chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Sensation of heaviness, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 13-FEB-2008 at 12:45 was vaccinated into the left arm with the first dose of GARDASIL (Lot # 659655/1486U). On 13-FEB-2008, immediately after the shot was administered, the patient developed pain in the left arm. She cried for about seven minutes and began to complain of heaviness in her arm and stinging and aching. She then became dizzy and had to lie supine for fifteen minutes. She left the office in stable condition. Within one to two hours she developed swelling and discoloration of all fingers of the left hand. This lasted twenty-four hours and resolved spontaneously. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL (lot number and dates unspecified).  Subsequently the patient experienced a rash on the opposite arm from injection site.  No additional information was provided.  The patient sought unspecified medical treatment.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a female consumer who was vaccinated with a dose of GARDASIL (Lot# not reported).  The patient reported that she developed a fever after receiving a dose and then she was fine the next day.  The patient's outcome is recovered.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning an unspecified number of female patients who were experiencing pain from vaccination with GARDASIL (Lot# not reported).  It is unknown if the patients sought medical attention.  The patients' outcomes are unknown.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  This is one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a physician concerning a patient currently diagnosed with infectious mononucleosis who on 26-JUN-2007 was vaccinated with the first dose of GARDASIL (lot number unspecified).  On 26-DEC-2007 the patient was vaccinated with the second dose of GARDASIL (lot number unspecified).  The patient called the physician's office to schedule the third dose but is now diagnosed with infectious mononucleosis.  No other symptoms reported.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood glucose, Blood thyroid stimulating hormone, Fatigue, Full blood count
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 29-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 658488/0930U) (site not reported).  The patient has experienced pain and irregular menstrual cycles since administration.  On 30-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 657006/0188U) (site not reported).  On 03-MAR-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 6659657/1487U) (site not reported).  On an unspecified date(s) the patient had a CBC, TSH and glucose test performed, no results reported.  On 29-APR-2008, the patient had an office visit where she informed the physician that she was still experiencing weakness, fatigue and menstrual problems.  The patient was treated with PONSTEL (not further specified).  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Menstruation irregular, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 29-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # 658488/0930U) (site not reported).  The patient has experienced pain and irregular menstrual cycles since administration.  On 30-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 657006/0188U) (site not reported).  On 03-MAR-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 6659657/1487U) (site not reported).  On an unspecified date(s) the patient had a CBC, TSH and glucose test performed, no results reported.  On 29-APR-2008, the patient had an office visit where she informed the physician that she was still experiencing weakness, fatigue and menstrual problems.  The patient was treated with PONSTEL (not further specified).  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Culture negative, Dysuria, Erythema, Pruritus, Urine analysis normal
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with anxiety disorder and reflux oesophagitis and no drug reactions/allergies who on 03-JAN-2007 was vaccinated with a first dose of GARDASIL 0.5 mL IM.  Concomitant therapy included LEXAPRO and PREVACID.  On 01-MAR-2007 the patient was vaccinated with a second dose of GARDASIL in her pediatrician's office.  The patient has not received a third dose.  On 15-MAR-2007 the patient developed persistent recurrent vaginitis, severe dysuria with itching and redness in the genital area.  Medical attention was sought.  On an unspecified date urinalysis and vaginal cultures were negative.  The patient was treated with multiple courses of oral DIFLUCAN, MYCOLOG cream, MONISTAT cream, an estrogen vaginal cream and one of course of VALTREX.  The symptoms recurred when treatment was discontinued.  At the time of reporting it was unknown if the patient had recovered.  No further information was provided.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with anxiety disorder and reflux oesophagitis and no drug reactions/allergies who on 03-JAN-2007 was vaccinated with a first dose of GARDASIL 0.5 mL IM.  Concomitant therapy included LEXAPRO and PREVACID.  On 01-MAR-2007 the patient was vaccinated with a second dose of GARDASIL in her pediatrician's office.  The patient has not received a third dose.  On 15-MAR-2007 the patient developed persistent recurrent vaginitis, severe dysuria with itching and redness in the genital area.  Medical attention was sought.  On an unspecified date urinalysis and vaginal cultures were negative.  The patient was treated with multiple courses of oral DIFLUCAN, MYCOLOG cream, MONISTAT cream, an estrogen vaginal cream and one of course of VALTREX.  The symptoms recurred when treatment was discontinued.  At the time of reporting it was unknown if the patient had recovered.  No further information was provided.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Laboratory test
