chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Blister, Blood test, Herpes zoster, Hypoaesthesia
Clinical narrative: Information has been received from a consumer concerning her daughter a 17 year old female without a pertinent medical history and without drug reactions or allergies who in May 2007 was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The reporter mentioned that the patient got all 3 doses of GARDASIL (dates of the second and third dose were unspecified) and after the first dose she experienced shingles on her left leg and after some time the blister went away however her left leg in the area that the shingles were was still numb.  It was also reported that the patient started experiencing swollen glands behind her ears every now and then.  The reporter stated that the last November the patient had her wisdom teeth removed and her oral surgeon found 2 lesions on the back of her throat that the surgeon removed and stated that he had them tested and they were not cancer, but also mentioned that they could have developed into cancer later on.  It was also reported that a "blood work" test was performed but the results were unspecified.  The patient sought medical attention in office visit.  At the time of reporting the patient was not recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lesion excision, Lymphadenopathy, Throat lesion, Wisdom teeth removal
Clinical narrative: Information has been received from a consumer concerning her daughter a 17 year old female without a pertinent medical history and without drug reactions or allergies who in May 2007 was vaccinated with her first dose of GARDASIL.  There was no concomitant medication.  The reporter mentioned that the patient got all 3 doses of GARDASIL (dates of the second and third dose were unspecified) and after the first dose she experienced shingles on her left leg and after some time the blister went away however her left leg in the area that the shingles were was still numb.  It was also reported that the patient started experiencing swollen glands behind her ears every now and then.  The reporter stated that the last November the patient had her wisdom teeth removed and her oral surgeon found 2 lesions on the back of her throat that the surgeon removed and stated that he had them tested and they were not cancer, but also mentioned that they could have developed into cancer later on.  It was also reported that a "blood work" test was performed but the results were unspecified.  The patient sought medical attention in office visit.  At the time of reporting the patient was not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of GARDASIL (Lot # not provided) 0.5 ml.  "Sometime last week" on approximately 05-OCT-2009 the patient had a reaction to one of the doses of GARDASIL.  The nurse did not mention what reaction it was.  The patient has sought medical attention at office visit.  At the time of this report, the patient's outcome was unspecified.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Bed rest, Cervix disorder, Drug exposure before pregnancy
Clinical narrative: Information has been received from a 20 year old female, for the Pregnancy Registry for GARDASIL, who was vaccinated with her third dose of GARDASIL.  Shortly after the vaccination, the patient became pregnant.  The patient saw the physician.  Pregnancy test was performed.  Follow up information has been received from the consumer who stated that in approximately November 2008, she was vaccinated with her third dose of GARDASIL (lot# not reported).  She said that the only problem she had with her pregnancy was that she started "dilating early- after 5 months in her pregnancy".  She was put on bed rest at home and carried the pregnancy to term.  She had a vaginal delivery of a healthy normal girl, two weeks before her due date.  The consumer's condition was considered to be disabling.  Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter with airborne allergies, asthma and allergic to "erythromycin" who was vaccinated with the first dose of GARDASIL on 04-MAR-2008 and the second dose in June 2008 and never got the third dose.  The patient missed her third dose.  Concomitant therapy included CLARITIN.  Adverse experience not reported.  The patient sought unspecified medical attention.  Follow-up information has been received from the consumer concerning her daughter with no medical history and allergic to "arithromycine" which might cause her a rash who in approximately MAY-JUNE 2008 experienced soreness on her arm after her second dose of GARDASIL injection.  The patient had not received the third dose.  The patient was due for the third dose on December 2008.  The patient did not seek medical attention.  The patient had recovered on the "same day" in June 2008.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Labour induction
