chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL, concerning a 16 year old female with allergic reaction to cephlosporins and a history of 1 pre-term delivery at 36 weeks with complication of apnea of prematurity and no birth defects who on 21-JAN-2008, was vaccinated with the first dose of GARDASIL (lot#657872/0515U).  Concomitant medication included ALESSE for birth control.  The physician reported that on 24-MAR-2008, the patient was vaccinated with the second dose of GARDASIL (lot # 657872/0515U) at her primary care office.  On 09-JUN-2008, the patient had a blood test and urine test for pregnancy, and an ultrasound that confirmed the pregnancy and showed the patient was 23 weeks and 6 days pregnant and the fetus had a normal anatomy.  The patient's LMP was 25-DEC-2007 and EDD 30-SEP-2008 and her date of conception was approximately 05 to 10-JAN-2008.  The patient sought medical attention at the physician's office.  In further follow up, the physician reported that the baby delivered on 31-AUG-2008 was male and weighed 5 pounds, 2 ounces, was 18 1/2 inches, and the APGAR score was 6/9.  The infant was normal, with no congenital anomalies and there were no other complications.  The patient had complications during the pregnancy and labor/delivery because was a precipitous delivery.  She was on bed rest at 31 weeks.  On 26-AUG-2008, the patient had an ultrasound which was normal size/fluid.  Other medications were used during this pregnancy, was terbutaline 5 mg every 4 hours for pre term labor from 06-AUG-2008 to 07-AUG-2008 and MACROBID, bid, for treatment of a urinary tract infection from 06-AUG-2008 to 13-AUG-2008.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Infection, Medication error, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse (R.N.) for the Pregnancy Registry for GARDASIL regarding a 15 year old female who on 14-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #, and site not reported). Concomitant therapy included a first dose of MENACTRA. On 27-SEP-2007, the patient was vaccinated with a second dose of MENACTRA was received in error. On 16-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot #, and site not reported). On 22-FEB-2008, the patient was vaccinated with her third dose of GARDASIL (Lot # 655165/1425F, site not reported). ON 10-APR-2008, the patient was vaccinated intramuscularly with her fourth dose of GARDASIL (Lot #655165/1425F, site not reported). The patient received the fourth dose of GARDASIL in error. Concomitant therapy included Tylenol. On an unspecified date the patient took a urine pregnancy test which was positive. The patient "thinks she became pregnant in the first week of November 2007" (LMP approximately 10-OCT-2007). On an unspecified date, the patient had an ultrasound (not further specified). The patient had no symptoms. The patient sough unspecified medical attention by seeing the nurse. No further information is available. Follow-up information was received on 03-NOV-2008 from the R.N. and a physician indicating that the patient is with ) previous pregnancies. The patient had no significant past medical history or concurrent medical conditions. It was reported that the third dose of GARDASIL (Lot #655165/1425F) was under bad storage and the dose was therefore repeated on 10-APR-2008. Other medication used during this pregnancy included occasional prenatal vitamins for nutrition and Zithromax (initialized on 05-MAY-2008), 250 mg, daily for an unknown infection (it was also reported that the patient had no infections or illness during pregnancy). The outcome of the infection was not reported. An ultrasound performed on 05-MAY-2008 was normal. On 11-AUG-2008, 40 weeks from her LMP, the patient delivered a normal female baby, weighing 3 kg. The patient's length was 48 cm. There were no congenital anomalies. There were no other complications or abnormalities. The patient had no complication during pregnancy or labor/delivery. Additional information is not reported.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse (R.N.) for the Pregnancy Registry for GARDASIL regarding a 15 year old female who on 14-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #, and site not reported). Concomitant therapy included a first dose of MENACTRA. On 27-SEP-2007, the patient was vaccinated with a second dose of MENACTRA was received in error. On 16-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot #, and site not reported). On 22-FEB-2008, the patient was vaccinated with her third dose of GARDASIL (Lot # 655165/1425F, site not reported). ON 10-APR-2008, the patient was vaccinated intramuscularly with her fourth dose of GARDASIL (Lot #655165/1425F, site not reported). The patient received the fourth dose of GARDASIL in error. Concomitant therapy included Tylenol. On an unspecified date the patient took a urine pregnancy test which was positive. The patient "thinks she became pregnant in the first week of November 2007" (LMP approximately 10-OCT-2007). On an unspecified date, the patient had an ultrasound (not further specified). The patient had no symptoms. The patient sough unspecified medical attention by seeing the nurse. No further information is available. Follow-up information was received on 03-NOV-2008 from the R.N. and a physician indicating that the patient is with ) previous pregnancies. The patient had no significant past medical history or concurrent medical conditions. It was reported that the third dose of GARDASIL (Lot #655165/1425F) was under bad storage and the dose was therefore repeated on 10-APR-2008. Other medication used during this pregnancy included occasional prenatal vitamins for nutrition and Zithromax (initialized on 05-MAY-2008), 250 mg, daily for an unknown infection (it was also reported that the patient had no infections or illness during pregnancy). The outcome of the infection was not reported. An ultrasound performed on 05-MAY-2008 was normal. On 11-AUG-2008, 40 weeks from her LMP, the patient delivered a normal female baby, weighing 3 kg. The patient's length was 48 cm. There were no congenital anomalies. There were no other complications or abnormalities. The patient had no complication during pregnancy or labor/delivery. Additional information is not reported.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Hepatic enzyme increased, Pregnancy induced hypertension
