chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from the pregnancy registry for GARDASIL vaccine from an 18 year old female consumer, who started therapy with GARDASIL vaccine "last year". On 01-May-2008 she was vaccinated in the arm with third dose of GARDASIL vaccine. On 12-May-2008, the patient found out she was pregnant, she does not know her exact trimester but does know she's very early in her pregnancy. Unspecified medical attention was sought, but no date of last menstrual period, or due date was reported. Follow-up information has been received from a physician's office concerning the patient's pregnancy outcome. It was reported that on an unknown date the patient delivered prematurely a normal infant weighting 4 lb and 13 oz. No congenital anomalies were noted. The patient's and and baby's final outcome was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: Information has been received from the pregnancy registry for GARDASIL via a nurse practitioner, concerning a 22 year old female with a history of asthma who on 25-APR-2008 was vaccinated with the first dose of GARDASIL, 0.5 ml, IM, (Lot#659962/1740U).  The patient sought unspecified medical attention at the office and had a confirmed pregnancy test.  Her last menstrual period was reported as 22-MAR-2008, and her due date is 27-DEC-2008.  No other symptoms have been noted.  Follow-up information has been received from the nurse practitioner, for GARDASIL, a Pregnancy Registry product.  On 25-APR-2008 the patient had urine beta-human chorionic gonadotropin test (ECG) performed which was negative.  The reporter noted that the last contact with patient was on 14-MAY-2008, when she called to report pregnancy, 8 weeks gestation.  And the patient experienced scant pink vaginal discharge.  The patient did not return phone calls on 16, 19, 22-MAY-2008, nor to card sent on 22-MAY-2008.  The estimated date of delivery was 28-DEC-2008.  The pregnancy outcome was unknown.  No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Premature labour
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry of GARDASIL, concerning a 24 year old female with anxiety and depression and no known allergies who on 15-Oct-2007 was vaccinated with the first dose of GARDASIL. On 14-Jan-2008 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot number 659055/1522U). Concomitant therapy included WELLBUTRIN. The patient is pregnant. Her LMP was 07-JAN-2008. Due date was 13-OCT-2008. The third dose was not administered. On 14-JAN-2008 the patient was placed on WELLBUTRIN. The patient took WELLBUTRIN for three weeks and then the patient stopped taking it since it was not working. The patient was not experiencing any problems. The patient sought unspecified medical attention via office visit. Follow-up information received from the physician reported limited pregnancy outcome information. On approximately 17-Aug-2008 the patient delivered a baby "at around 32 weeks gestation, almost two months early". The physician did not remember exactly and did not have the patient's chart at her immediate disposal. The physician also followed the baby in her practice. The physician reported " he was now around nine months old and weighed around 15 pounds. He had some failure to thrive issues and had some developmental delays". No further information was provided at this time. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry for GARDASIL vaccine from a registered nurse concerning a 20 year old female patient with juvenile diabetes and no known allergies who on 19-May-2008, was vaccinated with the first dose of GARDASIL vaccine (LOT # 658222/0927U) 0.5 ml IM. On 29-JUL-2008, was vaccinated with the second dose of GARDASIL vaccine (LOT # 659653/1448U) 0.5 ml IM. Concomitant therapy included insulin (manufacturer unknown). The patient was now pregnant. The last menstrual period was on 01-JUL-2008. On an unspecified date, pregnancy test was performed and resulted positive. No other symptoms were noted. The patient called the doctor for medical attention. Estimated date of delivery on 07-APR-2009. Follow-up information received from the registered nurse revealed that the patient had delivered a baby boy in March 2009 (exact date not known). She mentioned that the baby did have some "heart trouble"; the patient was told that her baby had a "rapid heartbeat". The baby was treated with INDERAL (additional details not known). The registered nurse reported that the patient was told by her doctor that her baby's rapid heartbeat was related to the patient's juvenile diabetes. It was reported that the patient did continue to wear an insulin pump. The reporter stated that she had seen the baby and he did "look normal". She confirmed that the patient had no congenital anomalies. Additional information was received from the nurse the next day. She reported that the baby was born on 18-MAR-2009. The nurse stated that she had said the baby's heart trouble as a "rapid heartbeat" was listed as an "enlargement heart" and was being treated with INDERAL. She had no further information to provide. This is one