Clinical narrative: Information has been received from a 20 year old female as part of the Merck pregnancy registry with no drug allergies or medical history for GARDASIL, who on 30-JAN-2009 was intramuscularly vaccinated with the first dose of GARDASIL because she thought that she was not pregnant.  There was no concomitant medication.  Her LMP was 02-DEC-2008.  On 08-FEB-2009 she discovered she was pregnant.  As of 08-FEB-2009 it was unknown if the patient would still continue the GARDASIL injection and the result of the fetus being exposed to GARDASIL in utero was unknown.  Follow up information received from an office staff who confirmed the patient was last seen in the office in February 2009, when her pregnancy test was confirmed.  Additional follow up information was received from the patient who stated that she had a healthy, normal baby who was doing well and was now eight months old.  She stated that she had no complications during her pregnancy, but she was induced at full-term (induction indication not provided).  She had a vaginal delivery of a 71lb female on 01-OCT-2009.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Drug screen positive, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on 21-JAN-2009 was vaccinated with the first dose of GARDASIL (Lot# not reported).  There was no concomitant medication.  The patient was pregnant, and her LMP was 16-OCT-2008.  The patient had not experienced any known symptoms.  The patient underwent a routine prenatal workup, the result was not reported.  It was reported that the patient sought medical attention: seen at the practice.  Follow-up information has been received from the nurse practitioner who reported that on 11-JUL-2009, 38 weeks from LMP, the patient delivered a normal, healthy male baby weighing 6 pounds, 7 ounces, APGAR score 9/9.  There were no complications during labor/delivery.  An urine drug screen test was performed on 24-FEB-2009, and the result was positive for marijuana.  A maternal serum alpha fetoprotein quad screen test was performed on 26-FEB-2009, and the result was negative.  An ultrasound was performed on 18-MAR-2009, and it came back normal anatomy at 22 1/7 weeks.  On approximately 04-MAR-2009 and 27-MAR-2009, the patient experienced urinary tract infection.  On 04-MAR-2009, the patient was treated with MACROBID, oral administration, 100 mg, twice a day for 7 days.  On 27-MAR-2009, the patient was treated with BACTRIM DS TABLETS, oral administration, 1 tablet, twice a day for 7 days.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis abnormal
Clinical narrative: Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with no pertinent medical history and no drug reactions/allergies who on 21-JAN-2009 was vaccinated with the first dose of GARDASIL (Lot# not reported).  There was no concomitant medication.  The patient was pregnant, and her LMP was 16-OCT-2008.  The patient had not experienced any known symptoms.  The patient underwent a routine prenatal workup, the result was not reported.  It was reported that the patient sought medical attention: seen at the practice.  Follow-up information has been received from the nurse practitioner who reported that on 11-JUL-2009, 38 weeks from LMP, the patient delivered a normal, healthy male baby weighing 6 pounds, 7 ounces, APGAR score 9/9.  There were no complications during labor/delivery.  An urine drug screen test was performed on 24-FEB-2009, and the result was positive for marijuana.  A maternal serum alpha fetoprotein quad screen test was performed on 26-FEB-2009, and the result was negative.  An ultrasound was performed on 18-MAR-2009, and it came back normal anatomy at 22 1/7 weeks.  On approximately 04-MAR-2009 and 27-MAR-2009, the patient experienced urinary tract infection.  On 04-MAR-2009, the patient was treated with MACROBID, oral administration, 100 mg, twice a day for 7 days.  On 27-MAR-2009, the patient was treated with BACTRIM DS TABLETS, oral administration, 1 tablet, twice a day for 7 days.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a nurse practitioner concerning her 17 year old sister who on approximately 17-AUG-2008 was vaccinated with a first dose of GARDASIL.  The patient received a 0.5 mL third dose of GARDASIL while she was pregnant.  Her last menstrual period was in December 2008 and her estimated delivery date will be on approximately 07-SEP-2009.  Laboratories studies performed include a pregnancy test.  The patient sought unspecified medical attention.  Follow up information received from an initial pregnancy questionnaire stated that it was a foreign patient with scabies, with no known medical history and concurrent conditions.  On 09-FEB-2009 the patient received the third dose of GARDASIL (lot # 661531/1311X).  Concomitant therapy includes ELOMET.  It was also reported that the patient's LMP was at the end of January.  Her estimated delivery date is 07-NOV-2009.  Follow up information has been received from the nurse practitioner who reported that on 27-OCT-2009 the patient delivered a male infant (WAES 0903USA02327B1) (weight 7 lb, length 20 inches, head circumference 13 3/4) with umbilical hernia and hypospadias which upon internal review were considered to be congenital anomalies.  There was no complication during pregnancy, complication during delivery or infections/illnesses during pregnancy.  This is an amended report.  The field of pregnancy outcome screen was fetus normal now reads No instead of Yes.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure increased, Drug exposure during pregnancy, Foetal disorder, Laboratory test normal, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician for the pregnancy Registry for GARDASIL concerning a 26 year old female patient with no pertinent medical history and no known allergies, who on 28-JUL-2008 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL, the second dose on 22-SEP-2008 and the third dose on 16-DEC-2008 and conceived 1 week later after the third dose.  The patient was seen on 18-MAR-2009 at the office and an ultrasound confirmed that the patient's gestation was 15 weeks and 2 days.  No adverse effect reported.  Follow up information has been received from a physician concerning a female patient who had not any previous pregnancies, spontaneous abortions, elective terminations or fetal deaths.  The EDD is 07-SEP-2009.  It was also reported that on 31-MAR-2009 the patient was transferred to another physician.  Follow up information was received from a certified nurse midwife.  