Clinical narrative: Information has been received from a 22 year old female consumer with no pertinent medical history or drug allergies, for the Pregnancy Registry for GARDASIL, concerning the consumer who on 27-MAR-2008 was vaccinated with the first 0.5 ml dose of GARDASIL.  Concomitant therapy included "petrocyclin."  On 02-APR-2008 the consumer took a pregnancy test, and discovered that she was pregnant.  The date of LMP was 03-MAR-2008, the estimated date of delivery was 08-DEC-2008.  The patient would discontinue the rest of the series until the pregnancy was over.  No further information was provided.  The patient sought unspecified medical attention.  Follow-up information was received from the patient who reported that she saw certified nurse midwife and she was well, not having any problems and her EDD was 08-DEC-2008.  Follow-up information on 24-NOV-2008 from a Certified Nurse Midwife who reported that on 27-MAR-2008, the patient who was a positive Group B streptococcus carrier and with no previous pregnancies was vaccinated with the first dose of GARDASIL.  Concomitant therapy included unspecified therapy.  On 18-APR-2008, the patient underwent serum alpha-fetoprotein test and result was within normal limit (negative).  On 21-JUL-2008, the patient underwent ultrasound for tetracycline exposure and family history of Meckel and result was normal.  On 03-NOV-2008, the patient delivered a normal infant (Weeks from LMP: 35).  There were no congenital anomalies.  The patient experienced pre term dilation, pregnancy induced hypertension, elevated liver enzymes, and positive proteinuria during the pregnancy.  Tetracycline was used for dermatologic reason during the pregnancy prior to knowledge.  At the time of reporting, the outcomes were unknown.  Additional information was requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Premature baby, Proteinuria, Ultrasound scan normal
Clinical narrative: Information has been received from a 22 year old female consumer with no pertinent medical history or drug allergies, for the Pregnancy Registry for GARDASIL, concerning the consumer who on 27-MAR-2008 was vaccinated with the first 0.5 ml dose of GARDASIL.  Concomitant therapy included "petrocyclin."  On 02-APR-2008 the consumer took a pregnancy test, and discovered that she was pregnant.  The date of LMP was 03-MAR-2008, the estimated date of delivery was 08-DEC-2008.  The patient would discontinue the rest of the series until the pregnancy was over.  No further information was provided.  The patient sought unspecified medical attention.  Follow-up information was received from the patient who reported that she saw certified nurse midwife and she was well, not having any problems and her EDD was 08-DEC-2008.  Follow-up information on 24-NOV-2008 from a Certified Nurse Midwife who reported that on 27-MAR-2008, the patient who was a positive Group B streptococcus carrier and with no previous pregnancies was vaccinated with the first dose of GARDASIL.  Concomitant therapy included unspecified therapy.  On 18-APR-2008, the patient underwent serum alpha-fetoprotein test and result was within normal limit (negative).  On 21-JUL-2008, the patient underwent ultrasound for tetracycline exposure and family history of Meckel and result was normal.  On 03-NOV-2008, the patient delivered a normal infant (Weeks from LMP: 35).  There were no congenital anomalies.  The patient experienced pre term dilation, pregnancy induced hypertension, elevated liver enzymes, and positive proteinuria during the pregnancy.  Tetracycline was used for dermatologic reason during the pregnancy prior to knowledge.  At the time of reporting, the outcomes were unknown.  Additional information was requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Infection
Clinical narrative: Information has been received through the pregnancy registry and a nurse concerning a 17 year old female who on 09-AUG-2007 and 11-OCT-2007 was vaccinated with a first and second dose of GARDASIL, respectively. Subsequently, she became pregnant. Her last menstrual period (LMP) was reported as July 2007. She received late prenatal care. On 30-MAR-2008, the patient was hospitalized "for delivery" and delivered a healthy baby. Her pregnancy was reported as normal. At the time of this report, the patient had recovered. No product quality complaint was involved. In follow up medical record it was reported that patient developed an infection two days after delivery. The outcome was not reported. Pediatric medical records were received and reviewed. The following experience with the baby were identified. On 08-APR-2008 the baby was brought to the clinic and thick white patch was present on her tongue. She was prescribed nystatin 4 cc on a swab. The mother was instructed to boil blttle nipples. She was instructed to call the clinic if it dose not clear within two weeks. On 11-APR-2008 the baby came to the clinic again. The mother thought she was fussy with bowel movement and felt that she had constipation. Mother reported that the baby was very irritable and screamed with bowel movement. She was advised to use 1-2 teaspoons of dark Karo syrup in every other bottle to see if it helps with the irritability and difficulty stooling. On 01-MAY-2008 baby had a visit to the clinic. On this visit mother reported that baby had watery left eye. It was reported that the baby recovered from constipation (date not reported). Her diaper area was reddened with multiple papules. No excess tearing from the eye noted in this visit. On 01-JUN-2008 the baby reported to have diaper candidiasis. She was called in clotrimazole cream to apply three times per day for ten days to the diaper area. It was discussed with mom other methods of improving diaper rash. Mom was concerned about a bump on baby's right hand. She wanted it to be checked. The physician reported it as a bony prominence on baby's hand. She was instructed by the physician to contact the clinic if any redness, increase in size or signs and symptoms of infection should occur. At the time of this report the outcome was unknown. The baby also had events after she was vaccinated with ROTATEQ, Hib conj vaccine (tet toxoid) (manufacturer unknown), PREVENAR, PEDIARIX which is reported in (WAES # 0811USA02266). Additional information is not expected. All medical records will be provided upon request.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Constipation, Diagnostic procedure, Drug exposure during pregnancy, Premature labour
