccurred 5/2/07. NO SOB, no wheeze.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody positive, Asthenia, Dizziness
Clinical narrative: Dizzy and weak - "Feels flimsy" Everything Spinning. Still with symptoms 3 mo after vaccine.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Diarrhoea, Nausea, Vertigo
Clinical narrative: 3 days of vertigo nausea and Diaerria 2 weeks following small Pox administering Sy Resolved in 5  May 2007
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall, Head injury, Respiratory arrest, Syncope
Clinical narrative: Pt had syncopal episode 2 minutes after injection given. Fell and hit back of head-had seizure lasting 1 min was unresponsive, not breathing x 30 min. Administered ammonia pads and called 911
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt had syncopal episode 2 minutes after injection given. Fell and hit back of head-had seizure lasting 1 min was unresponsive, not breathing x 30 min. Administered ammonia pads and called 911
Age: 1.0
Sex: F
Vaccine: FLU3, MMRV, PNC
Symptoms: Injection site rash, Pyrexia, Varicella
Clinical narrative: 2/21/07-Mother called and stated that her daughter-(14 mths) received 3 vaccines on 2/6/07. She states her daughter had a reaction to vaccine and was told by her pediatrician to report reaction to health dept. First noticed 3 red dots on shoulder above vaccine site. Pt has been breaking out sporadically on face, neck and legs with chickenpox. Pt ran fever of 103F on 7th day after injection mother took child to doctor on 2/20/07 to examine rash.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Fever, Redness, swollen arm
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives, Cluster of 2 patients (patient identification provided) with generalized hives throughout the entire body, after receiving Adacel (lot number C2631AA); Fluzone (lot number unknown) and Menactra (lot number U1922AB); received from a health care professional in the USA on 24 April 2007. Case 1: A 12 year old, male patient (with a history of no known allergies) developed generalized hives throughout the entire body, 2 months after she received Adacel (lot number C2631AA), Fluzone (lot number unknown) and Menactra (lot number U1922AB) on 15 February 2007. He has the influenza vaccine annually. The patient denies any illness or medications at the time of the vaccinations. He was treated with Cortisone, Singular and Atarax. It was reported the hives resolved and the patient recovered. The second case ( the patient's sister) is detailed in Case 2007-01400.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives, cluster of 2 patients (patient identification provided) with generalized hives throughout the entire body, after receiving Adacel (lot number C2631AA); Fluzone (lot number unknown), and Menactra (lot number U1922AB), received from a health care professional in the USA on 24 April 2007. Case 1: An 11 year old, female patient ( with a history of no known allergies) developed generalized hives throughout the entire body, 1.1/2 months after she received Adacel (lot number C2631AA); Fluzone (lot number unknown), and Menactra (lot number U1922AB) and Gardasil (Merck, lot number 0014U ) on the 15 February 2007. She has the Fluzone vaccine annually. The patient denies any illness or medications at the time of the vaccinations. She was treated with Cortisone, Singulair and Atarax. It was reported the hives resolved and the patient recovered. The second case  (the patient 's brother ) is detailed in case 2007-01399.