It was reported that on 02-SEP-2009 at 39 weeks from LMP, the patient gave birth to a male baby.  The baby had a congenital anomaly, weighing 6 pounds and 1 ounce, with an Apgar score of 7/9.  It was reported that the patient experienced mild blood pressure increase at the end of the pregnancy.  There were no complications during labor/delivery.  All routine tests were within normal limits.  Follow up information was received from a physician.  It was reported that the patient was transferred to another practice since the physician no longer did obstetrics.  The baby's experience is captured in WAES 0903USA03210B1.  Short sublingual frenulum and dacryocystitis were considered to be congenital anomalies.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Culture urine, Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a male who was born to a 26 year old female patient with pain in shoulder and reflux, back pain and pain traveled to right leg a history of abnormal PAP in June 2008, and no previous pregnancy who received the first and the second (661952/1129X) dose of GARDASIL on 29-JAN-2009 and 26-MAR-2009 respectively.  After the patient was given the second dose, the patient was given a pregnancy test because she was reporting symptoms of "being tired and missed her monthly cycle".  It was reported that everything was normal and the mother had normal pregnancy testing at 6 months of pregnancy.  The patient delivered a normal male baby on 04-NOV-2009, 39 weeks from LMP.  The baby weighted 7 pounds 13 ounces, length 20 inch.  There was no congenital anomalies.  The baby experienced vomits, had diarrhea and buttocks were irritated.  The pediatrician thought it was normal.  Follow up information received from a physician via medical records indicated that the patient's mother medical history also included high blood pressure, stroke and kidney disease.  The patient's physical examination was within normal limits.  On 18-JAN-2010 the patient had a urine culture: 10,000 colonies/mL (insignificant quantity for further workup - mixed skin/genital flora, no further identification).  It was also reported that on 06-NOV-2009 the patient was vaccinated with a first dose of hepatitis B virus vaccine (manufacturer unknown).  On 12-JAN-2010 the patient received a second dose of hepatitis B virus vaccine (manufacturer unknown); and the first doses of PENTACEL and ROTATEQ.  The patient was treated with OMNICEF 125 mg/5 mL.  No further information is available.  The mother's experience has been captured in WAES 0903USA04915.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Antibody test negative, Chorioamnionitis, Culture urine positive, Cystitis, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a female who was vaccinated with GARDASIL.  The patient became pregnant after getting GARDASIL vaccine.  The patient sought unspecified medical attention.  Follow up information received from a physician indicated that she was a 25 year old female patient (weight 132 lb) smoker (one and half packs per day (PPD) now down to half PPD), with no pre-existing allergies, birth defects or medical conditions, and no illness at time of vaccination and no history of previous pregnancies who on 16-FEB-2009 was vaccinated IM in her right deltoid with the first dose of GARDASIL.  Concomitant vaccination received the same day included a dose of TDAP (unspecified) (lot # A014).  The physician indicated that the patient was pregnant at time of vaccination but it was too early to detect it.  Her LMP was 26-JAN-2009, her EDD was 09-NOV-2009.  From 17-FEB-2009 to 03-MAR-2009, the patient took on CHANTIX to quit smoking.  On 04-MAR-2009, the patient had a positive urine pregnancy test.  Subsequently on 18-MAR-2009 and on 20-APR-2009, two ultrasounds were done respectively to verify dates and pregnancy viability, and confirmed that vaccination occurred around conception, her estimated conception date was 16-FEB-2009 (+/- 1 week).  Follow-up information has been received from medical records concerning the now 26 year old female who at 37 weeks, on 21-OCT-2009, at 17:59 delivered a 2862 grams baby girl.  The Apgar score was 7 in 1 minute and 9 in 5 minutes.  The patient was admitted on 20-OCT-2009 and was discharged on 23-OCT-2009.  The patient experienced cystitis, abnormal cervical cytology, chorioamnionitis and labial laceration during this pregnancy.  The cystitis was resolved prior to delivery.  The infant experienced intrauterine growth restriction, baseline fetal tachycardia, loss of fetal heart rate variability and fetal gastroschisis during labor and delivery.  Laboratory diagnostic studies while the patient was in labor and delivery were: blood type, A positive, antibody screen was negative, Pap smear was abnormal, Rubella immune, Venereal Disease Research Laboratory (VDRL) non reactive, GC negative, urine culture/screen positive, HBsAG negative, HIV negative; HGB performed at 24 weeks was 10.9; O'Sullivan test performed during 24-28 weeks was 99.  Fetal gastroschisis is considered a congenital anomaly.  The infant's experience has been captured in WAES 0904USA01023B1.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Foetal disorder, HIV test negative, Hepatitis B surface antigen, Rubella immunity confirmed, Smear cervix abnormal