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with a history of urinary tract infections, kidney infections, a previous pregnancy with an elective abortion, and an "abnormal pap with cryo" in December 2006, who on 14-NOV-2007 was vaccinated with her first dose of GARDASIL.  On 21-JAN-2008, the patient was vaccinated with her second dose of GARDASIL.  There was no concomitant medication.  Subsequently, the patient became pregnant.  No adverse symptoms were reported.  The registered nurse stated that the patient was 12 weeks pregnant as of 18-Mar-2008.  On an unspecified date, the patient took a urine pregnancy test which was positive.  The date of last menstrual period was 23-DEC-2007 and the estimated delivery date was 28-SEP-2008.  On 19-MAR-2008, the patient had a pelvic ultrasound with the normal result.  On 25-MAR-2008 the patient had a maternal serum alpha-fetoprotein test for first trimester screening which was negative.  On 26-APR-2008, the patient had an ultrasound for "anatomy" with "Echogenic Fetal Kidneys", results not provided.  The dose of GARDASIL were administered at another site while the patient attended college.  The patient sought unspecified medical attention in the office.  On 10-OCT-2008, the nurse practitioner reported that the patient had her baby at the end of September or beginning of October.  She did not have the patient's chart available at the moment so she wasn't sure of the exact date.  She also reported that "nothing ever came of that" about the echogenic fetal kidneys that were seen during the 18 week 1 day anatomy scan on 26-APR-2008.  The patient had undergone some genetic counseling/testing but everything was normal with the baby.  There were no congenital anomalies and the baby was healthy when it was born.  Follow-up information has been received from a completed questionnaire from a Certified Registered Nurse Practitioner.  Other medication used during pregnancy includes metronidazole (manufacturer unknown) for bacterial vaginitis on 11-APR-2008, COLACE for constipation on 11-APR-2008, and nifedipine (manufacturer unknown) for pre-term labor at 31 weeks on 31-JUL-2008.  On 06-MAY-2008, ultrasound follow-up, for echogenic fetal kidney - anatomy screen resulted cero problems.  A serum alpha fetoprotein test was performed resulting within normal limits.  There were no complications during labor/delivery.  On 26-SEP-2008, she delivered a normal and healthy male, 40 weeks from last menstrual period (previously reported as at the end of September or beginning of October).  There were no congenital anomalies.  Additional information is not available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal, Ultrasound scan normal, Urine human chorionic gonadotropin positive, Vaginitis bacterial
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a nurse practitioner, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with a history of urinary tract infections, kidney infections, a previous pregnancy with an elective abortion, and an "abnormal pap with cryo" in December 2006, who on 14-NOV-2007 was vaccinated with her first dose of GARDASIL.  On 21-JAN-2008, the patient was vaccinated with her second dose of GARDASIL.  There was no concomitant medication.  Subsequently, the patient became pregnant.  No adverse symptoms were reported.  The registered nurse stated that the patient was 12 weeks pregnant as of 18-Mar-2008.  On an unspecified date, the patient took a urine pregnancy test which was positive.  The date of last menstrual period was 23-DEC-2007 and the estimated delivery date was 28-SEP-2008.  On 19-MAR-2008, the patient had a pelvic ultrasound with the normal result.  On 25-MAR-2008 the patient had a maternal serum alpha-fetoprotein test for first trimester screening which was negative.  On 26-APR-2008, the patient had an ultrasound for "anatomy" with "Echogenic Fetal Kidneys", results not provided.  The dose of GARDASIL were administered at another site while the patient attended college.  The patient sought unspecified medical attention in the office.  On 10-OCT-2008, the nurse practitioner reported that the patient had her baby at the end of September or beginning of October.  She did not have the patient's chart available at the moment so she wasn't sure of the exact date.  She also reported that "nothing ever came of that" about the echogenic fetal kidneys that were seen during the 18 week 1 day anatomy scan on 26-APR-2008.  The patient had undergone some genetic counseling/testing but everything was normal with the baby.  There were no congenital anomalies and the baby was healthy when it was born.  Follow-up information has been received from a completed questionnaire from a Certified Registered Nurse Practitioner.  Other medication used during pregnancy includes metronidazole (manufacturer unknown) for bacterial vaginitis on 11-APR-2008, COLACE for constipation on 11-APR-2008, and nifedipine (manufacturer unknown) for pre-term labor at 31 weeks on 31-JUL-2008.  On 06-MAY-2008, ultrasound follow-up, for echogenic fetal kidney - anatomy screen resulted cero problems.  A serum alpha fetoprotein test was performed resulting within normal limits.  There were no complications during labor/delivery.  On 26-SEP-2008, she delivered a normal and healthy male, 40 weeks from last menstrual period (previously reported as at the end of September or beginning of October).  There were no congenital anomalies.  Additional information is not available.