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL from a medical assistant concerning a 26 year old female with erythromycin hypersensitivity who on 27-FEB-2007 was vaccinated with a dose of GARDASIL (Lot# 656372/0243U), 0.5 ml.  Concomitant therapy included NUVARING.  The patient received GARDASIL while being pregnant (LMP 05-FEB-2007).  Follow-up phone call information has been received from a nurse who reported that the patient delivered an 8 pound male, at 39 weeks EGA, with Apgars of 8 and 9.  Thick mecomium was noted after artificial rupture of membranes during labor.  The baby was healthy, normal and there were no complications.  No additional information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gestational diabetes, Glucose tolerance impaired, Live birth, Postpartum haemorrhage
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 26 year old female with a history of 2 pregnancies, 2 elective terminations and 0 live births and a history of scoliosis who on 02-FEB-2007 was vaccinated with GARDASIL (Lot number 653776/0014U). Subsequently, the patient discovered she was pregnant. On 06-MAR-2007, the patient underwent an ultrasound because she was unsure of her last menstrual period which revealed an intrauterine pregnancy, 9 weeks, 2 days. Her last menstrual period was determined to be 28-DEC-2006, with an expected delivery date of 07-OCT-2007. On 20-MAR-2007 the patient developed a urinary tract infection and was treated with KEFLEX qid x 7 days. On an unspecified date it was reported that the patient had a 3 hour glucose tolerance test performed, which showed elevated value. The patient's gestational diabetes mellitus did not require insulin therapy. On 02-OCT-2007 the patient delivered a normal, healthy baby girl with no congenital anomalies weighing 6 lbs 4 oz (length not reported). Apgar scores were 7 and 9. The patient experienced a post partum hemorrhage (not further specified). Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test, Ultrasound uterus, Urinary tract infection
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 26 year old female with a history of 2 pregnancies, 2 elective terminations and 0 live births and a history of scoliosis who on 02-FEB-2007 was vaccinated with GARDASIL (Lot number 653776/0014U). Subsequently, the patient discovered she was pregnant. On 06-MAR-2007, the patient underwent an ultrasound because she was unsure of her last menstrual period which revealed an intrauterine pregnancy, 9 weeks, 2 days. Her last menstrual period was determined to be 28-DEC-2006, with an expected delivery date of 07-OCT-2007. On 20-MAR-2007 the patient developed a urinary tract infection and was treated with KEFLEX qid x 7 days. On an unspecified date it was reported that the patient had a 3 hour glucose tolerance test performed, which showed elevated value. The patient's gestational diabetes mellitus did not require insulin therapy. On 02-OCT-2007 the patient delivered a normal, healthy baby girl with no congenital anomalies weighing 6 lbs 4 oz (length not reported). Apgar scores were 7 and 9. The patient experienced a post partum hemorrhage (not further specified). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Live birth, Pregnancy induced hypertension, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via physician concerning a 26 year old female with a history of Epstein-Barr virus infection, who on 09-MAR-2007 was vaccinated with a first dose of GARDASIL. On 10-MAY-2007 the patient was vaccinated with the second dose of GARDASIL. Subsequently the patient became pregnant. The patient's last menstrual period was on 22-JUN-2007. The estimated date of delivery is on 28-MAR-2008. Unspecified medical attention was sought. Ultrasounds were performed on 14-AUG-2007, 17-SEP-2007, and 13-NOV-2007 and were all within normal limits. At the time of the report patient's outcome was unknown. Follow-up information indicated that 37 1/7 weeks from her last menstrual period on 09-MAR-2008 the patient gave birth to a female infant. The infant weighed 7 pounds 3 ounces, and her apgar score was 9/9. The infant was normal with no congenital anomalies. The patient had no previous pregnancies and one full term delivery. Complications were possible mild pre-eclampsia and mild shoulder dystocia during labor and delivery. During pregnancy the patient experienced pregnancy induced hypertension (PIH). Diagnostic tests performed during pregnancy were a 24 hour urine every 6 weeks and NST's every week at starting at 32 weeks. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Live birth, Placenta praevia, Small for dates baby, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 22 year old female who had one previous pregnancy and one full term delivery, who on 31-JAN-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 654540/0800F).  