chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Carbon dioxide decreased, Culture stool negative, Culture urine negative, Dehydration, Intussusception
Clinical narrative: Information has been received from the FDA (VAERS # 278302) through the CDC concerning an 8-month-old male who on 24-MAR-2007 was vaccinated with a third dose of Rotateq (Lot # 655865/1109F). Concomitant therapy included a second dose of Daptacel (Lot # 0249U0A), a second dose of Ipol (Lot # Z0240), and a second dose of Prevnar) (Lot # 808672E). On 30-APR-2007, 37 days post vaccination, the patient experienced intussusception. An air enema was done. Follow up information received from the FDA (VAERS # 278302) through the CDC indicated that the patient experienced vomiting, decreased oral intake, abdominal pain, and intermittent lethargy. He was admitted to the hospital from 30-APR-2007 to 03-MAY-2007 (4 days). He was treated with IVF for dehydration. A surgical consult was done. The intussusception was successfully reduced. He was observed status post reduction and progressed well. The final diagnosis was vomiting (resolved) and intussusception s/p reduction with air contrast enema. It was noted that the patient had otitis media days prior to admittance (on 22-APR-2007). Laboratory data included: NA=130, K=3; CO2=22; guaiac + stools; KUB and air contrast enema revealed intussusception was successfully reduced by air contrast enema; stool and urine culture were negative. The patient recovered. A standard lot check investigation was performed for Lot # 655865/1109F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biological Evaluation and Research and was released. The events were considered to be life-threatening by the reporter. Additional information has been requested. VAERS # 278302
Age: 0.67
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Lethargy, Occult blood positive, Oral intake reduced, Otitis media, Urinary system X-ray
Clinical narrative: Information has been received from the FDA (VAERS # 278302) through the CDC concerning an 8-month-old male who on 24-MAR-2007 was vaccinated with a third dose of Rotateq (Lot # 655865/1109F). Concomitant therapy included a second dose of Daptacel (Lot # 0249U0A), a second dose of Ipol (Lot # Z0240), and a second dose of Prevnar) (Lot # 808672E). On 30-APR-2007, 37 days post vaccination, the patient experienced intussusception. An air enema was done. Follow up information received from the FDA (VAERS # 278302) through the CDC indicated that the patient experienced vomiting, decreased oral intake, abdominal pain, and intermittent lethargy. He was admitted to the hospital from 30-APR-2007 to 03-MAY-2007 (4 days). He was treated with IVF for dehydration. A surgical consult was done. The intussusception was successfully reduced. He was observed status post reduction and progressed well. The final diagnosis was vomiting (resolved) and intussusception s/p reduction with air contrast enema. It was noted that the patient had otitis media days prior to admittance (on 22-APR-2007). Laboratory data included: NA=130, K=3; CO2=22; guaiac + stools; KUB and air contrast enema revealed intussusception was successfully reduced by air contrast enema; stool and urine culture were negative. The patient recovered. A standard lot check investigation was performed for Lot # 655865/1109F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biological Evaluation and Research and was released. The events were considered to be life-threatening by the reporter. Additional information has been requested. VAERS # 278302
Age: 0.67
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, RV5, DTAP, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from the FDA (VAERS # 278302) through the CDC concerning an 8-month-old male who on 24-MAR-2007 was vaccinated with a third dose of Rotateq (Lot # 655865/1109F). Concomitant therapy included a second dose of Daptacel (Lot # 0249U0A), a second dose of Ipol (Lot # Z0240), and a second dose of Prevnar) (Lot # 808672E). On 30-APR-2007, 37 days post vaccination, the patient experienced intussusception. An air enema was done. Follow up information received from the FDA (VAERS # 278302) through the CDC indicated that the patient experienced vomiting, decreased oral intake, abdominal pain, and intermittent lethargy. He was admitted to the hospital from 30-APR-2007 to 03-MAY-2007 (4 days). He was treated with IVF for dehydration. A surgical consult was done. The intussusception was successfully reduced. He was observed status post reduction and progressed well. The final diagnosis was vomiting (resolved) and intussusception s/p reduction with air contrast enema. It was noted that the patient had otitis media days prior to admittance (on 22-APR-2007). Laboratory data included: NA=130, K=3; CO2=22; guaiac + stools; KUB and air contrast enema revealed intussusception was successfully reduced by air contrast enema; stool and urine culture were negative. The patient recovered. A standard lot check investigation was performed for Lot # 655865/1109F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biological Evaluation and Research and was released. The events were considered to be life-threatening by the reporter. Additional information has been requested. VAERS # 278302
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Dehydration, Intussusception, Vomiting