several reports from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test normal, Pregnancy induced hypertension, Ultrasound scan normal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician for the Pregnancy registry for GARDASIL, concerning a 25 year old female with no drug allergies and no medical history who on 22-Sep-2008 was vaccinated with the second dose of GARDASIL. Concomitant therapy included vitamins prenatal. Subsequently the patient determined to be pregnant. A urine pregnancy test on 07-Oct-2008 was positive. The pregnancy questionnaire was received on 15-Oct-2008, which indicated that the patient had two previous pregnancies and one full term (40 weeks birth) Date of LMP was 06-Aug-2008 and EBD is 13-May-2009. Second dose of GARDASIL was reported as 22-Sept-2008 (lot# 0573X). No history of reported pre-term deliveries, spontaneous terminations, elective terminations, fetal deaths and birth defects. On 07-Oct-2008, the patient was prescribed prenatal vitamins. Follow-up information from a physician revealed that the patient experienced no infections or illness but hypertension (date unknown) during pregnancy. The hypertension was treated with Pro Cardia XL 30mg, oral daily on 05-Jan-2009 (duration not reported). During the patient's pregnancy, she underwent the following diagnostics tests: on 25-Dec-2008, a Quad screen showed a negative result. Ultrasound done on 04-Dec-2008, 08-Jan-2009 and 27-Mar-2009 showed normal results. On 22-May-2009, 41 Weeks from the LMP, the patient delivered a normal, healthy female baby weighing 7 pounds 4 ounces with a length of 18.75 inches. No complication occurred during labor/delivery. The baby had Apgar score of 7/9 and congenital anomalies. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a medical assistant through the Pregnancy registry for GARDASIL concerning a 17 year old female with no previous pregnancies who on 17-Sep-2008, was vaccinated with the second dose of GARDASIL (lot# 659180/1758U) and then discovered that she was pregnant. There was no concomitant medication. No adverse effects reported. Late last menstrual period 16-Aug-2008. Estimated delivery date 23-May-2009. A routine ultrasound was performed on 15-Oct-2000, which was normal. The patient was placed on prenatal vitamins. The patient did not receive the first 2 doses of  HPV at the medical assistant's physician office. Follow up information has been received from the physician who reported that in 2009, the patient experienced mild anemia and was treated with ferrous sulfate 325 mg, daily from 11-Feb-2009 to 17-May-2009. Concomitant therapy during pregnancy included vitamins. On 17-May-2009, the patient delivered a normal female baby, at 39 weeks of gestation. The baby weighed 6 pounds, her length was 10.0 inches, and had on APGAR score of 9/9. There were no congenital anomalies and no complications or abnormalities reported. No further information is expected.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Failed trial of labour, Foetal non-stress test, Premature separation of placenta
Clinical narrative: Information has been received from a medical assistant, for the GARDASIL, concerning a 33 year old female who on 16-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 660620/0571X). There was no concomitant medication. It was subsequently learned that the patient was pregnant at the time of the above GARDASIL. The IMP was 25-AUG-2008. No adverse effects were reported. The patient sought unspecified medical attention. Follow-up information has been received from a health care professional who reported that concomitant therapy included PRENEXA and that the patient had a history of SINEQUAN use 2 years prior to pregnancy, 25 mg daily for depression. The patient did ultrasound on 21-OCT-2008, which showed estimated date of confinement on 03-JUN-2009 and additional ultrasounds occurred on 14-JAN-2009, 18-FEB-2009 and 14-MAY-2009. The MSAFP Test on 07-JAN-2009 showed negative. The Fetal Non-Stress test 2x per week starting from 32 showed reactive. On 25-MAY-2009 (38 weeks and 6 days from LMP) the patient with no previous pregnancy delivered a normal, healthy male baby weighing 7 pounds 15 ounces, Apgar score was 9/9. There was no congenital anomaly, other complication or abnormality. There were no infections, illnesses, or complications during pregnancy, however during pregnancy, however during labor/delivery the patient experienced failure to progress at 4cm, mild abruption during labor/delivery. No further information is available.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound abdomen