On 29-MAR-2008 the patient was vaccinated with a second dose of GARDASIL (Lot# 654885/1424F).  In July 2007 the patient was determined to be pregnant.  Her third dose of GARDASIL will be delayed until after completion of the pregnancy.  No problems were reported.  The patient sought unspecified medical attention.  On 28-AUG-2007 an ultrasound was performed for dating and the results were placenta previa.  On 28-NOV-2007 a repeat ultrasound revealed small gestational age and on 24-JAN-2008 an ultrasound revealed placenta previa resolved.  At the time of the report, the patient's outcome was unknown. No product quality complaint was involved.  Follow-up information indicated that 40.5 weeks from her last menstrual period on 13-MAR-2008 the patient gave birth to a male infant.  The infant weighed 7 pounds and had an Apgar score of 9/9.  The infant was normal with no congenital anomalies and no abnormalities.  The complication of marginal placenta previa took place during the pregnancy.  Other medication taken during the pregnancy starting on 23-JUL-2007 included prenatal vitamins once daily.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Live birth, Pregnancy test positive
Clinical narrative: Information has been received from the Pregnancy Registry for GARDASIL from a 23 year old female with a latex allergy and no pertinent medical history who on 22-FEB-2007 was vaccinated with a dose of GARDASIL (lot # unknown) injection. Concomitant therapy included "CHANPIX" [therapy unspecified]. On 22-FEB-2007 the patient received GARDASIL when she was 5 weeks pregnant. The date of the last menstrual period was approximately 01-JAN-2007. Medical attention was sought. On an unspecified date a pregnancy test was performed to confirm the results. The patient is currently 6 months pregnant. The estimated date of delivery is 08-OCT-2007. No further information is provided. Follow-up information was received from the patient. The patient called and advised that she will be in 90-95% range to have a high birth weight baby. (9lbs +). Patient advised that she may require a c-section. Follow-up information was received from the LPN and reported that the baby had a full-term live birth (female) weighing 7 pounds 3 ounces. The LPN had no further information. Follow-up was also received from the patient who reported her baby is now 7 months old and has a right hip "click". The baby was evaluated by a specialist (not specified) who told her the baby was normal. No further information was provided about the baby. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amniotic fluid volume decreased, Drug exposure during pregnancy, Laboratory test, Ultrasound scan normal
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow-up information has been received from a certified nurse midwife through the Merck pregnancy registry concerning a 16 year old white female that was positive for papilloma viral infection and a low grade squamous intraepithelial lesion in August 2007, with acne, and no drug allergies, who on 08-AUG-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 658488/0930U).  Concomitant therapy included prenatal vitamins (unspecified), 1 tablet once daily.  Subsequently, the patient was pregnant.  The patient's last menstrual period was 06-JUN-2007 and her estimated date of delivery was 15-MAR-2007.  The patient was reported to be 15 weeks pregnant.  The patient had an office visit.  Prenatal labs were performed and the results were unknown.  On 18-OCT-2007 an ultrasound was performed for anatomy and the results were within normal limits "primary change discrepancy dates."  The patient had no previous pregnancies.  There was no adverse experience related to this event.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Follow-up indicated that 40 weeks from her last menstrual period on 02-APR-2008 the patient gave birth to a normal baby with no congenital anomalies via vaginal delivery on 02-APR-2008.  The infant weighed 8 pounds 11 ounces, was 21 inches long, had a head circumference of 14.0, and had an apgar score of 8/9. It was noted that the patient experienced oligohydramnios and had to be induced due to low amniotic fluid.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Rhesus antibodies negative
Clinical narrative: Information has been received for the Pregnancy Registry for GARDASIL from a physician concerning a 16 year old female patient who on 04-SEP-2007 was vaccinated with a first dose of GARDASIL (lot # unknown) injection.  The physician was reported by the patient's mother and it was reported that the patient found out that she was pregnant on 06-SEP-2007.  Medical attention was sought.  No other information provided.   In follow up information it was reported that patient had prenatal vitamins (unspecified) therapy.  She was Rhesus (Rh) antibody negative and globulin, immune (RHOGHAM) was given to her at 30 weeks of her pregnancy.  On 07-MAY-2008 she delivered a normal male baby 39-40 weeks from her last menstrual period.  The baby was 21 inch in length and weighed 7lb 13.4 oz.  Her Apgar score was 9/10.  There was no congenital anomalies with the baby.  In follow up telephone call the medical assistant reported that patient had a vaccum assisted vaginal delivery of a healthy and normal, full term female baby. No complication for mother or baby.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test, Pregnancy induced hypertension, Premature baby, Premature labour