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a female who was vaccinated with GARDASIL.  The patient became pregnant after getting GARDASIL vaccine.  The patient sought unspecified medical attention.  Follow up information received from a physician indicated that she was a 25 year old female patient (weight 132 lb) smoker (one and half packs per day (PPD) now down to half PPD), with no pre-existing allergies, birth defects or medical conditions, and no illness at time of vaccination and no history of previous pregnancies who on 16-FEB-2009 was vaccinated IM in her right deltoid with the first dose of GARDASIL.  Concomitant vaccination received the same day included a dose of TDAP (unspecified) (lot # A014).  The physician indicated that the patient was pregnant at time of vaccination but it was too early to detect it.  Her LMP was 26-JAN-2009, her EDD was 09-NOV-2009.  From 17-FEB-2009 to 03-MAR-2009, the patient took on CHANTIX to quit smoking.  On 04-MAR-2009, the patient had a positive urine pregnancy test.  Subsequently on 18-MAR-2009 and on 20-APR-2009, two ultrasounds were done respectively to verify dates and pregnancy viability, and confirmed that vaccination occurred around conception, her estimated conception date was 16-FEB-2009 (+/- 1 week).  Follow-up information has been received from medical records concerning the now 26 year old female who at 37 weeks, on 21-OCT-2009, at 17:59 delivered a 2862 grams baby girl.  The Apgar score was 7 in 1 minute and 9 in 5 minutes.  The patient was admitted on 20-OCT-2009 and was discharged on 23-OCT-2009.  The patient experienced cystitis, abnormal cervical cytology, chorioamnionitis and labial laceration during this pregnancy.  The cystitis was resolved prior to delivery.  The infant experienced intrauterine growth restriction, baseline fetal tachycardia, loss of fetal heart rate variability and fetal gastroschisis during labor and delivery.  Laboratory diagnostic studies while the patient was in labor and delivery were: blood type, A positive, antibody screen was negative, Pap smear was abnormal, Rubella immune, Venereal Disease Research Laboratory (VDRL) non reactive, GC negative, urine culture/screen positive, HBsAG negative, HIV negative; HGB performed at 24 weeks was 10.9; O'Sullivan test performed during 24-28 weeks was 99.  Fetal gastroschisis is considered a congenital anomaly.  The infant's experience has been captured in WAES 0904USA01023B1.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Treponema test negative, Ultrasound scan, Vulval laceration
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a female who was vaccinated with GARDASIL.  The patient became pregnant after getting GARDASIL vaccine.  The patient sought unspecified medical attention.  Follow up information received from a physician indicated that she was a 25 year old female patient (weight 132 lb) smoker (one and half packs per day (PPD) now down to half PPD), with no pre-existing allergies, birth defects or medical conditions, and no illness at time of vaccination and no history of previous pregnancies who on 16-FEB-2009 was vaccinated IM in her right deltoid with the first dose of GARDASIL.  Concomitant vaccination received the same day included a dose of TDAP (unspecified) (lot # A014).  The physician indicated that the patient was pregnant at time of vaccination but it was too early to detect it.  Her LMP was 26-JAN-2009, her EDD was 09-NOV-2009.  From 17-FEB-2009 to 03-MAR-2009, the patient took on CHANTIX to quit smoking.  On 04-MAR-2009, the patient had a positive urine pregnancy test.  Subsequently on 18-MAR-2009 and on 20-APR-2009, two ultrasounds were done respectively to verify dates and pregnancy viability, and confirmed that vaccination occurred around conception, her estimated conception date was 16-FEB-2009 (+/- 1 week).  Follow-up information has been received from medical records concerning the now 26 year old female who at 37 weeks, on 21-OCT-2009, at 17:59 delivered a 2862 grams baby girl.  The Apgar score was 7 in 1 minute and 9 in 5 minutes.  The patient was admitted on 20-OCT-2009 and was discharged on 23-OCT-2009.  The patient experienced cystitis, abnormal cervical cytology, chorioamnionitis and labial laceration during this pregnancy.  The cystitis was resolved prior to delivery.  The infant experienced intrauterine growth restriction, baseline fetal tachycardia, loss of fetal heart rate variability and fetal gastroschisis during labor and delivery.  Laboratory diagnostic studies while the patient was in labor and delivery were: blood type, A positive, antibody screen was negative, Pap smear was abnormal, Rubella immune, Venereal Disease Research Laboratory (VDRL) non reactive, GC negative, urine culture/screen positive, HBsAG negative, HIV negative; HGB performed at 24 weeks was 10.9; O'Sullivan test performed during 24-28 weeks was 99.  Fetal gastroschisis is considered a congenital anomaly.  The infant's experience has been captured in WAES 0904USA01023B1.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with a history of papilloma viral infection who on 06-APR-2009 was vaccinated a dose of GARDASIL during pregnancy.  The Estimated date of the patient's last menstrual period was 02-MAR-2009 and the estimated delivery date was 07-DEC-2009.  The patient sought medical attention at the practice and had not experienced any known symptoms.  Follow-up information has been received from a nurse.  She stated that dose of GARDASIL that the patient received was not given at this office.  Follow-up information has been received from the nurse.  It was reported that on 16-OCT-2009, the patient delivered a normal, male baby via preterm forceps delivery at 32 weeks and 3 days of pregnancy.  The baby's weight was 1910 grams, Apgar score was 7/9.  The baby's experience has been captured in WAES # 0904USA03198B1.  No further information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Forceps delivery, Premature labour