Clinical narrative: Information has been received from a medical assistant, for the GARDASIL, concerning a 33 year old female who on 16-SEP-2008 was vaccinated with the first dose of GARDASIL (Lot # 660620/0571X). There was no concomitant medication. It was subsequently learned that the patient was pregnant at the time of the above GARDASIL. The IMP was 25-AUG-2008. No adverse effects were reported. The patient sought unspecified medical attention. Follow-up information has been received from a health care professional who reported that concomitant therapy included PRENEXA and that the patient had a history of SINEQUAN use 2 years prior to pregnancy, 25 mg daily for depression. The patient did ultrasound on 21-OCT-2008, which showed estimated date of confinement on 03-JUN-2009 and additional ultrasounds occurred on 14-JAN-2009, 18-FEB-2009 and 14-MAY-2009. The MSAFP Test on 07-JAN-2009 showed negative. The Fetal Non-Stress test 2x per week starting from 32 showed reactive. On 25-MAY-2009 (38 weeks and 6 days from LMP) the patient with no previous pregnancy delivered a normal, healthy male baby weighing 7 pounds 15 ounces, Apgar score was 9/9. There was no congenital anomaly, other complication or abnormality. There were no infections, illnesses, or complications during pregnancy, however during pregnancy, however during labor/delivery the patient experienced failure to progress at 4cm, mild abruption during labor/delivery. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Premature labour, Premature separation of placenta, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with bicornuate uterus and a history of chickenpox as child, on 17-SEP-2008 was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient was found to be pregnant. The date of last menstrual period was 01-SEP-2008 and the estimated delivery date is 08-JUN-2009. On 18-OCT-2008, the ultrasound showed that the patient had a bicornuate uterus. Follow-up information was received from the physician concerning the female patient. It was reported that during the pregnancy the patient also take NATELLE as prenatal vitamins. On an unspecified date the patient developed bacterial vaginosis, and on 18-NOV-2007 the patient was treated with FLAGYL 500 mg twice a day for 7 days. On 10-MAY-2008, at 36.5 weeks from LMP, the patient delivered a male baby, weighted 5 pound 6 OZ, APGAR score 7/7. It was reported that the baby was normal with no congenital anomalies. The physician also reported that during the delivery the patient had increased bleeding which was believed to be attributed to a partial placental abruption. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginitis bacterial
Clinical narrative: Information has been received from a physician for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with bicornuate uterus and a history of chickenpox as child, on 17-SEP-2008 was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient was found to be pregnant. The date of last menstrual period was 01-SEP-2008 and the estimated delivery date is 08-JUN-2009. On 18-OCT-2008, the ultrasound showed that the patient had a bicornuate uterus. Follow-up information was received from the physician concerning the female patient. It was reported that during the pregnancy the patient also take NATELLE as prenatal vitamins. On an unspecified date the patient developed bacterial vaginosis, and on 18-NOV-2007 the patient was treated with FLAGYL 500 mg twice a day for 7 days. On 10-MAY-2008, at 36.5 weeks from LMP, the patient delivered a male baby, weighted 5 pound 6 OZ, APGAR score 7/7. It was reported that the baby was normal with no congenital anomalies. The physician also reported that during the delivery the patient had increased bleeding which was believed to be attributed to a partial placental abruption. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour, Premature rupture of membranes, Small for dates baby, Ultrasound scan abnormal
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female with no known drug reactions/allergies and no pertinent medical history, who on 24-MAR-2008 was vaccinated with the first dose of GARDASIL (Lot #658282/0929U), 0.5ml, intramuscularly, on 25-APR-2008 with the second dose of GARDASIL (Lot #658282/0929U), 0.5ml, intramuscularly and on 25-SEP-2008 with the third dose of GARDASIL (Lot #659184/0843X), 0.5ml, intramuscularly. Concomitant therapy included HAVRIX. The healthcare worker reported that the patient, who received her third dose of GARDASIL on 25-SEP-2008, is pregnant. The last menstrual period was on 20-AUG-2008 and the estimated date of confinement is 27-MAY-2009. The patient experienced abdominal pain and discomfort which led to the diagnosis of pregnancy. The patient sough unspecified medical attention. Follow up information was received from a health care professional concerning a 20 year old female patient with no previous pregnancies or full terms deliveries who on 24-MAR-2008, 25-APR-2008 and 25-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively. Concomitant therapy used during the pregnancy included HAVRIX given on 25-SEP-2008, BACTRIM DS TABLET given on 27-DEC-2008 for a urinary tract infection. It was reported that the patient presented with an urinary tract infection during pregnancy. It was reported that ultrasounds were performed on 07-OCT-2008, 08-NOV-2008 and on 19-NOV-2008 (at 6 weeks 0 days, 12 weeks 3 days and 22 weeks 3 days, respectively). On 22-DEC-2008 a laboratory diagnostic test was performed and it was negative for Down syndrome, open spina bifida and Trisomy 18. It was reported that there were a premature rupture of membranes, preterm labor and short cervix. It was reported that on 03-APR-2009, at 32 weeks and 1 day of gestation, the patient delivered two female twins (ID # 36825, weight 1.660 Kg, the head circumference was 32.5 cm, APGAR score were 8/10 at the first minute and 9/10 at the 5 minute) and (ID # 36826, weight 1.645 Kg, Length was 44.5 cm, the head circumference was 29.0 cm, APGAR score were 8/10 at the first minute and 9/10 at the 5 minute). It was reported that the babies were premature but the reporter was not really sure if the babies were normal or had congenital anomalies. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a healthcare worker concerning a 20 year old female with no known drug reactions/allergies and no pertinent medical history, who on 24-MAR-2008 was vaccinated with the first dose of GARDASIL (Lot #658282/0929U), 0.5ml, intramuscularly, on 25-APR-2008 with the second dose of GARDASIL (Lot #658282/0929U), 0.5ml, intramuscularly and on 25-SEP-2008 with the third dose of GARDASIL (Lot #659184/0843X), 0.5ml, intramuscularly. Concomitant therapy included HAVRIX. The healthcare worker reported that the patient, who received her third dose of GARDASIL on 25-SEP-2008, is pregnant. The last menstrual period was on 20-AUG-2008 and the estimated date of confinement is 27-MAY-2009. The patient experienced abdominal pain and discomfort which led to the diagnosis of pregnancy. The patient sough unspecified medical attention. Follow up information was received from a health care professional concerning a 20 year old female patient with no previous pregnancies or full terms deliveries who on 24-MAR-2008, 25-APR-2008 and 25-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively. Concomitant therapy used during the pregnancy included HAVRIX given on 25-SEP-2008, BACTRIM DS TABLET given on 27-DEC-2008 for a urinary tract infection. It was reported that the patient presented with an urinary tract infection during pregnancy. It was reported that ultrasounds were performed on 07-OCT-2008, 08-NOV-2008 and on 19-NOV-2008 (at 6 weeks 0 days, 12 weeks 3 days and 22 weeks 3 days, respectively). On 22-DEC-2008 a laboratory diagnostic test was performed and it was negative for Down syndrome, open spina bifida and Trisomy 18. It was reported that there were a premature rupture of membranes, preterm labor and short cervix. It was reported that on 03-APR-2009, at 32 weeks and 1 day of gestation, the patient delivered two female twins (ID # 36825, weight 1.660 Kg, the head circumference was 32.5 cm, APGAR score were 8/10 at the first minute and 9/10 at the 5 minute) and (ID # 36826, weight 1.645 Kg, Length was 44.5 cm, the head circumference was 29.0 cm, APGAR score were 8/10 at the first minute and 9/10 at the 5 minute). It was reported that the babies were premature but the reporter was not really sure if the babies were normal or had congenital anomalies. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Migraine, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a female who in approximately 2007 was vaccinated with the second dose of GARDASIL. She was pregnant at the time the vaccination was administered. Her last menstrual period was in approximately March 2007. The patient did have her child who is approximately 17 months old currently. Following the birth, the patient received the third dose of GARDASIL. The patient sought medical attention. Follow-up information was received from the nurse. She reported that the patient's baby was healthy and normal. Follow up information has been received from the registered nurse concerning this 25 year old female who was vaccinated with the 1st, 2nd and 3rd doses of GARDASIL (1st lot #653735/0688F, 2nd lot #655165/1425F and 3rd lot #659441/1446U) on 13-NOV-2006, 19-JAN-2007 and 04-JAN-2008 respectively. Subsequently, the patient was pregnant at the time of vaccination. The patient's last menstrual period (LMP) was 02-JAN-2007. Her estimated date of delivery was 09-OCT-2007. It was noted that the patient had one elective termination, one previous pregnancy and one full term delivery. There were no birth defects and no infant complications in her previous pregnancy. On 08-FEB-2007, a urine beta-human chorionic gonadotropin test was performed because the patient missed her period. The test result was positive. It was reported that the patient took IMITREX 100 mg as needed for the treatment of migraines during her first trimester. On 10-OCT-2007, 40 weeks from her LMP, the patient delivered a normal, healthy, female baby. There were no complications or congenital anomalies. The baby weighed 7 pounds, 1 ounce, her length was 10 1/2 inches and her head circumference was 14 inches. There were no complications during pregnancy or labor and delivery. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Muscle disorder
Clinical narrative: Information has been received from a registered pharmacist concerning a "teenager" female who in February 2008, was vaccinated with the First dose of GARDASIL (Lot not reported). Subsequently the patient experienced "muscle problems". The pharmacist noted that the patient went to see her physician. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Hypotonia, Pallor, Sensation of heaviness