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry through a health care professional concerning a 21 year old female with nausea and pain, with a history of 1 pregnancy and 0 live births and a history of alcohol abuse, Papanicolaou smear abnormal, who had a colposcopy and a loop electrosurgical excision procedure performed in April 2007.  On 13-Mar-2007 the patient was vaccinated with her first dose of GARDASIL (lot number 655617/1447F) and on 14-May-2007 the patient received the second dose of GARDASIL (lot number 653736/0014U).  Concomitant therapy included NUVARING until May 2007, VITRUM PRENATAL, PHENERGAN and ADVIL.  the patient had on OB panel on 13-Sep-2007 and a Pap on 09-Oct-2007, results reported as "abnormal".  Patient is now pregnant (LMP=20-Jul-2007) estimated delivery date of 26-April-2007.  As of 10-Sep-2007 the patient is taking prenatal vitamins and PHENERGAN.  The patient's obstetric history included 1 previous pregnancy which ended in an elective termination at an unknown number of weeks from LMP.  A prenatal ultrasound was done on 04-DEC-2007 which showed to be normal.  The estimated delivery date was mentioned as 25-APR-2008 (previously reported as 26-APR-2007).  The patient sought medical attention with an office visit.  No adverse experience related to this event.  In follow up information from the doctor's office it was reported that mother had pregnancy induced hypertension and preterm labor (no onset dates reported).  It was also reported that she was positive for group B streptococcus agalactiae (+GBs) (date of onset not reported).  On 25-MAR-2008 she delivered a normal male baby 35 weeks 3 days from her LMP.  The baby weighed 7 lb 1 oz and his length was 19.5".  His Apgar score was 7/8 and head circumference was 12.6".  No complication or abnormalities were reported.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Streptococcal identification test positive, Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry through a health care professional concerning a 21 year old female with nausea and pain, with a history of 1 pregnancy and 0 live births and a history of alcohol abuse, Papanicolaou smear abnormal, who had a colposcopy and a loop electrosurgical excision procedure performed in April 2007.  On 13-Mar-2007 the patient was vaccinated with her first dose of GARDASIL (lot number 655617/1447F) and on 14-May-2007 the patient received the second dose of GARDASIL (lot number 653736/0014U).  Concomitant therapy included NUVARING until May 2007, VITRUM PRENATAL, PHENERGAN and ADVIL.  the patient had on OB panel on 13-Sep-2007 and a Pap on 09-Oct-2007, results reported as "abnormal".  Patient is now pregnant (LMP=20-Jul-2007) estimated delivery date of 26-April-2007.  As of 10-Sep-2007 the patient is taking prenatal vitamins and PHENERGAN.  The patient's obstetric history included 1 previous pregnancy which ended in an elective termination at an unknown number of weeks from LMP.  A prenatal ultrasound was done on 04-DEC-2007 which showed to be normal.  The estimated delivery date was mentioned as 25-APR-2008 (previously reported as 26-APR-2007).  The patient sought medical attention with an office visit.  No adverse experience related to this event.  In follow up information from the doctor's office it was reported that mother had pregnancy induced hypertension and preterm labor (no onset dates reported).  It was also reported that she was positive for group B streptococcus agalactiae (+GBs) (date of onset not reported).  On 25-MAR-2008 she delivered a normal male baby 35 weeks 3 days from her LMP.  The baby weighed 7 lb 1 oz and his length was 19.5".  His Apgar score was 7/8 and head circumference was 12.6".  No complication or abnormalities were reported.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pre-eclampsia, Prolonged labour, Ultrasound scan, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a licensed practical nurse for the Merck pregnancy registry for GARDASIL concerning an 18 year old female who on 08-JUN-2007 was vaccinated intramuscularly with the third dose of GARDASIL (lot# not reported).  Per the nurse, the patient received the third dose of GARDASIL while pregnant (LMP=17-Apr-2007).  The pregnancy was confirmed by a urine pregnancy test.  The reporter did not know when the patient received the first or second dose of GARDASIL.  The patient sought unspecified medical attention in the physician's office.  The reporter requested that all correspondence take place via mail as opposed to fax and that the mailing envelope be marked "CONFIDENTIAL".  Additional information received from pregnancy questionnaire and telephone memo (27-MAY-2008): On 15-FEB-2008 the patient gave birth to a normal, female baby (7.5 pounds, 20 inches long).  The patient developed pre-eclampsia at full-term and had a long "30-hour" labor.  Both the mother and baby are doing well.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cerebral ventricle dilatation, Delivery, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Information and follow up has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 14 year old Caucasian female who on approximately 04-OCT-2007 was vaccinated with her first dose of GARDASIL (lot# not reported).  Subsequently the patient was about 16 weeks pregnant (estimated LMP was 05-JUN-2007) with a due date of 13-MAR-2008.  On 07-DEC-2007 the patient had a level 2 ultrasound for mild cerebral dilated ventricles in the fetus.  The patient is taking prenatal vitamins (unspecified) daily.  The patient was seen in the office and her outcome was not reported.  Additional information has been requested.  The patient delivered a healthy female baby on 10-MAR-2008 by vaginal delivery.  There were no complications during the delivery and no known abnormalities in the baby.  The nurse practitioner indicated that the lateral ventricle dilation found on ultrasound had gotten smaller prior to delivery.  The babies birth weight was 7lbs. 5oz.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Infectious mononucleosis
