chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound antenatal screen normal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a 18 year old consumer, for GARDASIL, a Pregnancy Registry product, who on 25-MAR-2010 was vaccinated with the second dose of GARDASIL. The patient stated that she found out she was pregnant on 15-APR-2010 at her physician's office. The patient also stated that she got an ultrasound at a hospital and was notified that she was "no more than 4 weeks pregnant." The estimated delivery date is 23-DEC-2010. Follow up information had been received from a pregnancy questionnaire concerning that an 18 year old female with heart murmur as a child, had recent monitor and no current evidence of murmur, and no previous pregnancy who on 14-JAN-2010 was vaccinated with the first dose of GARDASIL (lot # 661758/1480Y) and on 25-MAR-2010 was vaccinated with the second dose of GARDASIL (lot # 661758/1480Y). The patient was Rh-negative during pregnancy and experienced bladder infection at 20 weeks gestation (approximately 20-SEP-2010) and was treated with MACROBID. Ultrasound on 29-APR-2010 showed positive cardiac activity. Ultrasound on 07-JUL-2010, 30-SEP-2010 and 07-DEC-2010 were normal fetal anatomy. On 17-DEC-2010 the patient delivered a normal, healthy male baby (weight 7 pounds 10 ounces, length 21 inch, Apgar score 7/9, head circumference 13, Rh negative status) at 39 weeks and 2 days gestation. The mother had 2 degree perineal laceration during labor/delivery. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Drug exposure during pregnancy, Threatened labour, Ultrasound foetal
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female patient with a history of no previous pregnancies who on 20-APR-2010 was vaccinated with the third dose of GARDASIL (lot n. 663559/1178Y) and was pregnant. An ultrasound was performed this date, however the results were not provided. It is unknown if the patient sought medical attention. Follow up information has been received from a physician concerning the female patient with a history of depression and mild asthma and no infections or illnesses during pregnancy. The patient's Last Menstrual Period (LMP) was approximately 11-MAR-2010. The physician reported that the patient experienced numerous episodes of threatened preterm labor (bed rest). Ultrasounds and routine screening labs were performed on 30-APR-2010, 30-JUL-2010 and 12-OCT-2010, the results were not provided. On 09-DEC-2010 at 39 weeks from LMP, the patient delivered a female baby with 7 pounds and 10 ounces of weight.  19 inches of length, apgar score 8/9 and 33 cm of head circumference. The infant was normal. There were no congenital anomalies. There were no other complications or abnormalities. There were no complications during labor/deliverly. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from an office billing supervisor concerning a female patient who on 11-JUN-2008 was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported). The office billing supervisor reported that on an unspecified date the patient ended up having an abnormal PAP and the patient required colposcopy. It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin negative, Drug exposure during pregnancy, Gestational diabetes, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female with no pertinent medical history and no drug allergies, who on 22-JUL-2009 was vaccinated with the first dose of GARDASIL (0.5ml, IM, lot # 662404/0312Y), and on 27-SEP-2009 she received the second dose (0.5ml, IM, lot # 663558/0819Y). There was no concomitant medication. The patient was found to be pregnant at a later time. A pregnant test was done prior to the second vaccination and was negative. Ultrasound showed the time of conception was around the second dose. "Special studies are fine to date". The patient had visited the office for medical attention. The patient's last menstrual period was around 27-SEP-2009, and estimated delivery date was around 04-JUL-2010. The patient had 20 weeks gestation at time of report. Follow-up information has been received from a physician concerning a 25 year old female non-smoker, gravida 5, para one, with a history of tonsillectomy, 1 live birth with group B strep positive bacteria (January 2006), and 3 elective abortions (2004, 2006, 2009), who on 22-JUL-2009 was vaccinated with a dose of GARDASIL (0.5ml, IM, lot # 662404/0312Y). The patient's last menstrual period was 02-SEP-2009 (previously reported as 27-SEP-2009). Her estimated due date was 16-JUN-2010 (previously reported as 04-JUL-2010). On 27-SEP-2009, the patient received the second dose (0.5ml, IM lot # 663558/0819Y). It was noted the patient experienced gestational diabetes for which she was started on glyburide twice daily prior to delivery. On 05-JUN-2010, the patient delivered a normal, healthy male baby weighing 6 pounds 14 ounces. Postpartum glucose challenge will be scheduled. Patient currently using condoms and has decided on PARAGARD IUD. All available medical records will be provided upon request. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Discomfort, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Haematology test normal
