chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RV5
Symptoms: Culture stool, Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician's assistant concerning a female with no allergies or pertinent medical history who in August 2008, was vaccinated po with a 2 ml first dose of ROTATEQ. There was no concomitant medication. The physician's assistant reported the patient experienced vomiting and diarrhea approximately 5 weeks, September 2008, after receiving ROTATEQ. Unspecified medical care was given at the practice. A stool culture was obtained. There was no additional information provided because the patient's chart was not available. Subsequently, on an unspecified date the patient recovered from vomiting and diarrhea. A product quality complaint was not involved. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Abnormal faeces, Decreased appetite, Faeces discoloured, Somnolence
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 2 month old patient with no medical history or allergies who on 05-SEP-2008 was vaccinated PO with the first dose of ROTATEQ. Concomitant therapy included vitamin D (unspecified). The NP reported that on 26-SEP-2008 (24 hours after vaccination), the patient developed greenish foul smelling stools. The patient also exhibited a decreased appetite and sleepiness. The patient's mother called the office for medical attention. There were no lab diagnostic studies performed and the course of treatment was not reported. The outcome was reported not recovered / not resolved. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient who on 27-JUN-2008 was vaccinated po with a first dose of ROTATEQ. There was no concomitant medication. On 06-OCT-2008 the patient received an second dose of ROTATEQ. No problems reported. A product quality complaint was not involved. No further information is available.
Age: 0.8
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Rash
Clinical narrative: Information has been received from a pharmacist concerning an 8 month old male infant who one month ago on approximately 07-SEP-2008 was vaccinated with a first dose of oral ROTATEQ.  Subsequently, the patient developed diarrhea after receiving his first and only dose.  The patient was taken to the hospital for hydration but was not admitted.  He did not have weight loss.  It was unspecified if lab studies were performed.  It was noted that after the patient received the vaccination, the patient was prescribed ZITHROMAX for unrelated infection and he developed a rash.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2008. Follow-up information was received from the physician assistant. "It has been determined that the diarrhea experienced by the infant is unrelated to ROTATEQ. Additional information is not expected.
Age: 0.53
Sex: F
Vaccine: DTAP, FLUX, HIBV, PPV, RV5
Symptoms: Anorexia, Irritability, Pyrexia
Clinical narrative: Information has been received from a consumer her 6 month old daughter who on 03-OCT-2008 was vaccinated with ROTATEQ. Concomitant vaccinations on the same day included Pneumococcal vaccinel (manufacturer unknown), Influenza vaccine (manufacturer unknown), Hib (manufacturer unknown) and DTaP (manufacturer unknown). It was noted that within 24 hours of vaccination the patient experienced fever, irritability and loss of appetite. There was no medical attention sought. The patient was treated with TYLENOL. It was reported that the patient's symptoms lasted about 24-36 hours post vaccination. At the time of the report, the patient "seemed fine". There was no product quality complaint involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diagnostic procedure, Gastrooesophageal reflux disease, Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old female who was vaccinated with her first dose of 2 ml oral ROTATEQ. The patient received other vaccines on the same day as the ROTATEQ, but unspecified date or names of the other vaccines. The patient developed reflux and vomiting sometime later after the dose of ROTATEQ. The mother took the infant to the Emergency Room and intussusception test were performed. The patient was not hospitalized. The physician does not believe the event had been due to the ROTATEQ, and that the patient is doing "just fine now". NO product quality complaint involved. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: This is in follow-up to repor(s) previously submitted on 11/14/2008. Information has been received from a physician concerning an 18 week old female with no pertinent medical history or known drug reactions/ allergies who on 30-JUL-2008 was vaccinated PO with the first dose of ROTATEQ and 30-SEP-2008 at 8:45a.m. was vaccinated PO with the second doses of ROTATEQ  vaccine (lot # for both doses 657671/0902U).  There was no concomitant medication. There was no illness at time of vaccination. The physician reported that two days after the second vaccination, approximately 02-OCT-2008, the patient developed vomiting and significant diarrhea (6-8 stools per day). The patient recovered in two days, approximately 04-OCT-2008.  On approximately 06-OCT-2008 (two days after patient recovered).  The patient relapsed and developed diarrhea and vomiting.  On 08-OCT-2008, a stool sample was obtained and the results were positive for rotavirus.  The patient sought medical attention at an office visit (the course of treatment was not reported).  The patient was reported as recovering.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. A positive fecal rotavirus was found on 09-OCT-2008. On approximately 10-OCT-2008, the patient recovered from diarrhea which lasted about 8 days. On an unspecified date the patient was considered recovered. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Culture urine, Diarrhoea, Pyrexia, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 3 month old daughter who on 25- Aug- 2008 was vaccinated with 2 ml oral dose of ROTATEQ. There was no concomitant medication. Within 24 hours of vaccination the patient developed vomiting and diarrhea that lasted 10 days after receiving ROTATEQ. The patient was brought to the ER but was not admitted. 5 days after vaccination she developed a fever which " spiked" 7 days after the vaccination. She also developed a urinary tract infection which the doctor believes may have been due to diarrhea. Laboratory test included urine culture. The patients condition improved with therapy and she recovered after 10 days from vomiting and diarrhea. No product quality complaint involved.