Clinical narrative: Information and follow-up information has been received from a physician's office worker and a nurse practitioner for the Pregnancy Registry for GARDASIL, concerning an 18 year old female who on 29-MAY-2007, 30-Jul-2007 and 02-Jan-2008 was vaccinated with her 0.5 ml first (lot# 657622/0388U), second (lot# 657622/0388U) and third (lot#659055/1522U) doses, respectively, of GARDASIL. Nurse reported that it was the patient's daughter or her friend, who told her about patient's pregnancy. Nurse noted that the patient was approximately 7 months pregnant (LMP approximately 15-Aug-2007). Unspecified medical attention was sought by contacting nurse. In September 2007, it was reported that the patient had mononucleosis, and was treated with AMOXIL, 500 mg BID. It was reported that on 30-Apr-2008 (40 weeks from LMP), the patient delivered a normal male baby. The baby weighed 7 lbs 6 oz and was 20.5 inches long. The patient had no complications during pregnancy and labor. No additional information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ear pain, Impetigo, Inappropriate schedule of drug administration, Pain in jaw
Clinical narrative: Information has been received through the Merck pregnancy registry concerning a 16 year old female, with no medical history or allergies reported, who on 30-JUL-2007 and 30-NOV-2007 was vaccinated with the first and second doses of GARDASIL, respectively (Lot # first dose 655617/1447F; second dose 657617/0384U).  Concomitant medication included BACTRIM DS and ibuprofen.  It was reported that the patient is now pregnant.  On 22-AUG-2007 the patient complained of jaw pain.  On 16-JAN-2008 the patient complained of ear pain.  On 25-JAN-2008 to 4-FEB-2008 the patient had impetigo.  On 01-APR-2008 an ultrasound was performed in the third trimester due to no prior obstetrical care.  Results were not reported.  No problems were reported.  On 01-MAY-2008 the patient delivered a 7 pound 6 ounce male infant, length 21 inches, a head circumference of 38 centimeters and Apgar scores 9/9.  There were no congenital anomalies or other complications or abnormalities noted.  There were no complications reported during the pregnancy or during labor/delivery.  No product quality complaint was involved.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received through the Merck pregnancy registry concerning a 16 year old female, with no medical history or allergies reported, who on 30-JUL-2007 and 30-NOV-2007 was vaccinated with the first and second doses of GARDASIL, respectively (Lot # first dose 655617/1447F; second dose 657617/0384U).  Concomitant medication included BACTRIM DS and ibuprofen.  It was reported that the patient is now pregnant.  On 22-AUG-2007 the patient complained of jaw pain.  On 16-JAN-2008 the patient complained of ear pain.  On 25-JAN-2008 to 4-FEB-2008 the patient had impetigo.  On 01-APR-2008 an ultrasound was performed in the third trimester due to no prior obstetrical care.  Results were not reported.  No problems were reported.  On 01-MAY-2008 the patient delivered a 7 pound 6 ounce male infant, length 21 inches, a head circumference of 38 centimeters and Apgar scores 9/9.  There were no congenital anomalies or other complications or abnormalities noted.  There were no complications reported during the pregnancy or during labor/delivery.  No product quality complaint was involved.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning approximately eleven college-aged females who on unspecified dates, were vaccinated with the first, second and third doses of GARDASIL. Subsequently the patient's were experiencing abnormal pap smears since receiving GARDASIL. Prior to receiving the GARDASIL, the patient's had normal pap smears. The patient's sought unspecified medical attention. Follow up information from the registered nurse indicated that she has no medical records for these patients and that the girls live in three separate states. At the time of the report, the patient's outcomes were unknown. No product quality complaint was involved. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood thyroid stimulating hormone normal, Inappropriate schedule of drug administration, Thyroid disorder, Thyroxine decreased