Clinical narrative: Information has been received from a patient's mother concerning an 18 year old female with no allergies who on 08-JUN-2009 was vaccinated with her first dose of GARDASIL. Concomitant therapy included YASMIN. Then within a short time after the first dose the patient's arm felt heavy, her face became pale, her body went limp and her arms and legs were flailing. This only happened for a couple of seconds and then she came to and her color in her face came back. The patient stayed at the office for ten more minutes and was given water and sugar since she had an empty stomach and was then fine to leave. No labs and diagnostic tests were performed. The patient slept the rest of the day, and was fine. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Injection site pain, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with a history of vaginosis bacterial on 19-MAR-2009 who on 02-JUN-2008 was vaccinated with a first dose of GARDASIL (Lot # not reported). On 07-AUG-2008 she received second dose of GARDASIL (Lot # not reported). On 05-DEC-2008 she received third dose of GARDASIL (Lot # not reported). Recently on unspecified date she had "pap smear" that demonstrated "high risk HPV DNA detected". The physician mentioned that the patient had a "PAP smear" prior to beginning the vaccines and it was negative. As a side note the physician mentioned that the patient complained that the second injection of vaccines was more painful than the first. The patient sought medical attention office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of GARDASIL, intramuscularly. A month or so ago the patient developed arthritis. The physician discontinued the series after this. The patient sought unspecified medical attention. This is one of two reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 23 year old female with no medical history and drugs allergies, who in November 2007, was vaccinated with a first dose of GARDASIL. The second and the third dose were given in January 2008 and May 2008 respectively. There was no concomitant medication. On 28-MAY-2009 the patient had an abnormal Pap test. The Pap test revealed "atypical cells of undetermined significance with high risk HPV to include HPV types 16 and 18". The nurse added that this was the patient's first abnormal Pap test. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient. It was reported that in January 2007 the patient's pap smear was normal and negative for HPV. In March 2008 the patient's pap smear was normal and no check for HPV. In December 2008, the patient got series of GARDASIL. In 09-May-2009, the pap smear revealed low grade cervical Intraepithelial Ceoplasia (CIN) and positive for HPV. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a nurse concerning a 11-year-11-month- old female patient who was vaccinated with the first dose of GARDASIL IM 0.5ml about 2 weeks ago on appropriately 27-May-2009. The patient had not had her period since she had been vaccinated. The patient had regular periods prior to receiving GARDASIL. It had been approximately 6 weeks since her last period. The patient had sought medical attention, she called the doctor's office. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Condition aggravated, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning her daughter, an 18-year-old female, who in July 2008 was vaccinated with the first dose of GARDASIL 7-10 days after the dose was given, the patient developed asthma like symptoms and sought medical attention and was treated with oral steroids for 3 months. The patient recovered. In October 2008, the patient was vaccinated with the second dose of GARDASIL. 7-10 days after the dose was given, the patient developed asthma like symptoms again and sought medical attention and had to be treated with steroids for 3 months. Subsequently, the patient recovered again. Prior to the vaccinations the patient did not have asthma symptoms for over 10 years. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician who has heard of a couple of female patient's who were vaccinated with dose of GARDASIL. The patient's developed arthritis after getting the dose of GARDASIL. Attempts are being made to obtain and verify additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Photosensitivity reaction, Rash
Clinical narrative: Information has been received from a consumer concerning her "teen" daughter who was vaccinated with three doses of GARDASIL as follows: 1st in January 2009, 2nd in February 2009, 3rd in March 2009. The concomitant medication was unspecified. The patient broke out in a white spotted rash while on vaccination after the 3rd dose. The patient was diagnosed with sun poisoning and recovered in about 2 weeks time. The reporter also noted possible mood changed in the teenager after the series that persisted. At the report time the outcome was unknown. No further information is available.