Clinical narrative: Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female with no drug reactions/allergies who was trying to get pregnant. The patient was vaccinated intramuscularly with three doses of GARDASIL (0.5 ml): 1st dose (lot # 663451/0216Y) on 30-JUL-2009, 2nd dose (lot # 663433/0249Z) on 30-SEP-2009 and 3rd dose 663454/0672Y on an unspecified date. Concomitant therapy included prenatal vitamins (unspecified). The patient was given a pregnancy test at the office prior to vaccination of the 3rd dose and it was negative. On 05-FEB-2010 the patient had a positive home pregnancy test. At the time of the report, the outcome was unknown. Follow-up information has been received from the licensed practical nurse and a registered nurse who reported that the female patient was vaccinated intramuscularly with the third dose of GARDASIL at right deltoid on 01-FEB-2010 at 16:38. The patient had three previous pregnancies, one was full term delivered from LMP of 39 weeks, and another one was spontaneously aborted from LMP of 12 weeks, and the third one was electively terminated at unknown weeks from LMP. There were no birth defects in previous pregnancies and infant complications. The current pregnancy's LMP was 05-JAN-2010 and EDD was 16-OCT-2010, conception date was approximately on 19-JAN-2010. On 15-FEB-2010, an ultrasound was tested for early pregnancy and pelvic pain; it revealed that patient had a 4 cm right ovarian cyst, normal yolk SAC. Maternal Serum Alpha-Fetoprotein Screening performed on 30-APR-2010 was negative. On an unspecified date, quad screen was negative. During pregnancy, the patient was placed on therapy with unspecified prenatal vitamins, omeprazole (manufacturer unknown) for gastrooesophageal reflux disease (GERD) and TYLENOL EXTRA STRENTH for discomfort. On 09-OCT-2010, 39 weeks from her LMP, the patient delivered a normal, healthy male baby weighing 7 pounds 14 ounces, length 22 inch, apgar score 9/9 and head circumference 35.5 cm. At the time of this report, the outcomes of GERD, pelvic pain, 4 cm right ovarian cyst and discomfort were unknown. Follow up information was received which indicated that the patient was not the physician's. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst, Pelvic pain, Pregnancy test positive, Ultrasound antenatal screen abnormal, Ultrasound scan abnormal
Clinical narrative: Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female with no drug reactions/allergies who was trying to get pregnant. The patient was vaccinated intramuscularly with three doses of GARDASIL (0.5 ml): 1st dose (lot # 663451/0216Y) on 30-JUL-2009, 2nd dose (lot # 663433/0249Z) on 30-SEP-2009 and 3rd dose 663454/0672Y on an unspecified date. Concomitant therapy included prenatal vitamins (unspecified). The patient was given a pregnancy test at the office prior to vaccination of the 3rd dose and it was negative. On 05-FEB-2010 the patient had a positive home pregnancy test. At the time of the report, the outcome was unknown. Follow-up information has been received from the licensed practical nurse and a registered nurse who reported that the female patient was vaccinated intramuscularly with the third dose of GARDASIL at right deltoid on 01-FEB-2010 at 16:38. The patient had three previous pregnancies, one was full term delivered from LMP of 39 weeks, and another one was spontaneously aborted from LMP of 12 weeks, and the third one was electively terminated at unknown weeks from LMP. There were no birth defects in previous pregnancies and infant complications. The current pregnancy's LMP was 05-JAN-2010 and EDD was 16-OCT-2010, conception date was approximately on 19-JAN-2010. On 15-FEB-2010, an ultrasound was tested for early pregnancy and pelvic pain; it revealed that patient had a 4 cm right ovarian cyst, normal yolk SAC. Maternal Serum Alpha-Fetoprotein Screening performed on 30-APR-2010 was negative. On an unspecified date, quad screen was negative. During pregnancy, the patient was placed on therapy with unspecified prenatal vitamins, omeprazole (manufacturer unknown) for gastrooesophageal reflux disease (GERD) and TYLENOL EXTRA STRENTH for discomfort. On 09-OCT-2010, 39 weeks from her LMP, the patient delivered a normal, healthy male baby weighing 7 pounds 14 ounces, length 22 inch, apgar score 9/9 and head circumference 35.5 cm. At the time of this report, the outcomes of GERD, pelvic pain, 4 cm right ovarian cyst and discomfort were unknown. Follow up information was received which indicated that the patient was not the physician's. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 24 year old female with no pertinent medical history and no drug reactions/allergies who was vaccinated with 3 doses of GARDASIL (lot # not reported) at unspecified physician's office and currently was positive for high risk HPV. Concomitant therapy included unspecified birth control. Papanicolaou (PAP) test was performed, result not provided. The patient's positive for high risk HPV persisted at the time of this report. The patient sought medical attention by office visit. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Arrested labour, Gestational diabetes, Human chorionic gonadotropin positive, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with no history of chicken pox and had negative varicella titers who on 27-OCT-2007 was vaccinated with a first dose of GARDASIL. On 20-OCT-2009, the patient was vaccinated with a second dose of GARDASIL. On 05-JAN-2010, the patient was vaccinated with a third dose of GARDASIL. There was no concomitant medication. After the third dose of vaccine was administered, the patient asked nurse for a pregnancy test. Urine pregnancy test performed on 05-JAN-2010 and the patient was pregnant. The patient was not experiencing any adverse effects. LMP was 25-NOV-2009; EDD was 31-AUG-2010. The patient sought unspecified medical attention. Follow-up information has been received from the licensed practical nurse concerning the 18 year old female (also reported as 19 year old) with no illness at time of vaccination and no any pre-existing allergies, birth defects or medical conditions and no previous pregnancies who on 20-OCT-2009 was vaccinated with a second dose of GARDASIL (LOT# 663454/0672Y) and on 05-JAN-2010 was vaccinated with a third dose of GARDASIL (route: intramuscularly, LOT# 661841/0653X). On 02-FEB-2010, a scheduled ultrasound was found the patient was pregnancy 12 weeks. On 18-MAR-2010, when the screening test of Maternal Serum Alpha-Fetoprotein Screening (MSAFP) revealed it was positive; however wrong due date was used "MSAFP" recalculated was normal. The patient had complication during pregnancy and delivery included onset of gestational diabetes and arrest of dilatations during the delivery; antenatal testing was performed two times weekly. Patient was treated with HUMALOG and HUMULIN for gestational diabetes during pregnancy. On 28-AUG-2010 at LMP of 39 weeks and 3 days, the patient delivered a normal, male infant, weight 9 pounds and 1 ounce and without congenital anomalies and other complications or abnormalities. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen
Clinical narrative: Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with no history of chicken pox and had negative varicella titers who on 27-OCT-2007 was vaccinated with a first dose of GARDASIL. On 20-OCT-2009, the patient was vaccinated with a second dose of GARDASIL. On 05-JAN-2010, the patient was vaccinated with a third dose of GARDASIL. There was no concomitant medication. After the third dose of vaccine was administered, the patient asked nurse for a pregnancy test. Urine pregnancy test performed on 05-JAN-2010 and the patient was pregnant. The patient was not experiencing any adverse effects. LMP was 25-NOV-2009; EDD was 31-AUG-2010. The patient sought unspecified medical attention. Follow-up information has been received from the licensed practical nurse concerning the 18 year old female (also reported as 19 year old) with no illness at time of vaccination and no any pre-existing allergies, birth defects or medical conditions and no previous pregnancies who on 20-OCT-2009 was vaccinated with a second dose of GARDASIL (LOT# 663454/0672Y) and on 05-JAN-2010 was vaccinated with a third dose of GARDASIL (route: intramuscularly, LOT# 661841/0653X). On 02-FEB-2010, a scheduled ultrasound was found the patient was pregnancy 12 weeks. On 18-MAR-2010, when the screening test of Maternal Serum Alpha-Fetoprotein Screening (MSAFP) revealed it was positive; however wrong due date was used "MSAFP" recalculated was normal. The patient had complication during pregnancy and delivery included onset of gestational diabetes and arrest of dilatations during the delivery; antenatal testing was performed two times weekly. Patient was treated with HUMALOG and HUMULIN for gestational diabetes during pregnancy. On 28-AUG-2010 at LMP of 39 weeks and 3 days, the patient delivered a normal, male infant, weight 9 pounds and 1 ounce and without congenital anomalies and other complications or abnormalities. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Chorioamnionitis, Maternal exposure during pregnancy, Normal newborn, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female patient who on 09-DEC-2009 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot # 662304/1013Y) and a second 0.5 ml dose of GARDASIL (Lot# 662299/1099Y) on 10-FEB-2010. On 17-FEB-2010 the patient was informed that she was pregnant after receiving two doses of GARDASIL. There was no adverse event reported. Follow-up information has been received from the physician concerning the female patient with polycystic ovarian syndrome, no significant past medical history and no previous pregnancies who on 09-DEC-2009 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot # 662304/1013Y) and on 10-FEB-2010, the second 0.5 ml dose of GARDASIL (Lot# 662299/1099Y) was administered. Other