Clinical narrative: Information has been received from a health professional concerning a male baby.  On 06-APR-2009, the baby's 17 year old mother was vaccinated with a dose of GARDASIL when she was 7 weeks pregnant.  On 16-OCT-2009, the baby's mother delivered the normal, male baby via preterm forceps delivery at 32 weeks and 3 days of pregnancy.  The baby's weight was 1910 grams, Apgar score was 7/9.  The mother's experience has been captured in WAES # 0904USA03198.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Foetal growth restriction, Induced labour, Pre-eclampsia
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female with asthma who was received her first dose of GARDASIL, 0.5ml, intramuscularly on 20-FEB-2009 (Lot # 661764/0650X), and the second dose on 22-APR-2009 (Lot # 661766/0652X).  The patient was now pregnant with the last menstrual period date of 22-FEB-2009 and the estimated delivery date of 29-NOV-2009.  The patient had a office visit to seek medical attention.  The outcome of the patient's pregnant was unknown.  Follow-up information has been received from a registered nurse who reported the patient experienced preeclampsia (no details provided).  Growth abnormality was revealed on ultrasound.  The patient was induced at "37 weeks and 5 days" on 13-NOV-2009 delivered an abnormal infant with no congenital anomaly and with low birth weight, 2338 gm.  Additional information has been received from the registered nurse, OB coordinator in a medicine practice.  The nurse reported the patient's ultra sound revealed intrauterine growth restriction (IUGR).  The patient had mild pre-eclampsia.  The patient was induced and delivered the infant.  The infant had a low birth weight.  The baby was normal with no problems other than a low birth weight.  The baby was being followed by another nurse practitioner who practiced in the same medicine office.  The nurse also reported the patient was received her first dose of GARDASIL on 20-FEB-2009 (Lot # 661766/0652X, also reported as 661764/0650X by the physician) and did not receive any concomitant vaccinations, and the second dose on 22-APR-2009 (Lot # 661766/0652X) and did not receive any concomitant vaccinations.  Follow-up information has been received from the registered nurse concerning the patient who on 22-APR-2009 at 16:50 was received her second dose of GARDASIL into her right deltoid.  The patient was pregnant at time of vaccine but was unaware of pregnancy.  The patient was around EGA 4 weeks and 2 days at the time of vaccination.  The patient delivered a healthy baby girl, weighing 5 pounds and 2 ounces with no problem.  The baby's experience had been captured in WAES # 0904USA04206B1.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female with asthma who was received her first dose of GARDASIL, 0.5ml, intramuscularly on 20-FEB-2009 (Lot # 661764/0650X), and the second dose on 22-APR-2009 (Lot # 661766/0652X).  The patient was now pregnant with the last menstrual period date of 22-FEB-2009 and the estimated delivery date of 29-NOV-2009.  The patient had a office visit to seek medical attention.  The outcome of the patient's pregnant was unknown.  Follow-up information has been received from a registered nurse who reported the patient experienced preeclampsia (no details provided).  Growth abnormality was revealed on ultrasound.  The patient was induced at "37 weeks and 5 days" on 13-NOV-2009 delivered an abnormal infant with no congenital anomaly and with low birth weight, 2338 gm.  Additional information has been received from the registered nurse, OB coordinator in a medicine practice.  The nurse reported the patient's ultra sound revealed intrauterine growth restriction (IUGR).  The patient had mild pre-eclampsia.  The patient was induced and delivered the infant.  The infant had a low birth weight.  The baby was normal with no problems other than a low birth weight.  The baby was being followed by another nurse practitioner who practiced in the same medicine office.  The nurse also reported the patient was received her first dose of GARDASIL on 20-FEB-2009 (Lot # 661766/0652X, also reported as 661764/0650X by the physician) and did not receive any concomitant vaccinations, and the second dose on 22-APR-2009 (Lot # 661766/0652X) and did not receive any concomitant vaccinations.  Follow-up information has been received from the registered nurse concerning the patient who on 22-APR-2009 at 16:50 was received her second dose of GARDASIL into her right deltoid.  The patient was pregnant at time of vaccine but was unaware of pregnancy.  The patient was around EGA 4 weeks and 2 days at the time of vaccination.  The patient delivered a healthy baby girl, weighing 5 pounds and 2 ounces with no problem.  The baby's experience had been captured in WAES # 0904USA04206B1.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal growth restriction, Small for dates baby
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a baby.  The baby's 15 year old mother with asthma who on 20-FEB-2009 was received her first dose of GARDASIL, 0.5ml, intramuscularly (Lot # 661764/0650X), and the second dose on 22-APR-2009 (Lot # 661766/0652X).  Subsequently, the baby's mother was pregnant with the last menstrual period date of 22-FEB-2009 and the estimated delivery date of 29-NOV-2009.  The mother experienced preeclampsia.  Growth abnormality was revealed on ultrasound.  The mother was induced at "37 weeks and 5 days" on 13-NOV-2009 delivered an abnormal infant with no congenital anomaly and with low birth weight, 2338 gm.  Additional information has been received from the registered nurse, OB coordinator in a medicine practice.  The nurse reported the patient's ultra sound revealed intrauterine growth restriction (IUGR).  The patient had mild pre-eclampsia.  