Age: 71.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Wrong drug administered
Clinical narrative: Information has been received from a 72 year old female consumer with blood pressure high, cholesterol and Oesophageal Reflux acid reflux concerning herself who was vaccinated with a dose of GARDASIL instead of the ZOSTAVAX (Merck) by mistake on 06-Jun-2009. Concomitant therapy included Aspirin, Minerals (unspecified), and Vitamins (unspecified), Centrum silver, Fish oil, Calcium citrate and Citracal D, Prilosec, Felodipine, Lipitor and Micardis. The reporter mentioned that she was not experienced any side effects, but was worried and need to know if she needed to be concerned. Unspecified blood work as performed (results not provided). At the report time the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Chest pain, Dermatitis allergic, Dizziness, Headache
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with seasonal allergy who in October 2008 was vaccinated with the first dose of GARDASIL, the second dose in December 2008, and the third dose on February 2009. Concomitant therapy included prednisone once daily and triamcinolone acetonide, 0.1 %, twice daily. In February 2009, the patient experienced severe skin allergies and she got hives and blisters all over her body. She was also experiencing severe headaches, dizziness and chest pains. The patient sought unspecified medical attention. There were no laboratory studies performed. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with seasonal allergy who in October 2008 was vaccinated with the first dose of GARDASIL, the second dose in December 2008, and the third dose on February 2009. Concomitant therapy included prednisone once daily and triamcinolone acetonide, 0.1 %, twice daily. In February 2009, the patient experienced severe skin allergies and she got hives and blisters all over her body. She was also experiencing severe headaches, dizziness and chest pains. The patient sought unspecified medical attention. There were no laboratory studies performed. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history or allergies who on 27-JAN-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL. On 26-MAR-2009 the patient was vaccinated IM with the second of GARDASIL (lot # 0074Y). On 02-JUN-2009 the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # 0294Y). There was no concomitant medication. After the patient received the second dose she experienced persistent headaches. At the time of this report, the patient had not recovered. The patient sought medical attention through a phone call. Headaches were considered to be disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac stress test, Cough, Drug exposure during pregnancy
Clinical narrative: Initial information has been received from a nurse practitioner, for GARDASIL, a pregnancy Registry product, concerning a 17 year old female with asthma who on 08-Oct-2008 was vaccinated with 0.5ml first dose of GARDASIL (lot# 660393/0067X). Concomitant therapy included Albuterol. Subsequently the patient was pregnant. Pregnancy tests were preformed and unspecified medical attention was sought. On 08-Jan-2009 and 08-Apr-2009 the patient was vaccinated with a 0.5ml second and third doses of GARDASIL (lot# 660393/0067X) respectively. On 17-Mar-2009 the patient delivered a healthy baby boy in a hospital. No adverse effects were reported. Follow up information has been received from the nurse practitioner on 19-June-2009 concerning the patient. Concomitant therapy included Ibuprofen. The patient underwent stress testing at 8 months. Normal testing. Started prenatal care at 8 months (received no prenatal care prior to 35-36 weeks)  On 17-Mar-2009 she delivered a normal, healthy male baby, weighing 7 pounds, at 40 weeks and 4 days from the LMP. The baby's length was 21 inches, head circumference was 14 inches. There was no congenital anomalies or other compilations. There were no complications during pregnancy or labor/delivery. Medication taken during pregnancy included cough medications (Nyquil), once, for cough, started in fall month of 2008. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Bilirubin conjugated increased, Diabetes mellitus
Clinical narrative: Information has been received from a registered pharmacist concerning a 14 year old female with no medical history and no allergies who on 06-MAY-2009 was vaccinated with the 1st dose of GARDASIL, 0.5ml, IM (lot#661846/1312X). There was no concomitant medication. Subsequently the patient experienced unspecified diabetes symptoms. Her only abnormal lab was an increased in bilirubin. She had sought medical attention, and was seen. The patient's diabetes persisted at the time of report. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood pressure decreased, Chest pain, Diarrhoea, Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 22 years old female with unknown medical history who on 09-JUN-2009 mid morning was vaccinated with the first dose of GARDASIL. On 10-JUN-2009 around 2:00 AM the patient started to feel nauseous, had vomited and had flu like symptoms. On 11-JUN-2009 around 5:00 AM the patient continued to feel sick and was also experiencing abdominal pain, diarrhea, chest pain, had a fever of 100.7F and her boyfriend who is an Emergency medical technician took her blood pressure which was low around the 70's. The patient had called physician for medical attention. It was unknown if the patient was going to receive the rest of the series. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 22 years old female with unknown medical history who on 09-JUN-2009 mid morning was vaccinated with the first dose of GARDASIL. On 10-JUN-2009 around 2:00 AM the patient started to feel nauseous, had vomited and had flu like symptoms. On 11-JUN-2009 around 5:00 AM the patient continued to feel sick and was also experiencing abdominal pain, diarrhea, chest pain, had a fever of 100.7F and her boyfriend who is an Emergency medical technician took her blood pressure which was low around the 70's. The patient had called physician for medical attention. It was unknown if the patient was going to receive the rest of the series. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain, Paraesthesia, Wrong technique in drug usage process