medications used during this pregnancy were prenatal vitamins and fish oil supplements. Date of last menstrual period was 15-DEC-2009. Estimated delivery date on 06-OCT-2010. On 09-MAR-2010, an ultrasound was performed as routine and the result was well. On 08-MAY-2010, a Quad screen was performed and the result was "low high". Two more ultrasounds were performed on 23-APR-2010 and on 14-MAY-2010 and the results were also well. There were no complications during pregnancy, the diagnostics tests during pregnancy were within normal limits and there were no infections or illness during pregnancy. The patient had chorioamnionitis right before delivering. On 05-OCT-2010, the patient delivered a normal male baby, 41 weeks from LMP, weighing 7 lb 13.6 oz. Apgar score test was 8/9. There were not congenital anomalies or other complications. The patient's baby experienced papular rash on arms and back, cough, stuffy nose, dermatitis atopic, spitting a lot. White blood cell count abnormal, reticulocyte count abnormal, red cell distribution width increased, mean cell haemoglobin concentration abnormal, mean cell volume abnormal and jaundice after therapy with hepatitis B virus vaccine rHBsAg (WAES#1103USA03784). No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain in extremity, X-ray normal
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with allergic reaction to cephalosporin and no pertinent medical history who on 16-MAR-2011 was vaccinated IM with the third 0.5 ml dose of GARDASIL (Lot number: 667866/1437Z). There was no concomitant medication. On 16-MAR-2011 the patient experienced pain in her left arm after receiving the third GARDASIL. The nurse reported that the patient could not move her arm up to 90 degrees. The patient did not experience this after the first GARDASIL. The nurse reported that an X-ray was done but it was negative. The patient sought unspecified medical attention. On an unspecified date, the patient had recovered. A lot check has been initiated. This is one of several reports received from same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia of pregnancy, Delivery, Maternal exposure during pregnancy, Ultrasound antenatal screen normal, Weight decreased
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a female with no pertinent medical history who in October 2008, was vaccinated with a first 0.5 ml dose of GARDASIL IM. On 17-SEP-2009 the patient, was vaccinated with a second 0.5 ml dose of GARDASIL IM. There was no concomitant medication. Subsequently, the patient found out she was pregnant. She was 20 weeks pregnancy on 18-FEB-2010. LMP was 30-SEP-2009, EDD was 27-JUN-2010. Ultrasound was normal on unspecified date. Pregnancy was reported to be normal to date. She sought medical attention in the office. Follow-up information has been received from a physician concerning a 20 year old female non-smoker, allergic to ibuprofen and latex, with no prior pregnancies and a history of cystitis and candidiasis (recurrent), and a family history of cerebrovascular accident (mother), who on 11-JUL-2010, at 40 weeks gestation, delivered a healthy 6 lb, 13 oz male baby via a normal spontaneous vaginal delivery. It was noted that patient delivered with postpartum anemia. The patient was seen on 24-AUG-2010 for a 6-week postpartum visit and had no complaints. She was prescribed ferrous sulfate and was continued on DEPO-PROVERA for contraception. It was reported the patient experienced weight loss with the DEPO-PROVERA. The patient was also advised to use condoms. All available medical records will be provided upon request. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypothyroidism, Maternal exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a female patient who on 21-SEP-2009 was vaccinated with the first dose of GARDASIL (lot# not reported). On 19-JAN-2010 the patient was vaccinated with the second dose of GARDASIL (lot# not reported) and she did not know she was pregnant. Vaccination with GARDASIL was discontinued. The patient experienced no adverse reaction. Follow up information has been received from the nurse who stated that the patient was no longer in their case. She was referred to another department. Follow up information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 27 year old female with hypothyroidism and a history of 1 pregnancy (a spontaneous abortion) and a history of stage III papillary thyroid cancer and thyroidectomy who on 21-SEP-2009 was vaccinated with GARDASIL (lot# not reported). The patient's date of last menstrual period was on 02-JAN-2010, estimated conception date was 14-JAN-2010 to 16-JAN-2010, and the estimated delivery date would be on 09-OCT-2011. On 04-MAR-2010 the patient has a ultrasound and saw the age of 8 6/7 weeks, "+FH", 52 days. On unknown date, the patient experienced Hypothyroidism and treated with SYNTHROID. On 10-FEB-2010, influenza virus vaccine (unspecified) was administered. The outcome of this pregnancy was unknown since the patient was lost of follow up. No further information is available.