Age: 0.31
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 16 week old female with no pertinent medical history or allergies who on 9-OCT-2008 was vaccinated with a dose of ROTATEQ. There was no concomitant medication. The physician reported that the patient received the first dose of ROTATEQ at 4 months of age.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of ROTATEQ. It was reported the patient developed rotavirus gastroenteritis following vaccination with ROTATEQ. The healthcare worker did not have specific information at the time of the report. A product quality complaint was not involved. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 9 month old patient who was vaccinated with a third dose of ROTATEQ.  A product quality complaint was not involved.  No further information was given.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 20 week old male who on 14-OCT-2008 was vaccinated with the first dose of ROTATEQ. The physician reported that there were no adverse symptoms noted. The patient sought medical attention in the office. A product quality complaint was not involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event, Regurgitation
Clinical narrative: Information has been received from a medical assistant concerning a 9 week old female who on 17-JUL-2003 and 14-OCT-2008 was vaccinated PO with the first, second and third doses respectively of ROTATEQ.  On 17-JUL-2008, the medical assistant reported that the patient spit some of the dose out.  No adverse effects were reported.  The patient sought medical attention at an office visit.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who started oral ROTATEQ. It was reported that the patient is over 12 weeks old. No adverse event reported. Unspecified medical attention was sought. No product quality complaint involved. Additional information is not expected.
Age: 0.8
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a nurse concerning a female who was vaccinated with the third dose of 1 tube of oral ROTATEQ when she was 9 months and 27 days old. No symptoms were noted. No product quality complaint involved. Additional information has been requested.
Age: 0.77
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from nurse concerning a 9 month old male who on 15-SEP-2008 was inadvertently administered a dose (one and only dose) of ROTATEQ (661035/0895X). Staff error only. No adverse events reported. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Cough, Immediate post-injection reaction, Infantile spitting up
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 16-OCT-2008 was vaccinated PO with a dose of ROTATEQ.  It was reported that immediately after administration of the vaccine the patient had turned and coughed (also reported as the child spit).  It is unknown if the patient sought medical attention.  A product quality complaint was not involved.  This is one of several reports received from the same source.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2008. No further information is available.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 13 week old male who on 20-AUG-2008 and on 21-OCT-2008 was vaccinated with the first and second doses of ROTATE. No problems were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Blood test, Laboratory test, Rotavirus infection, Rotavirus test positive, Secondary transmission
Clinical narrative: Information has been received from a medical assistant who reported a 2 month old patient received the first dose of 2 mL oral ROTATEQ approximately 4 months ago. The mother of the patient developed unspecified rotavirus symptoms a week later, and went to the emergency room. The emergency room confirmed that she had rotavirus. The patient sought medical attention at the emergency room. These was no product quality complaint. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 11/14/2008; 12/3/2008. Initial information has been received from a medical assistant and follow-up information was received from a registered nurse. It was reported that on 04-AUG-2008 at 10:30 AM the 27 year old patient's child received the third dose (also reported as the first dose) of 2 mL oral ROTATEQ (lot # 660882/0642X). Concomitant therapy on the same time included the third dose of RECOMBIVAX HB (MSD) (lot # 659670/0475X) given IM into the left leg, DAPTACEL (lot # C2953BA) given IM into the left leg, ACTHIB (UP218AB) given IM into the left arm, IPOL (lot # A0491) given SC into the right leg and PREVNAR (C45721K) given IM into the right leg. Concomitantly, the patient had rheumatoid arthritis and took "Flacwhynol" for arthritis. On 08-AUG-2008, the patient got rotavirus from the child after vaccination. The mother developed diarrhea, vomiting, extreme stomach cramps, chills and sweats and went to the emergency room. In the emergency room, the mother was given 2 bottles of dextrose drip, antispasm medication and pain medication for stomach spasms. Blood work was done in the ER and no results provided. No stool studies done. The emergency room confirmed that she had rotavirus. The mother was sent home with medications for pain and antispasms. On 11-AUG-2008, the mother attempted juice and vomited. On 12-AUG-2008 the mother tried clear liquid and then followed by bananas, rice, applesauce and toast (BRAT) diet. On the same day, the mother recovered. Additional information is not expected.