Clinical narrative: Information has been received from the FDA (VAERS # 278583) through the CDC concerning a 9-month-old male with no history/pre-existing conditions who was vaccinated with a third dose of Rotateq (Lot # 655864/1082F). Concomitant therapy that day included a third dose of Pediarix (Lot # AC21B079BA), a third dose of Acthib (Lot # UF011AA), and a third dose of Prevnar (Lot # B08670E). There were no other concomitant medications. Subsequently the patient experienced intussusception and was hospitalized. Vomiting and dehydration were noted. Intussusception was reduced with air enema. The air enema diagnosed and reduced the obstruction. The patient recovered. A standard lot check investigation was performed for Lot # 655864/1082F. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigations was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the Center for Biologics Evaluation and Research and was released. Intussusception was considered life threatening by the reporter. Additional information has been requested.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium enema, Chest X-ray, Full blood count, Haematochezia
Clinical narrative: Information has been received from an agency concerning an 8 month old male with a history of asthma, undescended testicle and umbilical hernia and no known drug allergies who on 03-MAR-2007 was vaccinated with the fourth dose of Rotateq (Lot # 655317/0980F). Concomitant therapy included the third dose of Pediarix (Lot # AC21B069AA), the patient third dose of PedvaxHIB (Lot # 652705/1160R) and the third dose of Prevnar (Lot # B08658E). On 18-MAY-2007, the patient developed intermittent acute abdominal pain. On 19-MAY-2007, the patient presented to healthcare system with abdominal pain. The pain continued on 19-MAY-2007, and the infant passed a large bloody, mucusy, stool in the emergency department. Barium enema study was positive for intussusception, which was reduced per radiologist by air contrast barium enema. The patient was observed overnight. Subsequently, the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laboratory test, Mucous stools
Clinical narrative: Information has been received from an agency concerning an 8 month old male with a history of asthma, undescended testicle and umbilical hernia and no known drug allergies who on 03-MAR-2007 was vaccinated with the fourth dose of Rotateq (Lot # 655317/0980F). Concomitant therapy included the third dose of Pediarix (Lot # AC21B069AA), the patient third dose of PedvaxHIB (Lot # 652705/1160R) and the third dose of Prevnar (Lot # B08658E). On 18-MAY-2007, the patient developed intermittent acute abdominal pain. On 19-MAY-2007, the patient presented to healthcare system with abdominal pain. The pain continued on 19-MAY-2007, and the infant passed a large bloody, mucusy, stool in the emergency department. Barium enema study was positive for intussusception, which was reduced per radiologist by air contrast barium enema. The patient was observed overnight. Subsequently, the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Barium enema, Chest X-ray normal, Culture stool negative
Clinical narrative: Information has been received from an agency concerning an 8 month old male with a history of asthma, undescended testicle and umbilical hernia and no known drug allergies who on 03-MAR-2007 was vaccinated with the fourth dose of Rotateq (Lot # 655317/0980F). Concomitant therapy included the third dose of Pediarix (Lot # AC21B069AA), the patient third dose of PedvaxHIB (Lot # 652705/1160R) and the third dose of Prevnar (Lot # B08658E). On 18-MAY-2007, the patient developed intermittent acute abdominal pain. On 19-MAY-2007, the patient presented to healthcare system with abdominal pain. The pain continued on 19-MAY-2007, and the infant passed a large bloody, mucusy, stool in the emergency department. Barium enema study was positive for intussusception, which was reduced per radiologist by air contrast barium enema. The patient was observed overnight. Subsequently, the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Full blood count normal, Haematochezia, Intussusception, Laboratory test, Mucous stools
Clinical narrative: Information has been received from an agency concerning an 8 month old male with a history of asthma, undescended testicle and umbilical hernia and no known drug allergies who on 03-MAR-2007 was vaccinated with the fourth dose of Rotateq (Lot # 655317/0980F). Concomitant therapy included the third dose of Pediarix (Lot # AC21B069AA), the patient third dose of PedvaxHIB (Lot # 652705/1160R) and the third dose of Prevnar (Lot # B08658E). On 18-MAY-2007, the patient developed intermittent acute abdominal pain. On 19-MAY-2007, the patient presented to healthcare system with abdominal pain. The pain continued on 19-MAY-2007, and the infant passed a large bloody, mucusy, stool in the emergency department. Barium enema study was positive for intussusception, which was reduced per radiologist by air contrast barium enema. The patient was observed overnight. Subsequently, the patient recovered. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Intussusception, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: Information has been received from an agency concerning a 22 week male, with no medical history or pre-existing conditions, who on 02-APR-2007 was vaccinated with a second dose of Rotateq (655296/0979F). Vaccinations on the same day included a second dose of Pediarix (aC21B079AA), a second dose of Acthib (UF010AA), and second dose of Prevnar (B36258H). On 06-MAY-2007 the patient was taken to the emergency room. Abnormal X-ray of the abdomen. On 07-MAY-2007, ultrasound findings were highly suggestive of ileocolic intussusception. The patient was treated with air reduction. On 07-MAY-2007, post-airreduction ultrasound showed successful pneumatic reduction of ileocolic intussusception. X-ray of the abdomen showed relative paucity of gas in right abdomen and region of right and transverse colon. 07-JUN-2007, medical records were received from the facility for dates of service 08-MAY-2007 to 11-MAY-2007 revealed a discharge diagnosis of intussusception and a one day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood or mucous. The patient was refusing to eat and was seen in the ER. A lot check has been requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Diarrhoea, Diet refusal, Flatulence, Intussusception