Age: 49.0
Sex: F
Vaccine: HPV4
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 50 year old female with condyloma acuminatum who on approximately 17-DEC-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). It was reported that the patient had received all three dose series of GARDASIL. Subsequently the patient was free of condyloma acuminatum symptoms for 9 months after injections were completed. The lesions had reoccurred and the patient was vaccinated with another dose of GARDASIL (lot # not reported) recently. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Follow up information has been received from a physician indicating that the patient did not administer the vaccines at their office, they had her gynecologist administered the vaccine.  It was reported that the patient had received 5 doses of GARDASIL total and she had been clear (of symptoms) for quite a while. This is one of several reports from the same source. This is a consolidation of 2 reports containing the same patient. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal, Vaginitis bacterial
Clinical narrative: Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with no medical history and drug reactions/allergies, who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated with intramuscularly with the first, second and third doses of GARDASIL (lot# for the last dose was 662304/1013Y) respectively. There was no concomitant medication. On 25-MAR-2010 the patient discovered that she was pregnant and that the conception time was near the final injection time. The patient's LMP was approximately 22-FEB-2010 (currently about 5 weeks into the pregnancy). Unspecified medical attention was sought. There were no lab diagnostics studies performed. No known adverse reactions were available. Follow-up information was received from the registered nurse concerning a 15 year old pregnant female with a history of 0 pregnancies and 0 live births and with no other medical history who on 11-AUG-2009, 16-OCT-2009 and 11-MAR-2010 was vaccinated intramuscularly with the first, second and third doses of GARDASIL (lot# for the third dose was 662304/1013Y) respectively. Concomitant therapy included OTC prenatal vitamins (PNV) (25-MAR-2010 to present) which was used for pregnancy. The patient's LMP was approximately 22-FEB-2010 and her estimated delivery date was 15-NOV-2010. On 30-APR-2010 HPV test showed HPV positive. On 01-MAY-2010 (11 week 3 days) ultrasound was performed for testing size and date and it showed there were abnormal cranial vault, no normal cerebral, hemispheres or choroid and portion of baby "calictium" absent. Then on 11-MAY-2010 (12 week 2 days), ultrasound was performed again and showed results within normal limits. On an unspecified date the patient experienced anemia which was treated by ferrous sulfate (since late July 2010, 325 mg daily). In August 2010, at 28 weeks of gestation, the patient experienced preterm labor (PTL) which was treated by betamethasone (from 27-AUG-2010 to 28-AUG-2010, 12 mg x2). On 27-AUG-2010 the patient experienced bacterial vaginosis which was treated by cytarabine (+) fludarabine phosphate (+) granulocyte colony stimulating factor (unspecified) (from 27-AUG-2010, duration 1 week, 500 mg twice a day). It was reported that the baby also experience intrauterine growth regardation (IUGR) on an unspecified date. On 05-NOV-2010, at 38 1/2 weeks (also reported as 38 6/7 weeks) of gestation, the patient delivered a normal, healthy male baby weighing 5 pounds 7. Apgar score was 9/9. Baby's length was 19 inch and head circumference was 81.5. There were no congenital anomalies reported. There were no complications during labor. However, the reporter thought the baby was delivered at small gestation age (SGA). Other laboratory test included: fetal fibronectin test (FFN) which was performed on 27-AUG-2010 and showed positive result. Gestational Blood Sugar (GBS) which was performed on 12-OCT-2010 and showed negative. The baby's experience has been captured in WAES 1004USA00203B1. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female who on 19-MAY-2010 was vaccinated with the first dose of GARDASIL (lot # not reported) and had not menstruated since. The patient was scheduled to receive dose two on 19-JUL-2010. The patient had not recovered. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician's assistant concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). "The physician's assistant heard from another healthcare worker that a patient had reported hair loss after a GARDASIL injection (which dose in the series was unknown)." The patient's outcome was not reported. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient who on unspecified dates was vaccinated with 0.5 ml all three does of GARDASIL injection (Lots# not reported). The physician stated that a year and a half after the patient received GARDASIL a pap smear was performed and the test showed a low grade HPV positive. At the time of the report the patient's outcome was not reported and the patient had no visible genital warts. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a female who in approximately July 2009, was vaccinated with the third dose of GARDASIL (Lots # unknown). The nurse reported that one year after the last dose in approximately July 2010 of GARDASIL the patient developed "a severe case of genital warts". In approximately July 2010, the patient experienced severe case of genital warts after the last dose. The patient's severe case of genital warts after the last dose persisted. The patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received form a licensed practical nurse (L.P.N) concerning a 13 year old female patient with no known drug allergies, who on 17-MAR-2011 at 16:15 was vaccinated with a second dose of GARDASIL (Lot # 0057AA) IM in the left arm. On 17-MAR-2011 at 16:20 the patient fainted after GARDASIL and VARIVAX were administered. The patient recovered in 2-3 minutes. Follow up information received from licensed practical nurse indicated that the patient was a female. The nurse reported that the patient did not have any laboratories tests done. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL (Lot# unknown). Subsequently the patient experienced weight gain. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site rash
Clinical narrative: Information has been received from a nurse concerning a female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On an unspecified date, the patient experienced a rash at the injection site. There was no lab diagnostics studies performed. Unspecified medical attention was sought. On an unspecified date, the patient recovered from a rash at the injection site (that eventually cleared out). Follow-up information has been received from the nurse who reported that the female patient experienced a bump at the injection site (previously reported as a rash at the injection site). Additional information is not expected. Follow-up information has been received from the 25 year old (also reported as 26 year old) unknown race female patient who on 16-JUN-2010 at 09:30 AM was vaccinated at upper left arm with the third dose (previously was reported as first dose) of GARDASIL (LOT# 0040Z). On the same day at PM, the patient complained 2X2 bump showed up on her arm. It was stated that the patient noticed that before she went to bed. This is the second of two reports received from same source. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in approximately 2009 " about a year ago" was vaccinated with a 0.5 ml first dose of GARDASIL injection (Lot #: not reported). The patient had an allergic reaction to GARDASIL. The registered nurse stated that the patient's mother was also a nurse who took care of the reaction and so the patient did not seek medical treatment. The patient decided to discontinue GARDASIL series. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on 08-JUL-2010 was vaccinated with a dose of GARDASIL, VARIVAX and hepatitis A vaccine (inactive) at the same visit. On 08-JUL-2010 the patient became dizzy and sat down. The patient went home and continued to complain of dizziness and headache and went to the physician on 09-JUL-2010. At the time of the report, the patient had not recovered. Follow-up information has been received from the registered nurse who reported the patient's age should be "10 years old" (previously reported as 15 year old). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Muscle spasms
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (lot#: not reported) and subsequently the patient developed chest pain. On an unspecified date the patient was vaccinated with a second dose of GARDASIL (lot#: not reported) and subsequently the patient developed leg cramps. At the time of the report, the physician stated that the patient refused to get her third dose of GARDASIL because all events listed above. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Menstruation delayed
Clinical narrative: Information has been received from a 26 year old female consumer with no pertinent medical history or allergies/drug reactions, for GARDASIL, a Pregnancy Registry product, concerning herself who on 03-MAY-2010 and on 06-JUL-2010 was vaccinated with a first and second dose respectively of GARDASIL (Lot # not provided). There was no concomitant therapy. On 08-JUL-2010 she was expecting to have her period and it never started. There was no relevant laboratory data. As of 11-JUL-2010 it was unknown if she was planning on having her third injection of GARDASIL and she still has not had her monthly period. The patient had asked if she was pregnant what would happen. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL (Lot# unknown). Subsequently the patient experienced weight gain. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Ultrasound antenatal screen normal, Underdose, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with 36 weeks pregnancy and with allergies to aspirin who on 07-JUL-2010 was vaccinated subcutaneously with 1.0 ml of GARDASIL (lot# not reported) in place of tuberculin purified protein derivative ("PPD") due to human error, not product confusion. Concomitant therapy included vitamins (unspecified). Office stated that 1 ml GARDASIL was given subcutaneous, not standard PPD dose of 0.1 ml. Unspecified medical attention was sought. The patient's last menstrual period was approximately 29-OCT-2010 and estimate delivery date will be 05-AUG-2010. Follow-up information has been received from the Registered Nurse. She reported that the prenatal patient was given 0.1 ml of