Age: 0.01
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning his 5 day old female daughter who on 23-OCT-2008 was vaccinated PO with the first dose of ROTATEQ vaccine. No adverse effect was reported. It was unknown if the patient sought medical attention. A product quality complaint was not involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. Follow-up information was received from a physician who reported that the patient (6 pounds, 6 ounces; 20.5 inches) with no known illness at the time of vaccination, and no known pre-existing allergies, on an unknown exact ime was vaccinated with ROTATEQ vaccine (Lot No 1033X) at private doctor's office/hospital by a nurse after not following protocoll to properly identify patient having the parents sign consent and then administering.   Follow up information received on 23-DEC-2008 from a physician who reported that the patient's birth weight was 6 pounds 13 ounces and that the lot  number of the ROTATEQ vaccine administered is 651430/1033X. No further information is available.
Age: 0.22
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an 11 week old female infant with no known drug allergies and gastroesophageal reflux disease who on 09-Sep- 2008 was vaccinated orally with a first 2ml dose of ROTATEQ. Subsequently, within 24 hours of receiving the vaccination, on 10- Sep-2008 the patient experience severe vomiting and diarrhea. Medical attention was sought. The family spoke to physician. There were no lab studies performed. On 15-Sep- 2008, the patient recovered. There was no product quality complaint involved. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 11/14/2008. Follow-up information from a physician indicated no new information. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 6 month old patient who on 28-OCT-2008 was vaccinated with dose 1 of ROTATEQ.  No symptoms reported.  No product quality complaint.  Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a nurse concerning a 6 month old patient who, on 28-OCT-2008, was vaccinated with dose 1 of ROTATEQ. No symptoms reported. No product quality complaint. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Cough, Decreased appetite, Insomnia, Irritability
Clinical narrative: Information has been received from medical records through the Merck pregnancy registry concerning a 2 month old female with no known drug allergies, who on 18-JUN-2008 and 18-AUG-2008 was vaccinated by mouth with a first and second dose of ROTATEQ (Lot # 660845/0289X). Concomitant administered on 18-JUN-2008 and 18-AUG-2008 included PEDIARIX (AC21B156EA) and (AC21B182AA) both administered in the left upper thigh, ACTHIB (UF263AA) administered in the left upper thigh and (UF401AB) administered in the right upper thigh, and PREVNAR (C54766) administered in the right lower thigh and (C45721F) administered in the left lower thigh. On 22-APR-2008, the patient was seen and was reported to be feeding well and was advised to return to the clinic in one week. On 08-MAY-2008, the patient was seen and complained of projectile vomiting within the last 12 hours. The patient was fussy, was breastfeeding, and spit up yellow, watery mucous on the exam table. The patient did not have a fever and it was reported that the patient's father had pyloric stenosis when he was a baby. An upper GI was scheduled for the patient. the patient was not on any medications at the time of the visit. On 19-MAY-2008, the patient was seen at the office for follow-up to a urinary tract infection which was diagnosed the previous week. The patient was currently taking OMNICEF and ZANTAC. The patient experienced a low grade fever four days before the visit. On 05-JUN-2008, the patient was seen and was fussy. The patient was currently taking ZANTAC. It was reported the patient had been pulling on her ear, her appetite decreased, and her sleep increased. On 26-JUN-2008, the patient was seen at the office for her ears. The patient was currently taking ZANTAC and TYLENOL. The patient was fussy, slightly congested, and an earache was in question. Two days prior to the visit a clear to yellow discharge was noticed. On 04-AUG-2008, the patient was seen for congestion. The patient had experienced nasal congestion for the past five days. The patient was more irritable within the last 24 hours. The patient's runny nose was clear. The patient's appetite was reported to be "ok" and her sleep decreased. The patient was not taking any medications at the time of the visit. On 11-AUG-2008, the patient had complaint about the neck and ears. The patient was pulling at ear, was cranky, and had a temperature of 99 the day before. The patient was prescribed BACTRIM for 1 week. At the time of this visit the patient's parents were also reported to be congested. On 29-SEP-2008, the patient was seen and was experiencing a fever, nasal congestion, and a slight cough. The patient's appetite was decreased. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Nasal congestion, Pyrexia, Rhinorrhoea, Urinary tract infection, Vomiting projectile