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female who on 20-AUG-2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot# not reported).  On 17-DEC-2007, the patient was vaccinated intramuscularly with a second dose of GARDASIL (Lot# not reported).  On 25-FEB-2008, the patient was vaccinated intramuscularly with a third dose of GARDASIL (Lot# not reported).  Concomitant therapy included multivitamins (unspecified).  The patient is now experiencing thyroid problems and on 25-APR-2008 was started on Synthroid 25 mcg po once daily.  It was reported that the patient had no thyroid problems in the past.  The patient reported that her hair was falling out. Many factors considered such as chemical coloring, stress, now BCP initiation. Patient's mother was convinced it was due to GARDASIL. Physician's records show hari loss back to March 2007. Thyroid tests were ordered. The patient's status was reported as not recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroxine free decreased
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 year old female who on 20-AUG-2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot# not reported).  On 17-DEC-2007, the patient was vaccinated intramuscularly with a second dose of GARDASIL (Lot# not reported).  On 25-FEB-2008, the patient was vaccinated intramuscularly with a third dose of GARDASIL (Lot# not reported).  Concomitant therapy included multivitamins (unspecified).  The patient is now experiencing thyroid problems and on 25-APR-2008 was started on Synthroid 25 mcg po once daily.  It was reported that the patient had no thyroid problems in the past.  The patient reported that her hair was falling out. Many factors considered such as chemical coloring, stress, now BCP initiation. Patient's mother was convinced it was due to GARDASIL. Physician's records show hari loss back to March 2007. Thyroid tests were ordered. The patient's status was reported as not recovered.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Body temperature, Cold sweat, Dizziness, Panic attack
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with a history of a panic attack not related to GARDASIL who on 11-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot # not reported). On 07-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# reported as 657706/1439U). Following the vaccination on 07-MAY-2008, the patient experienced a panic attack, tingling in fingers, dizziness, felt faint and clammy. The patient's blood pressure prior to injection was 100/80 and her temperature was 98.8F. The patient was assisted to supine position and rested in office. The patient felt better after resting and was instructed to see her primary care physician. On 08-MAY-2008 the patient recovered from the panic attack, tingling in fingers, dizziness, feeling faint and clammy. Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 6/13/2008. Initial information and follow up has been received from a nurse concerning an 18 year old female with an allergy to picolamine salicylate and omeprazole and a history of panic attacks not related to GARDASIL who on 11-FEB-2008 was vaccinated intramuscularly with her second dose of GARDASIL (lot# "reported as 657706/1493U"). On 30-APR-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported). Following the vaccination on 30-APR-2008, the patient experienced a panic attack, tingling in fingers, dizziness, felt faint and clammy. The patient's blood pressure prior to injection was 100/80 and her temperature was 98.8F. The patient was assisted to supine position and rested in office. The patient felt better after resting and was instructed to see her primary care physician. On an unspecified date the patient recovered from the panic attack, tingling in fingers, dizziness, feeling faint and clammy.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with a history of a panic attack not related to GARDASIL who on 11-FEB-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot # not reported). On 07-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# reported as 657706/1439U). Following the vaccination on 07-MAY-2008, the patient experienced a panic attack, tingling in fingers, dizziness, felt faint and clammy. The patient's blood pressure prior to injection was 100/80 and her temperature was 98.8F. The patient was assisted to supine position and rested in office. The patient felt better after resting and was instructed to see her primary care physician. On 08-MAY-2008 the patient recovered from the panic attack, tingling in fingers, dizziness, feeling faint and clammy. Additional information has been requested.  07/08/2008 This is in follow-up to report(s) previously submitted on 6/13/2008. Initial information and follow up has been received from a nurse concerning an 18 year old female with an allergy to picolamine salicylate and omeprazole and a history of panic attacks not related to GARDASIL who on 11-FEB-2008 was vaccinated intramuscularly with her second dose of GARDASIL (lot# "reported as 657706/1493U"). On 30-APR-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported). Following the vaccination on 30-APR-2008, the patient experienced a panic attack, tingling in fingers, dizziness, felt faint and clammy. The patient's blood pressure prior to injection was 100/80 and her temperature was 98.8F. The patient was assisted to supine position and rested in office. The patient felt better after resting and was instructed to see her primary care physician. On an unspecified date the patient recovered from the panic attack, tingling in fingers, dizziness, feeling faint and clammy.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated on unspecified dates with the first and second dose of GARDASIL (lot#'s not reported). Subsequently the patient fainted after her first dose of the vaccine. She did not faint after the second dose was given. Subsequently, the patient recovered from fainting  and sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Headache, Pregnancy test positive