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 25-MAR-2009 was vaccinated with the first dose of GARDASIL (intramuscular administration, lot#, site of administration not reported). On 02-JUN-2009 the patient received the second dose of GARDASIL (lot# 662229/1497X, intramuscular administration) which may had been administered in the bursa muscle. The patient experienced pain and tingling in the shoulder after receiving her second vaccination. The injection site was red and swollen and the pain radiated to the shoulder. On 08-JUN-2009 patient was seen in the office for pain. At the time of reporting the patient was not recovered. In follow up, a pharmacist called regarding the patient, requesting information on whether the dose should be repeated if it is administered in the bursa. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Subsequently the patient experienced syncope. The patient sought medical attention in the physician's office. At the report time the outcome was unknown.  This is one of several reports receiving from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tooth loss
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on an unspecified date was vaccinated with third dose of GARDASIL (dose, route and lot number not reported). Subsequently the patient fainted and her two front teeth were knocked out. The patent eventually recovered on the same day and was able to "walk out of the office". The patient sought medical attention at the office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Nausea, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 19 year old female who about a year ago (in approximately 2008) was vaccinated with the third dose of GARDASIL (dose, route and lot number not reported). The physician reported that the patient's mother reported to him that soon after receiving the third dose of GARDASIL (in approximately 2008), the patient experienced nausea, weight loss, fatigue and joint pain. The physician reported that the patient was sent to see a rheumatologist and the results came back fine. The physician reported that the patient had recovered and was fine. The patient sought medical attention by contacting the physician. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Diarrhoea, Dizziness, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning his 24 year old daughter with no pertinent medical history reported and no known drug allergies, who "about six weeks ago" (on approximately 04-MAY-2009) was vaccinated with first dose of GARDASIL (dose, route and lot number not reported).  Concomitant therapy included PROZAC during the week she had premenstrual syndrome.  "The same day of vaccination" (on approximately 06-MAY-2009), the patient fainted and developed vomiting, diarrhea and dizziness.  The patient recovered from fainted, nausea and vomiting, diarrhea and dizziness "about three days after vaccination" (on approximately 07-May-2009).  No lab studies were performed.  The patient sought unspecified medical attention.  Fainted, nausea and vomiting, diarrhea and dizziness were considered to be disabling by the physician because the patient missed work.  Additional information has been received from the physician who reported that he would not be supplying any more information about his daughter's event.  Since his daughter had received the vaccine and experienced the event at come clinic in another city, he did not have the vaccine date, lot number or adverse event onset date.  The healthcare professional contacted during the telephone follow up call could not supply the following information: date of vaccination, lot number or date of event.  Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning his 24 year old daughter with no pertinent medical history reported and no known drug allergies, who "about six weeks ago" (on approximately 04-MAY-2009) was vaccinated with first dose of GARDASIL (dose, route and lot number not reported).  Concomitant therapy included PROZAC during the week she had premenstrual syndrome.  "The same day of vaccination" (on approximately 06-MAY-2009), the patient fainted and developed vomiting, diarrhea and dizziness.  The patient recovered from fainted, nausea and vomiting, diarrhea and dizziness "about three days after vaccination" (on approximately 07-May-2009).  No lab studies were performed.  The patient sought unspecified medical attention.  Fainted, nausea and vomiting, diarrhea and dizziness were considered to be disabling by the physician because the patient missed work.  Additional information has been received from the physician who reported that he would not be supplying any more information about his daughter's event.  Since his daughter had received the vaccine and experienced the event at come clinic in another city, he did not have the vaccine date, lot number or adverse event onset date.  The healthcare professional contacted during the telephone follow up call could not supply the following information: date of vaccination, lot number or date of event.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Upper respiratory tract congestion, Urticaria