Clinical narrative: Information has been received from medical records through the Merck pregnancy registry concerning a 2 month old female with no known drug allergies, who on 18-JUN-2008 and 18-AUG-2008 was vaccinated by mouth with a first and second dose of ROTATEQ (Lot # 660845/0289X). Concomitant administered on 18-JUN-2008 and 18-AUG-2008 included PEDIARIX (AC21B156EA) and (AC21B182AA) both administered in the left upper thigh, ACTHIB (UF263AA) administered in the left upper thigh and (UF401AB) administered in the right upper thigh, and PREVNAR (C54766) administered in the right lower thigh and (C45721F) administered in the left lower thigh. On 22-APR-2008, the patient was seen and was reported to be feeding well and was advised to return to the clinic in one week. On 08-MAY-2008, the patient was seen and complained of projectile vomiting within the last 12 hours. The patient was fussy, was breastfeeding, and spit up yellow, watery mucous on the exam table. The patient did not have a fever and it was reported that the patient's father had pyloric stenosis when he was a baby. An upper GI was scheduled for the patient. the patient was not on any medications at the time of the visit. On 19-MAY-2008, the patient was seen at the office for follow-up to a urinary tract infection which was diagnosed the previous week. The patient was currently taking OMNICEF and ZANTAC. The patient experienced a low grade fever four days before the visit. On 05-JUN-2008, the patient was seen and was fussy. The patient was currently taking ZANTAC. It was reported the patient had been pulling on her ear, her appetite decreased, and her sleep increased. On 26-JUN-2008, the patient was seen at the office for her ears. The patient was currently taking ZANTAC and TYLENOL. The patient was fussy, slightly congested, and an earache was in question. Two days prior to the visit a clear to yellow discharge was noticed. On 04-AUG-2008, the patient was seen for congestion. The patient had experienced nasal congestion for the past five days. The patient was more irritable within the last 24 hours. The patient's runny nose was clear. The patient's appetite was reported to be "ok" and her sleep decreased. The patient was not taking any medications at the time of the visit. On 11-AUG-2008, the patient had complaint about the neck and ears. The patient was pulling at ear, was cranky, and had a temperature of 99 the day before. The patient was prescribed BACTRIM for 1 week. At the time of this visit the patient's parents were also reported to be congested. On 29-SEP-2008, the patient was seen and was experiencing a fever, nasal congestion, and a slight cough. The patient's appetite was decreased. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood bilirubin increased, Drug exposure during pregnancy, Foetal disorder, Laboratory test normal, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received from a 14 year old female for the Pregnancy Registry for GARDASIL with an allergy to KEFLEX who on 27-DEC-2006 was vaccinated with a first dose of GARDASIL 0.5 ml IM.  Subsequently she received the second dose of vaccine and on 27-SEP-2007 received the third dose of GARDASIL.  Concomitant medication included vitamins (PNV).  The patient's last menstrual period was 7 weeks ago (approximately 13-AUG-2007).  She sought medical attention.  On 29-SEP-2007, she found out that she was pregnant.  A pregnancy test was performed.  At the time of reporting, she had not experienced any adverse reactions.  The estimated date of delivery is 19-MAY-2008.  Follow-up information was received, concerning a 14 year old female patient with no previous medical history reported.  On 18-MAY-2008, the patient delivered a normal, healthy female baby weighing 7-9 lbs, length 21, Apgar score 8/9 and head circumference 14.5.  No complication during pregnancy, labor/delivery, infections or illness during pregnancy were reported.  On 23-MAY-2008 the baby had a 5 day well child visit and was doing well.  Weight was 7.45 pounds.  Bilirubin was 10.8 mg/dL.  On 02-JUN-2008 a newborn screening for congenital hypothyroidism, congenital adrenal hyperplasia, hemoglobinopathy, galactosemia, fatty acid disorders, organic acid disorders, amino acid disorders and cystic fibrosis were all normal.  On 21-JUL-2008 a 2-3 month old well child visit was performed and the baby was doing well.  Her parents reported some nasal congestion and constipation.  Otherwise she has a bowel movement every 24 hours.  The outcome of the congestion and constipation were not reported.  No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received from a 14 year old female for the Pregnancy Registry for GARDASIL with an allergy to KEFLEX who on 27-DEC-2006 was vaccinated with a first dose of GARDASIL 0.5 ml IM.  Subsequently she received the second dose of vaccine and on 27-SEP-2007 received the third dose of GARDASIL.  Concomitant medication included vitamins (PNV).  The patient's last menstrual period was 7 weeks ago (approximately 13-AUG-2007).  She sought medical attention.  On 29-SEP-2007, she found out that she was pregnant.  A pregnancy test was performed.  At the time of reporting, she had not experienced any adverse reactions.  The estimated date of delivery is 19-MAY-2008.  Follow-up information was received, concerning a 14 year old female patient with no previous medical history reported.  