The patient was induced and delivered the infant.  The infant had a low birth weight.  The baby was normal with no problems other than a low birth weight.  The baby was being followed by another nurse practitioner who practiced in the same medicine office.  Follow-up information has been received from the registered nurse who reported a healthy baby girl was delivered, weighing 5 pounds and 2 ounces with no problem.  At the time of report, the baby was with no known medical problems.  The mother's experience had been captured in WAES # 0904USA04206.  Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Induced labour, Pre-eclampsia, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse at OB/GYN office concerning a 27 year old female who on 10-FEB-2009 was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  As of 28-APR-2009, the patient was pregnancy.  Her last menstrual period was in February 2009.  It was ultrasound that confirmed the pregnancy and her due date was estimated to be 08-DEC-2009.  The GARDASIL vaccine was not given at reporter's office.  And the OB/GYN will be following her during the pregnancy.  The patient was seen in the office.  Follow up information was received from a registered nurse via initial pregnancy questionnaire.  It was reported the 27 year old female patient with no medical history or concurrent conditions had no previous pregnancies.  Concomitant therapy included prenatal vitamin.  The date of the patient's last menstrual period was 03-MAR-2009, the estimated conception date was 17-MAR-2009, and the estimated delivery date was 08-DEC-2009.  The ultrasound was performed to confirm viability on 22-APR-2009 and the result was the fetus was 7 weeks and 1 day.  Pregnancy and the estimated due date were confirmed.  Follow-up information was received from a physician via outcome pregnancy questionnaire concerning the patient who on 25-NOV-2009, 38 weeks after LMP, delivered a 6 pounds 6 ounces normal female baby.  The Apgar score was 8.1/9.5.  It was reported that the patient experienced maternal preeclampsia during pregnancy (date unspecified).  On an unspecified date during the pregnancy the patient had an ultrasound which was normal and the estimated gestational age (EGA) was reported to be 18 6/7 weeks.  The outcome of the patient was not reported.  Follow-up information was received from a medical record concerning the patient with a history of ear tubes at age 21 who on 25-NOV-2009, at 00:06 am delivered a 2900 g (also reported as 2798 g or 6 pounds 6 and 1/4 ounces) normal female baby.  The patient was induced and delivered the baby vaginally.  She also had an epidural.  The Apgar score was 8/9 (previously reported as 8.1/9.5).  The baby's head perimeter was 13 and 1/4 inches and her chest perimeter was 12 and 1/4 inches.  At 20 weeks pregnancy the patient experienced bleeding.  The outcome was not reported.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Haematuria, Ultrasound scan normal, Urinary tract infection
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female who on 07-MAY-2009 was vaccinated with the first dose of GARDASIL while pregnant.  After GARDASIL vaccine was given, unspecified pregnancy test was conducted and positive.  The patient's last menstrual period was 17-APR-2009 and estimated date of delivery was 22-JAN-2010.  The patient had gone to office to seek medical attention.  There were no adverse events reported.  Follow-up information has been received from a completed questionnaire, concerning a 17 year old female patient with no concurrent medical conditions and a history of THC use, 0 pregnancies, 0 spontaneous abortions, 0 elective terminations and 0 live births who on 07-MAY-2009 was vaccinated with the first dose of GARDASIL vaccine (lot # 659655/0940X).  It was reported that the patient's last menstrual period was 06-APR-2009 (previously reported as 17-APR-2009) and estimated date of delivery was 08-JAN-2010 (previously reported as 22-JAN-2010).  Three times ultrasounds performed on 08-MAY-2009, 02-AUG-2009 and 27-OCT-2009 respectively showed normal.  MSAFP and amniocentesis were not performed.  On an unknown date, the patient developed urinary tract infection (UTI) and hematuria during pregnancy.  On 23-DEC-2009, at 38 weeks from LMP, the patient delivered a male baby, who was normal and no congenital anomalies, and his weight was 6 lb 4 oz, length 19.5 inches, head circumference 12.75 inches and Apgar score 9/9.  There was no complication during labor/delivery.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive, Premature labour, Premature rupture of membranes
Clinical narrative: Information has been received from a 26 year old female patient with depression who on 02-JUN-2009 was vaccinated with 0.5 mL of the first dose of GARDASIL (Lot not reported).  Concomitant therapy included WELLBUTRIN.  On 02-JUN-2009 when the patient received GARDASIL vaccine she was one month pregnant (confirmed by a home pregnancy test).  Her LMP was on 28-APR-2009 and the EDD 02-FEB-2010.  Follow up information has been received from a licensed practical nurse concerning a 26 year old female patient with mild depression and a history of asthma and 1 pregnancy and 1 pre term delivery (35 weeks from LMP).  At the time of reporting there was no prenatal testing done.  There were no birth defects in previous pregnancy and no infant complications in previous pregnancy.  Follow up information has been received from a licensed practical nurse.  It was reported that on 04-JAN-2010 at 34 weeks and 2 days of gestation, the patient gave birth to a normal female infant with an Apgar score of 9/9.  The patient had a premature rupture of membrane and this forced the premature labor.  An ultrasound performed during pregnancy revealed a possible benign heart echogenic focus (WAES 0906USA01485B1).  No infections or illnesses were reported during pregnancy.  No other medications were used during pregnancy.  It was noted that the patient had a history of preterm labor.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal
Clinical narrative: Information has been received from a 26 year old female patient with depression who on 02-JUN-2009 was vaccinated with 0.5 mL of the first dose of GARDASIL (Lot not reported).  Concomitant therapy included WELLBUTRIN.  On 02-JUN-2009 when the patient received GARDASIL vaccine she was one month pregnant (confirmed by a home pregnancy test).  Her LMP was on 28-APR-2009 and the EDD 02-FEB-2010.  Follow up information has been received from a licensed practical nurse concerning a 26 year old female patient with mild depression and a history of asthma and 1 pregnancy and 1 pre term delivery (35 weeks from LMP).  At the time of reporting there was no prenatal testing done.  There were no birth defects in previous pregnancy and no infant complications in previous pregnancy.  Follow up information has been received from a licensed practical nurse.  It was reported that on 04-JAN-2010 at 34 weeks and 2 days of gestation, the patient gave birth to a normal female infant with an Apgar score of 9/9.  The patient had a premature rupture of membrane and this forced the premature labor.  An ultrasound performed during pregnancy revealed a possible benign heart echogenic focus (WAES 0906USA01485B1).  No infections or illnesses were reported during pregnancy.  No other medications were used during pregnancy.  It was noted that the patient had a history of preterm labor.  No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Blood test, Catatonia, Computerised tomogram, Dizziness
Clinical narrative: Muscle stiffness in (L) hand 1st at 4:00pm on 11-16-09 then diff. breathing all over body stiffness, eyes rolling back in head, right sided facial droop. Feet and legs stiffed. Transported by ambulance on 11-16-09. EMT gave VALIUM IM. She was admitted as an inpatient to pediatrics at that time. Complaints of severe headache, dizziness, nausea, numbness and tingling in limbs. On 11-17-09 diff. speaking. Sensitivity to hearing and light which lasted for 4 months. Her hand stayed in a dystonic state without relaxing for over 8 weeks. She had episodes of what I was told were a catatonic state or confusional migraines. During these episodes her eyes would roll back into her head and she would stiffen and have difficulty breathing. She has been in and out of a wheelchair since we came home from the hospital. She has weakness in her legs. She has been out of school since 11-06-09. She has been home schooling and has just returned to school on 8-19-10. She still has random right sided facial droop and dystonic positioning in her left hand. Her right foot remains in a dystonic state all the time. Even up to this point, 9-1-10. Pt's diagnoses were dystonia or possibly a conversion disorder. It is unclear which diagnoses is the correct one. The neurologist at the hospital feels that the diagnoses and the onset of symptoms shortly after the vaccine could be oddly coincidental.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Dystonia, Electroencephalogram, Gaze palsy, Headache
Clinical narrative: Muscle stiffness in (L) hand 1st at 4:00pm on 11-16-09 then diff. breathing all over body stiffness, eyes rolling back in head, right sided facial droop. Feet and legs stiffed. Transported by ambulance on 11-16-09. EMT gave VALIUM IM. She was admitted as an inpatient to pediatrics at that time. Complaints of severe headache, dizziness, nausea, numbness and tingling in limbs. On 11-17-09 diff. speaking. Sensitivity to hearing and light which lasted for 4 months. Her hand stayed in a dystonic state without relaxing for over 8 weeks. She had episodes of what I was told were a catatonic state or confusional migraines. During these episodes her eyes would roll back into her head and she would stiffen and have difficulty breathing. She has been in and out of a wheelchair since we came home from the hospital. She has weakness in her legs. She has been out of school since 11-06-09. She has been home schooling and has just returned to school on 8-19-10. She still has random right sided facial droop and dystonic positioning in her left hand. Her right foot remains in a dystonic state all the time. Even up to this point, 9-1-10. Pt's diagnoses were dystonia or possibly a conversion disorder. It is unclear which diagnoses is the correct one. The neurologist at the hospital feels that the diagnoses and the onset of symptoms shortly after the vaccine could be oddly coincidental.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hyperacusis, Hypoaesthesia, Migraine, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Muscle stiffness in (L) hand 1st at 4:00pm on 11-16-09 then diff. breathing all over body stiffness, eyes rolling back in head, right sided facial droop. Feet and legs stiffed. Transported by ambulance on 11-16-09. EMT gave VALIUM IM. She was admitted as an inpatient to pediatrics at that time. Complaints of severe headache, dizziness, nausea, numbness and tingling in limbs. On 11-17-09 diff. speaking. Sensitivity to hearing and light which lasted for 4 months. Her hand stayed in a dystonic state without relaxing for over 8 weeks. She had episodes of what I was told were a catatonic state or confusional migraines. During these episodes her eyes would roll back into her head and she would stiffen and have difficulty breathing. She has been in and out of a wheelchair since we came home from the hospital. She has weakness in her legs. She has been out of school since 11-06-09. She has been home schooling and has just returned to school on 8-19-10. She still has random right sided facial droop and dystonic positioning in her left hand. Her right foot remains in a dystonic state all the time. Even up to this point, 9-1-10. Pt's diagnoses were dystonia or possibly a conversion disorder. It is unclear which diagnoses is the correct one. The neurologist at the hospital feels that the diagnoses and the onset of symptoms shortly after the vaccine could be oddly coincidental.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Photophobia, Speech disorder