GARDASIL subcutaneously. She stated that event though the dose of GARDASIL was much less than the normal dose they were still given GARDASIL. The patient was given GARDASIL in place of PPD due to human error. Follow-up information has been received from the registered nurse. The nurse reported that the female patient was a non-smoker and she had no significant past medical history and no family history. The patient had 5 previous pregnancies: twice full term deliveries and twice elective terminations. There was no birth defect in previous pregnancies. On 14-JUL-2010, ultrasound was performed and it showed the patient was 37 weeks and 3 days, the result was normal. On the same the patient started ferrous sulfate 325 mg daily for Fe decreased. On 05-AUG-2010, 40.2 weeks from LMP, the patient delivered a female baby. Weighed 7lbs 13oz, Apgar scored 8/9. The baby was normal and there were no congenital anomalies. There were no complications during pregnancy or labor. There were no infections or illness during pregnancy. This is one of several reports received from the same source. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Underdose, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse, for GARDASIL, a Pregnancy Registered product, concerning a 25 year old female that was 26 weeks pregnant, and with no allergies who on 07-JUL-2010 was vaccinated subcutaneously with 1.0 ml GARDASIL (lot# not reported) in place of tuberculin purified protein derivative ("PPD") due to human error, not product confusion. Concomitant therapy included vitamins (unspecified). Office stated that 1 ml GARDASIL was given subcutaneous, not standard PPD dose of 0.1 ml. Unspecified medical attention was sought. The patient's last menstrual period was approximately 07-JAN-2010 and estimated delivery date will be 14-OCT-2010. Follow-up information has been received from the Registered Nurse. She reported that the prenatal patient was given 0.1 ml of GARDASIL subcutaneously. She stated that even though the dose of GARDASIL was much less than the normal dose they were still given GARDASIL. The patient was given GARDASIL in place of PPD due to human error. This is one of several reports received from the same source. Follow-up information has been received from the Registered Nurse who reported that the patient on 24-OCT-2010 at the 41 weeks from LMP delivered a normal male infant, weight 3730 grams and Apgar score 9/9. There were neither congenital anomalies nor other complications/abnormalities regarding the baby. For obstetric information, the mother also was no complication during pregnancy, during labor/delivery and no infections or illnesses during pregnancy. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with the first and second 0.5ml dose in the series of GARDASIL (Lot # unknown). The nurse reported that the patient had a rash after receiving the first and second dose. It was unknown if the patient sought medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Myalgia, Paraesthesia
Clinical narrative: Information has been received from a 24 year old female consumer patient with no drug reactions or allergies and no pertinent medical  history who in November 2009, was vaccinated with the first dose of GARDASIL (Lot number unknown). Concomitant therapy included ORTHO TRI-CYCLEN. The caller stated that on 13-JUL-2010 she received her third and final dose of GARDASIL and about one hour after receiving the shot she felt dizzy and her hands fell asleep and felt tingly. She noticed this in both extremities, as the opposed to just the left arm which she received the shot in. She called the doctor again and was told to take ibuprofen three times a day and call again on Monday 19-JUL-2010 if her side effects did not diminish. The caller stated that she no problems whatsoever with the previous two shots. There was no laboratory tests performed. At the time of the report, the consumer had not recovered from dizzy and tingling in her hands. The patient sought unspecified medical attention. Follow up information has been received from the physician's office. It was reported that the patient was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot number 666118/1539Y). It was reported that immediately after injection the patient experienced muscle pain and numbness in bilateral hands. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a "21 year" old female who "about a year ago", was vaccinated with the first dose of GARDASIL (0.5ml, IM). The patient fainting about 20 to 35 minutes after the shot and was surrounded by nurses. The patient received the shot at a hospital and the patient had not been seen since the adverse events. Who administered the shot was unknown. Therapy with human papillomavirus vaccine was discontinued "about a year ago". The outcome was unspecified. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an "around 13 to 14 years old" female who had been vaccinated with the series of GARDASIL (LOT#s not reported, third dose was 0.5 mL). After the series, she had her PAP tests done and came back positive for HPV (type unspecified for now). Unspecified medical attention was sought. It was reported that on an unspecified date the patient recovered. This is the first of three cases received from same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Muscle spasms, Nausea, Vaginal haemorrhage