Clinical narrative: Information has been received from a nurse, for the Merck pregnancy registry, concerning a 15 year old female with no previous medical history or no known drug allergies who on 21-MAY-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 ml first dose of GARDASIL (Lot # 654535/0960F).  On 21-MAY-2007, the patient developed a headache and took over the counter ibuprofen.  On 16-JAN-2008, the patient was vaccinated intramuscularly in the right deltoid with a 0.5 ml second dose of GARDASIL (Lot# 658558/1061U).  On 26-MAR-2008, the patient was vaccinated intramuscularly in the right deltoid with a 0.5 ml third dose of GARDASIL (Lot# 659657/1487U).  On 13-MAR-2008, the patient had a pre natal check up and lab work, blood test, and a pregnancy test.  It was reported that the patient is now pregnant with a LMP of 15-Dec-2007.  Unspecified medical attention was sought in the office.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Excoriation, Furuncle, Skin discolouration
Clinical narrative: Information has been received from a physician concerning 3 females who were vaccinated on unspecified dates with a dose of GARDASIL (lot#'s not reported). In approximately March-April 2008 the patient's experienced boils. Each patient had the boil in a different location. One patient's boil was under the arm: another patient's was in the groin area and the third patient's was on the outside of the calf. The one on the calf was reddish gray with an abrasion below it. One patient received the second dose of GARDASIL and has refused to get the 1st dose. A phone call was placed on 13-MAY-2008 to obtain more information, but the call has not been returned. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning an 11 year old female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not provided).  Subsequently a couple days after the vaccination, the patient experienced a rash all over her body.  The patient was not hospitalized and no medication.  The patient's outcome was not reported.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Scar
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL (lot# 656051/0244U). On 27-JUL-2007 the patient was vaccinated with the second dose of GARDASIL (lot# 658100/0525U). On 27-NOV-2007 the patient was vaccinated with the third dose of GARDASIL (lot# 655327/1287U). On 08-May-2008 the office manager reported that the patient experienced pain and decreased movement in the injection site arm on the same day of vaccination with the third dose of GARDASIL, 27-NOV-2007. The patient was seen in the office on 20-DEC-2007 and was referred to a neurologist (outcome unspecified). On 08-May-2008, the office manager reported that the patient was still having pain in the injection site arm, but it was improving. The arm had no redness, no numbness, no tingling or masses and the arm had normal capillary appearances. A scar was noted (not clear if the scar was related to vaccination). There was no other information to report. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis C antibody, Hepatitis C test negative, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female who on 06-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # reported as 0903U").  On 25-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 659435/1265U)  On 26-FEB-2008, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 660387/1967U).  There was no concomitant medication.  On an unspecified date, the patient had "blood work for hepatitis C".  The medical assistant reported that the patient has a "reported elevated Hepatitis C blood result" (not further specified).  Since 24-MAR-2008, the patient has had elevated fevers (not further specified).  The patient denied recreational drug use or sexual activity.  The patient was reporting to be recovering.  The patient sought unspecified medical attention with a phone call to the office.  No additional information is available.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident, Cervical dysplasia, Colposcopy, Double heterozygous sickling disorders, Human papilloma virus test positive
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/13/2008. Information has been received from a nurse practitioner concerning a 25 year old female, with a family history of sickle cell anemia (Father), lupus (mother) and stroke due to lupus (mother), who on 02-APR-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot # not reported). On 12-JUN-2007, the patient was vaccinated intramuscularly in the right deltoid with her second dose of GARDASIL (Lot # reported as "0089O"). On 14-DEC-2007, the patient was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (Lot # 655324/0089U). The nurse practitioner reported that the three GARDASIL doses were given at another office. Concomitant therapy included hormonal contraceptives (unspecified). The reporter stated "birth control started on 26-MAR-2007 (Patient was on birth control prior to this date but stopped at an unspecified time due to family reasons)". On 23-APR-2008 the patient had a thin prep PAP smear "(a high risk HPV test gets done goes along with thin prep PAP)." On 01-MAY-2008, the results of the PAP smear and HPV test were reported and the HPV test plus low grade squamous intraepithelial lesion (LGSIL) and cervical intraepithelial neoplasia I (CIN1) were positive. The patient was referred to gynaecologist for coloscopy and treatment. Previous pap smears performed on 09-JUN-2006 and 26-MAR-2007 were negative for lesions and malignancy. On an unspecified date, the patient was found to be positive for sickle cell anemia and will be going to a specialist. The patient will be going for a colposcopy for the abnormal PAP results. No further information was provided. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Sickle cell anaemia, Smear cervix, Smear cervix abnormal, Systemic lupus erythematosus
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/13/2008. Information has been received from a nurse practitioner concerning a 25 year old female, with a family history of sickle cell anemia (Father), lupus (mother) and stroke due to lupus (mother), who on 02-APR-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot # not reported). On 12-JUN-2007, the patient was vaccinated intramuscularly in the right deltoid with her second dose of GARDASIL (Lot # reported as "0089O"). On 14-DEC-2007, the patient was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (Lot # 655324/0089U). The nurse practitioner reported that the three GARDASIL doses were given at another office. Concomitant therapy included hormonal contraceptives (unspecified). The reporter stated "birth control started on 26-MAR-2007 (Patient was on birth control prior to this date but stopped at an unspecified time due to family reasons)". On 23-APR-2008 the patient had a thin prep PAP smear "(a high risk HPV test gets done goes along with thin prep PAP)." On 01-MAY-2008, the results of the PAP smear and HPV test were reported and the HPV test plus low grade squamous intraepithelial lesion (LGSIL) and cervical intraepithelial neoplasia I (CIN1) were positive. The patient was referred to gynaecologist for coloscopy and treatment. Previous pap smears performed on 09-JUN-2006 and 26-MAR-2007 were negative for lesions and malignancy. On an unspecified date, the patient was found to be positive for sickle cell anemia and will be going to a specialist. The patient will be going for a colposcopy for the abnormal PAP results. No further information was provided. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age unknown), who on 23-APR-2008 was vaccinated IM with a 0.5mL first dose of GARDASIL (Lot# 0152X).  Concomitant therapy included ORTHO TRI-CYCLEN LO.  On 23-APR-2008 several hours post vaccination the patient developed an outbreak of shingles on her chest.  The patient was seen at the office and was treated with acyclovir.  No laboratory diagnostics were performed.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: Information has been received from a 25 year old female consumer who on 29-MAR-2008 was vaccinated with her first dose of GARDASIL (Lot #, site and route not reported). There was no concomitant medication. In "early April 2008", the patient experienced a severe acne breakout on her cheeks and forehead. The patient sought medical treatment in the office. She was initially treated with one month supply of doxycycline (unspecified), but the acne did not improve. On 09-MAY-2008, the patient was switched to prednisone (not further specified). At the time of this reporting the severe acne breakout has persisted. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a consumer concerning a 13 year old granddaughter who, on an unspecified date was vaccinated with her second dose of GARDASIL (Lot #, site and route were not reported). Concomitant therapy included antibiotics (unspecified) for a cold and nasal spray (unspecified) for allergies. "Soon after receiving the shot", the patient experienced redness and soreness at the injection site. "This effect disappeared, but soon afterward a brown spot appeared at the injection site (like a birthmark), and is still present". The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypokinesia, Injected limb mobility decreased, Pain in extremity, Presyncope, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 07-MAR-2008 was vaccinated IM with the first dose of GARDASIL (659964/1978U). Per the reporter, the patient experienced extreme pain in her arm after receiving the first dose of GARDASIL. The pain was experienced in the same arm that the vaccine was administered and the patient noted that the pain made it difficult for her to move her arm. It was also noted that the patient nearly fainted at the office on the day of administration and that the patient had experienced vomiting in the evening of the date of administration. The patient sought unspecified medical attention in the physician's office. Subsequently, the patient recovered from her extreme pain, decreased mobility, near fainting and vomiting. No further information was provided. Additional information has been requested. Additional information received from B-form (03-JUN-2008). The nurse practitioner reports that the patient received the second dose of GARDASIL vaccine (lot # not reported) on 09-MAY-2008. No further information on patient's present status was provided. Additional information is not expected.