Age: 0.27
Sex: M
Vaccine: MMR, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 14 week patient with a history of premature infant who on 26-NOV-2008 was vaccinated with the first dose of ROTATEQ.  No adverse effect reported.  The patient's outcomes were unknown.  It was unspecified if the patient sought medical attention.  Additional information has been requested.  Follow up information was received from the registered nurse to report that the patient also vaccinated with a dose of MMR on 26-NOV-2008.  Additional infromation has been received on 06-JAN-2009 from Registered Nurse concerning a 14 weeks male with Grade III intraventricular hemorrhage neonatal and a history of premature birth at 23 6/7 weeks, pneumonia and neonatal respiratory distress syndrome. The infant was hospitalized from birth due to premature birth while in the hospital infant received the following vaccinations on 13-OCT-2008: PEDIARIX, PREVENAR and HIB (manufacturer unknown) (the date of discharge was not reported). On 19-NOV-2008, the infant received SYNAGIS in the physician's office. On 26-NOV-2008., the infant received ROTATEQ (Lot # 661685/0967X) at 12:35 PM.  Additional infromation is not exepected.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abnormal faeces, Body temperature increased, Diarrhoea, Drooling, Exposure to chemical pollution
Clinical narrative: Information has been received from a physician via medical records concerning an 18 week female with secondhand tobacco smoke exposure and a history of feeding problem in newborn, diaper rash and oral candidiasis (WAES # 0806USA03719) who on 19-AUG-2008 and 23-OCT-2008 was vaccinated orally with the first and second doses, respectively, of ROTATEQ (Lot # 660425/0278X). On 19-AUG-2008, the child also received ACTHIB (Lot #C57536), PREVNAR (Lot #C57536) and PEDIARIXF (Lot #AC21B143AA). It was reported that on 19-AUG-2008, the patient's body temperature was 99 F. She was placed on therapy with acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 23-OCT-2008, the child was taken to the office for routine health check, complaining of nasal congestion with maximum temperature of 99.5 F. Per her Great Aunt, she had had upper respiratory symptoms for several days with nasal congestion. It was reported that the child had otolaryngeal symptoms of pulling at the ears, nasal discharge, nasal passage blockage and excessive drooling. She strained to stool, but stools were soft and sometimes runny. Physical examination showed the patient temperature was 98.5 F, nasal discharge was clear and mucoid, nasal mucosa was normal. The patient was diagnosed with acute upper respiratory infection and was placed on therapy with Acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 29-OCT-2008 the child was taken to the office again, complaining of drainage from both ears. The discharge from the ears had existed for 2 days. It was reported that the child had no fever (body temperature 98.8 F) and gastrointestinal symptoms. Physical examination showed abnormalities purulent discharge in canals B. There was no nasal discharge seen. The child was diagnosed with acute suppurative otitis media B and was placed on therapy with Amoxicillin, 400 mg/5 ml powder for reconstitution, 4 ml, orally, twice a day for 10 days and Floxin, otic 0.3 % solution, 5 gtt in each affected ear, twice a day for 10 days. The outcome of the patient was not reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Nasal congestion, Otitis media acute, Otorrhoea, Purulent discharge, Rhinorrhoea
Clinical narrative: Information has been received from a physician via medical records concerning an 18 week female with secondhand tobacco smoke exposure and a history of feeding problem in newborn, diaper rash and oral candidiasis (WAES # 0806USA03719) who on 19-AUG-2008 and 23-OCT-2008 was vaccinated orally with the first and second doses, respectively, of ROTATEQ (Lot # 660425/0278X). On 19-AUG-2008, the child also received ACTHIB (Lot #C57536), PREVNAR (Lot #C57536) and PEDIARIXF (Lot #AC21B143AA). It was reported that on 19-AUG-2008, the patient's body temperature was 99 F. She was placed on therapy with acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 23-OCT-2008, the child was taken to the office for routine health check, complaining of nasal congestion with maximum temperature of 99.5 F. Per her Great Aunt, she had had upper respiratory symptoms for several days with nasal congestion. It was reported that the child had otolaryngeal symptoms of pulling at the ears, nasal discharge, nasal passage blockage and excessive drooling. She strained to stool, but stools were soft and sometimes runny. Physical examination showed the patient temperature was 98.5 F, nasal discharge was clear and mucoid, nasal mucosa was normal. The patient was diagnosed with acute upper respiratory infection and was placed on therapy with Acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 29-OCT-2008 the child was taken to the office again, complaining of drainage from both ears. The discharge from the ears had existed for 2 days. It was reported that the child had no fever (body temperature 98.8 F) and gastrointestinal symptoms. Physical examination showed abnormalities purulent discharge in canals B. There was no nasal discharge seen. The child was diagnosed with acute suppurative otitis media B and was placed on therapy with Amoxicillin, 400 mg/5 ml powder for reconstitution, 4 ml, orally, twice a day for 10 days and Floxin, otic 0.3 % solution, 5 gtt in each affected ear, twice a day for 10 days. The outcome of the patient was not reported. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sleep disorder, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician via medical records concerning an 18 week female with secondhand tobacco smoke exposure and a history of feeding problem in newborn, diaper rash and oral candidiasis (WAES # 0806USA03719) who on 19-AUG-2008 and 23-OCT-2008 was vaccinated orally with the first and second doses, respectively, of ROTATEQ (Lot # 660425/0278X). On 19-AUG-2008, the child also received ACTHIB (Lot #C57536), PREVNAR (Lot #C57536) and PEDIARIXF (Lot #AC21B143AA). It was reported that on 19-AUG-2008, the patient's body temperature was 99 F. She was placed on therapy with acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 23-OCT-2008, the child was taken to the office for routine health check, complaining of nasal congestion with maximum temperature of 99.5 F. Per her Great Aunt, she had had upper respiratory symptoms for several days with nasal congestion. It was reported that the child had otolaryngeal symptoms of pulling at the ears, nasal discharge, nasal passage blockage and excessive drooling. She strained to stool, but stools were soft and sometimes runny. Physical examination showed the patient temperature was 98.5 F, nasal discharge was clear and mucoid, nasal mucosa was normal. The patient was diagnosed with acute upper respiratory infection and was placed on therapy with Acetaminophen 80 mg/0.8 ml (12-17 pounds) drops, 0.8 ml, orally, every 4 to 6 hours for one day (as needed for fever). On 29-OCT-2008 the child was taken to the office again, complaining of drainage from both ears. The discharge from the ears had existed for 2 days. It was reported that the child had no fever (body temperature 98.8 F) and gastrointestinal symptoms. Physical examination showed abnormalities purulent discharge in canals B. There was no nasal discharge seen. The child was diagnosed with acute suppurative otitis media B and was placed on therapy with Amoxicillin, 400 mg/5 ml powder for reconstitution, 4 ml, orally, twice a day for 10 days and Floxin, otic 0.3 % solution, 5 gtt in each affected ear, twice a day for 10 days. The outcome of the patient was not reported. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 13 weeks old female who on 29-OCT-2008 was vaccinated with the first dose of ROTAEQ. The reporter stated that the patient received the first dose later than recommended. No adverse effect was reported. Follow-up information has been received from a helath professional concerning a 15 week old (previously reported as 13 weeks) white female patient who was orally vaccinated at 3:00 pm on 29-OCT-2008 with ROTATEQ (lot 662732/1100X) at 15 weeks. It was reported that the patient was fine without signs and symptoms. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Bronchiolitis, Drug exposure during pregnancy, Pregnancy test positive, Urinary tract infection
Clinical narrative: Information has been received from a physician for the Pregnancy Registry of GARDASIL concerning a 16 year old female who on 07-FEB-2008 was vaccinated  with her first dose of GARDASIL (lot # not reported).  Concomitant therapy included a dose of VARIVAX (lot number unknown).  Other concomitant therapy included MENACTRA.  On 19-FEB-2008 the patient had a positive pregnancy test.  Her LMP was 25-JAN-2008.  Follow-up information was received from the physician.  The patient had medical history of depression.  Concomitant medication during her pregnancy included KEFLEX for UTI (started on 11-JUN-2008) and ZITHROMAX for bronchiolitis (started on 08-SEP-2008).  On 29-OCT-2008, the patient delivered a normal, health male baby (no congenital anomalies), weighing 7 pounds 14 ounces, 20 inch in length, with Apgar score 9/9 and head circumference 50.5 cm.  There were no complication during labor or delivery.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Blood human chorionic gonadotropin positive, Cervical dysplasia, Drug exposure during pregnancy, Fungal infection
Clinical narrative: Information has been received from a health professional through the Pregnancy Registry for GARDASIL concerning an 18 year old female, with a history of ADHD as a child, who on 18-OCT-2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 658563/1063U). On 02-JAN-2008, the patient was vaccinated intramuscularly with her second 0.5 ml dose of GARADASIL (Lot # 659437/1266U). On 27-FEB-2008, the patient had a pregnancy test, in the doctor's office, which was positive (LMP = "mid-December 2007"). the patient sought unspecified medical attention in the office. Follow-up information received from a nurse practitioner concerning the patient. During the patient's pregnancy, on 02-JAN-2008 she developed yeast infection and was treated with TERAZOL on 2-JAN-2008, 1 mg, QHS for 7 days. On 20-FEB-2008, she was treated with prental vitamin, 1 mg, daily. An ultrasound was performed (results not provided). On 20-MAY-2008 cervix biopsy and papanicolaou test (PAP) were performed which revealed low-grade intraepithelial lesion (LSIL). On 12-JUN-2008, a PAP test revealed possible HPV changes. On 24-SEP-2008 the patient developed a paronychia infection and was treated with KEFLEX, tablet, oral, and 250mg twice daily for 14 days. On 04-OCT-2008, at 38 weeks gestation, delivered a normal, healthy female baby weighing 6.1 pounds. Length of the baby was 18 and head circumference was 12.25. On 13-NOV-2008, the patient underwent a repeat PAP test (results pending). No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Infection, Smear cervix abnormal