On 18-MAY-2008, the patient delivered a normal, healthy female baby weighing 7-9 lbs, length 21, Apgar score 8/9 and head circumference 14.5.  No complication during pregnancy, labor/delivery, infections or illness during pregnancy were reported.  On 23-MAY-2008 the baby had a 5 day well child visit and was doing well.  Weight was 7.45 pounds.  Bilirubin was 10.8 mg/dL.  On 02-JUN-2008 a newborn screening for congenital hypothyroidism, congenital adrenal hyperplasia, hemoglobinopathy, galactosemia, fatty acid disorders, organic acid disorders, amino acid disorders and cystic fibrosis were all normal.  On 21-JUL-2008 a 2-3 month old well child visit was performed and the baby was doing well.  Her parents reported some nasal congestion and constipation.  Otherwise she has a bowel movement every 24 hours.  The outcome of the congestion and constipation were not reported.  No additional information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Drug exposure during pregnancy, Meconium in amniotic fluid
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 24 year old female with no known allergies who on 18-SEP-2007 was vaccinated IM with her first dose of GARDASIL (Lot # 658560/1062U). concomitant therapy included (ASTELIN) and Albuterol. Subsequently the patient is pregnant which was confirmed via pregnancy test (LMP = 28-AUG-2007). No further information is available. Follow up information was received from a nurse who reported that on 12-JUN-2008, the patient went into labor spontaneously at 41+ 3/7 weeks with SROM with a moderate amount of meconium in the amniotic fluid. The patient had a vaginally delivered at a healthy female. The baby weight was 8 Lb, 7 oz, and had apgars of 9 and 9. The nurse reported that the patient's EDD was on 03-JUN-2007. The nurse also reported that the baby and the mother were doing well. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a health professional concerning a 16 year old female with a history of madelung's deformity who, on 01-SEP-2006, was vaccinated with her first dose of GARDASIL, IM. On 10-NOV-2006, the patient was vaccinated with her second dose of GARDASIL, IM. On 28-SEP-2007, the patient was vaccinated with her third dose of GARDASIL, IM, and a urine test in the office was negative. On 11-OCT-2007, a home pregnancy test was positive, and 2 repeated home pregnancy tests on a later date were also positive. The patient sought unspecified medical attention in the office and her outcome is unknown. Follow-up information was received on 29-OCT-2008 via phone call from a nurse indicating that, on 14-JUN-2008, the patient spontaneously delivered a healthy and normal male baby. Weighing 7 pounds, 7 ounces, 52 cm long with a head circumference of 32 cm at 40 and 3/7 weeks estimated gestational age. Apgars were 8/9. The baby was being watched for mild jaundice due to his mother's blood type. The mother was O negative and the baby was RH positive. The baby was discharged home with his adaptive parents on 16-JUN-2008, bottlefeeding and with routine care instructions. The mother did return to the office and saw a certified nurse midwife for her postpartum visit and physiologically was recovering well. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: 17-hydroxyprogesterone increased, Drug exposure during pregnancy
Clinical narrative: Initial and follow up information has been received from a mother and 16 year old female patient for the Pregnancy Registry for GARDASIL. On 21-AUG-2007, the patient was vaccinated with her first dose of GARDASIL (Lot # 658222/0927U; site and route not reported). On 23-OCT-2007 (previously reported as approximately 26-OCT-2007), the patient was vaccinated with her second dose of GARDASIL (Lot #657737/0522U; site and route not reported). There was no concomitant medication. Subsequently, the patient found out she was pregnant (LMP approximately 15-SEP-2007).The patient sought unspecified medical attention. On 24-JUN-2008, The patient gave birth to a normal female infant (6 Lb, 2 oz; 18.5 in). There were no congenital anomalies, complications or abnormalities. There were no complications during the pregnancy or labor and delivery. Additional information was provided from the patients physician. Laboratory work from 25-JUN-2008 revealed a CAH (17 Hydroxy Progesterone) level of 75.8 ng/ml. The analysis revealed unsatisfactory specimen. Repeat levels were done on 29-JUL-2008 that were within normal range. At the time of this report mother and baby were reported to be doing well. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Apgar score normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received through the pregnancy registry from a health care worker concerning a 17 year old female with an allergy to cefaclor (CECLOR) and no concomitant medications (lab diagnostics included a pregnancy test). The patient received three single doses of GARDASIL via injection and became pregnant sometime before she received her third dose. The patient was approximately 8 weeks pregnant at the time she received her third dose. The patient did not have any adverse experience. The first dose of GARDASIL (Lot #0211U) was receiving on 5-APR-2007, the second dose (Lot #0210U) was received on 05-JUN-2007 and the third dose (Lot #65454C/1209U) was received on 9-OCT-2007. Follow up information was received from a health care professional who reported that the patient delivered a full term baby on 04-JUL-2008. The health care professional reported that the baby was normal and healthy with no anomalies. Follow up information was received from a health care professional who reported that the patient delivered a full term baby on 04-JUL-2008. The health care professional reported that the baby was normal and healthy with no anomalies. Follow up information was received from a health care worker who reported that the patient delivered a normal female baby, with no complications during pregnancy, or no known complications during labor/ delivery. The mother's LMP was 40 3/7 weeks. The baby's weight was 6o ponds with 13 oz, and Apgar score was 9/9. There were no concurrent medical conditions reported. Other medications used during the patients pregnancy were reanitidine (ZANTAC) for heartburn, budesonide for allergies, and Zolpidem as needed or PRN for sleep aid. On 23-JAN-2008 a serum alph-fetoprotein test was performed with negative results. On 07-FEB-2008 an ultrasound was performed with normal results. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan normal, Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from a medical assistant, for the Pregnancy Registry for GARDASIL, concerning a 18 year old female with no previous pregnancy, who on 31-JUL-2007, was vaccinated IM in the left deltoid with the first dose of GARDASIL (658222/0927U). On 11-OCT-2007, the patient was vaccinated IM in the right deltoid with the second dose of GARDASIL (658488/1264U). On 07-JAN-2008, the medical assistant reported that the patient called the office last week stating that she took a home urine pregnancy test, which was positive. The patient sought unspecified medical attention. the medical assistant reported in follow up that on 11-JAN-2008, ultrasound was performed and the result was negative. On approximately 22-APR-2008, the patient developed urinary tract infection. On 22-APR-2008, the patient was treated with nitrofurantoin (MACROBID), 100 mg, twice a day. The outcome of urinary tract infection was unknown. On 02-AUG-2008, the patient delivered a normal, healthy female baby at 39 week gestation. The baby's weight was 7.8 pounds; length was 20.5 inches and Apgar was 8/9. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour, Premature rupture of membranes, Rash papular, Skin hypopigmentation
Clinical narrative: Initial and follow-up information has been received from the pregnancy registry for GARDASIL via a registered nurse concerning an 23 year old female smoker with "dermatological problems" and a history of cervical cancer with no documented HPV(2007), abnormal pap and loop electrosurgical excision procedure(14-JUN-2006) who on 20-NOV-2007 was vaccinated IM, with a 0.5 ml first dose of GARDASIL (LOT 657872/0515U). Concomitant therapy included DEPO-PROVERA and dermatologic (unspecified). Subsequently the patient became pregnant. On 04-DEC-2007 she had a positive pregnancy test. On 07-DEC-2007, ultrasound revealed gestational age was 7 weeks and 4 days. Last menstrual period was 12-OCT-2007 and estimated date of delivery was 20-JUL-2008. The patient was seen in the physician's office on 09-JAN-2008. Follow up information was received which reported that on 09-JUL-2008 the patient had spontaneous rupture of membranes and delivered a female infant at 38 weeks gestational via spontaneous pitocin augmented delivery. The baby's weight 6lb 12oz. The infant was normal. No congenital anomalies or other complications or abnormalities were noted, head moulding/cone was noted to be resolved. It was also reported that the patient had no complications during the pregnancy and labor. The patient continued to smoke throughout her pregnancy. On 11-JUL-2008 the infant was vaccinated with HEP B virus vaccine (manufacturer unknown), (WAES #0811USA00563). On 11-SEP-2008 it was reported that the patient had a papular rash with mild hypopigmentation to her antecubital crease. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix normal, Tobacco user, Ultrasound scan normal, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from the pregnancy registry for GARDASIL via a registered nurse concerning an 23 year old female smoker with "dermatological problems" and a history of cervical cancer with no documented HPV(2007), abnormal pap and loop electrosurgical excision procedure(14-JUN-2006) who on 20-NOV-2007 was vaccinated IM, with a 0.5 ml first dose of GARDASIL (LOT 657872/0515U). Concomitant therapy included DEPO-PROVERA and dermatologic (unspecified). Subsequently the patient became pregnant. On 04-DEC-2007 she had a positive pregnancy test. On 07-DEC-2007, ultrasound revealed gestational age was 7 weeks and 4 days. Last menstrual period was 12-OCT-2007 and estimated date of delivery was 20-JUL-2008. The patient was seen in the physician's office on 09-JAN-2008. Follow up information was received which reported that on 09-JUL-2008 the patient had spontaneous rupture of membranes and delivered a female infant at 38 weeks gestational via spontaneous pitocin augmented delivery. The baby's weight 6lb 12oz. The infant was normal. No congenital anomalies or other complications or abnormalities were noted, head moulding/cone was noted to be resolved. It was also reported that the patient had no complications during the pregnancy and labor. The patient continued to smoke throughout her pregnancy. On 11-JUL-2008 the infant was vaccinated with HEP B virus vaccine (manufacturer unknown), (WAES #0811USA00563). On 11-SEP-2008 it was reported that the patient had a papular rash with mild hypopigmentation to her antecubital crease. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with a penicillin allergy who on 27-Apr-2007, was vaccinated IM with first 0.5 ml dose of GARDASIL. On 26-Dec-3007, the patient received her third dose of the vaccine. The patient is pregnant. Unspecified medical attention was sought at the time of this report. Follow up information was received from the registered nurse who reported that in March 2008 , the ultrasound was normal at 29 6/7 weeks from her last menstrual period, the patient had preterm labor. the patient was treated with BETAMETHASONE on 21-May- 2008. The patient also had nifedipine. On 23- May- 2008 the patient took INDOMETHACIN. On 15-Jul-2008 the patient gave birth to a live born male APGAR=9/9. She was 39 1/7 weeks from her last menstrual period. The infant was reported to be normal and there were no congenital anomalies or other complications. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Apgar score normal, Chlamydial infection, Drug exposure during pregnancy, Gonorrhoea
Clinical narrative: Information has been received from a consumer and a physician, for pregnancy registry for GARDASIL, concerning a 17 year old female patient with penicillin allergy, sulfonamide allergy, attention deficit/hyperactivity disorder, left side of heart enlarged and asthma and a history of ventricular septal defect and USD, who on 27-SEP-2007, was vaccinated with the first dose of GARDASIL, and was pregnant (LMP- sometime around 11-DEC-2007, ECD- 07-SEP-2008). Concomitant therapy included ADHA medication, heart medication. Other medications used during pregnancy were albuterol on 18-AUG-2008 for wheezing. Subsequently, the patient experienced gonorrhea and chlamydia infection. AFP was performed with the result of negative, and fetal scan was also performed. On 12-DEC-2007, the patient was vaccinated with the second dose of GARDASIL. On 09-SEP-2008, the patient had a normal male infant. The Apgar score was 9/9. No congenital anomalies or complications were noted. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, Wheezing
Clinical narrative: Information has been received from a consumer and a physician, for pregnancy registry for GARDASIL, concerning a 17 year old female patient with penicillin allergy, sulfonamide allergy, attention deficit/hyperactivity disorder, left side of heart enlarged and asthma and a history of ventricular septal defect and USD, who on 27-SEP-2007, was vaccinated with the first dose of GARDASIL, and was pregnant (LMP- sometime around 11-DEC-2007, ECD- 07-SEP-2008). Concomitant therapy included ADHA medication, heart medication. Other medications used during pregnancy were albuterol on 18-AUG-2008 for wheezing. Subsequently, the patient experienced gonorrhea and chlamydia infection. AFP was performed with the result of negative, and fetal scan was also performed. On 12-DEC-2007, the patient was vaccinated with the second dose of GARDASIL. On 09-SEP-2008, the patient had a normal male infant. The Apgar score was 9/9. No congenital anomalies or complications were noted. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydial infection, Drug exposure during pregnancy, Ultrasound abdomen normal
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) for the Pregnancy Registry for GARDASIL concerning an 18 year old female with no known allergies and no reported medical history who received two doses of 0.5ml GARDASIL (unknown lot numbers) intramuscularly at another facility, possible in September and November of 2007. The patient is currently taking prenatal vitamins (unspecified brand) and iron supplements (unspecified brand). At 30 weeks pregnancy was discovered during an ultrasound on 23-JAN-2008. The patients LMP is approximately 25-JUN-2007. The ultrasound was performed since the patient said that she had a tumor which was kicking and biting her. No  symptoms have been reported. Estimated date of delivery is 03-APR-2008. Follow up information was received on 17-OCT-2008 from the L.P.N indicating that the patient is a female with no previous pregnancies. On 25-NOV-2007 and 26-DEC-2007 the patient was vaccinated with her first and second 0.5 ml doses, respectively, of GARDASIL (lot # of the two doses was probably 657006/0188U). An ultrasound performed on 23-JAN-2008 confirmed her pregnancy and the results were within normal limits. It was reported that the patient confirmed her pregnancy and the results were within normal limits. It was reported that the patient was late for prenatal care (30 weeks) because she wasn't aware of her pregnancy. Other medication used during pregnancy included prenatal vitamins, once daily from January 2008 to April 2008 and iron supplement, 325 mg daily from February 2008 to April 2008. During pregnancy, the patient developed chlyamdial infection and on 01-FEB-2008, was treated with ZITHROMAX, 1 gram once. The outcome of the chlamdial infection was not reported. On 10-APR-2008 the patient delivered a normal female baby, weighing 7 pounds, 2 ounces. The baby's length was 20, headache circumference was 13.5 and apgar score was 8/9. There were no congenital anomalies. There were no other complications or abnormalities. The patient had no complication during pregnancy or labor/delivery. No diagnostic test was performed during pregnancy. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Glucose urine, Haemoglobin, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with a history of allergic reaction to antibiotics (Ceclor) who on 25-MAR-2008 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included a dose of HAVRIX (inactive) (GlaxoSmithKline) and a dose of MENACTRA (Sanofi Pasteur). On 25-MAR-2008 the patient intially came in for family planning (to get birth control pills)/ The patient said she had normal periods and no skipped period from 28-FEB-2008 to 06-MAR-2008. The patient denied unprotected sex and was using condoms. During a vaginal exam (part of family planning) by the nurse practioner, it was found the patient had "Trichomonas." The nurse practioner wanted to treat the patient with Metronidazole and did a pregnancy test to make sure it was okay to give this medication. The pregnancy test was positive. Other lad diagnosic studies performed included: hemoglobin (results not provided) and dip stick urine for glucose and protein (results not provided.)  The patient's outcome was not reported. There was not product quality control involved. Follow-up information has been received through the pregnancy registry which reported that the pregnancy test was performed on 25-MAR-2008. An ultrasound was performed on 30-APR-2008 and was normal and on 26-JUN-2008 a serum alpha fetoprotein test which was normal. The patient was prescribed promethazine hydrochloride (PHENERGAN) for nausea. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Ultrasound scan normal, Urine protein, quantitative, Vaginal examination abnormal, Vulvovaginitis trichomonal
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with a history of allergic reaction to antibiotics (Ceclor) who on 25-MAR-2008 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included a dose of HAVRIX (inactive) (GlaxoSmithKline) and a dose of MENACTRA (Sanofi Pasteur). On 25-MAR-2008 the patient intially came in for family planning (to get birth control pills)/ The patient said she had normal periods and no skipped period from 28-FEB-2008 to 06-MAR-2008. The patient denied unprotected sex and was using condoms. During a vaginal exam (part of family planning) by the nurse practioner, it was found the patient had "Trichomonas." The nurse practioner wanted to treat the patient with Metronidazole and did a pregnancy test to make sure it was okay to give this medication. The pregnancy test was positive. Other lad diagnosic studies performed included: hemoglobin (results not provided) and dip stick urine for glucose and protein (results not provided.)  The patient's outcome was not reported. There was not product quality control involved. Follow-up information has been received through the pregnancy registry which reported that the pregnancy test was performed on 25-MAR-2008. An ultrasound was performed on 30-APR-2008 and was normal and on 26-JUN-2008 a serum alpha fetoprotein test which was normal. The patient was prescribed promethazine hydrochloride (PHENERGAN) for nausea. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Placental disorder, Pregnancy test positive, Ultrasound abdomen abnormal, Urinary tract infection
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL from a physician concerning a 18 year old female with a history of smoking (quit when she had a positive pregnancy test) and no known drug allergies, who on 27-JUL-2007, was vaccinated in the right arm with the first dose of GARDASIL (lot#65822/0927U). On 15-Nov-2007, the patient received the second dose in the left arm (lot# 659437/1266U). On 05-Apr-2008, the patient received IM in the right arm a 0.5 ml third dose (lot#659964/1978U). Other medications included prenatal vitamins from 03-APR-2008 to present, once daily. The physician reports that the patient is 15 weeks pregnant. The patient's LMP was 24-DEC-2007, the estimated delivery date is 29-SEP-2008. The patient sought unknown medical attention with her OB/GYN. Follow up information was received which reported that on 08-APR-2008 and 12-MAY-2008, ultrasound indicated low lying placenta. From 16-JUN-2008 to 21-JUN-2008, the patient was treated with ampicillin, 500mg, q8h, for urinary tract infection. From 13-AUG-2008 to 20- AUG-2008, the patient was treated with amoxicillin, 500 mg, q8h, for urinary tract infection. On 03-SEP-2008, the patient delivered a female infant at 36+ weeks from The infant's weight is 6 lb 11 oz with apgar scores of 7/9. The infant was normal, without congenital anomalies and other complications or abnormalities. There was no medical condition after the delivery. Additional information is not expected.