Clinical narrative: Information has been received from an agency concerning a 22 week male, with no medical history or pre-existing conditions, who on 02-APR-2007 was vaccinated with a second dose of Rotateq (655296/0979F). Vaccinations on the same day included a second dose of Pediarix (aC21B079AA), a second dose of Acthib (UF010AA), and second dose of Prevnar (B36258H). On 06-MAY-2007 the patient was taken to the emergency room. Abnormal X-ray of the abdomen. On 07-MAY-2007, ultrasound findings were highly suggestive of ileocolic intussusception. The patient was treated with air reduction. On 07-MAY-2007, post-airreduction ultrasound showed successful pneumatic reduction of ileocolic intussusception. X-ray of the abdomen showed relative paucity of gas in right abdomen and region of right and transverse colon. 07-JUN-2007, medical records were received from the facility for dates of service 08-MAY-2007 to 11-MAY-2007 revealed a discharge diagnosis of intussusception and a one day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood or mucous. The patient was refusing to eat and was seen in the ER. A lot check has been requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from an agency concerning a 22 week male, with no medical history or pre-existing conditions, who on 02-APR-2007 was vaccinated with a second dose of Rotateq (655296/0979F). Vaccinations on the same day included a second dose of Pediarix (aC21B079AA), a second dose of Acthib (UF010AA), and second dose of Prevnar (B36258H). On 06-MAY-2007 the patient was taken to the emergency room. Abnormal X-ray of the abdomen. On 07-MAY-2007, ultrasound findings were highly suggestive of ileocolic intussusception. The patient was treated with air reduction. On 07-MAY-2007, post-airreduction ultrasound showed successful pneumatic reduction of ileocolic intussusception. X-ray of the abdomen showed relative paucity of gas in right abdomen and region of right and transverse colon. 07-JUN-2007, medical records were received from the facility for dates of service 08-MAY-2007 to 11-MAY-2007 revealed a discharge diagnosis of intussusception and a one day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood or mucous. The patient was refusing to eat and was seen in the ER. A lot check has been requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Barium double contrast, Barium enema, Diarrhoea
Clinical narrative: Information has been received from an agency concerning a 22 week male, with no medical history or pre-existing conditions, who on 02-APR-2007 was vaccinated with a second dose of Rotateq (655296/0979F). Vaccinations on the same day included a second dose of Pediarix (aC21B079AA), a second dose of Acthib (UF010AA), and second dose of Prevnar (B36258H). On 06-MAY-2007 the patient was taken to the emergency room. Abnormal X-ray of the abdomen. On 07-MAY-2007, ultrasound findings were highly suggestive of ileocolic intussusception. The patient was treated with air reduction. On 07-MAY-2007, post-airreduction ultrasound showed successful pneumatic reduction of ileocolic intussusception. X-ray of the abdomen showed relative paucity of gas in right abdomen and region of right and transverse colon. 07-JUN-2007, medical records were received from the facility for dates of service 08-MAY-2007 to 11-MAY-2007 revealed a discharge diagnosis of intussusception and a one day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood or mucous. The patient was refusing to eat and was seen in the ER. A lot check has been requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received from an agency concerning a 22 week male, with no medical history or pre-existing conditions, who on 02-APR-2007 was vaccinated with a second dose of Rotateq (655296/0979F). Vaccinations on the same day included a second dose of Pediarix (aC21B079AA), a second dose of Acthib (UF010AA), and second dose of Prevnar (B36258H). On 06-MAY-2007 the patient was taken to the emergency room. Abnormal X-ray of the abdomen. On 07-MAY-2007, ultrasound findings were highly suggestive of ileocolic intussusception. The patient was treated with air reduction. On 07-MAY-2007, post-airreduction ultrasound showed successful pneumatic reduction of ileocolic intussusception. X-ray of the abdomen showed relative paucity of gas in right abdomen and region of right and transverse colon. 07-JUN-2007, medical records were received from the facility for dates of service 08-MAY-2007 to 11-MAY-2007 revealed a discharge diagnosis of intussusception and a one day history of emesis, nonbilious, nonbloody and multiple episodes of diarrhea with no blood or mucous. The patient was refusing to eat and was seen in the ER. A lot check has been requested. A review of the initial release testing for the lot number in question was found to conform to specifications. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Convulsion
Clinical narrative: Seizure lasting at 2 minutes and urinary incontinence at 5 minutes of non responsiveness.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Unresponsive to stimuli
Clinical narrative: Seizure lasting at 2 minutes and urinary incontinence at 5 minutes of non responsiveness.