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female who on 14-APR-2009 was vaccinated with second dose of GARDASIL (dose and route not reported, lot number 658563/1063U). The physician's assistant reported that after receiving the second dose, on the same day (14-APR-2009), the patient experienced congestion, hives and a rash on her face. The physician's assistant reported that the next day (15-APR-2009), "everything was cleared up and the patient was fine". The patient sought medical attention by calling the physician. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Gastrooesophageal reflux disease, Headache, Injection site pain, Sensation of foreign body
Clinical narrative: Information has been received from a 22 year old female patient who on 20-FEB-2009 was vaccinated with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On 20-FEB-2009 (also reported as "two days after vaccination"), the patient experienced soreness at the injection site, headache and lump in her throat. Later the patient experienced acid reflux. The patient stated that she will not receive any further doses of GARDASIL. The patient sought unspecified medical attention. Two months later, on approximately 20-APR-2009, the patient recovered from soreness at the injection site, headache, lump in her throat and acid reflux. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Nausea
Clinical narrative: Information has been received from a physician concerning her daughter, a 26 year old female who on 11-JUN-2009 was vaccinated with the first dose of GARDASIL. On 12-JUN-2009, the patient experienced chills, headache and queasiness. The physician reported that the patient was still experiencing chills and headache and queasiness. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Face injury, Fall, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from an office manager concerning a 17 year old female patient who on 15-JUN-2009 was vaccinated IM with a dose of GARDASIL (lot # not reported), 0.5 mL. It was reported that right after the patient received the GARDASIL she passed out, fell off the table and cut her face. She was brought to an emergency room but was unknown if she was admitted to the hospital. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Cyanosis, Dizziness, Feeling abnormal, Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who "3 weeks ago" on approximately 26-MAY-2009, was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA and other unspecified vaccines which were also given. On approximately 26-MAY-2009, after receiving the dose of GARDASIL the patient experienced syncope and turned blue. Oxygen was administered. The patient sought medical attention. The patient recovered within 20 minutes after the dose of GARDASIL was given. Follow-up information was received from a registered nurse concerning a 15 year old female patient. It was reported that on 12-MAY-2009, the patient received the first dose of GARDASIL (LOT # 661703/0651X). On 12-MAY-2009 the patient concomitantly received Tdap (manufacturer unknown) (LOT # C3029AA) and Hep A (manufacturer unknown) (LOT # AHABB319AA). It was reported that the patient did not receive concomitantly MENACTRA. After the patient had received GARDASIL, the patient became pale and light-headed. The patient never completely fainted. The patient's lips turned blue and the patient required oxygen for about 10 minutes. It took the patient "a long time before she felt normal". It was reported that the patient had eaten lunch before going to the physician's office. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Tonic clonic movements
Clinical narrative: Information has been received from a pharmacist concerning a female with unspecified drug reactions/allergies and medical history, who "a couple months ago" (approximately April 2009), was vaccinated with GARDASIL (dose, route and lot number unspecified). The pharmacist stated "A patient developed tonic-clonic movements directly after being given a dose of GARDASIL". At the time of this report the outcome of the patient was recovered (date unspecified). The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Injection site pain, Myalgia, Nausea, Vomiting
Clinical narrative: Information has been received concerning a 23 year old female with latex allergy and no pertinent medical history who on 03-DEC-2008 was vaccinated IM with the first 0.5mL dose of GARDASIL (lot # 66012/0229X). On 04-FEB-2009 was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # 660612/0229X), and on 20-MAY-2009 was vaccinated IM with the third 0.5 mL dose of GARDASIL (lot # 661766/0652X). On 21-MAY-2009, the patient developed nausea, muscle arm soreness near the injection site, a temperature of 102 degrees F and 2 episodes of vomiting. The patient recovered on 22-MAY-2009. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a pharmacist concerning a female who in June 2009, was vaccinated with a dose of GARDASIL (lot number, route and site of vaccination not reported). It was reported that the patient developed syncope immediately after a dose of GARDASIL. The patient sought an unspecified medical attention. At the time of reporting the patient's outcome was unknown additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP, HPV4, TDAP
Symptoms: Heart rate, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with no pertinent medical history who on 13-JUN-2009 was vaccinated with the first dose of GARDASIL. Lot number was not available. Concomitant therapy included (ADACEL) and hepatitis B virus vaccine (Unspecified). On 13-JUN-2009, the patient fainted after receiving her first dose of GARDASIL. The patient received all vaccines at the same time. The patient sought unspecified medical attention. Patient's heart rate was checked but no results were provided. On 13-JUN-2009, the patient recovered. Additional information has been requested.