Clinical narrative: Information has been received from a health professional through the Pregnancy Registry for GARDASIL concerning an 18 year old female, with a history of ADHD as a child, who on 18-OCT-2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 658563/1063U). On 02-JAN-2008, the patient was vaccinated intramuscularly with her second 0.5 ml dose of GARADASIL (Lot # 659437/1266U). On 27-FEB-2008, the patient had a pregnancy test, in the doctor's office, which was positive (LMP = "mid-December 2007"). the patient sought unspecified medical attention in the office. Follow-up information received from a nurse practitioner concerning the patient. During the patient's pregnancy, on 02-JAN-2008 she developed yeast infection and was treated with TERAZOL on 2-JAN-2008, 1 mg, QHS for 7 days. On 20-FEB-2008, she was treated with prental vitamin, 1 mg, daily. An ultrasound was performed (results not provided). On 20-MAY-2008 cervix biopsy and papanicolaou test (PAP) were performed which revealed low-grade intraepithelial lesion (LSIL). On 12-JUN-2008, a PAP test revealed possible HPV changes. On 24-SEP-2008 the patient developed a paronychia infection and was treated with KEFLEX, tablet, oral, and 250mg twice daily for 14 days. On 04-OCT-2008, at 38 weeks gestation, delivered a normal, healthy female baby weighing 6.1 pounds. Length of the baby was 18 and head circumference was 12.25. On 13-NOV-2008, the patient underwent a repeat PAP test (results pending). No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a Registered Nurse for the pregnancy registry for human papillommavirus vaccine concerning a female with a penicillin allergy who on 12-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot #654741/1208F).  The patient received the second dose on 01-MAY-2007 (Lot #655205/1426F) and the third dose on 15-AUG-2007 (Lot #657622/0388U).  The patient became pregnant after her last menstrual period of 08-NOV-2007.  No adverse effects were reported.  Follow up information was received from a licensed practical nurse concerning a Caucasian female with no history of previous pregnancies, who on 12-FEB-2007, 01-MAY-2007 and 15-AUG-2007 was vaccinated with the first, second and third dose of GARDASIL respectively.  Concomitant medication included TANDEM DHA.  The LPN reported that on 06-MAR-2008 an ultrasound was performed for size and date.  On 26-AUG-2008 the female patient gave birth to a normal male (weight 8 pounds 11 ounces and length 20.5 cm).  It was reported that there were no complications during pregnancy and none during labor/delivery.  The baby presented sleep apnea noted at 3 weeks.  Last menstrual period was 08-NOV-2007.  Estimated delivery date was 14-AUG-2008.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Gestational diabetes, Streptococcal identification test positive, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a certified nurse midwife for the pregnancy registry for GARDASIL, concerning an approximately 19 year old female with diabetes, papilloma viral infection, successful smoking cessation at 27 weeks of gestation and thalassaemia minor and a history of depression, who in October 2007, was vaccinated with the first dose of GARDASIL and subsequently was determined to be pregnant.  It was reported the patient has no previous pregnancies.  On 31-Jan-2008, the patient was placed on therapy with prenatal vitamins (unspecified), PRN for the pregnancy and the treatment of anemia.  Other therapies used in pregnancy included as follows:  On 31-JAN-2008, the patient was placed on therapy with metronidazole, 500 mg twice a day for the treatment of bacterial vaginosis.  On 04-FEB-2008, the patient was placed on ferrous sulfate, 325 mg twice a day for the treatment of anemia.  On 04-FEB-2008, an ultrasound was performed and was found within normal limits.  On 07-FEB-2008, therapy with metronidazole was discontinued.  On 28-APR-2008, the patient was placed on therapy with glyburide, 2.5 mg twice a day for the treatment of gestational diabetes.  On 09-MAY-2008, an ultrasound was performed and was found within normal limits.  On 27-MAY-2008, an ultrasound was performed and a biophysical profile of 8/10 was found.  Diagnostic laboratory tests during pregnancy also included a blood work for iron studies and a group B strep screen found positive.  The patient's LMP was on 24-SEP-2007.  On 11-JUN-2008, the patient delivered a 39 weeks healthy baby girl with an apgar score of 8 at one minute and 10 at 5 minutes.  The estimated date of delivery was 18-JUN-2008.  On 14-NOV-2008, the patient had a 5 month old visit and well child examination was found.  Baby's growth and developed was considered normal.  The baby was recommended for flu vaccine and scheduled for follow-up in two months.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginitis bacterial