Age: 11.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Seizure lasting at 2 minutes and urinary incontinence at 5 minutes of non responsiveness.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Contraception, Convulsion, Drug screen negative, Full blood count normal
Clinical narrative: Seizure occured 4 days after the vaccine was administered.  Eyes open, loss of bladder, wheezing, trembling/shaking.  CT Scan, blood work and urinalysis after episode were all normal.  Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up.  Pediatrician sent Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and indicative of future seizures. The EEG results were normal.  Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine taken prior to the episode.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Laboratory test normal, Loss of consciousness, Mood swings, Pain, Pollakiuria
Clinical narrative: Seizure occured 4 days after the vaccine was administered.  Eyes open, loss of bladder, wheezing, trembling/shaking.  CT Scan, blood work and urinalysis after episode were all normal.  Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up.  Pediatrician sent Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and indicative of future seizures. The EEG results were normal.  Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine taken prior to the episode.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Pregnancy test urine negative, Respiratory arrest, Urinary incontinence, Urine analysis normal
Clinical narrative: Seizure occured 4 days after the vaccine was administered.  Eyes open, loss of bladder, wheezing, trembling/shaking.  CT Scan, blood work and urinalysis after episode were all normal.  Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up.  Pediatrician sent Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and indicative of future seizures. The EEG results were normal.  Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine taken prior to the episode.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Drug screen negative, Full blood count normal, Laboratory test normal
Clinical narrative: Seizure occured 4 days after the vaccine was administered.  Eyes open, loss of bladder, wheezing, trembling/shaking.  CT Scan, blood work and urinalysis after episode were all normal.  Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up.  Pediatrician sent Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and indicative of future seizures. The EEG results were normal.  Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine taken prior to the episode.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Respiratory arrest, Urinary incontinence, Urine analysis normal
Clinical narrative: Seizure occured 4 days after the vaccine was administered.  Eyes open, loss of bladder, wheezing, trembling/shaking.  CT Scan, blood work and urinalysis after episode were all normal.  Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up.  Pediatrician sent Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and indicative of future seizures. The EEG results were normal.  Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine taken prior to the episode.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Tremor
Clinical narrative: Seizure occured 4 days after the vaccine was administered.  Eyes open, loss of bladder, wheezing, trembling/shaking.  CT Scan, blood work and urinalysis after episode were all normal.  Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up.  Pediatrician sent Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and indicative of future seizures. The EEG results were normal.  Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine taken prior to the episode.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Urinary incontinence, Urine analysis normal, Wheezing
Clinical narrative: Seizure occured 4 days after the vaccine was administered.  Eyes open, loss of bladder, wheezing, trembling/shaking.  CT Scan, blood work and urinalysis after episode were all normal.  Physician at ER said 90 percent sure it was a seizure and referred us to family pediatrician for follow up.  Pediatrician sent Sydney for EEG to see if there was any abnormal brainwave activity, indicating that the seizure might be indicitive of something other than the vaccine and indicative of future seizures. The EEG results were normal.  Pediatrician stated that the seizure is likely a one time episode..possibly related to the vaccine taken prior to the episode.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 102 rash resembling Rubella
Age: 0.1
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Nasal congestion, Rash