Clinical narrative: Muscle stiffness in (L) hand 1st at 4:00pm on 11-16-09 then diff. breathing all over body stiffness, eyes rolling back in head, right sided facial droop. Feet and legs stiffed. Transported by ambulance on 11-16-09. EMT gave VALIUM IM. She was admitted as an inpatient to pediatrics at that time. Complaints of severe headache, dizziness, nausea, numbness and tingling in limbs. On 11-17-09 diff. speaking. Sensitivity to hearing and light which lasted for 4 months. Her hand stayed in a dystonic state without relaxing for over 8 weeks. She had episodes of what I was told were a catatonic state or confusional migraines. During these episodes her eyes would roll back into her head and she would stiffen and have difficulty breathing. She has been in and out of a wheelchair since we came home from the hospital. She has weakness in her legs. She has been out of school since 11-06-09. She has been home schooling and has just returned to school on 8-19-10. She still has random right sided facial droop and dystonic positioning in her left hand. Her right foot remains in a dystonic state all the time. Even up to this point, 9-1-10. Pt's diagnoses were dystonia or possibly a conversion disorder. It is unclear which diagnoses is the correct one. The neurologist at the hospital feels that the diagnoses and the onset of symptoms shortly after the vaccine could be oddly coincidental.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: VIIth nerve paralysis, Wheelchair user
Clinical narrative: Muscle stiffness in (L) hand 1st at 4:00pm on 11-16-09 then diff. breathing all over body stiffness, eyes rolling back in head, right sided facial droop. Feet and legs stiffed. Transported by ambulance on 11-16-09. EMT gave VALIUM IM. She was admitted as an inpatient to pediatrics at that time. Complaints of severe headache, dizziness, nausea, numbness and tingling in limbs. On 11-17-09 diff. speaking. Sensitivity to hearing and light which lasted for 4 months. Her hand stayed in a dystonic state without relaxing for over 8 weeks. She had episodes of what I was told were a catatonic state or confusional migraines. During these episodes her eyes would roll back into her head and she would stiffen and have difficulty breathing. She has been in and out of a wheelchair since we came home from the hospital. She has weakness in her legs. She has been out of school since 11-06-09. She has been home schooling and has just returned to school on 8-19-10. She still has random right sided facial droop and dystonic positioning in her left hand. Her right foot remains in a dystonic state all the time. Even up to this point, 9-1-10. Pt's diagnoses were dystonia or possibly a conversion disorder. It is unclear which diagnoses is the correct one. The neurologist at the hospital feels that the diagnoses and the onset of symptoms shortly after the vaccine could be oddly coincidental.
Sex: U
Vaccine: FLUN(H1N1)
Symptoms: Febrile convulsion
Clinical narrative: A serious spontaneous report of febrile seizure has been received from a physician/healthcare professional concerning a child subsequent to H1N1, Intranasal. The patient's past medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on an unknown date for an unknown indication. The reporter stated that she has a patient who had a febrile seizure after receiving H1N1 Flumist and they were concerned about receiving this year's formulation. The outcome of febrile seizure was unknown.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, White blood cell count increased
Clinical narrative: He states he had 10/10 pain last noc. It is now 7/10 in his R arm,  shoulder, hip and knee. He states he had fever and chills overnight. His RUE has some redness around the injection site and is extremely sensitive to touch.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Basophil percentage decreased, Chills, Eosinophil percentage decreased, Haematocrit normal
Clinical narrative: He states he had 10/10 pain last noc. It is now 7/10 in his R arm,  shoulder, hip and knee. He states he had fever and chills overnight. His RUE has some redness around the injection site and is extremely sensitive to touch.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Haemoglobin normal, Injection site erythema, Injection site pain, Laboratory test abnormal, Lymphocyte percentage decreased
Clinical narrative: He states he had 10/10 pain last noc. It is now 7/10 in his R arm,  shoulder, hip and knee. He states he had fever and chills overnight. His RUE has some redness around the injection site and is extremely sensitive to touch.
Age: 53.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mean cell haemoglobin, Mean cell haemoglobin concentration normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count decreased
Clinical narrative: He states he had 10/10 pain last noc. It is now 7/10 in his R arm,  shoulder, hip and knee. He states he had fever and chills overnight. His RUE has some redness around the injection site and is extremely sensitive to touch.