Clinical narrative: Information has been received from a certified nurse midwife for the pregnancy registry for GARDASIL, concerning an approximately 19 year old female with diabetes, papilloma viral infection, successful smoking cessation at 27 weeks of gestation and thalassaemia minor and a history of depression, who in October 2007, was vaccinated with the first dose of GARDASIL and subsequently was determined to be pregnant.  It was reported the patient has no previous pregnancies.  On 31-Jan-2008, the patient was placed on therapy with prenatal vitamins (unspecified), PRN for the pregnancy and the treatment of anemia.  Other therapies used in pregnancy included as follows:  On 31-JAN-2008, the patient was placed on therapy with metronidazole, 500 mg twice a day for the treatment of bacterial vaginosis.  On 04-FEB-2008, the patient was placed on ferrous sulfate, 325 mg twice a day for the treatment of anemia.  On 04-FEB-2008, an ultrasound was performed and was found within normal limits.  On 07-FEB-2008, therapy with metronidazole was discontinued.  On 28-APR-2008, the patient was placed on therapy with glyburide, 2.5 mg twice a day for the treatment of gestational diabetes.  On 09-MAY-2008, an ultrasound was performed and was found within normal limits.  On 27-MAY-2008, an ultrasound was performed and a biophysical profile of 8/10 was found.  Diagnostic laboratory tests during pregnancy also included a blood work for iron studies and a group B strep screen found positive.  The patient's LMP was on 24-SEP-2007.  On 11-JUN-2008, the patient delivered a 39 weeks healthy baby girl with an apgar score of 8 at one minute and 10 at 5 minutes.  The estimated date of delivery was 18-JUN-2008.  On 14-NOV-2008, the patient had a 5 month old visit and well child examination was found.  Baby's growth and developed was considered normal.  The baby was recommended for flu vaccine and scheduled for follow-up in two months.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Apgar score normal, Blood human chorionic gonadotropin negative, Blood human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from a nurse and a certified medical midwife for the Pregnancy Registry for GARDASIL, concerning a 23 year old female patient who smokes cigarettes, who in 17-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot No 658563/1063U). In approximately 2008, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL. Concomitant therapy included Depo-Provera on 17-DEC-2007 for contraception. On 17-DEC-2007, the patient took a pregnancy test which came back negative. Patient came back approximately a week later and was pregnant. The last date of menstrual period was on 22-NOV-2008 and the estimated delivery date was on 02-SEP-2008. On 11-JAN-2008, 17-APR-2008, 23-JUL-2008, 08-AUG-2008 some ultrasounds were performed to check the dates, survey and bleeding was found it. On 04-APR-2008 a serum alpha-fetoprotein test performed with negative results. The certified medical midwife reported that on 04-SEP-2008 the patient delivered a normal male baby, with no congenital anomalies, and with no known complication during labor/delivery. The patient had an obstetric history of one previous pregnancy with an spontaneous abortion and history of yeast during pregnancy. There was a complication during the patient's pregnancy with a vaginal bleeding at 36 weeks. Other medication used during pregnancy were prenatal vitamins (PVN), ferrous sulfate for anaemia, and Diflucan for yeast. The baby's weight was 6 pounds with 8 onz, with length of 18 1/2 cm a head circumference of 32 cm and an Apgar score of 9/9. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Fungal infection, Ultrasound scan abnormal, Vaginal haemorrhage
Clinical narrative: Initial and follow up information has been received from a nurse and a certified medical midwife for the Pregnancy Registry for GARDASIL, concerning a 23 year old female patient who smokes cigarettes, who in 17-DEC-2007 was vaccinated with the first dose of GARDASIL (Lot No 658563/1063U). In approximately 2008, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL. Concomitant therapy included Depo-Provera on 17-DEC-2007 for contraception. On 17-DEC-2007, the patient took a pregnancy test which came back negative. Patient came back approximately a week later and was pregnant. The last date of menstrual period was on 22-NOV-2008 and the estimated delivery date was on 02-SEP-2008. On 11-JAN-2008, 17-APR-2008, 23-JUL-2008, 08-AUG-2008 some ultrasounds were performed to check the dates, survey and bleeding was found it. On 04-APR-2008 a serum alpha-fetoprotein test performed with negative results. The certified medical midwife reported that on 04-SEP-2008 the patient delivered a normal male baby, with no congenital anomalies, and with no known complication during labor/delivery. The patient had an obstetric history of one previous pregnancy with an spontaneous abortion and history of yeast during pregnancy. There was a complication during the patient's pregnancy with a vaginal bleeding at 36 weeks. Other medication used during pregnancy were prenatal vitamins (PVN), ferrous sulfate for anaemia, and Diflucan for yeast. The baby's weight was 6 pounds with 8 onz, with length of 18 1/2 cm a head circumference of 32 cm and an Apgar score of 9/9. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Drug exposure during pregnancy, Staphylococcal infection, Ultrasound scan normal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician through the Pregnancy Registry for GARDASIL concerning an 18 year old female with a history of deep vein thrombosis at the age of 15 and no drug allergies, who in the middle of September 2007 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL.   