Clinical narrative: Rash on neck, back, head but without itchiness, stuffy nose.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Death, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2-month-old patient who was vaccinated with a dose of Rotateq (lot number not provided). Concomitant therapy on that same day included "several other shots" (not further specified). The physician reported that, within 24 hours of vaccination, the patient had bloody stools and within 48 hours died. Upon internal review, bloody stools was determined to be an other important medical event. No further information is available.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Bronchitis, Condition aggravated
Clinical narrative: Information has been received from a physician concerning an 88 year old male with a history of aortic stenosis who on 30-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included "a lot of medications" (therapy unspecified). On 15-MAY-2007 the patient experienced exacerbated bronchitis and was admitted to the hospital. The patient's exacerbated bronchitis persisted. The reporter felt that exacerbated bronchitis was not related to therapy with Zostavax. No product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Kawasaki's disease, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who on 12-JAN-2007 and 13-MAR-2007 was vaccinated PO with the first and second doses, respectively, of Rotateq (lot number not reported). The physician reported that on 02-MAY-2007, the patient developed a fever. On 09-MAY-2007, the patient was admitted to the hospital where a diagnosis of Kawasaki's disease was made. At the time of this report, the outcome was unknown. The physician noted that the patient would not receive the third dose of Rotateq. Additional information has been requested.  07/16/2007 MR received for admission 5/10-13/2007 of a child who presented with a 9 day hx of fever, rash, and swelling of hands and feet. Rash was on head, chest, and abdomen.  Child's lips were dry, red and cracked, and conjuctival injection was present. Several episodes of vomiting the week before.  (+) peeling skin. Txd with Ig infusion and ASA. Discharge DX: Kawasaki Disease.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Deep vein thrombosis, Drug exposure during pregnancy, Dyspnoea, Laboratory test
Clinical narrative: Information has been received from the Merck Pregnancy Registry from a physician concerning a 17 year old female with no pertinent medical history who on 06-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 656049/0187U). The patient was prescribed ethinyl estradiol (+) norgestimate (ORTHO TRI-CYCLEN) on the day she received the vaccination, but the reporter did not have any information regarding whether the patient was taking them or not. It was later learned that the patient was pregnancy when she received the vaccination. On 07-APR-2007, the patient experienced shortness of breath. On 14-APR-2007, she was hospitalized due to shortness of breath. It was later determined that the patient was experiencing a blood clot in her left leg, deep vein thrombosis (DVT). On 16-APR-2007, the hospital determined that the patient was 11 weeks and 1 day pregnant. The estimated date of delivery was 04-NOV-2007. Subsequently, the patient had an abortion performed for personal reasons not related to the vaccine. On 14-JUN-2007, the patient had not recovered from the blood clot and the reporter indicated that an unspecified blood thinner was recommended as treatment. At the time of the report, the blood clot persisted. The physician considered shortness of breath, abortion and blood clot in left leg to be other important medical events. The physician considered shortness of breath and blood clot in left leg to be immediately life threatening events. Additional information has been requested. 7/11/07-ER records received for DOS 4/14/07-DX: Recently diagnosed deep venous thrombosis. Possible pulmonary embolism. DX of blood clot 2 weeks prior. 4/14/07-attempted to terminate pregnancy, 12 weeks pregnant. Procedure not performed. C/O dyspnes on exertion. RX with Lovenox. No chest pain. Left let swelling and tenderness especially in popliteal fossa this has been ongoing for 2-3 weeks.  8/24/07-records received for DOS 04/07-04/10/07- DC DX: Deep venous thrombosis, left lower extremity. Intrauterine pregnancy. Status post trauma. Hypercoagulable state. Found to have a DVT of the lower extremity. Seen on 4/07/07-HX of few days before admission falling off the tub in the bathroom and hurting her legs.  PE: tenderness and swelling in left lower extremity at level of calf and distal area of left thigh. Peripheral pulses present.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Thrombosis