Clinical narrative: Information has been received from a 26 year old female with a history of panic attacks and no drug allergy who on 21-JUL-2010 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy included XANAX. On 27-JUL-2010 the patient developed dizziness, headache , nausea and intermittent cramping with vaginal spotting. The patient didn't seek medical attention. No lab test performed. The patient sated that she planned to contact the nurse to schedule an evaluation. As of 29-JUL-2010 the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort
Clinical narrative: Information has been received from a 17 year old female consumer with no relevant medical history (also reported as healthy) who on 26-JUL-2010 was vaccinated with the third dose of GARDASIL (dose unknown). It was unknown if there were any relevant concomitant medications or any relevant past drug history. The patient reported that after she received the third dose of GARDASIL, on 26-JUL-2010, her "abdomen was feeling a little weird". The patient stated that she was not aware that she was pregnant. The patient's physician was not aware of the event. As of 28-JUL-2010, the patient was still experiencing the event. There was no relevant laboratory data. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a "couple" patients who on an unspecified date were vaccinated with GARDASIL (therapy dose, route and site unknown). Subsequently the patients fainted after receiving vaccination. Subsequently, the patients recovered. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, and hospital name (if applicable). Follow-up information has been received from the physician. The physician reported that one of the patients felt faint. The patient had loss of consciousness for few seconds. The patient had got 5 vaccines, not just GARDASIL. The physician could not recalled the patient's identities. This is one of several reports from the same source. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an "around 13 to 14 years old" female who had been vaccinated with the series of GARDASIL (LOT#s not reported, third dose was 0.5 mL). After the series, she had her PAP tests done and came back positive for HPV (type unspecified for now). Unspecified medical attention was sought. It was reported that on an unspecified date the patient recovered. This is the second of three cases received from same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female patient who on 28-JUL-2010 was injected with the first dose of GARDASIL (lot #, route and injection site not reported). On 28-JUL-2010 the patient experienced dizziness. The patient had sought unspecified medical attention. Subsequently, the patient recovered from dizziness. Additional information has been requested. This is one of two reports received from a same source.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 22-JUL-2010 was vaccinated with a first dose of GARDASIL (lot# not reported). On 23-JUL-2010 the patient experienced a rash on her arm and then the rash spread all over her body. The physician reported that the patient called the office on 23-JUL-2010 about this experience and would be coming into the office to have the rash looked at. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia, Vomiting
Clinical narrative: Information has been received from a currently 27 year old female nurse who is also the patient who about four years ago, in approximately 2006 was vaccinated with the first dose 0.5 ml dose of GARDASIL. There was no concomitant medication. The patient reported that she was 22 years old when received the first dose of the vaccine and she said that night she had flu-like symptoms. She was vomiting and had a fever. She received the second dose of GARDASIL on an unspecified date and did not have any symptoms. She believed she could have already been getting sick before she received the first injection. The patient recovered two to three days after receiving the vaccine. The patient sought unspecified medical attention. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an unspecified amount of female patients who on unspecified dates were vaccinated IM with three doses of GARDASIL. Subsequently the patients had PAP smears which were positive for Human papillomavirus (HPV). No lot number, expiration date, patient demographics, or number of patients provided. At the time of reporting, the patients' outcome were unknown. It was unspecified if the patients sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received from the physician. The approximately 16 year old patient informed the physician that she received the full series of vaccines from her pediatrician and had Pap smear be HPV with low grade squamous intraepithelial lesion (LGSIL). This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning an "around 12 to 14 years old" female who had been vaccinated with the series of GARDASIL (LOT#s not reported, third dose was 0.5 mL). After the series, she had her PAP tests done and came back positive for HPV (type unspecified for now). Unspecified medical attention was sought. It was reported that on an unspecified date the patient recovered. This is the third of three cases received from same source. Additional information has been requested.