The patient was vaccinated with a second dose of GARDASIL approximately from the middle to the end of November 2007.  There was no concomitant medication.  Subsequently, the patient was pregnant.  The patient sought medical attention from her primary care physician.  A urine pregnancy test was performed and was positive.  The patient's last menstrual period was 12-NOV-2007 and her estimated delivery date was 18-AUG-2008.  The patient contacted the physician for OB/GYN care.  No problems were reported.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Follow-up information was received from a nurse practitioner and patient who reported that the patient delivered a normal healthy baby on 12-AUG-2008.  The nurse practitioner reported that during the pregnancy the patient had a routine pregnancy ultrasound on 04-APR-2008, 23-JUN-2008 and 22-JUL-2008 and the results were normal.  On 29-MAY-2008, the patient had a glucose screen and was normal.  In further follow up, the patient reported that the baby was female and weighed 7 pounds, was 20 inches, the APGAR score was 8/9 and head circumference was 32.  The infant was normal, with no congenital anomalies and there were no other complications.  The patient had no complications during the pregnancy and labor/delivery.  Infection during the pregnancy included  a "staff" infection.  The medications used during her pregnancy were LOVENOX, 40mg, daily (January to July 2008) and HEPARIN, 20mg, twice daily (July to August 2008) for the treatment of deep  vein thrombosis.  No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Drug exposure during pregnancy, Gestational diabetes, Pregnancy test positive
Clinical narrative: Information has been received, for the Pregnancy Registry for GARDASIL, from a 24 year old female with a history of gestational diabetes who on 04-JAN-2008 was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The patient reported that after receiving GARDASIL, she found out that she was 5 weeks pregnant.  Her LMP was approximately 15-Dec-2007.  A pregnancy test was performed.  The patient did not seek medical attention.  Follow-up information was received on 01-FEB-2008 via phone call from a person of a doctor's office indicating that they did not have any record of the patient ever receiving GARDASIL or any indication that she was pregnant.  The patient was last seen in their office in November 2007.  Follow-up information was received from a person of a doctor's office indicating that the Hispanic patient had 2 previous pregnancies and 2 pre-term deliveries.  No birth defects occurred in previous pregnancies.  The patient had pre-eclampsia and gestational diabetes in previous pregnancies.  On 26-FEB-2008 an ultrasound was performed and the results were with normal limits.  The patient was also placed on prenatal vitamins.  Follow-up information was received on 03-NOV-2008 which confirmed that the patient had a past medical history of gestational diabetes.  The patient developed insulin dependent diabetes during this pregnancy.  She was treated with insulin human NOVOLIN (from 110JUL-2008 till EDC), 24 units, twice a day and insulin aspart NOVOLOG (from 11-JUL-2008 till EDC), 20/16 units, 20, every morning and 16, after supper.  Other medication used during this pregnancy included prenatal vitamin (initialized on 20-MAY-2008), 1 mg, daily.  On 02-SEP-2008, 37.3 weeks from her LMP, the patient delivered a normal male baby, weighing 7 pounds, 8 ounces.  The baby's length was 19.5, head circumference was 13.5 and apgar score was 7/10.  There were no congenital anomalies.  There were no other complications or abnormalities.  The patient had no complication during labor/delivery.  There were no infections or illness during pregnancy.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Anaemia, Drug exposure during pregnancy, Foetal disorder, Haemoglobin decreased
Clinical narrative: Initial and follow-up information has been received through Pregnancy Registry for a 22 year old female consumer with 2 previous full term deliveries  who on 28-AUG-2007 was vaccinated with a first dose of GARDASIL vaccine (lot # 656050/0245U).  There was no concomitant medication.  On approximately 04-Sep-2007, the patient had a pregnancy test which was positive (LMP approximately 04-JUL-2007).  The patient reported having an ultrasound;  however, no additional information was provided.  The patient sought unspecified medical attention.  On 30-OCT-2007, the patient had a positive pregnancy test.   The estimated conception date is 27-JUL-2007.  The estimated  date of delivery is 09-APR-2008.  In further follow up, a nurse practitioner reported that the patient delivered a female baby on 23-MAY-2008.  The baby weighed 10 pounds 2 ounces, was 20 inches, and the APGAR score was unknown.  The infant was macrosomic and had no other abnormalities or complications.  During pregnancy, the patient experienced anemia (HgE 10.9).  The patient experienced failure to progress because of the large baby during the labor/delivery.  On 14-DEC-2007, the patient had an ultrasound which was within normal limits.  On an unspecified date, the patient had a positive alpha-fetoprotein test.  There were no infections or illnesses during pregnancy.  Follow-up information was received from a nursing supervisor who stated that the patient went to their offices on 11-JUN-2008 suffering post-partum depression and was referred to "psych".  Additional information has been requested.