Clinical narrative: Information has been received from the Merck Pregnancy Registry from a physician concerning a 17 year old female with no pertinent medical history who on 06-MAR-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot # 656049/0187U). The patient was prescribed ethinyl estradiol (+) norgestimate (ORTHO TRI-CYCLEN) on the day she received the vaccination, but the reporter did not have any information regarding whether the patient was taking them or not. It was later learned that the patient was pregnancy when she received the vaccination. On 07-APR-2007, the patient experienced shortness of breath. On 14-APR-2007, she was hospitalized due to shortness of breath. It was later determined that the patient was experiencing a blood clot in her left leg, deep vein thrombosis (DVT). On 16-APR-2007, the hospital determined that the patient was 11 weeks and 1 day pregnant. The estimated date of delivery was 04-NOV-2007. Subsequently, the patient had an abortion performed for personal reasons not related to the vaccine. On 14-JUN-2007, the patient had not recovered from the blood clot and the reporter indicated that an unspecified blood thinner was recommended as treatment. At the time of the report, the blood clot persisted. The physician considered shortness of breath, abortion and blood clot in left leg to be other important medical events. The physician considered shortness of breath and blood clot in left leg to be immediately life threatening events. Additional information has been requested. 7/11/07-ER records received for DOS 4/14/07-DX: Recently diagnosed deep venous thrombosis. Possible pulmonary embolism. DX of blood clot 2 weeks prior. 4/14/07-attempted to terminate pregnancy, 12 weeks pregnant. Procedure not performed. C/O dyspnes on exertion. RX with Lovenox. No chest pain. Left let swelling and tenderness especially in popliteal fossa this has been ongoing for 2-3 weeks.  8/24/07-records received for DOS 04/07-04/10/07- DC DX: Deep venous thrombosis, left lower extremity. Intrauterine pregnancy. Status post trauma. Hypercoagulable state. Found to have a DVT of the lower extremity. Seen on 4/07/07-HX of few days before admission falling off the tub in the bathroom and hurting her legs.  PE: tenderness and swelling in left lower extremity at level of calf and distal area of left thigh. Peripheral pulses present.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient, Dizziness, Mydriasis
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who was vaccinated (date not specified) with the first dose of Gardasil, and following vaccination, felt like she was going to faint. The physician confirmed that the patient did not actually faint, though she had dilated pupils and she "lost sight" for approximately 10 minutes. The patient was instructed to lie down for 10 minutes, and then reported "she was okay." Upon internal review, "lost sight for approximately 10 minutes," was determined to be serious as an other important medical event. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Abnormal sensation in eye, Ear discomfort, Full blood count
Clinical narrative: We received via Vaccine Information Service the following information: A 24-year-old female patient, born on 9 JUL 1982, had a bat in her house that did not bite her, however it did hit her on the right shoulder. Therefore she received her first dose of RabAvert with one dose of HRIG on 17 JUN 2007. On 20 JUN 2007 at 1 a.m. the patient was presented to hospital with pressure behind her eyes and ears. A CBC was done which showed 8000 WBC and 50% lymphocytes. A dose of Solumedrol was administered. We are awaiting further information. Preliminary company assessment. Seriousness criterion: hospitalisation. Causality: pending. Expectedness assessment according to SPC: The reported symptoms are not expected after vaccination with RabAvert. No change in benefit-risk-ratio. No measure necessary. VIS no. NA07-002157
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: The patient was an athlete in peak condition. She was being treated for amenorrhea in Aug 2006 with PROVERA followed by YASMIN at the time of the first administration of Gardasil. After 10/16/06 administration of Gardasil she dropped from 120 lbs to 88 lbs by 1/15/07. She was hospitalized 2/14/07 for one week. Her condition was never diagnosed. Unexplained weight loss. 10/18/07-records received for DOS 2/12-2/26/07- DC DX: Weight Loss. Absence of Menstruation. 30 pound weight loss since October 2006, denies appetite changes. No nausea no vomiting, no abdominal pain, no headache. Denies being depressed.  Stopped taking pills in September 2006 and has had no periods since that day.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Kawasaki's disease
Clinical narrative: Kawasaki disease IVIG.  7/6/07 Received vax records from pcp which confirms RO dose & lot# as reported.  7/17/07 Received hospital medical records which reveal patient experienced fever, irritability, extremity swelling, diarrhea, decreased oral intake x 1 week, then a rash, foot swelling, red eyes, rhinorrhea & persistent diarrhea on day of admission.  Admitted 4/21-4/25/07.  ID, cardiology & rheumatology consults done.  Tx w/IVIG & ASA w/good improvement.  D/C to home on continued ASA after afebrile x 36 hrs to cardio & pcp f/u. FINAL DX: Kawasaki Disease.
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Contusion, Full blood count, Haematology test, Haematoma, Otitis media
Clinical narrative: Mom returned to office 6/7/07 for follow OM with covering PCP noted petechiae with multi scalp/head hematoma OM unresolved. Referred to ER was hospitalized x 3 days. Bruising of body and swelling right parietal from banging of head on concrete 2 days PTA. Follow up hematologist at facility after discharge.  7/6/07 Received office notes from pcp which indicate patient seen 4/18/07 for cough & pulling at left ear. Tx for otitis media.  No office note of 5/21/07.  7/17/07 Received hospital medical records which reveal patient experienced petechial rash when seen on routine f/u exam for OM by PCP.  Sent to hospital & admitted 6/7-6/10/07.   Heme consult done.  Patient had fallen/bumped head x 2 in week prior to admit.   Tx w/IVIG.  Responded well & d/c to home w/f/u by heme & pcp.  Returned to ER on 6/10 s/p vomiting & continued petechiae.  Plts at that time were 232,000. Final ER dx: vomiting as reaction likely due to IVIG.  D/C to home w/heme & pcp f/u.    FINAL DX: Immune Thrombocytopenic Purpura.
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Petechiae, Platelet count decreased, Reticulocyte count increased, Scan brain, Swelling
Clinical narrative: Mom returned to office 6/7/07 for follow OM with covering PCP noted petechiae with multi scalp/head hematoma OM unresolved. Referred to ER was hospitalized x 3 days. Bruising of body and swelling right parietal from banging of head on concrete 2 days PTA. Follow up hematologist at facility after discharge.  7/6/07 Received office notes from pcp which indicate patient seen 4/18/07 for cough & pulling at left ear. Tx for otitis media.  No office note of 5/21/07.  7/17/07 Received hospital medical records which reveal patient experienced petechial rash when seen on routine f/u exam for OM by PCP.  Sent to hospital & admitted 6/7-6/10/07.   Heme consult done.  Patient had fallen/bumped head x 2 in week prior to admit.   Tx w/IVIG.  Responded well & d/c to home w/f/u by heme & pcp.  Returned to ER on 6/10 s/p vomiting & continued petechiae.  Plts at that time were 232,000. Final ER dx: vomiting as reaction likely due to IVIG.  D/C to home w/heme & pcp f/u.    FINAL DX: Immune Thrombocytopenic Purpura.
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Immunoglobulins, Thrombocytopenic purpura
Clinical narrative: Mom returned to office 6/7/07 for follow OM with covering PCP noted petechiae with multi scalp/head hematoma OM unresolved. Referred to ER was hospitalized x 3 days. Bruising of body and swelling right parietal from banging of head on concrete 2 days PTA. Follow up hematologist at facility after discharge.  7/6/07 Received office notes from pcp which indicate patient seen 4/18/07 for cough & pulling at left ear. Tx for otitis media.  No office note of 5/21/07.  7/17/07 Received hospital medical records which reveal patient experienced petechial rash when seen on routine f/u exam for OM by PCP.  Sent to hospital & admitted 6/7-6/10/07.   Heme consult done.  Patient had fallen/bumped head x 2 in week prior to admit.   Tx w/IVIG.  Responded well & d/c to home w/f/u by heme & pcp.  Returned to ER on 6/10 s/p vomiting & continued petechiae.  Plts at that time were 232,000. Final ER dx: vomiting as reaction likely due to IVIG.  D/C to home w/heme & pcp f/u.    FINAL DX: Immune Thrombocytopenic Purpura.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: 4 x 4 cutaneous reaction at site of HPV injection.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abnormal faeces, Culture stool, Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: Loose stools with blood and mucous off and one since 4 days after vaccine for rotavirus - mom noticed foul smell to stools also. Afebrile, feeding well. No treatment at this time pt improving.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site inflammation, Lymphadenopathy, Myalgia, Syncope, Syncope vasovagal
Clinical narrative: 1. Fainting/vasovagal at vaccine administration, 2. Inflammatory response at vaccine site R deltoid with moderate myalgia and axillary lymphadenopathy
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Anxiety, Culture throat negative, Nausea, Palpitations, Pharyngolaryngeal pain
Clinical narrative: Sore throat, palpitations, nausea, anxiety
Age: 11.0
Sex: F
Vaccine: MNQ, PPV, TDAP, VARCEL
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Seen in office 6/26/07 with R arm swelling induration and warm at Menactra and PPV 23 injection sites (given on 6/25/07) Afebrile, c/o pain in L arm. MD instructed ice area, Motrin, Benadryl to call increased redness, swelling, fever.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Mydriasis, Pallor, Syncope
Clinical narrative: After receiving Gardasil at about 920am the pt stated R arm felt weird then turned pale, eyes dilated and fainted. Dr was called into the room immediately and examined pt and observed her for 45-50 min, then pt acted normal and went home.
Age: 8.0
Sex: M
Vaccine: HEPA, MEN, VARCEL, YF
Symptoms: Agitation, Mental status changes, Urticaria
Clinical narrative: Child received travel vaccines, within 1 hour had severe hive reaction and severe agitation, change in mental status
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased
Clinical narrative: Rapid heart beat about 6 hrs. after injection with headache.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site discharge, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Immunization administered at left deltoid on afternoon of 6/18/07, within 2 hours, began to have redness and swelling at injection site. Arm was painful down arm from site, into neck, and left hip. By 6/21, left arm pain, redness and swelling got worse, moving arm was increasingly painful - arm felt tight. "knot" formed on arm at site at time of injection. Alternating ice and heat to arm did not decreased symptoms. Saturday 6/23, site oozed pus-looking fluid drained from site when scratched. On Monday, 6/25, symptoms unchanged. NSAIDS did not decrease pain. 6/27, knot on arm persists, arm is painful to touch. Continues to have pain in left arm, neck and back.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Neck pain, Pain in extremity, Wound drainage
Clinical narrative: Immunization administered at left deltoid on afternoon of 6/18/07, within 2 hours, began to have redness and swelling at injection site. Arm was painful down arm from site, into neck, and left hip. By 6/21, left arm pain, redness and swelling got worse, moving arm was increasingly painful - arm felt tight. "knot" formed on arm at site at time of injection. Alternating ice and heat to arm did not decreased symptoms. Saturday 6/23, site oozed pus-looking fluid drained from site when scratched. On Monday, 6/25, symptoms unchanged. NSAIDS did not decrease pain. 6/27, knot on arm persists, arm is painful to touch. Continues to have pain in left arm, neck and back.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gave Adacel to pt over 65 years of age
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Gave Adacel in pt over 65 years of age
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Flushing, Injection site erythema, Nausea, Tremor
Clinical narrative: Patient felt nauseous, shaky, flushed on 6/27/07 in the afternoon, no vomiting, no diarrhea, sxs passed after about 1 hour. At time of exam on 6/28 <3mm area of erythema around injection site felt fine.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Has a raised, red area on fatty area of Lt arm. Measures approximately 2" wide x 1 1/2" high - Probably where Varicella given - also outside with mosquito's?
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: 6/26/07 1 1/2 hours after receiving vaccine patient presented back to nursing dept with a reddened raised area (5 1/2 cm x 3 1/2 cm) at injection sit - warm to touch and painful. Seen by Doctor and Ice applied. Recommended to call clinic if any other reactions occur. 6/27/07 - Injection site slightly red and still warm to touch, patient c/o HA in middle of night and now feels nauseated this AM.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: 10cm wheal treatment with Benadryl 25-50mg q 6 hours PRN.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Fever since 4:00 a.m. Friday left thigh red, swollen.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Body temperature increased, Fatigue, Headache, Influenza like illness
Clinical narrative: Gardasil given 6/25/07. Patient reports flu-like symptoms, nausea temperature 102 during night of 6/25/07- 6/26/07 flu-like symptom. Nausea continued, loss of consciousness "few minutes" at work. Has bad headaches, abdominal pain "feels like some one has hit me". C/O fatigue.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Gardasil given 6/25/07. Patient reports flu-like symptoms, nausea temperature 102 during night of 6/25/07- 6/26/07 flu-like symptom. Nausea continued, loss of consciousness "few minutes" at work. Has bad headaches, abdominal pain "feels like some one has hit me". C/O fatigue.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Presyncope
Clinical narrative: Near syncopal episode, dizzy, lightheaded
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives on one arm 5-7 minutes after IM injection of Menactra. Treated with Benadryl 50mg oral x 1. No further issues.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Next day after receiving Adacel developed fever, chills and swollen left supraclavicular lymph node. Area was red and swollen.
Age: 1.1
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Irritability, Rash, Sleep disorder
Clinical narrative: Vaccines given 6/28/2007. Mother brought patient to office 6/29/07 stating child was cranky, didn't sleep most of the night and developed a rash mostly on the trunk. She stated she noticed a rash this morning. Patient was seen by doctor given a prescription for Benadryl, Appt for follow up on 7/2/07.
Age: 1.1
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Body temperature increased
Clinical narrative: Rectal 103.8 fever for 14 hours. Pedialyte and Tylenol and Tipin bath.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient arm with redness and swelling from shoulder to elbow left side. Afebrile. Patient to go to ER if swelling/ redness, increase or because febrile or painful to the touch.